Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program
| Court | Centers For Medicare & Medicaid Services |
| Citation | 86 FR 25070 |
| Record Number | 2021-08888 |
| Published date | 10 May 2021 |
Federal Register, Volume 86 Issue 88 (Monday, May 10, 2021)
[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Proposed Rules]
[Pages 25070-25790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08888]
[[Page 25069]]
Vol. 86
Monday,
No. 88
May 10, 2021
Part II
Book 2 of 2 Books
Pages 25069-26798Department of Health and Human Services-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 413, 425, et al.
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates;
Quality Programs and Medicare Promoting Interoperability Program
Requirements for Eligible Hospitals and Critical Access Hospitals;
Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes
to the Medicare Shared Savings Program; Proposed Rule
Federal Register / Vol. 86 , No. 88 / Monday, May 10, 2021 / Proposed
Rules
[[Page 25070]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, 425, 455, and 495
[CMS-1752-P]
RIN 0938-AU44
Medicare Program; Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates;
Quality Programs and Medicare Promoting Interoperability Program
Requirements for Eligible Hospitals and Critical Access Hospitals;
Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes
to the Medicare Shared Savings Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: We are proposing to revise the Medicare hospital inpatient
prospective payment systems (IPPS) for operating and capital-related
costs of acute care hospitals to implement changes arising from our
continuing experience with these systems for FY 2022 and to implement
certain recent legislation. In addition, we are proposing to rebase and
revise the hospital market baskets for acute care hospitals, update the
labor-related share, and provide the market basket update that would
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 2022. We are also proposing policies relating to
Medicare graduate medical education (GME) for teaching hospitals to
implement certain recent legislation. The proposed rule would also
update the payment policies and the annual payment rates for the
Medicare prospective payment system (PPS) for inpatient hospital
services provided by long-term care hospitals (LTCHs) for FY 2022. In
this FY 2022 IPPS/LTCH PPS proposed rule, we are proposing to extend
New COVID-19 Treatments Add-on Payment (NCTAP) for certain eligible
products through the end of the fiscal year in which the PHE ends and
to discontinue the NCTAP for discharges on or after October 1, 2021 for
a product that is approved for new technology add-on payments beginning
FY 2022. We are also proposing to repeal the collection of market-based
rate information on the Medicare cost report and the market-based MS-
DRG relative weight methodology, as finalized in the FY 2021 IPPS/LTCH
PPS final rule.
We are proposing to establish new requirements and revise existing
requirements for eligible hospitals and critical access hospitals
(CAHs) participating in the Medicare Promoting Interoperability
Program. We are also providing estimated and newly established
performance standards for the Hospital Value-Based Purchasing (VBP)
Program, and proposing updated policies for the Hospital Readmissions
Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program,
Hospital VBP Program, Hospital-Acquired Condition (HAC) Reduction
Program, and the PPS-Exempt Cancer Hospital Reporting (PCHQR) Program,
and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP).
Additionally, due to the impact of the COVID-19 PHE on measure data
used in our value-based purchasing programs, we are proposing to
suppress several measures in the Hospital VBP, HAC Reduction, and
Hospital Readmissions Reduction Programs. In connection with our
measure suppression proposals for the FY 2022 Hospital VBP Program, we
are also proposing to revise the scoring and payment methodology for
the FY 2022 program year such that hospitals will not be scored using
quality measure data that are distorted by the effects of the COVID-19
public health emergency (PHE) and will not receive Total Performance
Scores or adjustments to their payments as a result. Similarly, we are
proposing to suppress affected measures for the FY 2022 HAC Reduction
Program such that hospitals will not be scored using distorted quality
measure data and will not receive Total HAC Scores based on those data.
For the Hospital Readmissions Reduction Program, we are proposing to
suppress one affected measure under the proposed measure suppression
policy for the FY 2023 applicable period such that hospitals will not
be assessed using distorted quality measure data and will not receive
payment reductions based on those data.
In addition, we are proposing to change, clarify, and codify
Medicare organ acquisition payment policies relative to organ
procurement organizations (OPOs), transplant hospitals, and donor
community hospitals. Also, we are proposing to add regulation requiring
that state Medicaid agencies accept valid enrollments from all
Medicare-enrolled providers and suppliers for purposes of processing
claims for Medicare cost-sharing liability for services furnished to
Medicare-Medicaid dually eligible individuals in order to alleviate a
long-standing problem related to claiming Medicare bad debt.
Additionally, we are proposing to amend the Medicare Shared Savings
Program regulations to allow eligible accountable care organizations
(ACOs) participating in the BASIC track's glide path the opportunity to
maintain their current level of participation for performance year (PY)
2022.
DATES: To be assured consideration, comments must be received at one of
the addresses provided in the ADDRESSES section, no later than 5 p.m.
EDT on June 28, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1752-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may (and we encourage you to) submit
electronic comments on this regulation to http://www.regulations.gov.
Follow the instructions under the ``submit a comment'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1752-P, P.O. Box 8013,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments via
express or overnight mail to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1752-P, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
For information on viewing public comments, we refer readers to the
beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Donald Thompson, (410) 786-4487, and Michele Hudson, (410) 786-
4487, Operating Prospective Payment, MS-DRG Relative Weights, Wage
Index, Hospital Geographic Reclassifications, Graduate Medical
Education, Capital Prospective Payment, Excluded Hospitals, Medicare
Disproportionate Share Hospital (DSH) Payment
[[Page 25071]]
Adjustment, Sole Community Hospitals (SCHs), Medicare-Dependent Small
Rural Hospital (MDH) Program, Low-Volume Hospital Payment Adjustment,
and Critical Access Hospital (CAH) Issues.
Emily Lipkin, (410) 786-3633 and Jim Mildenberger, (410) 786-4551,
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.
Allison Pompey, (410) 786-2348, New Technology Add On Payments and
New COVID-19 Treatments Add-on Payments Issues.
Mady Hue, (410) 786-4510, and Andrea Hazeley, (410) 786-3543, MS-
DRG Classifications Issues.
Mollie Knight, (410) 786-7948, and Bridget Dickensheets, (410) 786-
8670, Rebasing and Revising the Hospital Market Baskets Issues.
Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital
Demonstration Program Issues.
Jeris Smith, (410) 786-0110, Frontier Community Health Integration
Project Demonstration Issues.
Pamela Brown, [email protected], Hospital Readmissions
Reduction Program--Administration Issues.
Jim Poyer, [email protected], Hospital Readmissions Reduction
Program--Readmissions--Measures Issues.
Jennifer Tate, [email protected], Hospital-Acquired
Condition Reduction Program--Administration Issues.
Yuling Li, (410) 786-8421, Hospital-Acquired Condition Reduction
Program--Measures Issues.
Julia Venanzi, [email protected], Hospital Inpatient
Quality Reporting and Hospital Value-Based Purchasing Programs--
Administration Issues.
Katrina Hoadley, [email protected], Hospital Inpatient
Quality Reporting and Hospital Value-Based Purchasing Programs--
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.
Annie Hollis, [email protected], PPS-Exempt Cancer Hospital
Quality Reporting--Administration Issues.
Katrina Hoadley, [email protected], PPS-Exempt Cancer
Hospital Quality Reporting Program-Measure Issues.
Christy Hughes, (410) 786-5662, Long-Term Care Hospital Quality
Reporting Program--Data Reporting Issues.
Jessica Warren, [email protected], Dylan Podson,
[email protected], and Elizabeth Holland,
[email protected], Promoting Interoperability Programs.
Candace Anderson, (410) 786-1553, Medicaid Enrollment of Medicare
Providers and Suppliers for Purposes of Processing Claims for Cost-
Sharing for Services Furnished to Dually Eligible Beneficiaries.
Katie Lucas, (410) 786-7723, Amanda Michael, (410) 786-5834, and
Kellie Shannon (410) 786-0416, Organ Acquisition Payment Issues.
Naseem Tarmohamed, (410) 786-0814, or
[email protected], for issues related to the Shared
Savings Program.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov/. Follow the search instructions on that website to
view public comments.
Tables Available Through the Internet on the CMS Website
The IPPS tables for this FY 2022 proposed 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 2022 IPPS
Proposed rule Home Page'' or ``Acute Inpatient--Files for Download.''
The LTCH PPS tables for this FY 2022 proposed 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-1752-P. For
further details on the contents of the tables referenced in this
proposed rule, we refer readers to section VI. of the Addendum to this
FY 2022 IPPS/LTCH PPS proposed 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 That Would Be
Implemented in This Proposed Rule
D. Summary of the Provisions of This Proposed Rule
E. Advancing Health Information Exchange
F. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH
PPS Ratesetting
II. Proposed 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. Proposed FY 2022 MS-DRG Documentation and Coding Adjustment
D. Proposed Changes to Specific MS-DRG Classifications
E. Recalibration of the FY 2022 MS-DRG Relative Weights
F. Proposed Add-On Payments for New Services and Technologies
for FY 2022
III. Proposed Changes to the Hospital Wage Index for Acute Care
Hospitals
A. Background
B. Worksheet S-3 Wage Data for the Proposed FY 2022 Wage Index
C. Verification of Worksheet S-3 Wage Data
D. Method for Computing the Proposed FY 2022 Unadjusted Wage
Index
E. Proposed Occupational Mix Adjustment to the FY 2022 Wage
Index
F. Analysis and Implementation of the Proposed Occupational Mix
Adjustment and the Proposed FY 2022 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, and Proposed Budget Neutrality Adjustment
H. Proposed FY 2022 Wage Index Tables
I. Proposed Revisions to the Wage Index Based on Hospital
Redesignations and Reclassifications
J. Proposed 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. Proposed Labor-Related Share for the FY 2022 Wage Index
IV. Proposed Rebasing and Revising of the Hospital Market Baskets
for Acute Care Hospitals
A. Background
B. Rebasing and Revising the IPPS Market Basket
C. Market Basket for Certain Hospitals Presently Excluded From
the IPPS
D. Rebasing and Revising the Capital Input Price Index (CIPI)
V. Other Decisions and Changes to the IPPS for Operating System
[[Page 25072]]
A. Proposed Changes in the Inpatient Hospital Updates for FY
2021 (Sec. 412.64(d))
B. Rural Referral Centers (RRCs)--Proposed Annual Updates to
Case-Mix Index and Discharge Criteria (Sec. 412.96)
C. Proposed Payment Adjustment for Low-Volume Hospitals (Sec.
412.101)
D. Proposed Indirect Medical Education (IME) Payment Adjustment
Factor (Sec. 412.105)
E. Proposed Payment Adjustment for Medicare Disproportionate
Share Hospitals (DSHs) for FY 2022 (Sec. 412.106)
F. Counting Days Associated With Section 1115 Demonstration
Projects in the Medicaid Fraction
G. Hospital Readmissions Reduction Program: Proposed Updates and
Changes (Sec. Sec. 412.150 Through 412.154)
H. Hospital Value-Based Purchasing (VBP) Program: Proposed
Updates and Changes (Sec. Sec. 412.160 Through 412.167)
I. Hospital-Acquired Conditions (HAC) Reduction Program:
Proposed Updates and Changes (Sec. 412.170)
J. Proposed Payments for Indirect and Direct Graduate Medical
Education Costs (Sec. Sec. 412.105 and 413.75 through 413.83)
K. Rural Community Hospital Demonstration Program
L. Market-Based MS-DRG Relative Weight--Proposed Policy Changes
(Sec. 413.20)
M. Payment Adjustment for CAR T-cell Clinical Trial and Expanded
Use for Immunotherapy Cases (Sec. Sec. 412.85 and 412.312)
VI. Proposed Changes to the IPPS for Capital-Related Costs
A. Overview
B. Additional Provisions
C. Proposed Annual Update for FY 2022
VII. Proposed Changes for Hospitals Excluded From the IPPS
A. Proposed Rate-of-Increase in Payments to Excluded Hospitals
for FY 2022
B. Critical Access Hospitals (CAHs)
VIII. Proposed Changes to the Long-Term Care Hospital Prospective
Payment System (LTCH PPS) for FY 2022
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. Proposed Changes to the LTCH PPS Payment Rates and Other
Proposed Changes to the LTCH PPS for FY 2022
IX. Proposed Quality Data Reporting Requirements for Specific
Providers and Suppliers
A. Advancing to Digital Quality Measurement and the Use of Fast
Healthcare Interoperability Resources (FHIR) in Hospital Quality
Programs--Request for Information
B. Closing the Health Equity Gap in CMS Hospital Quality
Programs--Request For Information
C. Hospital Inpatient Quality Reporting (IQR) Program
D. Changes to the PPS-Exempt Cancer Hospital Quality Reporting
(PCHQR) Program
E. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)
F. Proposed Changes to the Medicare Promoting Interoperability
Programs
X. Proposed Changes for Hospitals and Other Providers and Suppliers
A. Medicaid Enrollment of Medicare Providers and Suppliers for
Purposes of Processing Claims for Cost-Sharing for Services
Furnished to Dually Eligible Beneficiaries--Proposed Policy Changes
(Sec. 455.410)
B. Organ Acquisition Payment--Proposed Policy Changes (Part 413,
Subpart L)
C. Medicare Shared Savings Program--Proposed Policy Changes
(Sec. 425.600)
XI. MedPAC Recommendations
XII. Other Required Information
A. Publicly Available Files
B. Collection of Information Requirements
C. Response to Public Comments
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, 2021 and Payment Rates for LTCHs
Effective for Discharges Occurring on or After October 1, 2021
I. Summary and Background
II. Proposed Changes to Prospective Payment Rates for Hospital
Inpatient Operating Costs for Acute Care Hospitals for FY 2022
A. Calculation of the Proposed Adjusted Standardized Amount
B. Proposed Adjustments for Area Wage Levels and Cost-of-Living
C. Calculation of the Proposed Prospective Payment Rates
III. Proposed Changes to Payment Rates for Acute Care Hospital
Inpatient Capital-Related Costs for FY 2022
A. Determination of the Proposed Federal Hospital Inpatient
Capital-Related Prospective Payment Rate Update for FY 2022
B. Calculation of the Proposed Inpatient Capital-Related
Prospective Payments for FY 2022
C. Capital Input Price Index
IV. Proposed Changes to Payment Rates for Excluded Hospitals: Rate-
of-Increase Percentages for FY 2022
V. Proposed Changes to the Payment Rates for the LTCH PPS for FY
2022
A. Proposed LTCH PPS Standard Federal Payment Rate for FY 2022
B. Proposed Adjustment for Area Wage Levels Under the LTCH PPS
for FY 2022
C. Proposed Cost-of-Living Adjustment (COLA) for LTCHs Located
in Alaska and Hawaii
D. Proposed Adjustment for LTCH PPS High-Cost Outlier (HCO)
Cases
E. Proposed Update to the IPPS Comparable/Equivalent Amounts to
Reflect the Statutory Changes to the IPPS DSH Payment Adjustment
Methodology
F. Computing the Proposed Adjusted LTCH PPS Federal Prospective
Payments for FY 2022
VI. Tables Referenced in This Proposed 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 Proposed Policy Changes
I. Effects of Proposed Changes in the Capital IPPS
J. Effects of Proposed Payment Rate Changes and Policy Changes
Under the LTCH PPS
K. Effects of Proposed Requirements for Hospital Inpatient
Quality Reporting (IQR) Program
L. Effects of Proposed Requirements for the PPS-Exempt Cancer
Hospital Quality Reporting (PCHQR) Program
M. Effects of Proposed Requirements for the Long-Term Care
Hospital Quality Reporting Program (LTCH QRP)
N. Effects of Proposed Requirements Regarding the Promoting
Interoperability Program
O. Alternatives Considered
P. Overall Conclusion
Q. 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 2022
A. Proposed FY 2022 Inpatient Hospital Update
B. Proposed Update for SCHs and MDHs for FY 2022
C. Proposed FY 2022 Puerto Rico Hospital Update
D. Proposed Update for Hospitals Excluded From the IPPS for FY
2022
E. Proposed Update for LTCHs for FY 2022
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 2022 IPPS/LTCH PPS proposed rule would make payment and
policy changes under the Medicare inpatient prospective payment systems
(IPPS) for operating and capital-related costs of acute care hospitals
as well as for certain hospitals and hospital units excluded from the
IPPS. In addition, it would make payment and policy changes for
inpatient hospital services
[[Page 25073]]
provided by long-term care hospitals (LTCHs) under the long-term care
hospital prospective payment system (LTCH PPS). This proposed rule also
would make policy changes to programs associated with Medicare IPPS
hospitals, IPPS-excluded hospitals, and LTCHs. In this FY 2022 proposed
rule, we are continuing policies to address wage index disparities
impacting low wage index hospitals; including a proposal to implement
the imputed floor wage index provision of the American Rescue Plan Act
of 2021; including proposals related to new technology add-on payments;
and proposing to repeal the collection of market-based rate information
on the Medicare cost report and the market-based MS-DRG relative weight
methodology, as finalized in the FY 2021 IPPS/LTCH PPS final rule. This
proposed rule also includes proposals to implement provisions of the
Consolidated Appropriations Act of 2021 relating to payments to
hospitals for direct graduate medical education (GME) and indirect
medical education (IME) costs.
We are proposing to establish new requirements and revise existing
requirements for eligible hospitals and CAHs participating in the
Medicare Promoting Interoperability Program.
We are providing estimated and newly established performance
standards for the Hospital Value-Based Purchasing (VBP) Program, and
proposing updated policies for the Hospital Readmissions Reduction
Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital
VBP Program, Hospital-Acquired Condition (HAC) Reduction Program, Long
Term Care Hospital Quality Reporting Program (LTCH QRP), and the PPS-
Exempt Cancer Hospital Reporting (PCHQR) Program. Additionally, due to
the impact of the COVID-19 PHE on measure data used in our value-based
purchasing programs, we are proposing to suppress several measures in
the Hospital VBP, HAC Reduction, and Hospital Readmissions Reduction
Programs. As a result of these measure suppressions for the Hospital
VBP Program we are also proposing a special scoring methodology for FY
2022 that results in a value-based incentive payment amount that
matches the 2 percent reduction to the base operating DRG payment
amount.
Under various statutory authorities, we either discuss continued
program implementation or are proposing to make changes to the Medicare
IPPS, to the LTCH PPS, other related payment methodologies and programs
for FY 2022 and subsequent fiscal years, and other policies and
provisions included in this rule. 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 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 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(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.
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
[[Page 25074]]
care amount of all DSH hospitals expressed as a percentage.
Section 1886(m)(5) of the Act, which requires the
Secretary to reduce by two percentage points the annual update to the
standard Federal rate for discharges for a long-term care hospital
(LTCH) during the rate year for LTCHs that do not submit data in the
form, manner, and at a time, specified by the Secretary.
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.
Section 1899 of the Act which established the Medicare
Shared Savings Program (Shared Savings Program) to facilitate
coordination and cooperation among providers and suppliers to improve
the quality of care for Medicare fee-for-service (FFS) beneficiaries
and reduce the rate of growth in expenditures under Medicare Parts A
and B.
Section 1902(a)(23) of the Act, which specifies Medicaid
provider enrollment requirements. States may set reasonable standards
relating to the qualifications of providers but may not restrict the
right of beneficiaries to obtain services from any person or entity
that is both qualified and willing to furnish such services.
2. Summary of the Major Provisions
The following is a summary of the major provisions in this proposed
rule. In general, these major provisions are being proposed as part of
the annual update to the payment policies and payment rates, consistent
with the applicable statutory provisions. A general summary of the
proposed changes in this proposed rule is presented in section I.D. of
the preamble of this proposed rule.
a. Proposed 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 2022, we are proposing to make an adjustment of
+0.5 percent to the standardized amount.
b. Proposed Changes to the New COVID-19 Treatments Add-On Payment
(NCTAP)
In response to the COVID-19 PHE, we established the New COVID-19
Treatments Add-on Payment (NCTAP) under the IPPS for COVID-19 cases
that meet certain criteria (85 FR 71157 and 71158). We believe that as
drugs and biological products become available and are authorized for
emergency use or approved by Food and Drug Administration (FDA) for the
treatment of COVID-19 in the inpatient setting, it is appropriate to
increase the current IPPS payment amounts to mitigate any potential
financial disincentives for hospitals to provide new COVID-19
treatments during the PHE. Therefore, effective for discharges
occurring on or after November 2, 2020 and until the end of the PHE for
COVID-19, CMS established the NCTAP.
We anticipate that there might be inpatient cases of COVID-19,
beyond the end of the PHE, for which payment based on the assigned MS-
DRG may not adequately reflect the additional cost of new COVID-19
treatments. In order to continue to mitigate potential financial
disincentives for hospitals to provide these new treatments, and to
minimize any potential payment disruption immediately following the end
of the PHE, we believe that the NCTAP should remain available for cases
involving eligible treatments for the remainder of the fiscal year in
which the PHE ends (for example, until September 30, 2022). At the same
time, we also believe that any new technology add-on payments that may
be approved for a COVID-19 treatment would also serve to mitigate any
potential financial disincentives for hospitals to provide that new
COVID-19 treatment, such that the NCTAP would no longer be needed for
that same product.
Therefore, we are proposing to extend NCTAP for eligible products
that are not approved for new technology add-on payments through the
end of the fiscal year in which the PHE ends (for example, September
30, 2022). We also are proposing to discontinue the NCTAP for
discharges on or after October 1, 2021 for a product that is approved
for new technology add-on payments beginning FY 2022.
c. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH PPS
Ratesetting
For the IPPS and LTCH PPS ratesetting, our longstanding goal is
always to use the best available data overall. In section I.F. of the
preamble of this proposed rule we discuss our analysis of the best
available data for use in the development of this FY 2022 IPPS/LTCH PPS
proposed rule given the potential impact of the public health emergency
(PHE) for the Coronavirus Disease (COVID-19). As discussed in section
I.F of the preamble of this proposed rule, we are proposing to use the
FY 2019 data, such as the FY 2019 MedPAR file, for the FY 2022
ratesetting for circumstances where the FY 2020 data is significantly
impacted by the COVID-19 PHE, primarily in that the utilization of
inpatient services reflect generally markedly different utilization for
certain types of services in FY 2020 than would have been expected in
the absence of the PHE. In section I.O. of Appendix A of this proposed
rule, we are also considering, as an alternative to this proposal, the
use of the same FY 2020 data that we would ordinarily use for purposes
of FY 2022 ratesetting, and which we may consider finalizing based on
consideration of comments received.
d. Proposed 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
[[Page 25075]]
PPS rule (84 FR 42326 through 42332), we adopted a policy to increase
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 2022, we are continuing the low wage index hospital
policy, and are also proposing to apply this policy in a budget neutral
manner by applying an adjustment to the standardized amounts.
e. Proposed Implementation of Section 9831 of the American Rescue Plan
Act of 2021 (Pub. L. 117-2) Imputed Floor Wage Index Policy for All-
Urban States
Section 9831 of the American Rescue Plan Act of 2021 (Pub. L. 117-
2) amended section 1886(d)(3)(E) of the Act (42 U.S.C. 1395ww(d)(3)(E))
to establish a minimum area wage index for hospitals in all-urban
States. Specifically, section 1886(d)(3)(E)(iv) of the Act (as added by
section 9831(a)(2) of Pub. L. 117-2) reinstates the imputed floor wage
index policy for all-urban states effective for discharges on or after
October 1, 2021 (FY 2022) with no expiration date using the methodology
described in 42 CFR 412.64(h)(4)(vi) as in effect for FY 2018.
Furthermore, section 1886(d)(3)(E)(iv)(III) of the Act provides that
the imputed floor wage index shall not be applied in a budget neutral
manner. We refer readers to section III.G.2. of this proposed rule for
a summary of the provisions of section 9831 of Public Law 117-2 that we
are proposing to implement in this proposed rule.
f. Proposed 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, FY 2014, Medicare
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 proposed rule, we are proposing to update our estimates of
the three factors used to determine uncompensated care payments for FY
2022. We are also proposing to 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. Consistent with the policy adopted in the FY
2021 IPPS/LTCH PPS final rule for FY 2022 and subsequent fiscal years,
we are using a single year of data on uncompensated care costs from
Worksheet S-10 of the FY 2018 cost reports to calculate Factor 3 in the
FY 2022 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 proposing to continue to use the low-income insured days proxy to
calculate Factor 3 for these hospitals for FY 2022. We are proposing
certain methodological changes for calculating Factor 3 for FY 2022.
Additionally, we are proposing to revise our regulation governing
the calculation of the Medicaid fraction of the DSH calculation. Under
this proposal, patient days of individuals receiving benefits under a
section 1115 waiver program would be counted in the numerator of the
Medicaid fraction only if the patient directly receives inpatient
hospital insurance coverage on that day under a waiver authorized under
section 1115(a)(2) of the Act.
g. Reduction of Hospital Payments for Excess Readmissions
We are proposing 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 2022 IPPS/LTCH PPS proposed rule, we are proposing
the following policies: (1) To adopt a cross-program measure
suppression policy; (2) to suppress the Hospital 30-Day, All-Cause,
Risk-Standardized Readmission Rate (RSRR) following Pneumonia
Hospitalization measure (NQF #0506) for the FY 2023 program year; (3)
to modify the remaining five condition-specific readmission measures to
exclude COVID-19 diagnosed patients from the measure denominators,
beginning with the FY 2023 program year; (4) to use the MedPAR data
that aligns with the applicable period for FY 2022; (5) to
automatically adopt the use of MedPAR data corresponding to the
applicable period beginning with the FY 2023 program year and all
subsequent program years, unless otherwise specified by the Secretary;
and (6) to update the regulatory text to reflect that our Hospital
Compare website has been renamed and is now referred to as Care
Compare. We are clarifying our Extraordinary Circumstances Exceptions
(ECE) policy, and we are also requesting public comment on
opportunities to advance health equity through possible future
stratification of results by race and ethnicity for condition/
procedure-specific readmission measures and by expansion of
standardized data collection to additional social factors, such as
language preference and disability status. We are also seeking comment
on mechanisms of incorporating other demographic characteristics into
analyses that address and advance health equity, such as the potential
to include administrative and self-reported data to measure co-
occurring disability status.
h. 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 proposed rule, we are proposing to: (1) Establish a measure
suppression policy for the duration of the public health emergency for
COVID-19; (2) suppress the Hospital Consumer Assessment of Healthcare
Providers and Systems (HCAHPS), Medicare Spending Per Beneficiary
(MSPB), and five Healthcare-Associated Infection (HAI) measures, for
the FY 2022 Program year; and (3) suppress the Hospital 30-Day,
[[Page 25076]]
All-Cause, Risk-Standardized Mortality Rate Following Pneumonia (PN)
Hospitalization (MORT-30-PN) measure for the FY 2023 program year. We
are also proposing to revise the scoring and payment methodology for
the FY 2022 program year such that hospitals' Total Performance Scores
will not include calculations based on these measures. We believe that
awarding a TPS to any hospital based off the remaining measures that
are not suppressed would not result in a fair national comparison and,
as a result, are proposing not to award a TPS to any hospital for the
FY 2022 program year. Instead, we are proposing to award each hospital
a payment incentive multiplier that results in a value-based incentive
payment that is equal to the amount withheld for the fiscal year (2
percent). We are proposing to remove the CMS Patient Safety and Adverse
Events Composite (PSI 90) measure beginning with FY 2023 because the
costs associated with the measure outweigh the benefit of its use in
the program. We are also proposing to update the baseline periods for
certain measures affected by the ECE granted in response to the COVID-
19 PHE and to make a technical update to our terminology used in the
Hospital VBP Program regulations.
i. 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 2022 IPPS/LTCH PPS proposed rule, we are proposing to:
(1) Clarify our ECE policy; (2) adopt a cross-program measure
suppression policy; (3) apply that measure suppression policy to
suppress certain program data; and (4) update the regulatory text to
reflect that our Hospital Compare website has been renamed and is now
referred to as Care Compare.
j. 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 2022 IPPS/LTCH PPS proposed rule, we are proposing to
make several changes. We are proposing to adopt five new measures: (1)
A new structural measure--Maternal Morbidity Structural Measure--
beginning with a shortened reporting period from October 1, 2021
through December 31, 2021 affecting the CY 2021 reporting period/FY
2023 payment determination; (2) the Hybrid Hospital-Wide All-Cause Risk
Standardized Mortality (Hybrid HWM) measure in a stepwise fashion,
beginning with a voluntary reporting period from July 1, 2022 through
June 30, 2023, and followed by mandatory reporting from July 1, 2023
through June 30, 2024, affecting the FY 2026 payment determination and
for subsequent years; (3) the COVID-19 Vaccination Coverage Among
Health Care Personnel (HCP) measure beginning with a shortened
reporting period from October 1, 2021 through December 31, 2021,
affecting the CY 2021 reporting period/FY 2023 payment determination
and with quarterly reporting beginning with the FY 2024 payment
determination and for subsequent years; and two medication-related
adverse event eCQMs beginning with the CY 2023 reporting period/FY 2025
payment determination; (4) Hospital Harm-Severe Hypoglycemia eCQM (NQF
#3503e); and (5) Hospital Harm-Severe Hyperglycemia eCQM (NQF #3533e).
We are also proposing to remove five measures: (1) Death Among
Surgical Inpatients with Serious Treatable Complications (CMS PSI-04)
beginning with the FY 2023 payment determination; (2) Exclusive Breast
Milk Feeding (PC-05) (NQF #0480) beginning with the FY 2026 payment
determination; (3) Admit Decision Time to ED Departure Time for
Admitted Patients (ED-2) (NQF #0497) beginning with the FY 2026 payment
determination; and two stroke-related eCQMs beginning with the FY 2026
payment determination; (4) Anticoagulation Therapy for Atrial
Fibrillation/Flutter eCQM (STK-03) (NQF #0436); and (5) Discharged on
Statin Medication eCQM (STK-06) (NQF #0439).
We are requesting comment from stakeholders on the potential future
development and inclusion of two measures: (1) A mortality measure for
patients admitted with COVID-19; and (2) a patient-reported outcomes
measure following elective total hip and/or total knee arthroplasty
(THA/TKA). We are also requesting comment from stakeholders on ways we
can leverage measures to address gaps in existing health equity
generally as well as comment on: (1) Potential future confidential
stratified reporting for the Hospital-Wide All-Cause Unplanned
Readmission (HWR) measure using both dual eligibility and race/
ethnicity; and (2) potential future reporting of a structural measure
to assess the degree of hospital leadership engagement in health equity
performance data. In this proposed rule, we are also requesting
feedback across programs on potential actions and priority areas that
would enable the continued transformation of our quality measurement
toward greater digital capture of data and use of the FHIR standard.
In addition, beginning with the CY 2023 reporting period/FY 2025
payment determination, we are proposing to require hospitals to use
certified technology that has been updated consistent with the 2015
Edition Cures Update and clarifying that certified technology must
support the reporting requirements for all available eCQMs. We also are
proposing that hybrid measures comply with the same certification
requirements as eCQMs, specifically that EHR technology must be
certified to the 2015 Edition Cures Update. We are proposing an update
to revise 42 CFR 412.140(a)(2) and 42 CFR 412.140(e)(2)(iii) replacing
the terms ``Security Administrator'' and ``System Administrator'' with
the term ``security official'' in alignment with other CMS quality
programs. Due to an updated URL for the QualityNet website from
QualityNet.org to QualityNet.cms.gov, we are also proposing to revise
Hospital IQR Program regulations at 42 CFR 412.140(a)(1) and 42 CFR
412.140(c)(2)(i) to reflect updates to the QualityNet website. Lastly,
we are proposing to extend the effects of the educational review
process for chart-abstracted measures beginning with validations
affecting the FY 2024 payment determination.
k. 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 proposed rule, we are proposing to remove the Oncology:
Plan of Care for Pain--Medical Oncology and
[[Page 25077]]
Radiation Oncology (NQF #0383) (PCH-15) measure beginning with the FY
2024 program year, adopt the COVID-19 Vaccination Coverage Among
Healthcare Personnel measure beginning with the FY 2023 program year,
make a technical update to the terminology we use in the program, and
codify existing PCHQR Program policies in our regulations.
l. Medicare Promoting Interoperability Program
For purposes of reducing the burden on eligible hospitals and CAHs,
we are proposing several changes to the Medicare Promoting
Interoperability Program. Specifically, we are proposing: (1) To
continue the EHR reporting period of a minimum of any continuous 90-day
period for new and returning eligible hospitals and CAHs for CY 2023
and to increase the EHR reporting period to a minimum of any continuous
180-day period for new and returning eligible hospitals and CAHs for CY
2024; (2) to maintain the Electronic Prescribing Objective's Query of
PDMP measure as optional while increasing its available bonus from five
points to 10 points for the EHR reporting period in CY 2022; (3) to
modify the Provide Patient's Electronic Access to Their Health
Information measure to establish a data availability requirement
beginning with encounters with a date of service on or after January 1,
2016, beginning with the EHR reporting period in CY 2022; (4) to add a
new Health Information Exchange (HIE) Bi-Directional Exchange measure
as a yes/no attestation, to the HIE objective as an optional
alternative to the two existing measures beginning with the EHR
reporting period in CY 2022; (5) to require reporting a ``yes'' on four
of the existing Public Health and Clinical Data Exchange Objective
measures (Syndromic Surveillance Reporting, Immunization Registry
Reporting, Electronic Case Reporting, and Electronic Reportable
Laboratory Result Reporting) or requesting the applicable exclusion(s);
(6) adding a new measure to the Protect Patient Health Information
objective that requires eligible hospitals and CAHs to attest to having
completed an annual assessment of SAFER Guides beginning with the EHR
reporting period in CY 2022; (7) to remove attestation statements 2 and
3 from the Promoting Interoperability Program's prevention of
information blocking requirement; (8) to increase the minimum required
score for the objectives and measures from 50 points to 60 points (out
of 100 points) in order to be considered a meaningful EHR user; and (9)
to adopt two new eCQMs to the Medicare Promoting Interoperability
Program's eCQM measure set beginning with the reporting period in CY
2023, in addition to removing four eCQMs from the measure set beginning
with the reporting period in CY 2024 which is in alignment with the
proposals for the Hospital IQR Program. We are amending our regulation
texts as necessary to incorporate several of these proposed changes.
m. Proposed Repeal of Market-Based Data Collection and Market-Based MS-
DRG Relative Weight Methodology
As discussed in section V.L. of the preamble of this proposed rule,
we are proposing to repeal the requirement that a hospital report on
the Medicare cost report the median payer-specific negotiated charge
that the hospital has negotiated with all of its MA organization
payers, by MS-DRG, for cost reporting periods ending on or after
January 1, 2021. We are also proposing to repeal the market-based MS-
DRG relative weight methodology adopted for calculating the MS-DRG
relative weights effective in FY 2024, and to continue using the
existing cost-based methodology for calculating the MS-DRG relative
weights for FY 2024 and subsequent fiscal years. Lastly, we are
soliciting comment on alternative approaches or data sources that could
be used in Medicare fee-for-service (FFS) ratesetting. The proposed
repeal of these policies would result in a reduction of 63,780 annual
burden hours for all hospitals.
n. Proposed Implementation of Sections 126, 127 and 131 of the
Consolidated Appropriations Act (CAA) of 2021
In this proposed rule, we are including proposals to implement
sections 126, 127 and 131 of the Consolidated Appropriations Act (CAA)
of 2021. Section 126(a) of the CAA amended section 1886(h) of the Act
by adding a new section 1886(h)(9) of the Act requiring the
distribution of additional residency positions to qualifying hospitals.
Section 127 of the CAA amended section 1886(h)(4)(H)(iv) of the Act to
specify that in the case of a hospital not located in a rural area that
established or establishes a medical residency training program (or
rural track) in a rural area, the hospital, and each such hospital
located in a rural area that participates in such a training, is
allowed to receive an adjustment to its full-time equivalent (FTE)
resident limit. Section 131 of the CAA amended section 1886(h)(2)(F) of
the Act to provide an opportunity to hospitals with such extremely low
or $0 per resident amounts (PRAs) that meet certain criteria to reset
and establish new PRAs if the hospital trains resident(s) in a cost
reporting period beginning on or after enactment [December 27, 2020]
and before the date that is 5 years after enactment [December 26,
2025]. Section 131 also amended section 1886(h)(4)(H)(i) of the Act to
provide an opportunity for hospitals that meet certain criteria and
that have very small FTE resident caps to replace those caps if the
Secretary determines the hospital begins training residents in a new
program beginning on or after enactment (December 27, 2020) and before
5 years after enactment (December 26, 2025). We refer readers to
section V.J.2. of this proposed rule for rule for a summary of the
provisions of sections 126, 127, and 131 of the CAA that we are
proposing to implement in this proposed rule.
o. Proposed Changes to Organ Acquisition Payment Policy
In section X.B.2.h. of the preamble of this proposed rule, we are
proposing to revise and codify the Medicare usable organ counting
policy to count only organs transplanted into Medicare beneficiaries so
that Medicare more accurately records and pays its share of organ
acquisition costs.
p. Medicare Shared Savings Program
We are proposing to make changes to policies for the Shared Savings
Program, which was established under section 1899 of the Act, to allow
eligible ACOs participating in the BASIC track's glide path the option
to elect to forgo automatic advancement along the glide path's
increasing levels of risk and potential reward for performance year
(PY) 2022. Under this proposal, prior to the automatic advancement for
PY 2022, an eligible ACO may elect to remain in the same level of the
BASIC track's glide path in which it participated during PY 2021. For
PY 2023, an ACO that elects this advancement deferral option would be
automatically advanced to the level of the BASIC track's glide path in
which it would have participated during PY 2023 if it had advanced
automatically to the required level for PY 2022 (unless the ACO elects
to advance more quickly before the start of PY 2023).
3. Summary of Costs and Benefits
The following table provides a summary of the costs, savings,
benefits associated with the major provisions described in section
I.A.3. of the preamble of this proposed rule.
BILLING CODE 4120-01-P
[[Page 25078]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.000
[[Page 25079]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.001
[[Page 25080]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.002
[[Page 25081]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.003
[[Page 25082]]
BILLING CODE 4120-01-C
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 beginning on 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 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
[[Page 25083]]
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 That Would Be
Implemented in This Proposed Rule
1. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10)
Section 414 of the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA, Pub. L. 114-10) specifies a 0.5 percent positive
adjustment to the standardized amount of Medicare payments to acute
care hospitals for FYs 2018 through 2023. These adjustments follow the
recoupment adjustment to the standardized amounts under section 1886(d)
of the Act based upon the Secretary's estimates for discharges
occurring from FYs 2014 through 2017 to fully offset $11 billion, in
accordance with section 631 of the ATRA. The FY 2018 adjustment was
subsequently adjusted to 0.4588 percent by section 15005 of the 21st
Century Cures Act.
2. Consolidated Appropriations Act, 2021 (Pub. L. 116-260)
Sections 126, 127 and 131 of the Consolidated Appropriations Act,
2021 made a number of changes to various sections of the Act relating
to payment for direct GME and IME costs to hospitals.
a. Section 126 of the Consolidated Appropriations Act, 2021
Section 126 amended section 1886(h) of the Act by adding a new
section 1886(h)(9) requiring the distribution of additional residency
positions to qualifying hospitals. Section 1886(h)(9)(A) requires that
for FY 2023, and for each succeeding fiscal year until the aggregate
number of full-time equivalent residency positions distributed is equal
to 1,000, the Secretary shall initiate separate rounds of applications
from hospitals for these additional residency positions. The Secretary
is required, subject to certain provisions in the law, to increase the
otherwise applicable resident limit for each qualifying hospital that
submits a timely application by the number of positions that may be
approved by the Secretary for that hospital. The Secretary is required
to notify hospitals of the number of positions distributed to them by
January 31 of the fiscal year of the increase, and the increase is
effective beginning July 1 of that fiscal year. Section 1886(h)(9)(A)
also limits the aggregate number of such positions made available in a
single fiscal year across all hospitals to no more than 200.
In determining the qualifying hospitals for which an increase is
provided, section 1886(h)(9)(B) requires the Secretary to take into
account the demonstrated likelihood of the hospital filling the
positions made available within the first 5 training years beginning
after the date the increase would be effective, as determined by the
Secretary.
Section 1886(h)(9)(B) of the Act also requires a minimum
distribution for certain categories of hospitals. Specifically, the
Secretary is required to distribute at least 10 percent of the
aggregate number of total residency positions available to each of four
categories of hospitals. Stated briefly, and discussed in greater
detail in later in this proposed rule, the categories are as follows:
(1) Hospitals located in rural areas or that are treated as being
located in a rural area; (2) hospitals in which the reference resident
level of the hospital is greater than the otherwise applicable resident
limit; (3) hospitals in states with new medical schools or additional
locations and branches of existing medical schools; and (4) hospitals
that serve areas designated as Health Professional Shortage Areas
(HPSAs). Additionally, section 1886(h)(9)(F)(ii) of the Act defines a
qualifying hospital as a hospital in one of these four categories.
Section 1886(h)(9)(C) of the Act places certain limitations on the
distribution of the residency positions. First, a hospital may not
receive more than 25 additional full-time equivalent residency
positions. Second, no increase in the otherwise applicable resident
limit of a hospital may be made unless the hospital agrees to increase
the total number of full-time equivalent residency positions under the
approved medical residency training program of the hospital by the
number of positions made available to that hospital.
b. Section 127 of the Consolidated Appropriations Act, 2021
Section 127 of the CAA amended section 1886(h)(4)(H)(iv) of the Act
to
[[Page 25084]]
specify that in the case of a hospital not located in a rural area that
established or establishes a medical residency training program (or
rural tracks) in a rural area, the hospital, and each such hospital
located in a rural areas that participates in such a training, is
allowed to receive an adjustment to its full-time equivalent (FTE)
resident limit.
c. Sections 131 of the Consolidated Appropriations Act, 2021
Section 131 of the CAA amended section 1886(h)(2)(F) of the Act to
provide an opportunity to hospitals with such extremely low or $0 per
resident amounts (PRAs) that meet certain criteria to reset and
establish new PRAs if the hospital trains resident(s) in a cost
reporting period beginning on or after enactment [December 27, 2020]
and before the date that is 5 years after enactment [December 26,
2025]. Section 131 of the CAA also amended section 1886(h)(4)(H)(i) of
the Act to provide an opportunity for hospitals that meet certain
criteria and that have very small FTE resident caps to replace those
caps if the Secretary determines the hospital begins training residents
in a program year beginning on or after enactment (December 27, 2020)
and before 5 years after enactment (December 26, 2025).
D. Summary of the Provisions of This Proposed Rule
In this proposed rule, we set forth proposed payment and policy
changes to the Medicare IPPS for FY 2022 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 2022.
The following is a general summary of the changes that we are
proposing to make in this proposed rule.
1. Proposed Changes to MS-DRG Classifications and Recalibrations of
Relative Weights
In section II. of the preamble of this proposed rule, we include--
Proposed changes to MS-DRG classifications based on our
yearly review for FY 2022.
Proposed adjustment to the standardized amounts under
section 1886(d) of the Act for FY 2022 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 2022 status of new
technologies approved for add-on payments for FY 2022, a presentation
of our evaluation and analysis of the FY 2022 applicants for add-on
payments for high-cost new medical services and technologies (including
public input, as directed by Public Law 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 2022 new
technology applicants under the alternative pathways for certain
medical devices and certain antimicrobial products.
A proposal to extend the New COVID-19 Treatments Add-on
Payment (NCTAP) through the end of the fiscal year in which the PHE
ends for certain products and discontinue NCTAP for products approved
for new technology add-on payments in FY 2022.
2. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals
In section III. of the preamble of this proposed rule we are
proposing to make revisions to the wage index for acute care hospitals
and the annual update of the wage data. Specific issues addressed
include, but were not limited to, the following:
The proposed FY 2022 wage index update using wage data
from cost reporting periods beginning in FY 2018.
Calculation, analysis, and implementation of the proposed
occupational mix adjustment to the wage index for acute care hospitals
for FY 2022 based on the 2019 Occupational Mix Survey.
Proposed application of the rural floor and the frontier
State floor, and continuation of the low wage index hospital policy.
Proposed implementation of the imputed floor wage index
policy for all-urban states under section 9831 of the American Rescue
Plan Act of 2021 (Pub. L. 117-2).
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 revisions to the regulations at Sec. 412.278
regarding the Administrator's Review of MGCRB decisions.
Proposed changes to rural reclassification cancellation
requirements at Sec. 412.103(g).
Proposed adjustment to the wage index for acute care
hospitals for FY 2022 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 2022 wage
index.
3. Proposed Rebasing and Revising of the Hospital Market Baskets
In section IV. of the preamble of this proposed rule, we are
proposing to rebase and revise the hospital market baskets for acute
care hospitals and update the labor-related share.
4. Other Decisions and Proposed Changes to the IPPS for Operating Costs
In section V. of the preamble of this proposed rule, we discuss
proposed changes or clarifications of a number of the provisions of the
regulations in 42 CFR parts 412 and 413, including the following:
Proposed inpatient hospital update for FY 2022.
Proposed updated national and regional case-mix values and
discharges for purposes of determining RRC status.
The statutorily required IME adjustment factor for FY
2022.
Proposed changes to the methodologies for determining
Medicare DSH payments and the additional payments for uncompensated
care.
Proposed requirements for payment adjustments under the
Hospital Readmissions Reduction Program for FY 2022.
The provision of estimated and newly established
performance standards for the calculation of value-based incentive
payments, as well as a proposal to suppress multiple measures and
provide net-neutral payment adjustments under the Hospital Value-Based
Purchasing Program.
Proposed requirements for payment adjustments to hospitals
under the HAC Reduction Program for FY 2022.
Discussion of and proposed changes relating to the
implementation of the Rural Community Hospital Demonstration Program in
FY 2022.
Proposed revisions to the regulations regarding the
counting of days associated with section 1115 demonstration projects in
the Medicaid fraction.
Proposals to implement provisions of the Consolidated
Appropriations Act relating to payments to hospitals for direct
graduate medical education (GME) and indirect medical education (IME)
costs.
Proposed repeal of the market-based data collection
requirement and market-based MS-DRG relative weight methodology.
[[Page 25085]]
5. Proposed FY 2022 Policy Governing the IPPS for Capital-Related Costs
In section VI. of the preamble to this proposed rule, we discuss
the proposed payment policy requirements for capital-related costs and
capital payments to hospitals for FY 2022.
6. Proposed Changes to the Payment Rates for Certain Excluded
Hospitals: Rate-of-Increase Percentages
In section VII. of the preamble of this proposed rule, we discuss--
Proposed changes to payments to certain excluded hospitals
for FY 2022.
Proposed continued implementation of the Frontier
Community Health Integration Project (FCHIP) Demonstration.
7. Proposed Changes to the LTCH PPS
In section VIII. of the preamble of this proposed rule, we set
forth proposed changes to the LTCH PPS Federal payment rates, factors,
and other payment rate policies under the LTCH PPS for FY 2022.
8. Proposed Changes Relating to Quality Data Reporting for Specific
Providers and Suppliers
In section IX. of the preamble of this proposed rule, we address
the following:
Proposed requirements for the Hospital Inpatient Quality
Reporting (IQR) Program.
Proposed changes to the requirements for the quality
reporting program for PPS-exempt cancer hospitals (PCHQR Program).
Proposed changes to the requirements under the LTCH
Quality Reporting Program (QRP). We are also seeking information on
CMS's future plans to define digital quality measures (dQMs) for the
LTCH QRP and on CMS' continued efforts to close the health equity gap.
Proposed changes to requirements pertaining to eligible
hospitals and CAHs participating in the Medicare Promoting
Interoperability Program.
9. Other Proposals Included in This Proposed Rule
Section X. of the preamble to this proposed rule includes the
following proposals:
Proposed changes pertaining to Medicaid enrollment of
Medicare-enrolled providers and suppliers to 42 CFR part 455.410 and
request for comment on provider experiences where state Medicaid
agencies apply the Medicaid payment and coverage rules to a claim for a
Medicare service rather than adjudicating the claim for Medicare cost-
sharing liability.
Proposed changes pertaining to Medicare's share of organ
acquisition costs transplanted into Medicare beneficiaries and the
charges for services provided to cadaveric organ donors by donor
community hospitals and transplants hospitals.
Proposed changes pertaining to the Shared Savings Program
that would allow eligible ACOs participating in the BASIC track's glide
path to maintain their current level of participation for PY 2022.
10. Other Provisions of This Proposed Rule
Section XI. of the preamble to this proposed rule includes our
discussion of the MedPAC Recommendations.
Section XII. of the preamble to this proposed rule includes 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.
11. 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 this proposed rule, we
set forth proposed changes to the amounts and factors for determining
the proposed FY 2022 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 this proposed rule, we address the
proposed update factors for determining the rate-of-increase limits for
cost reporting periods beginning in FY 2022 for certain hospitals
excluded from the IPPS.
12. 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 2022 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
2022. We are proposing to establish the adjustments for the wage index,
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.
13. 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.
14. 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 provide our recommendations of the
appropriate percentage changes for FY 2022 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.
15. 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 2021 recommendations concerning hospital inpatient
payment policies address the update factor for hospital inpatient
operating costs and capital-related costs for hospitals under the IPPS.
We address these recommendations in Appendix B of this proposed rule.
For further information relating specifically to the MedPAC March 2021
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.
To further interoperability in post-acute care settings, CMS and
the Office of the National Coordinator for Health
[[Page 25086]]
Information Technology (ONC) participate inin the Post-Acute Care
Interoperability Workgroup (PACIO http://pacioproject.org/) to
facilitate collaboration with industry stakeholders to develop FHIR
standards. These standards could support the exchange and reuse of
patient assessment data derived from the Minimum Data Set (MDS),
Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-
PAI), LTCH Continuity Assessment Record and Evaluation (CARE Data Set
(LCDS), Outcome and Assessment Information Set (OASIS), and other
sources. The PACIO Project has focused on FHIR implementation guides
for functional status, cognitive status and new use cases on advance
directives and speech language pathology. We encourage post-acute care
(PAC) provider and health information technology (IT) vendor
participation as the efforts advance.
The CMS Data Element Library (DEL) continues to be updated and
serves as the authoritative resource for PAC assessment data elements
and their associated mappings to health IT standards, such as Logical
Observation Identifiers Names and Codes (LOINC) and Systematized
Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS'
goal of data standardization and interoperability. These interoperable
data elements can reduce provider burden by allowing the use and
exchange of healthcare data; supporting provider exchange of electronic
health information for care coordination, person-centered care; and
supporting real-time, data driven, clinical decision-making. Standards
in the Data Element Library (https://del.cms.gov/DELWeb/pubHome)can be
referenced on the CMS website and in the ONC Interoperability Standards
Advisory (ISA). The 2021 ISA is available at https://www.healthit.gov/isa.
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted
December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. The Cures Act
includes a trusted exchange framework and common agreement (TEFCA)
provision \1\ that will enable the nationwide exchange of electronic
health information across health information networks and provide an
important way to enable bi-directional health information exchange in
the future. For more information on current developments related to
TEFCA, we refer readers to https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and
https://rce.sequoiaproject.org/.
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\1\ ONC, Draft 2 Trusted Exchange Framework and Common
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
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The ONC final rule entitled ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' (85 FR 25642) published in the May 1, 2020
Federal Register, (hereinafter referred to as ``ONC Cures Act Final
Rule'') implemented policies related to information blocking as
authorized under section 4004 of the 21st Century Cures Act.
Information blocking is generally defined as a practice by a health IT
developer of certified health IT, health information network, health
information exchange, or health care provider that, except as required
by law or specified by the HHS Secretary as a reasonable and necessary
activity, is likely to interfere with access, exchange, or use of
electronic health information. For a health care provider (as defined
in 45 CFR 171.102), the definition of information blocking (see 45 CFR
171.103) specifies that the provider knows that the practice is
unreasonable, as well as likely to interfere with access, exchange, or
use of electronic health information.\2\ To deter information blocking,
health IT developers of certified health IT, health information
networks and health information exchanges whom the HHS Inspector
General determines, following an investigation, have committed
information blocking, are subject to civil monetary penalties of up to
$1 million per violation. Appropriate disincentives for health care
providers need to be established by the Secretary through rulemaking.
Stakeholders can learn more about information blocking at https://www.healthit.gov/curesrule/final-rule-policy/information-blocking. ONC
has posted information resources including fact sheets (https://www.healthit.gov/curesrule/resources/fact-sheets), frequently asked
questions (https://www.healthit.gov/curesrule/resources/information-blocking-faqs), and recorded webinars (https://www.healthit.gov/curesrule/resources/webinars).
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\2\ For other types of actors (health IT developers of certified
health IT and health information network or health information
exchange, as defined in 45 CFR 171.102), the definition of
``information blocking'' (see 45 CFR 171.103) specifies that the
actor ``knows, or should know, that such practice is likely to
interfere with access, exchange, or use of electronic health
information.''
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We invite providers to learn more about these important
developments and how they are likely to affect LTCHs.
F. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH PPS
Ratesetting
We primarily use two data sources in the IPPS and LTCH PPS
ratesetting: 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 for discharges in a
fiscal year. Our goal is always to use the best available data overall
for ratesetting. Ordinarily, the best available MedPAR data would be
the most recent MedPAR file that contains claims from discharges for
the fiscal year that is 2 years prior to the fiscal year that is the
subject of the rulemaking. For FY 2022 ratesetting, under ordinary
circumstances, the best available data would be the FY 2020 MedPAR
file. The cost report data source is the Medicare hospital cost report
data files from the most recent quarterly HCRIS release. For example,
ordinarily, the best available cost report data used in relative weight
calculations would be based on the cost reports beginning 3 fiscal
years prior to the fiscal year that is the subject of the rulemaking.
For the FY 2022 ratesetting, under ordinary circumstances, that would
be the FY 2019 cost report data from HCRIS, which would contain many
cost reports ending in FY 2020 based on each hospital's cost reporting
period.
The FY 2020 MedPAR claims file and the FY 2019 HCRIS dataset both
contain data significantly impacted by the COVID-19 PHE, primarily in
that the utilization of inpatient services was generally markedly
different for certain types of services in FY 2020 than would have been
expected in the absence of the PHE, as we discuss in this section.
Accordingly, we question whether these data sources are the best
available data to use for the FY 2022 ratesetting. One factor in
assessing whether these data sources represent the best available data
is to what extent the FY 2019 data from before the COVID-19 PHE is a
better overall approximation of FY 2022 inpatient experience (for
example, whether the share of total inpatient utilization for elective
surgeries will be more similar to FY 2019 than to FY 2020), or
alternatively, to what extent the FY 2020 data which include the COVID-
19 PHE time period is a better overall approximation of FY 2022
inpatient experience (for example, whether the share of total inpatient
utilization for respiratory infections will be more similar to FY 2020
than to FY
[[Page 25087]]
2019). Another factor is to what extent the decision to use the FY 2019
or FY 2020 data differentially impacts the FY 2022 IPPS ratesetting.
In order to help assess likely inpatient utilization in FY 2022, we
examined the trend in the number of COVID-19 vaccinations in the United
States as reported to the Centers for Disease Control (CDC) (see
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html, accessed April 16, 2021).
The U.S. COVID-19 Vaccination Program began December 14, 2020. As
of April 15, 2021, 198.3 million vaccine doses have been administered.
Overall, about 125.8 million people, or 37.9 percent of the U.S.
population, have received at least one dose of vaccine as of this date.
About 78.5 million people, or 23.6 percent of the U.S. population have
been fully vaccinated.\3\ As of April 15, the 7-day average number of
administered vaccine doses reported to CDC per day was 3.3 million, a
10.3 percent increase from the previous week. As of April 15, 80
percent of people 65 or older have received at least one dose of
vaccine; 63.7 percent are fully vaccinated. Nearly one-half (48.3
percent) of people 18 or older have received at least one dose of
vaccine; 30.3 percent are fully vaccinated. Nationally, COVID-19-
related emergency department visits as well as both hospital admissions
and current hospitalizations have risen among patients ages 18 to 64
years in recent weeks, but emergency department visits and
hospitalizations among people ages 65 years and older have decreased,
likely demonstrating the important role vaccination plays in protecting
against COVID-19.
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\3\ People who are fully vaccinated (formerly receiving 2 doses)
represents the number of people who have received the second dose in
a two-dose COVID-19 vaccine series or one dose of the single-dose
J&J/Janssen COVID-19 vaccine.
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As indicated by the CDC, COVID-19 vaccines are effective at
preventing COVID-19.\4\ For example, a recent CDC report on the
effectiveness of the Pfizer-BioNTech and Moderna COVID-19 vaccines when
administered in real-world conditions found that after being fully
vaccinated with either of these vaccines a person's risk of infection
is reduced by up to 90 percent. With respect to inpatient utilization
in FY 2020, we believe that COVID-19 and the risk of disease were
drivers of the different utilization patterns observed. Therefore, the
continuing rapid increase in vaccinations coupled with the overall
effectiveness of the vaccines leads us to conclude based on the
information available to us at this time that there will be
significantly lower risk of COVID-19 in FY 2022 and fewer
hospitalizations for COVID-19 for Medicare beneficiaries in FY 2022
than there were in FY 2020. This calls into question the applicability
of inpatient data from FY 2020 to the FY 2022 time period for hospitals
paid under the IPPS and LTCH PPS.
---------------------------------------------------------------------------
\4\ Interim Estimates of Vaccine Effectiveness of BNT162b2 and
mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among
Health Care Personnel, First Responders, and Other Essential and
Frontline Workers--Eight U.S. Locations, December 2020-March 2021,
available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_e&ACSTrackingID=USCDC_921-DM53321&ACSTrackingLabel=MMWR%20Early%20Release%20-%20Vol.%2070%2C%20March%2029%2C%202021&deliveryName=USCDC_921-DM53321, accessed April 2, 2021).
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We also reviewed CDC guidance to healthcare facilities during the
COVID-19 PHE (see https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-hcf.html). In its most recent guidance, the CDC described how
the COVID-19 pandemic has changed how health care is delivered in the
United States and has affected the operations of healthcare facilities.
Effects cited by the CDC include increases in patients seeking care for
respiratory illnesses, patients deferring and delaying non-COVID-19
care, disruptions in supply chains, fluctuations in facilities'
occupancy, absenteeism among staff because of illness or caregiving
responsibilities, and increases in mental health concerns.
In order to investigate the effects cited by the CDC, we examined
the claims data from the FY 2020 MedPAR compared to the FY 2019 MedPAR.
