[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Rules and Regulations]
[Pages 58432-59107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19637]
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Vol. 85
Friday,
No. 182
September 18, 2020
Part II
Book 2 of 2 Books
Pages 58431-59172
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 412, 413, et al.
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long Term Care Hospital Prospective
Payment System and Final Policy Changes and Fiscal Year 2021 Rates;
Quality Reporting and Medicare and Medicaid Promoting Interoperability
Programs Requirements for Eligible Hospitals and Critical Access
Hospitals; Final Rule
Federal Register / Vol. 85 , No. 182 / Friday, September 18, 2020 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 412, 413, 417, 476, 480, 484, and 495
[CMS-1735-F]
RIN 0938-AU11
Medicare Program; Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Final Policy Changes and Fiscal Year 2021 Rates;
Quality Reporting and Medicare and Medicaid Promoting Interoperability
Programs Requirements for Eligible Hospitals and Critical Access
Hospitals
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 2021 and to implement certain
recent legislation. We are also making changes relating to Medicare
graduate medical education (GME) for 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
2021. 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
2021. In this FY 2021 IPPS/LTCH PPS final rule, we are finalizing
changes to the new technology add-on payment pathway for certain
antimicrobial products and other changes to new technology add-on
payment policies, and the collection of market-based rate information
on the Medicare cost report for cost reporting periods ending on or
after January 1, 2021 and finalizing the adoption of a market-based MS-
DRG relative weight methodology beginning in FY 2024. We are
establishing new requirements or revising existing requirements for
quality reporting by acute care hospitals and PPS-exempt cancer
hospitals. We also established new requirements and revised existing
requirements for eligible hospitals and critical access hospitals
(CAHs) participating in the Medicare and Medicaid Promoting
Interoperability Programs. We are also establishing performance
standards for the Hospital Value-Based Purchasing (VBP) Program, and
updating policies for the Hospital Readmissions Reduction Program and
the Hospital-Acquired Condition (HAC) Reduction Program.
DATES:
Effective date: This final rule is effective October 1, 2020.
Applicability dates: The amendments at Sec. 413.89(b)(1)(i),
(c)(1), (e)(2)(i)(A)(2) are applicable to cost reporting periods before
October 1, 2020. The amendments at Sec. 413.89(e)(2)(i)(A)(1), (4)
through (6), (i)(B), (iii), and (f) are applicable to cost reporting
periods before, on, and after October 1, 2020. The amendments at Sec.
413.89(b)(1)(ii), (c)(2), (e)(2)(i)(A)(3) and (e)(2)(ii) are applicable
to cost reporting periods beginning on or after October 1, 2020.
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, Medicare
Disproportionate Share Hospital (DSH) Payment Adjustment, Medicare-
Dependent Small Rural Hospital (MDH) Program, Low-Volume Hospital
Payment Adjustment, and Critical Access Hospital (CAH) Issues. Michele
Hudson, (410) 786-4487 and Emily Lipkin, (410) 786-3633, Long-Term Care
Hospital Prospective Payment System and MS-LTC-DRG Relative Weights
Issues. Emily Forrest, (202) 205-1922, Market-Based Data Collection and
Market-Based MS-DRG Relative Weight Methodology Issues.
Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital
Demonstration Program Issues.
Jeris Smith, (410) 786-0110, Frontier Community Health Integration
Project Demonstration Issues.
Erin Patton, (410) 786-2437, Hospital Readmissions Reduction
Program--Administration Issues.
Vinitha Meyyur, (410) 786-8819, Hospital Readmissions Reduction
Program--Readmissions--Measures Issues.
Lang Le, (410) 786-5693, Hospital-Acquired Condition Reduction
Program--Administration Issues.
Annese Abdullah-Mclaughlin, (410) 786-2995, Hospital-Acquired
Condition Reduction Program--Measures Issues.
Julia Venanzi, (410) 786-1471, Hospital Inpatient Quality Reporting
Program--Administration Issues Mihir Patel, (410) 786-2815 and Grace
Snyder, (410) 786-0700, Hospital Quality Reporting Program Validation
and Reconsideration Issues.
Julia Venanzi, (410) 786-1471and Pamela Brown (410) 786-3940,
Hospital Value-Based Purchasing Program--Administration Issues
Katrina Hoadley, (410) 786-8490, Hospital Inpatient Quality
Reporting and Hospital Value-Based Purchasing--Measures Issues Except
Hospital Consumer Assessment of Healthcare Providers and Systems
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.
Erin Patton, (410) 786-2437 and Katrina Hoadley, (410) 786-8490,
PPS-Exempt Cancer Hospital Quality Reporting Issues.
Mary Pratt, (410) 786-6867, Long-Term Care Hospital Quality Data
Reporting Issues.
Dylan Podson (410) 786-5031, Jessica Warren (410) 786-7519, and
Elizabeth Holland, (410) 786-1309, Promoting Interoperability Programs.
Steve Rubio, (410) 786-1782, Reimbursement for Submission of
Patient Records to Beneficiary and Family Centered Care Quality
Improvement Organizations (BFCC-QIOs) in Electronic Format.
Maude Shepard, (410) 786-5598, Provider Reimbursement Review Board
Electronic Filing.
Kellie Shannon, (410) 786-0416 and Bob Kuhl, (443) 896-8410,
Medicare Bad Debt.
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
The IPPS tables for this FY 2021 final rule are available through
the internet on the CMS website at: https://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 2021 IPPS Final
rule Home Page'' or ``Acute Inpatient--Files for Download.'' The LTCH
PPS tables for
[[Page 58433]]
this FY 2021 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-1735-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 FY 2021 IPPS/LTCH PPS final rule. Readers
who experience any problems accessing any of the tables that are posted
on the CMS websites, as previously identified, 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
E. Advancing Health Information Exchange
II. Changes to Medicare Severity Diagnosis-Related Group (MS-DRG)
Classifications and Relative Weights
A. Background
B. Adoption of the MS-DRGs and MS-DRG Reclassifications
C. FY 2021 MS-DRG Documentation and Coding Adjustment
D. Changes to Specific MS-DRG Classifications
E. Recalibration of the FY 2021 MS-DRG Relative Weights
F. Add-On Payments for New Services and Technologies for FY 2021
III. Changes to the Hospital Wage Index for Acute Care Hospitals
A. Background
B. Worksheet S-3 Wage Data for the FY 2021 Wage Index
C. Verification of Worksheet S-3 Wage Data
D. Method for Computing the FY 2021 Unadjusted Wage Index
E. Occupational Mix Adjustment to the FY 2021 Wage Index
F. Analysis and Implementation of the Occupational Mix
Adjustment and the FY 2021 Occupational Mix Adjusted Wage Index
G. Application of the Rural Floor, Application of the State
Frontier Floor, and Continuation of the Low Wage Index Hospital
Policy
H. FY 2021 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 2021 Wage Index
IV. Other Decisions and Changes to the IPPS for Operating System
A. Changes to MS-DRGs Subject to Postacute Care Transfer Policy
and MS-DRG Special Payments Policies (Sec. 412.4)
B. Changes in the Inpatient Hospital Updates for FY 2021 (Sec.
412.64(d))
C. Amendment To Address Short Cost Reporting Periods During
Applicable Timeframe for Establishment of Service Area for Sole
Community Hospitals Under Sec. 412.92(c)(3)
D. Rural Referral Centers (RRCs)--Annual Updates to Case-Mix
Index and Discharge Criteria (Sec. 412.96)
E. Payment Adjustment for Low-Volume Hospitals (Sec. 412.101)
F. Indirect Medical Education (IME) Payment Adjustment Factor
(Sec. 412.105)
G. Payment Adjustment for Medicare Disproportionate Share
Hospitals (DSHs) for FY 2021 (Sec. 412.106)
H. Payment for Allogeneic Hematopoietic Stem Cell Acquisition
Costs (Sec. 412.113)
I. Payment Adjustment for CAR T-cell Clinical Trial Cases
(Sec. Sec. 412.85 and 412.312)
J. Changes for Hospitals With High Percentage of End Stage Renal
Disease (ESRD) Discharges (Sec. 412.104)
K. Hospital Readmissions Reduction Program: Updates and Changes
(Sec. Sec. [thinsp]412.150 Through 412.154)
L. Hospital Value-Based Purchasing (VBP) Program: Updates
M. Hospital-Acquired Conditions (HAC) Reduction Program: Updates
and Changes (Sec. 412.170)
N. Payments for Indirect and Direct Graduate Medical Education
Costs (Sec. Sec. 412.105 and 413.75 Through 413.83)
O. Rural Commuity Hospital Demonstration Program
P. Market-Based MS-DRG Relative Weight Data Collection and
Potential Change in Methodology for Calculating MS-DRG Relative
Weights
V. Changes to the IPPS for Capital-Related Costs
A. Overview
B. Additional Provisions
C. Annual Update for FY 2021
VI. Changes for Hospitals Excluded From the IPPS
A. Rate-of-Increase in Payments to Excluded Hospitals for FY
2021
B. Report on Adjustment (Exception) Payment
C. Critical Access Hospitals (CAHs)
VII. Changes to the Long-Term Care Hospital Prospective Payment
System (LTCH PPS) for FY 2021
A. Background of the LTCH PPS
B. Medicare Severity Long-Term Care Diagnosis-Related Group (MS-
LTC-DRG) Classifications and Relative Weights for FY 2021
C. Changes to the LTCH PPS Payment Rates and Other Changes to
the LTCH PPS for FY 2021
D. Rebasing and Revising of the LTCH Market Basket
VIII. Quality Data Reporting Requirements for Specific Providers and
Suppliers
A. Hospital Inpatient Quality Reporting (IQR) Program
B. Changes to the 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 Promoting
Interoperability Programs
IX. Changes for Hospitals and Other Providers
A. Changes in the Submission of Electronic Patient Records to
Beneficiary and Family Centered Care Quality Improvement
Organizations (BFCC-QIOs)
B. Revised Regulations To Prepare for Implementation of
Mandatory PRRB Electronic Filing (42 CFR Part 405, Subpart R)
C. Revisions of Medicare Bad Debt Policy
X. MedPAC Recommendations
XI. Other Required Information
A. Publicly Available Data
B. Collection of Information Requirements
C. Waiver of the 60-day Delay in Effective Date for the Final
Rule
Regulation Text
Addendum--Schedule of Standardized Amounts, Update Factors, and Rate-
of-Increase Percentages Effective With Cost Reporting Periods Beginning
on or after October 1, 2020 and Payment Rates for LTCHs Effective for
Discharges Occurring on or after October 1, 2020
I. Summary and Background
II. Changes to Prospective Payment Rates for Hospital Inpatient
Operating Costs for Acute Care Hospitals for FY 2021
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 2021
A. Determination of the Federal Hospital Inpatient Capital-
Related Prospective Payment Rate Update for FY 2021
B. Calculation of the Inpatient Capital-Related Prospective
Payments for FY 2021
C. Capital Input Price Index
IV. Changes to Payment Rates for Excluded Hospitals: Rate-of-
Increase Percentages for FY 2021
V. Changes to the Payment Rates for the LTCH PPS for FY 2021
A. LTCH PPS Standard Federal Payment Rate for FY 2021
B. Adjustment for Area Wage Levels Under the LTCH PPS for FY
2021
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
F. Computing the Adjusted LTCH PPS Federal Prospective Payments
for FY 2021
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VI. Tables Referenced in This Final 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 Promoting
Interoperability Program
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 2021
A. FY 2021 Inpatient Hospital Update
B. Update for SCHs and MDHs for FY 2021
C. FY 2021 Puerto Rico Hospital Update
D. Update for Hospitals Excluded From the IPPS for FY 2021
E. Update for LTCHs for FY 2021
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 FY 2021 IPPS/LTCH PPS 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. In this FY 2021
final rule, we are continuing policies to address wage index
disparities impacting low wage index hospitals; and including policies
related to new technology add-on payments for certain antimicrobial
products, other policies related to new technology add-on payments,
collecting market-based rate information on the Medicare cost report
for cost reporting periods ending on or after January 1, 2021, and
finalizing the adoption of a market-based MS-DRG relative weight
methodology beginning in FY 2024.
We are establishing new requirements and revising existing
requirements for quality reporting by acute care hospitals and PPS-
exempt cancer hospitals that participate in Medicare. We are also
establishing new requirements and revising existing requirements for
eligible hospitals and CAHs participating in the Medicare and Medicaid
Promoting Interoperability Programs.
We are establishing performance standards for the Hospital Value-
Based Purchasing (VBP) Program and updating policies for the Hospital
Readmissions Reduction Program and the Hospital-Acquired Condition
(HAC) Reduction Program.
Under various statutory authorities, we either discuss continued
program implementation or are making changes to the Medicare IPPS, to
the LTCH PPS, and to other related payment methodologies and programs
for FY 2021 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 (Public Law (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, which provides for the
establishment of 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, 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.
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Section 1886(q) of the Act, as amended by section 15002 of
the 21st Century Cures Act, which establishes the Hospital Readmissions
Reduction Program. Under the program, payments for discharges from an
applicable hospital as defined under section 1886(d) of the Act will be
reduced to account for certain excess readmissions. Section 15002 of
the 21st Century Cures Act directs the Secretary to compare hospitals
with respect to the number of their Medicare-Medicaid dual-eligible
beneficiaries (dual-eligibles) 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; 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. 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 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. Waiver of the 60-day Delayed Effective Date for the Final Rule
The United States is responding to an outbreak of respiratory
disease caused by a novel (new) coronavirus that has now been detected
in more than 190 locations internationally, including in all 50 States
and the District of Columbia. The virus has been named ``SARS-CoV-2''
and the disease it causes has been named ``coronavirus disease 2019''
(abbreviated ``COVID-19'').
Due to the significant devotion of resources to the COVID-19
response, for the reasons discussed in the FY 2021 IPPS/LTCH PPS
proposed rule (85 FR 32889 through 32890) and as also discussed in
section XI.D. of the preamble of this final rule, we are hereby waiving
the 60-day delay in the effective date of the final rule.
3. Summary of the Major Provisions
The following is a summary of the major provisions in this final
rule. In general, these major provisions are 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 were included in the FY 2021 IPPS/LTCH PPS proposed 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 2021, we are making an adjustment of + 0.5
percent to the standardized amount.
b. Changes to the New Technology Add-On Payment Policy for Certain
Antimicrobial Products
In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42292 through
42297), we established an alternative inpatient new technology add-on
payment pathway for certain antimicrobial products in light of the
significant concerns related to the ongoing public health crisis
represented by antimicrobial resistance. Under this alternative
pathway, if a medical product receives the FDA's Qualified Infectious
Disease Product (QIDP) designation and received FDA marketing
authorization, such a product will be considered new and not
substantially similar to an existing technology for purposes of new
technology add-on payment under the IPPS and will not need to meet the
requirement that it represent an advance that substantially improves,
relative to technologies previously available, the diagnosis or
treatment of Medicare beneficiaries.
In the proposed rule, in light of recent information that continues
to highlight the significant concerns and impacts related to
antimicrobial resistance and emphasizes the continued importance of
this issue both with respect to Medicare beneficiaries and public
health overall, we proposed changes to the new technology add-on
payment policy for certain antimicrobials for FY 2021.
As discussed in section II.G.9.b. of the preamble of this final
rule, after consideration of public comments, we are finalizing our
proposal to expand our alternative new technology add-on payment
pathway for QIDPs to include products approved through FDA's Limited
Population Pathway for Antibacterial and Antifungal Drugs (LPAD
pathway). Under this policy, for applications received for new
technology add-on payments for FY 2022 and subsequent fiscal years, if
an antimicrobial product is approved through FDA's LPAD pathway, it
will be considered new and not substantially similar to an existing
technology for purposes of the new technology add-on payment under the
IPPS, and will not need to meet the requirement that it represent an
advance that substantially improves, relative to technologies
previously available, the diagnosis or treatment of Medicare
beneficiaries.
[[Page 58436]]
Under current policy, a new technology must receive FDA marketing
authorization (for example, approval or clearance) by July 1 to be
considered in the final rule in order to allow complete review and
consideration of all the information to determine if the technology
meets the new technology add-on payment criteria. For the reasons
discussed in section II.G.9.c. of the preamble of this final rule,
after consideration of public comments, we are finalizing our proposal
to provide for conditional new technology add-on payment approval for
products designated as QIDPs that do not receive FDA approval by July 1
and products that do not receive approval through FDA's LPAD pathway by
July 1 but otherwise meet the applicable add-on payment criteria. Under
this policy, cases involving eligible antimicrobial products would
begin receiving the new technology add-on payment sooner, effective for
discharges the quarter after the date of FDA marketing authorization
provided that the technology receives FDA marketing authorization by
July 1 of the particular fiscal year for which the applicant applied
for new technology add-on payments.
c. Continuation of the Low Wage Index Hospital Policy
To help mitigate wage index disparities between high wage and low
hospitals, in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42326 through
42332), we adopted a policy to provide an opportunity for certain low
wage index hospitals to increase employee compensation by increasing
the wage index values for certain hospitals with low wage index values
(the low wage index hospital policy). This policy was adopted in a
budget neutral manner through an adjustment applied to the standardized
amounts for all hospitals. We also indicated that this policy would be
effective for at least 4 years, beginning in FY 2020, in order to allow
employee compensation increases implemented by these hospitals
sufficient time to be reflected in the wage index calculation.
Therefore, for FY 2021, we are continuing the low wage index hospital
policy, and also applying this policy in a budget neutral manner by
applying an adjustment to the standardized amounts.
d. 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 final rule, we have updated our estimates of the three
factors used to determine uncompensated care payments for FY 2021. We
continue 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; however,
given the unprecedented effects on health insurance enrollment as a
result of the public health emergency for the COVID-19 pandemic, OACT
has updated the NHEA-based projection of the FY 2021 rate of
uninsurance using more recently available unemployment data. In
addition, we are using a single year of data on uncompensated care
costs from Worksheet S-10 of the FY 2017 cost reports to calculate
Factor 3 in the FY 2021 methodology for all eligible hospitals with the
exception of Indian Health Service (IHS) and Tribal hospitals and
Puerto Rico hospitals. For IHS and Tribal hospitals and Puerto Rico
hospitals we are continuing to use the low-income insured days proxy to
calculate Factor 3 for these hospitals. Furthermore, we are
establishing that to calculate Factor 3 for FY 2022 and all subsequent
fiscal years for all eligible hospitals, except IHS and Tribal
hospitals and Puerto Rico hospitals, we will use the most recent
available single year of audited Worksheet S-10 data. We are also
making other methodological changes for purposes of calculating Factor
3.
e. Reduction of Hospital Payments for Excess Readmissions
We are finalizing our proposal to make changes to policies for the
Hospital Readmissions Reduction Program, which was established under
section 1886(q) of the Act, as 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 2017 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), elective primary total hip arthroplasty/total knee
arthroplasty (THA/TKA), and coronary artery bypass graft (CABG)
surgery. In this FY 2021 IPPS/LTCH PPS final rule, we are finalizing
the following policies: (1) To automatically adopt applicable periods
beginning with the FY 2023 program year and all subsequent program
years, unless otherwise specified by the Secretary; and (2) to update
the definition of applicable period at 42 CFR 412.152 to align with
this policy.
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. In
this FY 2021 IPPS/LTCH PPS final rule, we are providing newly
established performance standards for certain measures for the FY 2023
program year, the FY 2024 program year, the FY 2025 program year, and
the FY 2026 program year.
h. Hospital-Acquired Condition (HAC) Reduction Program
Section 1886(p) of the 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 hospitals that rank 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. In this FY 2021 IPPS/LTCH PPS final rule, we are finalizing the
following policies: (1) To automatically adopt applicable periods
beginning with the FY 2023 program year and all subsequent program
years, unless otherwise specified by the secretary, (2) to make
refinements to the process for validation of HAC Reduction Program
measure data in alignment with the Hospital IQR Program measure
validation policies finalized in this rule; and (3) to update the
definition of applicable period at 42 CFR 412.170 to
[[Page 58437]]
align with the policy to automatically adopt applicable periods.
g. 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 FY 2021 IPPS/LTCH PPS final rule, we are finalizing
proposals related to the reporting, submission, and public display
requirements for eCQMs. These policies are: (1) Progressively
increasing the numbers of quarters of eCQM data reported, from one
self-selected quarter of data to four quarters of data over a three-
year period, by requiring hospitals to report: (a) Two quarters of data
for the CY 2021 reporting period/FY 2023 payment determination; (b)
three quarters of data for the CY 2022 reporting period/FY 2024 payment
determination; and (c) four quarters of data beginning with the CY 2023
reporting period/FY 2025 payment determination and for subsequent
years, while continuing to allow hospitals to report: (i) Three self-
selected eCQMs, and (ii) the Safe Use of Opioids eCQM; and (2)
beginning public display of eCQM data starting with data reported by
hospitals for the CY 2021 reporting period/FY 2023 payment
determination and for subsequent years. The eCQM-related policies are
in alignment with proposals under the Promoting Interoperability
Program. We also are finalizing our proposal to expand the requirement
to use EHR technology certified to the 2015 Edition for submitting data
on not only the previously finalized Hybrid Hospital-Wide Readmission
measure, but all hybrid measures in the Hospital IQR Program.
We also are finalizing proposals to streamline the validation
processes under the Hospital IQR Program. We are finalizing proposals
to: (1) Update the quarters of data required for validation for both
chart-abstracted measures and eCQMs; (2) expand targeting criteria to
include hospital selection for eCQMs; (3) change the validation pool
from 800 hospitals to 400 hospitals; (4) remove the current exclusions
for eCQM validation selection, (5) require electronic file submissions
for chart-abstracted measure data; (6) align the eCQM and chart-
abstracted measure scoring processes; and (7) update the educational
review process to address eCQM validation results.
h. PPS-Exempt Cancer Hospital Quality Reporting Program
Section 1866(k)(1) of the Act requires, for purposes of FY 2014 and
each subsequent fiscal year, that a hospital described in section
1886(d)(1)(B)(v) of the Act (a PPS-exempt cancer hospital, or a PCH)
submit data in accordance with section 1866(k)(2) of the Act with
respect to such fiscal year. There is no financial impact to PCH
Medicare payment if a PCH does not participate.
In this FY 2021 IPPS/LTCH PPS final rule, we are finalizing our
proposal to refine two existing program measures, Catheter-associated
Urinary Tract Infection (CAUTI) (NQF #0138) and Central Line-associated
Bloodstream Infection (CLABSI) (NQF #0139), to adopt the updated SIR
calculation methodology developed by the Center for Disease Control and
Prevention's (CDC) that calculates rates using updated HAI baseline
data that are further stratified by patient location.
i. Medicare and Medicaid Promoting Interoperability Programs
For purposes of an increased level of stability, reducing the
burden on eligible hospitals and CAHs, and clarifying certain existing
policies, we are finalizing several changes to the Medicare Promoting
Interoperability Program. Specifically, these policies include: (1) An
EHR reporting period of a minimum of any continuous 90-day period in CY
2022 for new and returning participants (eligible hospitals and CAHs);
(2) to maintain the Electronic Prescribing Objective's Query of PDMP
measure as optional and worth 5 bonus points in CY 2021; (3) to modify
the name of the Support Electronic Referral Loops by Receiving and
Incorporating Health Information measure; (4) to progressively increase
the number of quarters for which hospitals are required to report eCQM
data, from the current requirement of one self-selected calendar
quarter of data, to four calendar quarters of data, over a three year
period. Specifically, we finalized proposals to require: (a) Two self-
selected calendar quarters of data for the CY 2021 reporting period;
(b) three self-selected calendar quarters of data for the CY 2022
reporting period; and (c) four calendar quarters of data beginning with
the CY 2023 reporting period, where the submission period for the
Medicare Promoting Interoperability Program will be the 2 months
following the close of the respective calendar year; (5) to begin
publicly reporting eCQM performance data beginning with the eCQM data
reported by eligible hospitals and CAHs for the reporting period in CY
2021 on the Hospital Compare and/or data.medicare.gov websites or
successor websites; (6) to correct errors and amend regulation text
under Sec. 495.104(c)(5)(viii)(B) through (D) regarding transition
factors under section 1886(n)(2)(E)(i) for the incentive payments for
Puerto Rico eligible hospitals; and (7) to correct errors and amend
regulation text under Sec. Sec. 495.20(e)(5)(iii) and
(l)(11)(ii)(C)(1) for regulatory citations for the Office of the
National Coordinator for Health Information Technology (ONC)
certification criteria. We are amending our regulation texts as
necessary to incorporate these finalized changes.
j. Market-Based MS-DRG Relative Weight Data Collection and Change in
Methodology for Calculating MS-DRG Relative Weights
As discussed in section IV.P. of the preamble of this final rule,
in order to reduce the Medicare program's reliance on the hospital
chargemaster and to support the development of a market-based approach
to payment under the Medicare FFS system, we are finalizing our
proposal, with modification, to require that hospitals report certain
market-based payment rate information on their Medicare cost report for
cost reporting periods ending on or after January 1, 2021.
Specifically, we are finalizing that hospitals would report on the
Medicare cost report the median payer-specific negotiated charge that
the hospital has negotiated with all of its Medicare Advantage (MA)
organizations (also referred to as MA organizations) payers, by MS-DRG.
The market-based rate information we are finalizing for collection on
the Medicare cost report would be the median of the payer-specific
negotiated charges by MS-DRG, as described previously, for a hospital's
MA organization payers. The payer-specific negotiated charges used by
hospitals to calculate these medians would be the payer-specific
negotiated charges for service packages that hospitals are required to
make public under the requirements we finalized in the Hospital Price
Transparency Final Rule (84 FR 65524) that can be cross-walked to an
MS-DRG. We believe that because hospitals are already required to
publically report payer-specific negotiated charges, in accordance with
the Hospital Price Transparency Final Rule, that the additional
calculation and reporting of the median payer-specific negotiated
charge will be less burdensome for hospitals.
We are also finalizing the market-based MS-DRG relative weight
methodology as described in the FY
[[Page 58438]]
2021 IPPS/LTCH PPS proposed rule, which would incorporate this market-
based rate information, beginning in FY 2024.
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 percentage point 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 percentage point by section 15005 of
the 21st Century Cures Act.) For FY 2021, we are making an adjustment
of +0.5 percentage point to the standardized amount consistent with the
MACRA.
Changes to the New Technology Add-On Payment Policy for
Certain Antimicrobial Products. In light of recent information that
continues to highlight the significant concerns and impacts related to
antimicrobial resistance and emphasizes the continued importance of
this issue both with respect to Medicare beneficiaries and public
health overall, in this final rule we are making changes to the new
technology add-on payment policy for certain antimicrobials for FY
2021. We are expanding our alternative new technology add-on payment
pathway for QIDPs to include products approved through FDA's Limited
Population Pathway for Antibacterial and Antifungal Drugs (LPAD
pathway). Under this policy, for applications received for new
technology add-on payments for FY 2022 and subsequent fiscal years, if
an antimicrobial product is approved through FDA's LPAD pathway, it
will be considered new and not substantially similar to an existing
technology for purposes of the new technology add-on payment under the
IPPS, and will not need to meet the requirement that it represent an
advance that substantially improves, relative to technologies
previously available, the diagnosis or treatment of Medicare
beneficiaries.
We are also providing for conditional new technology add-on payment
approval for products designated as QIDPs that do not receive FDA
approval by July 1 and products that do not receive approval through
FDA's LPAD pathway by July 1 (the current deadline for consideration in
the final rule) but otherwise meet the applicable add-on payment
criteria. Under this policy, cases involving eligible antimicrobial
products would begin receiving the new technology add-on payment
sooner, effective for discharges the quarter after the date of FDA
marketing authorization provided that the technology receives FDA
marketing authorization by July 1 of the particular fiscal year for
which the applicant applied for new technology add-on payments.
Given the relatively recent introduction of the FDA's LPAD pathway
there have not been any drugs that were approved under the FDA's LPAD
pathway that applied for a new technology add-on payment under the
IPPS. If all of the future LPADs that would have applied for new
technology add-on payments would have been approved under existing
criteria, this finalized policy has no impact relative to current
policy. To the extent that there are future LPADs that are the subject
of applications for new technology add-on payments, and those
applications would have been denied under the current new technology
add-on payment criteria, this final policy is a cost, but that cost is
not estimable. Therefore, it is not possible to quantify the impact of
these policies.
Wage Index Disparities Between High and Low Wage Index
Hospitals. As discussed in section III.G.3. of the preamble of this
final rule, we are continuing to reduce the disparity between high and
low wage index hospitals by increasing the wage index values for
certain hospitals with low wage index values and applying a budget
neutrality adjustment to the standardized amount so that increase is
implemented in a budget neutral manner.
Medicare DSH Payment Adjustment and Additional Payment for
Uncompensated Care. For FY 2021, we are updating our estimates of the
three factors used to determine uncompensated care payments. To
calculate Factor 2, we are using uninsured estimates produced by OACT
as part of the development of the NHEA in conjunction with more
recently available data that take into consideration the effects of
COVID-19. We are using a single year of data on uncompensated care
costs from Worksheet S-10 for FY 2017 to determine Factor 3 for FY 2021
for all hospitals with the exception of Puerto Rico hospitals and
Indian Health Service and Tribal hospitals. To determine the amount of
uncompensated care for purposes of calculating Factor 3 for Puerto Rico
hospitals and Indian Health Service and Tribal hospitals, we are
continuing to use only data regarding low-income insured days for FY
2013. We project that the amount available to distribute as payments
for uncompensated care for FY 2021 will decrease by approximately $60
million, as compared to our estimate of the uncompensated care payments
that will be distributed in FY 2020. The uncompensated care payments
have redistributive effects, based on a hospital's uncompensated care
amount relative to the uncompensated care amount for all hospitals that
are projected to be eligible 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 363 LTCHs in our
database, we estimate that the changes to the payment rates and factors
that we present in the preamble of and Addendum to this final rule,
which reflect the end of the transition of the statutory application of
the site neutral payment rate and the update to the LTCH PPS standard
Federal payment rate for FY 2021, would result in an estimated decrease
in payments in FY 2021 of approximately $40 million.
Changes to the Hospital Readmissions Reduction Program.
For FY 2021 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), elective primary total
hip arthroplasty/total knee arthroplasty (THA/TKA), and coronary artery
bypass graft (CABG) surgery. We estimate that 2,545 hospitals will have
their base operating DRG payments reduced by their FY 2021 hospital-
specific payment adjustment factors. As a result, we estimate that the
Hospital Readmissions Reduction Program will save approximately $553
million in FY 2021.
Value-Based Incentive Payments under the Hospital VBP
Program. We estimate that there will be no net financial impact to
participating hospitals under the Hospital VBP Program for the FY 2021
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
2021 program year and, therefore, the estimated amount available for
value-based incentive payments for FY
[[Page 58439]]
2021 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. We are making no changes to
the scoring methodology, which will continue to use the Winsorized z-
score and equal measure weights approaches to determine the worst-
performing quartile of hospitals. Any significant impact due to the HAC
Reduction Program changes for FY 2021, including which hospitals will
receive the adjustment, will depend on the actual experience of
hospitals in the Program.
Changes to the Hospital Inpatient Quality Reporting (IQR)
Program. Across 3,300 IPPS hospitals, we estimate that our changes for
the Hospital IQR Program in this final rule would result in a total
information collection burden increase of 6,533 hours associated with
our policies and updated burden estimates and a total cost increase of
approximately $253,480, across a four-year period from the CY 2021
reporting period/FY 2023 payment determination through the CY 2024
reporting period/FY 2026 payment determination, compared to our
previously approved information collection burden estimates.
Changes to the Medicare and Medicaid Promoting
Interoperability Programs. With these finalized proposals, we do not
estimate any net change in burden hours or total cost for the Medicare
Promoting Interoperability Program for CY 2021, given that there are no
substantive change in current measures or data requirements for
eligible hospitals and CAHs that would affect previously-approved
burden. Unrelated to any of this rule's Promoting Interoperability
changes, an alteration to the annual information collection's total
cost is due to utilizing an updated hourly wage rate for the necessary
hospital staff involved in attesting to the objectives and measures
under 42 CFR 495.24(e). The Bureau of Labor Statistics (BLS) recently
released a 2018 wage rate which, compared to the 2017 rates used in FY
2020 IPPS/LTCH PPS final rule, result in an estimated increase of
$24,073 for the annual information collection burden (total cost) in FY
2021. Therefore, multiplying the total annual burden of 21,4950 hours
by the 2018 BLS labor cost of $69.34, we estimate the Promoting
Interoperability Program's total cost to be $1,487,343 for the CY 2021
EHR reporting period (21,450 hours x $69.34).
Market-Based MS-DRG Relative Weight Data Collection and
Change in Methodology for Calculating MS-DRG Relative Weights. In
section IV.P.4. of the preamble of this final rule, we are finalizing a
methodology for estimating the MS-DRG relative weights beginning in FY
2024 which utilizes the median payer-specific negotiated charge
information we are finalizing to collect on the Medicare cost report.
We estimate total annual burden hours for this data collection are as
follows: 3,189 hospitals times 20 hours per hospital equals 63,780
annual burden hours and $4,315,993. We refer readers to section
XI.B.11. of the preamble of this final rule for further analysis of
this assessment.
B. Background Summary
1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)
Section 1886(d) of 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 for fiscal years beginning on or after October 1,
2013, that considers the amount of uncompensated care furnished by the
hospital relative to all other qualifying hospitals.
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. In general, 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. In addition, certain transformative new devices and certain
antimicrobial products may qualify under an alternative inpatient new
technology add-on payment pathway by demonstrating that, absent an add-
on payment, they 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
[[Page 58440]]
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. 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.
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). 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, effective for LTCH's cost
reporting periods beginning in FY 2016 cost reporting period, 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.
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. 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). We did not make proposals or updates to
the LTCH Quality Reporting Program. We are continuing to maintain
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.
2. 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
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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.
3. Further Consolidated Appropriations Act, 2020 (Pub. L. 116-94)
Section 108 of the Further Consolidated Appropriations Act, 2020
(Pub. L. 116-94) provides that, effective for cost reporting periods
beginning on or after October 1, 2020, payment to a subsection (d)
hospital that furnishes an allogeneic hematopoietic stem cell
transplant for hematopoietic stem cell acquisition shall be made on a
reasonable cost basis, and that the Secretary shall specify the items
included in such hematopoietic stem cell acquisition in rulemaking.
This statutory provision also requires that, beginning in FY 2021, the
payments made based on reasonable cost for the acquisition costs of
allogeneic hematopoietic stem cells be made in a budget neutral manner.
D. Issuance of Notice of Proposed Rulemaking
In the FY 2021 IPPS/LTCH PPS proposed rule that appeared in the May
29, 2020 Federal Register (84 FR 32460), we set forth proposed payment
and policy changes to the Medicare IPPS for FY 2021 operating costs and
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 2021.
The following is a general summary of the changes that we proposed
to make.
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 2021.
Proposed adjustment to the standardized amounts under
section 1886(d) of the Act for FY 2021 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 2021 status of new
technologies approved for add-on payments for FY 2020, a presentation
of our evaluation and analysis of the FY 2021 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) for applications not submitted under an alternative pathway,
and a discussion of the proposed status of FY 2021 new technology
applicants under the alternative pathways for certain medical devices
and certain antimicrobial products.
Proposed revision to the new technology add-on payment
policy where the coding associated with an application for new
technology add-on payments or a previously approved technology that may
continue to receive new technology add-on payments is proposed to be
assigned to a proposed new MS-DRG.
Proposed changes to the timing of the IPPS new technology
add-on payment for certain antimicrobial products, and proposed
expansion of the alternative pathway for certain antimicrobial
products.
2. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals
In section III. of the preamble of 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 included, but
were not limited to, the following:
Proposed changes in the labor market area delineations
based on revisions to the OMB Core Based Statistical Area (CBSA)
delineations and proposed policies related to the proposed changes in
CBSAs.
The proposed FY 2021 wage index update using wage data
from cost reporting periods beginning in FY 2017.
Calculation, analysis, and implementation of the proposed
occupational mix adjustment to the wage index for acute care hospitals
for FY 2021 based on the 2016 Occupational Mix Survey.
Proposed application of the rural floor and the frontier
State floor, and continuation of the low wage index hospital policy.
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.
Proposed change to Lugar county assignments.
Proposed adjustment to the wage index for acute care
hospitals for FY 2021 based on commuting patterns of hospital employees
who reside in a county and work in a different area with a higher wage
index.
Proposed labor-related share for the proposed FY 2021 wage
index.
3. Other Decisions and Proposed Changes to the IPPS for Operating Costs
In section IV of the preamble of the proposed rule, we discuss
proposed changes or clarifications of a number of the provisions of the
regulations in 42 CFR parts 412 and 413, including the following:
Proposed changes to MS-DRGs subject to the post-acute care
transfer policy and special payment policy.
Proposed inpatient hospital update for FY 2021.
Proposed amendment to address short cost reporting periods
during applicable timeframe for establishment of service area for SCHs.
Proposed updated national and regional case-mix values and
discharges for purposes of determining RRC status, and proposed
amendment for hospital cost reporting periods that are longer or
shorter than 12 months.
The statutorily required IME adjustment factor for FY
2021.
Proposed changes to the methodology for determining
Medicare DSH for uncompensated care payments.
Proposed changes to payment for allogeneic hematopoietic
stem cell acquisition costs.
Proposed payment adjustment for chimeric antigen receptor
(CAR) T-cell therapy clinical trial cases.
Proposed requirements for payment adjustments under the
Hospital Readmissions Reduction Program for FY 2021.
The provision of estimated and newly established
performance standards for the calculation 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 2021.
Proposed policy changes related to medical residents
affected by residency program or teaching hospital closure.
Discussion of and proposed changes relating to the
implementation of the Rural Community Hospital Demonstration Program in
FY 2021.
Proposal to collect market-based rate information on the
Medicare cost
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report for cost reporting periods ending on or after January 1, 2021,
and request for comment on a potential market-based MS-DRG relative
weight methodology beginning in FY 2024, that we stated we may adopt in
this rulemaking.
4. Proposed FY 2021 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 2021.
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 2021.
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
2021.
Proposed rebasing and revising of the LTCH PPS market
basket.
7. Proposed Changes Relating to Quality Data Reporting for Specific
Providers and Suppliers
In section VIII. of the preamble of the proposed rule, we
addressed--
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 requirements pertaining to eligible
hospitals and CAHs participating in the Medicare and Medicaid Promoting
Interoperability Programs.
8. Other Proposed Changes
Section IX. of the preamble to the proposed rule included the
following:
Proposed changes pertaining to the submission format
requirements and reimbursement rates for patient records sent to the
Beneficiary and Family Centered Care Quality Improvement Organizations
(BFCC-QIOs).
Proposed changes pertaining to allowing for mandatory
electronic filing of Provider Reimbursement Review Board appeals.
Proposed changes pertaining to and codification of certain
longstanding Medicare Bad Debt policies.
9. Other Provisions of the Proposed Rule
Section X. of the preamble to the proposed rule included our
discussion of the MedPAC Recommendations.
Section XI. of the preamble to the proposed rule included the
following:
A descriptive listing of the public use files associated
with the proposed rule.
The collection of information requirements for entities
based on our proposals.
Information regarding our responses to public comments.
Waiver of the 60-day delay in effective date for the final
rule.
10. 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 2021 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 2021 for certain
hospitals excluded from the IPPS.
11. 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 2021 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
2021. We proposed to establish the adjustment for wage levels,
including the proposed changes in the CBSAs based on revisions to the
OMB labor market area delineations and a proposed adjustment to reflect
the expected increases in wages under the IPPS low wage index hospital
policy. We are proposing to establish the adjustments for 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.
12. 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, PCHs and other entities.
13. 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 2021 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.
14. 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 2020 recommendations concerning hospital inpatient
payment policies address the update factor for hospital inpatient
operating costs and capital-related costs for hospitals under the IPPS.
We addressed these recommendations in Appendix B of the proposed rule.
For further information relating specifically to the MedPAC March 2020
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.
E. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care and patient access
to their health information. The Office of the National Coordinator for
Health Information Technology (ONC) and CMS work collaboratively to
advance
[[Page 58443]]
interoperability across settings of care, including post-acute care.
To further interoperability in across all care settings, CMS
continues to explore opportunities to advance electronic exchange of
patient information across payers, providers and with patients,
including developing systems that use nationally recognized health IT
standards such as Logical Observation Identifier Names and Codes
(LOINC), Systemized Nomenclature of Medicine-Clinical Terms (SNOMED),
and Fast Healthcare Interoperability Recourses (FHIR). In addition, CMS
and ONC are collaborating with industry stakeholders via the Post-Acute
Care Interoperability Workgroup (PACIO) (to develop FHIR-based
standards for post-acute care (PAC) assessment content, which could
support the exchange and reuse of patient http://pacioproject.org/)
assessment data derived from the Minimum Data Set (MDS), Inpatient
Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI), Long
Term Care Hospital Continuity Assessment Record and Evaluation Data Set
(LTCH CARE data set), Outcome Assessment Information Set (OASIS)
assessment tools, and other sources. The Data Element Library (DEL)
(https://del.cms.gov/DELWeb/pubHome) continues to be updated and serves
as the authoritative resource for PAC assessment data elements and
their associated mappings to health IT standards. These interoperable
data elements can reduce provider burden by allowing the use and
exchange of healthcare data, support provider exchange of electronic
health information for care coordination, person-centered care, and
support real-time, data driven, clinical decision-making. Standards in
the DEL (https://del.cms.gov/) can be referenced on the CMS website and
in the ONC Interoperability Standards Advisory (ISA). The 2020 ISA is
available at https://www.healthit.gov/isa.
In the September 30, 2019 Federal Register, we published a final
rule titled, ``Medicare and Medicaid Programs; Revisions to
Requirements for Discharge Planning for Hospitals, Critical Access
Hospitals, and Home Health Agencies, and Hospital and Critical Access
Hospital Changes to Promote Innovation, Flexibility, and Improvement in
Patient Care'' (84 FR 51836) (``Discharge Planning final rule''), that
revises the discharge planning requirements that hospitals (including
psychiatric hospitals, long-term care hospitals, and inpatient
rehabilitation facilities), critical access hospitals (CAHs), and home
health agencies, must meet to participate in Medicare and Medicaid
programs. It also revises one provision regarding patient rights in
hospitals. The rule supports our interoperability efforts by promoting
the exchange of patient information between health care settings, and
by ensuring that a patient's necessary medical information is
transferred with the patient after discharge from a hospital, CAH, or
post-acute care services provider. For more information on the
discharge planning requirements, please visit the final rule at:
https://www.federalregister.gov/documents/2019/09/30/2019-20732/medicare-and-medicaid-programs-revisions-to-requirements-for-discharge-planning-for-hospitals.
We invite providers to learn more about these important
developments and how they are likely to affect LTCHs and encourage the
electronic exchange of health data across care settings and with
patients.
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.
(Beginning in FY 2008, CMS adopted the Medicare-Severity DRGs (MS-DRGs)
to better recognize severity of illness and resource use based on case
complexity.) 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. Adoption of the MS-DRGs and MS-DRG Reclassifications
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).
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 2020 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; 82 FR 38010 through 38085, 83 FR 41158 through 41258, and 84 FR
42058 through 42165, respectively).
C. FY 2021 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
[[Page 58444]]
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 American Taxpayer Relief Act of 2012 (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. Adjustments Made for FY 2018, FY 2019, and FY 2020 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 adjustment
for FY 2018 from a 0.5 percentage point positive adjustment to a 0.4588
percentage point positive adjustment. 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. In the FY 2019
IPPS/LTCH PPS final rule (83 FR 41157) and in the FY 2020 IPPS/LTCH PPS
final rule (84 FR 42057), consistent with the requirements of section
414 of the MACRA, we implemented 0.5 percentage point positive
adjustments to the standardized amount for FY 2019 and FY 2020,
respectively. We indicated that the FY 2018, FY 2019, and FY 2020
adjustments were permanent adjustments to payment rates. We also stated
that we plan to propose future adjustments required under section 414
of the MACRA for FYs 2021 through 2023 in future rulemaking.
3. Adjustment for FY 2021
Consistent with the requirements of section 414 of the MACRA, we
proposed to implement a 0.5 percentage point positive adjustment to the
standardized amount for FY 2021. We indicated that this would
constitute 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 2022 through 2023 in future
rulemaking.
Comment: Commenters stated that in order to comply with ATRA
requirements, CMS anticipated that a cumulative -3.2 percentage point
adjustment to the standardized amount would achieve the mandated $11
billion recoupment. A commenter stated that by retaining the -0.7
percentage point adjustment made in FY 2017, CMS has miscalculated the
directives issued by Congress, and has contravened Congress' clear
instructions and intent. The commenter contends that when Section 15005
of the 21st Century Cures Act (Pub. L. 114-255) altered the positive
adjustment for FY 2018 from 0.5 percentage points to 0.4588 percentage
points, Congress recognized that this difference would not be restored.
According to the commenter, Congress thus assumed that the 0.7
percentage point adjustment would be returned as part of the
restoration process; otherwise, it would have updated the ``baseline''
to reflect CMS' revised total negative adjustment of 3.9%. A commenter
asserted that the additional -0.7 percentage point adjustment made in
FY 2017 has been improperly continued in FY 2018, FY 2019, and FY 2020,
and failure to restore the additional 0.7 percentage point adjustment
will cause hospitals to experience a significant cut in their
reimbursement for FY 2021 (in addition to the losses already incurred
for FYs 2018, 2019, and 2020). Other commenters urged CMS to use its
exceptions and adjustments authority under section 1886(d)(5)(I) by FY
2024, to restore an additional 0.7 percentage point payment adjustment
to restore payment equity to hospitals and comply with what they
asserted was Congressional intent. Another commenter suggested CMS
implement an approximate positive adjustment of 1.0 percentage point by
FY 2024 to fully and permanently restore the entire -3.9 percentage
point recoupment adjustment to IPPS rates.
Response: As we discussed in the FY 2021 IPPS/LTCH PPS proposed
rule (85 FR 32471), and in response to similar comments in the FY 2020
IPPS/LTCH PPS final rule (84 FR 42057), we believe section 414 of the
MACRA and section 15005 of the 21st Century Cures Act 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 adjustment level estimated or implemented by CMS in previous
rulemaking. 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 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
[[Page 58445]]
MACRA would not fully restore even the 3.2 percentage point 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 point 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, nor are we
persuaded that it would be appropriate to use the Secretary's
exceptions and adjustments authority under section 1886(d)(5)(I) of the
Act to adjust payments in FY 2021 to restore any additional amount of
the original 3.9 percentage point reduction, given Congress'
prescriptive adjustment levels under section 414 of the MACRA and
section 15005 of the 21st Century Cures Act. We intend to address
adjustments for FY 2022 and later years in future rulemaking.
After consideration of the public comments we received, we are
finalizing our proposal to implement a 0.5 percentage point adjustment
to the standardized amount for FY 2021.
D. Changes to Specific MS-DRG Classifications
1. Discussion of Changes to Coding System and Basis for FY 2021 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 2021 MS-DRG Updates
Given the need for more time to carefully evaluate requests and
propose updates, as discussed in the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38010), we changed the deadline to request updates to the MS-
DRGs to November 1 of each year, which provided an additional 5 weeks
for the data analysis and review process. Interested parties had to
submit any comments and suggestions for FY 2021 by November 1, 2019,
and the comments that were submitted in a timely manner for FY 2021 are
discussed in this section of the preamble of this final rule. As we
discuss in the sections that follow, we may not be able to fully
consider all of the requests that we receive for the upcoming fiscal
year. We have found that, with the implementation of ICD-10, some types
of requested changes to the MS-DRG classifications require more
extensive research to identify and analyze all of the data that are
relevant to evaluating the potential change. We note in the discussion
that follows those topics for which further research and analysis are
required, and which we will continue to consider in connection with
future rulemaking.
We stated in the proposed rule that with the continued increase in
the number and complexity of the requested changes to the MS-DRG
classifications since the adoption of ICD-10 MS-DRGs, and in order to
consider as many requests as possible, more time is needed to carefully
evaluate the requested changes, analyze claims data, and consider any
updates. Therefore, we stated that we are changing the deadline to
request changes to the MS-DRGs to October 20th of each year to allow
for additional time for the review and consideration of any updates. We
stated that interested parties should submit any comments and
suggestions for FY 2022 by October 20, 2020 via the CMS MS-DRG
Classification Change Request Mailbox located at:
[email protected].
Comment: A commenter expressed concern that changing the deadline
to submit requested changes to the MS-DRGs from November 1st to October
20th will shorten the amount of time that hospitals have to review the
final rule each year and determine how changes may impact MS-DRG
recommendations for the following year. The commenter opposed the
change in date stating hospitals should be given more time to evaluate
impacts of the MS-DRG changes. We also received comments urging CMS to
consider the impact of the COVID-19 pandemic on the FY 2020 MedPAR data
in evaluating potential MS-DRG changes for FY 2022. Commenters noted
that the volume for MS-DRGs unrelated to COVID-19 hospitalizations may
not be typical as a result of the postponement or cancellation of
elective surgeries.
Response: We believe that a change in the deadline from November
1st to October 20th will continue to provide hospitals sufficient time
to assess potential impacts and inform future MS-DRG recommendations.
As noted later in this section, in response to prior public comments,
we provided a test version of the ICD-10 MS-DRG GROUPER Software,
Version 38 containing the proposed GROUPER logic for FY 2021 in
connection with the proposed rule, allowing providers to build case
examples reflecting the proposed MS-DRG changes. Therefore, we believe
providers have sufficient time to assess potential impacts. However,
because of the unique circumstance for this final rule for which we are
waiving the delayed effective date (as discussed in section I.A.2 of
this preamble), we are maintaining the deadline of November 1, 2020 for
FY 2022 MS-DRG classification change requests, and expect to reconsider
a change in the deadline beginning with comments and suggestions
submitted for FY 2023. In response to the public comments received
expressing concerns about evaluating potential MS-DRG changes for FY
2022 using the FY 2020 MedPAR claims data, which may reflect various
impacts as a result of the COVID-19 pandemic, we will consider these
concerns in developing FY 2022 proposals. Accordingly, interested
parties should submit any comments and suggestions for FY 2022 by
November 1, 2020 via the CMS MS-DRG Classification Change Request
Mailbox located at: [email protected].
Based on public comments received in response to the FY 2020 IPPS/
LTCH PPS proposed rule, we provided a test version of the ICD-10 MS-DRG
GROUPER Software, Version 38, in connection with the FY 2021 IPPS/LTCH
PPS proposed rule so that the public could better analyze and
understand the impact of the proposals included in the proposed rule.
We noted that this test software reflects the proposed GROUPER logic
for FY 2021. Therefore, it includes the new diagnosis
[[Page 58446]]
and procedure codes that are effective for FY 2021 as reflected in
Table 6A.--New Diagnosis Codes--FY 2021 and Table 6B.--New Procedure
Codes--FY 2021 that were associated with the proposed rule and does not
include the diagnosis codes that are invalid beginning in FY 2021 as
reflected in Table 6C.--Invalid Diagnosis Codes--FY 2021 that was
associated with the proposed rule. We also noted that there were not
any procedure codes that had been designated as invalid for FY 2021 at
the time of the development of the proposed rule. Those tables were not
published in the Addendum to the proposed 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 the proposed rule. Because
the diagnosis codes no longer valid for FY 2021 are not reflected in
the test software, we made available a supplemental file in Table 6P.1a
that includes the mapped Version 38 FY 2021 ICD-10-CM codes and the
deleted Version 37 FY 2020 ICD-10-CM codes that should be used for
testing purposes with users' available claims data. Therefore, users
had access to the test software allowing them to build case examples
that reflect the proposals that were included in the proposed rule. In
addition, users were able to view the draft version of the ICD-10 MS-
DRG Definitions Manual, Version 38.
The test version of the ICD-10 MS-DRG GROUPER Software, Version 38,
the draft version of the ICD-10 MS-DRG Definitions Manual, Version 38,
and the supplemental mapping file in Table 6P.1a of FY 2020 and FY 2021
ICD-10-CM diagnosis codes are available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
Following are the changes that we proposed to the MS-DRGs for FY
2021. 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 2021 IPPS/LTCH PPS proposed rule, our MS-DRG
analysis was based on ICD-10 claims data from the September 2019 update
of the FY 2019 MedPAR file, which contains hospital bills received
through September 30, 2019, for discharges occurring through September
30, 2019. In our discussion of the proposed MS-DRG reclassification
changes, we referred to these claims data as the ``September 2019
update of the FY 2019 MedPAR file.''
In this FY 2021 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 2021 final rule, we generally did not
perform any further MS-DRG analysis of claims data. Therefore, our MS-
DRG analysis is based on ICD-10 claims data from the September 2019
update of the FY 2019 MedPAR file, which contains hospital bills
received through September 30, 2019, for discharges occurring through
September 30, 2019, except as otherwise noted.
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.
In the FY 2021 IPPS/LTCH PPS proposed rule, we proposed to expand
the previously listed criteria to also include the NonCC subgroup. We
explained that we believe that applying these criteria to the NonCC
subgroup would better reflect resource stratification and also promote
stability in the relative weights by avoiding low volume counts for the
NonCC level MS-DRGs.
Specifically, in our analysis of the MS-DRG classification requests
for FY 2021 that we received by November 1, 2019, as well as any
additional analyses that were conducted in connection with those
requests, we applied these criteria to each of the MCC, CC and NonCC
subgroups, as described in the following table. We provided the
following table to better illustrate all five criteria and how they are
applied for each CC subgroup, including their application to the NonCC
subgroup beginning with the FY 2021 proposed rule. We also stated we
had revised the order in which the criteria are presented for
illustrative purposes.
[[Page 58447]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.000
In general, once the decision has been made to propose to make
further modifications to the MS-DRGs as described previously, such as
creating a new base MS-DRG, or in our evaluation of a specific MS-DRG
classification request to split (or subdivide) an existing base MS-DRG
into severity levels, all five criteria must be met for the base MS-DRG
to be split (or subdivided) by a CC subgroup. We note that in our
analysis of requests to create a new MS-DRG, we evaluate the most
recent year of MedPAR claims data available. For example, we stated
earlier that for the FY 2021 IPPS/LTCH PPS proposed rule and this final
rule, our MS-DRG analysis is based on ICD-10 claims data from the
September 2019 update of the FY 2019 MedPAR file. However, in our
evaluation of requests to split an existing base MS-DRG into severity
levels, as noted in prior rulemaking (80 FR 49368), we analyze the most
recent 2 years of data. This analysis includes 2 years of MedPAR claims
data to compare the data results from 1 year to the next to avoid
making determinations about whether additional severity levels are
warranted based on an isolated year's data fluctuation and also, to
validate that the established severity levels within a base MS-DRG are
supported. The first step in our process of evaluating if the creation
of a new CC subgroup within a base MS-DRG is warranted is to determine
if all the criteria are satisfied for a three way split. If the
criteria fail, the next step is to determine if the criteria are
satisfied for a two way split. If the criteria for both of the two way
splits fail, then a split (or CC subgroup) would generally not be
warranted for that base MS-DRG. If the three way split fails on any one
of the five criteria and all five criteria for both two way splits
(1_23 and 12_3) are met, we would apply the two way split with the
highest R2 value. We note that if the request to split (or subdivide)
an existing base MS-DRG into severity levels specifies the request is
for either one of the two way splits (1_23 or 12_3), in response to the
specific request, we will evaluate the criteria for both of the two way
splits, however we do not also evaluate the criteria for a three way
split.
Comment: A commenter acknowledged CMS's proposal to expand the
previously listed criteria to create subgroups to also include the
NonCC subgroup. This commenter expressed concern that the proposed
principles are limited and restrictive and more applicable to MCCs than
CCs.
Response: It is not clear to us from the limited discussion in the
comment why the commenter believes the principles are limited and
restrictive and more applicable to MCCs than CCs, as the commenter did
not provide further information or examples of this, nor suggest
alternative approaches. We note that the criteria to create subgroups
within the MS-DRGs as discussed in the FY 2021 IPPS/LTCH PPS proposed
rule (85 FR 32472 through 32473) are separate from the guiding
principles we discussed in the context of the comprehensive CC/MCC
analysis of diagnosis codes when reported as a secondary diagnosis (85
FR 32550). However, the commenter did not provide any further
information, alternative suggestions or recommendations with respect to
either analysis.
Comment: A commenter noted that in CMS's analysis of the MS-DRG
classification requests for FY 2021, the proposed expanded criteria
were applied to each of the MCC, CC and NonCC subgroups and it
questioned the appropriateness of applying the proposed subgroup
criteria to include the NonCC subgroup for FY 2021 prior to it being
finalized. This commenter also requested that CMS clarify how it will
apply the proposed expansion of the subgroup criteria going forward.
The commenter stated that if CMS were to apply the NonCC subgroup
criteria retroactively in future rulemaking there are concerns with
implications on the MS-DRG groupings and relative weights. The
commenter conducted its own preliminary analysis using the FY 2018
MedPAR data and noted that some MS-DRGs with three subgroups would have
two subgroups under the new framework and it was not clear how this may
impact the relative weights of those MS-DRGs.
Response: In the FY 2021 IPPS/LTCH PPS proposed rule, we proposed
to expand the existing criteria to create subgroups within a base MS-
DRG to include the NonCC subgroup (85 FR 32472 through 32473). We noted
that in our analysis of the MS-DRG classification requests for FY 2021,
we applied the proposed criteria to each of the MCC, CC and NonCC
subgroups. In response to the commenter's concern about the
appropriateness of applying
[[Page 58448]]
the proposed subgroup criteria for MS-DRG classification requests in FY
2021 prior to it being finalized, we note that we proposed and
requested comments on the expansion of these criteria to the NonCC
subgroup as part of this rulemaking and before finalization of this
approach for FY 2021 MS-DRG changes. We also note that in the absence
of applying the proposed criteria to include the NonCC subgroup, the
MS-DRG related proposals for FY 2021 involving such requests to create
subgroups would have similar results. However, to better illustrate for
the reader the criteria that were established in FY 2008 (72 FR 47169)
to determine if the creation of a new CC or MCC subgroup within a base
MS-DRG is warranted, we have provided this table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.001
As shown in the table, under column number two (Three-Way Split),
the first criterion requires ``500+ cases for MCC group; and 500+ cases
for CC group'' and the second criterion requires ``5%+ cases for MCC
group; and 5%+ cases for CC group''. We note that there is no volume or
percentage of cases requirement for the NonCC group under the first and
second criterion for this type of severity level split under the
existing criteria. We further note that the proposed expansion of the
criteria to include the NonCC subgroup, as discussed in the proposed
rule, is only applicable for a three-way split because as previously
illustrated in the table, the criteria for the NonCC subgroup already
exists in each of the options for a two-way split.
As stated previously, in the absence of applying the proposed
criteria to include the NonCC subgroup, the MS-DRG related proposals
for FY 2021 involving such requests to create subgroups would have
similar results. For example, in response to the request under the Pre-
MDC category to split MS-DRG 014 (Allogeneic Bone Marrow Transplant)
into two severity levels, based on the presence of a MCC, we discussed
our application of the criteria to create subgroups for each of the
two-way severity level splits. We noted that the criterion that there
be at least 500 cases for each subgroup (with MCC and without MCC)
failed due to low volume, for both years analyzed. The analysis did not
specifically rely on application of the proposed expansion of the
criteria for the NonCC subgroup since the request was not for a three-
way severity split and we noted there was already an insufficient
volume of cases (less than 500) in the CC subgroup (CC+NonCC group).
Another example under the Pre-MDC category is for the proposed new MS-
DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy), for
which we received public comments regarding CC subgroups and is
discussed in further detail in section II.E.2.b. of the preamble of
this final rule.
We take this opportunity to clarify that there are no plans to
apply the proposed expansion of the criteria to the NonCC subgroup
retroactively in future rulemaking. The commenter is correct that
application of the proposed NonCC subgroup criteria going forward may
result in modifications to certain MS-DRGs that are currently split
into three severity levels and result in MS-DRGs that are split into
two severity levels under the proposed new framework. Any proposed
modifications to the MS-DRGs would be addressed in future rulemaking
consistent with our annual process and reflected in the Table 5--
Proposed List of Medicare Severity Diagnosis Related Groups (MS-DRGs),
Relative Weighting Factors, and Geometric and Arithmetic Mean Length of
Stay for the applicable fiscal year.
After consideration of the public comments we received, we are
finalizing our proposal to expand the previously listed criteria to
also include the NonCC subgroup.
We are making the FY 2021 ICD-10 MS-DRG GROUPER and Medicare Code
Editor (MCE) Software Version 38, the ICD-10 MS-DRG Definitions Manual
files Version 38 and the Definitions of Medicare Code Edits Manual
Version 38 available to the public on our CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
2. Pre-MDC
a. Bone Marrow Transplants
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32473 through 32475), we received two separate requests that involve
the MS-
[[Page 58449]]
DRGs where bone marrow transplant procedures are assigned. The first
request was to redesignate MS-DRG 014 (Allogeneic Bone Marrow
Transplant), MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC
or T-Cell Immunotherapy), and MS-DRG 017 (Autologous Bone Marrow
Transplant without CC/MCC) from surgical MS-DRGs to medical MS-DRGs.
According to the requestor, bone marrow transplant procedures involve a
transfusion of donor cells and do not involve a surgical procedure or
require the resources of an operating room (O.R.). The second request
involving bone marrow transplant procedures was to split MS-DRG 014
(Allogeneic Bone Marrow Transplant) into two severity levels, based on
the presence of a MCC. In this section of this rule, we discuss each
request in more detail.
With regard to the first request, the requestor noted that the
logic for MS-DRG 014 consists of ICD-10-PCS procedure codes describing
allogeneic bone marrow transplants that are designated as non-operating
room (non-O.R.) procedures. The requestor also noted that the logic for
MS-DRGs 016 and 017 includes ICD-10-PCS procedure codes describing
autologous bone marrow transplants where certain procedure codes are
designated as O.R. and other procedure codes are designated as non-O.R.
procedures. The requestor stated that redesignating the bone marrow
transplant MS-DRGs from surgical to medical would clinically align with
the resources utilized in the performance of these procedures.
The requestor is correct that bone marrow transplant procedures are
currently assigned to MS-DRGs 014, 016, and 017 which are classified as
surgical MS-DRGs under the Pre-MDC category for the ICD-10 MS-DRGs. The
requestor is also correct that the logic for MS-DRG 014 consists of
ICD-10-PCS procedure codes describing allogeneic bone marrow
transplants that are designated as non-operating room (non-O.R.)
procedures and that the logic for MS-DRGs 016 and 017 includes ICD-10-
PCS procedure codes describing autologous bone marrow transplants where
certain procedure codes are designated as O.R. procedures and other
procedure codes are designated as non-O.R. procedures. We refer the
reader to the ICD-10 MS-DRG Definitions Manual Version 37 which is
available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software for complete documentation of the GROUPER
logic for MS-DRGs 014, 016, and 017.
As noted in the proposed rule, we consulted with our clinical
advisors and they agreed that bone marrow transplant procedures are
similar to a blood transfusion procedure, do not utilize the resources
of an operating room, and are not surgical procedures. Our clinical
advisors concurred that bone marrow transplants are medical procedures
and it is more accurate to designate the MS-DRGs to which these
procedures are assigned as medical MS-DRGs versus surgical MS-DRGs.
Therefore, we proposed to redesignate MS-DRGs 014, 016, and 017 as
medical MS-DRGs effective October 1, 2020 for FY 2021.
As noted previously, the logic for MS-DRGs 016 and 017 includes
ICD-10-PCS procedure codes describing autologous bone marrow
transplants and related procedures where certain procedure codes are
designated as O.R. and other procedure codes are designated as non-O.R.
procedures. We stated in the proposed rule that during our review of
the bone marrow transplant procedures assigned to these MS-DRGs, we
identified the following 8 procedure codes that are currently
designated as O.R procedures.
[GRAPHIC] [TIFF OMITTED] TR18SE20.002
In connection with our proposal to designate the MS-DRGs to which
these procedures are assigned as medical, as well as for clinical
consistency with the other procedure codes describing bone marrow
transplant procedures, we proposed to redesignate the listed ICD-10-PCS
procedure codes from O.R. to non-O.R. procedures, affecting their
current MS-DRG assignment for MS-DRGs 016 and 017, effective October 1,
2020 for FY 2021.
As discussed in the proposed rule and noted earlier in this
section, we also received a request to split MS-DRG 014 (Allogeneic
Bone Marrow Transplant) into two severity levels, based on the presence
of a MCC. For FY 2020, the requestor had requested that MS-DRG 014 be
split into two new MS-DRGs according to donor source. For the reasons
discussed in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19176
through 19180) and the FY 2020 IPPS/LTCH PPS final rule (84 FR 42067
through 42072), we did not propose to split MS-DRG 014 into two new MS-
DRGs according to donor source. However, according to the requestor, a
single (base) MS-DRG for allogeneic bone marrow and stem cell
transplants continues to not be as clinically or resource homogeneous
as it could be. The requestor conducted its own analysis and stated the
results revealed it was appropriate to split MS-DRG 014 based on the
presence of a MCC.
We noted in the proposed rule that we examined claims data from the
September 2019 update of the FY 2019 MedPAR file for MS-DRG 014. There
were 962 cases found in MS-DRG 014 with an average length of stay of
26.7 days and average costs of $89,586.
As stated in the proposed rule, consistent with our established
process, we conducted an analysis of MS-DRG 014 to determine if the
criteria to create subgroups were met. The process for conducting this
type of analysis includes examining 2 years of MedPAR claims data to
compare the data results
[[Page 58450]]
from 1 year to the next to avoid making determinations about whether
additional severity levels are warranted based on an isolated year's
data fluctuation and also, to validate that the established severity
levels within a base MS-DRG are supported. Therefore, we reviewed the
claims data for base MS-DRG 014 using the September 2018 update of the
FY 2018 MedPAR file and the September 2019 update of the FY 2019 MedPAR
file, which were used in our analysis of claims data for MS-DRG
reclassification requests for FY 2020 and FY 2021. Our findings are
shown in the table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.003
We applied the criteria to create subgroups for each of the two-way
severity level splits. As discussed in section II.D.1.b., in the FY
2021 IPPS/LTCH PPS proposed rule, we proposed to expand the previously
listed criteria to also include the NonCC group. The criterion that
there be at least 500 cases for each subgroup failed due to low volume,
as shown in the table for both years. Specifically, for the ``with
MCC'' and ``without MCC'' (CC+NonCC) split, there were only 183
(141+42) cases in the ``without MCC'' subgroup based on the data in the
FY 2019 MedPAR file and only 175 (140+35) cases in the ``without MCC''
subgroup based on the data in the FY 2018 MedPAR file. For the ``with
CC/MCC'' and ``without CC/MCC'' (NonCC) split, there were only 42 cases
in the NonCC subgroup based on the data in the FY 2019 MedPAR file and
only 35 cases in the NonCC subgroup based on the data in the FY 2018
MedPAR file. The claims data do not support a two-way severity level
split for MS-DRG 014, therefore, we proposed to maintain the current
structure of MS-DRG 014 for FY 2021.
Comment: Commenters supported the proposal to redesignate MS-DRGs
014, 016, and 017 as medical MS-DRGs and stated they agreed that bone
marrow transplant procedures are medical procedures that do not utilize
the resources of an operating room. However, the commenters also noted
that bone marrow transplants remain resource intensive procedures and
the patients are medically complex, often requiring additional
monitoring and increased lengths of stay. Commenters also agreed that
the ICD-10-PCS procedure codes describing bone marrow transplants
should have the same designation and supported the proposal to
redesignate the eight ICD-10-PCS procedure codes listed in the previous
table from O.R. to non-O.R. procedures, affecting their current MS-DRG
assignment for MS-DRGs 016 and 017. However, a single commenter
disagreed with the proposal to redesignate the eight ICD-10-PCS
procedure codes listed in the previous table from O.R. to non-O.R.
procedures stating that the proposal did not provide any detail as to
how the codes would be reassigned and recommended not finalizing the
proposal until more information was provided in future rulemaking.
Another commenter noted that the bone marrow transplant procedure codes
represent an example of why the current process of determining whether
a procedure qualifies for designation as an O.R. procedure may be
outdated. This commenter acknowledged CMS' discussion from section
II.D.11. in the proposed rule that stated while procedures have
typically been evaluated on the basis of whether they would be
performed in an operating room, there may be other factors to consider
with regard to resource consumption (85 FR 32542 through 32549).
Another commenter reported that in review of the eight procedure codes
CMS proposed to redesignate from O.R. to non-O.R., they queried the FY
2019 MedPAR claims data and discovered a limited number of claims
reflecting these procedure codes. This commenter consulted with its
clinical advisors to determine if a bone marrow transplant with an
``open approach'' (as described by the procedure codes and the ICD-10-
PCS classification), would generally occur. According to the clinical
advisors, it is illogical to maintain these procedure codes describing
an open approach for allogeneic and autologous bone marrow transplant
procedures. The commenter recommended that CMS remove the procedure
codes identified with an open approach from the classification.
Commenters also supported retaining the structure of MS-DRG 014 and
not creating a two-way severity level split based on the data and
information provided. A commenter stated they understood and did not
dispute CMS' logic based on the criteria to create subgroups, however,
they suggested that when proposals from the comprehensive CC/MCC
analysis are finalized that this MS-DRG be reevaluated given the
variation in the ``with CC/MCC'' and ``without CC/MCC'' subgroups
($90,924 versus $60,277, respectively) displayed in the CMS data
analysis. In addition, this commenter noted that the FY 2020 proposals
related to the CC/MCC analysis involved redesignating the neoplasm
codes from CC to NonCC and stated their belief that facilities
addressing the costly and unavoidable consequences of allogeneic bone
marrow transplants should be compensated for providing the care.
Response: We appreciate the commenters' support for our proposals
related to MS-DRGs 014, 016 and 017 for bone marrow transplant
procedures. We agree with the commenters that bone marrow transplants
are resource intensive procedures and the patients are medically
complex, often requiring additional monitoring and increased lengths of
stay. In response to the commenter who disagreed with the proposal to
redesignate the eight ICD-10-PCS procedure codes listed in the previous
table from O.R. to non-O.R. procedures because the proposal did not
provide any detail as to how the codes would be reassigned and
recommended not finalizing the proposal until more information was
provided in future rulemaking, we note that the proposed rule
specifically stated ``we are proposing to redesignate the listed ICD-
10-PCS procedure codes from O.R. to non-O.R. procedures, affecting
their current MS-DRG assignment for MS-DRGs 016 and 017, effective
October 1, 2020 for FY 2021''. As we also discussed in section
II.D.11.a. of the proposed rule, each procedure that is designated as a
non-O.R. procedure is
[[Page 58451]]
further classified as either affecting the MS-DRG assignment or not
affecting the MS-DRG assignment. We noted that the non-O.R.
designations that do affect the MS-DRG are referred to as ``non-O.R.
affecting the MS-DRG.'' Accordingly, redesignating these eight
procedure codes as non-O.R. procedures affecting their MS-DRG
assignment means that they are non-O.R. and will continue to be
assigned to MS-DRGs 016 and 017 for FY 2021.
In response to the commenter who recommended that CMS remove the
procedure codes describing an allogeneic or autologous bone marrow
transplant with an open approach from the classification, we thank the
commenter for their suggestion and note that proposed changes to these
procedure codes can be considered at an ICD-10 Coordination and
Maintenance Committee meeting. As discussed in section II.E.16. of the
preamble of this final rule, we encourage commenters to submit
proposals for procedure coding changes via Email to:
[email protected].
With regard to the commenter who suggested that MS-DRG 014 be
reevaluated when proposals from the comprehensive CC/MCC analysis are
finalized due to the variation in the ``with CC/MCC'' and ``without CC/
MCC'' subgroups as displayed in the CMS data analysis, we note that we
will evaluate and analyze data for all the MS-DRGs consistent with our
annual process.
After consideration of the public comments that we received, we are
finalizing our proposal to redesignate MS-DRGs 014, 016, and 017 from
surgical to medical MS-DRGs under the Pre-MDC category and finalizing
our proposal to redesignate the eight ICD-10-PCS procedure codes listed
in the previous table from O.R. to non-O.R. procedures, affecting their
current MS-DRG assignment for MS-DRGs 016 and 017 for FY 2021. We are
also finalizing our proposal to maintain the current structure of MS-
DRG 014 for FY 2021.
b. Chimeric Antigen Receptor (CAR) T-Cell Therapies
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32475 through
32476), we discussed several requests we received to create a new MS-
DRG for procedures involving CAR T-cell therapies. The requestors
stated that creation of a new MS-DRG would improve payment for CAR T-
cell therapies in the inpatient setting. Some requestors noted that
cases involving CAR T-cell therapies will no longer be eligible for new
technology add-on payments in FY 2021 and that this would significantly
reduce the overall payment for cases involving CAR T-cell therapies.
Some requestors also noted that in the absence of the creation of a new
MS-DRG for procedures involving CAR T-cell therapies, outlier payments
for these cases would increase significantly, which would increase the
share of total outlier payments that are attributable to CAR T-cell
therapies.
The requestors stated that the new MS-DRG for CAR T-cell therapies
should include cases that report 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) or XW043C3 (Introduction of engineered autologous
chimeric antigen receptor t-cell immunotherapy into central vein,
percutaneous approach, new technology group 3).
Given the high cost of the CAR T-cell product, some requestors
provided recommendations related to the differential treatment of cases
where the CAR T-cell product was provided without cost as part of a
clinical trial to ensure that the payment amount for the newly created
MS-DRG for CAR T-cell therapy cases would appropriately reflect the
average cost hospitals incur for providing CAR T-cell therapy outside
of a clinical trial. For example, some requestors suggested that CMS
make minor adjustments to its usual ratesetting methodology to exclude
clinical trial claims from the calculation of the relative weight for
any MS-DRG for CAR T-cell therapies. One requestor noted that these
adjustments are consistent with CMS' general authority under sections
1886(d)(4)(B) and (C) of the Act. Some requestors also suggested that
CMS apply an offset to the MS-DRG payment in cases where the provider
does not incur the cost of the CAR T-cell therapy.
Currently, procedures involving CAR T-cell therapies are identified
with ICD-10-PCS procedure codes XW033C3 and XW043C3, which became
effective October 1, 2017. In the FY 2019 IPPS/LTCH PPS final rule, we
finalized 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 the FY 2019 IPPS/LTCH PPS final rule for a complete
discussion of these final policies (83 FR 41172 through 41174).
As noted, the current procedure codes for CAR T-cell therapies both
became effective October 1, 2017. In the FY 2019 IPPS/LTCH PPS final
rule (83 FR 41172 through 41174), we indicated that we believed we
should collect more comprehensive clinical and cost data before
considering assignment of a new MS-DRG to these therapies. We stated in
the FY 2020 IPPS/LTCH PPS proposed rule that, while the September 2018
update of the FY 2018 MedPAR data file does contain some claims that
include those procedure codes that identify CAR T-cell therapies, the
number of cases is limited, and the submitted costs vary widely due to
differences in provider billing and charging practices for this
therapy. Therefore, while those claims could potentially be used to
create relative weights for a new MS-DRG, we stated that we did not
have the comprehensive clinical and cost data that we generally believe
are needed to do so. Furthermore, we stated in the FY 2020 IPPS/LTCH
PPS proposed rule that given the relative newness of CAR T-cell therapy
and our proposal to continue new technology add-on payments for FY 2020
for the two CAR T-cell therapies that currently have FDA approval
(KYMRIAHTM and YESCARTATM), at the time we
believed it was premature to consider creation of a new MS-DRG
specifically for cases involving CAR T-cell therapy for FY 2020. We
stated that in future years we would have additional data that could be
used to evaluate the potential creation of a new MS-DRG specifically
for cases involving CAR T-cell therapies.
We stated in the FY 2021 IPPS/LTCH PPS proposed rule that we now
have more data upon which to evaluate a new MS-DRG specifically for
cases involving CAR T-cell therapies. We stated that we agree with the
requestors it is appropriate to consider the development of a new MS-
DRG using the data that is now available. We examined the claims data
from the September 2019 update of the FY 2019 MedPAR data file for
cases that reported ICD-10-PCS procedure codes XW033C3 or XW043C3. For
purposes of this analysis, we identified clinical trial cases as claims
with ICD-10-CM diagnosis code Z00.6 (Encounter for examination for
normal comparison and control in clinical research program) which is
reported only for clinical trial cases, or with standardized drug
charges of less than $373,000, which is the average sales price of
KYMRIAH and YESCARTA, which are the two CAR T-cell medicines approved
to treat relapsed/refractory diffuse large B-cell lymphoma as of the
time of the development of the proposed rule and this final rule. We
stated that we
[[Page 58452]]
distinguished between clinical trial and non-clinical trial cases in
this analysis because we agree with the requestors who indicated that
given the high cost of the CAR T-cell product, it is appropriate to
distinguish cases where the CAR T-cell product was provided without
cost as part of a clinical trial so that the analysis appropriately
reflects the resources required to provide CAR T-cell therapy outside
of a clinical trial. We also noted that we included cases that would
have been identified as statistical outliers under our usual process
when examined as part of MS-DRG 016 due to the extreme cost differences
between the CAR T-cell therapy claims and other claims in MS-DRG 016,
but would not be identified as statistical outliers when examining CAR
T-cell therapy claims only. Our findings are shown in the table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.004
*We note that we included 18 cases that were flagged as statistical
outliers in our trim methodology due to the mix of CAR T- cell therapy
and non-CAR T--cell therapy cases in the current MS-DRG.
As shown in the table, we found 2,212 cases in MS-DRG 016, with an
average length of stay of 18.2 days and average costs of $55,001. Of
these 2,212 cases, 262 cases reported ICD-10-PCS procedure codes
XW033C3 or XW043C3; these cases had an average length of stay of 16.3
days and average costs of $127,408. Of these 262 cases, 94 were
identified as non-clinical trial cases; these cases had an average
length of stay of 17.2 days and average costs of $274,952. The
remaining 168 cases were identified as clinical trial cases; these
cases had an average length of stay of 15.8 days and average costs of
$44,853.
The data indicate that the average costs for the non-clinical trial
cases that reported ICD-10-PCS procedure codes XW033C3 or XW043C3 are
almost five times higher than the average costs for all cases in MS-DRG
016. We stated that our clinical advisors also believe that the cases
reporting ICD-10-PCS procedure codes XW033C3 or XW043C3 can be
clinically differentiated from other cases that group to MS-DRG 016,
which includes procedures involving autologous bone marrow transplants,
once the CAR T-cell therapy itself is taken into account in the
comparison.
As described earlier in this section, in deciding whether to
propose to make modifications to the MS-DRGs for particular
circumstances brought to our attention, we consider a variety of
factors pertaining to resource consumption and clinical
characteristics. We stated in the proposed rule that while we generally
prefer not to create a new MS-DRG unless it would include a substantial
number of cases, our clinical advisors believe that the vast
discrepancy in resource consumption as reflected in the claims data
analysis and the clinical differences warrant the creation of a new MS-
DRG. We therefore proposed to assign cases reporting ICD-10-PCS
procedure codes XW033C3 or XW043C3 to a new MS-DRG 018 (Chimeric
Antigen Receptor (CAR) T-cell Immunotherapy).
We stated in the proposed rule that if additional procedure codes
describing CART- cell therapies are approved and finalized, we would
use our established process to assign these procedure codes to the most
appropriate MS-DRG. Because these cases would no longer group to MS-DRG
016, we proposed to revise the title for MS-DRG 016 from ``Autologous
Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy'' to
``Autologous Bone Marrow Transplant with CC/MCC''.
Comments: The vast majority of commenters supported CMS' proposal
to create new MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell
Immunotherapy), stating that it will better reflect the resource use
involved in providing the CAR T-cell therapy. Commenters acknowledged
that CMS had considered many factors previously raised by stakeholders
in developing this new MS-DRG. A small number of commenters did not
support the creation of a new MS-DRG and recommended that CMS maintain
the new technology add-on payment for CAR T-cell therapies, delay
creating a new MS-DRG, and consider public-private partnerships for
data collection.
Response: We appreciate commenters' support. With respect to
commenters that requested that we instead maintain the new technology
add-on payments, we refer the reader to the section of this rule where
we address these comments. We believe that the data we currently have
available is sufficient to establish a relative weight at this time,
and therefore do not believe it is appropriate to delay the creation of
a new MS-DRG. We also note that the weights are recalibrated yearly to
reflect additional data as it becomes available. We note that the
commenter did not provide additional detail regarding potential public/
private partnerships with respect to data collection.
Comments: Some commenters requested that CMS clarify that all CAR
T-cell therapy products, or more
[[Page 58453]]
broadly, all T-cell immunotherapy products, would be assigned to MS-DRG
018 regardless of cost. One commenter expressed concern that MS-DRG 018
is specific to one mechanistic approach to cellular therapy and has not
provided for the array of cellular therapies in development.
Response: As we stated in the proposed rule, if additional
procedure codes describing CART-cell therapies are approved and
finalized, we would use our established process to assign these
procedure codes to the most appropriate MS-DRG. As described in the FY
2020 final rule (84 FR 42061), assigning new procedure codes involves
review of the predecessor procedure code's MS-DRG assignment. However,
this process does not automatically result in the new procedure code
being assigned (or proposed for assignment) to the same MS-DRG as the
predecessor code. There are several factors to consider during this
process that our clinical advisors take into account. For example, in
the absence of volume, length of stay, and cost data, they may consider
the specific service, procedure, or treatment being described by the
new procedure code, the indications, treatment difficulty, and the
resources utilized. Similarly, should additional cellular therapies
become available, we would use our established process to determine
whether there is a need to reconsider the MS-DRG assignment that would
otherwise result from the principal diagnosis and other factors that go
into MS-DRG assignment.
Comments: Some commenters requested that CMS consider subdividing
MS-DRG 018 into separate MS-DRGs for MCCs, CCs, and non-CCs in order to
account for the higher costs involved in caring for patients who
develop Cytokine Release Syndrome (CRS). Some commenters requested that
payments consider factors such as patients' burden of illness, comorbid
conditions and complications associated with receiving CAR T-cell
therapy treatment and consider complications and/or comorbidity or
major complications or comorbidity codes when evaluating reimbursement
for CAR T-cell therapies as more clinical data become available.
Response: As discussed in the proposed rule (85 FR 32472 through
32473), one of the criteria for the creation of a new complication or
comorbidity or major complication or comorbidity subgroup within a base
MS-DRG is at least 500 cases are in the CC or MCC subgroup which, as
discussed previously in this section, we are finalizing to also expand
to the NonCC subgroup beginning with FY 2021. As noted previously, we
identified 262 total cases reporting ICD-10-PCS procedure codes XW033C3
or XW043C3 in MS-DRG 016 based on the data from the September 2019
update of the FY MedPAR file. We may consider the creation of subgroups
within MS-DRG 018 in future rulemaking once additional data is
available.
Comments: Some commenters requested that CMS create two new cost
centers; one for cell therapy products, tied to revenue code 891, and
one for gene therapy products, tied to revenue code 892. A commenter
suggested that the use of a dedicated cost center would improve the
accuracy of cost estimates since it would allow the creation of a
separate CCR for CAR T-cell therapy products, and would not rely on
hospitals setting their charges for CAR T-cell therapy products at very
high levels. Commenters acknowledged that this would also require that
CMS modify the cost report to break out these revenue centers. Other
commenters requested that CMS issue a Medicare Learning Network (MLN)
article instructing hospitals regarding adjustment of charges for CAR
T-cell therapy products, while another commenter suggested that CMS
could create a standardized charging protocol for CAR T-cell therapy
products.
Response: We appreciate the commenters' request regarding the
creation of new cost centers for revenue codes 891 and 892 and may
consider this request in future rulemaking. With respect to the
commenters who expressed concerns about hospital charging practices, we
note that there is nothing that precludes hospitals from setting their
drug charges consistent with their CCRs.
Comments: A commenter stated that the indefinite use of MS-DRG 018
under the IPPS is not sustainable. Some commenters requested that CMS
consider value-based care or other alternative payment models, add-on
payments, or paying on a pass-through basis, as more appropriate
payment mechanisms for CAR T-cell therapies. A commenter urged CMS to
continue to engage all stakeholders to develop long-term sustainable
solutions that can be adapted over time and account for innovations
that transform how we treat disease. Another commenter stated that the
question of how to best pay for CAR T-cell therapies can best be
answered by Congress, but that CMS should continue pursuing policies
that enable hospitals to recoup all of their costs for providing CAR T-
cell therapies. Another commenter requested that CMS create an add-on
payment or otherwise modify the IPPS for pharmacy resources associated
with CAR T-cell therapies.
Response: We believe that is premature to make structural changes
to the IPPS at this time to pay for CAR T-cell therapies. As we gain
more experience with these therapies, including the use of a separate
MS-DRG for CAR T-cell therapies, we may consider these comments in
future rulemaking.
We note that commenters also raised some concerns about outpatient
billing instructions with respect to billing for outpatient cell
collection and cell processing charges on the inpatient claim, payment
issues for TEFRA hospitals, and questions regarding the MedPAR data
dictionary. While we consider these comments about outpatient billing
instructions and TEFRA hospitals outside of the scope of the proposals
in the proposed rule, we will take these comments into consideration
when developing policies and program requirements for future years.
With respect to comments about the MedPAR data dictionary, we
anticipate that the issues will be addressed in future MedPAR releases.
After consideration of public comments received, we are finalizing
our proposal to assign cases reporting ICD-10-PCS procedure codes
XW033C3 or XW043C3 to a new MS-DRG 018 (Chimeric Antigen Receptor (CAR)
T-cell Immunotherapy) and to revise the title for MS-DRG 016 from
``Autologous Bone Marrow Transplant with CC/MCC or T-cell
Immunotherapy'' to ``Autologous Bone Marrow Transplant with CC/MCC''.
We refer readers to section II.E.2.b. of the preamble of this final
rule for a discussion of the relative weight calculation for the new
MS-DRG 018 for CAR T-cell therapy, and to section IV.I. of the preamble
of this final rule for a discussion of the payment adjustment for CAR
T-cell clinical trial and expanded access use immunotherapy cases.
3. MDC 1 (Diseases and Disorders of the Nervous System)
a. Carotid Artery Stent Procedures
In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42078), we finalized
our proposal to reassign 96 ICD-10-PCS procedure codes describing
dilation of carotid artery with an intraluminal device(s) from MS-DRGs
037, 038, and 039 (Extracranial Procedures with MCC, with CC, and
without CC/MCC, respectively) to MS-DRGs 034, 035, and 036 (Carotid
Artery Stent Procedures with MCC, with CC, and without CC/MCC,
respectively). As discussed in the FY 2021 IPPS/LTCH proposed rule (85
[[Page 58454]]
FR 32476), we received a request to review six ICD-10-PCS procedure
codes describing dilation of a carotid artery (common, internal or
external) with drug eluting intraluminal devices(s) using an open
approach that were still assigned to the logic for case assignment to
MS-DRGs 037, 038, and 039 that were not included in the list of codes
finalized for reassignment to MS-DRGs 034, 035 and 036 in the FY 2020
IPPS/LTCH PPS final rule. The six codes are identified in the following
table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.005
The logic for case assignment to MS-DRGs 034, 035, and 036 as
displayed in the ICD-10 MS-DRG Version 37 Definitions Manual, available
via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html is comprised of a list of logic which
includes procedure codes for operating room procedures involving
dilation of a carotid artery (common, internal or external) with
intraluminal device(s). All of the ICD-10-PCS procedure codes in the
logic list assigned to MS-DRGs 034, 035, and 036 describe dilation of a
carotid artery with an intraluminal device.
In response to the request, we first examined claims data from the
September 2019 update of the FY 2019 MedPAR file for MS-DRGs 034, 035,
and 036 which only include those procedure codes that describe
procedures that involve dilation of a carotid artery with an
intraluminal device. Our findings are reported in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.006
As shown in the table, we found a total of 1,259 cases in MS-DRG
034 with an average length of stay of 6.9 days and average costs of
$28,668. We found a total of 3,367 cases in MS-DRG 035 with an average
length of stay of 3.0 days and average costs of $17,114. We found a
total of 4,769 cases in MS-DRG 036 with an average length of stay of
1.4 days and average costs of $13,501.
We then examined claims data from the September 2019 update of the
FY 2019 MedPAR file for MS-DRGs 037, 038, and 039 and identified cases
reporting any one of the 6 procedure codes listed in the table
previously to determine the volume of cases impacted and if the average
length of stay and average costs are consistent with the average length
of stay and average costs for MS-DRGs 034, 035 and 036. Our findings
are shown in the following table.
[[Page 58455]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.007
As shown in the table, we found a total of 3,331 cases with an
average length of stay of 7.3 days and average costs of $24,155 in MS-
DRG 037. There were 6 cases reporting at least one of the 6 procedure
codes that describe dilation of the carotid artery with an intraluminal
device using an open approach in MS-DRG 037 with an average length of
stay of 7 days and average costs of $22,272. For MS-DRG 038, we found a
total of 11,021 cases with an average length of stay of 3 days and
average costs of $12,306. There were 33 cases reporting at least one of
the 6 procedure codes that describe dilation of the carotid artery with
an intraluminal device in MS-DRG 038 with an average length of stay of
2.3 days and average costs of $16,777. For MS-DRG 039, we found a total
of 20,854 cases with an average length of stay of 1.4 days and average
costs of $8,463. There were 26 cases reporting at least one of the 6
procedure codes that describe dilation of the carotid artery with an
intraluminal device in MS-DRG 039 with an average length of stay of 1.2
days and average costs of $14,981.
The data analysis shows that for the cases in MS-DRGs 037, 038, and
039 reporting ICD-10-PCS codes 037H04Z, 037J04Z, 037K04Z, 037L04Z,
037M04Z, or 037N04Z, the average length of stay is shorter and the
average costs are higher than the average length of stay and average
costs (with the exception of the average costs for the 6 cases in MS-
DRG 037 which are slightly less) in the FY 2019 MedPAR file for MS-DRGs
037, 038, and 039 respectively. The data analysis also shows for the
cases in MS-DRGs 037, 038, and 039 reporting ICD-10-PCS codes 037H04Z,
037J04Z, 037K04Z, 037L04Z, 037M04Z, and 037N04Z the average length of
stay and the average costs are in-line with the average length of stay
and average costs in the FY 2019 MedPAR file for MS-DRGs 034, 035, and
036 respectively.
As noted in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19184)
and final rule (84 FR 42077), our clinical advisors stated that MS-DRGs
034, 035 and 036 are defined to include only those procedure codes that
describe procedures that involve dilation of a carotid artery with an
intraluminal device.
Therefore, we proposed to reassign the procedure codes listed in
the table from MS-DRGs 037, 038, and 039 that describe procedures that
involve dilation of the carotid artery with an intraluminal device to
MS-DRGs 034, 035, and 036.
In addition to our analysis of the claims data from the September
2019 MedPAR file for MS-DRGs 037, 038 and 039, we conducted an
examination of all the MS-DRGs where any one of the 6 procedure codes
listed previously were also reported to determine if any one of the 6
procedure codes were included in any other MS-DRG outside of MDC 01, to
further assess the current MS-DRG assignments. Our findings are shown
in the following table.
[[Page 58456]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.008
As shown in the table, we found one case reporting any one of these
6 procedure codes in each of MS-DRGs 023, 027, 035, 219, 233, 235 and
252. We noted that all of the listed MS-DRGs were assigned to MDC 01
with one exception: MS-DRG 252 (Other Vascular Procedures with MCC) in
MDC05 (Diseases and Disorders of the Circulatory System). As a result,
we reviewed the logic list for MS-DRGs 252, 253, and 254 (Other
Vascular Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 05 and found 36 ICD-10-PCS codes for procedures
that describe dilation of the carotid artery with an intraluminal
device with an open approach that were not currently assigned in MDC
01. The 36 ICD-10-PCS codes are listed in the following table.
BILLING CODE 4120-01-P
[[Page 58457]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.009
[[Page 58458]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.010
BILLING CODE 4120-01-C
We then examined the claims data to determine if there were other
MS-DRGs in which one of the 36 procedure codes listed in the table were
reported. We found 8 cases that grouped to MS-DRGs 981, 982, and 983
(Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) when a principal diagnosis
from MDC 01 was reported with one of the procedure codes in the table
that describes dilation of a carotid artery with an intraluminal
device, open approach.
As noted previously, in the FY 2020 IPPS/LTCH PPS proposed rule (84
FR 19184) and final rule (84 FR 42077), our clinical advisors stated
that MS-DRGs 034, 035, and 036 are defined to include those procedure
codes that describe procedures that involve dilation of a carotid
artery with an intraluminal device. As a result, our clinical advisors
supported adding the 36 ICD-10-PCS codes identified in the table to MS-
DRGs 034, 035, and 036 in MDC 01 for consistency to align with the
definition of MS-DRGs 034, 035, and 036 and also to permit proper case
assignment when a principal diagnosis from MDC 01 is reported with one
of the procedure codes in the table that describes dilation of a
carotid artery with an intraluminal device, open approach.
Therefore, for FY 2021, we also proposed to add the 36 ICD-10-PCS
codes identified in the table that are currently assigned in MDC 05 to
MS-
[[Page 58459]]
DRGs 252, 253, and 254 to the GROUPER logic for MS-DRGs 034, 035, and
036 in MDC 01.
Comment: Commenters expressed support for CMS' proposal to reassign
the identified ICD-10-PCS codes describing dilation of a carotid artery
with an intraluminal device from MS-DRGs 037, 038 and 039 to MS-DRGs
034, 035 and 036. Commenters also supported CMS' proposal to add the
ICD-10-PCS codes describing dilation of a carotid artery with an
intraluminal device currently assigned in MDC 05 to MDC 01. One
commenter stated that these were positive reassignments and another
stated that these reassignments will help to ensure consistency among
the MS-DRG classifications for procedures involving dilation of a
carotid artery with an intraluminal device.
Response: We thank the commenters for their support.
Comment: One commenter suggested that given the clinical congruence
with the procedures involved with dilation of a carotid artery with an
intraluminal device, procedure codes that describe vertebral and
intracranial artery dilation and device placement should also be
classified in MS-DRGs 034, 035 and 036, and that MS-DRG 034, 035 and
036 be renamed as Carotid, Vertebral and Intracranial Stent Procedures
and requested that this recommendation be assessed and analyzed for
inclusion in next year's proposed rule.
Response: We appreciate the commenter's suggestion. As stated in
section II.E.1.b. of the preamble of this final rule, we encourage
individuals with recommendations regarding changes to MS-DRG
classification to submit these comments no later than November 1, 2020
so that they can be considered for possible inclusion in the annual
proposed rule. We will consider these public comments for possible
proposals in future rulemaking as part of our annual review process.
After consideration of the public comments we received, we are
finalizing our proposal to reassign the 6 procedure codes discussed
above from MS-DRGs 037, 038, and 039 to MS-DRGs 034, 035, and 036
because the 6 procedure codes are consistent with the other procedures
describing dilation of a carotid artery with an intraluminal device
that are currently assigned to
MS-DRGs 034, 035, and 036. Additionally, we are finalizing our
proposal to add the 36 ICD-10-PCS codes identified in the table that
are currently assigned in MDC 05 to MS-DRGs 252, 253, and 254 to the
GROUPER logic for MS-DRGs 034, 035, and 036 in MDC 01.
b. Epilepsy With Neurostimulator
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32481), we received a request to reassign cases describing the
insertion of a neurostimulator generator into the skull in combination
with the insertion of a neurostimulator lead into the brain from 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) to MS-DRG 021 (Intracranial
Vascular Procedures with PDX Hemorrhage with CC) or to reassign these
cases to another MS-DRG for more appropriate payment. The Responsive
Neurostimulator (RNS(copyright)) System, a cranially
implanted neurostimulator that is a treatment option for persons
diagnosed with medically intractable epilepsy, is identified by the
reporting of an ICD-10-PCS code combination capturing a neurostimulator
generator inserted into the skull with the insertion of a
neurostimulator lead into the brain and cases are assigned to MS-DRG
023 when reported with a principal diagnosis of epilepsy.
We stated that as discussed in the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38015 through 38019), we finalized our proposal to reassign all
cases with a principal diagnosis of epilepsy and one of the following
ICD-10-PCS code combinations capturing cases with a neurostimulator
generator inserted into the skull with the insertion of a
neurostimulator lead into the brain (including cases involving the use
of the RNS(copyright) neurostimulator) to MS-DRG 023 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).
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H04MZ (Insertion of
neurostimulator lead into brain, percutaneous endoscopic approach).
We also finalized our change to the title of MS-DRG 023 from
``Craniotomy with Major Device Implant or Acute Complex Central Nervous
System (CNS) Principal Diagnosis (PDX) with MCC or Chemo Implant'' to
``Craniotomy with Major Device Implant or Acute Complex Central Nervous
System (CNS) Principal Diagnosis (PDX) with MCC or Chemotherapy Implant
or Epilepsy with Neurostimulator'' to reflect the modifications to the
MS-DRG structure.
As noted in the proposed rule, the requestor acknowledged the
refinements made to MS-DRG 023 effective for FY 2018, but stated that
despite the previously-stated changes, cases describing the insertion
of a neurostimulator generator into the skull in combination with the
insertion of a neurostimulator lead into the brain continue to be
underpaid. The requestor performed its own analysis and stated that it
found that the average costs of cases describing the insertion of the
RNS(copyright) neurostimulator were significantly higher
than the average costs of all cases in their current assignment to MS-
DRG 023, and as a result, cases describing the insertion of the
RNS(copyright) neurostimulator are not being adequately
reimbursed. The requestor suggested the following two options for MS-
DRG assignment updates: (1) Reassign cases describing the insertion of
a neurostimulator generator into the skull in combination with the
insertion of a neurostimulator lead into the brain from MS-DRG 023 to
MS-DRG 021 with a change in title to ``lntracranial Vascular Procedures
with PDX Hemorrhage with CC or Epilepsy with Neurostimulator;'' or (2)
reassign cases describing the insertion of a neurostimulator generator
into the skull in combination with the insertion of a neurostimulator
lead into the brain to another higher paying MS-DRG that would provide
adequate reimbursement. The requestor stated its belief that MS-DRG 021
is a better fit in terms of average costs and clinical coherence for
reassignment of RNS(copyright) System cases and recognized
that there is likely still not enough volume to warrant the creation of
new MS-DRGs for cases describing the insertion of the
RNS(copyright) neurostimulator.
We first examined claims data from the September 2019 update of the
FY 2019 MedPAR file for all cases in MS-DRG 023 and compared the
results to cases representing a neurostimulator generator inserted into
the skull with the insertion of a neurostimulator lead into the brain
(including cases involving the use of the RNS(copyright)
neurostimulator) that had a principal diagnosis of epilepsy in MS-DRG
023. The following table shows our findings:
[[Page 58460]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.011
As shown in the table, for MS-DRG 023, we identified a total of
11,938 cases, with an average length of stay of 9.8 days and average
costs of $40,264. Of the 11,938 cases in MS-DRG 023, there were 81
cases describing a neurostimulator generator inserted into the skull
with the insertion of a neurostimulator lead into the brain (including
cases involving the use of the RNS(copyright)
neurostimulator) that had a principal diagnosis of epilepsy with an
average length of stay of 3.3 days and average costs of $52,362. Our
clinical advisors reviewed these data, and agreed with the requestor
that the number of cases is too small to warrant the creation of a new
MS-DRG for these cases, for the reasons discussed in the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38015 through 38019).
We also examined the reassignment of cases describing a
neurostimulator generator inserted into the skull with the insertion of
a neurostimulator lead into the brain (including cases involving the
use of the RNS(copyright) neurostimulator) to MS-DRGs 020,
021, and 022 (Intracranial Vascular Procedures with PDX Hemorrhage with
MCC, with CC, and without CC/MCC, respectively). While the request was
to reassign these cases to MS-DRG 021, MS-DRG 021 is specifically
differentiated according to the presence of a secondary diagnosis with
a severity level designation of a complication or comorbidity (CC).
Cases with a neurostimulator generator inserted into the skull with the
insertion of a neurostimulator lead into the brain (including cases
involving the use of the RNS(copyright) neurostimulator) do
not always involve the presence of a secondary diagnosis with a
severity level designation of a complication or comorbidity (CC), and
therefore we reviewed data for all three MS-DRGs. The following table
shows our findings:
[GRAPHIC] [TIFF OMITTED] TR18SE20.012
As shown in the table, for MS-DRG 020, there were a total of 1,623
cases with an average length of stay of 16.1 days and average costs of
$75,668. For MS-DRG 021, there were a total of 409 cases with an
average length of stay of 12.3 days and average costs of $55,123. For
MS-DRG 022, there were a total of 131 cases with an average length of
stay of 6.3 days and average costs of $35,599.
We stated in the proposed rule that while the cases in MS-DRG 023
describing a neurostimulator generator inserted into the skull with the
insertion of a neurostimulator lead into the brain (including cases
involving the use of the RNS(copyright) neurostimulator) and
a principal diagnosis of epilepsy have average costs that are similar
to the average costs of cases in MS-DRG 021 ($52,362 compared to
$55,123), they have an average length of stay that is 9 days shorter
(3.3 days compared to 12.3 days), similar to our findings as summarized
in the FY 2018 IPPS/LTCH PPS final rule. We stated that our clinical
advisors reviewed the clinical issues and the claims data, and did not
support reassigning the cases describing a neurostimulator generator
inserted into the skull with the insertion of a neurostimulator lead
into the brain (including cases involving the use of the
RNS(copyright) neurostimulator) and a principal diagnosis of
epilepsy from MS-DRG 023 to MS-DRGs 020, 021 or 022. As discussed in
the FY 2018 IPPS/LTCH PPS final rule, the cases in MS-DRGs 020, 021 and
022 have a principal diagnosis of a hemorrhage. The
RNS(copyright) neurostimulator generators are not used to
treat patients with diagnosis of a hemorrhage. We stated our clinical
advisors continue to believe that it is inappropriate to reassign cases
representing a principal diagnosis of epilepsy to a MS-DRG that
contains cases that represent the treatment of intracranial hemorrhage,
as discussed in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38015
through 38019). They also stated that the differences in average length
of stay and average costs based on the more recent data continue to
support this recommendation.
We then explored alternative options, as was requested. We noted
that the 81 cases describing a neurostimulator generator inserted into
the skull with the insertion of a neurostimulator lead into the brain
(including cases involving the use of the RNS(copyright)
neurostimulator) and a principal diagnosis of epilepsy had an average
length of stay of 3.3 days and average costs of $52,362, as compared to
the 11,938 cases in MS-DRG 023 that had an average length of stay of
9.8 days and average costs of $40,264. While these neurostimulator
cases had average costs that were $12,098 higher than the average costs
of all cases in MS-DRG 023, there were only a total of 81 cases. There
may have been other factors contributing to the higher costs.
We further analyzed the data to identify those cases describing a
neurostimulator generator inserted into the skull with the insertion of
a neurostimulator lead into the brain (including cases involving the
use of the RNS(copyright) neurostimulator), with at least
one other procedure designated as an O.R. procedure, and a principal
diagnosis of epilepsy. 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. Our data findings for MS-DRG 023
demonstrate that of the 81 cases describing a neurostimulator generator
inserted into the skull with the insertion of a neurostimulator lead
into the brain (including cases involving
[[Page 58461]]
the use of the RNS(copyright) neurostimulator) and a
principal diagnosis of epilepsy, 19 reported at least one other
procedure designated as an O.R. procedure, and had higher average costs
($72,995 versus $52,362) compared to the average costs of all cases in
this subset of MS-DRG 023.
We also reviewed the cases reporting procedures describing a
neurostimulator generator inserted into the skull with the insertion of
a neurostimulator lead into the brain (including cases involving the
use of the RNS(copyright) neurostimulator), and a principal
diagnosis of epilepsy to identify the secondary diagnosis CC and/or MCC
conditions reported in conjunction with these procedures that also may
be contributing to the higher average costs for these cases. We
reviewed the claims data to identify the number (frequency) and types
of principal and secondary diagnosis CC and/or MCC conditions that were
reported. Our findings for the cases reporting secondary diagnosis MCC
and CC conditions, followed by the top 10 secondary diagnosis MCC and
secondary diagnosis CC conditions that were reported within the claims
data for this subset of cases are shown in the following tables:
[GRAPHIC] [TIFF OMITTED] TR18SE20.013
[GRAPHIC] [TIFF OMITTED] TR18SE20.014
[GRAPHIC] [TIFF OMITTED] TR18SE20.015
While the results of the claims analysis as previously summarized
indicate that the average costs of cases reporting a neurostimulator
generator inserted into the skull with the insertion of a
neurostimulator lead into the brain (including cases involving the use
of the RNS(copyright) neurostimulator), and a principal
diagnosis of epilepsy are higher compared to the average costs for all
cases in their assigned MS-DRG, we stated in the proposed rule we could
not ascertain from the claims data the resource use specifically
attributable to the procedure during a hospital stay. These data show
cases reporting a neurostimulator generator inserted into the skull
with the insertion of a neurostimulator lead into the brain (including
cases involving the use of the RNS(copyright)
neurostimulator), and a principal diagnosis of epilepsy, can present
greater treatment difficulty, and have a need for additional
intervention with other O.R. procedures. When reviewing consumption of
hospital resources for this subset of cases, the claims data also
clearly shows that the patients typically have multiple MCC and CC
conditions, and the increased costs appear to be
[[Page 58462]]
attributable to the severity of illness of the patient.
In summary, we stated that we believe that further analysis of
cases reporting a neurostimulator generator inserted into the skull
with the insertion of a neurostimulator lead into the brain (including
cases involving the use of the RNS(copyright)
neurostimulator), and a principal diagnosis of epilepsy is needed prior
to proposing any further reassignment of these cases to ensure clinical
coherence between these cases and the other cases with which they may
potentially be grouped. We stated that we expected in future years,
that we would have additional data that exhibit an increased number of
cases that could be used to evaluate the potential reassignment of
cases reporting a neurostimulator generator inserted into the skull
with the insertion of a neurostimulator lead into the brain (including
cases involving the use of the RNS(copyright)
neurostimulator), and a principal diagnosis of epilepsy. Therefore, we
did not propose to reassign cases describing a neurostimulator
generator inserted into the skull with the insertion of a
neurostimulator lead into the brain (including cases involving the use
of the RNS(copyright) neurostimulator) from MS-DRG 023 to
MS-DRG 021. We also did not propose to reassign Responsive
Neurostimulator (RNS(copyright)) System cases to another MS-
DRG at this time.
Comment: Commenters agreed with CMS' proposal not to reassign cases
describing a neurostimulator generator inserted into the skull with the
insertion of a neurostimulator lead into the brain (including cases
involving the use of the RNS(copyright) neurostimulator)
from MS-DRG 023 to MS-DRG 021 or to any another MS-DRG at this time. A
commenter specifically thanked CMS for its consideration of addressing
the costs and reimbursements associated with the insertion of the
Responsive Neurostimulator (RNS(copyright)) System. Another
commenter stated they appreciate CMS' willingness to continue to
analyze the data, recognizing the discrepancy in average costs and the
potential need for a MS-DRG assignment that provides adequate
reimbursement.
Although supporting the decision to not reassign cases reporting
the use of an RNS(copyright) System neurostimulator for
epilepsy, a few commenters expressed concern that the average costs of
these cases are higher than the average costs for all cases in the
assigned MS-DRG 023 and stated their belief that the costs for the
insertion of this device in traditional Medicare patients is not
recouped. These same commenters acknowledged the issue is complex and
beyond merely separating and reassigning neurostimulators for epilepsy.
One commenter stated neurostimulator insertion for the treatment of
epilepsy is not clinically similar to treatment of intracranial
hemorrhage. Another commenter noted that complex neurostimulator
implants may involve chronic disease states other than epilepsy,
including Parkinson's disease and essential tremor and stated they
agreed with CMS's decision to conduct further analyses, which would
provide an opportunity to obtain additional stakeholder input related
to improving MS-DRG assignments for neurostimulator procedures.
Commenters noted that MS-DRGs 023 and 024 combine a wide range of
principal diagnoses, procedures, and procedure approaches that could be
contributing to the wide variation of costs of cases assigned to these
MS-DRGs. Commenters proposed a number of ways CMS could attempt to
create more homogenous groups and improve clinical cohesion such as (1)
creating a new set of DRGs focused solely on the cost of the
implantation of CNS devices that could be modeled after currently
established MS-DRGs for the implantation of stents in carotid artery,
stents in the coronary arteries or pacemakers, AICDs or other high-cost
technologies in the heart, and/or (2) moving procedures assigned to MS-
DRGs 023 and 024 that describe extirpation, drainage and removal to MS-
DRGs 025, 026 and 027 (Craniotomy and Endovascular Intracranial
Procedures with MCC, with CC, and without CC/MCC, respectively).
Response: We appreciate the commenters' feedback and support.
We also appreciate the commenters' suggestions regarding other
potential changes to the current MS-DRG assignments for CMS's
consideration. We continue to be attuned to the requestors' and
commenters' concerns about reimbursement for cases describing the
insertion of the RNS(copyright) neurostimulator. As part of
our ongoing, comprehensive analysis of the MS-DRGs under ICD-10, we
will continue to explore mechanisms to ensure clinical coherence
between these cases and the other cases with which they may potentially
be grouped. Therefore, after consideration of the public comments we
received, and for the reasons stated above, we are finalizing our
proposal to maintain the assignment of cases describing a
neurostimulator generator inserted into the skull with the insertion of
a neurostimulator lead into the brain (including cases involving the
use of the RNS(copyright) neurostimulator) in MS-DRG 023 in
MDC 01.
4. MDC 3 (Diseases and Disorders of Ear, Nose and Throat):
Temporomandibular Joint Replacements
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32484 through
32490), we discussed a request we received to consider reassignment of
ICD-10-PCS procedure codes 0RRC0JZ (Replacement of right
temporomandibular joint with synthetic substitute, open approach) and
0RRD0JZ (Replacement of left temporomandibular joint with synthetic
substitute, open approach) from MS-DRGs 133 and 134 (Other Ear, Nose,
Mouth and Throat O.R. Procedures with and without CC/MCC, respectively)
to MS-DRGs 131 and 132 (Cranial and Facial Procedures with and without
CC/MCC, respectively) in MDC 03.
The requestor stated that it is inaccurate for procedure codes
0RRC0JZ and 0RRD0JZ that identify and describe replacement of the
temporomandibular joint (TMJ), which involves excision of the TMJ
followed by replacement with a prosthesis, to group to MS-DRGs 133 and
134 while excision of the TMJ alone, identified by procedure codes
0RBC0ZZ (Excision of right temporomandibular joint, open approach) and
0RBD0ZZ (Excision of left temporomandibular joint, open approach),
groups to the higher weighted MS-DRGs 131 and 132. According to the
requestor, reassignment of procedure codes 0RRC0JZ and 0RRD0JZ to the
higher weighted MS-DRGs 131 and 132 is reasonable and the MS-DRG title
of ``Cranial and Facial Procedures'' is more appropriate. However, the
requestor also stated that the cost of the prosthesis would continue to
be underpaid, despite that recommended reassignment. As an alternative
option, the requestor suggested CMS analyze if there may be other
higher weighted MS-DRGs that could more appropriately compensate
providers for a TMJ replacement with prosthesis procedure.
In addition, the requestor recommended that we analyze all
procedures involving the mandible and maxilla and consider reassignment
of those procedure codes from MS-DRGs 129 (Major Head and Neck
Procedures with CC/MCC or Major Device) and 130 (Major Head and Neck
Procedures without CC/MCC) to MS-DRGs 131 and 132 because the codes
describe procedures that are performed on facial and cranial
structures. Finally, the requestor also suggested another option that
included modifying the surgical hierarchy for MDC 03 by sequencing MS-
DRGs 131 and 132 above MS-DRGs 129 and 130, which the requestor
[[Page 58463]]
asserted would provide for more appropriate payment to providers for
the performance of multiple facial procedures.
In the proposed rule, we discussed these separate but related
requests that involve procedures currently assigned to MS-DRGs 129,
130, 131, 132, 133 and 134 in MDC 03.
As discussed in the proposed rule, in our analysis of the request
involving temporomandibular joint replacements, we first identified the
ICD-10-PCS procedure codes that describe the excision or replacement of
a temporomandibular joint as shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.016
In the proposed rule we noted that the requestor is correct that
procedure codes 0RRC0JZ and 0RRD0JZ that describe replacement of the
right and left TMJ with a prosthesis (synthetic substitute) by an open
approach group to MS-DRGs 133 and 134 and procedure codes 0RBC0ZZ and
0RBD0ZZ that describe excision of the right and left TMJ alone by an
open approach group to the higher weighted MS-DRGs 131 and 132. We also
noted that the corresponding related codes as previously listed in the
table that describe different approaches (excision procedures) or
different types of tissue substitute (replacement procedures) are also
assigned to the same respective MS-DRGs.
We stated in the proposed rule that we examined claims data from
the September 2019 update of the FY 2019 MedPAR file for MS-DRGs 133
and 134 to identify cases reporting ICD-10-PCS codes 0RRC0JZ or
0RRD0JZ. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.017
In MS-DRG 133, we found a total of 1,757 cases with an average
length of stay of 5.6 days and average costs of $15,337. Of those 1,757
cases, there were 13 cases reporting ICD-10-PCS code 0RRC0JZ or
0RRD0JZ, with an average length of stay of 3.1 days and average costs
of $21,677. In MS-DRG 134, we found a total of 849 cases with an
average length of stay of 2.5 days and average costs of $9,512. Of
those 849 cases, there were 23 cases reporting ICD-10-PCS code 0RRC0JZ
or 0RRD0JZ, with an average length of stay of 2.1 days and average
costs of $20,430. The analysis shows that cases reporting ICD-10-PCS
procedure codes 0RRC0JZ or 0RRD0JZ in MS-DRGs 133 and 134 have higher
average costs ($21,677 versus $15,337 and $20,430 versus $9,512,
respectively) and shorter lengths of stay (3.1 days versus 5.6 days and
2.1 days versus 2.5 days, respectively) compared to all the cases in
their assigned MS-DRG.
We also examined claims data from the September 2019 update of the
FY 2019 MedPAR file for MS-DRGs 131 and 132. Our findings are shown in
the following table.
[[Page 58464]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.018
In MS-DRG 131, we found a total of 1,181 cases with an average
length of stay of 5.4 days and average costs of $18,875. In MS-DRG 132,
we found a total of 464 cases with an average length of stay of 2.5
days and average costs of $11,558.
We stated in the proposed rule that overall, the data analysis
shows that the average costs for the cases reporting procedure codes
0RRC0JZ and 0RRD0JZ in MS-DRGs 133 and 134 are more aligned with the
average costs for all the cases in MS-DRG 131 ($21,677 and $20,430,
respectively versus $18,875) compared to MS-DRG 132 where the average
costs are not significantly different than the average costs of all the
cases in MS-DRG 134 ($11,558 versus $9,512). We stated that our
clinical advisors agreed that the replacement of a TMJ with prosthesis
procedures (codes 0RRC0JZ or 0RRD0JZ) are more resource intensive and
are clinically distinct from the cases reporting procedure codes
0RBC0ZZ and 0RBD0ZZ that involve excision of the TMJ alone. They also
agreed that procedure codes 0RRC0JZ and 0RRD0JZ should be reassigned to
a higher weighted MS-DRG. However, they recommended we conduct further
claims analysis to identify if there are other MS-DRGs in MDC 03 where
cases reporting these procedure codes may also be found and to compare
that data.
As previously noted, the requestor had also recommended that we
analyze all procedures involving the mandible and maxilla and consider
reassignment of those procedure codes from MS-DRGs 129 and 130 to MS-
DRGs 131 and 132. The requestor did not provide a specific list of the
procedure codes involving the mandible and maxilla, therefore, we
reviewed the list of procedure codes in MS-DRGs 129 and 130 and
identified the following 26 procedure codes describing procedures
performed on the mandible. There were no procedure codes describing
procedures performed on the maxilla in MS-DRGs 129 and 130.
[GRAPHIC] [TIFF OMITTED] TR18SE20.019
As noted in the proposed rule, based on the advice of our clinical
advisors as previously discussed, we conducted additional analyses for
MDC 03 using the same FY 2019 MedPAR data file and found cases
reporting procedure code 0RRC0JZ or 0RRD0JZ for the replacement of a
TMJ with prosthesis procedure in MS-DRGs 129, 130, 131, and 132. As
discussed in section II.D.15. of the proposed rule and section II.E.15.
of this final rule, cases with multiple procedures are assigned to the
highest surgical class in the hierarchy to which one of the procedures
is assigned. For example, if procedure code 0RRC0JZ which is assigned
to the logic for MS-DRGs 133 and 134 is reported on a claim with
procedure code 0NSR04Z (Reposition maxilla with internal fixation
device, open approach), which
[[Page 58465]]
is assigned to the logic for MS-DRGs 131 and 132, the case will group
to MS-DRG 131 or 132 (depending on the presence of a CC or MCC) when
reported with a principal diagnosis from MDC 03 because MS-DRGs 131 and
132 are sequenced higher in the surgical hierarchy than MS-DRGs 133 and
134. Therefore, since MS-DRGs 129, 130, 131, and 132 are sequenced
higher in the surgical hierarchy than MS-DRGs 133 and 134 in MDC 03,
cases reporting procedure code 0RRC0JZ or 0RRD0JZ along with another
O.R. procedure that is currently assigned to one of those MS-DRGs in
the GROUPER logic results in case assignment to one of those higher
surgical class MS-DRGs. We also identified cases reporting procedures
performed on the mandible from the previously discussed list of
procedure codes in MS-DRGs 129 and 130. Our findings are shown in the
following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.020
As shown in the table, for MS-DRG 129, there was a total of 2,080
cases with average length of stay of 5.2 days and average costs of
$18,091. Of these 2,080 cases, there were 3 cases reporting a TMJ
replacement with prosthesis procedure (code 0RRC0JZ or 0RRD0JZ) with an
average length of stay of 3 days and average costs of $33,581 and 592
cases reporting a mandible procedure with average length of stay of 6.9
days and average costs of $21,258. For MS-DRG 130, there was a total of
948 cases with average length of stay of 2.7 days and average costs of
$11,092. Of these 948 cases, there were there were 5 cases reporting a
TMJ replacement with prosthesis procedure (code 0RRC0JZ or 0RRD0JZ)
with an average length of stay of 3.4 days and average costs of $27,396
and 202 cases reporting a mandible procedure with average length of
stay of 3.5 days and average costs of $14,712. For MS-DRG 131, there
was a total of 1,181 cases with average length of stay of 5.4 days and
average costs of $18,875. Of these 1,181 cases there were 4 cases
reporting a TMJ replacement with prosthesis procedure (code 0RRC0JZ or
0RRD0JZ) with an average length of stay of 7.3 days and average costs
of $31,151. For MS-DRG 132, there was a total of 464 cases with average
length of stay of 2.5 days and average costs of $11,558. Of these 464
cases, there were 10 cases reporting a TMJ replacement with prosthesis
procedure (code 0RRC0JZ or 0RRD0JZ) with an average length of stay of
3.1 days and average costs of $24,099.
The data analysis demonstrates that the average costs of cases
reporting procedure code 0RRC0JZ or 0RRD0JZ for the replacement of a
TMJ with prosthesis procedure in MS-DRGs 129, 130, 131, and 132 and the
cases reporting procedures performed on the mandible in MS-DRGs 129 and
130 have higher average costs compared to all the cases in their
assigned MS-DRGs. While the volume of the cases reporting procedure
code 0RRC0JZ or 0RRD0JZ was low with a total of 22 cases across MS-DRGs
129, 130, 131, and 132, similar to the analysis results for MS-DRGs 133
and 134 described earlier, the average costs for the cases are higher
($33,581 versus $18,091; $27,396 versus $11,092; $31,151 versus
$18,875; and $24,099 versus $11,558) affirming that replacement of a
TMJ with prosthesis procedures are more costly. The analysis also
demonstrates that the average length of stay for cases reporting
procedure code 0RRC0JZ or 0RRD0JZ across MS-DRGs 130, 131, and 132 is
longer (3.4 days versus 2.7 days; 7.3 days versus 5.4 days; and 3.1
days versus 2.5 days) compared to all the cases in their assigned MS-
DRGs. For MS-DRG 129, we found that the average length of stay was
shorter (3 days versus 5.2 days) for cases reporting procedure code
0RRC0JZ or 0RRD0JZ. The data demonstrated similar results for the cases
reporting procedures performed on the mandible in MS-DRGs 129 and 130,
where the average costs for the cases are higher ($21,258 versus
$18,091 and $14,712 versus $11,092, respectively) and the average
length of stay was longer (6.9 days versus 5.2 days and 3.5 days versus
2.7 days, respectively) compared to all the cases in their assigned MS-
DRG.
The analysis of MS-DRGs 129, 130, 131, and 132 further demonstrated
that the average length of stay and average costs for all cases were
almost identical for each of the subgroups. For example, MS-DRG 129 is
defined as ``with CC/MCC or major device'' and MS-DRG 131 is defined as
``with CC/MCC'' while MS-DRGs 130 and 132 are both defined as ``without
CC/MCC''. For all of the cases in MS-DRG 129, we found that the average
length of stay was 5.2 days with an average cost of $18,091, and for
all of the cases in MS-DRG 131, the average length of stay was 5.4 days
with an average cost of $18,875. Similarly, for all of the cases in MS-
DRG 130, we found that the average length of stay was 2.7 days with an
average cost of $11,092, and for MS-DRG 132, we found the average
length of stay was 2.5 days with an average cost of $11,558.
We noted in the proposed rule that as a result of the data analysis
performed for MS-DRGs 129, 130, 131, and 132, including the analysis of
the procedures describing replacement of a TMJ with prosthesis in MS-
DRGs 133 and 134, as well as considering the requestor's suggestion
that we examine the appropriateness of modifying the surgical hierarchy
for MDC 03 by sequencing MS-DRGs 131 and 132
[[Page 58466]]
above MS-DRGs 129 and 130 to enable more appropriate payment for the
performance of multiple facial procedures, our clinical advisors
recommended evaluating all the procedures currently assigned to MS-DRGs
129, 130, 131, 132, 133, and 134 to compare costs, complexity of
service and clinical coherence to assess any potential reassignment of
these procedures. We refer the reader to the ICD-10 MS-DRG Definitions
Manual Version 37, which is available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software, for
complete documentation of the GROUPER logic for MS-DRGs 129, 130, 131,
132, 133, and 134.
As noted in the proposed rule, we examined claims data from the
September 2019 update of the FY 2019 MedPAR file for cases reporting
any of the procedure codes that are currently assigned to MS-DRGs 129,
130, 131, 132, 133, or 134. We refer the reader to Table 6P.2d
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/ for the detailed analysis. We
note that if a procedure code that is currently assigned to MS-DRGs
129, 130, 131, 132, 133, or 134 is not displayed it is because there
were no cases found reporting that code in the assigned MS-DRG.
The data analysis shows that there is wide variation in the volume,
length of stay, and average costs of cases reporting procedures
currently assigned to MS-DRGs 129, 130, 131, 132, 133, and 134. There
were several instances in which only one case was found to report a
procedure code from MS-DRG 129, 130, 131, 132, 133, or 134, and the
average length of stay for these specific cases ranged from 1 day to 31
days. For example, in MS-DRG 131, we found one case reporting procedure
code 0NB70ZZ (Excision of occipital bone, open approach) with an
average length of stay of 31 days which we consider to be an outlier in
comparison to all the other cases reported in that MS-DRG with an
average length of stay of 5.4 days. Overall, the average costs of cases
in MS-DRGs 129 and 130 range from $4,970 to $38,217, the average costs
of cases in MS-DRGs 131 and 132 range from $4,022 to $69,558 and the
average costs of cases in MS-DRGs 133 and 134 range from $1,089 to
$87,569. As noted previously, the data demonstrate there appear to be
similar utilization of hospital resources specifically for cases
reported in MS-DRGs 129, 130, 131 and 132.
The highest volume of cases was reported in MS-DRGs 129 and 130 for
the procedure codes describing resection of the right and left neck
lymphatic. For MS-DRG 129, there was a total of 750 cases reporting
procedure code 07T10ZZ (Resection of right neck lymphatic, open
approach) with an average length of stay of 4.7 days and average costs
of $17,155 and there was a total of 679 cases reporting procedure code
07T20ZZ (Resection of left neck lymphatic, open approach) with an
average length of stay of 4.8 days and average costs of $17,857. For
MS-DRG 130, there was a total of 358 cases reporting procedure code
07T10ZZ with an average length of stay of 2.6 days and average costs of
$10,432 and there was a total of 331 cases reporting procedure code
07T20ZZ with an average length of stay of 2.5 days and average costs of
$10,467. For MS-DRGs 131 and 132, the highest volume of cases was
reported for the procedure codes describing repositioning of the
maxilla with internal fixation and repositioning of the right and left
mandible with internal fixation. For MS-DRG 131, there was a total of
186 cases reporting procedure code 0NSR04Z (Reposition maxilla with
internal fixation device, open approach) with an average length of stay
of 5.1 days and average costs of $20,500; a total of 114 cases
reporting procedure code 0NST04Z (Reposition right mandible with
internal fixation device, open approach) with an average length of stay
of 5.7 days and average costs of $18,710, and a total of 219 cases
reporting procedure code 0NSV04Z (Reposition left mandible with
internal fixation device, open approach) with an average length of stay
of 6.0 days and average costs of $20,202. For MS-DRG 132, there was a
total of 84 cases reporting procedure code 0NSR04Z with an average
length of stay of 2.1 days and average costs of $12,991 and a total of
101 cases reporting procedure code 0NSV04Z with an average length of
stay of 2.8 days and average costs of $11,386. For MS-DRGs 133 and 134,
the highest volume of cases was reported for the procedure codes
describing excision of the facial nerve or nasal turbinate. For MS-DRG
133, there was a total of 60 cases reporting procedure code 09BL8ZZ
(Excision of nasal turbinate, via natural or artificial opening
endoscopic) with an average length of stay of 6.6 days and average
costs of $21,253 and for MS-DRG 134, there was a total of 50 cases
reporting procedure code 00BM0ZZ (Excision of facial nerve, open
approach) with an average length of stay of 1.4 days and average costs
of $8,048.
Our clinical advisors reviewed the procedures currently assigned to
MS-DRGs 129, 130, 131, 132, 133, and 134 to identify the patient
attributes that currently define each of these procedures and to group
them with respect to complexity of service and resource intensity. For
example, procedures that we believe represent greater treatment
difficulty and reflect a class of patients who are similar clinically
with regard to consumption of hospital resources were grouped
separately from procedures that we believe to be less complex but still
reflect patients who are similar clinically with regard to consumption
of hospital resources. This approach differentiated the more complex
and invasive procedures, such as resection of cervical lymph nodes,
repositioning of facial bones, and excision of mandible procedures from
the less complex and less invasive procedures such as excisions
(biopsies) of lymph nodes and facial nerves, drainage procedures of the
upper respiratory system, and tonsillectomies.
We stated in the proposed rule that after this comprehensive review
of all the procedures currently assigned to MS-DRGs 129, 130, 131, 132,
133, and 134, in combination with the results of the data analysis
discussed previously, our clinical advisors support distinguishing the
procedures currently assigned to those MS-DRGs by clinical intensity,
complexity of service and resource utilization and also support
restructuring of these MS-DRGs accordingly. We noted that during the
analysis of the procedures currently assigned to MS-DRGs 129 and 130,
we recognized the special logic defined as ``Major Device Implant'' for
MS-DRG 129 that identifies procedures describing the insertion of a
cochlear implant or other hearing device. We stated that our clinical
advisors supported the removal of this special logic from the
definition for assignment to any modifications to the MS-DRGs, noting
the costs of the device have stabilized over time and the procedures
can be appropriately grouped along with other procedures involving
devices in any restructured MS-DRGs. We also identified 2 procedure
codes currently assigned to MS-DRGs 131 and 132, 00J00ZZ (Inspection of
brain, open approach) and 0WJ10ZZ (Inspection of cranial cavity, open
approach), that our clinical advisors agreed should not be included in
any modifications to the MS-DRGs in MDC 03, stating that they are
appropriately assigned to MS-DRGs
[[Page 58467]]
in MDC 01 (Diseases and Disorders of the Nervous System). We further
noted that during our analysis of the procedures currently assigned to
MS-DRGs 133 and 134, we found 338 procedure codes that were
inadvertently included as a result of replication during our transition
from the ICD-9 to ICD-10 based MS-DRGs. We referred the reader to Table
6P.2c associated with the proposed rule for a detailed list of these
procedure codes that describe procedures performed on various sites,
such as the esophagus, stomach, intestine, skin, and thumb that we
stated our clinical advisors agree should be removed from the
definition for assignment to any modifications to the MS-DRGs under MDC
03.
As a result of our review, we proposed the deletion of MS-DRGs 129,
130, 131, 132, 133, and 134, and the creation of six new MS-DRGs.
Currently, MS-DRGs 129, 131, and 133 are defined as base MS-DRGs, each
of which is split by a two-way severity level subgroup. Our proposal
includes the creation of two new base MS-DRGs with a three-way severity
level split. As discussed in the proposed rule, our clinical advisors
suggested that based on the analysis of procedures currently assigned
to MS-DRGs 129, 130, 131, 132, 133, and 134 as described previously,
only 2 base MS-DRGs were needed, each divided into 3 levels according
to the presence of a CC or MCC. The MS-DRGs were developed consistent
with the analysis to differentiate the more complex and invasive
procedures from the less complex and less invasive procedures. As noted
previously, our analysis of MS-DRGs 129, 130, 131, and 132 demonstrated
that the average length of stay and average costs for all cases were
almost identical for each of the severity level subgroups and
therefore, the procedures assigned to these MS-DRGs were initially
reviewed together as one clinical group and then evaluated further in
comparison to the procedures currently assigned to MS-DRGs 133 and 134.
The objective was to better differentiate procedures by treatment
difficulty, clinical similarity, and resource use, and to propose a
more appropriate restructuring. For example, based on this analysis, in
some instances, we proposed to reassign procedures described by
procedure codes that are currently assigned to MS-DRGs 129 and 130 or
MS-DRGs 131 and 132 to what is being defined as the less complex MS-
DRGs. We stated that we believe the resulting MS-DRG assignments are
more clinically homogeneous, coherent and better reflect hospital
resource use.
We applied the criteria to create subgroups for the three-way
severity level split for the proposed new MS-DRGs and found that all
five criteria were met. We stated that for the proposed new MS-DRGs,
there is at least (1) 500 cases in the MCC group, the CC group and the
NonCC group; (2) 5 percent of the cases in the MCC group, the CC group
and the NonCC group; (3) a 20 percent difference in average costs
between the MCC group, the CC group and the NonCC group; (4) a $2,000
difference in average costs between the MCC group, the CC group and the
NonCC group; and (5) a 3-percent reduction in cost variance, indicating
that the severity level splits increase the explanatory power of the
base MS-DRG in capturing differences in expected cost between the MS-
DRG severity level splits by at least 3 percent and thus improve the
overall accuracy of the IPPS payment system. The following table
reflects our simulation for the proposed new MS-DRGs with a three-way
severity level split. We stated that our findings represent what we
would expect under the proposed modifications and proposed new MS-DRGs,
based on claims data in the FY 2019 MedPAR file.
[GRAPHIC] [TIFF OMITTED] TR18SE20.021
We proposed to create two new base MS-DRGs, 140 and 143, with a
three-way severity level split for proposed new MS-DRGs 140, 141, and
142 (Major Head and Neck Procedures with MCC, with CC, and without CC/
MCC, respectively) and proposed new MS-DRGs 143, 144, and 145 (Other
Ear, Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively).
We referred the reader to Table 6P. 2a and Table 6P.2b associated
with the proposed rule for the list of procedure codes we proposed for
reassignment from MS-DRGs 129, 130, 131, 132, 133, and 134 to each of
the new MS-DRGs. As noted, we also proposed the removal of procedure
codes 00J00ZZ and 0WJ10ZZ, and the 338 procedure codes listed in Table
6P. 2c associated with the proposed rule from the logic for MDC 03.
Comment: Commenters generally agreed with the proposal to delete
MS-DRGs 129, 130, 131, 132, 133, and 134, and to create proposed new
MS-DRGs 140, 141, and 142 under proposed new base MS-DRG 140, and to
create proposed new MS-DRGs 143, 144, and 145 under proposed new base
MS-DRG 143, however, the commenters recommended CMS review the list of
proposed procedure codes for assignment to the proposed new MS-DRGs. A
commenter noted that procedure codes describing reposition of the left
temporal bone were included in Table 6P.2a and proposed for assignment
to MS-DRGs 140,141, and 142 while procedure codes describing reposition
of the right temporal bone were included in Table 6P.2b and proposed
for assignment to MS-DRGs 143, 144, and 145. The commenter also
[[Page 58468]]
stated their belief that CMS should classify all repositions of
occipital, temporal, frontal and other bones of the skull as major
surgery and assign them to proposed new MS-DRGs 140, 141, and 142. The
commenter provided the following ICD-10-PCS procedure codes for CMS'
consideration.
[GRAPHIC] [TIFF OMITTED] TR18SE20.022
Another commenter stated there is not a clear understanding of the
scope of the proposed changes because the MedPAR data included in the
proposed rule referred to temporomandibular joint replacements;
however, the procedure listing for the MS-DRGs extended beyond those
procedures. The commenter stated that tables 6P.2a and
[[Page 58469]]
6P.2b associated with the proposed rule include procedures on vessels,
lymphatic and other organs in the head and neck. The commenter stated
the procedures noted in the tables cross multiple MS-DRGs such as 853,
857, 856, 571, 264, 570, 463, and 902 which were not discussed in the
proposed rule. The commenter requested that CMS provide clarity on this
topic.
A commenter acknowledged that CMS proposed removing a number of
ICD-10-PCS procedure codes from the MDC 03 logic that had been
inadvertently included as a result of replication during the transition
from ICD-9- to ICD-10-based MS-DRGs. However, according to the
commenter there are additional procedure codes not included on CMS'
list shown in table 6P.2c that should also be removed from the MDC 03
logic. The commenter noted an example of where some codes for
procedures on the esophagus have been proposed for removal from the MDC
03 logic, while other procedures performed on the esophagus are still
proposed for inclusion in the GROUPER logic. The commenter also noted
that procedures performed on the heart, carotid artery, chest, back
abdomen, buttock, liver, and leg are not ear, nose, mouth, or throat
procedures, but they are included in the proposed GROUPER logic for
proposed new MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth and
Throat O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively). The commenter stated that procedures on the chest, back,
and abdomen are not head or neck procedures, but they are included in
the proposed GROUPER logic for proposed new MS-DRGs 140, 141, and 142
(Major Head and Neck Procedures with MCC, with CC, and without CC/MCC,
respectively). In addition, the commenter stated that while CMS
proposed reassigning procedure code 0WJ10ZZ (Inspection of cranial
cavity, open approach) from MDC 03 (Diseases and Disorders of Ear, Nose
and Throat) to MDC 01 (Diseases and Disorders of the Nervous System),
codes for other procedures performed on the cranial cavity are proposed
to be included in the GROUPER logic for proposed new MS-DRGs 140, 141,
and 142. The commenter recommended that CMS review the procedure codes
listed in tables 6P.2a and 6P.2b to identify all of the procedure codes
that should be removed from the GROUPER logic for proposed new MS-DRGs
140, 141, 142, 143, 144, and 145. Lastly, the commenter suggested that
CMS consider whether proposed new MS-DRGs 140, 141, and 142 (Major Head
and Neck Procedures with MCC, with CC, and without CC/MCC,
respectively) belong in MDC 03 or whether the title of the MDC should
be changed since, according to the commenter, the MDC 03 description
``Diseases and Disorders of Ear, Nose and Throat'' covers a more
limited set of anatomic sites than the ``major head and neck
procedures'' included in proposed new MS-DRGs 140, 141, and 142.
Response: We thank the commenters for their support of the proposal
to create two new base MS-DRGs, 140 and 143, with a three-way severity
level split for new MS-DRGs 140, 141, and 142 and new MS-DRGs 143, 144,
and 145. We appreciate the commenter noting that some procedure codes
describing reposition of the left temporal bone were included in Table
6P.2a and proposed for assignment to proposed new MS-DRGs 140, 141, and
142, while procedure codes describing reposition of the right temporal
bone were included in Table 6P.2b and proposed for assignment to
proposed new MS-DRGs 143, 144, and 145. We note that this was an
inadvertent error, and the procedure codes describing reposition of the
left temporal bone that were included in Table 6P.2a were intended to
be included in Table 6P.2b with the codes describing reposition of the
right temporal bone, as both sets of codes were intended to be proposed
for reassignment to proposed new MS-DRGs 143, 144, and 145 because they
describe procedures that are considered to be less complex and less
invasive compared to the procedures proposed for reassignment to
proposed new MS-DRGs 140, 141, and 142 that describe more complex and
more invasive procedures. In response to the commenter's recommendation
to classify all repositions of occipital, temporal, frontal and other
bones of the skull as major surgery and assign them to proposed new MS-
DRGs 140, 141, and 142, our clinical advisors do not agree. In the
comprehensive review of all the procedures currently assigned to MS-
DRGs 129, 130, 131, 132, 133, and 134, which involved an analysis of
claims data and clinical judgment, they identified and separated out
the procedures they believed to be more clinically complex and resource
intensive and those are the procedures that were proposed to be
reassigned to proposed new MS-DRGs 140, 141, and 142 so that payment
rates are better aligned. Therefore, with respect to the procedure
codes describing reposition of temporal, frontal and other bones of the
skull identified by the commenter, our clinical advisors do not believe
these procedures reflect the complexity or resource utilization
consistent with the other procedure codes proposed for reassignment to
proposed new MS-DRGs 140, 141, and 142 because they are considered to
be less complex and less resource intensive. We note that while the
commenter suggested CMS review the procedure codes describing
reposition of the occipital bone, it did not include any of those
procedure codes for CMS' consideration in its list. We further note
that procedure codes describing reposition of the occipital bone were
already proposed to be reassigned to proposed new MS-DRGs 140, 141, and
142 as displayed in table 6P.2a associated with the proposed rule,
therefore we are unclear as to which procedure codes involving the
occipital bone the commenter is specifically referring to.