Overall, in FY 2020, inpatient admissions under the IPPS dropped by
approximately 14 percent compared to FY 2019. Elective surgeries
declined significantly, and the share of admissions for MS-DRGs
associated with the treatment of COVID-19 increased. For example, the
number of inpatient admissions for MS-DRG 470 (Major Hip and Knee Joint
Replacement or Reattachment of Lower Extremity without MCC) dropped by
40 percent in FY 2020. Its share of inpatient admissions dropped from
4.0 percent in FY 2019 to 2.8 percent in FY 2020. The number of
inpatient admissions for MS-DRG 177 (Respiratory Infections and
Inflammations with MCC) increased by +133 percent. Its share of
inpatient admissions increased from 0.8 percent in FY 2019 to 2.2
percent in FY 2020. This data analysis is consistent with the
observations in the CDC's guidance that COVID-19 increased the number
of patients seeking care for respiratory illnesses, and caused patients
to defer and delay non-COVID-19 care. We note that these observed
changes in the claims data also extend to the cost reports submitted by
hospitals that include the COVID-19 PHE time period, since those cost
reports that extend into the COVID-19 PHE are based in part on the
discharges that occurred during that time.
The effects noted by the CDC are specific to the pandemic and to
the extent that the effects on healthcare facilities noted by the CDC
are not expected to continue into FY 2022, it would suggest that the
inpatient data from FY 2020 impacted by the COVID-19 PHE may be less
suitable for use in the FY 2022 ratesetting.
We also considered the analysis of 2020 IPPS real case-mix included
in the notice titled ``CY 2021 Inpatient Hospital Deductible and
Hospital and Extended Care Services Coinsurance Amounts'' that appeared
in the Federal Register on November 12, 2020 (85 FR 71916). Section
1813(b) of the Act prescribes the method for computing the amount of
the inpatient hospital deductible. The inpatient hospital deductible is
an amount equal to the inpatient hospital deductible for the preceding
CY, adjusted by the best estimate of the payment-weighted average of
the applicable percentage increases used for updating the payment rates
to hospitals, and adjusted to reflect changes in real case-mix.
To develop the adjustment to reflect changes in real case-mix, we
first calculated an average case-mix for each hospital that reflected
the relative costliness of that hospital's mix of cases compared to
those of other hospitals. We then computed the change in average case-
mix for hospitals paid under the IPPS in FY 2020 compared to FY 2019,
using Medicare bills from IPPS hospitals received as of July 2020.
Those bills represented a total of about 6.1 million Medicare
discharges for FY 2020 and provided the most recent case-mix data
available at the time of that analysis. Based on these bills, the
change in average case-mix in FY 2020 was 2.8 percent. Based on these
bills and past experience, we expected the overall case-mix change to
be 3.8 percent as the year progressed and more FY 2020 data became
available.
Real case-mix is that portion of case-mix that is due to changes in
the mix of cases in the hospital and not due to coding optimization. As
stated in the November 2020 notice, COVID-19 has complicated the
determination of real case-mix increase. COVID-19 cases typically group
to higher-weighted MS-DRGs, and hospitals have experienced a concurrent
reduction in cases that group
[[Page 25088]]
to lower weighted MS-DRGs. Both of these factors cause a real increase
in case-mix. We compared the average case-mix for February 2020 through
July 2020 (COVID-19 period) with average case-mix for October 2019
through January 2020 (pre-COVID-19 period). Since this increase applies
for only a portion of CY 2020, we allocated this increase by the
estimated discharges over the 2 periods--a 2.5 percent increase for FY
2020. The 1.3-percent residual case-mix increase is a mixture of real
case-mix and coding optimization. Over the past several years, we have
observed total case-mix increases of about 0.5 percent per year and
have assumed that they are real. Thus, based on the information
available, we expect that 0.5 percent of the residual 1.3 percent
change in average case-mix for FY 2020 will be real. The combination of
the 2.5 percent COVID-19 effect and the remaining residual 0.5-percent
real case-mix increase results in an estimated 3.0 percent increase in
real case-mix for FY 2020.
Because this analysis was based on Medicare bills from IPPS
hospitals received as of July 2020, for this proposed rule, we
calculated case-mix values for FY 2019 and FY 2020 based on the full
year FY 2019 and FY 2020 MedPAR files to help assess the change in
case-mix based on more complete data. For FY 2019 we calculated a case-
mix value of 1.813 and for FY 2020 we calculated a case-mix value of
1.883, an increase in total case-mix of 3.9 percent. These were
calculated using the MS-DRG relative weights in effect for those time
periods.\5\ This is consistent with the estimate in the Notice of the
CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care
Services Coinsurance Amounts that the change in total case-mix for FY
2020 would be 3.8 percent when more complete data was available.
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\5\ Section 3710 of the Coronavirus Aid, Relief, and Economic
Security (CARES) Act directs the Secretary of HHS to increase the
weighting factor of the assigned DRG by 20 percent for an individual
diagnosed with COVID-19 discharged during the COVID-19 PHE period.
In order to make the case-mix values more comparable, the 20 percent
increase is not included.
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The increases in patients seeking care for respiratory illnesses
and patients deferring and delaying non-COVID-19 care during FY 2020,
the increasing number of vaccinations for COVID-19, and the high
estimate of FY 2020 real case-mix growth all lead us to believe that FY
2020 is not the best overall approximation of inpatient experience in
FY 2022. We believe that FY 2019 as the most recent complete FY prior
to the COVID-19 PHE is a better approximation of FY 2022 inpatient
experience.
As we indicated earlier, whether the data is a better overall
approximation of FY 2022 inpatient experience is one factor in
assessing which data source represents the best available data for the
FY 2022 rulemaking. Another factor is to what extent the decision to
use the FY 2019 or FY 2020 data differentially impacts the FY 2022
ratesetting. One way to assess this factor is to model the change in
the total case-mix, which is a driver of spending, if our assumption
regarding the FY 2022 inpatient experience used in calculating the MS-
DRG relative weights turns out to be less accurate based on actual FY
2022 experience. We estimated the difference in the total case-mix if
we calculated the MS-DRG relative weights based on the FY 2019 claims
data and the actual utilization is ultimately more similar to the FY
2020 data, as compared to if we calculated the MS-DRG relative weights
based on the FY 2020 data and the actual utilization is ultimately more
similar to the FY 2019 data.
We first calculated a set of MS-DRG relative weights using an
assumption that the FY 2022 inpatient experience would be similar to
the FY 2019 data. Specifically, we used the proposed version 39 GROUPER
(which would be applicable to discharges occurring in FY 2022) and the
FY 2019 MedPAR data to calculate MS-DRG relative weights. We refer to
these MS-DRG relative weights as the FY 2019-based weights.
We next calculated a set of MS-DRG relative weights using an
assumption that the FY 2022 inpatient experience would be more similar
to the FY 2020 data. Specifically, we used the proposed version 39
GROUPER and the FY 2020 MedPAR data to calculate MS-DRG relative
weights. This is how we would ordinarily calculate the proposed FY 2022
MS-DRG relative weights. We refer to these MS-DRG relative weights as
the FY 2020-based weights.
We then estimated the difference in case-mix under the FY 2019-
based weights and the FY 2020-based weights if the FY 2022 inpatient
experience ended up being the reverse of the assumption made when
calculating that set of relative weights. In other words, we compared
estimated case-mix calculated under four different scenarios. For the
FY 2019-based weights, we calculated the case-mix using claims from the
FY 2019 MedPAR as an approximation of the actual FY 2022 experience
(Scenario A), and using claims from the FY 2020 MedPAR as an
approximation of the actual FY 2022 experience (Scenario B). For the FY
2020-based weights, we calculated the case-mix using claims from the FY
2020 MedPAR as an approximation of the actual FY 2022 experience
(Scenario C), and using claims from the FY 2019 MedPAR as an
approximation of the actual FY 2022 experience (Scenario D).
The results are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.004
[[Page 25089]]
In Scenario A and Scenario C, there is by definition no
differential impact on total case-mix due to a less accurate assumption
made when the MS-DRG relative weights were calculated: The FY 2022
inpatient experience matches the assumption used when the MS-DRG
relative weights were calculated. In Scenario B and Scenario D, it is
the reverse of the assumption used when the MS-DRG relative weights
were calculated.
In Scenario B, when the FY 2019-based weights were used, but the FY
2022 inpatient experience turns out to be more similar to FY 2020 data,
the less accurate assumption does not differentially impact the
modelled case-mix. This can be seen by comparing the modelled case-mix
under Scenario B (1.885) with the modelled case-mix under Scenario C
(also 1.885). In other words, if the FY 2019-based weights and
inpatient experience turn out to be more similar to the FY 2020 data,
then the modelled case-mix is approximately the same as if we had used
the FY 2020-based weights. The results show that use of the FY 2019-
based weights did not impact the modelled case-mix compared to using
the FY 2020-based weights.
The same conclusion is not true of Scenario D where the FY 2020-
based weights were used, but the FY 2022 inpatient experience turns out
to be more similar to FY 2019 data. Here the less accurate assumption
does differentially impact the modelled case-mix, by -0.2 percent. This
can be seen by comparing the modelled case-mix under Scenario D (1.816)
with the modelled case-mix under Scenario A (1.820). In other words, if
we use the FY 2020-based weights, and FY 2022 inpatient experience
turns out to be more similar to FY 2019 data, the modelled case-mix is
-0.2 percent lower than if we had used the FY 2019-based weights. This
shows that use of the FY 2020-based weights does impact the modelled
case-mix compared to a result from using the FY 2019-based weights.
Putting aside that we believe FY 2019 is a more likely
approximation of the FY 2022 inpatient experience for the reasons
discussed earlier, the previous analysis indicates that the
differential effect of the FY 2022 MS-DRG relative weights is more
limited if the FY 2019-based weights are used than it is if the FY
2020-based weights are used, should the FY 2022 inpatient experience
not match the assumption used to calculate the MS-DRG relative weights.
Another payment factor that is impacted by the use of the FY 2019
or FY 2020 data in the FY 2022 ratesetting is the outlier fixed-loss
threshold. As discussed in section II.A.4.j. of this proposed rule,
section 1886(d)(5)(A) of the Act provides for payments in addition to
the basic prospective payments for ``outlier'' cases involving
extraordinarily high costs. To qualify for outlier payments, a case
must have costs greater than the sum of certain payments and the
``outlier threshold'' or ``fixed-loss'' amount (a dollar amount by
which the costs of a case must exceed payments in order to qualify for
an outlier payment). In accordance with section 1886(d)(5)(A)(iv) of
the Act, outlier payments for any year are projected to be not less
than 5 percent nor more than 6 percent of total operating DRG payments
plus outlier payments. We target 5.1 percent within this range. Section
1886(d)(3)(B) of the Act requires the Secretary to reduce the average
standardized amount by a factor to account for the estimated proportion
of total DRG payments made to outlier cases. In other words, outlier
payments are prospectively estimated to be budget neutral overall under
the IPPS.\6\
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\6\ More information on outlier payments may be found on the CMS
website at: http://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/AcuteInpatientPPS/outlier.html.
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Under an assumption that the FY 2022 inpatient experience will be
more similar to FY 2019 data, we estimate an outlier fixed-loss amount
of $30,967. Under an assumption that FY 2022 inpatient experience will
be more similar to FY 2020 data, we estimate an outlier fixed-loss
amount of $36,843, a difference of $5,876 or approximately 20 percent
higher. Again, putting aside that we believe FY 2019 is a better
approximation of the FY 2022 inpatient experience for the reasons
discussed earlier, the difference between the two estimated outlier
fixed-loss amounts means there is a consequence to making a decision as
to the best available data for estimating the FY 2022 outlier fixed-
loss amount in the form of potentially exceeding or falling short of
the targeted 5.1 percent of total operating DRG payments plus outlier
payments.
In summary, we have highlighted two factors in the decision
regarding the best available data to use in the FY 2022 ratesetting.
The first factor is to what extent the FY 2019 data from before the
COVID-19 PHE is a better overall approximation of FY 2022 inpatient
experience, or alternatively, to what extent the FY 2020 data including
the COVID-19 PHE time period is a better overall approximation of FY
2022 inpatient experience. After analyzing this issue and for the
reasons discussed, we believe for purposes of this proposed rule that
FY 2019 is generally a better overall approximation of FY 2022. The
second factor is to what extent the decision to use the FY 2019 or FY
2020 data differentially impacts the FY 2022 IPPS ratesetting. After
analyzing this issue, and as discussed previously, we have determined
that the decision does differentially impact the overall FY 2022 IPPS
ratesetting in two primary ways. First, a decision to base the MS-DRG
relative weights on the FY 2020 data has an impact of -0.2 percent if
the FY 2022 inpatient experience is more like FY 2019 data. Second, the
decision to use the FY 2019 or FY 2020 data results in an approximately
20 percent difference in the estimate of the outlier fixed-loss amount.
Taking these factors into account, we are proposing to use the FY
2019 data for the FY 2022 ratesetting for circumstances where the FY
2020 data is significantly impacted by the COVID-19 PHE, primarily in
that the data reflect generally markedly different utilization for
certain types of services in FY 2020 than would have been expected in
the absence of the PHE, as discussed previously. For example, we are
proposing to use the FY 2019 MedPAR claims data for purposes where we
ordinarily would have used the FY 2020 MedPAR claims data, such as in
our analysis of changes to MS-DRG classifications (as discussed in
greater detail section II.D. of the preamble of this proposed rule).
Similarly, we are proposing to use cost report data from the FY 2018
HCRIS file for purposes where we ordinarily would have used the FY 2019
HCRIS file, such as in determining the proposed FY 2022 IPPS MS-DRG
relative weights (as discussed in greater detail section II.E. of the
preamble of this proposed rule). (As noted previously, the FY 2019
HCRIS data would contain many cost reports ending in FY 2020 based on
each hospital's cost reporting period.) We note that MedPAR claims data
and cost report data from the HCRIS file are examples of the data
sources for which we discuss the proposed use of the FY 2019 data for
the FY 2022 ratesetting in this proposed rule. We have clearly
identified throughout this proposed rule where and how we are proposing
to use alternative data than what ordinarily would be used for the
proposed FY 2022 IPPS and LTCH PPS ratesetting, including certain
provider specific information.
As discussed in section I.O. of Appendix A of this proposed rule,
we are also considering, as an alternative to this proposal, the use of
the same FY 2020 data that we would ordinarily use for purposes of FY
2022 ratesetting, and
[[Page 25090]]
which we may consider finalizing based on consideration of comments
received. To facilitate comment on this alternative for FY 2022, we are
making available the FY 2020 MedPAR file and the FY 2019 HCRIS file
that we would ordinarily have provided in conjunction with this
proposed rule. We are also making available the MS-DRG and MS-LTC-DRG
relative weighting factors and length of stay information calculated
using the FY 2020 data we would have ordinarily used. We are providing
a file comparing the budget neutrality and other ratesetting
adjustments calculated under our proposal with those adjustments
calculated under this alternative approach. Finally, we are making
available other proposed rule supporting data files based on the use of
the FY 2020 data that we ordinarily would have provided, including: The
IPPS and LTCH PPS Impact Files; the AOR/BOR File; the Case Mix Index
File; and, the Standardizing File. We refer the reader to section I.O.
of Appendix A of this proposed rule for more information on where these
supplemental files may be found.
II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-
DRG) Classifications and Relative Weights
A. Background
Section 1886(d) of the Act specifies that the Secretary shall
establish a classification system (referred to as diagnosis-related
groups (DRGs) for inpatient discharges and adjust payments under the
IPPS based on appropriate weighting factors assigned to each DRG.
Therefore, under the IPPS, Medicare pays for inpatient hospital
services on a rate per discharge basis that varies according to the DRG
to which a beneficiary's stay is assigned. The formula used to
calculate payment for a specific case multiplies an individual
hospital's payment rate per case by the weight of the DRG to which the
case is assigned. Each DRG weight represents the average resources
required to care for cases in that particular DRG, relative to the
average resources used to treat cases in all DRGs.
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 2021 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, 84 FR
42058 through 42165, and 85 FR 58445 through 58596 respectively).
C. Proposed FY 2022 MS-DRG Documentation and Coding Adjustment
1. Background on the Prospective MS-DRG Documentation and Coding
Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90 and
the Recoupment or Repayment Adjustment Authorized by Section 631 of the
American Taxpayer Relief Act of 2012 (ATRA)
In the FY 2008 IPPS final rule with comment period (72 FR 47140
through 47189), we adopted the MS-DRG patient classification system for
the IPPS, effective October 1, 2007, to better recognize severity of
illness in Medicare payment rates for acute care hospitals. The
adoption of the MS-DRG system resulted in the expansion of the number
of DRGs from 538 in FY 2007 to 745 in FY 2008. By increasing the number
of MS-DRGs and more fully taking into account patient severity of
illness in Medicare payment rates for acute care hospitals, MS-DRGs
encourage hospitals to improve their documentation and coding of
patient diagnoses.
In the FY 2008 IPPS final rule with comment period (72 FR 47175
through 47186), we indicated that the adoption of the MS-DRGs had the
potential to lead to increases in aggregate payments without a
corresponding increase in actual patient severity of illness due to the
incentives for additional documentation and coding. In that final rule
with comment period, we exercised our authority under section
1886(d)(3)(A)(vi) of the Act, which authorizes us to maintain budget
neutrality by adjusting the national standardized amount, to eliminate
the estimated effect of changes in coding or classification that do not
reflect real changes in case-mix. Our actuaries estimated that
maintaining budget neutrality required an adjustment of -4.8 percentage
points to the national standardized amount. We provided for phasing in
this -4.8 percentage point adjustment over 3 years. Specifically, we
established prospective documentation and coding adjustments of -1.2
percentage points for FY 2008, -1.8 percentage points for FY 2009, and
-1.8 percentage points for FY 2010.
On September 29, 2007, Congress enacted the TMA [Transitional
Medical Assistance], Abstinence Education, and QI [Qualifying
Individuals] Programs Extension Act of 2007 (Pub. L. 110-90). Section
7(a) of Public Law 110-90 reduced the documentation and coding
adjustment made as a result of the MS-DRG system that we adopted in the
FY 2008 IPPS final rule with comment period to -0.6 percentage point
for FY 2008 and -0.9 percentage point for FY 2009.
As discussed in prior year rulemakings, and most recently in the FY
2017 IPPS/LTCH PPS final rule (81 FR 56780 through 56782), we
implemented a series of adjustments required under sections 7(b)(1)(A)
and 7(b)(1)(B) of Public Law 110-90, based on a retrospective review of
FY 2008 and FY 2009 claims data. We completed these adjustments in FY
2013 but indicated in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53274
through 53275) that delaying full implementation of the adjustment
required under section 7(b)(1)(A) of Public Law 110-90 until FY 2013
resulted in payments in FY 2010 through FY 2012 being overstated, and
that these overpayments could not be recovered under Public Law 110-90.
In addition, as discussed in prior rulemakings and most recently in
the FY 2018 IPPS/LTCH PPS final rule (82 FR 38008 through 38009),
section 631 of the 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.
[[Page 25091]]
2. Adjustments Made for FYs 2018, 2019, 2020 and 2021 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), the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42057), and the FY 2021 IPPS/LTCH PPS final rule (85 FR
58444-58445), 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, FY 2020, and FY 2021, respectively. We
indicated the FY 2018, FY 2019, FY 2020, and FY 2021 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 2022 and 2023 in future rulemaking.
3. Proposed Adjustment for FY 2022
Consistent with the requirements of section 414 of the MACRA, we
are proposing to implement a 0.5 percentage point positive adjustment
to the standardized amount for FY 2022. This would constitute a
permanent adjustment to payment rates. We plan to propose the final
adjustment required under section 414 of the MACRA for FY 2023 in
future rulemaking.
D. Proposed Changes to Specific MS-DRG Classifications
1. Discussion of Changes to Coding System and Basis for Proposed FY
2022 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 Proposed FY 2022 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 five
weeks for the data analysis and review process. In the FY 2021 IPPS/
LTCH PPS proposed rule (85 FR 32472), we stated 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 proposed updates. We further stated we were changing the
deadline to request changes to the MS-DRGs to October 20 of each year
to allow for additional time for the review and consideration of any
proposed updates. However, in the FY 2021 IPPS/LTCH PPS final rule (85
FR 58445), due to the unique circumstances for the FY 2021 IPPS/LTCH
PPS final rule for which we waived the delayed effective date, we
maintained the deadline of November 1, 2020 for FY 2022 MS-DRG
classification change requests. We also noted that we expected to
reconsider a change in the deadline beginning with comments and
suggestions submitted for FY 2023. While we continue to believe that a
change in the deadline from November 1 to October 20 will provide
hospitals sufficient time to assess potential impacts and inform future
MS-DRG recommendations, we are maintaining the deadline of November 1
for FY 2023 MS-DRG classification change requests.
As noted, interested parties had to submit MS-DRG classification
change requests for FY 2022 by November 1, 2020, and the comments that
were submitted in a timely manner for FY 2022 are discussed in this
section of the preamble of this proposed 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.
Interested parties should continue to submit any comments and
suggestions for FY 2023 by November 1, 2021 via the CMS MS-DRG
Classification Change Request Mailbox located at:
[email protected].
As we did for the FY 2021 IPPS/LTCH PPS proposed rule, for this FY
2022 IPPS/LTCH PPS proposed rule we are providing a test version of the
ICD-10 MS-DRG GROUPER Software, Version 39, so that the public can
better analyze and understand the impact of the proposals included in
this proposed rule. We note that this test software reflects the
proposed GROUPER logic for FY 2022. Therefore, it includes the new
diagnosis and procedure codes that are effective for FY 2022 as
reflected in Table 6A.--New Diagnosis Codes--FY 2022 and Table 6B.--New
Procedure Codes--FY 2022 associated with this proposed rule and does
not include the diagnosis codes that are invalid beginning in FY 2022
as reflected in Table 6C.--Invalid Diagnosis Codes--FY 2022 and Table
6D.--Invalid Procedure Codes--FY 2022 associated with this proposed
rule. These tables are not published in the Addendum to this proposed
rule, but are available via the
[[Page 25092]]
internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html as described in
section VI. of the Addendum to this proposed rule. Because the
diagnosis and procedure codes no longer valid for FY 2022 are not
reflected in the test software, we are making available a supplemental
file in Table 6P.1a that includes the mapped Version 39 FY 2022 ICD-10-
CM codes and the deleted Version 38 FY 2021 ICD-10-CM codes that should
be used for testing purposes with users' available claims data. In
addition, we are making available a supplemental file in Table 6P.1b
that includes the mapped Version 39 FY 2022 ICD-10-PCS codes and the
deleted Version 38 FY 2021 ICD-10-PCS codes that should be used for
testing purposes with users' available claims data. Therefore, users
will have access to the test software allowing them to build case
examples that reflect the proposals included in this proposed rule. In
addition, users will be able to view the draft version of the ICD-10
MS-DRG Definitions Manual, Version 39.
The test version of the ICD-10 MS-DRG GROUPER Software, Version 39,
the draft version of the ICD-10 MS-DRG Definitions Manual, Version 39,
and the supplemental mapping files in Table 6P.1a and Table 6P.1b of
the FY 2021 and FY 2022 ICD-10-CM diagnosis and ICD-10-PCS procedure
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 are proposing to the MS-DRGs for
FY 2022. We are inviting 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 this proposed
rule. In some cases, we are proposing changes to the MS-DRG
classifications based on our analysis of claims data and consultation
with our clinical advisors. In other cases, we are proposing to
maintain the existing MS-DRG classifications based on our analysis of
claims data and consultation with our clinical advisors. As discussed
in section I.F of the preamble of this proposed rule, we are proposing
to use claims data from the March 2020 update of the FY 2019 MedPAR
file in our analysis of proposed MS-DRG classification changes for FY
2022, consistent with our goal of using the best available data overall
for ratesetting. Alternatively, we are also providing the results of
our analysis of proposed MS-DRG classification changes using claims
data from the September 2020 update of the FY 2020 MedPAR file. As a
result, for this FY 2022 IPPS/LTCH PPS proposed rule, our MS-DRG
analysis was based on ICD-10 claims data from the March 2020 update of
the FY 2019 MedPAR file, which contains hospital bills received from
October 1, 2018 through March 31, 2020, for discharges occurring
through September 30, 2019. In addition, we also analyzed ICD-10 claims
data from the September 2020 update of the FY 2020 MedPAR file, which
contains hospital bills received from October 1, 2019 through September
30, 2020, for discharges occurring through September 30, 2020. In our
discussion of the proposed MS-DRG reclassification changes, we refer to
these claims data as the ``March 2020 update of the FY 2019 MedPAR
file'' and ``the September 2020 update of the FY 2020 MedPAR file.''
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 the FY 2021 IPPS/LTCH PPS final rule (85 FR 58448), we finalized
our proposal to expand our existing criteria to create a new
complication or comorbidity (CC) or major complication or comorbidity
(MCC) subgroup within a base MS-DRG. Specifically, we finalized the
expansion of the criteria to include the NonCC subgroup for a three-way
severity level split. We stated we believed that applying these
criteria to the NonCC subgroup would better reflect resource
stratification as well as promote stability in the relative weights by
avoiding low volume counts for the NonCC level MS-DRGs. We noted that
in our analysis of MS-DRG classification requests for FY 2021 that were
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. We also noted
that the application of the 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. We stated that any proposed modifications to the
MS-DRGs would be addressed in future rulemaking consistent with our
annual process and reflected in 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.
In our analysis of the MS-DRG classification requests for FY 2022
that we received by November 1, 2020, 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.
[[Page 25093]]
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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 typically evaluate the
most recent year of MedPAR claims data available. For example, we
stated earlier that for this FY 2022 IPPS/LTCH PPS proposed rule, our
MS-DRG analysis was based on ICD-10 claims data from both the March
2020 update of the FY 2019 MedPAR file and the September 2020 update of
the FY 2020 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 typically analyze the most recent two
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 is 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.
For this FY 2022 IPPS/LTCH PPS proposed rule, using the March 2020
update of the FY 2019 MedPAR file and the September 2020 update of the
FY 2020 MedPAR file, we also analyzed how applying the NonCC subgroup
criteria to all MS-DRGs currently split into three severity levels
would affect the MS-DRG structure beginning in FY 2022. Findings from
our analysis indicated that approximately 32 MS-DRGs would be subject
to change based on the three-way severity level split criterion
finalized in FY 2021. Specifically, we found that applying the NonCC
subgroup criteria to all MS-DRGs currently split into three severity
levels would result in the deletion of 96 MS-DRGs (32 MS-DRGs x 3
severity levels = 96) and the creation of 58 new MS-DRGs. These updates
would also involve a redistribution of cases, which would impact the
relative weights, and, thus, the payment rates proposed for particular
types of cases. We refer the reader to Table 6P.1c for the list of the
96 MS-DRGs that would be subject to deletion and the list of the 58 new
MS-DRGs that would be proposed for creation for FY 2022 under this
policy if the NonCC subgroup criteria were applied.
[[Page 25094]]
In light of the public health emergency (PHE), we have concerns
about the impact of implementing this volume of MS-DRG changes at this
time, and believe it may be appropriate to delay application of the
NonCC subgroup criteria to existing MS-DRGs in order to maintain more
stability in the current MS-DRG structure. Therefore, we are proposing
to delay the application of the NonCC subgroup criteria to existing MS-
DRGs with a three-way severity level split until FY 2023, and proposing
for FY 2022 to maintain the current structure of the 32 MS-DRGs that
currently have a three-way severity level split (total of 96 MS-DRGs)
that would otherwise be subject to these criteria.
2. Pre-MDC: MS-DRG 018 Chimeric Antigen Receptor (CAR) T-Cell Therapy
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58451 through
58453), we finalized our proposal to create Pre-MDC MS-DRG 018
(Chimeric Antigen Receptor (CAR) T-cell Immunotherapy) and to reassign
cases reporting 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) from Pre-MDC MS-DRG 016 (Autologous Bone Marrow
Transplant with CC/MCC or T-cell Immunotherapy), to new Pre-MDC MS-DRG
018 effective with discharges on and after October 1, 2020. We also
finalized our proposal 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'' to
reflect these changes.
Additionally, in the FY 2021 IPPS/LTCH PPS final rule in response
to public comments expressing concern that Pre-MDC MS-DRG 018 is
specific to one mechanistic approach to cellular therapy, and in
response to commenters who sought clarification on how future CAR T-
cell and non-CAR T-cell therapy products would be assigned, we stated
that if additional cellular therapies should become available, we would
use our established process to determine the MS-DRG assignment. The
commenters requested that CMS provide flexibility for future cellular
therapies, as they are made available and not restrict Pre-MDC MS-DRG
018 to CAR T-cell therapies alone. In this section of this rule, we
discuss the assignment of these therapies in more detail.
During the September 8-9, 2020 ICD-10 Coordination and Maintenance
Committee meeting, several topics involving requests for new procedure
codes related to CAR T-cell therapies, non-CAR T-cell therapies and
other immunotherapies were discussed. We refer the reader to the CMS
website at: https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials for additional detailed information regarding these requests
for new procedure codes. 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. As discussed in section II.D.13 of
the preamble of this proposed rule, Table 6B.--New Procedure Codes,
lists the new procedure codes that have been approved to date that will
be effective with discharges on and after October 1, 2021. Included in
Table 6B are the following new procedure codes that describe the
administration of CAR T-cell and non-CAR T-cell therapies and other
immunotherapies. Consistent with our established process, we examined
the MS-DRG assignment for the predecessor codes to determine the most
appropriate MS-DRG assignment and, consistent with the assignment of
those predecessor codes, we are proposing to classify the following new
procedure codes as non-O.R. procedures affecting Pre-MDC MS-DRG 018, as
shown in Table 6B.--New Procedure Codes associated with this proposed
rule and available via the internet on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/.
[[Page 25095]]
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In connection with our proposed assignment of the listed procedure
codes to Pre-MDC MS-DRG 018, we are also proposing to revise the title
for Pre-MDC MS-DRG 018 ``Chimeric Antigen Receptor (CAR) T-cell
Immunotherapy'' to ``Chimeric Antigen Receptor (CAR) T-cell and Other
Immunotherapies'' to better reflect the cases reporting the
administration of non-CAR T-cell therapies and other immunotherapies
that would also be assigned to this MS-DRG (for example, Introduction
of lifileucel immunotherapy into peripheral vein, percutaneous
approach, new technology group 7), in addition to CAR T-cell therapies.
3. MDC 03 (Diseases and Disorders of Ear, Nose and Throat)
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58462 through
58471), we finalized 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 (Major Head and Neck Procedures with MCC, with CC, and
without CC/MCC, respectively) and 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 provided the list of procedure codes
that were finalized to define the logic for the new MS-DRGs in Tables
6P.2a, 6P.2b, and 6P.2c associated with the final rule and available
via the internet on the CMS website at https://www.cms.gov/
[[Page 25096]]
Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/. We
received two separate but related requests to review and reconsider the
MS-DRG assignments for a subset of the procedure codes listed in Table
6P.2a (procedure codes assigned to MS-DRGs 140, 141, and 142) and Table
6P.2b (procedure codes assigned to MS-DRGs 143, 144, and 145). In this
section of this proposed rule, we discuss each of these separate, but
related requests.
a. Major Head and Neck Procedures
The requestor provided the following procedure codes from Table
6P.2a associated with the FY 2021 IPPS/LTCH PPS final rule for CMS to
examine.
[GRAPHIC] [TIFF OMITTED] TP10MY21.368
The requestor stated that the listed procedure codes do not appear
appropriately assigned to MS-DRGs 140, 141, and 142. According to the
requestor, if any one of the five procedure codes describing a
procedure performed on the cranial cavity (0W9100Z, 0W910ZZ, 0WC10ZZ,
0WC13ZZ, or 0WX14ZZ) is assigned in conjunction with a principal
diagnosis from MDC 03 (Diseases and Disorders of Ear, Nose, Mouth, and
Throat), it appears more appropriate that cases reporting the diagnosis
and procedure combination would group to MS-DRGs 25, 26, and 27
(Craniotomy and Endovascular Intracranial Procedures with MCC, with CC,
and without CC/MCC, respectively) (for example, ``craniotomy'' MS-DRGs)
in MDC 01 (Diseases and Disorders of the Central Nervous System) or to
MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively). The requestor stated that drainage and extirpation from
the cranial cavity always involves drilling or cutting through the
skull regardless of the approach, therefore the five procedure codes
identified warrant assignment to the ``craniotomy'' MS-DRGs. For the
three procedure codes describing excision of subcutaneous tissue of
chest, back, or abdomen (0JB60ZZ, 0JB70ZZ, and 0JB80ZZ), the requestor
stated those codes should group to MS-DRGs 987, 988, and 989 (Non-
extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) because they are not
pertinent to the ear, nose, mouth, or throat.
We reviewed this request and note that the five procedure codes
describing procedures performed on the cranial cavity are already
assigned to MDC 01 and group to the ``craniotomy'' MS-DRGs (25, 26, and
27) when reported with a principal diagnosis from MDC 01, and are also
currently classified as Extensive O.R. procedures, resulting in
assignment to MS-DRGs 981, 982, and 983 when any one of the five
procedure codes is reported on the claim and is unrelated to the MDC to
which the case was assigned based on the principal diagnosis. We also
note that in addition to MS-DRGs 25, 26, and 27, MS-DRG 23 (Craniotomy
with Major Device Implant or Acute Complex CNS Principal Diagnosis with
MCC or Chemotherapy Implant or Epilepsy with Neurostimulator) and MS-
DRG 24 (Craniotomy with Major Device Implant or Acute Complex CNS
Principal Diagnosis without MCC) include procedures performed on
structures located within the cranial cavity, are included in the range
of MS-DRGs known as the ``craniotomy'' MS-DRGs in MDC 01, and the five
procedure codes submitted by the requestor describing procedures
performed on the cranial cavity are also assigned to these MS-DRGs. We
refer the requestor to Appendix E of the ICD-10 MS-DRG Definitions
Manual for further discussion of how each procedure code may be
assigned to multiple MDCs and MS-DRGs under the IPPS. The ICD-10 MS-DRG
Definitions Manual is located on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software. We also note
that these five procedure codes were previously assigned to MS-DRGs 131
and 132 (Cranial and Facial Procedures with and without CC/MCC,
respectively) in MDC 03 under version 37 of the ICD-10 MS-DRGs prior to
the restructuring that was finalized effective FY 2021 for MS-DRG 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, and MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R.
Procedures with and without CC/MCC, respectively).
With regard to the three procedure codes describing excision of
subcutaneous tissue of chest, back, or abdomen (0JB60ZZ, 0JB70ZZ, and
0JB80ZZ), the requestor suggested that the codes should group to MS-
DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) specifically because they are not pertinent to the ear,
nose, mouth, or throat, however, it is unclear if the requestor was
concerned more broadly that the three procedure codes should not group
to any MS-DRGs in MDC 03 (Diseases and Disorders of Ear, Nose and
Throat), given the stated rationale for the request.
Upon our review, we believe that the three procedure codes
describing excision of subcutaneous tissue of chest, back, and abdomen
(0JB60ZZ, 0JB70ZZ, and 0JB80ZZ), which do not describe major head and
neck procedures, were inadvertently included in Table 6P.2a for
assignment to MS-DRGs 140, 141, and 142. However, we also believe that
the codes are appropriate for assignment
[[Page 25097]]
in MDC 03 and note that the three procedure codes were previously
assigned to MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R.
Procedures with and without CC/MCC, respectively) in MDC 03 prior to
the restructuring that was finalized effective FY 2021 for MS-DRGs 129,
130, 131, 132, 133, and 134. We also provided the following
clarification in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58470), 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.''
During our review of procedure codes 0JB60ZZ, 0JB70ZZ, and 0JB80ZZ
(describing excision of subcutaneous tissue of chest, back, and
abdomen, respectively) we also confirmed that these procedures are
currently designated as Extensive O.R. procedures. Consistent with
other procedure codes on the Non-extensive procedure code list, we do
not believe the procedures described by these procedure codes
necessarily utilize the resources or have the level of technical
complexity as the procedures on the Extensive O.R. procedures list.
Therefore, we agree that the procedure codes describing these
procedures would be more appropriately designated as Non-extensive
procedures and group to MS-DRGs 987, 988, and 989 (Non-extensive O.R.
Procedures Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) when any one of the three procedure codes
is reported on a claim and is unrelated to the MDC to which the case
was assigned based on the principal diagnosis. We refer the reader to
section II.D.10. of the preamble of this proposed rule for further
discussion regarding our proposal to reassign these procedure codes
from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R.
Procedures Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) for FY 2022.
Therefore, we are proposing to reassign the three procedure codes
describing excision of subcutaneous tissue of chest, back, or abdomen
(0JB60ZZ, 0JB70ZZ, and 0JB80ZZ) from MS-DRGs 140, 141, and 142 (Major
Head and Neck Procedures with MCC, with CC, and without CC/MCC,
respectively) to MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth And
Throat O.R. Procedures with MCC, with CC, and without CC/MCC,
respectively) in MDC 03 for FY 2022. We refer the reader to section
II.D.10. of the preamble of this proposed rule for further discussion
regarding the designation of these codes as Extensive O.R. procedures
versus Non-extensive O.R. procedures and our proposed reassignment of
these codes from MS-DRGs 981, 982, and 983 to MS-DRGs 987, 988, and 989
for FY 2022.
b. Other Ear, Nose, Mouth and Throat O.R. Procedures
As stated earlier, we received two separate but related requests to
review and reconsider the MS-DRG assignments for a subset of the
procedure codes listed in Table 6P.2a and Table 6P.2b. In this section
of this proposed rule, we discuss the second request related to
procedure codes listed in Table 6P.2b associated with the FY 2021 IPPS/
LTCH PPS final rule and currently assigned to MS-DRGs 143, 144 and 145.
The requestor provided a list of 82 procedure codes from Table
6P.2b associated with the FY 2021 IPPS/LTCH PPS final rule for CMS to
examine. We refer the reader to Table 6P.1d associated with this FY
2022 IPPS/LTCH PPS proposed rule and available via the internet at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/ for the list of procedure codes that were
provided by the requestor. According to the requestor, if any one of
the 82 procedure codes is assigned in conjunction with a principal
diagnosis code from MDC 03, it appears more appropriate that cases
reporting the diagnosis and procedure code combination would group to
MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) or to MS-DRGs 987, 988, and 989 (Non-extensive O.R.
Procedures Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) versus MS-DRGs 143, 144, and 145 (Other
Ear, Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively). However, the requestor also stated that
of the 82 procedure codes, the following three procedure codes
describing control of bleeding in the cranial cavity warrant grouping
to MS-DRGs 25, 26, and 27 (for example, ``craniotomy'' MS-DRGs) in MDC
01, for the same reasons previously described in the prior section
pertaining to the five other procedures performed on the cranial
cavity.
[GRAPHIC] [TIFF OMITTED] TP10MY21.007
We reviewed this request and similar to the discussion in the prior
section for the separate but related request, we note that 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. We continue to believe that the 82
[[Page 25098]]
procedure codes provided by the requestor are appropriately assigned to
MS-DRGs 143, 144, and 145 in MDC 03. With regard to the requestor's
assertion that cases reporting any one of the 82 procedure codes would
more appropriately group to the MS-DRGs for Extensive O.R. procedures
or Non-extensive O.R. procedures when reported in conjunction with a
principal diagnosis from MDC 03, we note that, as shown in Table 6P.2b
associated with the FY 2021 IPPS/LTCH PPS final rule, the procedure
codes that were finalized for assignment to MS-DRGs 143, 144, and 145
were previously assigned to MS-DRGs 129 and 130, 131 and 132, or 133
and 134 in MDC 03. We also note that, as discussed in prior rulemaking,
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. For these reasons, we are proposing
to maintain the current structure for MS-DRGs 143, 144, and 145 for FY
2022.
With regard to the three procedure codes describing control of
bleeding in the cranial cavity (0W310ZZ, 0W313ZZ, and 0W314ZZ), and the
requestor's suggestion that the codes should group to MS-DRGs 25, 26,
and 27 in MDC 01, we consulted with our clinical advisors who stated
these procedures are consistent with the existing procedure codes
included in the logic for case assignment to MS-DRGs 25, 26, and 27. We
refer the reader to section II.D.10. of the preamble of this proposed
rule for further discussion of this request, as well as our proposed
assignment of these codes to MS-DRGs 23, 24, 25, 26, and 27 for FY
2022.
4. MDC 04 (Diseases and Disorders of the Respiratory System)
a. Bronchiectasis
We received a request to reassign cases reporting diagnosis codes
describing bronchiectasis from MS-DRGs 190, 191, and 192 (Chronic
Obstructive Pulmonary Disease with MCC, with CC, and without CC/MCC,
respectively) to MS-DRGs 177, 178, and 179 (Respiratory Infections and
Inflammation with MCC, with CC, and without CC/MCC, respectively).
Bronchiectasis is described by the following diagnosis codes
[GRAPHIC] [TIFF OMITTED] TP10MY21.008
According to the requestor, the underlying pathophysiology of
bronchiectasis is more similar to cystic fibrosis than it is to chronic
obstructive pulmonary disease (COPD). The requestor stated that in
bronchiectasis, there is an inciting event that creates scarring in the
lung which prevents the lung from clearing out mucous like it normally
would. The accumulation of abnormal mucous results in an environment
conducive to bacterial growth and commonly found bacteria in this
setting is very similar to those of cystic fibrosis with staphylococcus
aureus, pseudomonas aeruginosa, and non-tuberculous mycobacterium. The
requestor reported that when patients develop an exacerbation of
bronchiectasis, this is because of a buildup of mucous compounded by
overwhelming growth of the previously mentioned bacteria. The requestor
also stated that patients admitted to the hospital for bronchiectasis
exacerbation are treated aggressively with intravenous (IV) antibiotics
to suppress the bacterial infection in combination with airway
clearance therapies. The requestor further stated that, unlike in an
acute COPD exacerbation, these patients do not always require steroids
as there is not necessarily airway reactivity.
The requestor maintained that the underlying reason for admission
to the hospital for these patients is the bacterial infection component
of the exacerbation, with the standard course of treatment for these
pulmonary bacterial infections averaging a minimum of 10-14 days due to
the slow growing nature of the bacteria commonly encountered in these
patients.
We reviewed this request and believe that bronchiectasis is
appropriately assigned to MS-DRGs 190, 191, and 192 (Chronic
Obstructive Pulmonary Disease with MCC, with CC, and without CC/MCC,
respectively) because bronchiectasis, like COPD, is a chronic
condition. With respect to the requestor's comments, cystic fibrosis, a
genetic disease that affects mucous producing cells resulting in
recurring lung infections, can lead to bronchiectasis. However, our
clinical advisors indicated that the cause of bronchiectasis can be
multifactorial or even remain undefined. Regardless of the cause, when
present, bronchiectasis is an irreversible chronic pulmonary condition
due to abnormal change to or destruction of normal pulmonary anatomy
(the major bronchi and bronchiole walls), resulting in impaired air
movement in and out of the lungs. COPD, regardless of the cause
(smoking, pollution, other exposures), is a chronic pulmonary condition
due to change/destruction of normal pulmonary anatomy, resulting in
impaired air movement in and out of the lungs. Both bronchiectasis and
COPD patients have abnormal pulmonary function tests and abnormal
anatomic findings on chest x-ray and/or chest CT. Therefore, for these
reasons, we are proposing to maintain the structure of MS-DRGs 190,
191, and 192 for FY 2022.
b. Major Chest Procedures
In the FY 2020 IPPS/LTCH PPS proposed (84 FR 19234) and final rules
(84 FR 42148), we stated that in review of the procedures that are
currently assigned to MS-DRGs 163, 164, and 165 (Major Chest Procedures
with MCC, with CC and without CC/MCC, respectively) and 166, 167, and
168 (Other Respiratory System O.R. Procedures with MCC, with CC, and
without CC/MCC, respectively), that further refinement of these MS-DRGs
may be warranted. In this section of this proposed rule, we discuss our
review of the procedures and our proposal for
[[Page 25099]]
restructuring these MS-DRGs for FY 2022.
We began our review of MS-DRGs 163, 164, 165, 166, 167, and 168 by
first examining all the procedures currently assigned to these MS-DRGs.
We refer the reader to the ICD-10 MS-DRG Definitions Manual Version
38.1, which is available via the internet on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS for complete documentation of the GROUPER logic for
MS-DRGs 163, 164, 165, 166, 167, and 168.
In our review of the procedures currently assigned to MS-DRGs 163,
164, 165, 166, 167, and 168, we found 17 procedure codes in MS-DRGs
163, 164, and 165 describing laser interstitial thermal therapy (LITT)
of body parts that do not describe areas within the respiratory system,
which would not be clinically appropriate to maintain in the logic.
These procedure codes are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.009
During our review of these 17 procedure codes, we identified
additional MDCs and MS-DRG assignments that are also not clinically
appropriate to maintain in the logic because the body parts described
by the codes are not consistent with the organ system, etiology or
clinical specialty of the MDC to which the procedure code is currently
assigned. For example, 16 of the 17 procedure codes (all except
procedure code DVY0KZZ) are included in the logic for case assignment
to MDC 12 (Diseases and Disorders of the Male Reproductive System) in
MS-DRGs 715 and 716 (Other Male Reproductive System O.R. Procedures for
Malignancy with and without CC/MCC, respectively) and MS-DRGs 717 and
718 (Other Male Reproductive System O.R. Procedures Except Malignancy
with and without CC/MCC, respectively) which is not clinically
appropriate. Therefore, we are proposing to reassign these 17 procedure
codes from their current MS-DRG assignments in MDC 04, and from the
additional MDCs and MS-DRGs identified during our review that were
found to be clinically inappropriate, to their clinically appropriate
MDC and MS-DRGs as shown in Table 6P.2b associated with this proposed
rule (which is available via the internet on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS).
During our review of the procedure codes describing LITT of various
body parts we also confirmed that these procedures are currently
designated as Extensive O.R. procedures. We do not believe the
procedures described by these procedure codes necessarily utilize the
resources or have the level of technical complexity as the other
procedures on the Extensive O.R. procedures list. We believe that the
procedure codes describing these procedures would be more appropriately
designated as Non-extensive procedures and group to MS-DRGs 987, 988,
and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively) when any one of
the procedure codes is reported on a claim and is unrelated to the MDC
to which the case was assigned based on the principal diagnosis. We
refer the reader to section II.D.10. of the preamble of this proposed
rule for further discussion regarding our proposal to reassign these
procedure codes from MS-DRGs 981, 982, and 983 (Extensive O.R.
Procedures Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-
extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) for FY 2022.
We also identified five procedure codes describing repair of the
esophagus procedures currently assigned to MS-DRGs 163, 164, and 165
that would not be clinically appropriate to maintain in the logic. The
procedure codes are 0DQ50ZZ (Repair esophagus, open approach), 0DQ53ZZ
(Repair esophagus, percutaneous approach), 0DQ54ZZ (Repair esophagus,
percutaneous
[[Page 25100]]
endoscopic approach), 0DQ57ZZ (Repair esophagus, via natural or
artificial opening), and 0DQ58ZZ (Repair esophagus, via natural or
artificial opening endoscopic), and are currently assigned to the
following MDCs and MS-DRGs.
BILLING CODE 4120-01-P
[[Page 25101]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.010
[[Page 25102]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.011
BILLING CODE 4120-01-C
The five procedure codes describing repair of esophagus procedures
are not clinically coherent with the other procedures in MS-DRGs 163,
164, and 165 that describe procedures performed on major chest
structures. Therefore, we are proposing to remove procedure codes
0DQ50ZZ, 0DQ53ZZ, 0DQ54ZZ, 0DQ57ZZ, and 0DQ58ZZ from the logic in MDC
04 for FY 2022.
During our review of procedure codes 0DQ50ZZ, 0DQ53ZZ, 0DQ54ZZ,
0DQ57ZZ, and 0DQ58ZZ (describing repair of esophagus procedures) we
also confirmed that these procedures are currently designated as
Extensive O.R. procedures. We do not believe the procedures described
by procedure codes 0DQ53ZZ, 0DQ57ZZ, and 0DQ58ZZ necessarily utilize
the resources or have the level of technical complexity as the other
procedures on the Extensive O.R. procedures list. We believe that the
procedure codes describing these procedures would be more appropriately
designated as Non-extensive procedures and group to MS-DRGs 987, 988,
and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively) when any one of
the three procedure codes is reported on a claim and is unrelated to
the MDC to which the case was assigned based on the principal
diagnosis. We refer the reader to section II.D.10. of the preamble of
this proposed rule for further discussion regarding our proposal to
reassign these procedure codes from MS-DRGs 981, 982, and 983
(Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989
(Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with
MCC, with CC, and without CC/MCC, respectively) for FY 2022.
Next, we examined claims data from the March 2020 update of the FY
2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR
file for all cases in MS-DRGs 163, 164, 165, 166, 167, and 168. Our
findings are shown in the following tables.
[GRAPHIC] [TIFF OMITTED] TP10MY21.012
[[Page 25103]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.013
As shown in the tables, there were a higher number of cases
reported in MS-DRGs 163, 164, 165, 166, 167, and 168 from the March
2020 update of the FY 2019 MedPAR file in comparison to the September
2020 update of the FY 2020 MedPAR file and overall, the cases reported
have comparable average lengths of stay and comparable average costs
for both fiscal years.
We then examined claims data from both the March 2020 update of the
FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR
file for MS-DRGs 163, 164, 165, 166, 167, and 168 to compare costs,
complexity of service and clinical coherence for each procedure code
currently assigned to these MS-DRGs to assess any potential
reassignment of the procedures. We refer the reader to Table 6P.1e and
Table 6P.1f associated with this proposed rule (which is available via
the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS) for the detailed
claims data analysis. Table 6P.1e contains the data analysis findings
of procedure codes currently assigned to MS-DRGs 163, 164, 165, 166,
167, and 168 from the March 2020 update of the FY 2019 MedPAR file and
Table 6P.1f contains the data analysis findings of procedure codes
currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168 from the
September 2020 update of the FY 2020 MedPAR file. We note that if a
procedure code that is currently assigned to MS-DRGs 163, 164, 165,
166, 167, or 168 is not displayed, it is because there were no cases
found reporting that code in the assigned MS-DRG.
As shown in Table 6P.1e and Table 6P.1f associated with this
proposed rule, in our examination of the claims data from both the
March 2020 update of the FY 2019 MedPAR file and September 2020 update
of the FY 2020 MedPAR file, we found there is wide variation in the
volume, length of stay, and average costs for the procedures currently
assigned to MS-DRGs 163, 164, 165, 166, 167, and 168. There were
several instances in which only one occurrence of a procedure was
reported with a procedure code from MS-DRGs 163, 164, 165, 166, 167, or
168, and the average length of stay for these specific cases ranged
from 1 day to 97 days. For example, in the analysis of claims data from
the March 2020 update of the FY 2019 MedPAR file, during our review of
MS-DRG 163, we found 153 procedures for which only one occurrence of
the procedure was reported with the average length of stay ranging from
2 days to 65 days and the average costs ranging from $3,760 to $195,447
for these cases. For MS-DRG 164, we found 145 procedures for which only
one occurrence of the procedure was reported with the average length of
stay ranging from 1 day to 28 days and the average costs ranging from
$1,886 to $137,810 for these cases. For MS-DRG 165, we found 111
procedures for which only one occurrence of the procedure was reported
with the average length of stay ranging from 1 day to 23 days and the
average costs ranging from $2,656 to $73,092 for these cases. For MS-
DRG 166, we found 150 procedures for which only one occurrence of the
procedure was reported with the average length of stay ranging from 1
day to 61 days and the average costs ranging from $3,230 to $246,679
for these cases. For MS-DRG 167, we found 110 procedures for which only
one occurrence of the procedure was reported with the average length of
stay ranging from 1 day to 23 days and the average costs ranging from
$2,058 to $149,220 for these cases. For MS-DRG 168, we found 68
procedures for which only one occurrence of the procedure was reported
with the average length of stay ranging from 1 day to 18 days and the
average costs ranging from $2,033 to $35,576 for these cases.
Our analysis of the claims data from the September 2020 update of
the FY 2020 MedPAR file resulted in similar findings to those from the
March 2020 update of the FY 2019 MedPAR file; there were several
instances in which only one occurrence of a procedure was reported with
a procedure code from MS-DRGs 163, 164, 165, 166, 167, or 168. During
our review of MS-DRG 163, we found 139 procedures for which only one
occurrence of the procedure was reported with the average length of
stay ranging from 2 days to 97 days and the average costs ranging from
$5,697 to $205,696 for these cases. For MS-DRG 164, we found 122
procedures for which only one occurrence of the procedure was reported
with the average length of stay ranging from 1 day to 35 days and the
average costs ranging from $3,204 to $120,128 for these cases. For MS-
DRG 165, we found 92 procedures for which only one occurrence of the
procedure was reported with the average length of stay ranging from 1
day to 16 days and the average costs ranging from $2,682 to $164,014
for these cases. For MS-DRG 166, we found 141 procedures for which only
one occurrence of the procedure was reported with the average length of
stay ranging from 1 day to 45 days and the average costs ranging from
$3,230 to $246,679 for these cases. For MS-DRG 167, we found 105
procedures for which only one occurrence of the procedure was reported
with the average length of stay ranging from 1 day to 22 days and the
average costs ranging from $2,150 to $112,465 for these cases. For MS-
DRG 168, we found 72 procedures for which only one occurrence of the
procedure was reported with the average length of stay ranging from 1
day to 9 days and the average costs ranging from $1,563 to $76,061 for
these cases.
Our clinical advisors reviewed the procedures currently assigned to
MS-DRGs 163, 164, 165, 166, 167, and 168 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. This
process included separating the procedures according to the surgical
approach (open, percutaneous, percutaneous endoscopic, via natural or
artificial opening, via natural or artificial opening endoscopic, and
external).
[[Page 25104]]
We also considered the claims data from the March 2020 update of
the FY 2019 MedPAR file and the September 2020 update of the FY 2020
MedPAR file for MS-DRGs 163, 164, 165, 166, 167, and 168 to further
analyze the average length of stay and average costs for the cases
reporting procedures assigned to any one of these MS-DRGs as well as
clinical coherence for these cases. 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 procedures, such as procedures
performed on the sternum and ribs (for example, major chest) from the
less complex procedures such as bypass procedures performed on
peripheral vessels or diagnostic biopsies.
As an initial step in our proposed restructuring of these MS-DRGs,
we identified the following 26 procedure codes that are currently
assigned to MS-DRGs 166, 167, and 168 that we believe represent
procedures performed on structures that align more appropriately with
the procedures assigned to MS-DRGs 163, 164, and 165 that describe
major chest procedures.
[GRAPHIC] [TIFF OMITTED] TP10MY21.014
We analyzed claims data from the March 2020 update of the FY 2019
MedPAR file for the listed procedure codes in MS-DRGs 166, 167, and
168. We note that if a listed procedure code is not displayed, it is
because there were no cases found reporting that code among MS-DRGs
166, 167, and 168. Our findings are shown in the following table.
[[Page 25105]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.015
We then analyzed claims data from the September 2020 update of the
FY 2020 MedPAR file for the listed procedure codes in MS-DRGs 166, 167,
and 168. We note that if a listed procedure code is not displayed, it
is because there were no cases found reporting that code among MS-DRGs
166, 167, and 168. Our findings are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.016
[[Page 25106]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.017
We refer the reader to Tables 6P.1e and 6P.1f for detailed claims
data for the previously listed procedures in MS-DRGs 163, 164, 165,
166, 167, and 168 from the March 2020 update of the FY 2019 MedPAR file
and the September 2020 update of the FY 2020 MedPAR file, respectively,
and note that while some of the 26 listed procedure codes identified in
MS-DRGs 166, 167, and 168 may not have been reported in either year's
MedPAR claims data or only had one occurrence in which the procedure
was reported, we believe these procedures described by the listed 26
procedure codes are clinically coherent with the other procedures that
are currently assigned to MS-DRGs 163, 164, and 165. For example, in
our analysis of the March 2020 update of the FY 2019 MedPAR file, as
shown in the table, we found procedure code 02QW0ZZ reported with one
occurrence with an average length of stay of 15 days and average costs
of $46,829. Despite finding only one case, we believe procedures
described by this procedure code, as well as related procedure codes
describing procedures performed on the great vessels, are more
clinically coherent with the procedures assigned to MS-DRGs 163, 164,
and 165 and align more appropriately with the average length of stay
and average costs of those MS-DRGs. Similarly, in our analysis of the
September 2020 update of the FY 2020 MedPAR file, as shown in the
table, we found procedure code 0PS204Z reported with 344 occurrences
with an average length of stay of 9.6 days and average costs of
$48,340. We believe procedures described by this procedure code, as
well as related procedure codes describing procedures performed to
repair or resect the ribs, are more clinically coherent with the
procedures assigned to MS-DRGs 163, 164, and 165 and also align more
appropriately with the average length of stay and average costs of
those MS-DRGs.
As a result of our preliminary review of MS-DRGs 163, 164, 165,
166, 167, and 168, for FY 2022 we are proposing the reassignment of the
listed 26 procedure codes (9 procedure codes describing repair of
pulmonary or thoracic structures, and 17 procedure codes describing
procedures performed on the sternum or ribs) from MS-DRGs 166, 167, and
168 to MS-DRGs 163, 164, and 165 in MDC 04. Our data analysis shows
that for the cases reporting any one of the 26 procedure codes,
generally, they have an average length of stay and average costs that
appear more consistent with the average length of stay and average
costs of cases in MS-DRGs 163, 164, and 165. Our clinical advisors also
agree that these procedures clinically align with the other procedures
that are currently assigned to MS-DRGs 163, 164, and 165. We refer the
reader to Table 6P.2c associated with this proposed rule for the list
of procedure codes we are proposing for reassignment from MS-DRGs 166,
167, and 168 to MS-DRGs 163, 164, and 165 in MDC 04.
After this initial review of all the procedures currently assigned
to MS-DRGs 163, 164, 165, 166, 167, and 168, in combination with the
results of the data analysis as reflected in Tables 6P.1e and 6P.1f,
our clinical advisors support a phased restructuring of these MS-DRGs.
We believe further analysis of the procedures assigned to these MS-DRGs
is warranted based on the creation of new procedure codes that have
been assigned to these MS-DRGs in recent years for which claims data
are not yet available and the need for additional time to examine the
procedures currently assigned to those MS-DRGs by clinical intensity,
complexity of service and resource utilization. We will continue to
evaluate the procedures assigned to these MS-DRGs as additional claims
data become available.
5. MDC 05 (Diseases and Disorders of the Circulatory System)
a. Short-Term External Heart Assist Device
Impella[supreg] Ventricular Support Systems are temporary heart
assist devices intended to support blood pressure and provide increased
blood flow to critical organs in patients with cardiogenic shock, by
drawing blood out of the heart and pumping it into the aorta, partially
or fully bypassing the left ventricle to provide adequate circulation
of blood (replace or supplement left ventricle pumping) while also
allowing damaged heart muscle the opportunity to rest and recover in
patients who need short-term support for up to 6 days. The ICD-10-PCS
codes that describe the insertion of Impella[supreg] heart assist
devices are
[[Page 25107]]
currently assigned to MS-DRG 215 (Other Heart Assist System Implant).