In response to the commenter who stated there is not a clear
understanding of the scope of the proposed changes because the MedPAR
data included in the proposed rule referred to other procedure codes in
addition to the procedure code for temporomandibular joint
replacements, we note that as discussed in the proposed rule (85 FR
32484 through 32490), this was a multi-part request involving the
reassignment of ICD-10-PCS procedure codes 0RRC0JZ and 0RRD0JZ that
describe replacement of the right and left temporomandibular joint from
MS-DRGs 133 and 134 to MS-DRGs 131 and 132, the reassignment of the
procedures involving the mandible and maxilla identified with procedure
codes from MS-DRGs 129 and 130 to MS-DRGs 131 and 132, and modifying
the surgical hierarchy for MS-DRGs 131, 132, 133, and 134. We stated
that we examined claims data for all the procedures identified by
procedure codes currently assigned to MS-DRGs 129, 130, 131, 132, 133,
and 134 and we provided our claims analysis in Table 6P.2d associated
with the proposed rule as well as discussion of our analysis and the
basis for our proposals. In response to the comments regarding Tables
6P.2a and 6P.2b that included proposals for procedure codes describing
procedures on vessels, lymphatic and other organs in the head and neck
across multiple MS-DRGs such as 853, 857, 856, 571, 264, 570, 463, and
902 we note that this is because certain procedure codes are currently
assigned to multiple MDCs and MS-DRGs as shown in Appendix E-Operating
Room Procedures and Procedure Code/MS-DRG Index of the ICD-10 MS-DRGs
Definitions Manual. For example, procedure code 07B00ZZ (Excision of
head lymphatic, open approach) which is listed in Table
[[Page 58470]]
6P.2b, is currently assigned to the following MDCs and MS-DRGs.
[GRAPHIC] [TIFF OMITTED] TR18SE20.023
We encourage the commenter to review Appendix E of the ICD-10 MS-
DRG Definitions Manual for further clarification and understanding of
how each procedure code may be assigned to multiple MDCs and MS-DRGs
under the IPPS.
In response to the commenter who stated their belief that there are
additional codes that should also be removed from the MDC 03 logic,
such as other procedures performed on the esophagus that were proposed
to be included in the GROUPER logic, and procedures performed on the
heart, carotid artery, chest, back abdomen, buttock, liver, and leg
that are not ear, nose, mouth, or throat procedures, but were included
in the proposed GROUPER logic for MS-DRGs 143, 144, and 145 (Other Ear,
Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and without
CC/MCC, respectively), we note that, as stated in the ICD-10 MS-DRG
Definitions Manual, ``In each MDC there is usually a medical and a
surgical class referred to as ``other medical diseases'' and ``other
surgical procedures,'' respectively. The ``other'' medical and surgical
classes are not as precisely defined from a clinical perspective. The
other classes would include diagnoses or procedures which were
infrequently encountered or not well defined clinically. For example,
the ``other'' medical class for the Respiratory System MDC would
contain the diagnoses ``other somatoform disorders'' and ``congenital
malformation of the respiratory system,'' while the ``other'' surgical
class for the female reproductive MDC would contain the surgical
procedures ``excision of liver'' (liver biopsy in ICD-9-CM) and
``inspection of peritoneal cavity'' (exploratory laparotomy in ICD-9-
CM). The ``other'' surgical category contains surgical procedures
which, while infrequent, could still reasonably be expected to be
performed for a patient in the particular MDC. There are, however, also
patients who receive surgical procedures which are completely unrelated
to the MDC to which the patient was assigned. An example of such a
patient would be a patient with a principal diagnosis of pneumonia
whose only surgical procedure is a destruction of prostate
(transurethral prostatectomy in ICD-9-CM). Such patients are assigned
to a surgical class referred to as ``unrelated operating room
procedures.'' These patients are ultimately never assigned to a well-
defined DRG.'' With regard to the comment that procedures on the chest,
back, and abdomen were included in the proposed GROUPER logic for
proposed new MS-DRGs 140, 141, and 142 (Major Head and Neck Procedures
with MCC, with CC, and without CC/MCC, respectively), we note that the
commenter did not provide the specific procedure codes for CMS to
review and therefore we were unable to evaluate the commenter's
concerns for FY 2021, however, we will take these comments under
consideration for future rulemaking. In response to the commenter's
statement that codes for other procedures performed on the cranial
cavity were proposed to be included in the GROUPER logic for proposed
new MS-DRGs 140, 141, and 142, we note that the logic for proposed new
MS-DRGs 140, 141, and 142 is comprised of a subset of procedure codes
describing procedures performed on the cranial cavity that are
currently assigned to MS-DRGs 131 and 132 (Cranial and Facial
Procedures with and without CC/MCC, respectively). Our clinical
advisors reviewed the list of procedures currently assigned to those
MS-DRGs and believed that procedure codes 00J00ZZ and 0WJ10ZZ could be
removed from the logic based on the analysis of all the procedure codes
and because these codes are currently assigned to MS-DRGs in MDC 01
which they stated is clinically more appropriate. With respect to the
commenter's suggestion that CMS consider whether proposed new MS-DRGs
140, 141, and 142 (Major Head and Neck Procedures with MCC, with CC,
and without CC/MCC, respectively) belong in MDC 03 or whether the title
of the MDC should be changed since, according to the commenter, the MDC
03 description ``Diseases and Disorders of Ear, Nose and Throat''
covers a more limited set of anatomic sites than the ``major head and
neck procedures'' included in proposed new MS-DRGs 140, 141, and 142,
we will take this under consideration for future rulemaking.
After consideration of the comments we received, we are finalizing
our proposal to create two new base MS-DRGs, 140 and 143, with a three-
way severity level split for new MS-DRGs 140, 141, and 142 and new MS-
DRGs 143, 144, and 145 and we are also finalizing our proposal to
delete MS-
[[Page 58471]]
DRGs 129, 130, 131, 132, 133, and 134 for FY 2021. We refer the reader
to Tables 6P.2a, 6P.2b, and 6P.2c associated with this final rule and
available via the internet at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS for the finalized list of
procedure codes that define the logic for the finalized MS-DRGs. We
note that discussion of the surgical hierarchy for the modifications is
discussed in section II.E.15. of this final rule.
5. MDC 5 (Diseases and Disorders of the Circulatory System)
a. Left Atrial Appendage Closure (LAAC)
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49363 through
49367), we finalized our proposal to create two new MS-DRGs to classify
percutaneous intracardiac procedures. Specifically, we created MS-DRGs
273 and 274 (Percutaneous Intracardiac Procedures with and without MCC,
respectfully) for cases reporting procedure codes describing cardiac
ablation and other percutaneous intracardiac procedures. In that
discussion, as FY 2016 was the first year of our transition from the
ICD-9 based MS-DRGs to the ICD-10 based MS-DRGs, we provided a list of
the ICD-9-CM procedure codes that identify and describe the cardiac
ablation procedures and other percutaneous intracardiac procedures that
were the subject of that MS-DRG classification change request, one of
which was ICD-9-CM procedure code 37.90 (Insertion of left atrial
appendage device).
Separately, we also discussed a request that we received for new
technology add-on payments for the WATCHMANTM Left Atrial
Appendage Closure (LAAC) device (80 FR 49480 through 49488). In that
discussion, we noted that effective October 1, 2004 (FY 2005), ICD-9-CM
procedure code 37.90 (Insertion of left atrial appendage device) was
created to identify and describe procedures using the
WATCHMANTM Left Atrial Appendage (LAA) Closure Technology
and that under ICD-10-PCS, procedure code 02L73DK (Occlusion of left
atrial appendage with intraluminal device, percutaneous approach) is
the comparable translation. We also noted that at the time of the new
technology request, under the ICD-9 based MS-DRGs, procedure code 37.90
was assigned to MS-DRGs 250 and 251 (Percutaneous Cardiovascular
Procedures without Coronary Artery Stent with MCC and without MCC,
respectively). We further noted that, as stated previously, we
finalized our proposal to assign procedures performed within the heart
chambers using intracardiac techniques, including those identified by
ICD-9-CM procedure code 37.90, and its comparable ICD-10-PCS code
translations (that specifically identify a percutaneous or percutaneous
endoscopic approach), including 02L73DK, to new MS-DRGs 273 and 274.
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32490 through 324950), we received two separate, but related requests
involving the procedure codes that describe the technology that is
utilized in the performance of LAAC procedures. The first request was
to reassign ICD-10-PCS procedure code 02L73DK (Occlusion of left atrial
appendage with intraluminal device, percutaneous approach) that
identifies the WATCHMANTM Left Atrial Appendage Closure
(LAAC) device, from MS-DRG 274 (Percutaneous Intracardiac Procedures
without MCC) to MS-DRG 273 (Percutaneous Intracardiac Procedures with
MCC) and revise the title for MS-DRG 273 to ``Percutaneous Intracardiac
Procedures with MCC or Major Device Implant for Left Atrial Appendage
Closure Procedures''. As stated in the proposed rule, cases involving
LAAC procedures with a percutaneous or percutaneous endoscopic
approach, including cases reporting ICD-10-PCS procedure code 02L73DK,
are currently assigned to MS-DRGs 273 and 274.
We stated in the proposed rule that according to the requestor's
analysis, the average cost for LAAC procedures reporting ICD-10-PCS
procedure code 02L73DK is $3,405 higher than the average cost for all
cases in MS-DRG 274. The requestor stated that based on its analysis,
this requested reassignment would have minimal impact on MS-DRGs 273
and 274 and would ensure adequate payments and better resource
coherency. The requestor stated that cases reporting procedure codes
describing a LAAC procedure with procedure code 02L73DK within MS-DRG
274 are more clinically similar and costs are more closely aligned to
cases within MS-DRG 273.
As indicated in the proposed rule, in response to the first
request, we examined claims data from the September 2019 update of the
FY 2019 MedPAR file for MS-DRGs 273 and 274 to identify cases reporting
ICD-10-PCS procedure code 02L73DK. Our findings are shown in the
following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.024
In MS-DRG 273, we found a total of 7,048 cases with an average
length of stay of 6.1 days and average costs of $28,100. Of those 7,048
cases, there were 1,126 cases reporting ICD-10-PCS procedure code
02L73DK, with an average length of stay of 2.7 days and average costs
of $29,504. In MS-DRG 274, we found a total of 24,319 cases with an
average length of stay of 2.0 days and average costs of $24,048. Of
those 24,319 cases, there were 13,423 cases reporting ICD-10-PCS
procedure code 02L73DK, with an average length of stay of 1.2 days and
average costs of $25,846.
The data analysis demonstrates that the average costs of the cases
reporting procedure code 02L73DK in MS-DRG 274 are slightly higher than
the average costs of all the cases in MS-DRG 274 ($25,846 versus
$24,048), with a difference of approximately $1,798, however, the
average length of stay for cases reporting procedure code 02L73DK in
MS-DRG 274 is shorter compared to all the cases in MS-DRG
[[Page 58472]]
274 (1.2 days versus 2 days). We stated in the proposed rule that if we
were to reassign cases reporting procedure code 02L73DK from MS-DRG 274
to MS-DRG 273, we would be assigning cases with an average length of
stay of 1.2 days to a MS-DRG with an average length of stay of 6.1
days, which our clinical advisors did not support. As indicated in the
proposed rule, the average costs of the cases reporting procedure code
02L73DK in MS-DRG 274 ($25,846) compared to the average costs of all
the cases in MS-DRG 273 ($28,100) show a difference of $2,254. We
stated in the proposed rule that our clinical advisors did not support
reassigning the 13,423 cases reporting procedure code 02L73DK without
an MCC from MS-DRG 274 to MS-DRG 273, which includes cases reporting a
MCC, noting that it would impact the average costs for all cases in
this MS-DRG. Lastly, as stated in the proposed rule, our clinical
advisors expressed concern regarding making MS-DRG changes based on a
specific, single technology (WATCHMANTM Left Atrial
Appendage Closure (LAAC) device), identified by only one unique
procedure code versus considering changes based on a group of related
procedure codes that can be reported to describe that same type or
class of technology, which is more consistent with the intent of the
MS-DRGs. Therefore, for these reasons, we did not propose to reassign
cases reporting ICD-10-PCS procedure code 02L73DK (Occlusion of left
atrial appendage with intraluminal device, percutaneous approach) from
MS-DRG 274 to MS-DRG 273.
In the proposed rule we also discussed a second request that we
received to create a new MS-DRG specific to all left atrial appendage
closure (LAAC) procedures or to map all LAAC procedures to a different
cardiovascular MS-DRG that has payment rates aligned with procedural
costs. The requestor stated that by creating a new MS-DRG specific to
all LAAC procedures or mapping all LAAC procedures to a different
cardiovascular MS-DRG, the MS-DRG would more appropriately recognize
the clinical characteristics and cost differences in LAAC cases.
The 9 ICD-10-PCS procedure codes that describe LAAC procedures and
their corresponding MS-DRG assignment are listed in the following
table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.025
Currently, the MS-DRG assignments for these procedure codes are
based on the surgical approach: open approach, percutaneous approach,
or percutaneous endoscopic approach. Procedures describing an open
approach are assigned to MS-DRGs 250 and 251 (Percutaneous
Cardiovascular Procedures without Coronary Artery Stent with and
without MCC, respectively); while procedures describing a percutaneous
or percutaneous endoscopic approach are assigned to MS-DRGs 273 and 274
(Percutaneous Intracardiac Procedures with and without MCC,
respectfully). Of the nine listed ICD-10-PCS procedure codes, three
(02L70CK, 02L70DK, and 02l70ZK) describe an open approach and are
currently assigned to MS-DRG 250 and 251, and six (02L73CK, 02L73DK,
02L73ZK, 02L74CK, 02L74DK, 02L74ZK) describe a percutaneous or
percutaneous endoscopic approach and are currently assigned to MS-DRG
273 and 274.
As indicated in the proposed rule, we examined claims data from the
September 2019 update of the FY 2019 MedPAR file for cases reporting
LAAC procedures with an open approach in MS-DRGs 250 and 251. Our
findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.026
[[Page 58473]]
In MS-DRG 250, we found a total of 4,192 cases with an average
length of stay of 5.0 days and average costs of $18,807. Of those 4,192
cases, there were 21 cases reporting a LAAC procedure with an open
approach, with an average length of stay of 7.0 days and average costs
of $44,012. In MS-DRG 251, we found a total of 4,941 cases with an
average length of stay of 2.6 days and average costs of $12,535. Of
those 4,941 cases, there were 74 cases reporting a LAAC procedure with
an open approach, with an average length of stay of 3.4 days and
average costs of $22,711. The analysis shows that the cases reporting a
LAAC procedure with an open approach in MS-DRGs 250 and 251 have higher
average costs compared to all cases in MS-DRGs 250 and 251 ($44,012
versus $18,807 and $22,711 versus $12,535, respectively). The analysis
also shows that the average length of stay for cases reporting a LAAC
procedure with an open approach in MS-DRGs 250 and 251 is longer
compared to all cases in MS-DRGs 250 and 251 (7.0 days versus 5.0 days
and 3.4 days versus 2.6 days, respectively). Overall, there were a
total of 95 (21+74) cases reporting a LAAC procedure with an open
approach in MS-DRGs 250 and 251 with an average length of stay of 4.2
days and average costs of $27,420. Based on the results of the claims
data described previously, we conducted further analysis for the 95
cases reporting a LAAC procedure with an open approach in MS-DRGs 250
and 251 to determine if there were additional factors that may be
contributing to the higher average costs and longer length of stay. Of
those 95 cases, we found a total of 20 cases in which there was another
O.R. procedure reported on the claim that is also currently assigned to
MS-DRGs 250 and MS-DRG 251 and believed to be influencing the average
costs and average length of stay, as shown in the following tables.
[GRAPHIC] [TIFF OMITTED] TR18SE20.027
As shown in the table, for MS-DRG 250, there were a total of 8
cases reporting another O.R. procedure with a LAAC procedure with an
open approach with an average length of stay of 8.9 days and average
costs of $63,653. The data shows that the average length of stay for
these 8 cases range from 4.0 days to 15.0 days and the average costs
range from $20,650 to $235,720.
As indicated in the proposed rule, overall, the data demonstrates
that the 8 cases reporting another O.R. procedure with a LAAC procedure
with an open approach in MS-DRG 250 have a longer length of stay (8.9
days versus 7 days) and higher average costs ($63,653 versus $44,012)
compared to all 21 cases reporting a LAAC procedure with an open
approach in MS-DRG 250.
[[Page 58474]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.028
As shown in the table, for MS-DRG 251, there were a total of 12
cases reporting another O.R. procedure with a LAAC procedure with an
open approach with an average length of stay of 6.5 days and average
costs of $31,560. The data shows that the average length of stay for
these 12 cases range from 1.0 day to 18.0 days and the average costs
range from $11,052 to $89,682.
As indicated in the proposed rule, the data demonstrates that the
12 cases reporting another O.R. procedure with a LAAC procedure with an
open approach in MS-DRG 251 have a longer average length of stay (6.5
days versus 3.4 days) and higher average costs ($31,560 versus $22,711)
compared to all 74 cases reporting a LAAC procedure with an open
approach in MS-DRG 251. The results of our claims analysis for the 20
cases reporting a LAAC procedure with an open approach and another O.R.
procedure in MS-DRGs 250 and 251 indicate that the longer average
length of stay and higher average costs of the 95 cases reporting a
LAAC procedure with an open approach in MS-DRGs 250 and 251 may be
attributed to the resource consumption of the additional O.R.
procedures reported in the subset of 20 cases. The claims analysis also
shows that the majority of the cases reporting a LAAC procedure with an
open approach in MS-DRGs 250 and 251 (75 cases out of 95 cases) were
without another O.R. procedure.
As noted previously, with respect to the first LAAC MS-DRG request,
our analysis of MS-DRG 273 found a total of 7,048 cases with an average
length of stay of 6.1 days and average costs of $28,100 and our
analysis of MS-DRG 274 found a total of 24,319 cases with an average
length of stay of 2.0 days and average costs of $24,048. The average
costs and average length of stay for cases reporting a LAAC procedure
with an open approach in MS-DRGs 250 and 251 ($44,012 and $22,711,
respectively) and (7.0 days and 3.4 days, respectively) appear to be
generally more aligned with the average costs and average length of
stay for all cases in MS-DRGs 273 and 274 ($28,100 and $24,048,
respectively) and (6.1 days and 2.0 days, respectively) as compared to
all cases in MS-DRGs 250 and 251 with average costs of $18,807 and
$12,535, respectively and an average length of stay of 5.0 days and 2.6
days, respectively. In addition, as also noted previously, the second
LAAC MS-DRG request was to create a new MS-DRG specific to all left
atrial appendage closure (LAAC) procedures or to map all LAAC
procedures to a different cardiovascular MS-DRG that has payment rates
aligned with procedural costs. We stated in the proposed rule that our
clinical advisors suggested that because our review of the cases
reporting a LAAC procedure with an open approach in MS-DRGs 250 and 251
demonstrated that these procedures are primarily performed in the
absence of another O.R. procedure and generally are not performed with
a more intensive
[[Page 58475]]
open chest procedure, that we should evaluate cases reporting LAAC
procedures with the other approaches in their assigned MS-DRGs.
As indicated in the proposed rule, we then examined claims data
from the September 2019 update of the FY 2019 MedPAR file for cases
reporting LAAC procedures with a percutaneous or percutaneous
endoscopic approach in MS-DRGs 273 and 274. Our findings are shown in
the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.029
In MS-DRG 273, we found a total of 7,048 cases with an average
length of stay of 6.1 days and average costs of $28,100. Of those 7,048
cases, there were 1,180 cases reporting a LAAC procedure with a
percutaneous or percutaneous endoscopic approach, with an average
length of stay of 2.9 days and average costs of $29,591. In MS-DRG 274,
we found a total of 24,319 cases with an average length of stay of 2.0
days and average costs of $24,048. Of those 24,319 cases, there were
13,774 cases reporting a LAAC procedure with a percutaneous or
percutaneous endoscopic approach, with an average length of stay of 1.2
days and average costs of $25,765.
The analysis shows that the cases reporting a LAAC procedure with a
percutaneous or percutaneous endoscopic approach in MS-DRGs 273 and 274
have very similar average costs compared to all the cases in MS-DRGs
273 and 274 ($29,591 versus $28,100 and $25,765 versus $24,048,
respectively). The analysis also shows that the average length of stay
for cases reporting a LAAC procedure with a percutaneous or
percutaneous endoscopic approach in MS-DRGs 273 and 274 is shorter
compared to all cases in MS-DRGs 273 and 274 (2.9 days versus 6.1 days
and 1.2 days versus 2.0 days, respectively). Overall, there were a
total of 14,954 (1,180 + 13,774) cases reporting a LAAC procedure with
a percutaneous or percutaneous endoscopic approach in MS-DRGs 273 and
274 with an average length of stay of 1.3 days and average costs of
$26,067.
We stated in the proposed rule that our clinical advisors did not
support creating a new MS-DRG for all LAAC procedures for FY 2021.
Rather, our clinical advisors believe that ICD-10-PCS codes 02L70CK,
02L70DK, and 02L70ZK that describe a LAAC procedure with an open
approach are more suitably grouped to MS-DRGs 273 and 274. As indicated
in the proposed rule our clinical advisors stated that this
reassignment would allow all LAAC procedures to be grouped together
under the same MS-DRGs and would improve clinical coherence. We noted
that all the procedure codes describing LAAC procedures are designated
as non-O.R. procedures that affect the MS-DRG to which they are
assigned. Therefore, in the proposed rule, we proposed to reassign ICD-
10-PCS codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250 and 251
(Percutaneous Cardiovascular Procedures without Coronary Artery Stent
with and without MCC, respectively) to MS-DRGs 273 and 274
(Percutaneous Intracardiac Procedures with and without MCC,
respectively).
Comment: Several commenters supported CMS' proposal to not reassign
cases reporting ICD-10-PCS procedure code 02L73DK from MS-DRG 274 to
MS-DRG 273 and to not revise the title for MS-DRG 273 to ``Percutaneous
Intracardiac Procedures with MCC or Major Device Implant for Left
Atrial Appendage Closure Procedures''. A commenter concurred that MS-
DRG categories should not be based on a specific medical technology or
unique procedure code. The commenter noted that the MS-DRGs are
intended to group procedures with both similar resource intensity and
clinical characteristics. This commenter further noted that the MS-DRG
categories are not intended to benefit a single technology or be
narrowly constituted such as by singling out a device implant in a
field with multiple other techniques and technologies that address a
similar disease that do not require an implant. The commenter stated
that if CMS were to change its methodology of comparing the procedure
requested for reassignment to all cases, as was requested for the
WATCHMANTM LAAC device, then in fairness, CMS should do so
for all the other procedure code MS-DRG reassignment requests it
receives and that this kind of methodological change should be outlined
in the proposed rule for comments so stakeholders can discuss the
implications. This commenter also stated its belief that it is
premature to modify the Percutaneous Intracardiac Procedures MS-DRGs at
this time, because there are a number of technologies in this field
using different techniques, including non-implanted devices, and are
being studied in CMS Investigational Device Exemption (IDE) approved
clinical trials. According to the commenter, it is anticipated that
some of these technologies will receive marketing authorization in the
near future and therefore, they should also be considered in any MS-
DRGs reclassification. In addition, the commenter stated that volume,
costs, and length of stay data for the procedures utilizing these
technologies
[[Page 58476]]
may not be fully incorporated in current hospital cost data, and
current clinical trial pricing for these devices, which is lower than
commercialized pricing, will not fully reflect true hospital costs. The
commenter noted it is critical to ensure that as these alternative
technologies are adopted by hospitals that they are not disadvantaged
in their MS-DRG assignments, particularly relative to existing implant
technologies. The commenter agreed that MS-DRGs 273 and MS-DRG 274
should continue to be broadly constituted to include the full range of
procedures performed within the heart chambers using intracardiac
techniques. The commenter also agreed with CMS that the title of MS-DRG
273 should remain ``Percutaneous Intracardiac Procedures'' and not
reference device implants or be limited to a particular device approach
when numerous other options exist and or are in clinical trials. The
commenter stated that to the extent CMS implements MS-DRG changes
impacting the assignment for WATCHMANTM LAAC procedures,
they request that such policies apply to all LAA procedures, regardless
of specific technique, including whether they involve an implant.
Response: We appreciate the commenters' support of our proposal to
maintain cases reporting procedure code 02L73DK in MS-DRG 274 and to
retain the current titles for MS-DRGs 273 and 274 by not revising to
include terminology referencing an implant. As discussed in the
proposed rule, we agree that the MS-DRGs are intended to group
procedures with both similar resource intensity and clinical
characteristics, rather than to identify a specific, single technology,
identified by only one unique procedure code. We further note that we
would expect to discuss any changes to CMS' current methodology for
evaluating MS-DRG requests involving reassignment of a procedure code
in future rulemaking. We appreciate the information provided by the
commenter regarding additional technologies and techniques for this
clinical area that are under study in CMS Investigational Device
Exemption (IDE) approved clinical trials and agree they should also be
considered in any potential future MS-DRG reclassification.
Comment: We received a comment (from the requestor) expressing
concern that in the proposed rule, CMS' summary of the requestor's
analysis for the average costs of LAAC procedures reporting ICD-10-PCS
procedure code 02L73DK (Occlusion of left atrial appendage with
intraluminal device, percutaneous approach), which identifies the
WATCHMANTM device, may have been misunderstood. The
commenter clarified that the $3,405 it referenced in its analysis
represented the difference between the average costs of the cases
identified by procedure code 02L73DK in MS-DRGs 273 and 274 versus all
other procedure codes that do not identify the WATCHMANTM
device in MS-DRGs 273 and 274. The commenter stated its belief that a
comparison of the cases reporting procedure code 02L73DK
``WATCHMANTM cases'' versus ``non-WATCHMANTM''
cases is more appropriate to evaluate cost alignment, opposed to the
comparison of procedure code 02L73DK to all cases in MS-DRG 273 and
274. The commenter noted that comparing the cases reporting procedure
code 02L73DK (``WATCHMANTM cases'') against all cases
includes cases reporting procedure code 02L73DK
(``WATCHMANTM cases'') and effectively compares ``WATCHMAN
cases'' to a pool of procedures in which ``WATCHMAN cases'' are a
significant subgroup, and therefore influences the MS-DRGs cost. The
commenter stated their belief that an accurate cost comparison requires
an evaluation of two distinct groups (that is, WATCHMANTM
procedures vs. non-WATCHMANTM procedures), as opposed to
comparing one group against another of which it is a part (that is,
WatchmanTM procedures vs. all procedures in the MS-DRG
category). The commenter also stated that if CMS intends to use a
methodology in which clinical/economic coherence is based upon a
comparison against the group in which that procedure is already
represented, this should be clarified for consistency in future
rulemaking. The commenter provided an updated data analysis using FY
2019 MedPAR and concluded that there is greater cost coherence between
WATCHMANTM cases currently assigned to DRG 274 and Non-
WATCHMANTM cases currently assigned to DRG 273 (a difference
of $2,019), as opposed to Non-WATCHMANTM cases currently
assigned to DRG 274 (a difference of $4,059). The commenter reiterated
its request for CMS to reassign all cases with procedure code 02L73DK
from MS-DRG 274 to MS-DRG 273 and rename MS-DRG 273 ``Percutaneous
Intracardiac Procedures with MCC or Major Device Implant for LAAC''.
Response: We thank the commenter for the additional information and
analysis provided. In response to the commenter's concern that CMS'
summary of the requestor's analysis was misunderstood, we note that we
inadvertently omitted the reference to MS-DRG 273 in our statement that
read, ``According to the requestor's analysis, the average cost for
LAAC procedures reporting ICD-10-PCS procedure code 02L73DK is $3,405
higher than the average cost for all cases in MS-DRG 274.'' For
clarification, the statement should have read, ``According to the
requestor's analysis, the average cost for LAAC procedures reporting
ICD-10-PCS procedure code 02L73DK is $3,405 higher than the average
cost for all cases in MS-DRG 273 and 274.'' With regard to the
commenter's remarks that an accurate cost comparison requires an
evaluation of two distinct groups, as opposed to comparing one group
against another of which it is a part, we note that we consider this
information and the data in this way to understand the impact of the
selected cases, however, we have generally not included this specific
information in our discussions or summaries of our analysis. The claims
data that is evaluated as part of the overall analysis includes the
``with'' and ``without'' cases related to the specific request where
applicable, therefore, CMS can consider including this additional data
analysis information in future rulemaking. With respect to the
commenter's statement that CMS should clarify in future rulemaking if
it intends to use a methodology in which clinical/economic coherence is
based upon a comparison against the group in which that procedure is
already represented, we note that due to the structure of the MS-DRGs
and the CC/MCC subgroups that exist, it is not entirely feasible to
expect that a comparison would not include other MS-DRGs in which that
procedure is already assigned. For the reasons previously discussed in
the FY 2021 IPPS/LTCH PPS proposed rule, our clinical advisors continue
to support the current structure of MS-DRGs 273 and 274 where all LAAC
procedures, with or without an implant, are grouped together.
Therefore, after consideration of the public comments that we received,
we are finalizing our proposal to not reassign cases reporting ICD-10-
PCS procedure code 02L73DK (Occlusion of left atrial appendage with
intraluminal device, percutaneous approach) from MS-DRG 274
(Percutaneous Intracardiac Procedures without MCC) to MS-DRG 273
(Percutaneous Intracardiac Procedures with MCC).
Comment: Several commenters supported CMS' proposal to reassign
ICD-10-PCS procedure codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs
250 and 251 to MS-DRGs 273 and 274.
[[Page 58477]]
A commenter stated that reassignment of these procedure codes is more
representative of the average costs and average length of stay
associated with procedures in the logic for MS-DRGs 273 and 274
compared to the procedures that are included in the logic for MS-DRGs
250 and 251. A commenter also suggested that CMS revise the titles for
MS-DRGs 273 and 274 to ``Percutaneous and Other Intracardiac Procedures
with and without MCC, respectively'', since the current MS-DRG titles
suggest that only percutaneous procedures apply to these MS-DRGs.
However, a commenter did not support CMS' proposal to reassign ICD-10-
PCS procedure codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250 and
251 to MS-DRGs 273 and 274 because according to the commenter, it would
result in an inappropriate grouping of open procedures under the title
of ``percutaneous'' procedures. The commenter asserted that although
open atrial appendage closures are rarely performed as standalone
procedures and are normally performed in conjunction with open coronary
bypass and open valve procedures, if an open atrial appendage closure
is actually performed standalone, MS-DRGs 228 and 229 (Other
Cardiothoracic Procedures with and without MCC, respectively), would
more appropriately compensate for the resources and longer length of
stays expected with open heart procedures.
Another commenter stated they understood CMS' rationale for not
proposing to create a separate MS-DRG for the insertion of
WATCHMANTM devices since the cost reductions involved in
their shorter length of stay balances out the costs of the device.
Response: We appreciate the commenters' support of the proposal to
reassign ICD-10-PCS procedure codes 02L70CK, 02L70DK, and 02L70ZK from
MS-DRGs 250 and 251 to MS-DRGs 273 and 274. We also agree with the
commenter who suggested that the titles for MS-DRGs 273 and 274 should
be revised to ``Percutaneous and Other Intracardiac Procedures with and
without MCC, respectively'', to reflect this reassignment, as the
current MS-DRG titles refer only to percutaneous procedures. In
response to the commenter who did not agree with the proposal to
reassign procedure codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250
and 251 to MS-DRGs 273 and 274 based on the current titles of the MS-
DRGs, as we have done in prior rulemaking and as another commenter
suggested, we may revise the title of a MS-DRG to better reflect the
procedures assigned to it. With regard to the commenter's statement
that open LAAC procedures are normally performed in conjunction with
open coronary bypass and open valve procedures, therefore, if an open
atrial appendage closure is actually performed standalone, it would
more appropriately compensate for the resources and longer length of
stays expected with open heart procedures if assigned to MS-DRGs 228
and 229, we consider this comment to be outside the scope of the
proposal discussed. We can consider additional claims data analysis for
these procedures in future rulemaking. With respect to the commenter
who stated they understood CMS' rationale for not proposing to create a
separate MS-DRG for the insertion of WATCHMANTM devices
since the cost reductions involved in their shorter length of stay
balances out the costs of the device, we are unclear as to what this
comment is in reference to as there was no discussion in the FY 2021
IPPS/LTCH PPS proposed rule about proposing to create a separate MS-DRG
for procedures involving the insertion of a WATCHMANTM
device, rather the discussion concerned reassigning cases reporting the
procedure code describing the insertion of a WATCHMANTM
device.
After consideration of the public comments that we received, we are
finalizing our proposal to reassign ICD-10-PCS procedure codes 02L70CK,
02L70DK, and 02L70ZK from MS-DRGs 250 and 251 to MS-DRGs 273 and 274,
and are finalizing a revision to the titles for MS-DRG 273 and 274 to
Percutaneous and Other Intracardiac Procedures with and without MCC,
respectively to reflect this reassignment for FY 2021.
b. Endovascular Cardiac Valve Replacement and Supplement Procedures
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32495 through
32496), we discussed a request we received to revise MS-DRGs 266 and
267 (Endovascular Cardiac Valve Replacement and Supplement Procedures
with and without MCC, respectively) by removing the current two-way
severity level split and creating a base MS-DRG without any severity
level splits. According to the requestor, patients treated with an
endovascular cardiac valve replacement procedure have severe heart
failure due to a valvular disorder, which may be documented as either
an exacerbation of heart failure or as chronic severe heart failure.
The requestor noted that in the cases reporting an endovascular
cardiac valve replacement procedure, a secondary diagnosis code
describing the specific type of heart failure may be the only MCC
reported on the claim and in instances where the heart failure
diagnosis code is reported as the principal diagnosis on a claim, it is
disregarded from acting as a MCC. In both scenarios, the requestor
reported that the heart failure is treated with the endovascular
cardiac valve replacement procedure, fluid balance, and medication.
The requestor also stated that providers are challenged in reaching
a consensus regarding this subset of patients' symptoms that may be
helpful in establishing a diagnosis for exacerbation of heart failure
versus chronic severe heart failure and stated that a single, base MS-
DRG would assist in the calculation of costs and charges more reliably,
regardless of the diagnosis reported in combination with the
endovascular cardiac valve replacement procedure.
We noted in the proposed rule that we examined claims data from the
September 2019 update of the FY 2019 MedPAR file for MS-DRGs 266 and
267. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.030
[[Page 58478]]
As shown in the table, there was a total of 19,012 cases with an
average length of stay of 5.3 days and average costs of $50,879 in MS-
DRG 266. For MS-DRG 267, there was a total of 27,084 cases with an
average length of stay of 2.1 days and average costs of $40,471.
As indicated in the proposed rule, to evaluate the request to
create a single MS-DRG for cases reporting endovascular cardiac valve
procedures, we conducted an analysis of base MS-DRG 266. This analysis
includes 2 years of MedPAR claims data to compare the data results from
1 year to the next to avoid making determinations about whether
additional severity levels are warranted based on an isolated year's
data fluctuation and also, to validate that the established severity
levels within a base MS-DRG are supported. Therefore, we reviewed the
claims data for base MS-DRG 266 using the September 2018 update of the
FY 2018 MedPAR file and the September 2019 update of the FY 2019 MedPAR
file, which were used in our analysis of claims data for MS-DRG
reclassification requests for FY 2020 and FY 2021. Our findings are
shown in the table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.031
As shown in the table, the data reflect that the criteria for a
two-way split (``with MCC'' and ``without MCC'') are satisfied using
both the data from the September 2018 update of the FY 2018 MedPAR file
and the data from the September 2019 update of the FY 2019 MedPAR file:
(1) At least 500 cases are in the MCC group and in the without MCC
subgroup; (2) at least 5 percent of the cases in the MS-DRG are in the
MCC group and in the without MCC subgroup; (3) at least a 20 percent
difference in average costs between the MCC group and the without MCC
group; (4) at least a $2,000 difference in average costs between the
MCC group and the without MCC group; and (5) at least a 3-percent
reduction in cost variance, indicating that the current severity level
splits increase the explanatory power of the base MS-DRG in capturing
differences in expected cost between the current MS-DRG severity level
splits by at least 3 percent and thus improve the overall accuracy of
the IPPS payment system. We stated in the proposed rule that our
clinical advisors also did not agree with the requestor's assertion
that a single, base MS-DRG would assist in calculating costs more
reliably. As shown in the claims data and stated previously, the
criteria are satisfied for the current two-way split. We further noted
that the basis for the MS-DRGs is to better recognize severity and
complexity of services, which is accomplished through the CC subgroups.
Based on the results of our analysis, for FY 2021, we proposed to
maintain the current structure of MS-DRGs 266 and 267 with a two-way
severity level split and not create a single, base MS-DRG.
Comment: Commenters supported CMS' proposal to retain the structure
of MS-DRGs 266 and 267 with the current two-way severity level split
based on the information and data analysis provided. A commenter also
acknowledged the requestor's sentiments regarding situations where a
secondary diagnosis code describing the specific type of heart failure
may be the only MCC reported on the claim and in instances where the
heart failure diagnosis code is reported as the principal diagnosis on
a claim, it is disregarded from acting as a MCC. This commenter stated
that inconsistencies in the MS-DRG CC Exclusion List for heart failure
also confound the issues involving heart failure. The commenter
suggested that CMS consider the following:
Allow all acute heart failure codes to be sequenced as a
principal diagnosis to serve as its own MCC in the same manner that
acute cor pulmonale serves as an MCC when sequenced as a principal
diagnosis with acute pulmonary embolism.
Amend the CC Exclusion List as to eliminate list 682 for
all the ICD-10-CM codes listed in this section of this rule and place
all of them in list 2025. The commenter stated that if CMS chooses not
to do this, it recommends that CMS transition the I50.23, I50.33,
I50.41 and I50.43 diagnosis codes into the 2025 category so that all
acute AND acute on chronic heart failure (I50.21, I50.23, I50.31,
I50.33, I50.41, I50.43) codes are treated equally.
I50.21 MCC 2025:29 codes, Acute systolic (congestive) heart failure
I50.22 CC 0682:30 codes, Chronic systolic (congestive) heart failure
I50.23 MCC 0682:30 codes, Acute on chronic systolic (congestive)
heart failure
I50.30 CC 0682:30 codes, Unspecified diastolic (congestive) heart
failure
I50.31 MCC 2025:29 codes, Acute diastolic (congestive) heart failure
I50.32 CC 0682:30 codes, Chronic diastolic (congestive) heart
failure
I50.33 MCC 0682:30 codes, Acute on chronic diastolic (congestive)
heart failure
I50.40 CC 0682:30 codes, Unspecified combined systolic (congestive)
and diastolic (congestive) heart failure
I50.41 MCC 0682:30 codes, Acute combined systolic (congestive) and
diastolic (congestive) heart failure
I50.42 CC 0682:30 codes, Chronic combined systolic (congestive) and
diastolic (congestive) heart failure
I50.43 MCC 0682:30 codes, Acute on chronic combined systolic
(congestive) and diastolic (congestive) heart failure
The commenter also suggested that CMS, as a member of the ICD-10
Coordination and Maintenance Committee, advocate to expand ICD-10-CM
diagnosis code I50.9 Heart failure, unspecified, and assign CC and MCC
status to these suggested expanded codes, consistent with how the
I50.2-, I50.3- and I50.4- series are assigned.
I50.90--Heart failure, unspecified
I50.91--Acute heart failure--should serve as an MCC
I50.92--Chronic heart failure--should serve as a CC
I50.93--Acute on chronic heart failure--should serve as an MCC
According to the commenter, this action would sufficiently
eliminate the administrative burden to providers regarding querying the
physician for the specific type of heart failure.
Response: We appreciate the commenters' support. In response to the
commenter who suggested modifying the logic of all the acute heart
failure codes to allow them to act as their own MCC or to amend the CC
Exclusion list, we appreciate the commenter's suggestions. However,
because we consider these public comments to be
[[Page 58479]]
outside the scope of the proposed rule, we are not addressing them in
this final rule. With regard to the commenter's suggestion to expand
diagnosis code I50.9 Heart failure, unspecified, as discussed in
section II.E.16. of the preamble of this final rule, the CDC/NCHS has
lead responsibility for the diagnosis code classification and proposals
for code updates should be directed to [email protected] for
consideration at a future ICD-10 Coordination and Maintenance Committee
meeting. In addition, as discussed in section II.E.1.b. of the preamble
of this final rule, we are maintaining the November 1 deadline for the
submission of MS-DRG classification requests for FY 2022, therefore,
with regard to the additional suggestions to modify the logic of all
the acute heart failure codes to allow them to act as their own MCC or
amend the CC Exclusion list, we encourage individuals with comments
about MS-DRG classifications to submit these comments no later than
November 1, 2020 so that they can be considered for possible inclusion
in the annual proposed rule. We will consider these public comments for
possible proposals in future rulemaking as part of our annual review
process.
After consideration of the public comments that we received, we are
finalizing our proposal to maintain the structure of MS-DRGs 266 and
277 for FY 2021.
c. Insertion of Cardiac Contractility Modulation Device
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32496), we received a request to review the MS-DRG assignment for cases
that identify patients who receive a cardiac contractility modulation
(CCM) device system for congestive heart failure. CCM is indicated for
patients with moderate to severe heart failure resulting from either
ischemic or non-ischemic cardiomyopathy. CCM utilizes electrical
signals which are intended to enhance the strength of the heart and
overall cardiac performance. CCM delivery device systems consist of a
programmable implantable pulse generator (IPG) and three leads which
are implanted in the heart. One lead is implanted into the right atrium
and the other two leads are inserted into the right ventricle. The lead
in the right atrium detects atrial electric signals and transmits them
to the IPG. The IPG, which is usually implanted into the subcutaneous
pocket of the pectoral region and secured to the fascia with a non-
absorbable suture, processes the atrial signal and generates the CCM
signals which are transmitted to the right ventricle via the two
ventricular leads. According to the requestor, MS-DRGs 222, 223, 224,
225, 226, and 227 (Cardiac Defibrillator Implant with and without
Cardiac Catheterization with and without AMI/HF/Shock with and without
MCC, respectively) include code combinations or ``code pairs''
describing the insertion of contractility modulation devices. Currently
however, the MS-DRG GROUPER logic requires the combination of the CCM
device codes and a left ventricular lead to map to MS-DRGs 222, 223,
224, 225, 226 and 227. The requestor stated the CCM device is
contraindicated in patients with a left ventricular lead. Therefore,
using the current V37 MS-DRG GROUPER logic, no case involving insertion
of the CCM system can be appropriately mapped to MS-DRGs 222, 223, 224,
225, 226 and 227. Instead, the cases map to MS-DRG 245 (AICD Generator
Procedures). According to the requestor, to date, the procedure has
been performed on an outpatient basis, but it is expected that some
Medicare patients will receive CCM devices on an inpatient basis. The
requestor asked that CMS revise the MS-DRG GROUPER logic to group cases
reporting the use of the CCM device appropriately.
As noted in the proposed rule, the ICD-10-PCS procedure code pairs
currently assigned to MS-DRGs 222, 223, 224, 225, 226 and 227 that
identify the insertion of contractility modulation devices are shown in
the following table:
[[Page 58480]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.032
We stated in the proposed rule that based on our analysis of cases
reporting ICD-10-PCS procedure codes for CCM device systems, we agreed
with the requestor that a procedure code pair for the insertion of a
CCM device and right ventricular and/or right atrial lead does not
exist in the logic for MS-DRGs 222, 223, 224, 225, 226 and 227. We also
noted that our analysis indicated that the ICD-10-PCS procedure code
combinations for right ventricular and/or right atrial lead insertion
with insertion of contractility modulation devices were inadvertently
excluded from MS-DRGs 222, 223, 224, 225, 226 and 227 as a result of
replicating the ICD-9 based MS-DRGs.
We then examined claims data from the September 2019 update of the
FY 2019 MedPAR file for MS-DRG 245 and identified the subset of cases
within MS-DRG 245 reporting procedure codes for the insertion of a
rechargeable CCM device and the insertion of right ventricular and/or
right atrium lead. We found zero cases in MS-DRG 245 reporting a
procedure code combination that identifies the insertion of
contractility modulation device and the insertion of a cardiac lead
into the right ventricle and/or right atrium lead.
We stated that our clinical advisors agreed that the insertion of a
rechargeable CCM system always involves placement of a right-sided
lead, and that the code combinations that currently exist in the MS-DRG
GROUPER logic are considered clinically invalid. We examined claims
data from the September 2019 update of the FY 2019 MedPAR file for MS-
DRGs 222, 223, 224, 225, 226 and 227 for this subset of cases to
determine if there were any cases that reported one of the 12
clinically invalid code combinations that exist in the GROUPER logic.
Because the combinations of codes that describe the insertion of a
rechargeable CCM device and the insertion of left ventricular lead are
considered clinically invalid procedures, we stated we would not expect
these code combinations to be reported in any claims data. We found
zero cases across MS-DRGs 222, 223, 224, 225, 226 and 227 reporting the
clinically invalid procedure code combination that identifies the
insertion of contractility modulation device and the insertion of a
cardiac lead into the left ventricle.
We noted that while our analysis did not identify any cases
reporting a procedure code combination for the insertion of
contractility modulation device and the insertion of a cardiac lead
into right ventricle or right atrium, recognizing that it is expected
that some Medicare patients will receive CCM devices on an inpatient
basis, we proposed to add the following 24 ICD-10-PCS code combinations
to MS-DRGs 222, 223, 224, 225, 226 and 227.
[[Page 58481]]
We also proposed to delete the 12 clinically invalid code combinations
from the GROUPER logic of MS-DRGs 222, 223, 224, 225, 226 and 227 that
describe the insertion of contractility modulation device and the
insertion of a cardiac lead into the left ventricle.
BILLING CODE 4120-01-P
[[Page 58482]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.033
[[Page 58483]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.034
BILLING CODE 4120-01-C
Comments: Commenters supported the proposal to modify the GROUPER
logic of MS-DRGs 222, 223, 224, 225, 226 and 227 by (1) adding the 24
ICD-10-PCS code combinations describing the insertion of contractility
modulation device and the insertion of a cardiac lead into right
ventricle or right atrium to MS-DRGs 222, 223, 224, 225, 226 and 227;
and (2) deleting the 12 clinically invalid procedure code combinations
that describe the insertion of contractility modulation device and the
insertion of a cardiac lead into the left ventricle. A commenter
specifically thanked CMS for consulting with their clinical advisors,
conducting a thorough analysis regarding these codes, and for
determining the most appropriate MS-DRG assignments for cardiac
contractility modulation devices. While indicating its support, one
commenter questioned why cardiac contractility modulation devices
qualify for MS-DRGs 222, 223, 224, 225, 226 and 227 and cardiac
resynchronization therapy pacemakers (CRT-P) without defibrillators do
not and requested that this be investigated in future rulemaking. This
commenter also
[[Page 58484]]
suggested that CMS change the name of MS- DRGs 222, 223, 224, 225, 226
and 227 since a cardiac modulation device is not used in all
circumstances. Another commenter noted its intention to monitor the
deletion of the 12 clinically invalid code combinations from the
GROUPER logic in hopes that no unintended consequences come from this
change.
Response: We appreciate the commenters' feedback and support.
In response to the commenter that questioned why cardiac
contractility modulation devices qualify for MS-DRGs 222, 223, 224,
225, 226 and 227 and cardiac resynchronization therapy pacemakers do
not, procedures involving CRT-P are assigned to a number of MS-DRGs.
Specifically, in MDC 05 (Diseases and Disorders of the Circulatory
System), procedures involving these pacemakers are assigned 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).
Procedures codes describing the insertion of total contractility
modulation device systems have been assigned to MS-DRGs 222, 223, 224,
225, 226 and 227 since the initial implementation of these procedure
codes in FY 2010 under ICD-9-CM, recognizing that insertion of the CCM
device might occur alone, in the presence of a pre-existing automatic
implantable cardioverter-defibrillator (AICD), or in a combined
implantation with an AICD. As stated in the proposed rule, the ICD-10-
PCS procedure code combinations for right ventricular and/or right
atrial lead insertion with insertion of contractility modulation
devices were inadvertently excluded from MS-DRGs 222, 223, 224, 225,
226 and 227 as a result of replicating the ICD-9 based MS-DRGs.
Recognizing that clinical practice might have changed since the
creation of codes for CCM devices, our clinical advisors believe
additional analyses are needed in MDC 05, specifically for cases
reporting both contractility modulation device systems and pacemakers,
as part of our efforts toward a broader approach to refining MS-DRGs
and to address the commenters' request. As such, we also do not believe
conforming changes to the titles of MS-DRGs 222, 223, 224, 225, 226 and
227 are warranted at this time until further review is complete.
CMS also will monitor claims data for unintended consequences as a
result of the deletion of the 12 clinically invalid code combinations
from the GROUPER logic as we continue our comprehensive analysis in
future rulemaking. Therefore, after consideration of the public
comments we received, we are finalizing our proposal to add the 24 ICD-
10-PCS code combinations as previously listed to MS-DRGs 222, 223, 224,
225, 226 and 227. We are also finalizing our proposal to delete the 12
clinically invalid code combinations from the GROUPER logic of MS-DRGs
222, 223, 224, 225, 226 and 227 that describe the insertion of
contractility modulation device and the insertion of a cardiac lead
into the left ventricle under the ICD-10 MS-DRGs Version 38, effective
October 1, 2020.
6. MDC 6 (Diseases and Disorders of the Digestive System): Acute
Appendicitis
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32500 through
32503), we discussed a request that we received to add ICD-10-CM
diagnosis code K35.20 (Acute appendicitis with generalized peritonitis,
without abscess) to the list of complicated principal diagnoses that
group to MS-DRGs 338, 339 and 340 (Appendectomy with Complicated
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) so that all ruptured/perforated appendicitis codes in MDC
06 (Diseases and Disorders of the Digestive System) group to MS-DRGs
338, 339, and 340. ICD-10-CM diagnosis code K35.20 currently groups to
MS-DRGs 341, 342, and 343 (Appendectomy without Complicated Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively). Under
current coding conventions, the following inclusion term for
subcategory K35.2 (Acute appendicitis with generalized peritonitis) is:
Appendicitis (acute) with generalized (diffuse) peritonitis following
rupture or perforation of the appendix. The requestor also noted that
diagnosis code K35.32 (Acute appendicitis with perforation and
localized peritonitis, without abscess) currently groups to MS-DRGs
338, 339, and 340, however, diagnosis code K35.20 which describes a
generalized, more extensive form of peritonitis does not. The requestor
stated that ICD-10-CM diagnosis code K35.20 is the only ruptured
appendicitis code not included in the list of complicated principal
diagnosis codes for MS-DRGs 338, 339 and 340 and stated that it is
clinically appropriate for all ruptured/perforated appendicitis
diagnosis codes to group to MS-DRGs 338, 339 and 340.
As indicated in the FY 2021 IPPS/LTCH PPS proposed rule, we
analyzed claims data from the September 2019 update of the FY 2019
MedPAR file for cases in MS-DRGs 341, 342, and 343 and claims reporting
ICD-10-CM diagnosis code K35.20 as a principal diagnosis. Our findings
are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.035
As shown in the table, we found a total of 718 cases with an
average length of stay of 5.9 days and average costs of $17,270 in MS-
DRG 341. Of those 718 cases, there were 62 cases reporting a principal
diagnosis code of K35.20 with
[[Page 58485]]
an average length of stay of 7.8 days, and average costs of $20,244. We
found a total of 2,184 cases with an average length of stay of 3.4 days
and average costs of $10,611 in MS-DRG 342. Of those 2,184 cases there
were 183 cases reporting a principal diagnosis code of K35.20 with an
average length of stay of 4.2 days, and average costs of $10,952. We
found a total of 2,329 cases with an average length of stay of 2.0 days
and average costs of $8,298 in MS-DRG 343. Of those 2,329 cases, there
were 137 cases reporting a principal diagnosis code of K35.20 with an
average length of stay of 2.6 days, and average costs of $8,088.
As indicated in the proposed rule, we also analyzed claims data
from the September 2019 update of the FY 2019 MedPAR file for MS-DRGs
338, 339, and 340. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.036
As shown in the table, we found a total of 685 cases with an
average length of stay of 8.1 days and average costs of $20,930 in MS-
DRG 338. We found a total of 2,245 cases with an average length of stay
of 5.0 days and average costs of $12,705 in MS-DRG 339. We found a
total of 1,840 cases, average length of stay 2.9 days, and average
costs of $9,101 in MS-DRG 340.
We stated in the proposed rule that our clinical advisors agreed
that the presence of an abscess would clinically determine whether a
diagnosis of acute appendicitis would be considered a complicated
principal diagnosis. As diagnosis code K35.20 is described as
``without'' an abscess, we stated our clinical advisors recommended
that it not be added to the list of principal diagnoses for MS-DRGS
338, 339, and 340 (Appendectomy with Complicated Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively). We stated in the
proposed rule, that we believe that while the average costs for cases
reporting diagnosis code K35.20 are similar to the cases in MS-DRGs
338, 339, and 340, diagnosis codes describing acute appendicitis that
do not indicate the presence of an abscess should remain in MS-DRGs
341, 342, and 343 (Appendectomy without Complicated Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively). Therefore, we did
not propose to reassign diagnosis code K35.20 from MS-DRGs 341, 342,
and 343 to MS-DRGs 338, 339, and 340.
As noted previously, the requestor pointed out that diagnosis
K35.32 (Acute appendicitis with perforation and localized peritonitis,
without abscess) currently groups to MS-DRGs 338, 339, and 340
(Appendectomy with Complicated Principal Diagnosis with MCC, with CC,
and without CC/MCC, respectively). Therefore, in the proposed rule, we
identified all the diagnosis codes describing acute appendicitis within
the ICD-10-CM classification under subcategory K35.2 (Acute
appendicitis with generalized peritonitis) and subcategory K35.3 (Acute
appendicitis with localized peritonitis) and reviewed their respective
MS-DRG assignments for clinical coherence. The diagnosis codes in these
subcategories are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.037
As indicated in the proposed rule, we analyzed claims data from the
September 2019 update of the FY 2019 MedPAR file for cases reporting
any one of the ICD-10-CM diagnosis codes as previously listed as a
principal diagnosis in MS-DRGs 338, 339, 340, 341, 342, and 343. Our
findings are shown in the following table.
[[Page 58486]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.038
As shown in the table, the diagnosis codes describing ``with
abscess'' (K35.21 and K35.33) are currently assigned to MS-DRGs 338,
339, and 340. In addition, the diagnosis codes describing ``without
abscess'' (K35.20, K35.30, and K35.31) are currently assigned to MS-
DRGs 341, 342, and 343. We stated in the proposed rule, that our
clinical advisors believe that cases reporting ICD-10-CM diagnosis
codes describing ``with abscess'' are associated with higher severity
of illness and resource consumption because of extended lengths of stay
and treatment with intravenous antibiotics. Therefore, in the proposed
rule, we noted that our clinical advisors determined that diagnosis
code K35.32 should also be assigned to MS-DRGs 341, 342, and 343 for
clinical consistency.
Accordingly, in the proposed rule, we proposed to reassign
diagnosis code K35.32 to MS-DRGs 341, 342, and 343 (Appendectomy
without Complicated Principal Diagnosis with MCC, with CC, and without
CC/MCC, respectively).
As also noted in the proposed rule, the ICD-10 MS-DRG Version 37
Definitions Manual currently lists the following ICD-10-CM diagnosis
codes as Complicated Principal Diagnoses in MS-DRGs 338, 339, 340, 341,
342, and 343: C18.1 (Malignant neoplasm of appendix); C7A.020
(Malignant carcinoid tumor of the appendix); K35.21 (Acute appendicitis
with generalized peritonitis, with abscess); K35.32 (Acute appendicitis
with perforation and localized peritonitis, without abscess) and K35.33
(Acute appendicitis with perforation and localized peritonitis, with
abscess). For the same reasons discussed previously, we proposed to
remove diagnosis code K35.32 from the complicated principal diagnosis
list to be clinically consistent.
Therefore, for the reasons discussed, in the proposed rule, we
proposed to (1) maintain the current assignment of diagnosis code
K35.20 (Acute appendicitis with generalized peritonitis, without
abscess) in MS-DRGs 341, 342, and 343 (Appendectomy without Complicated
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively); (2) reassign diagnosis code K35.32 from MS-DRGs 338, 339
and 340 to MS-DRGs 341, 342, and 343; and (3) remove diagnosis code
K35.32 from the complicated principal diagnosis list in MS-DRGs 338,
339, and 340 as listed in the ICD-10 MS-DRG Version 37 Definitions
Manual.
Comment: Commenters' supported CMS' proposal to reassign diagnosis
code K35.32 from MS-DRGs 338, 339 and 340 to MS-DRGs 341, 342, and 343
and to remove K35.32 from the complicated principal diagnosis list in
MS-DRGs 338, 339, and 340. One commenter stated that the
``peritonitis'' described by the diagnoses code may be just reactive
peritonitis from the appendicitis and therefore would not be associated
with an abscess or an increased length of stay. Another commenter
supported CMS' proposal not to reassign ICD-10-CM diagnosis code K35.20
(Acute appendicitis with generalized peritonitis, without abscess) from
MS-DRGs 341, 342, and 343 (Appendectomy without Complicated Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-
DRGs 338, 339, and 340 (Appendectomy with Complicated Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively). The
commenter stated their agreement with CMS clinical advisors that the
presence of an abscess should clinically determine whether a diagnosis
of acute appendicitis would be considered a complicated principal
diagnosis, therefore all diagnosis codes for acute appendicitis
``without'' abscess should be assigned to MS-DRGs 341, 342, and 343 for
clinical consistency.
Response: We appreciate the commenters' support.
Comment: One commenter stated that they disagreed with CMS on
clinical grounds that ICD-10-CM code K35.20 is not a complicating
diagnosis, and that all ICD-10-CM codes in subcategory K35.2 (Acute
appendicitis with
[[Page 58487]]
generalized peritonitis) should serve as an MCC in the same manner that
unspecified peritonitis serves as an MCC. This commenter also stated
that given that acute appendicitis is more commonly encountered in non-
Medicare patients and that MS-DRGs are a common payment methodology for
private insurance and Medicaid claims, CMS should additionally analyze
Medicaid claims.
Response: We thank the commenter for their feedback. We note
diagnosis codes for acute appendicitis described as ``without abscess''
or ``without perforation'' were assigned the CC severity level
designation in FY 2019 when diagnosis code K35.2 was subdivided into
diagnosis codes K35.20 (Acute appendicitis with generalized
peritonitis, without abscess) and K35.21 (Acute appendicitis with
generalized peritonitis, with abscess) because our clinical advisors
stated cases ``without abscess'' or ``without perforation'' are not as
severe clinical conditions compared to cases ``with abscess'' or ``with
perforation'' as discussed in the FY 2019 IPPS/LTCH PPS final rule (83
FR 41230). However, as noted in section II.E.12.b. of the preamble of
this final rule, we plan to continue a comprehensive CC/MCC analysis,
using a combination of mathematical analysis of claims data and the
application of nine guiding principles. We continue to solicit comments
regarding these guiding principles, as well as other possible ways we
can incorporate meaningful indicators of clinical severity. We
encourage the commenter to provide a detailed explanation of how
applying a suggested concept or principle would ensure that the
severity designation appropriately reflects resource use for diagnosis
code K35.20. Commenters should submit their recommendations to the
following email address: [email protected] by
November 1, 2020.
Comment: Some commenters opposed CMS' proposal to maintain the
current MS-DRG assignment for ICD-10-CM diagnosis code K35.20 (Acute
appendicitis with generalized peritonitis, without abscess). A
commenter stated that the costs for treating acute appendicitis with
generalized peritonitis are on the higher end of the scale as CMS's
data demonstrated in the proposed rule and requested that CMS
reconsider the request to move principal diagnosis code K35.20 from MS-
DRGs 341, 342, and 343 to MS-DRGs 338, 339 and 340 based on the
severity of illness and the cost of treatment. The commenter stated
that when ruptured appendicitis results in generalized peritonitis,
resources are greater because the infection is not walled off, not
localized, and has spread to two or more compartments within the
abdominal cavity. According to the commenter, clinical literature
supports the statement that generalized peritonitis is a more morbid
(severe) presentation than just perforation or localized abscess. The
commenter also stated that close postoperative monitoring is required
to identify any signs of sepsis or organ dysfunction indicating
persistent abdominal infection requiring intra-abdominal lavage via
postoperative drains or relaparotomy. In addition, according to the
commenter, antibiotics are given to the patient for 5-7 days until
temperature and white blood cell count are within normal limits.
Another commenter stated that the condition described by diagnosis code
K35.20 (Acute appendicitis with generalized peritonitis, without
abscess) can be associated with a risk of post-operative abscess
formation and extended length of hospital stay, thereby warranting the
classification as a complicated diagnosis. The commenter urged CMS to
reassign diagnosis code K35.20 from MS-DRGs 341, 342, and 343 to MS-
DRGs 338, 339 and 340. Another commenter stated that diagnosis code
K35.20, is a complicated diagnosis on clinical grounds and strongly
believes that when sequenced as a principal diagnosis along with an
appendectomy should continue to group to MS-DRGs 338, 339 and 340.
Other commenters did not support the proposal to reassign diagnosis
code K35.32 from MS-DRGs 338, 339 and 340 to MS-DRGs 341, 342, and 343
and urged CMS to reconsider reassigning diagnosis code K35.32. A
commenter stated that the condition described by ICD-10-CM diagnosis
code K35.32 (Acute appendicitis with perforation and localized
peritonitis, without abscess) represents a complicated diagnosis, and
asked CMS to maintain the current complicated diagnosis classification
for code K35.32. Another commenter analyzed data from their facility
and found claims reporting a principal diagnosis of K35.32 in MS-DRGs
338, 339 and 340 had an average LOS of 4.18 days and average charges of
$60,000. This commenter stated when compared to claims at their
facility grouped to MS-DRGs 341, 342 and 343, which had an average
length of stay of 1.91 days and average charges of $42,000, claims
reporting principal diagnosis ICD-10-CM diagnosis code K35.32 were more
congruent with MS-DRG's 338-340. This commenter also stated it was the
professional opinion of the critical care surgical staff of the
facility that the presence of appendiceal perforations resulting in
peritonitis (with or without abscess) requires longer hospitalizations
and increased resources, such as peritoneal washings, intravenous
antibiotics, and intravenous hydration to care for the increased
severity of illness.
Response: We appreciate the commenters' feedback.
While our clinical advisors continue to believe that when
peritonitis develops in a patient with acute appendicitis, the degree
and severity of the peritonitis can vary greatly, we concur that the
expansion of diagnosis codes K35.2 and K35.3 to introduce additional
clinical concepts effective October 1, 2018 significantly changed the
scope and complexity of the diagnosis codes for this subset of
patients. As noted in the FY 2019 IPPS/LTCH PPS final rule (83 FR
41236), when we 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
based on the manner in which diagnosis codes K35.2 and K35.3 were
expanded and confirmed that they would consider further review of these
newly expanded codes with respect to the clinical concepts. As such, we
believe it would be appropriate to maintain the current assignments at
this time in order to further examine the relevant clinical factors and
similarities in resource consumption in order to best represent this
subset of patients within the MS-DRG classification. Therefore, after
consideration of the public comments we received, and for the reasons
discussed, diagnosis code K35.20 (Acute appendicitis with generalized
peritonitis, without abscess) will be maintained in MS-DRGs 341, 342,
and 343 (Appendectomy without Complicated Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) for FY 2021. We are not
finalizing our proposal to reassign diagnosis code K35.32 (Acute
appendicitis with perforation and localized peritonitis, without
abscess) to MS-DRGs 341, 342, and 343; and we are not finalizing our
proposal to remove diagnosis code K35.32 from the complicated principal
diagnosis list in MS-DRGs 338, 339, and 340. Accordingly, the
assignment of ICD-10-CM code K35.32 will be maintained in MS-DRGs 338,
339, and 340 (Appendectomy with Complicated Principal Diagnosis with
MCC, with CC, and without CC/MCC, respectively) and
[[Page 58488]]
ICD-10-CM diagnosis code K35.32 will continue to be listed as a
Complicated Principal Diagnosis in MS-DRGs 338, 339, and 340, in the
ICD-10 MS-DRG Version 38 Definitions Manual. As additional claims data
become available, we will continue to analyze the clinical nature of
each of the diagnoses and their MS-DRG assignments to further improve
the overall accuracy of the IPPS payments in future rulemaking.
7. MDC 8 (Diseases and Disorders of the Musculoskeletal System and
Connective Tissue)
a. Cervical Radiculopathy
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32503 through 32505), we received a request to reassign ICD-10-CM
diagnosis codes M54.11 (Radiculopathy, occipito-atlanto-axial region),
M54.12 (Radiculopathy, cervical region) and M54.13 (Radiculopathy,
cervicothoracic region) from MDC 01 (Diseases and Disorders of the
Nervous System) to MDC 08 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue). The requestor stated
that when one of these diagnosis codes describing radiculopathy in the
cervical/cervicothoracic area of the spine is reported as a principal
diagnosis in combination with a cervical spinal fusion procedure code,
the case currently groups to MDC 01 in MS-DRG 028 (Spinal Procedures
with MCC), MS-DRG 029 (Spinal Procedures with CC or Spinal
Neurostimulators), and MS-DRG 030 (Spinal Procedures without CC/MCC).
The requestor acknowledged that radiculopathy results from nerve
impingement, however, the requestor noted it typically also results
from a musculoskeletal spinal disorder such as spondylosis or stenosis.
According to the requestor, the underlying musculoskeletal cause should
be reported as the principal diagnosis if documented. The requestor
stated that when the medical record documentation to support a
musculoskeletal cause is not available, cases reporting a cervical
spinal fusion procedure with a principal diagnosis of cervical
radiculopathy would be more consistent with other cervical spinal
fusion procedures if they grouped to MDC 08 in MS-DRGs 471, 472, and
473 (Cervical Spinal Fusion with MCC, with CC, and without CC/MCC,
respectively). The requestor stated that the following diagnosis codes
describing radiculopathy of the thoracic and lumbar areas of the spine
are currently assigned to MDC 08 and therefore, group appropriately to
the spinal fusion MS-DRGs in MDC 08.
[GRAPHIC] [TIFF OMITTED] TR18SE20.039
We noted that the requestor is correct that when diagnosis codes
M54.11, M54.12 or M54.13 are reported as a principal diagnosis in
combination with a cervical spinal fusion procedure, the case currently
groups to MDC 01 in MS-DRG 028, MS-DRG 029, and MS-DRG 030. This
grouping occurs because the diagnosis codes describing radiculopathy in
the cervical/cervicothoracic area of the spine are assigned to MDC 01
and the procedure codes describing a cervical spinal fusion procedure
are assigned to MDC 01 in MS-DRGs 028, 029 and 030. We further noted
that the requestor is also correct that diagnosis codes describing
radiculopathy of the thoracic and lumbar areas of the spine (M54.14,
M54.15, M54.16 and M54.17) are currently assigned to MDC 08 and
therefore, group to the spinal fusion MS-DRGs in MDC 08 consistent with
the GROUPER logic definitions. The MS-DRGs that involve spinal fusion
procedures of the cervical or lumbar regions that are currently
assigned in MDC 01 and MDC 08 are listed in the following table.
[[Page 58489]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.040
We referred the reader to the ICD-10 MS-DRG Version 37 Definitions
Manual (which is available via the internet on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software for complete
documentation of the GROUPER logic for the listed MS-DRGs.
As indicated in the FY 2021 IPPS/LTCH PPS proposed rule, we
examined claims data from the September 2019 update of the FY 2019
MedPAR file for all cases in MS-DRGs 028, 029, and 030 and for cases
reporting any one of the diagnosis codes describing radiculopathy of
the cervical/cervicothoracic area of the spine (M54.11, M54.12, or
M54.13) in combination with a cervical spinal fusion procedure. We
refer the reader to Table 6P.1b associated with the proposed rule and
this final rule (which is available via the internet on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/ for the list of procedure codes describing a
cervical spinal fusion procedure. Our findings are shown in the
following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.041
As shown in the table, there were a total of 2,105 cases with an
average length of stay of 11.9 days and average costs of $40,866 in MS-
DRG 028. Of those 2,105 cases, there were 22 cases reporting a
principal diagnosis of cervical radiculopathy with a cervical spinal
fusion procedure with an average length of stay of 8.2 days and average
costs of $44,980. For MS-DRG 029, there were a total of 3,574 cases
with an average length of stay of 6 days and
[[Page 58490]]
average costs of $24,026. Of those 3,574 cases, there were 176 cases
reporting a principal diagnosis of cervical radiculopathy with a
cervical spinal fusion procedure with an average length of stay of 2.6
days and average costs of $24,852. For MS-DRG 030, there were a total
of 1,338 cases with an average length of stay of 3.1 days and average
costs of $17,393. Of those 1,338 cases, there were 166 cases reporting
a principal diagnosis of cervical radiculopathy with a cervical spinal
fusion procedure with an average length of stay of 1.7 days and average
costs of $23,003.
We also reviewed the claims data for MS-DRGs 471, 472, and 473. Our
findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.042
As shown in the table, there were a total of 3,327 cases with an
average length of stay of 9 days and average costs of $36,941 in MS-DRG
471. There were a total of 15,298 cases with an average length of stay
of 3.3 days and average costs of $22,539 in MS-DRG 472. There were a
total of 11,144 cases with an average length of stay of 2 days and
average costs of $18,748 in MS-DRG 473.
Based on the claims data, the average costs of the cases reporting
a principal diagnosis of cervical radiculopathy with a cervical spinal
fusion procedure are consistent with the average costs of all the cases
in MS-DRGs 028, 029, and 030 in MDC 01. We also noted that the average
costs of all the cases in MS-DRGs 028, 029, and 030 in MDC 01 are also
comparable to the average costs of all the cases in MS-DRGs 471, 472,
and 473, respectively; ($40,886 versus $36,941; $24,026 versus $22,539;
and $17,393 versus $18,748).
We stated that our clinical advisors do not support reassigning
diagnosis codes M54.11, M54.12, and M54.13 that describe radiculopathy
in the cervical/cervicothoracic area of the spine from MDC 01 to MDC 08
until further analysis of the appropriate assignment of these and other
diagnosis codes describing radiculopathy. As the requestor pointed out,
the diagnosis codes describing radiculopathy of the thoracic and lumbar
areas of the spine (M54.14, M54.15, M54.16 and M54.17) are currently
assigned to MDC 08. We noted that there are also two other codes to
identify radiculopathy within the classification, diagnosis code M54.10
(Radiculopathy, site unspecified) and M54.18 (Radiculopathy, sacral and
sacrococcygeal region), both of which are currently assigned to MDC 01.
We stated that our clinical advisors recommended maintaining the
current assignment of diagnosis codes describing cervical radiculopathy
in MDC 01 until further analysis of whether all the diagnosis codes
describing radiculopathy of a specified or unspecified site should be
assigned to the same MDC and if so, whether those codes should be
assigned to MDC 01 or MDC 08. As part of this analysis, they also
recommended soliciting further input from the public on the appropriate
assignment for all of the diagnosis codes describing radiculopathy,
including from professional societies and national associations for
neurology and orthopedics. For these reasons, we did not propose to
reassign diagnosis codes M54.11, M54.12, and M54.13 from MDC 01 to MDC
08 at this time.
Comment: Commenters agreed with the proposal to maintain the
current assignment of diagnosis codes describing cervical radiculopathy
in MDC 01 until further analysis of whether all the diagnosis codes
describing radiculopathy of a specified or unspecified site should be
assigned to the same MDC, and if so, whether those codes should be
assigned to MDC 1 or MDC 8. Commenters also agreed with CMS' plan to
solicit clinical input from medical specialty societies on the
appropriate MDC classification for the diagnosis codes describing
radiculopathy. A commenter thanked CMS for the consideration of the
request and the solicitation for outside support from the industry
while continuing to evaluate. Another commenter recommended
reclassifying all cervical spinal fusion procedures to the same MS-
DRGs, regardless of the diagnosis for which the procedure is performed.
The commenter stated that the main driver for resource utilization is
the surgical procedure and the ICD-10-CM diagnosis codes describing
radiculopathy of the cervical/cervicothoracic spine would need to be
classified to MDC 08 in order to group clinically similar cases under
MS-DRGs 471, 472, and 473.
Response: We appreciate the commenters' support. In response to the
commenter who recommended reclassifying all cervical spinal fusion
procedures to the same MS-DRGs, regardless of the diagnosis for which
the procedure is performed, as noted above and stated in the FY 2021
IPPS/LTCH PPS proposed rule (85 FR 32505), our clinical advisors
recommended maintaining the current assignment of diagnosis codes
describing cervical radiculopathy in MDC 01 until further analysis of
whether all the diagnosis codes describing radiculopathy of a specified
or unspecified site should be assigned to the same MDC as well as
further input from the public, including professional societies, and
national associations for neurology and orthopedics. We agree with the
commenter that the main driver for resource utilization is the surgical
procedure and the ICD-10-CM diagnosis codes describing radiculopathy of
the cervical/cervicothoracic spine would need to be classified to MDC
08 in order to group clinically similar cases under MS-DRGs 471, 472,
and 473, however, it is the diagnosis codes and the MDC to which they
should be clinically classified that requires further evaluation. From
a clinical perspective, cervical radiculopathy involves inflammation or
damage to the nerve root in the cervical spine which can affect a
patient's neurological function. The underlying causes and risk factors
vary, and depending on the patient's age, may more likely be attributed
to a
[[Page 58491]]
musculoskeletal condition, an infection, congenital anomaly, injury or
a tumor.
After consideration of the public comments that we received, we are
maintaining the current assignment of diagnosis codes M54.11, M54.12,
and M54.13 describing cervical radiculopathy in MDC 01 for FY 2021, and
as discussed intend to further review and analyze all the diagnosis
codes describing radiculopathy of a specified or unspecified site to
determine if they should be assigned to the same MDC, and if so,
whether those codes should be assigned to MDC 1 or MDC 8.
b. Hip and Knee Joint Replacements
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32505 through
32510), we discussed a request we received to restructure the MS-DRGs
for total joint arthroplasty that utilize an oxidized zirconium bearing
surface implant in total hip replacement and total knee replacement
procedures. According to the requestor, several international joint
replacement registries, retrospective claims review, and published
clinical studies show compelling short-term, mid-term and long-term
clinical outcomes for patients receiving these implants. The requestor
stated that without specific MS-DRGs, beneficiary access to these
implants is restricted and the benefit to patients and cost savings
cannot be recognized.
The requestor noted that effective October 1, 2017, new ICD-10-PCS
procedure codes describing hip and knee replacement procedures with an
oxidized zirconium bearing surface implant were established, which
allow greater specificity and provide the ability to track costs and
clinical outcomes for the patients who receive the implant. The
requestor provided 3 options for CMS to consider as part of its request
which are summarized in this section of this rule.
The first option provided by the requestor was to create a new MS-
DRG by reassigning cases reporting a hip or knee replacement procedure
with an oxidized zirconium bearing surface implant from MS-DRG 470
(Major Hip and Knee Joint Replacement or Reattachment of Lower
Extremity without MCC) to the suggested new MS-DRG. The requestor
conducted its own analysis and noted that there were approximately
18,000 cases reporting a hip or knee replacement with an oxidized
zirconium bearing surface implant and the average length of stay for
these cases was shorter in comparison to the cases reporting hip and
knee replacement procedures without an oxidized zirconium bearing
surface implant. The requestor suggested that patients receiving an
oxidized zirconium bearing surface implant may be walking earlier after
surgery and the risk of infection may be reduced as a result of the
shorter hospitalization.
The requestor stated that separating out these cases reporting the
use of an oxidized zirconium bearing surface implant is clinically
justified because the implants are designed for increased longevity.
The requestor also stated that oxidized zirconium is an entirely
distinct material from traditional ceramic or metal implants, as it is
made through a unique thermal oxidation process which creates a
ceramicised surface while maintaining the biocompatible zirconium alloy
substrate. According to the requestor, this process creates an implant
with the unique properties of both metals and ceramics: Durability,
strength and friction resistance. Conversely, the requestor stated that
cobalt chrome used in metal implants contains up to 143x more nickel
(<0.5% vs <0.0035%) than oxidized zirconium and that nickel is the
leading cause of negative reactions in patients with metal
sensitivities.
The requestor asserted that creating a new MS-DRG for hip and knee
replacement procedures with an oxidized zirconium bearing surface
implant would be a logical extension of the unique procedure codes that
CMS finalized and stated that other countries have established higher
government reimbursement for these implants to reflect the increased
value of the technology. The requestor also asserted that multiple
joint replacement registries have reported excellent hip replacement
results, including a statistically significant 33 percent reduced risk
of revision (p<0.001) for oxidized zirconium on highly cross-linked
polyethylene (XLPE), from three months compared to the most common
bearing surface of metal/XLPE.
Lastly, the requestor stated that multiple U.S. data sources,
including Medicare claims, show strong short-term outcomes, reduced 30-
day readmissions, fewer discharges to skilled nursing facilities
(SNFs), shorter LOS, and more frequent discharges to home, resulting in
less costly post-acute care.
The second option provided by the requestor was to create a new MS-
DRG by reassigning all cases in MS-DRG 470 reporting a hip replacement
procedure (excluding those with an oxidized zirconium bearing surface
implant) with a principal diagnosis of hip fracture and all hip
replacement procedures with an oxidized zirconium bearing surface
implant, with or without a principal diagnosis of hip fracture to the
suggested new MS-DRG. The requestor stated that based on its own
analysis, this new MS-DRG would have approximately 58,000 cases with an
estimated relative weight between the current MS-DRGs for total joint
arthroplasty (MS-DRGs 469 and 470) to reflect the increased resource
consumption of total hip replacement procedures performed due to a hip
fracture, while also reflecting a higher resource grouping for oxidized
zirconium bearing surface implants used in total hip replacement
procedures, and lastly, to reflect statistically significant reductions
in revision of total hip replacement procedure rates.
The requestor also indicated that a new MS-DRG for total hip
replacement procedures with a hip fracture would correspond to
differentials recognized in the Comprehensive Care for Joint
Replacement (CJR) model, which established a separate target 90-day
episode price for total hip replacement procedures performed due to hip
fracture cases, as these are typically higher severity patients with
longer lengths of stay than hip replacement procedures absent a hip
fracture.
The requestor conducted its own analysis of Medicare claims data
(Q4 2017-Q3 2018) for total hip replacement procedures and compared
cases with an oxidized zirconium bearing surface implant to cases
without an oxidized zirconium bearing surface implant. The requestor
reported that it found statistically reduced SNF costs, hospital length
of stay, 90-day episode costs, and 55% decreased mortality at 180 days
for the oxidized zirconium bearing surface implant cases. The requestor
urged CMS to recognize this technology with a differentiated payment in
the form of a new MS-DRG, based on its findings of excellent clinical
outcomes for total hip replacement procedures that utilize an oxidized
zirconium bearing surface implant.
The third option provided by the requestor was to reassign all
cases reporting a total hip replacement procedure using an oxidized
zirconium bearing surface implant with a principal diagnosis of hip
fracture from MS-DRG 470 (Major Hip and Knee Joint Replacement or
Reattachment of Lower Extremity without MCC) to MS-DRG 469 (Major Hip
and Knee Joint Replacement or Reattachment of Lower Extremity with MCC
or Total Ankle Replacement). The requestor stated this option would
maintain the two existing MS-DRGs for total joint arthroplasty and
would only involve moving a small
[[Page 58492]]
subset of cases (approximately 300) from MS-DRG 470 to MS-DRG 469.
The requestor acknowledged that the third option was more limited
than the first two options, however, the requestor stated that it was
the least disruptive since the two MS-DRGs and estimated relative
weights would remain essentially the same. The requestor also stated
that reassigning cases reporting a total hip replacement procedure
using an oxidized zirconium bearing surface implant with a principal
diagnosis of hip fracture from MS-DRG 470 to MS-DRG 469 would encourage
hospitals to use these high-quality, proven implants.
The requestor also asserted that the third option focuses the
suggested payment changes on the population of patients that benefit
the most from the technology. According to the requestor, the analysis
of Medicare claims data suggests that there is potential to improve
care for the older population of patients who receive a total hip
replacement by encouraging providers to use an oxidized zirconium
bearing surface implant for hip fracture cases. In addition, the
requestor stated that long-term Medicare solvency concerns impel
consideration of incentives as a means to drive better outcomes at
lower cost. Specifically, the requestor asserted that if all of the
approximately 150,000 total hip replacement procedures performed
annually in the U.S. for hip fracture achieved 90-day episode cost
savings observed in Medicare claims for oxidized zirconium bearing
surface implants, based on the requestor's analysis, potential annual
savings of more than $650 million could be realized, in addition to
longer-term savings achieved through reduced revisions.
The requestor also welcomed additional analysis by CMS of the
claims data and consideration of alternative configurations that might
better align patient severity, clinical value and payment.
As indicated by the requestor, October 1, 2017, new ICD-10-PCS
procedure codes describing hip and knee replacement procedures with an
oxidized zirconium bearing surface implant were created. The procedure
codes are as follows:
[GRAPHIC] [TIFF OMITTED] TR18SE20.043
We indicated in the FY 2021 IPPS/LTCH PPS proposed rule that we
examined claims data from the September 2019 update of the FY 2019
MedPAR file for MS-DRGs 469 and 470 where hip and knee replacement
procedures are currently assigned for cases reporting the use of an
oxidized zirconium bearing surface implant to address the three options
provided by the requestor.
To evaluate the first option provided by the requestor, we analyzed
the cases reporting a total hip or total knee replacement procedure
with an oxidized zirconium bearing surface implant in MS-DRG 470 to
determine if a new MS-DRG is warranted. To evaluate the second option
provided by the requestor, we analyzed the cases reporting a total hip
replacement procedure without an oxidized zirconium bearing surface
implant with a principal diagnosis of hip fracture and
[[Page 58493]]
cases reporting a total hip replacement procedure with an oxidized
zirconium implant with or without a principal diagnosis of hip fracture
in MS-DRG 470 to determine if a new MS-DRG is warranted. We referred
the reader to Table 6P.1c associated with the proposed rule for a list
of the procedure codes that describe a hip replacement without an
oxidized zirconium bearing surface implant and to Table 6P.1e
associated with the proposed rule for a list of the diagnosis codes
describing a hip fracture that were provided by the requestor for
consideration of options 2 and 3. To evaluate the third option provided
by the requestor, we analyzed the cases reporting a total hip
replacement procedure with an oxidized zirconium bearing surface
implant and a principal diagnosis of fracture in MS-DRG 470 to
determine if the cases warrant reassignment to MS-DRG 469. Our findings
are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.044
As shown in the table, there was a total of 25,701 cases with an
average length of stay of 5.9 days and average costs of $22,126 in MS-
DRG 469. For MS-DRG 470, there was a total of 386,221 cases with an
average length of stay of 2.3 days and average costs of $14,326. Of
those 386,221 cases in MS-DRG 470, there was a total of 18,898 cases
reporting a total hip replacement or total knee replacement procedure
with an oxidized zirconium bearing surface implant with an average
length of stay of 2.1 days and average costs of $14,808; a total of
47,316 cases reporting a total hip replacement procedure with a
principal diagnosis of hip fracture with an average length of stay of
4.5 days and average costs of $16,077; a total of 7,241 cases reporting
a total hip replacement procedure with an oxidized zirconium bearing
surface implant with or without a principal diagnosis of hip fracture
with an average length of stay of 1.9 days and average costs of
$13,875; and a total of 316 cases reporting a total hip replacement
procedure with an oxidized zirconium bearing surface implant with a
principal diagnosis of hip fracture with an average length of stay of 4
days and average costs of $18,304.
We noted that the data analysis performed to evaluate the first
option provided by the requestor indicated that the 18,898 cases
reporting a total hip replacement or total knee replacement procedure
with an oxidized zirconium bearing surface implant in MS-DRG 470 have a
similar average length of stay (2.1 days versus 2.3 days) and similar
average costs ($14,808 versus $14,326) compared to all the cases in MS-
DRG 470. The results are also consistent with the requestor's findings
that there were approximately 18,000 cases reporting a hip or knee
replacement with an oxidized zirconium bearing surface implant. Based
on the claims analysis, our clinical advisors stated that the data does
not support creating a new MS-DRG for these procedures. We stated that
our clinical advisors also believed that the characteristics of the
patients
[[Page 58494]]
and resources used for a case that involves a total hip replacement or
total knee replacement procedure with an oxidized zirconium bearing
surface implant are not clinically distinct from the characteristics of
the patients and resources used for the cases reporting a total hip
replacement or total knee replacement procedure without an oxidized
zirconium bearing surface implant. Therefore, in consideration of the
first option provided by the requestor, we proposed to not create a new
MS-DRG for cases reporting a total hip or knee replacement procedure
with an oxidized zirconium bearing surface implant.
The data analysis performed to evaluate the second option provided
by the requestor indicated that the 47,316 cases reporting a total hip
replacement procedure without an oxidized zirconium bearing surface
implant with a principal diagnosis of hip fracture have an average
length of stay that is longer than the average length of stay for all
the cases in MS-DRG 470 (4.5 days versus 2.3 days) and the average
costs are higher when compared to all the cases in MS-DRG 470 ($16,077
versus $14,326). For the 7,241 cases reporting a total hip replacement
procedure with an oxidized zirconium bearing surface implant with or
without a principal diagnosis of hip fracture, the average length of
stay is shorter than the average length of stay for all the cases (1.9
days versus 2.3 days) and the average costs are slightly lower when
compared to all the cases in MS-DRG 470 ($13,875 versus $14,326). Our
analysis of the combined total number of cases identified for the
second option provided by the requestor indicated that the 54,557 cases
(47,316 + 7,241) have a longer average length of stay compared to the
average length of stay for all the cases in MS-DRG 470 (4.2 days versus
2.3 days) and the average costs are slightly higher ($15,785 versus
$14,326) when compared to all the cases in MS-DRG 470. The results are
also consistent with the requestor's findings that there were
approximately 58,000 cases reporting a total hip replacement procedure
without an oxidized zirconium bearing surface implant with a principal
diagnosis of hip fracture or a total hip replacement procedure with an
oxidized zirconium bearing surface implant with or without a principal
diagnosis of hip fracture. We stated that our clinical advisors
believed that the data does not support creating a new MS-DRG for the
subset of cases as suggested by the requestor. They noted the variation
in the volume (47,316 cases and 7,241 cases), average length of stay
(4.5 days and 1.9 days), and the average costs ($16,077 and $13,875)
for each subset of option 2 and that the total average cost for the
combined cases identified for the second option ($15,785) is very
similar to the costs of all the cases in MS-DRG 470 ($14,326).
Therefore, in consideration of the second option provided by the
requestor, we did not propose to create a new MS-DRG for cases
reporting a total hip replacement procedure without an oxidized
zirconium bearing surface implant with a principal diagnosis of hip
fracture and cases reporting a total hip replacement procedure with an
oxidized zirconium implant with or without a principal diagnosis of hip
fracture.
The data analysis performed to evaluate the third option provided
by the requestor indicated that the 316 cases reporting a total hip
replacement procedure with an oxidized zirconium bearing surface
implant with a principal diagnosis of hip fracture have a longer
average length of stay (4.0 days versus 2.3 days) and higher average
costs ($18,304 versus $14,326) compared to all the cases in MS-DRG 470.
The results are also consistent with the requestor's findings that
there were approximately 300 cases reporting a total hip replacement
procedure with an oxidized zirconium bearing surface implant with a
principal diagnosis of hip fracture. Our clinical advisors noted that
while the data shows a longer length of stay and higher average costs
for these cases under option 3, the analysis of the cases reporting a
total hip replacement procedure without an oxidized zirconium bearing
surface implant with a principal diagnosis of hip fracture under option
2 also demonstrated a longer length of stay and higher average costs.
They therefore recommended we conduct further review specifically of
those cases reporting a total hip replacement procedure with a
principal diagnosis of hip fracture, with or without an oxidized
zirconium bearing surface implant.
As indicated in the proposed rule, based on the advice of our
clinical advisors and in connection with the request for CMS to examine
the claims data and consider alternative configurations, we performed
additional analysis of those cases reporting a total hip replacement
procedure with a principal diagnosis of hip fracture for both MS-DRGs
469 and 470. We stated that the procedure codes for the hip replacement
procedures included in this additional analysis are displayed in Table
6P.1d associated with the proposed rule and the diagnosis codes for hip
fracture included in this additional analysis are displayed in Table
6P.1e associated with the proposed rule. Our findings are shown in the
following table.
[[Page 58495]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.045
As shown in the table, there was a total of 14,163 cases reporting
a total hip replacement procedure with a principal diagnosis of hip
fracture with an average length of stay of 7.2 days and average costs
of $21,951 in MS-DRG 469. There was a total of 47,632 cases reporting a
total hip replacement procedure with a principal diagnosis of hip
fracture with an average length of stay of 4.5 days and average costs
of $16,092 in MS-DRG 470. The average length of stay for the cases
reporting a total hip replacement procedure with a principal diagnosis
of hip fracture in MS-DRGs 469 and 470 were longer (7.2 days versus 5.9
days and 4.5 versus 2.3 days, respectively) compared to all the cases
in their assigned MS-DRGs. The average costs of the cases reporting a
total hip replacement procedure with a principal diagnosis of hip
fracture in MS-DRG 469 were approximately $175 less when compared to
the average costs of all cases in MS-DRG 469 ($21,951 versus $22,126)
and slightly more for MS-DRG 470 ($16,092 versus $14,326). Our clinical
advisors supported differentiating the cases reporting a total hip
replacement procedure with a principal diagnosis of hip fracture from
those cases without a hip fracture by assigning them to a new MS-DRG.
They noted that clinically, individuals who undergo hip replacement
following hip fracture tend to require greater resources for effective
treatment than those without hip fracture. They further noted that the
increased complexity associated with hip fracture patients can be
attributed to the post traumatic state and the stress of pain, possible
peri-articular bleeding, and the fact that this subset of patients,
most of whom have fallen as the cause for their fracture, may be on
average more frail than those who require hip replacement because of
degenerative joint disease.
We applied the criteria to create subgroups in a base MS-DRG as
discussed in section II.D.1.b. of the FY 2021 IPPS/LTCH PPS proposed
rule and section II.E.1.b. of this final rule. We noted that, as shown
in the table that follows, a three-way split of this base MS-DRG failed
to meet the criterion that there be at least a 20% difference in
average costs between the CC and NonCC subgroup and also failed to meet
the criterion that there be at least a $2,000 difference in average
costs between the CC and NonCC subgroup. The following table
illustrates our findings.
[GRAPHIC] [TIFF OMITTED] TR18SE20.046
We then applied the criteria for a two-way split for the ``with MCC
and without MCC'' subgroups and found that all five criteria were met.
We stated that for the proposed new MS-DRGs, there is at least (1) 500
cases in the MCC subgroup and 500 cases in the without MCC subgroup;
(2) 5 percent of the cases in the MCC group and 5 percent in the
without MCC subgroup; (3) a 20 percent difference in average costs
between the MCC group and the without MCC group; (4) a $2,000
difference in average costs between the MCC group and the without MCC
group; and (5) a 3-percent reduction in cost variance, indicating that
the severity level splits increase the explanatory power of the base
MS-DRG in capturing differences in expected cost between the MS-DRG
severity level splits by at least 3 percent and thus improve the
overall accuracy of the IPPS payment system. The following table
illustrates our findings.
[[Page 58496]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.047
For FY 2021, we proposed to create new MS-DRG 521 (Hip Replacement
with Principal Diagnosis of Hip Fracture with MCC) and new MS-DRG 522
(Hip Replacement with Principal Diagnosis of Hip Fracture without MCC).
We referred the reader to Table 6P.1d associated with this proposed
rule for the list of procedure codes describing hip replacement
procedures and to Table 6P.1e associated with the proposed rule for the
list of diagnosis codes describing hip fracture diagnoses that we
proposed to define in the logic for these new MS-DRGs.
Comment: Several commenters supported the proposal to create
proposed new MS-DRGs 521 and 522 for patients undergoing a hip
replacement due to a hip fracture. The commenters stated their belief
that the proposed new MS-DRGs and payment rates will better match the
resource utilization for these clinically distinct patients.
Specifically, a commenter noted that it is appropriate to differentiate
hip replacement cases based on whether the patient has a hip fracture
since, as noted in clinical literature, total hip arthroplasty (THA)
for hip fracture cases are subject to longer lengths of stay, and more
postoperative complications, readmissions, reoperations, and mortality
than THA cases performed for osteoarthritis of the hip. Another
commenter stated that combining hip fractures in the current MS-DRGs
469 and 470 with planned hip replacement procedures fails to take into
consideration and adequately compensate for the complex nature of and
additional care fracture patients require. The commenter noted that hip
fracture patients require an increased acute length of stay, often have
more post traumatic stressors due to their fall and are on average
frailer than those patients who choose to have an elective hip
replacement, therefore, creating two new MS-DRGs would help to capture
the differences in the care required and the cost between hip fracture
patients and elective hip replacement patients. Another commenter
expressed appreciation for CMS' effort to review the analysis and
provide results of each option and alternative options in detail with
the associated diagnosis and procedure codes in the proposed rule to
define in the logic for the proposed new MS-DRGs. Based on the results,
the commenter stated they agreed that differentiating the cases
reporting a total hip replacement procedure with a principal diagnosis
of hip fracture from those cases without a hip fracture by assigning
them to a new MS-DRG would better align cases by average length of stay
and average costs of cases, and lead to a more reasonable MS-DRG
classification of these cases. Lastly, a commenter specifically
expressed support for the establishment of the proposed new MS-DRGs,
regardless of the type of bearing surface implant used in the joint
replacement procedure.
However, a couple commenters who supported the concept of the
proposal to create proposed new MS-DRGs 521 and 522 recommended that
CMS not finalize the proposal until further analysis could be
conducted. The commenters expressed concern that the relative weight
and the average length of stay for proposed new MS-DRG 521 did not
appear to align with clinical experience and underlying data since it
is lower than the relative weight and average length of stay for MS-DRG
469. The commenters suggested that CMS re-evaluate and provide
clarification on the data analysis.
A commenter expressed appreciation for the consideration CMS
provided in response to the request to create MS-DRGs specifically for
oxidized zirconium implants utilized in hip and knee replacement
procedures. The commenter stated that although CMS' proposal did not
explicitly focus on oxidized zirconium implants, an alternative option
for the joint replacement procedures was examined and presented,
resulting in the proposed new MS-DRGs 521 and 522. The commenter stated
that these proposed MS-DRGs would improve distinguishing this subset of
patients with a hip fracture who undergo a hip replacement procedure,
however, the ability to differentiate meaningful parameters of care
quality is not realized since the proposal treats all implants the
same, despite what the commenter stated were the important clinical
improvements demonstrated in the Medicare claims data for oxidized
zirconium implants used for hip fracture patients. As a result, the
commenter stated its belief that CMS should revise its proposal and
adopt a specific MS-DRG for patients with a principal diagnosis of hip
fracture receiving an oxidized zirconium bearing surface implant in a
hip replacement procedure. According to the commenter, this would
reflect an improvement over the proposed MS-DRGs 521 and 522, and best
advance CMS policy and patient care objectives by creating incentives
that appropriately encourage the use of a technology that has been
shown to have substantial cost-saving and quality of care benefits. In
addition, the commenter asserted that CMS stated a separate MS-DRG for
oxidized zirconium is not warranted because certain criteria for
establishing MS-DRG CC subgroups are not met. The commenter indicated
CMS has broad statutory authority in the design of the Medicare
inpatient payment system and is not required to limit its MS-DRG
subgroups exclusively to be based on severity of co-morbidities or
complications. The commenter remarked CMS should also not be limited to
its five-step criteria for CC subgroups and by allowing for the
creation of MS-DRG subgroups where there is clear evidence of a
substantial clinical improvement will give CMS significantly greater
flexibility to accomplish its goals of transformative quality
improvement and cost-savings. The commenter stated that CMS has the
ability and authority to make payment policy decisions that it believes
will advance care and the Social Security Act grants CMS broad
authority to establish a classification of inpatient hospital
discharges by diagnosis-related groups and a methodology for
classifying specific hospital discharges within these groups. The
commenter maintained that nothing in the statute prohibits CMS from
creating MS-DRG groups or sub-groups based partly upon other important
policy criteria, such as actual improved patient outcomes. According to
the commenter, CMS should use its exceptions and adjustments authority
to accomplish this objective. The commenter provided the example that
although CMS did not propose to create a new MS-DRG for
[[Page 58497]]
oxidized zirconium implants, it could still adjust payment rates for
inpatient stays involving such implants and accomplish similar results.
The commenter expressed appreciation that the IPPS centrally organizes
MS-DRGs on the basis of resource usage and clinical coherence, however,
urged CMS to incorporate outcomes-based consideration. The commenter
also contended that CMS has the opportunity to more fully realize the
value of proven technologies by making incremental MS-DRG changes that
lend access to the technologies shown to provide the most significant
clinical benefits and signal to hospitals, surgeons, private payers,
and others that CMS sees the value of these implants and wants to make
sure Medicare beneficiaries can access these technologies. The
commenter suggested that CMS consider MS-DRG subgroup requests that
fall outside of the current five-step criteria for CC sub-groups,
provided that requestors can demonstrate a substantial clinical
improvement since this would allow the agency additional flexibility to
make changes in MS-DRGs for technologies that demonstrate substantial
clinical improvement based on lengthy track records of proven
performance. The commenter noted how CMS utilizes the substantial
clinical improvement criterion as part of assessing whether a new
technology is eligible for a New Technology Add-On Payment or
Transitional Pass-Through status and urged CMS to expand its use of
this standard as an alternative pathway when evaluating certain MS-DRG
subgroup requests. The commenter stated that in reviewing certain
technologies associated with total joint replacement procedures, CMS
should evaluate implants based on their ability to demonstrate
significant reductions in long-term revision rates which are critical
in studying improved patient outcomes and cost savings within the
Medicare program. Additional data for revision rates from international
joint replacement registries, reduced mortality rates from both
international registries and Medicare claims data, and readmission
rates from Medicare claims data was also provided by the commenter who
asserted the information compels CMS to determine whether to finalize
MS-DRGs that capture the broad category of hip fracture cases, or to
create a narrower hip fracture MS-DRG based on strong outcomes
differences observed in Medicare claims. The commenter asserted that
because the data show strong results for hip fracture patients treated
with an oxidized zirconium implant, CMS should also consider an
exception and expand on proposed MS-DRGs 521 and 522 by creating a
specific MS-DRG for hip fracture patients treated with an oxidized
zirconium implant.
Lastly, the commenter expressed its appreciation for the analytical
work and extensive consideration CMS provided to the request and
acknowledged oxidized zirconium implants are only used in a very small
portion of total hip replacement with hip fracture cases. The commenter
stated its belief that the proposed MS-DRGs 521 and 522 would improve
the ability to clinically distinguish hip fracture cases treated with a
hip replacement from elective hip replacement procedures if CMS
continues to believe a specific MS-DRG for hip fracture patients
treated with an oxidized zirconium implant is not warranted.
Another commenter stated the proposal to create proposed new MS-
DRGs 521 and 522 to account for differences in the cost of the THA
procedure for a hip fracture appeared to be a neutral act in terms of
cost. The commenter recommended that the proposal not be adopted as
final policy since the current THA MS-DRGs 469 and 470 already provide
similar reimbursement for the procedures through associated diagnostic
codes, and the added expense of treating hip fractures is accounted for
in the Comprehensive Care for Joint Replacement (CJR) Model. This
commenter stated their belief that it would be inappropriate to make
such a substantive change to the MS-DRG system without a strong body of
evidence to support proposals which directly benefit one device over
another. The commenter also stated they are not aware of any high-
quality randomized controlled trials which report beneficial effects of
the oxidized zirconium bearing surface. According to the commenter, any
reported beneficial effect is most likely due to selection bias (that
is, choosing younger, healthier patients for the oxidized zirconium
bearings), rather than any real difference in performance. The
commenter stated that this is true for registry data as well as
clinical cohort studies. In addition, the commenter noted that among
their society's hip replacement experts, the superiority of oxidized
zirconium-alloy bearings is not a generally accepted fact. The
commenter stated that they support higher reimbursement for hip
replacements with a fracture in the existing MS-DRGs 469 and 470,
however, they currently do not support creating the new MS-DRGs as
proposed.
Response: We appreciate the commenters' support of the proposal to
create proposed new MS-DRGs 521 and 522. We agree with the commenters
that the proposed new MS-DRGs and payment rates will better match the
resource utilization for these clinically distinct patients.
In response to the commenters who supported the concept of the
proposal however recommended that CMS conduct further analysis for
proposed new MS-DRG 521 because the proposed relative weight and
average length of stay did not appear to align with clinical experience
and underlying data in comparison to MS-DRG 469, we note that effective
October 1, 2017 (FY 2018) the logic for MS-DRG 469 includes total ankle
replacement procedures, therefore, the average length of stay, the
average costs, and the relative weight of MS-DRG 469 continue to
reflect the resource utilization associated with total ankle
replacement procedures. In addition, total knee replacement procedures
with a MCC are also included in the logic for MS-DRG 469.
The procedure codes identifying a total ankle replacement or total
knee replacement are as follows:
BILLING CODE 4120-1-P
[[Page 58498]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.048
[[Page 58499]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.049
[[Page 58500]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.050
BILLING CODE 4120-01-C
We analyzed data from the September 2019 update of the FY 2019
MedPAR file for cases reporting a total ankle replacement procedure or
a total knee replacement procedure in MS-DRG 469 for comparison to
proposed MS-DRG 521. Our findings are shown in the following tables.
[[Page 58501]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.051
We found a total of 25,701 cases in MS-DRG 469 with an average
length of stay of 5.9 days and average costs of $22,126. Of those
25,701 cases, we found a total of 2,819 cases reporting a total ankle
replacement procedure with an average length of stay of 1.7 days and
average costs of $22,327 and a total of 4,617 cases reporting a total
knee replacement procedure with an average length of stay of 4.9days
and average costs of $21,626.
As discussed in the proposed rule and shown in the table above, for
proposed MS-DRG 521, the average length of stay is 7.2 days which is
longer than the average length of stay of 5.9 days for MS-DRG 469, and
the average costs for proposed MS-DRG 521 are slightly lower ($175)
compared to the average costs of MS-DRG 469 ($21,951 versus $22,126,
respectively).
The data demonstrates that the average costs of the total ankle
replacement procedures in MS-DRG 469 are slightly higher than the
average costs of all the cases in MS-DRG 469 ($22,327 versus $22,126).
The proposal to reassign cases reporting a total hip replacement
procedure with a principal diagnosis of a hip fracture from MS-DRG 469
to proposed new MS-DRG 521 includes the reassignment of 14,163 cases
out of the 25,701 cases resulting in a total of 11,538 cases proposed
to remain in MS-DRG 469. Of those 11,538 cases remaining in MS-DRG 469,
a total of 2,819 cases reflect a higher utilization of resources,
thereby continuing to impact the relative weight of MS-DRG 469 such
that it is slightly higher than the proposed relative weight for
proposed MS-DRG 521 (3.0844 versus 3.0634). Therefore, the data appears
to reflect that the difference in the relative weights can be
attributed to the fact that the total ankle replacement procedures
continue to have an impact for MS-DRG 469.
In response to the commenter who stated that CMS should revise its
proposal and adopt a specific MS-DRG for patients with a principal
diagnosis of hip fracture receiving an oxidized zirconium bearing
surface implant in a hip replacement procedure, we note that, our
clinical advisors do not support the creation of a separate, specific
MS-DRG for oxidized zirconium bearing surface implants for reasons
previously discussed in the FY 2021 IPPS/LTCH PPS proposed rule. As the
commenter stated in its own comments, CMS organizes MS-DRGs on the
basis of resource usage and clinical coherence. Consistent with our
annual process of evaluating MS-DRG classification requests, we
performed a thorough review of the claims data for oxidized zirconium
bearing surface implants utilized in a hip replacement procedure and
provided a summary of that analysis, including input from our clinical
advisors, as discussed in the proposed rule. Our clinical advisors
believe that hip replacement procedures performed for a hip fracture
demonstrate similar and predictable resource demands, regardless of the
type of bearing surface implant used in the performance of the
procedure. Therefore, we proposed to create new MS-DRGs 521 and 522,
consistent with our efforts to continually refine the ICD-10 MS-DRGs
while maintaining clinically coherent groups that also more accurately
stratify Medicare patients with varying levels of severity. Therefore,
with respect to the commenter's statement that CMS has broad authority
to make policy changes, including the special exceptions and adjustment
authority, we do not believe such changes would be appropriate or
necessary for this group of hip replacement patients that receive an
oxidized zirconium bearing surface implant. We can consider the
commenter's suggestions to incorporate additional considerations into
our analysis of MS-DRG classification requests in future rulemaking. We
also wish to clarify for the commenter that the criteria to create
subgroups within a base MS-DRG was not applied in evaluating the
request to create a new MS-DRG. In other words, the criteria to create
subgroups is only applied after the decision to propose to create a
base MS-DRG is made.
Finally, in response to the commenter's statement that CMS should
expand its use of the substantial clinical improvement standard as an
alternative pathway when evaluating certain MS-DRG subgroup requests
similar to the new technology add-on payment policy process, we will
take this into future consideration.
In response to the commenter who stated their belief that it would
be inappropriate to make a substantive change to the MS-DRG system
without a strong body of evidence to support proposals which directly
benefit one device over another and that they are not aware of any
high-quality randomized controlled trials which report beneficial
effects of the oxidized zirconium bearing surface, we wish to clarify
that the CMS proposal did not involve proposing to directly benefit the
oxidized zirconium bearing surface implant over other bearing surface
implants. The CMS proposal presented was an alternative option to what
the requestor submitted for CMS' consideration. Specifically, the CMS
proposal was to group together all hip replacement procedures performed
to treat a hip fracture, regardless of the type of bearing surface
implant used, and the resulting MS-DRG assignment would be further
differentiated based on the presence of a MCC, hence the proposal to
create proposed new MS-DRGs 521 and 522 (Hip Replacement with Principal
Diagnosis of Hip Fracture with and without MCC, respectively).
After consideration of the comments we received, for the reasons
previously discussed, we are finalizing our
[[Page 58502]]
proposal to create MS-DRGs 521 and 522 (Hip Replacement with Principal
Diagnosis of Hip Fracture with and without MCC, respectively) for FY
2021. We refer readers to table 6P.1d for the list of procedure codes
describing hip replacements and table 6P.1e for the list of diagnosis
codes describing hip fractures (available via the internet on the CMS
web page at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS) that we are finalizing in the GROUPER logic
for MS-DRGs 521 and 522.
In the FY 2021 IPPS/LTCH PPS proposed rule, we also noted that the
Comprehensive Care for Joint Replacement (CJR) model includes episodes
triggered by MS-DRG 469 with hip fracture and MS-DRG 470 with hip
fracture. Given the proposal to create new MS-DRG 521 and MS-DRG 522,
we sought public comment on the effect this proposal would have on the
CJR model and whether to incorporate MS-DRG 521 and MS-DRG 522, if
finalized, into the CJR model's proposed extension to December 31,
2023. As discussed in the CJR proposed rule ``Comprehensive Care for
Joint Replacement Model Three-Year Extension and Changes to Episode
Definition and Pricing'' (85 FR 10516), we proposed to extend the
duration of the CJR model. We stated that this extension, if finalized,
would revise certain aspects of the CJR model including, but not
limited to, the episode of care definition, the target price
calculation, the reconciliation process, the beneficiary notice
requirements and the appeals process. Additionally, we stated that the
CJR proposed rule would allow time to test the changes by extending the
length of the CJR model through December 31, 2023, for certain
participant hospitals. The comment period for the CJR proposed rule
closed on June 23, 2020 (85 FR 22978). We intend to address the
comments on the proposed rule and this solicitation in the
Comprehensive Care for Joint Replacement Model Three-Year Extension and
Changes to Episode Definition and Pricing Final Rule. . In an interim
final rule that we published in the April 6, 2020 Federal Register, we
extended the duration of the CJR model through March 31, 2021, in light
of the COVID-19 pandemic, to ensure continuity of CJR model operations
in participant hospitals during the public health emergency so that we
did not create any additional disruptions to the standard of care
procedures hospitals have in place during this challenging time.
Because the model will continue until at least March 31, 2021, we
intend to adopt a policy in the CJR final rule that incorporates MS-DRG
521 and MS-DRG 522 into the CJR model as of the effective date of these
new MS-DRGs. We believe such an approach would avoid disruption to the
model for the remainder of PY5 (as extended) and thereafter, if our
proposal to extend the CJR model to December 31, 2023 is finalized.
8. MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)
a. Kidney Transplants
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32510), we received two separate but related requests to review the MS-
DRG assignment for procedures describing the transplantation of
kidneys. The first request was to designate kidney transplants as a
Pre-MDC MS-DRG in the same manner that other organ transplants are. The
requestor performed its own analysis and stated that it found that
cases with a principal diagnosis from MDC 05 (Diseases and Disorders of
the Circulatory System), for example I13.2 (Hypertensive heart and
chronic kidney disease with heart failure and with stage 5 chronic
kidney disease, or end stage renal disease), reported with a kidney
transplant from MDC 11 (Diseases and Disorders of the Kidney and
Urinary Tract), grouped to MS-DRG 981(Extensive O.R. Procedure
Unrelated to Principal Diagnosis with MCC). The requestor stated it did
not appear appropriate that a kidney transplant would group to MS-DRG
981 when diagnosis code I13.2 is a legitimate principal diagnosis for
this procedure. This requestor also suggested that if there was a
proposal for designating the MS-DRG for kidney transplants as a Pre-MDC
MS-DRG, that a severity level split should also be considered.
As discussed in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42128
through 42129), during our review of cases that group to MS-DRGS 981
through 983, we noted that when procedures describing transplantation
of kidneys (ICD-10-PCS procedure codes 0TY00Z0 (Transplantation of
right kidney, allogeneic, open approach) and 0TY10Z0 (Transplantation
of left kidney, allogeneic, open approach) are reported in conjunction
with ICD-10-CM diagnosis codes in MDC 05 (Diseases and Disorders of the
Circulatory System), the cases group to MS-DRGs 981 through 983. For
the reasons discussed, we proposed to add ICD-10-PCS procedure codes
0TY00Z0 and 0TY10Z0 to MS-DRG 264 in MDC 05. As summarized in the FY
2020 IPPS/LTCH PPS final rule, commenters opposed our proposal to add
ICD-10-PCS procedure codes 0TY00Z0 and 0TY10Z0 to MS-DRG 264 in MDC 05.
Commenters suggested that CMS instead assign these cases to MS-DRG 652,
noting that the length of stay for the vast majority of kidney
transplant cases involving serious cardiac conditions approximates the
length of stay for kidney transplants in general. After consideration
of public comments, we did not finalize our proposal to add ICD-10-PCS
procedure codes 0TY00Z0 and 0TY10Z0 to MS-DRG 264 in MDC 05. We stated
that we believed it would be appropriate to take additional time to
review the concerns raised by commenters consistent with the
President's Executive Order on Advancing American Kidney Health (see
https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/). Accordingly, cases reporting a
principal diagnosis in MDC 05 with a procedure describing kidney
transplantation (that is, procedure code 0TY00Z0 or 0TY10Z0) continue
to group to MS-DRGs 981 through 983 under the ICD-10 MS-DRGs Version
37, effective October 1, 2019.
In the proposed rule, we stated in response to these public
comments and the request we received on this topic for FY 2021
consideration, we examined claims data from the September 2019 update
of the FY 2019 MedPAR file for MS-DRG 652. In MS-DRG 652, there were
11,324 cases reporting one of the procedure codes listed describing a
kidney transplant procedure, with an average length of stay of 6 days
and average costs of $25,424.
[[Page 58503]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.052
We then analyzed claims data for cases reporting one of the
procedure codes listed describing the transplantation of kidney
reported in MS-DRGs 981, 982, and 983. We did not find any such cases
in MS-DRG 983.
[GRAPHIC] [TIFF OMITTED] TR18SE20.053
Of the 366 cases reporting procedures describing kidney transplants
in MS-DRGs 981 and 982, all of the cases reported a principal diagnosis
from MDC 05. The diagnoses reported are reflected in the table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.054
[[Page 58504]]
Our clinical advisors reviewed these data. As indicated previously,
in MS-DRG 652, there were 11,324 cases reporting one of the procedure
codes listed describing a kidney transplant procedure, with an average
length of stay of 6 days and average costs of $25,424. Our clinical
advisors noted that the average costs for cases reporting
transplantation of kidney with a diagnosis from MDC 05 listed
previously are generally similar to the average costs of cases in MS-
DRG 652. The diagnoses assigned to MDC 05 reflect conditions associated
with the circulatory system. We stated that our clinical advisors
agreed that although these diagnoses might also be a reasonable
indication for kidney transplant procedures, it would not be
appropriate to move these diagnoses into MDC 11 because it could
inadvertently cause cases reporting these same MDC 05 diagnoses with a
circulatory system procedure to be assigned to an unrelated MS-DRG.
To further examine the impact of moving MDC 05 diagnoses into MDC
11, we analyzed claims data for cases reporting a circulatory system
O.R. procedure and MDC 05 ICD-10-CM diagnosis code I13.2 (Hypertensive
heart and chronic kidney disease with heart failure and with stage 5
chronic kidney disease, or end stage renal disease). Diagnosis code
I13.2 was selected since this diagnosis was the MDC 05 diagnosis most
frequently reported with kidney transplant procedures. Our findings are
reflected in the following table:
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR18SE20.055
[[Page 58505]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.056
BILLING CODE 4120-01-C
As shown in the table, if we were to move diagnosis code I13.2 to
MDC 11, 4,366 cases would be assigned to the surgical class referred to
as ``unrelated operating room procedures'' as an unintended
consequence. Therefore, as an alternate option, we proposed to modify
the GROUPER logic for MS-DRG 652 by allowing the presence of a
procedure code describing transplantation of the kidney to determine
the MS-DRG assignment independent of the MDC of the principal diagnosis
in most instances. The logic for MDC 24 (Multiple Significant Trauma)
and MDC 25 (Human Immunodeficiency Virus Infections) will remain
unchanged, meaning there would be two exceptions to the modification of
the GROUPER logic for MS-DRG 652. If a principal diagnosis of trauma
and at least two significant traumas of different body sites are
present, the appropriate MS-DRG in MDC 24 would be assigned based on
the principal diagnosis and procedures reported, instead of MS-DRG 652.
Also, if either a principal diagnosis of HIV infection or a secondary
diagnosis of HIV infection with a principal diagnosis of a significant
HIV related condition are present, the appropriate MS-DRG in MDC 25
would be assigned based on the principal diagnosis and procedures
reported instead of MS-DRG 652. The diagram found towards the end of
this discussion illustrates how the MS-DRG logic for MS-DRG 652 (Kidney
Transplant) would function.
We stated we recognized MS-DRG 652 is one of the only transplant
MS-DRGs not currently defined as a Pre-MDC. Pre-MDCs were an addition
to Version 8 of the Diagnosis Related Groups. This proposal was the
first departure from the use of principal diagnosis as the initial
variable in DRG and subsequently MS-DRG assignment. For Pre-MDC DRGs,
the initial step in DRG assignment is not the principal diagnosis, but
instead certain surgical procedures with extremely high costs such as
heart transplant, liver transplant, bone marrow transplant, and
tracheostomies performed on patients on long-term ventilation. When
added in Version 8, these types of services were viewed as being very
resource intensive. Our clinical advisors have noted, however, that
treatment practices have shifted since the inception of Pre-MDCs. We
stated that the current proposed refinements to MS-DRG 652 represent
the first step in investigating how we may consider introducing this
concept of allowing certain procedures to affect the MS-DRG assignment
regardless of the MDC from which the diagnosis is reported in the
future, with the possibility of removing the Pre-MDC category entirely.
In other words, we would consider having the resource intensive
procedures currently assigned to the Pre-MDC MS-DRGs determine
assignment to MS-DRGs within the clinically appropriate MDC. We are
making concerted efforts to continue refining the ICD-10 MS-DRGs and we
believe that it is important to include the Pre-MDC category as part of
our comprehensive review.
Comment: Commenters agreed with CMS' proposal to modify the GROUPER
logic for MS-DRG 652 (Kidney Transplant) to allow the presence of a
procedure code describing
[[Page 58506]]
transplantation of the kidney to determine the MS-DRG assignment
independent of the MDC. A commenter also stated they agreed that CMS
should consider having the resource-intensive procedures currently
assigned to the Pre-MDC MS-DRGs determine assignment to MS-DRGs with
the ultimate goal of perhaps being able to eliminate the Pre-MDC
category entirely.
Response: We appreciate the commenters' support of the proposal and
CMS' plan to include the Pre-MDC category as part of our comprehensive,
systematic review of the ICD-10-PCS procedure codes. After
consideration of the public comments we received, we are finalizing the
proposal to modify the GROUPER logic for MS-DRG 652 to allow the
presence of a procedure code describing transplantation of the kidney
to determine the MS-DRG assignment independent of the MDC of the
principal diagnosis except in the two instances noted above.
We stated in the proposed rule, in response to the request for a
severity level split, since the request to designate kidney transplants
as a Pre-MDC MS-DRG did not involve a revision of the existing GROUPER
logic for MS-DRG 652, we applied the five criteria as described in
section II.E.1.b. of the preamble of this final rule to determine if it
would be appropriate to subdivide cases currently assigned to MS-DRG
652 into severity levels. This analysis includes 2 years of MedPAR
claims data to compare the data results from 1 year to the next to
avoid making determinations about whether additional severity levels
are warranted based on an isolated year's data fluctuation and also, to
validate that the established severity levels within a base MS-DRG are
supported. Therefore, we reviewed the claims data for base MS-DRG 652
using the September 2018 update of the FY 2018 MedPAR file and the
September 2019 update of the FY 2019 MedPAR file, which were used in
our analysis of claims data for MS-DRG reclassification requests for FY
2020 and FY 2021. Our findings are shown in the table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.057
We applied the criteria to create subgroups for the three-way
severity level split. As discussed in section II.D.1.b. of the proposed
rule and section II.E.1.b. of this final rule, we proposed, and are
finalizing, the expansion of the previously listed criteria to also
include the NonCC group. We found that the criterion that there be at
least a 20% difference in average costs between subgroups failed for
the average costs between the MCC and CC subgroups based on the data in
both the FY 2018 and FY 2019 MedPAR files. The criterion that there be
at least 500 cases for each subgroup also was not met, as shown in the
table for both years. Specifically, for the ``with MCC'', ``with CC'',
and ``without CC/MCC'' split, there were only 356 cases in the
``without CC/MCC'' subgroup based on the data in the FY 2019 MedPAR
file and only 464 cases in the ``without CC/MCC'' subgroup based on the
data in the FY 2018 MedPAR file. We then applied the criteria to create
subgroups for the two-way severity level splits and found that the
criterion that there be at least a 20 percent difference in average
costs between the ``with MCC'' subgroup and the ``without MCC'' group
failed for both years. The criterion that there be at least a 3-percent
reduction in cost variance between the ``with CC/MCC'' and ``without
CC/MCC'' subgroups also failed for both years, indicating that the
current base MS-DRG 652 maintains the overall accuracy of the IPPS
payment system. The claims data do not support a three-way or a two-way
severity level split for MS-DRG 652, therefore for FY 2021, we did not
propose to subdivide MS-DRG 652 into severity levels.
Comment: A commenter supported our proposal and expressed
appreciation for CMS's examination of the GROUPER logic for DRG 652.
Response: We appreciate the commenters' support.
After consideration of public comments, we are finalizing the
proposal to not subdivide MS-DRG 652 into severity levels. We refer the
reader to section II.E.1.b. of this final rule for the comments
regarding our proposal to expand the previously listed subgroup
criteria to also include the NonCC group, as well as our finalization
of that proposal.
As discussed in the proposed rule and earlier in this section we
received two separate but related requests. The second request was that
a new MS-DRG be created for kidney transplant cases where the patient
received dialysis during the inpatient stay and after the date of the
transplant. According to the requestor, transplant hospitals incur
higher costs related to post-transplant care of patients who receive
kidneys from ``medically complex donors'' (defined by the requestor as
coming from organ donors over aged 60 and donors after circulatory
death). The requestor also stated that their research indicated that
studies consistently identified organ donors over the age of 60 and
donors after circulatory death as the most significant areas for growth
in increasing the number of organ transplantations, but this growth is
hampered by the underutilization of these types of organs. The
requestor performed its own data analysis and stated that total
standardized costs were 32 percent higher for cases where the
beneficiary received dialysis during the inpatient stay and after the
date of transplant compared to all other kidney transplant cases
currently in MS-DRG 652 (Kidney Transplant), with the additional costs
serving as a disincentive to the use of viable kidneys for donation.
The requestor asserted that this financially disadvantages transplant
centers from using such organs, contributing to the kidney discard
rate.
The following ICD-10-PCS procedure codes identify the performance
of hemodialysis.
[[Page 58507]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.058
We stated that we acknowledged that the request was to review the
costs of dialysis performed after kidney transplantation during the
same inpatient admission, however our clinical advisors pointed out,
that while not routine, it is not uncommon for a patient to require
dialysis while admitted for kidney transplantation before the procedure
is performed due to factors related to the availability of the organ,
nor is it uncommon for a kidney that has been removed from the donor,
transported, and then implanted to require dialysis before it returns
to optimal function. Therefore, we examined claims data from the
September 2019 update of the FY 2019 MedPAR file for all cases in MS-
DRG 652 and compared the results to cases representing kidney
transplantation with dialysis performed during the same inpatient
admission either before or after the date of kidney transplantation.
The following table shows our findings:
[GRAPHIC] [TIFF OMITTED] TR18SE20.059
As shown by the table, for MS-DRG 652, we identified a total of
11,324 cases, with an average length of stay of 6.0 days and average
costs of $25,424. Of the 11,324 cases in MS-DRG 652, there were 3,254
cases describing the performance of hemodialysis in an admission where
the patient received a kidney transplant with an average length of stay
of 7.6 days and average costs of $30,606. Our clinical advisors noted
that the average length of stay and average costs of cases in MS-DRG
652 describing the performance of hemodialysis in an admission where
the patient received a kidney transplant were higher than the average
length of stay and average costs for all cases in the same MS-DRG.
We stated in further analyzing this issue, noting that patients can
require a simultaneous pancreas/kidney transplant procedure, we also
examined claims data from the September 2019 update of the FY 2019
MedPAR file for all cases in Pre-MDC MS-DRG 008 (Simultaneous Pancreas/
Kidney Transplant) and compared the results to cases representing
simultaneous pancreas/kidney transplantation with dialysis performed
during the same inpatient admission either before or after the date of
kidney transplantation. The following table shows our findings:
[GRAPHIC] [TIFF OMITTED] TR18SE20.060
As shown by the table, for Pre-MDC MS-DRG 008, we identified a
total of 374 cases, with an average length of stay of 10.9 days and
average costs of $41,926. Of the 374 cases in Pre-MDC MS-DRG 008, there
were 84 cases describing the performance of hemodialysis during an
admission where the patient received a simultaneous pancreas/kidney
transplant with an average length of stay of 13.4 days and average
costs of $49,001. We stated our clinical advisors again noted that the
average length of stay and average costs of cases in Pre-MDC MS-DRG 008
describing the performance of hemodialysis during an admission where
the patient received a simultaneous pancreas/kidney transplant were
higher than the average length of stay and average costs for all cases
in the same Pre-MDC MS-DRG.
In the proposed rule, we stated our clinical advisors believe that
these hemodialysis procedures either performed before or after kidney
transplant or before or after simultaneous pancreas/kidney transplant
contribute to increased resource consumption for these
[[Page 58508]]
transplant patients. While there is not a large number of cases
describing a simultaneous pancreas/kidney transplant with hemodialysis
procedures either performed before or after transplant represented in
the Medicare data, and we generally prefer not to create a new MS-DRG
unless it would include a substantial number of cases, we stated we
believe creating separate MS-DRGs for these cases would appropriately
address the differential in resource consumption consistent with the
President's Executive Order on Advancing American Kidney Health (see
https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/). For these reasons, we proposed to
create new MS-DRGs for the performance of hemodialysis during an
admission where the patient received a kidney transplant or
simultaneous pancreas/kidney transplant.
As stated in the proposed rule, to compare and analyze the impact
of our suggested modifications, we ran a simulation using the Version
37 ICD-10 MS-DRG GROUPER and the claims data from the September 2019
update of the FY 2019 MedPAR file. The following table reflects our
findings for all 3,254 cases representing kidney transplantation with
dialysis performed during the same inpatient admission either before or
after the date of kidney transplantation with a two-way severity level
split.
[GRAPHIC] [TIFF OMITTED] TR18SE20.061
As shown in the table, there was a total of 2,195 cases for the
kidney transplant with hemodialysis with MCC subgroup, with an average
length of stay of 8.0 days and average costs of $32,360. There was a
total of 1,059 cases for the kidney transplant with hemodialysis
without MCC subgroup, with an average length of stay of 6.8 days and
average costs of $26,972. We applied the criteria to create subgroups
for the two-way severity level split for the proposed MS-DRGs,
including our expansion of the criteria to also include the nonCC
group, and found that all five criteria were met. For the proposed MS-
DRGs, there is (1) at least 500 cases in the MCC subgroup and in the
without MCC subgroup; (2) at least 5 percent of the cases are in the
MCC subgroup and in the without MCC subgroup; (3) at least a 20 percent
difference in average costs between the MCC subgroup and the without
MCC subgroup; (4) at least a $2,000 difference in average costs between
the MCC subgroup and the without MCC subgroup; and (5) at least a 3-
percent reduction in cost variance, indicating that the proposed
severity level splits increase the explanatory power of the base MS-DRG
in capturing differences in expected cost between the proposed MS-DRG
severity level splits by at least 3 percent and thus improve the
overall accuracy of the IPPS payment system.
For the cases describing the performance of hemodialysis during an
admission where the patient received a simultaneous pancreas/kidney
transplant, we identified a total of 84 cases, so the criterion that
there are at least 500 or more cases in any subgroup could not be met.
Therefore, for FY 2021, we did not propose to subdivide the proposed
new Pre-MDC MS-DRG for the performance of hemodialysis in an admission
where the patient received a simultaneous pancreas/kidney transplant
into severity levels.
In summary, in the FY 2021 proposed rule, taking into consideration
that it clinically requires greater resources to perform hemodialysis
during an admission where the patient received a kidney or simultaneous
pancreas/kidney transplant, we proposed to create a new Pre-MDC MS-DRG
for cases describing the performance of hemodialysis during an
admission where the patient received a simultaneous pancreas/kidney
transplant. We also proposed to create two new MS-DRGs with a two-way
severity level split for cases describing the performance of
hemodialysis in an admission where the patient received a kidney
transplant in MDC 11. These proposed new MS-DRGs are new Pre-MDC MS-DRG
019 (Simultaneous Pancreas/Kidney Transplant with Hemodialysis), new
MS-DRG 650 (Kidney Transplant with Hemodialysis with MCC) and new MS-
DRG 651 (Kidney Transplant with Hemodialysis without MCC). We proposed
to add the procedure codes from current Pre-MDC MS-DRG 008 to the
proposed new Pre-MDC MS-DRG 019 with the procedure codes describing a
hemodialysis procedure. Similarly, we also proposed to add the
procedure codes from current MS-DRG 652 to the proposed new MS-DRGs 650
and 651 with the procedure codes describing a hemodialysis procedure.
In the proposed rule, we noted that the procedure codes describing
hemodialysis procedures are designated as non-O.R. procedures,
therefore, as part of the logic for these proposed new MS-DRGs, we also
proposed to designate these codes as non-O.R. procedures affecting the
MS-DRG.
Comment: Many commenters supported CMS' proposal. Commenters stated
that the establishment of new MS-DRGs for kidney and simultaneous
pancreas/kidney transplants with hemodialysis will increase the number
of viable kidneys for transplantation and decrease the kidney discard
rate by reducing the financial disincentive for using kidneys from
medically complex donors. A few commenters stated they appreciate CMS'
recognition of the higher cost involved in these cases and the effort
to make kidney transplant services more accessible by aligning payment
rates with the relative cost of services for kidney transplants. A
commenter stated the proposed creation of two new MS-DRGs for kidney
transplant cases with hemodialysis--one for cases with major
complications and comorbidities (MCC) and one for cases without MCC,
strengthens transplant programs and increases
[[Page 58509]]
patient access to this vital medical service. Another commenter stated
the inclusion of a MCC subgroup for kidney transplant with hemodialysis
is vital given the documented increase in the complexity of transplant
patients. One commenter specifically stated they strongly support
efforts to ensure that kidney transplant MS-DRGs better reflect the
cost of all associated care.
Response: We appreciate the commenters' support.
Comment: A few commenters opposed this proposal. One commenter
stated they are concerned that the proposal would decrease Medicare
payment for all kidney transplants not requiring post-transplant
dialysis and were against including components in the proposal that
would result in a reduction in inpatient payment for kidney transplant
in any category. Another commenter stated they were concerned that CMS
will extract money from existing MS-DRG 652 and Pre-MDC MS-DRG 008 to
pay for the proposed new MS-DRGs. A different commenter stated their
facility has a low volume of admissions with both hemodialysis and
kidney transplant performed, with only approximately 21 out of a total
of 110 kidney transplants having such a combination, and therefore
would be adversely affected should this proposal be finalized.
Response: We appreciate the commenters' concerns, however as we
have stated in prior rulemaking, the MS-DRGs are a classification
system intended to group together those diagnoses and procedures with
similar clinical characteristics and utilization of resources. We
continue to believe that consistent with this classification system,
the proposed new MS-DRGs would improve clinical coherence while
appropriately addressing the differential in resource consumption for
cases where hemodialysis is performed during an admission where the
patient receives a kidney or simultaneous pancreas/kidney transplant.
Each year, we calculate the relative weights by dividing the average
cost for cases within each MS-DRG by the average cost for cases across
all MS-DRGs. 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. We refer readers to
section II.E.2. of the preamble of this final rule for a discussion of
the relative weight calculations.
Therefore, after consideration of the public comments received, and
for the reasons stated above, we are finalizing our proposal to create
new Pre-MDC MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with
Hemodialysis) for cases describing the performance of hemodialysis
during an admission where the patient received a simultaneous pancreas/
kidney transplant. We are also finalizing our proposal to create new
MS-DRG 650 (Kidney Transplant with Hemodialysis with MCC) and new MS-
DRG 651 (Kidney Transplant with Hemodialysis without MCC) for cases
describing the performance of hemodialysis in an admission where the
patient received a kidney transplant in MDC 11. Accordingly, we are
also finalizing our proposal to designate procedure codes 5A1D70Z,
5A1D80Z, and 5A1D90Z that describe hemodialysis as non-O.R. procedures
affecting the MS-DRG.
The diagram illustrates how the MS-DRG logic for Kidney Transplants
will function. The diagram (Diagram 1.), which is the same Diagram 1
included in the proposed rule, begins by asking if the criteria for a
Pre-MDC MS-DRG is met. If yes, the logic asks if the criteria for Pre-
MDC MS-DRGs 018, 001-006, 014 or 007 is met. If yes, the logic directs
the case to either Pre-MDC MS-DRG 018, 001-006, 014 or 007 based on the
principal diagnosis and/or procedures reported. If no, the logic asks
if there is a simultaneous pancreas/kidney transplant with a qualifying
diagnosis reported on the claim. If no, the logic directs the case to
either Pre-MDC MS-DRGs 016, 017, or 010-013 based on the principal
diagnosis and/or procedures reported. If yes, the logic asks if there
was a hemodialysis procedure reported on the claim. If yes, the logic
assigns the case to new Pre-MDC MS-DRG 019 (Simultaneous Pancreas/
Kidney Transplant with Hemodialysis). If no, the logic assigns the case
to existing Pre-MDC MS-DRG 008 (Simultaneous Pancreas/Kidney
Transplant).
If the criteria for a Pre-MDC MS-DRG were not met at the first
step, the GROUPER logic asks if there was a principal diagnosis of
trauma and at least two significant traumas of different body sites. If
yes, the logic directs the case to the appropriate MS-DRG in MDC 24
based on the principal diagnosis and procedures reported. If no, the
logic asks if there was either a principal diagnosis of HIV infection
or a secondary diagnosis of HIV infection with a principal diagnosis of
a significant HIV related condition. If yes, the logic directs the case
to the appropriate MS-DRG in MDC 25 based on the principal diagnosis
and procedures reported. If no, the logic asks if there is kidney
transplant procedure reported on the claim. If no, the logic directs
the case to the appropriate MDC and MS-DRG based on the principal
diagnosis and procedures reported. If yes, the logic asks if there was
a hemodialysis procedure reported on the claim. If yes, the logic
assigns the case to new MS-DRGs 650 or 651 (Kidney Transplant with
Hemodialysis with MCC or without MCC, respectively). If no, the logic
assigns the case to existing MS-DRG 652 (Kidney Transplant).
We also received public comments regarding a number of kidney and
hemodialysis related MS-DRG issues that were outside the scope of the
proposals included in the FY 2021 IPPS/LTCH PPS proposed rule. These
comments were as follows:
One commenter requested that CMS establish a new MS-DRG
for Continuous Renal Replacement Therapy (CRRT).
One commenter requested that CMS review other transplant
cases that end up in MS-DRGs 981 through 983 for reassignment to a more
appropriate MS-DRG.
Two commenters requested that CMS evaluate and make
modifications to any MS-DRG related to the delivery of dialysis.
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.E.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, 2020 so that they can
be considered for possible inclusion in the annual proposed rule. We
will consider these public comments for possible proposals in future
rulemaking as part of our annual review process.
BILLING CODE 4120-01-P
[[Page 58510]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.062
[[Page 58511]]
b. Addition of Diagnoses to Other Kidney and Urinary Tract Procedures
Logic
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32519), we received a request to add 29 ICD-10-CM diagnosis codes to
the list of principal diagnoses assigned to MS-DRGs 673, 674, and 675
(Other Kidney and Urinary Tract Procedures with MCC, with CC, and
without CC/MCC, respectively) in MDC 11 (Diseases and Disorders of the
Kidney and Urinary Tract) when reported with procedure codes describing
the insertion of totally implantable vascular access devices (TIVADs)
and tunneled vascular access devices. The list of 29 ICD-10-CM
diagnosis codes submitted by the requestor, as well as their current
MDC assignments, are found in the table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.063
BILLING CODE 4120-01-C
The requestor stated that by adding the codes listed, cases
reporting principal diagnosis codes describing complications of
dialysis access sites and principal diagnosis codes describing kidney
disease in the setting of diabetes or hypertension, would group to MS-
DRGs 673, 674, and 675 when a TIVAD or tunneled vascular access device
is inserted. The requestor stated that patients who have kidney
transplant complications or dialysis catheter complications typically
also have chronic kidney disease, end stage renal disease (ESRD) or
resolving acute tubular necrosis (ATN) but ICD-10-CM coding guidelines
require a complication code to be sequenced first. The requester stated
that when reporting a diagnosis code describing ESRD and diabetes, a
diabetes code from ICD-10-CM Chapter 4 (Endocrine, Nutritional and
Metabolic Diseases) must be sequenced first and when coding ESRD,
hypertension, and heart failure, the combination code I13.2
(Hypertensive heart and chronic kidney disease with heart failure and
with stage 5 chronic kidney disease or end stage renal disease) must be
sequenced first per coding guidelines. The requestor pointed out that
code I13.11 (Hypertensive heart and chronic kidney disease without
heart failure with stage 5 CKD or ESRD) is currently one of the
qualifying principal diagnoses in MS-DRGs 673, 674, and 675 when
reported with procedure codes describing the insertion of TIVADs or
tunneled vascular access devices; therefore, according to the
requestor, diagnosis code I13.2 should reasonably be added.
As discussed in the proposed rule, to begin our analysis, we
reviewed the GROUPER logic for MS-DRGs 673, 674, and 675 including the
special logic in MS-DRGs 673, 674, and 675 for certain MDC 11 diagnoses
reported with
[[Page 58512]]
procedure codes for the insertion of tunneled or totally implantable
vascular access devices. As discussed in the FY 2003 IPPS/LTCH PPS
final rule (67 FR 49993 through 49994), the procedure code for the
insertion of totally implantable vascular access devices was added to
the GROUPER logic of DRG 315 (Other Kidney and Urinary Tract O.R.
Procedures), the predecessor DRG of MS-DRGs 673, 674, and 675, when
combined with principal diagnoses specifically describing renal
failure, recognizing that inserting these devices as an inpatient
procedure for the purposes of hemodialysis can lead to higher average
charges and longer lengths of stay for those cases.
We next reviewed the 29 ICD-10-CM codes submitted by the requestor.
In the proposed rule, we stated our clinical advisors noted that ICD-
10-CM diagnosis codes E10.21, E11.21, and E13.21 describing diabetes
mellitus with diabetic nephropathy; codes E10.29, E11.29, and E13.29
describing diabetes mellitus with other diabetic kidney complication;
T80.211A, T80.212A, and T80.218A describing infection due to central
venous catheters; and codes T82.7XXA, T82.818A, T82.828A, T82.838A,
T82.848A, T82.858A, T82.868A, and T82.898A describing complications of
cardiac and vascular prosthetic devices, implants and grafts, are not
necessarily indicative of a patient having renal (kidney) failure
requiring the insertion of a TIVAD or a tunneled vascular access device
to allow access to the patient's blood for hemodialysis purposes.
TIVADs and tunneled vascular access devices are widely used to provide
central venous access for the administration of intravenous
antibiotics, chemotherapeutic agents, parenteral nutrition and other
treatments. They are used in a variety of disease groups, and in both
children and adults. We stated in the proposed rule that as such, our
clinical advisors do not support adding these diagnoses to the list of
principal diagnosis codes in MS-DRG 673, 674, and 675 when reported
with procedure codes describing the insertion of TIVADs and tunneled
vascular access devices. They noted that TIVADs and tunneled vascular
access devices may be inserted for a variety of principal diagnoses,
and that adding these 17 diagnoses that are not specific to renal
failure would not maintain the clinical coherence with other cases in
this subset of cases in MS-DRGs 673, 674, and 675.