We refer the reader to the ICD-10 MS-DRG Definitions Manual Version
38.1, 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-DRG 215.
In the FY 2019 IPPS/LTCH PPS final rule (83 FR 41159 through
41170), we discussed public comments that recommended that CMS continue
to monitor the data in MS-DRG 215 for future consideration of
distinctions (for example, different approaches and evolving
technologies) that may impact the clinical and resource use of
procedures utilizing heart assist devices. Our data analysis showed a
wide range in the average length of stay and the average costs for
cases reporting procedures that involve a biventricular short-term
external heart assist system versus a short-term external heart assist
system. We noted we were aware that the AHA published Coding Clinic
advice that clarified coding and reporting for certain external heart
assist devices due to the technology being approved for new indications
but the claims data current at that time did not yet reflect that
updated guidance. We also noted that there had been recent updates to
the descriptions of the codes for heart assist devices. The qualifier
``intraoperative'' was added effective October 1, 2017 (FY 2018) to the
procedure codes describing the insertion of short-term external heart
assist system procedures to distinguish between procedures where the
device was only used intraoperatively and was removed at the conclusion
of the procedure versus procedures where the device was not removed at
the conclusion of the procedure and for which that qualifier would not
be reported. We agreed with the commenters that continued monitoring of
the data and further analysis was necessary prior to proposing any
modifications to MS-DRG 215 and finalized our proposal to maintain the
current structure of MS-DRG 215 for FY 2019.
In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42167) we discussed
public comments on our proposals related to recalibration of the FY
2020 relative weights and the changes in relative weights from FY 2019.
Several commenters expressed concern about significant reductions to
the relative weight for MS-DRG 215. Commenters stated that the
reduction in the proposed relative weight was 29 percent, the largest
decrease of any MS-DRG; commenters also noted that the cumulative
decrease to the relative weight for MS-DRG 215 would be 43 percent
since FY 2017. Commenters stated that the proposed relative weights
would result in significant underpayments to facilities, which would in
turn limit access to heart assist devices. After reviewing the comments
received and the data used in our ratesetting calculations, we
acknowledged an outlier circumstance where the weight for a MS-DRG was
seeing a significant reduction for each of the 3 years since CMS began
using the ICD-10 data in calculating the relative weights. Therefore,
for the reasons discussed in the FY 2020 final rule, we adopted a
temporary one-time measure for FY 2020 where 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.
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58598) we again
acknowledged an outlier circumstance where the weight for MS-DRG 215
was seeing a significant reduction for each of the 4 years since CMS
began using the ICD-10 data in calculating the relative weights. We
stated 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 adopted a temporary one-
time measure for FY 2021 for MS-DRG 215. Specifically, we 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.
For this FY 2022 IPPS/LTCH PPS proposed rule, we received a request
to reassign certain cases reporting procedure codes describing the
insertion of a percutaneous short-term external heart assist device
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 requestor,
there are two distinct clinical populations within MS-DRG 215: High-
risk Percutaneous Coronary Intervention (PCI) patients receiving short
term ``intraoperative'' external heart assist systems where the device
is only used intraoperatively and is removed at the conclusion of the
procedure, and those patients in or at risk of cardiogenic shock
requiring longer heart pump support and ICU stays. The requestor stated
that cases in which short-term external heart assist systems are placed
intraoperatively require fewer resources. The requestor suggested that
moving the less resource intensive cases that report a procedure code
that describes the intraoperative insertion of short-term external
heart assist systems from MS-DRG 215 into MS-DRG 216, 217, and 218,
will clinically align the two distinctly different patient populations,
and consequently will address the potential decrease in the relative
weight of MS-DRG 215.
The requestor stated it performed its own analysis of claims in MS-
DRG 215 that involve the intraoperative insertion of a short-term
external heart assist device (as identified by the presence of ICD-10-
PCS codes 02HA3RJ (Insertion of short-term external heart assist system
into heart, intraoperative, percutaneous approach) and 5A0221D
(Assistance with cardiac output using impeller pump, continuous). The
requestor stated that its analysis found that if procedures involving
intraoperative placement of a short-term external heart assist device
were moved into MS-DRGs 216, 217 and 218, it would result in an
increase in the average costs and average lengths of stay for the cases
that would remain to be assigned to MS-DRG 215.
During our review of this issue, we noted that when a patient is
admitted and has an Impella[supreg] external heart assist device
inserted two ICD-10-PCS codes are assigned: A code that describes the
insertion of the device and code 5A0221D that describes assistance with
an impeller pump. Therefore, our analysis included procedure code
02HA3RJ as identified by the requestor as well as similar procedure
codes 02HA0RJ (Insertion of short-term external heart assist system
into heart, intraoperative, open approach) and 02HA4RJ (Insertion of
short-term external heart assist system into heart, intraoperative,
percutaneous endoscopic approach) that also describe the intraoperative
insertion of a short-term heart assist device, differing only in
approach. Because the assistance with an Impella[supreg] is coded with
ICD-10-PCS code 5A0221D whether the device is used only
intraoperatively or in instances where the device is left in place at
the conclusion of the procedure, we did not include this code in our
analysis. We also note that the requestor suggested that the cases
reporting a procedure code describing
[[Page 25108]]
the intraoperative insertion of a short-term external heart assist
device be moved to MS-DRGs 216, 217 and 218 but these MS-DRGs are
defined by the performance of cardiac catheterization. Therefore, we
expanded our analysis to also include MS-DRGs 219, 220 and 221 (Cardiac
Valve and Other Major Cardiothoracic Procedures without Cardiac
Catheterization with MCC, with CC, and without CC/MCC, respectively).
First, we examined claims data from the March 2020 update of the FY
2019 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS
codes 02HA0RJ, 02HA3RJ or 02HA4RJ and a procedure code describing the
performance of a cardiac catheterization. Our findings are shown in the
following table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.018
As shown in the table, we identified a total of 7,741 cases within
MS-DRG 215 with an average length of stay of 7.8 days and average costs
of $68,234. Of these 7,741 cases, there are 2,943 cases that include
both a procedure code describing the intraoperative insertion of a
short-term external heart assist device and a procedure code describing
the performance of a cardiac catheterization with an average length of
stay of 7.1 days and average costs of $60,449. Of these 2,943 cases,
there are 23 cases reporting a procedure code describing the open
intraoperative insertion of a short-term external heart assist device
with a procedure code describing the performance of a cardiac
catheterization with an average length of stay of 8.9 days and average
costs of $85,806. There are 2,904 cases reporting a procedure code
describing a percutaneous intraoperative insertion of a short-term
external heart assist device with a procedure code describing the
performance of a cardiac catheterization with an average length of stay
of 7.1 days and average costs of $60,227. There are 16 cases reporting
a procedure code describing a percutaneous endoscopic intraoperative
insertion of a short-term external heart assist device with a procedure
code describing the performance of a cardiac catheterization approach
with an average length of stay of 6.4 days and average costs of
$64,217. The data analysis shows that for the cases in MS-DRG 215
reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure
code describing the performance of a cardiac catheterization,
generally, the average length of stay is shorter and the average costs
are lower than the average length of stay and average costs (with the
exception of the average costs and length of stay for the 23 cases
reporting a procedure code describing the open intraoperative insertion
of a short-term external heart assist device with a procedure code
describing the performance of a cardiac catheterization which are
higher) compared to all cases in that MS-DRG.
We also examined claims data from the March 2020 update of the FY
2019 MedPAR file for MS-DRGs 216, 217 and 218. Our findings are shown
in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.019
Because MS-DRG 215 is a base DRG and there is a three-way split
within MS-DRGs 216, 217, and 218, we also analyzed the cases reporting
a procedure code describing the intraoperative insertion of a short-
term external heart assist device with a procedure code describing the
performance of a cardiac catheterization for the presence or absence of
a secondary diagnosis designated as a complication or comorbidity (CC)
or a major complication or comorbidity (MCC).
[[Page 25109]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.020
This data analysis shows the cases in MS-DRG 215 reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing
the performance of a cardiac catheterization when distributed based on
the presence or absence of a secondary diagnosis designated as a
complication or comorbidity (CC) or a major complication or comorbidity
(MCC) have average costs generally more similar to the average costs in
the FY 2019 MedPAR file for MS-DRGs 216, 217 and 218 respectively,
while the average lengths of stay are shorter. While the cases from MS-
DRG 215 reporting a procedure code describing the intraoperative
insertion of a short-term external heart assist device with a procedure
code describing the performance of a cardiac catheterization ``with
CC'' and ``without CC/MCC'' have higher average costs than the average
costs of MS-DRGs 217 and 218, these costs are closer to the average
costs of those MS-DRGs than they are to the average costs of MS-DRG
215. The average costs of the cases from MS-DRG 215 reporting a
procedure code describing the intraoperative insertion of a short-term
external heart assist device with a procedure code describing the
performance of a cardiac catheterization ``with MCC'' are lower than
the average costs of both MS-DRGs 215 and 216.
Next, we examined claims data from the March 2020 update of the FY
2019 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS
codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code describing
the performance of a cardiac catheterization. Our findings are shown in
the following table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.021
As shown in the table, of the 7,741 cases within MS-DRG 215, there
are 432 cases that include a procedure code describing the
intraoperative insertion of a short-term external heart assist device
without a procedure code describing the performance of a cardiac
catheterization with an average length of stay of 4.8 days and average
costs of $53,607. Of these 432 cases, there are eight cases reporting a
procedure code describing the open intraoperative insertion of a short-
term external heart assist device without a procedure code describing
the performance of a cardiac catheterization with an average length of
stay of 8.8 days and average costs of $141,242. There are 423 cases
reporting a procedure code describing a percutaneous intraoperative
insertion of a short-term external heart assist device without a
procedure code describing the performance of a cardiac catheterization
with an average length of stay of 4.7 days and average costs of
$51,964. There is one case reporting a procedure code describing a
percutaneous endoscopic intraoperative insertion of a short-term
external heart assist device without a procedure code describing the
performance of a cardiac catheterization approach with a length of stay
of 2 days and costs of $47,289. The data analysis shows that for the
cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or
02HA4RJ without a
[[Page 25110]]
procedure code describing the performance of a cardiac catheterization,
generally, the average length of stay is shorter and the average costs
are lower than the average length of stay and average costs (with the
exception of the average costs and length of stay for the eight cases
describing the open intraoperative insertion of a short-term external
heart assist device without a procedure code describing the performance
of a cardiac catheterization which are higher) compared to all cases in
that MS-DRG.
We also examined claims data from the March 2020 update of the FY
2019 MedPAR file for MS-DRGs 219, 220 and 221. Our findings are shown
in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.022
Similarly, because MS-DRG 215 is a base DRG and there is a three-
way split within MS-DRGs 219, 220 and 221, we also analyzed the cases
reporting a procedure code describing the intraoperative insertion of a
short-term external heart assist device without a procedure code
describing the performance of a cardiac catheterization for the
presence or absence of a secondary diagnosis designated as a
complication or comorbidity (CC) or a major complication or comorbidity
(MCC).
[GRAPHIC] [TIFF OMITTED] TP10MY21.023
This data analysis shows the cases in MS-DRG 215 reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code
describing the performance of a cardiac catheterization when
distributed based on the presence or absence of a secondary diagnosis
designated as a complication or comorbidity (CC) or a major
complication or comorbidity (MCC) have average costs generally more
similar to the average costs in the FY 2019 MedPAR file for MS-DRGs
219, 220 and 221 respectively, while the average lengths of stay are
shorter. While the cases from MS-DRG 215 reporting a procedure code
describing the intraoperative insertion of a short-term external heart
assist device, without a procedure code describing the performance of a
cardiac catheterization ``with MCC'', ``with CC'' and ``without CC/
MCC'' have higher average costs than the average costs MS-DRGs 219, 220
and 221, respectively, these costs are closer to the average costs of
those MS-DRGs than they are to the average costs of MS-DRG 215.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing
the performance of a cardiac catheterization. Our findings are shown in
the following table:
[[Page 25111]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.024
As shown in the table, we identified a total of 6,275 cases within
MS-DRG 215 with an average length of stay of 7.9 days and average costs
of $72,144. Of these 6,275 cases, there are 2,395 cases that include
both a procedure code describing the intraoperative insertion of a
short-term external heart assist device and a procedure code describing
the performance of a cardiac catheterization with an average length of
stay of 6.8 days and average costs of $62,260. Of these 2,395 cases,
there were 25 cases reporting a procedure code describing the open
intraoperative insertion of a short-term external heart assist device
with a procedure code describing the performance of a cardiac
catheterization with an average length of stay of 8.2 days and average
costs of $85,954. There are 2,360 cases reporting a procedure code
describing a percutaneous intraoperative insertion of a short-term
external heart assist device with a procedure code describing the
performance of a cardiac catheterization with an average length of stay
of 6.8 days and average costs of $61,965. There are 10 cases reporting
a procedure code describing a percutaneous endoscopic intraoperative
insertion of a short-term external heart assist device with a procedure
code describing the performance of a cardiac catheterization approach
with an average length of stay of 6.9 days and average costs of
$72,564. The data analysis shows that for the cases in MS-DRG 215
reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure
code describing the performance of a cardiac catheterization, when
examined collectively, the average length of stay is shorter (6.8 days
versus 7.9 days) and the average costs are lower ($62,260 versus
$72,144) than the average length of stay and average costs (of all
cases in that MS-DRG). There were some differences noted in cases
reporting a procedure code describing the intraoperative insertion of a
short-term external heart assist device with a procedure code
describing the performance of a cardiac catheterization when examined
by operative approach. For the 25 cases reporting a procedure code
describing the open intraoperative insertion of a short-term external
heart assist device with a procedure code describing the performance of
a cardiac catheterization, the average costs were higher ($85,954
versus $72,144) and average length of stay was slightly longer (8.2
days versus 7.9 days) when compared to all cases in that MS-DRG. For
the 10 cases reporting a procedure code describing the percutaneous
endoscopic intraoperative insertion of a short-term external heart
assist device with a procedure code describing the performance of a
cardiac catheterization, the average costs were nearly equal ($72,564
versus $72,144) and average length of stay was shorter (6.9 days versus
7.9 days) when compared to all cases in that MS-DRG.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for MS-DRGs 216, 217 and 218. Our findings are
shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.025
Because MS-DRG 215 is a base DRG and there is a three-way split
within MS-DRGs 216, 217, and 218, we also analyzed the cases reporting
a procedure code describing the intraoperative insertion of a short-
term external heart assist device with a procedure code describing the
performance of a cardiac catheterization for the presence or absence of
a secondary diagnosis designated as a complication or comorbidity (CC)
or a major complication or comorbidity (MCC).
[[Page 25112]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.026
This data analysis shows the cases in MS-DRG 215 reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing
the performance of a cardiac catheterization when distributed based on
the presence or absence of a secondary diagnosis designated as a
complication or comorbidity (CC) or a major complication or comorbidity
(MCC) have average costs generally more similar to the average costs in
the FY 2020 MedPAR file for MS-DRGs 216, 217 and 218 respectively,
while the average lengths of stay are shorter. While the cases from MS-
DRG 215 reporting a procedure code describing the intraoperative
insertion of a short-term external heart assist device with a procedure
code describing the performance of a cardiac catheterization ``with
CC'' and ``without CC/MCC'' have higher average costs than the average
costs of MS-DRGs 217 and 218, these costs are closer to the average
costs of those MS-DRGs than they are to the average costs of MS-DRG
215. The average costs of the cases from MS-DRG 215 reporting a
procedure code describing the intraoperative insertion of a short-term
external heart assist device with a procedure code describing the
performance of a cardiac catheterization ``with MCC'' are lower than
the average costs of both MS-DRGs 215 and 216.
Next, we examined claims data from the September 2020 update of the
FY 2020 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code
describing the performance of a cardiac catheterization. Our findings
are shown in the following table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.027
As shown in the table, of the 6,275 cases within MS-DRG 215, there
are 331 cases that include a procedure code describing the
intraoperative insertion of a short-term external heart assist device
without a procedure code describing the performance of a cardiac
catheterization with an average length of stay of 4.5 days and average
costs of $52,181. Of these 331 cases, there are eight cases reporting a
procedure code describing the open intraoperative insertion of a short-
term external heart assist device without a procedure code describing
the performance of a cardiac catheterization with an average length of
stay of 8.9 days and average costs of $80,314. There are 332 cases
reporting a procedure code describing a percutaneous intraoperative
insertion of a short-term external heart assist device without a
procedure code describing the performance of a cardiac catheterization
with an average length of stay of 4.4 days and average costs of
$51,569. There is one case reporting a procedure code describing a
percutaneous endoscopic intraoperative insertion of a short-term
external heart assist device without a procedure code describing the
performance of a cardiac catheterization approach with a length of stay
of 2 days and costs of $24,379. The data analysis shows that for the
cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or
02HA4RJ without a
[[Page 25113]]
procedure code describing the performance of a cardiac catheterization,
generally, the average length of stay is shorter and the average costs
are lower than the average length of stay and average costs (with the
exception of the average costs and length of stay for the eight cases
reporting a procedure code describing the open intraoperative insertion
of a short-term external heart assist device without a procedure code
describing the performance of a cardiac catheterization which are
higher) compared to all cases in that MS-DRG.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for MS-DRGs 219, 220 and 221. Our findings are
shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.028
Similarly, because MS-DRG 215 is a base DRG and there is a three-
way split within MS-DRGs 219, 220 and 221, we also analyzed the 331
cases reporting a procedure code describing the intraoperative
insertion of a short-term external heart assist device without a
procedure code describing the performance of a cardiac catheterization
for the presence or absence of a secondary diagnosis designated as a
complication or comorbidity (CC) or a major complication or comorbidity
(MCC).
[GRAPHIC] [TIFF OMITTED] TP10MY21.029
This data analysis shows the cases in MS-DRG 215 reporting ICD-10-
PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code
describing the performance of a cardiac catheterization when
distributed based on the presence or absence of a secondary diagnosis
designated as a complication or comorbidity (CC) or a major
complication or comorbidity (MCC) have average costs generally more
similar to the average costs in the FY 2020 MedPAR file for MS-DRGs
219, 220 and 221 respectively, while the average lengths of stay are
shorter. While the cases from MS-DRG 215 reporting a procedure code
describing the intraoperative insertion of a short-term external heart
assist device without a procedure code describing the performance of a
cardiac catheterization ``with CC'' and ``without CC/MCC'' have higher
average costs than the average costs of MS-DRGs 220 and 221, these
costs are closer to the average costs of those MS-DRGs than they are to
the average costs of MS-DRG 215. The average costs of the cases from
MS-DRG 215 reporting a procedure code describing the intraoperative
insertion of a short-term external heart assist device without a
procedure code describing the performance of a cardiac catheterization
``with MCC'' are lower than the average costs of both MS-DRGs 215 and
219.
Our clinical advisors reviewed the clinical issues and the claims
data and agreed that cases reporting a procedure code that describes
the intraoperative insertion of a short-term external heart assist
device are generally less resource intensive and are clinically
distinct from other cases reporting procedure codes describing the
insertion of other types of heart assist devices currently assigned to
MS-DRG 215. Our clinical advisors state that critically ill patients
who are experiencing or at risk for cardiogenic shock from an emergent
event such as heart attack or virus that impacts the functioning of the
heart and requires longer heart pump support are different from those
patients who require intraoperative support only. Patients receiving a
short-term external heart assist device intraoperatively during
coronary interventions often have an underlying disease pathology such
as heart failure related to occluded coronary vessels that is broadly
similar in kind to other patients also receiving these interventions
without the need for an insertion of a short-term external heart assist
device. In the post-operative period, these patients can recover and
can be sufficiently rehabilitated prior to discharge. For these
reasons, our clinical advisors support reassigning
[[Page 25114]]
ICD-10-PCS codes 02HA0RJ, 02HA3RJ, and 02HA4RJ that describe the
intraoperative insertion of a short-term external heart assist device
to MS-DRGs 216, 217, 218, 219, 220 and 221 in MDC 05. They stated this
reassignment would improve clinical coherence in these MS-DRGs.
To compare and analyze the impact of our suggested modifications,
we ran a simulation using the Version 38.1 ICD-10 MS-DRG GROUPER and
the claims data from the March 2020 update of the FY 2019 MedPAR file.
The following table reflects our simulation for ICD-10-PCS procedure
codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the intraoperative
insertion of a short-term external heart assist device if they were
moved to MS-DRGS 216, 217, 218, 219, 220 and 221.
[GRAPHIC] [TIFF OMITTED] TP10MY21.030
We believe the resulting proposed MS-DRG assignments would be more
clinically homogeneous, coherent and better reflect hospital resource
use while at the same time addressing concerns related to the relative
weight of MS-DRG 215. A review of this simulation shows that this
distribution of ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ that
describe the intraoperative insertion of a short-term external heart
assist device if moved to MS-DRGs 216, 217, 218, 219, 220 and 221,
increases the average costs of the cases remaining in MS-DRG 215 by
over $4,500, while generally having a more limited effect on the
average costs of MS-DRGs 216, 217, 218, 219, 220 and 221.
We also ran a simulation using the Version 38.1 ICD-10 MS-DRG
GROUPER and the claims data from the September 2020 update of the FY
2020 MedPAR file. The following table reflects our simulation for ICD-
10-PCS procedure codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the
intraoperative insertion of a short-term external heart assist device
if they were moved to MS-DRGS 216, 217, 218, 219, 220 and 221.
[[Page 25115]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.031
As with our simulation based on the March 2020 update of the FY
2019 MedPAR file, we believe that this simulation supports that the
resulting proposed MS-DRG assignments would be more clinically
homogeneous, coherent and better reflect hospital resource use while at
the same time addressing concerns related to the relative weight of MS-
DRG 215. A review of this simulation shows that this distribution of
ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the
intraoperative insertion of a short-term external heart assist device
if moved to MS-DRGs 216, 217, 218, 219, 220 and 221, increases the
average costs of the cases remaining in MS-DRG 215 by over $6,000,
while generally having a more limited effect on the average costs of
MS-DRGS 216, 217, 218, 219, 220 and 221.
Therefore, for FY 2022, we are proposing to reassign ICD-10-PCS
codes 02HA0RJ, 02HA3RJ, and 02HA4RJ from MDC 05 in MS-DRG 215 to MS-
DRGs 216, 217, 218, 219, 220 and 221 in MDC 05.
b. Type II Myocardial Infarction
We received a request to review the MS-DRG assignment of ICD-10-CM
diagnosis code I21.A1 (Myocardial infarction type 2). The requestor
stated that when a type 2 myocardial infarction is documented, per
coding guidelines, it is to be coded as a secondary diagnosis since it
is due to an underlying cause. This requestor also noted that when a
type 2 myocardial infarction is coded with a principal diagnosis in MDC
05 (Diseases and Disorders of the Circulatory System), the GROUPER
logic assigns MS-DRGs 280 through 282 (Acute Myocardial Infarction,
Discharged Alive with MCC, with CC, and without CC/MCC, respectively).
The requestor questioned if this GROUPER logic was correct or if the
logic should be changed so that a type 2 myocardial infarction, coded
as a secondary diagnosis, does not result in the assignment of a MS-DRG
that describes an acute myocardial infarction.
To begin our analysis, we reviewed the GROUPER logic. The requestor
is correct that when diagnosis code I21.A1 is reported as a secondary
diagnosis in combination with a principal diagnosis in MDC 05, the case
currently groups to medical MS-DRGs 280 through 282 in the absence of a
surgical procedure, when the patient is discharged alive. We note that
if the patient expires, GROUPER logic instead will assign MS-DRGs 283
through 285 (Acute Myocardial Infarction, Expired with MCC, with CC,
and without CC/MCC, respectively) when diagnosis code I21.A1 is
reported as a secondary diagnosis in combination with a principal
diagnosis in MDC 05.
According to the Universal Definition of Myocardial Infarction
(MI), developed by a global task force that included the European
Society of Cardiology, the American College of Cardiology, the American
Heart Association and the World Heart Federation (WHF), the diagnosis
of MI requires the rise and/or fall of cardiac biomarkers with clinical
evidence of ischemia in which there is evidence of myocardial injury or
necrosis, defined by symptoms, electrocardiographic (ECG) changes, or
new regional wall motion abnormalities. Since 2007, this definition
further classifies myocardial infarctions into five distinct subtypes.
While a type 1 MI is defined as a MI due to an acute coronary syndrome,
type 2 MI is defined as a mismatch in myocardial oxygen supply and
demand due to other causes such as coronary dissection, vasospasm,
emboli, or hypotension that is not attributed to unstable coronary
artery disease (CAD).
Our clinical advisors reviewed this issue and do not recommend
changing the current MS-DRG assignment of ICD-10-CM diagnosis code
I21.A1. As noted by the requestor, the ICD-10-CM Official Guidelines
for Coding and Reporting state ``Type 2 myocardial infarction,
(myocardial infarction due to demand ischemia or secondary to ischemic
imbalance) is assigned to code I21.A1, Myocardial infarction type 2
with a code for the underlying cause coded first.'' Our clinical
advisors believe that cases reporting diagnosis code I21.A1 as a
secondary diagnosis are associated with a severity of illness on par
with cases reporting a principal diagnosis of another type myocardial
infarction. They state the diagnosis of myocardial infarction describes
myocardial cell death due to inadequate
[[Page 25116]]
oxygen supply to the myocardium for a prolonged period, regardless of
the subtype. Our clinical advisors state, for clinical consistency, it
is more appropriate to maintain the current assignment of ICD-10-CM
diagnosis code I21.A1 with the other codes that describe myocardial
infarction. Therefore, we are not proposing to reassign diagnosis code
I21.A1 from MS-DRGs 280 through 285.
During our review of this issue we noted that code I21.A1
(Myocardial infarction type 2) is currently one of the listed principal
diagnoses in the GROUPER logic for MS-DRGs 222 and 223 (Cardiac
Defibrillator Implant with Cardiac Catheterization with AMI, HF or
Shock with and without MCC, respectively). However, code I21.A1 is not
currently recognized in these same MS-DRGs when coded as a secondary
diagnosis. As a result, when coded as a secondary diagnosis in
combination with a principal diagnosis in MDC 05, MS-DRGs 224 and 225
(Cardiac Defibrillator Implant with Cardiac Catheterization without
AMI, HF, or Shock with and without MCC, respectively) are instead
assigned when reported with a listed procedure code. We refer the
reader to the ICD-10 MS-DRG Definitions Manual Version 38.1, 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 222, 223, 224, and 225.
Acknowledging that coding guidelines instruct to code I21.A1 after
the diagnosis code that describes the underlying cause, our clinical
advisors recommend adding special logic in MS-DRGs 222 and 223 to have
code I21.A1 also qualify when coded as a secondary diagnosis in
combination with a principal diagnosis in MDC 05 since these diagnosis
code combinations also describe acute myocardial infarctions.
As a result, we are proposing modifications to the GROUPER logic to
allow cases reporting diagnosis code I21.A1 (Myocardial infarction type
2) as a secondary diagnosis to group to MS-DRGs 222 and 223 when
reported with a listed procedure code for clinical consistency with the
other MS-DRGs describing acute myocardial infarction.
A diagnosis code may define the logic for a specific MS-DRG
assignment in three different ways. The diagnosis code 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 in
this proposed rule.
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.
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, we propose that code I21.A1, as a secondary diagnosis, be
used in the definition of the logic for assignment to MS-DRGs 222 and
223, similar to the example described previously, where a secondary
diagnosis of acute leukemia with chemotherapy is used to define MS-DRG
839, and therefore will not act as a MCC in these MS-DRGs.
In summary, for FY 2022, we are proposing to maintain the current
structure of MS-DRGs 280 through 285. We are also proposing to modify
the GROUPER logic to allow cases reporting diagnosis code I21.A1
(Myocardial infarction type 2) as a secondary diagnosis to group to MS-
DRGs 222 and 223 when reported with qualifying procedures.
c. Viral Cardiomyopathy
We received three separate but related requests to add ICD-10-CM
diagnosis code B33.24 (Viral cardiomyopathy) to the list of principal
diagnoses for MS-DRGs 314, 315, and 316 (Other Circulatory System
Diagnoses with MCC, with CC, and without CC/MCC, respectively) in MDC
05. The requestors noted that a discontinuity exists in the current MDC
assignment of diagnosis codes in ICD-10-CM subcategory B33.2. The list
of the five ICD-10-CM diagnosis codes in subcategory B33.2, as well as
their current MDC assignments, is found in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.369
A requestor noted ICD-10-CM codes B33.20, B33.21, B33.22, and
B33.23 are assigned to MDC 05 (Diseases and Disorders of the
Circulatory System), while code B33.24 is assigned to MDC 18
(Infectious and Parasitic Diseases, Systemic or Unspecified Sites). The
requestor stated that the placement of ICD-10-CM diagnosis code B33.24
within subcategory B33.2 is clinically appropriate, as all the
diagnoses within this subcategory share a common etiology, involve the
heart and supporting structures, and require the same intensity of
hospital care. However, the assignment of code B33.24 to a different
MDC is clinically incongruous with the placement of the other codes in
the subcategory. According to the requestor, all of the conditions
share similar etiology, anatomic location, and needs for care,
therefore the five codes should all be assigned to MDC 05. This
requestor also stated that reassigning code B33.24 to MDC 05 would
ensure both clinical continuity and coding consistency within the B33.2
subcategory. Another requestor stated MDC 05 surgical MS-DRGs should be
assigned when
[[Page 25117]]
procedures such as cardiac catheterization or coronary angioplasty are
performed for a principal diagnosis of viral cardiomyopathy.
To begin our analysis, we reviewed the GROUPER logic. Currently,
cases reporting ICD-10-CM diagnosis code B33.24 as a principal
diagnosis group to medical MS-DRGs 865 and 866 (Viral Illness with and
without MCC, respectively) in MDC 18 in the absence of a surgical
procedure. Our clinical advisors reviewed this issue and noted viral
cardiac infections may present as endocarditis (inflammation of the
heart's inner lining), myocarditis (inflammation of the middle layer of
the heart), pericarditis (inflammation of the pericardium), or
cardiomyopathy (disease of the heart muscle). The infection usually
begins somewhere other than the heart, often in the nose, lungs, or
stomach. As the infection progresses, and the microbe multiplies and
gets into the bloodstream, it can infiltrate the heart muscle. The
growth and replication of viruses inside the heart can endanger the
heart by destroying heart cells. The management of viral cardiomyopathy
is similar to the management of other viral cardiac infections and can
include bed rest, control of pain with non-steroidal anti-inflammatory
agents and anti-microbial therapy to avoid permanent myocardial damage,
cardiomegaly, and/or congestive cardiac failure.
Our clinical advisors agree that the diagnosis of viral
cardiomyopathy is clinically related to the other diagnoses in ICD-10-
CM subcategory B33.2. They believe it is clinically appropriate for all
five diagnoses in subcategory B33.2 to group to MDC 05 (Diseases and
Disorders of the Circulatory System) as these conditions describe
circulatory system conditions and complications and that this
modification will improve clinical coherence. Therefore, we are
proposing to reassign ICD-10-CM diagnosis code B33.24 from MDC 18 in MS
DRGs 865 and 866 (Viral Illness with and without MCC, respectively) to
MDC 05 in MS DRGs 314, 315, and 316 (Other Circulatory System Diagnoses
with MCC, with CC, and without CC/MCC, respectively). Under this
proposal, cases reporting procedure codes from MDC 05 in conjunction
with principal diagnosis B33.24, would group to MS-DRGs in MDC 05.
d. Left Atrial Appendage Closure (LAAC)
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58471 through
58477), we identified nine ICD-10-PCS procedure codes that describe
Left Atrial Appendage Closure (LAAC) procedures and noted their
corresponding MS-DRG assignments in the ICD-10 MS-DRGs Version 37 as
listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.032
As discussed in the FY 2021 IPPS/LTCH PPS final 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 (Percutaneous Cardiovascular Procedures without Coronary
Artery Stent with and without MCC, respectively). Our analysis showed
that the cases reporting a LAAC procedure with an open approach in MS-
DRGs 250 and 251 had higher average costs and longer average length of
stay compared to all cases in MS-DRGs 250 and 251. We also stated our
clinical advisors believed that ICD-10-PCS codes 02L70CK, 02L70DK, and
02L70ZK that describe a LAAC procedure with an open approach were more
suitably grouped to MS-DRGs 273 and 274 (Percutaneous Intracardiac
Procedures with and without MCC, respectfully). Therefore, we finalized
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. We also
finalized 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.
In response to this final policy, for this FY 2022 IPPS/LTCH PPS
proposed rule, we received a request to again review the MS-DRG
assignment of cases involving LAAC procedures with an open approach.
The requestor disagreed with CMS's FY 2021 IPPS/LTCH PPS final rule
decision to move the three procedure codes describing the open
occlusion of left atrial appendage to MS-DRGs 273 and 274 (Percutaneous
and Other Intracardiac Procedures with and without MCC, respectively).
The requestor stated they believe that MS-DRGs 228 and 229 (Other
Cardiothoracic Procedures with and without MCC, respectively), would
more appropriately correspond with the open procedural resources and
longer length of stay expected with open heart procedures.
Our clinical advisors reviewed this request and continue to support
the reassignment of ICD-10-PCS procedure
[[Page 25118]]
codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250 and 251 to MS-DRGs
273 and 274 because it allows all LAAC procedures to be grouped
together under the same MS-DRGs and improves clinical coherence. Our
clinical advisors state open LAAC procedures are primarily performed in
the absence of another O.R. procedure and generally are not performed
with a more intensive open chest procedure. When performed as
standalone procedures, open LAAC procedures share similar factors such
as complexity and resource utilization with all other LAAC procedures.
Our clinical advisors continue to state our FY 2021 final policy
results in MS-DRG assignments that are more clinically homogeneous and
better reflect hospital resource use. Therefore, we are proposing to
maintain the assignment of codes 02L70CK, 02L70DK, and 02L70ZK that
describe the open occlusion of the left atrial appendage in MS-DRGs 273
and 274.
e. Surgical Ablation
We received a two-part request to review the MS-DRG assignments for
cases involving the surgical ablation procedure for atrial
fibrillation. Atrial fibrillation (AF) is an irregular and often rapid
heart rate that occurs when the two upper chambers of the heart
experience chaotic electrical signals. AF presents as either paroxysmal
(lasting 7 days, but less than 1 year),
or long standing persistent (chronic) (lasting >1 year) based on time
duration and can increase the risk for stroke, heart failure, and
mortality. Management of AF has two primary goals: Optimizing cardiac
output through rhythm or rate control, and decreasing the risk of
cerebral and systemic thromboembolism. Patients that worsen in
symptomology or fail to respond to pharmacological treatment or other
interventions may be referred for surgical ablation to treat their AF.
Surgical ablation is a procedure that works by burning or freezing
tissue on the inside of the heart to disrupt faulty electrical signals
causing the arrhythmia, which can help the heart maintain a normal
heart rhythm.
The first part of this request was to create a new classification
of surgical ablation MS-DRGs to better accommodate the costs of open
concomitant surgical ablations. According to the requestor, patients
undergoing surgical ablation are treated under two potential scenarios:
(1) Open concomitant (combination) surgical ablation, meaning open
surgical ablation performed during another open-heart surgical
procedure such as mitral valve repair or replacement (MVR), aortic
valve repair or replacement (AVR), or coronary artery bypass grafting
(CABG) and (2) minimally invasive, percutaneous endoscopic, standalone
surgical ablation as the sole therapeutic procedure performed.
According to the requestor, open concomitant surgical ablation is an
efficient procedure, as it allows treatment of AF and another clinical
pathology in one procedure thereby decreasing the risk of future
readmits, need for future repeat catheter ablation procedures, and
patient mortality.
The requestor identified the following potential procedure
combinations that would comprise an ``open concomitant surgical
ablation'' procedure.
Open CABG + open surgical ablation
Open MVR + open surgical ablation
Open AVR + open surgical ablation
Open MVR + open AVR + open surgical ablation
Open MVR + open CABG + open surgical ablation
Open MVR + open AVR + open CABG + open surgical ablation
Open AVR + open CABG + open surgical ablation
The requestor performed its own analysis of these procedure code
combinations and stated that it found the average costs for open
concomitant surgical ablation procedures were consistently higher
compared to the average costs within their respective MS-DRGs, which
could limit beneficiary access to these procedures.
The requestor suggested that the following four MS-DRGs be created
to address the differences in average costs and average lengths of stay
it found in its data analysis:
Suggested New MS-DRG XXX--Open Surgical Ablation with or
without Other Cardiothoracic Procedure with Cardiac Catheterization
with MCC;
Suggested New MS-DRG XXX--Open Surgical Ablation with or
without Other Cardiothoracic Procedure with Cardiac Catheterization
without MCC;
Suggested New MS-DRG XXX--Open Surgical Ablation with or
without Other Cardiothoracic Procedure without Cardiac Catheterization
with MCC; and
Suggested New MS-DRG XXX--Open Surgical Ablation with or
without Other Cardiothoracic Procedure without Cardiac Catheterization
without MCC.
In reviewing this request, we identified nine ICD-10-PCS codes that
describe open surgical ablation. These codes and their corresponding
MDC and MS-DRG assignments are listed in the following table.
[[Page 25119]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.033
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, for open
concomitant surgical ablation procedures, the GROUPER logic assigns MS-
DRGs 228 and 229 (Other Cardiothoracic Procedures with and without MCC,
respectively) in most instances because MS-DRGs 228 and 229 are high in
the surgical hierarchy GROUPER logic of MDC 05 (Diseases and Disorders
of the Circulatory System). Since patients can have multiple procedures
reported with a principal diagnosis during a particular hospital stay,
and a patient can be assigned to only one MS-DRG, the surgical
hierarchy GROUPER logic provides a hierarchical order of surgical
classes from the most resource-intensive to the least resource-
intensive. Patients with multiple procedures are generally assigned to
the MS-DRG that correlates to the most resource-intensive surgical
class.
Our clinical advisors reviewed this grouping issue and noted in
open concomitant surgical ablation procedures, the CABG, MVR, and/or
AVR components of the procedure are more technically complex than the
open surgical ablation procedure. Our clinical advisors stated that in
open concomitant surgical ablation procedures, the MS-DRG assigned
should be based on the most resource-intensive procedure performed.
Therefore, we believe this request would be better addressed by
proposing to revise the surgical hierarchy in MDC 05 rather than
creating four new MS-DRGs. For FY 2022, we are proposing to revise the
surgical hierarchy for the MS-DRGs in MDC 05 to sequence MS-DRGs 231-
236 (Coronary Bypass) above MS-DRGs 228 and 229 to enable more
appropriate MS-DRG assignment for these types of cases. Under this
proposal, if a procedure code describing a CABG and a procedure code
describing an open surgical ablation are present, the GROUPER logic
would assign the CABG surgical class because a CABG would be sequenced
higher in the hierarchy than an open surgical ablation. We refer the
reader to section II.D.15. of the preamble of this proposed rule for
the discussion of the surgical hierarchy and the complete list of our
proposed modifications to the surgical hierarchy in MDC 05.
As mentioned earlier in this section, this request involved two
parts. The second part of the request was to reassign cases describing
standalone percutaneous endoscopic surgical ablation. According to the
requestor, standalone, percutaneous endoscopic surgical ablation is a
rapidly growing therapy, indicated for highly symptomatic patients that
have already failed medical management and/or percutaneous catheter
ablation procedures. The requestor identified nine ICD-10-PCS codes
that they stated describe percutaneous endoscopic surgical ablation.
These codes and their corresponding MDC and MS-DRG assignments are
listed in the following table.
[[Page 25120]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.034
The requestor performed its own analysis and stated that it found
the most common MS-DRG assignment for cases describing standalone
percutaneous endoscopic surgical ablation was MS-DRGs 228 and 229
(Other Cardiothoracic Procedures with and without MCC, respectively)
and that in those MS-DRGs, the standalone surgical ablation procedures
cost more than all the procedures in their currently assigned MS-DRGs
228 and 229. Therefore, the requestor recommended CMS reassign these
procedures to higher weighted MS-DRGs 219 and 220 (Cardiac Valve and
Other Major Cardiothoracic Procedures without Cardiac Catheterization
with MCC and with CC, respectively).
We examined claims data from the March 2020 update of the FY 2019
MedPAR file for all cases in MS-DRGs 228 and 229 and compared the
results to cases with a procedure code describing a standalone
percutaneous endoscopic surgical ablation procedure. Our findings are
shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.035
As shown in the table, the data analysis performed indicates that
the 99 cases in MS-DRG 228 reporting a procedure code that describes
percutaneous endoscopic surgical ablation have an average length of
stay that is shorter than the average length of stay for all the cases
in MS-DRG 228 (7.1 days versus 10.7 days) and higher average costs when
compared to all the cases in MS-DRG 228 ($48,281 versus $45,772). The
497 cases in MS-DRG 229 reporting a procedure code that describes
percutaneous endoscopic surgical ablation have an average length of
stay that is shorter than the average length of stay for all the cases
in MS-DRG 229 (3.7 days versus 5.8 days) and higher average costs when
compared to all the cases in MS-DRG 229 ($35,516 versus $29,454).
We then examined the claims data from the March 2020 update of the
FY 2019 MedPAR file to identify the average length of stay and average
costs for all cases in MS-DRGs 219 and 220. Our findings are shown in
the table.
[[Page 25121]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.036
As shown in the table, for MS-DRG 219, there were a total of 15,597
cases with an average length of stay of 10.9 days and average costs of
$57,845. For MS-DRG 220, there were a total of 15,074 cases with an
average length of stay of 6.5 days and average costs of $39,565.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for all cases in MS-DRGs 228 and 229 and compared
the results to cases with a procedure code describing a standalone
percutaneous endoscopic surgical ablation procedure. Our findings are
shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.037
As shown in the table, the data analysis performed indicates that
the 84 cases in MS-DRG 228 reporting a procedure code that describes
percutaneous endoscopic surgical ablation have an average length of
stay that is shorter than the average length of stay for all the cases
in MS-DRG 228 (6.9 days versus 10.2 days) and lower average costs when
compared to all the cases in MS-DRG 228 ($44,710 versus $46,508). The
393 cases in MS-DRG 229 reporting a procedure code that describes
percutaneous endoscopic surgical ablation have an average length of
stay that is shorter than the average length of stay for all the cases
in MS-DRG 229 (3.4 days versus 4.9 days) and higher average costs when
compared to all the cases in MS-DRG 229 ($34,237 versus $29,885).
We then examined the claims data from the September 2020 update of
the FY 2020 MedPAR file to identify the average length of stay and
average costs for all cases in MS-DRGs 219 and 220. Our findings are
shown in the table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.038
As shown in the table, for MS-DRG 219, there were a total of 11,863
cases with an average length of stay of 10.9 days and average costs of
$61,934. For MS-DRG 220, there were a total of 10,072 cases with an
average length of stay of 6.5 days and average costs of $41,800.
Our analysis indicates that MS-DRGs 219 and 220 generally have much
higher average costs and longer average lengths of stay than the cases
with a procedure code describing a standalone percutaneous endoscopic
surgical ablation procedure currently assigned to MS-DRGs 228 and 229.
Instead, the average costs and average length of stay for cases
reporting a standalone percutaneous endoscopic surgical ablation appear
to be generally more aligned with the average costs and average length
of stay for all cases in MS-DRGs 228 and 229, where they are currently
assigned. Our clinical advisors reviewed this issue and do not
recommend changing the assignment of procedure codes describing
percutaneous endoscopic surgical ablation. Therefore, for these
reasons, we are proposing to maintain the current structure of MS-DRGs
219 and 220.
f. Drug-Eluting Stents
We received a request to review the MS-DRG assignments of claims
involving the insertion of coronary stents in percutaneous coronary
interventions. The requestor suggested that CMS eliminate the
distinction between drug-eluting and bare-metal coronary stents in the
MS-DRG classification. According to the requestor, coated stents have a
clinical performance comparable to drug-eluting stents however they are
grouped with bare-metal stents because they do not contain a drug. The
requestor asserted that this comingling muddies the
[[Page 25122]]
clinical coherence of the MS-DRG structure, as one cannot infer
distinctions in clinical performance or benefits among the groups and
potentially creates a barrier (based on hospital decision-making) to
patient access to modern coated stents.
The requestor listed the following MS-DRGs in its request.
MS-DRG 246 (Percutaneous Cardiovascular Procedures with
Drug-Eluting Stent with MCC or 4+ Arteries or Stents);
MS-DRG 247 (Percutaneous Cardiovascular Procedures with
Drug-Eluting Stent without MCC);
MS-DRG 248 (Percutaneous Cardiovascular Procedures with
Non-Drug-Eluting Stent with MCC or 4+ Arteries or Stents); and
MS-DRG 249 (Percutaneous Cardiovascular Procedures with
Non-Drug-Eluting Stent without MCC).
According to the requestor, the non-drug-eluting stent MS-DRGs have
outlived their usefulness in the stent market. The requestor performed
its own analysis of MedPAR data from FY 2015 through FY 2019 and stated
that it found the volume of cases describing non-drug-eluting coronary
stents has declined since 2015, culminating in FY 2019, with drug-
eluting stents accounting for 96.1% of all stent cases within the
Medicare program, while non-drug-eluting stents accounted for only 3.9%
that year. The requestor asserted that the assignment of coated stents
to the non-drug-eluting stent category creates a market distortion as
this newer technology is being comingled with very old technology at a
payment disadvantage large enough to influence hospitals' willingness
to prescribe, while at the same time acknowledging that the separation
in average charges and costs between the non-drug-eluting stent
category and the drug-eluting stent category is minimal in their
analysis of the claims data.
Based on a review of the procedure codes that are currently
assigned to MS-DRGs 246, 247, 248 and 249, our clinical advisors agree
that further refinement of these MS-DRGs may be warranted. However, in
ICD-10-PCS, a stent is considered an intraluminal device. The
distinction between drug-eluting and non-drug eluting intraluminal
devices is found elsewhere in the ICD-10-PCS procedure code
classification and evaluating this request requires a more extensive
analysis to assess potential impacts across the MS-DRGs. For these
reasons, at this time, our clinical advisors recommend that rather than
evaluating the procedure codes assigned to MS-DRGs 246, 247, 248 and
249 in isolation, additional analysis should be performed for this
subset of procedure codes across the MS-DRGs, as part of the
comprehensive procedure code review described in section II.D.11. of
the preamble of this proposed rule. Therefore, we believe it would be
more appropriate to consider this request further during our
comprehensive procedure code review in future rulemaking.
6. MDC 08 (Diseases and Disorders of the Musculoskeletal System and
Connective Tissue)
a. Knee Joint Procedures
We received a request to examine the procedure code combinations
for procedures describing a right knee joint removal and replacement
and procedures describing a left knee joint removal and replacement in
MS-DRGs 466, 467, and 468 (Revision of Hip or Knee Replacement with
MCC, with CC, and without CC/MCC, respectively). According to the
requestor, when using the MS-DRG GROUPER software version 37, the left
knee joint procedure combinations group correctly to MS-DRG 468, while
the exact same right knee procedure code combinations group incorrectly
to MS-DRG 465 (Wound Debridement and Skin Graft Except Hand for
Musculoskeletal and Connective Tissue Disorders without CC/MCC).
The requestor provided the following procedure codes that describe
the procedure code combinations for the left knee joint removal and
replacement procedures currently assigned to MS-DRGs 466, 467, and 468.
[GRAPHIC] [TIFF OMITTED] TP10MY21.039
The requestor also provided the following procedure codes that
describe the procedure code combinations for right knee joint removal
and replacement procedures for CMS's review and consideration.
[[Page 25123]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.040
We reviewed the procedure code combinations listed and agree with
the requestor that the procedure codes that describe the procedure code
combinations for right knee joint removal and replacement procedures
were inadvertently excluded from the logic for MS-DRGs 466, 467, and
468.
During our review of the previously listed procedure code
combinations describing removal and replacement of the right and left
knee joints, we identified additional MS-DRGs in which the listed
procedure code combinations for the left knee joint are in the logic,
however, the listed procedure code combinations for the right knee
joint were inadvertently excluded from the logic. Specifically, the
listed procedure code combinations describing removal and replacement
of the left knee joint are also included in the logic for case
assignment to MS-DRGs 461 and 462 (Bilateral or Multiple Major Joint
Procedures of Lower Extremity with and without MCC, respectively) in
MDC 08 and in the logic for case assignment to 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). Our clinical
advisors stated that the procedure code combinations describing removal
and replacement of the right knee joint should be added to MS-DRGs 461,
462, 466, 467, and 468 in MDC 08 and MS-DRGs 628, 629, and 630 in MDC
10 for consistency with the procedure code combinations describing
removal and replacement of the left knee joint that are currently
assigned to those MS-DRGs. Adding these procedure codes will improve
clinical coherence and ensure more appropriate MS-DRG assignment for
these cases.
Therefore, for FY 2022, we are proposing to add the three procedure
code combinations listed previously describing removal and replacement
of the right knee joint that were inadvertently omitted from the logic
to MS-DRGs 461, 462, 466, 467, and 468 in MDC 08 and MS-DRGs 628, 629,
and 630 in MDC 10.
b. Pelvic Trauma With Internal Fixation
We received a request to reassign cases reporting a diagnosis code
describing a pelvic fracture in combination with a procedure code
describing repair of a pelvic fracture with internal fixation, from the
lower (NonCC) severity level MS-DRG of its current base MS-DRG
assignment to the higher (MCC) severity level MS-DRG of its current
base MS-DRG assignment. According to the requestor, there has been
steady growth in the volume of internal fixation procedures performed
for pelvic fractures since 2008. The requestor stated that due to this
growth rate and the anticipated increase in utilization of these
internal fixation devices in these procedures in the future that CMS
should reconsider the payment structure for these cases it referred to
as ``internal fixation for pelvic trauma''.
The requestor provided data for the Healthcare Common Procedural
Coding System (HCPCS) code G0413 (Percutaneous skeletal fixation of
posterior pelvic bone fracture and/or dislocation, for fracture
patterns which disrupt the pelvic ring, unilateral or bilateral,
(includes ileum, sacroiliac joint and/or sacrum) and current procedural
terminology (CPT) code 22848 (Pelvic fixation (attachment of caudal end
of instrumentation to pelvic bony structures) other than sacrum) from
2008 through 2018 that it crosswalked to ICD-10-PCS procedure codes.
The requestor stated that this CPT coded data indicated that physicians
have used pelvic fracture fixation, and pelvic instrumentation, for an
increasing number of trauma/fracture repair cases, demonstrating
expanded use of these devices in the pelvic area overall.
The requestor reported that sacral fractures are often
underdiagnosed and once the diagnosis is made, bedrest is common,
although prolonged bedrest is not recommended for the elderly. In
addition, the requestor stated that pelvic fractures may be isolated or
they may be associated with surrounding structures. For example, the
requester reported that the sacroiliac joint is involved in
approximately 30 to 35% of pelvic fracture cases. According to the
requestor, the standard of care has also transitioned, from bedrest-
only to surgery, and current medical practice has evolved to lower the
threshold for fracture repair surgery. For instance, the requestor
stated that smaller 5mm
[[Page 25124]]
fractures that were once left untreated now have standard treatment
protocols involving the use of pelvic instrumentation. As a result, the
requestor asserted that there will be greater utilization of internal
fixation devices to treat these smaller pelvic fractures.
The requestor provided the following procedure codes that it stated
describe procedures involving the use of internal fixation devices for
pelvic fracture repair.
[GRAPHIC] [TIFF OMITTED] TP10MY21.041
The requestor also provided the following diagnosis code
subcategories that it stated identify diagnoses describing pelvic
fracture.
[GRAPHIC] [TIFF OMITTED] TP10MY21.042
The requestor performed its own analysis of claims data and
reported findings for cases reporting a combination of the diagnosis
codes found in the listed diagnosis code subcategories and the listed
procedure codes (internal fixation for pelvic trauma) for MS-DRGs 515,
516, and 517 (Other Musculoskeletal System and Connective Tissue O.R.
Procedures with MCC, with CC, and without CC/MCC, respectively); MS-
DRGs 907, 908, and 909 (Other O.R. Procedures for Injuries with MCC,
with CC, and without CC/MCC, respectively); and MS-DRGs 957, 958, and
959 (Other O.R. Procedures for Multiple Significant Trauma with MCC,
with CC, and without CC/MCC, respectively). According to the requestor,
its findings support reassignment of these internal fixation for pelvic
trauma cases from the lower severity level MS-DRG 517 to the higher
severity level MS-DRG 515, from the lower severity level MS-DRG 909 to
the higher severity level 907, and from the lower severity level MS-DRG
959 to the higher severity level 957. The requestor suggested that
approximately 2,000 cases would be impacted by its recommendation to
reassign internal fixation for pelvic trauma cases. The requestor also
stated that these internal fixation for pelvic trauma cases currently
result in a high rate of CMS outlier payments to institutions that
perform a high volume of these procedures. Finally, the requestor
stated that there is precedent for reassignment of cases from the lower
severity level MS-DRGs to the higher severity level MS-DRG for cases
involving the use of a device in orthopedic surgery. The requestor
provided the examples of total ankle replacement procedures, spinal
disc replacement procedures and neurostimulator implantation procedures
to demonstrate how CMS has previously reassigned cases from the lower
severity level MS-DRG to the higher severity level MS-DRG.
We first examined the claims data from the March 2020 update of the
FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR
file for all cases in MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and
909; and MS-DRGs 957, 958, and 959. Our findings are shown in the
following tables.
[[Page 25125]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.043
[GRAPHIC] [TIFF OMITTED] TP10MY21.044
We then examined claims data from the March 2020 update of the FY
2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR
file for cases reporting any combination of the diagnosis and procedure
codes that the requestor provided to identify internal fixation for
pelvic trauma cases in MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and
909; and MS-DRGs 957, 958, and 959.
We note that our analysis identified two types of cases in which
the combination of a diagnosis code and a procedure code (that the
requestor provided to identify internal fixation for pelvic trauma
cases) was reported. The first type of case consisted of a diagnosis
code describing a pelvic fracture reported in combination with a single
procedure code describing repair of a pelvic fracture with internal
fixation on a claim, and the second type of case consisted of a
diagnosis code describing a pelvic fracture reported in combination
with two procedure codes describing repair of a pelvic fracture with
internal fixation (for example, one for the right side and one for the
left side) on a claim. These cases are described as single and
bilateral internal fixation procedures for pelvic trauma, respectively.
We refer the reader to Tables 6P.1h and 6P.1i associated with this
proposed rule (which are available via the internet on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS) for the list of diagnosis and procedure code
combinations reflecting single internal fixation for pelvic trauma
procedures reported by case ID in each MS-DRG, by fiscal year, along
with the detailed claims analysis. We refer the reader to Tables 6P.1j
and 6P.1k associated with this proposed rule (which are available via
the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS) for the list of
diagnosis and procedure code combinations reflecting bilateral internal
fixation for pelvic trauma procedures reported by case ID in each MS-
DRG, by fiscal year, along with the detailed claims analysis. For
example, Table 6P.1h shows the claims data analysis findings from the
March 2020 update of the FY 2019 MedPAR file. Line 2 identifies the
section for single cases reported in MS-DRG 515, line 13 identifies the
section for single cases reported in MS-DRG 516, and line 42 identifies
the single cases reported in MS-DRG 517. The following table summarizes
the information found in each column of the tables.
[[Page 25126]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.045
As shown in Table 6P.1h, line 4, column A, displays the Case ID
``Single-A'' for the first case; column B displays MS-DRG 515; column C
displays the diagnosis code S32.111A; column D displays the description
of the diagnosis code (Minimally displaced Zone 1 fracture of sacrum,
initial encounter for closed fracture); column E displays the procedure
code 0QS234Z; column F displays the description of the procedure code
(Reposition right pelvic bone with internal fixation device,
percutaneous approach); column G displays the case count 1; column H
displays an average length of stay of 3.0 days; column I displays
average costs of $8,433 for the case; column J displays the frequency
of the procedure reported was one (1) occurrence; column K displays a
3.0 day length of stay for the case; and column L displays $8,433 for
the cost of the case.
In our analysis of the claims data from the March 2020 update of
the FY 2019 MedPAR file, we found that there were no cases reporting
any combination of the diagnosis codes and procedure codes previously
listed in MS-DRGs 907, 908, and 909 or MS-DRGs 957, 958, and 959. Our
findings are shown in the following table for any cases found to report
a diagnosis code describing a pelvic trauma in combination with a
procedure code describing single internal fixation in MS-DRGs 515, 516,
and 517.
[GRAPHIC] [TIFF OMITTED] TP10MY21.046
[[Page 25127]]
As shown in the table, there were only three cases found in MS-DRG
517 reporting single internal fixation for pelvic trauma procedures,
with an average length of stay of 5.33 days and average costs of
$12,147. The average length of stay is longer and the average costs of
these three cases higher compared to the average length of stay and the
average costs for all cases in MS-DRG 517 (5.33 days versus 2.6 days
and $12,147 versus $10,316, respectively); however, overall, we believe
the data findings are comparable. Our clinical advisors did not support
reassignment of the three cases from MS-DRG 517 to MS-DRG 515 based on
the claims data analysis and also stated it would not be appropriate to
reassign these cases into the higher severity level MS-DRG in the
absence of a MCC and noted that the cases would not be clinically
coherent with regard to resource utilization.
In our analysis of the claims data from the March 2020 update of
the FY 2019 MedPAR file for cases in which a bilateral internal
fixation for pelvic trauma procedure was performed, we identified one
case in MS-DRG 517. As shown in Table 6P.1j, the average length of stay
for this case was 4.0 days and the average costs were $24,258, which is
longer than the average length of stay and greater than the average
costs for all cases in MS-DRG 517 (2.6 days and $10,316, respectively).
We also identified cases reporting various code combinations for MS-
DRGs 515 and 516, and provide the details in Table 6P.1j associated
with this proposed rule (which is available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS).
In our analysis of the claims data from the September 2020 update
of the FY 2020 MedPAR file we found that there were no cases reporting
any combination of the diagnosis codes and procedure codes previously
listed in MS-DRG 909 or in MS-DRGs 957, 958, and 959. Our findings are
shown in the following table for any cases found to report a diagnosis
code describing a pelvic trauma in combination with a procedure code
describing single internal fixation in MS-DRGs 515, 516, 517, 907, and
908.