We further stated that our clinical advisors also did not support
adding ICD-10-CM diagnosis code I13.2 (Hypertensive heart and chronic
kidney disease with heart failure and with stage 5 chronic kidney
disease, or end stage renal disease) to the special logic in MS-DRGs
673, 674, and 675. As discussed previously, code I13.2 is assigned to
MDC 05 (Diseases and Disorders of the Circulatory System). Our clinical
advisors agreed it would not be appropriate to move this diagnosis into
MDC 11 because it would inadvertently cause cases reporting this same
MDC 05 diagnosis with circulatory system procedures to be assigned to
an unrelated MS-DRG.
Therefore, for the reasons described previously, we did not propose
to add the following 18 ICD-10-CM codes to the list of principal
diagnosis codes for MS-DRGs 673, 674, and 675 when reported with a
procedures code describing the insertion of a TIVAD or a tunneled
vascular access device: E10.21, E10.29, E11.21, E11.29, E13.21, E13.29,
I13.2, T80.211A, T80.212A, T80.218A, T82.7XXA, T82.818A, T82.828A,
T82.838A, T82.848A, T82.858A, T82.868A, and T82.898A.
Comment: Commenters supported our proposal to not add the 18 ICD-
10-CM diagnosis codes listed to the special logic in MS-DRGs 673, 674,
and 675. One commenter specifically agreed stating these devices may be
inserted for a variety of diagnoses, and adding diagnosis codes that
are not specific to renal failure would not maintain clinical coherence
with other cases in these MS-DRGs.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to not add the following 18 ICD-10-CM codes to
the list of principal diagnosis codes for MS-DRGs 673, 674, and 675
when reported with a procedures code describing the insertion of a
TIVAD or a tunneled vascular access device: E10.21, E10.29, E11.21,
E11.29, E13.21, E13.29, I13.2, T80.211A, T80.212A, T80.218A, T82.7XXA,
T82.818A, T82.828A, T82.838A, T82.848A, T82.858A, T82.868A, and
T82.898A.
We then reviewed the remaining 11 diagnosis codes submitted by the
requestor. Codes T82.41XA, T82.42XA, T82.43XA and T82.49XA describe
mechanical complications of vascular dialysis catheters. We stated in
the proposed rule that our clinical advisors believe the insertion of
TIVADs or tunneled vascular access devices for the purposes of
hemodialysis is clearly clinically related to diagnosis codes
describing a mechanical complication of a vascular dialysis catheter
and that for clinical coherence, these cases should be grouped with the
subset of cases that report the insertion of totally implantable
vascular access devices or tunneled vascular access devices as an
inpatient procedure for the purposes of hemodialysis for renal failure.
As discussed in the proposed rule, codes T82.41XA, T82.42XA,
T82.43XA and T82.49XA that describe mechanical complications of
vascular dialysis catheters are currently assigned to MDC 05 and would
require reassignment to MDC 11 in MS-DRGs 673, 674, and 675 to group
with the subset of cases that report the insertion of totally
implantable vascular access devices or tunneled vascular access devices
as an inpatient procedure for the purposes of hemodialysis for renal
failure. We examined claims data from the September 2019 update of the
FY 2019 MedPAR file for all cases reporting procedures describing the
insertion of TIVADs or tunneled vascular access devices with a
principal diagnosis from the T82.4- series in MDC 05 and compared this
data to cases in MS-DRGs 673, 674 and 675. The following table shows
our findings:
[[Page 58513]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.064
As shown in the table, there were 13,068 cases in MS-DRG 673 with
an average length of stay of 11 days and average costs of $26,528.
There were 1,025 cases reporting a principal diagnosis describing a
mechanical complication of vascular dialysis catheter, with a secondary
diagnosis of MCC, and a procedure code for the insertion of a TIVAD or
tunneled vascular access device with an average length of stay of 4.6
days and average costs of $14,882. There were 6,592 cases in MS-DRG 674
with an average length of stay of 7.6 days and average costs of
$17,491. There were two cases reporting a principal diagnosis
describing a mechanical complication of vascular dialysis catheter,
with a secondary diagnosis of CC, and a procedure code for the
insertion of a TIVAD or tunneled vascular access device with an average
length of stay of 6 days and average costs of $15,016. There were 437
cases in MS-DRG 675 with an average length of stay of 3.4 days and
average costs of $12,506. There was one case reporting a principal
diagnosis describing a mechanical complication of vascular dialysis
catheter, without a secondary diagnosis of CC or MCC, and a procedure
code for the insertion of a TIVAD or tunneled vascular access device
with a length of stay of 3 days and costs of $9,317. Our clinical
advisors noted that the average length of stay and average costs of
cases reporting a diagnosis describing a mechanical complication of a
vascular dialysis catheter and the insertion of a TIVAD or a tunneled
vascular access device are lower than for all cases in MS-DRGs 673,
674, and 675, respectively.
For the reasons discussed, we stated in the proposed rule that our
clinical advisors believe that it is clinically appropriate for the
four ICD-10-CM diagnosis codes describing a mechanical complication of
a vascular dialysis catheter to group to the subset of GROUPER logic
that recognizes the insertion of totally implantable vascular access
devices or tunneled vascular access devices as an inpatient procedure
for the purposes of hemodialysis. Therefore, we proposed to reassign
ICD-10-CM diagnosis codes T82.41XA, T82.42XA, T82.43XA, and T82.49XA
from MDC 05 in MS-DRGs 314, 315, and 316 (Other Circulatory System
Diagnoses with MCC, with CC, and without CC/MCC, respectively) to MDC
11 (Diseases and Disorders of the Kidney and Urinary Tract) assigned to
MS-DRGs 673, 674, and 675 (Other Kidney and Urinary Tract Procedures
with MCC, with CC, and without CC/MCC, respectively) and 698, 699, and
700 (Other Kidney and Urinary Tract Diagnoses with MCC, with CC, and
without CC/MCC, respectively).
Comment: One commenter questioned the rationale as to the extent
totally implantable vascular access devices (TIVADs) are considered
``kidney and urinary tract procedures'' when placed to address a
condition assigned to MDC 05.
Response: We appreciate the commenters' concern.
As discussed in the proposed rule, the procedure code for the
insertion of totally implantable vascular access devices was originally
added to the GROUPER logic of DRG 315 (Other Kidney and Urinary Tract
O.R. Procedures), the predecessor DRG of MS-DRGs 673, 674, and 675,
when combined with principal diagnoses specifically describing renal
failure, recognizing that these devices are inserted as an inpatient
procedure for the purposes of hemodialysis. Our clinical advisors
believe the four ICD-10-CM diagnosis codes describing a mechanical
complication of a vascular dialysis catheter are clearly clinically
related to diagnosis codes that describe renal failure because the
complicated vascular dialysis catheter described by these diagnosis
codes would not be in place if hemodialysis was not indicated.
Therefore, our clinical advisors believe that it is clinically
appropriate for the four ICD-10-CM diagnosis codes describing a
mechanical complication of a vascular dialysis catheter to group to
[[Page 58514]]
the subset of GROUPER logic that recognizes the insertion of totally
implantable vascular access devices or tunneled vascular access devices
as an inpatient procedure for the purposes of hemodialysis.
Comment: Other commenters supported the reassignment of diagnosis
codes describing a mechanical complication of a vascular dialysis
catheter to MS-DRGs 673, 674, and 675 (Other Kidney and Urinary Tract
Procedures with MCC, with CC, and without CC/MCC, respectively) and
698, 699, and 700 (Other Kidney and Urinary Tract Diagnoses with MCC,
with CC, and without CC/MCC, respectively) in MDC 11.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to reassign ICD-10-CM diagnosis codes T82.41XA,
T82.42XA, T82.43XA, and T82.49XA from MDC 05 in MS-DRGs 314, 315, and
316 (Other Circulatory System Diagnoses with MCC, with CC, and without
CC/MCC, respectively) to MDC 11 (Diseases and Disorders of the Kidney
and Urinary Tract) assigned to MS-DRGs 673, 674, and 675 (Other Kidney
and Urinary Tract Procedures with MCC, with CC, and without CC/MCC,
respectively) and 698, 699, and 700 (Other Kidney and Urinary Tract
Diagnoses with MCC, with CC, and without CC/MCC, respectively) under
the ICD-10 MS-DRGs Version 38, effective October 1, 2020.
In reviewing ICD-10-CM codes E10.22, E11.22, and E13.22 describing
diabetes mellitus with diabetic chronic kidney disease, we noted that
related ICD-10-CM diagnosis code E09.22 (Drug or chemical induced
diabetes mellitus with diabetic chronic kidney disease) is also not
included in the current list of diagnosis codes included in the special
logic in MS-DRGs 673, 674, and 675 for certain MDC 11 diagnoses
reported with procedure codes for the insertion of tunneled or totally
implantable vascular access devices, and therefore we included E09.22
in our review. ICD-10-CM assumes a causal relationship between diabetes
mellitus and chronic kidney disease. According to the ICD-10-CM
Official Guidelines for Coding and Reporting, the word ``with'' or
``in'' should be interpreted to mean ``associated with'' or ``due to''
when it appears in a code title, the Alphabetic Index (either under a
main term or subterm), or an instructional note in the Tabular List,
meaning these conditions should be coded as related even in the absence
of provider documentation explicitly linking them, unless the
documentation clearly states the conditions are unrelated. To code
diabetic chronic kidney disease in ICD-10-CM, instructional notes
direct to ``code first any associated diabetic chronic kidney disease''
(that is, E09.22, E10.22, E11.22, and E13.22) with a second code from
subcategory of N18 listed after the diabetes code to specify the stage
of chronic kidney disease. Recognizing that coding guidelines instruct
to code E09.22, E10.22, E11.22, and E13.22 before codes that specify
the stage of chronic kidney disease, our clinical advisors recommended
adding diabetic codes E09.22, E10.22, E11.22, and E13.22 when reported
with a secondary diagnosis of either N18.5 Chronic kidney disease,
stage 5) or N18.6 (End stage renal disease) to the special logic in MS-
DRGs 673, 674, and 675 since these diagnosis code combinations describe
an indication that could require the insertion of a totally implantable
vascular access device or a tunneled vascular access device to allow
access to the patient's blood for hemodialysis purposes.
ICD-10-CM codes T86.11, T86.12, T86.13, and T86.19 describe
complications of kidney transplant and are currently assigned to MDC
11. We stated our clinical advisors believe these diagnoses are also
indications for hemodialysis and these cases represent a distinct,
recognizable clinical group similar to those cases in the subset of
cases assigned to the special logic in MS-DRGs 673, 674, and 675 when
reported with procedure codes describing the insertion of totally
implantable vascular access devices or tunneled vascular access devices
for hemodialysis.
To summarize, we proposed to add ICD-10-CM codes E09.22, E10.22,
E11.22, and E13.22, when reported with a secondary diagnosis of N18.5
or N18.6, to the list of principal diagnosis codes in the subset of
GROUPER logic in MS-DRGs 673, 674, and 675 that recognizes the
insertion of totally implantable vascular access devices or tunneled
vascular access devices as an inpatient procedure for the purposes of
hemodialysis. We also proposed to add ICD-10-CM codes T86.11, T86.12,
T86.13, and T86.19 to the list of principal diagnosis codes in this
subset of GROUPER logic in MS-DRGs 673, 674, and 675.
Comment: Commenters supported our proposal to add ICD-10-CM codes
E09.22, E10.22, E11.22, and E13.22, when reported with a secondary
diagnosis of N18.5 or N18.6, to the list of principal diagnosis codes
in the subset of GROUPER logic in MS-DRGs 673, 674, and 675. The
commenters stated they agreed that these diagnosis code combinations
describe an indication that could require the insertion of a totally
implantable vascular access device or a tunneled vascular access device
for hemodialysis purposes. Commenters also supported the addition of
ICD-10-CM codes for complications of kidney transplant to the list of
principal diagnosis codes in the subset of GROUPER logic in MS-DRGs
673, 674, and 675 that recognizes the insertion of totally implantable
vascular access devices or tunneled vascular access devices as an
inpatient procedure for the purposes of hemodialysis.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-CM codes E09.22, E10.22, E11.22,
and E13.22, when reported with a secondary diagnosis of N18.5 or N18.6,
to the list of principal diagnosis codes in the subset of GROUPER logic
in MS-DRGs 673, 674, and 675. We are also finalizing our proposal to
add ICD-10-CM codes T86.11, T86.12, T86.13, and T86.19 to the list of
principal diagnosis codes in this subset of GROUPER logic in MS-DRGs
673, 674, and 675.
Lastly, we reviewed the current list of 20 MDC 11 diagnoses
assigned to the special logic in MS-DRGs 673, 674, and 675 when
reported with procedure codes for the insertion of tunneled or totally
implantable vascular access devices. The list of MDC 11 diagnosis codes
currently included in the special logic of MS-DRGs 673, 674, and 675
are found in the following table:
[[Page 58515]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.065
[GRAPHIC] [TIFF OMITTED] TR18SE20.066
As stated in the proposed rule, our clinical advisors pointed out
that ICD-10-CM codes I12.9, I13.10, N18.1, N18.2, N18.3, N18.4, and
N18.9 do not describe renal failure and they do not describe
indications that would generally require the insertion of totally
implantable vascular access devices or tunneled vascular access devices
for the purposes of hemodialysis. Our advisors noted hemodialysis
replicates the function of the kidneys. In cases of acute kidney
failure and anuria, hemodialysis is indicated to prevent urea and other
waste material from building up in the blood until the kidneys return
to normal function. A diagnosis of chronic kidney disease stages 1
through 4, however, means the kidneys still have the ability to filter
waste and extra fluid out of the blood. Dialysis is not often initiated
in chronic kidney disease until the chronic kidney disease progresses
to stage 5 or ESRD, which is defined as when kidney function drops to
15 percent or less. Our clinical advisors stated that these seven codes
do not describe indications requiring the insertion of totally
implantable vascular access devices or tunneled vascular access devices
for hemodialysis and recommended these codes be removed from the
special logic in MS-DRGs 673, 674, and 675.
We examined claims data from the September 2019 update of the FY
2019 MedPAR file for MS-DRGs 673, 674, and 675 for this subset of cases
to determine if there were any cases that reported one of the seven
ICD-10-CM codes in the special logic of MS-DRGs 673, 674, and 675 that
do not necessarily describe indications requiring the insertion of
totally implantable vascular access devices or tunneled vascular access
devices for hemodialysis, the frequency with which they were reported
and the relative resource use as compared with all cases assigned to
the special logic in MS-DRGs 673, 674, and 675. The following table
shows our findings:
[[Page 58516]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.067
As shown by the table, for MS-DRG 673, we identified a total of
7,391 cases assigned to the special logic within this MS-DRG with an
average length of stay of 12.1 days and average costs of $28,273. Of
these 7,391 cases in the subset of MS-DRG 673, there were 34 cases
describing insertion of a TIVAD or tunneled vascular access device with
a principal diagnosis of I12.9, I13.10, N18.1, N18.2, N18.3, N18.4, or
N18.9 with an average length of stay of 14.2 days and average costs of
$27,844. For MS-DRG 674, we identified a total of 3,055 cases assigned
to the special logic within this MS-DRG with an average length of stay
of 7.8 days and average costs of $17,107. Of these 3,055 cases in the
subset of MS-DRG 674, there were 30 cases describing insertion of a
TIVAD or tunneled vascular access device with a principal diagnosis of
I12.9, I13.10, N18.1, N18.2, N18.3, N18.4, or N18.9 with an average
length of stay of 7.2 days and average costs of $11,227. For MS-DRG
675, we identified a total of 58 cases assigned to the special logic
within this MS-DRG with an average length of stay of 6.1 days and
average costs of $12,582. Of these 58 cases in the subset of MS-DRG
675, there was one case describing insertion of a TIVAD or tunneled
vascular access device with a principal diagnosis of I12.9, I13.10,
N18.1, N18.2, N18.3, N18.4, or N18.9 with a length of stay of 4 days
and costs of $6,549. Overall, for MS-DRGs 673, 674 and 675, there were
a relatively small number of cases reporting a principal diagnosis of
I12.9, I13.10, N18.1, N18.2, N18.3, N18.4, or N18.9 and a procedure
code describing the insertion of a TIVAD or tunneled vascular access
device demonstrating that these conditions are not typically addressed
by insertion of these devices.
As stated previously, TIVADs and tunneled vascular access devices
may be inserted for a variety of principal diagnoses. We stated in the
proposed rule that our clinical advisors believe that continuing to
include these seven diagnoses that are not specific to renal failure or
that do not otherwise describe indications requiring the insertion of
totally implantable vascular access devices or tunneled vascular access
devices for hemodialysis would not maintain clinical coherence with
other cases in this subset of cases in MS-DRGs 673, 674, and 675.
Therefore, for the reasons stated, we proposed to remove ICD-10-CM
codes I12.9, I13.10, N18.1, N18.2, N18.3, N18.4, and N18.9 from the
subset of GROUPER logic in MS-DRGs 673, 674, and 675 that recognizes
the insertion of totally implantable vascular access devices or
tunneled vascular access devices as an inpatient procedure for the
purposes of hemodialysis.
Comment: One commenter expressed concerns about the proposal and
did not fully agree with this change. This commenter described a
scenario in which a patient with stage 3 chronic kidney disease
develops acute kidney failure and has totally implantable vascular
access device inserted for the purpose of hemodialysis during an
inpatient hospitalization. The commenter questioned if this scenario
would qualify for the subset of GROUPER logic in MS-DRGs 673, 674, and
675 that recognizes the insertion of totally implantable vascular
access devices or tunneled vascular access devices as an inpatient
procedure for the purposes of hemodialysis.
Response: We appreciate the commenter's concern.
As discussed in the proposed rule, ICD-10-CM diagnosis codes N17.0,
[[Page 58517]]
N17.1 N17.2, N17.8 and N17.9 which describe acute kidney failure are
currently included in the special logic of MS-DRGs 673, 674, and 675.
These codes were not listed in the seven codes proposed to be removed.
In the hypothetical scenario described by the commenter, the case would
qualify for the subset of GROUPER logic in MS-DRGs 673, 674, and 675
that recognizes the insertion of totally implantable vascular access
devices or tunneled vascular access devices as long as the diagnosis of
acute kidney failure met the definition of principal diagnosis. We
encourage the commenter to review the Official ICD-10-CM Coding
Guidelines, which can be found on the CDC website at: http://www.cdc.gov/nchs/icd/icd10.htm.
Comment: Other commenters supported our proposal and stated they
agreed that the seven ICD-10-CM codes that do not describe renal
failure or indications that would generally require the insertion of
totally implantable vascular access devices for the purpose of
hemodialysis should be removed from the special logic in MS-DRGs 673,
674, and 675.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to remove ICD-10-CM codes I12.9, I13.10, N18.1,
N18.2, N18.3, N18.4, and N18.9 from the subset of GROUPER logic in MS-
DRGs 673, 674, and 675 that recognizes the insertion of totally
implantable vascular access devices or tunneled vascular access devices
as an inpatient procedure for the purposes of hemodialysis under the
ICD-10 MS-DRGs Version 38, effective October 1, 2020.
9. MDC 17 (Myeloproliferative Diseases and Disorders, Poorly
Differentiated Neoplasms): Inferior Vena Cava Filter Procedures
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32524), we received a request to review the GROUPER logic in MDC 17.
The requester stated that cases reporting the introduction of a high
dose chemotherapy agent, or reporting a chemotherapy principal
diagnosis with a secondary diagnosis describing acute leukemia, are
assigned to medical MS-DRGs 837 (Chemotherapy with Acute Leukemia as
Secondary Diagnosis or with High Dose Chemotherapy Agent with MCC), MS-
DRG 838 (Chemotherapy with Acute Leukemia as Secondary Diagnosis with
CC or High Dose Chemotherapy Agent), and MS-DRG 839 (Chemotherapy with
Acute Leukemia as Secondary Diagnosis without CC/MCC). However, when
procedure codes describing the placement of an inferior vena cava (IVC)
filter, namely 06H03DZ (Insertion of intraluminal device into inferior
vena cava, percutaneous approach), are also reported with the same
codes describing the introduction of a high dose chemotherapy agent or
report a chemotherapy principal diagnosis with a secondary diagnosis
describing acute leukemia, the cases are assigned to surgical MS-DRGs
829 and 830 (Myeloproliferative Disorders or Poorly Differentiated
Neoplasms with Other Procedure with and without CC/MCC, respectively).
According to the requestor, the additional resources used by the
hospital to place an IVC filter should not result in assignment to
lower-weighted MS-DRGs.
As stated in the proposed rule, the ICD-10-PCS codes that describe
the insertion of an infusion device or the insertion of an intraluminal
device into the inferior vena cava are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.068
We stated our analysis of this grouping issue confirmed that, when
procedure code 06H03DZ (Insertion of intraluminal device into inferior
vena cava, percutaneous approach) is reported with a procedure code
describing the introduction of a high dose chemotherapy agent, or when
it is reported with a chemotherapy principal diagnosis code with a
secondary diagnosis code describing acute leukemia, these cases group
to surgical MS-DRGs 829 and 830. ICD-10-PCS procedure code 06H03DZ
identifies the placement of an IVC filter and is designated as an
extensive O.R. procedure for purposes of MS-DRG assignment. We then
examined the GROUPER logic for medical MS-DRGs 837, 838 and 839. The
GROUPER logic for MS-DRGs 837, 838, and 839 is defined by a principal
diagnosis of chemotherapy identified with ICD-10-CM diagnosis codes Z08
(Encounter for follow-up examination after completed treatment for
malignant neoplasm), Z51.11 (Encounter for antineoplastic chemotherapy)
or Z51.112 (Encounter for antineoplastic immunotherapy) along with a
secondary diagnosis of acute leukemia or a procedure code for the
introduction of a high dose
[[Page 58518]]
chemotherapy agent as reflected in the logic table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.069
We refer the reader to the ICD-10 MS-DRG Version 37 Definitions
Manual (which is available via the internet on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software for complete
documentation of the GROUPER logic for the listed MS-DRGs.
We examined claims data from the September 2019 update of the FY
2019 MedPAR file for all cases in MS-DRGs 829 and 830 and for cases
reporting the insertion of an IVC filter (procedure codes 06H00DZ,
06H03DZ, and 06H04DZ) with a procedure code describing the introduction
of a high dose chemotherapy agent, or with a chemotherapy principal
diagnosis code with a secondary diagnosis code describing acute
leukemia. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.070
As shown in the table, there were a total of 1,697 cases with an
average length of stay of 9.2 days and average costs of $24,188 in MS-
DRG 829. Of those 1,697 cases, there were 18 cases reporting procedure
code 06H03DZ with a procedure code describing the introduction of a
high dose chemotherapy agent, or with a chemotherapy principal
diagnosis code with a secondary diagnosis code describing acute
leukemia with an average length of stay of 25.6 days and average costs
of $83,861. We noted that there were no cases reporting procedure codes
06H00DZ or 06H04DZ. For MS-DRG 830, there were a total of 311 cases
with an average length of stay of 2.9 days and average costs of
$10,885. We found zero cases in MS-DRG 830 reporting a procedure code
for the insertion of an IVC filter with a procedure code describing the
introduction of a high dose chemotherapy agent, or with a chemotherapy
principal diagnosis code with a secondary diagnosis code describing
acute leukemia. Based on the claims data, the cases reporting procedure
code 06H03DZ with a
[[Page 58519]]
procedure code describing the introduction of a high dose chemotherapy
agent, or with a chemotherapy principal diagnosis code with a secondary
diagnosis code describing acute leukemia have higher average costs
($83,861 versus $24,188) and a longer average length of stay (25.6 days
versus 9.2 days) than all the cases in MS-DRG 829.
We also reviewed the claims data for MS-DRGs 837, 838, and 839. Our
findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.071
As shown in the table, there were a total of 1,776 cases with an
average length of stay of 17 days and average costs of $40,667 in MS-
DRG 837. There were a total of 1,172 cases with an average length of
stay of 7.3 days and average costs of $16,594 in MS-DRG 838. There were
a total of 810 cases with an average length of stay of 5 days and
average costs of $10,994 in MS-DRG 839. Based on the claims data, the
cases reporting procedure code 06H03DZ with a procedure code describing
the introduction of a high dose chemotherapy agent, or with a
chemotherapy principal diagnosis code with a secondary diagnosis code
describing acute leukemia again have higher average costs ($83,861
versus $40,667, $16,594, and $10,994 respectively) and a longer average
length of stay (25.6 days versus 17 days, 7.3 days and 5 days,
respectively) than all the cases in MS-DRG 837, 838, and 839. We stated
our clinical advisors reviewed the claims data and noted there were
only a small number of cases reporting procedure code 06H03DZ with a
procedure code describing the introduction of a high dose chemotherapy
agent, or with a chemotherapy principal diagnosis code with a secondary
diagnosis code describing acute leukemia, and believe there may have
been other factors contributing to the higher costs for these cases.
Our clinical advisors stated the procedure to insert an IVC filter is
not surgical in nature and recommended further analysis.
We performed further analysis on the other ICD-10-PCS codes
describing the insertion of a device into the inferior vena cava to
identify if they have a similar extensive O.R. designations and noted
inconsistencies among the O.R. and non-O.R. designations. In Version 37
of the ICD-10 MS-DRGs, ICD-10-PCS procedure codes 06H003T, 06H003Z,
06H033T, 06H033Z, and 06H043Z identify the insertion of an infusion
device into the inferior vena cava with various approaches and are
classified as Non-O.R. procedures. ICD-10-PCS procedure codes 06H00DZ,
06H03DZ, and 06H04DZ identify the insertion of an intraluminal device
into the inferior vena cava (IVC filter procedure) with various
approaches and are classified as extensive O.R. procedures. We stated
that our clinical advisors indicated that codes 06H00DZ, 06H03DZ, and
06H04DZ describing the insertion of an intraluminal device into the
inferior vena cava do not require the resources of an operating room,
that the procedure to insert an IVC filter is not surgical in nature
and that these procedures are comparable to the related ICD-10-PCS
procedure codes that describe the insertion of infusion devices into
the inferior vena cava that are currently designated as Non-O.R.
procedures. We stated our clinical advisors believe that, given the
similarity in factors such as complexity, resource utilization, and
lack of a requirement for anesthesia administration between all
procedures describing insertion of a device into the inferior vena
cava, it would be more appropriate to designate these three ICD-10-PCS
codes describing the insertion of an intraluminal device into the
inferior vena cava as Non-O.R. procedures. Therefore, we proposed to
remove ICD-10-PCS procedure codes 06H00DZ, 06H03DZ, and 06H04DZ from
the FY 2021 ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--
Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures. Under this proposal, these procedures would no longer
impact MS-DRG assignment.
Comment: A few commenters supported CMS' proposal and agreed ICD-
10-PCS procedure codes 06H00DZ, 06H03DZ, and 06H04DZ describing the
insertion of an intraluminal device into the inferior vena cava should
be designated as non-O.R. procedures since these procedures are not
surgical in nature, and related ICD-10-PCS codes are currently
designated as non-O.R. procedures.
Response: We appreciate the commenters' support.
Comment: A commenter stated that they recommend that CMS remove
code Z08 from the GROUPER logic for MS-DRGs 837, 838, and 839. The
commenter stated that ICD-10-CM code Z08 identifies a follow-up visit
after completed treatment for a malignant neoplasm which implies that
the condition has been fully treated and no longer exists. Therefore,
ICD-10-CM code Z08 does not describe an admission for chemotherapy.
This commenter also noted that code Z08 is on the Unacceptable
Principal diagnosis edit code list.
Response: We appreciate the commenters' concern.
The GROUPER logic assignment for each diagnosis code as a principal
diagnosis is for grouping purposes only. As discussed in the FY 2019
IPPS/LTCH PPS final rule (83 FR 41227), because the diagnoses 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 does not correspond to coding
guidelines for reporting the principal diagnosis. 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. In other words, cases will group according to the
GROUPER logic, regardless of any coding guidelines or coverage
policies. It is the Medicare Code Editor (MCE)
[[Page 58520]]
and other payer-specific edits that identify inconsistencies in the
coding guidelines or coverage policies. 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. 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. The separation of the MS-DRG
grouping and data editing functions allows the MS-DRG GROUPER to remain
stable even though coding rules and coverage policies may change during
the fiscal year.
Comment: Other commenters opposed CMS' proposal. A commenter stated
the insertion of vena cava filters requires the use of specialized
interventional radiology suites and in other hospitals without such
specialized suites, the procedure may be performed in a multipurpose
operating room. A few commenters stated that that the insertion of an
inferior vena cava filter is not comparable to the insertion of an
infusion device and that while it may be true that in some hospitals
the procedure may be done at bedside similar to the insertion of
infusion devices, this is not universally true and facilities incur
significant costs beyond those for infusion devices to compensate for
the costly implanted devices, specialized procedure rooms, equipment,
and skill. A commenter stated that they believe that this proposed
change will result in insufficient reimbursement for the resources
utilized in delivering care to these patients. One commenter
specifically noted that the costs of vena cava filters are higher than
infusion catheters because filters can easily add over $4,000 to the
cost of the procedure. Another commenter stated all open and
laparoscopic vascular procedures should always be designated as O.R.
procedures strictly because of the approach.
Response: We appreciate the commenters' feedback and concern.
With regard to the comments about the implications for
reimbursement, 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.
Our clinical advisors reviewed the commenters' concerns and
continue to support changing the O.R. designation of procedures
describing insertion of an intraluminal device into the inferior vena
cava performed via a percutaneous approach for consistency with the
other procedure codes describing the insertion of a device into the
inferior vena cava that are currently designated as non-O.R procedures
because, as commenters noted in their own comments, inferior vena cava
filters are most often placed in Interventional Radiology suites. The
resources involved in furnishing these procedures are consistent with
non-O.R. procedures and our clinical advisors noted it is not uncommon
for anesthesia to be used in the radiology suite. Our clinical advisors
also disagree with the assertion that these procedures are dissimilar
to procedures describing the insertion of infusion devices into the
inferior vena cava and believe that these procedures involve similar
technical complexity.
Our clinical advisors do, however, concur with the commenters that
while the procedure to insert an IVC filter is not surgical in nature,
procedures describing the insertion of an intraluminal device into the
inferior vena cava performed via an open or a percutaneous endoscopic
approach could require greater resources than a procedure describing
insertion of an intraluminal device into the inferior vena cava
performed via a percutaneous approach. As such, we believe that at this
time it would be appropriate to take additional time to further examine
the relevant clinical factors and similarities in resource consumption
between procedures describing the insertion of an intraluminal device
into the inferior vena cava performed via an open or a percutaneous
endoscopic approach. As discussed in section II.E.11. of the preamble
of this final rule, we are exploring alternatives on how we may
restructure the current O.R. and non-O.R. designations for procedures
by leveraging the detail that is now available in the ICD-10 claims
data. We continue to develop our process and methodology, and will
provide more detail in future rulemaking.
Therefore, after consideration of the public comments we received,
and for the reasons stated above, under the ICD-10 MS-DRGs Version 38,
effective October 1, 2020, we are (1) finalizing our proposal to change
the designation of ICD-10-PCS procedure code 06H03DZ from O.R.
procedure to non-O.R. procedure and (2) maintaining the O.R.
designation of procedure codes 06H00DZ and 06H04DZ. Accordingly,
procedure codes 06H00DZ and 06H04DZ will continue to impact MS-DRG
assignment.
10. Review of Procedure Codes in MS-DRGs 981 Through 983 and 987
Through 989
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 (Non-Extensive 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 cases reporting these 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 use this information to
determine which procedure codes and diagnosis codes to examine. 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.
We also consider whether it would be more appropriate to move the
principal diagnosis codes into the MDC to which the procedure is
currently assigned.
In addition to this internal review, we also consider requests that
we receive to examine cases found to group to MS-DRGs 981 through 983
or MS-DRGs 987 through 989 to determine if it would be appropriate to
add procedure codes to one of the surgical MS DRGs for the MDC into
which the principal diagnosis falls or to move the principal diagnosis
to the surgical MS DRGs to which the procedure codes are assigned.
Based on the results of our review of the claims data from the
September 2019 update of the FY 2019 MedPAR file, as well as our review
of the requests that we received to examine cases found to group to MS-
DRGs 981 through 983 or MS-DRGs 987 through 989, we proposed to move
the cases reporting the procedures and/or principal diagnosis codes
described in this section of this rule 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 or procedure is assigned.
[[Page 58521]]
a. Horseshoe Abscess With Drainage
As discussed in the proposed rule, we received a request to
reassign cases reporting a principal diagnosis of a horseshoe abscess
with a procedure involving open drainage of perineum subcutaneous
tissue and fascia from MS-DRGs 987, 988, and 989 (Non-Extensive O.R.
Procedure Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) to MS-DRGs 356, 357, and 358 (Other
Digestive System O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 06. ICD-10-CM diagnosis code K61.31 (Horseshoe
abscess) is used to report a horseshoe abscess and is currently
assigned to MDC 06 (Diseases and Disorders of the Digestive System). A
horseshoe abscess is a specific type of ischiorectal abscess caused by
an abscessed anal gland located in the posterior midline of the anal
canal with suppuration found in the ischiorectal fossae. ICD-10-PCS
procedure code 0J9B0ZZ (Drainage of perineum subcutaneous tissue and
fascia, open approach) may be reported to describe drainage of an
abscess in the ischiorectal space and is currently assigned to MDC 08
(Diseases and Disorders of the Musculoskeletal System and Connective
Tissue), MDC 09 (Diseases and Disorders of the Skin, Subcutaneous
Tissue and Breast), MDC 21 (Injuries, Poisonings and Toxic Effects of
Drugs) and MDC 24 (Multiple Significant Trauma).
We stated in the proposed rule that our analysis of this grouping
issue confirmed when a horseshoe abscess is reported as a principal
diagnosis with ICD-10-PCS procedure code 0J9B0ZZ, these cases group to
MS-DRGs 987, 988, and 989. As previously noted, whenever there is a
surgical procedure reported on the claim that 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''.
We first examined the claims data to identify cases reporting
procedure code 0J9B0ZZ with a principal diagnosis of K61.31 that are
currently grouping to MS-DRGs 987, 988, and 989. Our findings are shown
in this table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.072
As previously noted, the requester asked that we reassign these
cases to MS-DRGs 356, 357, and 358. We therefore examined the data for
all cases in MS-DRGs 356, 357, and 358. Our findings are shown in this
table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.073
We stated while our clinical advisors noted that the average length
of stay and average costs of cases in MS-DRGs 356, 357, and 358 are
higher than the average length of stay and average costs for the small
subset of cases reporting procedure code 0J9B0ZZ and a principal
diagnosis code of K61.31 in MS-DRGs 987, 988, and 989, they believe
that the procedure is clearly clinically related to the principal
diagnosis and is a logical accompaniment of the diagnosis. Therefore,
they believe it is clinically appropriate for the procedure to group to
the same MS-DRGs as the principal diagnosis.
Therefore, we proposed to add ICD-10-PCS procedure code 0J9B0ZZ to
MDC 06 in MS-DRGs 356, 357, and 358. Under this proposal, cases
reporting procedure code 0J9B0ZZ in conjunction with a principal
diagnosis from MDC 06, such as diagnosis code K61.31, would group to
MS-DRGs 356, 357, and 358.
Comment: Commenters supported our proposal to add ICD-10-PCS
procedure code 0J9B0ZZ to MDC 06 in MS-DRGs 356, 357, and 358.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-PCS procedure code 0J9B0ZZ to MDC
06 in MS-DRGs 356, 357, and 358.
b. Chest Wall Deformity With Supplementation
We received a request to reassign cases reporting a principal
diagnosis of acquired deformity of chest and rib with a procedure
involving the placement of a biological or synthetic material that
supports or strengthens the body part 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) in MDC 08.
[[Page 58522]]
As discussed in the proposed rule, ICD-10-CM diagnosis code M95.4
(Acquired deformity of chest and rib) is used to report this condition
and is currently assigned to MDC 08 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue). ICD-10-PCS procedure
codes 0WU807Z (Supplement chest wall with autologous tissue substitute,
open approach), 0WU80JZ (Supplement chest wall with synthetic
substitute, open approach) and 0WU80KZ (Supplement chest wall with
nonautologous tissue substitute, open approach) may be reported to
describe procedures to supplement or reinforce the chest wall with
biologic or synthetic material. ICD-10-PCS procedure codes 0WU807Z and
0WU80KZ are currently assigned to MDC 04 (Diseases and Disorders of the
Respiratory System). We noted that ICD-10-PCS procedure code 0WU80JZ is
already assigned to MDC 08 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue) as well as MDC 04
(Diseases and Disorders of the Respiratory System), so these cases
already group to MS-DRGs 515, 516, and 517 when reported with a
principal diagnosis of ICD-10-CM diagnosis code M95.4.
We stated in the proposed rule that our analysis of this grouping
issue confirmed that when diagnosis code M95.4 is reported as a
principal diagnosis with ICD-10-PCS procedure codes 0WU807Z or 0WU80KZ,
these cases group to MS-DRGs 981, 982, and 983. As noted in the
previous discussion, whenever there is a surgical procedure reported on
the claim that 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''.
We examined the claims data to identify cases reporting procedure
codes 0WU807Z or 0WU80KZ with principal diagnosis code M95.4 that are
currently grouping to MS-DRGs 981, 982, and 983. Our analysis showed
one case reporting a principal diagnosis of code M95.4 with procedure
code 0WU807Z, with a length of stay of 2.0 days and average costs of
$11,594 in MS-DRG 983. We found zero cases in MS-DRGs 981 and 982
reporting procedure codes 0WU807Z or 0WU80KZ and a principal diagnosis
of M95.4.
We also examined the data for cases in MS-DRGs 515, 516, and 517,
and our findings are shown in this table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.074
While there was only one case reporting procedure codes 0WU807Z or
0WU80KZ with principal diagnosis M95.4 in MS-DRGs 981, 982, and 983, we
stated our clinical advisors reviewed this request and believe that the
cases involving procedures of chest wall supplementation with a
principal diagnosis of acquired deformity of chest and rib represent a
distinct, recognizable clinical group similar to those cases in MS-DRGs
515, 516, and 517, and that procedures reporting 0WU80JZ and 0WU80KZ
are clearly related to the principal diagnosis code. They believe that
it is clinically appropriate for the three ICD-10-PCS codes describing
procedures to supplement or reinforce the chest wall with biologic or
synthetic material to group to the same MS-DRGs as the principal
diagnoses.
Therefore, we proposed to add ICD-10-PCS procedure codes 0WU807Z
and 0WU80KZ to MDC 08 in MS-DRGs 515, 516, and 517. Under this
proposal, cases reporting procedure codes 0WU807Z or 0WU80KZ in
conjunction with a principal diagnosis code from MDC 08 would group to
MS-DRGs 515, 516, and 517.
Comments: Commenters supported the proposal to add ICD-10-PCS
procedure codes 0WU807Z and 0WU80KZ to MDC 08 in MS-DRGs 515, 516, and
517. The commenters stated that the proposal was reasonable, given the
ICD-10-CM code and the information provided. One commenter specifically
stated this reassignment would allow procedures describing chest wall
supplementation to be assigned to the appropriate MS-DRG when reported
with the principal diagnosis of acquired deformity of chest and rib
instead of one of the unrelated operating room procedure MS-DRGs.
Another commenter stated this would improve clinical consistency since
one of the codes describing these procedures is already assigned to MDC
08.
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 0WU807Z and
0WU80KZ to MDC 08 in MS-DRGs 515, 516, and 517.
c. Hepatic Malignancy With Hepatic Artery Embolization
As discussed in the proposed rule, we received a request to
reassign cases for hepatic malignancy when reported with procedures
involving the embolization of a hepatic artery from MS-DRGs 987, 988,
and 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 423,
424, and 425 (Other Hepatobiliary or Pancreas Procedures with MCC, with
CC, and without CC/MCC, respectively) in MDC 08.
We stated in the proposed rule that ICD-10-PCS procedure code
04V33DZ (Restriction of hepatic artery with intraluminal device,
percutaneous approach) may be reported to describe embolization
procedures to narrow or partially occlude a hepatic artery with an
intraluminal device and is currently assigned to MDC 05 (Diseases and
Disorders of the Circulatory System). ICD-10-PCS procedure code 04L33DZ
(Occlusion of hepatic artery with intraluminal device, percutaneous
approach) may be reported to describe embolization procedures to
completely close off a hepatic artery with an intraluminal device and
is currently assigned to MDC 05 (Diseases and Disorders of the
Circulatory System) and MDC 06 (Diseases and Disorders of the Digestive
System).
The requestor did not provide an ICD-10-CM diagnosis code in its
request so we reviewed ICD-10-CM diagnosis codes in the C00 through D49
code range to identify conditions that describe hepatic malignancies.
We
[[Page 58523]]
identified the following fourteen ICD-10-CM diagnosis codes, all
currently assigned to MDC 07 (Diseases and Disorders of the
Hepatobiliary System & Pancreas):
[GRAPHIC] [TIFF OMITTED] TR18SE20.075
Our analysis of this grouping issue confirmed that, when one of the
fourteen hepatic malignancy ICD-10-CM diagnosis codes previously listed
is reported as a principal diagnosis with ICD-10-PCS procedure code
04L33DZ, these cases group to MS-DRGs 987, 988, and 989. However, we
noted that when one of these fourteen hepatic malignancy ICD-10-CM
diagnosis codes is reported as a principal diagnosis with ICD-10-PCS
procedure code 04V33DZ, these cases currently 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). As noted in the
previous discussion, whenever there is a surgical procedure reported on
the claim that 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''.
To understand the resource use for the subset of cases reporting
procedure code 04V33DZ with a principal diagnosis of hepatic malignancy
that are currently grouping to MS-DRGs 981, 982, and 983, we examined
claims data for the average length of stay and average costs for these
cases. Our findings are shown in the following table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.076
We then examined the claims data to identify cases reporting
procedure code 04L33DZ reported with a principal diagnosis of hepatic
malignancy that are currently grouping to MS-DRGs 987, 987, and 989.
Our findings are shown in the following table:
[[Page 58524]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.077
We also examined the data for cases in MS-DRGs 423, 424, and 425,
and our findings are shown in the following table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.078
While the average lengths of stay of cases in MS-DRGs 423, 424, and
425 are longer than the average lengths of stay for the subset of cases
reporting procedure codes 04V33DZ or 04L33DZ and a principal diagnosis
of hepatic malignancy, the average costs of these same cases are
generally similar. We stated our clinical advisors also believe that
these procedures are clearly related to the principal diagnoses, as
they are an appropriate treatment for a number of hepatobiliary
diagnoses, including cancer and it is clinically appropriate for the
procedures to group to the same MDC as the principal diagnoses.
Therefore, we proposed to add ICD-10-PCS procedure codes 04V33DZ
and 04L33DZ to MDC 07 in MS-DRGs 423, 424 and 425. Under this proposal,
cases reporting procedure codes 04V33DZ or 04L33DZ in conjunction with
a principal diagnosis code for a hepatic malignancy from MDC 07 would
group to MS-DRGs 423, 424 and 425.
Comments: Commenters supported our proposal to add ICD-10-PCS
procedure codes 04V33DZ and 04L33DZ to MDC 07 in MS-DRGs 423, 424 and
425.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-PCS procedure codes 04V33DZ and
04L33DZ to MDC 07 in MS-DRGs 423, 424 and 425.
d. Hemoptysis With Percutaneous Artery Embolization
We received a request to reassign cases for hemoptysis when
reported with a procedure describing percutaneous embolization of an
upper artery with an intraluminal device 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 163, 164, and 165
(Major Chest Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 04. As discussed in the proposed rule, hemoptysis
is the expectoration of blood from some part of the respiratory tract.
ICD-10-CM diagnosis code R04.2 (Hemoptysis) is used to report this
condition and is currently assigned to MDC 04 (Diseases and Disorders
of the Respiratory System). ICD-10-PCS procedure code 03LY3DZ
(Occlusion of upper artery with intraluminal device, percutaneous
approach) may be reported to describe percutaneous embolization of an
upper artery with an intraluminal device and is currently assigned to
MDC 05 (Diseases and Disorders of the Circulatory System), MDC 21
(Injuries, Poisonings and Toxic Effects of Drugs) and MDC 24 (Multiple
Significant Trauma).
Our analysis of this grouping issue confirmed that when a procedure
describing percutaneous embolization of an upper artery with an
intraluminal device (such as ICD-10-PCS procedure code 03LY3DZ) is
reported with a principal diagnosis from MDC 04, such as R04.2, these
cases group to MS-DRGs 981, 982, and 983. We stated during our review
of this issue, we also examined claims data for similar procedures
03LY0DZ (Occlusion of upper artery with intraluminal device, open
approach) and 03LY4DZ (Occlusion of upper artery with intraluminal
device, percutaneous endoscopic approach) and noted the same pattern.
As noted in the previous discussion, whenever there is a surgical
procedure reported on the claim that 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''.
We examined the claims data to identify cases reporting procedure
codes 03LY0DZ, 03LY3DZ or 03LY4DZ with a principal diagnosis from MDC
04 that are currently grouping to MS-DRGs 981, 982, and 983. Our
findings are shown in this table:
[[Page 58525]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.079
As indicated earlier, the requestor suggested that we move ICD-10-
PCS procedure code 03LY3DZ to MS-DRGs 163, 164, and 165. We stated,
however, our clinical advisors believe that, within MDC 04, procedure
codes describing percutaneous embolization of an upper artery with an
intraluminal device are more clinically aligned with the procedure
codes assigned to MS-DRGs 166, 167, and 168 (Other Respiratory System
O.R. Procedures with MCC, with CC and without CC/MCC, respectively), as
these procedures would not be considered major chest procedures.
Therefore, we examined claims data to identify the average length of
stay and average costs for cases assigned to MS-DRGs 166, 167 and 168.
Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.080
While our clinical advisors noted that the average costs of cases
in MS-DRGs 166, 167, and 168 are lower than the average costs for the
subset of cases reporting procedure codes 03LY0DZ, 03LY3DZ or 03LY4DZ
and a principal diagnosis code from MDC 04, they believe that these
procedures are clearly related to the principal diagnoses as these
procedures are appropriate for certain respiratory tract diagnoses. We
stated that therefore, it is clinically appropriate for the procedures
to group to the same MDC as the principal diagnoses.
Therefore, we proposed to add ICD-10-PCS procedure codes 03LY0DZ,
03LY3DZ and 03LY4DZ to MDC 04 in MS-DRGs 166, 167, and 168. Under this
proposal, cases reporting procedure codes 03LY0DZ, 03LY3DZ or 03LY4DZ
in conjunction with a principal diagnosis code from MDC 04 such as
hemoptysis (R04.2) would group to MS-DRGs 166, 167, and 168.
Comment: A few commenters supported our proposal.
Response: We appreciate the commenters' support.
Comment: A commenter stated that ICD-10-PCS does not have procedure
codes with a root operation of control in association with these upper
arteries and there are times when an embolization procedure to control
acute bleeding manifested as hemoptysis is necessary. This commenter
also stated that the correct ICD-10-PCS root operation involving an
intervention to address current acute or postprocedural bleeding or to
prevent future bleeding is control involving the organ that is
bleeding.
Response: We appreciate the commenter raising its concerns.
While we agree that the ICD-10-PCS Official Guidelines for Coding
and Reporting define the root operation ``control'' as ``stopping or
attempting to stop, postprocedural or other acute bleeding'', the
guidelines also state that if a more definitive root operation is
required to stop the bleeding then the more definitive root operation
is coded instead of ``control''. That is, when embolization is
performed to stop acute postprocedural or other acute bleeding of a
tubular body part, the more definitive root operations that should be
coded in those instances are restriction (if the intent is to partially
close) or occlusion (if the intent is to completely occlude) the
tubular body part, and not the root operation ``control''. We encourage
this commenter to review the posted ICD-10-PCS Guidelines on the CMS
website at: https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs.html.
Comment: Another commenter disagreed with our proposal and stated
hemoptysis could be due to other non-respiratory reasons and believed
these procedures should be assigned to a ``circulatory'' over a
``respiratory'' DRG if the source of bleeding is not known and a non-
respiratory artery or circulatory vessel is occluded to stop the
bleeding.
Response: We disagree with the commenter that hemoptysis can be due
to other non-respiratory reasons and note that the term ``hemoptysis''
specifically refers to the expectoration of blood originating from the
respiratory tract. The expectoration of blood from a source other than
the respiratory tract is not defined as hemoptysis and would not be
coded with ICD-10-CM diagnosis code R04.2 (Hemoptysis).
As stated in the proposed rule, ICD-10-CM diagnosis code R04. 2
(Hemoptysis) is currently assigned to MDC 04 (Diseases & Disorders of
the Respiratory System), not MDC 05 (Diseases & Disorders of the
Circulatory System). We proposed to add these procedures to MDC 04, to
address the matter of these procedures producing assignment to MS-DRGs
981 through 983 when coded with this diagnosis.
We note that under this proposal ICD-10-PCS procedure codes
03LY0DZ, 03LY3DZ and 03LY4DZ will continue to also be assigned to
several MS-DRGs in three other MDCs (including MDC 05 (Diseases &
Disorders of the Circulatory System)) as discussed in the proposed
rule. With the exception of the pre-
[[Page 58526]]
MDC, assignment to MDCs is driven by the principal diagnosis and not by
the procedure. We also note that according to the ICD-10-CM Official
Guidelines for Coding and Reporting, diagnoses described by codes from
Chapter 18 (Symptoms, Signs and Abnormal Clinical and Laboratory
Findings) of ICD-10-CM, such as R04.2, are acceptable for reporting
when a related definitive diagnosis has not been established
(confirmed) by the provider. If the expectoration of blood from the
respiratory tract or another source is determined to be due another
condition, that condition should be coded as principal diagnosis
instead and assignment to a MDC will be driven by that principal
diagnosis.
Our clinical advisors continue to believe that these procedures are
also clearly related to ICD-10-CM diagnosis code R04.2 (Hemoptysis)
assigned to MDC 04 and believe that it is appropriate to add these
procedures to MDC 04. Therefore, after consideration of the public
comments received, we are finalizing our proposal to add ICD-10-PCS
procedure codes 03LY0DZ, 03LY3DZ and 03LY4DZ to MDC 04 in MS-DRGs 166,
167, and 168.
e. Acquired Coagulation Factor Deficiency With Percutaneous Artery
Embolization
As discussed in the proposed rule, we received a request to
reassign cases for acquired coagulation factor deficiency when reported
with a procedure describing the complete occlusion of an artery with an
intraluminal device 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 252, 253 and 254 (Other
Vascular Procedures with MCC, with CC, and without CC/MCC,
respectively) or 270, 271, and 272 (Other Major Cardiovascular
Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC
05 (Diseases and Disorders of the Circulatory System). The requestor
asked that we reassign ICD-10-CM diagnosis code D68.4 (Acquired
coagulation factor deficiency) from MDC 16 (Diseases and Disorders of
Blood, Blood Forming Organs, Immunologic Disorders) in MS-DRG 813
(Coagulation Disorders), to MDC 05. The requestor provided the
following list of 59 ICD-10-PCS procedure codes describing the complete
occlusion of an artery with an intraluminal device in its request for
consideration to reassign the ICD-10-CM diagnosis code for acquired
coagulation factor deficiency to MDC 05. The requester noted that the
diagnosis of Hemorrhage, not elsewhere classified (ICD-10-CM diagnosis
code R58) groups to MS-DRGs 252, 253 and 254 or 270, 271, and 272 in
MDC 05 when reported with one of the 59 ICD-10-PCS procedure codes
listed and requested that cases reporting a diagnosis describing
acquired coagulation factor deficiency also group to those MS-DRGs when
reported with one of the 59 ICD-10-PCS procedure codes listed.
BILLING CODE 4120-01-P
[[Page 58527]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.081
[[Page 58528]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.082
[[Page 58529]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.083
BILLING CODE 4120-01-C
We stated our analysis of this grouping issue confirmed that, when
diagnosis code D68.4 is reported as a principal diagnosis with one of
the 59 ICD-10-PCS procedure codes provided by the requestor, these
cases group to MS-DRGs 981, 982, and 983. As noted in the previous
discussion, whenever there is a surgical procedure reported on the
claim that 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''.
We examined the claims data to identify cases involving the 59
procedure codes in MDC 05 reported with a principal diagnosis of code
D68.4 that are currently grouping to MS-DRGs 981, 982, and 983. Our
analysis showed one case reported a principal diagnosis of D68.4 with a
procedure code in MDC 05, with a length of stay of 2.0 days and costs
of $21,890 in MS-DRG 981. We found zero cases in MS-DRGs 982 and 983
reporting a procedure code from MDC 05 and a principal diagnosis of
code D68.4.
Overall, for MS-DRGs 981, 982 and 983, there was a total of one
case reporting a principal diagnosis of acquired coagulation factor
deficiency with any of the procedures from MDC 05 provided by the
requestor, demonstrating that acquired coagulation factor deficiency is
not typically corrected surgically by occlusion of an artery with an
intraluminal device.
As discussed in the proposed rule, we also examined the data for
cases in MS-DRG 813, and our findings are shown in this table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.084
As shown in this table, there were a total of 16,680 cases in MS-
DRG 813, with an average length of stay of 4.7 days and average costs
of $11,286. In MS-DRG 813, we found 142 cases reporting a principal
diagnosis of an acquired coagulation factor deficiency with an average
length of stay of 6.41 days and average costs of $17,822. We note that
the average costs for the subset of cases in MS-DRG 813 reporting a
principal diagnosis of an acquired coagulation factor deficiency are
higher than the average costs of all cases that currently group to MS-
DRG 813.
We are clarifying in this final rule that cases reporting a
principal diagnosis of acquired coagulation factor deficiency group to
MS-DRGs 813, which is the medical MS-DRG that contains coagulation
disorders, in the absence of a surgical procedure. We note that every
diagnosis code is assigned to a medical MS-DRG to define the logic of
the MS-DRG either as a principal or secondary diagnosis. As discussed
in section II.E.12.a., certain procedure codes may affect the MS-DRG
and result in a surgical MS-DRG assignment. Cases reporting a principal
diagnosis of acquired coagulation factor deficiency group to MS-DRGs
799, 800 and 801 (Splenectomy with MCC, with CC, and without CC/MCC,
respectively) or MS-DRGs 802, 803, and 804 (Other O.R. Procedures of
the Blood and Blood Forming Organs with MCC, with CC, and without CC/
MCC, respectively) in the presence of a surgical procedure such as the
procedures listed by the requestor. We refer the reader to the ICD-10
MS-DRG Version 37 Definitions Manual for complete documentation of the
logic for case assignment to surgical MS-DRGs 799, 800, 801, 802, 803,
and 804 and to medical MS-DRG 813 (which is available via the internet
on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html).
However, as stated in the proposed rule, our clinical advisors
believe that diagnosis code D68.4 describes acquired bleeding disorders
in which the affected person lacks the necessary coagulation factors
for proper clot formation and wound healing, and therefore, is most
clinically aligned with the diagnosis codes assigned to MDC 16 (where
it is currently assigned). Our clinical advisors further note that a
diagnosis of an acquired bleeding disorder is not comparable to
conditions described by the ICD-10-CM code R58 (Hemorrhage, not
elsewhere classified) as suggested by the requestor. Diagnoses
described by codes from Chapter 18 (Symptoms, Signs and Abnormal
Clinical and Laboratory Findings) of ICD-10-CM, such as R58, can be the
result of a variety of underlying conditions, or describe conditions of
an unexplained etiology. We stated that as an ill-defined condition,
our clinical advisors do not believe it is appropriate to equate this
diagnosis code with a bleeding disorder. Therefore, we did not propose
to reassign ICD-10-CM diagnosis code D68.4 from MDC 16 to MDC 05.
Comments: Commenters agreed with CMS' proposal not to reassign ICD-
10-CM diagnosis code D68.4 from MDC 16 to MDC 05. One commenter stated
a diagnosis of an acquired bleeding disorder is not comparable to
conditions described by the ICD-10-CM code R58, Hemorrhage, not
elsewhere classified, and ICD-10-CM code D68.4 is most clinically
aligned with the diagnosis codes in MDC 16.
[[Page 58530]]
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to maintain the assignment of ICD-10-CM
diagnosis code D68.4 in MDC 16.
f. Epistaxis with Percutaneous Artery Embolization
We received a request to consider adding cases for a hemorrhage of
the nose when reported with a procedure describing percutaneous
arterial embolization to MDC 03 (Disease and Disorders of the Ear,
Nose, Mouth and Throat) in MS-DRGs 133 and 134 (Other Ear, Nose, Mouth
and Throat O.R. Procedures with CC/MCC and without CC/MCC,
respectively). ICD-10-CM diagnosis code R04.0 (Epistaxis) is used to
describe a hemorrhage of the nose or ``nosebleed'' and is currently
assigned to MDC 03. ICD-10-PCS procedure codes describing percutaneous
arterial embolization may be reported with procedure codes 03LM3DZ
(Occlusion of right external carotid artery with intraluminal device,
percutaneous approach), 03LN3DZ (Occlusion of left external carotid
artery with intraluminal device, percutaneous approach), or 03LR3DZ
(Occlusion of face artery with intraluminal device, percutaneous
approach) and are currently assigned to several MS-DRGs in five MDCs as
illustrated in the table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.085
According to the requestor, when diagnosis code R04.0 is reported
as a principal diagnosis with any one of the procedure codes describing
a percutaneous arterial embolization (03LM3DZ, 03LN3DZ, or 03LR3DZ),
these cases are grouping to MS-DRGs 981, 982, and 983 (Extensive O.R.
Procedure Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively).
As stated in the proposed rule, our analysis of this grouping issue
confirmed that, when epistaxis (ICD-10-CM diagnosis code R04.0) is
reported as a principal diagnosis with ICD-10-PCS procedure codes
03LM3DZ, 03LN3DZ, or 03LR3DZ, 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 that 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.''
For our review of this grouping issue and the request to have cases
reporting procedure codes 03LM3DZ, 03LN3DZ, or 03LR3DZ added to MDC 03
in MS-DRGs 133 through 134, we first examined claims data from
September 2019 update of the FY 2019 MedPAR file for cases reporting
ICD-10-PCS procedure codes 03LM3DZ, 03LN3DZ, or 03LR3DZ with a
principal diagnosis of R04.0 from MDC 03 that currently group to MS-
DRGs 981 through 983. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.086
We then examined the claims data to identify the average length of
stay and average costs for all cases in MS-DRGs 133 and 134. Our
findings are shown in the table.
[[Page 58531]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.087
As shown in the table, for MS-DRG 133, there were a total of 1,757
cases with an average length of stay of 5.6 days and average costs of
$15,337. For MS-DRG 134, there were a total of 849 cases with an
average length of stay of 2.5 days and average costs of $9,512. Our
clinical advisors believe that procedure codes 03LM3DZ, 03LN3DZ, and
03LR3DZ are appropriate procedures to treat commonly occurring ear,
nose, and throat bleeding diagnoses and expressed support for these
procedure codes to group to MDC 03.
We noted that, as discussed in section II.D.4 of the preamble of
the proposed rule and section II.E.4. of this final rule, we proposed
to delete MS-DRGs 133 and 134 and create new MS-DRGs 143, 144, and 145
(Other Ear, Nose, Mouth and Throat O.R. Procedures with MCC, with CC,
and without CC/MCC, respectively). Therefore, we proposed to add ICD-
10-PCS procedure codes 03LM3DZ, 03LN3DZ, and 03LR3DZ to MDC 03 in new
MS-DRGs 143, 144, and 145, if finalized. Under this proposal, cases
reporting ICD-10-PCS procedure codes 03LM3DZ, 03LN3DZ, or 03LR3DZ with
a principal diagnosis from MDC 03 would group to new MS-DRGs 143, 144,
and 145.
The following table reflects our simulation for ICD-10-PCS
procedure codes 03LM3DZ, 03LN3DZ, and 03LR3DZ in new MS-DRGs 143, 144,
and 145.
[GRAPHIC] [TIFF OMITTED] TR18SE20.088
Comment: A commenter supported our proposal to add procedure codes
describing a percutaneous arterial embolization to MDC 03. This
commenter also stated CMS should expand ICD-10-PCS to include procedure
codes describing the control of bleeding of the nasal passages
performed using a percutaneous and percutaneous endoscopic approach so
the resources involved in addressing acute or postprocedural bleeding
in this manner can be assessed.
Response: We appreciate the commenter's support. As discussed in
section II.E.16. of the preamble of this final rule, the ICD-10
Coordination and Maintenance Committee addresses updates to the ICD-10-
CM and ICD-10-PCS coding systems. We encourage commenters to submit
proposals for procedure coding changes via Email to:
[email protected].
Comment: Another commenter questioned CMS's proposal and stated
these procedures should be classified to the circulatory MS-DRGs if the
bleed is due to an artery or vessel and a procedure is performed on
that artery/vessel.
Response: We appreciate the comment and concerns raised on our
proposal.
As explained in the proposed rule, when conducting the review of
procedures producing assignment to MS-DRGs 981 through 983 or MS-DRGs
987 through 989, the objective is to 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, or to move the principal
diagnosis codes to the MDC in which the procedure falls.
As stated in the proposed rule, ICD-10-CM diagnosis code R04.0
(Epistaxis) is used to describe a hemorrhage of the nose or
``nosebleed'' and is currently assigned to MDC 03 (Diseases & Disorders
of the Ear, Nose, Mouth & Throat), not MDC 05 (Diseases & Disorders of
the Circulatory System). We proposed to add these procedures to MDC 03,
to address the matter of these procedures producing assignment to MS-
DRGs 981 through 983 when performed for a diagnosis of epistaxis.
We note that under this proposal ICD-10-PCS procedure codes
03LM3DZ, 03LN3DZ, and 03LR3DZ will continue to also be assigned to
several MS-DRGs in five other MDCs (including MDC 05 (Diseases &
Disorders of the Circulatory System)) as discussed in the proposed
rule. With the exception of the pre-MDC, assignment to MDCs is driven
by the principal diagnosis and not by the procedure. We also note that
according
[[Page 58532]]
to the ICD-10-CM Official Guidelines for Coding and Reporting,
diagnoses described by codes from Chapter 18 (Symptoms, Signs and
Abnormal Clinical and Laboratory Findings) of ICD-10-CM, such as R04.0,
are acceptable for reporting when a related definitive diagnosis has
not been established (confirmed) by the provider. If the nasal bleeding
is determined to be due another condition, that condition should be
coded as principal diagnosis instead and assignment to a MDC will be
driven by that principal diagnosis. Our clinical advisors continue to
believe that these procedures are also clearly related to the principal
diagnoses ICD-10-CM diagnosis code R04.0 (Epistaxis), assigned to MDC
03 and believe that it is appropriate to add these procedures to MDC
03.
Therefore, after consideration of the public comments we received,
we are finalizing our proposal to add ICD-10-PCS procedure codes
03LM3DZ, 03LN3DZ, and 03LR3DZ to MDC 03 in new MS-DRGs 143, 144, and
145. We refer the reader to section II.E.4. of this final rule for the
comments regarding our proposal to create new MS-DRGs 143, 144, and
145, as well as our finalization of that proposal.
g. Revision or Removal of Synthetic Substitute in Peritoneal Cavity
As discussed in the proposed rule, during our review of the cases
that group to MS-DRGs 981 through 983, we noted that when several ICD-
10-PCS procedure codes describing revision or removal of synthetic
substitute in the peritoneal cavity are reported in conjunction with
ICD-10-CM diagnosis codes in MDC 01 (Diseases and Disorders of the
Nervous System), such as complications of intracranial shunts, the
cases group to MS-DRGs 981 through 983. ICD-10-PCS procedure codes
0WWG0JZ (Revision of synthetic substitute in peritoneal cavity, open
approach), 0WWG4JZ (Revision of synthetic substitute in peritoneal
cavity, percutaneous endoscopic approach), and 0WPG0JZ (Removal of
synthetic substitute from peritoneal cavity, open approach) are
currently assigned to MDC 06 (Diseases and Disorders of the Digestive
System) in MS-DRGs 356, 357, and 358 (Other Digestive System O.R.
Procedures with MCC, with CC, and without CC/MCC, respectively).
As stated in the proposed rule, we examined cases that reported a
principal diagnosis in MDC 01 and procedure code 0WWG0JZ, 0WWG4JZ, or
0WPG0JZ that currently group to MS-DRGs 981 through 983. Our findings
are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.089
Within MDC 01, our clinical advisors believe that these procedures,
which describe revision or removal of synthetic substitute in
peritoneal cavity, are most clinically similar to those in MS-DRGs 031,
032, and 033 (Ventricular Shunt Procedures with MCC, with CC, and
without CC/MCC, respectively). We therefore examined the data for all
cases in MS-DRGS 031, 032, and 033.
[GRAPHIC] [TIFF OMITTED] TR18SE20.090
The average costs for the subset of cases in MS-DRGs 981, 982, and
983 that report procedures describing revision or removal of synthetic
substitute in the peritoneal cavity with a principal diagnosis from MDC
01 are lower than the average costs of cases in MS-DRGs 031, 032, and
033 as a whole, and the average length of stay for this subset of cases
is also lower in two of the MS-DRGs and higher in one. Our clinical
advisors believe the procedure codes describing revision or removal of
synthetic substitute in the peritoneal cavity are clearly related to
the principal diagnosis codes describing complications of intracranial
shunts and, therefore, it is clinically appropriate for the procedures
to group to the same MS-DRGs (031, 032, and 033) as the principal
diagnoses describing complications of intracranial shunts. We proposed
to add ICD-10-PCS procedure codes 0WWG0JZ, 0WWG4JZ, and 0WPG0JZ to MDC
01 (Diseases and Disorders of the Nervous System) in MS-DRGs 031, 032,
and 033.
Comments: Commenters supported our proposal to add ICD-10-PCS
procedure codes 0WWG0JZ, 0WWG4JZ, and 0WPG0JZ to MDC 01 (Diseases and
Disorders of the Nervous System) in MS-DRGs 031, 032, and 033. One
commenter stated that ICD-10-PCS procedure codes describing revision or
removal of synthetic substitute in the peritoneal cavity are related to
the principal diagnosis codes describing complications of intracranial
shunts, and so it is appropriate for the procedures to group to the
same MS-
[[Page 58533]]
DRGs as the principal diagnoses describing complications of
intracranial shunts. Another commenter noted that another indication
for shunt revision is most commonly complications of
ventriculoperitoneal shunts, and ICD-10-CM diagnosis codes describing
complication of the ventriculoperitoneal shunts are assigned to MDC 01.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-PCS procedure codes 0WWG0JZ,
0WWG4JZ, and 0WPG0JZ to MDC 01 (Diseases and Disorders of the Nervous
System) in MS-DRGs 031, 032, and 033.
h. Revision of Totally Implantable Vascular Access Devices
As discussed in the proposed rule, during our review of the cases
currently grouping to MS-DRGs 981 through 983, we noted that when
procedure codes describing Totally Implantable Vascular Access Devices
(TIVADs) are reported with ICD-10-CM diagnosis codes assigned to MDC 04
(Diseases and Disorders of the Respiratory System), MDC 06 (Diseases
and Disorders of the Digestive System), MDC 07 (Diseases and Disorders
of the Hepatobiliary System and Pancreas), MDC 08 (Diseases and
Disorders of the Musculoskeletal System and Connective Tissue), MDC 13
(Diseases and Disorders of the Female Reproductive System), or MDC 16
(Diseases and Disorders of Blood, Blood Forming Organs, Immunologic
Disorders), the cases group to MS-DRGs 981 through 983.
TIVADs are port catheter devices inserted for chemotherapy
treatment. The nine ICD-10-PCS procedure codes describing TIVADs are
listed in this table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.091
We examined claims data to identify the average length of stay and
average costs for cases in MS-DRGs 981 through 983 reporting ICD-10-PCS
procedure codes describing TIVADs in conjunction with a principal
diagnosis from MDCs 04, 06, 07, 08, 13, or 16. Our findings are shown
in the following table.
[[Page 58534]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.092
We stated our clinical advisors believe that cases reporting TIVADs
with a principal diagnosis in MDCs 04, 06, 07, 08, 13, or 16 would most
suitably group to the MS-DRGs describing ``Other'' procedures for each
of these MDCs. These TIVAD procedures cannot be assigned to the
specific surgical MS-DRGs within these MDCs since they are not
performed on the particular anatomical areas described by each of the
specific surgical MS-DRGs. For example, in MDC 04, TIVADs could not be
assigned to MS-DRGs 163, 164, and 165 (Major Chest Procedures with MCC,
with CC, and without CC/MCC, respectively) because they are not major
chest procedures.
We therefore examined the claims data for each of these MS-DRGs.
Our findings are shown in the following table.
[[Page 58535]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.093
In the proposed rule, we noted that while the average costs and
length of stay are similar in some cases and in some cases vary between
the subset of cases currently grouping to MS-DRGs 981 through 983 and
the cases currently grouping to the MS-DRGs describing ``Other''
procedures as set forth in the table, our clinical advisors noted that
TIVADs are frequently inserted in order to administer chemotherapy for
a variety of malignancies. MDCs 04, 06, 07, 08, 13, or 16 each contain
ICD-10-CM diagnosis codes that describe a variety of malignancies.
Therefore, our clinical advisors believe that the TIVAD procedures are
clearly related to the principal diagnoses within MDCs 04, 06, 07, 08,
13, and 16. For the reasons previously indicated, our clinical advisors
believe that cases reporting TIVADs with a principal diagnosis in MDCs
04, 06, 07, 08, 13, or 16 would mostly suitably group to the MS-DRGs
describing ``Other'' procedures for each of these MDCs.
Therefore, we proposed to add the nine ICD-10-PCS procedure codes
describing TIVADs as set forth in the table to the MS-DRGs describing
``Other'' procedures within each of MDCs 04, 06, 07, 08, 13, and 16,
specifically: MDC 04 in MS-DRGs 166, 167, and 168, MDC 06 in MS-DRGs
356, 357, and 358, MDC 07 in MS-DRGs 423, 424, and 425, MDC 08 in MS-
DRGs 515, 516, and 517, MDC 13 in MS-DRGs 749 and 750, and MDC 16 in
MS-DRGs 802, 803, and 804. Under this proposal, cases reporting a
principal diagnosis in MDCs 04, 06, 07, 08, 13, or 16 with a TIVAD
procedure would group to the respective MS-DRGs within the MDC.
Comments: Commenters supported the addition of ICD-10-PCS procedure
codes describing insertion of totally implantable vascular access
devices to the MS-DRGs describing ``Other'' procedures within MDCs 04,
06, 07, 08, 13, and 16.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add the nine ICD-10-PCS procedure codes
describing TIVADs as set forth in the table to the MS-DRGs describing
``Other'' procedures within each of MDCs 04, 06, 07, 08, 13, and 16,
specifically: MDC 04 in MS-DRGs 166, 167, and 168, MDC 06 in MS-DRGs
356, 357, and 358, MDC 07 in MS-DRGs 423, 424, and 425, MDC 08 in MS-
DRGs 515, 516, and 517, MDC 13 in MS-DRGs 749 and 750, and MDC 16 in
MS-DRGs 802, 803, and 804.
i. Multiple Trauma With Internal Fixation of Joints
As discussed in the proposed rule, for FY 2020, we received a
request to reassign cases involving diagnoses that identify multiple
significant trauma combined with internal fixation of joint procedures
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 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). The requestor
provided an example of several ICD-10-CM diagnosis codes that together
described multiple significant trauma in conjunction with ICD-10-PCS
procedure codes beginning with the prefix ``0RH'' and ``0SH'' that
describe internal fixation of upper and lower joints. The requestor
provided several suggestions to address this reassignment, including:
Adding all ICD-10-PCS procedure codes from MDC 08 (Diseases and
Disorders of the Musculoskeletal System and Connective Tissue) with the
exception of codes that group to MS-DRG 956 (Limb Reattachment, Hip and
Femur Procedures for Multiple Significant
[[Page 58536]]
Trauma) to MS DRGs 957, 958, and 959; adding codes with the prefix
``0RH'' and ``0SH'' to MDC 24; and adding ICD-10-PCS procedure codes
from all MDCs except those that currently group to MS-DRG 955
(Craniotomy for Multiple Significant Trauma) or MS-DRG 956 (Limb
Reattachment, Hip and Femur Procedures for Multiple Significant Trauma)
to MS-DRGs 957, 958, and 959 in MDC 24. In the FY 2020 IPPS/LTCH PPS
proposed rule, we stated that we believe any potential reassignment of
these cases requires significant analysis. We therefore did not propose
any changes to the cases identified by the requestor.
For FY 2021, as the first step of the comprehensive analysis needed
to assess the reassignment of cases involving diagnoses that identify
multiple significant trauma combined with internal fixation of joint
procedures, we stated in the proposed rule, our clinical advisors
reviewed the list of procedure codes in the ``0RH'' and ``0SH'' code
ranges, as suggested by the requestor. Our clinical advisors identified
161 ICD-10-PCS codes, which are listed in table 6P.1f., that they
believe are clinically related to diagnoses assigned to MDC 24. We
examined the claims data for cases that would be assigned to MDC 24
based on their diagnoses, but currently group to MS-DRGs 981 through
983 based on the presence of procedure codes in the ``0RH'' and ``0SH''
code ranges. Our findings are shown in this table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.094
In the proposed rule, we noted that we found only 8 claims, with
varying lengths of stay and average costs. We also examined the claims
data for all cases in MS-DRGs 957, 958, and 959. Our findings are shown
in this table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.095
[[Page 58537]]
The very small number of claims we identified for cases that would
be assigned to MDC 24 based on their diagnoses, but grouped to MS-DRGs
981 through 983 based on the presence of procedure codes in the ``0RH''
and ``0SH'' code ranges, have varying resource use relative to MS-DRGs
957, 958, and 959 as a whole. The average costs of the cases found in
MS-DRGs 981-983 range from $7,015 to $72,331 with average lengths of
stay ranging from 3 days to 14 days. The average costs of the cases
found in MS-DRGs 957-959 range from $20,563 to $54,771 with average
lengths of stay ranging from 5 days to 13.2 days. We stated given the
nature of trauma cases, the resource use would be expected to vary
based on the nature of the patient's injuries. In addition, as noted,
our clinical advisors believe that these procedure codes are clinically
related to the diagnoses in MDC 24. Therefore, we proposed to add the
161 ICD-10-PCS codes shown in Table 6P.1f associated with the proposed
rule to MDC 24 in MS-DRGs 957, 958, and 959. Under this proposal, cases
that would be assigned to MDC 24 based on their diagnoses, that also
report one of the 161 ICD-10-PCS codes included in table 6P.1f, will
group to MDC 24 in MS-DRGs 957, 958, and 959, rather than to MS-DRGs
981 through 983.
In the proposed rule, we noted that while we made this proposal to
address the grouping issue for internal fixation of upper and lower
joint procedures identified by the requestor, our clinical advisors
believe that a more comprehensive analysis is required within MDC 24 to
address the differences in severity level of diagnoses as well as the
assignment of procedure codes to the MS-DRGs within MDC 24. We plan to
continue this comprehensive analysis in future rulemaking.
Comment: Commenters supported our proposal to add the 161 ICD-10-
PCS codes shown in Table 6P.1f to MDC 24 in MS-DRGs 957, 958, and 959.
A commenter specifically stated they endorse the proposal as a means of
more accurately representing the costs associated with the care and
treatment of multi trauma patients. Commenters also stated they agreed
that a more comprehensive analysis of the diagnoses and procedures
assigned to MDC 24 should be undertaken.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add the 161 ICD-10-PCS codes shown in Table
6P.1f associated with this final rule to MDC 24 in MS-DRGs 957, 958,
and 959. Accordingly, cases that would be assigned to MDC 24 based on
their diagnoses, that also report one of the 161 ICD-10-PCS codes
included in table 6P.1f, will group to MDC 24 in MS-DRGs 957, 958, and
959 under the ICD-10 MS-DRGs Version 38, effective October 1, 2020. As
noted in the proposed rule, we plan to continue this comprehensive
analysis in future rulemaking.
j. 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 claims data in the September
2019 update of the FY 2019 MedPAR file, we proposed to reassign three
procedure codes from MS-DRGs 981, 982, and 983 (Extensive O.R.
Procedure Unrelated to Principal Diagnosis with MCC, with CC, without
CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-Extensive
Procedure Unrelated to Principal Diagnosis with MCC, with CC, without
CC/MCC, respectively). We also proposed to reassign three procedure
codes from MS-DRGs 987, 988, and 989 (Non-Extensive Procedure Unrelated
to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively)
to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to
Principal Diagnosis with MCC, with CC, without CC/MCC, respectively).
In conducting our review of the request to designate ICD-10-PCS
procedure code 0W3G0ZZ (Control bleeding in peritoneal cavity, open
approach) as an O.R. procedure (as described in section II.E.11.c.5. of
this final rule), our clinical advisors noted that ICD-10-PCS codes
0W3G3ZZ (Control bleeding in peritoneal cavity, percutaneous approach)
and 0W3G4ZZ (Control bleeding in peritoneal cavity, percutaneous
endoscopic approach) are currently assigned to MS-DRGs 981 through 983
when reported with a principal diagnosis that is not assigned to one of
the MDCs to which these procedure codes are assigned. We stated that
our clinical advisors believe that these procedures would be more
appropriately assigned to MS-DRGs 987 through 989 because they are on
average less complex and difficult than the same procedure performed by
an open approach, and therefore should be assigned to the ``less
extensive'' DRG. Therefore, we proposed to reassign ICD-10-PCS codes
0W3G3ZZ and 0W3G4ZZ from MS-DRGs 981 through 983 to 987 through 989.
Comment: A commenter supported our proposal.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to reassign ICD-10-PCS codes 0W3G3ZZ and
0W3G4ZZ from MS-DRGs 981 through 983 to 987 through 989, effective
October 1, 2020.
In conducting our review of the request to designate ICD-10-PCS
procedure codes 0WBC4ZX (Excision of mediastinum, percutaneous
endoscopic approach, diagnostic) and 0WBC3ZX (Excision of mediastinum,
percutaneous approach, diagnostic) as O.R. procedures (as described in
section II.E.11.c.1. of this final rule), our clinical advisors noted
that ICD-10-PCS code 0WBC0ZX (Excision of mediastinum, open approach,
diagnostic) is currently assigned to MS-DRGs 981 through 983 when
reported with a principal diagnosis that is not assigned to one of the
MDCs to which the procedure code is assigned. We stated that our
clinical advisors believe that this procedure would be more
appropriately assigned to MS-DRGs 987 through 989 because this
assignment is consistent with the assignment of other procedures that
describe excision of the mediastinum performed by an open,
percutaneous, or percutaneous endoscopic approach, and is consistent
with the proposal for procedure codes 0WBC4ZX and 0WBC3ZX (with
diagnostic qualifier) as discussed in section II.E.11.c.1. of this
final rule. Therefore, we proposed to reassign ICD-10-PCS code 0WBC0ZX
from MS-DRGs 981 through 983 to 987 through 989.
Comment: A commenter supported our proposal.
Response: We appreciate the commenter's support.
After consideration of the public comments we received, we are
finalizing our proposal to reassign ICD-10-PCS code 0WBC0ZX from MS-
DRGs
[[Page 58538]]
981 through 983 to 987 through 989, effective October 1, 2020.
As discussed in the proposed rule, we received a request to examine
cases reporting a procedure describing the open excision of
gastrointestinal body parts in the gastrointestinal body system. The
requester stated that when procedures describing the open excision of a
specific gastrointestinal body part in the gastrointestinal body system
are reported with a principal diagnosis such as C49.A3
(Gastrointestinal stromal tumor of small intestine (GIST)), the cases
are assigned to MS-DRGs 987, 988, and 989 (Non-Extensive O.R. Procedure
Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively). However, when procedures describing the excision of a
general gastrointestinal body part in the gastrointestinal body system
are reported with the same principal diagnosis of GIST, the cases are
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). The requestor stated that procedures describing a
specific body part value should be assigned to the same MS-DRG as
procedures describing a general body part value.
The requestor provided four ICD-10-PCS procedure codes in its
request. These four ICD-10-PCS procedure codes, as well as their MDC
assignments, are listed in the table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.096
In the proposed rule, we noted that in the FY 2020 IPPS/LTCH PPS
final rule (84 FR 42120 through 42122), we finalized our proposal to
move seven ICD-10-CM diagnosis codes describing gastrointestinal
stromal tumors (GIST), including C49.A3, from MDC 08 to MDC 06, under
the ICD-10 MS-DRGs Version 37, effective October 1, 2019. As a result,
cases reporting a principal diagnosis of GIST and a procedure code that
is assigned to MDC 06 (such as ICD-10-PCS codes 0DBA0ZZ, 0DBB0ZZ,
0DB80ZZ, and 0DB90ZZ) group to MS-DRGs in MDC 06.
We stated in the proposed rule that our analysis of this grouping
issue found that these four ICD-10-PCS codes describing related
procedures have dissimilar designations that determine whether and in
what way the presence of the procedure impacts the MS-DRG assignment.
We noted ICD-10-PCS code 0DB80ZZ is classified as an extensive O.R.
procedure and ICD-10-PCS codes 0DB90ZZ, 0DBA0ZZ, and 0DBB0ZZ are
classified as non-extensive O.R. procedures. As a result, whenever ICD-
10-PCS code 0DB80ZZ is reported with a principal diagnosis that is
assigned to a different MDC than the procedure code, the case would be
assigned to MS-DRGs 981 through 983. When ICD-10-PCS codes 0DB90ZZ,
0DBA0ZZ, or 0DBB0ZZ are reported with a principal diagnosis that is
assigned to a different MDC than the procedure code, the case would be
assigned to MS-DRGs 987 through 989.
We examined the claims data to identify cases reporting procedure
code 0DB80ZZ that are currently grouping to MS-DRGs 981, 982 and 983.
Our findings are shown in this table:
[GRAPHIC] [TIFF OMITTED] TR18SE20.097
We also examined the claims data to identify cases reporting
procedure codes 0DB90ZZ, 0DBA0ZZ, and 0DBB0ZZ that are currently
grouping to MS-DRGs 987, 988 and 989. Our findings are shown in this
table:
[[Page 58539]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.098
We stated the results of our data analysis indicated that cases
reporting procedure codes 0DB90ZZ, 0DBA0ZZ, and 0DBB0ZZ describing the
open excision of a specific gastrointestinal body part in MS-DRGs 987,
988, and 989 generally have a longer length of stay and higher average
costs when compared to all the cases in their assigned MS-DRG. The
subset of cases reporting 0DB90ZZ, 0DBA0ZZ, and 0DBB0ZZ and the subset
of cases in MS-DRGs 981, 982 and 983 reporting 0DB80ZZ are more closely
aligned in terms of the lengths of stay and average costs. Further we
stated, our clinical advisors believed that, given the similarity in
resource use required for procedures describing an open excision of a
gastrointestinal body part in terms of the use of an operating room,
anesthesia and skills required, for clinical coherence and consistency
in assignment with ICD-10-PCS code 0DB80ZZ, it would be appropriate to
also designate ICD-10-PCS codes 0DB90ZZ, 0DBA0ZZ, and 0DBB0ZZ as
extensive O.R. procedures.
Therefore, we proposed to change the designation of ICD-10-PCS
codes 0DB90ZZ, 0DBA0ZZ and 0DBB0ZZ from non-extensive O.R. procedures
to extensive O.R. procedures for FY 2021. Under this proposal, cases
reporting procedure codes 0DB90ZZ, 0DBA0ZZ and 0DBB0ZZ, which are
unrelated to the MDC to which the case would otherwise be assigned
based on the principal diagnosis, will group to MS-DRGs 981, 982 and
983.
Comment: A commenter supported our proposal to change the
designation of the three procedure codes so that when cases reporting
procedure codes 0DB90ZZ, 0DBA0ZZ and 0DBB0ZZ, which are unrelated to
the MDC to which the case would otherwise be assigned based on the
principal diagnosis, will group to MS-DRGs 981, 982 and 983 instead of
MS-DRGs 987, 988, and 989.
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 ICD-10-PCS codes
0DB90ZZ, 0DBA0ZZ and 0DBB0ZZ from non-extensive O.R. procedures to
extensive O.R. procedures, effective October 1, 2020.
11. Operating Room (O.R.) and Non-O.R. Issues
a. Background
Under the IPPS MS-DRGs (and former CMS MS-DRGs), we have a list of
procedure codes that are considered operating room (O.R.) procedures.
Historically, we developed this list using physician panels that
classified each procedure code based on the procedure and its effect on
consumption of hospital resources. For example, generally the presence
of a surgical procedure which required the use of the operating room
would be expected to have a significant effect on the type of hospital
resources (for example, operating room, recovery room, and anesthesia)
used by a patient, and therefore, these patients were considered
surgical. Because the claims data generally available do not precisely
indicate whether a patient was taken to the operating room, surgical
patients were identified based on the procedures that were performed.
Generally, if the procedure was not expected to require the use of the
operating room, the patient would be considered medical (non-O.R.).
Currently, each ICD-10-PCS procedure code has designations that
determine whether and in what way the presence of that procedure on a
claim impacts the MS-DRG assignment. First, each ICD-10-PCS procedure
code is either designated as an O.R. procedure for purposes of MS-DRG
assignment (``O.R. procedures'') or is not designated as an O.R.
procedure for purposes of MS-DRG assignment (``non-O.R. procedures'').
Second, for each procedure that is designated as an O.R. procedure,
that O.R. procedure is further classified as either extensive or non-
extensive. Third, for each procedure that is designated as a non-O.R.
procedure, that non-O.R. procedure is further classified as either
affecting the MS-DRG assignment or not affecting the MS-DRG assignment.
We refer to these designations that do affect MS-DRG assignment as
``non-O.R. affecting the MS-DRG.'' For new procedure codes that have
been finalized through the ICD-10 Coordination and Maintenance
Committee meeting process and are proposed to be classified as O.R.
[[Page 58540]]
procedures or non-O.R. procedures affecting the MS-DRG, our clinical
advisors recommend the MS-DRG assignment which is then made available
in association with the proposed rule (Table 6B.--New Procedure Codes)
and subject to public comment. These proposed assignments are generally
based on the assignment of predecessor codes or the assignment of
similar codes. For example, 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 to be newly designated as O.R. procedures. As discussed in
section II.E.13. of the preamble of this final rule, we are making
Table 6B.--New Procedure Codes--FY 2021 available on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. We also refer readers to the ICD-10 MS-
DRG Version 37 Definitions Manual at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html for detailed information regarding
the designation of procedures as O.R. or non-O.R. (affecting the MS-
DRG) in Appendix E--Operating Room Procedures and Procedure Code/MS-DRG
Index. In the FY 2020 IPPS/LTCH PPS proposed rule, we stated that,
given the long period of time that has elapsed since the original O.R.
(extensive and non-extensive) and non-O.R. designations were
established, the incremental changes that have occurred to these O.R.
and non-O.R. procedure code lists, and changes in the way inpatient
care is delivered, we plan to conduct a comprehensive, systematic
review of the ICD-10-PCS procedure codes. This will be a multi-year
project during which we will also review the process for determining
when a procedure is considered an operating room procedure. For
example, we may restructure the current O.R. and non-O.R. designations
for procedures by leveraging the detail that is now available in the
ICD-10 claims data. We refer readers to the discussion regarding the
designation of procedure codes in the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38066) where we stated that the determination of when a
procedure code should be designated as an O.R. procedure has become a
much more complex task. This is, in part, due to the number of various
approaches available in the ICD-10-PCS classification, as well as
changes in medical practice. While we have typically evaluated
procedures on the basis of whether or not they would be performed in an
operating room, we believe that there may be other factors to consider
with regard to resource utilization, particularly with the
implementation of ICD-10.
We discussed in the FY 2020 IPPS/LTCH PPS proposed rule that as a
result of this planned review and potential restructuring, procedures
that are currently designated as O.R. procedures may no longer warrant
that designation, and conversely, procedures that are currently
designated as non-O.R. procedures may warrant an O.R. type of
designation. We intend to consider the resources used and how a
procedure should affect the MS-DRG assignment. We may also consider the
effect of specific surgical approaches to evaluate whether to subdivide
specific MS-DRGs based on a specific surgical approach. We plan to
utilize our available MedPAR claims data as a basis for this review and
the input of our clinical advisors. As part of this comprehensive
review of the procedure codes, we also intend to evaluate the MS-DRG
assignment of the procedures and the current surgical hierarchy because
both of these factor into the process of refining the ICD-10 MS-DRGs to
better recognize complexity of service and resource utilization.
We will provide more detail on this analysis and the methodology
for conducting this review in future rulemaking. As we noted in the FY
2020 IPPS/LTCH PPS rulemaking, as we continue to develop our process
and methodology, as previously noted, we are soliciting recommendations
on other factors to consider in our refinement efforts to recognize and
differentiate consumption of resources for the ICD-10 MS-DRGs.
Therefore, in the FY 2021 proposed rule, we again solicited feedback on
what factors or criteria to consider in determining whether a procedure
is designated as an O.R. procedure in the ICD-10-PCS classification
system for future consideration. We stated commenters should submit
their recommendations to the following email address:
[email protected] by October 20, 2020.
In this FY 2021 IPPS/LTCH PPS final rule, we present a summation of
the comments we received in response to this discussion in the proposed
rule.
Comment: Several commenters supported CMS' plan to continue to
conduct the comprehensive, systematic review of the ICD-10-PCS codes
that includes a process for determining when a procedure is designated
as O.R. or Non-O.R. and acknowledged the magnitude of the potential
impact to significantly restructure MS-DRGs.
Response: We thank the commenters for their support and appreciate
their acknowledgement of the magnitude of this effort.
Comment: Two commenters stated that the public feedback they
submitted by November 1, 2019 in response to CMS' request for feedback
in the FY 2020 IPPS/LTCH PPS proposed rule was not stated in the FY
2021 IPPS/LTCH proposed rule.
Response: CMS appreciates the comments submitted in response to our
request for feedback in both the FY 2020 IPPS/LTCH PPS proposed rule
and in the FY 2021 IPPS/LTCH PPS proposed rule. While the comments
submitted by the November 1, 2019 deadline were not specifically
addressed in the FY 2021 IPPS/LTCH PPS proposed rule, feedback on what
factors and/or criteria to consider in determining whether a procedure
is designated as an O.R. procedure in the ICD-10-PCS classification
system will be included when we provide more detail on this analysis
and the methodology for conducting this comprehensive review in future
rulemaking.
Comment: Several commenters requested that CMS consider the drivers
of complexity and resource consumption surrounding the entire procedure
and not only O.R. charges. The commenters stated that while large
hospitals may have hybrid operating rooms or specialized procedure
rooms (for example, interventional radiology suites), many smaller
community hospitals may have multi-purpose O.R.s where the same room
may be used for invasive general surgeries as well as procedures that
may be performed in specialized procedure rooms in large hospitals. One
of these commenters provided an example of the complexity and resource
consumption of a procedure performed in a catheterization lab and
stated that O.R verses Non O.R. may not be the most critical
differentiator of resource consumption. Another commenter urged CMS to
consider the definition of a ``significant procedure'' as defined in
the Uniform Hospital Discharge Data Set (UHDDS) which states, ``A
significant procedure is one that is: Surgical in nature; carries a
procedural risk; carries an aesthetic risk; or requires specialized
training.'' This commenter stated that this definition does not include
whether an ``O.R.'' is required, but in many cases, the procedure
itself determines if it is ``surgical in nature'' and other procedures
that do not require an
[[Page 58541]]
``O.R.'' do require specialized training or carry risk.
Response: CMS appreciates the commenters' feedback and
recommendations as to factors to consider in evaluating O.R.
designations. As stated previously, we have typically evaluated
procedures on the basis of whether or not they would be performed in an
operating room. We agree with commenters and believe that there may be
other factors to consider with regard to resource utilization,
particularly with the implementation of ICD-10. As discussed in the
proposed rule, we are exploring alternatives on how we may restructure
the current O.R. and non-O.R. designations for procedures by leveraging
the detail that is now available in the ICD-10 claims data. We continue
to develop our process and methodology, and will provide more detail in
future rulemaking.
Comment: Several commenters suggested that CMS assemble an advisory
panel comprised of clinical, coding and financial stakeholders,
physician specialty societies and experts to review methodologies for
O.R. determination and that CMS should address procedures performed in
all settings as there may be variations based on geographical
differences, hospital size, resources and physician specialty
availability. Two commenters suggested that CMS allow sufficient time
for provider review and stated that thorough data analysis with
provider input is critical to allow for appropriate insight in provider
comments. These commenters stated that outside of the CMS noted
intentions for consideration, additional data for each ICD-10-PCS
procedure code should be provided so that a more thorough analysis can
be completed. One of these commenters further suggested revising the
October 20 deadline for submission of public comments if CMS could not
provide the additional data timely.
Response: CMS appreciates this feedback. While CMS has already
convened an internal workgroup comprised of clinicians, consultants,
coding specialists and other policy analysts, we look forward to
further collaboration with the industry. As discussed in section
II.D.1.b. of the preamble of the proposed rule, given the continued
increase in the number and complexity of the requested changes to the
MS-DRG classifications since the adoption of ICD-10 MS-DRGs, and in
order to consider as many requests as possible, more time is needed to
carefully evaluate the requested changes, analyze claims data, and
consider any proposed updates. Therefore, changing the deadline to
October 20th of each year would allow CMS the additional time for the
review and consideration of any proposed updates. However, as stated in
section II.E.1.b. of this final rule, we are maintaining the deadline
of November 1, 2020 for the submission of such requests for FY 2022.
Recognizing sufficient time is needed to provide feedback on what
factors or criteria to consider in determining whether a procedure
should be designated as an O.R. procedure in the ICD-10-PCS
classification system, we have provided opportunity for the public to
provide feedback beginning with the FY 2018 final rule and we continue
to solicit input. We encourage the public to submit comments on other
factors to consider in our refinement efforts to recognize and
differentiate consumption of resources for the ICD-10 MS-DRGs timely
for consideration. Once we are in a position to provide more detail on
this analysis and the methodology for conducting this comprehensive
review in future rulemaking, the public will again have the opportunity
to provide feedback.
In the FY 2021 IPPS/LTCH PPS proposed rule and this final rule, we
are addressing 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 this section of the rule we discuss the process
that was utilized for evaluating the requests that were received for FY
2021 consideration. For each procedure, our clinical advisors
considered--
Whether the procedure would typically require the
resources of an operating room;
Whether it is an extensive or a nonextensive procedure;
and
To which MS-DRGs the procedure should be assigned.
We note 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 in this
section of this rule. Instead, we only discuss MS-DRGs that require
explicitly adding the relevant procedure codes to the GROUPER logic in
order for those procedure codes to affect the MS-DRG assignment as
intended. In cases where we proposed to change the designation of
procedure codes from non-O.R. procedures 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.
In addition, cases that contain O.R. procedures will map to MS-DRG
981, 982, or 983 (Extensive O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-
DRG 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 this section of this rule.
For procedures that would not typically require the resources of an
operating room, our clinical advisors determined if the procedure
should affect the MS-DRG assignment.
As indicated in the proposed rule, we received several requests to
change the designation of specific ICD-10-PCS procedure codes from non-
O.R. procedures to O.R. procedures, or to change the designation from
O.R. procedures to non-O.R. procedures. In this section of this rule,
as we did in the proposed rule, we detail and respond to some of those
requests and, further, summarize and respond to the public comments we
received in response to our proposals, if applicable. With regard to
the remaining requests, as stated in the proposed rule, our clinical
advisors believe it is appropriate to consider these requests as part
of our comprehensive review of the procedure codes as previously
discussed.
b. O.R. Procedures to Non-O.R. Procedures
(1) Endoscopic Revision of Feeding Devices
One requestor identified three ICD-10-PCS procedure codes that
describe endoscopic revision of feeding devices, shown in the following
table.
[[Page 58542]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.099
In the ICD-10 MS-DRG Version 37 Definitions Manual, these three
ICD-10-PCS procedure codes are currently recognized as O.R. procedures
for purposes of MS-DRG assignment. The requestor noted that these
procedures would not require the resources of an operating room and
that they consume resources comparable to related ICD-10-PCS procedure
codes describing the endoscopic insertion of feeding tubes that
currently are designated as Non-O.R. procedures.
In the proposed rule, we stated that we agreed with the requestors
that these procedures do not typically require the resources of an
operating room, and are not surgical in nature. Therefore, we proposed
to remove 0DW08UZ, 0DW68UZ, and 0DWD8UZ from the FY 2021 ICD-10 MS-DRGs
Version 38 Definitions Manual in Appendix E--Operating Room Procedures
and Procedure Code/MS-DRG Index as O.R. procedures. We stated in the
proposed rule that, under this proposal, these procedures would no
longer impact MS-DRG assignment.
Comments: Commenters supported our proposal to designate ICD-10-PCS
procedure codes 0DW08UZ, 0DW68UZ, 0DWD8UZ as non-O.R. procedures. One
commenter specifically stated they believed that the endoscopic
revision of feeding devices does not typically require the resources of
an O.R. and can be safely performed in non-O.R. settings such as
interventional radiology or endoscopy suites.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of procedure codes
0DW08UZ, 0DW68UZ, and 0DWD8UZ from O.R. procedures to non-O.R.
procedures, effective October 1, 2020.
c. Non-O.R. Procedures to O.R. Procedures
(1) Percutaneous/Endoscopic Biopsy of Mediastinum
One requestor identified ICD-10-PCS procedure code 0WBC4ZX
(Excision of mediastinum, percutaneous endoscopic approach, diagnostic)
that describes a percutaneous endoscopic biopsy of the mediastinum that
the requestor stated is performed in the operating room under general
anesthesia, requires an incision through the chest wall, insertion of a
mediastinoscope in the space between the lungs and involves removal of
a tissue sample. The requestor recommended that all procedures
performed within the mediastinum by an open or percutaneous endoscopic
approach, regardless of whether it is a diagnostic or therapeutic
procedure, should be designated as O.R. procedures because the
procedures require great skill and pose risks to patients due to the
structures contained within the mediastinum. The requestor noted that
the mediastinum contains loose connective tissue, the heart and great
vessels, esophagus, trachea, nerves, and lymph nodes. The requestor
further noted that redesignating these procedures from non-O.R. to O.R.
would provide compensation for operating room resources and general
anesthesia.
We note that under the ICD-10-PCS procedure classification, biopsy
procedures are identified by the 7th digit qualifier value
``diagnostic'' in the code description. In response to the requestor's
suggestion that all procedures performed within the mediastinum by an
open or percutaneous endoscopic approach, regardless of whether it is a
diagnostic or therapeutic procedure should be designated as an O.R.
procedure, we examined the following procedure codes:
[GRAPHIC] [TIFF OMITTED] TR18SE20.100
In the ICD-10 MS-DRGs Definitions Manual Version 37, procedure
codes 0WBC0ZX, 0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ are currently designated
as O.R. procedures, however, procedure codes 0WBC3ZX and 0WBC4ZX are
not recognized as O.R. procedures for purposes of MS-DRG assignment. We
stated in the proposed rule that we agree with the requestor that
procedure code 0WBC4ZX would typically require the resources of an
operating room. We further stated that our clinical advisors also agree
that procedure code 0WBC3ZX would typically require the resources of an
operating room. Therefore, we proposed to add these 2 procedure codes
to the FY 2021 ICD-10 MS-DRGs Version 38 Definitions Manual in Appendix
E- Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures, assigned to MS-DRGs 166, 167 and 168 (Other Respiratory
System O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 04 (Diseases and Disorders of the Respiratory
[[Page 58543]]
System); MS-DRGs 628, 629, and 630 (Other Endocrine, Nutritional and
Metabolic O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 10 (Endocrine, Nutritional and Metabolic Diseases
and Disorders); MS-DRGs 820, 821, and 822 (Lymphoma and Leukemia with
Major O.R. Procedure with MCC, with CC, and without CC/MCC,
respectively) and 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
(Myeloproliferative Diseases and Disorders, Poorly Differentiated
Neoplasms); and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R.
Procedure Unrelated to Principal Diagnosis with MCC, with CC and
without MCC/CC, respectively).
As previously noted, procedure codes 0WBC0ZX, 0WBC0ZZ, 0WBC3ZZ, and
0WBC4ZZ are currently designated as O.R. procedures. As displayed in
the FY 2020 ICD-10 MS-DRGs Version 37 Definitions Manual in Appendix E-
Operating Room Procedures and Procedure Code/MS-DRG Index, these
procedure codes are assigned to several MS-DRGs across many MDCs.
During our process of reviewing potential MDC and MS-DRG assignments
for procedure codes 0WBC3ZX and 0WBC4ZX, our clinical advisors
recommended that we reassign procedure codes 0WBC0ZZ, 0WBC3ZZ, and
0WBC4ZZ from their current MS-DRG assignments in MDC 04 (Diseases and
Disorders of the Respiratory System). Procedure codes 0WBC0ZZ, 0WBC3ZZ,
and 0WBC4ZZ are currently assigned to MS-DRGs 163, 164, and 165 (Major
Chest Procedures with MCC, with CC, and without CC/MCC, respectively)
and procedure code 0WBC0ZX is assigned to MS-DRGs 166, 167 and 168
(Other Respiratory System O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively). We stated in the proposed rule that
according to our clinical advisors, procedure codes 0WBC0ZZ, 0WBC3ZZ,
and 0WBC4ZZ would be more appropriately and clinically aligned with the
same MS-DRG assignment as procedure code 0WBC0ZX, which is also
consistent with the assignment for other procedures performed on the
mediastinum. Therefore, we proposed to reassign procedure codes
0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ to MS-DRGs 166, 167 and 168 (Other
Respiratory System O.R. Procedures with MCC, with CC, and without CC/
MCC, respectively).
Comment: Commenters supported the proposal to reclassify ICD-10-PCS
procedure codes 0WBC4ZX (Excision of mediastinum, percutaneous
endoscopic approach, diagnostic) and 0WBC3ZX (Excision of mediastinum,
percutaneous approach, diagnostic) as O.R. procedures for the purposes
of MS-DRG assignment for FY 2021. A commenter stated their belief that
surgeries performed within the mediastinum by an open or percutaneous
endoscopic approach, regardless of whether it is a diagnostic or
therapeutic procedure, typically require the resources of the O.R. to
control for possible damage to the structures contained within the
mediastinum, including loose connective tissue, the heart and great
vessels, esophagus, trachea, nerves, and lymph nodes. The commenter
noted that the invasive nature of these procedures also necessitates
the sterile environment of an O.R. to limit the risk of secondary
infection.
Commenters also supported the proposal to reassign procedure codes
0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ from MS-DRGs 163, 164, and 165 to MS-DRGs
166, 167, and 168. However, a couple commenters did not agree with the
proposal and stated that the open, percutaneous, and endoscopic
therapeutic mediastinal excisions should remain distinct from the
diagnostic mediastinal procedures. The commenters noted that while the
approaches of the procedures are the same, the time, risk and resource
utilization is different for the therapeutic and diagnostic procedures.
The commenters stated that diagnostic procedures require only a small
mediastinal resection, more specifically an incisional biopsy, for
diagnostic purposes while the therapeutic mediastinal resection
involves the complete resection of large tumors, cysts or masses that
may be malignant or benign juxtaposed to critical mediastinal
structures. In addition, the commenters reported that therapeutic
mediastinal resections will often require more time in the O.R.,
slightly longer lengths of stay, and more post-operative care due to
the invasive nature of the procedures.
Response: We appreciate the commenters' feedback on the proposal to
reclassify ICD-10-PCS procedure codes 0WBC4ZX and 0WBC3ZX as O.R.
procedures for the purposes of MS-DRG assignment and on the proposal to
reassign procedure codes 0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ from MS-DRGs
163, 164, and 165 to MS-DRGs 166, 167, and 168. In response to the
commenters who did not agree with the proposal to reassign procedure
codes 0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ from MS-DRGs 163, 164, and 165 to
MS-DRGs 166, 167, and 168, as noted by the commenters, the approaches
of the therapeutic and diagnostic procedures are the same, however our
clinical advisors did not agree that the time, risk and resource
utilization are necessarily different for the therapeutic and
diagnostic procedures.
While the commenters' asserted that therapeutic mediastinal
procedures will often require more time in the O.R., slightly longer
lengths of stay, and more post-operative care due to the invasive
nature of the procedures, our analysis of claims data found that the
average length of stay and the average costs for the diagnostic
procedures were greater than those of the therapeutic procedures. We
examined data from the September 2019 update of the FY 2019 MedPAR data
for both diagnostic and therapeutic mediastinal excision procedures
across all MS-DRGs. Our findings are shown in the table below.
[[Page 58544]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.101
As shown in the table, there were a total of 1,141 cases reporting
a diagnostic excision of mediastinum procedure with an average length
of stay of 8.2 days and average costs of $21,279 and a total of 291
cases reporting a therapeutic excision of mediastinum procedure with an
average length of stay of 4.3 days and average costs of $17,267. Our
clinical advisors maintain that therapeutic and diagnostic procedures
involving excision of the mediastinum are clinically aligned and should
be grouped together. However, as noted in prior rule making (84 FR
42148), our clinical advisors recognize that MS-DRGs 163, 164, 165,
166, 167, and 168 may warrant further review and therefore, we plan to
begin this more detailed review beginning with our FY 2022 MS-DRG
classification analysis of claims data and determine what modifications
may need to be considered for future rulemaking.
After consideration of the public comments we received, we are
finalizing our proposal to add procedure codes 0WBC4ZX and 0WBC3ZX as
O.R. procedures to the FY 2021 ICD-10 MS-DRGs Version 38 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index as O.R. procedures, assigned to MS-DRGs 166, 167, and 168
(Other Respiratory System O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively) in MDC 04 (Diseases and Disorders of the
Respiratory System); MS-DRGs 628, 629, and 630 (Other Endocrine,
Nutritional and Metabolic O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively) in MDC 10 (Endocrine, Nutritional and
Metabolic Diseases and Disorders); MS-DRGs 820, 821, and 822 (Lymphoma
and Leukemia with Major O.R. Procedure with MCC, with CC, and without
CC/MCC, respectively) and 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
(Myeloproliferative Diseases and Disorders, Poorly Differentiated
Neoplasms); and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R.
Procedure Unrelated to Principal Diagnosis with MCC, with CC and
without MCC/CC, respectively). We are also finalizing our proposal to
reassign procedure codes 0WBC0ZZ, 0WBC3ZZ, and 0WBC4ZZ from MS-DRGs
163, 164, and 165 to MS-DRGs 166, 167, and 168, effective FY 2021.
One requestor identified ICD-10-PCS procedure code 3E0L4GC
(Introduction of other therapeutic substance into pleural cavity,
percutaneous endoscopic approach) that the requestor stated is
currently not recognized as an O.R. procedure for purposes of MS-DRG
assignment. The requestor noted that talc pleurodesis via video-
assisted thoracoscopic surgery (VATS), involves placing a thoracoscope
through the chest wall for visualization, then placing a port and
injecting talc, doxycycline, or other chemical into the pleural cavity
under general anesthesia and should therefore be recognized as an O.R.
procedure for purposes of MS-DRG assignment.
We stated in the proposed rule that we agreed with the requestor
that ICD-10-PCS procedure code 3E0L4GC typically requires the resources
of an operating room. We also note that the AHA published Coding Clinic
advice in 2015 that instructed to code both ICD-10-PCS procedure codes
0BJQ4ZZ (Inspection of pleura, percutaneous endoscopic approach) and
3E0L3GC (Introduction of other therapeutic substance into pleural
cavity, percutaneous approach) for thoracoscopic chemical pleurodesis.
In the publication, code 0BJQ4ZZ, recognized as an O.R. procedure for
purposes of MS-DRG assignment, was instructed to be reported for the
video-assisted thoracoscopic portion of the procedure since the
endoscopic component of the procedure could not be captured by the
approach values available at the time. In FY 2018, the approach value
``4'' Percutaneous Endoscopic was added to the root operation
Introduction table 3E0, to capture percutaneous endoscopic
administration of a therapeutic substance, meaning that code 0BJQ4ZZ
was no longer needed along with code 3E0L3GC to report thoracoscopic
chemical pleurodesis. Only code 3E0L4GC is needed to report all
components of the procedure. Designating code 3E0L4GC as an O.R.
procedure for purposes of MS-DRG assignment classifies the procedure as
intended when two codes were needed to fully code the procedure.
Therefore, we proposed to add procedure code 3E0L4GC to the FY 2021
ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating
Room Procedures and Procedure Code/MS-DRG Index as an O.R. procedure
assigned to MS-DRGs 166, 167, and 168 (Other Respiratory System O.R.
procedures with MCC, CC, without CC/MCC, respectively) in MDC 04
(Diseases and Disorders of the Respiratory System); and MS-DRG 264
(Other Circulatory System O.R. Procedures) in MDC 05 (Diseases and
Disorders of the Circulatory System).
Comments: Commenters supported our proposal to designate ICD-10-PCS
procedure code 3E0L4GC as an O.R. procedure. A commenter noted that
[[Page 58545]]
since code 0BJQ4ZZ, Inspection of pleura, percutaneous endoscopic
approach, is no longer necessary as an additional code to capture the
endoscopic component of the procedure it makes sense for code 3E0L4GC
to be designated as an O.R. procedure.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of procedure code
3E0L4GC from non-O.R. procedure to O.R. procedure, effective October 1,
2020.
(3) Percutaneous Endoscopic Excision of Stomach
One requestor identified ICD-10-PCS procedure code 0DB64ZZ
(Excision of stomach, percutaneous endoscopic approach) that the
requestor stated is currently not recognized as an O.R. procedure for
purposes of MS-DRG assignment. The requestor noted that percutaneous
endoscopic excisions of gastric lesions and percutaneous endoscopic
partial gastrectomies are performed in the operating room under general
anesthesia, use comparable resources, and are designated as O.R.
procedures. Therefore, the requestor stated that this procedure should
also be recognized as O.R. procedure for purposes of MS-DRG assignment.
We stated in the proposed rule that we agreed with the requestor
that ICD-10-PCS procedure code 0DB64ZZ typically requires the resources
of an operating room. During our review, we also noted that ICD-10-PCS
code 0DB64ZX (Excision of stomach, percutaneous endoscopic approach,
diagnostic) was not currently recognized as an O.R. procedure. We
proposed to add these codes to the FY 2021 ICD-10 MS-DRG Version 38
Definitions Manual in Appendix E--Operating Room Procedures and
Procedure Code/MS-DRG Index as O.R. procedures assigned to MS-DRGs 326,
327, and 328 (Stomach, Esophageal and Duodenal Procedures with MCC,
with CC, and without CC/MCC, respectively) in MDC 06 (Diseases and
Disorders of the Digestive System); MS-DRGs 619, 620, and 621
(Procedures for Obesity with MCC, with CC, and without CC/MCC,
respectively) in MDC 10 (Endocrine, Nutritional and Metabolic Diseases
and Disorders); and MS-DRGs 820, 821, and 822 (Lymphoma and Leukemia
with Major Procedure with MCC, with CC, and without CC/MCC,
respectively), MS-DRGs 826, 827, and 828 (Myeloproliferative Disorders
or Poorly Differentiated Neoplasms with Major Procedure with MCC, with
CC, and without CC/MCC, respectively), and MS-DRGs 829 and 830
(Myeloproliferative Disorders or Poorly Differentiated Neoplasms with
Other Procedure with CC/MCC and without CC/MCC, respectively) in MDC 17
(Myeloproliferative Diseases and Disorders, Poorly Differentiated
Neoplasms).
Comments: Many commenters supported our proposal. One commenter
specifically stated they concurred with the requestor's statement that
similar procedures such as percutaneous endoscopic excisions of gastric
lesions and percutaneous endoscopic partial gastrectomies are currently
classified as O.R. procedures, and that the two listed stomach excision
codes should be designated as O.R. procedures due to comparable costs
and resource use. This commenter also stated they believed that the
invasive nature of such procedures also necessitates the sterile
environment of an O.R. to limit the risk of secondary infection.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of procedure codes
0DB64ZZ and 0DB64ZX from non-O.R. procedures to O.R. procedures,
effective October 1, 2020.
As discussed in the proposed rule, during our review, we also noted
that ICD-10-PCS procedure code 0DB64Z3 (Excision of stomach,
percutaneous endoscopic approach, vertical (sleeve)), which is
clinically similar to ICD-10-PCS codes 0DB64ZZ and 0DB64ZX, is
designated as an O.R. procedure assigned to the same MS-DRGs as we
proposed for ICD-10-PCS codes 0DB64ZZ and 0DB64ZX, as well as to MS-DRG
264 (Other Circulatory System O.R. Procedures) in MDC 05 (Diseases and
Disorders of the Circulatory System); 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 stated our
clinical advisors believe that principal diagnoses in MDCs 05 and 21
are typically not indications for procedures describing percutaneous
endoscopic excision of stomach and that ICD-10-PCS procedure code
0DB64Z3 should be assigned to the same MS-DRGs as ICD-10-PCS codes
0DB64ZZ and 0DB64ZX.
We examined claims data from the September 2019 update of the FY
2019 MedPAR file to determine if there were any cases that reported
0DB64Z3 and were assigned to MDC 05, MDC 21, or MDC 24. The following
table shows our findings:
[GRAPHIC] [TIFF OMITTED] TR18SE20.102
[[Page 58546]]
We found zero cases in MS-DRGs 957, 958, and 959 reporting 0DB64Z3
and a principal diagnosis in MDC 24 (Multiple Significant Trauma). We
stated our analysis demonstrated that diagnoses assigned to MDC 05, MDC
21, and MDC 24 are not typically corrected surgically by percutaneous
endoscopic vertical (sleeve) gastrectomy given the small number of
cases reporting this procedure in these MDCs. We also stated our
clinical advisors believe procedure codes describing the percutaneous
endoscopic excision of stomach should have the same MDC assignments in
the ICD-10 MS-DRGs Version 38 for coherence. Therefore, we proposed to
remove the assignments of code 0DB64Z3 from MS-DRG 264 (Other
Circulatory System O.R. Procedures) in MDC 05 (Diseases and Disorders
of the Circulatory System); 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).
Comments: Commenters supported our proposal and stated they agreed
that diagnoses assigned to MDC 05 (Diseases and Disorders of the
Circulatory System), MDC 21 (Injuries, Poisonings and Toxic Effects of
Drugs), and MDC 24 (Multiple Significant Trauma) are not typically
corrected surgically by percutaneous endoscopic vertical (sleeve)
gastrectomy, and that procedure codes describing the percutaneous
endoscopic excision of stomach should all be assigned to the same MDCs.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to remove the assignments of code 0DB64Z3 from
MS-DRG 264 (Other Circulatory System O.R. Procedures) in MDC 05
(Diseases and Disorders of the Circulatory System); 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), effective
October 1, 2020.
Lastly, we stated while we were reviewing this request, we noted
inconsistencies in how procedures involving the excision of stomach are
designated. Excision of stomach codes differ by approach and qualifier.
ICD-10-PCS procedure codes describing excision of stomach with similar
approaches have been assigned different attributes in terms of
designation as an O.R. or Non-O.R. procedure. We identified the
following five related codes:
[GRAPHIC] [TIFF OMITTED] TR18SE20.103
As discussed in the proposed rule, in the ICD-10 MS-DRGs Version
37, these ICD-10-PCS codes are currently recognized as O.R. procedures
for purposes of MS-DRG assignment, while similar excision of stomach
procedure codes with the same approach but different qualifiers are
recognized as Non-O.R. procedures. We stated our clinical advisors
indicated that these procedures are not surgical in nature and do not
require an incision. Therefore, we proposed to remove ICD-10-PCS
procedure codes 0DB63Z3, 0DB63ZZ, 0DB67Z3, 0DB67ZZ, and 0DB68Z3 from
the FY 2021 ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--
Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures. Under this proposal, these procedures would no longer
impact MS-DRG assignment.
Comments: Commenters opposed our proposal. A few commenters noted
that the five procedure codes describing excision of stomach listed are
similar in nature to procedure codes 0DB64ZZ and 0DB64ZX that describe
percutaneous endoscopic excisions of the stomach, which CMS proposed to
change from non-O.R. procedures to O.R. procedures. One commenter also
stated that procedure codes describing excision of stomach via
percutaneous approach or excision of stomach via percutaneous
endoscopic approach should have the same O.R. procedure designation.
Response: We appreciate the comments and concerns raised on our
proposal.
Our clinical advisors continue to indicate that these procedures
are not surgical in nature and do not require an incision however,
after acknowledging the concerns raised by commenters, believe it would
be appropriate to take additional time to review the inconsistencies in
how procedures involving the excision of stomach are designated.
Therefore, after consideration of public comments, we are not
finalizing our proposal to remove ICD-10-PCS procedure codes 0DB63Z3,
0DB63ZZ, 0DB67Z3, 0DB67ZZ, and 0DB68Z3 from the FY 2021 ICD-10 MS-DRG
Version 38 Definitions Manual in Appendix E--Operating Room Procedures
and Procedure Code/MS-DRG Index as O.R. procedures. Accordingly, these
procedures will continue to impact MS-DRG assignment under the ICD-10
MS-DRGs Version 38, effective October 1, 2020.
(4) Percutaneous Endoscopic Drainage
One requestor identified six ICD-10-PCS procedure codes that
describe procedures involving laparoscopic drainage of peritoneum,
peritoneal cavity, and gallbladder that the requestor stated are
currently not recognized as O.R. procedures for purposes of MS-DRG
assignment. The six procedure codes are listed in the following table:
[[Page 58547]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.104
The requestor stated these procedures would commonly be performed
under general anesthesia and require the resources of an operating
room. The requestor also noted that similar procedures such as
percutaneous endoscopic inspection of gallbladder, percutaneous
endoscopic excision of peritoneum and percutaneous endoscopic
extirpation of matter from peritoneal cavity are currently classified
as O.R. procedures in Version 37 of the ICD-10 MS-DRGs and that the six
listed procedure codes should be designated as O.R. procedures due to
comparable costs and resource use.
We stated in the proposed rule that we agreed with the requestor
that the six ICD-10-PCS procedure codes listed in the table typically
require the resources of an operating room. Therefore, to the FY 2021
ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating
Room Procedures and Procedure Code/MS-DRG Index, we proposed to add
codes 0D9W4ZZ and 0D9W40Z as O.R. procedures assigned to MS-DRGs 356,
357, and 358 (Other Digestive System O.R. Procedures, with MCC, with
CC, and without CC/MCC, respectively) in MDC 06 (Diseases and Disorders
of the Digestive System); and 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). We also proposed to add codes 0W9G4ZZ and 0W9G40Z as O.R.
procedures assigned to MS-DRGs 356, 357, and 358 (Other Digestive
System O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 06 (Diseases and Disorders of the Digestive
System); MS-DRGs 420, 421, and 422 (Hepatobiliary Diagnostic
Procedures, with MCC, with CC, and without CC/MCC, respectively) in MDC
07 (Diseases and Disorders of the Hepatobiliary System and Pancreas);
MS-DRGs 673, 674, and 675 (Other Kidney and Urinary Tract Procedures,
with MCC, with CC, and without CC/MCC, respectively) in MDC 11
(Diseases and Disorders of the Kidney and Urinary Tract); MS-DRGs 749
and 750 (Other Female Reproductive System Procedures with and without
CC/MCC, respectively) in MDC 13 (Diseases and Disorders of the Female
Reproductive System); MS-DRGs 802, 803, and 804 (Other O.R. Procedures
of the Blood and Blood Forming Organs, with MCC, with CC, and without
CC/MCC, respectively) in MDC 16 (Diseases and Disorders of Blood, Blood
Forming Organs, Immunologic Disorders); MS-DRGs 820, 821, and 822
(Lymphoma and Leukemia with Major Procedure with MCC, with CC, and
without CC/MCC, respectively) and MS-DRGs 826, 827, and 828
(Myeloproliferative Disorders or Poorly Differentiated Neoplasms with
Major Procedure with MCC, with CC, and without CC/MCC, respectively) in
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly
Differentiated Neoplasms); and 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). Lastly, we proposed to add codes 0F944ZZ and 0F9440Z as O.R.
procedures assigned to MS-DRGs 408, 409, and 410 (Biliary Tract
Procedures Except Only Cholecystectomy with or without C.D.E., with
MCC, with CC, and without CC/MCC, respectively) in MDC 07 (Diseases and
Disorders of the Hepatobiliary System and Pancreas).
Comments: Commenters supported our proposal. One commenter stated
they concurred with the requestor's statement that similar procedures
such as percutaneous endoscopic inspection of gallbladder, percutaneous
endoscopic excision of peritoneum and percutaneous endoscopic
extirpation of matter from peritoneal cavity are currently classified
as O.R. procedures, and that the six listed procedure codes should be
designated as O.R. procedures due to comparable costs and resource use.
The commenter also stated they believed that the invasive nature of
such procedures also necessitates the sterile environment of an O.R. to
limit the risk of secondary infection. Other commenters stated they
agreed all ICD-10-PCS procedure codes describing procedures involving
laparoscopic drainage of peritoneum, peritoneal cavity, or gallbladder
should be designated as 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 ICD-10-PCS
procedure codes 0D9W4ZZ, 0D9W40Z, 0W9G4ZZ 0W9G40Z, 0F944ZZ and 0F9440Z
from non-O.R. procedures to O.R. procedures, effective October 1, 2020.
As discussed in the proposed rule, during our review of this
request, we identified related ICD-10-PCS procedure code 0F944ZX
(Drainage of gallbladder, percutaneous endoscopic approach, diagnostic)
that is also currently not recognized as an O.R. procedure for purposes
of MS-DRG assignment. We stated that our clinical advisors believe that
similar to the six procedure codes submitted by the requester, this
procedure typically requires the resources of an operating room and
should have the same attributes in Version 38 for coherence. Therefore,
we proposed to add code 0F944ZX as an O.R. procedure assigned to MS-
DRGs 420, 421 and 422 (Hepatobiliary Diagnostic Procedures, with MCC,
with CC, and without CC/MCC, respectively) in MDC 07 (Diseases and
Disorders of the Hepatobiliary System and Pancreas) to the FY 2021 ICD-
10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating Room
Procedures and Procedure Code/MS-DRG Index.
Comments: Commenters supported our proposal and as previously
mentioned stated they agreed all ICD-10-PCS procedure codes describing
procedures involving laparoscopic drainage of the peritoneum,
peritoneal cavity, or gallbladder should be designated as O.R.
procedures.
Response: We appreciate the commenters' support.
[[Page 58548]]
After consideration of the public comments we received, we are
finalizing our proposal to change the designation of 0F944ZX from non-
O.R. procedure to O.R. procedure, effective October 1, 2020.
In the proposed rule, we stated during our review, we also
identified the related ICD-10-PCS procedure codes 0F940ZZ (Drainage of
gallbladder, open approach), 0F940ZX (Drainage of gallbladder, open
approach, diagnostic) and 0F9400Z (Drainage of gallbladder with
drainage device, open approach). Our analysis found that the ICD-10-PCS
codes describing drainage of gallbladder have dissimilar MDC
assignments. Procedure codes 0F940ZZ and 0F940ZX are currently assigned
to MS-DRGs 356, 357, and 358 (Other Digestive System O.R. Procedures,
with MCC, with CC, and without CC/MCC, respectively) in MDC 06
(Diseases and Disorders of the Digestive System) and MS-DRGs 408, 409,
and 410 (Biliary Tract Procedures Except Only Cholecystectomy with or
without C.D.E, with MCC, with CC, and without CC/MCC, respectively) in
MDC 07 (Diseases and Disorders of the Hepatobiliary System and
Pancreas). However, ICD-10-PCS procedure code 0F9400Z is currently
assigned to MS-DRGs 408, 409, and 410 (Biliary Tract Procedures Except
Only Cholecystectomy with or without C.D.E, with MCC, with CC, and
without CC/MCC, respectively) in MDC 07 (Diseases and Disorders of the
Hepatobiliary System and Pancreas) alone. We stated our clinical
advisors believe that principal diagnoses in MDC 06 are typically not
indications for procedures describing the drainage of gallbladder. We
examined claims data from the September 2019 update of the FY 2019
MedPAR file to determine if there were any cases that reported
procedure codes 0F940ZZ or 0F940ZX and were assigned to MDC 06. We
found zero cases in MS-DRGs 356, 357, and 358 reporting code 0F944ZZ or
0F940ZX and a principal diagnosis in MDC 06 (Diseases and Disorders of
the Digestive System), demonstrating that diagnoses in MDC 06 are not
typically corrected surgically by drainage of the gallbladder. Our
clinical advisors believe procedure codes describing the drainage of
gallbladder should have the same MDC assignments in Version 38 for
coherence. Therefore, we proposed to remove procedure codes 0F940ZZ and
0F940ZX from MS-DRGs 356, 357, and 358 in MDC 06 (Diseases and
Disorders of the Digestive System).
Comments: Commenters supported our proposal and stated they agreed
that procedure codes describing the drainage of the gallbladder should
be assigned to the same MDC.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to remove procedure codes 0F940ZZ and 0F940ZX
from MS-DRGs 356, 357, and 358 in MDC 06 (Diseases and Disorders of the
Digestive System), effective October 1, 2020.
As stated in the proposed rule, our further analysis of this
request identified the nine ICD-10-PCS codes in the following table
describing drainage of the peritoneum, peritoneal cavity, or
gallbladder:
[GRAPHIC] [TIFF OMITTED] TR18SE20.105
We noted that these procedures are currently classified as
extensive O.R. procedures. Our clinical advisors have noted that
treatment practices have shifted since the initial O.R. procedure
designations. We stated our clinical advisors believe that, given the
similarity in factors such as complexity, resource utilization, and
requirement for anesthesia administration between procedures describing
the drainage of the peritoneum, peritoneal cavity, and gallbladder, it
would be more appropriate to designate these nine ICD-10-PCS codes as
non-extensive O.R. procedures. Therefore, we also proposed to change
the designation of ICD-10-PCS codes 0D9W00Z, 0D9W0ZX, 0D9W0ZZ, 0D9W4ZX,
0W9G00Z, 0W9G0ZZ, 0F9400Z, 0F940ZZ and 0F940ZX from extensive O.R.
procedures to non-extensive O.R. procedures for FY 2021.
Comment: A commenter supported our proposal to designate the nine
ICD-10-PCS codes describing drainage of the peritoneum, peritoneal
cavity, or gallbladder that are currently classified as extensive O.R.
procedures as non-extensive O.R. procedures.
Response: We appreciate the commenter's support.
Comment: One commenter opposed CMS' proposal and stated location
should be factored in. The commenter stated the designation of these
procedures should differ depending if the procedure was performed in an
operating room versus a radiology suite versus a procedure room. The
commenter also stated procedures performed via an open approach should
be designated as extensive O.R. procedures and procedures performed via
a percutaneous endoscopic approach should be designated as non-
extensive O.R. procedures. This same commenter specifically opposed
changing the designation of procedure codes that describe the open
drainage of the peritoneal cavity from extensive O.R. to non-extensive
O.R. procedure and believed the designation should depend on how deep
the open drainage incision site is.
Response: We do not agree that unilaterally all open procedures
should be designated as extensive O.R. procedures and procedures
performed laparoscopically should be designated
[[Page 58549]]
as non-extensive O.R. procedures. While the site in which the procedure
is performed and the procedural approach are important considerations
in the designation of a procedure, there are other clinical factors
such as procedure complexity, resource utilization, and need for
anesthesia administration that should also be considered. In this
regard, our clinical advisors believe the nine ICD-10-PCS codes that
describe the drainage of the peritoneum, peritoneal cavity, and
gallbladder, regardless of approach, are generally less complex than
other procedures designated as extensive O.R. procedures.
Also, we are not clear what the commenter means when they state
that ``the designation of procedure codes describing the open drainage
of the peritoneum should depend on how deep the open drainage incision
site is''. The peritoneum is defined as the smooth transparent serous
membrane that lines the cavity of the abdomen. Procedure codes for the
open drainage of the peritoneum are used to describe any procedure
where the skin or mucous membrane and any other body layers necessary
to expose the peritoneum are cut through to take or let out fluid and/
or gases. Any anatomical differences from patient to patient that might
factor into the technical complexity of the procedure, such as habitus,
would be captured in the ICD-10-CM diagnosis coding.
In the absence of a compelling clinical rationale for maintaining
the designation of these procedures as extensive O.R. procedures, our
clinical advisors continue to believe that, given the similarity in
factors such as complexity, resource utilization, and requirement for
anesthesia administration between procedures describing the drainage of
the peritoneum, peritoneal cavity, and gallbladder, it would be more
appropriate to designate these nine ICD-10-PCS codes as non-extensive
O.R. procedures. Therefore, after consideration of the public comments
we received, we are finalizing our proposal to change the designation
of ICD-10-PCS codes 0D9W00Z, 0D9W0ZX, 0D9W0ZZ, 0D9W4ZX, 0W9G00Z,
0W9G0ZZ, 0F9400Z, 0F940ZZ and 0F940ZX from extensive O.R. procedures to
non-extensive O.R. procedures, effective October 1, 2020.
(5) Control of Bleeding
One requestor identified ICD-10-PCS procedure code 0W3G0ZZ (Control
bleeding in peritoneal cavity, open approach) that describes a
procedure in which the bleeding source within the peritoneal cavity is
controlled by cautery, clips, and/or suture through an open abdominal
incision with direct visualization of the surgical site, that the
requestor stated requires the resources of an operating room and
general anesthesia but is currently not recognized as an O.R. procedure
for purposes of MS-DRG assignment. The requestor also noted that ICD-
10-PCS procedure codes 0W3F0ZZ (Control bleeding in abdominal wall,
open approach), 0W3H0ZZ (Control bleeding in retroperitoneum, open
approach), and 0W3J0ZZ (Control bleeding in pelvic cavity, open
approach) describe procedures to control bleeding in various anatomic
sites and are currently classified as O.R. procedures.
We stated in the proposed rule that we agree with the requestor
that it would be clinically appropriate to redesignate procedure code
0W3G0ZZ as an O.R. procedure consistent with procedure codes 0W3F0ZZ,
0W3H0ZZ and 0W3J0ZZ, that also describe procedures performed to control
bleeding and are designated as O.R. procedures. Therefore, we proposed
to add procedure code 0W3G0ZZ to the FY 2021 ICD-10 MS-DRG Version 38
Definitions Manual in Appendix E--Operating Room Procedures and
Procedure Code/MS-DRG Index as an O.R. procedure assigned to MS-DRG 264
(Other Circulatory O.R. Procedures) in MDC 05 (Diseases and Disorders
of the Circulatory System); MS-DRGs 356, 357, and 358 (Other Digestive
System O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 06 (Diseases and Disorders of the Digestive
System); MS-DRGs 423, 424, and 425 (Other Hepatobiliary or Pancreas
O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in
MDC 07 (Diseases and Disorders of the Hepatobiliary System and
Pancreas); MS-DRGs 673, 674, and 675 (Other Kidney and Urinary Tract
Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC
11 (Diseases and Disorders of the Kidney and Urinary Tract); MS-DRGs
820, 821, and 822 (Lymphoma and Leukemia with Major O.R. Procedure with
MCC, with CC, and without CC/MCC, respectively), 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), and MS-DRGs 829 and 830 (Myeloproliferative Disorders or
Poorly Differentiated Neoplasms with Other Procedure with and without
CC/MCC, respectively) in MDC 17 (Myeloproliferative Diseases and
Disorders, Poorly Differentiated Neoplasms); MS-DRGs 907, 908, and 909
(Other O.R. Procedures for Injuries with and without CC/MCC,
respectively) in MDC 21 ((Injuries, Poisonings and Toxic Effects of
Drugs); 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) and to MS-DRGs
981, 982 and 983 (Extensive O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively).
Comment: Commenters agreed with the proposed redesignation of ICD-
10-PCS procedure code 0W3G0ZZ as an O.R. procedure, and stated this
would be consistent with similar procedure codes describing control of
bleeding in other anatomic sites.
Response: We thank the commenters for their support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-PCS procedure code 0W3G0ZZ to the
ICD-10 MS-DRG Version 38 Definitions Manual in Appendix E--Operating
Room Procedures and Procedure Code/MS-DRG Index as an O.R. procedure
assigned to the MDCs and MS-DRGs noted earlier in this section,
effective October 1, 2020.
(6) Inspection of Penis
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32549), one requestor stated that ICD-10-PCS procedure code 0VJS0ZZ
(Inspection of penis, open approach) is currently not recognized as an
O.R. procedure for purposes of MS-DRG assignment. The requestor noted
that there are circumstances that warrant inpatient admission for open
exploration of the penis, such as to rule out penile fracture and
extravasation due to trauma. The requestor stated their belief that
because this procedure involves an open incision for exploration of
penile structures and utilizes general anesthesia in the operating
room, it would be appropriately classified as an O.R. procedure. In the
proposed rule, we stated that we agreed with the requestor that ICD-10-
PCS procedure code 0VJS0ZZ typically requires the resources of an
operating room. Therefore, we proposed to add ICD-10-PCS procedure code
0VJS0ZZ to the FY 2021 ICD-10 MS-DRG Version 38 Definitions Manual in
Appendix E- Operating Room procedures and procedure code/MS-DRG Index
as an O.R. procedure assigned to MS-DRGs 709 (Penis Procedures with CC/
MCC) and 710 (Penis Procedures without CC/
[[Page 58550]]
MCC) in MDC 12 (Diseases and Disorders of the Male Reproductive
System).
Comments: Several commenters supported CMS' proposal to reclassify
ICD-10-PCS procedure code 0VJS0ZZ from a non-O.R. procedure to an O.R
procedure for purposes of MS-DRG assignment for MS-DRGs 709 and 710.
Response: We appreciate the commenters' support.
After consideration of the public comments received, we are
finalizing our proposal to add ICD-10-PCS procedure code 0VJS0ZZ
(Inspection of penis, open approach) to the FY2021 ICD-10 MS-DRG
Version 38 Definitions Manual in Appendix E Operating Room Procedures
and Procedure Code/MS-DRG Index as an O.R. procedure to MS-DRGs 709
(Penis Procedures with CC/MCC) and 710 (Penis Procedures without CC/
MCC) in MDC 12 (Diseases and Disorders of the Male Reproductive System)
for FY2021 effective October 1, 2020.
12. Changes to the MS-DRG Diagnosis Codes for FY 2021
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. 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 a 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 the 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.
We noted in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19235)
that with the transition to ICD-10-CM and the significant changes that
have occurred to diagnosis codes since the FY 2008 review, we believed
it was necessary to conduct a comprehensive analysis once again. Based
on this analysis, we proposed changes to the severity level
designations for 1,492 ICD-10-CM diagnosis codes and invited public
comments on those proposals. As summarized in the FY 2020 IPPS/LTCH PPS
final rule, many commenters expressed concern with the severity level
designation changes overall and recommended that CMS conduct further
analysis prior to finalizing any proposals. After careful consideration
of the public comments we received, as discussed further in the FY 2020
final rule, we generally did not finalize our changes to the severity
designations for the ICD-10-CM diagnosis codes, other than the changes
to the severity level designations for the diagnosis codes in category
Z16- (Resistance to antimicrobial drugs) from a non-CC to a CC. We
stated that postponing adoption of the comprehensive changes in the
severity level designations would allow further opportunity to provide
additional background to the public on the methodology utilized and
clinical rationale applied across diagnostic categories to assist the
public in its review. We refer readers to the FY 2020 IPPS/LTCH PPS
final rule (84 FR 42150 through 42152) for a complete discussion of our
response to public comments regarding the severity level designation
changes for FY 2020.
c. Guiding Principles for Making Changes to Severity Levels
As discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32550), to provide the public with more information on the CC/MCC
comprehensive analysis discussed in the FY 2020 IPPS/LTCH PPS proposed
and final rules, CMS hosted a listening session on October 8, 2019. The
listening session included a review of the methodology to measure the
impact on resource use. It also provided an opportunity for CMS to
receive public input on this analysis and to address any questions in
order to assist the public in formulating written comments on the
current severity level designations for consideration in the FY 2021
rulemaking. We refer readers to https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html for the
transcript and audio file of the listening session. We also refer
readers to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html for
the supplementary file containing the data describing the impact on
resource use of specific ICD-10-CM diagnosis codes when reported as a
secondary diagnosis that was made available for the listening session.
Following the listening session, we further considered the public
comments received and reconvened an internal workgroup comprised of
clinicians, consultants, coding specialists and other policy analysts
to identify guiding principles to apply in evaluating whether changes
to the severity level designations of diagnoses are needed and to
ensure the severity designations appropriately reflect resource use
based on review of the claims data, as well as consideration of
relevant clinical factors (for example, the clinical nature of each of
the secondary diagnoses and the severity level of clinically similar
diagnoses) and improve the overall accuracy of the IPPS payments. In
the proposed rule, we stated our goal was to develop a set of guiding
principles that, when applied, could assist in determining whether the
presence of the specified secondary diagnosis would lead to increased
hospital resource use in most instances. The workgroup identified the
following nine guiding principles as meaningful indicators of expected
resource use by a secondary diagnosis.
Represents end of life/near death or has reached an
advanced stage associated with systemic physiologic decompensation and
debility.
Denotes organ system instability or failure.
Involves a chronic illness with susceptibility to
exacerbations or abrupt decline.
Serves as a marker for advanced disease states across
multiple different comorbid conditions.
[[Page 58551]]
Reflects systemic impact.
Post-operative condition/complication impacting recovery.
Typically requires higher level of care (that is,
intensive monitoring, greater number of caregivers, additional testing,
intensive care unit care, extended length of stay).
Impedes patient cooperation and/or management of care.
Recent (last 10 years) change in best practice, or in
practice guidelines and review of the extent to which these changes
have led to concomitant changes in expected resource use.
We stated in the FY 2021 IPPS/LTCH PPS proposed rule that we plan
to continue a comprehensive CC/MCC analysis, using a combination of
mathematical analysis of claims data as discussed in the FY 2020 IPPS/
LTCH PPS proposed rule (84 FR 19235) and the application of these
guiding principles, and present the findings and proposals in future
rulemaking. We invited public comments regarding these guiding
principles, as well as other possible ways we could incorporate
meaningful indicators of clinical severity. When providing additional
feedback or comments, we encouraged the public to provide a detailed
explanation of how applying a suggested concept or principle would
ensure that the severity designation appropriately reflects resource
use for any diagnosis code.
Comment: Many commenters supported the guiding principles.
Commenters stated the application of the nine guiding principles, as
laid out in the proposed rule, rather than solely relying on a
mathematical analysis of claims data is a reasoned approach in
addressing the concerns raised last year. A commenter specifically
stated they acknowledge and appreciate CMS' recognition that the
transition to ICD-10-CM, and the significant changes that have occurred
to diagnosis codes since the FY 2008 review, warrants a comprehensive
CC/MCC analysis.
Response: We thank the commenters for their support.
Comment: Some commenters noted general concerns with the guiding
principles. Commenters stated that the nine guiding principles appeared
to be open to interpretation or differences in clinical opinion and do
not provide clear logic for decision-making. Other commenters stated
that it was not clear how CMS will apply these guiding principles in
conjunction with the mathematical analyses of claims data to make
decisions about severity levels. These commenters stated that more
information is needed to better understand CMS's process for decision
making on the designation of diagnosis severity levels.
Response: We thank the commenters for sharing their concerns.
The nine guiding principles are not criteria, intended to turn the
analysis into a quantitative exercise, but instead to provide a
framework for assessing relevant clinical factors. As patients present
with a variety of diagnoses, in examining the secondary diagnoses, we
would consider what additional resources are required, above and beyond
those that are already being utilized to address the principal
diagnosis and/or other secondary diagnoses that might also be present
on the claim. The goal of our comprehensive analysis is to create
stratification for reimbursing inpatient hospitalization in the fewest
amount of categories with the most explanatory power in a clinically
cohesive way.
Our intended approach is first, CMS will use these guiding
principles in making an initial clinical assessment of the appropriate
severity level designation for each ICD-10-CM code as a secondary
diagnosis. CMS will then use a mathematical analysis of claims data as
discussed in the FY 2020 IPPS/LTCH PPS proposed rule to determine if
the presence of the ICD-10-CM code as a secondary diagnosis appears to,
or does not appear to, increase hospital resource consumption. There
may be instances in which we would decide that the clinical analysis
weighs in favor of proposing to maintain or proposing to change the
severity designation of an ICD-10-CM code after application of the nine
guiding principles.
Comment: Some commenters stated that the guiding principles
appeared to be more applicable to MCC conditions, were too strict and
could potentially eliminate CC conditions. A commenter stated that the
application of the guiding principles would represent a substantial
revision to the definition of a CC, noting MS-DRG Definition Manual
Version 37.1 provides the following definition: ``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 length of stay by at least one day in at least 75 percent
of the patients.'' A few commenters highlighted individual ICD-10-CM
diagnoses and stated these conditions warrant assignment into CC or MCC
MS-DRGs based on certain clinical criteria.
Response: We appreciate the commenters' feedback.
We do not believe the nine guiding principles would be mostly
applicable, or only applicable, to MCC conditions. In applying the nine
guiding principles in our review of the appropriate severity level
designation, the intention is not to require that a diagnosis code
satisfy each principle, or a specific number of principles in assessing
whether to designate a secondary diagnosis code as a non-CC versus a CC
versus a MCC. Rather, the severity level determinations would be based
on the consideration of the clinical factors captured by these
principles as well as the empirical analysis of the additional
resources associated with the secondary diagnosis.
We wish to clarify that the definition of a ``substantial
complication or comorbidity'' from the MS-DRG Definition Manual that
the commenter referenced, is the definition of a CC that was used in
Version 8 of the DRGs. In FY 2008, for Version 25 of the MS-DRGs, the
diagnoses comprising the CC list were completely redefined and instead
each CC was categorized as a major CC or a CC (that is, non-major CC)
based on relative resource use. As stated previously, we refer readers
to the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159) for a complete
discussion of our approach. We also wish to clarify that there is a
difference between the non-CC, CC, or MCC designation of an individual
diagnosis code and the requirements for GROUPER assignment into a
severity split MS-DRG. MS-DRG assignment is a different issue and is
based on GROUPER logic and the other codes reported on a claim.
Comment: A commenter encouraged the use of the APR-DRG GROUPER to
analyze severity levels for individual diagnoses and in conjunction
with certain principal diagnoses to reinforce change decisions or
identify conflicts requiring re-evaluation. Some commenters questioned
how conditions such as obstetrical diagnoses or congenital conditions
would, or would not, be considered in the application of the guiding
principles.
Response: We thank the commenters for sharing their input and
suggestions.
The Medicare GROUPER is for the Medicare population and is not
designed to account for all populations like the APR-DRG GROUPER, so we
generally do not believe it would be appropriate to use the APR-DRG
GROUPER severity of illness and risk of mortality scores to analyze
severity levels as they relate to Medicare inpatient prospective
payment. In regards to obstetric conditions, given the limited number
of cases reporting ICD-10-CM obstetrical codes in the Medicare claims
data, we are considering use of datasets other than MedPAR cost data,
as we indicated in the FY 2020 IPPS/LTCH PPS final rule
[[Page 58552]]
(84 FR 42152), to be used in addition to the application of these
guiding principles for future evaluation of severity level designation
for the ICD-10-CM diagnosis codes from the Obstetrics chapter of the
ICD-10-CM classification. In contrast, the diagnosis codes from the
Congenital Malformations, Deformities and Chromosomal Abnormalities
Chapter of the ICD-10-CM classification may be used throughout the life
of the patient. Our internal workgroup believe the nine guiding
principles are applicable to these conditions and these codes lend
themselves to review using a combination of mathematical analysis of
claims data as discussed in the FY 2020 IPPS/LTCH PPS proposed rule (84
FR 19235) and the application of these guiding principles.
In this FY 2021 IPPS/LTCH PPS final rule, we present a summation of
the comments we received for each of the nine guiding principles and
our responses to those comments. We thank commenters for sharing their
views and their willingness to support CMS in our efforts to continue a
comprehensive CC/MCC analysis.
Represents end of life/near death or has reached an
advanced stage associated with systemic physiologic decompensation and
debility.
Comment: A commenter opposed this principle and stated that
decisions in these patients are complex, especially when being guided
by family members as part of `person and community engagement' which
hospitals are scored on under the Value Based Purchasing program. This
commenter expressed concern that a family may insist on continued use
of resources that CMS then determines it will not pay for, placing the
financial burden onto the hospital.
Response: We note the target of our analysis is on individual ICD-
10-CM codes, as secondary diagnosis codes, as they relate to inpatient
prospective payment. While we appreciate the commenters' concern, we
note that in certain instances, conditions that denote end of life or
near death may conversely also decrease resource use as the decision to
withdraw care is made. We also note that the impact of the secondary
diagnosis is dependent on the principal diagnosis reported, with which
it is associated. If the secondary diagnosis is reported with a
principal diagnosis that reflects serious illness with treatment
complexity, then the marginal contribution of the secondary diagnosis
to the overall resource use may actually be relatively small. In
applying these principles as part of the clinical analysis of the
appropriate severity level designation for each ICD-10-CM code as a
secondary diagnosis, CMS will take this into consideration.
Denotes organ system instability or failure.
Comments: Commenters supported this guiding principle.
Response: We appreciate the commenters' support.
Involves a chronic illness with susceptibility to
exacerbations or abrupt decline.
Comments: Some commenters opposed this principle and stated this
principle may not be able to be applied across the board as many ICD-
10-CM diagnosis codes do not distinguish exacerbation. The commenters
stated there are conditions that have separate acute and chronic
diagnosis codes, combined acute/chronic concepts into single diagnosis
codes, and some conditions for which the diagnosis code does not
indicate the specificity of acute or chronic.
Response: All ICD-10-CM diagnosis codes, including codes that do
not explicitly describe acute exacerbations, would be reviewed using
this guiding principle to assess the degree to which the individual
ICD-10-CM diagnosis code as a secondary diagnosis affects hospital
resource consumption, to determine if the severity designation is more
appropriately non-CC, CC, or MCC. The intention is again, not to
require that every diagnosis code satisfy each principle, but instead
to identify relevant clinical factors to help denote if, and to what
degree, additional resources are required above and beyond those that
are already being utilized to address the principal diagnosis and/or
other secondary diagnoses that might also be present on the claim.
Serves as a marker for advanced disease states across
multiple different comorbid conditions.
Comment: A few commenters noted that this guiding principle is open
to interpretation.
Response: A marker is a clinical measurement that is associated
with or believed to be related pathophysiologically to a clinical
outcome and can serve as an indicator for health or disease. While we
appreciate that assessing relevant clinical factors will depend on the
particular diagnosis codes at issue, our clinical advisors believe this
principle, along with the other 8 principles, would provide appropriate
parameters for our clinical review.
Reflects systemic impact.
Comment: A commenter noted that many current CC or MCC diagnoses
are limited to a single body system and therefore, stated it is unclear
what the guideline means by ``systemic impact.''
Response: Systemic impact refers to conditions that affect more
than one body system or the entire body.
Post-operative condition/complication impacting recovery.
Comment: Several commenters recommended that CMS revise the
language used so that this guiding principle includes the term ``post-
procedure'' to more broadly recognize that some procedures also have
associated complications that are severe that can typically warrant
additional resources (that is, drugs, supplies, ancillary tests, etc.).
These commenters stated they believed stakeholders are likely to take
the wording of this guiding principle literally as originally stated.
Commenters also stated that the term ``recovery'' is conceptually
appropriate, so long as its use does not result in the exclusion of
consideration of costs that may impact the patient stay. Another
commenter also stated that CMS should describe the cost implications of
each of these principles.
Response: CMS agrees that adding the term ``post-procedure'' would
be appropriate to encompass procedures that have associated
complications that may warrant additional resources. We are revising
this guiding principle to ``post-operative/post-procedure condition/
complication impacting recovery''. To clarify for the commenters, when
reviewing costs, we do not analyze impact using a detailed cost
accounting approach. The approach that is utilized in the mathematical
analysis of claims data for impact analysis is the same expected cost
approach that used in the relative weight computations. All charges in
each revenue bucket, that already include supply and ancillary costs,
are adjusted specific to the revenue cost to charge ratio, on a
national scale and incorporated into impact values from a total
estimated cost perspective. As part of this statistical review to
determine if a secondary diagnosis appears to, or does not appear to,
increase resource consumption, our clinical workgroup will also examine
the additional days the secondary diagnosis contributed to the length
of stay against what would be expected.
Typically requires higher level of care (that is,
intensive monitoring, greater number of caregivers, additional testing,
intensive care unit care, extended length of stay).
Comment: Commenters stated that while they agree with this
principle, they request that CMS clarify if ``intermediate care'' will
be considered within this guiding principle. Other
[[Page 58553]]
commenters requested clarification on how conditions meeting this
principle would be determined. Other commenters noted that this
principle is similar to Section III of the ICD-10-CM Guidelines for
Coding and Reporting regarding reportable secondary diagnosis.
Response: Mathematical data regarding ICU usage will inform the
clinical decision making of our internal workgroup, but we note that
definitions for terms such as ``intermediate care'' and ``ICU'' vary
from institution to institution. We note as stated above, our intention
is not to be prescriptive in matching hospital costs, instead our
intention is to ensure the severity designations appropriately reflect
resource use and improve the overall accuracy of the IPPS payment
system. To clarify for the commenters, the definition for ``other
diagnoses'' as stated in the ICD-10-CM Official Guidelines for Coding
and Reporting is intended to ensure inpatient data elements are
reported in a standardized manner. This guiding principle is to
intended to assist in assessing what additional resources are required
for each ICD-10-CM code as a secondary diagnosis, above and beyond
those that are already being utilized to address the principal
diagnosis and/or other secondary diagnoses that might also be present
on the claim.
Impedes patient cooperation and/or management of care.
Comment: A number of commenters requested that codes for various
social determinants of health (SDOH) be considered in this principle
and in subsequent data analysis. One commenter suggested that CMS use
registry information, rather than relying solely on administrative
data, to take into consideration these underlying risk factors,
including socioeconomic status. Another commenter questioned whether
the post discharge environment should be added as a guiding principle.
Response: The ICD-10-CM classification in its entirety will be
reviewed in our comprehensive CC/MCC analysis, not excluding the ICD-
10-CM codes for the social determinants of health, which are the
socioeconomic, cultural and environmental circumstances in which
individuals live. We note the focus of our comprehensive analysis is on
the appropriate severity level designation of individual ICD-10-CM
codes as secondary diagnosis codes as they relate to the resource
utilization required while the patient is in the hospital and on
inpatient prospective payment. In reference to the comment that CMS use
registry information, we appreciate the suggestion but we do not
believe there is enough consistency in voluntary registry data for this
purpose, and it would also be challenging for CMS to operationalize.
Recent (last 10 years) change in best practice, or in
practice guidelines and review of the extent to which these changes
have led to concomitant changes in expected resource use.
Comment: Many commenters stated CMS needs a method to assign CC and
MCC designations to new ICD-10-CM diagnosis codes in advance of
receiving claims data, since the availability of claims data lags for
two years after new codes are released, to account for diagnoses which
require costly treatment or might otherwise require ICU care or
lengthier stays. Another commenter stated this guiding principle is
poorly worded at best and vague on how it would be converted to a
decision by CMS. Another commenter questioned the validity of this
principle and noted that most medical conditions have potentially had
some changes in best practices in the last 10 years
Response: We would like to clarify and note that CMS does have an
established process to assign severity level designation to new
diagnosis codes. Our process in assigning a severity level designation
to a new diagnosis code generally begins with identifying the
designation of the predecessor ICD-10-CM code. To inform our
assignments, we also review materials from the discussions relating to
proposed new diagnosis codes from the ICD-10 Coordination and
Maintenance Committee meetings to determine if there are new or revised
clinical concepts included in the new diagnosis codes that should also
be considered when assigning a severity level designation. We refer
readers to section II.E.16. of the preamble of this final rule for a
discussion of the ICD-10 (previously ICD-9-CM) Coordination and
Maintenance Committee meeting process.
We agree with the commenter that most medical conditions have
potentially had some changes in best practices in the last 10 years.
Significant strides have been made in the past 10 years to ensure that
Medicare beneficiaries have access to critical and life-saving new
cures and technologies that improve beneficiary health outcomes.
Consequently, we believe this comprehensive analysis should take into
account the way changes in medical practice have, or have not, affected
the impact on relative resource use for each ICD-10-CM code as a
secondary diagnosis since our last comprehensive analysis in FY 2008.
Therefore, after consideration of the public comments we received,
we are updating the nine guiding principles as follows:
Represents end of life/near death or has reached an
advanced stage associated with systemic physiologic decompensation and
debility.
Denotes organ system instability or failure.
Involves a chronic illness with susceptibility to
exacerbations or abrupt decline.
Serves as a marker for advanced disease states across
multiple different comorbid conditions.
Reflects systemic impact.
Post-operative/post-procedure condition/complication
impacting recovery.
Typically requires higher level of care (that is,
intensive monitoring, greater number of caregivers, additional testing,
intensive care unit care, extended length of stay).
Impedes patient cooperation and/or management of care.
Recent (last 10 years) change in best practice, or in
practice guidelines and review of the extent to which these changes
have led to concomitant changes in expected resource use.
Comment: A few commenters recommended that CMS convene a technical
advisory panel comprised of industry stakeholders and subject matter
experts (including clinicians and health information professionals) to
review the guiding principles. Other commenters requested that the
mathematical data to be utilized in our comprehensive analysis be again
presented and explained in a public listening session, similar to what
the agency held in October 2019 on this topic.
Response: We again thank commenters for sharing their views and
their willingness to support CMS in our efforts to continue a
comprehensive CC/MCC analysis. While CMS has already convened an
internal workgroup comprised of clinicians, consultants, coding
specialists and other policy analysts, as well as provided opportunity
to provide feedback on the guiding principles, we look forward to
further collaboration with the industry. We plan to make an updated
impact on resource use file available after publication of this final
rule.
We continue to solicit feedback regarding these guiding principles,
as well as other possible ways we can incorporate meaningful indicators
of clinical severity. When providing additional feedback or comments,
we encourage the public to provide a detailed explanation of how
applying a suggested concept or principle would
[[Page 58554]]
ensure that the severity designation appropriately reflects resource
use for any diagnosis code.
Commenters should submit their recommendations to the following
email address: [email protected] by November 1,
2020.
d. Additions and Deletions to the Diagnosis Code Severity Levels for FY
2021
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32550) we noted
the following tables identify the proposed additions and deletions to
the diagnosis code MCC severity levels list and the proposed additions
and deletions to the diagnosis code CC severity levels list for FY 2021
and are available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
Table 6I.1--Proposed Additions to the MCC List--FY 2021;
Table 6I.2--Proposed Deletions to the MCC List--FY 2021;
Table 6J.1--Proposed Additions to the CC List--FY 2021; and
Table 6J.2--Proposed Deletions to the CC List--FY 2021.
Comment: Commenters agreed with the proposed additions and
deletions to the MCC and CC lists as shown in tables 6I.1, 6I.2, 6J.1,
and 6J.2 associated with the proposed rule.
Response: We appreciate the commenters' support.
As discussed in section II.E.13. of the preamble of this final
rule, after consideration of the public comments received, we are
finalizing changes to the severity levels for new diagnosis codes
D89.833, D89.834, and D89.835 describing cytokine release syndrome
(CRS) from NonCC to CC for FY 2021. Therefore, these diagnosis codes
are now reflected in Table 6J.1--Additions to the CC List--FY 2021.
The following tables associated with this final rule reflect the
finalized severity levels under Version 38 of the ICD-10 MS-DRGs for FY
2021 and are available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
Table 6I.--Complete MCC List--FY 2021;
Table 6I.1--Additions to the MCC List--FY 2021;
Table 6I.2--Deletions to the MCC List--FY 2021;
Table 6J.--Complete CC List--FY 2021;
Table 6J.1--Additions to the CC List--FY 2021; and
Table 6J.2--Deletions to the CC List--FY 2021.
e. CC Exclusions List for FY 2021
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 37 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/MS-DRG-Classifications-and-Software.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. For all
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 patients
discharged alive; otherwise, they are assigned as a non-CC.
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32550 through
32551), we discussed a request we received to consider removing
diagnosis codes describing any type of stroke that is designated as a
MCC in the code range I60.00 through I63.9 from the CC Exclusion list
when a principal diagnosis of diabetes in the code range E08.00 through
E13 is reported. According to the requestor, acute strokes and chronic
diabetes are two distinct conditions, therefore a stroke that occurs
during an admission for an underlying diabetic condition should not be
excluded from acting as a MCC. The requestor provided an example of a
patient with type 2 diabetes who was admitted for treatment of infected
foot ulcers and then experienced a stroke prior to discharge, resulting
in assignment to MS-DRG 639 (Diabetes without CC/MCC). The requestor
asserted the more appropriate assignment is MS-DRG 637 (Diabetes with
MCC), which they stated more appropriately reflects severity of illness
and resources involved in the treatment of an acute stroke. In another
example provided by the requestor, a patient with type 2 diabetes and
osteomyelitis underwent a left below the knee amputation and
experienced a stroke before discharge, resulting in assignment to MS-
DRG 617 (Amputation of Lower Limb for Endocrine, Nutritional, and
Metabolic Diseases with CC). The requestor asserted the more
appropriate assignment is MS-DRG 616 (Amputation of Lower Limb for
Endocrine, Nutritional, and Metabolic Diseases with MCC), which they
stated more appropriately reflects severity of illness and resources
involved in the treatment of an acute stroke.
We stated in the proposed rule that our clinical advisors agreed
that acute strokes and chronic diabetes are two distinct conditions and
a case reporting a secondary diagnosis of a stroke in the code range
I60.00 through I63.9 should not be excluded from acting as a MCC when
reported with a principal diagnosis of diabetes in the code range
E08.00 through E13.9.
[[Page 58555]]
As noted in the proposed rule, we analyzed claims data from the
September 2019 update of the FY 2019 MedPAR file for cases reporting a
principal diagnosis of diabetes in the code range E08.00 through E13.9
with a secondary diagnosis of a stroke in the code range I60.00 through
I63.9. We refer the reader to table 6P.3a for a detailed list of the
diagnosis codes describing diabetes that were analyzed and table 6P.3b
associated with the proposed rule for a detailed list of the diagnosis
codes describing a stroke that were analyzed and that are also
designated as a MCC in this code range. We found a total of 1,109 cases
across 40 MS-DRGs with an average length of stay of 10.1 days and
average costs of $24,672 reporting a principal diagnosis of diabetes
with a secondary diagnosis of a stroke that was excluded from acting as
a MCC. Of those 1,109 cases, we identified 161 cases that would result
in assignment to the higher severity level ``with MCC'' MS-DRG if the
diagnosis of stroke was no longer excluded from acting as a MCC. The
remaining 948 cases would maintain their existing MS-DRG assignment
since they were either already grouped to the highest MCC severity
level based on another diagnosis code that is designated as a MCC or
they were assigned to one of the Pre-MDC MS-DRGs. We refer the reader
to table 6P.4a associated with the proposed rule for the detailed
analysis.
Based on the advice of our clinical advisors, for FY 2021, we
proposed to remove the diagnosis codes describing stroke in the code
range I60.00 through I63.9 that are designated as a MCC from the list
of CC Exclusions when reported with a principal diagnosis of diabetes
in the code range E08.00 through E13.9 from the ICD-10 MS-DRGs Version
38 CC Exclusion List as reflected in Table 6H.1.--Proposed Secondary
Diagnosis Order Deletions to the CC Exclusions List--FY 2021 and Table
6H.2.--Proposed Principal Diagnosis Order Deletions to the CC
Exclusions List--FY 2021 associated with the proposed rule and
available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS.
Comment: Commenters supported the proposal to remove diagnosis
codes describing stroke in the code range I60.00 through I63.9 that are
designated as a MCC from the list of CC Exclusions when reported with a
principal diagnosis of diabetes in the code range E08.00 through E13.9.
Response: We thank the commenters for their support.
We proposed additional changes to the ICD-10 MS-DRGs Version 38 CC
Exclusion List based on the diagnosis and procedure code updates as
discussed in section II.D.13. of the FY 2021 IPPS/LTCH PPS proposed
rule and set forth in Tables 6G.1, 6G.2, 6H.1, and 6H.2 associated with
the proposed rule and available via the internet on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS.
Comment: Commenters supported the proposed additions and deletions
to the CC Exclusion List as shown in tables 6G.1, 6G.2, 6H.1 and 6H.2.
Response: We appreciate the commenters' support.
After consideration of the public comments we received, we are
finalizing our proposal to remove diagnosis codes describing stroke in
the code range I60.00 through I63.9 that are designated as a MCC from
the list of CC Exclusions when reported with a principal diagnosis of
diabetes in the code range E08.00 through E13.9.
The proposed CC Exclusions for a subset of the diagnosis codes as
set forth in Tables 6G.1, 6G.2, 6H.1, and 6H.2 associated with the FY
2021 IPPS/LTCH PPS proposed rule reflect the proposed severity level
designations as discussed in section II.D.13. of the preamble of the
proposed rule. As discussed in section II.E.13. of the preamble of this
final rule, we are finalizing changes to the severity level
designations for three diagnosis codes after consideration of the
public comments received. Therefore, the finalized CC Exclusions List
as displayed in Tables 6G.1, 6G.2, 6H.1 6H.2, and 6K, associated with
this final rule reflect the severity levels under Version 38 of the
ICD-10 MS-DRGs.
We have developed Table 6G.1.--Secondary Diagnosis Order Additions
to the CC Exclusions List--FY 2021; Table 6G.2.--Principal Diagnosis
Order Additions to the CC Exclusions List--FY 2021; Table 6H.1.--
Secondary Diagnosis Order Deletions to the CC Exclusions List--FY 2021;
Table 6H.2.--Principal Diagnosis Order Deletions to the CC Exclusions
List--FY 2021; and Table 6K.--Complete List of CC Exclusions--FY 2021.
For Table 6G.1, each secondary diagnosis code for addition to the CC
Exclusion List is shown with an asterisk and the principal diagnoses 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 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 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. Table 6K is a list of all
of the codes that are defined as either CC or a MCC when used as a
secondary diagnosis. Within the table each code is specifically
indicated as CC or MCC. A table number is given to a collection of
diagnosis codes which, when used as the principal diagnosis, will cause
the CC or MCC to be considered as only a non-CC. Tables 6G.1., 6G.2.,
6H.1., 6H.2., and 6K. associated with this final rule are available via
the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
The ICD-10 MS-DRGs Version 38 CC Exclusion List is included as
Appendix C of the Definitions Manual (available in two formats; text
and HTML). The manuals are available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software and each
format 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. For all diagnosis codes on the list,
a link (HTML version) 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 patients discharged alive;
otherwise, they are assigned as a non-CC.
13. Changes to the ICD-10-CM and ICD-10-PCS Coding Systems
To identify new, revised and deleted diagnosis and procedure codes,
for FY 2021, we have developed Table 6A.--New Diagnosis Codes, Table
6B.--New Procedure Codes, Table 6C.--Invalid Diagnosis Codes, and Table
6E.--Revised Diagnosis Code Titles for this final rule.
These tables are not published in the Addendum to the proposed rule
or final rule, but are available via the internet on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-
[[Page 58556]]
for-Service-Payment/AcuteInpatientPPS/index.html as described in
section VI. of the Addendum to this final rule. As discussed in section
II.E.16. 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 meeting 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 2021 IPPS/LTCH PPS proposed rule (85 FR 32551 through
32552), we proposed the MDC and MS-DRG assignments for the new
diagnosis codes and procedure codes as set forth in Table 6A.--New
Diagnosis Codes and Table 6B.--New Procedure Codes. We also stated that
the proposed severity level designations for the new diagnosis codes
are set forth in Table 6A. and the proposed O.R. status for the new
procedure codes are set forth in Table 6B.
Comment: A commenter stated they appreciated the finalization of
new ICD-10-CM diagnosis code J84.170 (Interstitial lung disease with
progressive fibrotic phenotype in diseases classified elsewhere) that
was included in Table 6A--New Diagnosis Codes associated with the
proposed rule. The commenter stated this new diagnosis code will
provide clarification for current coding of Interstitial Lung Disease
(ILD) within the ICD-10-CM classification by enabling identification of
patients with chronic fibrotic ILD who exhibit a progressive phenotype.
The commenter noted this update is critical for facilitating research
for patients with a progressive fibrotic ILD phenotype which is an area
of high unmet needs. Another commenter also supported the creation of
diagnosis code J84.170 and stated they generally support new ICD-10
codes that enable identification of beneficiaries with specific
diseases or clinically important diagnoses, such as that represented by
diagnosis code J84.170. However, the commenter expressed concern that
the process for obtaining new ICD-10 codes can be cumbersome and cause
delays in approving new codes that are important to identify and
support appropriate treatment for patients with specific diseases or
conditions. The commenter provided an example that current ICD-10 codes
do not accurately characterize the disease progression of Alzheimer's
Disease and have not kept up with the current clinical documentation
and management of patient treatments, and do not accurately reflect the
various stages of disease progression. The commenter noted that proper
identification is necessary, not only in clinical practice, but also to
track the real word outcomes as patients progress through the disease
states. The commenter stated CMS, along with the CDC, should consider
steps to expedite the timetable for implementing important new
diagnosis codes in emerging therapeutic areas in order to ensure timely
patient access to vital treatment options.
Response: We appreciate the commenters' support. In response to the
commenter who expressed concern regarding the process and timing for
obtaining new ICD-10 codes, we note that, as discussed in section
II.E.16. of the preamble of this final rule, the CDC/NCHS has lead
responsibility for the ICD-10-CM diagnosis classification while CMS has
lead responsibility for the ICD-10-PCS procedure classification. Each
organization has their own established process in responding to
requests for code updates, including when specific topics may appear on
the agenda of an ICD-10 Coordination and Maintenance Committee meeting
and the fiscal year in which code proposals are considered for
implementation. With regard to the commenter's concerns involving
outdated and insufficient diagnosis code descriptions for Alzheimer's
Disease, we encourage the commenter to contact the CDC/NCHS directly as
they have lead responsibility for the ICD-10-CM diagnosis
classification. Requests for new and revised diagnosis code updates
must be submitted to [email protected] for consideration. In response
to the commenter's suggestion that CMS and CDC should consider steps to
expedite the timetable for implementing important new diagnosis codes
in emerging therapeutic areas in order to ensure timely patient access
to vital treatment options, we note that, as also discussed in section
II.E.16. of the preamble of this final rule, there are existing
processes in place to implement diagnosis codes in an expedited manner.
Comment: A commenter expressed appreciation for CMS' request for
comment on the MDC, MS-DRG and severity level for diagnosis code U07.1
(COVID-19). The commenter stated there are variable and changing
practices related to COVID-19, particularly as related to medication
use. In addition, the commenter noted as medications may be used off-
label or become newly approved for COVID-19, the cost of those
medications remains to be seen. According to the commenter, these costs
may have a significant impact on a hospital's ability to treat patients
with COVID-19. Therefore, the commenter suggested that as CMS considers
the most appropriate MDC, MS-DRG and severity level assignments for
diagnosis code U07.1, it recommended the agency account for the ongoing
changes in best practices and medication use related to COVID-19, and
whether additional reimbursement options or flexibilities could be
provided to limit financial risks to hospitals. Another commenter
applauded the speed with which CMS and CDC/NCHS addressed and
implemented the new ICD-10-CM diagnosis codes U07.0 (Vaping-related
disorder) and U07.1 (COVID-19) effective April 1, 2020 with MS-DRG
assignments. This commenter encouraged the agencies to respond swiftly
to address any similar public health emergencies in the future.
Response: We thank the commenters for their support. In Table 6A--
New Diagnosis Codes, associated with the proposed rule, we proposed to
continue to designate diagnosis code U07.1 (COVID-19) as a MCC in MDC
04 (Diseases and Disorders of the Respiratory System) for MS-DRGs 177,
178, and 179 (Respiratory Infections and Inflammations with MCC, with
CC, and without CC/MCC, respectively); in MDC 15 (Newborns and Other
Neonates with Conditions Originating in Perinatal Period) for MS-DRGs
791 (Prematurity with Major Problems) and 793 (Full Term Neonate with
Major Problems); and in MDC 25 (Human Immunodeficiency Virus
Infections) for MS-DRGs 974, 975, and 976 (HIV with Major Related
Condition with MCC, with CC, and without CC/MCC, respectively). We note
that these are the same MDC and MS-DRG assignments that were applied at
the time diagnosis code U07.1 was implemented, effective April 1, 2020,
as discussed in section II.D.16. of the FY 2021 IPPS/LTCH PPS proposed
rule (85 FR 32559). In response to the commenter's recommendation that
CMS account for changes in best practices and medications used for the
treatment of COVID-19 with respect to providing additional payment
options and flexibilities to limit financial risk to hospitals, we note
that we have developed several resources in the form of a Coronavirus
(COVID-19) Partner Toolkit available at the following CMS webpage:
https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-toolkit for various providers with respect to the
COVID-19 public health emergency. Specifically, on that CMS webpage
under the section titled ``If you are in a Care Setting'' there is a
``Hospitals and
[[Page 58557]]
Healthcare Systems'' list of 20 resource documents that have been made
publicly available.
Comment: Several commenters expressed concern regarding the
proposed NonCC severity level designation for a subset of the new ICD-
10-CM diagnosis codes describing cytokine release syndrome (CRS) as
displayed in Table 6A--New Diagnosis Codes (associated with the
proposed rule and available via the internet on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS). Specifically, the commenters stated diagnosis codes
D89.833 (Cytokine release syndrome, grade 3), D89.834 (Cytokine release
syndrome, grade 4), and D89.835 (Cytokine release syndrome, grade 5)
warrant further consideration. The commenters noted that CRS has
emerged as an established diagnosis in association with CAR T-cell
therapy for various cancers, and providers are now seeing this syndrome
in patients who present with COVID-19. The commenters requested CMS
reconsider how the diagnosis codes describing CRS are designated within
the ICD-10 MS-DRGs.
Some commenters suggested that the American Society for
Transplantation and Cellular Therapy (ASTCT) CRS Grading system be
examined in review of potential CC and MCC designations for the CRS
diagnosis codes. Other commenters stated that based on the ASTCT CRS
Grading system, the CRS diagnosis codes describing grades 3, 4, and 5
appear to satisfy many of the CMS guiding principles discussed in the
FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32550). A commenter
recommended that severity level assignments for the various grades of
CRS could be used as a test case for these new guiding principles.
According to the commenter, the guiding principles as described in the
proposed rule do not indicate that a required threshold for the number
of cases for Medicare patients be attained before an analysis of the
severity level assignment occurs. The commenter stated that based on
the ASTCT CRS Grading system, grades 3, 4 and 5 meet the criteria for 7
of the 9 proposed guiding principles. The commenter provided the
following information for CMS' consideration.
[GRAPHIC] [TIFF OMITTED] TR18SE20.106
This same commenter also suggested that CMS consider expanding the
logic for the CRS diagnosis codes to include patients diagnosed with
COVID-19. The commenter reported that based on current academic
literature, CRS is a common occurrence and a focus of treatment in
patients presenting with advanced COVID-19. According to the commenter,
the presence of CRS in the COVID-19 population also indicates that the
new CRS diagnosis codes meet the 4th guiding principle of ``marker for
advanced disease states across multiple different comorbid
conditions.''
Another commenter urged CMS to assign the CRS diagnosis codes
identified as Grades 3, 4, and 5 (D89.833, D89.834, and D89.835,
respectively) as a MCC and to assign the CRS diagnosis code identified
as Grade 2, D89.832 (Cytokine release syndrome, grade 2) as a CC based
on clinical significance. The commenter agreed with the proposed NonCC
designation for the CRS diagnosis code identified as Grade 1, D89.831
(Cytokine release syndrome, grade 1) until additional data is available
for analysis and consideration.
A commenter noted that for Table 6A--New Diagnosis Codes,
associated with the proposed rule, that the proposed MDC for the new
CRS diagnosis codes is MDC 16 (Diseases and Disorders of Blood, Blood
Forming Organs, Immunologic Disorders) and the proposed MS-DRGs are
814, 815, and 816 (Reticuloendothelial and Immunity Disorders with MCC,
with CC, and without CC/MCC, respectively). The commenter stated that
since the CRS diagnosis codes were proposed as NonCC it understood this
to equate to the CRS diagnosis codes being assigned to MS-DRG 816. The
commenter disagreed with the proposed severity levels for the CRS
diagnosis codes and recommended CMS consider revising. According to the
commenter, CRS is the most common complication of Immune Effector Cell
(IEC) therapy as described in the ASTCT's Consensus Grading
[[Page 58558]]
paper.\1\ Symptoms can be progressive, include fever at the onset, and
may include hypotension, hypoxia, and end organ dysfunction. The
commenter noted that patients with CRS grade 3 require treatment for
hypotension and hypoxia and patients with CRS grade 4 experience
hypoxia requiring treatment, are hemodynamically unstable, and have
capillary leak which can lead to pulmonary edema and ventilation
impairment and may require mechanical ventilation. Lastly, the
commenter noted CRS grade 5 is defined as ``death due to CRS,'' and
suggested this condition be considered a MCC. In addition, the
commenter compared the APR-DRG Grouper severity levels, as described in
the FY 2008 IPPS/LTCH PPS final rule (72 FR 47158) to inform how CMS
should assign CC/MCC designations for the new CRS codes. For example,
the commenter suggested diagnosis code D89.831 (Cytokine release
syndrome, grade (1) should be designated as NonCC; diagnosis code
D86.832 (Cytokine release syndrome, grade (2) should be designated as
CC; diagnosis code D89.833 (Cytokine release syndrome, grade (3) should
be designated as MCC; diagnosis code D89.834 (Cytokine release
syndrome, grade (4) should be designated as MCC; diagnosis code D89.835
(Cytokine release syndrome, grade (5) should be designated as MCC; and
diagnosis code D89.839 (Cytokine release syndrome, grade unspecified)
should be designated as NonCC.
---------------------------------------------------------------------------
\1\ ASTCT Consensus Grading for Cytokine Release Syndrome and
Neurologic Toxicity Associated with Immune Effector Cells. Lee,
Daniel W. et al. Biology of Blood and Marrow Transplantation, Volume
25, Issue 4, 625-638.
---------------------------------------------------------------------------
Similar to comments discussed earlier in this section, this
commenter also stated that when applying CMS' guiding principles as
described in the proposed rule for severity level assignments, many of
them are applicable to the new CRS diagnosis codes. The commenter
provided the following table for CMS' consideration and review which
also included recommended MS-DRG assignments.
[GRAPHIC] [TIFF OMITTED] TR18SE20.107
[[Page 58559]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.108
The commenter also noted that coding guidelines instruct the CRS
diagnosis codes to be sequenced as a secondary diagnosis with a
complication code (T code) sequenced first when CRS is a complication
due to a procedure. The commenter expressed concern regarding how CRS
cases will group into MS-DRGs 814, 815, and 816 as proposed by CMS
since sequencing a T code as the principal diagnosis results in a
different MS-DRG assignment. The commenter suggested CMS consider
revising the Grouper logic, proposing different MS-DRGs for CRS and
allow for public comment, or urging NCHS to change the coding
instruction at subcategory D89.83 to allow only for diagnosis code
T80.90XA (Unspecified complication following infusion and therapeutic
injection) to be reported first since it would group to MS-DRGs 814,
815, and 816. The commenter also urged CMS to request that the NCHS and
the AHA publish clear coding guidance to eliminate any confusion about
the appropriate T code to report for CRS due to CAR T-cell therapy.
Another commenter also recommended that CMS assign the new CRS
diagnosis codes to CC and MCC MS-DRGs within the MS-DRG 814, 815, and
816 series. The commenter stated their belief that several of the CMS
guiding principles described in the proposed rule provide sufficient
rationale for such assignments. The commenter also stated that once
information regarding the CRS codes becomes available in the claims
data, CMS can re-evaluate MS-DRG assignments.
Response: Consistent with our annual process of assigning new
diagnosis codes to MDCs, MS-DRGs, and designating a severity level
(MCC, CC or NonCC), we reviewed the predecessor diagnosis code
assignment for CRS. The predecessor code for CRS is diagnosis code
D89.89 (Other specified disorders involving the immune mechanism, not
elsewhere classified) which is designated as a NonCC, therefore our
proposed severity level designation for each of the CRS codes was also
a NonCC. After consideration of the commenters' concerns regarding the
proposed severity level designations for the new ICD-10-CM diagnosis
codes describing cytokine release syndrome (hereafter referred to as
``CRS codes'') as displayed in Table 6A--New Diagnosis Codes,
associated with proposed rule, we agree that the CRS codes warrant
further consideration.
Upon further review and consideration, our clinical advisors
believe a CC severity level for CRS codes identified as grade 3, 4, or
5 would be warranted since these patients may require additional
resources and treatment including intensive monitoring, blood pressure
support, oxygen or mechanical ventilation, that are above and beyond
the resources required for patients with CRS identified as a grade 1,
2, or an unspecified grade. Our clinical advisors continue to believe
that CRS codes with a grade 1, 2, or an unspecified grade do not
warrant the CC severity level.
Our clinical advisors also acknowledged the commenters'
recommendations to review the American Society for Transplantation and
Cellular Therapy (ASTCT) CRS Grading system to reassess potential CC
and MCC designations for the CRS codes and consider how the CMS guiding
principles discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32550) could be applied as a test case for the various grades of the
CRS codes. As noted previously, we applied our established process in
proposing severity level assignments for these codes and the other new
diagnosis codes for FY 2021. We also note that the guiding principles
continue to be under development as we consider the public comments
received, as discussed in section II.E.12.c. of the preamble of this
final rule. We further note that with respect to proposing severity
level assignments for new diagnosis codes in the future, we anticipate
continuing our current process of first reviewing the predecessor code
assignment, followed by review and consideration of the guiding
principles that may be applied, in future rulemaking.
We note that while our clinical advisors do not dispute the
commenters' assessments that the CRS codes would appear to meet most of
the guiding principles, they also noted, as discussed previously, that
a distinction between
[[Page 58560]]
assigning the codes as a CC versus a MCC cannot be made based on the
fact that they appear to meet several of the guiding principles nor can
assignment of a secondary diagnosis be based on whether the code meets
1 or 2 principles or meets 7 or 8 of the principles. Our clinical
advisors maintain that generally, the proposed severity level
ultimately depends on clinical judgement and, where the data is
available, the empirical analysis of the additional resources
associated with the secondary diagnosis. The impact of the secondary
diagnosis is dependent on the principal diagnosis reported, with which
it is associated. If the secondary diagnosis is reported primarily with
a principal diagnosis that reflects serious illness with treatment
complexity, then the marginal contribution of the secondary diagnosis
to the overall resource use may actually be relatively small. The CRS
codes initially appeared to fall into this category, since it occurs in
patients who are quite ill to begin with, the ``grading'' definitions
have varied among organizations, and it has evolved over time. However,
for the reasons noted, and after further consideration, we believe that
a CC severity level for CRS codes identified as grade 3, 4, or 5 is
warranted. We will continue to monitor the CRS codes and their impact
on resource use once the claims data becomes available to determine if
further modifications to the severity level are warranted.
In response to the commenter who expressed concern regarding how
CRS cases will group into MS-DRGs 814, 815, and 816 as proposed by CMS
(since sequencing certain T codes as the principal diagnosis results in
a different MS-DRG assignment), we note that after notification and
consideration of the concerns involving the proposed Tabular List
instructions for the CRS codes were brought to its attention, the CDC/
NCHS updated and finalized the Tabular instruction for the CRS codes.
As noted in section II.E.16. of the preamble of this final rule, the
CDC/NCHS has lead responsibility for the diagnosis codes and CMS has
lead responsibility for the ICD-10-PCS procedure codes. The finalized
changes effective FY 2021 include updates to the diagnosis codes
instructed to be sequenced first, followed by the applicable CRS code
as follows:
D89.83 Cytokine release syndrome
Code first underlying cause, such as:
Complications following infusion, transfusion and therapeutic injection
(T80.89-)
complications of transplanted organs and tissue (T86.-)
Use additional code to identify associated manifestations
D89.831 Cytokine release syndrome, grade 1
D89.832 Cytokine release syndrome, grade 2
D89.833 Cytokine release syndrome, grade 3
D89.834 Cytokine release syndrome, grade 4
D89.835 Cytokine release syndrome, grade 5
D89.839 Cytokine release syndrome, grade unspecified
As a result, CMS considered modifications to the GROUPER logic to
allow cases reporting diagnosis code T80.89XA (Other complications
following infusion, transfusion and therapeutic injection) as the
principal diagnosis with any one of the CRS codes as a secondary
diagnosis to group to MS-DRGs 814, 815, and 816. We note that diagnosis
code T80.90XA (Unspecified complication following infusion and
therapeutic injection) as the commenter suggested would not be
appropriate to report as the principal diagnosis for these cases since
the code descriptor refers to an ``unspecified complication'' and the
complication is specified as CRS. In response to the commenter's
suggestion that CMS request the NCHS and the AHA publish clear coding
guidance to eliminate any confusion about the appropriate T code to
report for CRS due to CAR T-cell therapy, we note that it is standard
practice for the AHA to publish coding guidance for the annual
diagnosis and procedure code updates in the AHA's Coding Clinic for
ICD-10-CM and ICD-10-PCS 4th Quarter publication each year.
With respect to the commenter who recommended that CMS assign the
new CRS diagnosis codes to CC and MCC MS-DRGs within the MS-DRG 814,
815, and 816 series, we note that whenever there are new diagnosis
codes finalized, the first step for incorporating the new diagnosis
code into the logic of the ICD-10 MS-DRGs is to assign the diagnosis
code to the appropriate MDC. The next step is to determine if and how
the diagnosis code may define the logic for a specific MS-DRG
assignment. For example, the diagnosis may be listed as principal or as
any one of the secondary diagnoses, as a secondary diagnosis, or only
as a secondary diagnosis as noted in more detail below.
Principal or secondary diagnoses. Indicates that a
specific set of diagnoses are used in the definition of the MS-DRG. The
diagnoses may be listed as principal or as any one of the secondary
diagnoses. A special case of this condition is MS-DRG 008 in which two
diagnoses (for example, renal and diabetic) must both be present
somewhere in the list of diagnoses in order to be assigned to MS-DRG
008.
Secondary diagnoses. Indicates that a specific set of
secondary diagnoses are used in the definition of the MS-DRG. For
example, a secondary diagnosis of acute leukemia with chemotherapy is
used to define MS-DRG 839.
Only secondary diagnoses. Indicates that in order to be
assigned to the specified MS-DRG no secondary diagnoses other than
those in the specified list may appear on the patient's record. For
example, in order to be assigned to MS-DRG 795, only secondary
diagnoses from the specified list may appear on the patient's record.
As discussed earlier in this section, modifications to the GROUPER
logic were made to allow cases reporting diagnosis code T80.89XA (Other
complications following infusion, transfusion and therapeutic
injection) as the principal diagnosis with any one of the CRS codes as
a secondary diagnosis to group to MS-DRGs 814, 815, and 816. We note
that whenever there is a secondary diagnosis component to the MS-DRG
logic, the diagnosis code can either be used in the logic for
assignment to the MS-DRG or to act as a CC/MCC. For this specific
scenario, the CRS codes, as secondary diagnoses, are being used in the
definition of the logic for assignment to MS-DRGs 814, 815, and 816,
similar to the example described above, where a secondary diagnosis of
acute leukemia with chemotherapy is used to define MS-DRG 839.
In response to the commenter that suggested CMS consider expanding
the logic for the CRS diagnosis codes to include patients diagnosed
with COVID-19, we note that for cases where CRS is present in a patient
diagnosed with COVID-19, depending on the circumstances of the
admission, the COVID-19 would be reported as the principal diagnosis
and the appropriate CRS code would be reported as a secondary
diagnosis. In this scenario, the case would group to a MS-DRG under MDC
04 (Diseases and Disorders of the Respiratory System) because that is
where diagnosis code U07.1, (COVID-19) is assigned. Therefore, we do
not agree that it is necessary to create specific logic for these
patients.
After consideration of the public comments received, and for the
reasons previously discussed, for FY 2021, we are modifying our
proposed severity level designations for a subset of the CRS codes as
shown in Table 6A--New Diagnosis Codes, associated with this
[[Page 58561]]
final rule, and displayed in the table below.
[GRAPHIC] [TIFF OMITTED] TR18SE20.109
We are also finalizing modifications to the ICD-10 MS-DRG GROUPER
logic V38 for MS-DRGs 814, 815, and 816. Effective with discharges on
and after October 1, 2020 (FY 2021), the logic for case assignment to
MS-DRGs 814, 815, and 816 will include a principal diagnosis of
T89.89XA with a secondary diagnosis of any CRS code as noted below.
Principal Diagnosis
T80.89XA Other complications following infusion, transfusion and
therapeutic injection, initial encounter
with
Secondary Diagnosis
D89.831 Cytokine release syndrome, grade 1
D89.832 Cytokine release syndrome, grade 2
D89.833 Cytokine release syndrome, grade 3
D89.834 Cytokine release syndrome, grade 4
D89.835 Cytokine release syndrome, grade 5
D89.839 Cytokine release syndrome, grade unspecified
Comment: Several commenters requested that CMS consider higher
reimbursement for the performance of ultrasound accelerated
thrombolysis procedures utilizing the EKOSTM device.
Specifically, the commenters recommended that ultrasound accelerated
thrombolysis procedures performed with the EKOSTM device for
the treatment of pulmonary embolism (PE) should be assigned to MS-DRGs
163, 164, and 165 (Major Chest Procedures with MCC, with CC, and
without CC/MCC, respectively) versus MS-DRGs 166, 167, and 168 (Other
Respiratory System O.R. Procedures with MCC, with CC, and without CC/
MCC, respectively), and ultrasound accelerated thrombolysis procedures
performed with the EKOSTM device for the treatment of deep
venous thrombosis (DVT) should be assigned to MS-DRGs 270, 271, and 272
(Other Major Cardiovascular Procedures with MCC, with CC, and without
CC/MCC, respectively) versus MS-DRGs 252, 253, and 254 (Other Vascular
Procedures with MCC, with CC, and without CC/MCC, respectively), as
proposed in Table 6B--New Procedure Codes associated with the proposed
rule, regardless of a physician's clinical decision to use a device
that removes matter or a device that fragments matter using ultrasound
accelerated thrombolysis. Some commenters asserted that unique devices
that remove matter, known as extirpating devices, are very similar to
the EKOSTM device in the performance of an ultrasound
accelerated thrombolysis procedure to treat PE or DVT. The commenters
stated the difference is that these extirpating devices, specifically
the FlowTriever[supreg] and ClotTriever[supreg] (Inari Medical, Inc)
and the Indigo[supreg] System (Penumbra), remove matter and the
EKOSTM device (Boston Scientific), fragments matter with the
use of thrombolytics and ultrasonic assistance.
A commenter stated its belief that:
A. Percutaneous ultrasonic fragmentation and extirpation are
both catheter-based procedures that address solid matter in a body
part;
B. Percutaneous ultrasonic fragmentation is similar to other
procedures in the requested MS-DRGs;
C. Both fragmentation and extirpation procedures were evaluated
using similar PE pivotal trial designs and have similar efficacy
results;
D. Both types of procedures have similar overall hospital
resource utilization;
E. Medicare cost data do not reflect EKOSTM cost; and
F. Medicare precedent exists for assignment of new codes to
higher paying groups.
Below we provide the commenters' summaries for each of the
statements listed above which also reflect similar statements or
sentiments submitted by several of the other commenters.
A. Percutaneous Ultrasonic Fragmentation and Extirpation are Both
Catheter-Based Procedures That Address Solid Matter in a Body Part
According to the commenter, clot reduction using percutaneous
ultrasonic fragmentation is similar to extirpation in many respects.
The commenter stated these technologies all use percutaneous
approaches, all treat serious PE, all reduce thrombus burden and all
treat patients in the inpatient hospital setting with intensive care
unit (ICU) care. The commenter provided the following table for
comparison of the different technologies.
[[Page 58562]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.110
The commenter stated that similarly, procedures using percutaneous
clot reduction devices for peripheral vascular (PV) procedures exhibit
many key similarities. All use percutaneous approaches, all manage PV
thromboemboli, all reduce thrombus burden, and all involve inpatient
hospital admission with ICU care. The commenter provided the following
table for comparison.
[GRAPHIC] [TIFF OMITTED] TR18SE20.111
B. Percutaneous Ultrasonic Fragmentation Is Similar to Procedures in
the Requested MS-DRGs
According to the commenter, for PE, percutaneous ultrasonic
fragmentation procedures are clinically similar to procedures that are
assigned to MS-DRGs 163, 164, and 165. The commenter stated that both
extirpation codes and percutaneous ultrasonic fragmentation codes are
reporting services that are intended to reduce clot burden, addressing
matter in the body. The commenter provided the following list of
procedure codes describing extirpation of matter from pulmonary
structures that are currently assigned to MS-DRGs 163, 164, and 165
that it stated are clinically similar to percutaneous ultrasonic
fragmentation procedures for PE.
[GRAPHIC] [TIFF OMITTED] TR18SE20.112
Alternatively, the commenter stated that PE percutaneous ultrasonic
fragmentation procedures are not clinically similar to other procedures
assigned to MS-DRGs 166, 167, and 168. According to the commenter,
percutaneous ultrasonic fragmentation is unlike the other percutaneous
procedure codes assigned to these MS-DRGs and even opposite to some.
The commenter noted an example of how occlusion procedures stop flow,
while percutaneous ultrasonic fragmentation restore flow. The commenter
provided the following list of procedure codes describing occlusion and
repair of pulmonary structures that are currently assigned to MS-DRGs
166, 167, and 168 that it stated are not clinically similar to
percutaneous ultrasonic fragmentation procedures for a PE.
[[Page 58563]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.113
[GRAPHIC] [TIFF OMITTED] TR18SE20.114
In addition, the commenter stated that for PV procedures,
percutaneous ultrasonic fragmentation procedures are clinically similar
to procedures in MS-DRGs 270, 271, and 272. The commenter reiterated
that both extirpation codes and fragmentation codes identify services
that are intended to reduce clot burden, addressing matter in the body.
The commenter provided the following list of procedure codes describing
extirpation of matter from PV structures that are currently assigned to
MS-DRGs 270, 271, and 272 it stated are clinically similar to
percutaneous ultrasonic fragmentation procedures for PE.
[GRAPHIC] [TIFF OMITTED] TR18SE20.115
According to the commenter, as it noted with PE, percutaneous
ultrasonic fragmentation PV procedures are generally unlike the codes
and even opposite to some of the other ICD-10-PCS procedures in MS-DRGs
252, 253, and 254. For example, the commenter stated that percutaneous
ultrasonic fragmentation is not comparable to dilation, which is the
root operation for balloon angioplasty or vascular stenting and is
primarily used to address peripheral artery disease, a condition which
is very different than thrombotic events. The commenter reported that
percutaneous ultrasonic fragmentation procedures using the
EKOSTM device typically involve leaving the
EKOSTM device in the body for multiple hours and in many
cases overnight, which allows time for the thrombolytic to break apart
the thrombus with ultrasonic assistance. The commenter noted the
duration of angioplasty or stenting procedures are typically measured
in minutes, rather than in hours. The commenter also noted that
percutaneous ultrasonic fragmentation procedures are not similar to
release procedures such as a carpal tunnel release procedure, which
usually takes around ten minutes and involves cutting the carpal
ligament. Conversely, percutaneous ultrasonic fragmentation catheters
typically remain in the patient's body for multiple hours or
[[Page 58564]]
overnight and do not cut ligaments, according to the commenter. The
commenter provided the following list of procedure codes describing
dilation (angioplasty) and release of PV structures that are currently
assigned to MS-DRGs 252, 253, and 254 that it stated are not clinically
similar to percutaneous ultrasonic fragmentation procedures for a PV
procedure.
[GRAPHIC] [TIFF OMITTED] TR18SE20.116
[GRAPHIC] [TIFF OMITTED] TR18SE20.117
C. Similar PE Pivotal Trial Designs and Efficacy Results
The commenter stated that pivotal clinical studies for the
treatment of PE with percutaneous ultrasonic fragmentation using
EKOSTM and for extirpation using comparable devices are
consistent, with all designed using the same primary outcome measure.
According to the commenter, the design of pivotal studies for the
extirpating devices (FLARE and EXTRACT-PE) closely mirrors that of the
EKOSTM PE study, SEATTLE II. The commenter provided a table
of device comparisons that were used in the three pivotal clinical
trials to assess treatment of PE followed by another table to
illustrate its findings.
The commenter stated that the FLARE and EXTRACT-PE trials have
nearly identical primary outcome measures and comparable results to
that of the EKOSTM device SEATTLE II study, further
validating the clinical similarity between the EKOSTM device
and the comparable extirpating devices. According to the commenter,
mirroring the EKOSTM SEATTLE II study design validates
comparability of patients and procedures. The commenter asserted that
percutaneous ultrasonic fragmentation procedures with the
EKOSTM device have comparable, and in some cases even
greater, use of hospital resources than extirpation procedures, with a
longer length of stay in the SEATTLE II study than extirpation
procedures in the FLARE study, with multi-day confidence intervals.
D. Similar Hospital Resource Utilization
The commenter stated that the SEATTLE II pivotal trial demonstrated
an average length of stay of 8.8 5 days for percutaneous
ultrasonic fragmentation procedures with the EKOS\TM\ device and the
FLARE pivotal trial showed the hospital average length of stay of 4.1
3.5 days for the FlowTriever[supreg] device. The commenter
also stated that an analysis of MedPAR
[[Page 58565]]
claims for extirpating PE admissions showed a geometric mean length of
stay similar to the FLARE study, with length of stay ranging from 2.9
to 5.1 days across MS-DRGs 163, 164 and 165. The commenter further
stated that from a hospital resource utilization perspective, the
SEATTLE II trial demonstrated that percutaneous ultrasonic
fragmentation procedures with the EKOS\TM\ device involved a length of
stay greater than or equal to that of the comparable extirpation
procedures performed with extirpation devices, given multi-day
confidence intervals. The commenter provided a table to illustrate its
findings of extirpation procedures performed for PE across MS-DRGs 163,
164, and 165.
The commenter also reported that the cost of the percutaneous
ultrasonic fragmentation procedure performed with the EKOS\TM\ device
is highly comparable to the cost of the extirpation procedure performed
with the Indigo[supreg] System, which is assigned to the higher paying
MS-DRGs. The commenter provided the following table to illustrate its
findings of the costs for performing a PE procedure among the different
devices.
[GRAPHIC] [TIFF OMITTED] TR18SE20.118
According to the commenter, overall, hospital resource utilization
is comparable: the length of stay of percutaneous ultrasonic
fragmentation procedures with the EKOS\TM\ device is at least as great
as if not longer than comparable extirpation procedures based on the
SEATTLE II study and Medicare claims data, and device costs are similar
to the Indigo[supreg] System.
E. Medicare Claims Data Do Not Reflect EKOS\TM\ Cost
The commenter stated that the EKOS\TM\ device obtained FDA
indications for PV procedures in July 2008 and for PE in May 2014. The
commenter noted that there has not been ICD-10 procedure coding
specific to EKOS\TM\, and the American Hospital Association (AHA)
recommended a combination of codes to describe the use of EKOS\TM\ in
PE procedures in late 2014:
6A750Z7 Ultrasound therapy of vessels, single
3E06317 Introduction of other thrombolytic into central
artery, percutaneous approach
The commenter conducted its own analysis for the following ICD-10-PCS
procedure codes describing the use of ultrasound and the percutaneous
introduction of thrombolytics and noted they found 544 claims, with 408
of those assigned to MS-DRG 175 (Pulmonary Embolism with MCC or Acute
Cor Pulmonale) and 116 of those assigned to MS-DRG 176 (Pulmonary
Embolism without MCC). According to the commenter, while the AHA coding
recommendation was helpful, it was unable to provide an accurate
assessment of volumes and costs.
[GRAPHIC] [TIFF OMITTED] TR18SE20.119
F. Medicare Precedent Exists for Assignment of New Codes to Higher
Paying Groups
The commenter stated there is precedent for CMS to use its
discretion to assign new codes to higher paying groups, such as the
APCs and MS-DRGs. The commenter provided an example of the 2020
Outpatient Prospective Payment System (OPPS) Proposed Rule and noted
that CMS proposed assigning two new procedure codes for describing
percutaneous creation of AV fistula to a lower level endovascular APC
and after reviewing comments, CMS decided to reconsider this
recommendation and ultimately assigned the codes to a higher level
endovascular APC, as noted in the 2020 OPPS final rule.
Finally, the commenter provided the following table that identifies
the procedure codes describing fragmentation of pulmonary and
peripheral vascular structures and the proposed O.R., MDC, and MS-DRG
assignments for the codes as shown in
[[Page 58566]]
Table 6B--New Procedure Codes associated with the proposed rule. The
commenter added a column with its requested MS-DRG assignments, as
shown in the last column to the right.
BILLING CODE 4120-01-P
[[Page 58567]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.120
[[Page 58568]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.121
[[Page 58569]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.122
[[Page 58570]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.123
[[Page 58571]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.124
BILLING CODE 4120-01-C
Another commenter indicated it was made aware of comments being
submitted in response to the FY 2021 IPPS/LTCH PPS proposed rule
regarding fragmentation codes (04FC3ZZ through 04FY3ZZ). This commenter
noted that
[[Page 58572]]
in each case, the commenter's request was for CMS to revise the MS-DRG
assignment of the fragmentation codes listed in the FY 2021 IPPS/LTCH
PPS proposed rule, from MS-DRGs 252, 253 and 254 to MS-DRGs 270, 271
and 272, which include extirpation procedures, by stating that
fragmentation procedures are clinically and economically similar to
extirpation procedures. The commenter stated it disagreed with the
comparison provided in these comments and specifically with the comment
that intravascular lithotripsy (IVL) fragmentation is more like
extirpation of matter than like other intraluminal balloon-based
procedures. This commenter further disagreed that fragmentation and
extirpation are of similar complexity or accomplish the same treatment
intent in peripheral vascular disease, especially for patients with
critical limb ischemia. The commenter requested that CMS maintain its
current proposed assignments of the new ICD-10-PCS codes for IVL
procedures (04FC3ZZ through 04FY3ZZ) to the MS-DRGs as described in the
proposed rule, and defer any changes to MS-DRG assignments until such
time that additional long-term clinical and economic data become
available to evaluate the new IVL procedures described by these new
codes.
Response: We appreciate the commenters' feedback on the proposed
MS-DRG assignments for the procedure codes that capture ultrasound
accelerated thrombolysis performed with the EkoSonic\TM\ Endovascular
System (EKOS\TM\), identified as ultrasonic fragmentation procedures as
displayed in Table 6B.--New Procedure Codes, associated with the
proposed rule and available via the internet on the CMS web page:
(https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS). We refer the reader to the table above for the list
of ICD-10-PCS procedure codes submitted by a commenter that accurately
identifies the procedure codes describing fragmentation of pulmonary
and peripheral vascular structures with ultrasound and the proposed
O.R., MDC, and MS-DRG assignments as shown in Table 6B--New Procedure
Codes associated with the proposed rule, that are effective October 1,
2020 for reporting ultrasound assisted thrombolysis.
As noted in prior rulemaking (85 FR 32543), for new procedure codes
that have been finalized through the ICD-10 Coordination and
Maintenance Committee meeting process and are proposed to be classified
as O.R. procedures or non-O.R. procedures affecting the MS-DRG, our
clinical advisors recommend the MS-DRG assignment which is then made
available in association with the proposed rule (Table 6B--New
Procedure Codes) and subject to public comment. These proposed
assignments are generally based on the assignment of predecessor codes
or the assignment of similar codes. Consistent with our established
process, we examined the MS-DRG assignment for the predecessor codes to
determine the most appropriate MS-DRG assignment. The predecessor codes
for the new procedure codes describing fragmentation of pulmonary and
peripheral vascular structures with ultrasound as shown in the
September 10, 2019 ICD-10 Coordination and Maintenance Committee
meeting materials are 6A750Z7 (Ultrasound therapy of other vessels,
single) and 3E06317 (Introduction of other thrombolytic into central
artery, percutaneous approach) or 3E05317 (Introduction of other
thrombolytic into peripheral artery, percutaneous approach). Because
these procedure codes are designated as non-O.R. they do not impact the
MS-DRG assignment. Therefore, when any combination of these procedure
codes is currently reported, case assignment is dependent upon the
principal diagnosis, any secondary diagnoses, and whether or not any
other procedures may have been performed and reported on the claim. The
MS-DRG assignment for cases with a principal diagnosis of PE is
generally medical MS-DRG 175 (Pulmonary Embolism with MCC or Acute Cor
Pulmonale) or medical MS-DRG 176 (Pulmonary Embolism without MCC). The
MS-DRG assignment for cases with a principal diagnosis of DVT is
generally medical MS-DRG 299, 300, or 301 (Peripheral Vascular
Disorders with MCC, with CC, and without CC/MCC, respectively).
Therefore, cases currently reporting the use of ultrasound accelerated
thrombolysis for PE or DVT would generally be assigned to one of those
medical MS-DRGs.
The commenters are correct that there are different types of
devices available in the treatment of pulmonary embolism (PE) and deep
venous thrombosis (DVT). The commenters are also correct that some
devices remove matter (clot, thrombus, etc.) while others fragment
(break up) matter, with or without the use of thrombolytics. Under the
ICD-10-PCS procedure classification system there are two root
operations, extirpation and fragmentation, specifically defined as:
Extirpation: Taking or cutting out solid matter from a body part
Fragmentation: Breaking solid matter in a body part into pieces
that are reported to describe the respective procedure that was
performed. Because the EKOS\TM\ device fragments matter, procedures
performed utilizing this device are identified and described by the
root operation Fragmentation, as shown in the titles of the procedure
codes listed in the table previously mentioned and discussed above. We
do not agree that a change in the proposed MS-DRG assignments for the
procedure codes describing ultrasound assisted thrombolysis with the
root operation Fragmentation is warranted at this time. We appreciate
the information provided by the commenters, however, our clinical
advisors do not believe that the treatment difficulty, resource
utilization and complexity of service for fragmentation and extirpation
procedures are similar in the treatment of PE and DVT. In response to
the commenter's statement that both extirpation codes and percutaneous
ultrasonic fragmentation codes are reporting services that are intended
to reduce clot burden, our clinical advisors agree, however, as shown
above, each of these procedures are defined by clinically distinct
definitions and objectives, and why there are separate and unique ICD-
10-PCS procedure codes within the classification for reporting
purposes. Our clinical advisors also do not believe it is appropriate
to specifically compare the devices being utilized in the performance
of these distinct procedures in consideration of MS-DRG assignment (as
the assignment is not related to a new technology add-on payment
application), rather, the emphasis is on the fragmentation and
extirpation procedures performed and evaluating the treatment
difficulty, resource utilization and complexity of service.
With respect to the commenter's statement that PE percutaneous
ultrasonic fragmentation procedures are not clinically similar to other
procedures assigned to MS-DRGs 166, 167, and 168, and PV percutaneous
ultrasonic fragmentation procedures are not clinically similar to other
procedures assigned to MS-DRGs 252, 253, and 254, we note that, as
stated in the ICD-10 MS-DRG Definitions Manual, ``In each MDC there is
usually a medical and a surgical class referred to as ``other medical
diseases'' and ``other surgical procedures,'' respectively. The
``other'' medical and surgical classes are not as precisely defined
from a clinical perspective. The
[[Page 58573]]
other classes would include diagnoses or procedures which were
infrequently encountered or not well defined clinically. For example,
the ``other'' medical class for the Respiratory System MDC would
contain the diagnoses ``other somatoform disorders'' and ``congenital
malformation of the respiratory system,'' while the ``other'' surgical
class for the female reproductive MDC would contain the surgical
procedures ``excision of liver'' (liver biopsy in ICD-9-CM) and
``inspection of peritoneal cavity'' (exploratory laparotomy in ICD-9-
CM). The ``other'' surgical category contains surgical procedures
which, while infrequent, could still reasonably be expected to be
performed for a patient in the particular MDC. There are, however, also
patients who receive surgical procedures which are completely unrelated
to the MDC to which the patient was assigned. An example of such a
patient would be a patient with a principal diagnosis of pneumonia
whose only surgical procedure is a destruction of prostate
(transurethral prostatectomy in ICD-9-CM). Such patients are assigned
to a surgical class referred to as ``unrelated operating room
procedures.'' These patients are ultimately never assigned to a well-
defined DRG.'' We further note that MS-DRGs 166, 167, and 168 (Other
Respiratory System O.R. Procedures with MCC, with CC, and without CC/
MCC, respectively) and MS-DRGs 252, 253, and 254 (Other Vascular
Procedures with MCC, with CC, and without CC/MCC, respectively) are
examples of the ``other'' surgical class, therefore it is expected that
there will be procedures not precisely clinically aligned within the
definition (logic) of these MS-DRGs.
We appreciate the commenter's feedback and information pertaining
to the pivotal trials that have been conducted, however, as stated
previously, fragmentation and extirpation procedures are clinically
distinct and separate procedures, uniquely defined within the
classification, and our clinical advisors do not believe it is
appropriate to specifically compare the devices being utilized in the
performance of these distinct procedures with respect to resource
utilization and in consideration of MS-DRG assignment. As discussed
earlier in this section, we followed our established process for
determining the most appropriate MS-DRG assignment for new procedure
codes.
We acknowledge the claims analysis conducted by the commenter and
because the current procedure codes do not uniquely identify and
describe ultrasound accelerated thrombolysis we concur it is difficult
to accurately assess the data.
The ICD-10-CM diagnosis codes that identify pulmonary embolism and
acute cor pulmonale that are included in the logic for MS-DRGs 175 and
176 are:
[GRAPHIC] [TIFF OMITTED] TR18SE20.125
We analyzed claims data from the September 2019 update of the FY
2019 MedPAR file for cases reporting fragmentation procedures in MS-
DRGs 175 and 176 with a principal diagnosis of PE and procedure codes
6A750Z7 with 3E06317 to identify the use of fragmentation via
ultrasound and thrombolytics. Our findings are shown in the following
table.
[[Page 58574]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.127
The data demonstrates that the 297 cases reporting a principal
diagnosis of PE with the use of ultrasound and thrombolytics in MS-DRGs
175 and 176 (235+62=297) have higher average costs compared to all the
cases in MS-DRGs 175 and 176 ($21,191 versus $10,515 and $19,035 versus
$6,268, respectively) and a comparable average length of stay (5.0 days
versus 5.0 days and 3.8 days versus 3.1 days, respectively).
The ICD-10-CM diagnosis codes that identify DVT that are included
in the logic for MS-DRGs 299, 300 and 301 are:
BILLING CODE 4120-01-P
[[Page 58575]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.128
[[Page 58576]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.129
[[Page 58577]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.130
BILLING CODE 4120-01-C
We also examined claims for cases reporting fragmentation
procedures in MS-DRGs 299, 300 and 301 with a principal diagnosis of
DVT and procedure codes 6A750Z7 with 3E06317 to identify the use of
fragmentation via ultrasound and thrombolytics. Our findings are shown
in the following table.
[[Page 58578]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.131
The data demonstrates that the 4 cases reporting a principal
diagnosis of DVT with the use of ultrasound and thrombolytics in MS-
DRGs 299 and 300 (3+1=4) have higher average costs compared to all the
cases in MS-DRGs 299 and 300 ($15,942 versus $10,611 and $12,930 versus
$7,378, respectively) and a comparable average length of stay (3.3 days
versus 5.2 days and 4.0 days versus 3.9 days, respectively). We note
that there were no cases found reporting a principal diagnosis of DVT
with the use of ultrasound and thrombolytics in MS-DRG 301.
We then analyzed claims data from the September 2019 update of the
FY 2019 MedPAR data for MS-DRGs 163, 164, and 165 and MS-DRGs 270, 271,
and 272. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TR18SE20.132
Overall, the data demonstrates that cases reporting a principal
diagnosis of PE with ultrasound and thrombolytic (fragmentation) in MS-
DRG 175 have average costs and an average length of stay that are less
than the average costs and average length of stay of all the cases in
MS-DRG 163 ($21,191 versus $34,718) and (5.0 days versus 11.6 days).
The data also demonstrates that cases reporting a principal diagnosis
of PE with ultrasound and thrombolytic (fragmentation) in MS-DRG 176
have average costs and an average length of stay that are less than the
average costs and average length of stay of all the cases in MS-DRG 164
($19,035 versus $19,120) and (3.8 days versus 5.4 days). We note that
because MS-DRG 175 is the ``with MCC'' MS-DRG and MS-DRG 176 is the
``without MCC'' (CC+NonCC) MS-DRG that it's possible a subset of the 62
cases found reporting a principal diagnosis of PE with ultrasound and
thrombolytic in MS-DRG 176 did not report a CC and those cases would
then be compared to MS-DRG 165, however, we were unable to analyze the
detailed data for the 62 cases.
The data demonstrates that cases reporting a principal diagnosis of
DVT with ultrasound and thrombolytic (fragmentation) in MS-DRG 299 have
average costs and an average length of stay that are less than the
average costs and average length of stay of all the cases in MS-DRG 270
($15,942 versus $37,100) and (3.3 days versus 9.4 days). The data also
demonstrates that cases reporting a principal diagnosis of DVT with
ultrasound and thrombolytic (fragmentation) in MS-DRG 300 have average
costs and an average length of stay that are less than the average
costs and average length of stay of all the cases in MS-DRG 271
($12,930 versus $28,219) and (4.0 days versus 5.8 days). For these
reasons, based on the claims analysis, our clinical advisors do not
support assignment of the new procedure codes describing fragmentation
via ultrasound accelerated thrombolysis for the treatment of PE to MS-
DRGs 163, 164, and 165 or to MS-DRGs 270, 271, and 272 for the
treatment of DVT.
We then analyzed claims data from the September 2019 update of the
FY 2019 MedPAR data for MS-DRGs 166, 167, and 168 and MS-DRGs 252, 253,
and 254. Our findings are shown in the following table.
[[Page 58579]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.133
Overall, the data demonstrates that cases reporting a principal
diagnosis of PE with ultrasound and thrombolytic (fragmentation) in MS-
DRG 175 have average costs and an average length of stay that are more
consistent with the average costs and average length of stay of all the
cases in MS-DRG 166 ($21,191 versus $26,702) and (5.0 days versus 10.3
days). The data also demonstrates that cases reporting a principal
diagnosis of PE with ultrasound and thrombolytic (fragmentation) in MS-
DRG 176 have average costs and an average length of stay that are more
consistent with the average costs and average length of stay of all the
cases in MS-DRG 167 ($19,035 versus $13,566) and (3.8 days versus 4.9
days). We note that it's possible that a subset of the 62 cases found
reporting a principal diagnosis of PE with ultrasound and thrombolytic
in MS-DRG 176 did not report a CC and those cases would then be
compared to MS-DRG 168, however, we were unable to analyze the detailed
data for the 62 cases.
The data also demonstrates that cases reporting a principal
diagnosis of DVT with ultrasound and thrombolytic (fragmentation) in
MS-DRG 299 have average costs and an average length of stay that are
more consistent with the average costs and average length of stay of
all the cases in MS-DRG 252 ($15,942 versus $24,369) and (3.3 days
versus 7.5 days). The data also demonstrates that cases reporting a
principal diagnosis of DVT with ultrasound and thrombolytic
(fragmentation) in MS-DRG 300 have average costs and an average length
of stay that are more consistent with the average costs and average
length of stay of all the cases in MS-DRG 253 ($12,930 versus $19,316)
and (4.0 days versus 5.4 days). As previously noted, there were no
cases found reporting a principal diagnosis of DVT with ultrasound and
thrombolytic (fragmentation) in MS-DRG 301. For these reasons, our
clinical advisors stated the claims analysis supports assignment of the
new procedure codes describing fragmentation via ultrasound accelerated
thrombolysis for the treatment of PE to MS-DRGs 166, 167, and 168 and
to MS-DRGs 252, 253, and 254 for the treatment of DVT.
With respect to the commenter who stated it disagreed with the
comparison provided in the other comments, specifically for IVL
fragmentation, we appreciate the commenter's feedback, however, we
believe that the commenter expressed concerns regarding a different
subset of procedure codes that are also reported with the root
operation fragmentation. The procedure codes describing fragmentation
that are reported to identify an IVL procedure was performed do not
include the term ``ultrasonic'' that is reported with the 7th digit
character qualifier value of ``0'' for the ultrasound accelerated
thrombolysis procedures. Alternatively, the procedure codes describing
fragmentation that are reported to identify an IVL procedure was
performed are reported with the 7th digit character qualifier value of
``Z''.
After consideration of the public comments we received, and for
reasons previously discussed, we are finalizing our proposal to assign
the ultrasound accelerated thrombolysis procedures described by the
root operation fragmentation and performed for the treatment of PE to
MS-DRGs 166, 167, and 168 and for the treatment of DVT to MS-DRGs 252,
253, and 254 as proposed in Table 6B--New Procedure Codes associated
with the proposed rule, and shown in Table 6B--New Procedure Codes
associated with this final rule.
We note that, as stated in prior rule making (84 FR 42148), our
clinical advisors recognize that MS-DRGs 163, 164, 165, 166, 167, and
168 may warrant further review and therefore, we plan to begin
conducting this detailed review beginning with our FY 2022 MS-DRG
classification analysis of claims data and determine what modifications
may need to be considered for future rulemaking.
Comment: A commenter expressed concern that ICD-10-PCS procedure
code XW0Q316 (Introduction of eladocagene exuparvovec into cranial
cavity and brain, percutaneous approach, new technology group 6) did
not have an O.R. procedure status proposed for FY 2021 as displayed in
Table 6--New Procedure Codes associated with the proposed rule.
According to the commenter, this new procedure code should have O.R.
status because it involves traversing the skull in order to place a
substance within the cranial cavity or brain. The commenter stated that
the skull must be opened by drilling/cutting a burr hole and that
although percutaneous (burr hole) procedures are performed through
smaller openings in the skull than larger open burr hole procedures,
they nonetheless require drilling through the skull under sterile
technique with anesthesia for pain control. The commenter also stated
that specialized equipment for a stereotactic approach, image-guidance
and/or endoscope is required. Lastly, the commenter reported that other
percutaneous procedures (including drainages) of the cranial cavities
and brain have been discussed with CMS and appropriately re-classified
to OR procedure status.
Response: We appreciate the commenter's feedback. 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 assignment. The predecessor
code for procedure code XW0Q316 is procedure code 3E0Q3GC (Introduction
of other therapeutic substance into cranial cavity and brain,
percutaneous approach) which is designated as a non-O.R. procedure. In
the absence of claims data, our clinical advisors also considered the
indication for the specific procedure being described by the new
procedure code, the treatment difficulty, and the resources utilized.
Upon review, our clinical advisors do not believe that a change in the
O.R. status for this procedure is warranted at this time.
[[Page 58580]]
After consideration of the comment we received, we are finalizing
our proposal to designate procedure code XW0Q316 as non-O.R. for FY
2021. As claims data becomes available for this procedure we can
reevaluate for future rule making.
We are making available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html
the following tables associated with this final rule:
Table 6A--New Diagnosis Codes-FY 2021;
Table 6B--New Procedure Codes-FY 2021;
Table 6C--Invalid Diagnosis Codes-FY 2021;
Table 6E--Revised Diagnosis Code Titles-FY 2021;
Table 6G.1--Secondary Diagnosis Order Additions to the CC
Exclusions List-FY 2021;
Table 6G.2--Principal Diagnosis Order Additions to the CC
Exclusions List-FY 2021;
Table 6H.1--Secondary Diagnosis Order Deletions to the CC
Exclusions List-FY 2021;
Table 6H.2--Principal Diagnosis Order Deletions to the CC
Exclusions List--FY 2021;
Table 6I--Complete MCC List-FY 2021;
Table 6I.1--Additions to the MCC List-FY 2021;
Table 6I.2-Deletions to the MCC List-FY 2021;
Table 6J--Complete CC List -FY 2021;
Table 6J.1--Additions to the CC List-FY 2021;
Table 6J.2--Deletions to the CC List -FY 2021; and
Table 6K--Complete List of CC Exclusions -FY 2021.14.
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 2020 IPPS/LTCH PPS final rule (84 FR 42156),
we made available the FY 2020 ICD-10 MCE Version 37 manual file. The
manual contains the definitions of the Medicare code edits, including a
description of each coding edit with the corresponding diagnosis and
procedure code edit lists. The link to this MCE manual file, along with
the link to the mainframe and computer software for the MCE Version 37
(and ICD-10 MS-DRGs) are posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
In the FY 2021 IPPS/LTCH PPS proposed rule, we addressed the MCE
requests we received by the November 1, 2019 deadline. We also
discussed the proposals we were making based on internal review and
analysis. In this FY 2021 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 have 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 2021 ICD-10 MCE Version 38 Manual file, along with the
link to the mainframe and computer software for the MCE Version 38 (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.
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 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 9-64 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) Maternity Diagnoses
Under the ICD-10 MCE, the Maternity diagnoses category for the Age
conflict edit considers the age range of 9 to 64 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.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6A.--New Diagnosis
Codes, lists the diagnosis codes that have been approved to date which
will be effective with discharges on and after October 1, 2020. We
proposed to add the following new ICD-10-CM diagnosis codes listed in
this section of this rule to the Maternity diagnoses category code list
under the Age conflict edit.
[[Page 58581]]
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In addition, as discussed in section II.D.13. of the preamble of
the proposed rule and section II.E.13. of this final rule, Table 6C.--
Invalid Diagnosis Codes, lists the diagnosis codes that are no longer
effective October 1, 2020. Included in this table is ICD-10-CM
diagnosis code O99.89 (Other specified diseases and conditions
complicating pregnancy, childbirth and the puerperium) which is
currently listed on the Maternity diagnoses category code list under
the Age Conflict edit. We proposed to remove this code from the
Maternity diagnoses category code list.
Comment: Commenters agreed with CMS' proposal to add the diagnosis
codes listed in the previous table to the Maternity diagnoses category
code list under the Age conflict edit. Commenters also agreed to remove
ICD-10-CM diagnosis code O99.89 (Other specified diseases and
conditions complicating pregnancy, childbirth and the puerperium) from
the Maternity diagnoses category edit code list under the Age Conflict
edit since it is no longer a valid code effective October 1, 2020.
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
previous table to the Maternity diagnoses category edit code list and
our proposal to remove ICD-10-CM diagnosis code O99.89 from the
Maternity diagnoses category edit code list under the ICD-10 MCE
Version 38, effective October 1, 2020.
(2) Adult Diagnoses
Under the ICD-10 MCE, the Adult diagnoses category for the Age
conflict edit considers the age range of 15 to 124 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.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6A.--New Diagnosis
Codes, lists the diagnosis codes that have been approved to date which
will be effective with discharges on and after October 1, 2020. We
proposed to add the following new ICD-10-CM diagnosis codes to the
Adult diagnoses category code list under the Age conflict edit.
[GRAPHIC] [TIFF OMITTED] TR18SE20.135
Comment: Commenters supported the proposal to add the diagnosis
codes listed in the previous table to the Adult diagnoses category code
list under the Age conflict edit.
Response: We thank the commenters for their support.
After consideration of the public comments we received, we are
finalizing our proposal to add the diagnosis codes listed in the
previous table to the Adult diagnoses category edit code list under the
ICD-10 MCE Version 38, effective October 1, 2020.
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
As discussed in section II.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6A.--New Diagnosis
Codes, lists the new diagnosis codes that have been approved to date
which will be effective
[[Page 58582]]
with discharges on and after October 1, 2020. We proposed to add the
following new ICD-10-CM diagnosis codes listed in this section of this
rule to the edit code list for the Diagnoses for Females Only edit.
[GRAPHIC] [TIFF OMITTED] TR18SE20.136
In addition, as discussed in section II.D.13. of the preamble of
the proposed rule and section II.E.13. of this final rule, Table 6C.--
Invalid Diagnosis Codes, lists the diagnosis codes that are no longer
effective October 1, 2020. Included in this table are ICD-10-CM
diagnosis code O99.89 (Other specified diseases and conditions
complicating pregnancy, childbirth and the puerperium) and ICD-10-CM
diagnosis code Q51.20 (Other doubling of uterus, unspecified) which are
currently listed on the Diagnoses for Females Only edit code list. We
proposed to delete these codes from the Diagnoses for Females Only edit
code list.
Comment: Commenters supported the proposal to add the ICD-10-CM
diagnosis codes listed in the previous table to the Diagnoses for
Females Only edit code list and to remove ICD-10-CM diagnosis codes
O99.89 and Q51.20 from the list of diagnosis codes for the Diagnoses
for Females Only edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments that we received, we are
finalizing our proposal to add the diagnosis codes displayed in the
previous table to the Diagnoses for Females Only edit code list and our
proposal to remove ICD-10-CM diagnosis code O99.89 and Q51.20 from the
Diagnoses for Females Only edit code list under the ICD-10 MCE Version
38, effective October 1, 2020.
(2) Procedures for Females Only Edit
As discussed in section II.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6B--New Procedure
Codes, lists the new procedure codes that have been approved to date
which will be effective with discharges on and after October 1, 2020.
We proposed to add the following new ICD-10-PCS procedure codes listed
in this section of this rule to the edit code list for the Procedures
for Females Only edit.
[GRAPHIC] [TIFF OMITTED] TR18SE20.137
Comments: Commenters supported our proposal to add the ICD-10-PCS
procedure codes listed in the previous table to the edit code list for
the Procedures for Females Only edit.
Response: We thank the commenters for their support.
After consideration of the public comments that we received, we are
finalizing our proposal to add the ICD-10-PCS procedure codes listed in
the previous table to the edit code list for the Procedures for Females
Only edit under the ICD-10 MCE Version 38, effective October 1, 2020.
(3) Procedures for Males Only
As discussed in section II.D.13. of the preamble of the proposed
rule and in section II.E.13. of this final rule, Table 6B--New
Procedure Codes, lists the new procedure codes that have been approved
to date which will be effective with discharges on and after October 1,
2020. We proposed to add the following new ICD-10-PCS procedure codes
listed in this section of this rule to the edit code list for the
Procedures for Males Only edit.
[GRAPHIC] [TIFF OMITTED] TR18SE20.138
Comments: Commenters agreed with our proposal to add the ICD-10-PCS
procedure codes listed in the previous table to the edit code list for
the Procedures for Males Only edit.
Response: We appreciate the commenters' support.
[[Page 58583]]
After consideration of the public comments that we received, we are
finalizing our proposal to add the ICD-10-PCS procedure codes listed in
the previous table to the edit code list for the Procedures for Males
Only edit under the ICD-10 MCE Version 38, effective October 1, 2020.
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.
As discussed in section II.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6A--New Diagnosis
Codes, lists the new diagnosis codes that have been approved to date
which will be effective with discharges on and after October 1, 2020.
We proposed to add the following new ICD-10-CM diagnosis codes listed
in this section of this rule to the edit code list for the
Manifestation Codes Not Allowed as Principal Diagnosis edit code list
because these codes are describing the manifestation of an underlying
disease and not the disease itself.
[GRAPHIC] [TIFF OMITTED] TR18SE20.139
Comment: We received comments in support of our proposal to add the
codes listed in the previous table to the Manifestation Codes Not
Allowed as Principal Diagnosis edit code list.
Response: We appreciate the commenters' support.
After consideration of the public comments that we received, we are
finalizing our proposal to add the ICD-10-CM diagnosis codes listed in
the previous table to the edit code list for the Manifestation Codes
Not Allowed as Principal Diagnosis edit under the ICD-10 MCE Version
38, effective October 1, 2020.
In addition, as discussed in section II.D.13. of the preamble of
the proposed rule and in section II.E.13. of this final rule, Table
6C.--Invalid Diagnosis Codes, lists the diagnosis codes that are no
longer effective October 1, 2020. Included in this table is ICD-10-CM
diagnosis code J84.17 (Other interstitial pulmonary diseases with
fibrosis in diseases classified elsewhere) which is currently listed on
the Manifestation Codes Not Allowed as Principal Diagnosis edit code
list. We proposed to delete this code from the Manifestation Codes Not
Allowed as Principal Diagnosis edit code list.
Comment: Commenters agreed with the proposal to delete ICD-10-CM
diagnosis code J84.17 (Other interstitial pulmonary diseases with
fibrosis in diseases classified elsewhere) from the Manifestation Codes
Not Allowed as Principal Diagnosis edit code list.
Response: We appreciate the commenters' support of our proposal.
After consideration of the public comments that we received, we are
finalizing our proposal to delete ICD-10-CM diagnosis code J84.17 from
the Manifestation Codes Not Allowed as Principal Diagnosis edit code
list under the ICD-10 MCE Version 38, effective October 1, 2020.
d. 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.
As discussed in Section II.D.13. of the preamble of the proposed
rule and section II.E.13. of this final rule, Table 6A.--New Diagnosis
Codes, lists the new diagnosis codes that have been approved to date
which will be effective with discharges on and after October 1, 2020.
We proposed to add the following new ICD-10-CM diagnosis codes listed
in this section of this rule to the Unacceptable Principal Diagnosis
edit code list.
[[Page 58584]]
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[GRAPHIC] [TIFF OMITTED] TR18SE20.141
Comment: Commenters supported our proposal to add the diagnosis
codes listed in the previous table to the Unacceptable Principal
Diagnosis edit code list. However, one commenter disagreed with adding
the diagnosis codes describing Cytokine release syndrome (CRS) (D89.831
through D89.839) to the Unacceptable Principal Diagnosis edit code
list. The commenter noted that at the ICD-10 Coordination and
Maintenance Committee meeting held on September 11-12, 2019, CRS was
described as a condition that may occur after treatment with some types
of immunotherapy, such as Chimeric Antigen Receptor (CAR) T-cell
therapy, and is the most common reaction after CAR T-cell therapy. The
commenter stated that if CRS is the reason for the admission and is an
adverse effect of the therapy/drug, the diagnosis code for the CRS must
be sequenced as the principal diagnosis per coding guidelines,
therefore, the CRS diagnosis codes should not be included on the
Unacceptable Principal Diagnosis edit code list. This commenter also
disagreed with adding diagnosis codes K74.00 (Hepatic fibrosis,
unspecified), K74.01 (Hepatic fibrosis, early fibrosis), and K74.02
(Hepatic fibrosis, advanced fibrosis) to the Unacceptable Principal
Diagnosis edit code list. The commenter noted that hepatic fibrosis may
be determined to be the underlying cause of symptoms such as weakness,
nausea, jaundice, or appetite loss in a patient. The commenter also
stated that the current diagnosis code, K74.0 (Hepatic fibrosis) is not
on the Unacceptable Principal Diagnosis edit code list, therefore,
diagnosis codes K74.00, K74.01 and K74.02 should not be included on the
Unacceptable Principal Diagnosis edit code list. This same commenter
also disagreed with adding diagnosis codes Z03.821 (Encounter for
observation for suspected ingested foreign body ruled out), Z03.822
(Encounter for observation for suspected aspirated (inhaled) foreign
body ruled out), and Z03.823 (Encounter for observation for suspected
inserted (injected) foreign body ruled out) to the Unacceptable
Principal Diagnosis edit code list. The commenter stated that
[[Page 58585]]
current codes in subcategory Z03.8 are only reportable as principal
diagnosis/first listed except when there are multiple encounters on the
same day and the medical records for the encounters are combined and
therefore, diagnosis codes Z03.821, Z03.822, and Z03.823 should not be
included on the Unacceptable Principal Diagnosis edit code list.
Response: We appreciate the commenters' feedback on our proposal.
In response to the commenter who disagreed with our proposal to add the
diagnosis codes describing Cytokine release syndrome (CRS) (D89.831
through D89.839) to the Unacceptable Principal Diagnosis edit code
list, we note that we consulted with the staff at the Centers for
Disease Control and Prevention'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 they do not
consider CAR T-cell therapy to be a drug since it is a gene therapy.
They noted that the ICD-10-CM Tabular instruction at subcategory
D89.83- (Cytokine release syndrome) has a ``Code first'' that reads:
``Code first underlying cause, such as:
complications following infusion, transfusion and therapeutic injection
(T80.89-) complications of transplanted organs and tissue (T86.-)''
They also stated that the intent is for the CRS codes to not be
reported as a principal diagnosis. Diagnosis codes K74.00 (Hepatic
fibrosis, unspecified), K74.01 (Hepatic fibrosis, early fibrosis), and
K74.02 (Hepatic fibrosis, advanced fibrosis) also have a ``Code first''
note at the new subcategory K74.0 (Hepatic fibrosis), effective October
1, 2020. The commenter is correct that currently, diagnosis code K74.0
is not on the Unacceptable Principal Diagnosis Code list and we note
that there is not a ``Code first'' note currently at that diagnosis
code. We point out that diagnosis code K74.0 has been expanded
effective October 1 and is therefore classified as a subcategory. The
ICD-10-CM Tabular instruction at new subcategory K74.0 has a ``Code
first'' note that reads:
``Code first underlying liver disease, such as:
nonalcoholic steatohepatitis (NASH) (K75.81)''
The ``Code first'' note at this subcategory applies to all three
new diagnosis codes, K74.00, K74.01, and K74.02.
In response to the commenter's disagreement with adding diagnosis
codes Z03.821 (Encounter for observation for suspected ingested foreign
body ruled out), Z03.822 (Encounter for observation for suspected
aspirated (inhaled) foreign body ruled out), and Z03.823 (Encounter for
observation for suspected inserted (injected) foreign body ruled out)
to the Unacceptable Principal Diagnosis edit code list, we note that
these diagnosis codes were created in response to a request from the
American Academy of Pediatrics, which indicated that since a child is
often not able to communicate what occurred, there needs to be a way to
identify and track these kinds of encounters, therefore, we would not
expect these codes to be reported in our Medicare claims data for an
inpatient stay.
After consideration of the public comments that we received, we are
finalizing our proposal to add the diagnosis codes listed in the
previous table to the Unacceptable Principal Diagnosis edit code list
under the ICD-10 MCE Version 38, effective October 1, 2020.
In addition, as discussed in section II.D.13. of the preamble of
the proposed rule and in section II.E.13. of this final rule, Table
6C.--Invalid Diagnosis Codes, lists the diagnosis codes that are no
longer effective October 1, 2020. Included in this table are the
following ICD-10-CM diagnosis codes that are currently listed on the
Unacceptable Principal Diagnosis edit code list. We proposed to delete
these codes from the Unacceptable Principal Diagnosis edit code list.
[GRAPHIC] [TIFF OMITTED] TR18SE20.142
Comment: Commenters agreed with our proposal to remove the codes
listed in the previous table from the Unacceptable Principal Diagnosis
edit code list since they are no longer valid effective October 1,
2020.
Response: We thank the commenters for their support.
After consideration of the public comments that we received, we are
finalizing our proposal to remove the diagnosis codes, as previously
listed, from the Unacceptable Principal Diagnosis edit code list under
the ICD-10 MCE Version 38, effective October 1, 2020.
e. 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. Subsequently, in the FY 2019 IPPS/LTCH PPS proposed rule (83
FR 20235) we stated that we engaged a contractor to assist in the
review of the limited coverage and non-covered 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 is 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. The
contractor is continuing to conduct this review.
We have also noted that the purpose of the MCE is to ensure that
errors and inconsistencies in the coded data are recognized during
Medicare claims processing. As we indicated in the FY
[[Page 58586]]
2019 IPPS/LTCH PPS final rule (83 FR 41228), 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 have discussed in prior rulemaking, 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, 2020.
15. 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 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 2021 IPPS/
LTCH PPS proposed rule, as discussed in section II.E.2.b. of the
preamble of this final rule, we proposed to revise the surgical
hierarchy for the Pre-MDC MS-DRGs as follows: In the Pre-MDC MS-DRGs we
proposed to sequence proposed new Pre-MDC MS-DRG 018 (Chimeric Antigen
Receptor (CAR) T-cell Immunotherapy) above Pre-MDC MS-DRGs 001 and 002
(Heart Transplant or Implant of Heart Assist System with and without
MCC, respectively). We also note that, as discussed in section
II.D.2.b. of the preamble of the proposed rule and in section II.E.2.b.
of this final rule, we proposed to revise the title for Pre-MDC MS-DRG
016 to ``Autologous Bone Marrow Transplant with CC/MCC''. In addition,
based on the changes that we proposed to make as discussed in section
II.D.8.a. of the preamble of the proposed rule and in section II.E.8.a.
of this final rule, we also proposed to sequence proposed new Pre-MDC
MS-DRG 019 (Simultaneous Pancreas/Kidney Transplant with Hemodialysis)
above Pre-MDC MS-DRG 008 (Simultaneous Pancreas/Kidney Transplant) and
below Pre-MDC MS-DRG 007 (Lung Transplant).
As discussed in section II.D.4. of the preamble of the proposed
rule and section II.E.4. of this final rule, we proposed to delete MS-
DRGs 129 (Major Head and Neck Procedures with CC/MCC or Major Device)
and MS-DRG 130 (Major Head and Neck Procedures without CC/MCC), MS-DRGs
131 and 132 (Cranial and Facial Procedures with CC/MCC and without CC/
MCC, respectively), and MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and
Throat O.R. Procedures with CC/MCC and without CC/MCC, respectively).
Based on the changes we proposed to make for those MS-DRGs in MDC 03,
we proposed to revise the surgical hierarchy for MDC 03 (Diseases and
Disorders of the Ear, Nose, Mouth and Throat) as follows: In MDC 03, we
proposed to sequence proposed new MS-DRGs 140, 141, and 142 (Major Head
and Neck Procedures with MCC, with CC, and without CC/MCC,
respectively) above new MS-DRGs 143, 144, and 145 (Other Ear, Nose,
Mouth and Throat O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively). We also proposed to sequence proposed new MS-DRGs 143,
144, and 145 above MS-DRGs 135 and 136 (Sinus and Mastoid Procedures
with CC/MCC and without CC/MCC, respectively). We also note that, based
on the changes that we proposed to make, as discussed in section
II.D.7.b. of the preamble of the proposed rule and section II.E.7.b. of
this final rule, we proposed to revise the surgical hierarchy for MDC
08 (Diseases and
[[Page 58587]]
Disorders of the Musculoskeletal System and Connective Tissue) as
follows: In MDC 08, we proposed to sequence proposed new MS-DRGs 521
and 522 (Hip Replacement with Principal Diagnosis of Hip Fracture with
and without MCC, respectively) above MS-DRGs 469 (Major Hip and Knee
Joint Replacement or Reattachment of Lower Extremity with MCC or Total
Ankle Replacement) and 470 (Major Hip and Knee Joint Replacement or
Reattachment of Lower Extremity without MCC). We further note that,
based on the changes we proposed to make, as discussed in section
II.D.8.a. of the preamble of the proposed rule and section II.E.8.a. of
this final rule, we proposed to revise the surgical hierarchy for MDC
11 (Diseases and Disorders of the Kidney and Urinary Tract) as follows:
In MDC 11, we proposed to sequence proposed new MS-DRGs 650 and 651
(Kidney Transplant with Hemodialysis with and without MCC,
respectively) above MS-DRG 652 (Kidney Transplant).
Our proposal for Appendix D MS-DRG Surgical Hierarchy by MDC and
MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 38 is
illustrated in the following tables.
[GRAPHIC] [TIFF OMITTED] TR18SE20.143
Comment: Commenters supported our proposal to sequence proposed new
Pre-MDC MS-DRG 018 above Pre-MDC MS-DRGs 001 and 002. Commenters also
supported our proposal to sequence proposed new Pre-MDC MS-DRG 019
above Pre-MDC MS-DRG 008 and below Pre-MDC MS-DRG 007.
Response: We appreciate the commenters' support. As discussed in
section II.E.2.b. of the preamble of this final rule, we are finalizing
our proposal to create new Pre-MDC MS-DRG 018. In addition, as
discussed in section II.E.8.a. of the preamble of this final rule, we
are finalizing our proposal to create new Pre-MDC MS-DRG 019.
Comment: Commenters agreed with our proposal to sequence proposed
new MS-DRGs 140, 141, and 142 above
[[Page 58588]]
proposed new MS-DRGs 143, 144, and 145 and our proposal to sequence
proposed new MS-DRGs 143, 144, and 145 above MS-DRGs 135 and 136 in MDC
03.
Response: We thank the commenters for their support. As discussed
in section II.E.4. of the preamble of this final rule, we are
finalizing our proposal to create new MS-DRGs 140, 141, and 142 and new
MS-DRGs 143, 144, and 145.
Comment: Commenters supported our proposal to sequence proposed new
MS-DRGs 521 and 522 above MS-DRGs 469 and 470 in MDC 08.
Response: We appreciate the commenters' support. As discussed in
section II.E.7.b. of the preamble of this final rule, we are finalizing
our proposal to create new MS-DRGs 521 and 522.
Comment: Commenters agreed with our proposal to sequence proposed
new MS-DRGs 650 and 651 above MS-DRG 652 (Kidney Transplant) in MDC 11.
Response: We thank the commenters for their support. As discussed
in section II.E.8.a. of the preamble of this final rule, we are
finalizing our proposal to create new MS-DRGs 650 and 651.
After consideration of the public comments we received, we are
finalizing the proposed changes as illustrated in the tables above for
the surgical hierarchy within Appendix D MS-DRG Surgical Hierarchy by
MDC and MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 38 for
FY 2021.
16. Maintenance of 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 CDC National Center for Health Statistics (NCHS) 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 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 2021 at a public meeting held on September 10-11,
2019, and finalized the coding changes after consideration of comments
received at the meetings and in writing by November 08, 2019.
The Committee held its 2020 meeting on March 17-18, 2020. The
deadline for submitting comments on these code proposals was April 17,
2020. It was announced at this meeting that any new diagnosis and
procedure codes for which there was consensus of public support and for
which complete tabular and indexing changes would be made by June 2020
would be included in the October 1, 2020 update to the ICD-10-CM
diagnosis and ICD-10-PCS procedure code sets. 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, and Table 6E--
Revised Diagnosis 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 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 are not published in the Addendum to the proposed or final
rule. Rather, they are available via the internet as discussed in
section VI. of the Addendum to the proposed rule and this final rule.
Live Webcast recordings of the discussions of the diagnosis and
procedure codes at the Committee's September 10-11, 2019 meeting and a
recording of the virtual meeting held on March 17-18, 2020 can be
obtained from the CMS website at: https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials. The materials for the discussions
relating to diagnosis codes at the September 10-11, 2019 meeting and
March 17-18, 2020 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 or participating in a Committee meeting, timeline
requirements and meeting dates.
We encourage commenters to address suggestions on coding issues
involving diagnosis codes via Email to: [email protected].
Questions and comments concerning the procedure codes should be
submitted via Email to: [email protected].
Comment: A commenter stated that there was a need to establish and
adhere to principles of greater transparency through making coding
proposals and revisions public. The commenter also recommended that
information be provided to entities that submit similar or related
coding requests to enable more efficient and in depth public discussion
and that reasonable notice is provided along with timely and accurate
agendas when a coding change is accepted for discussion so that key
stakeholders are able to participate in public meetings. The commenter
also
[[Page 58589]]
suggested that clear and timely transcripts or recordings of such
meetings should always be made publicly available as well as any
written comments that are provided following public meetings so that
stakeholders can understand the different perspectives under
consideration. According to the commenter, these improvements would
allow for timely and knowledgeable participation by experts in the
field, enabling CMS staff to have the background and understanding of
the current trajectory of treatment options to be reflected in their
recommended policies.
Response: As noted earlier in this section, the ICD-10 Coordination
and Maintenance Committee is co-chaired by the NCHS/CDC, and CMS. The
NCHS has lead responsibility for the ICD-10-CM diagnosis classification
while CMS has lead responsibility for the ICD-10-PCS procedure
classification. While it is an interdepartmental committee, each
organization has their own established processes in responding to
requests for coding updates and communicating with the requestors. With
regard to the commenter's recommendation that information be provided
to entities who submit similar or related coding requests to enable
more efficient and in depth public discussion, CMS currently, and has
historically informed requestors of similar or related coding requests
to provide those requestors with the option and opportunity to
collaborate on a joint proposal if they choose to do so. In response to
the commenter's recommendation that reasonable notice is provided along
with timely and accurate agendas when a coding change (proposal) is
accepted for discussion so that key stakeholders are able to
participate in public meetings, we note that notice of topics being
considered for discussion is provided in an announcement that is
published in the Federal Register two months in advance of each ICD-10
Coordination and Maintenance Committee meeting. For example, on January
30, 2020, the Federal Register Notice announcing the March 17-18, 2020
committee meetings was published with the tentative agenda items listed
for both diagnosis and procedure code topics. This notice is located
at: https://www.federalregister.gov/documents/2020/01/30/2020-01756/national-center-for-health-statistics-nchs-icd-10-coordination-and-maintenance-candm-committee. The agenda is considered tentative leading
up to the meeting date as requestors may decide to withdraw their topic
request or other topics that were not yet finalized for that specific
meeting at the time of the development of the Federal Register Notice
may subsequently be added to the final agenda. Upon receipt of a
procedure code request, CMS immediately acknowledges receipt of the
request and communicates to the requestor that additional follow up
will occur once an analyst has been assigned. In addition, CMS provides
information via Email communication in a letter to each requestor
outlining the meeting process and, beginning in 2019, CMS initiated
standard pre-meeting conference calls with requestors to discuss their
procedure code topic request in more detail in advance of the meeting.
Also, prior to the committee meeting, we make the procedure code topic
meeting materials publicly available, commonly referred to as the
``Agenda and Handout'' packet on our website at: https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials. Lastly, once the
meeting has concluded, CMS sends a follow-up letter to the requestor
informing them of next steps in the process so they can anticipate what
to expect.
In response to the commenter's recommendation that clear and timely
transcripts or recordings of such meetings should always be made
publicly available, as well as any written comments that are provided
following public meetings so that stakeholders can understand the
different perspectives under consideration, we note that we announce
during the meeting that a link to the recording (or webcast) will be
made publicly available on both the CDC and CMS web pages following the
meeting, along with the slides that were presented. This information is
generally posted no later than one week following the meeting and
additional details regarding each organization's website where
materials are posted is also included in our IPPS rule as discussed
earlier in this section. With respect to making written comments that
are received after the meeting publicly available so that stakeholders
can understand different perspectives, we will take that into
consideration for the future. We note that some organizations, such as
the AHIMA, routinely display the comments they have submitted in
response to code proposals on their website. Therefore, in response to
the commenter's concern, we believe that the processes we currently
have in place enable the CMS staff to have the background and
understanding of the current trajectory of treatment options to be
considered in our proposed policies.
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) of Public Law 108-173 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.
Comment: A commenter suggested that CMS consider accelerating the
ICD-10 coding timeline for novel indications to address rare and unmet
clinical needs, such as expediting the implementation of innovative
diagnosis codes for new or emerging therapeutic areas. The commenter
provided an example of how the Food and Drug Administration's (FDA's)
accelerated approval pathways, such as Breakthrough Designation, play
an important role in providing priority review for products that
address significant unmet need and have compelling clinical data.
According to the commenter, after FDA-approval,
[[Page 58590]]
however, patients are often still unable to access these therapies if
the disease does not yet have an appropriate ICD-10 diagnosis code. The
commenter stated that a lack of accurate ICD-10 coding may delay
patient access to treatment as providers engage in the time-consuming
process of demonstrating their patients' diagnosis to payers, which the
commenter stated typically results in ongoing appeals and exception
requests. The commenter stated this is particularly concerning in
patient populations with rare diseases experiencing progressive, and
oftentimes fatal, conditions.
The commenter acknowledged that CMS may grant implementation
exceptions for codes capturing new technology and understands that
topics presented during the fall meeting are considered for April 1
implementation if there is a strong and convincing case made by the
requester at the Committee's public meeting. However, relying on this
rationale, the commenter stated their belief that it is critical to
establish a process for expedited assignment of new ICD-10 diagnosis
codes for therapeutic areas that have medications under review via an
accelerated FDA review. According to the commenter, without timely
assignment of ICD-10 diagnosis codes, access to new products may be
delayed or denied, and resources appropriated by Congress and used by
FDA for its accelerated approval pathways go to waste. The commenter
encouraged CMS to revise and update the ICD-10 process to ensure timely
access to these innovative products.
Response: As stated earlier in this section, the ICD-10
Coordination and Maintenance Committee meeting is co-chaired by CDC/
NCHS and CMS with the CDC/NCHS having lead responsibility for the ICD-
10-CM diagnosis classification. Requests for new diagnosis codes must
be submitted to [email protected] for consideration. Also, as
previously noted, section 503(a) of Public Law 108-173 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. As discussed in the FY 2021 IPPS/LTCH
PPS proposed rule (85 FR 32559), the CDC/NCHS implemented new ICD-10-CM
diagnosis codes U07.0 (Vaping-related disorder) and U07.1, (COVID-19)
for reporting effective April 1, 2020. Therefore, with respect to the
commenter's concerns, we believe there are existing processes in place
to implement diagnosis codes in an expedited manner, however, we also
encourage the commenter to contact CDC/NCHS directly for additional
information and further discussion of any remaining concerns.
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 3 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. 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 requestor at the Committee's public meeting. The request
must identify the reason why a new code is needed in April for purposes
of the new technology process. The participants at the meeting and
those reviewing the Committee meeting materials and live webcast 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 submitted for an expedited April 1,
2020 implementation of a new code at the September 10-11, 2019
Committee meeting. However, as announced by the CDC on December 9,
2019, a new ICD-10 emergency code was established by the World Health
Organization (WHO) in response to recent occurrences of vaping related
disorders. Consistent with this update, the CDC/NCHS implemented a new
ICD-10-CM diagnosis code, U07.0 (Vaping-related disorder) for U.S.
reporting of vaping-related disorders effective April 1, 2020. In
addition, as announced by the CDC, a new emergency code was established
by the WHO on January 31, 2020, in response to the 2019 Novel
Coronavirus (2019-nCoV) disease outbreak that was declared a public
health emergency of international concern. Consistent with this update,
the CDC/NCHS implemented a new ICD-10-CM diagnosis code, U07.1 (COVID-
19) for U.S. reporting of the 2019 Novel Coronavirus disease effective
April 1, 2020. We refer the reader to the CDC web page at https://www.cdc.gov/nchs/icd/icd10cm.htm for additional details regarding the
implementation of these new diagnosis codes.
We provided the MS-DRG assignments for these codes effective with
discharges on and after April 1, 2020, consistent with our established
process for assigning new diagnosis codes. Specifically, we review the
predecessor diagnosis code and MS-DRG assignment most closely
associated with the new diagnosis code, and consider other factors that
may be relevant to the MS-DRG assignment, including the severity of
illness, treatment difficulty, and the resources utilized for the
specific condition/diagnosis. We note that this process does not
automatically result in the new diagnosis code being assigned to the
same MS-DRG as the predecessor code. Effective with discharges on and
after April 1, 2020, diagnosis code U07.0 is assigned to MDC 04
(Diseases and Disorders of the Respiratory System) in MS-DRGs 205 and
206 (Other Respiratory System Diagnoses with and without MCC,
respectively), consistent with the assignment of the predecessor
diagnosis code. Effective with discharges on and after April 1, 2020,
diagnosis code U07.1 is assigned to MDC 04 in MS-DRGs 177, 178 and 179
[[Page 58591]]
(Respiratory Infections and Inflammations with MCC, with CC, and
without CC/MCC, respectively), MDC 15 (Newborns and Other Neonates with
Conditions Originating in Perinatal Period) in MS-DRG 791 (Prematurity
with Major Problems) and MS-DRG 793 (Full Term Neonate with Major
Problems), and MDC 25 (Human Immunodeficiency Virus Infections) in MS-
DRGs 974, 975, and 976 (HIV with Major Related Condition with MCC, with
CC, and without CC/MCC, respectively).
These assignments for diagnosis codes U07.0 and U07.1 are reflected
in Table 6A- New Diagnosis Codes associated with the proposed rule and
this final rule (which is available via the internet on the CMS website
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS). We also noted that Change Request (CR) 11623,
Transmittal 4499, titled ``Update to the International Classification
of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) for
Vaping Related Disorder'', was issued on January 24, 2020 (available
via the internet on the CMS website at: https://www.cms.gov/files/document/r4499cp.pdf) regarding the release of an updated version of
the ICD-10 MS-DRG Grouper and Medicare Code Editor (MCE) software,
Version 37.1, to be effective with discharges on or after April 1, 2020
reflecting new diagnosis code U07.0. The updated software, along with
the updated ICD-10 MS-DRG V37.1 Definitions Manual and the Definitions
of Medicare Code Edits V37.1 manual was made available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software. In response to
the implementation of diagnosis code U07.1 (COVID-19), we subsequently
released a new updated version of the ICD-10 MS-DRG Grouper and
Medicare Code Editor (MCE) software, Version 37.1 R1, effective with
discharges on or after April 1, 2020 reflecting this new code, which
replaced the ICD-10 MS-DRG Grouper and Medicare Code Editor (MCE)
software, Version 37.1 that reflected diagnosis code U07.0 (Vaping-
related disorder). The updated software, along with the updated ICD-10
MS-DRG V37.1 R1 Definitions Manual and the Definitions of Medicare Code
Edits V37.1 R1 manual are available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
In response to the COVID-19 pandemic and new treatments that have
followed, on July 30, 2020 we announced the implementation of 12 new
ICD-10-PCS procedure codes to identify the introduction or infusion of
therapeutics for treating hospital inpatients with COVID-19. These
procedure codes will afford the healthcare industry the ability to
track the use of these drugs and their effectiveness in the inpatient
setting, effective with discharges on and after August 1, 2020. The 12
new ICD-10-PCS procedure codes listed in this section of this rule are
designated as non-O.R. and do not affect any MDC or MS-DRG assignment
as shown in the following table.
[[Page 58592]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.144
We also note that Change Request (CR) 11623, Transmittal 10317,
titled ``Update to the International Classification of Diseases, Tenth
Revision, (ICD-10) Diagnosis Codes for Vaping Related Disorder and
Diagnosis and Procedure Codes for the 2019 Novel Coronavirus (COVID-
19)'', was issued on August 21, 2020 (available via the internet on the
CMS website at: https://www.cms.gov/files/document/r10317OTN.pdf)
In response to the implementation of these procedure codes, we
subsequently released a new updated version of the ICD-10 MS-DRG
Grouper and Medicare Code Editor (MCE) software, Version 37.2,
effective with discharges on or after August 1, 2020 reflecting these
new codes, which replaced the ICD-10 MS-DRG Grouper and Medicare Code
Editor (MCE) software, Version 37.1 R1 that reflected diagnosis codes
U07.0 (Vaping-related disorder) and U07.1 (COVID-19). The updated
software, along with the updated ICD-10 MS-DRG V37.2 Definitions Manual
and the Definitions of Medicare Code Edits V37.2 manual are available
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
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://
[[Page 58593]]
www.cdc.gov/nchs/icd/icd10.htm. Additionally, information on new,
revised, and deleted ICD-10-CM diagnosis and ICD-10-PCS procedure 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.
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.
[GRAPHIC] [TIFF OMITTED] TR18SE20.145
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.
17. 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 2021
As discussed in the FY 2021 IPPS/LTCH proposed rule (84 FR 32560
through 32564) for FY 2021, we proposed to delete MS-DRGs 129 and 130,
add new MS-DRGs 140, 141, and 142 (Major Head and Neck Procedures with
MCC, with CC, and without CC/MCC, respectively) and to reassign a
subset of the procedures currently assigned to MS-DRGs 129 and 130 to
new MS-DRGs 140 through 142. Additionally, we proposed to create new
MS-DRGs 521 and 522 (Hip Replacement with Principal Diagnosis of Hip
Fracture with and without MCC, respectively) and to assign a subset of
the procedures currently assigned to MS-DRGs 469 and 470 to new MS-DRGs
521 and 522. (We note that in the proposed rule, we inadvertently
referred to these as MS-DRGs 551 and 552.)
As stated in the FY 2016 IPPS/LTCH PPS proposed rule (80 FR 24409),
we generally map new MS-DRGs onto the
[[Page 58594]]
list when they are formed from procedures previously assigned to MS-
DRGs that are already on the list. Currently, MS-DRGs 129, 130, 469 and
470 are on the list of MS-DRGs subject to the policy for payment under
the IPPS for replaced devices offered without cost or with a credit as
shown in the table in this section of this rule. Therefore, we proposed
that if the applicable MS-DRG changes are finalized, in addition to
deleting MS-DRGs 129 and 130, we also would add new MS-DRGs 140, 141,
142, 521 and 522 to the list of MS-DRGs subject to the policy for
payment under the IPPS for replaced devices offered without cost or
with a credit and make conforming changes as reflected in the table. We
also proposed to continue to include the existing MS-DRGs currently
subject to the policy as also displayed in the table in this section of
this rule.
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As discussed in section II.E.5.a. of the preamble of this final
rule, we are finalizing our proposal to delete MS-DRGs 129 and 130, add
new MS-DRGs 140, 141, and 142, and to reassign a subset of the
procedures currently assigned to MS-DRGs 129 and 130 to new MS-DRGs 140
through 142. Additionally, we are finalizing our proposal to create new
MS-DRGs 521 and 522 and to reassign a subset of the procedures
currently assigned to MS-DRGs 469 and 470 to new MS-DRGs 521 and 522.
We did not receive any public comments opposing our proposal to delete
MS-DRGs 129 and 130. Additionally, we did not receive any public
comments opposing our proposal to add MS-DRGs 140, 141, 142, 521 and
522 to the policy for replaced devices offered without cost or with
credit as reflected in the previous table or to continue to include the
existing MS-DRGs currently subject to the policy. Therefore, we are
finalizing the list of MS-DRGs in the table included in the proposed
rule and in this rule that will be subject to the replaced devices
offered without cost or with a credit policy effective October 1, 2020.
The final list of MS-DRGs subject to the IPPS policy for replaced
devices offered without cost or with a credit will be issued to
providers in the form of a Change Request (CR).
18. Out of Scope Public Comments Received
We received public comments on MS-DRG related issues that were
outside the scope of the proposals included in the FY 2021 IPPS/LTCH
PPS 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.E.1.b. of the preamble of this final rule, we
encourage individuals with comments about MS-DRG classifications to
submit these comments no later than November 1, 2020 so that they can
be considered for possible inclusion in the annual proposed rule. We
will consider these public comments for possible proposals in future
rulemaking as part of our annual review process.
E. Recalibration of the FY 2021 MS-DRG Relative Weights
1. Data Sources for Developing the Relative Weights
Consistent with our established policy, in developing the MS-DRG
relative weights for FY 2021, we proposed to use two data sources:
Claims data and cost report data. The claims data source is the MedPAR
file, which includes fully coded diagnostic and procedure data for all
Medicare inpatient hospital bills. The FY 2019 MedPAR data used in this
final rule include discharges occurring on October 1, 2018, through
September 30, 2019, based on bills received by CMS through March 31,
2019, 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 2019 MedPAR file used in calculating the relative weights
includes data for approximately 9,218,950 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, 2020 update of
the FY 2019 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 2021 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 2021 relative weights are based on the ICD-
10-CM diagnosis codes and ICD-10-PCS procedure codes from the FY 2019
MedPAR claims data, grouped through the ICD-10 version of the FY 2021
GROUPER (Version 38).
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,
2020 update of the FY 2018 HCRIS for calculating the FY 2021 cost-based
relative weights.
2. Methodology for Calculation of the Relative Weights
a. General
In this final rule, as we proposed, we calculated the FY 2021
relative weights based on 19 CCRs, as we did for FY 2020. The
methodology we proposed to use to calculate the FY 2021 MS-DRG cost-
based relative weights based on claims data in the FY 2019 MedPAR file
and data from the FY 2018 Medicare cost reports is as follows:
To the extent possible, all the claims were regrouped
using the FY 2021 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 2019 MedPAR file.
[[Page 58597]]
(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 92.8 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.
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. For additional information on the BPCI initiative, we refer
readers to the CMS' Center for Medicare and Medicaid Innovation's
website at: http://innovation.cms.gov/initiatives/Bundled-Payments/index.html and to section IV.H.4. of the preamble of the FY 2013 IPPS/
LTCH PPS final rule (77 FR 53341 through 53343).
The participation of hospitals in the BPCI initiative concluded on
September 30, 2018. The participation of hospitals in the BPCI Advanced
model started on October 1, 2018. The BPCI Advanced model, tested under
the authority of 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/. Consistent with our
policy for FY 2020, and consistent with how we have treated hospitals
that participated in the BPCI Initiative, for FY 2021, we continue to
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 previously, these hospitals are still receiving IPPS payments
under section 1886(d) of the Act. Consistent with FY 2020 IPPS/LTCH PPS
final rule, we also proposed to include all applicable data from
subsection (d) hospitals participating in
[[Page 58598]]
the Comprehensive Care for Joint Replacement (CJR) Model in our IPPS
payment modeling and ratesetting calculations.
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 2018 cost report data.
The 19 cost centers that we used in the relative weight calculation
are shown in a supplemental data file posted via the internet on the
CMS website for this final rule and available at http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. The supplemental data file shows the
lines on the cost report and the corresponding revenue codes that we
used to create the 19 national cost center CCRs. We stated in the
proposed rule that, if we receive comments about the groupings in this
supplemental file, we may consider these 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.
We invited public comments on our proposals related to
recalibration of the FY 2021 relative weights and the changes in
relative weights from FY 2020.
Comment: A commenter requested an explanation for the 187 discharge
difference in total discharges in Table 7A and Table 7B (proposed Table
7A for Grouper V37 included 9,127,118 discharges, yet proposed Table 7B
for Grouper V38 included 9,126,931 discharges).
Response: The discharge difference arises from the proposed
modification to our relative weight methodology to account for the
clinical trial CAR T-cell therapy cases(85 FR 32566). In the proposed
rule's Table 7B, proposed MS-DRG 018 showed only the 116 non-clinical
trial discharges for CAR-T cell therapy cases, under the proposed
relative weight calculation discussed in the next section. The 187
discharges the commenter referenced were clinical trial CAR T-cell
therapy cases, which are not included in the calculation of the average
cost for MS-DRG 018. In addition, these cases are not included in
calculating the average and percentile lengths of stay data for MS-DRG
018, so they are not included in the number of discharges in Table 7B.
In the proposed rule, we noted that in the FY 2020 IPPS/LTCH PPS
final rule, we adopted a temporary one-time measure for FY 2020 for an
MS-DRG where the FY 2018 relative weight declined by 20 percent from
the FY 2017 relative weight, and the FY 2020 relative weight would have
declined by 20 percent or more from the FY 2019 relative weight, which
was maintained at the FY 2018 relative weight. For an MS-DRG meeting
this criterion, the FY 2020 relative weight was set equal to the FY
2019 relative weight, which in turn had been set equal to the FY 2018
relative weight (84 FR 42167). For FY 2020, the only MS-DRG meeting
this criterion was MS-DRG 215. We invited public comments on the
proposed FY 2021 weight for MS-DRG 215 (Other Heart Assist System
Implant) as set forth in Table 5 associated with the proposed rule,
including comments on whether we should consider a policy under
sections 1886(d)(4)(B) and (C) of the Act similar to the measure
adopted in the FY 2020 IPPS/LTCH PPS final rule to maintain the FY 2021
relative weight equal to the FY 2020 relative weight for MS-DRG 215, or
an alternative approach such as averaging the FY 2020 relative weight
and the otherwise applicable FY 2021 weight.
Comment: Commenters supported a policy that would either maintain
the FY 2021 relative weight equal to the FY 2020 relative weight for
MS-DRG 215, or average the FY 2020 relative weight and the otherwise
applicable FY 2021 weight. Commenters stated that heart assist devices
are lifesaving devices that are implanted in patients undergoing high
risk procedures or are in cardiogenic shock, and that there have been
extensive coding changes such that hospitals are still not correctly
reporting their costs. Commenters stated that the proposed relative
weight would result in a payment that would be significantly below the
cost incurred by providers to provide these procedures and could
thereby limit access to Medicare beneficiaries. Commenters indicated
that CMS had the authority to adjust the relative weights to ensure
appropriate payment to providers for heart assist devices.
Some commenters requested that CMS consider this approach in any
situation when the relative weight for an MS-DRG is drastically reduced
in a given year, particularly when it follows a significant decline in
prior years. Some commenters pointed to MS-DRGs 796 (Vaginal Delivery
with Sterilization/D&C with MCC) and 933 (Extensive Burns or Full
Thickness Burns with MV >96 hrs without Skin Graft), which also have
significant decreases relative to FY 2020.
Response: As we indicated in the FY 2018 IPPS/LTCH final rule (82
FR 38103), and in response to similar comments in the FY 2019 IPPS/LTCH
PPS final rule (83 FR 41273) and the FY 2020 IPPS/LTCH final rule (84
FR 42167), 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 MS-DRG 215 is seeing a
significant reduction for each of the 4 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 in an abundance
of caution because this may be the MS-DRG assigned when a hospital
provides temporary right ventricular support for up to 14 days in
critical care patients for the treatment of acute right heart failure
or decompensation caused by complications related to COVID-19,
including pulmonary embolism, we are adopting a temporary one-time
measure for FY 2021 for MS-DRG 215. Specifically, we will set the 2021
relative weight for MS-DRG 215 equal to the average of the FY 2020
relative weight and the otherwise applicable FY 2021 weight.
With regard to the commenters who raised concerns about other MS-
DRGs with significant reductions relative to FY 2020, the other MS-DRGs
are low volume in our claims data, and therefore typically experience a
greater degree of year-to-year variation. For example, while MS-DRGs
796 and 933 would have significant decreases relative to FY 2020, those
MS-DRGs experienced considerable increases between FY 2019 and FY 2020.
We acknowledge the longstanding concerns related to low volume MS-DRGs
and will take into consideration the unique issues relating to such MS-
DRGs and the stability of their weights for future rulemaking.
Comment: Some commenters requested that CMS adopt a permanent
solution to stabilize payment for MS-
[[Page 58599]]
DRG 215, in addition to adopting a hold-harmless or blended rate to
stabilize the relative weight for MS-DRG 215, effective with discharges
beginning October 1, 2020 for FY 2021. Specifically, the commenters
suggested that CMS reassign cases reporting procedure code 02HA3RJ
(Insertion of short-term external heart assist system into heart,
intraoperative, percutaneous approach) from MS-DRG 215 to MS-DRGs 216,
217, and 218 (Cardiac Valve and Other Major Cardiothoracic Procedures
with Cardiac Catheterization with MCC, with CC, and without CC/MCC,
respectively). According to the commenters, these cases are more
clinically aligned with MS-DRGs 216, 217, and 218 and this reassignment
would improve the long-term stability of the heart assist MS-DRGs
including MS-DRG 215. The commenters also noted that reassigning the
cases reporting heart assist system procedures performed
intraoperatively from MS-DRG 215 into MS-DRGs 216, 217, and 218 in the
FY 2021 IPPS/LTCH PPS final rule would be consistent with CMS precedent
and authority.
Response: We note that we did not propose any changes to the
assignment of heart assist devices and need additional time to fully
analyze this request. Therefore, we are not making changes in this
final rule to the assignment of cases reporting heart assist system
procedures performed intraoperatively, and we will consider this issue
in future rulemaking.
b. Relative Weight Calculation for New MS-DRG 018 for CAR T-cell
Therapy
As discussed in section II.E.2.b. of this final rule, we proposed,
and are finalizing, to create new MS-DRG 018 for cases that include
procedures describing CAR T-cell therapies, which are currently
reported using ICD-10-PCS procedure codes XW033C3 or XW043C3. As
discussed in section IV.I. of this final rule, given the high cost of
the CAR T-cell product, we proposed, and are finalizing, a differential
payment for cases where the CAR T-cell product is provided without cost
as part of a clinical trial to ensure that the payment amount for CAR
T-cell therapy clinical trial cases appropriately reflects the relative
resources required for providing CAR T-cell therapy as part of a
clinical trial.
We stated in the proposed rule that we also believe it would be
appropriate to modify our existing relative weight methodology to
ensure that the relative weight for new MS-DRG 018 appropriately
reflects the relative resources required for providing CAR T-cell
therapy outside of a clinical trial, while still accounting for the
clinical trial cases in the overall average cost for all MS-DRGs.
Specifically, we proposed that clinical trial claims that group to new
MS-DRG 018 would not be included when calculating the average cost for
new MS-DRG 018 that is used to calculate the relative weight for this
MS-DRG, so that the relative weight reflects the costs of the CAR T-
cell therapy drug. Consistent with our analysis of the FY 2019 MedPAR
claims data as discussed in section IV.I. of this final rule, we
identified clinical trial claims as claims that contain ICD-10-CM
diagnosis code Z00.6 or contain standardized drug charges of less than
$373,000, which is the average sales price of KYMRIAH and YESCARTA,
which are the two CAR T-cell biological products licensed to treat
relapsed/refractory large B-cell lymphoma as of the time of the
development of the proposed rule and this final rule. We also proposed
to calculate the following adjustment to account for the CAR T-cell
therapy cases identified as clinical trial cases in calculating the
national average standardized cost per case that is used to calculate
the relative weights for all MS-DRGs and for purposes of budget
neutrality and outlier simulations:
Calculate the average cost for cases to be assigned to new
MS-DRG 018 that contain ICD-10-CM diagnosis code Z00.6 or contain
standardized drug charges of less than $373,000.
Calculate the average cost for cases to be assigned to new
MS-DRG 018 that do not contain ICD-10-CM diagnosis code Z00.6 or
standardized drug charges of at least $373,000.
Calculate an adjustor by dividing the average cost
calculated in step 1 by the average cost calculated in step 2.
Apply the adjustor calculated in step 3 to the cases
identified in step 1 as clinical trial cases, then add this adjusted
case count to the non-clinical trial case count prior to calculating
the average cost across all MS-DRGs.
Each year, when we calculate the relative weights, we use a
transfer-adjusted case count for each MS-DRG, which accounts for
payment adjustments resulting from our postacute care transfer policy.
This process is described in the FY 2006 IPPS/LTCH PPS final rule (70
FR 47697). We proposed to apply this adjustor to the case count for MS-
DRG 018 in a similar manner. We proposed to first calculate the
transfer-adjusted case count for MS-DRG 018, and then further adjust
the transfer-adjusted case count by the adjustor described previously.
Then, we proposed to use this adjusted case count for MS-DRG 018 in
calculating the national average cost per case, which is used in the
calculation of the relative weights. Based on the December 2019 update
of the FY 2019 MedPAR file, we estimated that the average costs of CAR
T-cell therapy cases identified as clinical trial cases were 15% of the
average costs of the CAR T-cell therapy cases identified as non-
clinical trial cases, and therefore, in calculating the national
average cost per case for purposes of the proposed rule, each case
identified as a clinical trial case was adjusted to 0.15. We indicated
that we expected to recalculate this proposed adjustor for the CAR T
cell therapy clinical trial cases for the final rule based on the
updated data available. We also noted that we were applying this
proposed adjustor for CAR T-cell therapy clinical trial cases for
purposes of budget neutrality and outlier simulations, as discussed
further in section II.A. of the Addendum to the proposed rule and this
final rule.
We invited public comments on our proposal.
Comment: A commenter expressed concern with our methodology to
divide cases into clinical trial and non-clinical trial cohorts,
stating that both criteria used to identify clinical trial cases, the
presence of ICD-10-CM diagnosis code Z00.6 or standardized drug charges
of less than $373,000, are problematic given the inconsistency of
charging practices for CAR T-cell therapies and the application of ICD-
10-CM diagnosis code Z00.6 in all clinical trial cases. This commenter
noted that it is possible that some cases were excluded as clinical
trial cases when the hospital actually incurred the full cost of the
drug. This commenter suggested that these criteria may have resulted in
a lower average adjusted cost for non-clinical trial cases below the
cost of the drug.
Some commenters also raised issues in the context of the payment
adjustment for CAR T-cell clinical trial cases regarding two relatively
less frequent scenarios. Commenters stated that when CAR T-cell therapy
products are used out of specification (also termed expanded access),
hospitals do not incur the cost of the CAR T-cell therapy product, but
the claim would not include ICD-10-CM diagnosis code Z00.6 because the
case is not part of a clinical trial. Commenters identified an
additional scenario, in which the CAR T-cell therapy product is
purchased in the usual manner, but the case involves a clinical trial
of another drug, in which case ICD-10-CM diagnosis code Z00.6 would be
included on the claim.
[[Page 58600]]
Response: We believe that given the available data, our methodology
to divide cases into clinical trial and non-clinical trial cohorts
provides reasonable estimates on average of the costs for clinical
trial and non-clinical trial cases. We note that in the MedPAR data
used in the proposed rule, there were only two cases that were flagged
as clinical trials that contained drug charges of more than $373,000.
The average drug charge of these two cases was less than the average
drug charge for all cases that were identified as non-clinical trial
cases. Had we instead assumed that these cases were not clinical trial
cases for CAR T-cell therapies, and included these two cases in the
calculation of the relative weight, the relative weight would have been
slightly lower, rather than higher as the commenter suggested. With
respect to the concern about hospital charging practices, we reiterate
our earlier response that there is nothing that precludes hospitals
from setting their drug charges consistent with their CCRs.
In response to commenters who raised issues in the context of the
payment adjustment for CAR T-cell clinical trial cases regarding two
scenarios, as discussed elsewhere in this final rule, we are adjusting
our proposed policy for the payment adjustment for CAR T-cell clinical
trial cases to address these scenarios. Similarly, we are adjusting our
methodology here such that (a) when the CAR T-cell therapy product is
purchased in the usual manner, but the case involves a clinical trial
of a different product, the claim will be included when calculating the
average cost for cases not determined to be clinical trial cases to the
extent such cases can be identified in the historical data, and (b)
when there is expanded access use of immunotherapy, these cases will be
included when calculating the average cost for cases determined to be
clinical trial cases to the extent such cases can be identified in the
historical data. To the best of our knowledge there are no claims in
the historical data used in the calculation of the adjustment for cases
involving a clinical trial of a different product, and to the extent
the historical data contain claims for cases involving expanded access
use of immunotherapy we believe those claims would have drug charges
less than $373,000.
Comment: Some commenters asked whether standardized drug charges
included charges for revenue center 891 in addition to charges from
revenue centers 025X, 026X, and 63X. Several commenters questioned
whether charges for revenue center 891 were included in CMS'
calculation of standardized drug charges given that the MedPAR data
dictionary seems to indicate that charges from revenue codes 081X-089X
are excluded from ratesetting. Commenters stated that it would be
incorrect to exclude charges in revenue center 891, since they would
include CAR T product charges. Another commenter asked that CMS include
claims with charges of greater than $373,000 in revenue center 891 in
identifying claims that were not part of a clinical trial. One
commenter requested that CMS apply a series of steps to determine
whether charges in revenue center 891 were related to CAR T-cell
therapy product acquisition.
Response: We appreciate commenters bringing this issue to our
attention. We agree with commenters that while revenue centers 081X-
089X are typically excluded from ratesetting, charges from revenue
center 891 should be included in our calculation of standardized drug
charges for MS-DRG 018. Therefore, for cases that group to MS-DRG 018,
we will consider the charges reported in revenue center 891 to be
related to CAR T-cell therapy product acquisition and include these
charges in determining whether the case contains standardized drug
charges of at least $373,000 and therefore should be determined to be
non-clinical trial case for purposes of this modified relative weight
methodology. We note that the same trims used in calculating the
standardized drug costs would apply to determine whether or not a given
case is determined to be a clinical trial case for purposes of these
modifications to the relative weight methodology.
After consideration of public comments received, we are finalizing
our proposal to not include claims determined to be clinical trial
claims that group to new MS-DRG 018 when calculating the average cost
for new MS-DRG 018 that is used to calculate the relative weight for
this MS-DRG, with the additional refinements that (a) when the CAR T-
cell therapy product is purchased in the usual manner, but the case
involves a clinical trial of a different product, the claim will be
included when calculating the average cost for new MS-DRG 018 to the
extent such claims can be identified in the historical data, and (b)
when there is expanded access use of immunotherapy, these cases will
not be included when calculating the average cost for new MS-DRG 018 to
the extent such claims can be identified in the historical data. We are
also finalizing our proposal to calculate the adjustment described
above to account for the CAR T-cell therapy cases determined to be
clinical trial cases, with the additional refinement of including
revenue center 891 in our calculation of standardized drug charges for
MS-DRG 018. Applying this finalized methodology, based on the March
2020 update of the FY 2019 MedPAR file, we estimate that the average
costs of CAR T-cell therapy cases determined to be clinical trial cases
($46,0662) are 17 percent of the average costs of CAR T cell therapy
cases determined to be non-clinical trial cases ($276,042), and
therefore, in calculating the national average cost per case for
purposes of this final rule, each case identified as a clinical trial
case was adjusted to 0.17. We also note that we are applying this
finalized adjustor for cases determined to be CAR T-cell therapy
clinical trial cases for purposes of budget neutrality and outlier
simulations, as discussed further in section II.A. of the Addendum to
the this final rule.
3. Development of National Average CCRs
We developed the national average CCRs as follows:
Using the FY 2018 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. Then we created CCRs for each provider for each cost
center (see the supplemental data file 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. Then we 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.
[[Page 58601]]
After we multiplied the total charges for each MS-DRG in each of
the 19 cost centers by the corresponding national average CCR, we
summed the 19 ``costs'' across each MS-DRG to produce a total
standardized cost for the MS-DRG. The average standardized cost for
each MS-DRG was then computed as the total standardized cost for the
MS-DRG divided by the transfer-adjusted case count for the MS-DRG. The
average cost for each MS-DRG was then divided by the national average
standardized cost per case to determine the relative weight.
The FY 2021 cost-based relative weights were then normalized by an
adjustment factor of 1.819227 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 2021 are as follows:
[GRAPHIC] [TIFF OMITTED] TR18SE20.149
Since FY 2009, the relative weights have been based on 100 percent
cost weights based on our MS-DRG grouping system.
When we recalibrated the DRG weights for previous years, we set a
threshold of 10 cases as the minimum number of cases required to
compute a reasonable weight. We proposed to use that same case
threshold in recalibrating the MS-DRG relative weights for FY 2021.
Using data from the FY 2019 MedPAR file, there were 7 MS-DRGs that
contain fewer than 10 cases. For FY 2021, 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 2020 relative
weights by the percentage change in the average weight of the cases in
other MS-DRGs from FY 2020 to FY 2021. The crosswalk table is as
follows.
[[Page 58602]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.150
After consideration of the comments we received, we are finalizing
our proposals, with the modifications for recalibrating the relative
weights for FY 2021 for MS-DRG 018 by including the charges reported in
revenue center 891 in determining whether the case should be determined
to be a non-clinical trial case, and for MS-DRG 215 by setting the
relative weight equal to the average of the FY 2020 relative weight and
the otherwise applicable FY 2021 weight.
F. Add-On Payments for New Services and Technologies for FY 2021
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 Sec. 412.87(b) specifies 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. In addition, certain transformative new devices and
Qualified Infectious Disease Products may qualify under an alternative
inpatient new technology add-on payment pathway, as set forth in the
regulations at Sec. 412.87(c) and (d). In this rule, 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) and the FY 2020 IPPS/LTCH PPS final rule (84 FR 42288
through 42300).
a. New Technology Add On Payment Criteria
(1) Newness Criterion
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 medical product 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
another medical product 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).
(2) Cost Criterion
a. Overview
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
[[Page 58603]]
technology exceed certain threshold amounts. The MS-DRG threshold
amounts generally used in evaluating new technology add-on payment
applications for FY 2021 are presented in a data file that is
available, along with the other data files associated with the FY 2020
IPPS/LTCH PPS final rule and correction notice, on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index. However, we refer readers to section
II.G.1.a.(2)b. of the preamble of this final rule where we discuss our
final policy to apply the proposed threshold value for new MS-DRG 018
in evaluating the cost criterion for the CAR T-cell therapy
technologies for purposes of FY 2021 new technology add-on payments.