[GRAPHIC] [TIFF OMITTED] TP10MY21.047
As shown in the table, there were only four cases found in MS-DRG
517 reporting single internal fixation for pelvic trauma procedures,
with an average length of stay of 2.5 days and average costs of
$10,136. For the same reasons described previously based on the FY 2019
analysis, our clinical advisors did not support reassignment of the
cases in the lower severity level MS-DRG 517 to the higher severity
level MS-DRG 515. In addition, the average length of stay and average
costs for these four cases reporting single internal fixation for
pelvic trauma procedures are less than the average length of stay and
average costs for all the cases in MS-DRG 517 (2.5 days versus 2.6 days
and $10,136 versus $11,301, respectively)); however, overall, we
believe the data findings are comparable.
In our analysis of the claims data from the September 2020 update
of the FY 2020 MedPAR file for cases in which a bilateral internal
fixation for pelvic trauma procedure was performed, we identified one
case in MS-DRG 517. As shown in Table 6P.1k, the average length of stay
for this case was 2.0 days and the average costs were $10,103, which is
shorter than the average length of stay and less than the average costs
for all cases in MS-DRG 517 (2.6 days and $11,301, respectively). We
also identified cases reporting various combinations for MS-DRGs 515,
516 and MS-DRG 907, and provide the details in Table 6P.1k associated
with this proposed rule (which is available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS).
We believe further analyses of these internal fixation for pelvic
trauma cases in the claims data is warranted. We note that our analysis
for both the single and bilateral cases was centered on the reporting
of a principal diagnosis code describing a pelvic trauma (fracture) in
combination with a procedure code describing internal fixation based on
the codes provided by the requestor. However, we also identified cases
in the claims data in which a pelvic trauma diagnosis code was reported
as a secondary diagnosis code in combination with a procedure code
describing internal fixation and believe these cases require further
evaluation. In addition, during our review of the diagnosis and
procedure codes that the requestor provided, we identified diagnosis
codes that we believe do not warrant consideration for purposes of this
request and additional procedure codes that describe internal fixation
for pelvic trauma procedures, which we believe do warrant further
analysis. For example, as previously noted, the requestor provided the
subcategories for
[[Page 25128]]
the diagnosis codes that it requested we consider for analysis. We do
not agree that diagnosis codes describing a pelvic fracture that
include the term ``sequela'' should be considered in the analysis to
examine this request because, in the ICD-10-CM classification, the term
sequela is defined as the residual effect (condition produced) after
the acute phase of an illness or injury has terminated.
We refer the reader to Table 6P.1g for the list of diagnosis codes
that are included in the diagnosis subcategories provided by the
requestor and the list of procedure codes provided by the requestor,
which also contains the procedure codes we identified. Additional time
is needed for data analysis given the volume of these code combinations
and corresponding data. We also believe that additional time is needed
to allow for further analysis of the claims data to determine the
causes of the fractures and other possible contributing factors with
respect to the length of stay and costs of these cases, as well as the
rate of outlier payments as identified by the requestor. Our clinical
advisors also believe that future data findings may demonstrate
additional variance in resource utilization for this patient
population. We further note that, as discussed in the FY 2021 IPPS/LTCH
PPS final rule, we finalized the addition of 161 procedure codes to MS-
DRGs 957, 958, and 959 in MDC 24 (Multiple Significant Trauma) that
include the insertion of internal fixation devices. We believe it would
be beneficial to examine future claims data to determine if there is a
change in the volume of cases in those specific MS-DRGs as a result of
that update. For these reasons, we are proposing to maintain the
structure of MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and 909; and
MS-DRGs 957, 958, and 959 for FY 2022.
7. MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract):
Chronic Renal Replacement Therapy (CRRT)
We received a request to create new MS-DRGs for cases where the
patient receives continuous renal replacement therapy (CRRT) during the
inpatient stay. According to the requestor, hospitals incur higher
costs related to CRRT and current MS-DRG definitions do not adequately
account for the clinical and resource requirements of CRRT. The
requestor stated Medicare reimbursement is insufficient to cover the
costs of administering CRRT, creating a disincentive in offering this
dialysis modality and is a barrier to further adoption of CRRT. The
requestor suggested that the following two new MS-DRGs be created:
Suggested New MS-DRG XXX--Continuous Renal Replacement
Therapy with CC/MCC; and
Suggested New MS-DRG XXX--Continuous Renal Replacement
Therapy without CC/MCC.
Renal replacement therapy (RRT) replaces kidney function by
exchanging solute and removing fluid from the blood as a means to
prevent or treat renal failure in patients with acute kidney injury
(AKI). Modalities of renal support include CRRT, conventional
intermittent hemodialysis (IHD), and prolonged intermittent renal
replacement therapies (PIRRTs), which are a hybrid of CRRT and IHD. IHD
provides solute clearance and filtration during relatively brief
treatment sessions, generally lasting from three to five hours. CRRT
provides gradual fluid removal and solute clearance over prolonged
treatment times, typically over a 24-hour period, mimicking the natural
function of the kidney to allow for the continuous removal or
replacement of fluid. The most common CRRT modalities are continuous
venovenous hemofiltration, continuous venovenous hemodialysis, and
continuous venovenous hemodiafiltration.
According to the requestor, CRRT is used primarily to treat
critically ill, hospitalized patients who experience AKI requiring more
intensive and continuous treatment than other dialysis modalities. The
requestor stated that CRRT offers fluid balance and convective
clearance that may be precisely adjusted for each patient, and has been
associated with a higher likelihood of kidney recovery as compared to
other modalities of RRT. The requestor asserted that IHD may worsen the
neurological status of patients with acute brain injury or other causes
of increased intracranial pressure by compromising their cerebral
perfusion by raising intracranial pressure. The ongoing modulation of
fluid balance and targeted fluid management capabilities of CRRT
enables its use in situations other than renal failure. According to
the requestor, CRRT, a slow continuous therapy, is preferred for
patients who are hemodynamically unstable because it helps prevent the
hemodynamic fluctuations common with the more rapid IHD. In light of
the COVID-19 pandemic, the requestor noted the National Institutes of
Health's Coronavirus Disease 2019 (COVID-19) Treatment Guidelines and
The American Society of Nephrology recommend CRRT as the preferred
renal replacement therapy for critically ill, COVID-19 patients
experiencing AKI, who develop indications for renal replacement
therapy, due to the hemodynamic instability often experienced in this
condition.
The requestor acknowledged that under the current MS-DRG
definitions, Medicare cases with beneficiaries receiving CRRT are
assigned to more than 300 MS-DRGs. Although these beneficiaries are
clinically similar in that they are critically ill patients who
experience AKI requiring more intensive and continuous treatment than
other dialysis modalities, the principal diagnoses for their inpatient
stays vary. The requestor stated their analysis of the variability in
principal diagnosis of the cases examined with beneficiaries receiving
CRRT indicated that, in general, IHD tends to be used more for patients
with chronic illnesses, and CRRT tends to be used for more acute
injuries and end of life scenarios. Therefore, the requestor suggested
that CMS create new MS-DRGs specific to CRRT, without regard to
principal diagnosis, in order to group the resource intensive,
clinically coherent, CRRT cases together in contrast to the existing
GROUPER definitions.
According to the requestor, continuing to assign CRRT to existing
MS-DRGs would be clinically inappropriate and remain financially
devastating to providers even when treating the most routine,
uncomplicated CRRT patients. The requestor performed its own data
analysis and stated hospitals lose over $22,000 per CRRT case on
average, even when outliers are considered, which they state is a
shortfall of more than 30 percent. The requestor asserted these losses
create a disincentive for providers to offer CRRT despite its clinical
benefits. The requestor also asserted the magnitude of financial losses
associated with the provision of CRRT at the current level of MS-DRG
payment could force many hospitals to examine the capacity and scope of
their CRRT programs if facilities continue to determine that the
financial burden of treating Medicare beneficiaries with CRRT is more
than the facility can sustain. As COVID-19 continues to strain hospital
resources, the requestor asserts the availability of CRRT should not be
impeded by inadequate MS-DRG payments related to CRRT.
The following ICD-10-PCS procedure code identifies the performance
of CRRT.
[[Page 25129]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.048
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
code 5A1D90Z is currently recognized as a non-O.R. procedure that
affects the MS-DRG to which it is assigned. Our clinical advisors agree
that the principal diagnosis assigned for inpatient admissions where
continuous renal replacement of therapy is utilized can vary. To
examine the impact of the use of CRRT, we examined claims data from the
March 2020 update of the FY 2019 MedPAR file for the top ten MS-DRGs
reporting the use of CRRT. Our findings are reflected in the following
table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.049
[[Page 25130]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.050
As shown in this table, our data findings demonstrate the average
lengths of stay were longer and the average costs were higher for the
cases reporting the use of CRRT when compared to all cases in their
respective MS-DRG. We note that the claims data demonstrate that the
MS-DRG with the largest number of cases reporting CRRT is MS-DRG 871
with 2,912 cases. Of the top 10 MS-DRGs reporting CRRT, the MS-DRG with
the smallest number of cases is MS-DRG 682 with 401 cases. The average
length of stay of this subset of cases ranges from a high of 35.5 days
in MS-DRG 004 to a low of 7.9 days in MS-DRG 871 for cases reporting
the use of CRRT. The average costs of this subset of cases ranges from
a high of $174,085 in MS-DRG 003 to a low of $27,681 in MS-DRG 871 for
cases reporting the use of CRRT.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for the top ten MS-DRGs reporting the use of CRRT.
Our similar findings are reflected in the following table:
[[Page 25131]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.051
As shown in this table, our data findings show that the average
lengths of stay were longer and the average costs were higher for the
cases reporting the use of CRRT when compared to all cases in their
respective MS-DRG. We note that the claims data demonstrate that the
MS-DRG with the largest number of cases reporting CRRT is MS-DRG 871
with 3,023 cases. Of the top 10 MS-DRGs reporting CRRT, the MS-DRG with
the smallest number of cases is MS-DRG 219 with 374 cases. The average
length of stay of this subset of cases ranges from a high of 34.9 days
in MS-DRG 004 to a low of 7.9 days in MS-DRG 871 for cases reporting
the use of CRRT. The average costs of this subset of cases ranges from
a high of $182,952 in MS-DRG 003 to a low of $29,248 in MS-DRG 871 for
cases reporting the use of CRRT.
While the results of the claims analysis indicate that the average
costs and average lengths of stay for cases reporting the use of CRRT
are higher compared to the average costs for all cases in their
assigned MS-DRG, we are unable to ascertain from the claims data the
resource use specifically attributable to CRRT during a hospital stay.
There is large variability in the differences in average costs from MS-
DRG to MS-DRG, indicating there may have been other factors
contributing to the higher costs. When reviewing consumption of
hospital resources for this subset of cases, the claims data clearly
demonstrate the patients typically have a major complication or co-
morbid (MCC) condition reported based on the MS-DRGs assigned. The
claims data also reflects, based on the top ten MS-DRGS, that the
procedure frequently occurs in cases with other procedures with higher
than average resource use such as mechanical ventilation, tracheostomy,
extracorporeal membrane oxygenation (ECMO) and other major
cardiovascular procedures that also may be contributing to the higher
average costs for these cases.
To further examine the variability in cases reporting the use of
CRRT, we also reviewed the claims data to identify the number
(frequency) and types of principal diagnoses that were reported to
determine what factors may also be contributing to the higher average
costs for these cases.
[[Page 25132]]
Our findings for the top 10 principal diagnoses that were reported
within the claims data from the March 2020 update of the FY 2019 MedPAR
file for this subset of cases is shown in the following table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.052
The claims data in this table reflects a wide variance with regard
to the frequency and types of principal diagnoses that were reported
along with the procedure code describing the use of CRRT. We note that
the claims data demonstrate that the diagnosis with the largest number
of cases reporting CRRT is A41.9 (Sepsis, unspecified organism) with
4,226 cases. Of the top 10 principal diagnoses reporting CRRT, the
diagnosis with the smallest number of cases is A41.01 (Sepsis due to
Methicillin susceptible Staphylococcus aureus) with 271 cases. The
average length of stay of this subset of cases ranges from a high of 20
days with a diagnosis of I13.0 (Hypertensive heart and chronic kidney
disease with heart failure and stage 1 through stage 4 chronic kidney
disease, or unspecified chronic kidney disease) to a low of 12.6 days
with a diagnosis of A41.9 (Sepsis, unspecified organism) for cases
reporting the use of CRRT. The average costs of this subset of cases
ranges from a high of $85,557 with a diagnosis of I21.4 (Non-ST
elevation (NSTEMI) myocardial infarction) to a low of $40,908 with a
diagnosis of N17.9 (Acute kidney failure, unspecified) for cases
reporting the use of CRRT.
Our findings for the top 10 principal diagnoses that were reported
within the claims data from the September 2020 update of the FY 2020
MedPAR file for this subset of cases is shown in the following table:
[[Page 25133]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.053
The claims data in this table also reflects a wide variance with
regard to the frequency and types of principal diagnoses that were
reported along with the procedure code describing the use of CRRT. As
shown, the claims data demonstrate that the diagnosis with the largest
number of cases reporting CRRT is A41.9 (Sepsis, unspecified organism)
with 4,128 cases. Of the top 10 principal diagnoses reporting CRRT, the
diagnosis with the smallest number of cases is N17.0 (Acute kidney
failure with tubular necrosis) with 270 cases. The average length of
stay of this subset of cases ranges from a high of 21.4 days with a
diagnosis of U07.1 (COVID-19) to a low of 11.8 days with a diagnosis of
J96.01 (Acute respiratory failure with hypoxia) for cases reporting the
use of CRRT. The average costs of this subset of cases ranges from a
high of $ 86,717 with a diagnosis of I21.4 (Non-ST elevation (NSTEMI)
myocardial infarction) to a low of $ 48,882 with a diagnosis of J96.01
(Acute respiratory failure with hypoxia) for cases reporting the use of
CRRT.
To evaluate the frequency with which the use of CRRT is reported
for different clinical scenarios, we examined claims from the March
2020 update of the FY 2019 MedPAR file across each of the 25 MDCs to
determine the number of cases reporting the use of CRRT. Our findings
are shown in this table.
BILLING CODE 4120-01-P
[[Page 25134]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.054
[[Page 25135]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.055
As shown in the table, the top five MDCs with the largest number of
cases reporting CRRT are MDC 18, with 6,761 cases; MDC 05, with 6,027
cases; MDC 04, with 1,370 cases; MDC 11, with 1,134 cases; and MDC 06,
with 987 cases. The top five MDCs with the highest average costs for
cases reporting the use of CRRT were MDC 13, with average costs of
$131,252; MDC 22, with average costs of $104,749; MDC 17, with average
costs of $95,309; MDC 07, with average costs of $87,272; and MDC 05,
with average costs of $86,024. The claims data indicate that the
average length of stay ranges from a high of 47.3 days in MDC 13 to a
low of 8 days in MDC 14 for cases reporting the use of CRRT across each
of the 25 MDCs.
We also examined claims from the September 2020 update of the FY
2020 MedPAR file across each of the 25 MDCs to determine the number of
cases
[[Page 25136]]
reporting the use of CRRT. Our findings are shown in this table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.056
[[Page 25137]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.057
BILLING CODE 4120-01-C
As shown in the table, the top five MDCs with the largest number of
cases reporting CRRT are MDC 18, with 7,678 cases; MDC 05, with 5,516
cases; MDC
[[Page 25138]]
04, with 2,191 cases; MDC 11, with 1,066 cases; and MDC 06, with 838
cases. The top five MDCs with the highest average costs for cases
reporting the use of CRRT were MDC 22, with average costs of $139,244;
MDC 17, with average costs of $88,182; MDC 05, with average costs of
$87,875; MDC 07, with average costs of $86,894; and MDC 08, with
average costs of $ 77,515. The claims data indicate that the average
length of stay ranges from a high of 26.7 days in MDC 22 to a low of 11
days in MDC 20 for cases reporting the use of CRRT across each of the
25 MDCs.
Our clinical advisors reviewed the clinical issues and the claims
data, and did not support creating new MS-DRGs for CRRT without regard
to principal diagnosis. Our clinical advisors noted that more than one
modality for RRT can be utilized for managing patients with AKI given
the needs of the patient. For example, a patient may initially start on
CRRT when they are hemodynamically unstable, but transition to IHD as
their condition is managed during the admission. While patients
requiring CRRT can be more resource intensive, it would not be
practical to create new MS-DRGs specifically for this subset of
patients given the various clinical presentations for which CRRT may be
utilized, and the variation of costs in their assigned MS-DRGs. We
believe that additional analysis and efforts toward a broader approach
to refining the MS-DRGs for cases of patients requiring renal
replacement therapy would be needed to address the concerns expressed
by the requestor. These data do show cases reporting the use of CRRT
can present greater treatment difficulty. However, when reviewing
consumption of hospital resources for this subset of cases, the claims
data also suggest that the increased costs may be attributable to the
severity of illness of the patient and other circumstances of the
admission.
In summary, the claims data reflect a wide variance with regard to
the frequency and average costs for cases reporting the use of CRRT.
Depending on the number of cases in each MS-DRG, it is difficult to
detect patterns of complexity and resource intensity. We believe the
creation of new MS-DRGs for cases with procedure codes reporting the
use of CRRT has the potential for creating instability in the relative
weights and disrupting the integrity of the MS-DRG system. Therefore,
we are not proposing to create new MS-DRGs for cases reporting the use
of continuous renal replacement therapy.
8. MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs and
Immunologic Disorders)
a. ANDEXXA[supreg] (Coagulation Factor Xa (Recombinant), Inactivated-
zhzo)
ANDEXXA[supreg] (coagulation factor Xa (recombinant), inactivated-
zhzo) is a recombinant decoy protein that rapidly reverses the
anticoagulant effects of two direct oral anticoagulants, apixaban and
rivaroxaban, when reversal of anticoagulation is needed due to life-
threatening or uncontrolled bleeding in indications such as
intracranial hemorrhages (ICHs) and gastrointestinal bleeds (GIBs).
ANDEXXA[supreg] received FDA approval on May 3, 2018. When administered
as a bolus followed by continuous infusion, ANDEXXA[supreg] blocks the
anticoagulants ability to inhibit FXa. ANDEXXA[supreg] was approved for
new technology add on payments in 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 and payment amount for ANDEXXA[supreg] for FY 2019
and FY 2020.
In section II.H.4.i. of the preamble of the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58614 through 58615), we noted the 3-year anniversary
date of the entry of ANDEXXA[supreg] onto the U.S. market (May 3, 2021)
will occur in the second half of FY 2021. We stated 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. After
consideration of the public comments received, we finalized our
proposal to continue new technology add-on payments for this technology
for FY 2021.
We received a request from the manufacturer to review potential
access issues in the inpatient setting for this drug in the future. The
requestor acknowledged that CMS approved the new technology add-on
payment for ANDEXXA[supreg] beginning in FY 2019 and noted that FY 2021
will be the last year before the add-on payments expire. According to
the requestor, ANDEXXA[supreg] is the only indicated factor Xa
inhibitor reversal agent, and the requestor stated a concern for the
future of access to ANDEXXA[supreg] for patients experiencing
uncontrolled bleeds caused by factor Xa inhibitors. The requestor
stated their claims modeling showed a significant drop in hospital
payment for cases involving use of ANDEXXA[supreg] following the
expiration of new technology add-on payments. Specifically, after new
technology add-on payments expire, the requestor stated their model
projects that approximately 59% of cases are likely to be paid less
than the wholesale acquisition costs for ANDEXXA[supreg].
The following ICD-10-PCS procedure codes identify the intravenous
administration of ANDEXXA[supreg].
[GRAPHIC] [TIFF OMITTED] TP10MY21.058
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes XW03372 and XW04372 are designated as non-O.R. procedures for
purposes of MS-DRG assignment. Our clinical advisors agree that the
principal diagnosis assigned for inpatient admissions where the
intravenous administration of ANDEXXA[supreg] is indicated can vary.
To evaluate the frequency with which the intravenous administration
of
[[Page 25139]]
ANDEXXA[supreg] is reported for different clinical scenarios, we
examined claims data from the March 2020 update of the FY 2019 MedPAR
file across the Pre-MDC category, each of the 25 MDCs and the surgical
class referred to as ``unrelated operating room procedures'' to
determine the number of cases reporting the use of ANDEXXA[supreg]. Our
findings are shown in the following table.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP10MY21.059
[[Page 25140]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.060
BILLING CODE 4120-01-C
As shown in the table, there were 461 cases reporting the
intravenous administration of ANDEXXA[supreg] with procedure codes
XW03372 or XW04372. The top five MDCs with the largest number of cases
reporting ANDEXXA[supreg] are MDC 01, with 250 cases; MDC 06 with 53
cases; MDC 05, with 33 cases; MDC 18, with 25 cases; and the Pre-MDC
category, with 16 cases. The claims data indicate that the average
costs range from a high of $107,741 in the Pre-MDC category to a low of
$22,242 in MDC 09 for cases reporting the use of ANDEXXA[supreg] across
the claims data. The claims data also indicates that the average length
of stay ranges from a high of 19.9 days in the Pre-MDC category to a
low of 4 days in MDC 09 for cases reporting the use of ANDEXXA[supreg].
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file across the Pre-MDC category, each of the 25 MDCs
and the surgical class referred to as ``unrelated operating room
procedures'' to determine the number of cases reporting the use of
ANDEXXA[supreg]. Our findings are shown in the following table.
BILLING CODE 4120-01-P
[[Page 25141]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.061
[[Page 25142]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.062
BILLING CODE 4120-01-C
As shown in the table, there were 719 cases reporting the
intravenous administration of ANDEXXA[supreg] with procedure codes
XW03372 or XW04372. The top five MDCs with the largest number of cases
reporting ANDEXXA[supreg] are MDC 01, with 364 cases; MDC 06 with 98
cases; MDC 18, with 52 cases; MDC 05, with 50 cases; and MDC 24, with
30 cases. The claims data indicate that the average costs range from a
high
[[Page 25143]]
of $123,750 in the Pre-MDC category to a low of $27,922 in MDC 09 for
cases reporting the use of ANDEXXA[supreg] across the claims data. The
claims data also indicates that the average length of stay ranges from
a high of 25 days in the Pre-MDC category to a low of 4.2 days in MDC
21 for cases reporting the use of ANDEXXA[supreg] across the claims
data.
To further examine the impact of the intravenous administration of
ANDEXXA[supreg], we examined claims data from the March 2020 update of
the FY 2019 MedPAR file for the top ten MS-DRGs reporting procedure
codes XW03372 or XW04372. Our findings are reflected in the following
table:
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP10MY21.063
[[Page 25144]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.064
BILLING CODE 4120-01-C
As shown in this table, the claims data demonstrate that the MS-DRG
with the largest number of cases reporting ANDEXXA[supreg] is MS-DRG
064 with 78 cases. Of the top 10 MS-DRGs reporting ANDEXXA[supreg], the
MS-DRG with the smallest number of cases is MS-DRG 003 with 13 cases.
The average length of stay of this subset of cases ranges from a high
of 21.5 days in MS-DRG 003 to a low of 4.2 days in MS-DRG 086 for cases
reporting the use of ANDEXXA[supreg]. The average costs of this subset
of cases ranges from a high of $117,265 in MS-DRG 003 to a low of
$26,992 in MS-DRG 083 for cases reporting the use of ANDEXXA[supreg].
We note while our data findings demonstrate the average costs were
higher for the cases reporting the intravenous administration of
ANDEXXA[supreg] when compared to all cases in their respective MS-DRG,
these cases represent a very small percentage of the total number of
cases reported in these MS-DRGs. We also note that the top 10 MS-DRGs
identified only account for 239 of the 461 cases in total that were
identified in the March 2020 update of the FY 2019 MedPAR file
reporting ICD-10-PCS codes XW03372 or XW04372. The remainder of the
cases are distributed in small numbers across the MS-DRGs.
We also examined claims data from the September 2020 update of the
FY 2020 MedPAR file for the top ten MS-DRGs reporting procedure codes
XW03372 or XW04372. Our findings are reflected in the following table:
BILLING CODE 4120-01-P
[[Page 25145]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.065
BILLING CODE 4120-01-C
As shown in this table, the claims data demonstrate that the MS-DRG
with the largest number of cases reporting ANDEXXA[supreg] is MS-DRG
064 with 111 cases. Of the top 10 MS-DRGs reporting ANDEXXA[supreg],
the MS-DRG with the smallest number of cases is MS-DRG 083 with 23
cases. The average length of stay of this subset of cases ranges from a
high of 10 days in MS-DRG 023 to a low of 3.5 days in MS-DRG 378 for
cases reporting the use of ANDEXXA[supreg]. The average costs of this
subset of cases ranges from a high of $59,478 in MS-DRG 025 to a low of
$24,348 in MS-DRG 378 for cases reporting the use of ANDEXXA[supreg].
As with our analysis of the
[[Page 25146]]
FY 2019 claims data, while these data findings demonstrate the average
costs were higher for the cases reporting the intravenous
administration of ANDEXXA[supreg] when compared to all cases in their
respective MS-DRG, these cases represent a very small percentage of the
total number of cases reported in these MS-DRGs. We also note that the
top 10 MS-DRGs identified only account for 385 of the 719 cases in
total that were identified in the September 2020 update of the FY 2020
MedPAR file reporting ICD-10-PCS codes XW03372 or XW04372. The
remainder of the cases are distributed in small numbers across the MS-
DRGs.
After reviewing the claims data, we believe it is premature to
consider a proposal for cases involving ANDEXXA[supreg] therapy for FY
2022. While the March 2020 update of the FY 2019 MedPAR file and the
September 2020 update of the FY 2020 MedPAR file do contain claims
reporting the procedure codes identifying the intravenous
administration of ANDEXXA[supreg], the number of cases is small across
the MDCs and MS-DRGs. The claims data also reflect a wide variance with
regard to the frequency and average costs for these cases reporting the
use of ANDEXXA[supreg]. Moreover, we were unable to identify another
MS-DRG that would be a more appropriate MS-DRG assignment for these
cases based on the indication for this therapeutic drug. As noted
previously, ANDEXXA[supreg] reverses the anticoagulant effects of
apixaban and rivaroxaban, when reversal of anticoagulation is needed
due to life-threatening or uncontrolled bleeding. The underlying cause
of the life-threatening or uncontrolled bleeding can vary which means
the principal diagnosis assigned for inpatient admissions where
ANDEXXA[supreg] is administered can vary. The MS-DRGs are a
classification system intended to group together diagnoses and
procedures with similar clinical characteristics and utilization of
resources. We generally seek to identify sufficiently large sets of
claims data with a resource/cost similarity and clinical similarity in
developing diagnostic-related groups rather than smaller subsets based
on the drugs administered. In reviewing this issue, our clinical
advisors expressed concern regarding making potential MS-DRG changes
based on a specific, single therapeutic agent, identified by unique
procedure codes rather than based on a group of related procedure codes
that can be reported to describe that same type or class of treatment
or technology, which is more consistent with the intent of the MS-DRGs.
We recognize the average costs of the small numbers of cases
involving the intravenous administration of ANDEXXA[supreg] are greater
when compared to the average costs of all cases in their respective MS-
DRG. The MS-DRG system is a system of averages and it is expected that
within the diagnostic related groups, some cases may demonstrate higher
than average costs, while other cases may demonstrate lower than
average costs. We further note that section 1886(d)(5)(A) of the Act
provides for Medicare payments to Medicare-participating hospitals in
addition to the basic prospective payments for cases incurring
extraordinarily high costs.
We acknowledge the importance of ensuring that patients diagnosed
with an indication for a factor Xa inhibitor reversal agent have
adequate access to care and receive the necessary treatment. While we
are sensitive to the requestors' concerns about continued access to
treatment for beneficiaries who require the reversal of anticoagulation
due to life-threatening or uncontrolled bleeding, additional time is
needed to explore options and other mechanisms through which to address
low volume high-cost drugs outside of the MS-DRGs.
Furthermore, we note that we are proposing to continue new
technology add-on payments for ANDEXXA[supreg] for FY 2022. We refer
the reader to section II.F.4.b of the preamble of this proposed rule
for further discussion regarding our proposal to allow a one-time
extension of new technology add-on payments for FY 2022 for 15
technologies for which the new technology add-on payment would
otherwise be discontinued, in connection with our proposal to use the
FY 2019 data to develop the proposed FY 2022 relative weights.
Therefore for the reasons stated previously, for FY 2022 we are not
proposing any MS-DRG changes for cases involving the intravenous
administration of ANDEXXA[supreg].
b. Cytokine Release Syndrome (CRS) Logic
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58557 through
58561), we finalized modifications to the proposed severity level
designations for a subset of the diagnosis codes describing Cytokine
Release Syndrome (CRS) based upon further review of the conditions and
in response to public comments. We provided the following table to
display the finalized severity level designations and stated that 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.
[GRAPHIC] [TIFF OMITTED] TP10MY21.066
In connection with the finalized severity level designations for
the listed CRS codes, we also finalized modifications to the ICD-10 MS-
DRG GROUPER logic V38 for MS-DRGs 814, 815, and 816
(Reticuloendothelial and Immunity Disorders with MCC, with CC, and
without CC/MCC, respectively) to conform to the updates the CDC
finalized in the ICD-10-CM Tabular List instructions for assigning and
reporting the CRS codes effective with discharges on and after October
1, 2020. The following modifications to the GROUPER logic were
finalized effective with discharges on and after October 1, 2020, for
case assignment involving CRS following CAR T-cell therapy to MS-
[[Page 25147]]
DRGs 814, 815, and 816. We noted that the GROUPER logic for MS-DRGs
814, 815, and 816 will include a principal diagnosis of T89.89XA with a
secondary diagnosis of any CRS code as shown in this section of this
proposed rule.
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
As discussed in section II.D.13 of the preamble of this proposed
rule, Table 6A.-New Diagnosis Codes, lists the new diagnosis codes that
have been approved to date and will be effective with discharges on and
after October 1, 2021. Included in Table 6A are the following codes
that describe complication of immune effector cellular therapy
identifying the timeframe of the encounter.
[GRAPHIC] [TIFF OMITTED] TP10MY21.067
Also included in Table 6A are the following diagnosis codes that
describe immune effector cell-associated neurotoxicity syndrome
(ICANS), with varying degrees of severity.
[GRAPHIC] [TIFF OMITTED] TP10MY21.068
Consistent with the Tabular List instruction for these two sets of
diagnosis codes as presented and discussed by the CDC at the September
8-9, 2020 ICD-10 Coordination and Maintenance Committee meeting, the
diagnosis codes describing a complication of the immune effector
cellular therapy (T80.82XA, T80.82XD, and T80.82XS) are to be sequenced
first, followed by the applicable diagnosis code to identify the
specified condition resulting from the complication. For example, the
types of complications that may result from immune effector cellular
therapy treatment (for example, CAR T-cell therapy) include ICANS or
CRS, as described by the listed diagnosis codes. Accordingly, the CDC
included the following instructional note in the Tabular List
modifications for code T80.82-
``Use additional code to identify the specific complication, such
as:
cytokine release syndrome (D89.83-) immune effector cell-associated
neurotoxicity syndrome (G92.0-)''
Materials relating to the discussions involving the diagnosis codes
from the September 8-9, 2020 ICD-10 Coordination and Maintenance
Committee meeting can be obtained from the CDC website at: https://www.cdc.gov/nchs/icd/icd10cm_maintenance.htm.
As noted previously, the current logic for case assignment
involving CRS following CAR T-cell therapy to MS-DRGs 814, 815, and 816
includes a principal diagnosis of T89.89XA with a secondary diagnosis
of any CRS code. However, with the finalization of new diagnosis code
T80.82-, diagnosis code T89.89XA would no longer be reported and these
cases would instead report new diagnosis code T80.82XA, effective with
discharges on and after October 1, 2020. As shown in Table 6A
associated with this proposed rule, we are proposing to assign
diagnosis code T80.82XA to MDC 16 (Diseases and Disorders of Blood,
Blood Forming Organs, and Immunologic Disorders) in MS-DRGs 814, 815,
and 816. If the MDC and MS-DRG assignment for new diagnosis code
T80.82XA is finalized, the current logic for MS-DRGs 814, 815, and 816
that includes a principal diagnosis code of T89.89XA with a secondary
diagnosis code of any CRS code would no longer be appropriate or
necessary.
Therefore, we are proposing to revise the structure of MS-DRGs 814,
815, and 816 by removing the logic that includes a principal diagnosis
of T89.89XA with a secondary diagnosis of any CRS code from MS-DRGs
814, 815, and 816 effective FY 2022.
9. MDC 17 (Myeloproliferative Diseases and Disorders, and Poorly
Differentiated Neoplasms): Inferior Vena Cava Filter Procedures
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58517 through
58520), we
[[Page 25148]]
discussed the ICD-10-PCS codes that describe the insertion of an
intraluminal device into the inferior vena cava that are listed in the
following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.069
We finalized a change in the designation of ICD-10-PCS procedure
code 06H03DZ from O.R. procedure to non-O.R. procedure and maintained
the O.R. designation of procedure codes 06H00DZ and 06H04DZ. In that
discussion, we noted our clinical advisors supported changing the O.R.
designation of procedures describing insertion of an intraluminal
device into the inferior vena cava performed via a percutaneous
approach since the procedure does not require the resources of an
operating room, while concurring that 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. We also noted 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 and not
whether the change in designation would impact payment in a particular
direction.
In response to this final policy, for this FY 2022 IPPS/LTCH PPS
proposed rule, we received a request to revise MS-DRGs 829 and 830
(Myeloproliferative Disorders or Poorly Differentiated Neoplasms with
Other Procedures with and without CC/MCC, respectively) by removing the
current two-way severity level split and creating a three-way severity
level split. The requestor respectfully disagreed with the FY 2021
IPPS/LTCH PPS final rule decision to change the designation of the
procedure code describing the insertion of an inferior vena cava
intraluminal device via percutaneous approach to a non-O.R. procedure,
and stated vena cava filters are most often placed in interventional
radiology suites and require a high level of skill to prevent rupture
of the vena cava; and although they are long-term devices, they must be
placed skillfully to allow for removal later if needed.
According to the requestor, it is a conundrum that patients with
principal and secondary diagnoses that qualify for 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) group to lower weighted surgical MS-DRGs 829
and 830 (Myeloproliferative Disorders or Poorly Differentiated
Neoplasms with Other Procedures with and without CC/MCC, respectively)
when a non-major O.R. procedure is performed. The requestor stated the
difference in relative weights might be occurring because of the two-
way split within MS-DRGs 829 and 830 and the three-way split within MS-
DRGs 837, 838 and 839. The requestor theorized that removing the
current two-way severity level split of MS-DRGs 829 and 830 and
creating a three-way severity level split could help resolve the
relative weight discrepancy when any non-major O.R. procedures are
performed during hospitalizations for chemotherapy for acute leukemia.
This requestor also suggested that if CMS' analysis did not support
creating a three-way split for MS-DRGs 829 and 830, exclusion of PCS
code 06H03DZ from the list of qualifying procedures and reinstatement
of O.R. procedure status to appropriately compensate providers for the
cost of devices and resources to place inferior vena cava filters
across the patient population should be proposed.
To evaluate the request to create a three-way severity split MS-DRG
for cases reporting myeloproliferative disorders or poorly
differentiated neoplasms with other procedures, we conducted an
analysis of base MS-DRG 829. 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 829 using
the September 2018 update of the FY 2018 MedPAR file and the March 2020
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
2022, respectively. Our findings are shown in the table:
[[Page 25149]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.070
We applied the criteria to create subgroups for the three-way
severity level split. We found that the criterion that there be at
least 500 cases for each subgroup was not met based on the data in both
the FY 2018 and FY 2019 MedPAR files, as shown in the table for both
years. Specifically, for the ``with MCC'', ``with CC'', and ``without
CC/MCC'' split, there were only 333 cases in the ``without CC/MCC''
subgroup based on the data in the FY 2019 MedPAR file and only 333
cases in the ``without CC/MCC'' subgroup based on the data in the FY
2018 MedPAR file. Accordingly, the claims data do not support a three-
way severity level split for base MS-DRG 829.
We also reviewed the claims data for base MS-DRG 829 using the
September 2019 update of the FY 2019 MedPAR file and the September 2020
update of the FY 2020 MedPAR file, which were used in our analysis of
claims data for MS-DRG reclassification requests for FY 2021 and FY
2022, respectively. Our findings are shown in the table:
[GRAPHIC] [TIFF OMITTED] TP10MY21.071
We applied the criteria to create subgroups for the three-way
severity level split. We found that the criterion that there be at
least 500 cases for each subgroup was not met based on the data in both
the FY 2019 and FY 2020 MedPAR files, as shown in the table for both
years. Specifically, for the ``with MCC'', ``with CC'', and ``without
CC/MCC'' split, there were only 303 cases in the ``without CC/MCC''
subgroup based on the data in the FY 2020 MedPAR file and, as
previously noted, only 333 cases in the ``without CC/MCC'' subgroup
based on the data in the FY 2019 MedPAR file. As shown in both sets of
data and stated previously, the claims data do not support a three-way
severity level split for base MS-DRG 829.
In response to the request to exclude ICD-10-PCS code 06H03DZ from
a list of qualifying procedures if CMS's analysis did not support
creating a three-way split for MS-DRGs 829 and 830, by definition,
procedure codes designated as non-O.R. procedures, not further
classified as ``affecting the MS-DRG assignment'', do not influence the
MS-DRG assignment. As stated previously, in the FY 2021 IPPS/LTCH PPS
final rule we finalized our proposal to change the designation of ICD-
10-PCS procedure code 06H03DZ from O.R. procedure to non-O.R.
procedure, therefore as a non-O.R. procedure, there is no need to
exclude ICD-10-PCS code 06H03DZ from a list of qualifying procedure
codes for MS-DRGs 829 and 830.
In response to the request to reinstate the O.R. procedure
designation of ICD-10-PCS code 06H03DZ if CMS's analysis did not
support creating a three-way split for MS-DRGs 829 and 830, the change
in designation from O.R. procedure to non-O.R. procedure is recent,
only becoming effective October 1, 2020. Our clinical advisors continue
to indicate that code 06H03DZ, describing the percutaneous insertion of
an intraluminal device into the inferior vena cava, does not require
the resources of an operating room, that the procedure to insert an IVC
filter percutaneously is not surgical in nature and that the resources
involved in furnishing this procedure 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. Our clinical advisors state our FY 2021 final
policy results in an O.R. designation of 06H03DZ that better reflects
the associated technical complexity and hospital resource use of this
procedure. We continue to explore 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, as discussed in the FY 2021 IPPS/LTCH PPS final rule and in
section II.D.11. of the preamble of this proposed rule. We continue to
develop our process and methodology, and will provide more detail in
future rulemaking.
In summary, based on the results of our analysis, for FY 2022, we
are proposing to maintain the current structure of MS-DRGs 829 and 830.
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.
[[Page 25150]]
Based on the results of our review of the claims data from the
March 2020 update of the FY 2019 MedPAR file and the September 2020
update of the FY 2020 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 are proposing 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.
As discussed in section II.D.3.b. of the preamble of this proposed
rule, we received a request to reassign cases with procedures
describing control of bleeding in the cranial cavity when reported with
a central nervous system diagnosis 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 MDC 01 (Diseases and
Disorders of the Central Nervous System) in MS-DRGs 25, 26, and 27
(Craniotomy and Endovascular Intracranial Procedures with MCC, with CC,
and without CC/MCC, respectively (for example, ``craniotomy'' MS-DRGs).
We note that in addition to MS-DRGs 25, 26, and 27, MS-DRG 23
(Craniotomy with Major Device Implant or Acute Complex CNS Principal
Diagnosis with MCC or Chemotherapy Implant or Epilepsy with
Neurostimulator) and MS-DRG 24 (Craniotomy with Major Device Implant or
Acute Complex CNS Principal Diagnosis without MCC) also include
procedures performed on structures located within the cranial cavity
and are included in the range of MS-DRGs known as the ``craniotomy''
MS-DRGs in MDC 01.
The management and treatment for bleeding (or hemorrhage) within
the cranial cavity varies depending on the location, cause and the
severity (or extent) of the bleed. Common causes include head trauma or
cerebral aneurysm. Control of bleeding in the cranial cavity procedures
are identified by ICD-10-PCS procedure codes 0W310ZZ (Control bleeding
in cranial cavity, open approach), 0W313ZZ (Control bleeding in cranial
cavity, percutaneous approach) and 0W314ZZ (Control bleeding in cranial
cavity, percutaneous endoscopic approach) and are currently assigned to
the following MDCs and MS-DRGs.
BILLING CODE 4120-01-P
[[Page 25151]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.072
BILLING CODE 4120-01-C
According to the requestor, procedures performed within the cranial
cavity always involve drilling or cutting through the skull regardless
of the
[[Page 25152]]
approach, therefore the three procedure codes identified (0W310ZZ,
0W313ZZ, and 0W314ZZ) warrant assignment to the ``craniotomy'' MS-DRGs.
Our analysis of this grouping issue confirmed that when a procedure
describing control of bleeding in the cranial cavity is reported with a
principal diagnosis from MDC 01, these cases group to MS-DRGs 981, 982,
and 983. 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 a MS-DRG assignment to a
surgical class referred to as ``unrelated operating room procedures''.
We examined claims data from the March 2020 update of the FY 2019
MedPAR file and the September 2020 update of the FY 2020 MedPAR file
for cases reporting any one of the three procedure codes (0W310ZZ,
0W313ZZ or 0W314ZZ) in MS-DRGs 981 through 983 with a principal
diagnosis from MDC 01. Our findings are shown in the following tables.
[GRAPHIC] [TIFF OMITTED] TP10MY21.074
[GRAPHIC] [TIFF OMITTED] TP10MY21.075
As noted previously, the requestor asked that we consider
reassignment of these cases to the craniotomy MS-DRGs (identified as
MS-DRGs 23, 24, 25, 26, and 27). We therefore examined the data for all
cases in MS-DRGs 23, 24, 25, 26, and 27. Our findings are shown in the
following tables.
[[Page 25153]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.076
[GRAPHIC] [TIFF OMITTED] TP10MY21.077
As shown, in our analyses of the claims data for MS-DRGs 981
through 983, we found a total of ten cases reporting procedures
describing control of bleeding in cranial cavity with a principal
diagnosis from MDC 01 in the March 2020 update of the FY 2019 MedPAR
file, and a total of two cases reporting procedures describing control
of bleeding in cranial cavity with a principal diagnosis from MDC 01 in
the September 2020 update of the FY 2020 MedPAR file.
Our clinical advisors stated these procedures describing control of
bleeding in the cranial cavity are consistent with the existing
procedure codes included in the logic for case assignment to MS-DRGs
25, 26, and 27, in addition to MS-DRG 23 (Craniotomy with Major Device
Implant or Acute Complex CNS Principal Diagnosis with MCC or
Chemotherapy Implant or Epilepsy with Neurostimulator) and MS-DRG 24
(Craniotomy with Major Device Implant or Acute Complex CNS Principal
Diagnosis without MCC) that also describe procedures performed on
structures located within the cranial cavity and are included in the
range of MS-DRGs known as the ``craniotomy'' MS-DRGs. While the claims
analysis based on the March 2020 update of the FY 2019 MedPAR file
identified only ten cases and the September 2020 update of the FY 2020
MedPAR file identified only two cases for which these procedures were
reported as a stand-alone procedure resulting in assignment to MS-DRGs
981 through 983, and the average length of stay and average costs for
these cases vary in comparison to the average length of stay and
average costs of all cases in MS-DRGs 23, 24, 25, 26, and 27, given the
nature of head trauma cases, the resource use would be expected to vary
based on the extent of the patient's injuries. We believe it is
clinically appropriate to add these procedure codes describing control
of bleeding in the cranial cavity to MS-DRGs 23, 24, 25, 26, and 27 in
MDC 01.
Therefore, we are proposing to add procedure codes 0W310ZZ,
0W313ZZ, and 0W314ZZ to MDC 01 in MS-DRGs 23, 24, 25, 26, and 27
(``craniotomy'' MS-DRGs) for FY 2022.
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.
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 for
the cases to be reassigned from one of the MS-DRG groups to the other.
Based on the results of our review of the claims data from the
March 2020 update of the FY 2019 MedPAR file and the September 2020
update of the FY 2020 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 are proposing to move
the cases reporting the procedures codes described in this section of
this rule from MS-DRGs 981 through 983 to MS-DRGs 987 through 989.
[[Page 25154]]
As discussed in section II.D.3.a. of the preamble of this proposed
rule, we received a request that we understood to be for our
consideration of the reassignment of the following three procedure
codes from Extensive O.R. procedures to Non-extensive O.R. procedures.
[GRAPHIC] [TIFF OMITTED] TP10MY21.078
In conducting our review of this request, our clinical advisors
noted that ICD-10-PCS codes 0JB60ZZ, 0JB70ZZ, and 0JB80ZZ currently
group 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. While our claims analysis of both the
March 2020 update of the FY 2019 MedPAR file and the September 2020
update of the FY 2020 MedPAR file did not identify any cases reporting
any one of the three listed procedure codes in MS-DRGs 981, 982, or
983, our clinical advisors believe that these procedures would be more
appropriately designated as Non-extensive procedures because they are
more consistent with other procedures on the Non-extensive procedure
code list. They stated that these procedures do not consume the
resources or require a similar level of technical complexity as the
procedures on the Extensive O.R. procedures list.
Therefore, we are proposing to reassign the three procedure codes
listed 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) for FY 2022.
As discussed in section II.D.4.b. of the preamble of this proposed
rule, we identified 17 procedure codes describing laser interstitial
thermal therapy (LITT) that are currently designated as extensive O.R.
procedures. In addition to those 17 procedure codes, we identified
additional procedure codes describing LITT of various body parts that
are also designated as extensive O.R. procedures. The ICD-10-PCS codes
describing LITT of various body parts are as follows.
[[Page 25155]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.079
Whenever one of these listed procedure codes is reported on a claim
that is unrelated to the MDC to which the case was assigned based on
the principal diagnosis, it currently results in assignment to MS-DRGs
981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, without CC/MCC, respectively). Our
clinical advisors stated that all of the listed procedure codes warrant
redesignation from the extensive procedure list and MS-DRGs 981, 982,
and 983 to the non-extensive procedure list and to MS-DRGs 987, 988,
and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with
MCC, with CC, without CC/MCC, respectively). Specifically, our clinical
advisors stated the procedures described by these codes are minimally
invasive and are consistent with other ablation (root operation
Destruction) type procedures that are designated as non-extensive
procedures in the ICD-10-PCS classification.
In our analysis of claims from the March 2020 update of the FY 2019
MedPAR file, we identified a total of six cases reporting procedure
codes describing LITT of various body sites in MS-DRGs 981, 982, and
983 with an average length of stay of 2.5 days and average costs of
$7,734. Specifically, we found one case reporting procedure code
DVY0KZZ (Laser interstitial thermal therapy of prostate) in MS-DRG 981
with an average length of stay of 4.0 days and average costs of $7,348.
For MS-DRG 982, we found five cases in which procedure codes describing
LITT of various body sites were reported. The first case reported
procedure code D0Y0KZZ (Laser interstitial thermal therapy of brain)
with an average length of stay of 1.0 day and average costs of $4,142,
the second case reported procedure code D0Y6KZZ (Laser interstitial
thermal therapy of spinal cord) with an average length of stay of 3.0
days and average costs of $20,007, the third case reported procedure
code DDY1KZZ (Laser interstitial thermal therapy of stomach) with an
average length of stay of 2.0 days and average costs of $3,424, the
fourth case reported procedure code DDY7KZZ (Laser interstitial thermal
therapy of rectum) with an average length of stay of 3.0 days and
average costs of $3,735, and
[[Page 25156]]
the fifth case reported procedure code DVY0KZZ (Laser interstitial
thermal therapy of prostate) with an average length of stay of 2.0 days
and average costs of $7,750. There were no cases found to report
procedures describing LITT in MS-DRG 983. Our findings are summarized
in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.081
In our analysis of claims from the September 2020 update of the FY
2020 MedPAR file, we identified one case reporting procedure code
D0Y6KZZ (Laser interstitial thermal therapy of spinal cord) with an
average length of stay of 6 days and average costs of $5,130, and two
cases reporting procedure code DVY0KZZ (Laser interstitial thermal
therapy of prostate) with an average length of stay of 8.5 days and
average costs of $20,329 in MS-DRGs 981, 982, or 983. Although our
claims analysis identified a limited number of cases reporting
procedures describing LITT, our clinical advisors believe that these
procedures would be more appropriately designated as Non-extensive
procedures because they are more consistent with other procedures on
the Non-extensive procedure code list.
Therefore, we are proposing to reassign the listed procedure codes
describing LITT of various body parts from MS-DRGs 981, 982, and 983
(Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989
(Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with
MCC, with CC, and without CC/MCC, respectively) for FY 2022.
As also discussed in section II.D.4.b. of the preamble of this
proposed rule, we identified five procedure codes describing repair of
the esophagus that are currently designated as extensive O.R.
procedures. The procedure codes are 0DQ50ZZ (Repair esophagus, open
approach), 0DQ53ZZ (Repair esophagus, percutaneous approach), 0DQ54ZZ
(Repair esophagus, percutaneous endoscopic approach), 0DQ57ZZ (Repair
esophagus, via natural or artificial opening), and 0DQ58ZZ (Repair
esophagus, via natural or artificial opening endoscopic). Whenever one
of these five procedure codes is reported on a claim that is unrelated
to the MDC to which the case was assigned based on the principal
diagnosis, it currently results in assignment to MS-DRGs 981, 982, and
983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with
MCC, with CC, without CC/MCC, respectively). Our clinical advisors
stated that three of these five procedures warrant redesignation from
the extensive procedure list and MS-DRGs 981, 982, and 983 to the non-
extensive procedure list and to MS-DRGs 987, 988, and 989 (Non-
Extensive Procedure Unrelated to Principal Diagnosis with MCC, with CC,
without CC/MCC, respectively). Specifically, our clinical advisors
stated the procedures identified by procedure codes 0DQ53ZZ, 0DQ57ZZ,
and 0DQ58ZZ do not involve the same utilization of resources with
respect to the performance of the procedure in comparison to the
procedures identified by procedure codes 0DQ50ZZ and 0DQ540ZZ. In our
analysis of claims from the March 2020 update of the FY 2019 MedPAR
file, we identified three cases reporting procedure code 0DQ58ZZ in MS-
DRGs 981, 982, and 983 with an average length of stay of 14 days and
average costs of $34,894. In our analysis of claims from the September
2020 update of the FY 2020 MedPAR file, we identified two cases
reporting procedure code 0DQ58ZZ in MS-DRGs 981, 982, or 983 with an
average length of stay of 8 days and average costs of $12,037. Our
clinical advisors believe that these procedures would be more
appropriately designated as Non-extensive procedures because they are
more consistent with other procedures on the Non-extensive procedure
code list. Therefore, we are proposing to reassign these three
procedure codes (0DQ53ZZ, 0DQ57ZZ, and 0DQ58ZZ) from MS-DRGs 981, 982,
and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis
with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987,
988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY
2022.
As discussed in section II.D.11.c.24. of the preamble of this
proposed rule, we identified procedure code 0T9D0ZZ (Drainage of
urethra, open approach) during our review of procedure code 0U9L0ZZ
(Drainage of vestibular gland, open approach), which is currently
designated as a non-O.R. procedure. We noted that the procedure
described by procedure code 0T9D0ZZ represents the male equivalent of
the female procedure described by procedure code 0U9L0ZZ. Procedure
code 0T9D0ZZ is currently designated as an extensive O.R. procedure and
is reported to describe procedures performed on the Cowper's
(bulbourethral) gland in males. Whenever this procedure code is
reported on a claim that is unrelated to the MDC to which the case was
assigned based on the principal diagnosis, it currently results in
assignment to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure
Unrelated to Principal
[[Page 25157]]
Diagnosis with MCC, with CC, without CC/MCC, respectively).
Our clinical advisors stated that this procedure warrants
redesignation from the extensive procedure list and MS-DRGs 981, 982,
and 983 to the non-extensive procedure list and to MS-DRGs 987, 988,
and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with
MCC, with CC, without CC/MCC, respectively). Specifically, our clinical
advisors stated that the procedure described by procedure code 0T9D0ZZ
continues to warrant an O.R. designation because it is performed on
deeper structures and requires a higher level of technical skill and it
is a more complex procedure when compared to the non-O.R. procedure
described by procedure code 0U9L0ZZ, however, abscess formation in the
Cowper's (bulbourethral) glands is uncommon and can often be treated
with ultrasound guided percutaneous aspiration. The need for open
surgical management is rare and includes chronic infection unresponsive
to non-operative management and complicated acute infection such as
perineal fistula formation. Open surgical management would require use
of the operating room for both appropriate anesthesia and for the
resources required to perform the more invasive perineal surgical
dissection. Therefore, our clinical advisors believe a non-extensive
O.R. designation is suitable for this procedure.
We analyzed claims data from the March 2020 update of the FY 2019
MedPAR file and the September 2020 update of the FY 2020 MedPAR file
for cases reporting procedure code 0T9D0ZZ in MS-DRGs 981, 982, and
983. We found one case in MS-DRG 981 with an average length of stay of
8.0 days and average costs of $23,566 in the March 2020 update of the
FY 2019 MedPAR file, and no cases in the September 2020 update of the
FY 2020 MedPAR file. Although our claims analysis identified only one
case reporting procedure code 0T9D0ZZ, our clinical advisors believe
that these procedures would be more appropriately designated as Non-
extensive procedures because they are more consistent with other
procedures on the Non-extensive procedure code list.
Therefore, we are proposing to reassign procedure code 0T9D0ZZ from
MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R.
Procedures Unrelated to Principal Diagnosis with MCC, with CC, and
without CC/MCC, respectively) for FY 2022.
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.
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 proposed to be newly designated as O.R. procedures. As
discussed in section II.D.13 of the preamble of this proposed rule, we
are making Table 6B.--New Procedure Codes--FY 2022 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 38.1 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,
[[Page 25158]]
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.
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58540 through
58541), we provided a summary of the comments we had received in
response to our request for 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.
In consideration of the PHE, we believe it may be appropriate to
allow additional time for the claims data to stabilize prior to
selecting the timeframe to analyze for this review. Additional time is
also necessary as we continue to develop our process and methodology.
Therefore, we will provide more detail on this analysis and the
methodology for conducting this review in future rulemaking.
In this proposed 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 2022 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 are proposing to change the designation of
procedure codes from non-O.R. procedures to O.R. procedures, we also
are proposing 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.
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, we detail and respond to some
of those requests. With regard to the remaining requests, 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) Open Drainage of Subcutaneous Tissue and Fascia
One requestor identified the following ICD-10-PCS procedure code
that describes the open drainage of right lower leg subcutaneous tissue
and fascia, shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.082
In the ICD-10 MS-DRG Version 38.1 Definitions Manual, this ICD-10-
PCS procedure code is currently recognized as an O.R. procedure for
purposes of MS-DRG assignment. The requestor noted that this procedure
consumes resources comparable to related ICD-10-PCS procedure code
0J9N00Z (Drainage of right lower leg subcutaneous tissue and fascia
with drainage device, open approach) that describes the open drainage
of right lower leg subcutaneous tissue and fascia with a drainage
device, which is currently designated as a Non-O.R. procedure. The
requestor stated that these comparable procedures should be recognized
similarly for purposes of MS-DRG assignment.
During our review of this issue, we identified 21 ICD-10-PCS
procedure codes that describe the open drainage of subcutaneous tissue
and fascia, shown in the following table that are clinically similar to
ICD-10-PCS code 0J9N0ZZ, and are also designated as O.R.
[[Page 25159]]
procedures in the ICD-10 MS-DRG Version 38.1 Definitions Manual.
[GRAPHIC] [TIFF OMITTED] TP10MY21.083
We reviewed these procedures and our clinical advisors agree that
procedures that describe the open drainage of subcutaneous tissue and
fascia consume resources comparable to the related ICD-10-PCS procedure
codes that describe the open drainage of subcutaneous tissue and fascia
with a drainage device that are currently designated as non-O.R.
procedures. These procedures do not typically require the resources of
an operating room, and are not surgical in nature. Therefore, we are
proposing to remove the 22 codes listed in the following table from the
FY 2022 ICD-10 MS-DRGs Version 39 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.
[[Page 25160]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.084
[GRAPHIC] [TIFF OMITTED] TP10MY21.085
[[Page 25161]]
c. Non-O.R. Procedures to O.R. Procedures
(1) Percutaneous Introduction of Substance Into Cranial Cavity and
Brain
One requestor identified ICD-10-PCS procedure code XW0Q316
(Introduction of eladocagene exuparvovec into cranial cavity and brain,
percutaneous approach, new technology group 6) that the requestor
stated is currently not recognized as an O.R. procedure for purposes of
MS-DRG assignment. The requestor recommended that this procedure be
designated as an O.R. procedure because the procedure requires
traversing the skull in order to place a substance within the cranial
cavity or brain. The requestor noted that CMS disagreed with
designating this procedure as an O.R. procedure last year in the
absence of claims data; however, the requestor stated that because the
skull must be opened by drilling or cutting a burr hole through the
skull, this procedure warrants O.R. status similar to other
transcranial procedures performed with an open or percutaneous approach
that are classified as O.R. procedures.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
code XW0Q316 is currently designated as a non-O.R. procedure for
purposes of MS-DRG assignment. We agree with the requestor that
procedure code XW0Q316 describes a procedure that involves the creation
of a burr hole in the skull. In the FY 2021 IPPS/LTCH PPS final rule
(85 FR 58579 through 58580), we stated that, 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 further review and consideration, our clinical advisors agree
that procedure code XW0Q316 describing a procedure that is performed by
creating a burr hole in the skull warrants designation as an O.R.
procedure consistent with other percutaneous procedures performed on
the cranial cavity and brain body parts. Therefore, we are proposing to
add this procedure code to the FY 2022 ICD-10 MS-DRGs Version 39
Definitions Manual in Appendix E- Operating Room Procedures and
Procedure Code/MS-DRG Index as an O.R. procedure, assigned to 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) 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).