As finalized in the FY 2019 IPPS/LTCH PPS final rule (83 FR 41275),
beginning with FY 2020, we include the thresholds applicable to the
next fiscal year (previously included in Table 10 of the annual IPPS/
LTCH PPS proposed and final rules) in the data files associated with
the prior fiscal year. Accordingly, the final thresholds for
applications for new technology add-on payments for FY 2022 are
presented in a data file that is available on the CMS website, along
with the other data files associated with this FY 2021 final rule, by
clicking on the FY 2021 IPPS Final Rule Home Page at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index. We note that, under our final policy discussed
in section II.G.1.a.(2).b. of the preamble of this final rule,
beginning with FY 2022, we will use the proposed threshold values
associated with the proposed rule for that fiscal year to evaluate the
cost criterion for all applications for new technology add-on payments
and previously approved technologies that may continue to receive new
technology add-on payments, if those technologies would be assigned to
a proposed new MS-DRG for that same fiscal year. In the September 7,
2001 final rule that established the new technology add-on payment
regulations (66 FR 46917), we discussed that applicants should submit a
significant sample of data to demonstrate that the medical service or
technology meets the high-cost threshold. Specifically, applicants
should submit a sample of sufficient size to enable us to undertake an
initial validation and analysis of the data. We also discussed in the
September 7, 2001 final rule (66 FR 46917) 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.
b. Cost Threshold Evaluation for Proposed New MS-DRG Reassignment
In the FY 2021 IPPS/LTCH PPS proposed rule, we made proposals
relating to our evaluation of the cost criterion for technologies that
are proposed to be assigned to a new MS-DRG (85 FR 32643 and 32644 and
32650 and 32651). We noted that, as we have discussed in prior
rulemaking with regard to the potential creation of a new MS-DRG for
CAR T-cell therapies (83 FR 41172), if a new MS-DRG for CAR T-cell
therapies 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. Section 1886(d)(5)(K)(ix) of the Act requires that, before
establishing any add-on payment for a new medical service or
technology, the Secretary shall seek to identify one or more DRGs
associated with the new technology, based on similar clinical or
anatomical characteristics and the costs of the technology and shall
assign the new technology into a DRG where the average costs of care
most closely approximate the costs of care using the new technology. As
discussed in previous rulemaking (71 FR 47996), no add-on payment will
be made if the new technology is assigned to a DRG that most closely
approximates its costs.
In the proposed rule, we referred readers to the FY 2016 IPPS/LTCH
PPS final rule (80 FR 49481 and 49482), where we discussed whether the
WATCHMAN[supreg] System met the cost criterion for a new technology
add-on payment. Specifically, we discussed whether the threshold value
associated with a proposed new MS-DRG should be considered in
determining whether the applicant meets the cost criterion. We also
discussed instances in the past where the coding associated with a new
technology application is included in a finalized policy to change one
or more MS-DRGs. For example, in the FY 2013 IPPS/LTCH PPS final rule
(77 FR 53360 through 53362), we described the cost analysis for the
Zenith[supreg] Fenestrated Abdominal Aortic Aneurysm Endovascular
Graft, which was identified by ICD-9-CM procedure code 39.78
(Endovascular implantation of branching or fenestrated graft(s) in
aorta). In that same rule, we finalized a change to the assignment of
that procedure code, reassigning it from MS- DRGs 252, 253, and 254 to
MS-DRGs 237 and 238. Because of that change, we determined that, for FY
2013, in order for the Zenith[supreg] Fenestrated Abdominal Aortic
Aneurysm Endovascular Graft to meet the cost criteria, it must
demonstrate that the average case weighted standardized charge per case
exceeded the thresholds for MS-DRGs 237 and 238. We noted that, in that
example, MS-DRGs 237 and 238 existed previously; therefore, thresholds
that were 75 percent of one standard deviation beyond the geometric
mean standardized charge for these MS-DRGs were available to the public
in Table 10 at the time the application was submitted. (We note that
for fiscal years prior to FY 2020, Table 10 included the cost
thresholds used to evaluate applications for new technology add-on
payments for the next fiscal year.) We stated in the FY 2016 IPPS/LTCH
PPS proposed rule (80 FR 24460) that in the case of WATCHMAN[supreg]
System, if MS-DRGs 273 and 274 were to be finalized for FY 2016, we
recognized that thresholds that are 75 percent of one standard
deviation beyond the geometric mean standardized charge would not have
been available at the time the application was submitted. We stated our
belief that it could be appropriate for the applicant to demonstrate
that the average case weighted standardized charge per case exceeded
these thresholds for MS-DRGs 273 and 274, for which this technology
would be reassigned. Accordingly, we made available supplemental
threshold values on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech that were
calculated using the data used to generate the FY 2015 IPPS/LTCH PPS
Table 10 and reassigned the procedure codes, in accordance with the
finalized policies discussed in section II.G.3.b. of the preamble of
the FY 2016 IPPS/LTCH PPS final rule.
We also noted that in the FY 2016 IPPS/LTCH PPS proposed rule, we
invited public comments on whether considering these supplemental
threshold values as part of the cost criterion evaluation for this
application was appropriate and also on how to address similar future
situations in a broader policy context should they occur. After
consideration of the comments, in the FY 2016 IPPS/LTCH PPS final rule
(80 FR 49482) we stated that we agreed with the commenters that we
should evaluate the cost threshold in effect at the time the new
[[Page 58604]]
technology add-on payment application is submitted to determine if an
applicant exceeds the cost threshold. We stated that we agreed with
commenters that this policy is most predictable for applicants. We also
stated that we were maintaining our current policy to use the
thresholds issued with each final rule for the upcoming fiscal year
when making a determination to continue add-on payments for those new
technologies that were approved for new technology add-on payments from
the prior fiscal year.
In the FY 2021 IPPS/LTCH PPS proposed rule, we noted that at the
time of the FY 2016 final rule, in applying this policy, we did not
anticipate the onset of new, extremely high cost, technologies such as
CAR T-cell therapy, nor such significant variance between the
thresholds at the time of application and the thresholds based on the
finalized MS-DRG assignment for the upcoming year. For example, in the
FY 2016 final rule, the difference between the MS-DRG threshold amount
for MS-DRGs 237 ($121,777) and 238 ($87,602) set forth in Table 10
associated with the FY 2015 final rule, and the supplemental MS- DRG
threshold amount based on the proposed new MS-DRGs 273 ($95,542) and
274 ($77,230), was $26,235 and $10,372 respectively. By comparison,
based on the data file released with the FY 2020 final rule (and
corresponding correction notice) for FY 2021 applications, the
threshold amount for MS-DRG 016 is $170,573. However, the threshold
amount for proposed new MS-DRG 018 (in the data file released with this
proposed rule) is $1,237,393, which is more than 7 times greater.
We stated that in light of the development of new technologies,
such as CAR T-cell therapies, and the more substantial shifts in the
MS-DRG threshold amounts that may result from the reassignment of new
technologies for the upcoming fiscal year, we believe it is appropriate
to revisit the policy described in the FY 2016 final rule. We stated
that while we continue to believe that predictability for applicants is
important, we also believe payment accuracy is equally important. We
stated our belief that it is necessary to balance predictability with a
more accurate evaluation of whether a new technology meets the new
technology add-on payment cost criterion by using threshold values that
are consistent with how the cases involving the use of the new
technology will be paid for in the upcoming fiscal year. We proposed to
revise our policy in situations when the procedure coding associated
with a new technology application is proposed to be assigned to a
proposed new MS-DRG. Specifically, we proposed that effective for FY
2022, for applications for new technology add-on payments and
previously approved technologies that may continue to receive new
technology add-on payments, the proposed threshold for a proposed new
MS-DRG for the upcoming fiscal year would be used to evaluate the cost
criterion for technologies that would be assigned to a proposed new MS-
DRG. For example, consider a technology that would be coded using
procedure codes assigned to MS-DRG ABC at the time of its application
for FY 2022, and then the procedure coding associated with the new
technology was proposed to be assigned to a proposed new MS-DRG XYZ in
the FY 2022 proposed rule. Instead of using the threshold for MS-DRG
ABC based on the data file released with the FY 2021 final rule for FY
2022 applications, we proposed to use the proposed threshold for the
newly proposed MS-DRG XYZ based on the data file released with the FY
2022 proposed rule, which would otherwise contain the proposed
thresholds for FY 2023 applications. We stated our belief that using
the proposed rule thresholds for the proposed new MS-DRG would further
promote payment accuracy by using the latest data available to assess
how the technology would be paid for in the upcoming fiscal year, if
the proposed reassignment to the new MS-DRG was finalized, while also
providing the applicant and the public adequate time to analyze whether
the technology meets the cost criterion using these proposed thresholds
and to provide public comment following the proposed rule.
In the FY 2021 proposed rule, we stated that we believe it is
important that the cost criterion be applied in a manner that
accurately reflects the anticipated payment for the technology. In
assessing the adequacy of the otherwise applicable MS-DRG payment rate
for a high cost new technology, where the reassignment of such a
technology to a proposed new MS-DRG may result in a substantial change
in the MS-DRG threshold amounts, we stated our belief that it is
necessary to evaluate that technology using the proposed thresholds for
the newly proposed MS-DRG to which the technology would be reassigned.
We also stated that we believe this policy is consistent with
section 1886(d)(5)(K)(ix) of the Act which, as previously noted,
requires that before establishing any add-on payment for a new medical
service or technology, the Secretary seek to identify one or more DRGs
associated with the new technology, based on similar clinical or
anatomical characteristics and the costs of the technology, and assign
the new technology into a DRG where the average costs of care most
closely approximate the costs of care using the new technology. This
provision further states that no add-on payment will be made with
respect to such new technology. As we have noted in prior rulemaking
with regard to the CAR T cell therapies (83 FR 41172), 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. For these
reasons, we also proposed, for purposes of FY 2021 new technology add-
on payments, to evaluate the cost criterion for the CAR T-cell therapy
technologies using the proposed threshold for the newly proposed MS-DRG
to which the procedure codes describing the use of the CAR T-cell
therapies would be assigned in FY 2021 (MS-DRG 018). We noted that this
proposed policy would apply to the new FY 2021 CAR T-cell therapy
applications, KTE-X19 and Liso-cel, and those CAR T-cell therapies
previously approved for new technology add-on payments, KYMRIAH[supreg]
and YESCARTA[supreg] (we note that KTE-X19 and Liso-cel did not meet
the July 1 deadline as specified in Sec. 412.87(e)). As discussed in
section II.E.2.b. of the preamble of this final rule, we are finalizing
our proposal to create a new MS-DRG 018 for cases reporting ICD-10-PCS
procedure codes XW033C3 or XW043C3 for FY 2021.
Comment: We did not receive any comments specifically regarding our
proposal that, effective for FY 2022, for applications for new
technology add-on payments and previously approved technologies that
may continue to receive new technology add-on payments, the proposed
threshold for a proposed new MS-DRG for the upcoming fiscal year would
be used to evaluate the cost criterion for technologies that would be
assigned to a proposed new MS-DRG. We also did not receive any comments
specifically on our proposal to apply this policy, effective for FY
2021, for purposes of evaluating the cost criterion for the CAR-T cell
therapy technologies using the proposed threshold for the newly
proposed MS-DRG to which the procedure codes describing the use of the
CAR-T cell therapies would be assigned in FY 2021 (MS-DRG 018).
Several commenters, who were also applicants for new technology
add-on payments for FY 2021, disagreed with
[[Page 58605]]
CMS's position that their technologies would not meet the cost
criterion based on the MS-DRG 018 threshold amount of $1,237,393. These
commenters presented updated cost analyses that they believe
demonstrate that the applicant technology meets the cost criterion. One
commenter stated that the proposed cost threshold for MS-DRG 018 is
inaccurate. Specifically, the commenter believed that $913,244, which
CMS cited as the standardized charge per case for DRG 018, is based on
the standard deviation charges for those cases, and that the actual
average standardized charge per case, according to the FY 2021 Proposed
BOR file for Version 38 of the MS-DRGs is $1,387,946.33, which exceeds
the cost threshold for MS-DRG 018. This commenter urged CMS to audit
its calculations and then reapply the new cost threshold to current new
technology add-on payment applicants.
Response: We thank the commenters for their input. We have reviewed
the data and agree that we inadvertently used the wrong value for the
average case-weighted standardized charge from the FY 2021 Proposed BOR
File. The commenter is correct that using the arithmetic mean charge of
$1,387,946.33 would exceed the proposed threshold for new MS-DRG 018 of
$1,237,393.
We noted in the FY 2021 IPPS/LTCH PPS proposed rule that, if
finalized, this policy would apply to the new FY 2021 CAR T-cell
therapy applications, KTE-X19 and Liso-cel., and those CAR T-cell
therapies previously approved for new technology add-on payments,
KYMRIAH[supreg] and YESCARTA[supreg]. However, we note that neither
Kite Pharma (the applicant for KTE-X19) nor Juno Therapeutics, a
Bristol-Myers Squibb Company (the applicant for Liso-cel) received FDA
approval for their therapies by July 1, and therefore, these
technologies were not eligible for consideration for new technology
add-on payments for FY 2021. We also note, as discussed later in this
rule, that KYMRIAH[supreg] and YESCARTA[supreg] are no longer
considered ``new'' for purposes of new technology add-on payments for
FY 2021. Accordingly, we are not applying this policy to evaluate the
cost criterion for CAR T-cell therapy technologies using the proposed
threshold for MS-DRG 018 to which the procedure codes describing the
use of the CAR T-cell therapies will be assigned beginning in FY 2021.
As discussed in the preamble of the proposed rule and this final
rule, while we continue to believe that predictability for applicants
is important, we also believe payment accuracy is equally important. In
order to promote payment accuracy, as previously discussed, and after
consideration of the comments received, we are finalizing our proposal
to use the proposed threshold for the upcoming fiscal year for any
proposed new MS-DRG to evaluate the cost criterion for technologies
that would be assigned to the proposed new MS-DRG, beginning with FY
2022 new technology add-on payments for all applicants and previously
approved technologies that may continue to receive new technology add-
on payments in FY 2022. As we have noted in prior rulemaking with
regard to the CAR T cell therapies (83 FR 41172), 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.
Finally, amidst our work on payment accuracy and coverage for CAR-
T, we have heard from stakeholders that cell therapy goes beyond CAR-T
to include Tumor-Infiltrating Lymphocyte (TIL) Therapy and Engineered T
Cell Receptor (TCR) Therapy. While all of these treatments are
autologous, CAR-T is currently limited to liquid tumors, and we foresee
the need to address solid tumor treatments such as TIL and TCR in the
near future. As the process and decisions on these issues take time, we
plan to continue to engage with stakeholders to understand the needs
necessary for patients and providers to get appropriate access as
quickly as possible to these potentially lifesaving treatments. Our
processes continue to evolve as innovative treatments evolve.
c. Substantial Clinical Improvement Criterion
Under the third criterion at Sec. 412.87(b)(1), a medical service
or technology must represent an advance that substantially improves,
relative to technologies previously available, the diagnosis or
treatment of Medicare beneficiaries. In the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42288 through 42292) we prospectively codified in our
regulations at Sec. 412.87(b) the following aspects of how we evaluate
substantial clinical improvement for purposes of new technology add-on
payments under the IPPS:
The totality of the circumstances is considered when
making a determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
A determination that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries means--
++ The new medical service or technology offers a treatment option
for a patient population unresponsive to, or ineligible for, currently
available treatments;
++ The new medical service or technology offers the ability to
diagnose a medical condition in a patient population where that medical
condition is currently undetectable, or offers the ability to diagnose
a medical condition earlier in a patient population than allowed by
currently available methods, and there must also be evidence that use
of the new medical service or technology to make a diagnosis affects
the management of the patient;
++ The use of the new medical service or technology significantly
improves clinical outcomes relative to services or technologies
previously available as demonstrated by one or more of the following: A
reduction in at least one clinically significant adverse event,
including a reduction in mortality or a clinically significant
complication; a decreased rate of at least one subsequent diagnostic or
therapeutic intervention; a decreased number of future hospitalizations
or physician visits; a more rapid beneficial resolution of the disease
process treatment including, but not limited to, a reduced length of
stay or recovery time; an improvement in one or more activities of
daily living; an improved quality of life; or, a demonstrated greater
medication adherence or compliance; or
++ The totality of the circumstances otherwise demonstrates that
the new medical service or technology substantially improves, relative
to technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
Evidence from the following published or unpublished
information sources from within the United States or elsewhere may be
sufficient to establish that a new medical service or technology
represents an advance that substantially improves, relative to services
or technologies previously available, the diagnosis or treatment of
Medicare beneficiaries: Clinical trials, peer reviewed journal
articles; study results; meta-analyses; consensus statements; white
papers; patient surveys; case studies; reports; systematic literature
reviews; letters from major healthcare associations;
[[Page 58606]]
editorials and letters to the editor; and public comments. Other
appropriate information sources may be considered.
The medical condition diagnosed or treated by the new
medical service or technology may have a low prevalence among Medicare
beneficiaries.
The new medical service or technology may represent an
advance that substantially improves, relative to services or
technologies previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new medical service or technology.
We refer the reader to the FY 2020 IPPS/LTCH PPS final rule for
additional discussion of the evaluation of substantial clinical
improvement for purposes of new technology add-on payments under the
IPPS.
We note, consistent with the discussion in the FY 2003 IPPS Final
Rule (67 FR 50015), although we are affiliated with FDA and we do not
question FDA's regulatory responsibility for decisions related to
marketing authorization (for example, approval, clearance, etc.), we do
not use FDA criteria to determine what drugs, devices, or technologies
qualify for new technology add-on payments under Medicare. Our criteria
do not depend on the standard of safety and efficacy on which FDA
relies but on a demonstration of substantial clinical improvement in
the Medicare population (particularly patients over age 65).
d. Alternative Inpatient New Technology Add-on Payment Pathway
Under Sec. 412.87(c) and (d) of the regulations, beginning with
applications for new technology add-on payments for FY 2021, certain
transformative new devices and Qualified Infectious Disease Products
(QIDPs) may qualify for the new technology add-on payment under an
alternative pathway, as described in this section. We refer the reader
to the FY 2020 IPPS/LTCH PPS final rule for complete discussion on this
policy (84 FR 42292 through 42297). We note, in section II.G.9.b. of
this preamble, we discuss our final policy to expand our current
alternative new technology add-on payment pathway for QIDPs to include
products approved under the Limited Population Pathway for
Antibacterial and Antifungal Drugs (LPAD) pathway. In addition, we are
finalizing our policy to refer more broadly to ``certain antimicrobial
products'' rather than specifying the particular FDA programs for
antimicrobial products (that is, QIDPs and LPADs) that are the subject
of the alternative new technology add-on payment pathway. (We refer the
reader to section II.G.9.b. of this preamble below for a complete
discussion regarding this final policy.) We note that a technology is
not required to have the specified FDA designation at the time the new
technology add-on payment application is submitted. CMS will review the
application based on the information provided by the applicant under
the alternative pathway specified by the applicant. However, to receive
approval for the new technology add-on payment under that alternative
pathway, the technology must have the applicable designation and meet
all other requirements in the regulations in Sec. 412.87(c) and (d),
as applicable.
(1) Alternative Pathway for Certain Transformative New Devices
For applications received for new technology add-on payments for FY
2021 and subsequent fiscal years, if a medical device is part of FDA's
Breakthrough Devices Program and received FDA marketing authorization,
it will be considered new and not substantially similar to an existing
technology for purposes of the new technology add-on payment under the
IPPS, and will not need to meet the requirement under Sec.
412.87(b)(1) that it represent an advance that substantially improves,
relative to technologies previously available, the diagnosis or
treatment of Medicare beneficiaries. This policy is codified at Sec.
412.87(c). Under this alternative pathway, a medical device that has
received FDA marketing authorization (that is, has been approved or
cleared by, or had a De Novo classification request granted by, FDA)
and that is part of FDA's Breakthrough Devices Program will need to
meet the cost criterion under Sec. 412.87(b)(3), as reflected in Sec.
412.87(c)(3), and will be considered new as reflected in Sec.
412.87(c)(2). We note, in section II.G.8. of the preamble of this final
rule, we are clarifying our policy that a new medical device under this
alternative pathway must receive marketing authorization for the
indication covered by the Breakthrough Devices Program designation. (We
refer the reader to section II.G.8. of this preamble below for a
complete discussion regarding this clarification.)
(2) Alternative Pathway for Qualified Infectious Disease Products
(QIDPs)
For applications received for new technology add-on payments for FY
2021 and subsequent fiscal years, if a technology is designated by FDA
as a QIDP and received FDA marketing authorization, it will be
considered new and not substantially similar to an existing technology
for purposes of new technology add-on payments and will not need to
meet the requirement that it represent an advance that substantially
improves, relative to technologies previously available, the diagnosis
or treatment of Medicare beneficiaries. We codified this policy at
Sec. 412.87(d). Under this alternative pathway for QIDPs, a medical
product that has received FDA marketing authorization and is designated
by FDA as a QIDP will need to meet the cost criterion under Sec.
412.87(b)(3), as reflected in Sec. 412.87(d)(3), and will be
considered new as reflected in Sec. 412.87(d)(2).
We refer the reader to the FY 2020 IPPS/LTCH PPS final rule for
complete discussion on this policy (84 FR 42292 through 42297). We
note, in section II.G.9.b. of the preamble of this final rule, we are
clarifying a new medical product seeking approval for the new
technology add-on payment under the alternative pathway for QIDPs must
receive marketing authorization for the indication covered by the QIDP
designation. (We refer the reader to section II.G.9.b. of this preamble
below for a complete discussion regarding this clarification.)
e. Additional Payment for New Medical Service or Technology
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. For discharges
occurring before October 1, 2019, under Sec. 412.88, if the costs of
the discharge (determined by applying CCRs as described in Sec.
412.84(h)) exceed the full DRG payment (including payments for IME and
DSH, but excluding outlier payments), Medicare made an add-on payment
equal to the lesser of: (1) 50 percent of the costs of the new medical
service or technology; or (2) 50 percent of the amount by which the
costs of the case exceed the standard DRG payment.
Beginning with discharges on or after October 1, 2019, for the
reasons discussed in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42297
through 42300), we finalized an increase in the new technology add-on
payment percentage, as reflected at Sec. 412.88(a)(2)(ii).
Specifically, for a new technology other than a medical product
designated by FDA as a QIDP, beginning
[[Page 58607]]
with discharges on or after October 1, 2019, if the costs of a
discharge involving a new technology (determined by applying 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) 65 percent of
the costs of the new medical service or technology; or (2) 65 percent
of the amount by which the costs of the case exceed the standard DRG
payment. For a new technology that is a medical product designated by
FDA as a QIDP, beginning with discharges on or after October 1, 2019,
if the costs of a discharge involving a new technology (determined by
applying 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) 75 percent of the costs of the new medical service or technology;
or (2) 75 percent of the amount by which the costs of the case exceed
the standard DRG payment. As set forth in Sec. 412.88(b)(2), unless
the discharge qualifies for an outlier payment, the additional Medicare
payment will be limited to the full MS-DRG payment plus 65 percent (or
75 percent for a medical product designated by FDA as a QIDP) of the
estimated costs of the new technology or medical service.
We refer the reader to the FY 2020 IPPS/LTCH PPS final rule (84 FR
42297 through 42300) for complete discussion on the increase in the new
technology add on payment beginning with discharges on or after October
1, 2019. We note, in section II.G.9.b. of the preamble of this final
rule, we discuss our final policy to increase the new technology add-on
payment percentage to 75 percent for products approved under FDA's LPAD
pathway. (We refer the reader to section II.G.9.b. of this preamble
below for a complete discussion regarding this final policy.)
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 subsequent years have not been subjected to budget neutrality.
f. Evaluation of Eligibility Criteria for New Medical Service or
Technology Applications
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
by July 1 of the year prior to the beginning of the fiscal year for
which the application is being considered. We note, in section
II.G.9.c. of the preamble of this final rule, we discuss our finalized
process by which a technology for which an application for new
technology add-on payments is submitted under the alternative pathway
for certain antimicrobial products would receive conditional approval
for such payment, provided the product receives FDA marketing
authorization by July 1 of the year for which the new technology add-on
payment application was submitted. (We refer the reader to section
II.G.9.c. of this preamble of this final rule for a complete discussion
regarding this final policy.)
g. Council on Technology and Innovation (CTI)
The Council on Technology and Innovation 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
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].
h. Application Information for New Medical Services or Technologies
Applicants for add-on payments for new medical services or
technologies for FY 2022 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 (unless the application is under one of the
alternative pathways as previously
[[Page 58608]]
described), 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 2022, 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 and approved under OMB control number 0938-1347.
As discussed previously, in the FY 2020 IPPS/LTCH PPS final rule,
we adopted an alternative inpatient new technology add-on payment
pathway for certain transformative new devices and for Qualified
Infectious Disease Products, as set forth in the regulations at Sec.
412.87(c) and (d). The change in burden associated with these changes
to the new technology add-on payment application process were discussed
in a revision of the information collection requirement (ICR) request
currently approved under OMB control number 0938-1347. In accordance
with the implementing regulations of the PRA, we detailed the revisions
of the ICR and published the required 60-day notice on August 15, 2019
(84 FR 41723) and 30-day notice on December 17, 2019 (84 FR 68936) to
solicit public comments. The ICR is currently pending OMB approval.
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 Pub. L. 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 2021 prior
to publication of the FY 2021 IPPS/LTCH PPS proposed rule, we published
a notice in the Federal Register on October 8, 2019 (84 FR 53732), and
held a town hall meeting at the CMS Headquarters Office in Baltimore,
MD, on December 16, 2019. 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
the FY 2021 new medical service and technology add-on payment
applications before the publication of the FY 2021 IPPS/LTCH PPS
proposed rule.
We stated in the FY 2021 IPPS/LTCH PPS proposed rule that
approximately 100 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 morning and afternoon sessions of the town hall on the CMS YouTube
web page at: https://www.youtube.com/watch?v=4z1AhEuGHqQ and https://www.youtube.com/watch?v=m26Xj1EzbIY, respectively. We considered each
applicant's presentation made at the town hall meeting, as well as
written comments submitted on the applications that were received by
the due date of January 3, 2020, in our evaluation of the new
technology add-on payment applications for FY 2021 in the development
of the FY 2021 IPPS/LTCH PPS proposed rule.
In response to the published notice and the December 16, 2019 New
Technology Town Hall meeting, we received written comments regarding
the applications for FY 2021 new technology add-on payments. We also
noted in the FY 2021 IPPS/LTCH PPS 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 (84 FR
53732 through 53734), 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 2021.
Therefore, we did not summarize those written comments in the proposed
rule that are unrelated to the substantial clinical improvement
criterion. In section II.G.5. of the preamble of the FY 2021 IPPS/LTCH
PPS proposed rule (85 FR 32581 through 32678), 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 notice or New Technology Town Hall meeting, at the end of
each discussion of the individual applications.
3. ICD-10-PCS Section ``X'' Codes for Certain New Medical Services and
Technologies
As discussed in the FY 2016 IPPS/LTCH PPS 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.
[[Page 58609]]
4. FY 2021 Status of Technologies Approved for FY 2020 New Technology
Add-On Payments
In section II.G.4. of the proposed rule (85 FR 32572 through
32580), we discussed the proposed FY 2021 status of 18 technologies
approved for FY 2020 new technology add-on payments. 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. We refer readers
to a table at the end of this section summarizing for FY 2021 the name
of each technology, newness start date, whether we are continuing or
discontinuing the add-on payment for FY 2021, relevant final rule
citations, final maximum add-on payment amount and coding assignments.
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[supreg] (tisagenlecleucel) and
YESCARTA[supreg] (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). On May 1, 2018, Novartis Pharmaceuticals Corporation
received FDA approval for KYMRIAH[supreg]'s second indication, the
treatment of adult patients with relapsed or refractory (r/r) large B-
cell lymphoma after two or more lines of systemic therapy including
diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high
grade B-cell lymphoma and DLBCL arising from follicular lymphoma. On
October 18, 2017, Kite Pharma, Inc. received FDA approval for the use
of YESCARTA[supreg] indicated 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, primary mediastinal large B-
cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from
follicular lymphoma. With respect to the newness criterion, because
potential cases representing patients who may be eligible for treatment
using KYMRIAH[supreg] and YESCARTA[supreg] 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[supreg] or YESCARTA[supreg]), and because 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 considered these two technologies to be substantially similar to
each other. We refer readers to the FY 2019 IPPS/LTCH PPS final rule
(83 FR 41285 through 41286) and FY 2020 IPPS/LTCH/PPS final rule (84 FR
42185 through 42187) for a complete discussion. We stated in the FY
2019 IPPS/LTCH PPS final rule (83 FR 41285 through 41286) and FY 2020
IPPS/LTCH PPS final rule (84 FR 42185 through 42186) that in accordance
with our policy, since we consider the technologies to be substantially
similar to each other, it is appropriate to use the earliest market
availability date submitted as the beginning of the newness period for
both technologies. According to the applicant for YESCARTA[supreg], the
first commercial shipment of YESCARTA[supreg] was received by a
certified treatment center on November 22, 2017. Therefore, based on
our policy, with regard to both technologies, we stated that the
beginning of the newness period would be November 22, 2017.
KYMRIAH[supreg] and YESCARTA[supreg] were approved for new technology
add-on payments for FY 2019 (83 FR 41299). We refer readers to section
II.H.5.a. of the preamble of the FY 2019 IPPS/LTCH PPS final rule (83
FR 41283 through 41299) and section II.H.4.d. of the preamble of the FY
2020 IPPS/LTCH PPS final rule (84 FR 42185 through 42187) for a
complete discussion of the new technology add-on payment application,
coding and payment amount for KYMRIAH[supreg] and YESCARTA[supreg] for
FY 2019 and FY 2020.
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 KYMRIAH[supreg] and
YESCARTA[supreg], as discussed in the FY 2019 IPPS/LTCH PPS final rule,
according to the applicant for YESCARTA[supreg], the first commercial
shipment of YESCARTA[supreg] was received by a certified treatment
center on November 22, 2017. As previously stated, we use the earliest
market availability date submitted as the beginning of the newness
period for both KYMRIAH[supreg] and YESCARTA[supreg]. Therefore, we
consider the beginning of the newness period for both KYMRIAH[supreg]
and YESCARTA[supreg] to commence November 22, 2017. Because the 3-year
anniversary date of the entry of the technology onto the U.S. market
(November 22, 2020) will occur in the first half of FY 2021, we
proposed to discontinue new technology add-on payments for this
technology for FY 2021. We invited public comments on our proposal to
discontinue new technology add-on payments for KYMRIAH[supreg] and
YESCARTA[supreg] for FY 2021.
Comment: Commenters supported CMS' proposal to discontinue new
technology add-on payments for KYMRIAH[supreg] and YESCARTA[supreg] for
FY 2021. One commenter expressed support for CMS's proposal to either
continue or discontinue new technology add-on payments based on the
anniversary date of the product's entry on the market, noting the
exception of products that enter the U.S. market in the latter half of
the fiscal year.
We also received comments that were not supportive of the proposal.
According to these commenters, the removal of new technology add-on
payment eligibility for KYMRIAH[supreg] and YESCARTA[supreg] will widen
the gap between therapy cost and reimbursement. According to the
commenters, reimbursement provided through a new MS-DRG payment will
not fully compensate providers for the extraordinarily high cost of the
treatment and the expanding gaps between reimbursement and total cost
of care may create barriers to this innovative treatment for Medicare
beneficiaries. Another commenter offered that CMS has the authority to
extend new technology add-on payments for CAR T-cell products into FY
2021 as the third program year. According to the commenter, although
November 22, 2017 was the date the first FDA-approved CAR T-cell
product was delivered for use to an approved facility, there were very
few facilities even able to conduct these procedures, and of those,
several were unwilling to do so due to the high cost of the product and
low likelihood of getting paid for it. As such, the commenter indicated
that November 22, 2017 is not the date to
[[Page 58610]]
most appropriately coincide with when the market was fully formed for
CAR T-cell products and procedures, particularly within the Medicare
beneficiary patient population. According to the commenter, a more
appropriate date to describe when the market was fully formed,
consisting of buyers and sellers of CAR T-cell products, was October 1,
2018, with the inclusion of CAR T-cell therapies within MS-DRG 016 for
FY 2019. The commenter explained that they believe this date is the
more appropriate ``first year'' of new technology add-on payment
eligibility under the newness criterion, in which case the third year
begins in full with the start of FY 2021. According to the commenter,
even if CMS is unwilling or unable to consider this alternate
conception of ``market availability'' and adjust the CAR T-cell newness
date accordingly, CMS nonetheless retains the authority to simply waive
its informal, internal ``six months'' policy and grant new technology
add-on payment participation for the entirety of FY 2021 as the third
(and final) new technology add-on payment year for KYMRIAH[supreg] and
YESCARTA[supreg]. Another commenter provided support for the extension
of the new technology add-on payment to KYMRIAH[supreg] and
YESCARTA[supreg] for another year but suggested that all CAR T-cell
product that becomes FDA-approved automatically receive new technology
add-on payment as well. Finally, other commenters stated a general
support for a continuation of new technology add-on payments for all
FDA approved CAR T-cell therapies for FY 2021.
Response: We thank the commenters for their input and suggestions.
While we appreciate the commenters' concerns, with regard to the
technology's newness, 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 become
available. 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 states 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.
With respect to the comment that CMS should consider the date when
the market was ``fully formed'' as the start of the newness period, we
note that while CMS may consider a documented delay in a technology's
availability on the U.S. market in determining when the newness period
begins, under our historical policy, we do not consider how frequently
the medical service or technology has been used in our determination of
newness (70 FR 47349). Similarly, our policy for determining whether to
extend new technology add-on payments for a third year generally
applies regardless of the claims volume for the technology after the
start of the newness period. As discussed 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
``new.'' Consistent with the statute, a technology no longer qualifies
as ``new'' once it is more than 2 to 3 years old, irrespective of how
frequently it has been used in the Medicare population. Therefore, if a
product is more than 2 to 3 years old, we consider its costs to be
included in the MS-DRG relative weights whether its use in the Medicare
population has been frequent or infrequent.
For these reasons, we do not agree that we should use October 1,
2018 as the start of the newness period or otherwise modify our policy
for determining whether to extend new technology add-on payments for a
third year in considering whether to continue new technology add-on
payments for FY 2021 for KYMRIAH[supreg] and YESCARTA[supreg].
Therefore, KYMRIAH[supreg] and YESCARTA[supreg] are no longer
considered ``new'' for purposes of new technology add-on payments for
FY 2021. We are finalizing our proposal to discontinue new technology
add-on payments for KYMRIAH[supreg] and YESCARTA[supreg] for FY 2021.
As discussed in section II.E.2.b. of the preamble of this final
rule, currently procedures involving CAR T-cell therapies are
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 became effective October 1, 2017. As
discussed in section II.E.2.b. of the preamble of this final rule, we
are finalizing our proposal to create a new MS-DRG 018 for cases
reporting ICD-10-PCS procedure codes XW033C3 or XW043C3 for FY 2021. We
also refer readers to section II.G.1.a.(2).b. of the preamble of this
final rule for a complete discussion of our final policy that,
effective for FY 2022, for applications for new technology add-on
payments and for previously approved technologies that may continue to
receive new technology add-on payments, the proposed threshold for the
upcoming fiscal year for a proposed new MS-DRG would be used to
evaluate the cost criterion for any new technologies that would be
assigned to a proposed new MS-DRG. As we also discuss in section
II.G.1.a.(2)b. of the preamble of this final rule, in the proposed rule
we stated that in light of the significant variance in the threshold
amount for proposed new MS-DRG 018 for cases involving CAR T-cell
therapies, we proposed to apply this policy in evaluating the CAR T-
cell therapy technologies for FY 2021 new technology add-on payments.
We stated that this would include both the new FY 2021 CAR T-cell
therapy applications and those CAR T-cell therapy technologies
previously approved for new technology add-on payments, KYMRIAH[supreg]
and YESCARTA[supreg]. Therefore, in the proposed rule we stated that
even if KYMRIAH[supreg] and/or YESCARTA[supreg] were still considered
new and within the 3-year anniversary date of the entry of the
technology onto the U.S. market, in determining whether these
technologies would continue to be eligible for the new technology add-
on payment, we proposed to evaluate whether they meet the cost
criterion using the proposed threshold for the proposed new MS-DRG 018
for FY 2021 payment.
Per the applicants' cost analyses in the FY 2019 IPPS/LTCH PPS
final rule (83 FR 41291), the final inflated average case-weighted
standardized charge per case for KYMRIAH[supreg] and YESCARTA[supreg]
is $39,723 (not including the charges related to the technology) and
$118,575 (not including the charges related to the technology),
respectively. However, we stated in the proposed rule that we now have
cases involving the use of CAR T-cell therapy within the FY 2019 MedPAR
data that we believe represent cases that would be eligible for
KYMRIAH[supreg] and YESCARTA[supreg] and which can be used to estimate
the average standardized charge per case for purposes of the proposed
rule. This charge information from the FY 2019 MedPAR data can be found
in the FY 2021 Proposed Before Outliers Removed
[[Page 58611]]
(BOR) File (available on the CMS website) for Version 38 of the MS-
DRGs. We stated that based on information from the FY 2021 Proposed BOR
File for Version 38 of the MS-DRGs, the standardized charge per case
for MS-DRG 018 is $913,224. The average case-weighted threshold amount
based on the proposed new MS-DRG 018 is $1,237,393. We stated that
because this estimated average case-weighted standardized charge per
case for KYMRIAH[supreg] and YESCARTA[supreg] ($913,224) does not
exceed the average case-weighted threshold amount for proposed new MS-
DRG 018 ($1,237,393), we did not believe that the technology would meet
the cost criterion and, as previously stated, proposed to discontinue
new technology add-on payments for this technology for FY 2021. We
invited public comment on our proposals.
Comment: According to one commenter, CMS' calculations explained in
the proposal may be based on an inappropriate figure. According to the
commenter, $913,244 was cited as the standardized charge per case for
MS-DRG 018; however, based on a review of information released with the
proposed rule, this figure is the standard deviation charges for those
cases, rather than the average standardized charge. According to the
commenter, the actual average standardized charge per case, according
to the FY 2021 Proposed BOR file for Version 38 of the MS-DRGs is
$1,387,946.33, which exceeds the cost threshold for MS-DRG 018. The
commenter encouraged CMS to re-run its calculations and to clarify this
issue and the amounts in the final rule.
Response: We reviewed the data and agree we inadvertently used the
wrong value for the average case-weighted standardized charge from the
FY 2021 Proposed BOR File. The commenter is correct that using the
arithmetic mean charge of $1,387,946.33 would exceed the proposed
threshold for new MS-DRG 018 of $1,237,393. As previously noted,
KYMRIAH[supreg] and YESCARTA[supreg] are no longer considered ``new''
for purposes of new technology add-on payments for FY 2021 and
therefore, as previously stated, we are finalizing our proposal to
discontinue new technology add-on payments for KYMRIAH[supreg] and
YESCARTA[supreg] for FY 2021.
b. VYXEOS\TM\ (Daunorubicin and Cytarabine) Liposome for Injection
Jazz Pharmaceuticals, Inc. submitted an application for new
technology add-on payments for the VYXEOS\TM\ technology for FY 2019.
VYXEOS\TM\ 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). CMS
approved VYXEOS\TM\ for new technology add on payments for FY 2019 (83
FR 41299). We refer readers to section II.H.5.b. of the preamble of the
FY 2019 IPPS/LTCH PPS final rule (83 FR 41299 through 41305) and
section II.H.4.e. of the preamble of the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42187 through 42188) for a complete discussion of the new
technology add on payment application, coding, and payment amount for
VYXEOS\TM\ for FY 2019 and FY 2020.
With regard to the newness criterion for VYXEOS\TM\, we consider
the beginning of the newness period to commence when VYXEOS\TM\ was
approved by FDA (August 3, 2017). Because the 3-year anniversary date
of the entry of the VYXEOS\TM\ onto the U.S. market (August 3, 2020)
will occur in FY 2020, we proposed to discontinue new technology add-on
payments for this technology for FY 2021. We invited public comments on
our proposal to discontinue new technology add-on payments for
VYXEOS\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for VYXEOS\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for VYXEOS\TM\
for FY 2021.
c. VABOMERE\TM\ (Meropenem and Vaborbactam)
Melinta Therapeutics, Inc., submitted an application for new
technology add-on payments for VABOMERE\TM\ for FY 2019. VABOMERE\TM\
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. VABOMERE\TM\
received FDA approval on August 29, 2017 and was approved for new
technology add on payments for FY 2019 (83 FR 41311). We refer readers
to section II.H.5.c. of the preamble of the FY 2019 IPPS/LTCH PPS final
rule (83 FR 41305 through 41311) and section II.H.4.f. of the preamble
of the FY 2020 IPPS/LTCH PPS final rule (84 FR 42188 through 42189) for
a complete discussion of the new technology add on payment application,
coding, and payment amount for VABOMERE\TM\ for FY 2019 and FY 2020.
With regard to the newness criterion for VABOMERE\TM\, we consider
the beginning of the newness period to commence when VABOMERE\TM\
received FDA approval (August 29, 2017). Because the 3-year anniversary
date of the entry of VABOMERE\TM\ onto the U.S. market (August 29,
2020) will occur in FY 2020, we proposed to discontinue new technology
add-on payments for this technology for FY 2021. We invited public
comments on our proposal to discontinue new technology add-on payments
for VABOMERE\TM\ for FY 2021.
Comment: Several commenters, including the applicant, did not
support CMS' proposal to discontinue new technology add-on payments for
FY 2021 for VABOMERE\TM\. Commenters highlighted the global health
crisis of antimicrobial resistance and corresponding importance of add-
on payments for maintaining adequate patient access to novel
antibiotics that are effective against multidrug resistant gram-
negative bacteria. Some commenters acknowledged the infrequent use of
VABOMERE\TM\ due to antibiotic stewardship considerations, but
nonetheless expressed concern about the cost burden of novel agents
like VABOMERE\TM\ in light of limited treatment options. A few
commenters urged CMS to consider the data limitations regarding the
infrequent use of novel antibiotics and their dispersion across many
MS-DRGs as justification for continuing add-on payments for
VABOMERE\TM\ for purposes of additional data collection and further
opportunity for relevant MS-DRGs to adjust to the availability of
VABOMERE\TM\. A commenter, who is also the applicant, suggested that
without appropriate reimbursement for novel antibiotics, such as
VABOMERE\TM\, it is unlikely that manufacturers will continue investing
in these vitally necessary products.
Several commenters described what they asserted was the particular
value of VABOMERE\TM\ during the current public health emergency, as
extended hospital stays and prolonged ventilator use for many COVID-19
patients can increase the risk of multidrug resistant bacterial
infections. A commenter, who is also the applicant, suggested that CMS
employ all of the tools within its authority to address the
unprecedented financial challenges health care providers are facing as
a result of the economic crisis caused by the COVID-19 pandemic and
ensuing public health emergency, including, at a minimum, ensuring
eligibility continues for the maximum period of time permitted by
statute (currently, a full three years) for
[[Page 58612]]
qualified infectious disease products (QIDPs), including VABOMERE\TM\.
The applicant also encouraged CMS to implement a DRG carve-out policy
for QIDPs that would provide for payment of QIDPs at 100 percent of ASP
under the IPPS, which it asserted would improve the balance of
incentives for providers who are treating patients with resistant
infections, maintain the sustainability of companies that develop and
commercialize QIDPs, as well as spur innovation in this critically
important area affecting clinical outcomes and public health.
Response: We thank the commenters for their comments. While we
appreciate the commenters' concerns, with regard to the technology's
newness, 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 become available. 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 states 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.
In addition, and as discussed 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 ``new.''
Consistent with the statute, a technology no longer qualifies as
``new'' once it is more than 2 to 3 years old, irrespective of how
frequently it has been used in the Medicare population, or how many MS-
DRGs the technology may be spread across. Therefore, if a product is
more than 2 to 3 years old, we consider its costs to be included in the
MS-DRG relative weights whether its use in the Medicare population has
been frequent or infrequent. Additionally, we did not propose any
policies relating to a DRG carve-out for QIDPs but appreciate the
commenter's suggestion.
Based on the reasons stated above, VABOMERE\TM\ is no longer
considered ``new'' for purposes of new technology add-on payments for
FY 2021. We are finalizing our proposal to discontinue new technology
add-on payments for VABOMERE\TM\ for FY 2021.
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. 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 (CSA). On
October 6, 2017, the remed[emacr][supreg] System was approved by FDA.
The remed[emacr][supreg] System was approved for new technology add on
payments for FY 2019. We refer readers to section II.H.5.d. of the
preamble of the FY 2019 IPPS/LTCH PPS final rule (83 FR 41311 through
41320) and section II.H.4.g. of the preamble of the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42189 through 42190) for a complete discussion of
the new technology add on payment application, coding and payment
amount for the remed[emacr][supreg] System for FY 2019 and FY 2020.
With regard to the newness criterion for the remed[emacr][supreg]
System, as we have discussed in prior rulemaking, we consider the
beginning of the newness period to commence when the
remed[emacr][supreg] System was approved by FDA on October 6, 2017.
However, as we summarized in the FY 2020 IPPS/LTCH PPS final rule (84
FR 42189 through 42190), a commenter on the FY 2020 IPPS/LTCH PPS
proposed rule, who was also the applicant, believed that the newness
period for the remed[emacr][supreg] System should start on February 1,
2018, instead of the FDA approval date of October 6, 2017. The
commenter stated that due to the required build out of operational and
commercial capabilities, the remed[emacr][supreg] System was not
commercially available upon FDA approval and the first case involving
its use did not occur until February 1, 2018. The commenter asserted
that the date of the first implant should mark the start of the newness
period since before that, the technology was not commercially
available. In response to that comment, we indicated that we would
consider the additional information the applicant provided when
proposing whether to continue new technology add-on payments for the
remed[emacr][supreg] System for FY 2021.
As we have discussed in prior rulemaking (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. With regard to the commenter's assertion that the date
of the first implant should mark the start of the newness period, we
note that while we may consider a documented delay in a technology's
availability on the U.S. market in determining when the newness period
begins, under our historical policy, we do not consider how frequently
the medical service or technology has been used in our determination of
newness (70 FR 47349). As we discussed in the proposed rule, without
additional information from the applicant, we cannot determine a
newness date based on such a documented delay in commercial
availability (and not the first case involving use of the
remed[emacr][supreg] System on February 1, 2018). However, even if we
were to consider the newness period to commence on February 1, 2018, as
recommended by the commenter, such that the 3-year anniversary date of
the entry of the remed[emacr][supreg] System onto the U.S. market would
be February 1, 2021 rather than October 6, 2020, that 3-year
anniversary date would still occur within the first half of FY 2021.
Because the 3-year anniversary date of the entry of the
remed[emacr][supreg] System onto the U.S. market will occur in the
first half of FY 2021, we proposed to discontinue new technology add-on
payments for this technology for FY 2021. We invited public comments on
our proposal to discontinue new technology add-on payments for the
remed[emacr][supreg] System for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for FY 2021 for the remed[emacr][supreg]
System.
Response: We appreciate the commenter's support.
Comment: A commenter did not support CMS' proposal to discontinue
new technology add-on payments for FY 2021 for the remed[emacr][supreg]
System. The commenter, who was also the applicant, requested that CMS
extend for one additional year all new technology add-on payments set
to expire at the end of FY 2020 due to the extraordinary circumstances
of the COVID-19 public health emergency. They expressed concerns that
the public health emergency dramatically limited availability of the
remed[emacr][supreg] System since March 2020, when most elective
procedures were halted across the United States. The commenter stated
that the reduced access to new technologies for Medicare beneficiaries
should be factored into consideration of the newness period expiration
date.
Response: We thank the commenter for their comments. While we
appreciate the commenter's concerns, with regard to the technology's
[[Page 58613]]
newness, 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 become available. 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 states 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. In addition, CMS's policy for determining whether to
extend new technology add-on payments for a third year generally
applies regardless of the claims volume for the technology. As
discussed in the FY 2006 IPPS final rule (70 FR 47349) and earlier in
this section, 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, a technology no longer qualifies
as ``new'' once it is more than 2 to 3 years old, irrespective of how
frequently it has been used in the Medicare population. Therefore, if a
product is more than 2 to 3 years old, we consider its costs to be
included in the MS-DRG relative weights whether its use in the Medicare
population has been frequent or infrequent.
Based on the reasons stated above, the remed[emacr][supreg] System
is no longer considered ``new'' for purposes of new technology add-on
payments for FY 2021. We are finalizing our proposal to discontinue new
technology add-on payments for the remed[emacr][supreg] System for FY
2021.
e. ZEMDRI\TM\ (Plazomicin)
Achaogen, Inc. submitted an application for new technology add-on
payments for ZEMDRI\TM\ (plazomicin) for FY 2019. According to the
applicant, ZEMDRI\TM\ is a next generation aminoglycoside antibiotic,
which has been found in vitro to have enhanced activity against many
multidrug resistant (MDR) gram-negative bacteria. The applicant
received approval from FDA on June 25, 2018, for use in the treatment
of adults who have been diagnosed with cUTIs, including pyelonephritis.
ZEMDRI\TM\ was approved for new technology add on payments for FY 2019
(83 FR 41334). We refer readers to section II.H.5.f. of the preamble of
the FY 2019 IPPS/LTCH PPS final rule (83 FR 41326 through 41334) and
section II.H.4.h. of the preamble of the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42190 through 42191) for a complete discussion of the new
technology add on payment application, coding and payment amount for
ZEMDRI\TM\ for FY 2019 and FY 2020.
With regard to the newness criterion for ZEMDRI\TM\, we consider
the beginning of the newness period to commence when ZEMDRI\TM\ was
approved by FDA on June 25, 2018. 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
ZEMDRI\TM\ onto the U.S. market (June 25, 2021) will occur in the
second half of FY 2021, we proposed to continue new technology add-on
payments for this technology for FY 2021. We proposed that the maximum
new technology add-on payment amount for a case involving the use of
ZEMDRI\TM\ would remain at $4,083.75 for FY 2021 (we refer readers to
the FY 2020 IPPS/LTCH PPS final rule for complete discussion of the
calculation of the new technology add on payment amount for
ZEMDRI\TM\). Cases involving ZEMDRI\TM\ that are eligible for new
technology add-on payments are identified by ICD-10-PCS procedure codes
XW033G4 (Introduction of Plazomicin anti-infective into peripheral
vein, percutaneous approach, new technology group 4) or XW043G4
(Introduction of Plazomicin antiinfective into central vein,
percutaneous approach, new technology group 4). We invited public
comments on our proposal to continue new technology add-on payments for
ZEMDRI\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for ZEMDRI\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for ZEMDRI\TM\ for
FY 2021. The maximum new technology add-on payment amount for a case
involving the use of ZEMDRI\TM\ will remain at $4,083.75 for FY 2021;
that is, 75 percent of the average cost of the technology.
f. GIAPREZA\TM\ (angiotensin II)
The La Jolla Pharmaceutical Company submitted an application for
new technology add-on payments for GIAPREZA\TM\ for FY 2019.
GIAPREZA\TM\, 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. GIAPREZA\TM\
was granted a Priority Review designation under FDA's expedited program
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. GIAPREZA\TM\ was approved for new technology add on payments
for FY 2019 (83 FR 41342). We refer readers to section II.H.5.g. of the
preamble of the FY 2019 IPPS/LTCH PPS final rule (83 FR 41334 through
41342) and section II.H.4.i. of the preamble of the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42191) for a complete discussion of the new
technology add on payment application, coding and payment amount for
GIAPREZA\TM\ for FY 2019 and FY 2020.
With regard to the newness criterion for GIAPREZA\TM\, we consider
the beginning of the newness period to commence when GIAPREZA\TM\ was
approved by FDA (December 21, 2017). 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
GIAPREZA\TM\ onto the U.S. market (December 21, 2020) will occur in the
first half of FY 2021, we proposed to discontinue new technology add-on
payments for this technology for FY 2021. We invited public comments on
our proposal to discontinue new technology add-on payments for
GIAPREZA\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for GIAPREZA\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for GIAPREZA\TM\
for FY 2021.
g. Cerebral Protection System (Sentinel[supreg] Cerebral Protection
System)
Claret Medical, Inc. submitted an application for new technology
add-on
[[Page 58614]]
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. The Sentinel Cerebral Protection System
was approved for new technology add on payments for FY 2019 (83 FR
41348). We refer readers to section II.H.5.h. of the preamble of the FY
2019 IPPS/LTCH PPS final rule (83 FR 41342 through 41348) and section
II.H.4.j. of the preamble of the FY 2020 IPPS/LTCH PPS final rule (84
FR 42191 through 42192) for a complete discussion the new technology
add on payment application, coding, and payment amount for the
Sentinel[supreg] Cerebral Protection System for FY 2019 and FY 2020.
With regard to the newness criterion for the Sentinel[supreg]
Cerebral Protection System, we consider the beginning of the newness
period to commence when FDA granted the De Novo request for the
Sentinel[supreg] Cerebral Protection System (June 1, 2017). Because the
3-year anniversary date of the entry of the Sentinel[supreg] Cerebral
Protection System onto the U.S. market (June 1, 2020) will occur in FY
2020, we proposed to discontinue new technology add-on payments for
this technology for FY 2021. We invited public comments on our proposal
to discontinue new technology add-on payments for the Sentinel[supreg]
Cerebral Protection System for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for the Sentinel[supreg] Cerebral Protection
System for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for the
Sentinel[supreg] Cerebral Protection System for FY 2021.
h. 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).
FDA granted the AQUABEAM System'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 AQUABEAM System was approved for new
technology add on payments for FY 2019 (83 FR 41355). We refer readers
to section II.H.5.i. of the preamble of the FY 2019 IPPS/LTCH PPS final
rule (83 FR 41348 through 41355) and section II.H.4.k. of the preamble
of the FY 2020 IPPS/LTCH PPS final rule (84 FR 42192 through 42193) for
a complete discussion of the new technology add on payment application,
coding, and payment for the AQUABEAM System for FY 2019 and FY 2020.
With regard to the newness criterion for the AQUABEAM System, we
consider the beginning of the newness period to commence on the date
FDA granted the De Novo request (December 21, 2017). 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 AQUABEAM System onto the U.S. market (December 21, 2020)
will occur in the first half of FY 2021, we proposed to discontinue new
technology add-on payments for this technology for FY 2021. We invited
public comments on our proposal to discontinue new technology add-on
payments for the AQUABEAM System for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for the AQUABEAM System for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for the AQUABEAM
System for FY 2021.
i. AndexXa\TM\ (coagulation factor Xa (recombinant), inactivated-zhzo)
Portola Pharmaceuticals, Inc. (Portola) submitted an application
for new technology add-on payments for FY 2019 for the use of
AndexXa\TM\ (coagulation factor Xa (recombinant), inactivated-zhzo).
AndexXa\TM\ received FDA approval on May 3, 2018, and is indicated for
use in the treatment of patients who are receiving treatment with
rivaroxaban and apixaban, when reversal of anticoagulation is needed
due to life-threatening or uncontrolled bleeding. AndexXa\TM\ was
approved for new technology add on payments for FY 2019 (83 FR 41362).
We refer readers to section II.H.5.j. of the preamble of the FY 2019
IPPS/LTCH PPS final rule (83 FR 41355 through 41362) and section
II.H.4.k. of the preamble of the FY 2020 IPPS/LTCH PPS final rule (84
FR 42193 through 42194) for a complete discussion of the new technology
add on payment application, coding, and payment amount for AndexXa\TM\
for FY 2019 and FY 2020.
With regard to the newness criterion for AndexXa\TM\, we consider
the beginning of the newness period to commence when AndexXa\TM\
received FDA approval (May 3, 2018). 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
AndexXa\TM\ onto the U.S. market (May 3, 2021) will occur in the second
half of FY 2021, we proposed to continue new technology add-on payments
for this technology for FY 2021. We proposed that the maximum new
technology add-on payment for a case involving AndexXa\TM\ would remain
at $18,281.25 for FY 2021 (we refer readers to the FY 2020 IPPS/LTCH
PPS final rule for complete discussion of the calculation of the new
technology add on payment amount for AndexXa\TM\). Cases involving the
use of AndexXa\TM\ that are eligible for new technology add-on payments
are identified by ICD-10-PCS procedure codes XW03372 (Introduction of
inactivated coagulation factor Xa into peripheral vein, percutaneous
approach, new technology group 2) or XW04372 (Introduction of
inactivated coagulation factor Xa into central vein, percutaneous
approach, new technology group 2). We invited public comments on our
proposal to continue new technology add-on payments for AndexXa\TM\ for
FY 2021.
Comment: Several commenters, including the applicant, supported
CMS' proposal to continue new technology add-on payments for FY 2021
for AndexXa\TM\.
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 AndexXa\TM\ for
FY 2021. The maximum new technology
[[Page 58615]]
add-on payment amount for a case involving AndexXa\TM\ will remain at
$18,281.25 for FY 2021; that is, 65 percent of the average cost of the
technology.
j. AZEDRA[supreg] (iobenguane Iodine-131) Solution
Progenics Pharmaceuticals, Inc. submitted an application for new
technology add-on payments for AZEDRA[supreg] (iobenguane Iodine-131)
for FY 2020. AZEDRA[supreg] is a drug solution formulated for
intravenous (IV) use in the treatment of patients who have been
diagnosed with obenguane avid malignant and/or recurrent and/or
unresectable pheochromocytoma and paraganglioma (PPGL). AZEDRA was
approved by FDA on July 30, 2018, as a radioactive therapeutic agent
indicated for the treatment of adult and pediatric patients 12 years
and older with iobenguane scan positive, unresectable, locally advanced
or metastatic pheochromocytoma or paraganglioma who require systemic
anticancer therapy. AZEDRA[supreg] was approved for new technology add
on payments for FY 2020. We refer readers to section II.H.5.a. of the
preamble of the FY 2020 IPPS/LTCH PPS final rule (84 FR 42194 through
42201) for a complete discussion of the new technology add on payment
application, coding and payment amount for AZEDRA[supreg] for FY 2020.
With regard to the newness criterion for AZEDRA[supreg], we
consider the beginning of the newness period to commence when
AZEDRA[supreg] was approved by FDA (July 30, 2018). 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 AZEDRA[supreg] onto the U.S. market (July 30, 2021) will occur
in the second half of FY 2021, we proposed to continue new technology
add-on payments for this technology for FY 2021. We proposed that the
maximum new technology add-on payment for a case involving
AZEDRA[supreg] would remain at $98,150 for FY 2021 (we refer readers to
the FY 2020 IPPS/LTCH PPS final rule for complete discussion of the
calculation of the new technology add on payment amount for
AZEDRA[supreg]). Cases involving the use of AZEDRA[supreg] that are
eligible for new technology add-on payments are identified by ICD-10-
PCS procedure codes XW033S5 (Introduction of Iobenguane I-131
antineoplastic into peripheral vein, percutaneous approach, new
technology group 5), and XW043S5 (Introduction of Iobenguane I-131
antineoplastic into central vein, percutaneous approach, new technology
group 5). We invited public comments on our proposal to continue new
technology add-on payments for AZEDRA[supreg] for FY 2021.
Comment: Several commenters supported CMS' proposal to continue new
technology add-on payments for FY 2021 for AZEDRA[supreg].
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 AZEDRA[supreg]
for FY 2021. The maximum new technology add-on payment amount for a
case involving AZEDRA[supreg] will remain at $98,150.00 for FY 2021;
that is, 65 percent of the average cost of the technology.
k. CABLIVI[supreg] (caplacizumab-yhdp)
The Sanofi Company submitted an application for new technology add-
on payments for CABLIVI[supreg] (caplacizumab-yhdp) for FY 2020. The
applicant described CABLIVI[supreg] as a humanized bivalent nanobody
consisting of two identical building blocks joined by a tri alanine
linker, which is administered through intravenous and subcutaneous
injection to inhibit microclot formation in adult patients who have
been diagnosed with acquired thrombotic thrombocytopenic purpura
(aTTP). CABLIVI[supreg] received FDA approval on February 6, 2019, for
the treatment of adult patients with acquired aTTP, in combination with
plasma exchange and immunosuppressive therapy. CABLIVI[supreg] was
approved for new technology add on payments for FY 2020. We refer
readers to section II.H.5.b. of the preamble of the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42201 through 42208) for a complete discussion of
the new technology add on payment application, coding, and payment
amount for CABLIVI[supreg] for FY2020.
With regard to the newness criterion for CABLIVI[supreg], we
consider the beginning of the newness period to commence when
CABLIVI[supreg] was approved by FDA (February 6, 2019). Because the 3-
year anniversary date of the entry of CABLIVI[supreg] onto the U.S.
market (February 6, 2022) will occur after FY 2021, we proposed to
continue new technology add-on payments for this technology for FY
2021. We proposed that the maximum new technology add-on payment for a
case involving CABLIVI[supreg] would remain at $33,215 for FY 2021 (we
refer readers to the FY 2020 IPPS/LTCH PPS final rule for complete
discussion of the calculation of the new technology add on payment
amount for CABLIVI[supreg]). Cases involving the use of CABLIVI[supreg]
that are eligible for new technology add-on payments are identified by
ICD-10-PCS procedure codes XW013W5 (Introduction of Caplacizumab into
subcutaneous tissue, percutaneous approach, new technology group 5),
XW033W5 (Introduction of Caplacizumab into peripheral vein,
percutaneous approach, new technology group 5) and XW043W5
(Introduction of Caplacizumab into central vein, percutaneous approach,
new technology group 5). We invited public comments on our proposal to
continue new technology add-on payments for CABLIVI[supreg] for FY
2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for CABLIVI[supreg] for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for CABLIVI[supreg]
for FY 2021. The maximum new technology add-on payment amount for a
case involving CABLIVI[supreg] will remain at $33,215 for FY 2021; that
is, 65 percent of the average cost of the technology.
l. ELZONRIS\TM\ (tagraxofusp-erzs)
Stemline Therapeutics submitted an application for new technology
add-on payments for ELZONRIS\TM\ for FY 2020. ELZONRIS\TM\
(tagraxofusp-erzs) is a targeted therapy for the treatment of blastic
plasmacytoid dendritic cell neoplasm (BPDCN) administered via infusion.
On December 21, 2018, FDA approved ELZONRIS\TM\ for the treatment of
blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric
patients 2 years old and older. ELZONRIS\TM\ was approved for new
technology add on payments for FY 2020. We refer readers to section
II.H.5.e. of the preamble of the FY 2020 IPPS/LTCH PPS final rule (84
FR 42231 through 42237) for a complete discussion of the new technology
add on payment application, coding and payment amount for ELZONRIS\TM\
for FY 2020.
With regard to the newness criterion for ELZONRIS\TM\, we consider
the beginning of the newness period to commence when ELZONRIS\TM\ was
approved by FDA (December 21, 2018). Because the 3-year anniversary
date of the entry of ELZONRIS\TM\ onto the U.S. market (December 21,
2021) will occur after FY 2021, we proposed to continue new technology
add-on payments for
[[Page 58616]]
this technology for FY 2021. We proposed that the maximum new
technology add-on payment for a case involving ELZONRIS\TM\ would
remain at $125,448.05 for FY 2021 (we refer readers to the FY 2020
IPPS/LTCH PPS final rule for complete discussion of the calculation of
the new technology add on payment amount for ELZONRIS\TM\). Cases
involving the use of ELZONRIS\TM\ that are eligible for new technology
add-on payments are identified by ICD-10-PCS procedure codes XW033Q5
(Introduction of Tagraxofusp-erzs antineoplastic into peripheral vein,
percutaneous approach, new technology, group 5) and XW043Q5
(Introduction of Tagraxofusp-erzs antineoplastic into central vein,
percutaneous approach, new technology group 5). We invited public
comments on our proposal to continue new technology add-on payments for
ELZONRIS\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for ELZONRIS\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for ELZONRIS\TM\
for FY 2021. The maximum new technology add-on payment amount for a
case involving ELZONRIS\TM\ will remain at $125,448.05 for FY 2021;
that is, 65 percent of the average cost of the technology.
m. Balversa\TM\ (Erdafitinib)
Johnson & Johnson Health Care Systems, Inc. (on behalf of Janssen
Oncology, Inc.) submitted an application for new technology add-on
payments for Balversa\TM\ for FY 2020. Balversa\TM\ is indicated for
the second line treatment of adult patients who have been diagnosed
with locally advanced or metastatic urothelial carcinoma whose tumors
exhibit certain fibroblast growth factor receptor (FGFR) genetic
alterations as detected by an FDA-approved test, and who have disease
progression during or following at least one line of prior chemotherapy
including within 12 months of neoadjuvant or adjuvant chemotherapy.
Balversa\TM\ received FDA approval on April 12, 2019. Balversa\TM\ was
approved for new technology add on payments for FY 2020. We refer
readers to section II.H.5.f. of the preamble of the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42237 through 42242) for a complete discussion of
the new technology add on payment application, coding and payment
amount for Balversa\TM\ for FY 2020.
With regard to the newness criterion for Balversa\TM\, we consider
the beginning of the newness period to commence when Balversa\TM\ was
approved by FDA (April 12, 2019). Because the 3-year anniversary date
of the entry of Balversa\TM\ onto the U.S. market (April 12, 2022) will
occur after FY 2021, we proposed to continue new technology add-on
payments for this technology for FY 2021. We proposed that the maximum
new technology add-on payment for a case involving Balversa\TM\ would
remain at $3,563.23 for FY 2021 (we refer readers to the FY 2020 IPPS/
LTCH PPS final rule for complete discussion of the calculation of the
new technology add on payment amount for Balversa\TM\). Cases involving
the use of Balversa\TM\ that are eligible for new technology add-on
payments are identified by ICD-10-PCS procedure code XW0DXL5
(Introduction of Erdafitinib antineoplastic into mouth and pharynx,
external approach, new technology group 5). We invited public comments
on our proposal to continue new technology add-on payments for
Balversa\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for Balversa\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for Balversa\TM\
for FY 2021. The maximum new technology add-on payment amount for a
case involving Balversa\TM\ will remain at $3,563.23 for FY 2021; that
is, 65 percent of the average cost of the technology.
n. ERLEADA\TM\ (Apalutamide)
Johnson & Johnson Health Care Systems Inc., on behalf of Janssen
Products, LP, Inc., submitted an application for new technology add-on
payments for ERLEADA\TM\ (apalutamide) for FY 2020. This oral drug is
an androgen receptor inhibitor approved by FDA on February 14, 2018,
for the treatment of patients who have been diagnosed with non-
metastatic castration-resistant prostate cancer (nmCRPC). ERLEADA\TM\
was approved for new technology add on payments for FY 2020. We refer
readers to section II.H.5.g. of the preamble of the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42242 through 42247) for a complete discussion of
the new technology add on payment application, coding and payment
amount for ERLEADA\TM\ for FY 2020.
With regard to the newness criterion for ERLEADA\TM\, we consider
the beginning of the newness period to commence when ERLEADA\TM\ was
approved by FDA (February 14, 2018). 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
ERLEADA\TM\ onto the U.S. market (February 14, 2021) will occur in the
first half of FY 2021, we proposed to discontinue new technology add-on
payments for this technology for FY 2021. We invited public comments on
our proposal to discontinue new technology add-on payments for
ERLEADA\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to discontinue new
technology add-on payments for ERLEADA\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to discontinue new technology add-on payments for ERLEADA\TM\
for FY 2021.
o. SPRAVATO\TM\ (Esketamine)
Johnson & Johnson Health Care Systems, Inc., on behalf of Janssen
Pharmaceuticals, Inc., submitted an application for new technology add-
on payments for SPRAVATO\TM\ (Esketamine) nasal spray for FY 2020. The
FDA-approved indication for SPRAVATO\TM\ is treatment resistant
depression (TRD). SPRAVATO\TM\ Nasal Spray was approved by FDA March 5,
2019. SPRAVATO\TM\ was approved for new technology add on payments for
FY 2020. We refer readers to section II.H.5.h. of the preamble of the
FY 2020 IPPS/LTCH PPS final rule (84 FR 42247 through 42256) for a
complete discussion of the new technology add on payment application,
coding and payment amount for SPRAVATO\TM\ for FY 2020.
With regard to the newness criterion for SPRAVATO\TM\, we consider
the beginning of the newness period to commence when SPRAVATO\TM\ was
approved by FDA (March 5, 2019). Because the 3-year anniversary date of
the entry of SPRAVATO\TM\ onto the U.S. market (March 5, 2022) will
occur after FY 2021, we proposed to continue new technology add-on
payments for this technology for FY 2021. We proposed that the maximum
new technology add-
[[Page 58617]]
on payment for a case involving SPRAVATO\TM\ would remain at $1,014.79
for FY 2021 (we refer readers to the FY 2020 IPPS/LTCH PPS final rule
for complete discussion of the calculation of the new technology add on
payment amount for SPRAVATO\TM\).
In the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19329), we noted
that the applicant had submitted a request to the ICD-10 Coordination
and Maintenance Committee for approval for a unique ICD-10-PCS
procedure code to specifically identify cases involving the use of
SPRAVATO\TM\, beginning in FY 2020. As of the time of the development
of the FY 2020 IPPS/LTCH PPS final rule, a unique ICD-10-PCS procedure
code to specifically identify cases involving the use of SPRAVATO\TM\
had not yet been finalized in response to the applicant's request.
Therefore, we stated that cases reporting SPRAVATO\TM\ would be
identified by ICD-10-PCS procedure code 3E097GC (Introduction of other
therapeutic substance into nose, via natural or artificial opening) for
FY 2020. Subsequent to the FY 2020 IPPS/LTCH PPS final rule, a unique
ICD-10-PCS procedure code to specifically identify cases involving the
use of SPRAVATO\TM\ was finalized, effective October 1, 2020. As a
result, cases involving the use of SPRAVATO\TM\ that are eligible for
new technology add-on payments would be identified by ICD-10-PCS
procedure code XW097M5 (Introduction of Esketamine Hydrochloride into
nose, via natural or artificial opening, new technology group 5) for FY
2021. Because new ICD-10-PCS procedure code XW097M5 is not effective
until October 1, 2020, ICD-10-PCS procedure code 3E097GC is the only
code available to report the use of the SPRAVATO\TM\ for FY 2020. For
FY 2021, beginning with discharges on or after October 1, 2020, cases
involving SPRAVATO\TM\ that are eligible for new technology add-on
payments will be identified using the new ICD-10-PCS procedure code
XW097M5 (that is effective for FY 2021). We invited public comments on
our proposal to continue new technology add-on payments for
SPRAVATO\TM\ for FY 2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for SPRAVATO\TM\ for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for SPRAVATO\TM\
for FY 2021. The maximum new technology add-on payment amount for a
case involving SPRAVATO\TM\ will remain at $1,014.79 for FY 2021; that
is, 65 percent of the average cost of the technology.
p. XOSPATA[supreg] (gilteritinib)
Astellas Pharma U.S., Inc. submitted an application for new
technology add-on payments for XOSPATA[supreg] (gilteritinib) for FY
2020. XOSPATA[supreg] received FDA approval November 28, 2018 and is
indicated for the treatment of adult patients who have been diagnosed
with relapsed or refractory acute myeloid leukemia (AML) with a FMS-
like tyrosine kinase 3 (FLT3) mutation as detected by an FDA approved
test. XOSPATA[supreg] was approved for new technology add on payments
for FY 2020. We refer readers to section II.H.5.i. of the preamble of
the FY 2020 IPPS/LTCH PPS final rule (84 FR 42256 through 42260) for a
complete discussion of the new technology add on payment application,
coding and payment amount for XOSPATA[supreg].
With regard to the newness criterion for XOSPATA[supreg], we
consider the beginning of the newness period to commence when
XOSPATA[supreg] was approved by FDA (November 28, 2018). Because the 3-
year anniversary date of the entry of XOSPATA[supreg] onto the U.S.
market (November 28, 2021) will occur after FY 2021, we proposed to
continue new technology add-on payments for this technology for FY
2021. We proposed that the maximum new technology add-on payment for a
case involving XOSPATA[supreg] would remain at $7,312.50 for FY 2021
(we refer readers to the FY 2020 IPPS/LTCH PPS final rule for complete
discussion of the calculation of the new technology add on payment
amount for XOSPATA[supreg]). Cases involving the use of XOSPATA[supreg]
that are eligible for new technology add-on payments are identified by
ICD-10-PCS procedure code XW0DXV5 (Introduction of Gilteritinib
antineoplastic into mouth and pharynx, external approach, new
technology group 5). We invited public comments on our proposal to
continue new technology add-on payments for XOSPATA[supreg] for FY
2021.
Comment: A commenter supported CMS' proposal to continue new
technology add-on payments for XOSPATA[supreg] for FY 2021.
Response: We appreciate the commenter's support. After
consideration of the public comments we received, we are finalizing our
proposal to continue new technology add-on payments for XOSPATA[supreg]
for FY 2021. The maximum new technology add-on payment amount for a
case involving XOSPATA[supreg] will remain at $7,312.50 for FY 2021;
that is, 65 percent of the average cost of the technology.
q. JAKAFI \TM\ (ruxolitinib)
Incyte Corporation submitted an application for new technology add-
on payments for JAKAFI \TM\ (ruxolitinib) for FY 2020. According to the
applicant, JAK inhibition represents a therapeutic approach for the
treatment of acute graft-versus-host disease (aGVHD) in patients who
have had an inadequate response to corticosteroids. JAKAFI \TM\
received FDA approval on May 24, 2019 for the treatment of steroid-
refractory aGVHD in adult and pediatric patients 12 years and older.
JAKAFI \TM\ was approved for new technology add on payments for FY
2020. We refer readers to section II.H.5.k. of the preamble of the FY
2020 IPPS/LTCH PPS final rule (84 FR 42265 through 42273) for a
complete discussion of the new technology add on payment application,
coding and payment amount for JAKAFI \TM\ for FY 2020.
With regard to the newness criterion for JAKAFI \TM\, we consider
the beginning of the newness period to commence when JAKAFI \TM\ was
approved by FDA (May 24, 2019). Because the 3-year anniversary date of
the entry of JAKAFI \TM\ onto the U.S. market (May 24, 2022) will occur
after FY 2021, we proposed to continue new technology add-on payments
for this technology for FY 2021. We proposed that the maximum new
technology add-on payment for a case involving JAKAFI \TM\ would remain
at $3,977.06 for FY 2021 (we refer readers to the FY 2020 IPPS/LTCH PPS
final rule for complete discussion of the calculation of the new
technology add on payment amount for JAKAFI \TM\). Cases involving the
use of JAKAFI \TM\ that are eligible for new technology add-on payments
are identified by ICD-10-PCS procedure code XW0DXT5 (Introduction of
Ruxolitinib into mouth and pharynx, external approach, new technology
group 5). We invited public comments on our proposal to continue new
technology add-on payments for JAKAFI \TM\ for FY 2021.
Comment: Several commenters supported our proposal to continue new
technology add-on payments for JAKAFI \TM\ for FY 2021.
One commenter, who was also the applicant, presented results from a
randomized, open-label, multicenter, Phase 3 REACH 2 study comparing
ruxolitinib (JAKAFITM) with the investigator's choice of
therapy in patients with steroid-refractory Grade II-IV aGVHD. The
applicant stated that these results were published in May
[[Page 58618]]
2020 and reinforced findings from the previously reported Phase 2
REACH1 study. The applicant noted that the REACH2 study met its primary
endpoint of overall response rate (ORR) at Day 28 with ruxolitinib
treatment (62.3% [96/154]) compared to control therapy (39.4% [61/155])
and that no new safety signals were observed. According to the
applicant, the most common adverse events up to Day 28 seen with
JAKAFITM were thrombocytopenia, anemia, and cytomegalovirus
infection. The applicant concluded that these data further support CMS'
assessment that JAKAFITM met the substantial clinical
improvement criterion in FY 2020.
The same commenter provided updated cost information and requested
that we revise the maximum add-on payment amount for
JAKAFITM to account for an increase in the Wholesale
Acquisition Cost, which is currently $13,504 per 60 tablets. The
commenter stated that per the FY 2020 IPPS final rule, CMS calculated
the maximum new technology add-on payment using the WAC for 60
JAKAFITM tablets, determining the per tablet amount,
multiplying that figure by two (as JAKAFITM is taken twice
daily), and using a 14 day anticipated duration. Under this
methodology, the average cost of JAKAFITM per case would
change from $6,118.56 to $6,301.86 ($13,504/60 * 2 * 14), and limiting
the maximum add-on payment to the lesser of 65% of the cost of the
technology or 65% of the amount by which the costs of the case exceed
the MS-DRG payment would result in a maximum payment of $4,096.21 for
JAKAFITM for FY 2021.
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 JAKAFI \TM\ for FY 2021. Based on the applicant's
updated cost information, the maximum new technology add-on payment for
a case involving the use of JAKAFITM is $4,096.21 for FY
2021; that is, 65 percent of the average cost of the technology.
r. T2Bacteria[supreg] Panel (T2Bacteria Test Panel)
T2Biosystems, Inc. submitted an application for new technology add-
on payments for the T2Bacteria Test Panel (T2Bacteria[supreg] Panel)
for FY 2020. The T2Bacteria[supreg] Panel received 510(k) clearance
from FDA on May 24, 2018 for use as an aid in the diagnosis of
bacteremia, bacterial presence in the blood, which is a precursor for
sepsis. Per the FDA-cleared indication, results from the
T2Bacteria[supreg] Panel are not intended to be used as the sole basis
for diagnosis, treatment, or other patient management decisions in
patients with suspected bacteremia. Concomitant blood cultures are
necessary to recover organisms for susceptibility testing or further
identification, and for organisms not detected by the
T2Bacteria[supreg] Panel. The T2Bacteria[supreg] Panel was approved for
new technology add on payments for FY 2020. We refer readers to section
II.H.5.m. of the preamble of the FY 2020 IPPS/LTCH PPS final rule (84
FR 42278 through 42288) for a complete discussion of the new technology
add on payment application, coding and payment amount for the
T2Bacteria[supreg] Panel for FY 2020.
With regard to the newness criterion for the T2Bacteria [supreg]
Panel, we consider the beginning of the newness period to commence when
the T2Bacteria [supreg] Panel was cleared by FDA (May 24, 2018). 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 T2Bacteria [supreg] Panel onto the
U.S. market (May 24, 2021) will occur in the second half of FY 2021, we
proposed to continue new technology add-on payments for this technology
for FY 2021. We proposed that the maximum new technology add-on payment
for a case involving the T2Bacteria [supreg] Panel would remain at
$97.50 for FY 2021 (we refer readers to the FY 2020 IPPS/LTCH PPS final
rule for complete discussion of the calculation of the new technology
add on payment amount for the T2Bacteria [supreg] Panel). Cases
involving the use of the T2Bacteria [supreg] Panel that are eligible
for new technology add-on payments are identified by ICD-10-PCS
procedure code XXE5XM5 (Measurement of infection, whole blood nucleic
acid-base microbial detection, new technology group 5). We invited
public comments on our proposal to continue new technology add-on
payments for the T2Bacteria [supreg] Panel for FY 2021.
Comment: Several commenters expressed support for our proposed
continuation of new technology add-on payments for the T2Bacteria
[supreg] Panel for FY 2021. One commenter, who was also the applicant,
stated that continuation of these payments for a second year is not
only consistent with CMS' longstanding definition of newness but is
also critical to increasing beneficiary access to the T2Bacteria
[supreg] Panel. The commenter noted that sepsis is the most expensive
U.S. hospital-treated condition, representing $23.7 billion in
healthcare costs per year and contributing to greater than 35% of
inpatient deaths, many of them Medicare beneficiaries. The commenter
concluded that, by enabling greater clinician access to the T2Bacteria
[supreg] Panel, CMS is playing a significant role in making sure
Medicare beneficiaries receive the most effective therapy for the
pathogen that they are infected with, reducing length-of-stay in the
hospital and saving lives.
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 the T2Bacteria
[supreg] Panel for FY 2021. The maximum new technology add-on payment
amount for a case involving the T2Bacteria [supreg] Panel will remain
at $97.50 for FY 2021; that is, 65 percent of the average cost of the
technology.
BILLING CODE 4120-01-P
[[Page 58619]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.151
[[Page 58620]]
BILLING CODE 4120-01-C
5. FY 2021 Applications for New Technology Add-On Payments (Traditional
Pathway)
We received 17 applications for new technology add-on payments for
FY 2021. In accordance with the regulations under Sec. 412.87(e),
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 for which the application is being considered. Two applicants
withdrew their applications prior to the issuance of the proposed rule.
Three applicants, Accelerate Diagnostics, Inc (the applicant for
Accelerate PhenoTest TM BC kit), Kite Pharma (the applicant
for KTE-X19) and Juno Therapeutics, a Bristol-Myers Squibb Company (the
applicant for Liso-cel) did not meet the deadline of July 1 for FDA
approval or clearance of the technology and, therefore, the
technologies are not eligible for consideration for new technology add-
on payments for FY 2021. We note that we did receive some comments
requesting that CMS extend the July 1 deadline for applications to
receive FDA marketing authorization for FY 2021 due to the COVID-19
public health emergency. The July 1 deadline for FDA approval or
clearance for consideration of new technology add-on payment
applications, as set forth in the regulations at Sec. 412.87(e),
continues to apply to applications for new technology add-on payments
for FY 2021, subject to our proposed conditional approval process for
certain antimicrobial products. A discussion of the remaining 12
applications, which met this deadline, is presented in this final rule.
b. BioFire [supreg] FilmArray [supreg] Pneumonia Panel
BioFire Diagnostics, LLC submitted an application for new
technology add-on payments for the BioFire [supreg] FilmArray [supreg]
Pneumonia Panel for FY 2021. According to the applicant, the BioFire
[supreg] FilmArray [supreg] Pneumonia Panel identifies 33 clinically
relevant targets, including bacterial and viral targets, from sputum
(including endotracheal aspirate) and bronchoalveolar lavage (including
mini-BAL) samples in about an hour. The applicant also stated that for
15 bacteria, the BioFire [supreg] FilmArray [supreg] Pneumonia Panel
provides semi-quantitative results, which may help determine whether an
organism is a colonizer or a pathogen.
According to the applicant, lower respiratory tract infections are
a leading cause of morbidity and mortality. The applicant stated that
world-wide, they are the leading cause of infectious disease death and
the 5th leading overall cause of death.\2\ The applicant also asserted
that in the United States, community acquired pneumonia (CAP) is the
second most common cause of hospitalization and the most common
infectious disease cause of death.3 4 The applicant also
stated that in addition to CAP, Hospital-acquired Pneumonia (HAP) and
Ventilator-associated Pneumonia (VAP) are the most common hospital
acquired infections (HAI) accounting for 22 percent of all HAIs.\5\
According to the applicant, HAP and VAP are of particular concern for
patients admitted to intensive care units (ICUs) where mortality rates
can be up to 50 percent.6 7
---------------------------------------------------------------------------
\2\ Troeger, C., Forouzanfar, M., Rao, P.C., Khalil, I., Brown,
A., Swartz, S., Fullman, N., Mosser, J., Thompson, R.L., Reiner Jr,
R.C. and Abajobir, A., ``Estimates of the global, regional, and
national morbidity, mortality, and aetiologies of lower respiratory
tract infections in 195 countries: A systematic analysis for the
Global Burden of Disease Study 2015,'' The Lancet Infectious
Diseases, 2017, vol. 17(11), pp.1133-1161.
\3\ Xu, J. Murphy SL, Kochanek KD, Bastian BA, ``Deaths: Final
Data for 2013'' Natl Vital Stat Rep, 2016, vol. 64(2), p. 1.
\4\ Pfuntner, A., Wier, L. M., & Stocks, C. ``Most frequent
conditions in US hospitals, 2011,'' Healthcare Cost and Utilization
Project (HCUP) Statistical Brief #162, 2013.
\5\ Magill,.S., Edwards, J.R., Bamberg, W., Beldavs, Z.G.,
Dumyati, G., Kainer, M.A., Lynfield, R., Maloney, M., McAllister-
Hollod, L., Nadle, J. and Ray, S.M., ``Multistate point-prevalence
survey of health care-associated infections,'' N. Engl. J. of Med.,
2014, vol. 370(13), pp.1198-1208.
\6\ Sopena, N., Sabri[agrave], M. and Neunos 2000 Study Group,
``Multicenter study of hospital-acquired pneumonia in non-ICU
patients,'' Chest, 2005, vol. 127(1), pp. 213-219.
\7\ Esperatti, M., Ferrer, M., Giunta, V., Ranzani, O.T.,
Saucedo, L.M., Bassi, G.L., Blasi, F., Rello, J., Niederman, M.S.
and Torres, A., ``Validation of predictors of adverse outcomes in
hospital-acquired pneumonia in the ICU,'' Crit. Care Med., 2013.
Vol. 41(9), pp.2151-2161.
---------------------------------------------------------------------------
According to the applicant, timely administration of effective
antibiotics is essential for ensuring a good prognosis. The applicant
stated that mortality increases for each hour of delay in initiating
antibiotic therapy for hospitalized pneumonia patients,8 9
and ideally, antimicrobial therapy would be pathogen-specific and
guided by the results of microbiology tests. However, the applicant
stated that current microbiologic methods are slow and fail to identify
a causative pathogen in over 50 percent of patients, even when
comprehensive methods are used.\10\ As a result, the applicant noted
that current guidelines recommend empiric treatment with broad spectrum
antibiotics,\11\ and that broad-spectrum antibiotics lead to overuse of
antibiotics, which increases the risk of an antibiotic related adverse
event (for example, diarrhea, allergic reactions, C. difficile
infection) for the patient and contributes to the well-known problem of
antimicrobial resistance. In addition, the applicant noted that 6-15
percent of hospitalized patients with CAP fail to respond to the
initial antibiotic treatment, in part due to ineffective antibiotic
therapy.12 13 14 15
---------------------------------------------------------------------------
\8\ Benenson, R., Magalski, A., Cavanaugh, S. and Williams, E.,
``Effects of a pneumonia clinical pathway on time to antibiotic
treatment, length of stay, and mortality,'' Acad. Emerg. Med., 1999,
vol. 6(12), pp.1243-1248.
\9\ Houck, P.M., Bratzler, D.W., Nsa, W., Ma, A. and Bartlett,
J.G., ``Timing of antibiotic administration and outcomes for
Medicare patients hospitalized with community-acquired pneumonia,''
Arch. Intern. Med., 2004, vol. 164(6), pp.637-644.
\10\ Jain, S., Self, W.H., Wunderink, R.G., Fakhran, S., Balk,
R., Bramley, A.M., Reed, C., Grijalva, C.G., Anderson, E.J.,
Courtney, D.M. and Chappell, J.D., ``Community-acquired pneumonia
requiring hospitalization among US adults,'' N. Engl. J. Med., 2015,
vol. 373(5), pp.415-427.
\11\ Kalil, A.C., Metersky, M.L., Klompas, M., Muscedere, J.,
Sweeney, D.A., Palmer, L.B., Napolitano, L.M., O'Grady, N.P.,
Bartlett, J.G., Carratal[agrave], J. and El Solh, A.A., ``Management
of adults with hospital-acquired and ventilator-associated
pneumonia: 2016 clinical practice guidelines by the Infectious
Diseases Society of America and the American Thoracic Society,''
Clin. Infect. Dis., 2016, vol. 63(5), pp.e61-e111.
\12\ Ros[oacute]n, B., Carratala, J., Fern[aacute]ndez-
Sab[eacute], N., Tubau, F., Manresa, F. and Gudiol, F., ``Causes and
factors associated with early failure in hospitalized patients with
community-acquired pneumonia,'' Arch. Intern. Med., 2004, vol.
164(5), pp.502-508.
\13\ Menendez, R., Torres, A., Zalacain, R., Aspa, J.,
Villasclaras, J.M., Border[iacute]as, L., Moya, J.B., Ruiz-Manzano,
J., de Castro, FR, Blanquer, J. and P[eacute]rez, D., ``Risk factors
of treatment failure in community acquired pneumonia: Implications
for disease outcome,'' Thorax, 2004. Vol. 59(11), pp. 960-965.
\14\ Arancibia, F., Ewig, S., Martinez, J.A., Ruiz, M., Bauer,
T., Marcos, M.A., Mensa, J. and Torres, A., ``Antimicrobial
treatment failures in patients with community-acquired pneumonia:
Causes and prognostic implications,'' Am. J. Respir. Crit. Care
Med., 2000, vol. 162(1), pp.154-160.
\15\ Men[eacute]ndez, R., Torres, A., Rodr[iacute]guez de
Castro, F., Zalaca[iacute]n, R., Aspa, J., Mart[iacute]n
Villasclaras, J.J., Border[iacute]as, L., Ben[iacute]tez, J.M.M.,
Ruiz-Manzano, J., Blanquer, J. and P[eacute]rez, D., ``Reaching
stability in community-acquired pneumonia: The effects of the
severity of disease, treatment, and the characteristics of
patients,'' Clin. Infect. Dis., 2004, vol. 39(12), pp.1783-1790.
---------------------------------------------------------------------------
According to the applicant, there are three current methods for
determining the causative organism of pneumonia: bacterial culture, lab
developed and commercial singleplex PCR (polymerase chain reaction)
tests, and off-label use of upper respiratory multiplex syndromic
panels.
According to the applicant, semi-quantitative bacterial culture is
routinely performed on lower respiratory specimens. The applicant
explained that a calibrated loop is used to spread sample on
appropriate media. A quadrant streak method is generally employed and,
depending on how many of the quadrants the organism grows in,
determines its semi-quantification.
[[Page 58621]]
According to the applicant, normal flora will often grow in all 4
quadrants and technicians must differentiate between potential
pathogens and normal flora, and potential pathogens are picked from the
plate and isolated on another media plate. According to the applicant,
after growing isolate, final identification and susceptibility is
performed.
According to the applicant, there are also FDA and lab-developed
tests for single targets that cause pneumonia. The applicant stated
that these are for the more serious pathogens (for example, Methicillin
resistant Staphylococcus aureus, MRSA) or fastidious organisms (for
example, Mycobacterium tuberculosis). According to the applicant, these
tests range from sample-to-answer (Cepheid [supreg] Xpert [supreg] MTB/
RIF) to lab-developed tests that are often multi-step and multiple
pieces of equipment that require isolating nucleic acid from a sample
and then adding appropriate reagents to perform a PCR assay on the
isolated nucleic acid.
According to the applicant, a number of academic hospital labs have
also performed off-label validation of commercially available
respiratory panels designed for upper respiratory syndromes. The
applicant stated that these tests are used primarily on BAL specimens
for the rapid detection of viral causes of Pneumonia.
With respect to the newness criterion, the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel received FDA clearance via 510(k) on
November 9, 2018, based on a determination of substantial equivalence
to a legally marketed predicate device (Curetis UnyveroTM).
According to the applicant, the Pneumonia Panel was launched globally
on December 11, 2018. According to the applicant, there was a delay
between FDA clearance date and U.S. market availability (global launch
date) in order to satisfy documentation requirements in preparation of
the global launch. The applicant stated that it has been granted a
Proprietary Laboratory Analyses (PLA) code by the American Medical
Association; PLA Code 0151U was published on October 1, 2019 and became
effective on January 1, 2020. According to the applicant, the PLA code
assigned to the BioFire[supreg] FilmArray[supreg] Pneumonia Panel
uniquely identifies this test and no other technologies use this code.
The applicant submitted a request for approval for a unique ICD-10-PCS
code for the administration of the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel beginning in FY 2021 and was granted approval for the
following procedure code effective October 1, 2020: XXEBXQ6
(Measurement of infection, lower respiratory fluid nucleic acid-base
microbial detection, new technology group 6).
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 purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel is the only sample-to-answer, rapid (~1 hour), and
comprehensive molecular panel available for the diagnosis of the major
bacterial and viral causes of infectious pneumonia. The applicant
further explained that the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel is also the only semi-quantitative molecular solution available
for rapidly diagnosing infectious causes of pneumonia. The applicant
noted that this important feature allows labs and clinicians to better
differentiate whether an organism is normal flora or the cause of the
patient's illness. The applicant asserted that the current best
practice is standard culture technique, discussed previously. The
applicant further stated that other comprehensive molecular
technologies include Curetis UnyveroTM which is a multi-step
process, only has bacterial targets, and only provides qualitative
results for all of its targets.
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 patients who may be eligible for treatment involving
the BioFire[supreg] FilmArray[supreg] Pneumonia Panel would be assigned
to the same MS-DRGs as cases representing patients who receive
diagnostic information from competing technologies.
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 BioFire[supreg] FilmArray[supreg] Pneumonia Panel is the
only FDA cleared comprehensive molecular panel approved for use on both
sputum (including endotracheal aspirate) and bronchoalveolar lavage
(including mini-BAL) samples allowing for diagnosis of pneumonia in
hospital, community, and ventilator associated populations. The
applicant stated that the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel is also the only molecular panel that detects both bacterial and
viral causes of lower respiratory infections and pneumonia.
In addition, the applicant added that the ability of the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel to detect pathogens
and related susceptibility traits is a unique feature of the panel that
differentiates it from existing respiratory panels that have been
designed and approved for use on upper respiratory specimens and not
lower respiratory specimens. The applicant stated that Furukawa, D., et
al., evaluated the ability of the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel to detect pathogens and related susceptibility traits,
specifically looking at the impact of MRSA detection, and showed that
the BioFire[supreg] FilmArray[supreg] Pneumonia panel has the potential
to significantly expedite time to MRSA results allowing for rapid
escalation or de-escalation of therapy.\16\
---------------------------------------------------------------------------
\16\ Furukawa, D., Kim, B., Jeng, A., BioFire[supreg]
FilmArray[supreg] Pneumonia Panel: A Powerful Rapid Diagnostic Test
for Antimicrobial Stewardship. Poster presented at Infectious
Disease Week; 2019 October 2-6. Washington, DC.
---------------------------------------------------------------------------
We stated in the proposed rule that based on the applicant's
statements as presented previously, we are concerned there is
insufficient information to determine whether the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel mechanism of action is different from
existing products. In the FDA decision summary, the test is described
as a multiplex nucleic acid test, or PCR accompanied by the applicant's
software. However, it is unclear from the new technology add-on payment
application how the mechanism of action is new or different from other
products that utilize PCR. While the applicant described this test as
the only sample-to-answer, rapid (~1 hour), and comprehensive molecular
panel available for the diagnosis of the major causes of infectious
pneumonia and as also semi-quantitative, and further described another
comprehensive molecular product (Curetis UnyveroTM) as
having only bacterial targets and providing only qualitative results
for all of its targets, we stated that we are uncertain how the
underlying mechanism of action of the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel is different from existing PCR-based tests.
Additionally, based on the information provided by the applicant, we
stated that it appears as though the product does not treat a different
disease or population compared to other products. Finally, with respect
to the Furukawa study, which the applicant cited to support that the
BioFire has the potential to specifically expedite time to MRSA results
allowing for rapid escalation or de-escalation of therapy,
[[Page 58622]]
we noted that the study authors also concluded that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel ``has good agreement with SOC for
detection of bacteria and viruses'' and that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel ``detects additional S. aureus
bacteria not reported by SOC,'' but that ``[a]dditional S. aureus
detection are more likely to be at low concentration and are of unclear
clinical significance.'' We invited public comments on whether the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel is substantially
similar to other technologies and whether the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel meets the newness criterion.
We did not receive any public comments on whether the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel meets the newness
criterion. We continue to have the same concerns as summarized in the
proposed rule that the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel is substantially similar to other products that are currently
available on the U.S. market. Despite the information the applicant
previously submitted with its application describing the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel as the only sample-
to-answer, rapid (~1 hour), and comprehensive molecular panel available
for the diagnosis of the major causes of infectious pneumonia and as
also semi-quantitative, it remains unclear how the mechanism of action
is specifically new or different from other products that utilize PCR.
Moreover, it appears that the patient population of cases that may be
eligible for tests using the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel also currently has access to other PCR-based tests and
similar technologies that are also used in the testing of similar
conditions. Therefore, we are unable to determine that the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel 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.
The applicant stated that it used 2018 data from Definitive Health
Care at defhc.com, and that it searched these data for cases in MS-DRGs
193, 194, and 195 (Simple Pneumonia and Pleurisy with MCC, with CC, and
without CC/MCC, respectively), which resulted in 297,956 cases. The
applicant indicated that the data was from proprietary data drawn from
one hospital in Indianapolis in 2018. However, the scope of the data as
described by the applicant is unclear to us, as it seems unlikely that
a single hospital in Indiana would have observed 297, 956 cases of
simple pneumonia in 1 year. It is also not clear how these cases
correspond to any of the later steps in the cost analysis. For example,
the applicant did not indicate whether the charge values from the data
are based on the same 297,956 cases identified in the three MS-DRGs.
In its analysis, the applicant stated that no charges were removed
for any prior technologies as the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel does not eliminate culture testing of specimens. The
applicant standardized the charges and then inflated the charges. The
applicant reported using an inflation factor of 5.50 percent based on
the charge inflation factor published by CMS in the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42629). The applicant appears to have made a
minor error in this inflation factor, since the actual, 1-year
inflation factor in the FY 2020 IPPS/LTCH PPS final rule was 5.4
percent. To estimate the cost of the technology, the applicant used the
per-test list price cost of the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel. The applicant indicated that it did not incorporate an
estimate of technician time spent administering the test, asserting
that ``2-5 minutes of technician time is nearly obsolete due to ease of
use of the test.'' The applicant also indicated that it did not
incorporate an estimate of instrumentation cost into its costing of the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel, noting that ``a
number of'' labs already have sufficient instrumentation to run the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel test. The applicant
added charges for the BioFire[supreg] FilmArray[supreg] Pneumonia Panel
based on an estimated range of projected patient charges for the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel technology. The
applicant stated that the charge to the patient varies by location and
the methodology of the hospital or lab charge master. The applicant
noted that the estimate was based on patient charges for other
BioFire[supreg] products that had been reported by hospitals and
reference labs. Based on this analysis, the applicant computed a final
inflated average case-weighted standardized charge per case of $78,156,
as compared to an average case-weighted threshold amount of $42,812.
Because the final inflated average case-weighted standardized charge
per case exceeded the average case-weighted threshold amount, the
applicant asserted that the technology meets the cost criterion.
We stated in the proposed rule that we are concerned that many of
the calculated values in the applicant's analysis, such as the average-
cost-per case, unweighted and unstandardized, were reportedly based on
proprietary claims data that came from one hospital in Indianapolis. We
are concerned that an analysis based on one hospital would not
adequately represent the cost of cases using the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel as the data could be skewed or biased
based on one hospital. We stated in the proposed rule that we are also
concerned with the lack of description of how the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel maps to the three MS-DRGs for simple
pneumonia (that is, MS-DRGs 193, 194 and 195); for example, whether the
analysis included all the cases in these MS-DRGs or was limited to
specific cases. We note there are several additional pneumonia-related
MS-DRGs to which we believe potential cases that may be eligible for
the use of the product could be mapped, but which were not included in
the cost analysis; for example, MS-DRGs 177, 178 and 179 (Respiratory
Infections and Inflammations with MCC, with CC, and without CC/MCC,
respectively) and MS-DRGs 974, 975, and 976 (HIV with Major Related
Condition with MCC, with CC, and without CC/MCC, respectively). We
invited public comments on whether the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel meets the cost criterion.
We did not receive any public comments on whether the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel meets the cost
criterion. We continue to have the same concerns regarding the cost
analysis for the BioFire[supreg] FilmArray[supreg] Pneumonia Panel as
summarized previously. We remain concerned that many of the calculated
values in the applicant's analysis would not adequately represent the
cost of cases using the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel as they are based on proprietary claims data that came from one
hospital. We also continue to be concerned with the lack of description
of how the BioFire[supreg] FilmArray[supreg] Pneumonia Panel maps to
the three MS-DRGs for simple pneumonia (that is, MS-DRGs 193, 194 and
195); for example, whether the analysis included all the cases in these
MS-DRGs or was limited to specific cases. Therefore, we are unable to
determine that the BioFire[supreg] FilmArray[supreg] Pneumonia Panel
meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that data from studies conducted with the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel show that it can
detect major causes of pneumonia with a high degree of sensitivity and
specificity in a clinically relevant timeframe. The applicant explained
that results from the BioFire[supreg] FilmArray[supreg]
[[Page 58623]]
Pneumonia Panel also have the potential to impact antibiotic usage and
lead to improved stewardship and possible cost savings.
The applicant submitted four studies presented as posters at
national conferences to support its assertion that the product
represents a substantial clinical improvement, noting that data for
this test is still new and has not yet been published in academic
journals.
According to the applicant, Buchan, et al. compared the results of
conventional testing (bacterial culture and clinician directed
molecular testing for viruses and atypical bacteria) with the results
from the BioFire[supreg] FilmArray[supreg] Pneumonia Panel for 259 BAL
and 48 sputum samples.\17\ We note that in their poster, Buchan, et al.
specified that conventional testing specifically included bacterial
culture and PCR based on clinician order. Also, while Buchan, et al.
did report on the BAL specimens, the poster did not appear to report
information regarding sputum samples. According to Buchan, et al.,
specimens were obtained from inpatients aged 18 years and older with
symptoms of respiratory tract infection at 8 hospitals in the U.S.
Chart review was conducted to determine type and duration of antibiotic
therapy for each subject. According to the applicant, at least one
bacterial pathogen was identified by standard methods and by the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel for 23 percent of
BALs samples (n=60) and 35 percent (n=17) of sputum samples; however,
the BioFire[supreg] FilmArray[supreg] Pneumonia Panel detected a
bacterial pathogen in an additional 15 percent (n=40) of BAL samples
and 21 percent (n=10) of the sputum samples. For the 259 BAL samples,
75 bacteria were identified by both standard methods and by the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel. The applicant noted
that the BioFire[supreg] FilmArray[supreg] Pneumonia Panel identified
an additional 84 bacteria, with the most common detections for
Staphylococcus aureus (N=21), Haemophilus influenzea (n=19), Moxaella
catarrhalis (n=8), Pseudomonas aeruginosa (n=6) and Klebsiella oxytoca
(n=6). The applicant also explained that an evaluation of the medical
and laboratory records for the affected patients found that 50 percent
had been on antibiotics within 72 hours of samples collection, 42
percent of the organisms may have been present in the culture but were
not reported (due either to low quantification (<10\4\ cfu/mL) or the
presence of mixed colonies) and only 8 percent of the detections were
unexplained.
---------------------------------------------------------------------------
\17\ Buchan, B.W., Windham, S., Faron, M.L., et al. Clinical
Evaluation and Potential Impact of a Semi-Quantitative Multiplex
Molecular Assay for the Identification of Pathogenic Bacteria and
Viruses in Lower Respiratory Specimens. Poster presented at American
Thoracic Society; 2018 May 02. San Diego, CA.
---------------------------------------------------------------------------
According to the applicant, an important feature of the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel is the inclusion of
assays for viral agents. The applicant noted that in Buchan, et al.,
the BioFire[supreg] FilmArray[supreg] Pneumonia Panel identified at
least 1 virus in 19 percent of 259 BAL samples from hospitalized adults
\18\ and viruses were the only pathogen detection in 12 percent (n=31)
of BAL specimens, while 7 percent (n=18) had both bacterial and viral
pathogen detections. The applicant summarized that the most common
viral pathogens were human rhinovirus (n=17), coronavirus (n=9) and
influenza (n=5). Twenty-three percent of the samples with a viral
detection had a corresponding test ordered as part of standard of care.
The applicant stated that this finding highlights that the role of
viruses in pneumonia is still under appreciated. The applicant further
stated that identification of a viral agent in the absence of a
bacterial detection may allow reduction in the use of antibiotics.
---------------------------------------------------------------------------
\18\ Ibid.
---------------------------------------------------------------------------
According to the applicant, the ability of the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel to impact patient management has been
evaluated by two different groups (Buchan, et al. and Enne, et al). The
applicant stated that Buchan, et al. performed a theoretical outcomes
analysis by using the result of the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel to modify antimicrobial therapy and then judge if the
modification was correct using the final microbiology results. The
applicant explained that in this analysis of 243 BAL samples, 68
percent (n=165) could have had an antibiotic adjustment; 48 percent
(n=122) would have had antibiotics appropriately de-escalated or
discontinued, 31 percent (n=78) would have had no change, and 2 percent
(n=5) would have had appropriate escalation or initiation of
antibiotics.\19\ Alternately, 17 percent (n=42) would have received
inappropriate escalation and 2 percent (n=6) would have received
inappropriate de-escalation when compared to culture results. The
applicant summarized that the most common de-escalations occurred due
to discontinuation of vancomycin due to non-detection of MRSA (35
percent) and discontinuation of piperacillin/tazobactam due to non-
detection of Enterobacteriaceae (23 percent). According to the
applicant, the de-escalation due to non-detection of these pathogens is
possible because the increased sensitivity of the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel for detection of bacterial pathogen
provides a high negative predictive value for these non-detections. The
applicant explained that the authors estimated the results could have
potentially saved >18,000 antibiotic hours equating to an average of
6.5 days/patient (we note that in the poster by Buchan, et al., they
reported an average of 6.2 d/patient rather than 6.5 mentioned in the
application).\20\
---------------------------------------------------------------------------
\19\ Ibid.
\20\ Ibid.
---------------------------------------------------------------------------
According to the applicant, in an analysis of 120 ICU patients (79
males and 41 females; 33 children, with a median age of 1; and adults
with a median age of 68) in the UK by Enne, et al., patients were
divided into a group with positive outcomes (pneumonia resolved within
21 days) and negative outcomes (pneumonia not resolved in 21 days or
contributed to the patient's death). Enne, et al., evaluated the
appropriateness of antimicrobials used for HAP/VAP versus both routine
culture and two rapid PCR tests, BioFire[supreg] FilmArray[supreg]
Pneumonia Panel (1h) and Curetis UnyveroTM Pneumonia Panel
(5.5h). Consented or assented ICU patients were recruited at 4 diverse
UK hospitals: 1 district general, 1 tertiary referral, 1 children's and
1 private. Patients were those starting or changing antibiotics for
suspected pneumonia, already hospitalized for >48h and with a timely
respiratory sample. According to the applicant, the results of the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel and routine culture
were evaluated to determine if the test results would have identified
the antibiotic therapy as active or inactive. The applicant explained
that in the group with positive outcomes, the results of the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel were able to
correctly classify the patient's therapy as active for 35 percent of
patients compared to only 20 percent for routine culture (p=0.005). The
applicant also explained that in the group of 27 percent of patients
that had negative outcomes, the results of the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel would have classified the initial
antibiotic therapy as inactive for 41 percent of patients compared to
only 15.6 percent for routine culture.\21\ The
[[Page 58624]]
study authors also reported that routine microbiology and Curetis
UnyveroTM detected a potential pathogen in 41.7 percent and
59.2 percent of specimens respectively, whereas BioFire[supreg]
FilmArray[supreg] Pneumonia Panel detected a potential pathogen in 66.7
percent of respiratory samples from patients enrolled in the study. The
applicant stated that these study results indicate that the test
results of the BioFire[supreg] FilmArray[supreg] Pneumonia Panel
provide information that can lead to more targeted and effective
therapy in a shorter period of time, and may help to improve patient
outcomes.
---------------------------------------------------------------------------
\21\ Enne, V.I., Baldan, R., Russell, C., et al. INHALE WP2:
Appropriateness of Antimicrobial Prescribing for Hospital-acquired
and Ventilator-associated Pneumonia (HAP/VAP) in UK ICUs assessed
against PCR-based Molecular Diagnostic Tests. Poster presented at
European Congress of Clinical Microbiology and Infectious Disease;
2019 April 13-16. Amsterdam, Netherlands
---------------------------------------------------------------------------
The applicant also submitted Rand et al., which conducted a
retrospective analysis of BAL (n=197) and endotracheal aspirates (n=93)
samples from 270 unique hospitalized patients that were collected and
stored at -70[deg] C until thawed and tested on the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel compared to routine microbiology
results.\22\ Patient data were extracted from the electronic medical
record. Cultures were performed by standard methods and identified by
Vitek II and mass spectrometry. The applicant explained that the
authors found a high correlation between standard methods and
BioFire[supreg] FilmArray[supreg] results and that the authors
concluded the BioFire[supreg] FilmArray[supreg] Pneumonia Panel would
have had a significant impact on time to result which could potentially
lead to more rapid and appropriate use of antibiotics. The applicant
also noted that the authors found significant association with
clinical/outcome variables and that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel's semi-quantification was ``at least
as strong'' as standard culture methods, which according to the
applicant, have been developed and improved over decades.
---------------------------------------------------------------------------
\22\ Rand, K.H., Beal S.G., Cherabuddi, K., et al. Relationship
of a Multiplex Molecular Pneumonia Panel (PP) Results with Hospital
Outcomes and Clinical Variables. Poster presented at Infectious
Disease Week; 2019 October 2-6. Washington, DC.
---------------------------------------------------------------------------
The applicant also submitted White, et al., which conducted a
comparison of the BioFire[supreg] FilmArray[supreg] Pneumonia Panel on
sputum samples to a multi-test diagnostic bundle for patients admitted
from the emergency department (ED) with community acquired pneumonia
(CAP).\23\ We note that White, et al. specifically described the
diagnostic bundle as including the following: (1) Blood Cultures; (2)
Sputum culture and sensitivity; (3) Urine antigens: Legionella and S.
pneumoniae; (4) Nasal swab (NS) PCR for MRSA and S. pneumoniae; (5)
FilmArray (Biofire) PCR Panel (NS): Detects 17 viruses, 4 bacteria. Of
585 enrolled patients, 278 were evaluable. The applicant explained that
the authors found that the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel detected a higher rate of potential pathogens than the multi-test
bundle (90.6 percent versus 81 percent). The applicant also noted that
the authors determined that the urine antigen testing, S. aureus and S.
pnuemoniae, and PCR upper respiratory panel use could be eliminated for
this sample/patient type in the future.\24\
---------------------------------------------------------------------------
\23\ White, E., Ferdosian, S., Gelfer, G., et al. Sputum
FilmArray Pneumonia Panel Outperforms A Diagnostic Bundle in
Hospitalized CAP Patients. Poster presented at Infectious Disease
Week; 2019 October 2-6. Washington, DC
\24\ Ibid.
---------------------------------------------------------------------------
The applicant also submitted a poster by Furukawa, et al. which
reported a retrospective case review of 43 samples (17 used for
clinical use and 26 obtained randomly by microbiology lab) in which
BioFire[supreg] FilmArray[supreg] Multiplex PCR was utilized.\25\
According to the applicant, initial use of BioFire FilmArray Pneumonia
panel had 100 percent intervention rate leading to de-escalation or
prevention of inappropriate antibiotics and the authors found that
there was a low risk of unnecessary antibiotics being administered due
to the increased sensitivity of the BioFire[supreg] FilmArray[supreg]
Pneumonia panel. The applicant added that the authors believe that with
additional data they may be able to discontinue empiric broad spectrum
coverage due to the rapid and sensitive nature of the BioFire FilmArray
Pneumonia Panel. The applicant also noted that they have a number of
ongoing prospective studies being conducted to further support their
claims.
---------------------------------------------------------------------------
\25\ Furukawa, D., Kim, B., Jeng, A., BioFire[supreg]
FilmArray[supreg] Pneumonia Panel: A Powerful Rapid Diagnostic Test
for Antimicrobial Stewardship. Poster presented at Infectious
Disease Week; 2019 October 2-6. Washington, DC.
---------------------------------------------------------------------------
The applicant asserted that Buchan, et al. and Rand, et al. support
their claim of decreased time to actionable results based on: (1) The
conclusion in Buchan, et al., that greater than 60 percent of patients
potentially could have had an antibiotic adjustment 3-4 days earlier
than standard methods based on BioFire[supreg] FilmArray[supreg]
Pneumonia Panel results, and (2) the conclusion in Rand, et al., that
the BioFire[supreg] FilmArray[supreg] Pneumonia Panel would have a
major impact on the time to report potential pathogens that may cause
Pneumonia in intubated/ICU patients.
The applicant asserted that Buchan, et al., and Enne, et al.
support their claim of improved antibiotic stewardship. The applicant
pointed to the conclusions in Buchan, et al., that >60 percent of
patients potentially could have had an antibiotic adjustment with
BioFire[supreg] FilmArray[supreg] Pneumonia Panel results and 50
percent of potential antibiotic adjustments from BioFire[supreg]
FilmArray[supreg] Pneumonia Panel testing were discontinuation or
narrowing, as well as the estimate that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel results enabled >18,000 antibiotic
hours saved on 243 patients. The applicant pointed to Enne, et al. for
the results that of the 27 percent of patients who had negative
outcomes, 15.6 percent had a pathogen resistant to initial therapy
based on culture and 41.9 percent were resistant to initial therapy
based on BioFire[supreg] FilmArray[supreg] Pneumonia Panel results
(p=0.029).
The applicant asserted that White, et al. and Enne, et al. support
its claim of increased diagnostic yield because White, et al. concluded
that of patients with a final diagnosis of pneumonia, BioFire[supreg]
FilmArray[supreg] Pneumonia Panel detected a potential pathogen in 90.6
percent compared to 81 percent with standard methods, and Enne, et al.
reported that routine methods detected a pathogen in 41.7 percent of
specimens compared to the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel which detected a pathogen in 66.7 percent of specimens.
In summary, the applicant explained that lower respiratory tract
infections are a common and serious health care problem, current
diagnostic tests are slow and do not identify a causative pathogen in
over 50 percent of patients, and the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel is an easy-to-use multiplex panel that has been shown
to increase diagnostic yield and significantly decrease time to results
when compared to standard testing both because of improved test
sensitivity and because it includes assays for typical bacteria,
viruses and selected antibiotic resistance genes. According to the
applicant, retrospective review of BioFire[supreg] FilmArray[supreg]
Pneumonia Panel and patient data indicates a potential to impact
antibiotic utilization to ensure patients are on appropriate therapy in
a timely manner. The applicant also noted that molecular testing for
pneumonia is relatively new and there is a lot to learn about how to
best use these tests, and that there are currently several prospective
studies underway to clarify the role that this tool may play in
improving the outcomes for patients with pneumonia, reducing use of
unnecessary antibiotics, improving targeted therapy and potentially
reducing health care costs due to more directed and efficient patient
[[Page 58625]]
management. According to the applicant, early theoretical outcomes
evaluations provide reason to be optimistic.
We noted in the proposed rule that the studies the applicant
submitted to support its assertions regarding substantial clinical
improvement were presented only as posters, and that information
pertaining to full manuscripts with further study details were not
provided. We stated that it is also unclear if the studies described in
the posters have been submitted for peer-reviewed publication or
whether full manuscripts with detailed methods and data tables are
available.
We stated in the proposed rule that we are concerned that the
studies do not appear to be designed or powered to be able to show
conclusive evidence of clinical impact. In particular, the studies
appear to describe analysis of clinical results for patients and state
that there is potential for the results to impact clinical decisions
about antimicrobial therapy. However, it appears the applicant did not
submit evidence of the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel product in real-world, prospective use (randomized or non-
randomized) with actual antimicrobial decisions or effect on patient
management. This may require larger sample sizes. We stated that we are
also concerned that only one study provided by the applicant (Enne, et
al.) compared BioFire[supreg] FilmArray[supreg] Pneumonia Panel to
Curetis UnyveroTM, which is another PCR-based technology,
and that a statistical difference was not reported between BioFire and
Unyvero for the outcomes reported in the poster. While we understand
that Curetis UnyveroTM may be somewhat slower than
BioFire[supreg] FilmArray[supreg] Pneumonia Panel and does not include
viruses, the clinical impact of the differences between these two
products is unclear. We stated that we are also uncertain how Buchan,
et al. calculated their estimate that >18,000 antibiotic hours were
saved on 243 patients using the BioFire[supreg] FilmArray[supreg]
Pneumonia Panel results. The applicant stated that there are currently
several prospective studies underway to clarify the role that this tool
may play in improving the outcomes for patients with pneumonia,
reducing use of unnecessary antibiotics, improving targeted therapy and
potentially reducing health care costs due to more directed and
efficient patient management; however, data or results from those
studies were not included with the application. We invited public
comment on whether the BioFire[supreg] FilmArray[supreg] Pneumonia
Panel meets the substantial clinical improvement criterion.
Comment: One commenter suggested that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel, as well as other rapid infectious
diseases diagnostics tests, be evaluated based on their clinical
improvements over historical microbiology testing methods as opposed to
other rapid tests currently in the marketplace.
Response: We appreciate the commenter's input and suggestion. We
note that consistent with our current approach in evaluating the new
technology add-on payment substantial clinical improvement criterion we
accept a wide range of data and other evidence to support the
conclusion of substantial clinical improvement, including data
regarding historical technologies and currently available technologies.
We refer the commenter to the FY 2020 IPPS/LTCH PPS final rule (84 FR
42289 through 42292) for further discussion of the substantial clinical
improvement criterion as well as to the regulations at Sec. 412.87(b).
For the purposes of evaluating whether the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel meets the substantial clinical
improvement criterion, data regarding both historical technologies and
currently available technologies were considered.
We did not receive any public comments addressing the concerns we
indicated in the proposed rule regarding whether the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel meets the substantial clinical
improvement criterion. Accordingly, after consideration of the public
comment we received, we are unable to determine that the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel represents a
substantial clinical improvement over the currently available
technologies.
After consideration of the information previously submitted in the
BioFire[supreg] FilmArray[supreg] Pneumonia Panel application and
previously summarized in this final rule, and the public comment we
received, we are unable to determine that the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel meets the newness, cost and
substantial clinical improvement criteria. Therefore, we are not
approving new technology add-on payments for the BioFire[supreg]
FilmArray[supreg] Pneumonia Panel for FY 2021.
c. ContaCT
Viz.ai Inc. submitted an application for new technology add-on
payments for ContaCT for FY 2021. The individual components of ContaCT
are currently marketed by Viz.ai, Inc. under the tradenames ``Viz LVO''
(for the algorithm), ``Viz Hub'' (for the text messaging and calling
platform), and ``Viz View'' (for the mobile image viewer). According to
the applicant, ContaCT is a radiological computer-assisted triage and
notification software system intended for use by hospital networks and
trained clinicians. The applicant asserted that ContaCT analyzes
computed tomography angiogram (CTA) images of the brain acquired in the
acute setting, sends notifications to a neurovascular specialist(s)
that a suspected large vessel occlusion (LVO) has been identified, and
recommends review of those images.
The applicant asserted early notification of the stroke team can
reduce time to treatment and increase access to effective specialist
treatments, like mechanical thrombectomy. Specifically, the applicant
asserted that shortening the time to identification of LVO is critical
because the efficacy of thrombectomy in patients with acute ischemic
stroke decreases as the time from symptom onset to treatment increases.
The applicant also asserted in a condition like stroke, where 1.9
million neurons die every minute and for which 34 percent of patients
hospitalized are under the age of 65, reducing time to treatment
results in reduced disability.\26\ The applicant asserted ContaCT
streamlines the standard workflow using artificial intelligence to
substantially shorten the period of time between when a patient
receives a stroke CT/CTA and when the patient is referred to a stroke
neurologist and neurointerventional surgeon.
---------------------------------------------------------------------------
\26\ Hall MJ, Levant S, DeFrances CJ. Hospitalization for stroke
in U.S. hospitals, 1989-2009. NCHS data brief, no 95. Hyattsville,
MD: National Center for Health Statistics. 2012. https://www.cdc.gov/nchs/data/databriefs/db95.pdf.
---------------------------------------------------------------------------
With respect to the newness criterion, according to the applicant,
FDA granted marketing authorization to ContaCT on February 13, 2018
under the de novo pathway, which is only available to devices of a new
type with low-to-moderate risk for which there are no legally marketed
predicates, and classified it as a Class II medical device. We note
that FDA issued a de novo order memorandum describing ContaCT as ``an
artificial intelligence algorithm [used] to analyze images for findings
suggestive of a pre-specified clinical condition and to notify an
appropriate medical specialist of these findings in parallel to
standard of care image interpretation.'' The order specified that
``identification of suspected findings is not for diagnostic use beyond
notification.''
[[Page 58626]]
The applicant asserted that ContaCT was not available immediately
after FDA's marketing authorization due to establishing Quality
Management Systems and processes for distributing ContaCT as well as
staff training and installation. Per the applicant, ContaCT was not
commercially available until October 2018. The applicant submitted a
request for approval for a unique ICD-10-PCS procedure code for the
administration of ContaCT beginning in FY 2021 and was granted approval
for the following procedure code effective October 1, 2020: 4A03X5D
(Measurement of arterial flow, intracranial, external approach).
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, the
applicant asserted no existing technology is comparable to ContaCT. The
applicant further asserted, because of the technology's novelty, the
product was reviewed under FDA's de novo pathway. The applicant first
outlined the clinical workflow for patients presenting to a hospital
with signs or symptoms of LVO prior to the availability of ContaCT:
1--Patient presents with stroke/suspected stroke to hospital
emergency department (ED).
2--Patient receives stroke CT/CTA imaging after brief initial
evaluation by hospital ED physician.
3--Technologist processes and reconstructs the CT/CTA imaging and
manually routes to hospital picture archiving and communication system
(PACS).
4--Radiologist reads CT/CTA imaging.
5--If needed, a neuroradiology consult is sought.
6--A radiological diagnosis of LVO is made.
7--The radiologist informs hospital ED physician of positive LVO
either verbally or in the radiologist report.
8--ED physician performs comprehensive exam and refers the patient
to a stroke neurologist.
9--The stroke neurologist reviews the CT/CTA imaging and clinical
history and determines whether to prescribe or recommend prescription
of thrombolysis with tissue plasminogen activator (tPA).
10--The stroke neurologist refers the patient to a
neurointerventional surgeon. Together they decide whether the patient
is a candidate for mechanical thrombectomy.
11--If appropriate, the patient proceeds to treatment with
mechanical thrombectomy.
The applicant asserted that facilities utilizing the ContaCT system
can substantially shorten the period of time between when the patient
receives stroke CT/CTA imaging (step 2) and when the patient is
referred to a stroke neurologist and neurointerventional surgeon (steps
9 and 10). They further asserted that ContaCT streamlines this workflow
using artificial intelligence to analyze CTA images of the brain
automatically and notifies the stroke neurologist and
neurointerventional surgeon that a suspected LVO has been identified,
and then enables them to review imaging and make a treatment decision
faster. The applicant concluded that shortening the time to
identification of LVO is critical because the efficacy of thrombectomy
in patients with acute ischemic stroke decreases as the time from
symptom onset to treatment increases.
With regard to the second criterion, whether the technology is
assigned to the same or a different MS-DRG, the applicant did not
specifically address whether the technology meets this criterion.
However, we believe that cases involving the use of the technology
would be assigned to the same MS-DRGs as cases without the technology
where the patient moves through the hospital according to the
traditional workflow outlined above.
With regard to the third criterion, whether the use of the new
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, the applicant also
did not specifically address whether the technology meets this
criterion. However, we stated in the proposed rule that we believe
cases involving the use of the technology would treat the same or
similar type of disease and the same or similar patient population as
the traditional workflow outlined above.
We noted that the applicant described ContaCT's mechanism of action
as shortening the time to identification of LVO through artificial
intelligence (AI). Specifically, the applicant asserted that facilities
utilizing the ContaCT system can substantially shorten the period of
time between when the patient receives stroke CT/CTA imaging and when
the patient is referred to a stroke neurologist and neurointerventional
surgeon. We stated in the proposed rule that we were unclear as to
whether the streamlining of hospital workflow would represent a unique
mechanism of action. Rather, we stated that it seems that the mechanism
of action for ContaCT would be the use of AI to analyze images and
notify physicians rather than streamlining hospital workflow. However,
we also referred the reader to our discussion below and in the proposed
rule regarding our concerns with respect to general parameters for
identifying a unique mechanism of action based on the use of AI, an
algorithm and/or software.
To the extent that the applicant asserted that streamlined hospital
workflow through the use of ContaCT represents a unique mechanism of
action, we stated in the proposed rule that it was unclear to us the
degree to which ContaCT changes the traditional workflow. Per the FDA,
``ContaCT is limited to analysis of imaging data and should not be used
in-lieu of full patient evaluation or relied upon to confirm
diagnosis.'' \27\ We stated that it was unclear to CMS how ContaCT
shortens time to treatment via AI if the CT machine still performs the
scanning and clinicians are still needed to view the images to diagnose
an LVO and perform a full patient evaluation for the best course of
treatment. The applicant also indicated to CMS that the use of ContaCT
is not automatic, and the E.R. physician must submit an order to
utilize it specifically when suspecting an LVO. We stated that we were
unclear how ContaCT streamlines the workflow for stroke treatment via
AI if it is not to be used for diagnostic purposes per the FDA and
still requires personnel to order the scan and make the diagnosis.
---------------------------------------------------------------------------
\27\ U.S. Food and Drug Administration, DEN170073. Evaluation of
Automatic Class III Designation for ContaCT Decision Summary.
---------------------------------------------------------------------------
We stated in the proposed rule that we were also generally
concerned as to whether the use of AI, an algorithm or software, which
are not tangible, may be considered or used to identify a unique
mechanism of action. In addition, we questioned how updates to AI, an
algorithm or software would affect an already approved technology or a
competing technology, including whether software changes for an already
approved technology could be considered a new mechanism of action. We
also questioned whether, if there were competing technologies to an
already approved AI new technology, an improved algorithm by a
competitor would represent a unique mechanism of action if the outcome
is the same as the technology first approved. We welcomed comments from
the public regarding the general parameters for identifying a unique
mechanism of
[[Page 58627]]
action based on the use of AI, an algorithm and/or software.
We also invited public comments on whether the applicant meets the
newness criterion, including specifically with respect to the mechanism
of action.
Comment: The applicant submitted a comment to address newness
concerns raised by CMS in the proposed rule. The applicant asserted
that there was a brief delay in the availability of ContaCT due to
establishing Quality Management Systems (QMS) and processes for
distributing ContaCT. Because of this delay, the first hospital
installation of ContaCT was not completed until January 2019. According
to the applicant, because the commercial use of ContaCT did not begin
at the start of FY 2019, the Medicare data which is used to set FY 2021
MS-DRG relative weights (data from FY 2019 October 1, 2018 through
September 30, 2019), do not reflect fully the cost of the technology.
Therefore, the applicant believed that the newness period should begin
on the date the first installation was completed, rather than the date
of commercial availability noted in the FY 2019 IPPS/LTCH PPS proposed
rule (85 FR 32601), which was October 2018.
The applicant asserted that no existing technology is comparable to
ContaCT. According to the applicant, with regard to the first criterion
for newness, ContaCT does not use the same or a similar mechanism of
action as compared to an existing technology. The applicant stated that
ContaCT was reviewed through FDA's de novo pathway, which is only
available to novel medical devices that have not previously been
classified by the FDA. With regard to the second criterion for newness,
the applicant stated that ContaCT is used in cases of stroke and
suspected stroke. Consequently, stroke and suspected stroke cases in
which ContaCT is used are expected to be assigned to the same DRGs as
stroke and suspected stroke cases without the technology. With regard
to the third criterion for newness, the applicant stated that cases in
which ContaCT is used are expected to be the same or similar to cases
without the technology.
With respect to the first substantial similarity criterion, the
applicant asserted that computer-assisted triage and notification is
the mechanism of action for ContaCT and that the mechanism of action
for ContaCT is not AI per se. According to the applicant, AI is a
necessary component of ContaCT, but is not sufficient to achieve
therapeutic effect. Furthermore, the applicant stated that under 42 CFR
412.87(b)(2) and CMS criteria for evaluating a technology with respect
to newness, there are no requirements that a new technology have a
specific type of mechanism of action to be eligible for new technology
add-on payments.
The applicant expressed concern that CMS is questioning whether AI,
an algorithm or software may never be considered a unique mechanism of
action, because such technology may simulate human intelligence or
human processes that already exist. According to the applicant, CMS has
defined an existing technology as another FDA approved or cleared
technology. Human intelligence and human processes are not FDA approved
or cleared technologies and, therefore, should not be used as a
comparator to evaluate whether ContaCT, or any technology, meets the
definition of newness. The applicant stated that, as for other new
technologies, comparators for AI, algorithm or software-based devices
should be other FDA approved or cleared technologies. More broadly, the
applicant urged CMS not to make a broad determination that technologies
that use AI, an algorithm or software to achieve a therapeutic effect
are ineligible for new technology add-on payments. They stated CMS
should evaluate each new technology individually with respect to
whether it meets the established criteria.
In addressing CMS concerns about whether software changes for an
already approved technology could be considered a new mechanism of
action, the applicant stated that an update to the ContaCT algorithm
that does not alter this mechanism of action would have the same or a
similar mechanism of action. In addressing CMS concerns about whether
an improved algorithm by a competitor would represent a unique
mechanism of action if the outcome is the same as the technology first
approved, the applicant likewise stated that a different technology
that shortens time to notification in patients with acute ischemic
stroke caused by large vessel occlusions by using an AI algorithm to
identify suspected LVO, triage patients and notify the stroke team more
rapidly would likely be determined to have a mechanism of action that
is the same or similar to ContaCT.
In addition, the applicant stated that the newness of the overall
mechanism of action or the means by which a product achieves the
therapeutic outcome should be assessed, rather than the newness of the
individual inputs or components. They provided an example from FY 2017
when CMS determined MIRODERM not to be ``new'' because the product
achieved the intended therapeutic outcome, wound healing, in the same
way as other acellular skin substitutes by providing a scaffold of
collagen with a mix of matrix proteins (81 FR 56893). The applicant
stated that CMS acknowledged that MIRODERM matrix proteins were
different from the proteins found in other acellular skin substitutes,
but the determination of newness was based on MIRODERM's overall
mechanism of action--a collagen scaffold that promotes wound healing.
Just as in the MIRODERM example where the matrix proteins were not
sufficient to establish the technology as new, changes to the AI,
algorithm and/or software would not be sufficient to establish future
computer-aided triage and notification systems for large vessel
occlusion ischemic stroke as new if these involve essentially the same
mechanism of action as ContaCT. The applicant thus argued that
technologies that utilize AI, an algorithm and/or software should be
evaluated for newness in the same way as CMS evaluates any other
medical device applying for new technology add-on payments.
Other commenters responded to CMS' concerns about whether the
applicant meets the newness criterion. In response to our stated
uncertainty regarding how ContaCT streamlines the workflow for stroke
treatment via AI if it is not to be used for diagnostic purposes per
the FDA and still requires personnel to order the scan and make the
diagnosis, a commenter responded that ContaCT will enhance, not
replace, human action as it relates to patient outcomes, and asserted
that all innovation will be based upon AI in some fashion moving
forward. Another commenter responded to our concerns as to whether the
use of AI, an algorithm or software may be considered or used to
identify a unique mechanism of action and also how updates to AI, an
algorithm or software would affect an already approved technology or a
competing technology for purposes of new technology add-on payments.
The commenter stated that technologies that utilize AI, an algorithm
and/or software may be evaluated for newness in the same way CMS
evaluates any other medical device applying for new technology add-on
payments. Such a technology would not be new if there is an existing
FDA-approved technology that has been on the market for more than 2 to
3 years and that has the same mechanism of action, is assigned to the
same DRGs, or is used in the same or similar type of disease and
patient population. The commenter further suggested that this apply to
both incremental changes to
[[Page 58628]]
the same device as well as to competing devices. The commenter urged
CMS to consider that evaluating technologies that use AI, an algorithm
and/or software is no different than evaluating other technologies for
purposes of new technology add-on payments. They stated that
technologies are not required to have a specific type of mechanism of
action to be eligible for add-on payment, and as such, each submission
must be evaluated independently.
Response: After considering the comments received regarding the new
technology add-on payment application for ContaCT, we agree that
ContaCT does not use the same or a similar mechanism of action to
achieve a therapeutic outcome when compared to existing treatments
because there are currently no FDA approved or cleared technologies
that use computer-assisted triage and notification to rapidly detect an
LVO and shorten time to notification. Therefore, we believe that
ContaCT is not substantially similar to an existing technology and
meets the newness criterion. We consider the beginning of the newness
period to commence on October 1, 2018. We have previously stated in the
FY 2013 IPPS/LTCH PPS final rule (77 FR 53348) and FY 2019 IPPS/LTCH
PPS final rule (83 FR 41313), 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. Without
additional information, we continue to believe that the newness period
for ContaCT begins on October 1, 2018. We may consider any further
information that may be provided regarding the date of availability in
future rulemaking.
We will continue to consider the issues related to determining
newness for technologies that use AI, an algorithm or software,
including devices classified as radiological computer aided triage and
notification software, as discussed in the proposed rule, including how
these technologies may be considered or used to identify a unique
mechanism of action, how updates to AI, an algorithm or software would
affect an already approved technology or a competing technology,
whether software changes for an already approved technology could be
considered a new mechanism of action, and whether an improved algorithm
by competing technologies would represent a unique mechanism of action
if the outcome is the same as an already approved AI new technology, as
we gain more experience in this area.
With respect to the cost criterion, the applicant provided the
following analysis. First, the applicant extracted claims from the FY
2018 MedPAR dataset. The applicant explained that many patients present
to the emergency department with signs or symptoms suggesting an LVO.
That presentation would be the basis for ordering a CTA with ContaCT
added. Of these patients, some will be identified as stroke and LVO,
some as stroke but not from an LVO, and others will have diagnoses
completely unrelated to stroke. As a result, according to the
applicant, there may be a very broad range of principal diagnoses and
MS-DRGs representing patients who would be eligible for and receive a
CTA with ContaCT. The applicant noted that it used admitting diagnoses
codes rather than principal or secondary diagnosis codes to identify
cases of stroke due to LVO, stroke not due to LVO, and no stroke. The
applicant utilized a multi-step approach:
Step 1: The applicant first extracted claims from the
stroke-related MS-DRGs (023, 024, 061, 062, 063, 064, 065, 066, 067,
068, and 069).
Step 2: The applicant analyzed the admitting diagnosis on
claims extracted in Step 1 to identify the reason for admission. The
applicant found that the top five admitting diagnoses for patients in
the stroke-related MS-DRGs included: Cerebral infarction, unspecified
(I63.9), transient cerebral ischemic attack, unspecified (G45.9),
slurred speech (R4781), aphasia (R4701), and facial weakness (R29.810).
Step 3: The applicant identified all MS-DRGs assigned to
the admitting diagnosis codes identified in Step 2 to identify ContaCT
cases that did not map to one of the stroke MS-DRGs.
Step 4: The applicant identified a list of unique MS-DRGs
and admitting diagnosis code combinations to which cases involving
ContaCT would map. The applicant stated that it reviewed with clinical
experts the MS-DRG and admitting diagnosis combinations and eliminated
any that were unlikely to include the use of ContaCT.
The applicant identified a total of 375,925 cases across 143 MS-
DRGs, with approximately 66 percent of cases mapping to MS-DRGs 039,
057, 064, 065, 066, 069 and 312. The average unstandardized case-
weighted charge per case was $52,001. The applicant noted it did not
remove any charges for a prior technology, as it asserted that no other
technology is comparable to ContaCT. Based on the results of a research
study,\28\ the applicant assumed ContaCT cases resulting in mechanical
thrombectomy would have charges reduced by 38% as a result of reduced
specialty care days and therefore removed the related charges, which
only affected cases mapping to MS-DRGs 023, 024, 025, and 026. The
applicant standardized the charges and applied an inflation factor of
11.1 percent, which is the same inflation factor used by CMS to update
the outlier threshold in the FY 2020 IPPS/LTCH PPS final rule (84 FR
42629), to update the charges from FY 2018 to FY 2020.
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\28\ Goldstein ED, Schnusenberg L, Mooney L, et al. Reducing
Door-to- Reperfusion Time for Mechanical Thrombectomy With a
Multitiered Notification System for Acute Ischemic Stroke. Mayo Clin
Proc Innov Qual Outcomes. 2018;2(2): 119-128.
---------------------------------------------------------------------------
The applicant then added the charges for the new technology. The
applicant explained it calculated the cost per patient by dividing the
total overall cost of ContaCT per year per hospital by the number of
total estimated cases for which ContaCT was used at each hospital that
currently subscribes to ContaCT (based on the estimated number of cases
receiving CTA), and averaging across all such hospitals. The following
is the methodology the applicant used to determine the cost per case:
Step 1: The applicant first determined the estimated total
cases (both Medicare and non-Medicare) for each current subscriber
hospital. The applicant explained it used total cases for both Medicare
and non-Medicare cases since the cost per case is not specific to
Medicare cases. In order to determine total cases, which include both
Medicare and non-Medicare cases, the applicant divided the total
Medicare cases per subscriber hospital from the FY 2018 MedPAR data by
the percentage of Medicare beneficiaries (71 percent) in the CONTACT
FDA research study (for example, 1,136 Medicare cases divided by 0.71
equals 1,600 total Medicare and non-Medicare cases).
Step 2: To analyze actual rates (percentages) of CTA
across subscriber hospital cases, the applicant first used the
beneficiary ID in the FY 2018 SAF data set to find matching physician
claims in the carrier file for CT and CTA services with a site of
service of 21 (Inpatient hospital) or 23 (emergency department) and a
date of service consistent with the inpatient stay. The applicant then
calculated provider-specific CTA rates (percentages) for each
subscriber hospital. The applicant dropped five hospitals with a low
volume of Medicare inpatient stays that had no matching services in the
carrier file. The applicant calculated an average CTA rate of 21.6
percent across all hospitals that subscribe to ContaCT.
[[Page 58629]]
Step 3: The applicant determined the estimated total
number of cases that received CTA for each current subscriber hospital
by multiplying the total cases (Medicare and non-Medicare) for each
subscriber hospital in step 1 by the provider-specific CTA rate
calculated in Step 2. In cases where a provider had fewer than 11 cases
in the carrier file or where a provider had a CTA rate that was an
outlier, the applicant multiplied the total cases for the provider by
the average CTA rate of 21.6 percent.
Step 4: The applicant then calculated the cost per year
per hospital. If a hospital had multiple sites under the same CCN, the
applicant multiplied the total overall cost of ContaCT per hospital by
the number of sites. For example, if the cost for ContaCT was $25,000
per year and Hospital A had only one site under its CCN, then the total
cost for ContaCT for Hospital A would be $25,000. However, if Hospital
B had three sites under its CCN, then the total cost for ContaCT for
Hospital B would be $75,000 per year ($25,000 x 3).
Step 5: The applicant then divided the cost per year per
hospital by the total cases that received CTA for each customer
hospital in Step 3 to determine the estimated cost per case for each
customer hospital. If Hospital A from the example in Step 4 had 50
patients, then the total hospital cost per case would be $500 per
patient ($25,000/50). If Hospital B (with three sites under its CCN)
also had 50 patients, then the total hospital cost per case would be
$1,500 per patient ($75,000/50).
Step 6: The applicant averaged the cost per case across
all hospitals to determine the average cost per patient. The average
cost per case across Hospital A and Hospital B in the previous example
would be $1,000.
Step 7: To convert the cost of the technology in Step 6 to
charges, the applicant divided the average cost per patient by the
national average cost-to-charge (CCR) of 0.14 for the Radiology cost
center from the FY 2020 IPPS/LTCH PPS final rule (84 FR 42179).
Although the applicant submitted data related to the cost of the
technology, the applicant noted that the cost of the technology was
proprietary information.
The applicant calculated a case-weighted threshold amount of
$51,358 and a final inflated average case-weighted standardized charge
per case of $62,006. Based on this analysis, the applicant asserted
that ContaCT meets the cost criterion because the final inflated
average case-weighted standardized charge per case exceeds the case-
weighted threshold amount.
The applicant submitted three additional cost analyses to
demonstrate that it meets the cost criterion using the same methodology
above but with limits on the cases. The first alternative limited the
analysis to only those cases in the primary stroke-related MS-DRGs 023,
024, 061, 062, 063, 064, 065, 066, 067, 068, and 069. This first
alternative method resulted in a case-weighted threshold of $53,885 and
a final inflated average case weighted standardized charge per case of
$62,175. The second alternative limited the analysis to cases in MDC 01
(Diseases and Disorders of the Nervous System) with the following MS-
DRGs:
[GRAPHIC] [TIFF OMITTED] TR18SE20.152
This second alternative method resulted in a case-weighted
threshold of $55,053 and a final inflated average case weighted
standardized charge per case of $63,741. The third alternative limited
cases to MS-DRGs where the total volume of cases was greater than 100.
This third alternative method resulted in a case-weighted threshold of
$49,652 and a final inflated average case-weighted standardized charge
per case of $59,365. Across all cost-analysis methods, the applicant
maintained that the technology meets the cost criterion because the
final inflated average case-weighted standardized charge per case
exceeds the average case-weighted threshold amount.
We noted in the proposed rule that we believe a case weight would
provide more accuracy in determining the average cost per case as
compared to the average of costs per case across all hospitals that was
used by the applicant in Step 6 as summarized previously. We therefore
computed a case-weighted cost per case across all current subscriber
hospitals. We then inflated the case-weighted cost per case to a charge
based on Step 7 above and used this amount in the comparison of the
case-weighted threshold amount to the final inflated average case-
weighted standardized charge per case (rather than the applicant's
average cost per case). In all the scenarios above, the final inflated
average case-weighted standardized charge per case exceeded the case-
weighted threshold amount by an average of $2,961.
We stated in the proposed rule that we had the following concerns
regarding whether the technology meets the cost criterion. The
applicant used a single list price of ContaCT per hospital
[[Page 58630]]
with a cost per patient that can vary based on the volume of cases. We
stated that we were concerned that the cost per patient varies based on
the utilization of the technology by the hospitals. The cost per
patient could be skewed by the small number of hospitals utilizing the
technology and their low case volumes. It is possible, if hospitals
with large patient populations adopt ContaCT, the cost per patient
would be significantly lower.
We stated in the proposed rule that an alternative to the
applicant's calculation may be a methodology that expands the
applicant's sample from total cases (which include both Medicare and
non-Medicare cases) receiving CTA at subscriber hospitals in Step 1 to
all inpatient hospitals for the use of ContaCT (and then using the same
steps after Step 1 for the rest of the analysis). In this alternative,
the applicant would continue to extract cases representing patients
that are eligible for the use of ContaCT from MedPAR, but the cost per
patient would be determined by dividing the overall cost per year per
hospital by the average number of patients eligible for the use of
ContaCT across all such hospitals. For example, if the cost for ContaCT
is $25,000 per year and the average hospital has 500 patients who are
eligible to receive ContaCT per year, then under this alternative
methodology, the total cost per patient would be $50 ($25,000/500).
We noted in the proposed rule that if ContaCT were to be approved
for new technology add-on payments for FY 2021, we believed the cost
per case from the cost analysis above may also be used to determine the
maximum new technology add-on payment (that is, 65 percent of the cost
determined above). We stated that we understood there are unique
circumstances to determining a cost per case for a technology that
utilizes a subscription for its cost. We welcomed comments from the
public as to the appropriate method to determine a cost per case for
such technologies, including comments on whether the cost per case
should be estimated based on subscriber hospital data as described
previously, and if so, whether the cost analysis should be updated
based on the most recent subscriber data for each year for which the
technology may be eligible for the new technology add-on payment.
We also invited public comments on whether the applicant meets the
cost criterion.
Comment: One commenter, who was also the applicant, maintained that
ContaCT met the cost criterion and submitted two additional analyses
following CMS' suggestions in the FY 2021 IPPS/LTCH PPS Proposed Rule.
First, the applicant updated its cost analyses to include all IPPS
hospitals, utilizing the same methodology described in detail in the
proposed rule. Under this methodology, the cost per patient is
calculated by dividing the total overall cost of ContaCT per year per
hospital by the number of total estimated cases for which ContaCT would
be used at each hospital (based on the estimated number of cases
receiving CTA), and then averaging across all such hospitals. The
applicant's updated cost analysis included 3,035 Medicare provider
numbers representing 3,062 general acute care hospitals. The updated
analysis yielded a final inflated average case-weighted standardized
charge per case of $71,568, which exceeded the threshold amount of
$51,358.
The applicant also updated the three alternative analyses (which
used the same methodology as above but limited the cases included) to
include all IPPS hospitals. The parameters of these analyses were
discussed in detail in the proposed rule (85 FR 32602 through 32603).
Per the applicant, the first alternative analysis resulted in a case-
weighted threshold of $53,885 and a final inflated average case-
weighted standardized charge per case of $71,736; the second
alternative analysis resulted in a case-weighted threshold of $55,053
and a final inflated average case weighted standardized charge per case
of $73,302; and the third resulted in a case-weighted threshold of
$49,652 and a final inflated average case-weighted standardized charge
per case of $68,925. In all three alternative analyses, the final
average case-weighted standardized charge per case exceeded the average
case-weighted threshold amount, meeting the cost criterion.
The applicant also calculated a case-weighted average cost per case
for each of the analyses above in response to CMS' suggestion that a
case-weighted average cost per case would be more accurate compared to
the average of costs per case across all hospitals, as the applicant
had done initially. The applicant analyzed the average number of
patients eligible to receive ContaCT per hospital among subscribers and
compared it to the average number of patients eligible to receive
ContaCT among all IPPS hospitals. The applicant found that, among
ContaCT subscribers, the average number of patients eligible to receive
ContaCT per Medicare provider number and per hospital are 141 and 121,
respectively. In contrast, among all IPPS hospitals, the applicant
found that the average number of patients eligible to receive ContaCT
per Medicare provider number and per hospital are 99 and 82,
respectively. The applicant concluded that ContaCT subscribers have a
higher average number of patients eligible to receive ContaCT compared
to all IPPS hospitals, and that the cost per patient for ContaCT is
skewed to yield a higher cost per patient across all IPPS hospitals
than among ContaCT subscribers alone. The applicant noted that the cost
per patient among ContaCT subscribers is lower than if all IPPS
hospitals adopted ContaCT, and that expanding the analyses above to
include all IPPS hospitals increased the cost per patient.
Per the applicant, ContaCT would meet the cost criterion in each of
these average number of patients eligible to receive ContaCT across all
cost-analysis methods. Using a case-weighted cost per case, the
applicant also met the cost criterion across all cost-analysis methods,
as the final inflated average case-weighted standardized charge per
case exceeded the average case-weighted threshold amount.
The applicant also noted that technologies sold on a subscription
basis are provided to the customer at a recurring price at regular
intervals. As a result, the cost per unit for a subscription technology
is directly impacted not only by the price, but how frequently the
customer utilizes the technology, in that customers with low
utilization of a subscription-based technology have a higher cost per
unit than customers with high utilization. The commenter stated that,
because the overall cost per unit of subscription technologies is
determined by each customer's ratio of price to utilization, an
analysis that requires an estimate of cost per unit should be limited
to subscribers. The commenter believed that including estimates of cost
per unit for potential customers that do not currently subscribe to the
technology may result in a cost-per-case that does not reflect the
actual costs of current users. The commenter recommended that the cost
per unit of technologies sold on a subscription basis, like ContaCT,
should be based on data from current subscribers only. However, the
applicant agreed with CMS that yearly updates to the cost per unit
analysis are reasonable to reflect changes in subscribers and thus the
overall cost per unit.
The commenter offered several examples of how its recommendation is
consistent with CMS' methodology in calculating costs across a variety
of payment systems and programs. The commenter noted that CMS considers
only costs from hospitals for cases billed
[[Page 58631]]
to Medicare when setting MS-DRG relative weights. In addition, if a
hospital does not provide the type of care described by a specific MS-
DRG, CMS does not attempt to estimate what the cost and MS-DRG relative
weights might be if a broader range of hospitals delivered that type of
care. The commenter stated that another example is the average sales
price methodology used by CMS to determine payment for certain
separately payable products, which includes only data from actual
customer sales. The commenter noted that although the unit price for
these products often varies based on utilization, with customers with
low utilization paying more per unit than customers with higher
utilization, CMS does not attempt to calculate average sales price by
forecasting how future customers may alter the current average sales
price. The applicant concluded that, consistent with these examples,
the cost per unit for subscription technologies should be based on data
from current subscribers only and yearly updates are reasonable.
Response: After consideration of the applicant's updated cost
analyses for ContaCT, we agree that the average case-weighted
standardized charge per case exceeded the average case-weighted
threshold amount in all scenarios. Therefore, ContaCT meets the cost
criterion for FY 2021. CMS will continue to consider the issues
relating to calculation of the cost per unit of technologies sold on a
subscription basis as we gain more experience in this area.
With respect to the substantial clinical improvement criterion,
according to the applicant, ContaCT represents an advance that
substantially improves the ability to diagnose a large vessel occlusion
stroke earlier by automatically identifying suspected disease in CTA
images and notifying the neurovascular specialist directly in parallel
to the standard of care. The applicant further asserted a major
limitation in the traditional acute stroke workflow is the time delay
from initial image acquisition of a suspected LVO patient (CT, CT
angiography, and CT perfusion), notification of the interventional
team, and execution of an endovascular thrombectomy. The time from
stroke onset to reperfusion (when blood supply returns to tissue after
a period of ischemia or lack of oxygen) is negatively correlated with
the probability of an independent functional status.\29\ The applicant
stated the time from initial presentation to eventual reperfusion can
be long, resulting in poor outcomes, using the existing standard of
care. The median onset-to-revascularization time has been reported as
202.0 minutes for patients presenting directly to interventional
centers (or comprehensive stroke centers), and 311.5 minutes for
patients that initially presented to a non-interventional center.\30\
The applicant further stated that part of that time is the time from
initial CTA to the time that the neurovascular specialist is notified
of a possible LVO (the CTA to notification time). A retrospective study
examined work-flow for stroke patients and demonstrated an initial CT
to CSC (Comprehensive Stroke Center) notification time per standard of
care >60 minutes in patients transferred for endovascular reperfusion
in acute ischemic stroke.\31\
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\29\ Khatri P, Abruzzo T, Yeatts SD, et al. Good clinical
outcome after ischemic stroke with successful revascularization is
time-dependent. Neurology. 2009; 73(13):1066-1072.
\30\ Froehler MT, Saver JL, Zaidat 00, et al. Interhospital
transfer before thrombectomy is associated with delayed treatment
and worse outcome in the STRATIS registry. Circulation. 2017;
136(24):2311-2321.
\31\ Sun CH, Nogueira J, Glenn RG, et al. Picture-to-puncture: A
novel time metric to enhance outcomes in patients transferred for
endovascular reperfusion in acute ischemic stroke. Circulation.
2013; 127:1139-1148.
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The applicant asserted that ContaCT facilitates a workflow parallel
to the standard of care workflow and results in a notified specialist
entering the workflow earlier. In the applicant's study to support the
De Novo request, ContaCT's performance was compared with standard of
care workflow, demonstrating that ContaCT resulted in faster specialist
notification. According to the applicant, the average time to
specialist notification for ContaCT was 7.32 minutes [95% CI: 5.51,
9.13] whereas time to notification for standard of care workflow was
58.72 minutes [95% CI: 46.21, 71.23]. The applicant also asserted that
ContaCT saved an average of 51.4 minutes, an improvement that could
markedly improve time to intervention for LVO patients. In addition,
the applicant noted that the standard deviation was reduced from 41.14
minutes in the standard of care workflow to 5.95 minutes with ContaCT,
demonstrating ContaCT's potential to reduce variation in care and
patient outcome across geographies and time of day.\32\
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\32\ U.S. Food and Drug Administration (FDA). Center for Devices
and Radiological Health. Evaluation of Automatic Class III
Designation for ContaCT. Decision Memorandum No. 170073 (DEN170073).
2018. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf.
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To support the applicant's assertion that ContaCT substantially
improves the ability to diagnose a large vessel occlusion stroke
earlier, the applicant presented a multicenter prospective
observational trial, DISTINCTION, which is ongoing and compares a
prospective cohort of patients in which ContaCT is used (intervention
arm) to a retrospective cohort in which ContaCT was not used (control
arm). Patients are also segmented based on whether they initially
present to a non-interventional center or an interventional center. Per
the applicant, early data from one non-interventional hospital in the
Erlanger Health System indicates that for the control arm the median
time from CTA to clinician notification was 59.0 minutes. For the
intervention arm, early data indicates that the median time from CTA to
clinician notification was 5.3 minutes. The applicant stated that these
early data indicate time savings of approximately 53 minutes, which is
consistent with the 51.4 minute time savings demonstrated in the
studies sponsored/conducted by the De Novo requester.\33\
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\33\ U.S. Food and Drug Administration (FDA). Center for Devices
and Radiological Health. Evaluation of Automatic Class III
Designation for ContaCT. Decision Memorandum No. 170073 (DEN170073).
2018. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf.
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Next, the applicant presented the Automated Large Artery Occlusion
Detection In Stroke Imaging Study (ALADIN), a multicenter retrospective
analysis of CTAs randomly picked from a retrospective cohort of acute
ischemic stroke patients, with and without anterior circulation LVOs,
admitted at three tertiary stroke centers, from 2014-2017. Per the
applicant, ALADIN evaluated ContaCT's performance characteristics
including area under the curve, sensitivity, specificity, positive
predictive value, negative predictive value, and processing or running
time. The applicant asserted that, through this study, researchers
concluded that the ContaCT algorithm may permit early and accurate
identification of LVO stroke patients and timely notification to
emergency teams, enabling quick decision-making for reperfusion
therapies or transfer to specialized centers if
needed.34 35 36
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\34\ Barreira C, Bouslama M, Lim J, et al. E-108 ALADIN study:
Automated large artery occlusion detection in stroke iaging study--a
multicenter analysis. J Neurointerv Surg. 2018;10(Suppl 2):A101-
A102.
\35\ Barreira C, Bouslama M, Haussen D, et al. Abstract WP61:
Automated large artery occlusion detection in stroke imaging--ALADIN
study. Stroke. 2018;49:AWP61.
\36\ Rodrigues GM, Barreira CM, Bouslama M, et al. Automated
large artery occlusion detection in stroke imaging study (ALADIN).
Abstract WP71: Multicenter ALADIN: Automated large artery occlusion
detection in stroke imaging using artificial intelligence. Stroke.
30 Jan 2019;50:AWP71.
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[[Page 58632]]
According to the applicant, the use of ContaCT to facilitate a
faster diagnosis and treatment decision directly affects management of
the patient by enabling early notification of the neurovascular
specialist and faster time to treatment utilizing mechanical
thrombectomy to remove the large vessel occlusion. The applicant stated
that mechanical thrombectomy with stent retrievers is one of the
standards of care for treatment of acute ischemic stroke patients
caused by LVO and that mechanical thrombectomy therapy is highly time-
critical with each minute saved in onset-to-treatment time resulting in
a reported average of 4.2 days of extra healthy life.\37\ According to
the applicant, the use of ContaCT affects the management of the patient
by facilitating early identification of patients with suspected LVO and
early notification of the neurovascular specialist. The applicant
asserted that this may affect the management of the patient in two
ways. First, it may offer improved access to mechanical thrombectomy
for patients who would otherwise not have access because of factors
such as time of day and the specialty capabilities of the hospital they
are in, and second, it may involve the neurovascular team earlier,
decreasing the time to thrombectomy. The applicant stated that ContaCT
saved an average of 51.4 minutes in time to notification relative to
standard of care workflow and reduced standard deviation in time to
notification from 41.14 minutes (standard of care workflow) to 5.95
minutes (ContaCT).\38\ Furthermore, the applicant stated that ContaCT
could markedly improve time to intervention for LVO patients and has
the potential to reduce variation in care and patient outcome across
geographies and time of day.
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\37\ Fransen PS, Berkhemer OA, Lingsma HF, et al. Time to
reperfusion and treatment effect for acute ischemic stroke: A
randomized clinical trial. JAMA Neurol. 2016;73:190-196 ; Meretoja
A, Keshtkaran M, Tatlisumak T, Donnan GA and Churilov L.
Endovascular therapy for ischemic stroke: save a minute-save a week.
Neurology. 2017;88(22):2123-2127.
\38\ U.S. Food and Drug Administration (FDA). Center for Devices
and Radiological Health. Evaluation of Automatic Class III
Designation for ContaCT. Decision Memorandum No. 170073 (DEN170073).
2018. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf.
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The applicant stated that according to five clinical trials, the
clinical efficacy of endovascular mechanical thrombectomy has been
demonstrated for patients with LVO strokes up to 6 hours after onset of
stroke.\39\ The applicant also stated that two meta-analyses of these
randomized trials have been completed.\40\ Campbell et al. performed a
patient-level pre-specified pooled meta-analysis of four randomized
clinical trials which concluded that thrombectomy for large vessel
ischemic stroke is safe and highly effective at reducing disability.
Goyal et al. pooled and analyzed patient-level data from all five
trials. Per the applicant, the results indicated that mechanical
thrombectomy leads to significantly reduced disability. According to
the applicant, together, these five randomized trials and two meta-
analyses, have demonstrated that treatment for intracranial large
vessel occlusion with mechanical thrombectomy with stent retrievers is
the standard of care.
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\39\ Berkhemer OA, Fransen PS, Beumer D, et al. MR CLEAN
Investigators. A randomized trial of intraarterial treatment for
acute ischemic stroke. N Engl J Med. 2015;372:11-20.doi: 10.1056/
NEJMoa1411587; Campbell BCV, Mitchell PJ, Kleinig TJ, et al.
Endovascular therapy for ischemic stroke with perfusion-imaging
selection. N Engl J Med. 2015;372(11):1009-1018; Jovin TG, Chamorro
A, Cobo E, de Miquel MA, Molina CA, Rovira A, et al.; REVASCAT Trial
Investigators. Thrombectomy within 8 hours after symptom onset in
ischemic stroke. N Engl J Med. 2015;372(24):2296-2306.
\40\ Campbell BC, Hill MD, Rubiera M et al. Safety and efficacy
of solitaire stent thrombectomy: Individual patient data meta-
analysis of randomized trials. Stroke. 2016;47(3):798-806; Goyal M,
Menon BK, van Zwam WH, et al. Endovascular thrombectomy after large-
vessel ischaemic stroke: A meta-analysis of individual patient data
from five randomised trials. Lancet N Am Ed. 2016;387(10029):1723-
1731.
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The applicant also asserted that real world evidence further
supports the efficacy of mechanical thrombectomy. Data from the STRATIS
registry (Systematic Evaluation of Patients Treated With
Neurothrombectomy Devices for Acute Ischemic Stroke), which
prospectively enrolled patients treated in the United States with a
Solitaire Revascularization Device and Mindframe Capture Low Profile
Revascularization Device within 8 hours from symptom onset, was
compared with the interventional cohort from the patient-level meta-
analysis from Campbell et al. to assess whether similar process
timelines and technical and functional outcomes could be achieved in a
large real-world cohort as in the randomized trials. The article
concluded that the results indicate randomized trials can be reproduced
in the real world (Mueller-Kronast et al., 2017).\41\
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\41\ Mueller-Kronast NH, Zaidat OO, Froehler MT, et al.
Systematic evaluation of patients treated with neurothrombectomy
devices for acute ischemic stroke: primary results of the STRATIS
registry. Stroke. 2017;48(10):2760-2768.
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The applicant stated that based on these data, U.S. clinical
guidelines now recommend mechanical thrombectomy for the treatment of
large vessel occlusion strokes when performed <=6 hours from symptom
onset. The American Stroke Association/American Heart Association (ASA/
AHA) ``2018 Guidelines for the Early Management of Patients With Acute
Ischemic Stroke'' recommended mechanical thrombectomy with a stent
retriever in patients that meet the following criteria: (1) Prestroke
modified Rankin Scale (mRS) 0-1; (2) causative occlusion of the
internal carotid artery (ICA) or middle cerebral artery (MCA) segment 1
(M1); (3) age >=18; (4) National Institute of Health Stroke Scale
(NIHSS) >=6; (5) Alberta Stroke Program Early CT Score (ASPECTS) >=6;
and (6) treatment can be initiated within 6 hours of symptom onset
(Powers et al., 2018). The ASA/AHA notes the need for expeditious
treatment with both intravenous thrombolysis and mechanical
thrombectomy.\42\
---------------------------------------------------------------------------
\42\ Powers WJ, Rabinstein AA, Ackerson T et al. On behalf of
the American Heart Association Stroke Council. 2018 Guidelines for
the early management of patients with acute ischemic stroke: A
guideline for healthcare professionals from the American Heart
Association/American Stroke Association. Stroke. 2018;49:e46-e110.
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The applicant also stated that recently, randomized trials have
demonstrated the clinical efficacy of mechanical thrombectomy for large
vessel occlusion strokes for select patients from 6 to 24 hours after
symptom onset.\43\ Among patients with acute stroke who were last known
well 6 to 24 hours earlier and who had a mismatch between clinical
deficit and infarct, outcomes for disability at 90 days were better
with thrombectomy plus standard care compared with standard care alone.
---------------------------------------------------------------------------
\43\ Albers GW, Marks MP, Kemp S, et al. Thrombectomy for stroke
at 6 to 16 hours with selection by perfusion imaging. N Engl J Med.
2018;378(8):708-718; Nogueira RG, Jadhav AP, Haussen DC, et al.
Thrombectomy 6 to 24 hours after stroke with a mismatch between
deficit and infarct. N Engl J Med. 2018;378(1):11-21.
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The applicant asserted that the use of ContaCT reduces time to
treatment by notifying the stroke team faster than the standard of care
and enabling the team to diagnose and treat the patient earlier, which
is known to improve clinical outcomes in stroke, and that mechanical
thrombectomy has been shown to reduce disability, reduce length of stay
and recovery time (Campbell et al., 2017).\44\
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\44\ Campbell BCV, Mitchell PJ, Churilov L, et al. Endovascular
Thrombectomy for Ischemic Stroke Increases Disability-Free Survival,
Quality of Life, and Life Expectancy and Reduces Cost. Front Neurol.
2017;8:657.
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[[Page 58633]]
According to the applicant, other studies have also demonstrated
that time to reperfusion is a predictor of patient outcomes. The
applicant asserted that several major randomized controlled trials for
mechanical thrombectomy have demonstrated improvements in functionality
with faster time to reperfusion. The primary outcome of some of these
trials was the modified Rankin scale (mRs) score, a categorical scale
measure of functional outcome, with scores ranging from 0 (no symptoms)
to 6 (death) at 90 days.\45\ Pooled patient-level data from these five
trials demonstrated that in the mechanical thrombectomy group the odds
of better disability outcomes at 90 days (mRS scale distribution)
declined with longer time from symptom onset to expected arterial
puncture. Among the mechanical thrombectomy plus medical therapy group
patients in whom substantial reperfusion was achieved, delays in
reperfusion times were associated with increased levels of 3-month
disability.\46\
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\45\ Berkhemer OA, Fransen PS, Beumer D, et al. MR CLEAN
Investigators. A randomized trial of intraarterial treatment for
acute ischemic stroke. N Engl J Med. 2015;372:11-20.doi: 10.1056/
NEJMoa1411587; Campbell BCV, Mitchell PJ, Kleinig TJ, et al.
Endovascular therapy for ischemic stroke with perfusion-imaging
selection. N Engl J Med. 2015;372(11):1009-1018; Goyal M, Demchuk
AM, Menon BK, Eesa M, Rempel JL, Thornton J, et al.; ESCAPE Trial
Investigators. Randomized assessment of rapid endovascular treatment
of ischemic stroke. N Engl J Med. 2015;372(11):1019-1030; Jovin TG,
Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, et al.;
REVASCAT Trial Investigators. Thrombectomy within 8 hours after
symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):2296-
2306; Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM,
et al.; SWIFT PRIME Investigators. Stent-retriever thrombectomy
after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015
Jun 11;372(24):2285-95.
\46\ Saver JL, Goyal M, van der Lugt A, et al.; HERMES
Collaborators. Time to treatment with endovascular thrombectomy and
outcomes from ischemic stroke: a meta-analysis. JAMA. 2016;316:1279-
1288.
---------------------------------------------------------------------------
The applicant referred to the American Stroke Association/American
Heart Association (ASA/AHA) ``2018 Guidelines for the Early Management
of Patients With Acute Ischemic Stroke,'' which recognized that the
benefit of mechanical thrombectomy is time dependent, with earlier
treatment within the therapeutic window leading to bigger proportional
benefits. The guidelines also state that any cause for delay to
mechanical thrombectomy, including observing for a clinical response
after intravenous alteplase, should be avoided.\47\
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\47\ Powers WJ, Rabinstein AA, Ackerson T et al. On behalf of
the American Heart Association Stroke Council. 2018 Guidelines for
the early management of patients with acute ischemic stroke: A
guideline for healthcare professionals from the American Heart
Association/American Stroke Association. Stroke. 2018;49:e46-e110.
---------------------------------------------------------------------------
The applicant asserted that the phrase ``time is brain'' emphasizes
that human nervous tissue is rapidly lost as stroke progresses. Per the
applicant, recent advances in quantitative neurostereology and stroke
neuroimaging permit calculation of just how much brain is lost per unit
time in acute ischemic stroke. To illustrate this point, the applicant
stated that in the event of a large vessel acute ischemic stroke, the
typical patient loses 1.9 million neurons, 13.8 billion synapses, and
12 km (7 miles) of axonal fibers each minute in which stroke is
untreated. Furthermore, for each hour in which treatment fails to
occur, the brain loses as many neurons as it does in almost 3.6 years
of normal aging.\48\ The applicant asserted that given the time-
dependent nature of treatment in acute ischemic stroke patients,
ContaCT could play a critical role in preserving human nervous tissue,
as the application results in faster detection in more than 95 percent
of cases and saves an average of 51.4 minutes in time to
notification.\49\
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\48\ Saver JL. Time is brain--quantified. Stroke. 2006
Jan;37(1):263-6.
\49\ U.S. Food and Drug Administration (FDA). Center for Devices
and Radiological Health. Evaluation of Automatic Class III
Designation for Contact. Decision Memorandum No. 170073 (DEN170073).
2018. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf.
---------------------------------------------------------------------------
We stated in the proposed rule that we had the following concerns
regarding whether the technology meets the substantial clinical
improvement criterion. The applicant provided a total of 19 articles
specifically for the purposes of addressing the substantial clinical
improvement criterion: four retrospective studies/analyses, nine
randomized clinical trials (RCTs), three meta-analyses, one registry,
one guideline, and one systematic review.
The four retrospective studies/analyses included the FDA decision
memorandum, a single site of a RCT, and two abstracts related to the
Automated Large Artery Occlusion Detection in Stroke Imaging (ALADIN)
study. The applicant stated that the studies sponsored/conducted by the
De Novo requester indicated that ContaCT substantially shortens the
time to notifying the specialist for LVO cases as compared with the
standard of care. However, the sample size was limited to only 85 out
of 300 patients having sufficient data of CTA to notification time
available. To calculate the sensitivity and specificity of ContaCT,
neuro-radiologists reviewed images and established the empirical
evidence. Specifically, the sensitivity and specificity was 87.8
percent (95% CI: 81.2-92.5%) and 89.6 percent (83.7-93.9%),
respectively. In the proposed rule, we stated that we had concerns
regarding whether this represents a substantial clinical improvement,
as ContaCT missed approximately 12 percent of images with a true LVO
and incorrectly identified approximately 10 percent as having an LVO.
Additionally, the small sample size of less than 100 raises concerns
for generalizability. Additionally, we agree with the FDA that ContaCT
is limited to analysis of imaging data and should not be used in lieu
of full patient evaluation or relied upon to make or confirm
diagnosis.\50\
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\50\ U.S. Food and Drug Administration (FDA). Center for Devices
and Radiological Health. Evaluation of Automatic Class III
Designation for ContaCT. Decision Memorandum No. 170073 (DEN170073).
2018. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf.
---------------------------------------------------------------------------
With respect to the study that was a single site of an RCT \51\
presented by the applicant, the study conducted a retrospective review
of the time between an initial CT at an outside hospital and the
notification to the comprehensive stroke center. This retrospective
analysis was conducted for one site enrolled in one of the RCTs
(unspecified). The authors noted there was substantial difference in
the time between initial CT at the outside hospital to comprehensive
stroke center notification, due to multiple factors, including delays
in neurological assessments, interpretation of imaging, utilization of
advance modality imaging, and determination of tPA effectiveness.
Specifically, the authors noted in their study that obtainment of
advanced imaging contributed to a 57-minute delay in decision making
without substantial benefits in patient outcome. We stated in the
proposed rule that it was unclear whether and how this time delay and
the utilization of faster notification would affect the clinical
outcome of patients.
---------------------------------------------------------------------------
\51\ Sun CH, Nogueira J, Glenn RG, et al. Picture-to-puncture: A
novel time metric to enhance outcomes in patients transferred for
endovascular reperfusion in acute ischemic stroke. Circulation.
2013;127:1139-1148.
---------------------------------------------------------------------------
The applicant also submitted two separate abstracts for a
retrospective analysis of the ALADIN study, which only provide interim
results. The applicant noted for the primary analysis, the algorithm
obtained sensitivity of 0.97 and specificity of 0.52, with a positive
predictive value (PPV) of 0.74 and negative predictive (NPV) of 0.91,
and overall accuracy of
[[Page 58634]]
0.78. For the secondary analysis, which included analysis of additional
(secondary) vessels, the algorithm obtained sensitivity of 0.92 and
specificity of 0.75, with a PPV of 0.92 and NPV of 0.75, and overall
accuracy of 0.88. In the proposed rule, we stated that we were
concerned both that these are only partial results as it is not clear
what the full outcome of the ALADIN study will indicate, and also that
the initial overall accuracy of ContaCT varied by 10 percent between
the types of strokes.
The RCTs included the following: (1) Multicenter Randomized
Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in
the Netherlands (MR CLEAN);(2) Thrombolysis in Emergency Neurological
Deficits--Intra-Arterial (EXTEND-IA) Trial; (3) The Endovascular
Treatment for Small Core and Anterior Circulation Proximal Occlusion
with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial;
(4) Randomized Trial of Revascularization with Solitaire FR Device
versus Best Medical Therapy in the Treatment of Acute Stroke Due to
Anterior Circulation Large Vessel Occlusion Presenting within Eight
Hours of Symptom Onset (REVASCAT); (5) Solitaire with the Intention for
Thrombectomy as Primary Endocascular Treatment (SWIFT PRIME) trial; (6)
Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke;
(7) DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-
Up and Late Presenting Strokes Undergoing Neurointervention with Trevo
(DAWN) trial; and (8) Interventional Manage of Stroke (IMS) Phase I and
II trials. The MR CLEAN trial, EXTEND-IA trial, ESCAPE trial, REVASCAT
trial, SWIFT PRIME trial, Endovascular Therapy Following Imaging
Evaluation for Ischemic Stroke trial, and DAWN were all multicenter
prospective RCTs evaluating a treatment group of either a microcatheter
with a thrombolytic agent or mechanical thrombectomy versus a control
group of the standard of care. These RCTs were evaluating the outcomes
from specific treatment for patients who suffered from various strokes
and not the time of imaging to treatment. While each study may have
included a time-element as an experimental analysis or additional end-
point, we stated that we are unsure how they support the use of ContaCT
as a substantial clinical improvement over existing technologies. Also,
while the IMS trials provided evidence to support a positive clinical
outcome following technically successful angiographic reperfusion using
time from stroke onset to procedure termination, they did not specify
which part of the overall standard of care treatment affected an
increase or decrease of time. The three meta-analyses utilized data
from the RCTs. The Safety and Efficacy of Solitaire Stent Thrombectomy
examined four trials, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND-IA. The
Highly Effective Reperfusion evaluated in Multiple Endovascular Stroke
Trials (HERMES) collaboration authored two of the three meta-analyses.
The HERMES collaboration examined data and results from five RCTs, MR
CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND-IA. These meta-
analyses confirmed the results of each of the individual RCTs of the
benefits of thrombectomy versus the standard of care. However, we
stated that we have concerns as to whether these meta-analyses, along
with the RCTs, indicate a substantial clinical improvement with shorter
notification times of an LVO.
Two articles submitted by the applicant evaluated data using the
STRATIS registry. One article \52\ evaluated the use of mechanical
thrombectomy in consecutive patients with acute ischemic stroke because
of LVO in the anterior circulation. The two groups consisted of (1)
patients who presented directly to a comprehensive stroke center; and
(2) patients who were transferred to a comprehensive stroke center.
This study identified a difference of 124 minutes between groups, which
was primarily related to longer door-to-tPA times at nonenrolling
hospitals, delay between IV-tPA and departure from the initial
hospital, and length of transport time. The author's primary outcome
was functional status at 90 days, which found those with shorter time
to treatment achieved better functional independence at 90 days. There
was no difference in mortality in the two groups. While this article
supports that shorter time to treatment may increase positive clinical
outcomes for functional status, the study indicated time to departure
from the non-enrolling hospital and transfer time as primary reasons in
delayed thrombectomy treatment. These two time lapses include multiple
covariates; for example, the distance between the facilities and the
response of available transport (for example, ambulance). We stated in
the proposed rule that these potential confounders raise questions as
to the use of ContaCT shortening time to treatment.
---------------------------------------------------------------------------
\52\ Froehler MT, Saver JL, Zaidat 00, et al. Interhospital
transfer before thrombectomy is associated with delayed treatment
and worse outcome in the STRATIS registry. Circulation. 2017;
136(24):2311-2321.
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Lastly, the applicant submitted the AHA/ASA guidelines and a
systematic literature review as support for clinical improvement. We
stated that we are concerned the guidelines do not support a finding of
substantial clinical improvement for ContaCT because the guidelines are
for the current standard of care. The systematic literature review
identified the quantitative estimates of the pace of neural circuity
loss in human ischemic stroke. While this supports the urgency of
stroke care, we stated that we were unsure how it demonstrates a
substantial clinical improvement in how ContaCT supports the urgency of
stroke care.
We invited public comment as to whether ContaCT meets the
substantial clinical improvement criterion.
Comment: In addressing substantial clinical improvement concerns
raised by CMS in the proposed rule, the applicant summarized additional
clinical evidence demonstrating ContaCT reduces time to notification,
and that the device also reduces time to treatment and improves
clinical outcomes.
With respect to improved clinical outcomes, the applicant described
a study submitted for publication that used a prospectively-maintained
database of patients undergoing thrombectomy for LVO and assessed the
impact of ContaCT implementation on door-to-treatment time and patient
outcomes for all patients who presented to a Primary Stroke Center
currently utilizing ContaCT in the Mount Sinai Health System in New
York and who subsequently underwent mechanical thrombectomy. To
evaluate impact in a controlled fashion, data from pre-ContaCT
implementation (October 1, 2018 to March 15, 2019) and post-ContaCT
implementation (October 1, 2019 to March 15, 2020) were compared from a
total of 42 patients who met the inclusion criteria. According to the
applicant, the study investigators found that the post-ContaCT cohort
had significantly better clinical outcomes and level of disability, as
measured by a lower 5-day NIH Stroke Scores (NIHSS) and lower discharge
modified Rankin Score (mRS) scores compared to the pre-ContaCT cohort,
10.78 vs. 21.93 (p=0.02) and 2.92 vs. 4.62 (p=0.03), respectively. The
post-ContaCT cohort also demonstrated significantly lower median 90-day
mRS scores compared to the pre-ContaCT cohort (3 vs. 5; p=0.02). In
addition to these outcome measures, the post-ContaCT cohort also had
significantly shorter median door-to-interventional radiologist (INR)
[[Page 58635]]
notification time (21.5 vs. 36 minutes, p=0.02) and shorter median
door-to-puncture time (165 vs. 185 minutes, p=0.20).
With respect to shorter time to treatment, the applicant summarized
unpublished data from three distinct single center, retrospective
investigator-initiated reviews from hospital systems that have
implemented ContaCT in Colorado, Georgia, and Tennessee. The three
reviews evaluated ContaCT's impact on the time from hospital arrival
(Door) to skin puncture (Puncture), or DTSP, for LVO patients initially
presenting to the clinical site.
At the first site, 32 patients initially presented to the emergency
department at SkyRidge Medical Center in Colorado. Patients included in
the analysis were divided into two cohorts. The pre-ContaCT cohort
included the 16 thrombectomy patients immediately preceding ContaCT
implementation and the post-ContaCT cohort included the 16 thrombectomy
patients immediately after ContaCT implementation. Overall, ContaCT
implementation resulted in an average reduction in door-to-puncture
time of 24 minutes. Additionally, ContaCT implementation resulted in
statistically significant improvements in the percentage of patients
with door to puncture times of less than 90 minutes (p=0.013) and less
than 60 minutes (p=.005). After installing ContaCT, 94 percent of
thrombectomy cases had DTSP <90 minutes (p=0.013).
At the second site, 120 patients initially presented to the
emergency department at Wellstar Hospital in Georgia. Patients included
in the analysis were divided into two cohorts. Patients from pre-
ContaCT implementation (July 2018 through June 2019) and patients from
post-ContaCT implementation (July 2019 to June 2020) were compared.
Overall, ContaCT implementation resulted in an average reduction in
door to puncture time of 30 minutes (p=0.01).
At the third site, 46 patients initially presented to a Primary
Stroke Center currently utilizing ContaCT in the Methodist LeBonheur
Healthcare System in Tennessee. Patients included in the analysis were
divided into two cohorts: Patients with LVOs identified by ContaCT and
patients with LVOs not identified by ContaCT. Overall, ContaCT
implementation resulted in an average reduction in door-to-puncture
time of 44 minutes (p=0.03).
With respect to shorter time to notification, the applicant
described data maintained by Viz.ai indicating that real-world
performance of ContaCT is consistent with the results achieved in the
FDA clinical study. Across 4,763 patients analyzed by ContaCT in the
past six months, the median time from CT angiogram to notification of
the specialist was 4.31 minutes. This compares with 5.6 minutes in the
ContaCT cohort (compared with 58.7 minutes in the standard of care
cohort) in the FDA clinical trial. The percentage of notifications
viewed by the specialist within five minutes was 90 percent in the same
cohort of patients.
In addressing concerns raised by CMS in the proposed rule regarding
whether the clinical study supporting the applicant's De Novo request
for ContaCT represents a substantial clinical improvement, the
applicant stated that the sensitivity and specificity (87% and 90%,
respectively) of ContaCT are consistent with the performance
characteristic for other diagnostic services that inform clinical care
and that no tests have perfect performance. Moreover, the applicant
stated that because ContaCT is a triage and notification system, no
harm is expected to result from false positives or false negatives.
ContaCT will triage and alert on false positives resulting in an
earlier read of the CT angiogram image than what otherwise would be and
are quickly reviewed and appropriately triaged to non-treatment. False
negatives, when no alert is sent, are managed exactly the same as
today's standard of care without ContaCT, as no alert is sent in the
standard of care. The applicant noted the benefit for patients with LVO
that are correctly identified by ContaCT (true positives).
In addressing concerns raised by CMS in the proposed rule regarding
whether the results of the clinical study supporting the applicant's De
Novo request for ContaCT are generalizable, the applicant stated that
data maintained by Viz.ai (and referenced above) suggest that real-
world performance of ContaCT is even faster than what was found in the
FDA clinical trial. According to the applicant, these internal data are
supported by the additional clinical evidence provided to CMS that
demonstrate not only does ContaCT reduce time to notification of the
neurointerventionalist, it reduces time to treatment and improves
clinical outcomes as demonstrated by lower 5-day NIHSS and lower
discharge mRS.
The applicant also addressed concerns noted by CMS that results
provided in the new technology application from the ALADIN study were
partial results and showed somewhat more variable accuracy estimates
than the FDA study. The applicant stated that complete results from the
ALADIN study were unnecessary to support the performance of the ContaCT
system as the primary objective of the ALADIN study was to fine-tune
and optimize the ContaCT algorithm prior to the FDA study. According to
the applicant, the best and most reliable data on the performance of
the ContaCT device is the data from the pivotal study conducted for and
submitted to the FDA as part of the de novo classification request.
In the proposed rule, CMS pointed to the multiple steps and
variables that impact time to treatment and clinical outcomes in LVO,
questioning the ability of ContaCT to shorten time to treatment. In
their comment, the applicant stated that the existence of other
variables that impact time to treatment and clinical outcomes does not
preclude clinical benefits from one variable, such as time to
notification. The applicant stated that alerting the stroke specialist
earlier than the standard of care enables them to make treatment
decisions earlier, shortening the amount of time to treatment and
improving clinical outcomes.
The applicant also addressed CMS' concern about whether and how
utilization of faster analysis and notification of suspected LVOs
derived from CTA images would affect the clinical outcome of patients,
considering evidence demonstrating that obtainment of advanced imaging
like CTA contributed to a 57-minute delay in decision making.\53\ The
applicant stated that AHA's ``2019 Update to the 2018 Guidelines for
the Early Management of Patients With Acute Ischemic Stroke'' recommend
vessel imaging, such as CTA, for patients with suspected LVOs.\54\
Furthermore, according to the applicant, the AHA's broad
recommendations supporting vessel imaging are consistent with
requirements of pivotal trials for mechanical thrombectomy, all of
which required noninvasive CTA or MR angiography (MRA) diagnosis of LVO
as an inclusion criterion. Additionally, secondary analyses from the
Interventional Management of Stroke (IMS) III Trial, which helped
established vessel imaging as standard of care in
[[Page 58636]]
stroke imaging,\55\ found that use of CTA with or without CT perfusion
did not delay IV-tPA or endovascular therapy as compared to non-
contrast CT in the IMS III trial.\56\
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\53\ Sun CH, Nogueira J, Glenn RG, et al. Picture-to-puncture: A
novel time metric to enhance outcomes in patients transferred for
endovascular reperfusion in acute ischemic stroke. Circulation.
2013;127:1139-1148.
\54\ Powers WJ, Rabinstein AA, Ackerson T, et al; on behalf of
the American Heart Association Stroke Council. Guidelines for the
early management of patients with acute ischemic stroke: 2019 update
to the 2018 guidelines for the early management of acute ischemic
stroke: A guideline for healthcare professionals from the American
Heart Association/American Stroke Association. Stroke. 2019;50:e344-
e418.
\55\ Menon BK, Qazi E, Nambiar V, et al.; for the Interventional
Management of Stroke III Investigators. Differential effect of
baseline computed tomographic angiography collaterals on clinical
outcome in patients enrolled in the Interventional Management of
Stroke III Trial. Stroke. 2015; 46:1239-1244.
\56\ Vagal A, Foster LD, Menon B, et al. Multimodal CT Imaging:
Time to Treatment and Outcomes in the IMS III Trial. AJNR Am J
Neuroradiol. 2016;37(8):1393-1398.
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Finally, with regards to CMS' concerns about whether ContaCT
provides substantial clinical improvement, the applicant stated that
all available clinical guidelines support faster time to treatment.
They reiterated that the importance of time in stroke care is well
established, and that reducing time to treatment improves clinical
outcomes. They asserted that the new clinical evidence provided in
their comment demonstrated the direct effect that ContaCT has on both
time to treatment and patient outcomes and they maintained that these
data are consistent with a well-established body of evidence that
reduced time to notification and treatment of LVO improves outcomes in
patients with ischemic stroke.
We also received comments from many other commenters expressing
their support for new technologies that reduce time to treatment for
stroke patients, noting that rapid identification and treatment of
these patients at comprehensive stroke centers offers the possibility
to minimize the stroke burden and deficit and maximize the potential of
a good outcome and return to function. Several commenters also
recognized that rapid triaging of stroke patients has been endorsed as
a best practice in published clinical guidelines. Some commenters
supported the use of AI in the care of stroke patients and neuroscience
patients generally, but did not endorse a particular technology,
device, product, or manufacturer.
Several commenters noted their direct experience with ContaCT upon
implementation of the new technology at their hospitals, asserting that
communication between all providers involved in the acute care of
patients with stroke has significantly improved. A commenter stated
that the ContaCT triage and notification system directly saved the
lives of many patients at their hospital. The commenter referenced that
their hospital team performed analyses which demonstrated that the use
of the ContaCT system resulted in a statistically significant
improvement on transfer patient outcomes. Another commenter experienced
with the ContaCT system stated it led to a dramatic improvement in
patient workflow for acute stroke patients and has significantly
decreased door-in door-out times for patients needing emergent
treatment who present to spoke hospitals, improved decision times for
``go'' or ``no go'' for endovascular therapy at patients presenting to
both spoke and hub hospitals, and has led to improved overall outcomes
of patients.
Some commenters stated that rapid identification of stroke patients
is especially pressing at smaller hospitals that are trying their best
to transfer stroke patients to the nearest stroke center. A commenter
noted that the reduction of time to treatment by ContaCT is leading to
better outcomes clinically, less societal drain of resources, and fewer
financial burdens to families requiring the incomes of the patients
suffering from stroke disability. Another commenter asserted that if
ContaCT receives approval for add-on payments, more hospitals would be
able to implement this technology and, as a result, more patients would
have access to life saving treatment, leading to a significant
reduction of disability from stroke. According to the commenter,
allowing hospitals to receive reimbursement for ContaCT would not only
benefit communities in large metro areas but, more importantly, in
rural areas where access to stroke care and technology is limited due
to limited resources.
Response: We appreciate the commenters' input, including the
additional information and analysis provided by the applicant in
response to our concerns regarding substantial clinical improvement.
After reviewing the additional clinical information and other analysis
submitted by the applicant in response to our concerns raised in the
proposed rule, we have determined that ContaCT represents a substantial
clinical improvement over existing technologies because, based on the
information provided by the applicant, the technology shortens time to
notification, which has been shown in some instances to be critical in
improving long-term outcomes in the treatment of stroke.
After consideration of the public comments we received, we have
determined that ContaCT meets all of the criteria for approval for new
technology add-on payments. Therefore, we are approving new technology
add-on payments for ContaCT for FY 2021. Cases involving the use of
ContaCT that are eligible for new technology add-on payments will be
identified by ICD-10-PCS procedure code 4A03X5D.
In its application, the applicant stated that the cost per patient
of ContaCT will vary based on the number of cases. As discussed
previously, per the applicant, the cost per patient is calculated based
on the annual list price of ContaCT multiplied by the number of
subscribers, and divided by the number of ContaCT cases across such
subscribers. We noted that, if ContaCT were to be approved for new
technology add-on payments for FY 2021, we believed the cost per case
from the applicant's original cost analysis above may also be used to
determine the maximum new technology add-on payment (that is, 65
percent of the cost determined above). The applicant estimated that the
average cost of ContaCT to the hospital is $1,600 based on customer
data. Under Sec. 412.88(a)(2), we limit new technology add-on payments
to the lesser of 65 percent of the costs of the new medical service or
technology, or 65 percent of the amount by which the costs of the case
exceed the MS-DRG payment. As a result, the maximum new technology add-
on payment for a case involving the use of ContaCT is $1,040 for FY
2021.
d. Supersaturated Oxygen (SSO2) Therapy (DownStream[supreg]
System)
TherOx, Inc. submitted an application for new technology add-on
payments for Supersaturated Oxygen (SSO2) Therapy (the
TherOx DownStream[supreg] System) for FY 2021. We note that the
applicant previously submitted an application for new technology add-on
payments for FY 2019, which was withdrawn prior to the issuance of the
FY 2019 IPPS/LTCH PPS final rule. We also note that the applicant again
submitted an application for new technology add-on payments for FY
2020, but CMS was unable to determine that SSO2 Therapy
represents a substantial clinical improvement over the currently
available therapies used to treat STEMI patients.
Per the applicant, The DownStream[supreg] System is an adjunctive
therapy that creates and superoxygenated arterial blood and delivers it
directly to reperfused areas of myocardial tissue which may be at risk
after an acute myocardial infarction (AMI), or heart attack. Per FDA,
SSO2 Therapy is indicated for the preparation and delivery
of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted
ischemic regions perfused by the patient's left anterior descending
coronary artery immediately following revascularization by means of
[[Page 58637]]
percutaneous coronary intervention (PCI) with stenting that has been
completed within 6 hours after the onset of anterior acute myocardial
infarction (AMI) symptoms caused by a left anterior descending artery
infarct lesion. The applicant stated that the net effect of the
SSO2 Therapy is to reduce the size of the infarction and,
therefore, lower the risk of heart failure and mortality, as well as
improve quality of life for STEMI patients.
SSO2 Therapy consists of three main components: The
DownStream[supreg] System; the DownStream cartridge; and the
SSO2 delivery catheter. The DownStream[supreg] System and
cartridge function together to create an oxygen-enriched saline
solution called SSO2 solution from hospital-supplied oxygen
and physiologic saline. A small amount of the patient's blood is then
mixed with the SSO2 solution, producing oxygen-enriched
hyperoxemic blood, which is delivered to the left main coronary artery
(LMCA) via the delivery catheter at a flow rate of 100 ml/min. The
duration of the SSO2 Therapy is 60 minutes and the infusion
is performed in the catheterization laboratory. The oxygen partial
pressure (pO2) of the infusion is elevated to ~1,000 mmHg,
therefore providing oxygen locally to the myocardium at a hyperbaric
level for 1 hour. After the 60-minute SSO2 infusion is
complete, the cartridge is unhooked from the patient and discarded per
standard practice. Coronary angiography is performed as a final step
before removing the delivery catheter and transferring the patient to
the intensive care unit (ICU).
The applicant for the SSO2 Therapy received premarket
approval from FDA on April 2, 2019. FDA noted the applicant must
conduct ``a post-approval study to confirm the safety and effectiveness
of the TherOx DownStream System for use of delivery of SuperSaturated
Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions
of the patient's coronary vasculature in qualifying anterior acute
myocardial infarction (AMI) patients who have undergone successful
percutaneous coronary intervention (PCI) with stenting within 6 hours
of experiencing AMI symptoms.'' \57\ The applicant stated that use of
the SSO2 Therapy can be identified by the ICD-10-PCS
procedure codes 5A0512C (Extracorporeal supersaturated oxygenation,
intermittent) and 5A0522C (Extracorporeal supersaturated oxygenation,
continuous).
---------------------------------------------------------------------------
\57\ https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170027A.pdf.
---------------------------------------------------------------------------
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 therefore not be considered
``new'' for purposes of new technology add-on payments. We note that in
the FY 2020 IPPS/LTCH PPS final rule (84 FR 42275), we stated that
based on the information submitted by the applicant as part of its FY
2020 new technology add-on payment application for SSO2
Therapy, as discussed in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR
19353), and as summarized in the FY 2020 IPPS/LTCH PPS final rule, we
believe that SSO2 Therapy has a unique mechanism of action
as it delivers a localized hyperbaric oxygen equivalent to the coronary
arteries immediately after administering the standard-of-care, PCI with
stenting, in order to restart metabolic processes within the stunned
myocardium and reduce infarct size. Therefore, we stated that we
believe SSO2 Therapy is not substantially similar to
existing technologies and meets the newness criterion. We also stated
that we would consider the beginning of the newness period to commence
when SSO2 Therapy was approved by the FDA on April 2, 2019.
We refer the reader to the FY 2020 final rule for the complete
discussion of how SSO2 Therapy meets the newness criterion.
We invited public comments on whether SSO2 Therapy is
substantially similar to an existing technology and whether it meets
the newness criterion for purposes of its application for new
technology add-on payments for FY 2021.
Comment: Several commenters, including the applicant, agreed with
CMS' assessment in the FY 2020 IPPS/LTCH PPS final rule that
SSO2 Therapy meets the newness criterion and is not
substantially similar to existing technologies. These commenters stated
their belief that SSO2 Therapy is a novel and efficacious
therapy with a unique mechanism of action. The commenters stated that
the current standard of care does not address myocardial tissue death
and scarring, which is often linked to increased risk of heart failure
and long-term mortality.
Response: We appreciate the commenters' support.
Based on consideration of the comments received and information
submitted by the applicant as part of its FY 2021 new technology add-on
payment application for SSO2 Therapy, as discussed in the
proposed rule (85 FR 32608-32609) and previously summarized in the FY
2020 IPPS/LTCH PPS final rule (84 FR 42274-42275), we believe that
SSO2 Therapy does not use the same or a similar mechanism of
action to achieve a therapeutic outcome when compared to existing
treatments. Therefore, we believe that SSO2 Therapy is not
substantially similar to an existing technology and meets the newness
criterion. We consider the beginning of the newness period to commence
when SSO2 Therapy was approved by the FDA on April 2, 2019.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that SSO2 Therapy meets
the cost criterion. The applicant searched the FY 2018 MedPAR file for
claims reporting diagnoses of anterior STEMI by ICD-10-CM diagnosis
codes I21.01 (ST elevation (STEMI) myocardial infarction involving left
main coronary artery), I21.02 (ST elevation (STEMI) myocardial
infarction involving left anterior descending coronary artery), or
I21.09 (ST elevation (STEMI) myocardial infarction involving other
coronary artery of anterior wall) as a principal diagnosis, which the
applicant believed would describe potential cases representing
potential patients who may be eligible for treatment involving the
SSO2 Therapy. The applicant identified 9,111 cases mapping
to 4 MS-DRGs, with approximately 95 percent of all potential cases
mapping to MS-DRG 246 (Percutaneous Cardiovascular Procedures with
Drug-Eluting Stent with MCC or 4+ Arteries/Stents) and MS-DRG 247
(Percutaneous Cardiovascular Procedures with -DrugEluting- Stent
without MCC). The remaining 5 percent of potential cases mapped to MS-
DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting
Stent with MCC or 4+ Arteries/Stents) and MS-DRG 249 (Percutaneous
Cardiovascular Procedures with Non-Drug-Eluting Stent without MCC).
The applicant determined that the average case-weighted
unstandardized charge per case was $97,049. The applicant then
standardized the charges. The applicant did not remove charges for the
current treatment because, as previously discussed, SSO2
Therapy would be used as an adjunctive treatment option following
successful PCI with stent placement. The applicant then added charges
for the technology, which accounts for the use of 1 cartridge per
patient, to the average charges per case. The applicant did not apply
an inflation factor to the charges for the technology. The applicant
also added charges related to the technology, to account for the
additional supplies used in the administration of SSO2
Therapy, as well as 70 minutes of procedure room
[[Page 58638]]
time, including technician labor and additional blood tests. The
applicant inflated the charges related to the technology. In the
applicant's analysis, the inflated average case-weighted standardized
charge per case was $150,115 and the average caseweighted- threshold
amount was $98,332. Because the inflated average case-weighted
standardized charge per case exceeds the average case-weighted
threshold amount, the applicant maintained that the technology meets
the cost criterion.
We invited public comments on whether the SSO2 Therapy
meets the cost criterion.
Comment: One commenter, who is also the applicant, supported CMS'
conclusion in the FY 2020 IPPS/LTCH PPS final rule that SSO2
Therapy meets the cost criterion, based on an analysis of the 2017
MedPAR file which yielded an inflated case-weighted standardized charge
per case that exceeded the average case-weighted threshold amount.
Other commenters stated their belief that SSO2 Therapy is
inadequately paid under the MS-DRGs noted in the application. These
commenters urged CMS to approve SSO2 Therapy for new
technology add-on payments to ensure access to Medicare beneficiaries.
Response: Based on the applicant's cost analysis as previously
summarized and consideration of the comments received, we agree that
the average case-weighted standardized charge per case exceeded the
average case-weighted threshold amount. Therefore, SSO2
Therapy meets the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that SSO2 Therapy represents a
substantial clinical improvement over existing technologies because it
improves clinical outcomes for STEMI patients as compared to the
currently available standard-of-care treatment, PCI with stenting
alone. Specifically, the applicant asserted that: (1) Infarct size
reduction improves mortality outcomes; (2) infarct size reduction
improves heart failure outcomes; (3) SSO2 Therapy
significantly reduces infarct size; (4) SSO2 Therapy
prevents left ventricular dilation; and (5) SSO2 Therapy
reduces death and heart failure at 1 year. The applicant highlighted
the importance of the SSO2 Therapy's mechanism of action,
which treats hypoxemic damage at the microvascular or microcirculatory
level. Specifically, the applicant noted that microvascular impairment
in the myocardium is irreversible and leads to a greater extent of
infarction. According to the applicant, the totality of the data on
myocardial infarct size, ventricular remodeling, and clinical outcomes
strongly supports the substantial clinical benefit of SSO2
Therapy administration over the SOC.
As stated above, TherOx, Inc. submitted an application for new
technology add-on payments for FY 2020 that was denied on the basis of
substantial clinical improvement. In the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42278), we stated that we were not approving new technology
add-on payments for SSO2 Therapy for FY 2020 because, after
consideration of the comments received, we remained concerned that the
current data did not adequately support a sufficient association
between the outcome measures of heart failure, rehospitalization, and
mortality with the use of SSO2 Therapy specifically to
determine that the technology represents a substantial clinical
improvement over existing available options. The applicant resubmitted
its application for new technology add-on payments for FY 2021 with new
information that, per the applicant, demonstrates that there is an
unmet medical need for STEMI, and that SSO2 Therapy provides
a treatment option for a patient population unresponsive to currently
available treatments. Below we summarize the studies the applicant
submitted with both its FY 2020 and FY 2021 applications, followed by
the new information the applicant submitted with its FY 2021
application to support that the technology represents a substantial
clinical improvement.
In the FY 2020 application, as summarized in the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42275), and the FY 2021 application, the
applicant cited an analysis of the Collaborative Organization for
RheothRx Evaluation (CORE) trial and a pooled patient-level analysis to
support the claims that infarct size reduction improves mortality and
heart failure outcomes.
The CORE trial was a prospective, randomized, double-
blinded, placebo-controlled trial of Poloxamer 188, a novel therapy
adjunctive to thrombolysis at the time the study was conducted.\58\ The
applicant sought to relate left ventricular ejection fraction (EF),
end-systolic volume index (ESVI) and infarct size (IS), as measured in
a single, randomized trial, to 6-month mortality after myocardial
infarction treated with thrombolysis. According to the applicant,
subsets of clinical centers participating in CORE also participated in
one or two radionuclide sub-studies: (1) Angiography for measurement of
EF and absolute, count-based LV volumes; and (2) single-photon emission
computed tomographic sestamibi measurements of IS. These sub-studies
were performed in 1,194 and 1,181 patients, respectively, of the 2,948
patients enrolled in the trial. Furthermore, ejection fraction, ESVI,
and IS, as measured by central laboratories in these sub-studies, were
tested for their association with 6-month mortality. According to the
applicant, the results of the study showed that ejection fraction
(n=1,137; p=0.0001), ESVI (n=945; p=0.055) and IS (n=1,164; p=0.03)
were all associated with 6-month mortality, therefore, demonstrating
the relationship between these endpoints and mortality.\59\
---------------------------------------------------------------------------
\58\ Burns, R.J., Gibbons, R.J., Yi, Q., et al., ``The
relationships of left ventricular ejection fraction, end-systolic
volume index and infarct size to six-month mortality after hospital
discharge following myocardial infarction treated by thrombolysis,''
J Am Coll Cardiol, 2002, vol. 39, pp. 30-6.
\59\ Ibid.
---------------------------------------------------------------------------
The pooled patient-level analysis was performed from 10
randomized, controlled trials (with a total of 2,632 patients) that
used primary PCI with stenting.\60\ The analysis assessed infarct size
within 1 month after randomization by either cardiac magnetic resonance
(CMR) imaging or technetium-99m sestamibi single-photon emission
computed tomography (SPECT), with clinical follow-up for 6 months.
Infarct size was assessed by CMR in 1,889 patients (71.8 percent of
patients) and by SPECT in 743 patients (28.2 percent of patients)
including both inferior wall and more severe anterior wall STEMI
patients. According to the applicant, median infarct size (or percent
of left ventricular myocardial mass) was 17.9 percent and median
duration of clinical follow-up was 352 days. The Kaplan-Meier estimated
1-year rates of all-cause mortality, re-infarction, and HF
hospitalization were 2.2 percent, 2.5 percent, and 2.6 percent,
respectively. The applicant noted that a strong graded response was
present between infarct size (per 5 percent increase) and the 2 outcome
measures of subsequent mortality (Cox-adjusted hazard ratio: 1.19 [95
percent confidence interval: 1.18 to 1.20]; p<0.0001) and
hospitalization for heart failure (adjusted hazard ratio: 1.20 [95
percent confidence interval: 1.19 to 1.21]; p<0.0001), independent of
other baseline factors.\61\ The applicant concluded from this study
that infarct size, as measured by CMR or technetium-99m sestamibi SPECT
within 1 month after primary PCI, is strongly associated with all-cause
[[Page 58639]]
mortality and hospitalization for heart failure within 1 year.
---------------------------------------------------------------------------
\60\ Stone, G.W., Selker, H.P., Thiele, H., et al.,
``Relationship between infarct size and outcomes following primary
PCI,'' J Am Coll Cardiol, 2016, vol. 67(14), pp. 1674-83.
\61\ Ibid.
---------------------------------------------------------------------------
In the FY 2020 application, the applicant also cited the AMIHOT I
and II studies to support the claim that SSO2 Therapy
significantly reduces infarct size.
The AMIHOT I clinical trial was designed as a prospective,
randomized evaluation of patients who had been diagnosed with AMI,
including both anterior and inferior patients, and received treatment
with either PCI with stenting alone or with SSO2 Therapy as
an adjunct to successful PCI within 24 hours of symptom onset.\62\ The
study included 269 randomized patients and 3 co-primary endpoints:
Infarction size reduction, regional wall motion score improvement at 3
months, and reduction in ST segment elevation. The study was designed
to demonstrate superiority of the SSO2 Therapy group as
compared to the control group for each of these endpoints, as well as
to demonstrate non-inferiority of the SSO2 Therapy group
with respect to 30-day Major Adverse Cardiac Event (MACE). The
applicant stated that results for the control versus SSO2
Therapy group comparisons for the three co-primary effectiveness
endpoints demonstrated a nominal improvement in the test group,
although this nominal improvement did not achieve clinical and
statistical significance in the entire population. The applicant
further stated that a pre-specified analysis of the SSO2
Therapy patients who were revascularized within 6 hours of AMI symptom
onset and who had anterior wall infarction showed a marked improvement
in all 3 co-primary endpoints as compared to the control group.\63\ Key
safety data revealed no statistically significant differences in the
composite primary endpoint of 1-month (30 days) MACE rates between the
SSO2 Therapy and control groups. MACE includes the combined
incidence of death, re-infarction, target vessel revascularization, and
stroke. In total, 9/134 (6.7 percent) of the patients in the
SSO2 Therapy group and 7/135 (5.2 percent) of the patients
in the control group experienced 30-day MACE (p=0.62).\64\
---------------------------------------------------------------------------
\62\ O'Neill, W.W., Martin, J.L., Dixon, S.R., et al., ``Acute
Myocardial Infarction with Hyperoxemic Therapy (AMIHOT), J Am Coll
Cardiol, 2007, vol. 50(5), pp. 397-405.
\63\ Ibid.
\64\ Ibid.
---------------------------------------------------------------------------
The AMIHOT II trial randomized 301 patients who had been
diagnosed with and were receiving treatment for anterior AMI with
either PCI plus the SSO2 Therapy or PCI alone.\65\ The
AMIHOT II trial had a Bayesian statistical design that allows for the
informed borrowing of data from the previously completed AMIHOT I
trial. The primary efficacy endpoint of the study required proving
superiority of the infarct size reduction, as assessed by Tc-99m
Sestamibi SPECT imaging at 14 days post PCI/stenting, with the use of
SSO2 Therapy as compared to patients who were receiving
treatment involving PCI with stenting alone. The primary safety
endpoint for the AMIHOT II trial required a determination of non-
inferiority in the 30-day MACE rate, comparing the SSO2
Therapy group with the control group, within a safety delta of 6.0
percent.\66\ Endpoint evaluation was performed using a Bayesian
hierarchical model that evaluated the AMIHOT II result conditionally in
consideration of the AMIHOT I 30-day MACE data. According to the
applicant, the results of the AMIHOT II trial showed that the use of
SSO2 therapy, together with PCI and stenting, demonstrated a
relative reduction of 26 percent in the left ventricular infarct size
and absolute reduction of 6.5 percent compared to PCI and stenting
alone.\67\
---------------------------------------------------------------------------
\65\ Stone, G.W., Martin, J.L., de Boer, M.J., et al., ``Effect
of Supersaturated Oxygen Delivery on Infarct Size after Percutaneous
Coronary Intervention in Acute Myocardial Infarction,'' Circ
Cardiovasc Intervent, 2009, vol. 2, pp. 366-75.
\66\ Ibid.
\67\ Ibid.
---------------------------------------------------------------------------
Next, to support the claim that SSO2 Therapy prevents
left ventricular dilation, the applicant cited the Leiden study, which
represents a single-center, sub-study of AMIHOT I patients treated at
Leiden University in the Netherlands. The study describes outcomes of
randomized selective treatment with intracoronary aqueous oxygen (AO),
the therapy delivered by SSO2 Therapy, versus standard care
in patients who had acute anterior wall myocardial infarction within 6
hours of onset. Of the 50 patients in the sub-study, 24 received
treatment using adjunctive AO and 26 were treated according to standard
care after PCI, with no significant differences in baseline
characteristics between groups. LV volumes and function were assessed
by contrast echocardiography at baseline and 1 month. According to the
applicant, the results demonstrated that treatment with aqueous oxygen
prevents LV remodeling, showing a reduction in LV volumes (3 percent
decrease in LV end-diastolic volume and 11 percent decrease in LV end-
systolic volume) at 1 month as compared to baseline in AO-treated
patients, as compared to increasing LV volumes (14 percent increase in
LV end diastolic volume and 18 percent increase in LV end-systolic
volume) at 1 month in control patients.\68\ The results also show that
treatment using AO preserves LV ejection fraction at 1 month, with AO-
treated patients experiencing a 10 percent increase in LV ejection
fraction as compared to a 2 percent decrease in LV ejection fraction
among patients in the control group.\69\
---------------------------------------------------------------------------
\68\ Warda, H.M., Bax, J.J., Bosch, J.G., et al., ``Effect of
intracoronary aqueous oxygen on left ventricular remodeling after
anterior wall ST-elevation acute myocardial infarction,'' Am J
Cardiol, 2005, vol. 96(1), pp. 22-4.
\69\ Ibid.
---------------------------------------------------------------------------
Finally, to support the claim that SSO2 Therapy reduces
death and heart failure at 1 year, the applicant submitted the results
from the IC-HOT clinical trial, which was designed to confirm the
safety and efficacy of the use of the SSO2 Therapy in those
individuals presenting with a diagnosis of anterior AMI, who have
undergone successful PCI with stenting of the proximal and/or mid left
anterior descending artery within 6 hours of experiencing AMI symptoms.
It is an IDE, nonrandomized, single arm study. The study primarily
focused on safety, utilizing a composite endpoint of 30-day Net Adverse
Clinical Events (NACE). A maximum observed event rate of 10.7 percent
was established based on a contemporary PCI trial of comparable
patients who had been diagnosed with anterior wall STEMI. The results
of the IC-HOT trial exhibited a 7.1 percent observed NACE rate, meeting
the study endpoint. Notably, no 30-day mortalities were observed, and
the type and frequency of 30-day adverse events occurred at similar or
lower rates than in contemporary STEMI studies of PCI-treated patients
who had been diagnosed with anterior AMI.\70\ Furthermore, according to
the applicant, the results of the IC-HOT study supported the
conclusions of effectiveness established in AMIHOT II with a measured
30-day median infarct size = 19.4 percent (as compared to the AMIHOT II
SSO2 Therapy group infarct size = 20.0 percent).\71\ The
applicant stated that notable measures include 4-day microvascular
obstruction (MVO), which has been shown to be an independent predictor
of outcomes, 4-day and 30-day left ventricular end diastolic and end
systolic volumes, and
[[Page 58640]]
30-day infarct size.\72\ The applicant also stated that the IC-HOT
study results exhibited a favorable MVO as compared to contemporary
trial data, and decreasing left ventricular volumes at 30 days,
compared to contemporary PCI populations that exhibit increasing left
ventricular size.\73\ The applicant asserted that the IC-HOT clinical
trial data continue to demonstrate the substantial clinical benefit of
the use of SSO2 Therapy as compared to SOC, PCI with
stenting alone.
---------------------------------------------------------------------------
\70\ David, SW, Khan, Z.A., Patel, N.C., et al., ``Evaluation of
intracoronary hyperoxemic oxygen therapy in acute anterior
myocardial infarction: The IC-HOT study,'' Catheter Cardiovasc
Interv, 2018, pp. 1-9.
\71\ Ibid.
\72\ Ibid.
\73\ Ibid.
---------------------------------------------------------------------------
The applicant also performed controlled studies in both porcine and
canine AMI models to determine the safety, effectiveness, and mechanism
of action of the SSO2 Therapy.74 75 According to
the applicant, the key summary points from these animal studies are:
---------------------------------------------------------------------------
\74\ Spears, J.R., Henney, C., Prcevski, P., et al., ``Aqueous
Oxygen Hyperbaric Reperfusion in a Porcine Model of Myocardial
Infarction,'' J Invasive Cardiol, 2002, vol. 14(4), pp. 160-6.
\75\ Spears, J.R., Prcevski, P., Xu, R., et al., ``Aqueous
Oxygen Attenuation of Reperfusion Microvascular Ischemia in a Canine
Model of Myocardial Infarction,'' ASAIO J, 2003, vol. 49(6), pp.
716-20.
---------------------------------------------------------------------------
SSO2 Therapy administration post-AMI acutely
improves heart function as measured by left ventricular ejection
fraction (LVEF) and regional wall motion as compared with non-treated
control subjects.
SSO2 Therapy administration post-AMI results in
tissue salvage, as determined by post-sacrifice histological
measurements of the infarct size. Control animals exhibit larger
infarcts than the SSO2-treated animals.
SSO2 Therapy has been shown to be non-toxic to
the coronary arteries, myocardium, and end organs in randomized,
controlled swine studies with or without induced acute myocardial
infarction.
SSO2 Therapy administration post-AMI has
exhibited regional myocardial blood flow improvement in treated animals
as compared to controls.
A significant reduction in myeloperoxidase (MPO) levels in
the SSO2-treated animals versus controls, which indicate
improvement in underlying myocardial hypoxia.
Transmission electron microscopy (TEM) photographs showing
amelioration of endothelial cell edema and restoration of capillary
patency in ischemic zone cross-sectional histological examination of
the SSO2-treated animals, while non-treated controls exhibit
significant edema and vessel constriction at the microvascular level.
In the FY 2020 final rule (84 FR 42278), after consideration of all
the information from the applicant, as well as the public comments we
received, we stated that we were unable to determine that
SSO2 Therapy represented a substantial clinical improvement
over the currently available therapies used to treat STEMI patients. We
stated that we remained concerned that the current data does not
adequately support a sufficient association between the outcome
measures of heart failure, rehospitalization, and mortality with the
use of SSO2 Therapy specifically to determine that the
technology represented a substantial clinical improvement over existing
available options. Therefore, we did not approve new technology add-on
payments for SSO2 Therapy for FY 2020.
For FY 2021, the applicant submitted new information that,
according to the applicant, demonstrates that there is an unmet medical
need for STEMI, and that SSO2 Therapy provides a treatment
option for a patient population unresponsive to currently available
treatments. The applicant presented this information in the context of
CMS's concerns as identified in the FY 2020 IPPS/LTCH PPS proposed and
final rules, specifically that (1) it is unclear whether use of the
SSO2 Therapy would demonstrate the same clinical improvement
as compared to the current standard of care; (2) that the current data
does not adequately support a sufficient association between the
outcome measures of heart failure, rehospitalization, and mortality
with the use of SSO2 Therapy, and (3) that SSO2
may not provide long-term clinical benefits in patients with AMI. Below
we summarize this information, which the applicant believes addresses
these concerns.
With regard to CMS's concern that it is unclear whether use of
SSO2 Therapy would demonstrate the same clinical improvement
as compared to the current standard-of care, the applicant restated our
concern as whether ``these data [AMIHOT I and AMIHOT II are] adequate
to show the relevant outcomes in the control (standard of care
percutaneous coronary intervention (PCI))''. In response to this
concern, the applicant asserted that patient outcomes post-PCI have
remained relatively stable over the past 10 years and there is a strong
clinical need for new therapies like SSO2 in addition to PCI
in the management of patients with anterior STEMI to reduce the risk
and severity of heart failure and death. To support its assertion of an
unmet clinical need for anterior wall STEMI treatment, the applicant
presented data from multiple references to illustrate the following:
A plateau in STEMI 1-year mortality rates at 10 percent
with the advent of drug-eluting stents, according to reports from the
SWEDEHEART registry. This statistic is in agreement with the 9% 1 year
STEMI mortality rate following PCI reported in a 2015 paper by Bullock
et al.\76\
---------------------------------------------------------------------------
\76\ Bulluck H, Yellon DM, and Hausenloy DJ. Reducing myocardial
infarct size: Challenges and future opportunities. Heart
2016;102:341-48.
---------------------------------------------------------------------------
No improvement in U.S. in-hospital post-PCI STEMI
mortality rates between 2001 and 2011 based on work done by Sugiyama et
al.\77\
---------------------------------------------------------------------------
\77\ Sugiyama T, Hasegawa K, Kobayashi Y, Takahashi O, Fukui T,
Tsugawa Y. Differential time trends of outcomes and costs of care
for acute myocardial infarction hospitalizations by ST elevation and
type of intervention in the United States, 2001-2011. J AmHeart
Assoc. 2015;4:e001445. doi:10.1161/JAHA.114.001445.
---------------------------------------------------------------------------
No decrease in one-year mortality risk as illustrated by
Kalesan et al.,\78\ a meta-analysis of 15 clinical trials totaling
7,867 patients that compared outcomes data for STEMI patients treated
with bare metal stents versus drug eluting stents.\79\
---------------------------------------------------------------------------
\78\ Kalesan B, Pilgrim T, Heinimann K, et al. Comparison of
drug-eluting stents with bare metal stents in patients with ST-
segment elevation myocardial infarction. Eur Heart J 2012;33:977-87.
\79\ Id.
---------------------------------------------------------------------------
A markedly higher one-year mortality rate at 19.4% for the
Medicare population as compared to the total population of PCI-treated
anterior wall STEMI patients, according to the most recent Medicare
Standard Analytic File (SAF) data (2017).
No improvement in congestive heart failure (CHF) rates
after STEMI treated pPCI; the applicant referenced Szummer et al.'s
\80\ work which indicated 1 year post primary PCI CHF rates of 10
percent as well as a statistical analysis of CHF readmission outcomes
that showed heart failure rates for this patient population have
remained stable at 9 to 10 percent from 2012 to 2017.
---------------------------------------------------------------------------
\80\ Szummer K, Wallentin L, Lindhagen L, et al. Improved
outcomes in patients with ST-elevation myocardial infarction during
the last 20 years are related to implementation of evidence-based
treatments: experiences from the SWEDEHEART registry 1995-2014. Eur
Heart J 2017;38:3056-65.
---------------------------------------------------------------------------
A decrease in 30-day STEMI re-hospitalizations due to the
evolution of PCI therapy; the applicant cited the work of Kim et
al.,\81\ noting the readmission rates trended slightly downward from
approximately 12 percent in 2010 to 10 percent in 2014. According to
the applicant, these data
[[Page 58641]]
illustrate that PCI treats macrovascular aspects of STEMI events, but
does not address the underlying infarct damage, which is highly
correlated with worse long-term outcomes.
---------------------------------------------------------------------------
\81\ Kim LK, Yeo I, Cheung, JW, et al. Thirty-Day Readmission
Rates, Timing, Causes, and Costs after ST-Segment Myocardial
Infarction in the United States: A National Readmission Database
Analysis 2010-2014. J Am Heart Assoc 2018;7(18):1-34.
---------------------------------------------------------------------------
The applicant reiterated statements from its prior application
that, in order to reduce outcomes like mortality and heart failure in
the STEMI population, therapies must be available above and beyond PCI
to reduce the size of the infarct that results from a STEMI event. Per
the applicant, the benefits shown in the AMIHOT I 6-hour sub-study,
AMIHOT II and IC-HOT studies show statistically significant and
clinically meaningful improvements in infarct size, left ventricular
size and function, and long term outcomes that support the claim that
SSO2 offers a substantial clinical improvement over PCI by
filling an important gap in therapy with PCI, and specifically the need
to reduce infarct size beyond simply opening occluded large vessels
alone.
With regard to CMS's second concern that the current data does not
adequately support a sufficient association between the outcome
measures of heart failure, rehospitalization, and mortality with the
use of SSO2 Therapy, the applicant restated our concern as
``the importance of the reduction of infarct size as an outcome for
patients with anterior STEMI.'' The applicant provided multiple animal
and human studies to illustrate how TherOx SSO2 potentially
impacts outcome measures of heart failure, rehospitalization and
mortality. Regarding animal studies, the applicant cited the porcine
and canine study by Spears et al. and summarized above to illustrate
how aqueous oxygen hyperoxemic perfusion attenuates microvascular
ischemia.82 83 Regarding human studies, the applicant cited
a 2004 review by Gibbons et al. to support its assertion that the best
physical measure of the consequences of AMI in post-intervention
patients is the quantification of the extent of necrosis or infarction
in the muscle. In this 2004 review article, Gibbons et al. sought to
summarize published evidence for quantification of infarct size using
data from studies that assessed biomarkers, cardiac SPECT sestamibi and
magnetic resonance imaging.\84\ Regarding the use of cardiac SPECT
sestamibi imaging, Gibbons et al. found five separate lines of clinical
evidence that validated the use of SPECT sestamibi imaging for
determining infarct size.\85\ The applicant also referenced the CORE
trial that it submitted with its original application and which we
summarize above. Per the applicant, a substudy of CORE trial data by
Burns et al. demonstrated that an absolute infarct size reduction of 3
percent was associated with a mortality benefit.\86\ Specifically, the
trial showed that six-month mortality was significantly related to
infarct size. Per the applicant, among the 753 patients who underwent
ejection fraction measurements, the odds ratio for infarct size for
six-month mortality was 1.033--that is, for each 1 percent increase in
infarct size, mortality in the next 6 months was 1.033 times more
likely. A 5 percent increase in infarct size would therefore mean that
6-month mortality was 1.176 times more likely. A patient with an
infarct size that was greater by 5 percent of the left ventricle would
therefore have a 17.6 percent greater chance of dying within the next 6
months.\87\
---------------------------------------------------------------------------
\82\ Spears JR, Henney C, Prcevski P, et al. Aqueous Oxygen
Hyperbaric Reperfusion in a Porcine Model of Myocardial Infarction.
J Invasive Cardiol 2002; 14(4):160-6.
\83\ Spears JR, Prcevski P, Xu R, et al. Aqueous Oxygen
Attenuation of Reperfusion Microvascular Ischemia in a Canine Model
of Myocardial Infarction. ASAIO J 2003; 49(6):716-20.
\84\ Gibbons RJ, Valeti US, Araoz PA, et al. The quantification
of infarct size. J Am Coll Cardiol 2004; 44:1533-42.
\85\ Id.
\86\ Burns RJ, Gibbons RJ, Yi Q, et al. The relationships of
left ventricular ejection fraction, end-systolic volume index and
infarct size to six-month mortality after hospital discharge
following myocardial infarction treated by thrombolysis. J Am Coll
Cardiol 2002; 39:30-6.
\87\ Id.
---------------------------------------------------------------------------
The applicant further noted the CORE trial and associated studies
were conducted when thrombolytic therapy was the standard of care for
coronary artery reperfusion. The transition to PCI led directly to a
measured absolute infarct size reduction of 5.1 percent in STEMI
patients treated with PCI as compared to thrombolytic therapy, which
correlated to a significant decrease in cardiovascular events. The
applicant asserted that the infarct size reduction demonstrated with
PCI compared to thrombolytic therapy helped establish PCI as the
preferred standard of care, and that the results demonstrating the
importance of infarct size reduction hold true in randomized PCI trials
of STEMI patients, with infarct size evaluated by either Tc-99
sestabmibi SPECT imaging or cardiac MRI. The applicant referred to the
substudy of CORE trial data by Burns et al., which found that, among
the three clinical prognostic outcomes studied, ejection fraction (EF)
was superior to infarct size (IS) and end-systolic volume index (ESVI)
in predicting 6-month mortality.\88\ The authors also noted that all
three radionuclide measures were significantly associated with each
other, and that the strongest correlation was between ESVI and EF. The
study noted that infarct size was significantly correlated with both EF
and ESVI despite being determined from a different radionuclide
measurement, and that infarct location was not found to be
significant.\89\
---------------------------------------------------------------------------
\88\ Id.
\89\ Id.
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The applicant also provided a study by Stone et al.\90\ to address
our concern that the current data does not adequately support a
sufficient association between the outcome measures of heart failure,
rehospitalization, and mortality with the use of SSO2
Therapy. The applicant provided Stone et al.'s recent analysis of 10
pooled randomized trials involving 2,632 subjects, including some
subjects from the AMIHOT II trial. Stone et al. set out to determine
the strength of the relationship between infarct size assessed within 1
month after pPCI in STEMI and subsequent all-cause mortality,
reinfarction and hospitalization for heart failure.\91\ Infarct size
was assessed using cardiac SPECT sestamibi or cardiac magnetic
resonance and clinical follow-up data greater than or equal to 6
months. The authors found infarct size reduction measured by either
imaging method within 1 month correlated strongly with reduced
mortality and heart failure hospitalization at 1 year. The applicant
asserted that the results demonstrated that every 5 percent absolute
increase in left ventricular infarct size was associated with a 19
percent increase in 1-year mortality, correlating well with the 17.6
percent estimate established from earlier data and underscoring the
important, independent relationship between infarct size and mortality
regardless of the treatment modality. The applicant asserted that the
published analysis also demonstrated that infarct size measured within
1 month after pPCI for STEMI using either imaging method is a powerful
independent predictor of hospitalization for heart failure at 1 year.
The applicant reiterated that overall, a 5 percent absolute infarct
size increase was associated with a 20 percent increase in either death
or heart failure at 1 year. The applicant explained that because
infarct size is the quantification of the extent of scarring of the
left ventricle post-AMI, it is a direct measure of the health of the
myocardium and indirectly of the heart's structure and function. A
[[Page 58642]]
large infarct means the muscle cannot contract normally, leading to
left ventricular enlargement, reduced ejection fraction, clinical heart
failure, and death. Per the applicant, the Kaplan-Meier curves for the
rates of heart failure at 12 months as a function of infarct size also
show that a 5 percent increase in left ventricle infarct size
corresponded to a 50-100 percent increase in the risk of heart failure
at 12 months for the most severe infarcts. The applicant concluded that
reducing infarct size 5 or more percentage points provides a clear and
dramatic clinical benefit for patients as demonstrated by a wealth of
trial data. Significantly, the applicant noted that even as treatment
of the primary occlusion improved, the relationship between infarct
size and mortality and heart failure persisted and remained present
throughout the study data.
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\90\ Stone GW, Selker, HP, Thiele H, et al. Relationship between
infarct size and outcomes following primary PCI. JACC
2016;67(14):1674-83.
\91\ Id.
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Finally, with regard to CMS's third concern that SSO2
may not provide long-term clinical benefits in patients with AMI, the
applicant again referred to the 1-year outcomes data collected from
patients in the IC-HOT trial and which were compared to a control
population from the INFUSE AMI study after propensity-matching. The
applicant asserted that STEMI patients treated with SSO2
Therapy showed statistically significant and clinically meaningful
improvements in several critically important outcomes for patients with
anterior STEMI at 1 year, such as--
Death;
New onset of heart failure and readmission for heart
failure;
Composite rate of death and new onset of heart failure;
Composite rate of death, new onset of heart failure or
readmission for heart failure, or clinically-driven target vessel
revascularization;
Composite of death, reinfarction/spontaneous MI,
clinically driven target vessel revascularization or new onset heart
failure or readmission for heart failure.
The applicant concluded that, taken together, there is abundant
evidence to support the claim that SSO2 Therapy represents a
substantial clinical improvement over PCI alone in the management of
patients with anterior STEMI. Per the applicant, there remains a strong
unmet need for new therapies like SSO2 in addition to PCI in
the management of patients with anterior STEMI to reduce the risk and
severity of heart failure and death. The applicant maintained that the
timely delivery of supersaturated oxygen therapy improves microvascular
and tissue level flow, reduces infarct size, facilitates recovery of
left ventricular function and preserves left ventricular stability, and
improves patient outcomes, most notably lowering mortality and heart
failure rates at 1 year post-procedure.
We thank the applicant for the additional information to address
the concerns discussed in the FY 2020 IPPS/LTCH PPS final rule. We
appreciate how this information, and specifically the seven studies
referenced in response to the applicant's restatement of our first
concern, illustrates a potential unmet medical need. However, we stated
in the proposed rule that we are concerned that the AMIHOT I and AMIHOT
II data may not adequately demonstrate the relevant outcomes in the
control (standard of care PCI) because the standard of care has evolved
since the two trials were performed. Additionally, we stated that we
are concerned that the results presented in these seven studies may be
based on patients with all types of STEMI and are not specific to the
FDA-approved indicated use of SSO2 Therapy for the treatment
of anterior STEMI. We stated that ultimately, we remain concerned that
the current data does not support a sufficient association between the
outcome measures of heart failure, rehospitalization, and mortality
with the use of SSO2 Therapy specifically to determine that
the technology represents a substantial clinical improvement over
existing available options. Therefore, we invited public comment on
whether SSO2 Therapy meets the substantial clinical
improvement criterion.
We invited public comments on whether the SSO2 Therapy
meets the substantial clinical improvement criterion.
Comment: The applicant submitted comments regarding the concerns
raised by CMS in the proposed rule about whether SSO2
Therapy meets the substantial clinical improvement criterion. The
commenter first recapped the clinical studies used to support
SSO2 Therapy's Premarket Approval, which were the AMIHOT I
and II and IC-HOT clinical trials.
As discussed in the FY 2020 IPPS/LTCH PPS final rule and the FY
2021 IPPS/LTCH PPS proposed rule, the AMIHOT I was a prospective,
randomized study that enrolled both inferior and anterior STEMI
patients assigned to either PCI with stenting alone (control group) or
with SSO2 administered post-PCI (treatment group). The
AMIHOT I trial showed a therapeutic benefit in the pre-specified
anterior STEMI subgroup by reducing infarct size (the primary
endpoint). However, as the AMIHOT I was not designed to test
statistical superiority in the subgroup with anterior STEMI, for which
SSO2 Therapy is indicated, the manufacturer undertook a
second prospective, randomized controlled trial for this population,
the AMIHOT II study.
The AMIHOT II trial only enrolled anterior STEMI patients
randomized to either PCI with stenting alone (control) or with
SSO2 administered post-PCI (treatment). At the FDA's
recommendation, the AMIHOT II utilized a pre-specified Bayesian
statistical model for the primary endpoint analysis, which pooled
anterior STEMI patients from the AMIHOT I and AMIHOT II patients. The
results of AMIHOT II demonstrated superiority in the anterior STEMI
population for the primary endpoint of reducing infarct size, or heart
muscle damage, which the commenter asserted is a well-recognized
predictor of heart failure and mortality.\92\
---------------------------------------------------------------------------
\92\ Stone GW, Selker, HP, Thiele H, et al. Relationship between
infarct size and outcomes following primary PCI. J Am Coll Cardiol
2016;67(14):1674-83.
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Finally, the manufacturer undertook a third study, IC-HOT.\93\ The
purpose of IC-HOT was to confirm the safety and efficacy results of
SSO2 Therapy after technical modifications to device design.
Per the applicant, the IC-HOT study enrolled a treatment-only cohort,
met its primary endpoint, and confirmed the earlier AMIHOT findings for
infarct size reduction and mortality. The commenter noted that the
results are consistent across all key studies and demonstrate that
SSO2 Therapy significantly reduces infarct size, or heart
muscle damage.
---------------------------------------------------------------------------
\93\ David SW et al. Evaluation of intracoronary hyperoxemic
oxygen therapy in acute anterior myocardial infarction: The IC-HOT
study. Catheter Cardiovasc Interv, 2019:93(5);882-90.
---------------------------------------------------------------------------
Next, the applicant presented two new studies that had not been
available at the time its FY 2021 new technology add-on payment
application was submitted. The first (which the applicant referred to
as the Chen paper) was an analysis of mortality and heart failure rates
found in IC-HOT patients as compared to a historical propensity-matched
population of anterior STEMI patients from the 2012 INFUSE-AMI trial.
The applicant referenced this analysis in its FY 2021 new technology
add-on payment application and has since had it peer-reviewed and
accepted for publication. The analysis presented one-year follow-up
data showing mortality and heart failure rates between the two groups.
This new data showed treatment with SSO2 Therapy was
associated with a lower 1-year rate of
[[Page 58643]]
the composite endpoint of all-cause death or new-onset heart failure or
hospitalization for heart failure (0.0% vs. 12.3%, p=0.001), with
reductions in the individual 1-year outcomes of death (0% vs. 7.6%,
p=0.01) and new-onset heart failure or hospitalization for heart
failure (0.0% vs. 7.4%, p =0.001). However, we note that the applicant
did not observe a statistically significant result in the outcome
measurements of reinfarction and target vessel revascularization.
The applicant also commissioned the Medicare Mortality Analysis,
which matched the IC-HOT patients with a population of anterior STEMI
patients from 2018 Medicare inpatient data. The populations were
matched for multiple covariates, using propensity scores and regression
analysis. The applicant applied the same inclusion and exclusion
criteria as the IC-HOT study, resulting in an eligible comparison group
of 2,587 cases. The applicant then developed one-year follow-up data
showing mortality rates between the two groups. Per the applicant, the
IC-HOT treatment group had no mortality over the 30-day and 1-year
follow-up periods, in contrast to the matched Medicare comparison
group, which had a 30-day mortality of 5 percent and a 1-year mortality
of 7.3 percent. The applicant stated that the differences in mortality
between the IC-HOT sample and the matched Medicare sample were
statistically significant at a 5 percent significance level. The
applicant further developed data showing differences in the rate of re-
hospitalization for chronic heart failure. The applicant found that the
mortality rate in the IC-HOT sample was 1 percent over the 30-day and
1-year follow-up periods, but that the difference between the two
populations was not statistically significant.
The applicant also presented a Medicare Longitudinal Analysis of
heart failure outcomes in anterior STEMI patients treated with PCI. The
applicant obtained Medicare inpatient claims data from 2005-2008 (when
the AMIHOT trials were conducted) and from 2016-2018 (during enrollment
of the IC-HOT trial). Because the 2005-2007 Medicare Inpatient Limited
Datasets only report the quarter of discharge from the hospital, the
applicant examined outcomes by quarters and divided their sample into
two cohorts based on year of discharge from the hospital. The early
cohort included cases discharged in 2005 and 2007, and the later cohort
included cases discharged in 2016, 2017, and 2018. The applicant found
that, among Medicare beneficiaries diagnosed with STEMI who are treated
with PCI with stenting, 4-quarter mortality rates following
hospitalization was 8.9 percent in the 2005/2007 cohort and 10.3
percent in the 2016/2017/2018 cohort. While the difference in these
mortality rates between the early and later cohorts was statistically
insignificant, the 8-quarter mortality rate increased from 11.4 percent
in 2005 to 14.5 percent in 2016/2017, yielding a statistically
significant difference of 3.1 percentage points. Per the applicant,
controlling for differences in clinical characteristics between the
early and later cohorts using Elixhauser comorbidities yielded a 4
quarter mortality rate that increased by 2.3 percentage points, and an
8-quarter mortality rate that increased by 4.2 percentage points
between early and later cohorts. Per the applicant, risk-adjusted 4-
quarter rehospitalization rates for chronic heart failure decreased by
6.9 percentage points between the 2005/2007 cohort and the 2016/2017/
2018 cohort. The applicant found no statistically significant change in
8-quarter rehospitalization rate for chronic heart failure between the
two cohorts. Per the applicant, these results demonstrate that
mortality and heart failure outcomes in anterior STEMI patients treated
with PCI have not improved since 2005 between the matched population of
the earlier cohort and the later cohort.
The applicant then addressed CMS' concerns (85 FR 32613)
individually. With respect to the concern that the AMIHOT I and AMIHOT
II data may not adequately demonstrate the relevant outcomes in the
control group because the standard of care has evolved since the two
trials were performed, the applicant responded that refinements to the
standard of care have not improved mortality or heart failure since the
studies were conducted. According to the applicant, the changes to the
standard of care since AMIHOT I and AMIHOT II were conducted have been
modest rather than transformative, and largely comprised of (1) earlier
PCI intervention through reduced door-to-balloon times, (2) new
adjunctive pharmacological alternatives, and (3) incremental
improvements in stent design and delivery tools and techniques. The
applicant reiterated that these changes have led to a reduction in
rehospitalization and revascularization, but no improvement in
mortality or heart failure rates.
The applicant further noted that, with respect to earlier PCI
intervention, it is important to recognize that door-to-balloon times
in the AMIHOT control groups were already at the optimized levels seen
in clinical practice today, as evidenced by the requirement in the
AMIHOT trials to perform successful PCI within 6 hours of symptom
onset, and the adherence to prompt door-to-balloon times in the PCI
centers that participated in the study.\94\ Accordingly, the applicant
asserted that the AMIHOT control group accurately reflects the current
standard of care in this manner. The applicant asserted that other
refinements have resulted in better PCI results, but have not improved
mortality or heart failure rates. For example, the migration from bare
metal stents to drug-eluting stents reduced target vessel
revascularization rate by 46% but did not reduce cardiac death.\95\ The
applicant referenced the Medicare Longitudinal Analysis, which saw an
increase in the one-year mortality rate from 7.8% in 2005 to 10.8% in
2018. The applicant noted that, in the same analysis, the trend in two-
year mortality rate also increased from 11.4% in 2005 to 15.3% in 2017.
Similarly, two-year heart failure rate increased from 7.8% in 2005 to
10.6% in 2018.
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\94\ Median D2B = 75 min for Controls and 77 min for
SSO2 subjects in the AMIHOT II trial.
\95\ Kalesan et. al. Comparison of drug-eluting stents with bare
metal stents in patients with ST-segment elevation myocardial
infarction. Euro Heart J 2012;33:977-87.
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The applicant concluded that both the clinical literature and
Medicare's own anterior STEMI patient data demonstrate refinements to
the PCI standard of care have not resulted in improved heart failure or
mortality for anterior STEMI patients since the conduct of the AMIHOT
trials, and that the AMIHOT I and II control group continues to be
relevant. The applicant reiterated that, without a therapy to address
microvascular injury in the heart muscle following an anterior STEMI,
outcomes that are strongly correlated to microvascular injury are
unlikely to improve. The applicant stated that in contrast to PCI
refinements, SSO2 Therapy is specifically designed to
address microvascular injury and improves anterior STEMI outcomes
related to the development of heart failure and heart failure
mortality.
With respect to the concern that the results presented in the seven
studies submitted with the applicant's FY 2021 application were based
on patients with all types of STEMI and are not specific to the FDA-
approved indicated use of SSO2 Therapy for the treatment of
anterior STEMI, the applicant responded that the studies presented are
relevant even though they were not specific to the FDA approved
indication. The applicant stated that the AMIHOT II and IC-HOT studies
targeted the anterior STEMI population
[[Page 58644]]
after the pre-defined anterior STEMI subgroup in AMIHOT I saw the
greatest benefit from SSO2 Therapy. To further confirm these
results, the applicant referenced the Medicare Mortality Analysis,
which included only anterior STEMI patients. The new analysis showed
that the IC-HOT treatment group had no mortality over 30-day and 1-year
follow-up periods. In contrast, the propensity-matched population from
2018 Medicare inpatient data had a 30-day mortality of 5 percent, and
1-year mortality of 7.3 percent. The differences in mortality between
the IC-HOT sample and the matched Medicare sample were statistically
significant at a 5 percent significance level, while the differences in
re-hospitalization rate for CHF between the IC-HOT sample and the
matched Medicare sample were statistically insignificant.
The applicant noted that its FY 2021 application included a wide
array of data demonstrating the absence of progress in mortality or
heart failure outcomes in all types of STEMI patients, since large,
longitudinal STEMI studies reported by infarct location are limited. As
seen in AMIHOT I and the Medicare Mortality Analysis, clinical outcomes
are worse in anterior STEMI patients and this population drives overall
STEMI mortality and heart failure rates. The applicant again referenced
the Medicare Longitudinal Analysis, which is derived from CMS data and
specific to the anterior STEMI and matched population to support their
assertion that there is a lack of progress in improving mortality and
heart failure outcomes in anterior STEMI patients between 2005 and
2018. The applicant explained that anterior STEMI carries a higher
heart failure and mortality risk and thus any data presented that is
not specific to the anterior STEMI population would tend to cause a
bias towards underestimating adverse outcomes with anterior STEMI and
therefore underestimate the clinical benefit from SSO2
Therapy by comparison.\96\ The applicant maintained that all clinical
data reported showing a benefit of SSO2 Therapy are among
patients with anterior STEMI, so this bias can only exist for
comparison data. The applicant stated as such, comparisons of
SSO2 Therapy data in patients with anterior STEMI to data
among patients with STEMI overall would tend to understate the benefits
of SSO2 Therapy.
---------------------------------------------------------------------------
\96\ Entezarjou et al. Culprit vessel: Impact on short-term and
long-term prognosis in patients with ST-elevation myocardial
infarction. Open Heart 2018;5:e000852. doi:10.1136/openhrt-2018-
000852.
---------------------------------------------------------------------------
With respect to CMS' third concern that the current data does not
support a sufficient association between the outcome measures of heart
failure, rehospitalization, and mortality with the use of
SSO2 Therapy specifically to determine that the technology
represents a substantial clinical improvement over existing available
options, the applicant submitted new supporting analyses while
disagreeing with CMS' assessment. The applicant submitted the newly
published Chen Paper which compares the outcomes of the most recent
trial data from IC-HOT to an appropriate comparator population of
subjects receiving the standard of care. As noted above, results
demonstrated clinically and statistically lower one-year rates of
mortality and heart failure in anterior STEMI patients treated with
SSO2 Therapy as compared to a propensity matched population
treated with only PCI. Per the applicant, the Medicare Mortality
Analysis replicated these findings and demonstrated a clinically and
statistically significant one-year mortality reduction in anterior
STEMI patients treated with SSO2 Therapy as compared to
matched control patients treated with only PCI.
Finally, the applicant also compared outcomes of this same matched
IC-HOT population to outcomes from the PCI standard of care control
group from the CONDI-2/ERIC PPCI study, which to the commenter's
knowledge is the most recently reported study with a large PCI control
group.\97\ Per the applicant, this trial included 974 anterior STEMI
control patients with outcomes very similar to those presented from the
matched INFUSE-AMI population. The applicant stated that the one-year
mortality and heart failure rates for the anterior STEMI patients
analyzed were 5.2% and 11.6%, respectively. The applicant noted that
these outcomes are consistent with the matched control populations
above and substantially worse than the IC-HOT SSO2-treated
group.
---------------------------------------------------------------------------
\97\ Hausenloy DJ et al. Effect of remote ischaemic conditioning
on clinical outcomes in patients with acute myocardial infarction
(CONDI-2/ERIC-PPCI): a single-blind randomized controlled trial.
Lancet 2019; 394: 1415-24.
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The applicant reiterated that, as seen in the AMIHOT I, AMIHOT II,
and IC-HOT trials, SSO2 Therapy reduces infarct size. The
applicant asserted that preserving heart tissue and reducing infarct
size in patients who have had an anterior STEMI leads to heart function
improvement, and patients experience fewer heart failure episodes,
fewer heart failure symptoms, and lower incidence of death. The
applicant maintained that this is a substantial clinical improvement
beyond standard anterior STEMI care, not only because infarct size is
itself clinically important, but also because, per the applicant,
research has shown that use of SSO2 Therapy reduces rates of
death and heart failure in the intended use population. The applicant
asserted that, consistently, across multiple control groups, large and
small, randomized and matched, SSO2 Therapy outperformed PCI
alone in the critical outcomes of mortality and heart failure. The
applicant further asserted that these results support the benefit of
employing a treatment strategy of effective PCI first, then healing the
injured myocardium with SSO2 Therapy administration.
In conclusion, the commenter stated that the data presented in the
FY2021 new technology add-on payment application supplemented by the
data presented in its comment letter show that SSO2 Therapy
meets the substantial clinical improvement criterion in addition to
meeting the newness and cost criteria and merits approval for new
technology add-on payments for FY 2021. The commenter stated that
denial of new technology add-on payments would limit use of this
beneficial technology in many hospitals, and disproportionately hinder
improvements in anterior STEMI outcomes in economically disadvantaged
communities, including rural areas, and prolong treatment for critical
care.
We also received comments from several other commenters asserting
that SSO2 Therapy filled an unmet medical need while also
being superior to the current standard of care, PCI with stenting.
These commenters stated that there have been no significant
advancements in anterior STEMI treatment that have impacted infarct
size or heart failure since the AMIHOT I and AMIHOT II trials were
conducted. According to these commenters, other drugs and therapies
have not been able to reduce infarct size and had limited impact on
reducing death and heart failure hospitalization rates. Additionally,
several commenters reviewed the clinical data from the AMIHOT I, AMIHOT
II, and IC-HOT trials for reductions in infarct size and improved
ejection fraction and other indications of improved patient outcomes,
which they believe correlate to reduced heart failure and improved
mortality beyond the benefit of PCI and stenting alone.
Several commenters cited their personal experience treating
patients with SSO2 Therapy and noted the positive results in
these patients,
[[Page 58645]]
including signs of clinical recovery such as restored normal heart
functions and improved ejection fraction that they believe would not
have occurred under PCI with stenting alone. One such commenter claimed
to have treated three patients who all showed normal heart functions
within one month of being treated with SSO2 Therapy.
Overall, these commenters expressed their support of the applicant's
claim that SSO2 Therapy has a measurable improved impact on
patient outcomes and quality of life measurements.
Response: We appreciate the commenters' input, including the
additional information and analysis submitted by the applicant to
address CMS' concerns. With respect to the original studies, we note
that the AMIHOT I was a Phase II study designed to test efficacy. We
also note that, while AMIHOT I and AMIHOT II were randomized, they were
designed to show that SSO2 Therapy reduces infarct size but
were not designed to demonstrate improved outcomes among anterior STEMI
patients.
The IC-HOT study was a single-arm study that recruited a treatment-
only group to confirm an objective safety performance goal, and was not
statistically powered to look at any efficacy endpoint. The applicant
compared one-year clinical outcomes to a propensity-matched control
group of similar patients with anterior STEMI enrolled in the INFUSE-
AMI trial. We recognize that the results show all-cause mortality,
driven by cardiovascular mortality, and new-onset heart failure or
heart failure hospitalization, were each individually lower in patients
treated with SSO2 Therapy. However, there may be variability
from the types of patients enrolled in a single-arm registry such as
IC-HOT and those in a comparator control group drawn from the
randomized INFUSE-AMI trial. We note that the IC-HOT trial included
more patients in Killip Class I (individuals with no clinical signs of
heart failure), with 95.2 percent of patients compared to 85.5 percent
of patients enrolled in INFUSE-AMI. We also note that IC-HOT had fewer
patients in Killip Class II (individuals with rales or crackles in the
lungs, an S3, and elevated jugular venous pressure), with
3.6 percent of patients compared to 13.2 percent in INFUSE-AMI.
As stated by the applicant and summarized above, the Chen paper was
an analysis of mortality and heart failure rates found in IC-HOT
patients as compared to a propensity-matched population enrolled in the
INFUSE-AMI trial. Chen et al. noted the following study limitations:
(1) The population represents a selected cohort of patients and,
therefore, its findings may not apply to all patients with STEMI, such
as those with cardiogenic shock, nonanterior MI, and others who did not
undergo pPCI with stenting within six hours of symptom onset; (2)
because patients from the comparator control group were drawn from the
randomized INFUSE-AMI trial, there may be variability from the types of
patients enrolled in a single-arm registry such as IC-HOT; and (3) they
could not rule out the possibility that its analysis was confounded by
other unmeasured factors that are correlated with SSO2
Therapy treatment. Chen et al. concluded that based on the overall
review of the data and study limitations that its results should be
considered only hypothesis-generating. Finally, Chen et al. noted that
the study results were an analysis from a modest-sized propensity-
matched cohort and recommended appropriately powered randomized
controlled trials to demonstrate the effect of SSO2 Therapy
treatment on outcomes in patients with anterior STEMI after successful
PCI.
We also reviewed two additional studies the applicant submitted,
the Medicare Mortality Analysis and the Medicare Longitudinal Analysis.
Per the applicant, these studies show that there is an unmet medical
need in the population of anterior STEMI patients, as well as the
superiority of SSO2 Therapy over PCI with stenting alone in
mortality and heart failure outcomes among anterior STEMI patients.
However, these analyses used results from the IC-HOT study, a study
designed to look at safety only, to reach an efficacy endpoint.
Similarly, though they state that the design of the Medicare Mortality
Analysis used a propensity-matched population of anterior STEMI
patients from Medicare inpatient data, and the Medicare Longitudinal
Analysis also used matching to ensure appropriate comparison
populations, it is unclear if baseline morbidity and other confounding
factors were matched between arms.
We also note that the FDA ordered a post-approval study to confirm
the safety and effectiveness of SSO2 Therapy. The FDA
specified that the new enrollment study should be a prospective global,
multicenter, randomized (1:1), confirmatory study with patients
randomized to either standard therapy or post-procedure infusion of
SSO2 Therapy for a duration of 60 minutes and followed for
12 months. The FDA also specified that the primary effectiveness
endpoint of infarct size would be evaluated with a superiority test,
and that the powered primary safety composite endpoint, which includes
death, stent thrombosis, major bleeding, reinfarction, new onset severe
heart failure and possibly other adverse events, would be developed
with an appropriate non-inferiority margin. We note that this study has
not begun enrollment nor been completed.
In summary, while the applicant has submitted additional data to
respond to our concerns, we do not believe that this data provides
sufficient evidence that use of SSO2 Therapy specifically
results in improved mortality and heart failure outcomes among anterior
STEMI patients. While there is room for outcomes improvement in
mortality and heart failure rates post-PCI and stenting, we believe
additional data is needed to demonstrate the effects of SSO2
Therapy in improving these outcomes as compared to currently available
therapies.
After consideration of all the information from the applicant, as
well as the comments we received, we are unable to determine that
SSO2 Therapy represents a substantial clinical improvement
over existing technologies, and we are not approving new technology
add-on payments for SSO2 Therapy for FY 2021.
e. Eluvia\TM\ Drug-Eluting Vascular Stent System (Eluvia)
Boston Scientific submitted an application for new technology add-
on payments for the EluviaTM Drug-Eluting Vascular Stent
System for FY 2021. EluviaTM, a drug-eluting stent for the
treatment of lesions in the femoropopliteal arteries, received FDA
premarket approval (PMA) September 18, 2018. The applicant asserted
that EluviaTM was first commercially available on the market
on October 4, 2018 and the first procedure with EluviaTM
following FDA approval in the U.S. occurred on October 5, 2018. We note
that the applicant submitted an application for new technology add-on
payments for FY 2020. In the FY 2020 IPPS/LTCH PPS final rule (84 FR
42231), we stated that we remain concerned that we do not have enough
information to determine that the EluviaTM device represents
a substantial clinical improvement over existing technologies.
Therefore, we did not approve the EluviaTM device for FY
2020 new technology add-on payments. We refer the reader to the FY 2020
IPPS/LTCH PPS final rule (84 FR 42220 through 42231) for a complete
discussion regarding the EluviaTM device's FY 2020 new
technology application.
[[Page 58646]]
According to the applicant, the EluviaTM system is a
sustained release drug-eluting stent indicated for the treatment of
lesions in the femoropopliteal arteries and is designed to restore
blood flow in the peripheral arteries above the knee--specifically the
superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The applicant asserted that this device/drug combination product for
endovascular treatment of peripheral artery disease (PAD) utilizes a
polymer that carries and protects the drug before and during the
procedure and ensures that the drug is released into the tissue in a
controlled, sustained manner to prevent the restenosis of the vessel.
The applicant further asserted that EluviaTM system's stent
platform is purpose-built to address the mechanical challenges of the
SFA with an optimal amount of strength, flexibility and fracture
resistance. According to the applicant, EluviaTM's polymer-
based drug delivery system is uniquely designed to sustain the release
of paclitaxel beyond 1 year to match the restenotic process in the SFA.
The EluviaTM system is indicated for improving luminal
diameter in the treatment of symptomatic de-novo or restenotic lesions
in the native SFA and/or PPA with reference vessel diameters (RVD)
ranging from 4.0 to 6.0 mm and total lesion lengths up to 190 mm,
according to the applicant.
The applicant asserted that the EluviaTM system is
comprised of the implantable endoprosthesis and the stent delivery
system. The stent is a laser cut self-expanding stent composed of a
nickel titanium alloy (nitinol). On both the proximal and distal ends
of the stent, radiopaque markers made of tantalum increase visibility
of the stent to aid in placement. The triaxial designed delivery system
consists of an outer shaft to stabilize the stent delivery system, a
middle shaft to protect and constrain the stent, and an inner shaft to
provide a guidewire lumen. The delivery system is compatible with 0.035
in (0.89 mm) guidewires. The EluviaTM stent is available in
a variety of diameters and lengths. The delivery system is offered in
two working lengths including 75 and 130 cm.
Peripheral artery disease (PAD) is a circulatory problem in which
narrowed arteries reduce blood flow to the limbs, usually in the legs.
Symptoms of PAD may include lower extremity pain due to varying degrees
of ischemia and claudication, which is characterized by pain induced by
exercise and relieved with rest. Risk factors for PAD include age >=70
years; age 50 to 69 years with a history of smoking or diabetes; age 40
to 49 with diabetes and at least one other risk factor for
atherosclerosis; leg symptoms suggestive of claudication with exertion,
or ischemic pain at rest; abnormal lower extremity pulse examination;
known atherosclerosis at other sites (for example, coronary, carotid,
renal artery disease); smoking; hypertension, hyperlipidemia, and
homocysteinemia.\98\ PAD is primarily caused by atherosclerosis--the
buildup of fatty plaque in the arteries. PAD can occur in any blood
vessel, but it is more common in the legs than the arms. Approximately
8.5 million people in the United States have PAD, including 12-20% of
individuals older than age 60.\99\
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\98\ Neschis, David G. & MD, Golden, M. (2018). Clinical
features and diagnosis of lower extremity peripheral artery disease.
Retrieved October 29, 2018, from https://www.uptodate.com/contents/clinical-features-and-diagnosis-of-lower-extremity-peripheral-artery-disease.
\99\ Centers for Disease Control and Prevention. (2018).
Peripheral Arterial Disease (PAD) Fact Sheet. Retrieved from https://www.cdc.gov/DHDSP/data_statistics/fact_sheets/fs_PAD.htm.
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A diagnosis of PAD is established with the measurement of an ankle-
brachial index (ABI) <=0.9. The ABI is a comparison of the resting
systolic blood pressure at the ankle to the higher systolic brachial
pressure. Duplex ultrasonography is commonly used in conjunction with
the ABI to identify the location and severity of arterial
obstruction.\100\
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\100\ Berger, J. & Davies, M. (2018). Overview of lower
extremity peripheral artery disease. Retrieved October 29, 2018 from
https://www.uptodate.com/contents/overview-of-lower-extremity-peripheral-artery-disease.
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Management of PAD is aimed at improving symptoms, improving
functional capacity, and preventing amputations and death. Management
of patients with lower extremity PAD may include medical therapies to
reduce the risk for future cardiovascular events related to
atherosclerosis, such as myocardial infarction, stroke, and peripheral
arterial thrombosis. Such therapies may include antiplatelet therapy,
smoking cessation, lipid-lowering therapy, and treatment of diabetes
and hypertension. For patients with significant or disabling symptoms
unresponsive to lifestyle adjustment and pharmacologic therapy,
intervention (percutaneous, surgical) may be needed. Surgical
intervention includes angioplasty, a procedure in which a balloon-tip
catheter is inserted into the artery and inflated to dilate the
narrowed artery lumen. The balloon is then deflated and removed with
the catheter. For patients with limb-threatening ischemia (for example
pain while at rest and or ulceration), revascularization is a priority
to reestablish arterial blood flow. According to the applicant,
treatment of the SFA is problematic due to multiple issues, including
high rate of restenosis and significant forces of compression.
The applicant asserted that the EluviaTM Drug-Eluting
Vascular Stent System is a sustained-release drug-eluting self-
expanding, nickel titanium alloy (nitinol) mesh stent used to
reestablish blood flow to stenotic arteries. According to the
applicant, the EluviaTM system is the first stent
specifically designed for deployment in the SFA and/or PPA that
utilizes the anti-restenotic drug paclitaxel in conjunction with a
polymer. EluviaTM is built on the InnovaTM Stent
System platform, consisting of a self-expanding nitinol stent and an
advanced, 6F low-profile triaxial delivery system for added support and
placement accuracy. The EluviaTM stent is coated with the
drug paclitaxel, which helps prevent the artery from restenosis. The
EluviaTM Stent System is comprised of the implantable
endoprosthesis and the stent delivery system (SDS).
According to the applicant, there are four principal treatment
options for PAD, including two endovascular approaches (angioplasty and
stenting):
Medical therapy, typically for those with mild to medium
symptoms. This may include pharmacotherapy (for example, cilostazil)
and exercise therapy.
Angioplasty, a procedure in which a catheter with a
balloon on the tip is inserted into an artery and inflated to expand
the artery and reduce the blockage. The balloon is then deflated and
removed with the catheter. Some procedures use drug coated balloons, in
which a drug is applied to the lesion at the time of balloon inflation.
Stenting via a procedure in which a stent is placed in the
artery to keep the artery open and prevent it from re-narrowing. This
can be done with a bare metal stent or with a drug-eluting stent, which
also releases a drug that helps slow the re-narrowing of the vessel.
For patients with severe narrowing that is blocking blood
flow, bypass surgery may be warranted. In the procedure, a healthy vein
is used to make a new path around the narrowed or blocked artery.
The applicant further asserted that aside from EluviaTM,
the alternative existing endovascular approaches (angioplasty and
stenting) do not provide a sustained release application of a drug and
that EluviaTM is the first polymer-based, drug-eluting stent
designed to treat and restore blood flow in the peripheral arteries
above the knee, and the eluted medication helps to prevent tissue
regrowth during the
[[Page 58647]]
entire period most commonly associated with restenosis. According to
the applicant, the sustained release of the anti-restenotic drug is
intentionally designed to elute over a 12-15-month period delivering
the drug when restenosis is most likely to occur, which the applicant
stated is a significantly longer period than the two-month duration of
drug eluted from drug-coated balloons and the paclitaxel-coated Zilver
PTX drug eluting stent.
The EluviaTM stent system was granted approval for the
following ICD-10-PCS procedure codes effective October 1, 2019:
[GRAPHIC] [TIFF OMITTED] TR18SE20.153
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 therefore not be considered
``new'' for purposes of new technology add-on payments. We note that in
the FY 2020 IPPS/LTCH PPS final rule (84 FR 42227), we stated that
after consideration of the applicant's comments, we believe that the
EluviaTM device uses a unique mechanism of action to achieve
a therapeutic outcome when compared to existing technologies such as
the paclitaxel-coated stent. Therefore, we stated that the
EluviaTM device meets the newness criterion. We refer the
reader to the FY 2020 final rule for the complete discussion of how the
EluviaTM device meets the newness criterion. The applicant
noted in its FY 2021 application that for FY 2020, CMS concluded that
the EluviaTM device met the newness criterion. The applicant
stated that it believes there is no basis for CMS to reach a contrary
conclusion with regard to whether the EluviaTM system meets
the newness criterion for FY 2021. The applicant also reiterated that
the EluviaTM device uses a unique mechanism of action
because it utilizes a sustained-release of a low-dose of
[[Page 58648]]
paclitaxel. In the proposed rule, we invited public comments on whether
the EluviaTM device is substantially similar to an existing
technology and whether it meets the newness criterion for purposes of
its application for new technology add-on payments for FY 2021.
Comment: A commenter stated that total paclitaxel dose, not just
dose density should be considered when comparing the
EluviaTM device to the Zilver[supreg] PTX for newness. The
commenter noted the applicant's comparison of the dose density of
paclitaxel for the polymer matrix vs the paclitaxel coated stent which
as described by the applicant is 0.167ug/mm2 vs 3ug/mm2 respectively.
The commenter stated that on the surface this statement may be
technically accurate. However, according to the commenter, the
EluviaTM drug-eluting stent (DES) is coated on all surfaces
with a permanent, non-degradable, polymer matrix containing paclitaxel.
In comparison, the Zilver PTX DES is coated only on the abluminal
(outer) surface of the stent that is in contact with the vessel wall
after implantation. As a result, according to the commenter, when
comparing the paclitaxel dose of the devices, the total dose should
also be considered, not just the dose density. The commenter further
stated that whereas the dose density suggests a ~18x decrease in the
amount of paclitaxel used, the actual paclitaxel dose is only decreased
<3x, and reporting only the dose density could lead the reader into
underestimating the amount of paclitaxel contained on the Eluvia DES.
The commenter also noted that the applicant stated that
``Paclitaxel is released directly to the target lesion with the polymer
matrix stent and that paclitaxel release is non-specific to the target
lesion with paclitaxel-coated stents.'' According to the commenter, the
clinical, scientific, or logical basis for this statement is unclear.
The commenter further stated that the EluviaTM DES is coated
circumferentially with a paclitaxel-containing polymer matrix. The
commenter stated that as a result of this historic coating technology
that has been used on coronary stents initially approved by the FDA
more than 15 years ago, the Eluvia stent releases paclitaxel
circumferentially and nonspecific to the target lesion, which is only
in contact with the abluminal surface of the stent. In contrast, as
described above, the commenter stated that the Zilver PTX DES is only
coated on the abluminal surface of the stent that is in contact with
the treated vessel wall. Therefore, according to the commenter, the
Zilver PTX releases paclitaxel directly to the target lesion in
contrast with the nonspecific release of Eluvia.
The commenter further stated that avoiding the use of a polymer, if
possible, is a preferred stent design. Additionally, the commenter
noted that the applicant reiterates that the EluviaTM device
uses a unique mechanism of action because it utilizes a sustained
release of a low-dose of paclitaxel. However, according to the
commenter, this mechanism of action is neither new nor unique and has
been used on coronary stents since approval of the first device in
2004. The commenter stated that newer technologies have advanced to use
biodegradable polymer coatings or, like the Zilver PTX DES, eliminated
the risk of a polymer coating altogether. According to the commenter,
the ability to provide similar clinical outcomes without the need for a
permanent, and potentially thrombogenic, polymer would seem to be the
preferred technology. The commenter stated that research published in
2013 by authors from Boston Scientific, manufacturer of the
EluviaTM DES, have reported that the polymer of vinylidene
fluoride-hexafluoropropylene (PVDF-HFP) polymer used on the
EluviaTM DES results in increased thrombogenicity compared
with a bare metal stent: ``PVDF-HFP-coated struts exposed to blood flow
offer a more thrombogenic surface compared with a bare luminal
platinum-chromium (PtCr) stent, resulting in more initial thrombus and
subsequently more neointima from thrombus organization.'' \101\ The
commenter concluded by supporting the benefits of short-term and
polymer-free drug delivery like that offered by the Zilver PTX DES:
``our data suggest that short-term drug elution while polymer
absorption occurs is biologically preferable to maintaining a
continuous and permanent polymeric surface once drug elution has
occurred. This approach offers the benefits of minimizing polymeric
load, while avoiding chronic inflammatory reactions but maintaining the
beneficial anti-proliferative effect.'' \102\ The commenter stated that
based on this published research by the manufacturer of the
EluviaTM DES, it is surprising that the EluviaTM
technology would be considered to meet newness standards as compared to
the polymer-free Zilver PTX DES.
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\101\ Eppihimer MJ, et al. Impact of Stent Surface on
Thrombogenicity and Vascular Healing--A Comparative Analysis of
Metallic and Polymeric Surfaces. Circ Cardiovasc Interv.
2013;6(4):370-377, p. 376.
\102\ Eppihimer MJ, et al. Impact of Stent Surface on
Thrombogenicity and Vascular Healing--A Comparative Analysis of
Metallic and Polymeric Surfaces. Circ Cardiovasc Interv.
2013;6(4):370-377, p. 377.
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The applicant commented that the EluviaTM system
satisfies the newness criterion because it is recently FDA-approved and
is not substantially similar to existing devices due to its new and
unique polymer carrier-enabled mechanism of action. The applicant
asserted that EluviaTM is the first and only sustained-
release drug-eluting stent for the treatment of lesions in the
superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The applicant reiterated that EluviaTM is significantly
different from existing drug-coated stent technology, which lacks a
mechanism for sustained and controlled release of paclitaxel. According
to the applicant, the sustained-release mechanism the
EluviaTM system offers enables the use of significantly less
paclitaxel compared to current stent technology to inhibit restenosis.
The applicant also commented that in addition, Eluvia's stent platform
is purpose-built to address the mechanical challenges of the SFA,
balancing strength, flexibility and fracture resistance.
The applicant also noted CMS's concerns regarding newness expressed
in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42228) and provided the
following reiteration of their FY2020 comments which compared the
EluviaTM to the Zilver[supreg] PTX (Zilver[supreg] drug-
eluting peripheral stent). The applicant commented that the
EluviaTM device's mechanism of action is different from that
of Zilver[supreg] PTX because the EluviaTM device's polymer
matrix layer allows for targeted, localized, sustained, low-dose
amorphous paclitaxel delivery with minimal systemic distribution or
particulate loss. The applicant provided a comparison of the polymer
matrix stent vs the paclitaxel-coated stent. According to the
applicant, the polymer matrix stent is encased in a polymer matrix, the
paclitaxel-coated stent is not. The dose density of paclitaxel for the
polymer matrix vs the paclitaxel coated stent is 0.167ug/mm2 vs 3ug/
mm2. Paclitaxel is delivered to the lesion via a diffusion gradient
with the polymer matrix stent whereas the paclitaxel-coated stent has
no diffusion gradient. Paclitaxel is released directly to the target
lesion with the polymer matrix stent. Paclitaxel release is non-
specific to the target lesion with paclitaxel-coated stent. Paclitaxel
is released over approximately 12-15
[[Page 58649]]
months with the polymer matrix stent. Paclitaxel release is complete at
two months with paclitaxel coated stents.
The applicant also commented that CMS determined that Eluvia
satisfied the newness and cost criteria in the FY2020 Final Rule and
committed to ``monitor new information and recommendations as they
become available.''
Response: We appreciate the comments received regarding the
comparison of the polymer matrix Eluvia\TM\ vs the paclitaxel-coated
Zilver PTX with regard to the mechanism of action and newness. After
consideration of the information provided by both the applicant and the
commenter as to whether the Eluvia\TM\ should be considered new for
purposes of new technology add on payments, we agree with the applicant
that Eluvia\TM\ uses a unique mechanism of action because the sustained
release of paclitaxel combats restenosis for 12-15 months as compared
to other drug-coated balloons or drug-coated stents that deliver drug
to the artery for about two months. Accordingly, after consideration of
the comments, we believe that the EluviaTM device uses a
unique mechanism of action to achieve a therapeutic outcome when
compared to existing technologies such as the paclitaxel-coated stent
and therefore meets the newness criterion. As previously stated, the
EluviaTM device received FDA approval under a PMA on
September 18, 2018. The device was first available on the U.S. market
on October 4, 2018. We consider the beginning of the newness period to
commence when Eluvia was first available on the U.S. market on October
4, 2018.
With regard to the cost criterion, the applicant conducted two
analyses based on 100 percent of identified claims and 76 percent of
identified claims. To identify potential cases where
EluviaTM could be utilized, the applicant searched the FY
2018 MedPAR file for ICD-10-PCS codes from the Peripheral Drug Eluting
Stent and Peripheral Bare Metal Stent categories. For the analysis
using 100 percent of cases, the applicant identified a total of 11,051
cases spanning 150 MS-DRGs. The applicant then removed charges for the
technology being replaced. The applicant stated that because it was
unable to determine a more specific percentage reduction, it chose the
most conservative approach for calculation purposes and removed 100% of
charges associated with service category Medical/Surgical Supply Charge
Amount, which included revenue center 027x. The applicant then
standardized the charges and applied an inflation factor of 11.1%,
which is the same inflation factor used by CMS to update the outlier
threshold in the FY 2020 IPPS/LTCH PPS final rule, to update the
charges from FY 2018 to FY 2020 (84 FR 42629). The applicant added
charges for the new technology by multiplying the cost of the
technology by the national CCR for implantable devices (0.299) from the
FY 2020 IPPS final rule. Under the analysis based on 100% of identified
claims, the applicant determined an average case-weighted threshold
amount of $100,851 and a final average inflated standardized charge per
case of $157,343.
Under the analysis based on 76 percent of identified claims, the
applicant used the same methodology, which identified 8,335 cases
across 8 MS-DRGs. The applicant determined the average case-weighted
threshold amount of $98,196 and a final inflated average standardized
charge per case of $147,343. Because the final inflated average
standardized charge per case exceeded the case-weighted threshold
amount under both analyses, the applicant asserted that the technology
meets the cost criterion. In the proposed rule, we invited public
comments on whether EluviaTM meets the cost criterion.
Comment: The applicant commented that the cost analysis, as
summarized in the proposed rule, demonstrates that EluviaTM
meets the new technology add-on payment cost criterion. The applicant
further commented that it analyzed the cost criterion associated with
Eluvia in various scenarios utilizing different assumptions and that in
each of these analyses, the cost criterion was achieved. The applicant
noted that CMS did not express any concerns regarding any of the
analyses provided and as such, the applicant maintained that
EluviaTM meets the cost criterion.
Response: We appreciate the applicant's comments concerning the
cost criterion. Based on the cost analysis as summarized previously and
after consideration of the public comments we received, we agree that
the EluviaTM device meets the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that EluviaTM represents a substantial
clinical improvement over existing technologies because it achieves
superior primary patency; reduces the rate of subsequent therapeutic
interventions; decreases the number of future hospitalizations or
physician visits; reduces hospital readmission rates; reduces the rate
of device related complications; and achieves similar functional
outcomes and EQ-5D index values while associated with half the rate of
TLRs.
As stated above, Boston Scientific submitted an application for new
technology add-on payments for the EluviaTM device for FY
2020 that was not approved. In the FY 2020 IPPS/LTCH PPS final rule (84
FR 42231), we noted the FDA's preliminary review of data that
identified a potentially concerning signal of increased long-term
mortality in study subjects treated with paclitaxel-coated products
compared to patients treated with uncoated devices, and stated that we
remained concerned that we did not have enough information to determine
that the EluviaTM device represents a substantial clinical
improvement over existing technologies. The applicant resubmitted its
application for new technology add-on payments for FY 2021 with updated
two-year primary patency results to demonstrate that the
EluviaTM device represents a substantial clinical
improvement over existing technologies. Below we summarize the studies
the applicant submitted with both its FY 2020 and FY 2021 applications,
followed by the new information the applicant submitted with its FY
2021 application to support that the technology represents a
substantial clinical improvement.
The applicant submitted the results of the MAJESTIC study, a
single-arm first-in-human study of EluviaTM. The MAJESTIC
\103\ study is a prospective, multicenter single-arm, open label study.
Per the applicant, the MAJESTIC study demonstrated long-term treatment
durability among patients whose femoropopliteal arteries were treated
with the EluviaTM stent. The MAJESTIC study enrolled 57
patients with symptomatic lower limb ischemia and lesions in the
superficial femoral artery or proximal popliteal artery. Efficacy
measures at 2 years included primary patency, defined as duplex
ultrasound peak systolic velocity ratio of <2.5 and the absence of
target lesion revascularization (TLR) or bypass. Safety monitoring
through 3 years included adverse events and TLR. The 24-month clinic
visit was completed by 53 patients; 52 had Doppler ultrasound evaluable
by the core laboratory, and 48 patients had radiographs taken for stent
fracture analysis. The 3-year follow-up was completed by 54 patients.
At 2 years, 90.6% (48/53) of patients had improved by one or more
Rutherford categories as compared with the pre-
[[Page 58650]]
procedure level without the need for TLR (when those with TLR were
included, 96.2% sustained improvement); only one patient exhibited a
worsening in level, 66.0% (35/53) of patients exhibited no symptoms
(category 0) and 24.5% (13/53) had mild claudication (category 1) at
the 24-month visit. Mean ABI improved from 0.73 0.22 at
baseline to 1.02 0.20 at 12 months and 0.93
0.26 at 24 months. At 24 months, 79.2% (38/48) of patients had an ABI
increase of at least 0.1 compared with baseline or had reached an ABI
of at least 0.9. According to the applicant, the primary patency rate
at 12 months was 96.4%. With regard to the EluviaTM stent
achieving superior primary patency, the applicant submitted the results
of the IMPERIAL \104\ trial in which the EluviaTM stent is
compared, head-to-head, to the Zilver[supreg] PTX[supreg] drug-eluting
stent. The IMPERIAL study is a global, multi-center, randomized
controlled trial consisting of 465 subjects. Eligible patients were
aged 18 years or older and had symptomatic lower-limb ischemia, defined
as Rutherford category 2, 3, or 4 and stenotic, restenotic (treated
with a drug-coated balloon >12 months before the study or standard
percutaneous transluminal angioplasty only), or occlusive lesions in
the native superficial femoral artery or proximal popliteal artery,
with at least one infrapopliteal vessel patent to the ankle or foot.
Patients had to have stenosis of 70% or more (via angiographic
assessment), vessel diameter between 4 mm and 6 mm, and total lesion
length between 30 mm and 140 mm.
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\103\ M[uuml]ller-H[uuml]lsbeck S et al. Long-Term Results from
the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for
Femoropopliteal Treatment: 3-Year Follow-up. Cardiovasc Intervent
Radiol. 2017 Dec; 40(12):1832-1838.
\104\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018 Sep 24.
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Subjects who had previously stented target lesion/vessels treated
with drug-coated balloon <12 months prior to randomization/enrollment
and subjects who had undergone prior surgery of the SFA/PPA in the
target limb to treat atherosclerotic disease were excluded from the
study. Two concurrent single-group (EluviaTM only) sub
studies were done: a non-blinded, non-randomized pharmacokinetic sub
study and a non-blinded, non-randomized study of patients with long
lesions (>140 mm). The IMPERIAL study is a prospective, multicenter,
single-blinded randomized, controlled (RCT) non-inferiority trial.
Patients were randomized (2:1) to implantation of either a paclitaxel-
eluting polymer stent (EluviaTM) or a paclitaxel-coated
stent (Zilver[supreg] PTX[supreg]) after the treating physician had
successfully crossed the target lesion with a guide wire. The primary
endpoints of the study are Major Adverse Events defined as all causes
of death through 1 month, Target Limb Major Amputation through 12
months and/or TLR through 12 months, and primary vessel patency at 12
months post-procedure. Secondary endpoints included the Rutherford
categorization, Walking Impairment Questionnaire, and EQ-5D assessments
at 1 month and 6 months post-procedure. Patient demographic and
characteristics were balanced between EluviaTM stent and
Zilver[supreg] PTX[supreg] stent groups.
The applicant noted that lesion characteristics for the
EluviaTM stent vs Zilver[supreg] PTX[supreg] stent arms were
comparable. Clinical follow-up visits related to the study were
scheduled for 1 month, 6 months, and 12 months after the procedure,
with follow-up planned to continue through 5 years, including clinical
visits at 24 months and 5 years and clinical or telephone follow-up at
3 and 4 years.
The applicant asserted that in the IMPERIAL study, the
EluviaTM stent demonstrated superior primary patency over
the Zilver[supreg] PTX[supreg] stent, with 86.8% vs. 77.5% respectively
(p=0.0144). The non-inferiority primary efficacy endpoint was also met.
The applicant asserted that the SFA presents unique challenges with
respect to maintaining long-term patency. There are distinct
pathological differences between the SFA and coronary arteries. The SFA
tends to have higher levels of calcification and chronic total
occlusions when compared to coronary arteries. Following an
intervention within the SFA, the SFA produces a healing response which
often results in restenosis or re-narrowing of the arterial lumen. This
cascade of events leading to restenosis starts with inflammation,
followed by smooth muscle cell proliferation and matrix formation.\105\
Because of the unique mechanical forces in the SFA, this restenotic
process of the SFA can continue well beyond 300 days from the initial
intervention. Primary patency at 12 months, by Kaplan-Meier estimate,
was significantly greater for EluviaTM than for
Zilver[supreg] PTX[supreg], with 88.5% and 79.5% respectively
(p=0.0119). According to the applicant, these results are consistent
with the 96.4% primary patency rate at 12 months in the MAJESTIC study,
the single-arm first-in-human study of EluviaTM.
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\105\ Forrester JS, Fishbein M, Helfant R, Fagin J. A paradigm
for restenosis based on cell biology: Clues for the development of
new preventive therapies. J Am Coll Cardiol. 1991 Mar 1;17(3):758-
69.
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The IMPERIAL study included two concurrent single-group
(EluviaTM only) sub studies: a non-blinded, non-randomized
pharmacokinetic sub study and a non-blinded, non-randomized study of
patients with long lesions (>140 mm). For the pharmacokinetic sub
study, patients had venous blood drawn before stent implantation, at
intervals ranging from 10 minutes to 24 hours post implantation, and
then at either 48 hours or 72 hours post implantation. The
pharmacokinetics sub study confirmed that plasma paclitaxel
concentrations after EluviaTM implantation were well below
thresholds associated with toxic effects in studies in patients with
cancer (0[middot]05 [mu]M or ~43 ng/mL).
The IMPERIAL sub study long lesion subgroup consisted of 50
patients with average lesion length of 162.8 mm that were each treated
with two EluviaTM stents. Twelve-month outcomes for the long
lesion subgroup are 87% primary patency and 6.5% TLR. In a subgroup
analysis of patients 65 years and older (Medicare population), the
primary patency rate in the EluviaTM stent group is 92.6%,
compared to 75.0% for the Zilver[supreg] PTX[supreg] stent group
(p=0.0386).
With regard to reducing the rate of subsequent therapeutic
interventions, secondary outcomes in the IMPERIAL study included repeat
re-intervention on the same lesion, TLR. The rate of subsequent
interventions, or TLRs, in the EluviaTM stent group was 4.5%
compared to 9.0% in the Zilver[supreg] PTX[supreg] stent group. The
applicant asserted that TLR rate in the EluviaTM group
represents a substantial reduction in re-intervention on the target
lesion compared to that of the Zilver[supreg] PTX[supreg] stent group.
With regard to decreasing the number of future hospitalizations or
physician visits, the applicant asserted that the substantial reduction
in the lesion revascularization rate led to a reduced need to provide
additional intensive care, distinguishing the EluviaTM group
from the Zilver[supreg] PTX[supreg] group. In the IMPERIAL study,
EluviaTM-treated patients required fewer days of re-
hospitalization. There were 13.9 post procedure in-hospital days in the
EluviaTM group for all adverse events compared to 17.7 post
procedure in-hospital days in the Zilver[supreg] PTX[supreg] group.
There were 2.8 post procedure in-hospital days in the
EluviaTM group for TLR/Total Vessel Revascularization (TVR)
compared to 7.1 post procedure in-hospital days in the Zilver[supreg]
PTX[supreg] group. And lastly, there were 2.7 post-procedure in-
hospital days from the
[[Page 58651]]
EluviaTM group for procedure/device related adverse events
compared to 4.5 post procedure in-hospital days for the Zilver[supreg]
PTX[supreg] group.
With regard to reducing hospital readmission rates, the applicant
asserted that patients treated in the EluviaTM group
experienced reduced rates of hospital readmission following the index
procedure compared to those in the Zilver[supreg] PTX[supreg] group.
Hospital readmission rates at 12 months were 3.9% for the
EluviaTM group compared to 7.1% for the Zilver[supreg]
PTX[supreg] group. Similar results were noted at 1 and 6 months; 1.0%
vs 2.6% and 2.4% vs 3.8% respectively.
With regard to reducing the rate of device related complications,
the applicant asserted that while the rates of adverse events were
similar in total between treatment arms in the IMPERIAL study, there
were measurable differences in device-related complications. Device-
related adverse-events were reported in 8% of patients in the
EluviaTM group compared to 14% of patients in the
Zilver[supreg] PTX[supreg] group.