(2) Open Drainage of Maxilla and Mandible
One requestor identified three ICD-10-PCS procedure codes that
describe the open drainage of maxilla or mandible that the requestor
stated are currently not recognized as O.R. procedures for purposes of
MS-DRG assignment. The three procedure codes are listed in the
following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.086
The requestor stated that procedures that describe the open
drainage of the maxilla or mandible should be designated as O.R.
procedures because these procedures, indicated for diagnoses such as
subperiosteal abscesses, are performed in the operating room under
general anesthesia and involve making open incisions through muscle and
stripping away the periosteum. The requestor identified procedure codes
0W950ZZ (Drainage of lower jaw, open approach) and 0W940ZZ (Drainage of
upper jaw, open approach) that are currently designated as O.R.
procedures. The requestor noted that ICD-10-PCS guidelines instruct
that the procedure codes in Anatomical Regions, General, can be used
when the procedure is performed on an anatomical region rather than a
specific body part, or on the rare occasion when no information is
available to support assignment of a code to a specific body part. The
requestor stated that because bone is a specific body part in ICD-10-
PCS, procedure codes should be assigned for subperiosteal drainage of
mandible and maxilla bones from table 0N9, Drainage of Head and Facial
Bones, instead of codes from table 0W9, Drainage of Anatomical Regions,
General, when these procedures are performed. Therefore, the requestor
stated that procedure codes 0N9R0ZZ, 0N9T0ZZ, and 0N9V0ZZ should also
be recognized as O.R. procedures for purposes of MS-DRG assignment.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0N9R0ZZ, 0N9T0ZZ, and 0N9V0ZZ are currently designated as non-
O.R. procedures for purposes of MS-DRG assignment. Our clinical
advisors reviewed this issue and disagree that the procedures
describing the open drainage of the maxilla or mandible are typically
performed in the operating room under general anesthesia. Our clinical
advisors state that these procedures can be done in an oral surgeon's
office or an outpatient setting and are rarely performed in the
inpatient setting. Our clinical advisors also state a correlation
cannot be made between procedures performed in general anatomic regions
and procedures performed in specific body parts because these
procedures coded with the general anatomic regions body part represent
a broader range of procedures that cannot be coded to a specific body
part. Therefore, we are proposing to maintain the current non-O.R.
designation of ICD-10-PCS procedure codes 0N9R0ZZ, 0N9T0ZZ, and
0N9V0ZZ.
(3) Thoracoscopic Extirpation of Pleural Cavities
One requestor identified ICD-10-PCS procedure codes 0WC94ZZ
(Extirpation of matter from right pleural cavity, percutaneous
endoscopic approach) and 0WCB4ZZ (Extirpation of matter from left
pleural cavity, percutaneous
[[Page 25162]]
endoscopic approach) that the requestor stated are currently not
recognized as O.R. procedures for purposes of MS-DRG assignment. The
requestor stated that these procedures should be designated as O.R.
procedures because they are thoracoscopic procedures that are always
performed in the operating room under general anesthesia. The requestor
stated procedure codes 0W994ZZ (Drainage of right pleural cavity,
percutaneous endoscopic approach) and 0W9B4ZZ (Drainage of left pleural
cavity, percutaneous endoscopic approach) are currently designated as
O.R. procedures, therefore procedure codes 0WC94ZZ and 0WCB4ZZ should
also be recognized as O.R. procedures for purposes of MS-DRG assignment
because they utilize the same resources.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0WC94ZZ and 0WCB4ZZ are currently designated as non-O.R.
procedures for purposes of MS-DRG assignment. Our clinical advisors
reviewed this issue and disagree that procedure codes describing the
thoracoscopic drainage of the pleural cavities should necessarily have
the same designation as procedure codes describing the thoracoscopic
extirpation of matter from the pleural cavities. We note that our
review of the designation of ICD-10-PCS codes as an O.R. procedure or a
non-O.R. procedure considers the resources used as well as whether that
procedure should affect the MS-DRG assignment, and if so, in what way.
Our clinical advisors state that thoracoscopic drainage of the pleural
cavities is performed for distinct indications in clinically different
scenarios. Our clinical advisors state that drainage is the process of
taking out, or letting out, fluids and/or gases from a body part and is
typically performed in the pleural cavity for indications such as
congestive heart failure, infection, hemothorax and empyema. In
contrast, the procedures describing the thoracoscopic extirpation of
the pleural cavities are performed for a wider range of indications
because the solid matter removed may be an abnormal byproduct of a
biological function or a foreign body. Our clinical advisors note that
the thoracoscopic extirpation of the pleural cavities is generally
performed with other procedures such as heart transplant, lung
transplant mechanical ventilation, and other major chest procedures and
would not be the main reason for inpatient hospitalization or be
considered the principal driver of resource expenditure.
Therefore, we are proposing to maintain the current non-O.R.
designation of ICD-10-PCS procedure codes 0WC94ZZ and 0WCB4ZZ.
(4) Open Pleural Biopsy
One requestor identified ICD-10-PCS procedure codes 0BBN0ZX
(Excision of right pleura, open approach, diagnostic) and 0BBP0ZX
(Excision of left pleura, open approach, diagnostic), that describe an
open pleural biopsy that the requestor stated are performed in the
operating room with general anesthesia. The requestor also stated that
procedure codes 0BBN0ZZ (Excision of right pleura, open approach) and
0BBP0ZZ (Excision of left pleura, open approach) describing open
pleural biopsy for non-diagnostic purposes are justifiably designated
as O.R. procedures. According to the requestor, these procedure codes
describing an open pleural biopsy should be designated as O.R.
procedures regardless of whether they are performed for diagnostic or
therapeutic purposes.
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 procedures performed for a pleural biopsy by an open
approach, regardless of whether it is a diagnostic or therapeutic
procedure, should be designated as an O.R. procedure, we examined
procedure codes 0BBN0ZX, 0BBN0ZZ, 0BBP0ZX, and 0BBP0ZZ.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0BBN0ZZ and 0BBP0ZZ are currently designated as O.R. procedures,
however, procedure codes 0BBN0ZX and 0BBP0ZX are not recognized as O.R.
procedures for purposes of MS-DRG assignment. We agree with the
requestor that procedure codes 0BBN0ZX and 0BBP0ZX would typically
require the resources of an operating room. Our clinical advisors also
agree that procedure codes 0BBN0ZX and 0BBP0ZX would typically require
the resources of an operating room. Therefore, we are proposing to add
these 2 procedure codes to the FY 2022 ICD-10 MS-DRGs Version 39
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).
(5) Percutaneous Revision of Intraluminal Devices
One requestor identified five ICD-10-PCS procedure codes that
describe the percutaneous revision of intraluminal vascular devices
that the requestor stated are currently not recognized as O.R.
procedures for purposes of MS-DRG assignment. The five procedure codes
are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.087
The requestor stated that the procedure codes that describe the
percutaneous revision of intraluminal vascular devices within arteries,
veins, and great vessels should be designated as O.R. procedures to
compensate for the resources needed to perform these procedures. The
requestor also stated procedures to reattach, realign, or otherwise
revise intraluminal devices percutaneously require anesthesia,
specialized equipment for intravascular visualization, significant
skill, and time, therefore, it is important for these codes
[[Page 25163]]
to be designated with O.R. procedure status.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 02WY3DZ, 03WY3DZ, 04WY3DZ, 05WY3DZ, and 06WY3DZ are currently
designated as non-O.R. procedures for purposes of MS-DRG assignment. We
agree with the requestor that these five ICD-10-PCS procedure codes
typically require the resources of an operating room. Therefore, to the
FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E--
Operating Room Procedures and Procedure Code/MS-DRG Index, we are
proposing to add code 02WY3DZ as an O.R. procedure assigned to MS-DRGs
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). We are also proposing to add
codes 03WY3DZ, 04WY3DZ, 05WY3DZ, and 06WY3DZ as O.R. procedures
assigned to MS-DRGs 252, 253, and 254 (Other Vascular Procedures with
MCC, with CC, and without CC/MCC, respectively) in MDC 05 (Diseases and
Disorders of the Circulatory System).
(6) Occlusion of Left Atrial Appendage
One requestor identified nine ICD-10-PCS procedure codes that
describe left atrial appendage closure (LAAC) procedures that the
requestor stated are currently not recognized as O.R. procedures for
purposes of MS-DRG assignment in all instances. The nine procedure
codes are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.088
The requestor stated that these procedures are currently designated
as non-O.R. procedures that route to surgical MS-DRGs only when
assigned in combination with a principal diagnosis within MDC 05
(Diseases and Disorders of the Circulatory System). The requestor
stated these procedures should also be designated as O.R. procedures
when assigned in combination with diagnoses outside of the circulatory
system, such as sepsis or trauma, to compensate for the associated
resource use, skill requirements, and device costs.
In the ICD-10 MS-DRG Version 38.1 Definitions Manual, the nine ICD-
10-PCS procedure codes that describe left atrial appendage closure are
currently recognized as non-O.R. procedures that affect the MS-DRG to
which they are assigned. We refer readers to section II.D.5.d of the
preamble of this proposed rule, where we address ICD-10-PCS procedure
codes 02L70CK, 02L70DK, and 02L70ZK that describe a LAAC procedure
performed with an open approach. These codes were discussed in response
to a request to reassign these codes to MS-DRGs 228 and 229 (Other
Cardiothoracic Procedures with and without MCC, respectively) and, for
the reasons discussed, we are proposing to maintain the assignment in
MS-DRGs 273 and 274 (Percutaneous and Other Intracardiac Procedures
with and without MCC, respectively) in MDC 05.
Our clinical advisors reviewed this related issue and believe the
current designation of LAAC procedures as non-O.R. procedures that
affect the assignment for MS-DRGs 273 and 274 is clinically appropriate
to account for the subset of patients undergoing left atrial appendage
closure specifically. LAAC is indicated and approved as a treatment
option for patients diagnosed with atrial fibrillation, a heart rhythm
disorder that can lead to cardiovascular blood clot formation, who are
also at increased risk for stroke. LAAC procedures block off the left
atrial appendage to prevent emboli that may form in the left atrial
appendage from exiting and traveling to other sites in the vascular
system, thereby preventing the occurrence of ischemic stroke and
systemic thromboembolism. The ICD-10-CM diagnosis codes used to report
atrial fibrillation are currently assigned to MDC 05 (Diseases and
Disorders of the Circulatory System). Our clinical advisors believe
that circumstances in which a patient is admitted for a principal
diagnosis outside of MDC 05 and a left atrial appendage closure is
performed as the only surgical procedure in the same admission are
infrequent, and if they do occur, the LAAC procedure would not be a
significant contributing factor in the increased intensity of resources
needed for facilities to manage these complex cases. Our clinical
advisors state LAAC procedures generally do not require the resources
of an operating room. LAAC procedures are most often performed
percutaneously in settings such as cardiac catheterization laboratories
and take approximately one hour. When performed with an open approach
or percutaneous endoscopic approach, these procedures share similar
factors such as complexity, and resource
[[Page 25164]]
utilization with all other LAAC procedures. Therefore, we are proposing
to maintain the current designation of ICD-10-PCS procedure codes
02L70CK, 02L70DK, 02L70ZK, 02L73CK, 02L73DK, 02L73ZK, 02L74CK, 02L74DK,
and 02L74ZK as non-O.R. procedures affecting the MS-DRGs to which they
are assigned.
(7) Arthroscopic Drainage of Joints
One requestor identified six ICD-10-PCS procedure codes that
describe the percutaneous endoscopic drainage of joints 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.
[GRAPHIC] [TIFF OMITTED] TP10MY21.089
The requestor stated that these procedures should be designated as
O.R. procedures because procedures describing the arthroscopic drainage
of major joints such as knee, hip, and shoulder are performed in the
operating room under general anesthesia. The requestor stated these
procedures are indicated for conditions such as symptomatic septic/
pyogenic arthritis, which can require inpatient admission for
intravenous antibiotics and arthroscopic drainage to resolve infection.
Therefore, the requestor stated it is reasonable for these arthroscopic
procedures to be designated as O.R. procedures to compensate for
operating room resources.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0S9C4ZZ, 0S9D4ZZ, 0S994ZZ, 0S9B4ZZ, 0R9J4ZZ, and 0R9K4ZZ are
currently designated as non-O.R. procedures for purposes of MS-DRG
assignment. Our clinical advisors reviewed this issue and disagree that
procedures describing the percutaneous endoscopic drainage of major
joints such as knee, hip, and shoulder are typically performed in the
operating room under general anesthesia. With development of better
instrumentation and surgical techniques, many patients now have
arthroscopic procedures performed in an outpatient setting and return
home several hours after the procedure. Our clinical advisors also
state the percutaneous endoscopic drainage of joints can be performed
using local or regional anesthesia, and general anesthesia is not
always required. In cases where the patient is admitted for diagnoses
such as septic/pyogenic arthritis, as identified by the requestor, the
requirement for intravenous antibiotics would be the main reason for
admission because the percutaneous endoscopic drainage procedure could
be done as an outpatient. Therefore, we are proposing to maintain the
current non-O.R. designation of ICD-10-PCS procedure codes 0S9C4ZZ,
0S9D4ZZ, 0S994ZZ, 0S9B4ZZ, 0R9J4ZZ, and 0R9K4ZZ.
(8) Arthroscopic Irrigation of Joints
One requestor identified ICD-10-PCS procedure codes 3E1U48X
(Irrigation of joints using irrigating substance, percutaneous
endoscopic approach, diagnostic) and 3E1U48Z (Irrigation of joints
using irrigating substance, percutaneous endoscopic approach) that the
requestor stated are currently not recognized as O.R. procedures for
purposes of MS-DRG assignment. The requestor stated that these
procedures should be designated as O.R. procedures because the
arthroscopic irrigation of joints such as knee, hip, and shoulder is
performed in the operating room under general anesthesia. The requestor
states procedure codes 3E1U48X and 3E1U48Z are used to describe
surgical joint irrigations in the absence of more definitive
procedures, therefore procedure codes 3E1U48X and 3E1U48Z should be
recognized as O.R. procedures for purposes of MS-DRG assignment.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 3E1U48X and 3E1U48Z are currently designated as non-O.R.
procedures for purposes of MS-DRG assignment. Our clinical advisors
reviewed this issue and disagree that procedure codes describing the
arthroscopic irrigation of joints should be designated as O.R.
procedures. Our clinical advisors note the arthroscopic irrigation of
joints is rarely performed independently as a standalone procedure in
the inpatient setting to be considered the principal driver of resource
expenditure in those admissions. Instead, the arthroscopic irrigation
of joints is generally performed with other definitive procedures such
as debridement or synovectomy. We note that in the operative note sent
by the requestor to support the requested change in O.R. status, the
arthroscopic irrigation of the joint was performed along with a
surgical debridement procedure. Therefore, we are proposing to maintain
the current non-O.R. designation of ICD-10-PCS procedure codes 3E1U48X
and 3E1U48Z.
(9) Percutaneous Reposition With Internal Fixation
One requestor identified four ICD-10-PCS procedure codes describing
procedures performed on the sacroiliac and hip joints that involve
percutaneous repositioning with internal fixation that the requestor
stated are not recognized as O.R. procedures for purposes of MS-DRG
assignment but warrant an O.R. designation. The procedure codes are
listed in the following table.
[[Page 25165]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.090
Our clinical advisors reviewed the procedures described by these
four procedure codes and agree that these percutaneous reposition
procedures involving internal fixation in the sacroiliac and hip joint
warrant an O.R. designation. They noted that these procedures are major
operations that would require the resources of an operating room,
involve a higher level of technical complexity and a greater
utilization of hospital resources.
Therefore, we are proposing to add the two procedure codes
describing percutaneous reposition of the sacroiliac joint with
internal fixation procedures (0SS734Z and 0SS834Z) to the FY 2022 ICD-
10 MS-DRGs Version 39 Definitions Manual in Appendix E--Operating Room
Procedures and Procedure Code/MS-DRG Index as O.R. procedures, assigned
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 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue) 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
proposing to add the two procedure codes describing percutaneous
reposition of the hip joint with internal fixation procedures (0SS934Z
and 0SSB34Z) to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index as O.R. procedures, assigned to MS-DRGs 480, 481, and 482
(Hip and Femur Procedures Except Major Joint with MCC, with CC, and
without CC/MCC, respectively) in MDC 08 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue) 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).
(10) Open Insertion and Removal of Spacer Into Shoulder Joint
One requestor identified four ICD-10-PCS procedure codes describing
procedures performed on the shoulder joint that involve the insertion
or removal of a spacer by an open approach that the requestor stated
are not recognized as O.R. procedures for purposes of MS-DRG
assignment. The procedure codes are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.091
According to the requestor, insertion and removal of joint spacers
from the hips and knees are designated with an O.R. procedure status
and although similar procedures performed on the shoulder joint may be
performed less frequently, these procedures warrant an O.R. designation
because they are performed in the operating room under general
anesthesia. During our review, we noted that the following procedure
codes describing procedures performed on the shoulder joint that
involve the insertion or removal of a spacer by a percutaneous
endoscopic approach are also not recognized as O.R. procedures for
purposes of MS-DRG assignment.
[GRAPHIC] [TIFF OMITTED] TP10MY21.092
[[Page 25166]]
Our clinical advisors reviewed the procedures described by these
eight procedure codes and agree that these procedures involving the
insertion or removal of a spacer in the shoulder joint with an open or
percutaneous endoscopic approach warrant an O.R. designation. They
noted that the insertion of a spacer is typically performed to treat an
infection at the site of a previously placed prosthesis and the removal
of a spacer is typically performed once the infection is healed and the
site is ready for a new prosthetic replacement or to exchange for a new
spacer if the infection is not yet healed.
Therefore, we are proposing to add the listed procedure codes
describing the insertion or removal of spacer in the shoulder joint to
the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix
E--Operating Room Procedures and Procedure Code/MS-DRG Index as O.R.
procedures, assigned to MS-DRGs 510, 511, and 512 (Shoulder, Elbow or
Forearm Procedures, Except Major Joint Procedures with MCC, with CC,
and without CC/MCC, respectively) in MDC 08 (Diseases and Disorders of
the Musculoskeletal System and Connective Tissue) 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).
(11) Open/Percutaneous Extirpation of Jaw
One requestor identified four ICD-10-PCS procedure codes that
describe the extirpation of matter from the upper or lower jaw that the
requestor stated are currently not recognized as O.R. procedures for
purposes of MS-DRG assignment. The four procedure codes are listed in
the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.093
The requestor stated that the procedure codes that describe the
extirpation of matter from the upper or lower jaw by an open or
percutaneous endoscopic approach should be designated as O.R.
procedures. The requestor stated these procedures would commonly be
performed under general anesthesia and require the resources of an
operating room. The requestor also stated that these ICD-10-PCS codes
were specifically created to describe the surgical evacuation of solid
matter from deep jaw structures therefore, it is important for these
codes to be designated with O.R. procedure status.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0WC40ZZ, 0WC44ZZ, 0WC50ZZ, 0WC54ZZ are currently designated as
non-O.R. procedures for purposes of MS-DRG assignment. We agree with
the requestor that these four ICD-10-PCS procedure codes typically
require the resources of an operating room. Therefore, to the FY 2022
ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E--Operating
Room Procedures and Procedure Code/MS-DRG Index, we are proposing to
add codes 0WC40ZZ, 0WC44ZZ, 0WC50ZZ, 0WC54ZZ as O.R. procedures
assigned to MS-DRGs 143, 144 and 145 (Other Ear, Nose, Mouth and Throat
O.R. procedures, with MCC, with CC, and without CC/MCC, respectively)
in MDC 03 (Diseases and Disorders of the Ear, Nose, Mouth and Throat).
(12) Open Extirpation of Subcutaneous Tissue and Fascia
One requestor identified 22 ICD-10-PCS procedure codes that
describe the open extirpation of matter from the subcutaneous tissue
and fascia that the requestor stated are currently not recognized as
O.R. procedures for purposes of MS-DRG assignment. The 22 procedure
codes are listed in the following table.
[[Page 25167]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.094
The requestor stated that procedure codes that describe the open
extirpation of matter from the subcutaneous tissue and fascia should be
designated as O.R. procedures because these procedures are performed
through open incisions with direct visualization of subcutaneous tissue
and fascia in the operating room under general anesthesia. The
requestor noted procedure codes that describe the open drainage of
subcutaneous tissue and fascia and use comparable resources are
currently designated as O.R. procedures. The requestor noted that root
operation ``Drainage'' is assigned when fluid is drained; and root
operation of ``Extirpation'' is assigned when any of the substance
evacuated is solid. The requestor stated whether the evacuated
substance is fluid, gelatinous, or solid, a procedure involving an open
incision with direct visualization of subcutaneous tissue and fascia
for evacuation of substances should be classified as an O.R. procedure.
Therefore, the requestor stated that these procedures should also be
recognized as O.R. procedures for purposes of MS-DRG assignment.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, the 22 ICD-
10-PCS procedure codes listed in the table are currently designated as
non-O.R. procedures for purposes of MS-DRG assignment. While we
disagree that drainage procedures are comparable to extirpation
procedures, we agree with the requestor that these 22 ICD-10-PCS
procedure codes typically require the resources of an operating room.
Our clinical advisors state that drainage is the process of taking out,
or letting out, fluids and/or gases from a body part and is typically
performed for indications such as abscess, infection, and other
systemic conditions. In contrast, extirpation procedures are performed
for a wider range of indications because the solid matter removed may
be an abnormal byproduct of a biological function or a retained foreign
body. Therefore, to the FY 2022 ICD-10 MS-DRG Version 39 Definitions
Manual in Appendix E--Operating Room Procedures and Procedure Code/MS-
DRG Index, we are proposing to add the 22 ICD-10-PCS listed previously
as O.R. procedures assigned to MS-DRGs 579, 580 and 581 (Other Skin,
Subcutaneous Tissue and Breast Procedures, with MCC, with CC, and
without CC/MCC, respectively) in MDC 09 (Diseases and Disorders of the
Skin, Subcutaneous Tissue and Breast) 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).
(13) Open Revision and Removal of Devices From Subcutaneous Tissue and
Fascia
One requestor identified six ICD-10-PCS procedure codes describing
open revision and removal of neurostimulator generators, monitoring
devices, and totally implantable vascular access devices (TIVADs)
procedures that are not currently designated as O.R. procedures for
purposes of MS-DRG assignment. The six procedure codes are listed in
the following table.
[[Page 25168]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.096
The requestor stated that although removal of these devices is
often performed in outpatient surgery, device complications can require
removal or revision during inpatient hospitalizations. The requestor
indicated it is reasonable for these open procedures to be designated
as O.R. procedures to compensate for operating room resources during
such inpatient stays.
Our clinical advisors reviewed this request and do not agree that
these procedures warrant an O.R. designation. They noted that these
procedures are generally performed in the outpatient setting and when
performed during a hospitalization, it is typically in conjunction with
another O.R. procedure. Therefore, we are proposing to maintain the
current non-O.R. designation for procedure codes 0JPT0MZ, 0JPT02Z,
0JPT0WZ, 0JWT0MZ, 0JWT0WZ, and 0JWT03Z for FY 2022.
(14) Open Insertion of Feeding Device
One requestor identified ICD-10-PCS procedure code 0DHA0UZ
(Insertion of feeding device into jejunum, open approach) that the
requestor stated is currently not recognized as an O.R. procedure for
purposes of MS-DRG assignment. The requestor stated the open insertion
of a feeding device into the jejunum should be designated as an O.R.
procedure because this procedure is performed in the operating room
under general anesthesia. The requestor noted comparable procedure code
0DH60UZ (Insertion of feeding device into stomach, open approach) is
currently designated as an O.R. procedure. Therefore, the requestor
stated that procedure code 0DHA0UZ should also be recognized as an O.R.
procedure for purposes of MS-DRG assignment.
Our analysis of this issue confirmed that in the ICD-10 MS-DRG
Version 38.1 Definitions Manual, for purposes of MS-DRG assignment,
0DHA0UZ is recognized as a non-O.R. procedure and 0DH60UZ is currently
recognized as an O.R. procedure. In reviewing this request, we also
identified the following four related codes:
[GRAPHIC] [TIFF OMITTED] TP10MY21.097
In the ICD-10 MS-DRGs Version 38.1, these four ICD-10-PCS codes are
currently recognized as non-O.R. procedure for purposes of MS-DRG
assignment. While we agree with the requestor that procedures
describing the open insertion of a feeding device into the jejunum are
comparable to procedures describing the open insertion of a feeding
device into the stomach, we do not agree that these procedures should
be designated as O.R. procedures. Our clinical advisors state the
procedures that describe the open insertion of a feeding device into
the jejunum or the stomach should instead have the same designation as
the related ICD-10-PCS procedure codes that describe the open insertion
of a feeding device into the esophagus, small intestine, duodenum and
ileum that are currently designated as non-O.R. procedures.
With advancements in procedural techniques, feeding devices are
most commonly placed using a percutaneous endoscopic approach. Our
clinical advisors state feeding devices are usually not placed using an
open surgical approach; this approach is
[[Page 25169]]
generally only used if the patient requires another surgical procedure
at the same time. When placed at the same time as another surgical
procedure, our clinical advisors state the surgical procedure, as the
main determinant of resource use for those cases, should drive the MS-
DRG assignment, not the procedure that describes the open insertion of
a feeding device. For these reasons, our clinical advisors state
procedures that describe the open insertion of a feeding device in the
gastrointestinal system should all have the same non-O.R. designation
in the ICD-10 MS-DRGs Version 39 for coherence.
Therefore, we are proposing to maintain the current non-O.R.
designation of ICD-10-PCS procedure code 0DHA0UZ. We are also proposing
to remove ICD-10-PCS procedure code 0DH60UZ from the FY 2022 ICD-10 MS-
DRG Version 39 Definitions Manual in Appendix E--Operating Room
Procedures and Procedure Code/MS-DRG Index as an O.R. procedure. Under
this proposal, this procedure would no longer impact MS-DRG assignment.
(15) Laparoscopic Insertion of Feeding Tube
One requestor identified ICD-10-PCS procedure codes 0DH64UZ
(Insertion of feeding device into stomach, percutaneous endoscopic
approach) and 0DHA4UZ (Insertion of feeding device into jejunum,
percutaneous endoscopic approach) that the requestor stated are
currently not recognized as O.R. procedures for purposes of MS-DRG
assignment. The requestor stated the procedures describing the
percutaneous endoscopic insertion of a feeding device into the stomach
or the jejunum should be designated as O.R. procedures because these
procedures are performed in the operating room under general
anesthesia. The requestor stated all laparoscopic procedures,
regardless if they are diagnostic or therapeutic, should be classified
as O.R. procedures to compensate for operating room resources.
Our analysis of this issue confirmed that in the ICD-10 MS-DRG
Version 38.1 Definitions Manual, 0DH64UZ and 0DHA4UZ are currently
designated as non-O.R. procedures for purposes of MS-DRG assignment. In
reviewing this request, we also identified the following four related
codes:
[GRAPHIC] [TIFF OMITTED] TP10MY21.098
In the ICD-10 MS-DRGs Version 38.1, these four ICD-10-PCS codes are
currently recognized as non-O.R. procedures for purposes of MS-DRG
assignment. Our clinical advisors reviewed this request and do not
agree that unilaterally all laparoscopic procedures should be
designated as O.R. procedures. While the procedural approach is an
important consideration in the designation of a procedure, there are
other clinical factors such as the site of procedure, the procedure
complexity, and resource utilization that should also be considered. In
this regard, our clinical advisors indicated that codes 0DH64UZ and
0DHA4UZ describing the percutaneous endoscopic insertion of a feeding
device into the stomach or the jejunum, do not require the resources of
an operating room, are not surgical in nature, and are generally
performed in the outpatient setting. The percutaneous endoscopic
insertion of a feeding device also does not require general anesthesia.
As opposed to being rendered unconscious, patients can receive a local
anesthetic (usually a lidocaine spray), an intravenous (IV) pain
reliever, and a mild sedative if needed. Patients receiving these
devices usually return home the same day after placement, unless they
are in the hospital for treatment of another condition.
Our clinical advisors state the percutaneous endoscopic insertion
of a feeding device into the stomach or the jejunum is comparable to
the related ICD-10-PCS procedure codes that describe the insertion of
feeding devices of other gastrointestinal system body parts that are
currently designated as non-O.R. procedures. Our clinical advisors
believe all procedures that describe the percutaneous endoscopic
insertion of a feeding device in the gastrointestinal system should
continue to have the same non-O.R. designation in the ICD-10 MS-DRGs
Version 39 for coherence. Therefore, for the reasons discussed, we are
proposing to maintain the current non-O.R. designation of ICD-10-PCS
procedure codes 0DH64UZ and 0DHA4UZ.
(16) Endoscopic Fragmentation and Extirpation of Matter of Urinary
Tract
One requestor sent two separate but related requests related to
endoscopic procedures performed in the urinary system. With regard to
the first request, the requestor identified six ICD-10-PCS procedure
codes that describe endoscopic fragmentation in the kidney pelvis,
ureter, bladder, and bladder neck 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 25170]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.099
The requestor stated that these procedures should be designated as
O.R. procedures because procedures such as the endoscopic fragmentation
of calculi within the kidney pelvis, ureter, bladder, and bladder neck
are performed in the operating room under anesthesia. The requestor
stated that procedures that describe the endoscopic extirpation of
calculi from the kidney pelvis or ureter use comparable resources, and
are designated as O.R. procedures. Therefore, the requestor asserted it
is reasonable that procedure codes that describe endoscopic
fragmentation in kidney pelvis, ureter, bladder, and bladder neck also
be designated as O.R. procedures.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0TF38ZZ, 0TF48ZZ, 0TF68ZZ, 0TF78ZZ, 0TFB8ZZ, and 0TFC8ZZ are
designated as non-O.R. procedures for purposes of MS-DRG assignment.
Our clinical advisors reviewed this issue and disagree that procedures
describing the endoscopic fragmentation of calculi within the kidney
pelvis, ureter, bladder, and bladder neck are typically performed in
the operating room. In endoscopic fragmentation procedures in the
kidney pelvis, ureter, bladder, and bladder neck, the scope is passed
through a natural or artificial orifice. The procedure is not surgical
in nature and involves no skin incisions. With advancements in scope
size, deflection capabilities, video imaging, and instrumentation, many
patients now have these endoscopic urinary procedures performed in an
outpatient setting, instead of the inpatient setting. Therefore, we are
proposing to maintain the current non-O.R. designation of ICD-10-PCS
procedure codes 0TF38ZZ, 0TF48ZZ, 0TF68ZZ, 0TF78ZZ, 0TFB8ZZ, and
0TFC8ZZ.
In the second request, the requestor also identified two ICD-10-PCS
procedure codes that describe endoscopic extirpation of matter from the
bladder and bladder neck that the requestor stated are also currently
not recognized as O.R. procedures for purposes of MS-DRG assignment.
The two procedure codes are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.100
The requestor stated that these procedures also should be
designated as O.R. procedures because they performed in the operating
room under anesthesia.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0TCB8ZZ and 0TCC8ZZ are currently designated as a non-O.R.
procedure for purposes of MS-DRG assignment. To review the request to
designate 0TCB8ZZ and 0TCC8ZZ as O.R. procedures and in response to the
requestor's suggestion that resource consumption is comparable in
procedures describing endoscopic fragmentation in the urinary system
and procedures describing the endoscopic extirpation in the urinary
system, we examined the following procedure codes:
[[Page 25171]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.101
In the ICD-10 MS-DRG Version 38.1 Definitions Manual, these six
ICD-10-PCS procedure codes are currently recognized as O.R. procedures
for purposes of MS-DRG assignment. Our clinical advisors indicated that
these procedures are not surgical in nature. In endoscopic extirpation
procedures, the scope enters the urinary tract through the urethra,
which is the tube that carries urine out of the body, or through an
artificial orifice. Our clinical advisors state the urinary system is
one conduit so the scope continues to pass through the urethra,
bladder, and into the ureter or kidney (if necessary) to access the
stone. For that reason, the procedures describing endoscopic
extirpation from a urinary body part should all have the same non-O.R.
designation in the ICD-10 MS-DRGs Version 39 for coherence.
Therefore, we are proposing to maintain the current non-O.R.
designation of ICD-10-PCS procedure codes 0TCB8ZZ and 0TCC8ZZ. We are
also proposing to remove ICD-10-PCS procedure codes 0TC08ZZ, 0TC18ZZ,
0TC38ZZ, 0TC48ZZ, 0TC68ZZ, and 0TC78ZZ from the FY 2022 ICD-10 MS-DRG
Version 39 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.
(17) Endoscopic Removal of Ureteral Stent
One requestor identified ICD-10-PCS procedure code 0TP98DZ (Removal
of intraluminal device from ureter, via natural or artificial opening
endoscopic) that the requestor stated is not recognized as an O.R.
procedure for purposes of MS-DRG assignment. The requestor suggested
that this procedure warrants an O.R. designation because the procedure
code describes a procedure that is performed in the operating room with
anesthesia. The requestor stated that while most ureteral stents can be
removed by string, some complicated cases require endoscopic removal
using forceps in the operating room under general anesthesia and may be
performed during inpatient stays precipitated by severe urinary tract
infection, sepsis, or urinary obstructions. The requestor asserted that
procedure codes for insertion of ureteral stent(s) via a ureteroscopic,
endoscopic approach have been justifiably designated as O.R. procedures
because they are performed in the O.R. under anesthesia. Therefore, the
requestor suggested it is reasonable for endoscopic removal of the
stent to be designated with OR procedure status to compensate for
operating room resources and anesthesia.
Our clinical advisors reviewed this procedure and do not agree that
it warrants an O.R. designation. They noted that this procedure is
generally not the focus of the admission when it is performed and does
not reflect the technical complexity or resource intensity in
comparison to other procedures that are designated as O.R. procedures.
Therefore, we are proposing to maintain the current non-O.R.
designation for procedure code 0TP98DZ for FY 2022.
(18) Endoscopic/Transorifice Inspection of Ureter
One requestor identified ICD-10-PCS procedure code 0TJ98ZZ
(Inspection of ureter, via natural or artificial opening endoscopic),
that describes procedures involving endoscopic viewing of the ureter
that the requestor stated is currently not recognized as an O.R.
procedure for purposes of MS-DRG assignment.
The requestor stated this ureteroscopy procedure is performed in
the operating room with anesthesia. According to the requestor, the
inspection of ureter procedure code is assigned when obstruction is
found during the ureteroscopy and procedures to break up
(fragmentation), remove calculi (extirpation), or place a ureteral
stent cannot be performed.
Our clinical advisors reviewed this procedure and disagree that it
warrants an O.R. designation. They noted that this procedure typically
does not require hospitalization and is generally not the reason for
the patient's admission since it is often performed in connection with
another O.R. procedure when it is performed. Therefore, we are
proposing to maintain the current non-O.R. designation for procedure
code 0TJ789ZZ for FY 2022.
(19) Endoscopic Biopsy of Ureter and Kidney
One requestor identified six ICD-10-PCS procedure codes that
describe endoscopic biopsy procedures performed on the ureter and
kidney structures that the requestor stated are currently not
recognized as O.R. procedures for purposes of MS-DRG assignment.
According to the requestor, regardless of whether it is a diagnostic or
therapeutic procedure, these procedures should be designated as O.R.
procedures because the procedures utilize operating room, anesthesia
and recovery room resources. The requestor stated that after the
surgeon places the scope into the bladder that ureteral orifices must
be identified and instruments carefully navigated to obtain excisional
biopsies from within the ureter or further within the kidney.
[[Page 25172]]
The six procedure codes are listed in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.102
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.
Our clinical advisors do not agree that endoscopic biopsy
procedures performed on the ureter and kidney structures warrant an
O.R. designation. They stated these procedures are typically not the
focus for the patient's admission and are frequently performed in
conjunction with another O.R. procedure. Therefore, we are proposing to
maintain the current non-O.R. designation for procedure codes 0TB08ZX,
0TB18ZX, 0TB38ZX, 0TB48ZX, 0TB68ZX, and 0TB78ZX for FY 2022.
(20) Transorifice Insertion of Ureteral Stent
One requestor identified three ICD-10-PCS procedure codes that the
requestor stated are not recognized as O.R. procedures for purposes of
MS-DRG assignment. The requestor suggested that the procedure described
by these procedure codes warrants an O.R. designation because it
involves the insertion of an indwelling ureteral stent through a
nephrostomy with image-guidance in the interventional radiology suite.
According to the requestor, image-guided technology now allows
placement of ureteral stents through nephrostomy tracts. The requestor
stated this procedure may or may not be performed in the operating
room, however, it involves placement of device(s), interventional
radiology resources, sedation, and continuous monitoring of vital
signs. The three procedure codes are shown in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.103
Our clinical advisors reviewed this request and do not agree that
this procedure warrants an O.R. designation. They noted that this
procedure is not surgical in nature, does not require the resources of
an operating room and is not a technically complex procedure requiring
increased hospital resources. Therefore, we are proposing to maintain
the current non-O.R. designation for procedure codes 0T767DZ, 0T777DZ,
and 0T787DZ for FY 2022.
(21) Percutaneous Insertion of Ureteral Stent
One requestor identified three ICD-10-PCS procedure codes that the
requestor stated are not recognized as O.R. procedures for purposes of
MS-DRG assignment. The requestor suggested that the procedure described
by these procedure codes warrants an O.R. designation because the
procedure is typically performed following a failed ureteral stent
insertion procedure in the operating room, which can only be reported
as a cystoscopy or ureteroscopy, neither of which are designated as
O.R. procedures. According to the requestor, percutaneous ureteral
stenting through the abdominal wall is subsequently performed in an
interventional radiology suite with image-guidance, sedation, and
continuous vital sign monitoring. The three procedure codes are shown
in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.104
[[Page 25173]]
Our clinical advisors reviewed this request and do not agree that
the procedure warrants an O.R. designation. They noted that this
procedure is not surgical in nature, does not involve technical
complexity or require the resources of an operating rom. Therefore, we
are proposing to maintain the current non-O.R. designation for
procedure codes 0T763DZ, 0T773DZ, and 0T783DZ for FY 2022.
(22) Endoscopic Dilation of Urethra
One requestor identified ICD-10-PCS procedure code 0T7D8DZ
(Dilation of urethra with intraluminal device, via natural or
artificial opening endoscopic) that the requestor stated is not
recognized as an O.R. procedure for purposes of MS-DRG assignment. The
requestor suggested that this procedure warrants an O.R. designation
because the procedure code describes a procedure that utilizes the
UroLift[supreg] System, a minimally invasive technology to treat lower
urinary tract symptoms (LUTS) due to benign prostatic hyperplasia
(BPH). According to the requestor, the technology is placed
endoscopically within the prostatic urethra in the operating room under
anesthesia.
Our clinical advisors reviewed this request and do not agree that
the procedure warrants an O.R. designation. They noted that this
procedure is performed without incision, resection or thermal injury to
the prostate and is primarily performed in the outpatient setting. It
is generally not the cause for the patient's admission and utilization
of resources when it is performed. Therefore, we are proposing to
maintain the current non-O.R. designation for procedure code 00T7D8DZ
for FY 2022.
(23) Open Repair of Scrotum
One requestor identified ICD-10-PCS procedure code 0VQ50ZZ (Repair
scrotum, open approach) that the requestor stated is not recognized as
an O.R. procedure for purposes of MS-DRG assignment. The requestor
suggested that this procedure warrants an O.R. designation because it
involves repair of scrotal tissue deeper than the skin with direct
visualization and utilizes general anesthesia in the operating room.
Our clinical advisors do not agree that open repair of the scrotum
merits an O.R. designation. They stated this procedure would not
typically require the resources of an operating room and would
generally not be a contributing factor impacting hospital resource use
during the patient's admission when it is performed. Therefore, we are
proposing to maintain the current non-O.R. designation for procedure
code 0VQ50ZZ for FY 2022.
(24) Open Drainage of Vestibular Gland
One requestor identified ICD-10-PCS procedure code 0U9L0ZZ
(Drainage of vestibular gland, open approach) that describes a
procedure commonly performed for the treatment of an abscess that the
requestor stated is performed in the operating room under general
anesthesia and therefore warrants an O.R designation. The requestor
stated this procedure is comparable to the procedure described by
procedure code 0UBL0ZZ (Excision of vestibular gland, open approach)
which is currently designated as an O.R. procedure.
During our review of procedure code 0U9L0ZZ, we also examined
procedure codes 0U9L0ZX (Drainage of vestibular gland, open approach,
diagnostic), 0U9LXZX (Drainage of vestibular gland, external approach,
diagnostic), and 0UBL0ZZ. Separately, we reviewed procedure code
0T9D0ZZ (Drainage of urethra, open approach) because it represents the
male equivalent of the female procedure described by procedure code
0U9L0ZZ.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
codes 0T9D0ZZ, 0U9L0ZX, 0U9LXZX, and 0UBL0ZZ are currently designated
as O.R. procedures, however, procedure code 0U9L0ZZ is not recognized
as an O.R. procedure for purposes of MS-DRG assignment. We examined
procedure code 0U9L0ZZ and do not believe this drainage procedure
warrants an O.R. designation, nor do we agree that this drainage of the
vestibular gland procedure (0U9L0ZZ) is comparable to an excision of
the vestibular gland procedure (0UBL0ZZ), which is currently designated
as an O.R. procedure.
In the ICD-10-PCS classification, drainage is defined as taking or
letting out fluids and/or gases from a body part and excision is
defined as cutting out or off, without replacement, a portion of a body
part. Therefore, the classification specifically defines and
distinguishes the underlying objectives of each distinct procedure. Our
clinical advisors stated a drainage procedure is frequently performed
in the outpatient setting and is generally not the cause for the
patient's admission and utilization of resources when it is performed.
Drainage of the vestibular gland, also known as Bartholin's glands, is
typically indicated when a cyst or abscess is present and may or may
not involve the placement of a Word catheter. Conversely, excision of
the vestibular gland is not considered an office-based procedure and is
generally reserved for a vulvar mass or for patients who have not
responded to more conservative attempts to create a drainage tract. In
addition, after review, our clinical advisors recommended changing the
O.R. status for procedure codes 0U9L0ZX and 0U9LXZX from O.R. to non-
O.R. for similar reasons. These procedures do not typically require the
resources of an operating room.
Therefore, we are proposing to remove procedure codes 0U9L0ZX and
0U9LXZX from the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual
in Appendix E- Operating Room Procedures and Procedure Code/MS-DRG
Index as O.R. procedures. Under this proposal, these procedure codes
would no longer impact MS-DRG assignment. We refer the reader to
section II.D.10 of the preamble of this proposed rule for further
discussion related to procedure code 0T9D0ZZ.
(25) Transvaginal Repair of Vagina
One requestor identified ICD-10-PCS procedure code 0UQG7ZZ (Repair
vagina, via natural or artificial opening) that the requestor stated is
currently not recognized as an O.R. procedure for purposes of MS-DRG
assignment. The requestor stated that procedures described by this code
such as the non-obstetric transvaginal repair of the vaginal cuff and
the non-obstetric transvaginal repair of vaginal lacerations should be
designated as O.R. procedures because these procedures are performed in
the operating room under general anesthesia. The requestor noted
procedure codes 0USG7ZZ (Reposition vagina, via natural or artificial
opening), 0UBG7ZZ (Excision of vagina, via natural or artificial
opening), and 0UQG8ZZ (Repair vagina, via natural or artificial opening
endoscopic) are currently designated as O.R. procedures, therefore
procedure code 0UQG7ZZ should also be recognized as an O.R. procedure
for purposes of MS-DRG assignment.
In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure
code 0UQG7ZZ is currently designated as a non-O.R. procedure for
purposes of MS-DRG assignment. Our clinical advisors reviewed this
issue and disagree that a correlation can be made between procedures
described as the transvaginal repair of the vagina and the procedures
described by ICD-10-PCS codes 0USG7ZZ, 0UBG7ZZ, and 0UQG8ZZ. The root
operation ``repair'' represents a broad range of procedures for
restoring the anatomic structure of a body part such as suture of
lacerations, while the root operations ``reposition,'' and ``excision''
define procedures with more
[[Page 25174]]
distinct objectives. Also the approach ``via natural or artificial
opening'', for example, transvaginal, is defined as the entry of
instrumentation through a natural or artificial external opening to
reach the site of the procedure while the ``via natural or artificial
opening endoscopic approach'' is defined as the entry of
instrumentation (for example a scope) through a natural or artificial
external opening to both reach and visualize the site of the procedure.
Our clinical advisors also disagree that procedures described as the
transvaginal repair of the vagina are typically performed in the
operating room under general anesthesia. Our clinical advisors state
transvaginal repair can be performed using regional anesthesia, used to
numb only the area of the body that requires surgery instead of
rendering the patient unconscious. Therefore, for the reasons
described, we are proposing to maintain the current non-O.R.
designation of ICD-10-PCS procedure code 0UQG7ZZ.
(26) Percutaneous Tunneled Vascular Access Devices
One requestor identified ten ICD-10-PCS procedure codes describing
percutaneous insertion of tunneled vascular access devices into various
body parts that the requestor stated are not recognized as an O.R.
procedure for purposes of MS-DRG assignment. The requestor suggested
that these procedures warrant an O.R. designation because they are
placed in an interventional radiology suite or in the operating room
under anesthesia. The ten procedure codes are shown in the following
table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.105
According to the requestor, it does not make sense for tunneled
vascular access devices to group to procedural MS-DRGs in limited
circumstances as is the case currently with the logic in MDC 9
(Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast)
and MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract).
The requestor stated that these procedures should be grouping to
procedural MS-DRGs across all MDCs.
We note that we have addressed requests related to these procedures
in previous rulemaking (85 FR 58511 through 58517). Our clinical
advisors reviewed this request and disagree that procedures performed
to insert a tunneled vascular access device should group to procedural
MS-DRGs across all MDCs. They stated that these percutaneous procedures
are generally performed in the outpatient setting and when performed
during a hospitalization, they are frequently performed in combination
with another O.R. procedure. Therefore, we are proposing to maintain
the current non-O.R. status for the ten procedure codes listed
previously for FY 2022.
12. Proposed Changes to the MS-DRG Diagnosis Codes for FY 2022
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
[[Page 25175]]
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 (NonCC, 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 NonCC 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 assigning severity
levels to new codes and 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
through 19246) 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 proposed 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 proposed 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 NonCC to a CC. We stated that postponing
adoption of the proposed 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 proposed severity level designation
changes for FY 2020.
We discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58550
through 58554) 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 nine guiding principles and plan to present the
findings and proposals in future rulemaking. The nine guiding
principles are 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.
We refer readers to the FY 2021 IPPS/LTCH PPS final rule for a
complete discussion of our response to public comments regarding the
nine guiding principles. 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 ensure that the severity designation appropriately reflects
resource use for any diagnosis code.
For new diagnosis codes approved for FY 2022, consistent with our
annual process for designating a severity level (MCC, CC or NonCC) for
new diagnosis codes, we first review the predecessor code designation,
followed by review and consideration of other factors that may be
relevant to the severity level designation, including the severity of
illness, treatment difficulty, complexity of service and the resources
utilized in the diagnosis and/or treatment of the condition. We note
that this process does not automatically result in the new diagnosis
code having the same designation as the predecessor code. We refer the
reader to II.D.13 of this proposed rule for the discussion of the
proposed changes to the ICD-10-CM and ICD-10-PCS coding systems for FY
2022.
For this FY 2022 IPPS/LTCH PPS proposed rule, we received several
requests to change the severity level designations of specific ICD-10-
CM diagnosis codes. Our clinical advisors believe it is appropriate to
consider these requests in connection with our continued comprehensive
CC/MCC analysis in future rulemaking, rather than proposing to change
the designation of individual ICD-10-CM diagnosis codes at this time.
As stated earlier in this section, 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 will consider
these individual requests received for changes to severity level
designations as we continue our comprehensive CC/MCC analysis and will
provide more detail in future rulemaking.
c. Potential Change to Severity Level Designation for Unspecified
Diagnosis Codes for FY 2022
For this FY 2022 IPPS/LTCH PPS proposed rule, as another interval
step as we continue to address the comprehensive review of the severity
designations of ICD-10-CM diagnosis codes in which we have been engaged
over the past two years, we are requesting public comments on a
potential change to the severity level designations for ``unspecified''
ICD-10-CM diagnosis codes that we are considering adopting for FY 2022.
[[Page 25176]]
Specifically, we are considering changing the severity level
designation of all ``unspecified'' diagnosis codes to a NonCC where
there are other codes available in that code subcategory that further
specify the anatomic site, effective for FY 2022, after consideration
of the public comments we receive in response to this proposed rule.
According to the ICD-10-CM Official Guidelines for Coding and
Reporting, codes titled ``unspecified'' are for use when the
information in the medical record is insufficient to assign a more
specific code. In our review of severity level designation of the codes
in the ICD-10-CM classification, we noted 3,490 ``unspecified''
diagnosis codes designated as either CC or MCC, where there are other
codes available in that code subcategory that further specify the
anatomic site with an equivalent severity level designation. For
example, ICD-10-CM code L89.003 (Pressure ulcer of unspecified elbow,
stage 3) is currently designated as a MCC. In the same code subcategory
of L89.0- (Pressure ulcer of elbow), ICD-10-CM codes L89.013 (Pressure
ulcer of right elbow, stage 3) and code L89.023 (Pressure ulcer of left
elbow, stage 3) are also designed as MCCs.
In the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159), we described
the categorization of diagnoses as an MCC, a CC, or a NonCC,
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. As such, the
designation of CC or MCC is intended to account for the increased
resources required to address a condition as a secondary diagnosis. The
usage of ``unspecified'' diagnosis codes where there are other codes
available in that code subcategory that further specify the anatomic
site may contribute to and eventually result in less reliable data for
researching clinical outcomes. If documentation is not available to
code to the highest level of specificity as to the laterality of the
condition treated, and an unspecified code is reported by the hospital,
it may be harder to quantify in the claims data what additional
resources were expended to address that condition in terms of requiring
clinical evaluation, therapeutic treatment, diagnostic procedures,
extended length of hospital stay, increased nursing care and/or
monitoring.
As stated previously, we discussed in the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58550 through 58554) that 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, and plan to present the findings and proposals in future
rulemaking. As patients present with a variety of diagnoses, in
examining the secondary diagnoses, we stated we would consider what
additional resources are required, that surpasses 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. We believe more robust claims data would facilitate this effort to
determine the impact on resource use and inform our decision-making in
determining the most appropriate CC subclass (NonCC, CC, or MCC)
assignment for each diagnosis as a secondary diagnosis. As part of this
effort, we are soliciting comments on adopting a change to the severity
level designation of the 3,490 ``unspecified'' diagnosis codes
currently designated as either CC or MCC, where there are other codes
available in that code subcategory that further specify the anatomic
site, to a NonCC for FY 2022.
As discussed in the HIPAA Administrative Simplification:
Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and
ICD-10-PCS proposed rule (73 FR 49796 through 49803), in proposing the
adoption of ICD-10-CM and ICD-10-PCS, we listed that the addition of
laterality in ICD-10-CM-- specifying which organ or part of the body is
involved when the location could be on the right, the left, or could be
bilateral, was one of several improvements over ICD-9-CM. We also noted
that in comparison to ICD-9-CM, ICD-10-CM diagnosis codes are very
specific and that this specificity improves the richness of data for
analysis and improves the accuracy of data used for medical research.
In the Modifications to Medical Data Code Set Standards To Adopt ICD-
10-CM and ICD-10-PCS final rule (74 FR 3328 through 3362), we adopted
the ICD-10-CM and ICD-10-PCS as medical data code sets under HIPAA,
replacing ICD-9-CM Volumes 1 and 2, and Volume 3 and noted that ICD-10-
CM and ICD-10-PCS provide specific diagnosis and treatment information
that can improve quality measurements and patient safety, and the
evaluation of medical processes and outcomes. We continue to believe
that reporting the most specific diagnosis codes supported by the
available medical record documentation and clinical knowledge of the
patient's health condition would more accurately reflect the health
care encounter and improve the reliability and validity of the coded
data.
We believe that changing the severity level for these ``unspecified
codes'' as compared to the more specific codes in the same subcategory
recognizing laterality would leverage the additional specificity
available under the ICD-10 system, by fostering the reporting of the
most specific diagnosis codes supported by the available medical record
documentation and clinical knowledge of the patient's health condition
to more accurately reflect each health care encounter and improve the
reliability and validity of the coded data. However in consideration of
the PHE, and to the extent that some providers may not currently have
programs in place that focus on improving documentation, we are
requesting public comments on making this change to the severity level
designation for these unspecified ICD-10-CM diagnosis codes for FY
2022.
The diagnosis codes for which we are soliciting comments on a
change in severity level designation as described in this proposed rule
are shown in Table 6P.2a (which is available via the internet on the
CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html). We note we are also
making available the data describing the impact on resource use when
reported as a secondary diagnosis for all 3,490 ICD-10-CM unspecified
diagnosis codes. While these claims data were not used in our
identification of the ``unspecified'' diagnosis codes for which there
are other codes available in the code subcategory that further specify
the anatomic site, as mentioned earlier in this section, these data are
consistent with data historically used to mathematically measure impact
on resource use for secondary diagnoses, and the data which we plan to
use in combination with application of the nine guiding principles as
we continue a comprehensive CC/MCC analysis. Therefore, we are
displaying the data on these unspecified codes in order to facilitate
public comment on these potential changes in the severity level
designation for these codes.
In Table 6P.2a associated with this proposed rule, column C
displays the FY 2020 severity level designation for these diagnosis
codes in MS-DRG Grouper Version 37.2. Column D displays CMS' current FY
2021 severity level designation in MS-DRG Grouper
[[Page 25177]]
Version 38.1 and column E displays the potential changes to the
severity level designation that we are considering adopting. Columns F-
O show data on the impact on resource use generated using discharge
claims from the September 2019 update of the FY 2019 MedPAR file and
MS-DRG Grouper Version 37.2. Columns Q-Z show data on the impact on
resource use generated using discharge claims from the September 2020
update of the FY 2020 MedPAR file and MS-DRG Grouper Version 38.1.
For further information on the data on the impact on resource use
as displayed in Columns F-O and Columns Q-Z, we refer readers to the FY
2008 IPPS/LTCH PPS final rule (72 FR 47159) for a complete discussion
of the methodology utilized to mathematically measure the impact on
resource use. Also, 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 this methodology
utilized to mathematically measure the impact on resource use. 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/MedicareFee-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.
This table shows the Version 38.1 ICD-10 MS-DRG categorization of
diagnosis codes by severity level.
[GRAPHIC] [TIFF OMITTED] TP10MY21.106
We are requesting public comments on a modification to the Version
38.1 severity level subclass assignments for 4.8 percent of the ICD-10-
CM diagnosis codes, potentially effective with the Version 39 ICD-10
MS-DRG MCC/CC list. The following table compares the Version 38.1 ICD-
10 MS-DRG MCC/CC list and the potential Version 39 ICD-10 MS-DRG MCC/CC
list. There are 17,957 diagnosis codes on the Version 38.1 MCC/CC
lists. These potential MCC/CC severity level changes would reduce the
number of diagnosis codes on the MCC/CC lists to 14,467 (2,771+
11,696).
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The net result of these potential changes to the Version 39 ICD-10
MS-DRG MCC/CC list, for the 72,621 diagnosis codes in the ICD-10-CM
classification, would be a decrease of 507 (3,278-2,771) codes
designated as an MCC, a decrease of 2,983 (14,679-11,696) codes
designated as a CC, and an increase of 3,490 (58,154-54,664) codes
designated as a NonCC.
The following table compares the Version 38.1 ICD-10 MS-DRG
severity level list and the potential Version 39 ICD-10 MS-DRG severity
level list by each of the 22 chapters of the ICD-10-CM classification
to display how each chapter of ICD-10-CM might be affected by these
modifications.
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As shown in the table, the Diseases of the Musculoskeletal System
and Connective Tissue (M00-M99) chapter of ICD-10-CM would have the
largest percentage reduction in codes designated as CC/MCC. Twelve
chapters would have a zero percentage change to the percentage of codes
designated as CC/MCC.
As stated previously, we are requesting public comments on our
possible adoption of a change to the severity level designation of
these 3,490 ``unspecified'' diagnosis codes currently designated as
either CC or MCC, where there are other codes available in that code
subcategory that further specify the anatomic site, to a NonCC,
potentially effective with the Version 39 ICD-10 MS-DRG MCC/CC list. As
part of this request, we would be interested in comments regarding
whether this modification might present operational challenges and how
we might otherwise foster the reporting of the most specific diagnosis
codes supported by the available medical record documentation and
clinical knowledge of the patient's health condition to more accurately
[[Page 25180]]
reflect each health care encounter and improve the reliability and
validity of the coded data.
d. Proposed Additions and Deletions to the Diagnosis Code Severity
Levels for FY 2022
The following tables identify the proposed additions and deletions
to the diagnosis code MCC severity levels list and the proposed
additions to the diagnosis code CC severity levels list for FY 2022 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--FY2022;
Table 6I.2-- Proposed Deletions to the MCC List--FY2022; and
Table 6J.1-- Proposed Additions to the CC List--FY2022.
e. Proposed CC Exclusions List for FY 2022
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 38.1 CC Exclusion List is included as
Appendix C in the ICD-10 MS-DRG Definitions Manual, which is available
via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html, and
includes two lists identified as Part 1 and Part 2. Part 1 is the list
of all diagnosis codes that are defined as a CC or MCC when reported as
a secondary diagnosis. For all diagnosis codes on the list, a link is
provided to a collection of diagnosis codes which, when reported as the
principal diagnosis, would cause the CC or MCC diagnosis to be
considered as a NonCC. Part 2 is the list of diagnosis codes designated
as a MCC only for patients discharged alive; otherwise, they are
assigned as a NonCC.
As discussed in section II.D.12.c. of the preamble of this proposed
rule, we are requesting public comments on potential changes to the
severity level for 3,490 diagnosis codes describing an ``unspecified''
anatomic site, from a CC severity level to a NonCC severity level, for
FY 2022. We refer the reader to Table 6P.3a associated with this
proposed rule (which is available via the internet on the CMS website
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) for the list of the 3,490 diagnosis codes
that are currently listed in Part 1 of the CC Exclusions List and are
defined as a CC when reported as a secondary diagnosis. Table 6P.3a is
divided into several tabs, with the first tab titled ``SDX Codes and
Exclu Categories'' containing columns A, B, and C. Column A (titled
``ICD-10-CM Code'') lists the ``unspecified'' diagnosis codes that are
currently listed in Part 1 of Appendix C of the CC Exclusions List,
column B (titled ``Description'') lists the narrative description of
each diagnosis code, and column C (titled Exclusion Category) contains
a hyperlink to the collection of diagnosis codes which, when reported
as the principal diagnosis, would cause the CC diagnosis to be
considered as a NonCC. For example, for line 2, Column A displays
diagnosis code C34.00, column B displays ``Malignant neoplasm of
unspecified main bronchus'' and column C displays a hyperlink to
Exclusion Category number 280. When the user clicks on the hyperlink
for number 280, they are directed to another tab labeled ``PDX Category
280'' that contains the list of diagnosis codes which, when reported as
the principal diagnosis, would cause the corresponding CC diagnosis to
be considered as a NonCC. In connection with the request for public
comments on the potential changes to the severity level for 3,490
diagnosis codes describing an ``unspecified'' anatomic site, from a CC
severity level to a NonCC severity level for FY 2022, Table 6P.3a is
being made available for readers to review and consider the list of the
3,490 ``unspecified'' diagnosis codes that are currently included in
Part 1 of the CC Exclusions List and the principal diagnosis exclusion
category with which they are currently associated. If we were to
finalize the potential changes to the severity level for the 3,490
diagnosis codes describing an ``unspecified'' anatomic site from a CC
severity level to a NonCC severity level for FY 2022, we would also
finalize the removal of these codes from the CC Exclusions List for FY
2022.