Lastly, with regard to achieving similar functional outcomes and
EQ-5D index values, while associated with half the rate of TLRs, the
applicant asserted that narrowed or blocked arteries within the SFA can
limit the supply of oxygen-rich blood throughout the lower extremities,
causing pain or discomfort when walking. The applicant further asserted
that performing physical activities is often challenging because of
decreased blood supply to the legs, typically causing symptoms to
become more challenging overtime unless treated. The applicant asserted
that while functional outcomes appear similar between the
EluviaTM and Zilver[supreg] PTX[supreg] groups at 12 months,
these improvements for the Zilver[supreg] PTX[supreg] group are
associated with twice as many TLRs to achieve similar EQ-5D index
values.\106\ At 12 months, of the patients with complete Rutherford
assessment data, 241 (86 percent) of 281 patients in the
EluviaTM group and 120 (85 percent) of 142 patients in the
Zilver[supreg] PTX[supreg] group had symptoms reported as Rutherford
Category 0 or 1 (none to mild claudication). The mean ankle-brachial
index was 1[middot]0 (SD 0[middot]2) in both groups at 12 months
(baseline mean ankle-brachial index 0[middot]7 [SD 0[middot]2] for
EluviaTM; 0[middot]8 [0[middot]2] for Zilver[supreg]
PTX[supreg]), with sustained hemodynamic improvement for approximately
80 percent of the patients in both groups. Walking function improved
significantly from baseline to 12 months in both groups, as measured
with the Walking Impairment Questionnaire and the 6-minute walk test.
In both groups, the majority of patients had sustained improvement in
the mobility dimension of the EQ-5D and roughly half had sustained
improvement in the pain or discomfort dimension. No significant
between-group differences were observed in the Walking Impairment
Questionnaire, 6-minute walk test, or EQ-5D. Secondary endpoint results
for the EluviaTM stent and Zilver[supreg] PTX[supreg] stent
groups are as follows:
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\106\ Gray WA, Keirse K, Soga Y, et al. A polymer-coated,
paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-
coated stent (Zilver PTX) for endovascular femoropopliteal
intervention (IMPERIAL): A randomized, non-inferiority trial. Lancet
2018; published online Sept 22. http://dx.doi.org/10.1016/S0140-6736(18)32262-1.
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Hemodynamic improvement in walking--80.8 percent versus
78.7 percent;
Walking impairment questionnaire scores (change from
baseline)--40.8 (36.5) versus 35.8 (39.5);
Distance (change from baseline)--33.2 (38.3) versus 29.5
(38.2);
Speed (change from baseline)--18.3 (29.5) versus 18.1
(28.7);
Stair climbing (change from baseline)--19.4 (36.7) versus
21.1 (34.6); and
6-Minute walk test distance (m) (change from baseline)--
44.5 (119.5) versus 51.8 (130.5).
As summarized in the FY 2020 IPPS/LTCH PPS final rule (84 FR
42230), in our discussion of the comments received regarding
substantial clinical improvement with respect to the new technology
add-on payment application for EluviaTM for FY 2020, we
received a comment expressing safety concerns with paclitaxel-coated
devices used to treat PAD. The commenter stated they were aware of an
FDA alert concerning paclitaxel-coated devices. The commenter stated
the applicant and other manufacturers of devices using paclitaxel
should consider an alternative to paclitaxel.
We stated in response that we were aware of FDA's March 15, 2019
letter to healthcare providers regarding the ``Treatment of Peripheral
Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting
Stents Potentially Associated with Increased Mortality''. We noted that
in March 2019, FDA conducted a preliminary analysis of long-term
follow-up data (up to 5 years in some studies) of the pivotal premarket
randomized trials for paclitaxel-coated products indicated for PAD. We
stated that while the analyses are ongoing, according to FDA, the
preliminary review of the data had identified a potentially concerning
signal of increased long-term mortality in study subjects treated with
paclitaxel-coated products compared to patients treated with uncoated
devices.\107\ Of the three trials with 5-year follow-up data, each
showed higher mortality in subjects treated with paclitaxel-coated
products than subjects treated with uncoated devices. In total, among
the 975 subjects in these 3 trials, there was an approximately 50
percent increased risk of mortality in subjects treated with
paclitaxel-coated devices versus those treated with control devices
(20.1 percent versus 13.4 percent crude risk of death at 5 years).
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\107\ https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting.
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We also noted that FDA stated that the data should be interpreted
with caution for several reasons. First, there is large variability in
the risk estimate of mortality due to the limited amount of long-term
data. Second, the studies were not originally designed to be pooled,
introducing greater uncertainty in the results. Third, the specific
cause and mechanism of the increased mortality is unknown.
We further stated that based on the preliminary review of available
data, FDA made the following recommendations regarding the use of
paclitaxel-coated balloons and paclitaxel-eluting stents: That health
care providers consider the following until further information is
available; continue diligent monitoring of patients who have been
treated with paclitaxel-coated balloons and paclitaxel-eluting stents;
when making treatment recommendations and as part of the informed
consent process, consider that there may be an increased rate of long-
term mortality in patients treated with paclitaxel-coated balloons and
paclitaxel-eluting stents; discuss the risks and benefits of all
available PAD treatment options with your patients; for most patients,
alternative treatment options to paclitaxel-coated balloons and
paclitaxel-eluting stents should generally be used until additional
analysis of the safety signal has been performed; for some individual
patients at particularly high risk for restenosis, clinicians may
determine that the benefits of using a paclitaxel-coated product may
outweigh the risks; ensure patients receive optimal medical therapy for
PAD and other cardiovascular risk factors as well as guidance on
healthy lifestyles including weight control, smoking cessation, and
exercise.
We also noted that FDA further stated that paclitaxel-coated
balloons and stents are known to improve blood flow
[[Page 58652]]
to the legs and decrease the likelihood of repeat procedures to reopen
blocked blood vessels. However, because of this concerning safety
signal, FDA stated that it believes alternative treatment options
should generally be used for most patients while FDA continues to
further evaluate the increased long-term mortality signal and its
impact on the overall benefit-risk profile of these devices. FDA stated
it intends to conduct additional analyses to determine whether the
benefits continue to outweigh the risks for approved paclitaxel-coated
balloons and paclitaxel-eluting stents when used in accordance with
their indications for use. FDA stated it will also evaluate whether
these analyses impact the safety of patients treated with these devices
for other indications, such as treatment of arteriovenous access
stenosis or critical limb ischemia.
Furthermore, we stated that because of concerns regarding this
issue, FDA convened an Advisory Committee meeting of the Circulatory
System Devices Panel on June 19 and 20, 2019 to: Facilitate a public,
transparent, and unbiased discussion on the presence and magnitude of a
long-term mortality signal; discuss plausible reasons, including any
potential biological mechanisms, for a long-term mortality signal; re-
examine the benefit-risk profile of this group of devices; consider
modifications to ongoing and future U.S. clinical trials evaluating
devices containing paclitaxel, including added surveillance, updated
informed consent, and enhanced adjudication for drug-related adverse
events and deaths; and guide other regulatory actions, as needed. The
June 19 and 20, 2019 Advisory Committee meeting of the Circulatory
System Devices Panel concluded that analyses of available data from
FDA-approved devices show an increase in late mortality (between 2 and
5 years) associated with paclitaxel-coated devices intended to treat
femoropopliteal disease.\108\ However, causality for the late mortality
rate increase could not be determined. Additional data may be needed to
further assess the magnitude of the late mortality signal, determine
any potential causes, identify patient sub-groups that may be at
greater risk, and to update benefit-risk considerations of this device
class.\109\
---------------------------------------------------------------------------
\108\ https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-19-20-2019-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting#event-materials.
\109\ https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-19-20-2019-circulatory-system-devices-panel-medical-devices-advisory-committee-meeting#event-materials.
---------------------------------------------------------------------------
We stated that FDA continues to recommend that health care
providers report any adverse events or suspected adverse events
experienced with the use of paclitaxel-coated balloons and paclitaxel-
eluting stents. FDA stated that it will keep the public informed as any
new information or recommendations become available.
In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42231), after
consideration of the public comments we received and the latest
available information from the FDA advisory panel, we noted the FDA
panel's preliminary review of the data had identified a potentially
concerning signal of increased long-term mortality in study subjects
treated with paclitaxel-coated products compared to patients treated
with uncoated devices. We stated that additionally, since FDA has
stated that it believes alternative treatment options should generally
be used for most patients while it continues to further evaluate the
increased long-term mortality signal and its impact on the overall
benefit-risk profile of these devices, we remained concerned that we
did not have enough information to determine that the
EluviaTM device represents a substantial clinical
improvement over existing technologies. Therefore, we stated that we
were not approving the EluviaTM device for FY 2020 new
technology add-on payments. We also stated that we would monitor any
new information or recommendations as they become available.
Since the FY 2020 IPPS/LTCH PPS final rule, the FDA issued an
August 7, 2019 update: ``Treatment of Peripheral Arterial Disease with
Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially
Associated with Increased Mortality''.\110\ In its update, the FDA
included recommendations to healthcare providers for assessing and
treating patients with PAD using paclitaxel-coated devices. Based on
the FDA's review of available data and the Advisory Panel conclusions,
the FDA recommends that healthcare providers consider the following:
---------------------------------------------------------------------------
\110\ https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel.
---------------------------------------------------------------------------
Continue diligent monitoring of patients who have been
treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
When making treatment recommendations, and as part of the
informed consent process, consider that there may be an increased rate
of long-term mortality in patients treated with paclitaxel-coated
balloons and paclitaxel-eluting stents.
Discuss the risks and benefits of all available PAD
treatment options with your patients. For many patients, alternative
treatment options to paclitaxel-coated balloons and paclitaxel-eluting
stents provide a more favorable benefit-risk profile based on currently
available information.
For individual patients judged to be at particularly high
risk for restenosis and repeat femoropopliteal interventions,
clinicians may determine that the benefits of using a paclitaxel-coated
device outweigh the risk of late mortality.
In discussing treatment options, physicians should explore
their patients' expectations, concerns and treatment preferences.
Ensure patients receive optimal medical therapy for PAD
and other cardiovascular risk factors as well as guidance on healthy
lifestyles including weight control, smoking cessation, and exercise.
Report any adverse events or suspected adverse events
experienced with the use of paclitaxel-coated balloons and paclitaxel-
eluting stents.
In addition, the August 7, 2019 update noted the following. Based
on the conclusions of its analysis and recommendations of the advisory
panel, FDA stated that it is taking additional steps to address this
signal, including working with manufacturers on updates to device
labeling and clinical trial informed consent documents to incorporate
information about the late mortality signal. FDA also stated that it is
continuing to actively work with the manufacturers and investigators on
additional clinical evidence development for assessment of the long-
term safety of paclitaxel-coated devices. FDA noted that paclitaxel-
coated balloons and stents improve blood flow to the legs and decrease
the likelihood of repeat procedures to reopen blocked blood vessels
compared to uncoated devices. The update stated that the panel
concluded that the benefits of paclitaxel-coated devices (for example,
reduced reinterventions) should be considered in individual patients
along with potential risks (for example, late mortality).
The applicant stated in its FY 2021 application that while CMS
denied the application for new technology add-on payments for
EluviaTM for FY 2020 because of its concerns about
paclitaxel, the available evidence and policymaking from the FDA would
suggest that this device is safe, effective and a substantial clinical
improvement. To address the substantial clinical
[[Page 58653]]
improvement concerns stated in the FY 2020 final rule, the applicant
stated that EluviaTM is not associated with increased all-
cause mortality and that two-year all-cause mortality data are
consistent with FDA-published rates for uncoated angioplasty devices.
The applicant further asserted that most recent publications on
peripheral paclitaxel-coated devices do not replicate the strong
mortality signal identified in the meta-analysis. The applicant stated
that it submitted information on EluviaTM to the FDA for the
June 19-20 Circulatory System Devices Panel of the Medical Devices
Advisory Committee meeting. The applicant further asserted that the FDA
continues to find that paclitaxel devices are effective, specifically
that ``Paclitaxel-coated balloons and stents improve blood flow to the
legs and decrease the likelihood of repeat procedures to reopen blocked
blood vessels compared to uncoated devices''.\111\ The applicant stated
that the FDA, following months of investigation, multiple letters to
health care providers and an advisory panel meeting, has not changed
the marketed status of peripheral paclitaxel devices. Therefore, the
applicant respectfully requested that CMS consider that
EluviaTM satisfies the substantial clinical improvement
criterion in light of this information. The applicant referred to the
FDA's meta-analysis of long-term follow-up data from the pivotal
premarket randomized trials for paclitaxel-coated devices used to treat
PAD. The FDA's meta-analysis of these trials \112\ identified a late
mortality signal in study subjects treated with paclitaxel-coated
devices compared to patients treated with uncoated devices.
Specifically, in three randomized trials which enrolled a total of
1,090 patients, the crude mortality rate at 5 years was 19.8% (range
15.9%-23.4%) in patients treated with paclitaxel-coated devices
compared to 12.7% (range 11.2%-14.0%) in subjects treated with uncoated
devices. The relative risk for increased mortality at 5 years was 1.57
(95% confidence interval 1.16-2.13), which corresponds to a 57%
relative increase in mortality in patients treated with paclitaxel-
coated devices.
---------------------------------------------------------------------------
\111\ FDA Letter to Health Care Providers, August 7, 2019. Last
accessed at https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel on September 10,
2019.
\112\ https://www.fda.gov/medical-devices/letters-health-care-providers/update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel-eluting.
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In its application for FY 2021, the applicant stated that they
respectfully disagree with CMS's conclusion that EluviaTM
did not satisfy the substantial clinical improvement criterion as the
IMPERIAL randomized controlled trial demonstrates superiority over the
closest comparative device. In its application for FY 2021, in response
to these concerns related to peripheral paclitaxel devices, the
applicant referred to the updated bulletin FDA issued in August 2019 to
provide the latest information on its analysis of long-term follow-up
data from premarket trials and to provide summary information from its
June 2019 advisory panel meeting. Specifically, the applicant noted
that FDA stated that paclitaxel-coated balloons and stents improve
blood flow to the legs and decrease the likelihood of repeat procedures
to reopen blocked blood vessels compared to uncoated devices. The June
2019 advisory panel concluded that the benefits of paclitaxel-coated
devices (for example, reduced reinterventions) should be considered in
individual patients along with potential risks (for example, late
mortality).
The applicant also noted that it has worked closely with FDA to
address questions about the late mortality signal associated with some
peripheral paclitaxel-coated devices, as identified in the meta-
analysis. The applicant noted that EluviaTM was not included
in the meta-analysis.
Additionally, the applicant stated that it has demonstrated (a) the
absence of a mortality signal with EluviaTM and (b) the
absence of a mortality signal with sustained-release drug eluting
paclitaxel stent technology in the large long-term data for the TAXUS
coronary stent.\113\
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\113\ Stone GW, Ellis SG, Colombo A, et al. Long-term safety and
efficacy of paclitaxel-eluting stents final 5-year analysis from the
TAXUS Clinical Trial Program. JACC Cardiovasc Interv. 2011;4(5):530-
542.
---------------------------------------------------------------------------
With regard to the absence of a mortality signal with
EluviaTM, the applicant further stated that
EluviaTM is not associated with increased all-cause
mortality. The applicant explained that EluviaTM shows no
mortality signal at 2 years in over 300 patients. Additionally, the
applicant noted that its parent company Boston Scientific has extensive
experience with sustained-release paclitaxel-eluting stent technology
and noted that TAXUS has over 10 years of clinical data, with long-term
mortality in clinical trials following approximately 2,800 patients,
without an observed mortality signal.
As it relates to EluviaTM, the applicant stated that
findings of the FDA analysis should be interpreted with caution for
several reasons. First, EluviaTM was not included in the FDA
meta-analysis. Second, the applicant stated the analysis failed to find
any plausible mechanism that could explain the observed mortality
signal. Third, the applicant asserted that the analysis contained
structural flaws that may have contributed to its findings, including
small sample size, presence of ascertainment bias and lack of patient
level data.
The applicant added that additional analyses have been conducted
since the publication of the meta-analysis. In a Medicare claims
analysis of over 150,000 patients who underwent femoropopliteal artery
revascularization, the applicant noted that no mortality signal was
seen in the group treated with paclitaxel-coated devices.\114\
According to the applicant, this finding was echoed by other studies.
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\114\ Secemsky EA at al. Drug-Eluting Stent Implantation and
Long-Term Survival Following Peripheral Artery Revascularization. J
Am Coll Cardiol. 2019 May 28;73(20):2636-2638.
---------------------------------------------------------------------------
Finally, the applicant stated that it believes the FDA recognized
the value of allowing physicians to treat their PAD patients with
paclitaxel devices in its letter published on August 7, 2019,
acknowledging the signal in the meta-analysis and recognizing the
benefits that paclitaxel devices offer for these patients.
In summary, the applicant stated that EluviaTM should be
approved for new technology add-on payments based on the following:
Updated August 2019 FDA letter to providers issued after
the FY 2020 IPPS/LTCH PPS final rule, maintaining peripheral paclitaxel
devices on the market;
Multiple recently published studies\115\ \116\
demonstrating the absence of increased mortality associated with
peripheral paclitaxel devices;
---------------------------------------------------------------------------
\115\ 18Spreen MI, Martens JM, Knippenberg B, et al. Long-Term
Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty
Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical
Limb Ischemia. J Am Heart Assoc. 2017;6(4).
\116\ UPDATE: Treatment of Peripheral Arterial Disease with
Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially
Associated with Increased Mortality--Letter to Health Care
Providers. 2019; Last accessed at https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm on
October 9, 2019.
---------------------------------------------------------------------------
An analysis of over 150,000 Medicare beneficiaries,
designed with FDA input, demonstrating no difference in mortality
between patients treated with peripheral paclitaxel devices
[[Page 58654]]
compared to those treated without paclitaxel devices;
Confounding factors in the 2018 JAHA Katsanos et al. meta-
analysis (meta-analysis)\117\ and ascertainment bias, as highlighted at
the 2019 Vascular Leaders Forum,\118\ and no plausible mechanism has
been identified for increased mortality;
---------------------------------------------------------------------------
\117\ https://www.ahajournals.org/doi/full/10.1161/JAHA.118.011245.
\118\ Varcoe R. Unintended Consequences of Various trial
Designs, Potential Effect on Mortality and Other Outcomes. Vascular
Leaders Forum, March 2019.
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The rate of mortality for patients treated with
EluviaTM at 2 years is consistent with the rate of non-
paclitaxel-based peripheral devices.\119\
---------------------------------------------------------------------------
\119\ Pooled all-cause mortality rate includes IMPERIAL and
MAJESTIC Trials. 2-year all-cause mortality rate for IMPERIAL
(includes IMPERIAL RCT, Long Lesion, and PK sub-studies) is 7.0%.
MAJESTIC follow-up is final at 3 years. IMPERIAL follow-up is
complete through 2 years and ongoing through 5 years. As-treated
ELUVIA patients. FDA PTA reference based on FDA Executive Summary.
Two-year mortality rate within the PTA arm of ILLUMENATE was 7.4%
and within the PTA arm of IN.PACT SFA was 1.0%.
---------------------------------------------------------------------------
Although the EluviaTM system was not included in the
meta-analysis, in the proposed rule we stated that we were concerned
with the conclusion of the meta-analysis results. Specifically, we
stated that we were concerned with the conclusion that there is an
increased risk of death following application of
paclitaxel[hyphen]coated balloons and stents in the femoropopliteal
artery of the lower limb and how it impacts substantial clinical
improvement for the EluviaTM system.
We also noted the FDA's statement in the August 2019 letter that
because of the demonstrated short-term benefits of the devices, the
limitations of the available data, and uncertainty regarding the long-
term benefit-risk profile of paclitaxel-coated devices, the FDA
believes clinical studies of these devices may continue and should
collect long-term safety (including mortality) and effectiveness data.
Per the FDA, these studies require appropriate informed consent and
close safety monitoring to protect enrolled patients.
Comment: A commenter stated that the design of the MAJESTIC
clinical study is inadequate to support a claim of substantial clinical
improvement due to its small size, strict inclusion/exclusion criteria,
and lack of a comparator group. According to the commenter, the
MAJESTIC study is inadequate to demonstrate substantial clinical
improvement and that use of this single arm study to support
substantial clinical improvement should be considered with care due to
the small (n=57) and highly selected patient population (for example,
lesion length limited to a maximum of 11 cm). The commenter stated that
although the applicant reports a very high primary patency rate of
96.4% at 12 months, this rate drops substantially to 77.9% at just 25
months, suggesting the potential of a late catch-up phenomenon as
previously observed with other polymer-coated peripheral DES.\120\
\121\ The commenter also noted that the TLR rate appears to double each
year (that is quadruple from year 1 to year 3), increasing from 3.6% at
1 year to 7.2% at 2 years to 14.7% at 3 years.\122\
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\120\ Duda SH, et al. Drug-eluting and Bare Nitinol Stents for
the Treatment of Atherosclerotic Lesions in the Superficial Femoral
Artery: Long-Term Results From the SIROCCO Trial. J Endovasc Ther.
2006;13(6):701-710.
\121\ Lammer J, et al. First Clinical Trial of Nitinol Self-
Expanding Everolimus-Eluting Stent Implantation for Peripheral
Arterial Occlusive Disease. J Vasc Surg. 2011;54(2):394-401.
\122\ M[uuml]ller-H[uuml]lsbeck S, et al. Long-Term Results from
the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for
Femoropopliteal Treatment: 3-Year Follow-up. Cardiovasc Intervent
Radiol. 2017;40(12):1832-1838.
---------------------------------------------------------------------------
The commenter also stated that there are errors in the published 1-
year IMPERIAL study primary patency results, which is the primary
endpoint of the study which require a correction of the 1-year
publication and results. The commenter stated that although the errors
have been identified, to their knowledge no correction to the paper has
yet been published. As such, according to the commenter, the ability to
understand the outcomes of this study, particularly patency, which is
the primary endpoint of the study, is hindered.
The commenter also stated that patency results are inconsistently
presented. The primary endpoint of 12-month patency was reported after
the required sample size of 409 patients completed 12-month follow-up
or had an endpoint event; these results indicate primary patency of
86.8% (231/266) for Eluvia vs. 81.5% (106/130) for Zilver PTX. However,
a post-hoc analysis reports a larger difference of 86.8% (243/280) for
Eluvia vs. 77.5% (110/142) for Zilver PTX. This represents an
additional 14 Eluvia patients and 12 Zilver PTX patients compared to
the primary analysis. While the results for the Eluvia patients are
consistent between the primary and post-hoc analyses (86.8% [231/266]
vs. 85.7% [12/14]), the results for the final 12 Zilver PTX patients
added to the post-hoc analysis appear to be outliers who had
significantly worse outcomes than the primary patient cohort (patency
77.5% [110/142] in primary cohort vs. 33.3% [4/12] in post-hoc cohort,
p=0.002); according to the commenter, this raises questions about the
pooling of data between the primary cohort and the post-hoc cohort that
is used in the post-hoc analysis and reporting.
The commenter further stated that claims of ``superior primary
patency'' and ``highest reported'' two-year primary patency are
misleading. From the most recently presented two-year results (with
data correction), there is no significant difference in patency between
Eluvia and Zilver PTX at two years (83.0% vs. 77.1%, p=0.10, not
significant). Based on these results, a claim of superior primary
patency cannot be maintained, according to the commenter. The commenter
also expressed concerns regarding the claim of ``highest reported''
two-year patency. The commenter stated that by its very nature, this
claim can only be made by comparing results across numerous distinct
clinical trials, each enrolling patients and analyzing outcomes based
on study-specific criteria and variable definitions. For example, the
commenter noted that the Zilver PTX randomized trial included the
enrollment of patients with critical limb ischemia, a group with known
poor outcomes that were excluded from the IMPERIAL trial. The Zilver
PTX trial also had a more stringent definition for patency, requiring
the peak systolic velocity ratio (PSVR) to be <2.0 for a lesion to be
considered patent.\123\ In comparison, in the IMPERIAL trial, the
requirement for patency was a more lenient criterion of PSVR <=2.4. The
commenter stated that more concerning is that the definition of patency
at two years in the IMPERIAL trial has been redefined to eliminate any
patency failures that may have occurred prior to 730 days and is now
defined as ``clinically-driven TLR up to 730 days and duplex ultrasound
data at 24 months.'' This change in the definition can be observed by
comparing the one-year Kaplan-Meier curves to the two-year curves and
noting that patency at 24 months is actually increased compared with
what was previously reported at 13 months; that is, patency failures
occurring on imaging, but not resulting in a re-intervention have been
eliminated prior to 730 days.\124\ The
[[Page 58655]]
commenter stated that this modified definition is inconsistent with
other studies, further highlighting the inability to appropriately
compare data across studies.
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\123\ Dake MD, et al. Durable Clinical Effectiveness With
Paclitaxel-Eluting Stents in the Femoropopliteal Artery 5-Year
Results of the Zilver PTX Randomized Trial. Circulation.
2016;133(15):1472-1483.
\124\ Gray WA. 2-year Outcomes from the IMPERIAL Randomized Head
to Head Study of Eluvia DES and Zilver PTX. Oral presentation at:
The Leipzig Interventional Course (LINC) Annual Meeting; January
2020; Leipzig, Germany.
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The commenter also stated that the secondary randomization (that
is, the provisional DES arm) of the Zilver PTX RCT was specifically
excluded from this comparison. These Zilver PTX patients actually had a
higher two-year primary patency rate of 83.4% compared with 83.0% for
Eluvia. According to the commenter, this blanket claim of superiority
appears to be in stark contrast to traditionally accepted criteria
established by FDA to allow such superiority claims. The commenter
further stated that the FDA has not indicated that Eluvia provides a
substantial clinical improvement.
We also received a comment stating that section Sec. 412.87(b)
describes the eligibility criteria associated with the substantial
clinical improvement criterion, specifically that it ``improves
clinical outcomes relative to services or technologies previously
available...'' The commenter stated that CMS' conclusions that there is
insufficient evidence to determine substantial clinical improvement
included in both the FY 2020 and 2021 rules does not articulate why the
clinical trial information provided by the applicant is not sufficient.
Instead, CMS relies on the potential signal described in the meta-
analysis and the FDA review of the data on paclitaxel-coated devices.
The commenter further stated that despite the various deliberations
by the FDA, it has not limited the use of paclitaxel devices and more
importantly, CMS has not limited coverage of paclitaxel devices. Per
the language in Sec. 412.87(b), the substantial clinical improvement
criterion is to be evaluated ``relative to services or technologies
previously available.'' The commenter stated that it appears the
applicant has provided a comparison of the Eluvia device to existing,
comparable devices for the treatment of peripheral arterial disease.
The commenter contended this is the data that should be utilized to
determine if the technology represents a SCI.
The commenter also asserted that if the FDA had removed existing
paclitaxel devices from the market, or CMS had issued non-coverage for
paclitaxel devices at the national or local level based on the FDA
analyses, they would concur that there would be insufficient data to
determine SCI. The commenter stated that since the FDA has not
materially changed the label for paclitaxel devices nor has CMS issued
non-coverage policies for any paclitaxel devices, existing paclitaxel
devices represent an appropriate comparison when evaluating substantial
clinical improvement in the new technology add-on payment application
as they represent a medically reasonable medical option for Medicare
patients.
The commenter contended that the EluviaTM device meets
the substantial clinical improvement criterion as it showed superiority
over the only other paclitaxel peripheral stent in a head-to-head
randomized controlled trial, and that the results have been sustained
based on longest follow up clinical data published to date for the
EluviaTM device.
The applicant commented that the IMPERIAL trial was designed as a
non-inferiority study, as are many head-to-head trials of medical
devices. Boston Scientific defined a pre-specified, post-hoc
superiority analysis before evaluation of the clinical trial results;
therefore, the non-inferiority and subsequent superiority testing
methodology and results were not subjected to bias. The superiority
testing was performed after the 12-month follow-up window for all
enrolled subjects had closed.
According to the applicant, from a statistical perspective, the
pre-specified success criteria for superiority used the same logic as
the pre-specified success criteria for non-inferiority: ``ELUVIA will
be concluded to be superior to Zilver PTX for device effectiveness if
the one-sided lower 95% confidence bound on the difference between
treatment groups in 12-month primary patency is greater than zero.''
The commenter stated that a more stringent one-sided lower 97.5%
confidence bound (shown as two-sided 95% confidence interval) on the
difference between treatment groups was observed to be greater than
zero and the corresponding p-value was 0.0144.
In addition to the internal analysis performed by Boston
Scientific, these data were published in The Lancet following its peer-
review process. As stated in The Lancet, ``The superiority analysis of
primary patency in the full-analysis cohort was a pre-specified post-
hoc analysis'' and ``In this head-to-head randomized trial, the primary
non-inferiority endpoints for efficacy and safety at 12 months were
met, and post-hoc analysis of the 12-month patency rate showed
superiority for Eluvia over Zilver PTX.'' \125\ According to the
applicant, these claims are non-misleading and supported by valid
scientific evidence.
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\125\ Gray WA, Keirse K, Soga Y, et al. A polymer-coated,
paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-
coated stent (Zilver PTX) for endovascular femoropopliteal
intervention (IMPERIAL): a randomised, non-inferiority trial. The
Lancet. 2018;392(10157):1541-1551.
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The applicant also provided a comment in response to CMS' request
for comments on the implications of the recent meta-analysis addressing
paclitaxel-coated balloons and stents. The applicant maintained that
EluviaTM is different from the devices evaluated in the
meta-analysis. The applicant stated that as CMS noted,
EluviaTM was not addressed in the meta-analysis. Further,
the applicant maintained that EluviaTM delivers paclitaxel
in much lower doses than the products discussed in the meta-analysis
and is the only peripheral device to deliver paclitaxel through a
sustained-release mechanism of action where delivery of paclitaxel is
controlled and focused on the target lesion. Thus, according to the
applicant, the suggestion in the meta-analysis of a late-term mortality
risk associated with paclitaxel coated devices is not directly
applicable to the EluviaTM device. Boston Scientific
submitted information (available at https://www.fda.gov/media/127704/download) to the FDA on paclitaxel relative to EluviaTM in
advance of FDA's June 19-20 Circulatory System Devices Panel of the
Medical Devices Advisory Committee Meeting.
Consequently, the applicant does not believe that the findings of
limited generalizability suggested in the meta-analysis should inhibit
CMS from determining that EluviaTM satisfies the substantial
clinical improvement criterion.
The applicant further commented that given the differences between
EluviaTM and other peripheral paclitaxel coated devices, it
would be more appropriate to examine safety considerations for
EluviaTM relative to products with similar mechanisms of
action and dose levels, such as the Taxus coronary stent indicated in
the treatment of lesions in native coronary arteries. Boston Scientific
asserted that it has more experience with sustained-release drug-
eluting stents than any other manufacturer. According to the applicant,
Boston Scientific developed coronary sustained-release drug-eluting
stent technology, first with its Taxus coronary drug-eluting stent.
According to the applicant, the EluviaTM and Taxus stents
are similar in design intent and mechanism of action. We note that the
Taxus stent involves the treatment of a different patient population.
According to the applicant, with the same drug and comparable low-dose
controlled drug elution profiles achieved via a polymer matrix, the
EluviaTM peripheral stent bears greater similarity to the
Taxus
[[Page 58656]]
coronary stent than to any peripheral paclitaxel-coated balloon or non-
polymeric paclitaxel-coated stent with respect to design features and
drug release kinetics. The applicant asserted that given the similarity
in disease presentation for coronary and peripheral atherosclerotic
lesions and the same anti-proliferative impact of paclitaxel on the
lesions regardless of vessel bed, signals for any potential long-term
systemic effects of targeted paclitaxel eluted from a stent polymer
matrix would be apparent in patients treated with Taxus. Therefore, the
applicant asserted that data on the controlled, localized and low dose
paclitaxel elution by Taxus in the coronary or infrapopliteal
vasculature can be used to gauge potential systemic effects of
paclitaxel eluted from EluviaTM. According to the applicant,
Taxus stent use has been extensively studied with more than 14 years of
commercial experience and clinical trial data out to 10 years in
patients with coronary\126\ \127\ \128\ \129\ implants and 5 years for
those with infrapopliteal implants.
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\126\ Yamaji K, Raber L, Zanchin T, et al. Ten-year clinical
outcomes of first-generation drug-eluting stents: the Sirolimus-
Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization
(SIRTAX) VERY LATE trial. Eur Heart J. 2016;37(45):3386-3395.
\127\ Ormiston JA, Charles O, Mann T, et al. Final 5-year
results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS
ATLAS Long Lesion clinical trials of the TAXUS Liberte paclitaxel-
eluting stent in de-novo coronary artery lesions. Coron Artery Dis.
2013;24(1):61-68.
\128\ Kereiakes DJ, Cannon LA, Dauber I, et al. Long-term
follow-up of the platinum chromium TAXUS Element (ION) stent: The
PERSEUS Workhorse and Small Vessel trial five-year results. Catheter
Cardiovasc Interv. 2015;86(6):994-1001.
\129\ Stone GW, Ellis SG, Colombo A, et al. Long-term safety and
efficacy of paclitaxel-eluting stents final 5-year analysis from the
TAXUS Clinical Trial Program. JACC Cardiovasc Interv. 2011;4(5):530-
542.
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The applicant commented that in the Taxus stent family series of
coronary studies, paclitaxel-based treatment showed consistent benefits
compared to bare metal stenting and did not differentially affect long-
term all-cause mortality as compared to bare stent treatment. Stone et
al. report 5-year patient-level pooled results from nearly 2800
patients in randomized studies showing that all-cause mortality for
patients treated with Taxus was similar to that of patients treated
with the bare metal platform (9.8% vs 9.1%, p=0.53). The event rate
analysis of mortality through 5 years for patients treated with Taxus
(n=1400) compared to patients treated with the bare metal platform
(n=1397) log-rank p=0.5283.
These analyses represent approximately triple the sample size of
the studies with >2 year data included in the Katsanos meta-analysis
and in FDA's analysis of 5-year data from paclitaxel-coated devices. In
addition, long-term data from more than 4000 patients who received
coronary Taxus in randomized and nonrandomized studies show mortality
rates consistent with those expected for this patient population.\130\
\131\
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\130\ Shishehbor MH, Goel SS, Kapadia SR, et al. Long-term
impact of drug-eluting stents versus baremetal stents on all-cause
mortality. J Am Coll Cardiol. 2008;52(13):1041-1048.
\131\ Bravata DM, Gienger AL, McDonald KM, et al. Systematic
review: the comparative effectiveness of percutaneous coronary
interventions and coronary artery bypass graft surgery. Ann Intern
Med. 2007;147(10):703-716.
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The applicant also commented that it remains questionable and
unproven that the root cause of the observed higher mortality in
certain retrospective meta-analyses has a direct relationship to the
presence of paclitaxel in the evaluated devices. In the March 15 Letter
to Health Care Providers,\132\ the FDA observed, ``These data should be
interpreted with caution for several reasons. First, there is large
variability in the risk estimate of mortality due to the limited amount
of long-term data. Second, these studies were not originally designed
to be pooled, introducing greater uncertainty in the results. Third,
the specific cause and mechanism of the increased mortality is
unknown.''
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\132\ UPDATE: Treatment of Peripheral Arterial Disease with
Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially
Associated with Increased Mortality--Letter to Health Care
Providers. 2019; https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm. Accessed April 15, 2019,
2019.
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The applicant commented that notably, the number of studies,
patients, and devices contributing to the mortality calculations
significantly decreased with the longer follow-up time frames. In
addition, the applicant asserted that understanding possible effects of
paclitaxel exposure is not possible without complete analysis of
uniformly re-adjudicated patient level data, particularly with
treatment arm crossover and previous interventions or subsequent re-
interventions with paclitaxel-coated devices, which occurred in the
analyzed studies.
The applicant commented that explanations unrelated to drug
exposure may account for the signal observed in the meta-analysis by
Katsanos et al.\133\ These include preferential follow-up for control-
arm patients (that is, more physician visits, closer monitoring,
enhanced comorbidity management), which may improve survival in these
arms. Not adjusting for between-arm imbalance of predisposing
conditions or comorbidities associated with increased mortality risk in
the cohort-level analysis could also contribute to a false signal.
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\133\ Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M,
Karnabatidis D. Risk of Death Following Application of Paclitaxel-
Coated Balloons and Stents in the Femoropopliteal Artery of the Leg:
A Systematic Review and Meta-Analysis of Randomized Controlled
Trials. J Am Heart Assoc. 2018;7(24): e011245.
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The applicant further commented that currently, no plausible
mechanistic link between paclitaxel and death has been postulated or
established. To the contrary, the applicant stated that systemic
paclitaxel infusions are known to improve survival among cancer
patients.\134\ \135\ The periodically-repeated systemic doses of
paclitaxel for chemotherapy are multiple orders of magnitude greater
than the doses following treatment with either paclitaxel-coated
devices\136\ \137\ \138\ \139\ or EluviaTM. The applicant
stated that it is extremely unlikely that localized micro-doses
associated with peripheral device use would have a negative effect on
long-term survival.
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\134\ Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak AK. Taxanes
for adjuvant treatment of early breast cancer. Cochrane Database
Syst Rev. 2007(4):CD004421.
\135\ Ghersi D, Willson ML, Chan MM, Simes J, Donoghue E,
Wilcken N. Taxane-containing regimens for metastatic breast cancer.
Cochrane Database Syst Rev. 2015(6):CD003366.
\136\ BD announces new 300-mm length for Lutonix 018 DCB.
Endovascular Today. March 2, 2020.
\137\ Speck U, Cremers B, Kelsch B, et al. Do pharmacokinetics
explain persistent restenosis inhibition by a single dose of
paclitaxel? Circ Cardiovasc Interv. 2012;5(3):392-400.
\138\ Yazdani SK, Pacheco E, Nakano M, et al. Vascular,
downstream, and pharmacokinetic responses to treatment with a low
dose drug-coated balloon in a swine femoral artery model. Catheter
Cardiovasc
Interv. 2014;83(1):132-140.
\139\ Scheinert D, Duda S, Zeller T, et al. The LEVANT I
(Lutonix paclitaxel-coated balloon for the prevention of
femoropopliteal restenosis) trial for femoropopliteal
revascularization: first-in-human randomized trial of low-dose drug-
coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc
Interv. 2014;7(1):10-19.
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The applicant commented that as no local vascular-based causes of
mortality have been identified, any paclitaxel effect on mortality
would occur via a systemic or non-vascular mechanism and would be
apparent following paclitaxel exposure regardless of the administration
route or implant location. The applicant asserted that no such effect
on mortality was seen among thousands of patients who received a TAXUS
paclitaxel-eluting coronary stent with a design very similar to that of
EluviaTM, and no systemic effect should be expected with
peripheral application.
[[Page 58657]]
Response: We appreciate the comments received from the applicant
and other commenters.
CMS has always considered all evidence in its decision whether a
technology represents a substantial clinical improvement over existing
technologies. We refer the commenter to the regulations at Sec. 412.87
which states a new medical service or technology represents an advance
that substantially improves, relative to technologies previously
available, the diagnosis or treatment of Medicare beneficiaries. Some
highlights of what we consider includes the following but not limited
to are:
The totality of the circumstances when making a
determination that a new medical service or technology represents an
advance that substantially improves, relative to services or
technologies previously available, the diagnosis or treatment of
Medicare beneficiaries.
The totality of the information otherwise demonstrates
that the new medical service or technology substantially improves,
relative to technologies previously available, the diagnosis or
treatment of Medicare beneficiaries.
Evidence from published or unpublished information sources
from within the United States or elsewhere such as clinical trials,
peer reviewed journal articles, study results, meta-analyses, consensus
statements and white papers may be sufficient to establish that a new
medical service or technology represents an advance that substantially
improves, relative to services or technologies previously available,
the diagnosis or treatment of Medicare beneficiaries. Information
sources we consider are listed including ``other appropriate
information sources may be considered''.
We believe the IMPERIAL and MAJESTIC trials show a number of
improved outcomes such as primary patency rates and decreased need for
subsequent interventions. As stated above, the applicant provided the
following two-year results from the IMPERIAL global randomized
controlled clinical trial, comparing EluviaTM to
Zilver[supreg] PTX[supreg]:
EluviaTM maintains higher primary patency than
Zilver[supreg] PTX[supreg] at 2 years, 83.0% compared to 77.1%. The
applicant contended that guidelines recognize the importance of primary
patency in assessing the efficacy of peripheral endovascular
therapies.\140\
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\140\ Writing Committee Members, Gerhard-Herman MD, Gornik HL et
al. 2016 AHA/ACC Guideline on the Management of Patients with Lower
Extremity Peripheral Artery Disease: Executive Summary. Vasc Med.
2017 Jun; 22(3):NP1-NP43.
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EluviaTM's tw2-year primary patency is the
highest reported in a superficial femoral artery US pivotal trial for a
drug-eluting stent or drug-coated balloon.\141\ Per the applicant, the
2-year primary patency results are consistent with the 2-year TLR
results released earlier in 2019.\142\ According to the applicant,
EluviaTM sustained a statistically significant reduction in
TLR at 2 years compared to Zilver PTX, 12.9% vs. 20.5% (p=0.0472).\143\
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\141\ Highest two-year primary patency based on 24-month Kaplan-
Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE,
LEVANT II and Primary Randomization for Zilver PTX RCT.
\142\ BSC Data on File. As-treated ELUVIA and PTxControl data
from IMPERIAL RCT.FDA PTA reference based on FDA Executive Summary
(median of PTA arms).Abbreviations: DES, drug-eluting stent; TLR,
target lesion revascularization; PTx, paclitaxel.
\143\ Boston Scientific Presentation to the Circulatory System
Devices Panel of the Medical Devices Advisory Committee Meeting,
June 19, 2019.
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In a subgroup analysis of patients 65 years and older
(Medicare population), the primary patency rate in the
EluviaTM stent group is 92.6%, compared to 75.0% for the
Zilver[supreg] PTX[supreg] stent group (p=0.0386).
Additionally, after the FY 2020 IPPS/LTCH final rule last year, as
noted above, in its August 7, 2019 update, the FDA stated that
``Paclitaxel-coated balloons and stents improve blood flow to the legs
and decrease the likelihood of repeat procedures to reopen blocked
blood vessels compared to uncoated devices. The Panel concluded that
the benefits of paclitaxel-coated devices (for example, reduced
reinterventions) should be considered in individual patients along with
potential risks (for example, late mortality).'' \144\ Furthermore, per
the FDA August 2019 update, ``for individual patients judged to be at
particularly high risk for restenosis and repeat femoropopliteal
interventions, clinicians may determine that the benefits of using a
paclitaxel-coated device outweigh the risk of late mortality.'' \145\
We expect that clinicians will discuss the risks and benefits of all
available PAD treatment options with patients and that they will
continue to diligently monitor patients who have been treated with
paclitaxel-coated balloons and paclitaxel-eluting stents. We will
continue to monitor the data and any further information provided by
the FDA regarding the EluviaTM system. Therefore, based on
the above, we believe the EluviaTM system represents a
substantial clinical improvement over existing technologies.
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\144\ https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel.
\145\ https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel.
---------------------------------------------------------------------------
After consideration of the public comments we received and for the
reasons discussed, including the IMPERIAL and MAJESTIC trials which
show a number of improved outcomes and the FDA August 7, 2019 update
which concluded that the benefits of paclitaxel-coated devices (for
example, reduced reinterventions) should be considered in individual
patients along with potential risks (for example, late mortality) as
well as for individual patients judged to be at particularly high risk
for restenosis and repeat femoropopliteal interventions, clinicians may
determine that the benefits of using a paclitaxel-coated device
outweigh the risk of late mortality, we believe EluviaTM
represents a substantial clinical improvement over existing
technologies. Therefore, we have determined that the
EluviaTM system meets all of the criteria for approval of
new technology add-on payments for FY 2021. Cases involving
EluviaTM that are eligible for new technology add-on
payments will be identified by the following ICD-10-PCS procedure
codes:
[[Page 58658]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.154
According to the applicant, the cost per case for the
EluviaTM device is $5,610. Under Sec. 412.88(a)(2), we
limit new technology add-on payments to the lesser of 65 percent of the
costs of the new medical service or technology, or 65 percent of the
amount by which the costs of the case exceed the MS-DRG payment. As a
result, the maximum new technology add-on payment for a case involving
the use of the EluviaTM device is $3,646.50 for FY 2021.
f. GammaTile
GT Medical Technologies, Inc. submitted an application for new
technology add-on payments for FY 2021 for the GammaTile\TM\. We note
that Isoray Medical, Inc. and GammaTile, LLC previously submitted an
application for new technology add-on payments for GammaTile\TM\ for FY
2018, which was withdrawn, and also for FY 2019; however, the
technology did not receive FDA marketing authorization by July 1, 2018
and, therefore, was not eligible for consideration for new technology
add-on payments for FY 2019. GT Medical Technologies, Inc. submitted an
application for FY 2020, which was not approved as CMS was unable to
make a determination that GammaTileTM technology represents
a substantial clinical improvement over existing therapies.
The GammaTile\TM\ is a brachytherapy device for use in the
treatment of patients who have been diagnosed with recurrent
intracranial neoplasms, which uses cesium-131 radioactive sources
embedded in a collagen matrix. GammaTile\TM\ is designed to provide
adjuvant radiation therapy to eliminate remaining tumor cells in
patients who required surgical resection of recurrent brain tumors.
According to the applicant, the GammaTile\TM\ constitutes a new form of
internal radiation, with collagen tile structural offsets acting as an
internal compensator for the delivery of cesium-131 brachytherapy
sources embedded within the product. The applicant stated that the
technology has been manufactured for use in the setting of a craniotomy
resection site where there is a high chance of local
[[Page 58659]]
recurrence of a Central Nervous System (CNS) or dual-based tumor. The
applicant asserted that the use of the GammaTile\TM\ technology
provides a new, unique modality for treating patients who require
radiation therapy to augment surgical resection of malignancies of the
brain. By offsetting the radiation sources with a 3mm gap of a collagen
matrix, the applicant asserted that the use of the GammaTile\TM\
technology resolves issues with ``hot'' and ``cold'' spots associated
with brachytherapy, improves safety, and potentially offers a treatment
option for patients with limited or no other available options. The
GammaTile\TM\ is biocompatible and bioabsorbable, and is left in the
body permanently without need for future surgical removal. The
applicant asserted that the commercial manufacturing of the product
will significantly improve on the process of constructing customized
implants with greater speed, efficiency, and accuracy than is currently
available, and requires less surgical expertise in placement of the
radioactive sources, allowing a greater number of surgeons to utilize
brachytherapy techniques in a wider variety of hospital settings.
The GammaTile\TM\ technology received FDA Section 510(k) clearance
as a medical device on July 6, 2018. According to the applicant, due to
finalization of design and manufacturing activities, the technology was
not commercially available until January of 2019. Subsequently, the FDA
cleared GammaTile\TM\ as a Class II medical device under the corporate
name of GT Medical Technologies, Inc. on March 13, 2019. The cleared
indications for use state that GammaTile\TM\ is intended to deliver
radiation therapy (brachytherapy) in patients who have been diagnosed
with recurrent intercranial neoplasms. The applicant submitted a
request for approval for a unique ICD-10-PCS code for the use of the
GammaTile\TM\ technology, which was approved effective October 1, 2017
(FY 2018). The ICD-10-PCS procedure code used to identify procedures
involving the use of the GammaTile\TM\ technology is 00H004Z (Insertion
of radioactive element, cesium-131 collagen implant into brain, open
approach).
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 therefore not be considered
``new'' for purposes of new technology add-on payments. We note that in
the FY 2020 IPPS/LTCH PPS final rule (84 FR 42261), we stated that
after consideration of comments, we believe that the
GammaTileTM mechanism of action is different from current
forms of radiation therapy and brachytherapy as it is the first FDA
cleared device to use a manufactured collagen matrix which offsets
radiation sources for use for the treatment of recurrent intracranial
neoplasms. Therefore, we stated that the GammaTileTM is not
substantially similar to existing brachytherapy technology and meets
the newness criterion. We refer the reader to the FY 2020 final rule
for the complete discussion of how the GammaTileTM meets the
newness criterion. We invited public comments on whether the
GammaTileTM is substantially similar to an existing
technology and whether it meets the newness criterion for purposes of
its application for new technology add-on payments for FY 2021, but did
not receive any additional comments. We continue to believe that the
GammaTileTM is not substantially similar to existing
brachytherapy technology and meets the newness criterion for purposes
of its application for new technology add-on payments for FY 2021.
With regard to the cost criterion, the applicant conducted the
following analysis. The applicant worked with the Barrow Neurological
Institute at St. Joseph's Hospital and Medical Center (St. Joseph's) to
obtain actual claims from mid-2015 through mid-2016 for craniotomies
that did not involve placement of the GammaTile\TM\ technology. The
cases were assigned to MS-DRGs 025, 026, and 027 (Craniotomy and
Endovascular Intracranial Procedures with MCC, with CC, and without CC/
MCC, respectively). For the 460 claims, the average case-weighted
unstandardized charge per case was $143,831. The applicant standardized
the charges for each case and inflated each case's charges by applying
the outlier charge inflation factor of 1.054 included in the FY 2020
IPPS/LTCH PPS final rule (84 FR 42629) by the age of each case (that
is, the factor was applied to 2015 claims 4 times and 2016 claims 3
times). The applicant then calculated an estimate for ancillary charges
associated with placement of the GammaTile\TM\ device, as well as
standardized charges for the GammaTile\TM\ device itself. The applicant
determined it meets the cost criterion because the final inflated
average caseweighted standardized charge per case (including the
charges associated with the GammaTile\TM\ device) of $270,445 exceeds
the average case-weighted threshold amount of $151,193 for MS-DRG 023
(Craniotomy with Major Device Implant or Acute Complex CNS PDX with MCC
or Chemotherapy Implant or Epilepsy with Neurostimulator), the MS-DRG
that would be assigned for cases involving the GammaTile\TM\ device.
The applicant stated that its analysis does not include a reduction
in costs due to reduced operating room times. According to the
applicant, the cost analysis reflects the time associated with a
craniotomy and device placement. The applicant does not anticipate any
reduction in operating room time relative to prior operative methods.
We invited public comments on whether the GammaTile\TM\ technology
meets the cost criterion. We did not receive any additional comments.
Based on the analysis above, we believe that GammaTile\TM\ meets the
cost criterion.
With regard to substantial clinical improvement, the applicant
stated that the GammaTile\TM\ technology offers a treatment option for
a patient population unresponsive to, or ineligible for, currently
available treatments for recurrent CNS malignancies and significantly
improves clinical outcomes when compared to currently available
treatment options. The applicant explained that therapeutic options for
patients who have been diagnosed with large or recurrent brain
metastases are limited (for example, stereotactic radiotherapy,
additional EBRT, or systemic immunochemotherapy). However, according to
the applicant, the GammaTile\TM\ technology provides a treatment option
for patients who have been diagnosed with radiosensitive recurrent
brain tumors that are not eligible for treatment with any other
currently available treatment options. Specifically, the applicant
stated that the GammaTile\TM\ device may provide the only radiation
treatment option for patients who have been diagnosed with tumors
located close to sensitive vital brain sites (for example, brain stem)
and patients who have been diagnosed with recurrent brain tumors who
may not be eligible for additional treatment involving the use of
external beam radiation therapy. There is a lifetime limit for the
amount of radiation therapy a specific area of the body can receive.
Patients whose previous treatment includes external beam radiation
therapy may be precluded from receiving high doses of radiation
associated with subsequent external beam radiation therapy, and the
GammaTile\TM\ technology can also be used to treat tumors that are too
large for treatment with external beam radiation therapy. According to
the applicant,
[[Page 58660]]
patients who have been diagnosed with these large tumors are not
eligible for treatment with external beam radiation therapy because the
radiation dose to healthy brain tissue would be too high.
The applicant summarized how the GammaTile\TM\ technology improves
clinical outcomes compared to existing treatment options, including
external beam radiation therapy and other forms of brain brachytherapy
as: (1) Providing a treatment option for patients with no other
available treatment options; (2) reducing the rate of mortality
compared to alternative treatment options; (3) reducing the rate of
radiation necrosis; (4) reducing the need for re-operation; (5)
reducing the need for additional hospital visits and procedures; and
(6) providing more rapid beneficial resolution of the disease process
treatment.
The applicant cited several sources of data to support these
assertions. The applicant referenced a paper by Brachman, Dardis et
al., which was published in the Journal of Neurosurgery on December 21,
2018.\146\ This study, a follow-up on the progress of 20 patients with
recurrent previously irradiated meningiomas, is a feasibility or
superior progression-free survival study comparing the patient's own
historical control rate against subsequent treatment with
GammaTile\TM\.
---------------------------------------------------------------------------
\146\ Brachman, D., et al., ``Resection and permanent
intracranial brachytherpay using modular, biocompatible cesium-131
implants: Results in 20 recurrent previously irradiated
meningiomas,'' J Neurosurgery, December 21, 2018.
---------------------------------------------------------------------------
An additional source of clinical data is from Gamma Tech's internal
review of data from two centers treating brain tumors with
GammaTile\TM\; the two centers are the Barrow Neurological Institute
(BNI) at St. Joseph's Hospital and St. Joseph's Medical Center,
Phoenix, AZ, and this internal review is referred to here as the
``BNI'' study.\147\ The BNI study summarized Gamma Tech's experience
with the GammaTile\TM\ technology. The applicant also included a
reference to its updated study, described on ClinicalTrials.gov under
NCT03088579, which includes 79 recurrent, previously irradiated
intracranial neoplasms.
---------------------------------------------------------------------------
\147\ Brachman, D., et al., ``Surgery and Permanent
Intraoperative Brachytherapy Improves Time to Progress of Recurrent
Intracranial Neoplasms,'' Society for Neuro-Oncology Conference on
Meningioma, June 2016.
---------------------------------------------------------------------------
Another source of data that the applicant cited to support its
assertions regarding substantial clinical improvement is an abstract by
Pinnaduwage, D., et al. Also submitted in the application were
abstracts from 2014 through 2018 in which updates from the progression-
free survival study and the BNI study were presented at specialty
society clinical conferences. The following summarizes the findings
cited by the applicant to support its assertions regarding substantial
clinical improvement.
Regarding the assertion of local control, the 2018 article which
was published in the Journal of Neurosurgery found that, with a median
followup of 15.4 months (range 0.03-47.5 months), there were 2 reported
cases of recurrence out of 20 meningiomas, with median treatment site
progression time after surgery and brachytherapy with the GammaTile\TM\
precursor and prototype devices not yet being reached, compared to 18.3
months in prior instances. Median overall survival after resection and
brachytherapy was 26 months, with 9 patient deaths. In a presentation
at the Society for Neuro-Oncology in November 2014,\148\ the outcomes
of 20 patients who were diagnosed with 27 tumors covering a variety of
histological types treated with the GammaTile\TM\ prototype were
presented. The applicant noted the following with regard to the
patients: (1) All tumors were intracranial, supratentorial masses and
included low and high-grade meningiomas, metastases from various
primary cancers, high-grade gliomas, and others; (2) all treated masses
were recurrent following treatment with surgery and/or radiation and
the group averaged two prior craniotomies and two prior courses of
external beam radiation treatment; and (3) following surgical excision,
the prototype GammaTile\TM\ were placed in the resection cavity to
deliver a dose of 60 Gray to a depth of 5 mm of tissue; and (4) all
patients had previously experienced regrowth of their tumors at the
site of treatment and the local control rate of patients entering the
study was 0 percent.
---------------------------------------------------------------------------
\148\ Dardis, C., ``Surgery and Permanent Intraoperative
Brachytherapy Improves Times to Progression of Recurrent
Intracranial Neoplasms,'' Society for Neuro-Oncology, November 2014.
---------------------------------------------------------------------------
With regard to outcomes, the applicant stated that, after their
initial treatment, patients had a median progression-free survival time
of 5.8 months; post treatment with the prototype GammaTile\TM\, at the
time of this analysis, only 1 patient had progressed at the treatment
site, for a local control rate of 96 percent; and median progression-
free survival time, a measure of how long a patient lives without
recurrence of the treated tumor, had not been reached (as this value
can only be calculated when more than 50 percent of treated patients
have failed the prescribed treatment).
The applicant stated that it received two peer-reviewed awards for
comprehensive clinical trial reporting on the treatment of 79 recurrent
brain tumors treated with GammaTile. The applicant provided a recent
summary presentation titled: ``Surgically Targeted Radiation Therapy: A
Prospective Trial in 79 Recurrent, Previously Irradiated Intracranial
Neoplasms'' at The American Brachytherapy Society.\149\ The clinical
endpoints included time to tumor progression and survival, which the
applicant stated provided objective, clinically important measures. The
median local control after GammaTile therapy versus prior treatment was
12.0 versus 9.5 months for high-grade glioma patients (p=0.13) and 48.8
months versus 23.3 months for meningioma patients (p=0.01). For the
metastasis patients, the median local control had not been reached
versus 5.1 months with prior treatment (p=0.02). The median overall
survival was 12.0 months for high grade glioma patients, 12.0 months
for brain metastasis patients, and 49.2 months for the meningioma
patients. According to the applicant, these data demonstrate dramatic,
clinically meaningful difference in Kaplan-Meier curves comparing time
to local recurrence at same site in the same patients. The applicant
stated that GammaTileTM is significantly outperforming the
initial therapies attempted in this patient population.
---------------------------------------------------------------------------
\149\ Brachman D, Youssef E, Dardis C, et al.: Surgically
Targeted Radiation Therapy: Safety Profile of Collagen Tile
Brachytherapy in 79 Recurrent, Previously Irradiated Intracranial
Neoplasms on a Prospective Clinical Trial. Brachytherapy 18 (2019)
S35-36.
---------------------------------------------------------------------------
The applicant also cited the findings from Brachman, et al. to
support local control of recurrent brain tumors. At the Society for
Neuro-Oncology Conference on Meningioma in June 2016,\150\ a second set
of outcomes on the prototype GammaTile\TM\ was presented. This study
enrolled 16 patients with 20 recurrent Grade II or III meningiomas, who
had undergone prior surgical excision and external beam radiation
therapy. These patients underwent surgical excision of the tumor,
followed by adjuvant radiation therapy with the prototype
GammaTile\TM\. The applicant noted the following outcomes: (1) Of the
20 treated tumors, 19 showed no evidence of radiographic progression at
[[Page 58661]]
last follow-up, yielding a local control rate of 95 percent; 2 of the
20 patients exhibited radiation necrosis (1 symptomatic, 1
asymptomatic); and (2) the median time to failure from the prior
treatment with external beam radiation therapy was 10.3 months and
after treatment with the prototype GammaTile\TM\ only 1 patient failed
at 18.2 months. Therefore, according to the applicant, the median
treatment site progression-free survival time after the prototype
GammaTile\TM\ treatment had not yet been reached (average follow-up of
16.7 months, range 1 to 37 months).
---------------------------------------------------------------------------
\150\ Brachman, D., et al., ``Surgery and Permanent
Intraoperative Brachytherapy Improves Time to Progress of Recurrent
Intracranial Neoplasms,'' Society for Neuro-Oncology Conference on
Meningioma, June 2016.
---------------------------------------------------------------------------
A third prospective study was accepted for presentation at the
November 2016 Society for Neuro-Oncology annual meeting.\151\ In this
study, 13 patients who were diagnosed with recurrent high-grade gliomas
(9 with glioblastoma and 4 with Grade III astrocytoma) were treated in
an identical manner to the cases previously described. Previously, all
patients had failed the international standard treatment for high-grade
glioma, a combination of surgery, radiation therapy, and chemotherapy
referred to as the ``Stupp regimen.'' For the prior therapy, the median
time to failure was 9.2 months (range 1 to 40 months). After therapy
with a prototype GammaTile\TM\, the applicant noted the following: (1)
The median time to same site local failure had not been reached and 1
failure was seen at 18 months (local control 92 percent); and (2) with
a median follow-up time of 8.1 months (range 1 to 23 months) 1
symptomatic patient (8 percent) and 2 asymptomatic patients (15
percent) had radiation-related MRI changes. However, no patients
required re-operation for radiation necrosis or wound breakdown. Dr.
Youssef was accepted to present at the 2017 Society for Neuro-Oncology
annual meeting, where he provided an update of 58 tumors treated with
the GammaTile\TM\ technology. At a median whole group follow-up of 10.8
months, 12 patients (20 percent) had a local recurrence at an average
of 11.33 months after implant. 6- and 18-month recurrence-free survival
was 90 percent and 65 percent, respectively. Five patients had
complications, at a rate that was equal to or lower than rates
previously published for patients without access to the GammaTile\TM\
technology.
---------------------------------------------------------------------------
\151\ Youssef, E., ``C-131 Implants for Salvage Therapy of
Recurrent High Grade Gliomas,'' Society for Neuro-Oncology Annual
Meeting, November 2016.
---------------------------------------------------------------------------
In support of its assertion of a reduction in radiation necrosis,
the applicant also included discussion of a presentation by D.S.
Pinnaduwage, Ph.D., at the August 2017 annual meeting of the American
Association of Physicists in Medicine. Dr. Pinnaduwage compared the
brain radiation dose of the GammaTile\TM\ technology with other
radioactive seed sources. Iodine-125 and palladium-103 were substituted
in place of the cesium-131 seeds. The study reported findings that
other radioactive sources reported higher rates of radiation necrosis
and that ``hot spots'' increased with larger tumor size, further
limiting the use of these isotopes. The study concluded that the larger
high-dose volume with palladium-103 and iodine-125 potentially
increases the risk for radiation necrosis, and the inhomogeneity
becomes more pronounced with increasing target volume. The applicant
also cited a presentation by Dr. Pinnaduwage at the August 2018 annual
meeting of the American Association of Physicists in Medicine, in which
research findings demonstrated that seed migration in collagen tile
implantations was relatively small for all tested isotopes, with
Cesium-13 showing the least amount of seed migration.
The applicant asserted that, when considered in total, the data
reported in these presentations and studies and the intermittent data
presented in their abstracts support the conclusion that a significant
therapeutic effect results from the addition of GammaTile\TM\ radiation
therapy to the site of surgical removal. According to the applicant,
the fact that these patients had failed prior best available treatments
(aggressive surgical and adjuvant radiation management) presents the
unusual scenario of a salvage therapy outperforming the current
standard of care. The applicant noted that follow-up data continues to
accrue on these patients.
Regarding the assertion that GammaTile\TM\ reduces mortality, the
applicant stated that the use of the GammaTile\TM\ technology reduces
rates of mortality compared to alternative treatment options. The
applicant explained that studies on the GammaTile\TM\ technology have
shown improved local control of tumor recurrence. According to the
applicant, the results of these studies showed local control rates of
92 percent to 96 percent for tumor sites that had local control rates
of 0 percent from previous treatment. The applicant noted that these
studies also have not reached median progression-free survival time
with follow-up times ranging from 1 to 37 months. Previous treatment at
these same sites resulted in median progression-free survival times of
5.8 to 10.3 months.
The applicant further stated that the use of the GammaTile\TM\
technology reduces rates of radiation necrosis compared to alternative
treatment options. The applicant explained that the rate of symptomatic
radiation necrosis in the GammaTile\TM\ clinical studies of 5 to 8
percent is substantially lower than the 26 percent to 57 percent rate
of symptomatic radiation necrosis requiring re-operation historically
associated with brain brachytherapy, and lower than the rates reported
for initial treatment of similar tumors with modern external beam and
stereotactic radiation techniques. The applicant indicated that this is
consistent with the customized and ideal distribution of radiation
therapy provided by the GammaTile\TM\ technology.
The applicant also asserted that the use of the GammaTile\TM\
technology reduces the need for re-operation compared to alternative
treatment options. The applicant explained that patients receiving a
craniotomy, followed by external beam radiation therapy or
brachytherapy, could require re-operation in the following three
scenarios:
Tumor recurrence at the excision site could require
additional surgical removal;
Symptomatic radiation necrosis could require excision of
the affected tissue; and
Certain forms of brain brachytherapy require the removal
of brachytherapy sources after a given period of time.
However, according to the applicant, because of the high local
control rates, low rates of symptomatic radiation necrosis, and short
half-life of cesium-131, the GammaTile\TM\ technology will reduce the
need for re-operation compared to external beam radiation therapy and
other forms of brain brachytherapy.
Additionally, the applicant stated that the use of the
GammaTile\TM\ technology reduces the need for additional hospital
visits and procedures compared to alternative treatment options. The
applicant noted that the GammaTile\TM\ technology is placed during
surgery, and does not require any additional visits or procedures. The
applicant contrasted this improvement with external beam radiation
therapy, which is often delivered in multiple fractions that must be
administered over multiple days. The applicant provided an example
where whole brain radiotherapy (WBRT) is delivered over 2 to 3 weeks,
while the placement of the GammaTile\TM\ technology occurs during
[[Page 58662]]
the craniotomy and does not add any time to a patient's recovery.
Based on consideration of all of the previously presented data, the
applicant believed that the use of the GammaTile\TM\ technology
represents a substantial clinical improvement over existing
technologies. We noted in the proposed rule that the clinical data
submitted as of that time in connection with its application for new
technology add-on payments for FY 2021 is essentially identical to what
was submitted in connection with its application for new technology
add-on payments for FY 2020. As we indicated in previous rulemaking (84
FR 42260 through 42265), the findings presented appear to be derived
from relatively small case-studies and not data from clinical trials
conducted under an FDA-approved investigational device exemption
application. We noted that the study performed on 74 patients with 79
tumors was a single-arm and single-institution study, where each
patient functioned as their own control and the study goal was to
compare the time to local recurrence after GammaTileTM
treatment to the time of local recurrence after initial treatment of
intracranial tumors. That is, the control arm were patients treated for
initial intracranial brain tumors, and the treatment arm or the
GammaTileTM treatment arm were the same control patients now
experiencing local recurrent intracranial brain tumors in the same site
with the same brain tumor type. In this clinical trial, the applicant
compared the time from initial treatment to first local recurrence
(control arm) vs. time from GammaTileTM treatment of first
local recurrence to second local recurrence of the same brain tumor
site and tumor type. There was a statistically significant difference
between the control arm treatment and GammaTileTM treatment
for patients with recurrent meningioma and brain metastases and no
statistically significant difference between the control arm treatment
and GammaTileTM treatment for patients with recurrent high-
grade glioma.
We stated in the proposed rule that we continue to have concerns
that, while the applicant described increases in median time to disease
recurrence for certain intra-cranial tumors (in a small number of
patients with different histologies) in support of clinical
improvement, the lack of analysis, meta-analysis, or statistical tests
indicates that the clinical efficacy and safety data for seeded
brachytherapy is limited. While we acknowledged the difficulty in
establishing randomized control groups in studies involving recurrent
brain tumors, we stated that we are concerned that GammaTile\TM\
technology does not represent a substantial clinical improvement over
existing therapies and requires additional clinical data to demonstrate
substantial clinical improvement. We noted that the applicant has
stated its intention to provide additional clinical data and
information in connection with its application for new technology add-
on payments for FY 2021, potentially including an update on patient
outcomes from the completed clinical trial (ClinicalTrials.gov,
NCT03088579), additional clinical data from early adopting locations,
and additional meta-analysis to address the concerns previously raised
by CMS.
We invited public comments on whether the GammaTile TM
technology meets the substantial clinical improvement criterion.
Comment: The applicant submitted a comment providing additional
clinical data and information to support a determination of substantial
clinical improvement, including updated clinical data from the pivotal
clinical trial on GammaTile TM, additional clinical data
from early adopting clinical locations, and results from a systematic
literature review, meta-analyses, and analyses of historic controls.
The applicant submitted new data and analyses as evidence to support
GammaTile TM's substantial clinical improvement for the
treatment of three types of brain tumors: Recurrent high-grade gliomas;
recurrent meningiomas; and recurrent metastatic brain tumors. According
to the applicant, the single arm pivotal clinical trial on GammaTile
TM limited enrollment to patients who were unable to receive
other forms of radiation therapy.
The applicant included new data to show substantial clinical
improvement using GammaTile TM for recurrent high-grade
gliomas. They reported updated data from the pivotal trial
demonstrating a median overall survival (OS) of 16.7 months and a
median progression free survival (PFS) of 12.9 months for 40 patients
with high-grade gliomas receiving GammaTile TM plus
bevacizumab, with a mean follow-up time of 10.7 months. The applicant
also reported results from a meta-analysis comparing median overall
survival for recurrent high-grade gliomas with a range of comparators,
and noted the median OS using GammaTile TM plus bevacizumab,
external beam radiotherapy plus bevacizumab, bevacizumab, resection,
Optune[supreg], and best supportive care were 16.7 months, 10.1 months,
9.7 months, 7.3 months, 6.6 months, and 4.8 months, respectively. The
applicant stated there was a statistically significant difference for
GammaTile TM plus bevacizumab versus surgical resection
alone (p<0.001), as well as for GammaTile TM plus
bevacizumab versus best supportive care (p<0.001). The applicant noted
there was insufficient publicly available information to perform
statistical comparisons of GammaTile TM plus bevacizumab
versus either external beam radiotherapy plus bevacizumab or
bevacizumab alone.\152\ The applicant also conducted a systematic
literature review and selected a total of 16 articles with 695 patients
for analysis. According to the applicant, the literature review and
meta-analysis included a total of nine articles involving the treatment
of recurrent high-grade gliomas in 522 patients. Of these nine studies,
three utilized interstitial high-dose rate brachytherapy (HDR), one
utilized interstitial low-dose rate brachytherapy (LDR), one utilized
intracavitary HDR, and four utilized intracavitary LDR techniques. The
applicant stated it could not perform statistical analyses on these
outcomes due to the small number of studies and inconsistent reporting
of OS and PFS. According to the applicant, the pooled meta-analysis for
high-grade gliomas showed the mean rate of radiation necrosis requiring
surgical intervention using traditional brachytherapy was 3.0 percent
(standard error [SE]=1.0 percent),\153\ whereas in the pivotal trial
involving GammaTile TM, 0 percent of patients treated with
GammaTile TM for recurrent glioblastoma reported radiation
necrosis requiring surgical intervention.\154\
---------------------------------------------------------------------------
\152\ Brachman D, Nakaji P, Smith K, et al. Resection and
Surgically Targeted Radiation Therapy for Treatment of Recurrent
GBM. (submitted to the 2021 American Association of Neurological
Surgeons (AANS) Annual Scientific Meeting).
\153\ Choi M, Zabramski, JM. Re-irradiation Using Brachytherapy
for Recurrent Intracranial Tumors: A Systematic Review and Meta-
analysis of the Literature. (submitted to Cureus).
\154\ Brachman D, Nakaji P, Smith K, et al. Resection and
Surgically Targeted Radiation Therapy for Treatment of Recurrent
GBM. (submitted to the 2021 American Association of Neurological
Surgeons (AANS) Annual Scientific Meeting).
---------------------------------------------------------------------------
The applicant cited two abstracts submitted to the 2020 annual
Congress of Neurological Surgeons and 2020 annual meeting of the
Society for Neuro-Oncology to report updated data on GammaTile
TM treatment for recurrent meningiomas. According to the
applicant, the updated data from the single arm pivotal clinical trial
on GammaTile TM with a median follow-up of 25 months
demonstrated a 6-month
[[Page 58663]]
PFS rate of 100 percent for the 28 patients with 35 recurrent,
previously-irradiated meningioma tumors treated with surgical resection
plus GammaTile TM treatment. Additionally, the applicant
asserted that the 3-year PFS rate matches the 2-year PFS rate (72
percent and 72 percent, respectively) for the patients included in the
trial. The applicant noted that median time to progression had not been
reached (95 percent CI > 35.6 months).\155\ The applicant also noted
that individuals with recurrent meningioma tumors treated with
chemotherapeutic agents without radiation have a 6-month PFS rate of 26
percent,\156\ and those who received stereotactic radiosurgery have 3-
year PFS of 55%.\157\ The applicant stated GammaTile TM
treatment provides a substantial clinical improvement for recurrent
meningioma tumors over existing treatment options considering the
differences between reported 6-month, 2-year, and 3-year PFS rates.
---------------------------------------------------------------------------
\155\ Rogers L, Nakaji P, Youssef E, et al. Resection and
Surgically Targeted Radiation Therapy for Initial or Salvage
Treatment of Aggressive Meningioma: Results from a Prospective
Trial. (submitted to the 2020 Congress of Neurological Surgeons
(CNS) Annual Meeting); Rogers L, Nakaji P, Youssef E, et al. A
Prospective Trial of Resection and Surgically Targeted Radiation
Therapy for Initial or Salvage Treatment of Aggressive Meningioma.
(submitted to the 2020 Society for Neuro-Oncology (SNO) Annual
Meeting).
\156\ Kaley T, Barani I, Chamberlain M, et al. Historical
Benchmarks for Medical Therapy Trials in Surgery- and Radiation-
Refractory Meningioma: A RANO Review. Neuro Oncol. 2014;16:829-40.
\157\ Kim M, Lee DH, Kim Rn HJ, et al. Analysis of the results
of recurrent intracranial meningiomas treated with re-radiosurgery.
Clin Neurol Neurosurg. 2017;153:93-101.
---------------------------------------------------------------------------
The applicant noted that in the update of the GammaTile
TM pivotal trial which included 29 recurrent meningiomas,
there were statistically significant improvements in treatment site
local control achieved with resection plus GammaTile TM
versus the prior most recent treatments in the same patients. The
applicant stated local control at 24 months was 51.7 percent with prior
treatment versus 89.7 percent with GammaTile TM (hazard
ratio [HR]=0.2 [p=0.0008]).\158\ The applicant noted that the pivotal
trial showed significant improvement in prognosis for patients with
recurrent meningiomas. According to the applicant, the Cox's regression
comparing the time-to-progression of the prior therapy to that of the
GammaTile TM therapy produced a log-rank test with a p-value
of 0.0008. The applicant stated that the median time to progression was
18.3 months in the prior period, but with a median study follow-up time
of 15.4 months and only 2 failures, the median time to progression in
the GammaTile TM period had not been reached, nor was it
close.\159\ According to the applicant, it performed a pooled meta-
analysis of 16 articles with 695 patients, and included four articles
involved in the treatment of recurrent meningioma tumors in 87
patients. The applicant stated that results from the meta-analysis
showed a mean rate of radiation necrosis of 17.3 percent (SE=5.0
percent) and a mean rate of radiation necrosis requiring surgical
intervention of 11.9 percent (SE=5.3 percent),\160\ whereas in the
pivotal trial involving treatment of recurrent meningioma using
GammaTile TM, 6% of patients had radiation necrosis and 0
percent of patients had radiation necrosis requiring surgical
intervention.\161\
---------------------------------------------------------------------------
\158\ Rogers L, Nakaji P, Youssef E, et al. Resection and
Surgically Targeted Radiation Therapy for Initial or Salvage
Treatment of Aggressive Meningioma: Results from a Prospective
Trial. (submitted to the 2020 Congress of Neurological Surgeons
(CNS) Annual Meeting); Rogers L, Nakaji P, Youssef E, et al. A
Prospective Trial of Resection and Surgically Targeted Radiation
Therapy for Initial or Salvage Treatment of Aggressive Meningioma.
(submitted to the 2020 Society for Neuro-Oncology (SNO) Annual
Meeting).
\159\ Rogers L, Nakaji P, Youssef E, et al. Resection and
Surgically Targeted Radiation Therapy for Initial or Salvage
Treatment of Aggressive Meningioma: Results from a Prospective
Trial. (submitted to the 2020 Congress of Neurological Surgeons
(CNS) Annual Meeting); Rogers L, Nakaji P, Youssef E, et al. A
Prospective Trial of Resection and Surgically Targeted Radiation
Therapy for Initial or Salvage Treatment of Aggressive Meningioma.
(submitted to the 2020 Society for Neuro-Oncology (SNO) Annual
Meeting).
\160\ Choi M, Zabramski, JM. Re-irradiation Using Brachytherapy
for Recurrent Intracranial Tumors: A Systematic Review and Meta-
analysis of the Literature. (submitted to Cureus).
\161\ Rogers L, Nakaji P, Youssef E, et al. Resection and
Surgically Targeted Radiation Therapy for Initial or Salvage
Treatment of Aggressive Meningioma: Results from a Prospective
Trial. (submitted to the 2020 Congress of Neurological Surgeons
(CNS) Annual Meeting); Rogers L, Nakaji P, Youssef E, et al. A
Prospective Trial of Resection and Surgically Targeted Radiation
Therapy for Initial or Salvage Treatment of Aggressive Meningioma.
(submitted to the 2020 Society for Neuro-Oncology (SNO) Annual
Meeting).
---------------------------------------------------------------------------
The applicant cited two abstracts submitted to the 2020 annual
meeting of the Society for Neuro-Oncology Metastases and 2020 annual
Congress of Neurological Surgeons as well as an unpublished manuscript
submitted to World Neurosurgery to report updated data on GammaTile
TM treatment for recurrent brain metastases. The applicant
reported updated data from the single arm pivotal clinical trial on
GammaTile TM for 12 previously-irradiated brain metastases
treated with surgery and re-irradiation via permanently implanted
GammaTile TM brachytherapy. The applicant reported that,
with a median follow-up of 9.5 months, the median time to progression
after the prior standard of care treatments was 4.8 months (95 percent
CI; 1.9-22.0 months) and has not yet been reached after GammaTile
TM therapy (95 percent CI gives a lower limit of at least
10.9 months). The applicant stated that when looking at all patients by
tumor size, Kaplan-Meier estimated local control at 1 year for all
tumors, tumors <2.5 cm, and >2.5 cm was 83 percent, 100 percent, and 75
percent, respectively. The applicant stated that with site-level
frailty term, the HR=0.052 (p=0.0073; 95 percent CI = 0.006-0.452).
Following a systematic review of the clinical literature, the applicant
cited an MD Anderson Cancer Center postoperative resection cavity
study, which evaluated 64 patients with completed resected brain
metastases who were randomized to stereotactic radiosurgery (SRS)
versus observation, at median follow-up of 11.1 months. According to
the applicant, in the SRS arm, 1-year local control for all metastases,
small metastases (<2.5cm), and large metastases (>2.5cm) were 72
percent, 91 percent, and 40-46 percent, respectively.\162\ The
applicant asserted that compared to the MD Anderson Cancer Center
study, which was a primary cited example in guidance from the RANO
Brain Metastases Working Group, GammaTile TM treatment
offers a clear and substantial clinical improvement.
---------------------------------------------------------------------------
\162\ Mahajan A, Ahmed S, McAleer MF, et al. Post-Operative
Stereotactic Radiosurgery versus Observation for Completely Resected
Brain Metastases: A Single-Centre, Randomised, Controlled, Phase 3
Trial. Lancet Oncol. 2017;18:1040-1048; Alexander BM, Brown PD,
Ahluwalia MS, et al. Clinical Trial Design for Local Therapies for
Brain Metastases: A Guideline by the Response Assessment in Neuro-
Oncology Brain Metastases Working Group. Lancet Oncol. 2018;19:e33-
e42.
---------------------------------------------------------------------------
According to the applicant, it performed a pooled meta-analysis of
16 articles with 695 patients, and included three articles involved in
the treatment of recurrent brain metastases in 86 patients. The
applicant stated it could not perform statistical analyses on these
outcomes due to the small number of studies and inconsistent reporting
of PFS and OS. The applicant stated that results from the meta-analysis
showed mean rates of symptomatic radiation necrosis and radiation
necrosis requiring surgical intervention of 22.4 percent (SE=7.0
percent) and 10.0 percent (SE=7.3 percent), respectively,\163\ whereas
in the pivotal trial involving GammaTile TM, 8 percent and 0
percent of patients treated with
[[Page 58664]]
GammaTile TM for recurrent brain metastases reported
symptomatic radiation necrosis and radiation necrosis requiring
surgical intervention, respectively.\164\
---------------------------------------------------------------------------
\163\ Choi M, Zabramski, JM. Re-irradiation Using Brachytherapy
for Recurrent Intracranial Tumors: A Systematic Review and Meta-
analysis of the Literature. (submitted to Cureus).
\164\ Brachman D, Nakaji P, Smith K, et al. A Prospective Trial
of Resection Plus Surgically Targeted Radiation Therapy for Brain
Metastasis. (accepted to 2020 Society for Neuro-Oncology (SNO)
Metastasis Annual Meeting; Nakaji P, Youssef E, Smith K, et al. A
Prospective Trial of Resection Plus Surgically Targeted Radiation
Therapy for Brain Metastasis. (submitted to the 2020 Congress of
Neurological Surgeons (CNS) Annual Meeting); Nakaji P, Smith K,
Youssef E, et al. A Prospective Trial of Resection Plus Surgically
Targeted Radiation Therapy for Brain Metastasis. (submitted to World
Neurosurgery).
---------------------------------------------------------------------------
The applicant noted that in the update of the GammaTile
TM pivotal trial which included 12 recurrent brain
metastases, there were statistically significant improvements in
treatment site local control achieved with resection plus GammaTile
TM versus the prior most recent treatments in the same
patients. The applicant stated local control at 6 months was 41.7
percent with prior treatment versus 100 percent with resection plus
GammaTile TM; at 12 months, local control was 33.3 percent
with prior treatment versus 83.3 percent with resection plus GammaTile
TM (HR=0.052 [p = 0.0073]).\165\ The applicant noted that
the pivotal trial showed significant improvement in prognosis for
patients with recurrent brain metastases. According to the applicant,
the Cox's regression comparing the time-to-progression of the prior
therapy to that of the GammaTile TM therapy produced a log-
rank test with a p-value of 0.0073. The applicant stated that the
median time to progression was 4.8 months in the prior period, but with
a median study follow-up time of 9.5 months and only 1 failure, the
median time to progression in the GammaTile TM period had
not been reached, nor was it close.\166\
---------------------------------------------------------------------------
\165\ Brachman D, Nakaji P, Smith K, et al. A Prospective Trial
of Resection Plus Surgically Targeted Radiation Therapy for Brain
Metastasis. (accepted to 2020 Society for Neuro-Oncology (SNO)
Metastasis Annual Meeting; Nakaji P, Youssef E, Smith K, et al. A
Prospective Trial of Resection Plus Surgically Targeted Radiation
Therapy for Brain Metastasis. (submitted to the 2020 Congress of
Neurological Surgeons (CNS) Annual Meeting); Nakaji P, Smith K,
Youssef E, et al. A Prospective Trial of Resection Plus Surgically
Targeted Radiation Therapy for Brain Metastasis. (submitted to World
Neurosurgery).
\166\ Brachman D, Nakaji P, Smith K, et al. A Prospective Trial
of Resection Plus Surgically Targeted Radiation Therapy for Brain
Metastasis. (accepted to 2020 Society for Neuro-Oncology (SNO)
Metastasis Annual Meeting; Nakaji P, Youssef E, Smith K, et al. A
Prospective Trial of Resection Plus Surgically Targeted Radiation
Therapy for Brain Metastasis. (submitted to the 2020 Congress of
Neurological Surgeons (CNS) Annual Meeting); Nakaji P, Smith K,
Youssef E, et al. A Prospective Trial of Resection Plus Surgically
Targeted Radiation Therapy for Brain Metastasis. (submitted to World
Neurosurgery).
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The applicant stated that it conducted a survey of 27 early
adopters at 14 institutions who were involved in 51 commercial cases
involving use of the GammaTile TM device for treatment of
recurrent brain tumors. The applicant asserted that the survey reported
an overall adverse event/complication rate occurring during the 30 days
following surgery of 3.8 percent, below the expected complication rate
ranging from 9-40 percent that has been reported for intracranial
neoplasm surgery.\167\
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\167\ Brachman DG, Youssef E, Dardis CJ, et al. Resection and
Permanent Intracranial Brachytherapy Using Modular, Biocompatible
Cesium-131 Implants: Results in 20 Recurrent, Previously Irradiated
Meningiomas. J Neurosurg. 2018;131:1819-1828; Ferreira C, Parham A,
Chen C, et al. First Experience with GammaTile Permanent Implants
for Recurrent Brain Tumors. Neuro-Oncology. 2019;i:216; Wong JM,
Panchmatia JR, Ziewacz JE, et al. Patterns in Neurosurgical Adverse
Events: Intracranial Neoplasm Surgery. Neurosurg Focus. 2012;33:E16;
Brachman D, Youssef E, Dardis C, et al. Surgically Targeted
Radiation Therapy: Safety Profile of Collagen Tile Brachytherapy in
79 Recurrent, Previously Irradiated Intracranial Neoplasms on a
Prospective Clinical Trial. Brachytherapy, An International
Multidisciplinary Journal. 2019;18:S35-S36.
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The applicant also claimed that GammaTile TM therapy
provides a substantial clinical improvement because use of GammaTile
TM therapy leads to a substantially decreased number of
future visits to radiation oncology centers and to more rapid
resolution of adjuvant radiation therapy treatment. According to the
applicant, as the only truly available adjuvant radiation therapy for
recurrent brain tumors that can be administered at the time of surgical
excision, GammaTile TM provides individuals access to
adjuvant radiation therapy who otherwise are unable or unlikely to
return for multiple follow-up visits for other forms of radiation
therapy. According to the applicant, this substantial clinical
improvement is critically important for many Medicare beneficiaries who
live in distant rural areas and individuals in low-income households
who are unlikely to return for follow-up due to socio-economic factors,
and for individuals who are fearful or at high-risk if exposed to
COVID-19 while traveling on public transportation, staying in hotels,
or otherwise participating in follow-up radiation therapy visits.
The applicant further stated that CMS data demonstrates the unique
ICD-10-PCS code for GammaTileTM that maps to MS-DRG 023
results in significantly more reimbursement for large, urban academic
institutions as compared to smaller, community-based non-academic
hospitals. The applicant asserted that approving new technology add-on
payments for GammaTileTM will enable adoption in community
and non-urban hospitals, improving both access to care and outcomes for
patients by leveling the playing field for all institutions.
Other commenters expressed their support for GammaTileTM
meeting the substantial clinical improvement criterion. Several
commenters noted that GammaTileTM provides a safe and
effective treatment option for a patient population that is in great
need of new treatment options, especially given that individuals with
recurrent brain cancer often are poor candidates for other forms of
repeat same-site irradiation. Several commenters stated there was a
growing body of evidence confirming that GammaTileTM therapy
is well tolerated and improves local tumor control and survival.
Some commenters stated their direct experience with
GammaTileTM therapy has been positive, and that they have
seen lower complication rates than would otherwise be expected in these
complex patients who are at higher risk for complications due to their
prior treatments. A commenter referenced studies demonstrating the
clinical outcomes involving the recurrent tumor (treated with
GammaTileTM) exceeded the outcomes achieved during the prior
attempt to treat the tumor in the same patient. The commenter noted the
superior outcomes with GammaTileTM occurred despite the fact
that recurrent tumors are known to be more aggressive and faster
moving, and also despite the fact that the patients were older at the
time of recurrence.
Some commenters suggested that GammaTileTM therapy
reduces the physical and financial burden of treatment for brain tumor
patients by reducing the number of physician visits required for
radiation therapy. Some commenters also noted that the ``one-and-done''
aspect of GammaTileTM therapy reduces caregiver burden and
provides a radiation treatment option that minimizes the need for
exposure to other individuals during travel and participation in
follow-up visits, which is especially important during the ongoing
COVID-19 public health emergency. Several commenters asserted that
GammaTileTM therapy ensures 100 percent patient compliance
since it is implanted at the time of surgery. A commenter noted their
support for patient access to GammaTileTM because of the
large proportion of their cancer center patients who travel well over
an hour from their home to receive post-
[[Page 58665]]
resection radiation treatments, and having to travel that far has a
negative impact on patient compliance.
Response: We thank the commenters for their comments, including the
updated data and additional analyses provided by the applicant to
address the concerns discussed in the proposed rule.
After further review, including review of the additional clinical
data and information submitted by the applicant, CMS continues to have
concerns with respect to whether GammaTileTM meets the
substantial clinical improvement criterion for approval for new
technology add-on payments. While the updated pivotal trial data
provided by the applicant in its comment compared the treatment of the
recurrent tumor with GammaTileTM to the prior most recent
treatments in the same patients for all three tumor types, we have
concerns that a primary tumor and tumor recurrence may not be
comparable diseases and therefore question whether the pivotal trial
data is appropriate for the purposes of evaluating substantial clinical
improvement. Furthermore, the applicant provided data from abstracts
and an unpublished manuscript submitted for publication to report
updated data on the GammaTileTM pivotal trial for recurrent
meningiomas and recurrent brain metastases, but did not provide
statistical data or meta-analyses that demonstrate significant efficacy
of GammaTileTM when compared to conventional radiation
therapy. The applicant also performed a meta-analysis for each of the 3
cancer sub-types, which showed the only improvement in overall survival
for patients treated with GammaTileTM was for those with
high-grade gliomas when treated in combination with bevacizumab when
compared to surgery alone, but not other modalities. The meta-analyses
looking at recurrent meningiomas and recurrent brain metastases did not
show statistically significant improvements in clinical outcomes.
Furthermore, the authors of the systematic literature review and meta-
analyses noted the limitations of the study, including the small number
of studies available on same site reirradiation using brachytherapy for
recurrent brain tumors. Moreover, the vast majority of studies included
in the literature review and meta-analyses included no randomization
and no control group in their study designs. While the applicant
provided summary results for the meta-analyses showing outcomes for
GammaTileTM when compared to existing treatments (as well as
the studies used), we have concerns that we are unable to determine
superiority for GammaTileTM without any data analysis and
methods for these meta-analyses.
After review of all data received to date, we continue to have the
same concerns as noted in the FY 2020 final rule and the FY 2021
proposed rule, discussed previously. Therefore, based on the
information stated above, we are unable to make a determination that
GammaTileTM technology represents a substantial clinical
improvement over existing therapies, and we are not approving new
technology add-on payments for the GammaTileTM for FY 2021.
g. Hemospray[supreg] Endoscopic Hemostat
Cook Medical submitted an application for new technology add-on
payments for the Hemospray [supreg] Endoscopic Hemostat (Hemospray) for
FY 2021. According to the applicant, Hemospray is indicated by the FDA
for hemostasis of nonvariceal gastrointestinal bleeding. Using an
endoscope to access the gastrointestinal tract, the Hemospray delivery
system is passed through the accessory channel of the endoscope and
positioned just above the bleeding site without making contact with the
GI tract wall. The Hemospray powder, bentonite, is propelled through
the application catheter, either a 7 or 10 French polyethylene
catheter, by release of CO2 from the cartridge located in
the device handle and sprayed onto the bleeding site. According to the
applicant, bentonite can rapidly absorb 5 to 10 times its weight in
water and swell up to 15 times its dry volume, becoming cohesive to
itself and adhesive to tissue forming a physical barrier to aqueous
fluid (for example, blood). Hemospray powder is not absorbed by the
body and does not require removal as it passes through the GI tract
within 72 hours. Hemospray is single-use and disposable.
According to the applicant, current standard of care hemostatic
modalities used for the management of nonvariceal gastrointestinal
bleeding have a failure rate of 8 to 15 percent and a rebleeding rate
of 10 to 25 percent, or worse, depending on patient etiology and
morbidity.\168\ The applicant asserted that the risk of morbidity,
mortality, and rebleeding can be predicted using validated scoring
methods such as the Rockall Score (RS).\169\ Cancerous lesions, which
are more frequently identified as a result of advances in locating and
determining the cause of bleeding,\170\ have lower rates of hemostasis
(as low as 40 percent), with higher recurrent bleeding rates (over 50
percent within 1 month), with high 3 month mortality.\171\ \172\
Continued bleeding that is not controlled by conventional techniques,
or recurrent bleeding from the same lesion, may be treated by repeated
attempts at endoscopic hemostasis, interventional radiology hemostasis
(IRH) with guided transarterial embolization (TAE), or surgery.\173\
According to the applicant, a recent systematic review found minimally
invasive rescue options like TAE had re-bleeding rates that were higher
than those from surgery with no significant difference in
mortality.\174\ According to the applicant, patients who are not
surgical candidates have very few options for ``rescue'' when
conventional hemostasis techniques fail.
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\168\ Lau J, Barkun A, Fan D, Kuipers E, Yang Y, Chan F.
Challenges in the management of acute peptic ulcer bleeding. Lancet
2013; 381: 2033-43.
\169\ Mokhtare M, Bozorgi V, Agah S et al. Comparison of
Glasgow-Blatchford score and full Rockall score systems to predict
clinical outcomes in patients with upper gastrointestinal bleeding.
Clin. Exp. Gastroenterol. 2016; 9: 337-43.
\170\ Heller SJ, Tokar JL, Nguyen MT, et al. Management of
bleeding GI tumors. Gastrointest Endosc 2010;72:817-24.
\171\ Kim YI, Choi IJ, Cho SJ, et al. Outcome of endoscopic
therapy for cancer bleeding in patients with unresectable gastric
cancer. J Gastroenterol Hepatol 2013;28:1489-95.
\172\ Roberts SE, Button LA, Williams JG. Prognosis following
upper gastrointestinal bleeding. PLoS One 2012;7:e49507.
\173\ Lau JY, Sung JJ, Lam YH, et al. Endoscopic retreatment
compared with surgery in patients with recurrent bleeding after
initial endoscopic control of bleeding ulcers. N Engl J Med 1999;
340: 751-756.
\174\ Beggs AD, Dilworth MP, Powell SL, et al. A systematic
review of transarterial embolization versus emergency surgery in
treatment of major nonvariceal upper gastrointestinal bleeding. Clin
Exp Gastroenterol 2014; 7: 93-104.
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The applicant asserted that, in addition to increased morbidity and
mortality, the financial impact of failure to achieve hemostasis is
considerable. Based on a retrospective claims analysis by the applicant
of the 2012 MedPAR file and the Provider of Services file, 13,501 cases
were identified which showed all-cause mortality for patients requiring
more than 1 endoscopy (6%), IRH (9%), or surgery (14%) was
significantly higher than for patients requiring only 1 endoscopy
(3%).\175\ The median hospital costs for these patients were
considerable, with costs for patients requiring over 1 endoscopy of
$20,055, for patients requiring IRH of $34,730, and for patients
requiring surgery of $47,589. According to the applicant, Hemospray is
an alternative to IRH and surgery and the applicant
[[Page 58666]]
asserts it would avoid the costs associated with these procedures.
---------------------------------------------------------------------------
\175\ Roy A, Kim M, Hawes R, Varadarajulu S. The clinical and
cost implications of failed endoscopic hemostasis in gastroduodenal
ulcer bleeding. UEG Journal 2017; 5(3): 359-364.
---------------------------------------------------------------------------
With respect to the newness criterion, the applicant for Hemospray
was granted a FDA de novo classification request on May 7, 2018. The
applicant stated revisions to the instructions for use were required by
the FDA and therefore the device was not commercially available until
July 1, 2018. The FDA has classified Hemospray as a Class II device for
intraluminal gastrointestinal use. The applicant submitted a request
for approval for a unique ICD-10-PCS code for the administration of
Hemospray beginning in FY 2021 and was granted approval for the
following procedure codes: XW0G886 (Introduction of mineral-based
topical hemostatic agent into upper GI, via natural or artificial
opening endoscopic, new technology group 6) and XW0H886 (Introduction
of mineral-based topical hemostatic agent into lower GI, via natural or
artificial opening endoscopic, new technology group 6).
According to information submitted by the applicant, Cook Medical
recalled Hemospray [supreg] Endoscopic Hemostat due to complaints
received that the handle and/or activation knob on the device in some
cases has cracked or broken when the device is activated and in some
cases has caused the carbon dioxide cartridge to exit the handle. The
applicant stated that Cook Medical received 1 report of a superficial
laceration to the user's hand that required basic first aid; however,
there have been no reports of laceration, infection, or permanent
impairment of a body structure to users or to patients due to the
carbon dioxide cartridge exiting the handle. The applicant stated that
Cook Medical initiated an investigation to determine the appropriate
corrective action(s) to prevent recurrence of this issue. According to
the applicant, although the recall did restrict availability of the
device, they wished to continue their application for new technology
add-on payment as they believe the use of Hemospray significantly
improves clinical outcomes for certain patient populations compared to
currently available treatments.
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. The applicant
identified three treatment options currently available for the
treatment of bleeding of the gastrointestinal system, which were
thermal modalities, injection needles, and mechanical modalities. The
applicant stated that thermal modalities are those endoscopic methods
that treat gastrointestinal hemorrhage by means of bipolar
electrocautery, hemostatic graspers, and argon plasma coagulation.
These devices generate heat resulting in edema, coagulation of tissue
protein, and contraction of vessels and indirect activation of the
coagulation cascade. The applicant stated that injection needles treat
gastrointestinal hemorrhage through the injection of various materials
including epinephrine, saline, histoacryl, ethanolamine, and ethanol.
This method achieves hemostasis by both mechanical tamponade and
cytochemical mechanisms.\176\ The applicant stated that mechanical
modalities including hemostatic endoclips, detachable loop ligators and
multi-band ligators control gastrointestinal hemorrhage by applying
mechanical pressure to the bleeding site. The applicant claimed these
treatment options (thermal modalities, injection needles, and
mechanical modalities) are insufficient in achieving hemostasis as
evidenced by rates of failed hemostasis of 8 to 15 percent.\177\ The
applicant stated that all the current treatments result in injury to
the tissue, which in some cases can result in a worsening of the
severity of the bleeding or perforation. Furthermore, it stated that
with the exception of argon plasma coagulation, the current hemostatic
modalities require precise targeting of the source of the bleed, which
may limit their utility when diffuse or non-precise bleeding occurs.
According to the applicant, the primary benefit of all endoscopic
hemostasis procedures, including Hemospray, is the achievement of
hemostasis without conversion to interventional radiology or surgery,
both of which carry higher risk of mortality and morbidity.\178\
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\176\ ASGE, The role of endoscopy in the management of acute
non-variceal upper GI bleeding, Gastrointestinal Endoscopy. 2012;
75(6): 1132-1138.
\177\ Lau J, Barkun A, Fan D, Kuipers E, Yang Y, Chan F.
Challenges in the management of acute peptic ulcer bleeding. Lancet
2013; 381: 2033-43.
\178\ Beggs AD, Dilworth MP, Powell SL, et al. A systematic
review of transarterial embolization versus emergency surgery in
treatment of major nonvariceal upper gastrointestinal bleeding. Clin
Exp Gastroenterol 2014; 7: 93-104.
---------------------------------------------------------------------------
With regard to the first criterion, whether a product uses the same
or similar mechanism of action to achieve a therapeutic outcome, the
application asserted that Hemospray is a novel device in which the
mechanism of action differs from alternative treatments by creating a
diffuse mechanical barrier over the site of bleeding with a non-
thermal, non-traumatic, noncontact modality.
With respect to the second criterion, whether a product is assigned
to the same or different MS-DRG, the applicant did not specifically
comment. The applicant stated that cases involving the use of Hemospray
would span a wide variety of MS-DRGs, but that the technology would
most likely be used for cases in MS-DRGs 377, 378, and 379 (G.I.
Hemorrhage with MCC, with CC, and without CC/MCC, respectively). We
believe that cases involving the use of the technology would be
assigned to the same MS-DRG as cases involving the current standard of
care treatments.
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 noted that the
applicant also did not comment specifically on this criterion. However,
we noted that we believed that this technology would be used to treat
the same or similar type of disease and the same or similar patient
population as the current standard of care treatments.
Based on the applicant's statements as summarized previously, the
applicant believed that Hemospray was not substantially similar to
other currently available therapies and/or technologies and met the
``newness'' criterion. However, we stated in the proposed rule that we
were concerned that the mechanism of action of Hemospray may be similar
to existing endoscopic hemostatic treatments. Specifically, we noted
that as described in literature provided by the applicant, technologies
such as Ankaferd Bloodstopper and EndoClot Polysaccharide Hemostatic
System appeared to utilize a similar mechanism of action as Hemospray
to achieve hemostasis.\179\ Based on the literature provided by the
applicant, EndoClot, a device developed in California, USA, ``. . .
consists of absorbable modified polymer . . . [which is] biocompatible,
non-pyogenic, and starch-derived compound that rapidly absorbs water
from serum and concentrates platelets, red blood cells, and coagulation
proteins at the bleeding site to accelerate the clotting cascade.''
\180\ EndoClot received 510(k) premarket notification January 18, 2017
and is indicated by the FDA to assist the delivery of a powdered
hemostatic agent to the treatment site in endoscopic
[[Page 58667]]
surgeries. Therefore, we were concerned with the similarity of this
mechanism of action. Moreover, as previously noted, the applicant
asserted generally it did not meet the substantial similarity criteria,
but did not specifically address the second and third substantial
similarity criteria. We believed that cases involving the use of the
Hemospray would be assigned to the same MS-DRG as cases involving the
current standard of-care treatments and that the technology would be
used to treat the same or similar type of disease and the same or
similar patient population as the current standard-of-care treatments.
We invited public comments on whether Hemospray is substantially
similar to other currently available therapies and/or technologies and
whether this technology meets the newness criterion.
---------------------------------------------------------------------------
\179\ Barkun, A., Moosavi, S., & Martel, M. (2013). Topical
hemostatic agents: A systematic review with particular emphasis on
endoscopic application in GI bleeding. Gastrointestinal Endoscopy,
77(5), 692-700.
\180\ Ibid.
---------------------------------------------------------------------------
Comment: The applicant reasserted that Hemospray meets the newness
criterion because of the FDA de Novo classification, which according to
the applicant confirms there is no comparable predicate hemostasis
device cleared for use in the United States. The applicant stated that
both the Ankaferd Blood Stopper (ABS) and EndoClot systems are not
cleared for use in the United States with the latter only having
clearance for the delivery system and for a product intended for
submucosal injection.
In regard to the first substantial similarity criterion, the
applicant stated that Hemospray has a different mechanism of action as
compared to ABS and the EndoClot systems which are, according to the
applicant, comprised of biologically active materials or absorbable
polysaccharides. The applicant stated that ABS uses an active process
related to proteins, via the formation of an encapsulated protein
network that provides focal points for vital erythrocyte aggregation,
that is substantially different from Hemospray. The applicant then
stated with regard to EndoClot that the product produces a gelled
matrix that adheres to and seals bleeding tissue; according to the
applicant EndoClot substantially differs from Hemospray in its
composition and properties that permit dissolution and degradation.
Furthermore, the applicant stated that labeling in markets where
EndoClot is commercially available limits its use to non-bleeding
wounds within the GI tract, while Hemospray is indicated for active
bleeding.
With regard to the second substantial similarity criterion, the
applicant maintained that currently all control of GI bleeding no
matter the treatment is typically grouped to MS-DRGs 377, 378, and 379.
With regard to the third substantial similarity criterion, the
applicant stated that Hemospray will treat the same or similar type of
disease and a similar patient population. They added that the unique
features of the product differ substantially from other treatments and
therefore, Hemospray meets the newness criterion.
Response: After consideration of the public comments we received
and information submitted by the applicant in its application, we
believe that while potential cases representing patients who may be
eligible for treatment involving Hemospray would be assigned to the
same MS-DRGs as cases representing patients who receive SOC treatment
for a diagnosis of nonvariceal gastrointestinal bleeding, and that
Hemospray is used to treat the same or similar type of disease (a
diagnosis of nonvariceal gastrointestinal bleeding) and a similar
patient population as currently available treatment options, we agree
with the applicant that Hemospray does not use the same or similar
mechanism of action as other technologies used for the treatment of
nonvariceal gastrointestinal bleeding. We believe that Hemospray's
mechanism of action, which creates a diffuse mechanical barrier over
the site of bleeding with a non-thermal, non-traumatic, non-contact
modality, is unique and distinct from other forms of treatment
available in the U.S. for nonvariceal gastrointestinal bleeding and,
therefore, we believe that Hemospray meets the newness criterion. We
consider the beginning of the newness period to commence on the first
date Hemospray was commercially available, July 1, 2018.
With regard to the cost criterion, the applicant provided the
following analysis to demonstrate the technology meets the cost
criterion. The applicant asserted patients who would use Hemospray are
identified by using a combination of one ICD-10-PCS procedure code and
one ICD-10-CM diagnosis code. The applicant provided a list of 39 ICD-
10-PCS procedure codes that included 21 Non O.R. digestive system
procedures and 18 Extensive O.R. digestive system procedures. The
applicant provided a list of 32 ICD-10-CM diagnosis codes that included
29 principal diagnoses in MS-DRGs 377, 378, and 379 (G.I. Hemorrhage
with MCC, with CC, and without CC/MCC, respectively) and 3 principal
diagnoses in MDC 06 (Diseases and Disorders of the Digestive System)
across 10 MS-DRG classifications. The applicant extracted claims from
the FY 2018 MedPAR final rule dataset based on the presence of one
procedure and one diagnosis code in the list provided. The applicant
stated MS-DRGs 377, 378, and 379 made up 3 of the top 4 MS-DRGs by
volume and about 64 percent of cases were grouped to these 3 MS-DRGs.
The applicant stated consequently they limited their analysis to the
cases assigned to MS-DRGs 377, 378, and 379 and those claims that would
be used for IPPS rate setting. The applicant identified a total of
40,012 cases.
The applicant first calculated a case weighted threshold of $46,568
based upon the dollar threshold for each MS-DRG grouping and the
proportion of cases in each MS-DRG. The applicant then calculated the
average charge per case. The applicant stated Hemospray may not replace
other therapies occurring during an inpatient stay and therefore chose
to not remove charges for the prior technology or technology being
replaced. Next the applicant calculated the average standardized charge
per case using the FY 2018 IPPS Final Rule Impact file. The 2-year
inflation factor of 11.1% (1.11100) was obtained from the FY 2020 IPPS/
LTCH PPS final rule and applied to the average standardized charge per
case. To determine the charges for Hemospray, the applicant used the
inverse of the FY 2020 IPPS/LTCH PPS final rule supplies and equipment
national average CCR of 0.299, based on an assumption that hospitals
would use the inverse of the national average CCR for supplies and
equipment to mark-up charges, and therefore assumed an average charge
for Hemospray of $8,361.20. The applicant calculated the final inflated
average case-weighted standardized charge per case by adding the
charges for the new technology to the inflated average standardized
charge per case. The applicant determined a final inflated average
case-weighted standardized charge per case of $60,193, which exceeds
the average case-weighted threshold amount of $46,568. We invited
public comments on whether Hemospray meets the cost criterion.
Comment: The applicant maintained that Hemospray meets the cost
criterion as the inflated average case-weighted standardized charge per
case of $60,193 exceeds the average case-weighted threshold amount of
$46,568. The applicant stated that they did not remove the costs for
other devices because some physicians may choose to use Hemospray in
conjunction with endoscopic clips or thermal coagulation.
Response: We appreciate the applicant's comment in response to the
[[Page 58668]]
proposed rule. Based on the cost analysis as described previously and
after consideration of public comments we received, we believe
Hemospray meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that Hemospray represents a substantial clinical
improvement over existing technologies. According to the applicant,
Hemospray is a topically applied mineral powder that offers a novel
primary treatment option for endoscopic bleeding management, serves as
an option for patients who fail conventional endoscopic treatments, and
serves as an alternative to interventional radiology hemostasis (IRH)
and surgery. Broadly, the applicant outlined two treatment areas in
which it asserted Hemospray would provide a substantial clinical
improvement: (1) As a primary treatment or a rescue treatment after the
failure of a conventional method, and (2) for the treatment of
malignant lesions.
The applicant provided eight articles specifically for the purpose
of addressing the substantial clinical improvement criterion. Three
articles are systematic reviews, three are prospective studies, and two
are retrospective studies.
The first article provided by the applicant was a prospective
single armed multicenter phase two safety and efficacy study performed
in France.\181\ From March 2013 to January 2015, 64 endoscopists in 20
centers enrolled 202 patients in the study in which Hemospray was used
as either a first line treatment (46.5%) or as salvage therapy (53.5%)
following the unsuccessful treatment with another method. The
indication for Hemospray as a first-line therapy or salvage therapy was
at the discretion of the endoscopist. Of the 202 patients the mean age
was 68.9, 69.3 percent were male, and all patients were classified into
four primary etiologic groups: Ulcers (37.1%), malignant lesions
(30.2%), post-endoscopic bleeding (17.3%), and other (15.3%). Patients
were further classified by the American Society of Anesthesiologist
(ASA) physical status scores with 4.5 percent as a normal healthy
patient, 24.3 percent as a patient with mild systemic disease, 46
percent as a patient with severe systemic disease, 22.8 percent as a
patient with severe systemic disease that is a constant threat to life,
and 2.5 percent as a moribund patient who is not expected to survive
without an operation.182 183 Immediate hemostasis was
achieved in 96.5 percent across all patients; among treatment subtypes
immediate hemostasis was achieved in 96.8 percent of first-line treated
patients and 96.3 percent of salvage therapy patients. At day 30 the
overall rebleeding was 33.5 percent of 185 patients with cumulative
incidences of 41.4 percent for ulcers, 37.7 percent for malignant
lesions, 17.6 percent for post-endoscopic bleedings, and 25 percent for
others. When Hemospray was used as a first-line treatment, rebleeding
at day 30 occurred in 26.5 percent (22/83) of overall lesions, 30.8
percent of ulcers, 33.3 percent of malignant lesions, 13.6 percent of
post-endoscopic bleedings, and 22.2 percent of other. When Hemospray
was used as a salvage therapy, rebleeding at day 30 occurred in 39.2
percent (40/102) of overall lesions, 43.9 percent of ulcers, 50.0
percent of malignant lesions, 25.0 percent of post-endoscopic
bleedings, and 26.3 percent for others. According to the article, the
favorable hemostatic results seen from Hemospray are due to its
threefold mechanism of action: Formation of a mechanical barrier;
concentration of clotting factors at the bleeding site; and enhancement
of clot formation.\184\ No severe adverse events were noted; however,
the authors note the potential for pain exists due to the use of carbon
dioxide. Lastly, the authors stated that while Hemospray was found to
reduce the need for radiological embolization and surgery as salvage
therapies, it was not found to be better than other hemostatic methods
in terms of preventing rebleeding of ulcers.
---------------------------------------------------------------------------
\181\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
\182\ Ibid.
\183\ ASA House of Delegates/Executive Committee. (2014, October
15). ASA Physical Status Classification System. Retrieved from
American Society of Anesthesiologists: https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system.
\184\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
---------------------------------------------------------------------------
A second article provided by the applicant contained a systematic
review of published Hemospray case data summarizing 17 human and 2
animal studies.\185\ The authors do not provide the total number of
articles reviewed but do provide search terms and engines used to
conduct the review. The studies included in this review included 6 case
reports and 13 case series taking place in North America, Europe, Hong
Kong, and Egypt up until August 2014. A total of 234 cases were
identified of which 28.2 percent involved gastric bleeding, 6.4 percent
esophageal bleeding, 26.5 percent duodenal bleeding, 3.85 percent
bleeding of the gastroesophageal junction, and 11 percent bleeding of
the lower gastrointestinal tract. (We note it is unclear what form of
bleeding the remaining 24.1 percent of cases addressed.) The mean size
of the bleeding source was 37.4 mm ranging from 8 mm to 350 mm.
Hemospray was used as a primary and sole treatment in 83 percent of
cases while 17 percent of cases used Hemospray as a follow-up
treatment. Hemospray achieved hemostasis in 88.5 percent of all
reviewed cases. Within the 72 hour post-treatment period, rebleeding
occurred in 16.2 percent of patients and 27.3 percent of animal models.
The authors acknowledge the potential for rare adverse events such as
embolism, intestinal obstruction, and allergic reaction, but state no
procedure related adverse events were associated with Hemospray-.\186\
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\185\ Changela K, Papafragkakis H, Ofori E, et al. Hemostatic
powder spray: a new method for managing gastrointestinal bleeding.
Ther Adv Gastroenterol 2015; 8(3): 125-135.
\186\ Ibid.
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The applicant provided a third article consisting of an abstract
from another systematic review article.\187\ The abstract purports to
cover a review of prospective, retrospective, and randomized control
trials evaluating Hemospray as a rescue therapy. Eighty-five articles
were initially identified and 23 were selected for review. Of those, 5
studies were selected which met the inclusion criteria of the analysis.
The median age of patients was 69, 68 percent were male. The abstract
concludes that when used as a rescue therapy after the failure of
conventional endoscopic modalities, in nonvariceal gastrointestinal
bleeding, Hemospray seems to have significantly higher rates of
immediate hemostasis.
---------------------------------------------------------------------------
\187\ Moole, V., Chatterjee, T., Saca, D., Uppu, A., Poosala,
A., & Duvvuri, A. A Systematic review and meta-analysis: analyzing
the efficacy of hemostatic nanopowder (TC-325) as rescue therapy in
patients with nonvariceal upper gastrointestinal bleeding.
Gastroenterology 2019; 156(6), S-741.
---------------------------------------------------------------------------
A fourth article provided by the applicant described a single-arm
retrospective analytical study of 261 enrolled patients conducted at 21
hospitals in Spain.\188\ The mean age was 67 years old, 69 percent of
patients were male, and the overall technical success, defined as
correct assembly and delivery of Hemospray to a bleeding lesion, was
97.7 percent (95.1%-
[[Page 58669]]
99.2%). The most common causes of bleeding in patients were peptic
ulcer (28%), malignancy (18.4%), therapeutic endoscopy-related (17.6%),
and surgical anastomosis (8.8%). Overall, 93.5 percent (89.5%-96%) of
procedures achieved hemostasis. Recurrent bleeding, defined as (1) a
new episode of bleeding symptoms, (2) a decrease in hemoglobin of >2 g/
dL within 48 hours of an index endoscopy or > 3g/dL in 24 hours, or 3)
direct visualization of active bleeding at the previously treated
lesion on repeat endoscopy, had a cumulative incidence at 3 and 30 days
of 16.1 percent (11.9%-21%) and 22.9 percent (17.8%-28.3%)
respectively. The overall risk of Hemospray failure at 3 and 30 days
was 21.1 percent (16.4%-26.2%) and 27.4 percent (22.1%-32.9%)
respectively with no statistically significant differences (p = 0.07)
between causes at 30 days (for example peptic ulcer, malignancy,
anastomosis, therapeutic endoscopy-related, and other causes). With the
use of multivariate analysis, spurting bleeding vs. nonspurting
bleeding (subdistribution hazard ratio [sHR] 1.97 (1.24-3.13)),
hypotension vs. normotensive (sHR 2.14 (1.22-3.75)), and the use of
vasoactive drugs (sHR 1.80 (1.10-2.95)) were independently associated
with Hemospray failure. The overall 30-day survival was 81.9 percent
(76.5%-86.1%) with 46 patients dying during follow-up and 22
experiencing bleeding related deaths; 20 patients (7.6%) with
intraprocedural hemostasis died before day 30. The authors indicated
the majority of Hemospray failures occurred within the first 3 days and
the rate of immediate hemostasis was similar to literature reports of
intraprocedural success rates of over 90 percent. The authors stated
that the hemostatic powder of Hemospray is eliminated from the GI tract
as early as 24 hours after use, which could explain the wide ranging
recurrent bleeding percentage. The authors reported that importantly,
adverse events are rare, but cases of abdominal distension, visceral
perforation, transient biliary obstruction, and splenic infarct have
been reported; one patient involved in this study experienced an
esophageal perforation without a definitive causal relationship.
---------------------------------------------------------------------------
\188\ Rodriguez de Santiago E, Burgos-Santamaria D, Perez-Carazo
L, et al. Hemostatic spray TC-325 for GI bleeding in a nationwide
study: survival analysis and predictors of failure via competing
risks analysis. Gastrointest Endosc 2019; 90(4), 581-590.
---------------------------------------------------------------------------
A fifth article provided by the applicant described a single-arm
multicenter prospective registry involving 314 patients in Europe which
collected data on days 0, 1, 3, 7, 14, and 30 after endotherapy with
Hemospray.\189\ The outcomes of interest in this study were immediate
endoscopic hemostasis (observed cessation of bleeding within 5 minutes
post Hemospray application) with secondary outcomes of rebleeding
immediately following treatment and during follow-up, 7 and 30 day all-
cause mortality, and adverse events. The sample was 74 percent male
with a median age of 71 with the most common pathologies of peptic
ulcer (53%), malignancy (16%), post-endoscopic bleeding (16%), bleeding
from severe inflammation (11%), esophageal variceal bleeding (2.5%),
and cases with no obvious cause (1.6%). The median baseline Blatchford
score (BS) and RS were 11 and 7 respectively. The BS ranges from 0 to
23 with higher scores indicating increasing risk for required
endoscopic intervention and is based upon the blood urea nitrogen,
hemoglobin, systolic blood pressure, pulse, presence of melena,
syncope, hepatic disease, and/or cardiac failure.\190\ The RS ranges
from 0 to 11 with higher scores indicating worse potential outcomes and
is based upon age, presence of shock, comorbidity, diagnosis, and
endoscopic stigmata of recent hemorrhage.\191\ Immediate hemostasis was
achieved in 89.5 percent of patients following the use of Hemospray;
only the BS was found to have a positive correlation with treatment
failure in multivariate analysis (OR 1.21 (1.10-1.34)). Rebleeding
occurred in 10.3 percent of patients who achieved immediate hemostasis
again with only the BS having a positive correlation with rebleeding
(OR: 1.13 (1.03-1.25)). At 30 days the all-cause mortality was 20.1
percent with 78 percent of these patients having achieved immediate
endoscopic hemostasis and a cause of death resulting from the
progression of other comorbidities. A subgroup analysis of treatment
type (monotherapy, combination therapy, and rescue therapy groups) was
performed showing no statistically significant difference in immediate
hemostasis across groups (92.4 percent, 88.7 percent, and 85.5 percent
respectively). Higher all-cause mortality rates at 30 days were highest
in the monotherapy group (25.4%, p=0.04) as compared to all other
groups. According to the authors, in comparison to major recent
studies, they were able to show lower rebleeding rates overall and in
all subgroups despite the high-risk population.\192\ The authors
further note limitations in that the inclusion of patients was
nonconsecutive and at the discretion of the endoscopist, at the time of
the endoscopy, which allows for the potential introduction of selection
bias which may have affected these study results.
---------------------------------------------------------------------------
\189\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\190\ Saltzman, J. (2019, October). Approach to acute upper
gastrointestinal bleeding in adults. (M. Feldman, Editor) Retrieved
from UpToDate: https://www.uptodate.com/contents/approach-to-acute-upper-gastrointestinal-bleeding-in-adults
\191\ Ibid.
\192\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
---------------------------------------------------------------------------
The fifth article also described the utility of Hemospray in the
treatment of malignant lesions. According to the applicant, malignant
lesions pose a significant clinical challenge as successful hemostasis
rates are as low as 40 percent with high recurrent bleeding over 50
percent within 1 month following standard treatments.\193\ \194\ The
applicant added that bleeding from tumors is often diffuse and consists
of friable mucosa decreasing the utility of traditional treatments (for
example, ligation, cautery). From the fifth article, the applicant
noted that 50 patients were treated for malignant bleeding with overall
immediate hemostasis in 94 percent of patients.\195\ Of the 50
patients, 33 were treated with Hemospray alone, 11 were treated with
Hemospray as the final treatment, and 4 were treated with Hemospray as
rescue therapy of which 100 percent, 84.6 percent and 75 percent
experienced immediate hemostasis respectively.\196\ Similarly, from the
first discussed article, the applicant noted that among malignant
bleeding patients, 95.1 percent achieved immediate hemostasis with
lower rebleeding rates at 8 days when Hemospray was used as a primary
treatment as compared to when used as a rescue therapy (17.1 percent
vs. 46.7 percent respectively).\197\ The applicant concluded that
Hemospray may provide an advantage as a primary treatment to patients
with malignant bleeding.
---------------------------------------------------------------------------
\193\ Kim YI, Choi IJ, Cho SJ, et al. Outcome of endoscopic
therapy for cancer bleeding in patients with unresectable gastric
cancer. J Gastroenterol Hepatol 2013;28:1489-95.
\194\ Roberts SE, Button LA, Williams JG. Prognosis following
upper gastrointestinal bleeding. PLoS One 2012;7:e49507.
\195\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\196\ Ibid.
\197\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: a multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
---------------------------------------------------------------------------
A sixth article provided by the applicant consisted of a systematic
[[Page 58670]]
review from January 1950 to August 2014 concerning all available
powdered topical hemostatic agents.\198\ Of an initial 3,799 articles,
105 were initially reviewed and after excluding nonendoscopic data,
review articles, in vitro studies, and animal models 61 articles were
ultimately included in the study. Three primary hemostatic agents were
identified in this review, the Ankaferd Blood Stopper (ABS), Hemospray,
and EndoClot. The applicant noted the authors of this article
identified 131 high risk patients treated with Hemospray, of which 28
had tumor bleeding. According to the applicant, all 28 patients
achieved immediate hemostasis with 25 percent experiencing rebleeding
at 7-day follow-up. The overall immediate hemostasis in this particular
study was 91.6 percent and 7-day rebleeding was 25.8 percent among
high-risk rebleeding patients.\199\
---------------------------------------------------------------------------
\198\ Chen Y-I, Barkun A. Hemostatic powders in gastrointestinal
bleeding, a systematic review. Gastrointest Endoscopy Clin N Am
2015; 25: 535-552.
\199\ Ibid.
---------------------------------------------------------------------------
The applicant provided a seventh article which consisted of a
journal pre-proof article detailing a 1:1 randomized control trial of
20 patients treated with Hemospray versus the standard of care (for
example, thermal and injection therapies) in the treatment of malignant
gastrointestinal bleeding.\200\ The goals of this pilot study were to
determine the feasibility of a definitive trial. The primary outcome of
the study was immediate hemostasis (absence of bleeding after 3
minutes) with secondary outcomes of recurrent bleeding at days 1, 3,
30, 90, and 180 and adverse events at days 1, 30, and 180. The mean age
of patients was 67.2, 75 percent were male, and on average patients
presented with 2.9 1.7 comorbidities. All patients had
active bleeding at endoscopy and the majority of patients had an ASA
score of 2 (45%) or 3 (40%). Immediate hemostasis was achieved in 90
percent of Hemospray patients and 40 percent of standard of care
patients (5 injection alone, 3 thermal, 1 injection with clips, and 1
unknown). Of those patients in the control group, 83.3 percent crossed
over to the Hemospray treatment. One patient died while being treated
with Hemospray from exsanguination; post-mortem examination
demonstrated that bleeding was caused by rupture of a malignant
inferior mesenteric artery aneurysm. Overall, 86.7 percent of patients
treated with Hemospray initially or as crossover treatment achieved
hemostasis. Recurrent bleeding was lower in the Hemospray group (20%)
as compared to the control group (60%) at 180 days. Forty percent of
the treated group received blood transfusions as compared to 70 percent
of the control group. The overall length of stay was 14.6 days among
treated patients as compared to 9.4 in the control group. Mortality at
180 days was 80 percent in both the treated and control groups. The
authors noted the potential for operator bias in the use of Hemospray
prior to switching to another method when persistent bleeding exists.
Lastly, the authors noted that while they did not occur during this
study, there are concerns around the risks of perforation, obstruction,
and systemic embolization with the use of Hemospray.
---------------------------------------------------------------------------
\200\ Chen Y-I, Wyse J, Lu Y, Martel M, Barkun AN, TC-325
hemostatic powder versus current standard of care in managing
malignant GI bleeding: A pilot randomized clinical trial.
Gastrointestinal Endoscopy (2019), doi: https://doi.org/10.1016/j.gie.2019.08.005.
---------------------------------------------------------------------------
An eighth article provided by the applicant described a single-arm
multicenter retrospective study from 2011 to 2016 involving 88 patients
who bled as a result of either a primary GI tumor or metastases to the
GI tract.\201\ In this study the authors define immediate hemostasis as
no further bleeding at least one minute after treatment with Hemospray
and recurrent bleeding was suspected if one of seven criteria were met:
(1) Hematemesis or bloody nasogastric tube >6 hours after endoscopy;
(2) melena after normalization of stool color; (3) hematochezia after
normalization of stool color or melena; (4) development of tachycardia
or hypotension after >1 hour of vital sign stability without other
cause; (5) decrease in hemoglobin level greater than or equal to 3
hours apart; (6) tachycardia or hypotension that does not resolve
within 8 hours after index endoscopy; or (7) persistent decreasing
hemoglobin of >3 g/dL in 24 hours associated with melena or
hematochezia). The sample for this study consisted of 88 patients (with
a mean age of 65 years old and 70.5 percent male) of which 33.3 percent
possessed no co morbid illness, and 25 percent were on current
antiplatelet/anticoagulant medication. The mean BS was 8.7 plus or
minus 3.7 with a range from 0 to 18. Overall, 72.7 percent of patients
had a stage 4 adenocarcinoma, squamous cell carcinoma, or lymphoma.
Immediate hemostasis was achieved in 97.7 percent of patients.
Recurrent bleeding occurred among 13 of 86 (15%) and 1 of 53 (1.9%) at
3 and 30 days, respectively. A total of 25 patients (28.4%) died during
the 30-day follow up period. Overall, 27.3 percent of patients re-bled
within 30 days after treatment of which half were within 3 days. Using
multivariate analysis, the authors found that patients with good
performance status, no end-stage cancer, or receiving any combination
of definitive hemostasis treatment modalities had significantly greater
survival. The authors acknowledged the recurrent bleeding rate post
Hemospray treatment at 30 days of 38 percent is comparable with that
seen in sole conventional hemostatic techniques (40-50%) and state this
implies that the long-term effect of Hemospray does not differ from
conventional techniques and remains unsatisfactory for upper GI tumor-
related bleeding. However, they state that Hemospray is more
predictably effective in providing initial hemostasis for tumor-related
GI bleeding than conventional methods as SOC methods provide variable
immediate hemostasis rates of 31 to 93 percent while Hemospray had a
97.7% success rate in this study. They further conclude that though
Hemospray may provide only a temporary hemostatic effect in this group
of patients, its strong efficacy in the short-term allows patients to
subsequently receive definitive hemostatic treatment that may translate
into higher 6-month survival rates.
---------------------------------------------------------------------------
\201\ Pittayanon R, Rerknimitr R, Barkun A. Prognostic factors
affecting outcomes in patients with malignana GI bleeding treated
with a novel endoscopically delivered hemostatic powder.
Gastrointest Endosc 2018; 87:991-1002.
---------------------------------------------------------------------------
Ultimately, the applicant concluded nonvariceal gastrointestinal
bleeding is associated with significant morbidity and mortality in
older patients with multiple co-morbid conditions. Inability to achieve
hemostasis and early rebleeding are associated with increased cost and
greater resource utilization. According to the applicant, patients with
bleeding from malignant lesions have few options that can provide
immediate hemostasis without further disrupting fragile mucosal tissue
and worsening the active bleed. The applicant asserted Hemospray is an
effective agent that provides immediate hemostasis in patients with GI
bleeding as part of multimodality treatment, as well as when used to
rescue patients who have failed more conventional endoscopic
modalities. Furthermore, the applicant stated that in patients with
malignant bleeding in the GI tract, Hemospray provides a high rate of
immediate hemostasis and fewer recurrent bleeding episodes, which in
combination with definitive cancer treatment may lead to improvements
in long term survival. Lastly, the applicant asserted Hemospray is an
important
[[Page 58671]]
new technology that permits immediate and long-term hemostasis in GI
bleeding cases where standard of care treatment with clip ligation or
cautery are not effective.
We noted in the proposed rule that the majority of studies provided
lack a comparator when assessing the effectiveness of Hemospray. Three
of the articles provided were systematic reviews of the literature. We
noted that while we found these articles helpful in establishing a
background for the use of Hemospray, we were concerned that they may
not provide strong evidence of substantial clinical improvement. Four
studies appeared to be single-armed studies assessing the efficacy of
Hemospray in the patient setting. We stated that in all of these
articles, comparisons were made between Hemospray and standard of care
treatments; however, without the ability to control for factors such as
study design, patient characteristics, etc., it was difficult to
determine if any differences seen result from Hemospray or confounding
variables. Furthermore, within the retrospective and prospective
studies lacking a control subset, some level of selection bias appeared
to potentially be introduced in that providers may be allowed to select
the manner and order in which patients are treated, thereby potentially
influencing outcomes seen in these studies.
Additionally, one randomized control trial provided by the
applicant appeared to be in the process of peer-review and was not yet
published. Furthermore, we noted that this article was written as a
feasibility study for a potentially larger randomized control trial and
contains a sample of only 20 patients. This small sample size left us
concerned that the results are not representative of any larger
population. Lastly, as described, we were concerned the control group
can receive one of multiple treatments which lack a clear designation
methodology beyond physician choice. For instance, 50 percent of the
control patients received injection therapy alone, which according to
the literature provided by the applicant was not an acceptable
treatment for endoscopic bleeding. Accordingly, it was not clear
whether performance seen in the treated group as compared to the
control group is due to Hemospray itself or due to confounding factors.
Third, we were concerned with the samples chosen in many of the
studies presented. Firstly, we noted that the Medicare population is a
diverse group of men and women. Many of the samples provided by the
applicant were overwhelmingly male. Secondly, many of the studies
provided were performed in European and other settings outside of the
United States. We were therefore concerned that the samples chosen
within the literature provided may not represent the Medicare
population.
Lastly, we were concerned about the potential for adverse events
resulting from Hemospray. It was unclear from the literature provided
by the applicant what the likelihood of these events were and whether
or not an evaluation for the safety of Hemospray was performed. About
one-third of the articles submitted specifically addressed adverse
events with Hemospray. However, the evaluation of adverse events was
limited and most of the patients in the studies died of disease
progression. A few of the provided articles stated the potential for
severe adverse reactions (for example, abdominal distension, visceral
perforation, biliary obstruction, splenic infarct). Specifically, one
article \202\ recorded adverse events related to Hemospray, including
abdominal distention and esophageal perforation. We invited public
comments on whether Hemospray meets the substantial clinical
improvement criterion.
---------------------------------------------------------------------------
\202\ Rodriguez de Santiago E, Burgos-Santamaria D, Perez-Carazo
L, et al. Hemostatic spray TC-325 for GI bleeding in a nationwide
study: Survival analysis and predictors of failure via competing
risks analysis. Gastrointest Endosc 2019; 90(4), 581-590.
---------------------------------------------------------------------------
Comment: According to the applicant, a recently published study
randomized Hemospray against dual therapy as first treatment and
demonstrated Hemospray is a viable alternative to dual therapy.\203\
This multicenter non-inferiority randomized controlled trial assigned
patients with active non-variceal upper GI bleeding to receive either
Hemospray or standard dual modality treatment. A total of 224 patients
were randomized. With intention-to-treat analysis, the re-bleeding free
probability over 30 days was 89.8% in the TC-325 group and 81.1% in the
standard treatment group (difference in proportions, 95% CI; 8.7%, -
1.3%, 18,7%). There were fewer failures in the control of bleeding
during index endoscopy with the use of Hemospray (3 vs. 11, OR, 95% CI,
3.88, 1.05-14.32), although 30-day re-bleeding and mortality was not
different between groups.
---------------------------------------------------------------------------
\203\ AB14 GASTROINTESTINAL ENDOSCOPY Volume 91, No. 6S: 2020.
#98 by Lau et al.
---------------------------------------------------------------------------
The applicant agreed with CMS that the use of single arm and
retrospective studies potentially suffer from selection bias. The
applicant asserted that while this bias is inevitable, the
retrospective studies specifically exclude those cases successfully
treated with conventional dual therapy. According to the applicant,
this therefore ensured the bias was toward the patients with the
highest risk of treatment failure, morbidity, and mortality, and
representing the most challenging hemostasis cases. The applicant
stated that in both the Rodriguez de Santiago et al. and Alzoubaidi et
al. articles, there was an overall treatment success with no rebleeding
in 70% of cases where Hemospray was used after all other conventional
treatments failed.
In response to CMS' concerns about the randomized control trial
(RCT), the applicant stated that the study evaluated patients with
bleeding from malignant lesions and has now been published. According
to the applicant, the comparator treatment used in this study,
injection only, is consistent with the 2016 guidelines of the European
Society of Gastrointestinal Endoscopy for the treatment of bleeding
from upper GI malignancies which recommends, ``endoscopic monotherapy
with epinephrine injection . . . or saline injection . . .''.\204\ The
applicant stated that while the study was a small sample size pilot
study, the results are representative of the general population with
malignant GI bleeding. Further, the applicant stated that in the study
by Alzoubaidi et al. 50 patients with symptomatic bleeding secondary to
malignancy were treated. Hemospray monotherapy was the most common mode
of treatment (33/50 = 66 percent) with a hemostasis rate of 100
percent. In the remaining patients, Hemospray was used in combination
with conventional methods or as a rescue, with a lower aggregate rate
of immediate hemostasis.
---------------------------------------------------------------------------
\204\ Gralnek IM, Dumonceau J-M, Kuipers EJ. Diagnosis and
management of nonvariceal upper gastrointestinal hemorrhage:
European Society of Gastrointestinal Endoscopy (ESGE) Guideline.
Endoscopy 2015; 47: 1-46
---------------------------------------------------------------------------
In response to CMS' concerns about the study samples presented, the
applicant acknowledged that the majority of data came from outside of
the United States due to commercial availability. The applicant stated
that the FDA considered the outside of the United States data to be
representative of the US population when granting a de novo
classification request for the product. In response to CMS' concern
that the provided literature showed a predominance of males, the
applicant stated that the 2016 Healthcare Cost and Utilization Project
(HCUP) showed that 60% of patients that underwent endoscopic control of
bleeding were male. Lastly, the applicant stated that
[[Page 58672]]
from the three studies 205 206 207 representing 777
patients, the median or average age ranged from 67-71 which they
believed to be representative of the Medicare population.
---------------------------------------------------------------------------
\205\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\206\ Rodriguez de Santiago E, Burgos-Santamaria D, Perez-Carazo
L, et al. Hemostatic spray TC-325 for GI bleeding in a nationwide
study: Survival analysis and predictors of failure via competing
risks analysis. Gastrointest Endosc 2019; 90(4), 581- 590.
\207\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
---------------------------------------------------------------------------
In response to CMS' concerns about potential adverse events, the
applicant stated that the FDA determined the product is safe and
effective for its intended use and has an acceptable risk/benefit ratio
when it granted de Novo classification request and authorization to
market in the United States. According to the applicant, any procedure
is associated with risks. The applicant stated that they understand the
potential risks associated with Hemospray and that they clearly labeled
their product with such information. The applicant also conducts
physician training to ensure physicians understand the risks and select
patients who they believe would benefit most from Hemospray. In
addition, the applicant conveyed that they diligently monitor reported
complaints or complications related to a device once it is in the real
world. According to the applicant, the same will be done with Hemospray
and if the risk ratio increases to an unacceptable level; the applicant
will take appropriate steps to correct it. According to the applicant,
these are the standard processes with any device and the applicant does
not see a reason to divert from these processes for Hemospray.
The applicant acknowledged that it had initiated a voluntary recall
of Hemospray due to complaints received that the handle and/or
activation knob on the device in some cases had cracked or broken when
the device was activated and in some cases had caused the carbon
dioxide cartridge to exit the handle. According to the applicant, as of
June 10, 2020, the FDA cleared Hemospray to return to the market
(K200972) after the applicant sufficiently addressed the issue that led
to the cartridge exiting the handle. As such, Hemospray will return to
the US market in July 2020.
One commenter stated that they frequently use Hemospray and believe
it is irreplaceable in the role of controlling tumor bleeding. The
commenter added that Hemospray has a critical role in rescue bleeding
in cases that preclude contact hemostatic methods due to the risk of
perforation. They stated that Hemospray's ability to buy time to
resuscitate during challenging bleeding cases is the most understated
benefit of the device. Lastly, the commenter stated that there are
currently no hemostatic powder alternatives on the market in the United
States.
Response: We appreciate the commenters' input in response to the
concerns discussed in the proposed rule regarding the substantial
clinical improvement criterion. We agree with the applicant that the
control therapy in the RCT, injection only as compared to dual therapy,
was appropriate based on the 2016 guidelines of the European Society of
Gastrointestinal Endoscopy for the treatment of bleeding from upper GI
malignancies. In the commenter's response to CMS regarding potential
selection bias in single arm and retrospective studies, the applicant
stated that based on the study design, any potential bias introduced
was toward the patients with the highest risk of negative outcomes. We
appreciate the applicant's response to our concerns and agree that this
potential bias is no longer a concern. Regarding the applicant's
comment on study samples, we agree with the applicant that these
samples are adequately representative of the Medicare population. We
also appreciate the comment response to the potential for adverse
events. We will continue to monitor available data for Hemospray in
regard to any potential risk of adverse events. Finally, we appreciate
the applicant's update on the status of their voluntary recall of the
Hemospray system.
While we acknowledge the limitations of some of the data, we
believe that Hemospray represents a substantial clinical improvement
for the treatment of gastrointestinal bleeding for the following
reasons. We believe that given the results from the RCT trials and the
single-armed studies Hemospray provides a treatment benefit
particularly for those with bleeding from GI malignancies. We also see
the clinical importance of Hemospray as an alternative to invasive
treatments traditionally used as salvage therapy. Lastly, we note that
Hemospray provides treatment for bleeding without requiring tissue
trauma or precise targeting.
After consideration of the public comments we received and the
information included in the applicant's new technology add-on payment
application, we have determined that Hemospray meets the criteria for
approval of the new technology add-on payment. Therefore, we are
approving new technology add-on payments for this technology for FY
2021. Cases involving the use of Hemospray that are eligible for new
technology add-on payments will be identified by procedure codes
XW0G886 (Introduction of mineral-based topical hemostatic agent into
upper GI, via natural or artificial opening endoscopic, new technology
group 6) and XW0H886 (Introduction of mineral-based topical hemostatic
agent into lower GI, via natural or artificial opening endoscopic, new
technology group 6).
In its application, the applicant estimated that the cost of
Hemospray is $2,500.00 per patient. Under Sec. 412.88(a)(2), we limit
new technology add-on payments to the lesser of 65 percent of the
average cost of the technology, or 65 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 Hemospray is
$1,625.00 for FY 2021.
h. IMFINZI[supreg] (durvalumab) and TECENTRIQ[supreg] (atezolizumab)
Two manufacturers, AstraZeneca PLC and Genentech, Inc., submitted
separate applications for new technology add-on payments for FY 2021
for IMFINZI[supreg] (durvalumab) and TECENTRIQ[supreg] (atezolizumab),
respectively. Both of these technologies are programmed death-ligand 1
(PD-L1) blocking antibodies used for the treatment of patients with
extensive-stage small cell lung cancer (ES-SCLC).\208\ In the proposed
rule, we discussed these applications as two separate technologies.