We received three requests related to the CC Exclusions List logic,
as we discuss in this section of this proposed rule.
We received a request to review the secondary diagnoses that are
excluded as a CC or MCC in the CC Exclusions List logic when any one of
the following three diagnosis codes is reported as the principal
diagnosis.
[[Page 25181]]
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According to the requestor, in the ICD-10 MS-DRGs version 37.2 CC
Exclusions List logic, the predecessor code for the listed diagnosis
codes, diagnosis code O99.89 (Other specified diseases and conditions
complicating pregnancy, childbirth and the puerperium) is listed in the
collection of principal diagnosis list number 1000, therefore, when a
CC or MCC secondary diagnosis associated with that principal diagnosis
list describes a condition as occurring in pregnancy, childbirth or the
puerperium, the CC Exclusions List logic will render that diagnosis
code as a NonCC. The requestor stated that because diagnosis code
O99.89 under version 37.2 of the ICD-10 MS-DRGs is now a subcategory
under version 38.1 of the ICD-10 MS-DRGs, with three unique diagnosis
codes to specify which obstetric stage the patient is in, that further
analysis of the new diagnosis codes (O99.891, O99.892, and O99.893)
should occur to determine if changes to the collection of principal
diagnosis list is warranted. The requestor provided three examples for
CMS to review and consider for possible changes to the CC Exclusions
List logic.
In the first example, the requestor noted that diagnosis code O72.1
(Other immediate postpartum hemorrhage) is listed as a CC secondary
diagnosis associated with the collection of principal diagnosis list
number 1000, and that under the ICD-10 MS-DRGs version 38.1 CC
Exclusions List logic, the diagnosis listed in principal diagnosis
collection 1000 is now diagnosis code O99.893 (Other specified diseases
and conditions complicating puerperium). Thus, both diagnosis codes
(O72.1 and O99.893) are describing conditions occurring specifically in
the postpartum or puerperium period. The postpartum period is defined
as the period beginning immediately after delivery and continues for
six weeks following delivery. A postpartum complication is any
complication occurring within the six-week period. The requestor stated
that because diagnosis code O72.1 is assigned for documented postpartum
uterine atony with hemorrhage when it occurs immediately following the
delivery of the baby and placenta, that CMS should review diagnosis
code O99.892 (Other specified diseases and conditions complicating
childbirth) and determine if it should be added to the collection of
principal diagnosis list number 1000 to cause diagnosis code O72.1 to
be considered as a NonCC when diagnosis code O99.892 is reported as the
principal diagnosis.
In the second example, the requestor noted that diagnosis code
O98.32 (Other infections with a predominantly sexual mode of
transmission complicating childbirth) is associated with principal
diagnosis collection number 1012. The requestor also noted that
principal diagnosis collection number 1012 does not list diagnosis
codes O99.891, O99.892, or O99.893 as a principal diagnosis to exclude
the CC secondary diagnosis code O98.32, however, it does list diagnosis
codes O98.311 (Other infections with a predominantly sexual mode of
transmission complicating pregnancy, first trimester), O98.312 (Other
infections with a predominantly sexual mode of transmission
complicating pregnancy, second trimester), and O98.313 (Other
infections with a predominantly sexual mode of transmission
complicating pregnancy, third trimester) as a principal diagnosis to
exclude the CC secondary diagnosis code O98.32. The requestor
recommended CMS review diagnosis codes O98.32 (Other infections with a
predominantly sexual mode of transmission complicating childbirth) and
O98.33 (Other infections with a predominantly sexual mode of
transmission complicating the puerperium), to determine if diagnosis
codes O99.891, O99.892 or O99.893, when reported as a principal
diagnosis, should exclude CC secondary diagnosis codes O98.32 and
O98.33. Thus, the requestor suggested CMS consider if it is appropriate
to add diagnosis codes O99.891, O99.892 and O99.893 to principal
diagnosis collection number 1012 to cause diagnosis code O98.32 to be
considered as a NonCC when diagnosis codes O99.891, O99.892 or O99.893
are reported as the principal diagnosis.
In the third example, the requestor noted that diagnosis code O87.2
(Hemorrhoids in the puerperium) is associated with principal diagnosis
collection number 4041. The requestor also noted that principal
diagnosis collection number 4041 lists diagnosis code O99.893 as a
principal diagnosis to exclude the CC diagnosis code O87.2, however, it
does not list diagnosis code O99.892. The requestor further noted that
the ``Includes'' note at Category O87 (Venous complications and
hemorrhoids in the puerperium) in the FY 2021 ICD-10-CM Tabular List
includes ``venous complications in labor, delivery and the
puerperium'', therefore, diagnosis code O87.2 would also be reported
for documented hemorrhoids during labor and delivery. The requestor
recommended CMS review diagnosis code O99.892 to determine if, when
reported as a principal diagnosis, it should exclude CC diagnosis code
O87.2. Thus, the requestor suggested CMS consider if it is appropriate
to add diagnosis code O99.892 to principal diagnosis collection number
4041 to cause diagnosis code O87.2 to be considered as a NonCC when
diagnosis code O99.892 is reported as the principal diagnosis.
We reviewed diagnosis codes O99.891, O99.892 and O99.893 with
respect to the principal diagnosis collection list and because these
diagnosis codes are specifically describing ``other specified diseases
and conditions complicating pregnancy, childbirth, and the
puerperium,'' respectively, we do not believe that any of these three
diagnosis codes, when reported as a principal diagnosis, should exclude
any CC secondary diagnosis. In cases where any one of these three
diagnosis codes is reported as a principal diagnosis, which are
generally anticipated to be rare, it is understood that there is not a
more specific diagnosis code available in the classification to report
as the principal diagnosis that identifies the underlying or associated
cause of the disease or the condition complicating the specific
obstetric stage (pregnancy, childbirth, or puerperium), hence the
``other specified'' in the code title. Specifically, the title of
category O99 is ``Other maternal diseases classifiable elsewhere but
complicating pregnancy, childbirth and the puerperium'' and there are
nine subcategories, each of which is generally associated with a single
organ
[[Page 25182]]
system or etiology, with the exception of the ``other specified''
subcategory (O99.8) as displayed in the following table.
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The instructional note at category O99 states ``use additional code
to identify specific condition'' and included at each subcategory
(O99.0-O99.7) are a range of codes that refer to diagnoses that are
associated with the condition in the title of the subcategory that are
to be reported in addition to the applicable code within the respective
subcategory. For example, at subcategory O99.0 (Anemia complicating
pregnancy, childbirth, and the puerperium), the range of associated
codes to identify the specific condition (for example, type of anemia)
includes conditions in diagnosis code range D50-D64, meaning that when
any one of the diagnosis codes under subcategory O99.0 describing
anemia complicating a specific obstetric stage (pregnancy, childbirth,
or puerperium) is reported, a code within the D50-D64 code range to
identify the specific type of anemia would also be expected to be
reported when supported by the medical record documentation. It is
therefore reasonable to associate the two conditions (one from
subcategory O99.0 and one from code range D50-D64) when reported on a
claim. However, the same cannot be stated for subcategory O99.8. There
is no range of associated codes from which users are instructed to
report located at this particular subcategory in addition to the
specific code under sub-subcategory O99.89 (Other specified diseases
and conditions complicating pregnancy, childbirth and the puerperium).
We note that subcategory O99.8 and sub-subcategory O99.89 have the same
title. Therefore, when a diagnosis code from other than that sub-
subcategory is reported that describes a condition occurring in any one
of the obstetric stages (pregnancy, childbirth, or puerperium) it is
not clear if the condition can reasonably be associated to correspond
to the ``other specified diseases and conditions'' diagnosis. In
addition, the code ranges included at subcategory O99.8 are D00-D48,
H00-H95, M00-N99, and Q00-Q99. Consequently, diagnosis codes within
those code ranges would be expected to be reported with one of the
diagnosis codes under subcategory O99.8 when reported as a principal
diagnosis.
In all three of the requestor's examples, the diagnosis codes
provided for CMS to review and consider are located in the ``O'' code
range (O72.1, O98.32, and O87.2 in addition to O99.891, O99.892, and
O99.893). As noted previously, the code ranges included at subcategory
O99.8 as listed, do not include any codes in ``O'' code range. Upon
review of the diagnosis codes provided by the requestor, it is also
reasonable to expect that any one of those diagnosis codes (O72.1,
O98.32, and O87.2) could be reported as a principal diagnosis alone.
For instance, there are no instructional notes at diagnosis code O72.1
that preclude that diagnosis code from being reported as the principal
diagnosis.
During our review of the CC Exclusions List logic in response to
the requestor's recommendations, we also identified some diagnosis
codes describing the specific trimester of pregnancy that we believe
warrant further examination. We are unable to fully evaluate these
conditions for FY 2022, therefore, we will continue to analyze for
future rulemaking.
For the reasons discussed, we do not believe that any of the three
diagnosis codes (O99.891, O99.892, and O99.893), when reported as a
principal diagnosis, should exclude any CC secondary diagnosis.
Therefore, we are proposing to remove diagnosis codes O99.891, O99.892,
and O99.893 from the CC Exclusions List logic principal diagnosis
collection lists. Specifically, we are proposing to remove those
diagnosis codes from the following principal
[[Page 25183]]
diagnosis collection list numbers 0085, 0954, 0956 through 0963, 0972,
0988, 0991 through 0998, 1000 through 1002, 1004, 1006, 1009, 1011,
1014, 1015, 1019, 3999, 4000, 4002 through 4006, 4008, 4010, through
4013, 4017, 4020, 4021, 4023 through 4026, 4030, 4031, 4033 through
4043, 4050 through 4054, 4059 through 4063, 4065 and 4067, effective FY
2022.
We also received a request to review diagnosis codes describing
oxygen dependence, chronic obstructive pulmonary disease with
exacerbation, and chronic respiratory failure with regard to assignment
in MS-DRG 191 (Chronic Obstructive Pulmonary Disease with CC) and to
consider whether any changes to principal diagnosis collection number
0744 in the CC Exclusions List logic are warranted.
The requestor provided diagnosis codes J44.1 (Chronic obstructive
pulmonary disease with (acute) exacerbation), J96.11 (Chronic
respiratory failure with hypoxia (CC)) and Z99.81 (Dependence on
supplemental oxygen) for CMS to review. Specifically, the requestor
suggested that if oxygen dependence, by definition, is clinically
inherent to chronic respiratory failure, then CMS should consider
adding diagnosis code J44.1 to the CC Exclusions List logic principal
diagnosis collection list number 0744 and cause diagnosis code J96.11
to be considered as a NonCC when J44.1 is reported as the principal
diagnosis.
We reviewed the diagnosis codes and MS-DRG assignment as the
requestor suggested. We confirmed that when diagnosis code J44.1 is
reported as the principal diagnosis with the CC secondary diagnosis
code J96.11, and secondary diagnosis code Z99.81, the resulting MS-DRG
assignment is MS-DRG 191. We believe that diagnosis code J96.11 should
continue to group as a CC, to the ``with CC'' MS-DRG 191, when reported
as a secondary diagnosis code with diagnosis code J44.1 reported as the
principal diagnosis. We disagree with the requestor's suggestion that
every oxygen-dependent COPD patient has chronic respiratory failure,
and that separately reporting the chronic respiratory failure is
clinically redundant. Patients can be oxygen-dependent with COPD and
not have a diagnosis of chronic respiratory failure. Therefore, we are
proposing to maintain the structure of principal diagnosis collection
list number 0744 in the CC Exclusions List logic for FY 2022.
Finally, we received a request to reconsider the MCC exclusions for
diagnosis code I11.0 (Hypertensive heart disease with heart failure)
when reported as the principal diagnosis. According to the requestor,
there appears to be an inconsistency for the CC Exclusions List logic.
Specifically, the requestor noted that when diagnosis code I11.0 is
reported as the principal diagnosis, it causes the following MCC
secondary diagnosis codes to be considered as a NonCC.
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However, the requestor stated that diagnosis codes I50.21 (Acute
systolic (congestive) heart failure) and I50.31 (Acute diastolic
(congestive) heart failure) are not excluded from acting as MCCs when
diagnosis code I11.0 is reported as the principal diagnosis. The
requestor also stated that all diagnosis codes in category I50 (Heart
Failure) share common etiologies and demonstrate comparable severity of
illness. Therefore, the requestor suggested that none of the conditions
in this category (I50) should be excluded from acting as a MCC when
diagnosis code I11.0 is reported as a principal diagnosis.
We examined all the diagnosis codes in category I50 with regard to
the CC Exclusions List logic. In addition to diagnosis code I11.0, we
also reviewed 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) when reported as a principal
diagnosis because that diagnosis code also has the Tabular instruction
``use additional code to identify the type of heart failure''.
We found additional inconsistencies in the CC secondary diagnosis
heart failure codes where some diagnoses were excluded depending on the
principal diagnosis reported and others were not excluded. As a result,
we are proposing to revise the CC Exclusions Logic list for diagnosis
codes I11.0 and I13.2 when reported as a principal diagnosis to ensure
they are consistent in the CC and MCC diagnoses they exclude. In the
following table we show the findings for each diagnosis code in
category I50 with respect to the current severity level (MCC, CC or
NonCC), if it is currently excluded as a CC or MCC when reported with
either diagnosis code I11.0 or I13.2 as the principal diagnosis, and
what our proposal is under the CC Exclusions List logic for FY 2022.
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We are proposing additional changes to the ICD-10 MS-DRGs Version
39 CC Exclusion List based on the diagnosis and procedure code updates
as discussed in section II.D.13. of this FY 2022 IPPS/LTCH PPS proposed
rule. Therefore, we have developed Table 6G.1.--Proposed Secondary
Diagnosis Order Additions to the CC Exclusions List--FY 2022; Table
6G.2.--Proposed Principal Diagnosis Order Additions to the CC
Exclusions List--FY 2022; Table 6H.1.--Proposed Secondary Diagnosis
Order Deletions to the CC Exclusions List--FY 2022; and Table 6H.2.--
Proposed Principal Diagnosis Order Deletions to the CC Exclusions
List--FY 2022. For Table 6G.1, each secondary diagnosis code proposed
for addition to the CC Exclusion List is shown with an asterisk and the
principal diagnoses proposed to exclude the secondary diagnosis code
are provided in the indented column immediately following it. For Table
6G.2, each of the principal diagnosis codes for which there is a CC
exclusion is shown with an asterisk and the conditions proposed for
addition to the CC Exclusion List that will not count as a CC are
provided in an indented column immediately following the affected
principal diagnosis. For Table 6H.1, each secondary diagnosis code
proposed for deletion from the CC Exclusion List is shown with an
asterisk followed by the principal diagnosis codes that currently
exclude it. For Table 6H.2, each of the principal diagnosis codes is
shown with an asterisk and the proposed deletions to the CC Exclusions
List are provided in an indented column immediately following the
affected principal diagnosis. Tables 6G.1., 6G.2., 6H.1., and 6H.2.
associated with this proposed rule are available via the internet on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
[[Page 25186]]
13. Proposed Changes to the ICD-10-CM and ICD-10-PCS Coding Systems
To identify new, revised and deleted diagnosis and procedure codes,
for FY 2022, we have developed Table 6A.--New Diagnosis Codes, Table
6B.--New Procedure Codes, Table 6C.--Invalid Diagnosis Codes, Table
6D.--Invalid Procedure Codes and Table 6E.--Revised Diagnosis Code
Titles for this proposed rule.
These tables are not published in the Addendum to this 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 this proposed rule. As discussed in section II.D.16. of the
preamble of this proposed 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.
We are proposing 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. In addition, 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. Consistent with our
established process, we examined the MS-DRG assignment and the
attributes (severity level and O.R. status) of the predecessor
diagnosis or procedure code, as applicable, to inform our proposed
assignments and designations. Specifically, we review the predecessor
code and MS-DRG assignment most closely associated with the new
diagnosis or procedure code, and in the absence of claims data, we
consider other factors that may be relevant to the MS-DRG assignment,
including the severity of illness, treatment difficulty, complexity of
service and the resources utilized in the diagnosis and/or treatment of
the condition. We note that this process does not automatically result
in the new diagnosis or procedure code being proposed for assignment to
the same MS-DRG or to have the same designation as the predecessor
code.
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 proposed rule:
Table 6A.--New Diagnosis Codes--FY 2022;
Table 6B.--New Procedure Codes--FY 2022;
Table 6C.--Invalid Diagnosis Codes--FY 2022;
Table 6D.--Invalid Procedure Codes--FY 2022;
Table 6E.--Revised Diagnosis Code Titles--FY 2022;
Table 6G.1.--Proposed Secondary Diagnosis Order Additions
to the CC Exclusions List--FY 2022;
Table 6G.2.--Proposed Principal Diagnosis Order Additions
to the CC Exclusions List--FY 2022;
Table 6H.1.--Proposed Secondary Diagnosis Order Deletions
to the CC Exclusions List--FY 2022;
Table 6H.2.--Proposed Principal Diagnosis Order Deletions
to the CC Exclusions List--FY 2022;
Table 6I.1.--Proposed Additions to the MCC List--FY 2022;
Table 6I.2.--Proposed Deletions to the MCC List--FY 2022;
and
Table 6J.1.--Proposed Additions to the CC List--FY 2022.
14. Proposed 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 2021 IPPS/LTCH PPS final rule (85 FR 58448),
we made available the FY 2021 ICD-10 MCE Version 38 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 38
(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.
For this FY 2022 IPPS/LTCH PPS proposed rule, we address the MCE
requests we received by the November 1, 2020 deadline. We also discuss
the proposals we are making based on our internal review and analysis.
a. External Causes of Morbidity Codes as Principal Diagnosis
In the MCE, the external cause codes (V, W, X, or Y codes) describe
the circumstance causing an injury, not the nature of the injury, and
therefore should not be used as a principal diagnosis.
As discussed in section II.D.13. of the preamble of this proposed
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, 2021. We are proposing to add the following new
ICD-10-CM diagnosis codes to the External Causes of Morbidity edit code
list.
[GRAPHIC] [TIFF OMITTED] TP10MY21.115
[[Page 25187]]
b. 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) Pediatric Diagnoses
Under the ICD-10 MCE, the Pediatric diagnoses category for the Age
conflict edit considers the age range of 0 to 17 years inclusive. For
that reason, the diagnosis codes on this Age conflict edit list would
be expected to apply to conditions or disorders specific to that age
group only.
As discussed in section II.D.13. of the preamble of this proposed
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, 2021. We are proposing to add the following new
ICD-10-CM diagnosis codes to the Pediatric diagnoses category code list
under the Age conflict edit.
[GRAPHIC] [TIFF OMITTED] TP10MY21.116
c. 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 this proposed
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, 2021. We are proposing to add the following new
ICD-10-CM diagnosis codes to the edit code list for the Diagnoses for
Females Only edit.
[GRAPHIC] [TIFF OMITTED] TP10MY21.117
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 this proposed
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, 2021. In addition, as a result of proposed new
instructional notes to ``Code first underlying disease'' (which
indicate the proper sequencing order of the codes) for existing
diagnosis codes found at subcategory M40.1 (Other secondary kyphosis)
and subcategory M41.5 (Other secondary scoliosis) discussed at the
September 8-9, 2020 ICD-10 Coordination and Maintenance Committee
meeting, we are proposing to add the following new and, if these
instructional notes are finalized, existing ICD-10-CM diagnosis codes
at subcategories M40.1 and M41.5, to the Unacceptable Principal
Diagnosis edit code list.
BILLING CODE 4120-01-P
[[Page 25188]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.118
BILLING CODE 4120-01-C
In addition, as discussed in section II.D.13. of the preamble of
this proposed rule, Table 6C.--Invalid Diagnosis Codes, lists the
diagnosis codes that are
[[Page 25189]]
no longer effective October 1, 2021. 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 are proposing to
delete these codes from the Unacceptable Principal Diagnosis edit code
list.
[GRAPHIC] [TIFF OMITTED] TP10MY21.119
e. Unspecified Codes
As discussed in section II.D.12.c. of the preamble of this proposed
rule, we are requesting public comments on a potential change to the
severity level designations for ``unspecified'' ICD-10-CM diagnosis
codes that we are considering adopting for FY 2022. In connection with
that request, we are also requesting public comments on the potential
creation of a new MCE code edit involving these ``unspecified'' codes
for FY 2022. Specifically, this MCE code edit could trigger when an
``unspecified'' diagnosis code currently designated as either a CC or
MCC, that includes other codes available in that code subcategory that
further specify the anatomic site, is entered. We refer the reader to
table 6P.3a (which is available via the internet on the CMS website at:
http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) for the list of unspecified diagnosis
codes that would be subject to this edit. This edit could signal to the
provider that a more specific code is available to report. We believe
this edit aligns with documentation improvement efforts and leverages
the specificity within ICD-10. As part of our request for comment on
the potential creation of this new MCE code edit for these
``unspecified'' codes, we are interested in comments on how this MCE
code edit may be developed for FY 2022 to more accurately reflect each
health care encounter and improve the reliability and validity of the
coded data.
f. Future Enhancement
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38053 through 38054)
we noted the importance of ensuring accuracy of the coded data from the
reporting, collection, processing, coverage, payment and analysis
aspects. 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.
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 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, 2021.
15. Proposed Changes to Surgical Hierarchies
Some inpatient stays entail multiple surgical procedures, each one
of which, occurring by itself, could result in assignment of the case
to a different MS-DRG within the MDC to which the principal diagnosis
is assigned. Therefore, it is necessary to have a decision rule within
the GROUPER by which these cases are assigned to a single MS-DRG. The
surgical hierarchy, an ordering of surgical classes from most resource-
intensive to least resource-intensive, performs that function.
Application of this hierarchy ensures that cases involving multiple
surgical procedures are assigned to the MS-DRG associated with the most
resource-intensive surgical class.
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
[[Page 25190]]
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 proposed
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.
For this FY 2022 IPPS/LTCH PPS proposed rule, we received a request
to examine the MS-DRG hierarchy within MDC 05 (Diseases and Disorders
of the Circulatory System). The requestor stated its request to review
the hierarchy within MDC 05 was based on the relative weights within
each MS-DRG subdivision which they stated are supportive of higher
position within the hierarchy. The requestor stated that when multiple
procedures are performed, it is reasonable for providers to be
compensated for the highest weighted procedure. The requestor did not
specify which data year it analyzed to identify the relative weights.
As discussed in this section, in reviewing the surgical hierarchy, we
weigh the average costs of each MS-DRG in the class by frequency (that
is, by the number of cases in the MS-DRG), not the relative weights of
each MS-DRG as suggested by the requestor, to determine average
resource consumption for the surgical class; therefore, consistent with
our annual process, we used the methodology as described previously to
review the surgical hierarchy within MDC 05.
Based on our review of the surgical hierarchy within MDC 05 in
response to this request, and in response to the request we received to
review the MS-DRG assignments for cases involving the surgical ablation
procedure for atrial fibrillation as discussed in section II.D.5.e. of
the preamble of this proposed rule, we are proposing to revise the
surgical hierarchy for the MS-DRGs in MDC 05 for FY 2022. Specifically,
we are proposing to sequence MS-DRGs 231-236 above MS-DRGs 222-227 and
below MS-DRGs 216-221, sequence MS-DRGs 222-227 above MS-DRGs 266-227
and below MS-DRGs 231-236, sequence MS-DRGs 266-267 above MS-DRGs 268-
269 and below MS-DRGs 222-227, sequence MS-DRGs 228-229 above MS-DRGs
319-320 and below MS-DRGs 268-269.
Our proposal for Appendix D MS-DRG Surgical Hierarchy by MDC and
MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 39 is
illustrated in the following table.
[GRAPHIC] [TIFF OMITTED] TP10MY21.120
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 Centers for Disease Control and Prevention's (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/
[[Page 25191]]
codes.html. The official list of ICD-10-CM and ICD-10-PCS codes can be
found on the CMS website at: http://www.cms.gov/Medicare/Coding/ICD10/index.html.
The NCHS has lead responsibility for the ICD-10-CM and ICD-9-CM
diagnosis codes included in the Tabular List and Alphabetic Index for
Diseases, while CMS has lead responsibility for the ICD-10-PCS and ICD-
9-CM procedure codes included in the Tabular List and Alphabetic Index
for Procedures.
The Committee encourages participation in the previously mentioned
process by health-related organizations. In this regard, the Committee
holds public meetings for discussion of educational issues and proposed
coding changes. These meetings provide an opportunity for
representatives of recognized organizations in the coding field, such
as the American Health Information Management Association (AHIMA), the
American Hospital Association (AHA), and various physician specialty
groups, as well as individual physicians, health information management
professionals, and other members of the public, to contribute ideas on
coding matters. After considering the opinions expressed during 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 2022 at a public meeting held on September 8-9,
2020 and finalized the coding changes after consideration of comments
received at the meetings and in writing by November 09, 2020.
The Committee held its 2021 meeting on March 9-10, 2021. The
deadline for submitting comments on these code proposals was April 9,
2021. 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 2021
would be included in the October 1, 2021 update to the ICD-10-CM
diagnosis and ICD-10-PCS procedure code sets. As discussed in earlier
sections of the preamble of this proposed rule, there are new, revised,
and deleted ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes
that are captured in Table 6A.--New Diagnosis Codes, Table 6B.--New
Procedure Codes, Table 6C.--Invalid Diagnosis Codes, Table 6D.--Invalid
Procedure Codes, and Table 6E.--Revised Diagnosis Code Titles for this
proposed 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 rule. Rather, they are available via the
internet as discussed in section VI. of the Addendum to the proposed
rule.
Recordings for the virtual meeting discussions of the procedure
codes at the Committee's September 8-9, 2020 meeting and the March 9-
10, 2021 meeting 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 8-9, 2020 meeting and March 9-10, 2021 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, participating in a
Committee meeting, timeline requirements and meeting dates.
We encourage commenters to submit questions and comments on coding
issues involving diagnosis codes via Email to: cdc.gov">[email protected]cdc.gov.
Questions and comments concerning the procedure codes should be
submitted via Email to: [email protected].
As a result of the ongoing COVID-19 public health emergency, the
CDC implemented six new diagnosis codes describing conditions related
to COVID-19 into the ICD-10-CM effective with discharges on and after
January 1, 2021. The diagnosis codes are
[GRAPHIC] [TIFF OMITTED] TP10MY21.121
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 the six diagnosis codes
effective with discharges on and after January 1, 2021, 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
[[Page 25192]]
diagnosis code being assigned to the same MS-DRG as the predecessor
code. The assignments for the previously listed diagnosis codes are
reflected in Table 6A- New Diagnosis Codes (which is available via the
internet on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS). As with the other new
diagnosis codes and MS-DRG assignments included in Table 6A of this
proposed rule, we are soliciting public comments on the most
appropriate MDC, MS-DRG, and severity level assignments for these codes
for FY 2022, as well as any other options for the GROUPER logic.
In addition, CMS implemented 21 new procedure codes describing the
introduction or infusion of therapeutics, including monoclonal
antibodies and vaccines for COVID-19 treatment, into the ICD-10-PCS
effective with discharges on and after January 01, 2021. The 21
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
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP10MY21.122
[[Page 25193]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.123
BILLING CODE 4120-01-C
The ICD-10 MS-DRG assignment for cases reporting any one of the 21
procedure codes is dependent on the reported principal diagnosis, any
secondary diagnoses defined as a CC or MCC, procedures or services
performed, age, sex, and discharge status. The 21 procedure codes are
reflected in Table 6B--New Procedure Codes (which is available via the
internet on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS.) As with the other new
procedure codes and MS-DRG assignments included in Table 6B of this
proposed rule, we are soliciting public comments on the most
appropriate MDC, MS-DRG, and operating room status assignments for
[[Page 25194]]
these codes for FY 2022, as well as any other options for the GROUPER
logic.
We note that Change Request (CR) 11895, Transmittal 10654, titled
``Fiscal Year (FY) 2021 Annual Update to the Medicare Code Editor (MCE)
and International Classification of Diseases, Tenth Revision, Clinical
Modification (ICD-10-CM) and Procedure Coding System (ICD-10-PCS)'',
was issued on March 12, 2021 (available via the internet on the CMS
website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10654cp) regarding the release of an updated
version of the ICD-10 MS-DRG GROUPER and Medicare Code Editor software,
Version 38.1, effective with discharges on and after January 1, 2021,
reflecting the new diagnosis and procedure codes. The updated software,
along with the updated ICD-10 MS-DRG V38.1 Definitions Manual and the
Definitions of Medicare Code Edits V38.1 manual is available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.
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.
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.
Historically, 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 during 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. Meeting participants and those
reviewing the Committee meeting materials are provided the opportunity
to comment on this expedited request. All other topics are considered
for the October 1 update. Participants of the Committee meeting and
those reviewing the Committee meeting materials are encouraged to
comment on all such requests. There were no code requests approved for
an expedited April 1, 2021 implementation at the September 8-9, 2020
Committee meetings. Therefore, there were no new codes implemented
April 1, 2021.
At the March 9-10, 2021 ICD-10 Coordination and Maintenance
Committee meeting we announced our consideration of an April 1
implementation date for ICD-10-CM diagnosis and ICD-10-PCS procedure
code updates, in addition to the current October 1 annual update for
ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes. We stated
that this April 1 code update would be in addition to the existing
April 1 update under section 1886(d)(5)(k)(vii) of the Act for
diagnosis or procedure code revisions needed to describe new
technologies and medical services for purposes of the new technology
add-on payment process. As explained during the March 9-10, 2021
meeting, we believe this additional April 1 implementation date for new
codes would allow for earlier recognition of diagnoses, conditions, and
illnesses as well as procedures, services, and treatments in the claims
data. We also believe this earlier recognition would be beneficial for
purposes of reporting, data collection, tracking clinical outcomes,
claims processing, surveillance, research, policy decisions and data
interoperability. We note, as previously summarized, that in 2005, in
connection with the implementation of the current April 1 update for
diagnosis or procedure code revisions for purposes of the new
technology add-on payment process, stakeholders expressed concerns with
an April 1 update, specifically with regard to the time needed to
update hospital systems and obtain new code books and coding software.
We believe that the advances in technology that have occurred since
[[Page 25195]]
that time, including the use of electronic health records (EHRs),
electronic coding books, and updated encoder software that are now
utilized by the majority of providers, would alleviate those concerns
and make a broader April 1 update more feasible today. Consistent with
our established process for the existing April 1 update under section
1886(d)(5)(k)(vii) of the Act, if adopted, any new ICD-10 code updates
finalized for implementation on the following April 1 would be
announced in November of the prior year, which would provide a 4-month
timeframe for the public to receive notice about the diagnosis and/or
procedure code updates with respect to the codes, code descriptions,
code designations (severity level for diagnosis codes or O.R. status
for procedure code) and code assignment under the ICD-10 MS-DRGs. As
discussed during the March 9-10, 2021 meeting, all April 1 code update
files would be made publicly available by February 1, providing a 2-
month timeframe for providers to incorporate systems updates. We also
do not anticipate any need for code book publishers to issue new code
books as a result of an April 1 code update, if adopted. Rather, as was
done in the past at the publisher's discretion, supplemental pages
containing the code update information were made available and sent to
purchasers of the code book products. We further note that
historically, coders would hand-write any updates or notes directly
into their code books. In addition, with the availability of electronic
code book files, we would anticipate any April 1 code updates, if
adopted, could be reasonably completed in the allotted timeframe. For
these same reasons, we also do not believe a 5-month time period would
continue to be needed to update providers' systems to reflect newly
approved coding changes. We further note that if an April 1 update were
to be adopted, it could be through a phased approach, such that
initially, the number and nature of the code updates would be fewer and
less comprehensive as compared to the existing October 1 update. For
example, it was discussed during the meeting that consideration could
first be given to proposals identified as ``Addenda''. For diagnosis
codes, the proposed addenda updates typically consist primarily of
minor revisions to the Index and Tabular List, such as corrections to
typos and changes to instructional notes. For procedure codes, the
proposed addenda updates typically consist primarily of minor revisions
to the Index and Tables, such as adding or deleting entries to describe
a body part or approach value or making changes to the Substance and
Device Keys. We would use our established process to implement an April
1 code update, which would include presenting proposals for April 1
consideration at the September ICD-10 Coordination and Maintenance
Committee meeting, requesting public comments, reviewing the public
comments, finalizing codes, and announcing the new codes with their
assignments consistent with the new GROUPER release information. Under
our contemplated process, requestors would indicate whether they are
submitting their code request for consideration for an April 1
implementation date, if adopted, or an October 1 implementation date.
The ICD-10 Coordination and Maintenance Committee would make efforts to
accommodate the requested implementation date for each request
submitted. However, the Committee would determine which requests would
be presented for consideration for an April 1 implementation date or an
October 1 implementation date. We refer the reader to the Agenda packet
from the meeting at: https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials for additional information regarding this
announcement and our request for comments.
If this new April 1 implementation date is adopted, we would assign
the codes approved for the April 1 update to an MS-DRG(s) using our
established process for GROUPER assignments for new diagnosis and
procedure codes. Specifically, consistent with our established process
for assigning new diagnosis and procedure codes, we would review the
predecessor code and MS-DRG assignment most closely associated with the
new diagnosis or procedure code, and in the absence of claims data, we
would consider other factors that may be relevant to the MS-DRG
assignment, including the severity of illness, treatment difficulty,
complexity of service and the resources utilized in the diagnosis and/
or treatment of the condition. We note that this process would not
automatically result in the new diagnosis or procedure code being
assigned to the same MS-DRG or having the same designation as the
predecessor code.
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 electronic files containing 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 be found on the CDC website at:
https://www.cdc.gov/nchs/icd/icd10cm.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. The AHA also distributes
coding update information to publishers and software vendors.
For FY 2021, there are currently 72,621 diagnosis codes and 78,136
ICD-10-PCS procedure codes. As displayed in Table 6A.--New Diagnosis
Codes and in Table 6B.--New Procedure Codes associated with this
proposed rule (and available via the internet on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/, there are 147 new diagnosis codes and 106 new
procedure codes that have been finalized for FY 2022 at the time of the
development of this proposed rule. The code titles are adopted as part
of the ICD-10 Coordination and Maintenance Committee process. Thus,
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.
We will continue to provide the October updates in this manner in the
IPPS proposed and final rules.
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.
[[Page 25196]]
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. Proposed Changes for FY 2022
For FY 2022 we are proposing not to add any MS-DRGs to the policy
for replaced devices offered without cost or with a credit. We are
proposing to continue to include the existing MS-DRGs currently subject
to the policy as displayed in the following table.
BILLING CODE 4120-01-P
[[Page 25197]]
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[[Page 25198]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.125
BILLING CODE 4120-01-C
The final list of MS-DRGs subject to the IPPS policy for replaced
devices offered without cost or with a credit will be included in the
FY 2022 IPPS/LTCH PPS final rule and also will be issued to providers
in the form of a Change Request (CR).
II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-
DRG) Classifications and Relative Weights
E. Recalibration of the FY 2022 MS-DRG Relative Weights
1. Data Sources for Developing the Relative Weights
In accordance with our proposal as discussed in section I.F. of
this proposed rule, for the purposes of establishing the FY 2022 MS-DRG
relative weights, we are proposing to use the FY 2019 MedPAR claims
data, based on claims received by CMS through March 31, 2020, and the
March 2020 update of the FY 2018 HCRIS file where we ordinarily would
have used the FY 2020 MedPAR claims data, based on claims received by
CMS through December 31, 2020, and the December 2020 update of the FY
2019 HCRIS file. We refer the reader to section I.F. of this
[[Page 25199]]
proposed rule for further discussion of our analysis of the best
available data for purposes of the FY 2022 ratesetting and our related
proposals.
Consistent with our established policy, in developing the MS-DRG
relative weights for FY 2022, we are proposing 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
proposed rule include discharges occurring on October 1, 2018, through
September 30, 2019, based on bills received by CMS through March 31,
2020, 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 proposed relative
weights includes data for approximately 9,217,828 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
proposed relative weights for FY 2022 also excludes claims with claim
type values not equal to ``60.'' The data exclude CAHs, including
hospitals that subsequently became CAHs after the period from which the
data were taken. We note that the proposed FY 2022 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 proposed FY 2022 GROUPER (Version 39).
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. However, as discussed earlier in this section, we are
proposing to use the March 31, 2020 update of the FY 2018 HCRIS for
calculating the proposed FY 2022 cost-based relative weights.
Consistent with our historical practice, for this FY 2022 proposed
rule, we are providing the version of the HCRIS from which we
calculated these proposed 19 CCRs on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Click on the link on the left side of the
screen titled ``FY 2022 IPPS Proposed Rule Home Page'' or ``Acute
Inpatient Files for Download.'' We note that this file is identical to
the file used for the FY 2021 IPPS/LTCH PPS final rule. As discussed
previously, we are also making available the FY 2019 HCRIS and the FY
2020 MedPAR file as well as other related information and data files
for purposes of public comment on our alternative approach of using the
same FY 2020 data that we would ordinarily use for purposes of FY 2022
ratesetting.
2. Methodology for Calculation of the Relative Weights
a. General
We calculated the proposed FY 2022 relative weights based on 19
CCRs, as we did for FY 2021. The methodology we are proposing to use to
calculate the FY 2022 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 proposed FY 2022 MS-DRG classifications discussed in sections
II.B. and II.F. of the preamble of this proposed rule.
The transplant cases that were used to establish the
relative weights for heart and heart-lung, liver and/or intestinal, and
lung transplants (MS-DRGs 001, 002, 005, 006, and 007, respectively)
were limited to those Medicare-approved transplant centers that have
cases in the FY 2019 MedPAR file. (Medicare coverage for heart, heart-
lung, liver and/or intestinal, and lung transplants is limited to those
facilities that have received approval from CMS as transplant centers.)
Organ acquisition costs for kidney, heart, heart-lung,
liver, lung, pancreas, and intestinal (or multivisceral organs)
transplants continue to be paid on a reasonable cost basis.
Because these acquisition costs are paid separately from the
prospective payment rate, it is necessary to subtract the acquisition
charges from the total charges on each transplant bill that showed
acquisition charges before computing the average cost for each MS-DRG
and before eliminating statistical outliers.
Section 108 of the Further Consolidated Appropriations Act, 2020
provides that, for cost reporting periods beginning on or after October
1, 2020, costs related to hematopoietic stem cell acquisition for the
purpose of an allogeneic hematopoietic stem cell transplant shall be
paid on a reasonable cost basis. We refer the reader to the FY 2021
IPPS/LTCH PPS final rule for further discussion of the reasonable cost
basis payment for cost reporting periods beginning on or after October
1, 2020 (85 FR 58835 to 58842). For FY 2022 and subsequent years, we
are proposing to subtract the hematopoietic stem cell acquisition
charges from the total charges on each transplant bill that showed
hematopoietic stem cell 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.
[[Page 25200]]
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 2021, and consistent with how we have treated hospitals
that participated in the BPCI Initiative, for FY 2022, 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 the FY 2021 IPPS/LTCH
PPS final rule, we are also proposing to include all applicable data
from subsection (d) hospitals participating in 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 proposed
national average CCRs developed from the FY 2018 cost report data,
consistent with our proposed FY 2022 ratesetting discussed in section
II.A.4 of the Addendum of this proposed rule.
The 19 cost centers that we used in the proposed relative weight
calculation are shown in a supplemental data file, Cost Center HCRIS
Lines Supplemental Data File, posted via the internet on the CMS
website for this proposed 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 proposed 19
national cost center CCRs. If we receive comments about the groupings
in this supplemental data file, we may consider these comments as we
finalize our policy.
Consistent with historical practice, we account for rare situations
of non-monotonicity in a base MS-DRG and its severity levels, where the
mean cost in the higher severity level is less than the mean cost in
the lower severity level, in determining the relative weights for the
different severity levels. If there are initially non-monotonic
relative weights
[[Page 25201]]
in the same base DRG and its severity levels, then we combine the cases
that group to the specific non-monotonic MS-DRGs for purposes of
relative weight calculations. For example, if there are two non-
monotonic MS-DRGs, combining the cases across those two MS-DRGs results
in the same relative weight for both MS-DRGs. The relative weight
calculated using the combined cases for those severity levels is
monotonic, effectively removing any non-monotonicity with the base DRG
and its severity levels. For this FY 2022 proposed rule, this
calculation was applied to address non-monotonicity for cases that
grouped to MS-DRG 504 and MS-DRG 505. We note that cases were also
combined in calculating the relative weights for these two MS-DRGs for
FY 2021. In the supplemental file titled AOR/BOR File, we include
statistics for the affected MS-DRGs both separately and with cases
combined.
We are inviting public comments on our proposals related to
recalibration of the proposed FY 2022 relative weights and the changes
in relative weights from FY 2021.
b. Relative Weight Calculation for MS-DRG 018
As discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58599
through 58600), we created MS-DRG 018 for cases that include procedures
describing CAR T-cell therapies, which were reported using ICD-10-PCS
procedure codes XW033C3 or XW043C3. We refer the reader to section
II.D.2. of this proposed rule for discussion of the procedure codes for
CAR T-cell and non-CAR T-cell therapies and other immunotherapies that
we are proposing for assignment to MS-DRG 018 for FY 2022.
In the FY 2021 IPPS/LTCH PPS final rule, we finalized our proposals
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, with additional refinements
in response to comments. For cases that group to MS-DRG 018, we
finalized 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 (85 FR 58600). We also
finalized our proposal to calculate an adjustment to account for the
CAR T-cell therapy cases determined to be clinical trial cases, as
described in the FY 2021 IPPS/LTCH PPS final rule, 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
for the FY 2021 IPPS/LTCH PPS final rule, we estimated that the average
costs of CAR T-cell therapy cases determined to be clinical trial cases
($46,062) were 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 the FY 2021 IPPS/LTCH PPS final rule, each case identified
as a clinical trial case was adjusted by 0.17. We also noted that we
were applying this adjustor for cases determined to be CAR T-cell
therapy clinical trial cases for purposes of budget neutrality and
outlier simulations. We refer the reader to the FY 2021 IPPS/LTCH PPS
final rule for complete discussion of our finalized modifications to
the relative weight calculation for MS-DRG 018.
Since we are proposing to use the same FY 2019 MedPAR claims data
for FY 2022 ratesetting that we did for the FY 2021 final rule, we are
also proposing to continue to use the same process to identify clinical
trial claims in the FY 2019 MedPAR for purposes of calculating the FY
2022 relative weights. We continue to use the proxy of standardized
drug charges of less than $373,000, which was the average sales price
of KYMRIAH and YESCARTA, which are the two CAR T-cell biological
products in the MedPAR data used for the FY 2021 final rule and this
proposed rule. Using the same methodology from the FY 2021 IPPS/LTCH
PPS final rule, we are proposing to apply an 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:
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.
Additionally, we are continuing our finalized methodology for
calculating this payment adjustment, 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 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. However,
we continue to believe to the best of our knowledge there are no claims
in the historical data (FY 2019 MedPAR) 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. Consistent with our
proposal to use the FY 2019 data for the FY 2022 ratesetting, we are
also proposing to calculate this adjustor based on the March 2020
update of the FY 2019 MedPAR file for purposes of establishing the FY
2022 relative weights. Accordingly, as we did for FY 2021, we are
proposing to adjust the transfer-adjusted case count for MS-DRG 018 by
applying the proposed adjustor of 17 percent to the applicable clinical
trial cases, and 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. Therefore, in calculating the
national average cost per case for purposes of this proposed rule, each
case identified as a clinical trial case was adjusted by 17 percent. As
we did for FY 2021, we are proposing to apply this same adjustor for
the applicable cases that group to MS-DRG 018 for purposes of budget
neutrality and outlier simulations.
As discussed in section I.F. of this proposed rule, we are also
soliciting
[[Page 25202]]
comments on an alternative approach of using the same FY 2020 data that
we would ordinarily use for purposes of the FY 2022 rulemaking, which
we may consider finalizing for FY 2022 based on consideration of
comments received. We note that using the methodology as finalized in
the FY 2021 IPPS/LTCH PPS final rule, we calculated an adjustor of 0.25
based on this alternative approach of using the FY 2020 MedPAR file.
3. Development of Proposed National Average CCRs
Consistent with our proposal to use the FY 2019 data for the FY
2022 ratesetting, as discussed earlier in this section, we are
proposing to continue to use the national average CCRs that were
calculated for the FY 2021 final rule using that same data.
Specifically, we calculated these 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.
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 proposed relative weight.
The proposed FY 2022 cost-based relative weights were then
normalized by an adjustment factor of 1.820783 so that the average case
weight after recalibration was equal to the average case weight before
recalibration. The normalization adjustment is intended to ensure that
recalibration by itself neither increases nor decreases total payments
under the IPPS, as required by section 1886(d)(4)(C)(iii) of the Act.
The proposed 19 national average CCRs for FY 2022 are as follows:
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[[Page 25203]]
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 are proposing to use that same case
threshold in recalibrating the proposed MS-DRG relative weights for FY
2022. Using data from the FY 2019 MedPAR file, there were 7 MS-DRGs
that contain fewer than 10 cases. For FY 2022, because we do not have
sufficient MedPAR data to set accurate and stable cost relative weights
for these low-volume MS-DRGs, we are proposing to compute relative
weights for the low-volume MS-DRGs by adjusting their final FY 2021
relative weights by the percentage change in the average weight of the
cases in other MS-DRGs from FY 2021 to FY 2022. The crosswalk table is
as follows.
[GRAPHIC] [TIFF OMITTED] TP10MY21.128
F. Add-On Payments for New Services and Technologies for FY 2022
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 42 CFR 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
antimicrobial 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). We note that section 1886(d)(5)(K)(i) of the
Act requires that the Secretary establish a mechanism to recognize the
costs of new medical services and technologies under the payment system
established under that subsection, which establishes the system for
paying for the operating costs of inpatient hospital services. The
system of payment for capital costs is established under section
1886(g) of the Act. Therefore, as discussed in prior rulemaking (72 FR
47307 through 47308), we do not include capital costs in the add-on
payments for a new medical service or technology or make new technology
add-on payments under the IPPS for capital-related costs. 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 of the new technology add-
on payment criteria, we refer readers to the FY 2012 IPPS/LTCH PPS
final rule (76 FR 51572 through 51574), FY 2020 IPPS/LTCH PPS final
rule (84 FR 42288 through 42300) and the FY 2021 IPPS/LTCH PPS final
rule (85 FR 58736 through 58742).
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 no longer be considered
``new'' for purposes of new medical service or technology add-on
payments after CMS has recalibrated the MS-DRGs, based on available
data, to reflect the cost of the technology. 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)
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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
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 of the
cases involving a new medical service or technology will exceed a
threshold amount that is the lesser of 75 percent of the standardized
amount (increased to reflect the difference between cost and charges)
or 75 percent of one standard deviation beyond the geometric mean
standardized charge for all cases in the MS-DRG to which the new
medical service or technology is assigned (or the case-weighted average
of all relevant MS-DRGs if the new medical service or technology occurs
in many different MS-DRGs). The MS-DRG threshold amounts generally used
in evaluating new technology add-on payment applications for FY 2022
are presented in a data file that is available, along with the other
data files associated with the FY 2021 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.
We note that, under the policy finalized in the FY 2021 IPPS/LTCH
PPS final rule (85 FR 58603 through 58605), beginning with FY 2022, we
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.
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 proposed thresholds for
applications for new technology add-on payments for FY 2023 are
presented in a data file that is available on the CMS website, along
with the other data files associated with this FY 2022 proposed rule,
by clicking on the FY 2022 IPPS Proposed Rule Home Page at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index. We note, for the reasons discussed in section
I.F of the preamble of this proposed rule, we are proposing to use the
FY 2019 MedPAR claims data where we ordinarily would have used the FY
2020 MedPAR claims data for purposes of proposed FY 2022 ratesetting.
We refer the reader to section I.F. of the preamble of this proposed
rule for further discussion of our analysis of the best available data
for FY 2022 ratesetting and our related proposals. For the FY 2023
proposed threshold values, consistent with our proposal, we are
proposing to use FY 2019 claims data to evaluate whether the charges of
the cases involving a new medical service or technology will exceed a
threshold amount that is the lesser of 75 percent of the proposed FY
2022 standardized amount (increased to reflect the difference between
cost and charges) or 75 percent of one standard deviation beyond the
geometric mean standardized charge (using FY 2019 claims data) for all
cases in the MS-DRG (using FY 2019 claims data) to which the new
medical service or technology is assigned (or the case-weighted average
of all relevant MS-DRGs if the new medical service or technology occurs
in many different MS-DRGs), rather than the FY 2020 data we would
otherwise use. As discussed in section I.F of the preamble of this
proposed rule, we are also considering, as an alternative to our
proposal, the use of the same FY 2020 data that we would ordinarily use
for purposes of FY 2022 ratesetting. If we were to finalize this
alternative approach for FY 2022, we would use the FY 2020 claims data
for purposes of the final thresholds for applications for new
technology add-on payments for FY 2023 in the FY 2022 IPPS/LTCH PPS
final rule. We are making available the threshold values calculated
using the FY 2020 claims data at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS. 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.
(3) 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
[[Page 25205]]
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: Cinical 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; 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), that although we are affiliated with the FDA and we
do not question the FDA's regulatory responsibility for decisions
related to marketing authorization (for example, approval, clearance,
etc.), we do not rely upon FDA criteria in our determination of 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 the FDA relies but on a demonstration of
substantial clinical improvement in the Medicare population
(particularly patients over age 65).
c. Alternative Inpatient New Technology Add-On Payment Pathway
Beginning with applications for FY 2021 new technology add-on
payments, under the regulations at Sec. 412.87(c), a medical device
that is part of FDA's Breakthrough Devices Program may qualify for the
new technology add-on payment under an alternative pathway.
Additionally, under the regulations at Sec. 412.87(d) for certain
antimicrobial products, beginning with FY 2021, a drug that is
designated by the FDA as a Qualified Infectious Disease Product (QIDP),
and, beginning with FY 2022, a drug that is approved by the FDA under
the Limited Population Pathway for Antibacterial and Antifungal Drugs
(LPAD), may also qualify for the new technology add-on payment under an
alternative pathway. We refer the reader to the FY 2020 IPPS/LTCH PPS
final rule (84 FR 42292 through 42297) and the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58737 through 58739) for a complete discussion on
this 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 FDA 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), and will be
considered new as reflected in Sec. 412.87(c)(2). We note, in the FY
2021 IPPS/LTCH PPS final rule (85 FR 58734 through 58736), we clarified
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 the FY
2021 IPPS/LTCH PPS final rule (85 FR 58734 through 58736) for a
complete discussion regarding this clarification.
(2) Alternative Pathway for Certain Antimicrobial Products
For applications received for new technology add-on payments for
certain antimicrobial products, beginning with FY 2021, if a technology
is designated by FDA as a QIDP and received FDA marketing
authorization, and, beginning with FY 2022, if a drug is approved under
FDA's LPAD pathway and used for the indication approved under the LPAD
pathway, 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 and
LPADs, a medical product that has received FDA marketing authorization
and is designated by FDA
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as a QIDP or approved under the LPAD pathway will need to meet the cost
criterion under Sec. 412.87(b)(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 (84 FR
42292 through 42297) and FY 2021 IPPS/LTCH PPS final rule (85 FR 58737
through 58739) for a complete discussion on this policy. We note, in
the FY 2021 IPPS/LTCH PPS final rule (85 FR 58737 through 58739), we
clarified that 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 also finalized our policy to expand our alternative new
technology add-on payment pathway for certain antimicrobial products to
include products approved under the LPAD pathway and used for the
indication approved under the LPAD pathway.
d. 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. As noted
previously, we do not include capital costs in the add-on payments for
a new medical service or technology or make new technology add-on
payments under the IPPS for capital-related costs (72 FR 47307 through
47308).
For discharges occurring before October 1, 2019, under Sec.
412.88, if the costs of the discharge (determined by applying operating
cost-to-charge ratios (CCRs) as described in Sec. 412.84(h)) exceed
the full DRG payment (including payments for IME and DSH, but excluding
outlier payments), CMS 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 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. For a new
technology that is a medical product approved under FDA's LPAD pathway,
beginning with discharges on or after October 1, 2020, 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 certain antimicrobial products (QIDPs and LPADs)) 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.
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.
e. 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 specified 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. In the FY 2021 IPPS final rule, to more precisely
describe the various types of FDA approvals, clearances and
classifications that we consider under our new technology add-on
payment policy, we finalized a technical clarification to the
regulation to indicate that new technologies must receive FDA marketing
authorization (such as pre-market approval (PMA); 510(k) clearance; the
granting of a De Novo classification request, or approval of a New Drug
Application (NDA)) by July 1 of the year prior to the beginning of the
fiscal year for which the application is being considered. Consistent
with our longstanding policy, we consider FDA marketing authorization
as representing that a product has received FDA approval or clearance
when considering eligibility for the new technology add-on payment
under Sec. 412.87(e)(2) (85 FR 58742).
Additionally, in the FY 2021 IPPS final rule (85 FR 58739 through
58742), we finalized our proposal to provide conditional approval for
new technology add-on payment for a technology for which an application
is submitted under the alternative pathway for certain antimicrobial
products at Sec. 412.87(d) that does not receive FDA marketing
authorization by the July 1 deadline specified in Sec. 412.87(e)(2),
provided that the technology otherwise meets 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
[[Page 25207]]
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.
f. 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].
g. Application Information for New Medical Services or Technologies
Applicants for add-on payments for new medical services or
technologies for FY 2023 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 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 2023, 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.
2. Public Input Before Publication of a Notice of Proposed Rulemaking
on Add-On Payments
Section 1886(d)(5)(K)(viii) of the Act, as amended by section
503(b)(2) of Public Law 108-173, provides for a mechanism for public
input before publication of a notice of proposed rulemaking regarding
whether a medical service or technology represents a substantial
clinical improvement or advancement. The process for evaluating new
medical service and technology applications requires the Secretary to--
Provide, before publication of a proposed rule, for public
input regarding whether a new service or technology represents an
advance in medical technology that substantially improves the diagnosis
or treatment of Medicare beneficiaries;
Make public and periodically update a list of the services
and technologies for which applications for add-on payments are
pending;
Accept comments, recommendations, and data from the public
regarding whether a service or technology represents a substantial
clinical improvement; and
Provide, before publication of a proposed rule, for a
meeting at which organizations representing hospitals, physicians,
manufacturers, and any other interested party may present comments,
recommendations, and data regarding whether a new medical service or
technology represents a substantial clinical improvement to the
clinical staff of CMS.
In order to provide an opportunity for public input regarding add-
on payments for new medical services and technologies for FY 2022 prior
to publication of this FY 2022 IPPS/LTCH PPS proposed rule, we
published a notice in the Federal Register on October 16, 2020 (85 FR
65815), and held a virtual town hall meeting on December 15 and 16,
2020. In the announcement notice for the meeting,
[[Page 25208]]
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 2022 new medical service and technology add on payment
applications before the publication of the FY 2022 IPPS/LTCH PPS
proposed rule.
Approximately 330 individuals registered to attend the 2-day
virtual town hall meeting. We posted the recordings of the 2-day
virtual town hall on the CMS web page at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech. We
considered each applicant's presentation made at the town hall meeting,
as well as written comments received by the December 28, 2020 deadline,
in our evaluation of the new technology add on payment applications for
FY 2022 in the development of this FY 2022 IPPS/LTCH PPS proposed rule.
In response to the published notice and the December 15-16, 2020
New Technology Town Hall meeting, we received written comments
regarding the applications for FY 2022 new technology add on payments.
As explained earlier and in the Federal Register notice announcing the
New Technology Town Hall meeting (85 FR 65815 through 65817), the
purpose of the meeting was specifically to discuss the substantial
clinical improvement criterion with regard to pending new technology
add-on payment applications for FY 2022. Therefore, we are not
summarizing those written comments in this proposed rule that are
unrelated to the substantial clinical improvement criterion. In section
II.H.5. of the preamble of this proposed rule, we are summarizing
comments regarding individual applications, or, if applicable,
indicating 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: https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs,
including guidelines for ICD-10-PCS Section ``X'' codes. We encourage
providers to view the material provided on ICD-10-PCS Section ``X''
codes.
4. Proposed FY 2022 Status of Technologies Approved for FY 2021 New
Technology Add-On Payments
In this section of the proposed rule, we discuss the proposed FY
2022 status of 23 technologies approved for FY 2021 new technology add-
on payments, as set forth in the tables that follow. 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 the
reader to section II.F.6.b.(1). of the preamble of this proposed rule
for discussion of CONTEPO, which we conditionally approved for FY 2021
new technology add-on payments under the alternative pathway for
certain antimicrobial products, subject to the technology receiving FDA
marketing authorization by July 1, 2021. As of the time of the
development of this proposed rule, CONTEPO has not yet received FDA
marketing authorization.
a. Proposed Continuation of New Technology Add-On Payments for FY 2022
for Technologies Still Considered To Be New
In the table in this section of the proposed rule, we present our
proposals to continue the new technology add-on payment for FY 2022 for
those technologies that were approved for the new technology add-on
payment for FY 2021 and which would still considered ``new'' for
purposes of new technology add-on payments for FY 2022.
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).
The table in this section lists the technologies for which we are
proposing to continue making new technology add-on payments for FY 2022
because they would still be considered new for purposes of new
technology add-on payments. This table also presents the newness start
date, new technology add-on payment start date, relevant final rule
citations from prior fiscal years, proposed maximum add-on payment
amount, and coding assignments. We refer readers to the cited final
rules in the following table for a complete discussion of the new
technology add-on payment application, coding and payment amount for
these technologies, including the applicable indications and discussion
of the newness start date.
BILLING CODE 4120-01-P
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b. Proposal To Extend New Technology Add-On Payments
Section 1886(d)(5)(K)(ii)(II) of the Act provides for the
collection of data with respect to the costs of a new medical service
or technology described in subclause (I) for a period of not less than
2 years and not more than 3 years beginning on the date on which an
inpatient hospital code is issued with respect to the service or
technology. As explained in the FY 2005 IPPS final rule (69 FR 49002),
the intent of section 1886(d)(5)(K) of the Act and regulations under
Sec. 412.87(b)(2) is to pay for new medical services and technologies
for the first 2 to 3 years that a product comes on the market, during
the period when the costs of the new technology are not yet fully
reflected in the DRG weights. Generally, we use FDA approval (that is,
marketing authorization) as the indicator of the time when a technology
begins to become available on the market and data reflecting the costs
of the technology begin to become available for recalibration of the
DRGs. The costs of the new medical service or technology, once paid for
by Medicare for this 2-year to 3-year period, are accounted for in the
MedPAR data that are used to recalibrate the DRG weights on an annual
basis. Therefore, we limit the add-on payment window for those
technologies that have passed this 2- to 3-year timeframe.
As discussed in the FY 2006 IPPS final rule (70 FR 47349) and
subsequent years, 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 have historically considered
its costs to be included in the MS-DRG relative weights whether its use
in the Medicare population has been frequent or infrequent.
However, in light of the unique circumstances for FY 2022
ratesetting, for which we are proposing to use the FY 2019 MedPAR
claims data where we ordinarily would have used the FY 2020 MedPAR
claims data for purposes of developing the FY 2022 relative weights,
for the reasons discussed in section I.F. of the preamble of this
proposed rule, we believe it may be appropriate to make a one-time
exception to this long-standing policy for all technologies approved
for new technology add-on payments for FY 2021, but for which the add-
on payments would otherwise be discontinued beginning in FY 2022
because the technologies would no longer be considered new.
As discussed in section I.F. of the preamble of this proposed rule,
ordinarily, the best available MedPAR data for ratesetting would be the
most recent MedPAR file that contains claims from discharges for the
fiscal year that is 2 years prior to the fiscal year that is the
subject of the rulemaking. For FY 2022 ratesetting, under ordinary
circumstances, the best available data would be the FY 2020 MedPAR
file. As discussed in section I.F. of the preamble of this proposed
rule, the FY 2020 MedPAR claims file contains data significantly
impacted by the COVID-19 PHE, primarily in that the utilization of
inpatient services was generally markedly different for certain types
of services in FY 2020 than would have been expected in the absence of
the PHE. Accordingly, we question whether the FY 2020 MedPAR claims
file is the best available data to use for the FY 2022 ratesetting.
In our discussion in section I.F. of the preamble of this proposed
rule, we highlighted two factors we considered in assessing which data
sources would represent the best available data to use in the FY 2022
ratesetting. The first factor is whether the FY 2019 data, which is
from before the COVID-19 PHE, or the FY 2020 data, which includes the
COVID-19 PHE time period, is a better overall approximation of the FY
2022 inpatient experience. After analyzing this issue, for the reasons
discussed in section I.F. of the preamble of this proposed rule, we
believe for purposes of this proposed rule that FY 2019 data are
generally a better overall approximation of FY 2022. The second factor
is to what extent the decision to use the FY 2019 or FY 2020 data
differentially impacts the FY 2022 IPPS ratesetting. As discussed more
fully in section I.F of the preamble of this proposed rule, after
analyzing this issue, we determined that the decision does
differentially impact the overall FY 2022 IPPS ratesetting. For
example, we determined that the effect on the FY 2022 MS-DRG relative
weights is more limited if the FY 2019-based weights are used rather
than the FY 2020-based weights, should the FY 2022 inpatient experience
not match the assumption used to calculate the MS-DRG relative weights.
Based on our analyses, we are proposing to use FY 2019 data for the
FY 2022 ratesetting for circumstances
[[Page 25212]]
where the FY 2020 data is significantly impacted by the COVID-19 PHE.
Because we believe the FY 2020 MedPAR claims data is significantly
impacted by the COVID-19 PHE, we are proposing to use the FY 2019
MedPAR claims data for purposes where we ordinarily would have used the
FY 2020 MedPAR claims data, including for purposes of developing the FY
2022 relative weights. We refer the reader to section I.F. of the
preamble of this proposed rule for a further discussion on our analysis
of the best available data for FY 2022 ratesetting.
As discussed previously, 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 we are proposing to use FY 2019
MedPAR data instead of FY 2020 MedPAR data for the FY 2022 IPPS
ratesetting, the costs for a new technology for which the 3-year
anniversary date of the product's entry onto the U.S. market occurs
prior to the latter half of the upcoming fiscal year (FY 2022) may not
be fully reflected in the MedPAR data used to recalibrate the MS-DRG
relative weights for FY 2022. Therefore, in light of our proposal to
use FY 2019 data instead of FY 2020 data to develop the FY 2022
relative weights, we believe it would be appropriate to allow for a
one-year extension of new technology add-on payments for those
technologies for which the new technology add-on payment would
otherwise be discontinued beginning with FY 2022. Accordingly, we are
proposing to use our authority under section 1886(d)(5)(I) of the Act
to provide for a one-year extension of new technology add-on payments
for FY 2022 for those technologies listed in the table that follows. We
note that if we were to finalize our alternative approach of using the
same FY 2020 data that we would ordinarily use for purposes of FY 2022
ratesetting, including development of the FY 2022 relative weights, as
discussed in section I.F. of the preamble of this proposed rule, we
would also finalize to discontinue the new technology add-on payments
for these expiring technologies beginning in FY 2022, consistent with
our historic policies.
We note that this table also presents the newness start date, new
technology add-on payment start date, relevant final rule citations
from prior fiscal years, proposed maximum add-on payment amount, and
coding assignments for these technologies. We refer readers to the
final rules cited in the table for a complete discussion of the new
technology add-on payment application, coding and payment amount for
these technologies, including the applicable indications and discussion
of the newness start date.
We are inviting public comment on our proposal to use our authority
under section 1886(d)(5)(I) of the Act to provide for a 1-year
extension of new technology add-on payments for FY 2022 for those
technologies for which the new technology add-on payment would
otherwise be discontinued beginning with FY 2022.
We finally note, with regard to ContaCT which is a technology sold
on a subscription basis, we continue to welcome comments from the
public as to the appropriate method to determine a cost per case for
technologies sold on a subscription basis, 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.
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BILLING CODE 4120-01-C
5. FY 2022 Applications for New Technology Add-On Payments (Traditional
Pathway)
a. Aidoc Briefcase for PE
Aidoc Medical Ltd. (Aidoc) submitted an application for new
technology add-on payments for Aidoc Briefcase for PE (``Briefcase for
PE'') for FY 2022. According to the applicant, Briefcase for PE is an
FDA cleared, artificial intelligence (AI)-based solution for triage and
notification of suspected pulmonary embolism (PE) cases.
The applicant stated that the device assists hospitals and
radiologists by flagging and communicating suspected positive findings
of PE in computed tomography (CT) pulmonary angiography (CTPA)
examinations, which prompts the radiologist to assess relevant Digital
Imaging and Communications in Medicine (DICOM) imaging files, allowing
suspect cases to receive attention sooner than otherwise would have
occurred, which in turn improves clinical outcomes. According to the
applicant, patients with PE or suspected PE typically present at
hospital emergency departments (EDs). The applicant stated that for
these patients, ED physicians complete a brief evaluation and order
imaging, which typically includes CTPA. With Briefcase for PE, CTPA
images are automatically forwarded to the applicant's cloud-based
engine where they are analyzed by an AI algorithm. The applicant claims
that when Briefcase for PE detects a suspected PE, the radiologist is
alerted via the user interface of the Aidoc Worklist Application that
is installed on the radiologist's desktop. The applicant asserted that
the notification prompts the radiologist to review the CTPA images and
communicate with the emergency room team currently caring for the
patient so that the appropriate clinical action may be taken sooner
than it would otherwise have occurred in the absence of the tool.
The applicant stated that acute PE is a severe manifestation of
venous thromboembolism (VTE) and occurs when a blood clot (thrombus)
forms in a vein and then dislodges and travels to the pulmonary
arteries in the lungs. The applicant stated acute symptomatic PE can
cause death within 1 hour of onset in up to 10 percent of cases \7\ and
it is estimated to be the third largest cause of cardiovascular death
after coronary artery disease and stroke.8 9 10 11 The
applicant further noted that acute PE is a life-threatening medical
emergency that demands urgent intervention and clinical studies have
demonstrated a strong correlation between time to communication of PE
findings, treatment, and clinical outcomes.12 13 14
According to the applicant, in a typical workflow, a patient presenting
to a hospital with signs or symptoms of PE would move through the
system as follows: (1) Patient presents with suspected PE to the ED;
(2) Patient receives contrast-enhanced CTPA imaging; (3) Technologist
processes and reconstructs the CT images and manually routes them to
the hospital picture archiving and communication system (PACS); (4) The
exam enters a first-in-first-out (FIFO) reading queue, where it awaits
radiological interpretation; (5) Radiologist reads the CT images and
makes the diagnosis of PE; (6) The radiologist informs the referring
physician of positive PE either verbally or through the radiologist
report; (7) ED physician and/or on-call pulmonologist decide on the
management strategy; (8) If appropriate, the patient proceeds to
treatment.
---------------------------------------------------------------------------
\7\ Naess IA, Christiansen SC, Romundstad P, Cannegieter SC,
Rosendaal FR, Hammerstr[oslash]m J. Incidence and mortality of
venous thrombosis: A population-based study. J Thromb Haemost. 2007
Apr;5(4):692-9. doi: 10.1111/j.1538-7836.2007.02450.x. PMID:
17367492.
\8\ Giuntini C, Di Ricco G, Marini C, Melillo E, Palla A.
Pulmonary embolism: Epidemiology. Chest. 1995 Jan;107(1 Suppl):3S-
9S. doi: 10.1378/chest.107.1_supplement.3s. PMID: 7813326.
\9\ Becattini C, Agnelli G. Risk factors for adverse short-term
outcome in patients with pulmonary embolism. Thromb Res. 2001 Sep
15;103(6):V239-44. doi: 10.1016/s0049-3848(01)00291-2. PMID:
11567661.
\10\ Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary
embolism: Clinical outcomes in the International Cooperative
Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr
24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5. PMID:
10227218.
\11\ Klok FA, Mos IC, Huisman MV. Brain-type natriuretic peptide
levels in the prediction of adverse outcome in patients with
pulmonary embolism: A systematic review and meta-analysis. Am J
Respir Crit Care Med. 2008 Aug 15;178(4):425-30. doi: 10.1164/
rccm.200803-459OC. Epub 2008 Jun 12. PMID: 18556626.
\12\ Smith SB, Geske JB, Maguire JM, Zane NA, Carter RE,
Morgenthaler TI. Early anticoagulation is associated with reduced
mortality for acute pulmonary embolism. Chest. 2010 Jun;137(6):1382-
90. doi: 10.1378/chest.09-0959. Epub 2010 Jan 15. PMID: 20081101;
PMCID: PMC3021363.
\13\ Soh S, Kim JM, Park JH, Koh SO, Na S. Delayed
anticoagulation is associated with poor outcomes in high-risk acute
pulmonary embolism. J Crit Care. 2016 Apr;32:21-5. doi: 10.1016/
j.jcrc.2015.11.024. Epub 2015 Dec 8. PMID: 26764578.
\14\ Wood KE. Major pulmonary embolism: Review of a
pathophysiologic approach to the golden hour of hemodynamically
significant pulmonary embolism. Chest. 2002 Mar;121(3):877-905.
PMID: 11888976.
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The applicant asserted that the FIFO workflow is the standard of
care. The applicant stated that Briefcase for PE allows facilities to
substantially shorten the period of time between when the patient
receives CTPA imaging (Step 2) and when the radiologist informs the
referring physician of positive PE (Step 5). The applicant stated that
Briefcase for PE streamlines this workflow using AI to analyze CTPA
images of the chest automatically and notifies the radiologist that a
suspected PE has been identified, enabling the radiologist to review
imaging and make diagnostic decisions faster by prioritizing these
images for review in the queue.
With respect to the newness criterion, Briefcase for PE received
FDA 510(k) clearance on April 15, 2019 to market the device under FDA
510(k) number K190072. The FDA clearance for Briefcase for PE was based
on substantial equivalence to the legally marketed predicate device,
Briefcase for Intracranial Hemorrhage (ICH) (FDA 510(k) number
K180647), as both of these devices use AI algorithms to analyze images
and highlight cases for further action based on CT images. Briefcase
for ICH received FDA 510(k) clearance on August 1, 2018. The predicate
device for Briefcase for ICH is Viz.AI's ContaCT, which received De
Novo premarket approval in February of 2018. The applicant asserted
Briefcase for ICH is indicated for use in the analysis of non-enhanced
head CT images, whereas Briefcase for PE is indicated for use in the
analysis of non-enhanced CTPA images. According to the applicant, there
are currently no ICD-10-PCS procedure codes to adequately describe
Briefcase for PE. The applicant submitted a request for approval of a
unique ICD-10-PCS procedure code to identify use of the technology
beginning FY 2022.
Under the newness criterion, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for purposes of new technology add-on payments.
With respect to the first criterion, whether a product uses the
same or similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, Briefcase for PE is the only FDA-cleared
technology that uses computer-aided triage and notification to rapidly
detect PE and shorten time to notification of the radiologist. The
applicant claimed that no other FDA approved or cleared technology uses
the same mechanism of action for computer-aided triage and
prioritization of PE.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated it expects that
patients evaluated for PE or suspected PE using Briefcase for PE will
be assigned to the
[[Page 25218]]
same DRGs as patients evaluated for PE or suspected PE under the
current workflow or standard of care. The applicant estimates that
under the MS-DRG grouper for FY 2021, Briefcase for PE could map to 279
different MS-DRGs, with MS-DRGs 175 (Pulmonary embolism with major
complication or comorbidity (MCC) or acute cor pulmonale) and 176
(Pulmonary embolism without MCC) accounting for approximately 45
percent of the estimated cases.
With respect to the third criterion, whether the new use of
technology involves the treatment of the same or similar type of
disease and the same or similar patient population when compared to an
existing technology, the applicant did not directly respond to the
criterion but reiterated that no other existing technology is
comparable to Briefcase for PE and that Briefcase for PE is the only
FDA-cleared technology that uses computer aided triage and notification
to rapidly detect PE and shorten time to notification of the
radiologist.
We have the following concerns regarding whether the technology
meets the substantial similarity criteria and whether it should be
considered new. We note that the applicant asserted that Briefcase for
ICH, the predicate device for Briefcase for PE, is identical in all
aspects and differs only with respect to the training of the algorithm
on PE (that is, non-enhanced head CT) and ICH (that is, non-enhanced
CTPA) images. We are unclear whether the training of the algorithim on
PE and ICH images would distinguish the mechanism of action for
Briefcase for PE from Briefcase for ICH, or its predicate device,
ContaCT, and we invite comment on whether Briefcase for PE represents a
new mechanism of action. We note that although the applicant did not
directly state whether Briefcase for PE involves the treatment of the
same or similar type of disease and the same or similar patient
population, we believe that Briefcase for PE would be used for a
different disease and patient population than Briefcase for ICH and
ContaCT.
We continue to be interested in public comments regarding issues
related to determining newness for technologies that use AI, an
algorithm, or software, as discussed in the FY 2021 IPPS/LTCH PPS final
rule (85 FR 58628). Specifically, we are interested in public comment
on how these technologies, including devices classified as radiological
computer aided triage and notification software and radiological
computer-assisted diagnostic software, may be considered for the
purpose of identifying 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.
We invite public comments on whether Briefcase for PE meets the
newness criterion.
With regard to the cost criterion, the applicant presented the
following analysis. The applicant first identified the principal
diagnoses associated with the PE-related MS-DRGs 175 (``Pulmonary
embolism with MCC or acute cor pulmonale'') and 176 (``Pulmonary
embolism without MCC''). The applicant then searched the FY 2019
proposed rule MedPAR Limited Data Set (LDS) for claims where the
principal diagnoses were listed in any position on an inpatient claim.
The applicant mapped the 2,517 identified claims to the list of unique
MS-DRGs corresponding to these claims and aggregated the claims by MS-
DRG. Per the applicant, under the MS-DRG grouper for FY 2021, potential
cases representing patients who may be eligible for treatment using
Briefcase for PE map to 279 MS-DRGs, with MS-DRGs 175 and 176
accounting for approximately 45 percent of estimated cases. The
applicant also provided a table of the top 10 MS-DRGs, which represent
approximately 69 percent of estimated cases.
[GRAPHIC] [TIFF OMITTED] TP10MY21.136
The applicant standardized the charges and applied the 2-year
charge inflation factor used to adjust the outlier threshold
determination, which the applicant stated was 10.22 percent. We note
that the actual 2-year inflation factor in the FY 2021 IPPS/LTCH PPS
final rule was 13.2 percent (85 FR 59039), which would have increased
the inflated charges figure. The applicant did not remove charges for
prior technology as the applicant maintained that no existing
technology is comparable to Briefcase for PE. However, the applicant
removed 31.9 percent of total accommodation charges, which the
applicant maintained is consistent with their internal study which
indicated that Briefcase for PE reduced the length of stay for PE-
diagnosed patients.\15\ Per the applicant, the study demonstrated a
mean length of stay of 8.77 and 5.97 days for pre-AI and post-AI time
periods, respectively.\16\
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\15\ Maya M. et al. Artificial Intelligence Software for
Flagging Pulmonary Embolism on CTPA Associated with Reduced Length
of Stay. Abstract draft of an internal study performed by the
applicant (unpublished).
\16\ Ibid.
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Next, the applicant added charges for the new technology. To
calculate the charges for the new technology, the applicant multiplied
the cases involving Briefcase for PE from each of its subscribing
providers by a Medicare share of 52 percent to obtain the total
estimated Medicare and non-Medicare cases. The applicant obtained the
52 percent Medicare share figure from a
[[Page 25219]]
nationwide sample of inpatient claims provided by the Agency for
Healthcare Research and Quality (AHRQ). Specifically, the applicant
searched data from the Healthcare Cost and Utilization Project for
discharges with the following codes: I2699, I2609, I2692, I2602, I2782,
T790XXA, T800XXA, T791XXA, I2693, I2694, and I2601.\17\ The applicant
found 189,575 discharges, of which 52 percent identified Medicare as
the payer. The applicant divided the total cost of the technology by
the estimated total number of cases for each customer to obtain a
provider-specific cost per case, which it then averaged across all
customers to obtain an overall average cost per case. Finally, the
applicant divided the average cost per case by the national average CCR
for the CT cost center of 0.034 from the FY 2021 IPPS/LTCH PPS final
rule (85 FR 58601).
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\17\ Healthcare Cost and Utilization Project. Free Health Care
Statistics. https://hcupnet.ahrq.gov/#setup.
---------------------------------------------------------------------------
The applicant calculated a final inflated average case-weighted
standardized charge per case of $87,483, which exceeded the average
case-weighted threshold amount of $71,312. Because the final inflated
average case-weighted standardized charge per case exceeded the average
case-weighted threshold amount, the applicant maintained that Briefcase
for PE meets the cost criterion.
We would like more information regarding the methodology by which
the applicant selected the diagnosis codes associated with MS-DRGs 175
and 176, as well as subanalyses that limit the cases to MS-DRGs 175 and
176 and the top 10 MS-DRGs, which per the applicant represent 45
percent of estimated cases and 69 percent of estimated cases,
respectively. Additionally, the applicant appears to have used a single
list price of Briefcase for PE per hospital with a cost per patient
that can vary based on the volume of cases. We question whether the
cost per patient varies based on the utilization of the technology by
the hospitals. We are interested in more information about the
applicant's cost per case calculation, including how the applicant
selected the codes it used to search for discharges from the Healthcare
Cost and Utilization Project, as well as the per unit cost of Briefcase
for PE and how the total cost of the technology was calculated for each
subscribing provider.
In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58630), we stated
our understanding that there are unique circumstances to determining a
cost per case for a technology that utilizes a subscription for its
cost. We stated our intent to continue to consider the issues relating
to the calculation of the cost per unit of technologies sold on a
subscription basis as we gain more experience in this area. We continue
to welcome 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 invite public comment on whether
Briefcase for PE meets the cost criterion, particularly in light of the
subscription model, for which the number of subscribers and the
estimated cost per case based on that subscriber data may change over
time.
With regard to the substantial clinical improvement criterion, the
applicant claimed that Briefcase for PE represents an advance that
substantially improves the ability to diagnose pulmonary embolism by
pre-reading images of CTPAs, automatically identifying suspected PE in
CTPA images, and notifying the radiologist before the radiologist would
have opened the study in the standard of care, which the applicant
claims is the FIFO workflow. The applicant also asserted that because
of a reduction in time-to-exam-open, where Briefcase for PE notifies
the radiologist to open and read CTPA studies that have a high
probability of being positive for PE sooner than the radiologist would
have under the FIFO workflow, the treating physician can initiate
treatment sooner, which can reduce mortality and reduce length of stay
related to PE.
The applicant provided data from an FDA pivotal study in support of
its assertion that Briefcase for PE reduces time-to-exam-open compared
to the standard of care and helps in prioritization of diagnosis.\18\
For the FDA pivotal study, the applicant conducted a retrospective,
blinded, multicenter, multinational study of the assessment of 184
CTPAs from 3 clinical sites (2 US and 1 outside US) using Briefcase for
PE. The primary endpoint was to evaluate the software's performance in
identifying pulmonary embolism on an approximately equal number of
positive and negative cases (images with PE versus without PE), with a
performance goal of at least 80 percent sensitivity (true positive
rate) and specificity (true negative rate). Per the applicant, both
measures exceeded the performance goal, with 90.6 percent sensitivity
(95 percent CI: 82.2 percent-95.9 percent) and 89.9 percent specificity
(95 percent CI: 82.2 percent-95.1 percent).
---------------------------------------------------------------------------
\18\ Aidoc Briefcase for PE--Pivotal Study 1--FDA 510(k)--
K190072. http://www.accessdata.fda.gov/cdrh_docs/pdf19/K190072.pdf.
---------------------------------------------------------------------------
According to the applicant, the secondary endpoint of the FDA
pivotal study was to evaluate time-to-notification for true positive PE
cases compared to the FIFO workflow. The study showed that time-to-
notification with Briefcase for PE is 3.9 minutes (95 percent CI: 3.7-
4.1). The applicant noted that, in contrast, the time-to-exam-open in
the FIFO workflow was significantly longer at 64.1 minutes (95 percent
CI 36.6-91.5). The applicant stated the mean difference of 60.2 minutes
(95 percent CI 32.7-87.6) for these two metrics is statistically
significant, and assuming the radiologist receives a notification on a
true positive PE case and acts on it immediately, it can save an
average of 60.2 minutes (95 percent CI 32.7-87.6) compared to the time-
to exam-open in a FIFO reading queue. Based on this data, the applicant
concluded Briefcase for PE substantially shortened the time to
diagnosis for PE cases as compared with the FIFO workflow.
The applicant further claimed that clinical studies and other real-
world data have demonstrated comparable performance characteristics and
shown that the integration of the Briefcase for PE software into the
radiology workflow markedly improves time to notification for PE
patients across a variety of clinical settings, geographies, and
facilities. The applicant submitted a retrospective, single-site study
by Weikert T., et al., which evaluated Briefcase for PE performance on
1,465 retrospective CTPA examinations from 2017 in an academic center
outside the US.\19\ The sensitivity and specificity were measured to be
92.7 percent (95 percent CI: 88.3-95.5 percent) and 95.5 percent (95
percent CI: 94.2-96.6 percent), respectively. The researchers concluded
that the system has high diagnostic performance for the automatic
detection of PE on CTPA exams and as such, speeds up the diagnostic
workup of critical cases.
---------------------------------------------------------------------------
\19\ Weikert T, Winkel DJ, Bremerich J, Stieltjes B, Parmar V,
Sauter AW, Sommer G. Automated detection of pulmonary embolism in CT
pulmonary angiograms using an AI-powered algorithm. Eur Radiol. 2020
Jul 3. doi: 10.1007/s00330-020-06998-0. Epub ahead of print. PMID:
32621243
---------------------------------------------------------------------------
The applicant stated that unpublished data maintained by Aidoc
suggest that real-world performance of Briefcase for PE is consistent
with what was found in
[[Page 25220]]
the FDA pivotal study.20 21 The applicant stated that across
26 sites encompassing a variety of geographic locations across the
United States, a total of 36,084 CTPA examinations were analyzed over a
90-day period (July 13, 2020-October 11, 2020). Time-to-notification
metrics were calculated for all 4,748 CTPAs analyzed by the software
and identified as positive for PE. Time-to-notification was calculated
as the time to get the DICOM exam, de-identify it, upload it to the
cloud, analyze and send a notification back to the worklist
application. The applicant claimed that the mean time-to-notification
for PE was 7.0 minutes (median: 6.1/IQR: 4.8). According to the
applicant, over 85 percent of CTPA examinations identified as positive
for PE were notified in under 10 minutes. The applicant concluded that
the study demonstrates the ability of Briefcase for PE to provide fast
time-to-notification on positive PE cases and its generalizability
across different centers and patient populations.
---------------------------------------------------------------------------
\20\ Avondo, J. Yalon R., Ashkenasi C. Time-to-notification
Analysis Across US Facilities with Aidoc Briefcase for PE. Internal
study performed by the applicant (unpublished).
\21\ Ibid.
---------------------------------------------------------------------------
The applicant submitted additional unpublished data from the 26
sites spread across a variety of geographic locations of the United
States aggregated over a different 90-day period (September 17, 2020 to
December 17, 2020).\22\ Seven sites were excluded from the analysis due
to having third-party integrations that prevented the ability to
capture engagement metrics. Two engagement metrics were calculated: The
open percentage and the time-to-open. The open percentage metric was
calculated as the percentage of notifications that were presented to
the radiologist and opened by at least one radiologist. The time-to-
open metric was measured by calculating the time between the arrival of
the Briefcase for PE notification and the time first opened by a
radiologist. A total of 2,138 notifications for CTPA examinations found
to be positive for PE by Briefcase for PE were analyzed. The open
percentage was found to be 97 percent across all sites (min: 80
percent, max: 100 percent), and the mean time-to-open was found to be
2.13 minutes (median: 1.0/interquartile range: 2.0). The data provided
by the applicant indicated over 90 percent of notifications were found
to be opened in under 5 minutes. Based on this data, the study
concluded that radiologists in the US readily engage with notifications
for positive PE cases provided by Briefcase for PE and do so in a
timely manner. The study asserted that engagement is an important
metric to assess radiologist adoption of this technology, which is
critical to its practical utility in shortening time to diagnosis and
communication of PE to reduce the time to treatment and improve
clinical outcomes.
---------------------------------------------------------------------------
\22\ Avondo, J. Yalon R., Ashkenasi C. Radiologist Engagement
Analysis Across US Facilities with Aidoc Briefcase for PE. Internal
study performed by the applicant (unpublished).
---------------------------------------------------------------------------
The applicant also claimed that Briefcase for PE significantly
improves clinical outcomes relative to the current standard of care
using the FIFO workflow because the use of Briefcase for PE reduces
time to diagnosis and treatment by notifying the radiologist to review
the image for suspected PE faster in the workflow. The applicant
claimed early diagnosis and treatment is important in acute PE where
there exists a ``golden hour,'' during which a timely approach to
diagnosis and therapy can affect outcomes by reducing mortality and
reducing length of stay.\23\
---------------------------------------------------------------------------
\23\ The term ``golden hour'' references a critical period of
time which may be longer or shorter than a literal hour.
---------------------------------------------------------------------------
The applicant provided two unpublished internal studies in support
of the impact of Briefcase for PE on clinical outcomes. The applicant
stated that in a single-site retrospective study, Maya M., et al. have
shown a reduction in hospital length of stay for PE patients following
the use of the Briefcase for PE system, compared to an equivalent time
period prior to the use of the system.\24\ The applicant stated that
Maya M., et al. compared mean length of stay for 366 patients with a
positive PE diagnosis during 10-month periods before and after
Briefcase for PE was implemented at Cedars-Sinai Medical Center in
December 2018 (206 patients before the use of Briefcase for PE and 160
patients after the AI intervention). 3,997 patient encounters that
underwent CTPA imaging but that were not diagnosed with PE were split
as 1,926 and 2,071 patient encounters for the pre/post-AI periods based
on the admission dates. Hip fracture was chosen as a comparison group
due to acuity, treatment-related factors, and similar length of stay to
PE. 2,422 patient encounters for patients diagnosed with hip fractures,
identified by ICD9 code 820 and 821, were split as 1,279 and 1,143
patient encounters for the pre/post-AI periods based on the admission
dates. According to the applicant, the pre- and post-implementation had
similar seasonality and numbers of ``hospital-wide patient encounters''
(103,626 vs 104,733 encounters). The applicant noted that for the PE
diagnosed patients, a mean length of stay of 8.77 and 5.97 days was
observed for the pre-AI and post-AI time periods, respectively. The
applicant stated that the mean difference was 2.80 days (p-value
0.05). Additionally, for the
hospital wide patients, a mean length of stay of 5.78 and 5.96 days was
observed for the pre-AI and post-AI time periods, respectively. The
mean difference was -0.18 days (p-value 1.5
hours of CTPA acquisition) in direct communication of acute PE
diagnosis from radiologists to referring physicians was significantly
correlated with a higher risk of delayed treatment initiation and death
within 30 days. Another prospective, single-site study, Kline J., et
al., concluded that patients with a delayed diagnosis had a higher rate
of in-hospital adverse events (9 percent vs. 30 percent; p = 0.01). An
additional retrospective, single-site study by Smith S., et al.
observed an association between early administration of anticoagulation
therapy and reduced mortality for patients with acute PE. Lastly, a
retrospective, single-site study asserting a ``golden hour'' by Soh S.,
et al. was submitted by the applicant to demonstrate an association
between early initiation of anticoagulation therapy and in-hospital
mortality in high-risk PE patients who needed ICU care. According to
the applicant, Soh S., et al. concluded that their analysis showed that
the cutoff point of anticoagulation initiation to achieve improved
survival rates was 5.2 hours (that is, golden hour). The applicant
stated that the study observed an association between early
anticoagulation and reduced mortality for patients with acute PE.
In reviewing the information submitted by the applicant as part of
its FY 2022 new technology add-on payment application for Briefcase for
PE, we note that the clinical literature provided by the applicant only
compares the technology to unassisted FIFO workflows and not against
existing electronic (for example, EHR ``stat'' orders) or manual (for
example, verbal communication to radiologist) forms of prioritization,
or other types of existing risk stratification tools or features
currently available in EHRs. Additionally, we note that some of the
studies provided by the applicant that took place over many years may
not have accounted for confounding variables (for example, improvements
in care for patients with suspected PE) that may have occurred during
the study period. Comparing to the FIFO workflow alone assumes that no
other changes occurred before and after the adoption of the system and
that the hospitals in question did not implement any other changes to
their standard operating procedures to stratify suspected PE cases over
the period of time many of the provided studies took place. We also
note that the applicant has not provided data on potential outcome
concerns associated with this type of clinical decision support tool
(for example, treatment delays due to false negatives, false positives,
or multiple workflow prioritization alerts presented to the physician
at the same time). We invite public comment on whether these issues may
affect the tool's ability to help diagnose a medical condition earlier
in a patient population.
Lastly, we note that the applicant does not measure the effect of
its technology on actual treatment outcomes, instead relying on the
assumption that faster treatment results in better outcomes. Without
measuring this impact on treatment outcomes, we are uncertain if the
technology will lead to substantive clinical outcomes. Given that the
applicant references a critical ``golden hour'' which may be as long as
5.2 hours, the potential time savings resulting from the use of
Briefcase for PE may be insubstantial in relation to the time within
which outcomes are affected in the setting of PE.
We are inviting public comments on whether Briefcase for PE meets
the substantial clinical improvement criterion.
We received a written public comment from the applicant in response
to the New Technology Town Hall meeting regarding the application of
Briefcase for PE for new technology add-on payments.
Comment: The applicant responded to questions received at the New
Technology Town Hall Meeting. First the applicant was asked what the
sensitivity and specificity of the standalone device is for identifying
pulmonary embolism and how the sensitivity and specificity of the
radiologist alone compare to the sensitivity and specificity of the
radiologist when using the device. The applicant responded by
reiterating the sensitivity and specificity data provided in the FDA
pivotal study and restating that Briefcase for PE is a computer-aided
triage and notification system that is not intended to aid in the
diagnosis of PE but rather, Briefcase for PE identifies cases of
suspected PE on CTPAs and, via triage and notification, prioritizes
these cases for radiologist review.26 27 The applicant
further restated that this triage and notification modifies the
traditional radiology workflow in which images are reviewed on a FIFO
basis to reduce the time-to-open-exam from over one hour to several
minutes (standard of care vs. Briefcase for PE). The applicant restated
that this reduction in time-to-open-exam has been demonstrated to
improve patient outcomes, including hospital length of stay and post-
discharge mortality. The applicant further noted that, because
Briefcase for PE is a triage and notification system, no patient harm
results from false positives or false negatives that may occur. The
applicant explained that with respect to false positives, these
suspected cases of PE will be triaged and the radiologist will be
notified, prompting earlier review and diagnosis of the CTPA image by
the radiologist. The applicant explained that for cases of PE that are
missed by Briefcase for PE (that is, false negatives), the radiologist
will review these CTPA images on a FIFO basis the same as today's
standard of care and that triage and notification do not occur in the
standard of care.
---------------------------------------------------------------------------
\26\ Aidoc Briefcase for PE--Pivotal Study 1--FDA 510(k)--
K190072. http://www.accessdata.fda.gov/cdrh_docs/pdf19/K190072.pdf.
\27\ Weikert T, Winkel DJ, Bremerich J, et al. Automated
detection of pulmonary embolism in CT pulmonary angiograms using an
AI-powered algorithm. Eur Radiol. 2020;30(12):6545-6553.
doi:10.1007/s00330-020-06998-0.
---------------------------------------------------------------------------
Second, the applicant was asked if Briefcase for PE decreased time
outside of clinical trial protocols and how the applicant can be
certain reducing time-to-notification affects the time period between
when the CTPA is completed and the study is interpreted. In response,
the applicant again reiterated data from the FDA pivotal study in
restating that implementation of Briefcase for PE saves on average 60.2
minutes relative to the standard of care FIFO clinical workflow and
that data maintained by Aidoc demonstrate that real-world performance
of Briefcase for PE is consistent with the results achieved in the FDA
study. The
[[Page 25222]]
applicant also submitted data summarized previously indicating mean
time-to-open, as measured by calculating the time between when a
notification first became available in the application and the time of
open, was 2.13 minutes (median: 1.0/IQR: 2.0). The applicant restated
that in addition to measuring the mean time-to-open, the open rate, or
the percentage of notifications opened, was measured for this same
population and the open rate was found to be 97 percent (min: 80
percent, max: 100 percent), with over 90 percent of notifications found
to be opened in under 5 minutes.\28\
---------------------------------------------------------------------------
\28\ Avondo, J. Yalon R., Ashkenasi C. Radiologist Engagement
Analysis Across US Facilities with Aidoc Briefcase for PE. Internal
study performed by the applicant (unpublished).
---------------------------------------------------------------------------
Also in response to this second question, the applicant reiterated
data describing an independent analysis performed by Raskin, et al.,
examining the impact of Briefcase for PE implementation on 30- and 120-
day all-cause mortality for all patients age 18 years or older with a
diagnosis of PE on CTPA and admitted to Sheba Medical Center in Tel
Aviv, Israel. The applicant restated data described previously
indicating that investigators found that the post- Briefcase cohort had
significantly reduced 30- and 120-day all-cause mortality compared to
the pre-Briefcase cohort--14.9 percent vs 11.0 percent and 26.1 percent
vs 20.4 percent, respectively. The applicant stated these observed
effects equate to a reduction ratio of 26.6 percent (p 31 32 and of those, at
least 9 percent have atypical EGFR mutations like exon 20 ins.\33\ The
applicant selected 0.93% (82.5% * 12.5% * 9%) of the cases identified
based on the lung cancer diagnosis codes listed previously. The
applicant stated this is the target population for amivantamab, which
the applicant used for the cost analysis.
---------------------------------------------------------------------------
\30\ ``What is Lung Cancer?'' American Cancer Society. 1 October
2019: https://www.cancer.org/content/cancer/en/cancer/lung- cancer/
about/what-is.html.
\31\ Wee, P., & Wang, Z. (2017). Epidermal growth factor
receptor cell proliferation signaling pathways. Cancers, 9(5), 52.
\32\ Pao, W., & Girard, N. (2011). New driver mutations in non-
small-cell lung cancer. The Lancet Oncology, 12(2), 175-180.
\33\ Arcila, M. E., Nafa, K., Chaft, J. E., Rekhtman, N., Lau,
C., Reva, B. A., and Ladanyi, M. (2013). EGFR exon 20 insertion
mutations in lung adenocarcinomas: Prevalence, molecular
heterogeneity, and clinicopathologic characteristics. Molecular
Cancer Therapeutics, 12(2), 220-229.
---------------------------------------------------------------------------
The applicant then accounted for the circumstances where
amivantamab would be administered during an inpatient stay. The
applicant stated that amivantamab will typically be administered in the
outpatient setting, and that it assumed that amivantamab would be
administered during an inpatient stay, possibly for care unrelated to a
patient's cancer treatment, when that stay coincided with the 2-week
cycle during which a patient receiving amivantamab would undergo an
infusion in the outpatient setting were it not for their inpatient
admission. The applicant stated that, because it is very important that
patients receive continuity of cancer care, it assumed that some
patients would receive their amivantamab infusion during their hospital
stay. To account for this scenario, the applicant calculated the
average length of stay for all of the cases in its patient population,
which it asserted was about 5.862 days. The applicant then divided the
average length of stay for all of the cases by 14, as per the applicant
amivantamab is administered on 28-day cycle, with a weekly
administration for the first cycle, and an administration every 2 weeks
thereafter.
The applicant stated that current clinical guidelines are expected
to give medical professionals discretion to administer amivantamab
during the hospitalization or pause the treatment cycle. To account for
physician discretion, the applicant included only 50 percent of these
cases in the final cost analysis.
The applicant identified 349 cases mapping to the following MS-
DRGs. The applicant has not made a request for amivantamab to map to a
new or different MS-DRG for FY 2022.
[GRAPHIC] [TIFF OMITTED] TP10MY21.140
The applicant assumed patients receiving amivantamab would receive
one dose of the drug during their inpatient stay. Because amivantamab
would be administered in addition to any other drugs the patient was
receiving during their inpatient admission, the applicant did not
remove costs associated with any previous technology. The applicant
then standardized the charges using the FY 2019 IPPS/LTCH PPS final
rule Impact file. Then the applicant applied the 2-year inflation
factor of 13.2 percent (1.13218) from the FY 2021 IPPS/LTCH PPS final
rule (85 FR 59039). The applicant then added charges for amivantamab,
which the applicant determined using the inverse of the FY 2021 IPPS/
LTCH PPS final rule pharmacy national average cost to charge ratio
(CCR) of 0.187 (85 FR 58601).
Because the applicant calculated a final inflated average case-
weighted standardized charge per case of $108,159, which exceeds the
case weighted threshold of $64,736, the applicant maintains the
technology meets the cost criterion.
Based on the information provided by the applicant, we have several
concerns with regard to whether the technology meets the cost
criterion. In its cost analysis, the applicant combined 234 cases from
multiple MS-DRGs into one group with a case-weight of 67 percent of
cases. We do not believe this is appropriate for the cost analysis. As
reflected in Sec. 412.87(b)(3), where cases eligible for a particular
technology may be assigned to multiple MS-DRGs, in performing the cost
analysis, the applicant should compare the charges of the cases to a
threshold amount that is the lesser of 75 percent of the standardized
amount or 75 percent of one standard deviation beyond the case-weighted
average of all MS-DRGs to which the cases map. In the event that a
single MS-DRG has fewer than 11 cases, the applicant should impute a
minimum case number of 11 rather than the actual value. In this way,
the appropriate threshold and case weighted threshold value can be
calculated.
[[Page 25225]]
In its analysis, the applicant appears to take a sample of a larger
case population based on clinical data. It is unclear whether the
applicant is taking a simple random sample or a targeted sample of
cases. We note that, if the applicant obtained a random sample, this
sample may not be any more representative of the larger population of
cases identified by the lung cancer diagnosis codes listed previously.
If the applicant instead non-randomly sampled cases from the larger
population, we would like to understand the process used by the
applicant to identify this targeted sample. Under either approach, we
would request information on how a sampling of cases from the greater
population is more representative of potential amivantamab patients.
We are inviting public comments on whether amivantamab meets the
cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that amivantamab represents a substantial clinical
improvement over existing technologies. The applicant asserted several
claims of substantial clinical improvement for amivantamab: (1)
Amivantamab is anticipated to be the first therapy to treat the
metastatic NSCLC with exon 20 insertion mutations for patients whose
disease has progressed on or after platinum-based chemotherapy; (2) the
objective response rate (ORR) was higher than what would be expected
with chemotherapy or immunotherapy; (3) a clinical benefit rate higher
than what would be expected with chemotherapy or immunotherapy; (4) a
duration of response higher than what would be expected with
chemotherapy or immunotherapy; (5) the median progression free survival
was higher than what would be expected with chemotherapy or
immunotherapy; and (6) the incidence and severity of diarrhea was lower
than what would be expected with any oral EGFR inhibitor.
The applicant stated that patients with NSCLC and EGFR exon 20
insertion mutations have a form of disease that is generally
insensitive to available EGFR TKI treatments and, as a result, carries
a worse prognosis compared to patients with more common EGFR
mutations.\34\ Per the applicant, the current standard of care for the
initial treatment of exon 20 insertion metastatic NSCLC is platinum-
based chemotherapy; \35\ and, after a patient with EGFR exon 20
insertion metastatic NSCLC disease progresses on or during platinum-
based chemotherapy, there is no standard of care. The applicant stated
there are currently no FDA-approved targeted therapies for patients
with lung cancer who have EGFR exon 20 insertion mutations.\36\ The
applicant cited an analysis of the Flatiron Health database, which
includes electronic health data records from over 265 cancer clinics
representing over 2 million active US cancer patients, that found
prescribers use a wide variety of treatment strategies, all of which
have an unclear role in the second-line treatment of exon 20 insertion
mutated metastatic NSCLC or are known to be ineffective and/or have
potential tolerability issues.\37\ Specifically, the analysis showed
that in the second-line treatment of exon 20 insertion metastatic
NSCLC, approximately 33 percent of patients received single-agent
immunotherapy, 14.1 percent received an EGFR-targeting oral agent, 5.9
percent received chemoimmunotherapy combination, 5.9 percent received
chemotherapy with a VEGF inhibitor, 5.9 percent received a clinical
study drug, and the remainder received a variety of single-agent
chemotherapies or other regimens. The applicant stated this re-iterates
the lack of an accepted standard of care for the second-line treatment
of exon 20 insertion metastatic NSCLC and thus underscores the unmet
need of these patients. According to the applicant, based on the
Breakthrough Therapy designation for amivantamab, it is anticipated
that amivantamab's first expected approval will be for the second-line
treatment of exon 20 insertion metastatic NSCLC.
---------------------------------------------------------------------------
\34\ Vyse, S., and Huang, P. H. (2019). Targeting EGFR exon 20
insertion mutations in non-small cell lung cancer. Signal
Transduction and Targeted Therapy, 4(1), 1-10.
\35\ Chantharasamee, J., Poungvarin, N., Danchaivijitr, P., and
Techawatanawanna, S. (2019). Clinical outcome of treatment of
metastatic non-small cell lung cancer in patients harboring uncommon
EGFR mutation. BMC Cancer, 19(1), 701.
\36\ Yasuda, H., Kobayashi, S., and Costa, D. B. (2012). EGFR
exon 20 insertion mutations in non-small-cell lung cancer:
Preclinical data and clinical implications. The Lancet Oncology,
13(1), e23-e31.
\37\ Flatiron Health database, Second Line Treatment Regimens in
Advanced NSCLC (January 2015-October 2019).
---------------------------------------------------------------------------
The applicant provided three references to support a finding of
substantial clinical improvement for amivantamab as well as some
supplementary information in the application itself. The first
reference was a conference presentation given at the 2019 Annual
Meeting of the Society for Clinical Oncology titled ``JNJ-61186372
(JNJ-372), an EGFR-cMet bispecific antibody, in EGFR-driven advanced
non-small cell lung cancer (NSCLC)'' by Haura et al. The second was a
poster presented at the 2020 Annual Meeting of the American Society for
Clinical Oncology titled ``Amivantamab (JNJ-61186372), an anti-EGFR-MET
bispecific antibody, in patients with EGFR Exon 20 insertion
(Exon20ins)-mutated non-small cell lung cancer (NSCLC)'' by Park et al.
The third was a conference presentation given in January 2021 at the
World Conference on Lung Cancer titled ``Amivantamab in Post-platinum
EGFR Exon 20 Insertion Mutant Non-small Cell Lung Cancer'' by Sabari et
al.
These three references all describe the ongoing Phase 1 trial
titled ``A Phase 1, First-in-Human, Open-Label, Dose Escalation Study
of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects
With Advanced Non-Small Cell Lung Cancer'' (https://clinicaltrials.gov/ct2/show/NCT02609776). This open label, multicenter, first-in-human
study, also known as ``CHRYSALIS,'' consists of two parts.\38\ Part 1
was a dose escalation study used to establish the recommended Phase 2
dosing regimen.\39\ Part 2 was a dose expansion study to assess safety
and efficacy at the recommended Phase 2 dosing regimen.\40\ The primary
efficacy endpoint was the overall response rate per Response Evaluation
Criteria in Solid Tumors v1.1.\41\ Key secondary endpoints included
clinical benefit rate (CBR), duration of response (DOR), progression-
free survival (PFS), and overall survival (OS).\42\
---------------------------------------------------------------------------
\38\ https://clinicaltrials.gov/ct2/show/study/NCT02609776
https://clinicaltrials.gov/ct2/show/study/NCT02609776
\39\ Sabari JK, Shu CA, Park K, et al. Amivantamab in post-
platinum EGFR exon 20 insertion mutant non-small cell lung cancer.
Oral presentation presented at: International Association for the
Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer
Singapore (WCLC 2020); January 28-31, 2021; Worldwide Virtual Event.
\40\ Ibid.
\41\ Ibid.
\42\ Ibid.
---------------------------------------------------------------------------
Key eligibility criteria for the post-platinum population of
patients enrolled in the study included: Metastatic/unresectable NSCLC,
EGFR exon 20 insertion mutation, and progression on platinum-based
chemotherapy.\43\ Patients received the recommended Phase 2 dose of
1050 mg (1400 mg for patients >=80 kg) amivantamab intravenously once
weekly for the first cycle and biweekly thereafter.\44\ The safety
population
[[Page 25226]]
(N=114) included all post-platinum exon 20 ins patients who received
amivantamab at the recommended Phase 2 dose, and the response-evaluable
population (n=81) included post-platinum exon 20 ins patients who had
at least three disease assessments or had discontinued, progressed, or
died prior to the third post-baseline assessment at the time of
clinical cut-off.\45\
---------------------------------------------------------------------------
\43\ Ibid.
\44\ Ibid.
\45\ Ibid.
---------------------------------------------------------------------------
In the efficacy population, the median age was 62.\46\ In addition,
59 percent of the patients were female, 49 percent of the patients were
Asian, and 47 percent had a history of smoking.\47\ Median time from
initial diagnosis was 17 months with a range of 1-130 months.\48\ All
patients, by definition, had a prior history of platinum-based
chemotherapy while 46 percent had prior immuno-oncology therapy and 25
percent had a history of EGFR TKI treatment.\49\
---------------------------------------------------------------------------
\46\ Ibid.
\47\ Ibid.
\48\ Ibid.
\49\ Ibid.
---------------------------------------------------------------------------
In the safety population, 98 percent of patients experienced a
treatment-related adverse event.\50\ Of these, 16 percent were Grade 3
or higher, 9 percent were serious, 4 percent led to discontinuation, 13
percent led to dose reduction, and 21 percent led to dose
interruption.\51\ Of note, 2 percent discontinued due to rash and 10
percent had treatment-related diarrhea with 8.5 percent at grade 1-2
and 3.5 percent at grade 3.\52\
---------------------------------------------------------------------------
\50\ Ibid.
\51\ Ibid.
\52\ Ibid.
---------------------------------------------------------------------------
The applicant stated that preliminary safety results from the
CHRYSALIS trial presented at the 2020 ASCO meeting appear to
demonstrate that amivantamab has a manageable safety profile, with 60%
of adverse events at grade 1 to 2.\53\ Per the applicant, this appears
to be an improvement relative to the types and frequency of adverse
events reported for platinum based chemotherapies overall in advanced
NSCLC, with over half of patients reporting adverse events of grade 3
to 5, such as neutropenia, nausea, and vomiting.\54\ The applicant
noted the best tolerated EGFR-targeting oral agent osimertinib was
associated with a rate of discontinuation due to adverse events of 13
percent in the phase 3 FLAURA study.\55\ In addition, the applicant
noted osimertinib was associated with a rate of any grade diarrhea of
58 percent with 2 percent of patients having grade 3 or higher in this
study.\56\ In the same phase 3 FLAURA study, the applicant noted the
comparator arm (gefitinib or erlotinib) was associated with a 57
percent incidence of any grade diarrhea with 2 percent of patients
experiencing grade 3 or higher.
---------------------------------------------------------------------------
\53\ 2020 ASCO Annual Meeting: Park, K, et al. J Clin Oncol
38:2020 (suppl; abstr 9512).
\54\ Schiller, JH et al. (2002). Comparison of four chemotherapy
regimens for advanced non-small-cell lung cancer. New England
Journal of Medicine, 346(2), 92-98.
\55\ Ibid.
\56\ Ibid.
---------------------------------------------------------------------------
Regarding efficacy, in the Sabari et al reference, a blinded
independent central review found an ORR in the efficacy population of
40 percent (95 percent CI 29-51) and a median DOR of 11.1 months (95
percent CI 6.9-not reached).\57\ Patients experienced a complete
response in 4 percent of cases, partial response in 36 percent of
cases, stable disease in 48 percent of cases, progressive disease in 10
percent of cases, and one percent of patients was not evaluable.\58\
Finally, the CBR (defined as complete response, partial response, or
stable disease for at least two disease assessments) was 74 percent (95
percent CI 63-83).\59\ The median patient follow-up in this most recent
analysis was 9.7 months (range 1.1-29.3). Of note, 47 percent of
patients remained on treatment at time of data cutoff and 63 percent
had responses of at least six months.\60\ The median PFS was 8.3 months
(95 percent CI 6.5-10.9), and the median overall survival was 22.8
months (95 percent CI 14.6-not reached).\61\
---------------------------------------------------------------------------
\57\ Sabari JK, Shu CA, Park K, et al. Amivantamab in post-
platinum EGFR exon 20 insertion mutant non-small cell lung cancer.
Oral presentation presented at: International Association for the
Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer
Singapore (WCLC 2020); January 28-31, 2021; Worldwide Virtual Event.
\58\ Ibid.
\59\ Ibid.
\60\ Ibid.
\61\ Ibid.
---------------------------------------------------------------------------
The applicant stated that, while direct comparison between
therapies cannot be definitively made in the absence of comparative
trials, amivantamab results appear promising and numerically better
than those expected with current therapies (chemotherapy,
immunotherapy, chemoimmunotherapy combination, or oral EGFR tyrosine
kinase inhibitors) based on available data. The applicant stated
platinum-based chemotherapy has been associated with a median
progression free survival of 5.1 to 6.0 months in patients with exon 20
T790m mutations-the most common mutation observed following resistance
to small molecule TKI inhibitors commonly used in advanced EGFR
mutation positive NSCLC.\62\ The applicant stated that oral EGFR
tyrosine kinase inhibitors (for example, erlotinib, gefitinib,
afatinib, dacomitinib, osimertinib) and immunotherapies are also used
to treat patients with exon 20 insertion metastatic NSCLC but generally
have limited efficacy as exon 20 insertion mutations have been
associated with resistance to EGFR tyrosine kinase inhibitors.\63\ The
applicant stated most immunotherapy and chemoimmunotherapy studies have
excluded patients with EGFR mutation because single-agent
immunotherapies have very limited efficacy in patients with EGFR-
mutated NSCLC.
---------------------------------------------------------------------------
\62\ Yoshida, T., Kuroda, H., Oya, Y., Shimizu, J., Horio, Y.,
Sakao, Y., et al. . . . and Yatabe, Y. (2017). Clinical outcomes of
platinum-based chemotherapy according to T790M mutation status in
EGFR-positive non-small cell lung cancer patients after initial
EGFR-TKI failure. Lung Cancer, 109, 89-91.
\63\ Vyse, S., & Huang, P. H. (2019). Targeting EGFR exon 20
insertion mutations in non-small cell lung cancer. Signal
Transduction and Targeted Therapy, 4(1), 1-10.
---------------------------------------------------------------------------
The applicant provided the following table 1, which outlines median
progression free survival (mPFS) and response rate (ORR) data among
patients with exon 20 insertion mutation for amivantamab and some of
the currently existing therapies. The applicant noted this table is
intended to provide general information about individual therapies and
is not intended for making direct comparisons between therapies as
differences between study populations, follow-up time, prior
treatments, and other factors may exist.
[GRAPHIC] [TIFF OMITTED] TP10MY21.141
[[Page 25227]]
Finally, the applicant cited an analysis presented at the 2020
American Society of Clinical Oncology (ASCO) Annual Meeting, which
found patients experienced a median ORR of 13% and PFS of 3.5 months
when receiving a wide variety of different therapies, including
immunotherapies, chemoimmunotherapies, EGFR-targeting TKIs, and other
chemotherapy regimens as second-line treatment.\64\
---------------------------------------------------------------------------
\64\ Park, K. (2020, May). Amivantamab (JNJ-61186372), an anti-
EGFR-MET bispecific antibody, in patients with EGFR Exon 20
insertion (Exon20ins)-mutated non-small cell lung cancer (NSCLC).
Poster presented at the 2020 Annual Meeting of the American Society
of Clinical Oncology.
---------------------------------------------------------------------------
After review of the information provided by the applicant, we have
the following concerns regarding whether the technology meets the
substantial clinical improvement criterion. Currently, results provided
by the applicant are based on an ongoing Phase 1 trial. We are
concerned that these are potentially partial results, from which end
conclusions may not be drawn, and also about the potential for
overestimating treatment effects when trials stop early or report
interim results. We further note that the only study cited by the
application to establish substantial clinical improvement is a single-
armed study assessing the safety and efficacy of amivantamab in the
target population. As noted by the applicant, no formal comparisons to
other therapies have been made. Without the ability to control for
factors such as study design, patient characteristics, etc., we may be
unable to determine whether any differences seen are the result of
amivantamab's potentially superior efficacy or confounding variables.
We also note that the single-arm study design results in an inability
to distinguish between the effect of amivantamab treatment, a placebo
effect, and the effect of natural course of the disease.
We are inviting public comments on whether amivantamab meets the
substantial clinical improvement criterion.
We did not receive any written comments in response to the New
Technology Town Hall meeting notice published in the Federal Register
regarding the substantial clinical improvement criterion for
amivantamab.
c. Breyanzi[supreg] (lisocabtagene maraleucel)
Juno Therapeutics, a Bristol-Myers Squibb Company, submitted an
application for new technology add-on payment for FY 2022 for
Breyanzi[supreg]. Breyanzi[supreg] is a CD19-directed, autologous
chimeric antigen receptor (CAR) T-cell immunotherapy that is comprised
of individually formulated CD8 (killer) and CD4 (helper) CAR T-cells
indicated for the treatment of adult patients with relapsed or
refractory (r/r) large B-cell lymphoma after at least two prior
therapies. We note that Juno Therapeutics previously submitted an
application for new technology add-on payments for Breyanzi[supreg] for
FY 2021, as summarized in the FY 2021 IPPS/LTCH PPS proposed rule,
under the name lisocabtagene maraleucel (85 FR 32647-32652).
According to the National Comprehensive Cancer Network, Diffuse
Large B-cell lymphoma (DLBCL) is the most common type of Non-Hodgkin's
Lymphoma (NHL) in the U.S. and worldwide, accounting for nearly 30% of
newly diagnosed cases of B-cell NHL in U.S.\65\ DLBCL is characterized
by spreading of B-cells through the body that have either arrived de
novo or by the transformation from indolent lymphoma.
---------------------------------------------------------------------------
\65\ Ferlay J, Colombet M, Soerjomataram, et al., Estimating the
global cancer incidence and mortality in 2018: GLOBOCAN sources and
methods, Int J Cancer. 144: 1941-1953 (Ferlay, 2019); NCCN Clinical
Practice Guidelines in Oncology (NCCN Guidelines[supreg]) for B-Cell
Lymphomas V. 5.2019. (copyright) National Comprehensive Cancer
Network, Inc. 2019 (NCCN, 2019).
---------------------------------------------------------------------------
According to the applicant, the standard-of-care, first-line
immune-chemotherapy for DLBCL includes regimens such as
cyclophosphamide, doxorubicin, vincristine, and prednisone plus
rituximab (R-CHOP).\66\ These regimens result in long-lasting remission
in more than 50% of patients.\67\ However, approximately 10% to 15% of
patients will have primary refractory disease (that is, nonresponse or
relapse within 3 months of first-line therapy), and an additional 20%
to 25% will relapse following an initial response to therapy.\68\
Patients with relapses of aggressive B-cell lymphomas are believed to
have a poor prognosis because of potential treatment resistance and
rapid tumor growth, with only about 30% to 40% responding to salvage
chemotherapy (for example, R-ICE, DHAP, or Gem-ox) followed by high-
dose therapy and autologous stem cell transplantation for patients
demonstrating chemotherapy-sensitive disease.69 70 Among
patients eligible to undergo autologous stem cell transplantation
(ASCT), only 50% will achieve a remission adequate to proceed to ASCT,
and approximately 50% will relapse after transplantation.\71\ The
applicant also noted that transplant eligibility is also restricted
based on age and tolerance to high dose chemotherapy and thus excludes
a moderate subset of patients with r/r DLBCL.
---------------------------------------------------------------------------
\66\ Coiffier, BBertrand et. al, Long-term outcome of patients
in the LNH-98.5 trial, the first randomized study comparing
rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a
study by Group d'Etudes des Lymphomes de l'Adulte, blood 2010 116:
2040-2045. (Coiffier, 2010).
\67\ Ibid
\68\ Ibid
\69\ Crump M, Neelapu SS, Farooq U, et al., Outcomes in
refractory diffuse large B-cell lymphoma: results from the
international SCHOLAR-1 study, Blood. 2017; 130(16): 1800-1808
(Crump, 2017).);
\70\ Cunningham D, Hawkes EA, Jack A, et al. Rituximab plus
cyclophosphamide, doxorubicin, vincristine, and prednisolone in
patients with newly diagnosed diffuse large B-cell non-Hodgkin
lymphoma: a phase 3 comparison of dose intensification with 14-day
versus 21-day cycles Lancet. 2013; 381: 1817-1826 (Cunningham,
2013).