After further consideration and as discussed below, we believe
IMFINZI[supreg] and TECENTRIQ[supreg] are substantially similar to each
other and that it is appropriate to evaluate both technologies as one
application for new technology add-on payments under the IPPS. We refer
the reader below for a complete discussion regarding our analysis of
the substantial similarity of IMFINZI[supreg] and TECENTRIQ[supreg].
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\208\ TECENTRIQ (atezolizumab) [prescribing information]. San
Francisco, CA: Genentech, Inc., 2019.
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In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32631) we noted,
and as summarized in the following table, the FDA initially approved
IMFINZI[supreg] on May 1, 2017 for the indicated treatment of patients
with locally advanced or metastatic urothelial carcinoma who have
disease
[[Page 58673]]
progression during or following platinum-containing chemotherapy or who
have disease progression within 12 months of neoadjuvant or adjuvant
treatment with platinum containing chemotherapy. The FDA subsequently
approved IMFINZI[supreg] on February 16, 2018 for a second indication,
treatment of patients with unresectable, Stage III non-small cell lung
cancer (NSCLC) whose disease has not progressed following concurrent
platinum-based chemotherapy and radiation therapy. IMFINZI[supreg] in
combination with etoposide and either carboplatin or cisplatin was
approved by the FDA as first-line treatment of patients with extensive-
stage small cell lung cancer (ES-SCLC) on March 27, 2020, the
indication for which the applicant is seeking new technology add-on
payments.\209\With regard to TECENTRIQ[supreg], and as summarized in
the following table, the applicant stated TECENTRIQ[supreg] was
initially approved by FDA on May 18, 2016, for treatment of patients
with locally advanced or metastatic urothelial carcinoma,\210\ and
subsequently for patients with metastatic non-small cell lung cancer
who have disease progression during or following platinum-containing
chemotherapy on October 18, 2016; \211\ for the first-line treatment of
patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic
tumor aberrations on December 6, 2018; \212\ and for metastatic triple
negative breast cancer on March 8, 2019.\213\ TECENTRIQ[supreg]
received FDA approval on March 18, 2019 in combination with carboplatin
and etoposide for the first-line treatment of adult patients with ES-
SCLC, the indication for which the applicant is seeking new technology
add-on payments. The applicant stated that TECENTRIQ[supreg] is the
first cancer immunotherapy to be approved in the first-line treatment
of ES-SCLC.\214\ The applicant stated that the National Comprehensive
Cancer Network (NCCN) recommends TECENTRIQ[supreg] + carboplatin +
etoposide as the only category 1 preferred initial treatment for
patients with ES-SCLC.\215\
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\209\ https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-extensive-stage-small-cell-lung-cancer.
\210\ U.S. Department of Health and Human Services. BLA
Accelerated Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf. Accessed
August 9, 2019.
\211\ U.S. Department of Health and Human Services. BLA
Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761041Orig1s000ltr.pdf. Accessed August 9, 2019.
\212\ U.S. Department of Health and Human Services. Supplement
Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s009ltr_REPLACEMENT.pdf. Accessed August 9, 2019.
\213\ U.S. Department of Health and Human Services. Accelerated
Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s018ltr.pdf. Accessed August 9, 2019.
\214\ U.S. Department of Health and Human Services. Supplemental
Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s019ltr.pdf. Accessed August 9, 2019.
\215\ National Comprehensive Cancer Network. NCCN Clinical
Practice Guidelines in Oncology. Small Cell Lung Cancer Version
2.2019. https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed August 16, 2019.
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BILLING CODE 4120-01-P
[[Page 58674]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.155
BILLING CODE 4120-01-C
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32663), we noted
that the applicant for TECENTRIQ[supreg] submitted a request for a
unique ICD-
[[Page 58675]]
10-PCS code for TECENTRIQ[supreg] beginning in FY 2021. The following
ICD-10-PCS codes, effective October 1, 2020, were approved for
procedures involving the administration of TECENTRIQ[supreg]: XW033D6
(Introduction of atezolizumab antineoplastic into peripheral vein,
percutaneous approach, new technology group 6) and XW043D6
(Introduction of atezolizumab antineoplastic into central vein,
percutaneous approach, new technology group 6). In the FY 2021 IPPS/
LTCH PPS proposed rule (85 FR 32632), we noted that the applicant for
IMFINZI[supreg] submitted a request for a unique ICD-10-PCS code for
IMFINZI[supreg] beginning in FY 2021. The following ICD-10-PCS codes,
effective October 1, 2020, were approved for procedures involving the
administration of IMFINZI[supreg]: XW03336 (Introduction of durvalumab
antineoplastic into peripheral vein, percutaneous approach, new
technology group 6) and XW04336 (Introduction of durvalumab
antineoplastic into central vein, percutaneous approach, new technology
group 6).
According to the applicant for TECENTRIQ[supreg], lung cancer is
the second most commonly diagnosed cancer and the leading cause of
cancer-related death among men and women in the United States.\216\
SCLC is a high-grade neuroendocrine tumor comprising small cells with
minimal cytoplasm, poorly defined cell borders, and either no nucleoli
or unremarkable nucleoli.217 218 The most aggressive of all
lung cancers, it accounts for about 10-15 percent of lung cancer
cases.\219\ Key characteristics of SCLC include its rapid doubling time
and the early development of widespread metastases.220 221
About 72 percent of SCLC cases are diagnosed at the extensive stage,
which is associated with a 5-year survival rate of 2.9
percent.222 223 According to the applicant for
IMFINZI[supreg], 75 percent of patients are diagnosed in the late/
metastatic stage described as ES-SCLC and are considered incurable,
with a median overall survival of 9-11 months with standard of care
(SOC).224 225 The median overall survival for ES-SCLC has
remained the same for the past 20 years with essentially no
improvements or new therapies.\226\
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\216\ American Cancer Society. Lung Cancer Prevention and Early
Detection. American Cancer Society. https://www.cancer.org/cancer/lung-cancer/prevention-and-early-detection.html. Accessed October 3,
2019.
\217\ Meerbeeck, J.P.V., Fennell, D.A., Ruysscher, D.K.D,
``Small-cell Lung Cancer,'' The Lancet, 2011, 378(9804), pp.1741-
1755, doi:10.1016/s0140-6736(11):60165-7.
\218\ Kalemkerian, G., ``Small Cell Lung Cancer,'' Seminars in
Respiratory and Critical Care Medicine, 2016, 37(05) pp.783-796,
doi:10.1055/s-0036-1592116.
\219\ WebMD, LLC. Types of Lung Cancer. https://www.webmd.com/lung-cancer/lung-cancer-types#1. Accessed August 15, 2019.
\220\ Harris, K., Khachaturova, I., Azab, B., et al., ``Small
Cell Lung Cancer Doubling Time and its Effect on Clinical
Presentation: a Concise Review,'' Sage Journals, 2012, 6, pp.199-
203, doi:10.4137/CMO.S9633.
\221\ Pietanza, M.C., Averett, L., Minna, J., Rudin, C.M.,
``Small Cell Lung Cancer: Will Recent Progress Lead to Improved
Outcomes?,'' Clinical Cancer Research, 2015, (21), pp. 2244-2255,
doi: 10.1158/1078-0432.CCR-14-2958.
\222\ American Lung Association. Trends in Lung Cancer Morbidity
and Mortality. https://www.lung.org/assets/documents/research/lc-trend-report.pdf. Accessed August 15, 2019.
\223\ Noone, A.M., Howlader, N., Krapcho, M., et al., SEER
Cancer Statistics Review, 1975-2015, based on November 2017 SEER
data submission, posted to the SEER website, April 2018. Bethesda,
MD: National Cancer Institute. 2018; https://seer.cancer.gov/csr/1975_2015/results_merged/sect_15_lung_bronchus.pdf. Accessed
September 23, 2019.
\224\ Sabari, J.K., Lok, B.H., Laird, J.H., et al.,
``Unravelling the biology of SCLC: Implications for therapy,''
Nature Reviews Clinical Oncology, 2017, 14(9), pp. 549-561.
\225\ Farago, A..F., Keane F.K., ``Current standards for
clinical management of small cell lung cancer,'' Translational Lung
Cancer Research, 2018, 7, pp. 69-79.
\226\ Ibid.
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According to the applicant for TECENTRIQ[supreg], the current SOC
treatment for ES-SCLC is a combination of etoposide, which is FDA-
approved in SCLC only in combination with cisplatin, and carboplatin,
which is used in preference to cisplatin for toxicity reasons, despite
being off-label.\227\ Although ES-SCLC is highly sensitive to platinum/
etoposide in the first-line setting with response rates of 50-60
percent, the majority of patients will relapse within the first year of
treatment, with a median progression-free survival (PFS) of 4-6
months.\228\ The applicant for IMFINZI[supreg] also asserted that
overall, responses to SOC are short-lived and long-term outcomes remain
poor.\229\
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\227\ UpToDate, Inc. ES-Small Cell Lung Cancer: Initial
Management. https://www.uptodate.com/contents/extensive-stage-small-cell-lung-cancer-initial-management. Accessed July 26, 2019.
\228\ Hurwitz, J.L., McCoy, F., Scullin, P., et al., ``New
advances in the second-line treatment of small cell lung cancer,''
Oncologist, 2009, 14(10), pp. 986-994.
\229\ Haque, N., Raza, A., McGoey, R., et al., ``Small cell lung
cancer: time to diagnosis and treatment,'' Southern Medical Journal,
2012, 105(8), pp. 418-423.
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The applicant for IMFINZI[supreg] further stated that diagnosis
often occurs at later stages and SCLC patients may be sicker at the
time of diagnosis, presenting with comorbidities.230 231 For
these reasons, the applicant asserted that a significant number of
patients present and are diagnosed in the hospital inpatient setting.
According to the applicant, ES-SCLC is very responsive to chemotherapy
treatment, with response rates to platinum/etoposide ranging from 44
percent to 78 percent,\232\ and given the severity of symptoms, it is
recommended to initiate treatment within two weeks of diagnosis.\233\
According to the applicant, many patients have a clinical response and
improvement of symptoms with the initiation of platinum/etoposide,
confirming the clinical observation that many SCLCs are highly
sensitive to platinum/etoposide in the first-line setting.\234\
According to the applicant for TECENTRIQ[supreg], despite SOC
chemotherapy regimens using etoposide and carboplatin, the majority of
patients with ES-SCLC will experience recurrence within 1 year. Median
progression-free survival (PFS) and overall survival (OS) rates are 2
months and 10 months, respectively, after initial
chemotherapy.235 236 237
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\230\ Bennett, B.M., Wells, J.R., Panter, C., et al., ``The
humanistic burden of small cell lung cancer (SCLC): A systematic
review of health-related quality of life (HRQoL) literature,''
Frontiers in Pharmacology, 2017, 8, p. 339.
\231\ Aarts, M.J., Aerts, J.G., van den Borne, B.E., et al.,
``Comorbidity in patients with small-cell lung cancer: Trends and
prognostic impact,'' Clinical Lung Cancer, 2015, 16(4), pp. 282-291.
\232\ Farago, A.F., Keane, F.K, ``Current standards for clinical
management of small cell lung cancer,'' Translational Lung Cancer
Research, 2018, 7, pp. 69-79.
\233\ Haque, N., Raza, A., McGoey, R., et al., ``Small cell lung
cancer: Time to diagnosis and treatment,'' Southern Medical Journal,
2012, 105(8), pp. 418-423.
\234\ Ibid.
\235\ Kalemkerian, G., ``Small Cell Lung Cancer,'' Seminars in
Respiratory and Critical Care Medicine, 2016, 37(05):783-796.
doi:10.1055/s-0036-1592116.
\236\ Gadgeel, S.M., Pennell, N.A., Fidler, M.J., et al.,
``Phase II Study of Maintenance Pembrolizumab in Patients with ES-
Small Cell Lung Cancer (SCLC),'' Journal of Thoracic Oncology, 2018,
13(9), pp. 1393-1399. doi:10.1016/j.jtho.2018.05.002.
\237\ Rossi, A., ``Relapsed Small-Cell Lung Cancer: Platinum Re-
Challenge Or Not,'' Journal of Thoracic Disease, 2016, 8(9), pp.
2360-2364, doi:10.21037/jtd.2016.09.28.
---------------------------------------------------------------------------
According to the applicant for TECENTRIQ[supreg], progress in the
treatment of ES-SCLC has been limited. Over the past 40 years, the 2-
year OS has increased from 3.4 percent to 5.6 percent, and the median
OS has remained at about 10 months since the
1980s.238 239 240 One paper submitted by
[[Page 58676]]
the applicant noted that more than 40 phase III trials evaluating other
regimens in SCLC have failed since 1970.\241\
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\238\ Kalemkerian, G., ``Small Cell Lung Cancer,'' Seminars in
Respiratory and Critical Care Medicine, 2016, 37(05), pp. 783-796,
doi:10.1055/s-0036-1592116.
\239\ Evans, W.K., Shepherd, F.A., Feld, R., Osoba, D., Dang,
P., Deboer, G., ``VP-16 and Cisplatin as First-Line Therapy for
Small-Cell Lung Cancer,'' Journal of Clinical Oncology, 1985, 3(11),
pp. 1471-1477, doi:10.1200/jco.1985.3.11.1471.
\240\ Boni, C., Cocconi, G., Bisagni, G., Ceci, G., Peracchia,
G., Cisplatin and Etoposide (VP-16) as a Single Regimen for Small
Cell Lung Cancer. A phase II trial,'' Cancer, 1989, 63(4), pp. 638-
642, doi:10.1002/1097-0142(19890215)63:4<638:aid-
cncr2820630406>3.0.co;2-8.
\241\ Byers, L.A., Rudin, C.M., ``Small Cell Lung Cancer: Where
Do We Go from Here?,'' Cancer, 2014, 121(5), pp. 664-672,
doi:10.1002/cncr.29098.
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As stated earlier and for the reasons discussed further later in
this section, we believe that IMFINZI[supreg] and TECENTRIQ[supreg] are
substantially similar to each other such that it is appropriate to
analyze these two applications as one technology for purposes of new
technology add-on payments, in accordance with our policy. Below we
discuss the information provided by the applicants, as summarized in
the proposed rule, regarding whether IMFINZI[supreg] and
TECENTRIQ[supreg] 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 regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant for TECENTRIQ[supreg] asserted that the mechanism of action
of ES-SCLC is not the same as or similar to an existing technology. The
applicant described TECENTRIQ[supreg] as a programmed PD-L1 blocking
antibody, and as the first and only blocking antibody to target the PD-
L1/PD-1 pathway that is FDA-approved for the treatment of ES-SCLC. The
applicant explained that PD-L1 is a protein expressed on the surface of
cancer cells, which allows them to inactivate the T-cells of the
patient's immune system which would normally attack the cancer cells.
The applicant asserted that TECENTRIQ[supreg] blocks the PD-L1 protein,
rendering the cancer cells susceptible to attack.\242\ The applicant
indicated that the current standard of care drugs etoposide,
carboplatin, and cisplatin impart their cytotoxic effects by
interfering with the processes of DNA replication.243 244
Therefore, the applicant stated the mechanism of action of
TECENTRIQ[supreg] is unique and distinct from other available forms of
treatment for ES-SCLC.
---------------------------------------------------------------------------
\242\ Chen, D.S., Irving, B.A., Hodi, F.S., ``Molecular
Pathways: Next-Generation Immunotherapy--Inhibiting Programmed
Death-Ligand 1 and Programmed Death-1,'' Clinical Cancer Research,
2012, 18(24), pp. 6580-6587. doi:10.1158/1078-0432.ccr-12-1362.
\243\ ETOPOPHOS (etoposide phosphate) [prescribing information].
Deerfield, IL: Baxter Healthcare, Co., 2017.
\244\ Sousa, G.F.D., Wlodarczyk SR, Monteiro G., ``Carboplatin:
Molecular Mechanisms of Action Associated with Chemoresistance,''
Brazilian Journal of Pharmaceutical Sciences, 2014, 4(50), pp. 693-
701, doi:10.1590/S1984-82502014000400004.
---------------------------------------------------------------------------
The applicant for IMFINZI[supreg] asserted that IMFINZI[supreg]
offers a novel mechanism of action for the treatment of ES-SCLC
compared to the SOC chemotherapy. The applicant for IMFINZI[supreg]
stated that first line SOC treatment of ES-SCLC is standard
chemotherapy, including a platinum agent (typically carboplatin or
cisplatin) plus etoposide.\245\ The mechanism of action of platinum
chemotherapy agents (including cisplatin and carboplatin) is based on
the agent's ability to crosslink with the purine bases on the DNA;
crosslinking interferes with DNA repair mechanisms, causes DNA damage,
and subsequently induces apoptosis in cancer cells.246 247
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\245\ Farago, A.F., Keane, F.K., ``Current standards for
clinical management of small cell lung cancer,'' Translational Lung
Cancer Research, 2018, 7, pp. 69-79.
\246\ Dasari, S., Tchounwou, P.B., ``Cisplatin in cancer
therapy: Molecular mechanisms of action,'' European Journal of
Pharmacology, 2014, 740, pp. 364-378.
\247\ Thirumaran R, Prendergast GC, Gilman PB, ``Cytotoxic
chemotherapy in clinical treatment of cancer,'' In: Prendergast,
G.C., Jaffee, E.M., editors, Cancer Immunotherapy: Immune
Suppression and Tumor Growth, USA: Elsevier Inc, 2007, pp. 101-116,
http://dx.doi.org/10.1016/B978-012372551-6/50071-7.
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The applicant for IMFINZI[supreg] asserted that etoposide phosphate
is a plant alkaloid prodrug that is converted to its active moiety,
etoposide, by dephosphorylation. Further, the applicant explained
etoposide causes the induction of DNA strand breaks by an interaction
with DNA-topoisomerase II or the formation of free radicals, leading to
cell cycle arrest, primarily at the G2 stage of the cell cycle, and
cell death.248 249
---------------------------------------------------------------------------
\248\ Ibid.
\249\ Etopophos[supreg] (etoposide phosphate) [Prescribing
Information]. Princeton, NJ; Bristol-Myers Squibb, 2019.
---------------------------------------------------------------------------
The applicant stated IMFINZI[supreg] is a selective, high-affinity,
human IgG1[kappa] monoclonal antibody that blocks PD-L1 binding to
programmed cell death-1 and CD80 without antibody-dependent cell-
mediated cytotoxicity.\250\ The applicant asserted that
IMFINZI[supreg], in combination with chemotherapy, demonstrated a
statistically and clinically significant improvement in overall
survival in a randomized Phase III study (CASPIAN), which is discussed
later in this section.\251\
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\250\ Pas-Ares, L., Jiang, H., Huang, Y., et al., A Phase III
Randomized Study of First-Line DurvalumabTremelumimab+Platinum-based Chemotherapy (EP) vs. EP Alone in
Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC):CASPIAN
[Poster]. Presented at: the ASCO annual meeting, Chicago, IL June 2-
6, 2017.
\251\ Paz-Ares, L., Chen, Y., Reinmuth, N., et al., Overall
Survival with Durvalumab Plus Platinum-Etoposide in First-Line
Extensive-Stage SCLC: Results from the CASPIAN Study [presentation],
Presented at: World Conference on Lung Cancer, Barcelona, Spain,
September 7-10, 2019.
---------------------------------------------------------------------------
With regard to the second criterion, whether IMFINZI[supreg] and
TECENTRIQ[supreg] will be assigned to the same or a different MS-DRG,
the applicant for TECENTRIQ[supreg] referenced the FY 2016 IPPS/LTCH
PPS Final Rule (80 FR 49445) to support that this criterion is not met
in cases where the subject technology is treating a disease for which
the current SOC involves non-FDA-approved therapies that are also
associated with different MS-DRGs. As previously noted, the applicant
stated that the current SOC treatment for ES-SCLC is a combination of
etoposide, which is FDA-approved in SCLC only in combination with
cisplatin, and carboplatin, which is used in preference to cisplatin
for toxicity reasons, despite being off-label. The applicant for
TECENTRIQ[supreg] also pointed out that irinotecan, a topoisomerase
inhibitor indicated in colon and rectal cancers, is sometimes used in
place of etoposide.
The applicant for TECENTRIQ[supreg] also stated that the MS-DRG
payment system cannot differentiate between patients with NSCLC and ES-
SCLC and noted that MS-DRGs 180 (Respiratory Neoplasms with MCC) and
181 (Respiratory Neoplasms with CC) are applicable to both diseases.
The applicant for TECENTRIQ[supreg] also noted that category C34
(Malignant neoplasm of bronchus and lung) of the ICD-10-CM diagnosis
coding classification system can be used to identify NSCLC and SCLC
cases but does not differentiate between them. As a result, the
applicant for TECENTRIQ[supreg] suggested both TECENTRIQ[supreg] and an
existing technology (such as one used to treat NSCLC) may be assigned
to either of these MS DRGs, even though, as previously noted, the NSCLC
and SCLC patient populations are different.
The applicant for IMFINZI[supreg] asserted that extensive stage
small cell lung cancer patients are identified under category C34
(Malignant neoplasm of bronchus and lung) of the ICD-10-CM coding
classification system. According to the applicant for IMFINZI[supreg],
category C34 is all encompassing and does not distinguish between the
lung cancer subtypes. The applicant also stated that both non-small
cell lung cancer patients as well as earlier stages of small cell lung
cancer (that is, limited stage) are captured under category C34, all of
[[Page 58677]]
which have differing epidemiological considerations and treatment
interventions. The applicant for IMFINZI[supreg] concluded that
patients diagnosed with ES-SCLC, identified using category C34, map to
MS-DRGs 180, 181, and 182 (Respiratory Neoplasms with MCC, with CC, and
without CC/MCC, respectively). The applicant for IMFINZI[supreg] stated
that the existing ICD-10-PCS coding system does not allow for
visibility into the different MS-DRGs that ES-SCLC patients map to
versus NSCLC patients, making it difficult to show that ES-SCLC
patients receiving IMFINZI[supreg] would map to a unique MS-DRG from
NSCLC cases, where IMFINZI[supreg] and other immuno-oncology therapies
are already being used.
To further identify the patient population of interest, the
applicant for IMFINZI[supreg] searched charge level data from the
Premier Hospital Database to determine which MS-DRGs these cases are
mapping to, beyond relying on the broad lung cancer category C34. The
applicant asserted that the Premier Hospital database is a large U.S.
hospital-based, all payer database that contains discharge information
from geographically diverse non-governmental, community, and teaching
hospitals and health systems across both rural and urban areas. The
applicant for IMFINZI[supreg] stated that this database contains data
from standard hospital discharge files providing access to all
procedures, diagnoses, drugs, and devices received for each patient
regardless of the insurance or disease state. The applicant for
IMFINZI[supreg] used charge level hospital data from the Premier
Hospital Database to identify cases that used category C34 as well as
carboplatin or cisplatin plus etoposide, the chemotherapy doublet
specifically used for ES-SCLC patients. The applicant also looked for
the use of prophylactic cranial irradiation (PCI), a type of radiation
therapy used for ES-SCLC patients to address the frequent occurrence of
multiple brain metastases associated with SCLC. Based on this
assessment of hospital charge-level data, the applicant for
IMFINZI[supreg] stated that over 60 percent of ES-SCLC patients map to
MS-DRGs 180 (Respiratory Neoplasms with MCC), 181 (Respiratory
Neoplasms with CC), and 164 (Major Chest Procedures with CC). We agreed
with the applicant that patients receiving IMFINZI[supreg] would map to
the same DRGs as patients receiving standard therapy for ES-SCLC.
With regard to the third criterion, whether IMFINZI[supreg] and
TECENTRIQ[supreg] will be used to treat the same or similar disease in
the same or similar patient population when compared to existing
therapies, the applicant for IMFINZI[supreg] stated that
IMFINZI[supreg], in combination with standard chemotherapy, represents
a new treatment option for patients with extensive stage small cell
lung cancer, demonstrating statistically and clinically significant
improved overall survival as compared to standard chemotherapy (Hazard
ratio [HR] 0.73; 95 percent CI 0.59-0.91; p=0.0047).\252\ The applicant
for IMFINZI[supreg] asserted that IMFINZI[supreg] in combination with
chemotherapy represents a new treatment option for ES-SCLC patients.
The applicant for TECENTRIQ[supreg] stated the use of TECENTRIQ[supreg]
in ES-SCLC does not involve the treatment of the same or a similar type
of disease and the same or similar patient population when compared to
an existing technology.
---------------------------------------------------------------------------
\252\ Paz-Ares, L., Dvorkin, M., Chen, Y., et al., ``Durvalumab
plus platinum-etoposide versus platinum-etoposide in first-line
treatment of extensive-stage small-cell lung cancer (CASPIAN): a
randomized, controlled, open-label, phase 3 trial [article and
supplementary appendix],'' Lancet, 2019.
---------------------------------------------------------------------------
We invited public comments on whether IMFINZI[supreg] or
TECENTRIQ[supreg] is substantially similar to an existing technology
and whether they meet the newness criterion.
In the proposed rule we stated that both IMFINZI[supreg] and
TECENTRIQ[supreg] seem to be intended for similar patient populations
and would involve the treatment of the same conditions: Patients with
locally advanced or metastatic urothelial carcinoma and patients with
SCLC. We stated that we were interested in information on how these two
technologies may differ from each other with respect to the substantial
similarity criteria and newness criterion, to inform our analysis of
whether IMFINZI[supreg] and TECENTRIQ[supreg] are substantially similar
to each other and therefore should be considered as a single
application for purposes of new technology add-on payments.
Comment: The applicants for TECENTRIQ[supreg] and IMFINZI[supreg]
each provided comments regarding whether TECENTRIQ[supreg] and
IMFINZI[supreg] were substantially similar to the other, or to any
existing technology.
The applicant for TECENTRIQ[supreg] (Genentech) commented that
TECENTRIQ[supreg] is a humanized programmed death-ligand 1 (PD-L1)
blocking antibody (which binds to PD-L1 and blocks its interactions
with both PD-1 and B7.1 receptors) with multiple oncology indications,
including one in combination with carboplatin and etoposide for the
first-line treatment of adult patients with ES-SCLC.\253\ According to
the commenter, TECENTRIQ[supreg] has a total of nine indications--two
in urothelial carcinoma, four in NSCLC, one in triple-negative breast
cancer, one in ES-SCLC, and one in hepatocellular carcinoma.\254\ The
commenter stated that, in addition, TECENTRIQ[supreg] was the first
cancer immunotherapy to be approved for the first line treatment of ES-
SCLC, on March 18, 2019; \255\ and the first drug to improve median OS
in ES-SCLC which has remained at ~10 months or less since the
1980s.256 257 The commenter explained that over 40 Phase III
trials evaluating 60+ other regimens have been attempted since 1970,
none of which led to additional FDA approvals in first-line ES-
SCLC.\258\ Furthermore, the applicant stated that the use of
TECENTRIQ[supreg] to treat ES-SCLC also amounts to a paradigm shift
that was validated by the subsequent approval of IMFINZI[supreg] for an
almost identical indication. According to the applicant, the
combination of TECENTRIQ[supreg] with carboplatin and etoposide is also
the first FDA approval for the first-line treatment of ES-SCLC since
the approval of carboplatin and etoposide alone in 1999 and prior to
that, the most recent approval was that of cisplatin and etoposide, in
1985.\259\ The applicant asserted that, whereas TECENTRIQ[supreg] in
combination with carboplatin and etoposide is associated with a
statistically significant increase in overall survival and progression-
free survival compared to placebo plus carboplatin and etoposide, this
was not the case for the combination of KEYTRUDA (pembrolizumab),
another
[[Page 58678]]
well-known PD-1 blocking antibody, with either carboplatin or
cisplatin, and etoposide.\260\ According to the applicant, since March
2019, TECENTRIQ[supreg] in combination with carboplatin and etoposide
has become the standard of care for first-line ES-SCLC, with over 60%
of newly diagnosed patients receiving the regimen according to the
applicant.\261\
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\253\ TECENTRIQ (atezolizumab) [prescribing information]. San
Francisco, CA: Genentech, Inc.; 2020.
\254\ TECENTRIQ (atezolizumab) [prescribing information]. San
Francisco, CA: Genentech, Inc.; 2020.
\255\ U.S. Department of Health and Human Services. Supplemental
Approval.
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s019ltr.pdf. Accessed June 11, 2020.
\256\ Evans WK, Shepherd FA, Feld R, Osoba D, Dang P, Deboer G.
VP-16 and cisplatin as first-line therapy for smallcell lung cancer.
Journal of Clinical Oncology. 1985;3(11):1471-1477. doi:10.1200/
jco.1985.3.11.1471
\257\ Boni C, Cocconi G, Bisagni G, Ceci G, Peracchia G.
Cisplatin and etoposide (VP-16) as a single regimen for small cell
lung cancer. A phase II trial. Cancer. 1989;63(4):638-642.
doi:10.1002/1097-0142(19890215)63:4<638::aidcncr2820630406>3.0.co;2-
8.
\258\ Byers LA, Rudin CM. Small cell lung cancer: Where do we go
from here? Cancer. 2014;121(5):664-672. doi:10.1002/cncr.29098.
\259\ Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM.
Unravelling the biology of SCLC: Implications for therapy. Nat Rev
Clin Oncol. 2017;14(9):549-561. doi:10.1038/nrclinonc.2017.71.
\260\ Rudin CM, Awad MM, Navarro A, et al. Pembrolizumab or
Placebo Plus Etoposide and Platinum as First-Line Therapy for
Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind,
Phase III KEYNOTE-604 Study [published online ahead of print, 2020
May 29]. J Clin Oncol. 2020;JCO2000793. doi:10.1200/JCO.20.00793.
\261\ FlatIron EMR Data, April 2020.
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The applicant for TECENTRIQ[supreg] stated that IMFINZI[supreg] is
a human PD-L1 blocking antibody \262\ (that blocks the interaction of
PD-L1 with both PD-1 and CD80 receptors).\263\ According to the
applicant for TECENTRIQ[supreg], IMFINZI[supreg] has indications in
urothelial carcinoma, NSCLC, and, most recently, ES-SCLC.\264\ The
applicant explained that IMFINZI[supreg] was the second cancer
immunotherapy to be approved for the first-line treatment of ES-SCLC, a
little over a year after TECENTRIQ[supreg] and after the deadline for
the submission of the FY 2021 new technology add-on payment
application, on March 27, 2020.\265\ The commenter stated that although
there are slight molecular differences between TECENTRIQ[supreg] and
IMFINZI[supreg], they both fall into the same class of PD-L1 blocking
antibodies. The applicant noted that if CMS believes that
TECENTRIQ[supreg] and IMFINZI[supreg] are similar, then they presume
CMS will consider them as a single application for purposes of new
technology add-on payments in a way that was analogous to what was done
for KYMRIAH and YESCARTA in FY 2019 in which both were approved for new
technology add-on payments.
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\262\ IMFINZI (durvalumab) [prescribing information].
Wilmington, DE: AstraZeneca Co.; 2020.
\263\ Harding FA, Stickler MM, Razo J, DuBridge RB. The
immunogenicity of humanized and fully human antibodies: Residual
immunogenicity resides in the CDR regions. MAbs. 2010;2(3):256-265.
doi:10.4161/mabs.2.3.11641.
\264\ IMFINZI (durvalumab) [prescribing information].
Wilmington, DE: AstraZeneca Co.; 2020.
\265\ U.S. Department of Health and Human Services. Supplemental
Approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761069Orig1s018ltr.pdf. Accessed June 21, 2020.
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The applicant for IMFINZI[supreg] (AstraZeneca) commented that the
addition of IMFINZI[supreg] to the standard of care--etoposide and
platinum-based chemotherapy (either carboplatin or cisplatin)--offers a
novel mechanism of action for the first-line treatment of ES-SCLC.
Therefore, the applicant stated that IMFINZI[supreg] is not
substantially similar to the standard of care because it does not have
the same or similar mechanism of action. The applicant for
IMFINZI[supreg] stated that it offers a new, unique treatment option
for the specific patient population facing this much more aggressive
form of lung cancer, small cell cancer.
The applicant for IMFINZI[supreg] asserted that IMFINZI[supreg] and
TECENTRIQ[supreg] are unique molecular entities, with unique active
ingredients and should be considered separately for new technology add-
on payments. According to the commenter, IMFINZI[supreg] is a
selective, high-affinity, human IgG1 monoclonal antibody.\266\ The
commenter explained that in comparison, TECENTRIQ[supreg] is a
humanized monoclonal antibody.267 268 According to the
commenter, theoretically, human antibodies, which have no non-human
genetic material as humanized antibodies do, should have less
immunogenicity and therefore induce less development of anti-drug
antibodies (ADA).\269\ Also according to the commenter, in the CASPIAN
study, of those who received IMFINZI[supreg], none of the 201 patients
tested positive for treatment-emergent ADA.\270\ The commenter
indicated, comparatively, 18.6% of patients were reported to have
treatment-emergent ADA in the TECENTRIQ[supreg] IMPower 133 study.\271\
The applicant for IMFINZI[supreg] stated that the two new drugs
IMFINZI[supreg] and TECENTRIQ[supreg] were evaluated in distinct and
differently structured clinical trials. The commenter explained that
the CASPIAN trial with IMFINZI[supreg] was studied in combination with
etoposide and either carboplatin or cisplatin \272\ whereas the
TECENTRIQ[supreg] study omitted cisplatin as an option.\273\ The
applicant also noted that the inclusion of patients with asymptomatic
brain metastases is another aspect of the CASPIAN trial that
differentiated the expected IMFINZI[supreg] patient population
according to the applicant.\274\
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\266\ IMFINZI[supreg] (durvalumab) [prescribing information].
Wilmington, DE. AstraZeneca, Inc.
\267\ National Cancer Institute Dictionary of Cancer Terms
https://www.cancer.gov/publications/dictionaries/cancer-terms/def.
Accessed June 2020.
\268\ Enrico D et al. Antidrug Antibodies Against Immune
Checkpoint Blockers: Impairment of Drug Efficacy or Indication of
Immune Activation? American Association for Cancer Research Journal.
2020. Volume 26 (4) 787-792. https://clincancerres.aacrjournals.org/content/26/4/787. Accessed June 16, 2020.
\269\ Enrico D et al. Antidrug Antibodies Against Immune
Checkpoint Blockers: Impairment of Drug Efficacy or Indication of
Immune Activation? American Association for Cancer Research Journal.
2020. Volume 26 (4) 787-792. https://clincancerres.aacrjournals.org/content/26/4/787. Accessed June 16, 2020.
\270\ IMFINZI[supreg] (durvalumab) [prescribing information].
Wilmington, DE. AstraZeneca, Inc.
\271\ TECENTRIQ EMA Assessment report, July 25, 2019. https://www.ema.europa.eu/en/documents/variation-report/tecentriq-h-c-004143-ii-0018-epar-assessment-report-variation_en.pdf; accessed
June 2020.
\272\ Paz-Ares L, et al. Durvalumab tremelimumab +
platinum-etoposide in first-line extensive-stage SCLC: Updated
results from the phase 3 CASPIAN study. 2020 ASCO Annual meeting,
abstract 9002.
\273\ TECENTRIQ[supreg] (atezolizumab) [prescribing
information]. South San Francisco, CA. Genentech, Inc.
\274\ National Comprehensive Cancer Network, Inc. NCCN Clinical
Practice Guidelines in Oncology (NCCN Guidelines) for Small Cell
Lung Cancer version 3.2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed May 2020.
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The applicant further stated that IMFINZI[supreg]'s unique ICD-10
procedure code which has an October 1, 2020 effective date, is distinct
from that of TECENTRIQ[supreg], to enable data to be collected specific
to each technology for specific uses and patient populations,
supporting a conclusion that the technologies should be considered
separately for new technology add-on payments. Therefore, the
manufacturer for IMFINZI[supreg] requested that CMS discretely grant
new technology add-on payments for IMFINZI[supreg], stating that
current evidence does not support consideration of new technology add-
on payments for IMFINZI[supreg] jointly with another applicant.
Response: We thank the applicants for their comments. After
consideration of the public comments we received, although we recognize
that there may be slight molecular differences, we believe
IMFINZI[supreg] and TECENTRIQ[supreg] both fall into the same class of
PD-L1 blocking antibodies. Also, we are not convinced that these
differences result in the use of a different mechanism of action and,
therefore, we believe that the two technologies' mechanisms of action
are the same. Furthermore, we believe that IMFINZI[supreg] and
TECENTRIQ[supreg] are substantially similar to one another because the
technologies are intended to treat the same or similar disease in the
same or similar patient population--patients with ES-SCLC, and are
purposed to achieve the same therapeutic outcome using the same or
similar mechanism of action using PD-L1 blocking antibodies.
We also believe IMFINZI[supreg] and TECENTRIQ[supreg] are not
substantially similar to any other existing technologies because, as
both applicants asserted in their FY 2021 new technology add-on payment
applications and in their comments the technologies do not use the same
or similar mechanism of action to achieve a therapeutic outcome as any
other
[[Page 58679]]
existing drug or therapy assigned to the same or different MS-DRG.
Based on the information described in this section, we believe
IMFINZI[supreg] and TECENTRIQ[supreg] meet the newness criterion.
We also note that proposals to create, delete, or revise codes
under the ICD-10-PCS structure are referred to the ICD-10 Coordination
and Maintenance Committee. The decisions of this committee are
independent from any decision for new technology add on payments.
Therefore, we do not agree with the commenter that the fact that
IMFINZI[supreg] and TECENTRIQ[supreg] have separate codes supports a
conclusion that the technologies should be considered separately for
new technology add-on payments.
Based on the above, we are making one determination regarding
approval for new technology add-on payments that will apply to both
applications, and in accordance with our policy, we use the earliest
market availability date submitted as the beginning of the newness
period for both IMFINZI[supreg] and TECENTRIQ[supreg].
We believe our current policy for evaluating new technology payment
applications for two technologies that are substantially similar to
each other 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).
With respect to the newness criterion, as previously stated,
IMFINZI[supreg] received FDA approval on March 27, 2020 and
TECENTRIQ[supreg] received FDA approval on March 18, 2019. In
accordance with our policy, because these technologies are
substantially similar to each other, we use the earliest market
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 believe that the beginning of the newness period would
be March 18, 2019.
The applicants submitted separate cost and clinical data, and in
the proposed rule, we reviewed and discussed each set of data
separately. However, as stated above, for this final rule, we will make
one determination regarding new technology add-on payments that will
apply to both applications. 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).
If substantially similar technologies are submitted for review in
different (and subsequent) years, rather than the same year, we
evaluate and make a determination on the first application and apply
that same determination to the second application. However, because the
technologies have been submitted for review in the same year, and
because we believe they are substantially similar to each other, we
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.
As we discussed in the proposed rule and as stated above, each
applicant submitted separate analyses 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 respect to the cost criterion, the applicant for
IMFINZI[supreg] conducted the following analysis to demonstrate that
IMFINZI[supreg] meets the cost criterion. To identify cases that may be
eligible for the use of IMFINZI[supreg], the applicant searched the FY
2018 MedPAR LDS file for claims reporting an ICD-10-CM code of category
C34 in combination with Z51.11 (Encounter for antineoplastic
chemotherapy) or Z51.12 (Encounter for antineoplastic immunotherapy).
The applicant also included any cases within MS-DRGs 180, 181, 182 with
an ICD-10-CM diagnosis code from category C34 as the applicant
suggested hospitals may not always capture the encounter for
chemotherapy. Based on the FY 2018 MedPAR LDS file, the applicant
identified a total of 24,193 cases. Of the MS-DRGs with more than 11
cases, the applicant found 23,933 cases which were mapped to 12 unique
MS-DRGs. The applicant excluded MS-DRGs with case volume less than 11
total cases.
Using these 23,933 cases, the applicant for IMFINZI[supreg] then
calculated the unstandardized average charges per case for each MS-DRG.
The applicant determined that it did not need to remove any charges as
IMFINZI[supreg] is not expected to offset historical charges already
included within the MS-DRGs. The applicant asserted that ES-SCLC
patients will receive their initial dose of IMFINZI[supreg] in the
inpatient setting. The applicant for IMFINZI[supreg] then standardized
the charges and inflated the charges by 1.11100 or 11.10 percent, the
same inflation factor used by CMS to update the outlier threshold in
the FY 2020 IPPS/LTCH PPS final rule (84 FR 42629). The applicant then
added the charges for IMFINZI[supreg] by converting the costs to a
charge by dividing the cost by the national average cost-to-charge
ratio of 0.189 for drugs from the FY 2020 IPPS/LTCH PPS final rule (84
FR 42179).
Based on the FY 2020 IPPS/LTCH PPS final rule correction notice
data file thresholds, the average case-weighted threshold amount for
IMFINZI[supreg] was $53,209. In the applicant's analysis, the final
inflated average case-weighted standardized charge per case was
$111,093. Because the final inflated average case-weighted standardized
charge per case exceeds the average case-weighted threshold amount, the
applicant for IMFINZI[supreg] maintained that the technology meets the
cost criterion.
To identify cases that may be eligible for TECENTRIQ[supreg], the
applicant searched the FY 2018 MedPAR LDS file for claims reporting an
ICD-10-CM code from category C34 and considered only cases where the
diagnosis codes were in the primary or admitting position to
differentiate ES-SCLC from limited-stage SCLC. Cases classified with
one or more of 48 surgical lung procedure codes were not considered to
differentiate ES-SCLC from NSCLC. This resulted in 33,404 cases, which
the applicant for TECENTRIQ[supreg] indicated constitute what it
defines as an ES-
[[Page 58680]]
SCLC case through the reconciliation of clinical presentation,
applicable ICD-10-CM and ICD-10-PCS codes, and MedPAR data fields,
which mapped to 264 MS-DRGs.
Using these 33,404 cases, the applicant for TECENTRIQ[supreg] then
calculated the unstandardized average charges per case for each MS-DRG.
The applicant determined that it did not need to remove any charges
because TECENTRIQ[supreg] is administered as a combination therapy with
carboplatin and etoposide to treat ES-SCLC.
The applicant for TECENTRIQ[supreg] then standardized the charges
and inflated the charges by 1.11100 or 11.10 percent, the same
inflation factor used by CMS to update the outlier threshold in the FY
2020 IPPS/LTCH PPS final rule (84 FR 42629). The applicant then added
the estimated cost of an ES-SCLC TECENTRIQ[supreg] administration to
the MedPAR cases. The applicant then added the charges for
TECENTRIQ[supreg] by converting the costs to a charge by dividing the
cost by what the applicant described as a conservative cost-to-charge
ratio of 0.5.
Based on the FY 2020 IPPS/LTCH PPS final rule correction notice
data file thresholds, the average case-weighted threshold amount for
TECENTRIQ[supreg] was $65,738. In the applicant's analysis, the final
inflated average case-weighted standardized charge per case for
TECENTRIQ[supreg] was $88,561. Because the final inflated average case-
weighted standardized charge per case exceeds the average case-weighted
threshold amount, the applicant maintained that the technology meets
the cost criterion.
The applicant for TECENTRIQ[supreg] also provided a sensitivity
analysis using this same methodology but considered only the MS-DRGs
representing 1 percent of case volume, producing a list of 10 MS-DRGs
that cumulatively represent 88.31 percent of case volume, or 29,500
cases. Based on the FY 2020 IPPS/LTCH PPS final rule correction notice
data file thresholds, the average case weighted threshold amount was
$56,987. In the applicant's analysis, the final inflated average case-
weighted standardized charge per case for TECENTRIQ[supreg] was
$88,404. Because the final inflated average case-weighted standardized
charge per case exceeds the average case-weighted threshold amount, the
applicant maintained that the technology meets the cost criterion.
The ICD-10-CM diagnosis codes and MS-DRGs in the cost analysis for
IMFINZI[supreg] differ from those used in the cost analysis for
TECENTRIQ[supreg]. Specifically, as noted previously, the applicant for
TECENTRIQ[supreg] searched for claims with ICD-10-CM diagnosis codes
from category C34 while the applicant for IMFINZI[supreg] searched for
ICD-10-CM diagnosis codes from category C34 in combination with Z51.11
or Z51.12. As noted in the proposed rule, we were concerned as to why
the diagnosis codes would differ between the cost analysis for
IMFINZI[supreg] and for TECENTRIQ[supreg] as one analysis may lend more
accuracy to the calculation depending on which is more reflective of
the applicable patient population.
We invited public comment on whether IMFINZI[supreg] or
TECENTRIQ[supreg] meet the cost criterion.
Comment: Genentech, the applicant for TECENTRIQ[supreg], commented
that while the cost analysis approaches taken for TECENTRIQ[supreg] and
IMFINZI[supreg] are different, both independently concluded that the
cost criterion was met. Regarding the contrast in selection of
diagnostic codes, Genentech considered AstraZeneca's decision to
include patient cases of the ICD-10-CM category C34 in combination with
the ICD-10-CM codes Z51.11 (Encounter for antineoplastic chemotherapy)
or Z51.12 (Encounter for antineoplastic immunotherapy) \275\ to be
reasonable. However, the real-world scenario where the patient is
diagnosed with ES-SCLC in the inpatient setting and then treated there
due to their immediate need for treatment may not result in Z51.11 and/
or Z51.12 appearing in the corresponding claim, because the inpatient
stay was not solely or primarily for the administration of
chemotherapy. Regarding the contrasting cost-to-charge ratios,
Genentech stated that the one used by Genentech (0.5) is more
conservative than that used by AstraZeneca (0.189), but both can be
justified.
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\275\ 85 FR 32,633.
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1. Genentech (CCR of 0.5): This was noted by CMS in the FY 2016
IPPS Final Rule, with reference to the successful application for NTAP
of BLINCYTO.\276\
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\276\ 80 FR 49,446.
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2. AstraZeneca (CCR of 0.189): This figure was calculated by CMS,
specifically for drugs, from FY 2017 cost report data.\277\
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\277\ 84 FR 42,179.
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The applicant for IMFINZI[supreg] also commented that both
applicants utilized the ``C34 Malignant neoplasm of bronchus and lung''
ICD-10-CM code series (85 FR 32633).
Although the same primary diagnosis code was used, each applicant
further refined the patient population using different subsequent
methods. The applicant for IMFINZI[supreg] stated that the case-
weighted threshold amount published in the proposed rule, using their
methodology, is $65,738. Although this threshold presented in the
proposed rule and the inflated case-weighted standardized charges from
analyses AstraZeneca performed were calculated using different
methodologies, the applicant stated that comparing them suggests that
IMFINZI[supreg] would meet the cost criterion if this analysis was
performed with IMFINZI[supreg] charges.
Response: We thank the applicants for their comments. We agree that
both IMFINZI[supreg] and TECENTRIQ[supreg] meet the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant for IMFINZI[supreg] asserted that IMFINZI[supreg] represents
a substantial clinical improvement over existing technologies because
it offers a treatment option for a patient population unresponsive to
currently available treatments. The applicant for IMFINZI[supreg] also
stated that it represents a substantial clinical improvement because
the technology reduces mortality, decreases disease progression, and
improves quality of life.
The CASPIAN clinical trial for IMFINZI[supreg] was a randomized,
open-label, phase 3 trial at 209 sites across 23 countries. Eligible
patients were adults with untreated ES-SCLC, with World Health
Organization (WHO) performance status 0 or 1 and measurable disease as
per Response Evaluation Criteria in Solid Tumors (RECIST). Patients
were randomly assigned (in a 1:1:1 ratio) to durvalumab plus platinum-
etoposide; durvalumab plus tremelimumab plus platinum-etoposide; or
platinum-etoposide alone. All drugs were administered intravenously.
Platinum-etoposide consisted of etoposide 80-100 mg/m2 on days 1-3 of
each cycle with investigator's choice of either carboplatin area under
the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on
day 1 of each cycle). Patients received up to four cycles of platinum-
etoposide plus durvalumab 1500 mg with or without tremelimumab 75 mg
every 3 weeks followed by maintenance durvalumab 1500 mg every 4 weeks
in the immunotherapy groups and up to 6 cycles of platinum-etoposide
every 3 weeks plus prophylactic cranial irradiation (investigator's
discretion) in the platinum-etoposide group. The primary endpoint was
overall survival in the intention-to-treat population. The applicant
for IMFINZI[supreg] stated that the median OS was 13.0 months (95
percent CI, 11.5-14.8) for patients treated with IMFINZI[supreg] plus
chemotherapy vs. 10.3 months (95 percent CI, 9.3-11.2) for
[[Page 58681]]
SOC chemotherapy. The results also showed a sustained OS benefit with
34 percent survival at 18 months following treatment with
IMFINZI[supreg] plus chemotherapy vs. 25 percent following SOC
chemotherapy. No data was provided on patients treated with durvalumab
plus tremelimumab plus platinum-etoposide in the interim analysis
submitted in the application.\278\
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\278\ Paz-Ares, L., Dvorkin, M., Chen, Y., et al., ``Durvalumab
plus platinum-etoposide versus platinum-etoposide in first-line
treatment of extensive-stage small-cell lung cancer (CASPIAN): A
randomized, controlled, open-label, phase 3 trial,'' Lancet, 2019,
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32222-6/fulltext. Accessed October 7, 2019.
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The applicant for IMFINZI[supreg] further stated that other key
secondary endpoints demonstrated consistent and durable improvement for
IMFINZI[supreg] plus chemotherapy, including a higher progression-free
survival (PFS) rate at 12 months (17.5 percent vs. 4.7 percent), a 10
percent increase in confirmed objective response rate (ORR) (67.9
percent vs. 57.6 percent), and improved duration of response at 12
months (22.7 percent vs. 6.3 percent). The median progression-free
Survival was 5.1 months with IMFINZI[supreg] versus 5.4 months for the
control arm, which was not significantly different.
The applicant for IMFINZI[supreg] stated that in combination with
etoposide and platinum-based chemotherapy, IMFINZI[supreg] provided a
significant improvement in survival and notable changes in patient
reported outcomes. According to the applicant, patients receiving
IMFINZI[supreg] plus etoposide and platinum-based chemotherapy
experienced reduced symptom burden over 12 months for pre-specified
symptoms of fatigue, appetite loss, cough, dyspnea, and chest pain
(based on adjusted mean change from baseline, MMRM). The applicant
stated a large difference over 12 months was observed for appetite loss
in favor of IMFINZI[supreg] plus etoposide and platinum-based
chemotherapy compared to standard of care etoposide and platinum-based
chemotherapy. The applicant further stated that patients receiving
IMFINZI[supreg] plus etoposide and platinum-based chemotherapy also
experienced longer time to deterioration in a broad range of patient-
reported symptoms (dyspnea, appetite loss, chest pain, arm/shoulder
pain, other pain, insomnia, constipation, diarrhea), functioning
(physical, cognitive, role, emotional, social), and Health Related
Quality of Life (HRQoL) indicators, compared to cisplatin
(EP).279 280 281 282
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\279\ AstraZeneca Press Release, September 9, 2019, Available
at: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/imfinzi-is-first-immunotherapy-to-show-both-significant-survival-benefit-and-improved-durable-responses-in-extensive-stage-small-cell-lung-cancer-09092019.html.
\280\ Paz-Ares, L., Chen, Y., Reinmuth, N., et al., Overall
Survival with Durvalumab Plus Platinum-Etoposide in First-Line
Extensive-Stage SCLC: Results from the CASPIAN Study [presentation],
Presented at: World Conference on Lung Cancer, Barcelona, Spain,
September 7-10, 2019.
\281\ Paz-Ares, L., Dvorkin, M., Chen, Y., et al., ``Durvalumab
plus platinum-etoposide versus platinum-etoposide in first-line
treatment of extensive-stage small-cell lung cancer (CASPIAN): A
randomized, controlled, open-label, phase 3 trial,'' Lancet. 2019,
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32222-6/fulltext. Accessed October 7, 2019.
\282\ Paz-Ares, L., Goldman, J.W., Garassino, M.C., et al., PD-
L1 expression, patterns of progression and patient-reported outcomes
(PROs) with durvalumab plus platinum-etoposide in ES-SCLC: Results
from CASPIAN [presentation], Presented at European Society for
Medical Oncology; Barcelona, Spain, September 27-October 1, 2019.
---------------------------------------------------------------------------
As stated previously, the applicant asserted that IMFINZI[supreg]
represents a substantial clinical improvement over existing
technologies because it offers a treatment option for a patient
population unresponsive to currently available treatments. The
applicant explained that the CASPIAN study demonstrated the following
endpoints: Patient population baseline characteristics, treatment
exposure, overall survival (including pre-specified subgroups),
progression-free survival, sites of progression, objective response
rate, duration of response, and detailed safety analysis. All results
provided comparison of the active IMFINZI[supreg] plus SOC chemotherapy
arm to the SOC chemotherapy alone arm.\283\
---------------------------------------------------------------------------
\283\ Paz-Ares, L., Dvorkin, M., Chen, Y., et al., ``Durvalumab
plus platinum-etoposide versus platinum-etoposide in first-line
treatment of extensive-stage small-cell lung cancer (CASPIAN): A
randomized, controlled, open-label, phase 3 trial [article and
supplementary appendix],'' Lancet, 2019.
---------------------------------------------------------------------------
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32634), we had
concerns that the CASPIAN study is ongoing, and the information is
preliminary. Specifically, the three arms in the study had not yet been
analyzed at time of application. Additionally, while the data show a
median survival benefit of about 3 months with treatment with
IMFINZI[supreg], we stated that we did not see any data that
demonstrates significant improvement in median progression-free
survival. Also, while we recognized that the trials are ongoing and
that the analysis of the three study arms is not complete, we stated
that we were interested in any updates and additional information
concerning adverse events to help us better understand the safety
profile of IMFINZI[supreg].
The applicant for TECENTRIQ[supreg] asserted that TECENTRIQ[supreg]
plus standard of care represents a substantial clinical improvement
over existing technologies because it offers a treatment option for a
patient population unresponsive to, or ineligible for currently
available treatments. The applicant also maintained that
TECENTRIQ[supreg] represents a substantial clinical improvement because
the technology demonstrates statistically significant improvement in
overall survival, statistically significant improvement in progression-
free survival, as well as improved HRQoL (Health-related quality of
life, which is an individual's or a group's perceived physical and
mental health over time) \284\ and reduced symptomatology.
---------------------------------------------------------------------------
\284\ https://www.cdc.gov/hrqol/index.htm. Accessed December 27,
2019.
---------------------------------------------------------------------------
According to the applicant, the use of TECENTRIQ[supreg] in cases
of ES-SCLC was evaluated in IMpower133, a phase III (efficacy) and
phase I (safety), double-blind, placebo-controlled, randomized,
multicenter study designed to compare the efficacy and safety of
TECENTRIQ[supreg] vs. placebo in combination with carboplatin and
etoposide in patients with ES-SCLC who did not receive prior systemic
therapy.\285\ Over 40 percent of the population of the IMpower133
clinical trial were of Medicare age.\286\
---------------------------------------------------------------------------
\285\ Horn, .L, Mansfield, A.S., Szcz[eogon]sna, A., et al.,
``First-Line Atezolizumab plus Chemotherapy in Extensive Stage
Small-Cell Lung Cancer,'' New England Journal of Medicine, 2018,
379(23), pp. 2220-2229, doi:10.1056/nejmoa1809064.
\286\ Ibid.
---------------------------------------------------------------------------
Key inclusion criteria were as follows: Histologically or
cytologically confirmed ES-SCLC as defined by the VA Lung Study Group
staging system; measurable ES-SCLC according to RECIST version 1.1;
ECOG PS of 0-1; no prior systemic treatment for ES-SCLC; and treated
asymptomatic CNS metastases. Key exclusion criteria were as follows:
History of autoimmune disease and prior treatment with CD137 agonists
or immune checkpoint inhibitors.
A total of 403 patients were enrolled. Patients were stratified by
gender, ECOG PS (0 or 1), and the presence of brain metastases.
Baseline characteristics were comparable across both treatment arms.
The following table summarizing baseline patient characteristics
indicates that more than 40 percent of the patients in both treatment
arms were of Medicare age.
[[Page 58682]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.156
At the time of data cutoff (April 24, 2018), the median follow-up
was 13.9 months. The applicant stated that patients treated with
TECENTRIQ[supreg] + carboplatin + etoposide experienced a significantly
longer OS and PFS compared with patients treated with placebo +
carboplatin + etoposide in the ITT population. The 1-year OS with
TECENTRIQ[supreg] + carboplatin + etoposide, compared with the placebo
+ carboplatin + etoposide rate, was approximately 13 percent higher;
the 1-year PFS was approximately 7 percent higher, as shown in the
following table that summarizes Landmark Overall Survival and
Progression-free Survival Rates (Data Cutoff: April 24, 2018).
[GRAPHIC] [TIFF OMITTED] TR18SE20.157
The incidence of treatment-related AEs was similar in both
treatment arms. The following table provides information about the
safety profiles (Data Cutoff: April 24, 2018) (safety population)--
IMpower133. The most common treatment-related Grade 3/4 AEs for
TECENTRIQ[supreg] + carboplatin + etoposide and for placebo +
carboplatin + etoposide was neutropenia (22.7 percent vs. 24.5 percent,
respectively), anemia (14.1 percent vs. 12.2 percent), and decreased
neutrophil count (14.1 percent vs. 16.8 percent). Treatment-related
deaths occurred in three patients in the TECENTRIQ[supreg] group (due
to neutropenia, pneumonia, and unspecified cause) and three patients in
the placebo group (due to pneumonia, septic shock, and cardiopulmonary
failure).
[[Page 58683]]
[GRAPHIC] [TIFF OMITTED] TR18SE20.158
More patients in the TECENTRIQ[supreg] group than in the placebo
group experienced immune-related AEs, with rash and hypothyroidism
being the most common. The following table summarizes immune-related
AEs occurring in >=5 patients in any treatment arm (data cutoff: April
24, 2018) (safety population).
[GRAPHIC] [TIFF OMITTED] TR18SE20.159
The median treatment duration of TECENTRIQ[supreg] was 4.7 months
(range: 0-1), and the median number of TECENTRIQ[supreg] doses
administered was 7 (range: 1-30). The median dose intensity, total
cumulative dose, and median number of chemotherapy doses (four doses of
carboplatin, 12 doses of etoposide) were similar in the two treatment
groups.
The addition of TECENTRIQ[supreg] to carboplatin + etoposide
demonstrated a statistically significant improvement in OS and PFS
compared with placebo + carboplatin + etoposide for the first-line
treatment of ES-SCLC. Overall, the safety profiles of TECENTRIQ[supreg]
+ carboplatin + etoposide and placebo + carboplatin + etoposide were
comparable to the safety profiles of each individual agent; no new
safety signals were identified with the combinations.
The applicant asserted that TECENTRIQ[supreg] plus standard of care
therapy represents a substantial clinical improvement over existing
technologies because it offers a treatment option for a patient
population unresponsive to or ineligible for currently available
treatments. The applicant also asserted that TECENTRIQ[supreg]
represents a significant clinical improvement over existing
technologies because the technology produces a statistically
significant improvement in overall survival, a statistically
significant improvement in progression-free survival, as well as
improved HRQoL and reduced symptomatology.
In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32667), we stated
we were concerned that the survival benefit of the addition of
TECENTRIQ[supreg] was a median duration of only 2 months over standard
therapy and the improvement on the median progression-free survival was
less than one month. We were also concerned that the short survival and
progression-free survival may not be clinically significant.
Additionally, we were concerned that the participants did not have a
clinically significant improvement in their quality of life given the
number of AEs in the TECENTRIQ[supreg] treatment arm combined with the
number of treatments given in that arm.
We invited public comments on whether IMFINZI[supreg] or
TECENTRIQ[supreg] meet the substantial clinical improvement criterion.
Comment: Multiple commenters, including the applicant for
TECENTRIQ[supreg], remarked that outcomes in ES-SCLC have been poor for
decades and that the current standard therapy of platinum + etoposide
chemotherapy was introduced in the 1970's. The commenters referenced
multiple unsuccessful studies in the intervening decades and that
TECENTRIQ[supreg] was the first advance to change that standard of
care. The commenters cited the results from IMpower133, a randomized,
[[Page 58684]]
placebo-controlled, phase III trial, which showed that the addition of
atezolizumab to standard chemotherapy significantly improved survival
(Horn et al, N Engl J Med 2018).\287\ The commenters also cited that
adding atezolizumab to standard chemotherapy did not significantly
worsen toxicity and also improved symptom control (Mansfield et al, Ann
Oncol 2019).\288\
---------------------------------------------------------------------------
\287\ Horn L et al. New England Journal of Medicine.
2018;379(23):2220-2229. doi:10.1056/nejmoa1809064.
\288\ Califano R et al. Annals of Oncology. 2018;29(suppl_10).
---------------------------------------------------------------------------
Multiple commenters, including the applicant for TECENTRIQ[supreg],
remarked that SCLC is the most aggressive type of lung cancer,
accounting for 10-15% of lung cancer cases.\289\ The commenters
explained that the majority of these (72%) are diagnosed at the
extensive stage,\290\ which is associated with a 5-year survival rate
of only 2.9%.\291\ According to the commenters, ES-SCLC necessitates
immediate treatment, and TECENTRIQ[supreg] is FDA-approved to be
administered to Medicare beneficiaries on the very first day of
treatment.\292\ The commenters stated that ideally, this would be with
the current best therapy, atezolizumab plus chemotherapy, but without
the new technology add-on payment, the commenters stated that some
patients will be treated with inferior therapy. The applicant stated
that delaying immunotherapy is suboptimal--as a phase III study
exploring immunotherapy after chemotherapy (CheckMate 451) did not
improve survival (Owonikoko, ELCC 2019).
---------------------------------------------------------------------------
\289\ WebMD, LLC. Types of Lung Cancer. https://www.webmd.com/lung-cancer/Jung-cancer-types# I. Accessed September 19, 2019.
\290\ American Lung Association. Trends in Lung Cancer Morbidity
and Mortality. https://www.lung.org/assets/documents/researcb/lc-trend-report.pdf. Published November 2014. Accessed September 19,
2019.
\291\ Noone AM, Howlader N, K.rapcho M, et al. SEER Cancer
Statistics Review, 1975-2015, based on November 2017 SEER data
submission, posted to the SEER website, April 2018. Bethesda, MD:
National Cancer Institute. 2018; https://seer.cancer.gov/csr/1975_2015/. Accessed Sept 19, 2019.
\292\ TENCENTRIQ (atezolizumab) [prescribing information]. San
Francisco, CA: Genentech, Inc.; 2019.
---------------------------------------------------------------------------
The applicant for IMFINZI[supreg] commented that the final analysis
of the CASPIAN trial was presented on May 29, 2020 at the 2020 ASCO
Annual Meeting.\293\ According to the commenter, the final evidence
supporting this indication demonstrated clinical and meaningful
improvement in PFS and OS in the completed and final first experimental
arm of the CASPIAN trial. According to the applicant, results from the
CASPIAN trial continued to demonstrate improvement in OS vs EP, with a
HR of 0.75 (95% CI 0.62-0.91; nominal p=0.0032); median OS 12.9 vs 10.5
mo, respectively. 22.2% of pts were alive at 2 y with durvalumab +
cisplatin or carboplatin vs 14.4% of pts with cisplatin or carboplatin.
The study concluded that the addition of durvalumab to cisplatin or
carboplatin continued to demonstrate improvement in OS compared with a
robust control arm, further supporting this regimen as a new standard
of care for 1L ES-SCLC offering the flexibility of platinum choice.
---------------------------------------------------------------------------
\293\ Paz-Ares L, et al. Durvalumab tremelimumab +
platinum-etoposide in first-line extensive-stage SCLC: Updated
results from the phase 3 CASPIAN study. 2020 ASCO Annual meeting,
abstract 9002.
---------------------------------------------------------------------------
Response: We appreciate the commenters' input and 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 IMFINZI[supreg] and TECENTRIQ[supreg] represent a substantial
clinical improvement over existing technologies because the
technologies significantly improve clinical outcomes. These two
treatments are the first to show improved overall survival in the
treatment of ES-SCLC, an aggressive and deadly disease, in more than 20
years. In summary, we have determined that IMFINZI[supreg] and
TECENTRIQ[supreg] meet all of the criteria for approval of new
technology add-on payments. Therefore, we are approving new technology
add-on payments for IMFINZI[supreg] and TECENTRIQ[supreg] for FY 2021.
As previously stated, cases involving IMFINZI[supreg] that are eligible
for new technology add-on payments will be identified by ICD-10-PCS
procedure codes XW03336 (Introduction of durvalumab antineoplastic into
peripheral vein, percutaneous approach, new technology group 6) or
XW04336 (Introduction of durvalumab antineoplastic into central vein,
percutaneous approach, new technology group 6). Cases involving
TECENTRIQ[supreg] that are eligible for new technology add-on payments
will be identified by ICD-10-PCS procedure codes XW033D6 (Introduction
of atezolizumab antineoplastic into peripheral vein, percutaneous
approach, new technology group 6) or XW043D6 (Introduction of
atezolizumab antineoplastic into central vein, percutaneous approach,
new technology group 6), respectively.
Each of the applicants submitted cost information for its
application. The manufacturer of IMFINZI[supreg] stated that the cost
of its technology is $10,833. The applicant projected that 6,073 cases
will involve the use of IMFINZI[supreg] in FY 2021. The manufacturer of
TECENTRIQ[supreg] stated that the cost of its technology is $9,013.75.
The applicant projected that 806 cases will involve the use of
TECENTRIQ[supreg] in FY 2021. Because the technologies are
substantially similar to each other, we believe using a single cost for
purposes of determining the new technology add-on payment amount is
appropriate for IMFINZI[supreg] and TECENTRIQ[supreg] even though each
applicant has its own set of codes. We also believe using a single cost
provides predictability regarding the add on payment when using
IMFINZI[supreg] or TECENTRIQ[supreg] for the treatment of patients with
ES-SCLC. As such, we believe that the use of a weighted average of the
cost of IMFINZI[supreg] and TECENTRIQ[supreg] based on the projected
number of cases involving each technology to determine the maximum new
technology add-on payment would be most appropriate. To compute the
weighted cost average, we summed the total number of projected cases
for each of the applicants, which equaled 6,879 cases (6,073 plus 806).
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: 86 Percent for IMFINZI[supreg] and
14 percent for TECENTRIQ[supreg]. We then multiplied the cost per case
for the manufacturer specific drug by the case-weighted percentage
(0.86 * $10,833 = $9,316.38 for IMFINZI[supreg] and 0.14 * $9,013.75 =
$1,261.93 for TECENTRIQ[supreg]). This resulted in a case-weighted
average cost of $10,578.53 for the technology. Under Sec.
412.88(a)(2), we limit new technology add-on payments to the lesser of
65 percent of the average cost of the device or 65 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 IMFINZI[supreg] or
TECENTRIQ[supreg] is $6,875.90 for FY 2021.
i. Soliris
Alexion, Inc, submitted an application for new technology add-on
payments for Soliris[supreg] (eculizumab) for FY 2021. Soliris[supreg]
is approved for the treatment of neuromyelitis optica spectrum disorder
(NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody
positive.
According to the applicant, NMOSD is a rare and severe condition
that attacks the central nervous system without warning. The applicant
explained that NMOSD attacks, also referred to as relapses, can cause
progressive and irreversible damage to
[[Page 58685]]
the brain, optic nerve and spinal cord, which may lead to long-term
disability, and in some instances, the damage may result in death.
According to the applicant, the serious nature of an NMOSD relapse
frequently requires inpatient hospitalization and treatment should be
initiated as quickly as possible.
According to the applicant, in patients with AQP4 antibody-positive
NMOSD, the body's own immune system can turn against itself to produce
auto-antibodies against AQP4, a protein on certain cells in the eyes,
brain and spinal cord that are critical for the survival of nerve
cells. The applicant explained that the binding of these anti-AQP4
auto-antibodies activates the complement cascade, another part of the
immune system.
According to the applicant, complement activation by anti-AQP4
auto-antibodies is one of the primary causes of NMOSD. The applicant
explained that formation of membrane attack complex (MAC) is the end
product of the activated complement system which is directly
responsible for the damage to astrocytes leading to astrocytopathy
(astrocyte death) and ensuing neurologic damage associated with NMOSD
and relapses. According to the applicant, the primary goal of NMOSD
treatment is to prevent these relapses, which over time lead to
irreversible neurologic damage.
According to the applicant, Soliris[supreg] is a first-in-class
complement inhibitor that works by selectively inhibiting the
complement system, a central part of the immune system involved in
inflammatory processes, pathogen elimination, activation of the
adaptive immune response, and maintenance of homeostasis. The applicant
explained that the complement system distinguishes between healthy host
cells, cell debris, apoptotic cells, and external pathogens. The
applicant further explained that the complement system triggers a
modulated immune response, and functions through a combination of
effector proteins, receptors, and regulators. The applicant asserted
that when the complement system detects a threat, an initial protease
is activated. This protease (either alone or in a complex) then cleaves
its target, which in turn becomes active and starts to cleave the next
target in the chain, and so on, leading to a cascade.
Per the applicant, initial activation of the complement system
occurs via three different pathways, which all ultimately lead to the
formation of the membrane attack complex (MAC) and release of the
anaphylatoxins: (1) The classical pathway is activated by antibody-
antigen complexes; (2) The alternative pathway is activated at a
constant low level via ``tick-over'' (spontaneous hydrolysis) of
Complement component 3 (C3), a protein of the immune system; (3) The
lectin pathway is activated by carbohydrates frequently found on the
surface of microbes. According to the applicant, all pathways of
complement activation result in the formation of C3 convertase
(``proximal complement''), and converge at the cleavage of C5 leading
to the generation of C5a and C5b by the C5 convertase enzyme complexes
(``Terminal complement''). The applicant explained that C3 is the most
abundant complement protein in plasma, occurring at a concentration of
1.2 mg/mL and C3 cleavage products bridge the innate and the adaptive
immune systems. The applicant also explained that C3a acts as an
anaphylatoxin and is a mediator of inflammatory processes and C3b
opsonizes the surface of recognized pathogens and facilitates
phagocytosis and binds C3 convertase to form C5 convertase. The
applicant also explained that C5 convertase cleaves C5 into C5a and
C5b; C5a is chemotactic agent and anaphylatoxin, causing leukocyte
activation, endothelial cell activation, and proinflammatory and
prothrombotic effects.
According to the applicant, imbalance between complement activation
and regulation leads to host tissue damage, and congenital deficiencies
in the complement system can lead to an increased susceptibility to
infection. The applicant explained that the complement system is also
associated with the pathogenesis of non-infectious diseases such as
chronic inflammation, autoimmune diseases, thrombotic microangiopathy,
transplant rejection reactions, ischemic, neurodegenerative age-
associated diseases, and cancer. According to the applicant, the
complement system is also recognized as important in the antibody-
mediated autoimmune disease AQP4 antibody-positive NMOSD. The applicant
stated that Soliris[supreg] is the first and only FDA approved
treatment for adult patients with NMOSD who are AQP4 antibody-positive
that is proven to reduce the risk of relapse.
The incidence of NMOSD in the United States is 0.7/100,000 while
the prevalence is 3.9/100,000 population.\294\ The median onset of
NMOSD is 39 years of age and 83 percent of cases are
female.295 296 NMOSD was commonly misdiagnosed as multiple
sclerosis (MS) in the past.\297\ According to the applicant, at least
two-thirds of NMOSD cases are associated with aquaporin-4 antibodies
(AQP4-IgG) and complement-mediated damage to the central nervous
system.
---------------------------------------------------------------------------
\294\ Flanagan EP, et al., ``Epidemiology of aquaporin-4
autoimmunity and neuromyelitis optica spectrum,'' Ann Neurol, 2016,
vol. 79(5), pp. 775-783.
\295\ Bukhari W, et al., ``Incidence and prevalence of NMOSD in
Australia and New Zealand,'' J Neurol Neurosurg Psychiatry, 2017,
vol. 88(8), pp. 632-638.
\296\ Wingerchuk DM, et al., ``The spectrum of neuromyelitis
optica,'' Lancet Neurol, 2007, vol. 6, pp. 805-815.
\297\ Jarius S, et al., ``Contrasting disease patterns in
seropositive and seronegative neuromyelitis optica: A multicentre
study of 175 patients,'' J Neuroinflammation, 2012, vol. 9, pp. 14.
---------------------------------------------------------------------------
According to the applicant, Soliris[supreg] is administered via an
IV infusion by a healthcare professional. The applicant explained that
for adult patients with neuromyelitis optica spectrum disorder,
Soliris[supreg] therapy consists of 900 mg weekly for the first 4
weeks, followed by 1200 mg for the fifth dose 1 week later, then 1200
mg every 2 weeks thereafter. According to the applicant,
Soliris[supreg] should be administered at the recommended dosage
regimen time points, or within 2 days of these time points. The
applicant also explained that for adult and pediatric patients with
NMOSD, supplemental dosing of Soliris[supreg] is required in the
setting of concomitant plasmapheresis or plasma exchange, or fresh
frozen plasma infusion (PE/PI).
The applicant explained that Soliris[supreg] has a boxed warning
for risk of serious meningococcal infections. According to the
applicant, life-threatening and fatal meningococcal infections have
rarely occurred in patients treated with Soliris[supreg] and can be
mitigated with proper vaccination. The applicant explained that by
blocking the terminal complement system, Soliris[supreg] increases the
risk of meningococcal and encapsulated bacterial infection. According
to the applicant, all the patients in a pivotal trial received
meningococcal vaccination, and no cases of meningococcal infection were
reported. The applicant also noted that Soliris[supreg] is available
only through a restricted program under a Risk Evaluation and
Mitigation Strategy (REMS) and under the Soliris[supreg] REMS,
prescribers must enroll in the program.
With respect to the newness criterion, FDA approved Soliris[supreg]
for the indication of treatment of NMOSD in adult patients who are AQP4
antibody positive on June 27, 2019. Soliris[supreg] was first approved
by FDA on March 19, 2007 for the treatment of patients with paroxysmal
nocturnal hemoglobinuria (PNH) to reduce hemolysis, followed by
[[Page 58686]]
approvals for the treatment of patients with atypical hemolytic uremic
syndrome (aHUS) to inhibit complement mediated thrombotic
microangiopathy, and for an efficacy supplement to add the indication
of treatment of generalized myasthenia gravis (gMG) in adult patients
who are anti-acetylcholine receptor (AChR) antibody positive. The
applicant has applied for new technology add-on payments for use of
Soliris[supreg] only for the indication of treatment of NMOSD in adult
patients who are AQP4 antibody positive. The applicant stated that FDA
granted Soliris[supreg] Orphan Drug Designation for the treatment of
neuromyelitis optica on June 24, 2014. Additionally, the applicant
stated that Soliris[supreg] was filed as a supplemental biologics
license application (sBLA; BLA125166/S-431) for the treatment of NMOSD
in adult patients who are AQP4 antibody positive, which FDA assigned
Priority Review status.
According to the applicant, patients with NMOSD are currently
identified by ICD-10-CM diagnosis code: G36.0 Neuromyelitis optica
(Devic's syndrome). The applicant submitted a request for approval for
a unique ICD-10-PCS procedure code for the administration of
Soliris[supreg] beginning in FY 2021 and was granted approval for the
following ICD-10-PCS procedure codes effective October 1, 2020: XW033C6
(Introduction of eculizumab into peripheral vein, percutaneous
approach, new technology group 6) and XW043C6 (Introduction of
eculizumab into central vein, percutaneous approach, new technology
group 6).
As stated previously, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and, therefore, 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 similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, Soliris[supreg] is the only treatment for
NMOSD that works by specifically inhibiting the complement cascade as
described previously. According to the applicant, Soliris[supreg] is
the only FDA approved treatment for NMOSD, although several off-label
products are used to treat relapse prevention in NMOSD. As mentioned
previously, the applicant explained that the formation of the membrane
attack complex (MAC) is the end product of the activated complement
system which is directly responsible for the damage to astrocytes
leading to astrocytopathy (astrocyte death) and the ensuing neurologic
damage associated with NMOSD and relapses.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that cases
involving the administration of Soliris[supreg] will likely be assigned
to the same MS-DRGs as other therapies that are currently used but not
indicated to treat NMOSD. These therapies that are used off-label
include axiothiprine, rituximab, low-dose steroids (prednisone),
mycophenolate mofetil, methotrexate, mitoxantrone, cyclophosphamide,
tacrolimus, tocilizumab, cyclosporin A, and plasma exchange. As stated
previously, the applicant asserted that Soliris[supreg] is the first
approved treatment for NMOSD in adult patients who are AQP4 antibody
positive.
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
maintained that although Soliris[supreg] will be treating the same
disease and patient population as currently available therapies, it
will improve the treatment of NMOSD as there were previously no FDA
labeled treatments. As stated previously, the applicant asserted that
Soliris[supreg] is the first approved treatment for NMOSD in adult
patients who are AQP4 antibody positive.
In summary, the applicant asserted that Soliris[supreg] meets the
newness criterion because it is the only FDA approved treatment for
NMOSD that works by specifically inhibiting the complement cascade. We
invited public comments on whether Soliris[supreg] is substantially
similar to other technologies and whether Soliris[supreg] meets the
newness criterion.
Comment: One commenter asserted that the mechanism of action for
Soliris[supreg] does meet the newness criterion. A second commenter
observed that Soliris[supreg] was the first FDA-approved complement
inhibitor indicated for the treatment of adults with AQP4 antibody-
positive NMOSD, and that this is a novel therapy for NMOSD.
Response: We thank the commenters for their input concerning the
application of the newness criterion to Soliris[supreg].
Based on these comments and on information submitted by the
applicant as part of its FY 2021 new technology add-on payment
application for Soliris[supreg], as discussed in the proposed rule (85
FR 32653) and previously summarized, we believe that Soliris[supreg]
has a unique mechanism of action in the treatment of patients with AQP4
antibody-positive NMOSD. Therefore, we believe Soliris[supreg] is not
substantially similar to existing treatment options and does meet the
newness criterion. We consider the beginning of the newness period to
commence when Soliris[supreg] was approved by FDA for the indication of
treatment of NMOSD, on June 27, 2019.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that the technology meets the cost
criterion. The applicant searched claims in the FY 2018 MedPAR final
rule dataset reporting an ICD-10-CM diagnosis code of G36.0.
This search identified 1,151 cases primarily spanning 14 MS-DRGs.
According to the applicant, cases representing patients who may be
eligible for treatment with Soliris[supreg] for NMOSD would most likely
map to MS-DRGs 058, 059 and 060 (Multiple Sclerosis and Cerebellar
Ataxia with MCC, with CC and without CC/MCC, respectively)--the family
of MS-DRGs for multiple sclerosis & cerebellar ataxia. According to the
applicant, these three MS-DRGs were three of the top four MS-DRGs by
volume to which cases reporting a diagnosis code G36.0 were assigned,
and together these MS-DRGs accounted for about 32 percent of the 1,151
originally identified cases reporting a diagnosis code G36.0.
Consequently, the applicant limited its analysis to the 376 cases that
grouped to these three MS-DRGs (058, 059 and 060).
The applicant performed its cost analysis based on the 376 claims
assigned to MS-DRGs 058, 059 and 060. The applicant first removed
charges for other technologies. According to the applicant,
Soliris[supreg] would replace other drug therapies, such as
azathioprine, methotrexate, and rituximab, among others. Because it is
generally not possible to differentiate between different drugs on
inpatient claims, the applicant removed all charges in the drug cost
center. The applicant also removed all charges from the blood cost
center, because Soliris[supreg] will replace plasma exchange
procedures. Lastly, the applicant removed an additional $12,000 of cost
for the plasma exchange procedural costs, based on an internal analysis
of the average cost of plasma exchange. To convert these costs to
charges, the applicant used the ``other services'' national average
cost-to-charge ratio (0.346). According to the applicant, this was
likely an overestimate of the charges that would be replaced by using
Soliris[supreg].
After removing charges for the prior technology to be replaced, the
applicant standardized the charges. The applicant
[[Page 58687]]
then used the 2-year inflation factor of 11.1 percent, as published in
the FY 2020 IPPS final rule (84 FR 42629), to inflate the charges from
FY 2018 to FY 2020. To determine the charges for Soliris[supreg], the
applicant assumed hospitals would use the inverse of the national
average cost to charge ratio for pharmacy costs (0.189) from the FY
2020 IPPS/LTCH PPS final rule to mark-up charges.
Based on the aforementioned analysis, the applicant computed a
final inflated average case-weighted standardized charge per case of
$72,940, as compared to a calculated threshold value of $44,420.
Because the final inflated average case-weighted standardized charge
per case exceeded the average case-weighted threshold amount, the
applicant asserted that the technology meets the cost criterion.
We note that, in the proposed rule, we inadvertently omitted the
charges for Soliris[supreg] in the applicant's cost analysis. After
accounting for these charges, the applicant computed a final inflated
average case-weighted standardized charge per case of $172,867, which
exceeds the calculated threshold value of $44,420. However, as
previously noted, the final inflated average case-weighted standardized
charge per case exceeded the average case-weighted threshold amount
even without the addition of charges for Soliris[supreg]. We invited
public comments on whether Soliris[supreg] meets the cost criterion.
We did not receive any public comments on whether Soliris[supreg]
meets the cost criterion. Based on the information submitted by the
applicant as part of its FY 2021 new technology add-on payment
application for Soliris[supreg], as discussed in the proposed rule (85
FR 32652 through 32655) and previously summarized, the final inflated
average case-weighted standardized charge per case exceeded the average
case-weighted threshold amount. Therefore, Soliris[supreg] meets the
cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that Soliris[supreg] represents a substantial
clinical improvement over existing technologies because it
significantly improves clinical outcomes relative to services or
technologies previously available, as demonstrated by the applicant's
clinical data and patient outcomes, such as the prevention of relapses
in patients with NMOSD.
The applicant provided a randomized, controlled trial in support of
its claims of reduction of first-adjudicated on-trial relapse with
Soliris[supreg] (PREVENT).\298\ The PREVENT study enrolled 143 adults
who were randomly assigned in a 2:1 ratio to receive intravenous
eculizumab (at a dose of 900 mg weekly for the first four doses
starting on day 1, followed by 1200 mg every 2 weeks starting at week
4) or a matched placebo. The continued use of stable-dose
immunosuppressive therapy was permitted. The primary endpoint studied
was the first adjudicated relapse. Secondary outcomes included the
adjudicated annualized relapse rate, quality-of-life measures, and the
score on the Expanded Disability Status Scale (EDSS), which ranges from
0 (no disability) to 10 (death). Adjudicated relapses occurred in 3 of
96 patients (3 percent) in the Soliris[supreg] group and 20 of 47 (43
percent) in the placebo group (hazard ratio, 0.06; 95 percent
confidence interval [CI], 0.02 to 0.20; P<0.001). The adjudicated
annualized relapse rate was 0.02 in the eculizumab group and 0.35 in
the placebo group (rate ratio, 0.04; 95 percent CI, 0.01 to 0.15;
P<0.001). The applicant also explained that 97.9 percent of patients on
Soliris[supreg] remained NMOSD relapse free at 48 weeks, 96.4 percent
at 96 weeks and 96.4 percent at 144 weeks. There was no significant
between-group difference in measures of disability progression. The
mean change in the EDSS score was -0.18 in the eculizumab group and
0.12 in the placebo group (least-squares mean difference, -0.29; 95%
CI, -0.59 to 0.01).
---------------------------------------------------------------------------
\298\ Pittock, S.J., Berthele, A., Fujihara, K., Kim, H.J.,
Levy, M., Palace, J., Nakashima, I., Terzi, M., Totolyan, N.,
Viswanathan, S., Wang, K.C., Pace, A., Futita, K.P., Armstrong, R.,
Wingerchuk, D.M., ``Eculizumab in Aquaporin-4-Positive Neuromyelitis
Optica Spectrum Disorder.'' N Engl J Med., 2019, vol 381(7), pp.,
614-625.
---------------------------------------------------------------------------
The applicant also submitted a poster presentation of post hoc
efficacy analyses in pre-specified subgroups from the PREVENT
study.\299\ Pre-specified subgroup summaries for time to first
adjudicated relapse were based on immunosuppressive therapies (IST) use
(five subgroups for concomitant IST use; two subgroups according to
whether or not rituximab was previously used), geographic region, age,
sex, race and randomization stratum. Time to first adjudicated relapse
was increased with eculizumab compared with placebo in all subgroups
analyzed. Significant treatment effects were observed in all subgroups
for IST use, region, age, sex and race, except for the smallest
subgroups in which the differences were similar to the others but did
not reach nominal significance owing to small sizes (patients using
other ISTs, n = 7; Black/African American patients, n = 17, among whom
none of the nine patients receiving eculizumab experienced a relapse),
and in patients from the Americas owing to the performance of the
placebo arm. In patients who had received rituximab more than 3 months
before the study, the adjudicated relapse risk reduction was 90.7
percent with eculizumab compared with placebo (p = 0.0055). The
proportion of patients who were relapse-free at week 48 was
consistently higher with eculizumab than with placebo in all pre-
specified IST subgroups.
---------------------------------------------------------------------------
\299\ Pittock, S.J., Berthele, A., Fujihara, K., Kim, H.J.,
Levy, M., Palace, J., Nakashima, I., Terzi, M., Totolyan, N.,
Viswanathan, S., Wang, K.C., Pace, A., Futita, K.P., Yountz, M.,
Armstrong, R., Wingerchuk, D.M., ``Subgroup analyses from the phase
3 PREVENT study in patients with aquaporin-4 antibody-positive
neuromyelitis optica spectrum disorder,'' September 11-13, 2019,
Poster presentation at ECTRIMS, Stockholm, Sweden.
---------------------------------------------------------------------------
As stated previously, the applicant asserted that Soliris[supreg]
represents a substantial clinical improvement over existing
technologies because it reduces relapses in patients with NMOSD. The
applicant explained that the PREVENT study demonstrated several
endpoints. The applicant explained that Soliris[supreg] reduced first
adjudicated on-trial relapse with eculizumab in comparison to placebo
with a 94 percent relative risk reduction (Hazard Ratio, 0.006; 95% CI,
0.02-0.20). The applicant also explained that 97.9 percent of
Soliris[supreg] patients were relapse free at 48 weeks, compared to
63.2 percent for the placebo group. The applicant further noted that in
a subgroup of patients utilizing monotherapy (patients on eculizumab or
placebo only, without concomitant immunosuppressant agents), 100
percent of Soliris[supreg] patients were relapse free at 48 weeks
compared to 60.6 percent for placebo. The applicant also explained that
in the PREVENT subgroup analysis presented as a poster, the treatment
effect was observed regardless of whether it was used as a monotherapy
or with concomitant ISTs (corticosteroids alone, azathioprine,
mycophenolate mofetil); previous IST use (including rituximab);
geographical region; age; sex; and race.
The applicant also explained that the Soliris[supreg] U.S.
Prescribing Information contains the following information on resource
utilization in the applicant's phase III trials (corticosteroid use,
plasma exchange treatment, and hospitalizations): Compared to placebo-
treated patients, the PREVENT study showed that Soliris[supreg]-treated
patients had reduced annualized rates of (1) hospitalizations (0.04 for
Soliris[supreg] versus 0.31 for placebo), (2) of corticosteroid
administration to treat acute relapses
[[Page 58688]]
(0.07 for Soliris[supreg] versus 0.42 for placebo), and (3) of plasma
exchange treatments (0.02 for Soliris[supreg] versus 0.19 for placebo).
The applicant explained that annualized rates were calculated by
dividing the total number of on-trial relapses requiring acute
treatment during the study period for all patients by the number of
patient-years in the study period.
After reviewing the information submitted by the applicant as part
of its FY 2021 new technology add-on payment application for Soliris,
we stated in the proposed rule that we are concerned that the applicant
provided only one study in support of its assertions of substantial
clinical improvement, which is the PREVENT trial, with additional
supporting documents all based on the same trial. We noted that the
study compared Soliris to placebo but that there was no comparison of
Soliris to currently available treatments to gauge real world efficacy,
nor was there information about how these current treatments work and
why they are ineffective. Furthermore, in the PREVENT trial, the
applicant did not provide the dosage amounts for the patients on
continuing medication in addition to placebo or Soliris. We stated that
it is not clear to us if the patients receiving Soliris had higher
dosages of continuing medications than those in the placebo group. We
stated that we would be interested in more information about the dosage
amounts in the treatment and control groups in the PREVENT trial. We
invited public comment on whether Soliris[supreg] technology meets the
substantial clinical improvement criterion.
Comment: The applicant submitted comments in response to CMS's
concerns in the proposed rule regarding whether Soliris[supreg] meets
the substantial clinical improvement criterion.
With respect to the concern that the applicant provided only one
study in support of its assertions of substantial clinical improvement,
the PREVENT trial, the applicant responded that although evidence from
two or more well-controlled studies is a common benchmark for
demonstrating efficacy, regulatory agencies (including FDA) have
acknowledged that a single adequate and well-controlled study can, in
some circumstances, constitute sufficient basis for a demonstration of
clinical efficacy. According to the applicant, reliance on single
studies is typically limited to situations in which the trial has
demonstrated a clinically meaningful effect on mortality or
irreversible morbidity, and confirmation of the result with a second
trial would be practically or ethically difficult to carry out. The
applicant noted in this context that clinical trials for NMOSD in
particular present challenges due to the rarity of the disease, ethical
concerns regarding placebo-controlled designs, and a lack of validated
outcome measures or biomarkers.
According to the applicant, the PREVENT study was an adequately
designed and well-controlled trial based on general FDA guidance on
rare disease clinical trials and on specific recommendations made by
the Center for Drug Evaluation and Research. The applicant reiterated
that the PREVENT study was a large, multicenter study, involved a
double-blind randomized design, and enrolled patients who demonstrated
a large unmet medical need (>=2 relapses in previous 12 months, or >=3
relapses in previous 24 months with a least one relapse in the previous
12 months). The applicant also pointed out that many of these patients
were on corticosteroids and immunosuppressive therapies (ISTs), which
are used off-label in patients with NMOSD. Finally, the applicant
repeated several of the core findings from the PREVENT trial, with
regard to the comparative effectiveness of Soliris.
With respect to the concern that the PREVENT trial compared Soliris
to placebo, but that there was no comparison of Soliris to currently
available treatments to gauge real world efficacy, the applicant
responded that at the start of the PREVENT trial, there were no other
FDA-approved therapies for managing NMOSD. The applicant further
asserted that even today, the other off-label immunosuppressant
therapies (ISTs) used in the treatment of NMOSD (including
corticosteroids, mycophenolate mofetil, azathioprine, tacrolimus, and
rituximab) are employed primarily based on empiric evidence, but there
is no uniform consensus on appropriate standard of care. Given this, in
order to evaluate the efficacy of Soliris in NMOSD, a randomized,
placebo-controlled trial was necessary, according to the applicant.
The applicant also noted that the PREVENT trial included
comparisons involving several of the available IST treatments, when
used with Soliris, to use of the same IST treatments with placebo. The
PREVENT trial included an eculizumab arm and a placebo arm, and
patients in both arms could continue to receive ISTs (including
corticosteroids, azathioprine, and/or mycophenolate mofetil) at stable
dosages throughout the study. According to the applicant, the PREVENT
trial demonstrated statistically persuasive findings showing the
effectiveness of Soliris in preventing NMOSD relapses, including among
the subset of study patients who also received maintenance treatment
with ISTs.
With respect to the concern that the applicant did not provide
information about how the alternative IST treatments for NMOSD work,
and why these are ineffective, the applicant asserted that it cannot
explain how these current, off-label treatments work, but the available
data, which are primarily from case reports and small prospective or
retrospective studies, suggest that these alternatives are not
effective.
According to the applicant, current treatment goals for NMOSD rely
on long-term stabilization of disease course by preventing relapses and
relapse-associated symptoms. The available efficacy and safety data for
the use of non-FDA-approved therapies in patients with NMOSD is
primarily from case reports and small prospective or retrospective
studies. In addition, despite increasingly common use of rituximab off-
label as a preferred therapy in NMOSD, experience in patients with
NMOSD is mostly derived from retrospective analyses. According to the
applicant, approximately one-third of patients enrolled in PREVENT had
previously received rituximab, but not within 3 months before enrolling
in PREVENT.
The applicant then asserted that available data show that current
IST treatments are not effective in the long-term control of NMOSD. The
applicant noted data from a study showing that the five-year prognosis
of patients with AQP4-IgG seropositive NMOSD is:
55% relapse within one year of onset;
22% required canes, crutches, or braces to walk (95% CI
15%-29%);
8% restricted to bed, chair, or wheelchair (95% CI 3%-
13%);
41% legally blind in one or both eyes (95% CI 33%-50%);
and
9% legally blind in both eyes (95% CI 4%-14%) \300\
---------------------------------------------------------------------------
\300\ Jiao Y, et al. Neurology. 2013;81(14):1197-1204.
---------------------------------------------------------------------------
The applicant concluded that in the PREVENT trial, the hazard ratio
based on a stratified Cox proportional hazards model for relapse was
0.06 (95% CI, 0.02 to 0.20) indicating that Soliris-treated patients
experienced a 94% relative relapse risk reduction (p <0.0001) compared
to patients on placebo. The time to the first adjudicated on-trial
relapse was significantly longer in eculizumab-
[[Page 58689]]
treated patients compared to placebo-treated patients (p <0.0001).
With regard to the concern that it was not clear if the patients in
the PREVENT study who received Soliris had higher dosages of continuing
IST medications than those in the placebo group, the applicant provided
additional information on the dosage of those medications. The
applicant acknowledged that the inclusion of patients receiving
concomitant ISTs in PREVENT raised the possibility that the treatment
effect ascribed to Soliris might have resulted from one of the other
background therapies instead. However, the applicant asserted that
several approaches were taken in PREVENT to mitigate the potentially
confounding influence of concomitant ISTs. In particular, background
IST dosages were not permitted to change during the trial, to ensure
that increased IST dosages did not confound efficacy evaluations. Also,
the total daily corticosteroid dose should not have exceeded 20 mg/day
of prednisone or equivalent, to ensure that no significant imbalance
between groups in regards to corticosteroid use could exist.
The applicant also provided additional data showing that the
average doses of concomitant ISTs (Azathioprine; Corticosteroids;
Mycophenolate Mofetil) in patients randomized to the eculizumab and
placebo groups in PREVENT were similar, thereby arguing against any
imbalance between treatment groups that may have influenced the
efficacy results.
In addition, several other commenters wrote letters of support for
the Soliris[supreg] new technology add-on payment application, in which
they asserted that Soliris[supreg] had been shown effective in the
PREVENT trial, and therefore that Soliris[supreg] meets the substantial
clinical improvement criterion. A few of the commenters cited their own
clinical experience in working with NMOSD patients, and either
described the potential value of Soliris[supreg] based on their own
experience, or based on the unique mechanism of action of
Soliris[supreg].
Response: We appreciate the commenters' input, including the
additional information and analysis provided by the applicant 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 with the applicant
that Soliris[supreg] represents a substantial clinical improvement over
existing technologies because, based on the information provided by the
applicant, the technology offers a treatment option for preventing
relapses and improving long-term outcomes in the treatment of NMOSD,
for which it is the first and only FDA approved treatment.
After consideration of the public comments we received, we have
determined that Soliris[supreg] meets all of the criteria for approval
for new technology add-on payments. Therefore, we are approving new
technology add-on payments for Soliris[supreg] for FY 2021. Cases
involving the use of Soliris[supreg] that are eligible for new
technology add-on payments will be identified by ICD-10-PCS procedure
codes XW033C6 and XW043C6.
In its application, the applicant stated that Soliris[supreg] is
available in a 30ml package with a strength of 10mg/1ml. According to
the applicant, the WAC per package of Soliris[supreg] is $6,523. The
applicant stated that the typical patient will receive a 900mg dose
each week the patient is in the hospital, which is equivalent to three
packages for a cost of $19,569 per week. Based on the cases in the
applicant's sample, the applicant calculated that the average cost per
hospital visit per patient for Soliris[supreg] is $28,416.69, which is
approximately 1.45 doses per hospital stay. However, according to FDA
labeling, all packages of Soliris[supreg] are single-dose. Therefore,
we have determined that cases involving Soliris[supreg] would incur an
average cost of $32,615, which is the equivalent of 5 packages (900mg
per dose x 1.45 doses per hospital stay = 1,305mg per hospital stay/
300mg per package = 4.35 vials). Under Sec. 412.88(a)(2), we limit new
technology add-on payments to the lesser of 65 percent of the costs of
the new medical service or technology, or 65 percent of the amount by
which the costs of the case exceed the MS-DRG payment. As a result, the
maximum new technology add-on payment for a case involving the use of
Soliris[supreg] is $21,199.75 for FY 2021.
k. The SpineJack[supreg] System
Stryker, Inc., submitted an application for new technology add-on
payments for the SpineJack[supreg] Expansion Kit (hereinafter referred
to as the SpineJack[supreg] system) for FY 2021. The applicant
described the SpineJack[supreg] system as an implantable fracture
reduction system, which is indicated for use in the reduction of
painful osteoporotic vertebral compression fractures (VCFs) and is
intended to be used in combination with Stryker VertaPlex and VertaPlex
High Viscosity (HV) bone cement.
The applicant explained that the SpineJack[supreg] system is
designed to be implanted into a collapsed vertebral body (VB) via a
percutaneous transpedicular approach under fluoroscopic guidance.
According to the applicant, once in place, the intravertebral implants
are expanded to mechanically restore VB height and maintain the
restoration. The applicant explained that the implants remain within
the VB and, together with the delivered bone cement, stabilize the
restoration, provide pain relief and improve patient mobility.
According to the applicant, the SpineJack[supreg] system further
reduces the risk of future adjacent level fractures (ALFs).\301\
---------------------------------------------------------------------------
\301\ Noriega, D., et al., ``A prospective, international,
randomized, noninferiority study comparing an implantable titanium
vertebral augmentation device versus balloon kyphoplasty in the
reduction of vertebral compression fractures (SAKOS study),'' The
Spine Journal, November 2019, vol 19(11), pp. 1782-1795.
---------------------------------------------------------------------------
The applicant explained that the SpineJack[supreg] system is
available in three sizes (4.2, 5.0 and 5.8 mm), and implant size
selection is based upon the internal cortical diameter of the pedicle.
According to the SpineJack[supreg] system Instructions for Use, the use
of two implants is recommended to treat a fractured VB. According to
the applicant, multiple VBs can also be treated in the same operative
procedure as required.
The applicant explained that using a bilateral transpedicular
approach, the SpineJack[supreg] implants are inserted into the
fractured VB. The applicant stated that the implants are then
progressively expanded though actuation of an implant tube that pulls
the two ends of the implant towards each other in situ to mechanically
restore VB height. The applicant explained that the mechanical working
system of the implant allows for a progressive and controlled reduction
of the vertebral fracture.\302\ The applicant stated that when
expanded, each SpineJack[supreg] system implant exerts a lifting
pressure on the fracture through a mechanism that may be likened to the
action of a scissor car jack, and that the longitudinal compression on
the implant causes it to open in a craniocaudal direction. The
applicant explained that the implant is locked into the desired
expanded position as determined and controlled by the treating
physician.\303\
---------------------------------------------------------------------------
\302\ Vanni D., et al., ``Third-generation percutaneous
vertebral augmentation systems,'' J. Spine Surg., 2016, vol. 2(1),
pp. 13-20.
\303\ Noriega D. et al., ``Clinical Performance and Safety of
108 SpineJack Implantations: 1-Year Results of a Prospective
Multicentre Single-Arm Registry Study,'' BioMed Res. Int., 2015,
vol. 173872.
---------------------------------------------------------------------------
The applicant further explained that once the desired expansion has
been
[[Page 58690]]
obtained, polymethylmethacrylate (PMMA) bone cement is injected at low
pressure into and around the implant to stabilize the restored
vertebra, which leads the implant to become encapsulated with the
delivered bone cement. According to the applicant, restoration of the
anatomy and stabilization of the fracture results in pain relief as
well as improved mobility for the patient.\304\
---------------------------------------------------------------------------
\304\ Ibid.
---------------------------------------------------------------------------
According to the applicant, osteoporosis is one of the most common
bone diseases worldwide that disproportionately affects aging
individuals. The applicant explained that in 2010, approximately 54
million Americans aged 50 years or older had osteoporosis or low bone
mass,\305\ which resulted in more than 2 million osteoporotic fragility
fractures in that year alone.\306\ The applicant stated it has been
estimated that more than 700,000 VCFs occur each year in the United
States (U.S.),\307\ and of these VCFs, about 70,000 result in hospital
admissions with an average length of stay of 8 days per patient.\308\
Furthermore, the applicant noted that in the first year after a painful
vertebral fracture, patients have been found to require primary care
services at a rate 14 times greater than the general population.\309\
The applicant explained that medical costs attributed to VCFs in the
U.S. exceeded $1 billion in 2005 and are predicted to surpass $1.6
billion by 2025.\310\
---------------------------------------------------------------------------
\305\ National Osteoporosis Foundation. (2019). What is
osteoporosis and what causes it? Available from: https://www.nof.org/patients/what-isosteoporosis/.
\306\ King A and Fiorentino D. ``Medicare payment cuts for
osteoporosis testing reduced use despite tests' benefit in reducing
fractures.'' Health Affairs (Millwood), 2011, vol. 30(12), pp. 2362-
2370.
\307\ Riggs B and Melton L. ``The worldwide problem of
osteoporosis: Insights afforded by epidemiology.'' Bone, 1995, vol.
17(Suppl 5), pp. 505-511.
\308\ Siemionow K and Lieberman I. ``Vertebral augmentation in
osteoporotic and osteolytic fractures: Current Opinion in Supportive
and Palliative Care.'' 2009, vol. 3(3), pp. 219-225.
\309\ Wong C and McGirt M. ``Vertebral compression fractures: A
review of current management and multimodal therapy.'' Journal of
Multidisciplinary Healthcare, 2013, vol 6, pp. 205- 214.
\310\ Burge R et al. ``Incidence and economic burden of
osteoporosis-related fractures in the United States: 2005-2025.''
Journal of Bone and Mineral Research. 2007, vol 22(3), pp. 465-475.
---------------------------------------------------------------------------
The applicant explained that osteoporotic VCFs occur when the
vertebral body (VB) of the spine collapses and can result in chronic
disabling pain, excessive kyphosis, loss of functional capability,
decreased physical activity and reduced quality of life. The applicant
stated that as the spinal deformity progresses, it reduces the volume
of the thoracic and abdominal cavities, which may lead to crowding of
internal organs. The applicant noted that the crowding of internal
organs may cause impaired pulmonary function, abdominal protuberance,
early satiety and weight loss. The applicant indicated that other
complications may include bloating, distention, constipation, bowel
obstruction, and respiratory disturbances such as pneumonia,
atelectasis, reduced forced vital capacity and reduced forced
expiratory volume in 1 second.
The applicant stated that if VB collapse is >50 percent of the
initial height, segmental instability will ensue. As a result, the
applicant explained that adjacent levels of the VB must support the
additional load and this increased strain on the adjacent levels may
lead to additional VCFs. Furthermore, the applicant summarized that
VCFs also lead to significant increases in morbidity and mortality risk
among elderly patients, as evidenced by a 2015 study by Edidin et al.,
in which researchers investigated the morbidity and mortality of
patients with a newly diagnosed VCF (n=1,038,956) between 2005 to 2009
in the U.S. Medicare population. For the osteoporotic VCF subgroup, the
adjusted 4-year mortality was 70 percent higher in the conservatively
managed group than in the balloon kyphoplasty procedures (BKP)-treated
group, and 17 percent lower in the BKP group than in the vertebroplasty
(VP) group. According to the applicant, when evaluating treatment
options for osteoporotic VCFs, one of the main goals of treatment is to
restore the load-bearing bone fracture to its normal height and
stabilize the mechanics of the spine by transferring the adjacent level
pressure loads across the entire fractured vertebra and in this way,
the intraspinal disc pressure is restored and the risk of adjacent
level fractures (ALFs) is reduced.
The applicant explained that treatment of osteoporotic VCFs in
older adults most often begins with conservative care, which includes
bed rest, back bracing, physical therapy and/or analgesic medications
for pain control. According to the applicant, for those patients that
do not respond to conservative treatment and continue to have
inadequate pain relief or pain that substantially impacts quality of
life, vertebral augmentation (VA) procedures may be indicated. The
applicant explained that VP and BKP are two minimally invasive
percutaneous VA procedures that are most often used in the treatment of
osteoporotic VCFs and another VA treatment option includes the use of a
spiral coiled implant made from polyetheretherketone (PEEK), which is
part of the Kiva[supreg] system.
According to the applicant, among the treatment options available,
BKP is the most commonly performed procedure and the current gold
standard of care for VA treatment. The applicant stated that it is
estimated that approximately 73 percent of all vertebral augmentation
procedures performed in the United States between 2005 and 2010 were
BKP.\311\ According to the applicant, the utilization of the
Kiva[supreg] system is relatively low in the U.S. and volume
information was not available in current market research data.\312\
---------------------------------------------------------------------------
\311\ 0 Goz V et al. ``Vertebroplasty and kyphoplasty: National
outcomes and trends in utilization from 2005 through 2010.'' The
Spine Journal. 2015, vol. 15(5), pp. 959-965.
\312\ Lin M. ``Minimally invasive vertebral compression fracture
treatments. Medtech 360, Market Insights, Millennium Research Group.
2019.
---------------------------------------------------------------------------
The applicant stated that VA treatment with VP may alleviate pain,
but it cannot restore VB height or correct spinal deformity. The
applicant stated that BKP attempts to restore VB height, but the
temporary correction obtained cannot be sustained over the long-term.
The applicant stated that the Kiva[supreg] implant attempts to
mechanically restore VB height, but it has not demonstrated superiority
to BKP for this clinical outcome.\313\
---------------------------------------------------------------------------
\313\ Ibid.
---------------------------------------------------------------------------
With respect to the newness criterion, the SpineJack[supreg]
Expansion Kit received FDA 510(k) clearance on August 30, 2018, based
on a determination of substantial equivalence to a legally marketed
predicate device. We note, except for this paragraph summarizing FDA
clearance documentation and market availability, we refer to the
SpineJack[supreg] Expansion Kit in this final rule as the
SpineJack[supreg] system. The applicant explained that although the
SpineJack[supreg] Expansion Kit received FDA 510(k) clearance on August
30, 2018, due to the time required to prepare for supply and
distribution channels, it was not available on the U.S. market until
October 11, 2018. As we discussed previously, the SpineJack[supreg]
Expansion Kit is indicated for use in the reduction of painful
osteoporotic VCFs and is intended to be used in combination with
Stryker VertaPlex and VertaPlex High Viscosity (HV) bone cements. In
the FY 2021 IPPS/LTCH PPS proposed rule, we noted that the applicant
submitted a request for approval for a unique ICD-10-PCS procedure code
for the implantation of the SpineJack[supreg] Expansion Kit beginning
in FY 2021. The applicant was granted approval for
[[Page 58691]]
the following procedure codes: XNU0356 (Supplement lumbar vertebra with
mechanically expandable (paired) synthetic substitute, percutaneous
approach, new technology group 6) and XNU4356 (Supplement thoracic
vertebra with mechanically expandable (paired) synthetic substitute,
percutaneous approach, new technology group 6).
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 therefore 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 similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, there are several factors that highlight
the different mechanism of action in treating osteoporotic VCFs with
the SpineJack[supreg] system compared to other BKP implants to reduce
the incidence of ALFs and improve midline VB height restoration.
According to the applicant, these differences include implant
construction, mechanism of action, bilateral implant load support and
>500 Newtons (N) of lift pressure.
The applicant described the SpineJack[supreg] system as including
two cylindrical implants constructed from Titanium-6-Aluminum-4-
Vanadium (Ti6Al4V) with availability in three sizes 4.2 mm (12.5 mm
expanded), 5.0 mm (17 mm expanded) and 5.8 mm (20 mm expanded).
According to the applicant, the SpineJack[supreg] system implant
exerts lifting pressure on the fracture through a mechanism that may be
likened to the action of a scissor car jack. The applicant explained
that following the insertion of the implant into the vertebral body
(VB), it is progressively expanded though actuation of an implant tube
that pulls the two ends of the implant towards each other and the
longitudinal compression on the implant causes it to open in a
craniocaudal direction. According to the applicant, the force generated
by the bilateral the SpineJack[supreg] system implants varies according
to implant size, ranging from 500-1,000 Newtons for fracture reduction
and superior endplate lift. In addition, the applicant explained that
the SpineJack[supreg] system implant provides symmetric, broad load
support under the fractured endplate and spinal column which
differentiates the mechanism of action from BKP.\314\
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\314\ Jacobson R et al. ``Re-expansion of osteoporotic
compression fractures using bilateral SpineJack implants: Early
clinical experience and biomechanical considerations.'' Cureus.
2019, vol 11(4), e4572.
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The applicant stated that the SpineJack[supreg] system implant is
uniquely constructed from a titanium alloy, which the applicant claims
allows for plastic deformation when it encounters the hard cortical
bone of the endplate yet still provides the lift force required to
restore midline VB height in the fractured vertebra. The applicant
stated that the SpineJack[supreg] system notably contains a self-
locking security mechanism that restricts further expansion of the
device when extreme load forces are concentrated on the implant. As a
result, the applicant asserted that this feature significantly reduces
the risk of vertebral endplate breakage while it further allows
functional recovery of the injured disc.\315\
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\315\ Vanni D et al. ``Third-generation percutaneous vertebral
augmentation systems.'' Journal of Spine Surgery. 2016, vol 2(1),
pp. 13-20.
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According to the applicant, the expansion of the SpineJack[supreg]
system implants creates a preferential direction of flow for the bone
cement; PMMA bone cement is deployed from the center of the implant
into the VB. The applicant stated that when two implants are
symmetrically positioned in the VB, this allows for a more homogenous
spread of PMMA bone cement. The applicant asserted that the
interdigitation of bone cement creates a broad supporting ring under
the endplate, which is essential to confer stability to the VB.
The applicant explained that the SpineJack[supreg] system implants
provide symmetric, broad load support for osteoporotic vertebral
collapse, which is based upon precise placement of bilateral ``struts''
that are encased in PMMA bone cement, whereas BKP and vertebroplasty
(VP) do not provide structural support via an implanted device. The
applicant explained that the inflatable balloon tamps utilized in BKP
are not made from titanium and are not a permanent implant. According
to the applicant, the balloon tamps are constructed from thermoplastic
polyurethane, which have limited load bearing capacity. The applicant
noted that although the balloon tamps are expanded within the VB to
create a cavity for bone cement, they do not remain in place and are
removed before the procedure is completed. The applicant explained that
partial lift to the VB is obtained during inflation, resulting in
kyphotic deformity correction and partial gains in anterior VB height
restoration, but inflatable balloon tamps are deflated prior to removal
so some of the VB height restoration obtained is lost upon removal of
the bone tamps. According to the applicant, BKP utilizes the placement
of PMMA bone cement to stabilize the fracture and does not include an
implant that remains within the VB to maintain fracture reduction and
midline VB height restoration.
According to the applicant, the Kiva[supreg] system is constructed
of a nitinol coil and PEEK-OPTIMA sheath, with sizes including a 4-loop
implant (12 mm expanded) and a 5-loop implant (15 mm expanded), and
unlike the SpineJack[supreg] system, is not made of titanium and does
not include a locking scissor jack design. The applicant stated that
the specific mechanism of action for the Kiva[supreg] system is
different from the SpineJack[supreg] system. The applicant explained
that during the procedure that involves implanting the Kiva[supreg]
system, nitinol coils are inserted into the VB to form a cylindrical
columnar cavity. The applicant stated that the PEEK-OPTIMA is then
placed over the nitinol coil. The applicant explained that the nitinol
coil is removed from the VB and the PEEK material is filled with PMMA
bone cement. The applicant stated that the deployment of 5 coils
equates to a maximum of height of 15 mm. The applicant stated that the
lifting direction of the Kiva[supreg] system is caudate and
unidirectional. According to the applicant, in the KAST (Kiva Safety
and Effectiveness Trial) pivotal study, it was reported that
osteoporotic VCF patients treated with the Kiva[supreg] system had an
average of 2.6 coils deployed.\316\ Additionally, in a biomechanical
comparison conducted for the Kiva[supreg] system and BKP using a
loading cycle of 200-500 Newtons in osteoporotic human cadaver spine
segments filled with bone cement, there were no statistically
significant differences observed between the two procedures for VB
height restoration, stiffness at high or low loads, or displacement
under compression.\317\
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\316\ Tutton S et al. KAST Study: The Kiva system as a vertebral
augmentation treatment--a safety and effectiveness trial: A
randomized, noninferiority trial comparing the Kiva system with
balloon kyphoplasty in treatment of osteoporotic vertebral
compression fractures. Spine. 2015; 40(12):865-875.
\317\ Wilson D et al. An ex vivo biomechanical comparison of a
novel vertebral compression fracture treatment system to
kyphoplasty. Clinical Biomechanics. 2012; 27(4):346-353.
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The applicant summarized the differences and similarities of the
SpineJack[supreg] system, BKP, and PEEK coiled implant as follows: (1)
With respect to construction, the SpineJack[supreg] system is made of
Titanium-6-Aluminum-4-Vanadium compared to
[[Page 58692]]
thermoplastic polyurethanes for BKP and nitinol and PEEK for the PEEK
coiled implant; (2) with respect to mechanism of action, the
SpineJack[supreg] system uses a locking scissor jack encapsulated in
PMMA bone cement compared to hydrodynamic cavity creation and PMMA
cavity filler for BKP and coil cavity creation and PEEK implant filled
with PMMA bone cement for the PEEK coiled implant; (3) with respect to
plastic deformation, the SpineJack[supreg] system and BKP allow for
plastic deformation while the PEEK coiled implant does not; (4) with
respect to craniocaudal expansion, the SpineJack[supreg] system allows
for craniocaudal expansion, whereas BKP and the PEEK coiled implant do
not; (5) with respect to bilateral load support, the SpineJack[supreg]
system provides bilateral load support whereas BKP and the PEEK coiled
implant do not; and (6) with respect to lift pressure of >500 N, the
SpineJack[supreg] system provides lift pressure of >500 N whereas BKP
and the PEEK coiled implant do not. The applicant summarized that the
SpineJack[supreg] system is uniquely constructed and utilizes a
different mechanism of action than BKP, which is the gold standard of
treatment for osteoporotic VCFs, and that the construction and
mechanism of action of the SpineJack[supreg] system is further
differentiated when compared with the PEEK coiled implant.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant did not specify
whether it believed cases involving the SpineJack[supreg] system would
be assigned to the same MS-DRG as existing technology. However, we note
that the MS-DRGs the applicant included in its cost analysis were the
same MS-DRGs to which cases involving BKP procedures are typically
assigned.
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 did
not specifically address whether the technology meets this criterion.
However, the applicant generally summarized the disease state that the
technology treats as osteoporotic VCFs, and described other treatment
options for osteoporotic VCFs as including VP, BKP and the PEEK coiled
implant.
In summary, the applicant asserted that the SpineJack[supreg]
system is not substantially similar to any existing technology because
it utilizes a different mechanism of action, when compared to existing
technologies, to achieve a therapeutic outcome.
We invited public comments on whether the SpineJack[supreg] system
is substantially similar to other currently available technologies and
whether the SpineJack[supreg] system meets the newness criterion.
Comment: Several commenters expressed their specific and general
support for approval of the SpineJack[supreg] system for new technology
add-on payment. Many of these commenters shared their academic
knowledge of and first-hand clinical experience with vertebral
augmentation procedures, including claims of familiarity and expertise
with the use of the Kiva[supreg] system, BKP and the SpineJack[supreg]
system. According to many of these commenters, the SpineJack[supreg]
system provides a significant benefit beyond that which is achieved by
other vertebral augmentation technology. Many commenters also indicated
that the price compared to the reimbursement rate has been an
impediment to use of the SpineJack[supreg] system in some cases.
Finally, several of these commenters expressed their belief that the
SpineJack[supreg] system may reduce costs to hospitals and the U.S.
health system overall by preventing the onset of additional adjacent
fractures in patients.
Response: We thank the commenters for the analysis and feedback
provided.
Comment: The applicant submitted a comment restating information
that was previously provided in their application for new technology
add-on payment and described in the proposed rule and previously in
this final rule. According to the applicant, the SpineJack[supreg]
system meets the newness criterion, because it received FDA 510(k)
clearance on August 30, 2018, and was commercially available in the
United States on October 11, 2018. The applicant also explained that
based on the information submitted in the application for new
technology add-on payment, specifically regarding implant construction,
mechanism of action, bilateral implant load support and lift pressure,
the SpineJack[supreg] system has a unique mechanism of action to
achieve a therapeutic outcome, compared to other VCF treatments.
In response to CMS' concern that the applicant did not specify
whether it believed cases involving the SpineJack[supreg] system would
be assigned to the same MS-DRGs as existing technology, the applicant
provided additional clarification, and acknowledged that the
SpineJack[supreg] system would be assigned to the same MS-DRGs as
existing technology for vertebral augmentation.
In response to CMS' concern that the applicant did not specifically
address 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 SpineJack[supreg] system is
used in the reduction of osteoporotic VCFs, and does target the same or
similar type of disease and the same or similar patient population as
targeted by VP, BKP and other mechanical vertebral augmentation
systems.
Two commenters asserted that the applicant's description of the
mechanism of action of the SpineJack[supreg] system relative to other
implant devices (including BKP and the Kiva[supreg] system) contained
important inaccuracies, including with regard to the claims that the
SpineJack[supreg] system acts uniquely to achieve craniocaudal
expansion, bilateral load support, and lift pressure >500 Newtons. The
commenters stated that BKP does offer craniocaudal expansion while
creating a void for safer cement fill. Furthermore, with respect to
bilateral load support, according to the commenters, BKP has been
offered since 1998 as a bilateral procedure option to maximize lift
potential and reduce stress exerted on endplates. The commenters went
on to explain that BKP provides bilateral symmetric load support to
fractured endplates by providing a larger surface area when restoring
height. Finally, the commenters asserted that several of the
commenter's claims of superiority for the SpineJack[supreg] system were
misleading, and furthermore that the newest generation of BKP implants
is capable of inflating to 700 psi and generating a lift force of 1200
Newtons.
Another commenter made a different substantial similarity argument,
with regard to the SpineJack[supreg] system and the Kiva[supreg]
system. The commenter asserted that both the Kiva[supreg] system and
SpineJack[supreg] systems use a similar mechanism of action (mechanical
lift) to achieve a therapeutic outcome (reducing osteoporotic VCFs).
The commenter noted that although the way the implant provides
mechanical expansion within the vertebral body is different between the
Kiva[supreg] and SpineJack[supreg] systems, both processes still
qualify as mechanical expansion. The commenter described several other
functional similarities in regard to the effect achieved by the
Kiva[supreg] and SpineJack[supreg] systems, and further pointed out
that the Kiva[supreg] system served as the predicate device for the
SpineJack[supreg] system, with regard to the FDA 510(k) clearance
process for the SpineJack[supreg] system. On this basis, the commenter
asserted that the Kiva[supreg] and the SpineJack[supreg] system are
substantially similar technologies.
[[Page 58693]]
One commenter expressed their general belief that the
SpineJack[supreg] system meets the new technology add-on payment
newness criterion because it utilizes a distinct mechanism of action,
especially in comparison to the mechanisms of action utilized by the
Kiva[supreg] system and balloon kyphopasty.
Response: We thank the commenters for their input and technical
comments with regard to the SpineJack[supreg] system and the newness
criterion. We note that some of these comments rest on conflicting
factual assertions made by commenters and the applicant, which we are
unable directly to resolve. After consideration of the comments
received, however, we believe that the physical construction and
mechanism of action by which the SpineJack[supreg] system implant
exerts a lift force is mechanically different from either the
Kiva[supreg] system (coil) implant, or from the inflation mechanism of
a BKP implant. In our view, these differences support that the
SpineJack[supreg] system does not use the same or similar mechanism of
action to achieve a therapeutic outcome and therefore is not
substantially similar to prior technology.
After consideration of the public comments we received and
information submitted by the applicant as part of its FY 2021 new
technology add-on payment application for the SpineJack[supreg] system,
as discussed in the proposed rule (85 FR 32656) and previously in this
final rule, we believe that the SpineJack[supreg] system has a unique
mechanism of action in the treatment of patients with osteoporotic
VCFs. Therefore, we believe that the SpineJack[supreg] system is not
substantially similar to existing treatment options and meets the
newness criterion. We consider the beginning of the newness period to
commence following the approval of the SpineJack[supreg] system by the
FDA, on the date when it became commercially available on the U.S.
market, which was October 11, 2018.
With regard to the cost criterion, the applicant conducted the
following analysis to demonstrate that the technology meets the cost
criterion. The applicant searched the FY 2018 MedPAR file for inpatient
hospital claims that reported the following ICD-10-PCS procedure codes:
0PS43ZZ (Reposition thoracic vertebra, percutaneous approach) in
combination with 0PU43JZ (Supplement thoracic vertebra with synthetic
substitute, percutaneous approach) and 0QS03ZZ (Reposition lumbar
vertebra, percutaneous approach) in combination with 0QU03JZ
(Supplement lumbar vertebra with synthetic substitute, percutaneous
approach). According to the applicant, the results included cases
involving BKP procedures. This resulted in 15,352 cases spanning
approximately 130 MS-DRGs, with approximately 77 percent of those cases
(n=11,841) mapping to the following top 6 MS-DRGs:
[GRAPHIC] [TIFF OMITTED] TR18SE20.160
The applicant performed two separate analyses with regard to the
cost criterion, one based on 100 percent of the claims reporting the
specified ICD-10-PCS procedure codes, and the second based on the 77
percent of claims mapping to the top six MS-DRGs.
The applicant used the following methodology for both analyses. The
applicant first removed the charges for the prior technology being
replaced by the SpineJack[supreg] system. The applicant explained that
it estimated charges associated with the prior technology as 50 percent
of the charges associated with the category Medical Surgical Supply
Charge Amount (which included revenue centers 027x). The applicant
stated that use of the SpineJack[supreg] system would replace some but
not all of the device charges included in these claims, as some
currently used medical and surgical supplies and devices would still be
required for patients during their hospital stay, even after
substituting the SpineJack[supreg] system for BKP and other surgical
interventions. The applicant stated that it was unable to determine a
more specific percentage for the appropriate amount of prior medical
and surgical supply charges to remove from the relevant patient claims,
but asserted that removing 50 percent of the charges was a conservative
approach for calculation purposes. The applicant then standardized the
charges and inflated the charges from FY 2018 to FY 2020. The applicant
reported using an inflation factor of 11.1 percent, as published in the
FY 2020 IPPS final rule (84 FR 42629).
The applicant then calculated and added the charges for the
SpineJack[supreg] system technology by taking the estimated per patient
cost of the device, and converting it to a charge by dividing the costs
by the national average CCR (cost-to-charge ratio) of 0.299 for
implantable devices from the FY 2020 IPPS/LTCH PPS final rule (84 FR
42179).
We stated in the proposed rule that in the analysis based on 100
percent of claims, the applicant computed a final inflated average
case-weighted standardized charge per case of $108,760, as compared to
an average case-weighted threshold amount of $77,395. In the analysis
based on 77 percent of claims from only the top six MS-DRGs, the
applicant computed a final inflated average case-weighted standardized
charge per case of $92,904, as compared to an average case-weighted
threshold amount of $72,273.
Because the final inflated average case-weighted standardized
charge per case exceeded the average case-weighted threshold amount
under both analyses described previously, the applicant asserted that
the technology meets the cost criterion. We invited public comments on
whether the SpineJack[supreg] system meets the cost criterion.
Comment: The applicant offered a minor typographic correction in
regard to the charge threshold analysis that was included in the
proposed rule for the SpineJack[supreg] system. The applicant explained
that in its new technology add-on payment application submission for
the SpineJack[supreg] system, the inflated case-weighted standardized
charge per case was reported as $108,670 for the analysis based on 100
percent of claims. The applicant noted that a transposition error was
made in the proposed rule,
[[Page 58694]]
such that this figure was incorrectly reported as $108,760. The
applicant concluded that the difference between these figures is
negligible and does not impact the result of the average case-weighted
standardized charge per case exceeding the average case-weighted
threshold amount. Therefore, the applicant maintained that the
SpineJack[supreg] system does meet the cost criterion.
Response: We thank the applicant for this correction and
clarification with regard to the cost analysis for the
SpineJack[supreg] system.
Comment: We received comments that were not directly related to the
cost analysis, including that the different mechanism of action, time,
and expertise involved in the use of the SpineJack[supreg] system uses
warrants a separate billable code.We also received comments questioning
the costs associated with the SpineJack[supreg] system, including that
the estimated $100,000 cost per case appears high compared to the
approximately $3,500 cost of other treatment options like kyphoplasty.
Response: We appreciate the commenters' feedback. We also note that
proposals to create, delete, or revise codes under the ICD-10-PCS
structure are referred to the ICD-10 Coordination and Maintenance
Committee. The decisions of this committee are independent from any
decision for new technology add on payments.
After consideration of the public comments we received and based on
the information included in the applicant's new technology add-on
payment application, we believe that the SpineJack[supreg] system meets
the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that the treatment of osteoporotic vertebral
compression fracture (VCF) patients with the SpineJack[supreg] system
represents a substantial clinical improvement over existing
technologies because clinical research supports that it reduces future
interventions, hospitalizations, and physician visits through a
decrease in adjacent level fractures (ALFs), which the applicant
asserted are clinically significant adverse events associated with
osteoporotic VCF. The applicant also asserted that treatment with the
SpineJack[supreg] system greatly reduces pain scores and pain
medication use when compared to BKP, which the applicant stated is the
current gold standard in vertebral augmentation (VA) treatment. The
applicant submitted eight studies to support that its technology
represents a substantial clinical improvement over existing
technologies.
The applicant explained that the SpineJack[supreg] system has been
available for the treatment of patients with osteoporotic VCFs for over
10 years in Europe. The applicant explained that, as a result, the
SpineJack[supreg] system implant has been extensively studied, and
claims from smaller studies are supported by the results from a recent,
larger prospective, randomized study known as the SAKOS
(SpineJack[supreg] versus Kyphoplasty in Osteoporotic Patients) study.
The applicant cited the SAKOS study \318\ in support of multiple
clinical improvement claims. The applicant explained that the SAKOS
study was the pivotal trial conducted in support of the FDA 510(k)
clearance for the SpineJack[supreg] system and that the intent of the
study was to compare the safety and effectiveness of the
SpineJack[supreg] system with the KyphX Xpander Inflatable Bone Tamp
(BKP) for treatment of patients with painful osteoporotic VCFs in order
to establish a non-inferiority finding for use of the SpineJack[supreg]
system versus balloon kyphoplasty procedure (BKP).
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\318\ Noriega, D., et al., ``A prospective, international,
randomized, noninferiority study comparing an implantable titanium
vertebral augmentation device versus balloon kyphoplasty in the
reduction of vertebral compression fractures (SAKOS study),'' The
Spine Journal, 2019, vol. 19(11), pp. 1782-1795.
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The SAKOS study is a prospective, international, randomized, non-
inferiority study comparing a titanium implantable vertebral
augmentation device (TIVAD), the SpineJack[supreg] system, versus BKP
in the reduction of vertebral compression fractures with a 12-month
follow-up. The primary endpoint was a 12-month responder rate based on
a composite of three components: (1) Reduction in VCF fracture-related
pain at 12 months from baseline by >20 mm as measured by a 100-mm
Visual Analog Scale (VAS) measure, (2) maintenance or functional
improvement of the Oswestry Disability Index (ODI) score at 12 months
from baseline, and (3) absence of device-related adverse events or
symptomatic cement extravasation requiring surgical reintervention or
retreatment at the index level. If the primary composite endpoint was
successful, a fourth component (absence of ALF) was added to the three
primary components for further analysis. If the analysis of this
additional composite endpoint was successful, then midline target
height restoration at 6 and 12 months was assessed. According to the
applicant, freedom from ALFs and midline VB height restoration were two
additional superiority measures that were tested. According to the
SAKOS study, secondary clinical outcomes included changes from baseline
in back pain intensity, ODI score, EuroQol 5-domain (EQ-5D) index score
(to evaluate quality of life), EQ-VAS score, ambulatory status,
analgesic consumption, and length of hospital stay. Radiographic
endpoints included restoration of vertebral body height (mm), and Cobb
angle at each follow-up visit. Adverse events (AEs) were recorded
throughout the study period. The applicant explained that researchers
did not blind the treating physicians or patients, so each group was
aware of the treatment allocation prior to the procedure; however, the
three independent radiologists that performed the radiographic reviews
were blinded to the personal data of the patients, study timepoints and
results of the study.
The SAKOS study recruited patients from 13 hospitals across 5
European countries and randomized 152 patients with osteoporotic
vertebral compression fractures (OVCFs) (1:1) to either the
SpineJack[supreg] system or BKP procedures. Specifically, patients were
considered eligible for inclusion if they met a number of criteria,
including (1) at least 50 years of age, (2) had radiographic evidence
of one or two painful VCF between T7 and L4, aged less than 3 month,
due to osteoporosis, (3) fracture(s) that showed loss of height in the
anterior, middle, or posterior third of the VB >=15% but <=40%, and (4)
patient failed conservative medical therapy, defined as either having a
VAS back pain score of >=50 mm at 6 weeks after initiation of fracture
care or a VAS pain score of >=70% mm at 2 weeks after initiation of
fracture care. Eleven of the originally recruited patients were
subsequently excluded from surgery (9 randomized to the
SpineJack[supreg] system and 2 to BKP). A total of 141 patients
underwent surgery, and 126 patients completed the 12-month follow-up
period (61 TIVAD and 65 BKP). The applicant contended that despite the
SAKOS study being completed outside the U.S., results are applicable to
the Medicare patient population, noting that 82 percent (116 of 141) of
the patients in the SAKOS trial that received treatment (the
SpineJack[supreg] system or BKP) were age 65 or older.
The applicant explained further that the FDA evaluated the
applicability of the SAKOS clinical data to the U.S. population and FDA
concluded that although the SAKOS study was performed in Europe, the
final study demographics were very similar to what has been reported in
the literature for U.S.-based studies of BKP. The applicant also
explained that FDA determined that the data was acceptable
[[Page 58695]]
for the SpineJack[supreg] system 510(k) clearance including two
clinical superiority claims versus BKP.
The SAKOS study reported that analysis on the intent to treat
population using the observed case method resulted in a 12-month
responder rate of 89.8 percent and 87.3 percent, for the
SpineJack[supreg] system and BKP respectively (p=0.0016). The
additional composite endpoint analyzed in observed cases resulted in a
higher responder rate for the SpineJack[supreg] system compared to BKP
at both 6 months (88.1% vs. 60.9%; p<0.0001) and 12 months (79.7% vs.
59.3%; p<0.0001). Midline VB height restoration, tested for superiority
using a t test with one-sided 2.5 percent alpha in the ITT population,
was greater with the SpineJack[supreg] system than BKP at 6 months
(1.142.61 mm vs 0.312.22 mm; p=0.0246) and at
12 months (1.312.58 mm vs. 0.102.23 mm;
p=0.0035), with similar results in the per protocol (PP) population.
Also, according to the SAKOS study, decrease in pain intensity
versus baseline was more pronounced in the SpineJack[supreg] system
group compared to the BKP group at 1 month (p=0.029) and 6 months
(p=0.021). At 12 months, the difference in pain intensity was no longer
statistically significant between the groups, and pain intensity at 5
days post-surgery was not statistically different between the groups.
The SAKOS study publication also reported that at each timepoint, the
percentage of patients with reduction in pain intensity >20 mm was
>=90% in the SpineJack[supreg] system group and >=80% in the BKP group,
with a statistically significant difference in favor of
SpineJack[supreg] at 1 month post-procedure (93.8% vs 81.4%; p=0.03).
The study also reported--(1) no statistically significant difference in
disability (ODI score) between groups during the follow-up period,
although there was a numerically greater improvement in the
SpineJack[supreg] system group at most time points; (2) at each time
point, the percentage of patients with maintenance or improvement in
functional capacity was at or close to 100 percent; and (3) in both
groups, a clear and progressive improvement in quality of life was
observed throughout the 1-year follow-up period without any
statistically significant between-group differences.
In the SAKOS study, both groups had similar proportions of VCFs
with cement extravasation outside the treated VB (47.3% for TIVAD,
41.0% for BKP; p=0.436). No symptoms of cement leakage were reported.
The SAKOS study also reported that the BKP group had a rate of adjacent
fractures more than double the SpineJack[supreg] system group (27.3%
vs. 12.9%; p=0.043). The SAKOS study also reported that the BKP group
had a rate of non-adjacent subsequent thoracic fractures nearly 3 times
higher than the SpineJack[supreg] system group (21.9% vs. 7.4%) (a p-
value was not reported for this result). The most common AEs reported
over the study period were back pain (11.8 percent with the
SpineJack[supreg] system, 9.6 percent with BKP), new lumbar vertebral
fractures (11.8 percent with the SpineJack[supreg] system, 12.3 percent
with BKP), and new thoracic vertebral fractures (7.4 percent with the
SpineJack[supreg] system, 21.9 percent with BKP). The most frequent
SAEs were lumbar vertebral fractures (8.8 percent with the
SpineJack[supreg] system; 6.8 percent with BKP) and thoracic vertebral
fractures (5.9 percent with the SpineJack[supreg] system, 9.6 percent
with BKP). We also note that the length of hospital stay (in days) for
osteoporotic VCF patients treated in the SAKOS trial was 3.8 3.6 days for the SpineJack[supreg] system group and 3.3 2.4 days for the BKP group (p=0.926, Wilcoxon test).
The applicant also submitted seven additional studies, which are
described in more detail in this section, related to the applicant's
specific assertions regarding substantial clinical improvement.
As stated previously, the applicant asserted that the
SpineJack[supreg] system represents a substantial clinical improvement
over existing technologies because it will reduce future interventions,
hospitalizations, and physician visits through a decrease in ALFs. The
applicant explained that ALFs are considered clinically significant
adverse events associated with osteoporotic VCFs, citing studies by
Lindsay et al.\319\ and Ross et al.\320\ The applicant explained that
these studies reported, respectively, that having one or more VCFs
(irrespective of bone density) led to a 5-fold increase in the
patient's risk of developing another vertebral fracture, and the
presence of two or more VCFs at baseline increased the risk of ALF by
12-fold. The applicant asserted that analysis of the additional
composite endpoint in the SAKOS study demonstrated statistical
superiority of the SpineJack[supreg] system over BKP (p<0.0001) for
freedom from ALFs at both 6 months (88.1 percent vs. 60.9 percent) and
12 months (79.7 percent vs. 59.3 percent) post-procedure. The applicant
noted that the results were similar on both the intent to treat and PP
patient populations. In addition, the applicant asserted the
SpineJack[supreg] system represents a substantial clinical improvement
because in the SAKOS study, compared to patients treated with the
SpineJack[supreg] system, BKP-treated patients had more than double the
rate of ALFs (27.3 percent vs. 12.9 percent; p=0.043) and almost triple
the rate of non-adjacent thoracic VCFs (21.9 percent vs. 7.4 percent).
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\319\ Lindsay R. et al., ``Risk of new vertebral fracture in the
year following a fracture,'' Journal of the American Medical
Association, 2001, vol. 285(3), pp. 320-323.
\320\ Ross P. et al., Pre-existing fractures and bone mass
predict vertebral fracture incidence in women. Annals of Internal
Medicine. 1991, vol. 114(11), pp. 919-923.
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The applicant also asserted superiority with respect to mid-
vertebral body height restoration with the SpineJack[supreg] system.
The applicant explained that historical treatments of osteoporotic VCFs
have focused on anterior VB height restoration and kyphotic Cobb angle
correction; however, research indicates that the restoration of middle
VB height may be as important as Cobb angle correction in the
prevention of ALFs.\321\
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\321\ Lin J et al. Better height restoration, greater kyphosis
correction, and fewer refractures of cemented vertebrae by using an
intravertebral reduction device: A 1-year follow-up study. World
Neurosurgery. 2016; 90:391-396.
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According to the applicant, the depression of the mid-vertebral
endplate leads to decreased mechanics of the spinal column by
transferring the person's weight to the anterior wall of the level
adjacent to the fracture, and as a result the anterior wall is the most
common location for ALFs. The applicant further asserted that by
restoring the entire fracture, including mid-VB height, the vertebral
disc above the superior vertebral endplate is re-pressurized and
transfers the load evenly, preventing ALFs.\322\ The applicant stated
that the SpineJack[supreg] system showed superiority over BKP with
regard to midline VB height restoration at both 6 and 12 months,
pointing to the SAKOS study results in the intent to treat population
at 6 months (1.142.61 mm vs 0.312.22 mm;
p=0.0246) and 12 months (1.312.58 mm vs. 0.102.23 mm; p=0.0035) post-procedure. The applicant noted that
similar results were also observed in the PP population (134 patients
in the intent-to-treat population without any major protocol
deviations).
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\322\ Tzermiadianos M., et al., ``Altered disc pressure profile
after an osteoporotic vertebral fracture is a risk factor for
adjacent vertebral body fracture,'' European Spine Journal, 2008,
vol. 17(11), pp. 1522-1530.
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The applicant also provided two prospective studies, a
retrospective study, and two cadaveric studies in
[[Page 58696]]
support of its assertions regarding superior VB height restoration. The
applicant stated that in a prospective comparative study by Noriega D.,
et al.,\323\ VB height restoration outcomes utilizing the
SpineJack[supreg] system were durable out to 3 years. This study was a
safety and clinical performance pilot that randomized 30 patients with
painful osteoporotic vertebral compression fractures to the
SpineJack[supreg] system (n=15) or BKP (n=15).\324\ Twenty-eight
patients completed the 3-year study (14 in each group). The clinical
endpoints of analgesic consumption, back pain intensity, ODI, and
quality of life were recorded preoperatively and through 36-months
post-surgery.\325\ Spine X-rays were also taken 48 hours prior to the
procedure and at 5 days, 6, 12, and 36 months post-surgery.\326\ The
applicant explained that over the 3-year follow-up period, VB height
restoration and kyphosis correction was better compared to BKP,
specifically that VB height restoration and kyphotic correction was
still evident at 36 months with a greater mean correction of anterior
VB height (10