\71\ Ibid
---------------------------------------------------------------------------
Additionally, the applicant explained that the available therapies
for 3L+ large B-cell lymphoma include the following:
CD19-directed genetically modified autologous CAR T-cell
immunotherapy axicabtagene ciloleucel (YESCARTA[supreg]), approved in
October 2017 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
(FL).\72\
---------------------------------------------------------------------------
\72\ YESCARTA[supreg]'s approval was based on a single arm study
(ZUMA-1) demonstrating an IRC-assessed ORR of 72%, CR of 51%, and an
estimated median DOR of 9.2 months in 101 subjects included in the
modified intent-to-treat (mITT population).
---------------------------------------------------------------------------
CAR T-cell therapy tisagenlecluecel (KYMRIAH[supreg]),
approved in May 2018, 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, high grade B-cell lymphoma,
and DLBCL arising from FL.\73\
---------------------------------------------------------------------------
\73\ KYMRIAH[supreg]'s approval was based on a single-arm study
(JULIET) demonstrating an ORR of 50% and a CR rate of 32% in 68
efficacy-evaluable subjects. A median DOR was not reached with a
median follow-up of 9.4 months.
---------------------------------------------------------------------------
Programmed death receptor-1 (PD-1)-blocking antibody
(KEYTRUDA[supreg]), approved in 2018, for the treatment of adult and
pediatric patients with refractory primary mediastinal B-cell lymphoma
(PMBCL), or who have relapsed after two or more prior lines of
therapy.\74\
---------------------------------------------------------------------------
\74\ KEYTRUDA is not recommended for treatment of patients with
PMBCL who require urgent cytoreductive therapy. Keytruda USPI
(2019).
---------------------------------------------------------------------------
CD79b-directed antibody-drug conjugate polatuzumab vedotin
(POLIVY[supreg]), in combination with bendamustine and rituximab,
approved in 2019, for the treatment of adult patients with r/r DLBCL,
not otherwise specified, after at least two prior therapies.
[[Page 25228]]
According to the applicant, despite the availability of these
therapies, r/r large B-cell lymphoma remains a major cause of morbidity
and mortality due to the aggressive disease course. The applicant noted
that the safety profiles of these therapies exclude many r/r large B-
cell lymphoma patients from being able to undergo treatment with these
therapies.\75\
---------------------------------------------------------------------------
\75\ Smith SD, Reddy P, Sokolova A, et al., Eligibility for CAR
T-cell therapy: An analysis of selection criteria and survival
outcomes in chemorefractory DLBCL, Am. J. Hematol. 2019; E119: 1-4
(Smith, 2019).
---------------------------------------------------------------------------
With respect to the newness criterion, the applicant submitted a
BLA for Breyanzi[supreg] in October 2019, and was approved by FDA on
February 5, 2021. Breyanzi[supreg] was granted Breakthrough Therapy
Designation (BTD) on December 15, 2016 and Regenerative Medicine
Advanced Therapy (RMAT) designation on October 20, 2017, for the
treatment of patients with r/r aggressive large B-cell NHL, including
DLBCL, not otherwise specified (DLBCL NOS; de novo or transformed from
indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL), or
follicular lymphoma Grade 3B (FL3B)). Breyanzi[supreg] is a CD19-
directed genetically modified autologous T cell immunotherapy indicated
for the treatment of adult patients with relapsed or refractory large
B-cell lymphoma after two or more lines of systemic therapy, including
diffuse large B-cell lymphoma (DLBCL) not otherwise specified
(including DLBCL arising from indolent lymphoma), high-grade B-cell
lymphoma, primary mediastinal large B-cell lymphoma, and follicular
lymphoma grade 3B. Breyanzi[supreg] is not indicated for the treatment
of patients with primary central nervous system lymphoma. We note that
effective October 1, 2021 the following ICD-10-PCS codes may be used to
uniquely describe procedures involving the infusion of
Breyanzi[supreg]: XW033N7 (Introduction of lisocabtagene maraleucel
immunotherapy into peripheral vein, percutaneous approach, new
technology group 7) and XW043N7 (Introduction of lisocabtagene
maraleucel immunotherapy into central vein, percutaneous approach, new
technology group 7). The applicant also submitted a request for a new
HCPCS code, which will uniquely describe procedures involving the use
of Breyanzi[supreg]. The applicant noted in their application that
Breyanzi[supreg] would likely map to the same MS-DRG as other CAR T-
cell therapies, MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell
Immunotherapy).
As previously discussed, 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 described two ways in which it believes the mechanism of
action for Breyanzi[supreg] differs from previously approved therapies
for DLBCL. First, the applicant described the therapy as being
comprised of individually formulated cryopreserved patient-specific
helper (CD4) and killer (CD8) CAR T-cells in suspension that are
administered as a defined composition of CAR-positive viable T-cells
(from individually formulated CD8 and CD4 components). The applicant
stated that the therapy involves a different mechanism of action from
other CAR-T cell therapies because the CD4 and CD8 T-cells are purified
and cultured separately to maintain compositional control of each cell
type. Furthermore, during culture, each cell type is separately
modified to have the CAR on the cell surface, expanded and quantified,
and frozen in two separate cell suspensions. The applicant then
described how Breyanzi[supreg] is infused with the same target dose of
CD4 and CD8 CAR T-cells for every patient. The applicant asserted that
because Breyanzi[supreg] controls the same dosage for both CD4 and CD8,
it differs from other CAR T-cell therapies for DLBCL and could
potentially provide for higher safety and efficacy; the applicant
stated that CAR T-cell therapies that do not control for CD8 CAR T-cell
dosage have demonstrated higher rates of severe and life-threatening
toxicities, such as cytokine release syndrome (CRS) and neurotoxicity
(NT).
The second feature the applicant described as distinguishing
Breyanzi[supreg]'s mechanism of action from existing CD19-directed CAR
T-cell therapies was the presence of an EGFRt cell surface tag. The
applicant explained that the EGFRt cell surface tag could
hypothetically be targeted for CAR T-cell clearance by separately
administering cetuximab, a monoclonal antibody. According to the
applicant, if the patient was separately administered cetuximab, the
presence of the EGFRt cell surface tag within Breyanzi[supreg] would
allow cetuximba to bind to the CAR T-cells and clear the cells from the
patient. The applicant highlighted studies that showed that persistent
functional CD19-directed CAR T-cells in patients caused sustained
depletion of a patient's normal B-cells that expressed CD19, resulting
in hypogammaglobulinemia and an increased risk of life-threatening or
chronic infections.\76\ The applicant further explained that such
prolonged low levels of normal B-cells could place a patient at risk of
life-threatening or chronic infections. According to the applicant, the
ability to deplete CAR T-cells, via the administration of cetuximab,
when a patient achieves a long-term remission could hypothetically
allow recovery of normal B-cells and potentially reduce the risk of
life-threatening or chronic infections. The applicant noted that
experiments in a laboratory setting showed that targeting EGFRt with
the monoclonal antibody cetuximab eliminated CAR T-cells expressing the
EGFRt marker, which resulted in long-term reversal of B-cell aplasia in
mice.\77\ However, the applicant noted that this mechanism of CAR T-
cell clearance, via administration of cetuximab and EGFRt cell surface
tags/markers, has not been tested in humans, including patients treated
with Breyanzi[supreg].
---------------------------------------------------------------------------
\76\ Kalos M, Levine BL, Porter DL, et al., T Cells with
Chimeric Antigen Receptors Have Potent Antitumor Effects and Can
Establish Memory in Patients with Advanced Leukemia, Sci Transl Med.
2011; 3(95): 1-21 (Kalos, 2011).
\77\ Paszkiewicz PJ, Frable SP, Srivastava S, et al., Targeted
antibody-mediated depletion of murine CD19 CAR T cells permanently
reverses B cell aplasia, J Clin Invest. 2016; 126(11): 4262-4272
(Paszkiewicz, 2016).
---------------------------------------------------------------------------
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant acknowledged that the
ICD-10-PCS procedure codes used to uniquely identify procedures
involving the administration of Breyanzi[supreg] XW033N7 (Introduction
of lisocabtagene maraleucel Immunotherapy into peripheral vein,
percutaneous approach, new technology group 7) and XW043N7
(Introduction of lisocabtagene maraleucel Immunotherapy into central
vein, percutaneous approach, new technology group 7) are assigned to
MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy). The
applicant has not made a request for the technology to map to a new or
different MS-DRG for FY 2022.
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, Breyanzi[supreg] fills an unmet need in the treatment of
large B-cell lymphoma because Breyanzi[supreg] would be indicated as a
third-line treatment option for patients with r/r DLBCL, who cannot be
treated with existing CAR T-
[[Page 25229]]
cell therapies. The applicant asserted that Breyanzi[supreg] would be
able to treat these patients that present with uncommon subtypes of
DLBCL including, PMBCL, FL3B, and DLBCL transformed from indolent
lymphoma from other follicular lymphoma, elderly patients (>= 65 years
old), patients with secondary CNS involvement by lymphoma, and those
with moderate renal or cardiac comorbidities. The applicant asserted
that these patient populations were excluded from registrational trials
for YESCARTA[supreg] and KYMRIAH[supreg], and therefore represent an
unmet patient need.
Regarding newness, we are concerned whether a differing production
and/or dosage represents a different mechanism of action as compared to
previously FDA-approved CAR T-cell therapies. We are also concerned
about whether the existence of an EGFRt cell surface tag equates to a
new mechanism of action given that in order to activate this cell
surface tag, an additional medication, cetuximab, which targets the CAR
T-cells for clearance, would be needed. We also express concern that,
based on our understanding, the presence of the EGFRt cell surface tag
is a potential way to treat an adverse event of the Breyanzi[supreg]
therapy and is not critical to the way the drug treats the underlying
disease. We note that the applicant referenced that while this EGFRt
cell surface tag is included within the Breyanzi[supreg] compound, it
remains dormant without activation by cetuximab. Finally, the applicant
noted that Breyanzi[supreg] has been shown safe and effective for
patient populations excluded from registrational trials for
YESCARTA[supreg] and KYMRIAH[supreg], including patients with uncommon
subtypes of large B-cell lymphoma, including PMBCL, FL3B, and DLBCL
transformed from indolent lymphoma other than FL, elderly patients (>=
65 years old), patients with secondary CNS involvement by lymphoma and
those with moderate renal or cardiac comorbidities.\78\ We note that
the FDA label for YESCARTA[supreg] and KYMRIAH[supreg] does not appear
to specifically exclude these patient populations or NHL subtypes. As
such, it is unclear whether Breyanzi[supreg] would in fact treat a
patient population different from other CAR T-cell therapies that treat
patients with DLBCL.
---------------------------------------------------------------------------
\78\ Lisocabtagene maraleucel Biologics License Application
(BLA).
---------------------------------------------------------------------------
We are inviting public comments on whether Breyanzi[supreg] is
substantially similar to other technologies and whether
Breyanzi[supreg] meets the newness criterion.
With regard to the cost criterion, the applicant searched the FY
2019 MedPAR correction notice (December 1, 2020) data file to identify
potential cases representing patients who may be eligible for treatment
using Breyanzi[supreg]. The applicant identified claims that reported
an ICD-10-CM diagnosis code of: C83.30 (DLBCL, unspecified site);
C83.31 (DLBCL, lymph nodes of head, face and neck); C83.32 (DLBCL,
intrathoracic lymph nodes); C83.33 (DLBCL, intra-abdominal lymph
nodes); C83.34 (DLBCL, lymph nodes of axilla and upper limb); C83.35
(DLBCL, lymph nodes of inquinal region and lower limb); C83.36 (DLBCL,
intrapelvic lymph nodes); C83.37 (DLBCL, spleen); or C83.38 (DLBCL,
lymph nodes of multiple sites) in one of the first five diagnosis code
positions on the claim. The applicant excluded claims if they had one
or more diagnoses from the list below because these conditions would
preclude use of Breyanzi[supreg].
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP10MY21.142
[[Page 25230]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.143
[[Page 25231]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.144
BILLING CODE 4120-01-C
However, the applicant noted that the aforementioned C83.XX ICD-10-
CM codes do not differentiate r/r patients from the broader DLBCL
population. A clinical literature search completed by the applicant
found that the r/r population makes up one-fourth of the DLBCL
population, but since r/r patients typically have higher inpatient
costs the applicant selected 19.36 percent of the cases with the
highest total charges for their cost analysis. Applying the previously
mentioned parameters, the applicant found a total of 991 cases mapped
to 12 MS-DRGs.
The applicant stated that the use of Breyanzi[supreg]'s therapy
would replace chemotherapy or other drug therapies, including other CAR
T-cell therapies. Because of this, the applicant stated they removed
all charges in the drug cost center since it was not possible to
differentiate between different drugs on inpatient claims. The
standardized charges per case were then calculated using the 2019 IPPS/
LTCH PPS final rule Impact file and the 2-year inflation factor of 13.2
percent (1.3218) was applied. Finally, to determine the charges for
Breyanzi[supreg], the applicant used the inverse of a simulated
alternative cost-to-charge ratio (CCR) specifically for CAR T-CELL
therapies to account for CAR T-cell therapies' higher costs compared to
other drugs. To determine this alternative CCR for CAR T-cell
therapies, the applicant referred to the FY 2021 IPPS final rule AOR/
BOR file and calculated an alternative markup percentage by dividing
the AOR drug charges within MS-DRG 018 by the number of cases to
determine a per case drug charge. The applicant then divided the drug
charges per case by $373,000, the acquisition cost of YESCARTA and
KYMRIAH, the CAR T-cell products used in those claims, to arrive at a
CCR of 0.295. The applicant noted that the cost of Breyanzi[supreg] had
not yet been determined at the time of application. However, for the
purposes of its cost analysis, the applicant assumed the per-patient
cost to the hospital will be $373,000. Based on the FY 2021 IPPS/LTCH
PPS final rule correction notice data file thresholds for FY 2022, the
applicant calculated a final inflated average case-weighted
standardized charge per case of $1,377,616 which exceeded the MS-DRG
018 average case-weighted threshold of $1,251,127 by $126,489.
Therefore, the applicant stated that Breyanzi[supreg] met the cost
criterion.
As noted in previous discussions, the submitted costs for CAR T-
cell therapies vary widely due to differences in provider billing and
charging practices for this therapy. Therefore, with regard to the use
of this data for purposes of calculating a CAR T-cell CCR, we are
uncertain how representative this data is for use in the applicant's
cost analyses given this potential for variability.
We continue to be interested in public comments regarding the
eligibility of CAR T-cell technologies for new technology add-on
payments when assigned to MS-DRG 018. As we have noted in prior
rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85
FR 58603 through 58608), if a new MS-DRG were to be created, then
consistent with section 1886(d)(5)(K)(ix) of the Act, there may no
longer be a need for a new technology add-on payment under section
1886(d)(5)(K)(ii)(III) of the Act. We welcome comment on this issue.
[[Page 25232]]
We invite public comment on whether Breyanzi[supreg] meets the cost
criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that Breyanzi[supreg] represents a substantial
clinical improvement over existing technologies because: (1) The
totality of the circumstances regarding Breyanzi[supreg]'s clinical
efficacy, safety, and data make clear that Breyanzi[supreg]
substantially improves, relative to services or technologies previously
available, the treatment of Medicare beneficiaries with R/R NHL; (2)
Breyanzi[supreg] offers a treatment option for a patient population
unresponsive to, or ineligible for, currently available treatments; (3)
Breyanzi[supreg] has, overall, an improved safety profile compared to
YESCARTA and KYMRIAH; (4) Breyanzi[supreg] has a comparable or superior
effectiveness compared to existing therapies; and (5)
Breyanzi[supreg]'s patient population in its registrational study more
accurately reflects real-world NHL patients compared to the studies of
currently available CAR T-cell therapies.
The applicant asserts that the totality of the clinical efficacy
and safety data from the TRANSCEND NHL 001 trial, which is a
prospective, single arm, multicenter study of Breyanzi[supreg] in
patients with r/r aggressive B-cell NHL, and the supportive safety data
from the Breyanzi[supreg] clinical studies included in their Biologics
License Application (BLA) submission demonstrate that Breyanzi[supreg]
has equal or better efficacy and a better safety profile in a broad R/R
patient population that better approximates the real world large B-cell
lymphoma patient population--a population that the applicant asserted
includes NHL subtypes not studied or approved for treatment with
current approved or conditionally approved agents.
The applicant shared the results of the Phase I TRANSCEND NHL 001
trial, which was a prospective, single arm, multicenter study of
lisocabtagene maraleucel in patients with relapsed/refractory
aggressive B-cell NHL. The applicant noted that TRANSCEND NHL 001
included subjects with the average age of 63 years with 111 subjects
(41%) over 65 years of age and 27 (10%) subjects older than 75 years of
age. These patients also failed previous therapies. Of the total number
of subjects studied (efficacy: n=256; safety: n=269), 137 subjects
(51%) had DLBCL, 60 (22%) had DLBCL transformed from FL, 18 (7%) had
DLBCL transformed other indolent lymphomas, 36 patients (13%) had high
grade lymphoma, 15 (6%) had PMBCL and 3 (1%) had FL3B.\79\
Additionally, the applicant explained that TRANSCEND NHL 001 was more
inclusive, compared to the registrational trials for KYMRIAH[supreg]
and YESCARTA[supreg], of Medicare aged patients with comorbidities and
NHL disease subtypes seen in the real world presentation of the
disease. To support this, the applicant referenced that within this
study, between 40% to 50% of subjects studied had cardiac ejection
fraction, 3% had secondary CNS lymphoma, 51 patients (19%) had a
creatinine clearance between 30-60 mL/min and 39 patients (14.6%) had
grade >= 3 cytopenias. Furthermore, the applicant noted that 51
patients (19%) had decreased renal function and 13 patients (4.9%) had
decreased cardiac function. The applicant stated that the TRANSCEND NHL
001 study showcased that the patient population treated during the
study better reflected the real world large B-cell lymphoma patient
population, a population that the applicant asserted included NHL
subtypes not studied or approved for treatment with currently approved
or conditionally approved agents, while providing similar safety and
efficacy. The applicant contended that these high-unmet need large B-
cell lymphoma subsets included patients with DLBCL transformed from
rare indolent lymphomas other than FL, patients with FL3B, patients 65
years of age and older, as well as patients with moderate comorbidities
of renal and cardiac insufficiency.
---------------------------------------------------------------------------
\79\ Ibid.
---------------------------------------------------------------------------
The applicant further explained that Breyanzi[supreg] provided
improved effectiveness as compared to existing therapies. Patients with
aggressive large B-cell NHL who have failed at least 2 prior therapies
or SCT are treated with combinations of agents or monotherapy based on
institutional preferences, but there is no standard of care for salvage
therapies beyond first treatment therapy.\80\ The applicant noted that
commonly used salvage therapies (non-CAR T-cell therapies) for
relapsed, large B-cell lymphoma demonstrated objective response rates
(ORRs) in the range of 12% to 46% and complete response (CR) rates of
6% to 38%. Among the patients who did achieve a response, the median
duration of response (DOR) ranges from approximately 6 to 17 months and
median overall survival was generally less than 12
months.81 82 83 84 85 86 87 Comparatively, TRANSCEND NHL
001, which provided subjects with Breyanzi[supreg], met its primary
endpoint of Independent Review Committee (IRC)-assessed ORR in adult
patients with r/r large lymphoma after at least 2 prior therapies, as
reported by the applicant. In the 256 efficacy evaluable patients, the
ORR was 73% (95% confidence interval (CI): 67.0% to 78.3%), and the CR
rate was 53% (95% CI: 46.6% to 59.2%). With a median follow-up of 10.8
months, the median DOR per IRC assessment was 13.3 months and the
median DOR for CR was not reached. By comparison, the applicant
summarized that YESCARTA[supreg], as demonstrated in the Phase I-II
ZUMA-1 study (see the FY 2019 IPPS/LTCH PPS final rule 83 FR 41295 for
a description of this study), had an ORR of 72.0% (95% confidence
interval (CI: 62.0% to 81.0%)). Also, according to the applicant,
KYMRIAH[supreg], as demonstrated by the Phase II JULIET study (see the
FY 2019 IPPS/LTCH PPS final rule 83 FR 41293 for a description of this
study), had an ORR of 50.0% (95% confidence interval (CI: 38.0% to
62.0%)). The applicant contended that the results for Breyanzi[supreg]
(ORR of 73% (95% confidence interval (CI): 67.0% to 78.3%), and the CR
rate of 53% (95% CI: 46.6% to 59.2%) were observed across all subgroups
tested, including
[[Page 25233]]
elderly subjects, those with high burden disease or high baseline
inflammatory biomarkers, those requiring anti-lymphoma therapy for
disease control, as well as rare patient populations with a high unmet
medical need (for example, PMBCL, DLBCL transformed from indolent
lymphoma other than FL, and FL3B). The applicant contended that this
data supports that Breyanzi[supreg] demonstrates comparable or superior
effectiveness compared to existing therapies for patients with r/r
large B-cell NHL.88 89
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\80\ National Comprehensive CancerNetwork Treatment of Cancer:
Guidelines, 2019. NCCN, 2019.
\81\ Czuczman MS, Davies A, Linton KM, et al., A Phase 2/3
Multicenter, Randomized Study Comparing the Efficacy and Safety of
Lenalidomide Versus Investigator's Choice in Relapsed/Refractory
DLBCL, Blood. 2014; 124: 628 (Czuczman, 2014).
\82\ Jacobsen ED, Sharman JP, Oki Y, et al., Brentuximab vedotin
demonstrates objective responses in a phase 2 study of relapsed/
refractory DLBCL with variable CD30 expression, Blood. 2015; 125(9):
1394-1402 (Jacobsen, 2015).
\83\ Nagle SJ, Woo K, Schuster SJ, et al., Outcomes of patients
with relapsed/refractory diffuse large B-cell lymphoma with
progression of lymphoma after autologous stem cell transplantation
in the rituximab era, Am. J. Hematol. 2013; 88: 890-894 (Nagle,
2013).
\84\ Pettengell R, Coiffier B, Narayanan G, et al., Pixantrone
dimaleate versus other chemotherapeutic agents as a single-agent
salvage treatment in patients with relapsed or refractory aggressive
non-Hodgkin lymphoma: a phase 3, multicenter, open-label, randomised
trial, Lancet Oncol. 2012; 13: 696-706 (Pettengell, 2012).
\85\ Rigacci L, Puccini B, Cortelazzo S, et al., Bendamustine
with or without rituximab for the treatment of heavily pretreated
non-Hodgkin's lymphoma patients, Ann Hematol. 2012; 91: 1013-1022
(Rigacci, 2012).
\86\ Van Den Neste E, Schmitz N, Mounier N, et al., Outcome of
patients with relapsed diffuse large B-cell lymphoma who fail
second-line salvage regimens in the International CORAL study, Bone
Marrow Transplantation. 2016; 51: 51-57 (Van Den Neste, 2016).
\87\ Wang M, Fowler N, Wagner-Bartak N, et al., Oral
lenalidomide with rituximab in relapsed or refractory diffuse large
cell, follicular and transformed lymphoma: a phase II clinical
trial, Leukemia. 2013; 27: 1902-1909 (Wang, 2013).
\88\ YESCARTA[supreg] United States Prescribing Information USPI
(2019).
\89\ KYMRIAH[supreg] United States Prescribing Information USPI
(2018).
---------------------------------------------------------------------------
Furthermore, the applicant stated that Breyanzi[supreg] had an
improved safety profile in comparison to YESCARTA[supreg] and
KYMRIAH[supreg]. The applicant stated that both of these FDA-approved
CAR T-cell therapies had higher rates of toxicity as compared to
Breyanzi[supreg]. In the TRANSCEND NHL 001 registrational study
(n=268), 42% and 2% of subjects developed all-grade and Grade > 3 CRS,
respectively, and 30% and 10% developed all-grade and Grade > 3 NT. The
applicant compared these results to the results of the JULIET study as
found in KYMRIAH's[supreg] prescribing information and summarized that
KYMRIAH[supreg] had higher rates of all-grade and Grade > 3 CRS (74%
and 23%, respectively) and all-grade and Grade > 3 NT (58% and 18%,
respectively). The applicant provided the same comparison of the
toxicity results of Breyanzi[supreg] to the results showcased in the
ZUMA-1 study featuring YESCARTA[supreg] as found in YESCARTA[supreg]'s
prescribing information and summarized that YESCARTA[supreg] had higher
rates of all-grade and Grade > 3 CRS (94% and 13%, respectively) and
all-grade and Grade > 3 NT (87% and 31%, respectively).90 91
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\90\ YESCARTA[supreg] USPI (2019).
\91\ KYMRIAH[supreg] USPI (2018).
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After reviewing the information submitted by the applicant as part
of its FY 2022 new technology add-on payment application, we are
concerned that there are no published studies directly comparing
Breyanzi[supreg] and the two currently available CAR T-cell therapies
for r/r DLBCL, YESCARTA[supreg] and KYMRIAH[supreg]. Additionally, we
are concerned with the lack of long-term data supporting the
effectiveness and efficacy of Breyanzi[supreg] and whether the lack of
long-term data may limit the generalizability of the findings from the
TRANSCEND NHL 001 study to the general Medicare population. While there
have been no direct comparison studies of Breyanzi[supreg],
YESCARTA[supreg] and KYMRIAH[supreg], the applicant does provide a
comparison of the ORR, CR, PR and DOR across all three CAR T-cell
therapies. While we note that Breyanzi[supreg] does appear to provide
an improved ORR, CR, PR, and DOR compared to the other FDA-approved CAR
T-cell therapies based on the data presented by the applicant, we
further note that these differences appear to be small in magnitude,
between 1-2% for the ORR, CR, and PR. Without a direct comparison of
outcomes between these therapies, we are concerned as to whether these
differences translate to clinically meaningful differences or
improvements. Breyanzi[supreg] appears to demonstrate similar patient
outcomes to that of YESCARTA[supreg] and we question whether the
TRANSCEND NHL 001 study is evidence that Breyanzi[supreg] is a more
effective therapy to treat DLBCL over existing CAR T-cell therapies.
Additionally, as previously discussed, the applicant noted that
Breyanzi[supreg] has been shown safe and effective for patient
populations excluded from registrational trials for YESCARTA[supreg]
and KYMRIAH[supreg]. However, it is unclear whether this suggests that
Breyanzi[supreg] is a treatment option for patients who cannot be
treated with these existing CAR T-cell therapies, given that the FDA
label for YESCARTA[supreg] and KYMRIAH[supreg] appears to not
specifically exclude these patient populations. Finally, we are
concerned that the use of the EGFRt cell surface tag was not activated
in patients receiving Breyanzi[supreg] to study the impact of clearing
these CAR T-cells after remission and that this feature has not yet
been tested on humans or in conjunction with patients treated with
Breyanzi[supreg]. We express concern regarding the safety and efficacy
of this feature given its lack of testing.
We are inviting public comments on whether Breyanzi[supreg] meets
the substantial clinical improvement criterion.
We did not receive any written comments in response to the New
Technology Town Hall meeting notice published in the Federal Register
regarding the substantial clinical improvement criterion for
Breyanzi[supreg] or at the New Technology Town Hall meeting.
d. Ciltacabtagene Autoleucel
Janssen Biotech, Inc., submitted an application for new technology
add-on payments for ciltacabtagene autoleucel for FY 2022.
Ciltacabtagene autoleucel is an autologous chimeric-antigen receptor
(CAR) T-cell therapy directed against B cell maturation antigen (BCMA)
for the treatment of patients with multiple myeloma.
Ciltacabtagene autoleucel refers to both JNJ-4528, an
investigational BCMA-directed CAR T-cell therapy for previously treated
patients with multiple myeloma, and LCAR-B38M, the investigational
product (ciltacabtagene autoleucel) being studied in China. Both JNJ-
4528 and LACAR-B38M are representative of the same CAR T-cell therapy,
ciltacabtagene autoleucel. Ciltacabtagene autoleucel has not yet
received FDA approval.
Multiple myeloma (MM) is typically characterized by the neoplastic
proliferation of plasma cells producing a monoclonal immunoglobulin.
The plasma cells proliferate in the bone marrow and can result in
extensive skeletal destruction with osteolytic lesions, osteopenia,
and/or pathologic fractures. The diagnosis of MM is often suspected
because of one (or more) of the following clinical presentations:
Bone pain with lytic lesions discovered on routine
skeletal films or other imaging modalities.
An increased total serum protein concentration and/or the
presence of a monoclonal protein in the urine or serum.
Systemic signs or symptoms suggestive of malignancy, such
as unexplained anemia.
Hypercalcemia, which is either symptomatic or discovered
incidentally.
Acute renal failure with a bland urinalysis or rarely
nephrotic syndrome due to concurrent immunoglobulin light chain (AL)
amyloidosis.
It is important to distinguish MM both from other causes of the
clinical presentations mentioned previously and from other plasma cell
dyscrasias for the purposes of prognosis and treatment.\92\ Data from
the US Surveillance, Epidemiology, and End Results (SEER) registry
estimate 32,000 new cases of MM and 13,000 deaths from MM annually in
the U.S. This correlates with an annual incidence of approximately 7
per 100,000 men and women per year. MM is largely a disease of older
adults. The median age at diagnosis is 65 to 74 years. MM is also
slightly more frequent in men than in women (approximately 1.4:1). MM
is associated with substantial morbidity and mortality \93\
[[Page 25234]]
and approximately 25% of patients have a median survival of 2 years or
less.\94\
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\92\ Laubauch, J.P. (2021). Multiple myeloma: Clinical features,
laboratory manifestations, and diagnosis. UptoDate. Available from
https://www.uptodate.com/contents/multiple-myeloma-clinical-
features-laboratory-manifestations-
anddiagnosis?search=multiple%20myeloma&source=search_result&selectedT
itle=1~150& usage_type=default&display_rank=1.
\93\ Cowan AJ, Allen C, Barac A, Basaleem H, Bensenor I, Curado
MP, Foreman K, Gupta R, Harvey J, Hosgood HD, Jakovljevic M, Khader
Y, Linn S, Lad D, Mantovani L, Nong VM, Mokdad A, Naghavi M, Postma
M, Roshandel G, Shackelford K, Sisay M, Nguyen CT, Tran TT, Xuan BT,
Ukwaja KN, Vollset SE, Weiderpass E, Libby EN, Fitzmaurice C. Global
Burden of Multiple Myeloma: A Systematic Analysis for the Global
Burden of Disease Study 2016. JAMA Oncol. 2018 Sep 1;4(9):1221-1227.
\94\ Biran N, Jagannath S, Chari A. Risk stratification in
multiple myeloma, part 1: characterization of high-risk disease.
Clin Adv Hematol Oncol. 2013 Aug;11(8):489-503.
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According to the applicant, introduction of new treatment options
in the last 2 decades has extended the median survival of multiple
myeloma patients. The applicant asserted that the introduction of
proteasome inhibitors (PI) (e.g., bortezomib, carfilzomib, and
ixazomib), histone deacetylase inhibitors (e.g., panobinostat,
vorinostat), immunomodulatory agents (IMiD) (e.g., thalidomide,
lenalidomide, and pomalidomide), monoclonal antibodies (daratumumab and
elotuzumab), and stem cell transplantation, have allowed numerous
therapeutic options for patients with multiple myeloma (Rajkumar 2020).
According to the applicant, the National Comprehensive Cancer Network
(NCCN) recommended treatment regimen for first-line therapy of multiple
myeloma is Bortezomib (a proteosome inhibitor (PI)), lenalidomide (an
immunomodulatory agent (IMiD)) and dexamethasone.\95\ The strategy of
triplet therapies for patients with newly diagnosed multiple myeloma,
followed by high-dose chemotherapy and autologous stem-cell
transplantation for eligible patients, and subsequently consolidation
and maintenance therapy, is the current treatment roadmap for
patients.\96\ However, despite these treatments, according to the
applicant, most patients will relapse after first-line treatment and
require further treatment \97\ with only 50% survival of relapsed
patients after 5 years.98 99 As multiple myeloma progresses,
each subsequent line of treatment is associated with shorter
progression free survival (PFS) and decreased rate, depth, and
durability of response and worsening of quality of life.\100\ In
addition, cumulative and long-term toxicities are often associated with
long-term therapy (Ludwig, 2018). Thus, according to the applicant,
there remains an ongoing need for additional therapeutic approaches
when the disease is resistant to available therapy.
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\95\ National Comprehensive Cancer Network (NCCN) NCCN clinical
practice guidelines in oncology. Multiple Myeloma. Version 2. 2021-
September 9, 2020.
\96\ Branagan A, Lei M, Lou U, Raje N. Current Treatment
Strategies for Multiple Myeloma. JCO Oncol Pract. 2020 Jan;16(1):5-
14.
\97\ Sonneveld P, Broij lA. Treatment of relapsed and refractory
multiple myeloma. Haematologica. 2016;101(4):396-406.
\98\ SEER database 2020; https://seer.cancer.gov/statfacts/html/mulmy.html.
\99\ GLOBOCAN database 2018; https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
\100\ Yong K, Delforge M, Driessen C, Fink L, Flinois A,
Gonzalez-McQuire S, Safaei R, Karlin L, Mateos MV, Raab MS, Schoen
P, Cavo M. Multiple myeloma: patient outcomes in real-world
practice. Br J Haematol. 2016 Oct;175(2):252-264.
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The applicant asserts that relapsed and refractory multiple myeloma
(RRMM) constitutes a specific unmet medical need. According to the
applicant, patients with r/r disease are defined as those who, having
achieved a minor response or better, relapse and then progress while on
therapy, or experience progression within 60 days of their last
therapy.\101\ The introduction of a new class of agents, CD38-targeting
monoclonal antibodies (CD38 MoABs), daratumumab and isatuximab, have
improved options in r/r patients.\102\ The applicant asserts that given
these advances, guideline recommendations following first-line therapy
are varied, with treatment options including combinations of novel
agents with existing standard of care regimens, and triplet and
quadruplet regimens, creating a complex treatment landscape.\103\
According to the applicant, while triplet regimens should be used as
the standard therapy for patients with multiple myeloma, elderly or
frail patients may be treated with double regimens.104 95
The applicant further states that for patients with RRMM who have
received at least 3 prior lines of therapy including a PI, an IMiD and
an anti-CD38, there does not exist a standard or consensus for
treatment at this time, and often, supportive care/palliative care is
the only option.\105\
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\101\ Castelli R, Orofino N, Losurdo A, Gualtierotti R, Cugno M.
Choosing treatment options for patients with relapsed/refractory
multiple myeloma. Expert Rev Anticancer Ther. 2014 Feb;14(2):199-
215.
\102\ Van de Donk NWCJ, Richardson PG, Malavasi F. CD38
antibodies in multiple myeloma: back to the future. Blood. 2018 Jan
4;131(1):13-29.
\103\ National Comprehensive Cancer Network (NCCN) NCCN clinical
practice guidelines in oncology. Multiple Myeloma. Version 2. 2021--
September 9, 2020.
\104\ Ibid.
\105\ Maples KT, Joseph NS, Harvey RD. Current developments in
the combination therapy of relapsed/refractory multiple myeloma.
Expert Rev Anticancer Ther. 2020 Sep 24.
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According to the applicant, multiple myeloma remains incurable and
most patients eventually relapse, even with the advent of new
treatments.\106\ The applicant further states that novel, innovative
therapies are needed to improve long-term survival and outcomes. The
applicant asserts that CAR T-cell-based therapies offer potential
advantages over current therapeutic strategies. According to the
applicant, while other therapies require long-term repetitive
administration generally until progression of disease, CAR T-cell
therapy is a single infusion treatment due to live T-cell expansion in
the patient and long-term disease response. The applicant asserts that
ciltacabtagene autoleucel is an autologous CAR T-cell therapy directed
against B cell maturation antigen (BCMA) for the treatment of patients
with multiple myeloma. The applicant states that BCMA, a protein that
is highly expressed on myeloma cells \107\ and is a member of the tumor
necrosis factor (TNF) receptor family, plays a central role in
regulating B-cell maturation and differentiation into plasma
cells.\108\ BCMA is selectively expressed on a subset of B cells
(plasma cell neoplasms including myeloma cells) and is more stably
expressed specifically on the B cell lineage, compared with key plasma
cell marker CD138 which is also expressed on normal fibroblasts and
epithelial cells.109 110 111 These expression
characteristics, per the applicant, make BCMA an ideal therapeutic
target for the treatment of multiple myeloma.112 113
Ciltacabtagene autoleucel, according to the applicant, is a unique,
structurally differentiated BCMA-targeting chimeric antigen receptor
with two distinct BCMA-binding domains that can identify and eliminate
myeloma cells.
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\106\ Rajkumar SV, Kumar S. Multiple myeloma current treatment
algorithms. Blood Cancer J. 2020 Sep 28;10(9):94.
\107\ Cho SF, Anderson KC, Tai YT. Targeting B Cell Maturation
Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based
Immunotherapy. Front Immunol. 2018 Aug 10;9:1821.
\108\ Ibid.
\109\ Ibid.
\110\ Tai YT, Anderson KC. Targeting B-cell maturation antigen
in multiple myeloma. Immunotherapy. 2015;7(11):1187-99.
\111\ Palaiologou M, Delladetsima I, Tiniakos D. CD138
(syndecan-1) expression in health and disease. Histol Histopathol.
2014 Feb;29(2):177-89.
\112\ Ibid.
\113\ Frigyesi I, Adolfsson J, Ali M, Christophersen MK,
Johnsson E, Turesson I, Gullberg U, Hansson M, Nilsson B. Robust
isolation of malignant plasma cells in multiple myeloma. Blood. 2014
Feb 27;123(9):1336-40.
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The applicant asserts that CAR T-cell technology is a form of
immunotherapy and is a ``living drug'' that utilizes specially altered
T cells, part of the immune system, to fight cancer. A
[[Page 25235]]
sample of the patient's T cells are collected from the blood, then
modified in a laboratory setting to express a chimeric antigen receptor
(CAR).\114\ Chimeric antigen receptors are specifically designed
receptor proteins that are made up of three distinct features: (1) A
target recognition domain (typically derived from a single domain of an
antibody) that sits on the cell's exterior, (2) a co-stimulatory domain
on the cell's interior that boosts activation, enhances survival and
expansion of the modified cells, and (3) an interior stimulatory domain
that supports activation and target killing.\115\ The binding domain
expressed on the surface of T cells gives them the new ability to
target a specific protein. When the target is recognized, the
intracellular portions of the receptor send signals within the T cells
to destroy the target cells. These engineered CAR T-cells are reinfused
back into the same patient which enables these specialized T cells to
latch onto the target antigen and abolish the tumor cells.
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\114\ June CH, Sadelain M. Chimeric Antigen Receptor Therapy. N
Engl J Med. 2018 Jul 5;379(1):64-73.
\115\ Sadelain M. Chimeric antigen receptors: driving immunology
towards synthetic biology. Curr Opin Immunol. 2016 Aug;41:68-76.
---------------------------------------------------------------------------
According to the applicant, ciltacabtagene autoleucel is a CAR T-
cell immunotherapy designed to recognize myeloma cells and target their
destruction. Ciltacabtagene autoleucel's CAR T-cell technology consists
of harvesting the patient's own T cells, programming them to express a
chimeric antigen receptor that identifies BCMA, a protein highly
expressed on the surface of malignant multiple myeloma B-lineage cells,
and reinfusing these modified cells back into the patient where they
bind to and eliminate myeloma tumor cells. The applicant asserts that,
unlike the chimeric antigen receptor design of currently approved CAR
T-cell immunotherapies, which are composed of a single-domain antibody
(sdAbs), ciltacabtagene autoleucel is composed of two antibody binding
domains that allow for high recognition of human BCMA (CD269) and
elimination of BCMA expressing myeloma cells. The two distinct BCMA-
binding domains, according to the applicant, confer avidity and
distinguish ciltacabtagene autoleucel from other BCMA-targeting
products. The BCMA binding domains are linked to the receptor's
interior costimulatory (4-1BB) and signaling (CD3[zeta]) domains
through a transmembrane linker (CD8a). These intracellular domains are
critical components for T cell growth and anti-tumor activity \116\ in
the body once CAR T-cells are bound to a BCMA target on multiple
myeloma cells.
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\116\ Maher J, Brentjens RJ, Gunset G, Rivi[egrave]re I,
Sadelain M. Human T-lymphocyte cytotoxicity and proliferation
directed by a single chimeric TCRzeta/CD28 receptor.
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With respect to the newness criterion, according to the applicant,
ciltacabtagene autoleucel was granted Breakthrough Therapy designation
in December 2019 for the treatment of patients with RRMM who have
previously received a PI, an IMiD, and an anti-CD38 antibody. In
December 2020, the applicant submitted a Biologic License Application
(BLA) with the FDA but at the time of the development of this proposed
rule, it has not yet received FDA approval. The applicant stated that
procedures involving the administration of ciltacabtagene autoleucel
can be reported using the following ICD-10-PCS procedure codes: XW033C3
(Introduction of engineered autologous chimeric antigen receptor t-cell
immunotherapy into peripheral vein, percutaneous approach, new
technology group 3); and XW043C3 (Introduction of engineered autologous
chimeric antigen receptor t-cell immunotherapy into central vein,
percutaneous approach, new technology group 3). The applicant noted
that there are currently no ICD-10-PCS codes that uniquely identify
procedures involving the use of ciltacabtagene autoleucel. The
applicant submitted a request for unique ICD-10-PCS codes to describe
the administration of ciltacabtagene autoleucel beginning in FY 2022.
The applicant also noted that they will submit a request for a
Healthcare Common Procedure Coding System (HCPCS) code specific to the
administration of ciltacabtagene autoleucel once the product is
eligible for such a code.
As previously stated, if a technology meets all three of the
substantial similarity criteria as previously described, 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 respect to whether a product uses the same or a similar
mechanism of action when compared to an existing technology to achieve
a therapeutic outcome, the applicant asserts that ciltacabtagene
autoleucel has a unique mechanism of action because it has two distinct
binding domains that confer avidity to the BCMA antigen, a 4-1BB
costimulatory domain and a CD3z signaling domain, whereas other CAR T-
cell products have only one target binding domain. However, we note
that idecabtagnene vicleucel, another CAR T-cell therapy for which an
application for new technology add-on payments was submitted for FY
2022, as discussed later in this section, appears to have a mechanism
of action that is similar to that of ciltabatagene: A chimeric antigen
receptor (CAR)-positive T cell therapy targeting B-cell maturation
antigen (BCMA), which is expressed on the surface of normal and
malignant plasma cells. The idecabtagene vicleucel CAR construct
includes an anti-BCMA scFv-targeting domain for antigen specificity, a
transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB
costimulatory domain. Antigen-specific activation of idecabtagene
vicleucel results in CAR-positive T cell proliferation, cytokine
secretion, and subsequent cytolytic killing of BCMA-expressing cells.
The applicant also asserts that its mechanism of action differs
from Blenrep's mechanism of action. Blenrep is a BCMA-targeting agent
indicated in the treatment of RRMM. According to the applicant, Blenrep
belongs to the class of antibody-drug conjugates, which are therapies
that are essentially composed of a monoclonal antibody linked to a
toxic drug. Once the antibody portion of Blenrep recognizes BCMA on
multiple myeloma cells, the toxin is released into cells, resulting in
cell death. Therefore, according to the applicant, ciltacbtagene
autoleucel's mechanism of action differs from Blenrep's. Additionally,
the applicant states that there is currently no commercially available
CAR T-cell product that binds to the BCMA antigen. Lastly, the
applicant provided a list of other currently available treatments for
multiple myeloma and a description of their mechanisms of action (Table
1).
[[Page 25236]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.145
With regard to whether a product is assigned to the same DRG when
compared to an existing technology, the applicant expects that cases
involving the administration of ciltacabtagene autoleucel will be
assigned to the same MS-DRG, MS-DRG 018 (Chimeric Antigen Receptor
(CAR) T-cell Immunotherapy), as other CAR T-cell therapies.
---------------------------------------------------------------------------
\117\ Cook G, et al. Crit Rev Oncol Hematol. 2018;121:74-89.
\118\ Nejadmoghaddam MR, et al. Avicennna J Med Biotechnol.
2019;11(1):3-23.
\119\ Pufall MA. Adv Exp Med Biol. 2015;872:315-33.
\120\ Siddik ZH. The Cancer Handbook. New York: John Wiley &
Sons, Ltd; 2002.
\121\ Podar K, et al. Expert Opin Pharmacother. 2020
Mar;21(4):399-408.
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With regard to 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 when compared to an existing technology, the
applicant asserts that ciltacabtagene autoleucel is indicated for a
broader population than other available therapies, specifically
multiple myeloma patients having received three prior therapies.
In summary, the applicant asserts that ciltacabtagene autoleucel
meets the newness criterion and is not substantially similar to other
available therapies because it has a unique mechanism of action with
two distinct binding domains that confer avidity to the BCMA antigen,
and because it treats a different patient population, RRMM patients who
received three prior therapies. However, we note that ciltacabtagene
autoleucel may have a similar mechanism of action to that of
idecabtagene vicleucel, for which we received an application for new
technology add-on payments for FY 2022 for the treatment of adult
patients with relapsed or refractory multiple myeloma after four or
more prior lines of therapy, including an immunomodulatory agent, a
proteasome inhibitor, and an anti-CD38 monoclonal antibody. Per the new
technology add-on payment application for idecabtagene vicleucel, the
technology's mechanism of action is described as targeting B-cell
maturation antigen (BCMA), which is expressed on the surface of normal
and malignant plasma cells. The chimeric antigen receptor (CAR)
construct includes an anti-BCMA scFv-targeting domain for antigen
specificity, a transmembrane domain, a CD3-zeta T cell activation
domain, and a 4-1BB costimulatory domain. Antigen-specific activation
of idecabtagene vicleucel results in CAR-positive T cell proliferation,
cytokine secretion, and subsequent cytolytic killing of BCMA-expressing
cells. Because of the potential similarity with the BCMA antigen and
other actions, we believe that the mechanism of action for
ciltacabtagene autoleucel may be the same or similar to that of
idecabtagene vicleucel.
We believe that ciltacabtagene autoleucel may not treat the same or
similar patient population as currently existing treatments. However,
we believe that ciltacabtagene autoleucel and idecabtagene vicleucel
may treat the same or similar disease (RRMM) in the same or similar
patient population (patients who have previously received a proteasome
inhibitor (PI), and immunomodulatory agent (IMiD) and an anti-CD38
antibody). Accordingly, as it appears that ciltacabtagene autoleucel
and idecabtagene vicleucel are purposed to achieve the same therapeutic
outcome using the same or similar mechanism of action and would be
assigned to the same MS-DRG, we believe that these technologies may be
substantially similar to each other such that they should be considered
as a single application for purposes of new technology add-on payments.
We are 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
idecabtagene vicleucel and ciltacabtagne autoleucel are substantially
similar to each other and therefore should be considered as a single
application for purposes of new technology add-on payments.
We are inviting public comment on whether ciltacabtagene autoleucel
meets the newness criterion, including whether ciltacabtagene
autoleucel is substantially similar to idecabtagene vicleucel and
whether these technologies should be evaluated as a single technology
for purposes of new technology add-on payments.
[[Page 25237]]
With regard to the cost criterion, the applicant searched the FY
2019 MedPAR correction notice (December 1, 2020) file to identify
potential cases representing patients who may be eligible for treatment
using Ciltacabtagene autoleucel. In its analysis, the applicant
identified a primary cohort to assess whether this therapy met the cost
criterion. The following ICD-10-CM diagnosis codes were used to
identify claims involving multiple myeloma procedures.
[GRAPHIC] [TIFF OMITTED] TP10MY21.146
The applicant chose to limit its analysis to MS-DRG 016 (Autologous
Bone Marrow Transplant W CC/MCC or T-Cell Immunotherapy) because
patients receiving autologous bone marrow transplant (BMT) are
generally patients with relapsed or refractory multiple myeloma and are
most similar to patients who would be eligible to receive CAR T-cell
therapy. The claim search conducted by the applicant resulted in 1,215
claims mapped to MS-DRG 016 using the FY 2019 MedPAR. The applicant
determined an average unstandardized case weighted charge per case of
$1,237,393. The applicant used the New Technology Threshold for FY 2022
from the FY 2021 IPPS/LTCH PPS final rule for MS-DRG 018. The applicant
removed all charges in the drug cost center for the prior technology
because, according to the applicant, it is not possible to
differentiate between different drugs on inpatient claims. The
applicant added that this is likely an overestimate of the charges that
would be replaced by the use of ciltacabtagene autoleucel. The
applicant then standardized the charges using the FY 2019 final rule
impact file. Next, the applicant applied the 2-year inflation factor
used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier
threshold charges (1.13218). To calculate the charges for the new
technology, the applicant used the inverse of a simulated alternative
cost-to-charge ratio (CCR) specifically for CAR T cell therapies to
account for CAR T-cell therapies' higher costs compared to other drugs
and the potential for hospitals' charging practices to differ for these
drugs. To determine this alternative CCR for CAR T-cell therapies, the
applicant referred to the FY 2021 IPPS final rule AOR/BOR file and
calculated an alternative markup percentage by dividing the AOR drug
charges within MS-DRG 018 by the number of cases to determine a per
case drug charge. The applicant then divided the drug charges per case
by $373,000, the acquisition cost of YESCARTA and KYMRIAH, the CAR T-
cell products used in those claims, to arrive at a CCR of 0.295. The
applicant calculated a final inflated average case-weighted
standardized charge per case of $1,646,522, which it stated exceeded
the average case-weighted threshold amount of $1,251,126. The applicant
stated that because the final inflated average case-weighted
standardized charge per case exceeded the average case-weighted
threshold amount, the therapy meets the cost criterion.
As noted in previous discussions, the submitted costs for CAR T-
cell therapies vary widely due to differences in provider billing and
charging practices for this therapy. Therefore, with regard to the use
of this data for purposes of calculating a CAR T-cell CCR, we are
uncertain how representative this data is for use in the applicant's
cost analyses given this potential for variability.
We continue to be interested in public comments regarding the
eligibility of CAR T-cell technologies for new technology add-on
payments when assigned to MS-DRG 018. As we have noted in prior
rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85
FR 58603 through 58608), if a new MS-DRG were to be created, then
consistent with section 1886(d)(5)(K)(ix) of the Act, there may no
longer be a need for a new technology add-on payment under section
1886(d)(5)(K)(ii)(III) of the Act.
We invite public comment on whether ciltacabtagene autoleucel meets
the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that it believes that ciltacabtagene autoleucel
represents a substantial clinical improvement over existing
technologies because it: (1) Offers a treatment for a patient
population with limited options and continued disease progression,
despite having been treated with multiple prior therapies; and (2)
provides a significantly improved clinical outcome relative to other
therapies, either approved or still under FDA review, used in the
relapsed and refractory multiple myeloma setting. With regard to the
applicant's assertion that ciltacabtagene autoleucel offers a treatment
for a patient population with limited options and continued disease
progression, despite having been treated with multiple prior therapies,
the applicant cited results from the CARTITUDE-1 STUDY, a Phase 1b/2,
open-label, multicenter, multi-national (including US) study to
evaluate the safety and efficacy of ciltacabtagene autoleucel in adult
patients who have RRMM who have previously received a PI, an IMiD, and
an anti-CD38 antibody. The applicant asserts that ciltacabtagene
autoleucel was granted Breakthrough Therapy designation for patients
who have RRMM who have previously received a PI, an IMiD, and an anti-
CD38 antibody, based on data from the Phase1b/2 CARTITUDE-1 study. One
hundred thirteen patients were enrolled in the study. Sixteen patients
discontinued the study, including 9 patients who died due to
progressive disease. Ninety-seven patients received ciltacabtagene
autoleucel. The Phase 1b portion of the study included 29 of the 97
patients.
Two patients died during the study: one due to CRS and one due to
acute myeloid leukemia (not treatment-related). Twenty-four of the
remaining patients were ongoing in the Phase 1b dose confirmation
period, with an additional 59 patients ongoing in the Phase 2 portion.
The primary objective of the Phase 1b portion of the trial was to
confirm the safety of the selected dose based on the data from the
ongoing Phase 1 trial in China (Legend-2), as discussed later in this
section. The primary objective of the Phase 2 portion of the trial is
to evaluate the efficacy of ciltacabtagene autoleucel.
The applicant asserts that at median follow-up of 12.4 months,
ciltacabtagene autoleucel led to a 97% overall response rate (ORR) in
all 97 study patients who
[[Page 25238]]
received ciltacabtagene autoleucel.\122\ The applicant asserts that
this unprecedented overall response rate of (97%), represents early,
deep, and durable responses in all patients, minimal residual disease
negativity (meaning minimal residual cancer cells after treatment to
the -nth degree) in the majority of patients who achieved a complete
response (CR) and a very manageable toxicity profile. The applicant
provided a comparison of the ORR in phase 1 studies for other therapies
used to treat RRMM and noted the following: idecabtagene vicleucel ORR
73%,\123\ daratumumab ORR 31%,\124\ Selinexor ORR 26% \125\ and Blenrep
ORR 31%.\126\
---------------------------------------------------------------------------
\122\ Madduri D et. al. CARTITUDE-1: Phase 1b/2 Study of
Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed
Chimeric Antigen Receptor T-Cell Therapy, in Relapsed/Refractory
Multiple Myeloma
\123\ Munshi et al. ASCO 2020
\124\ Usmari et al. Blood 2016, 128(1), 37-44.
\125\ Chari A et al N Engl J Med 22019, 38 2(8);727-738
\126\ DREAMM2 Lonai S et al Lancet 2019.
---------------------------------------------------------------------------
The applicant further asserts that ciltacabtagene autoleucel led to
early and deep clinical responses in the phase1b/2 portion of the
CARTITUDE-1 study at median follow up of 12.4 months. Results of
CARTITUDE-1 showed a 97% overall response rate (ORR) with 67% of
patients attaining a stringent complete response (sCR) and 93% of
patients attaining a very good partial response (VGPR) or better after
receiving a low dose (median of 0.72 million CAR T-cells per kilogram)
of ciltacabtagene autoleucel within approximately a year. ORR and depth
of response were independent of BCMA expression on myeloma cells at
baseline. The median time to first response was one month (range, 0.9-
8.5).\127\
---------------------------------------------------------------------------
\127\ Berdeja JG, Madduri D, Usmani SZ, Singh I, Zudaire E, Yeh
TM, Allred AJ, Olyslager Y, Banerjee A, Goldberg JD, Schecter S,
Geng D, Wu X, Carrasco-Alfonso M, Rizvi S, Fan F, Jakubowiak AJ,
Jagannath S. Update of CARTITUDE-1: A phase Ib/II study of JNJ-4528,
a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy, in
relapsed/refractory multiple myeloma. Journal of Clinical Oncology.
2020 38:15_suppl, 8505-8505.
---------------------------------------------------------------------------
The applicant also asserted that most patients attained a status of
minimal residual disease (MRD)-negativity by the time they were
evaluable for a complete response (CR). Of evaluable patients, 93.0%
achieved MRD 10-5 negativity. Fifty-eight percent of
patients were both MRD negative and in sCR at MRD detection level of
10-5. Median time to MRD 10-5 negativity: 1 month
(0.8-7.7). Among patients with 6 months individual follow-up, most had
ciltacabtagene autoleucel CAR+ T-cells below the level of
quantification (2 cells/[mu]L) in peripheral blood.
In addition, progression-free survival (PFS) at 12 months was 77%
(95% CI; 66.0-84.37).\128\ The applicant believes this represents a
substantial clinical improvement when compared to existing technologies
that treat RRMM. The applicant further asserts that nearly all of the
individuals participating in the study (22 of the 29 patients) were
alive and continued showing no signs of disease progression after a
period of 9 months. Median PFS was not reached. At median follow-up of
12.4 months, there were 14 deaths during the Phase 1b/2 study: One due
to cytokine release syndrome (CRS) and hemophagocytic
lymphohistiocytosis (HLH), one due to neurotoxicity, and 12 due to
other causes.\98\ The applicant asserts that the CRS was manageable in
most patients. CRS was the most common adverse event (AE) (94.8%)
observed in the CARTITUDE-1 study. The median time to onset of CRS was
7 days (range 1-12 days) post ciltacabtagene autoleucel infusion. The
median duration of CRS was 4 days. Eighty-seven patients (94.6%)
experienced Grade 1-2 CRS and 5 patients (5% experienced grade 3 or
greater CRS)122.
---------------------------------------------------------------------------
\128\ Ibid.
---------------------------------------------------------------------------
The applicant noted that neurotoxicity with immune effector cell-
associated neurotoxicity syndrome (ICANS) was infrequently observed in
the context of CRS and was generally low grade. Neurotoxicity with
ICANS was observed in 20 patients (20.6%) including 10 patients (10.3%)
with Grade 3 or above toxicity.122
The LEGEND-2 study \129\ is an ongoing Phase 1, single-arm, open-
label, multicenter, first-in-human trial to determine the safety and
efficacy of ciltacabtagene autoleucel (LCAR-B38M in China) in the
treatment of patients with relapsed or refractory multiple myeloma.
Enrollment in this investigator-initiated study (study proposed,
initiated, and conducted by an investigator that is funded by industry)
completed in November 2017; a total of 74 patients with RRMM have been
treated with ciltacabtagene autoleucel CAR T-cell therapy. The clinical
cutoff for the analysis of these 74 patients was February 6, 2018 with
updated survival and efficacy data as of November 26, 2019 (which
represents 2 years of follow-up from the date of the last subject's
infusion). Seventeen patients (17/57-29%) died during the study and
follow up period (19 months) mostly due to progressive disease. None
were related to cytokine release syndrome or neurotoxicity, the two
most common adverse events associated with CAR T-cell therapy. At data
cutoff, 57 patients had received LCAR-B38M CAR T-cells.
---------------------------------------------------------------------------
\129\ Zhao et al. Journal of Hematology and Oncology. (2018)
11:141.
---------------------------------------------------------------------------
The applicant further asserts that outcomes from the LEGEND-2 study
show that cilltacabtagene autoleucel provides a significantly improved
clinical outcome relative to other therapies, either approved or still
under FDA review, used in the RRMM setting. At cutoff, the median
follow-up was 19 months [17-22]. The overall survival (OS) rate at 18
months was 68% with a median duration of response (mDOR) of 22 months.
Of MRD-negative patients with CR, 91% were still alive at data cut,
with a 27 month mDOR. The median time to first response was 1.1 months.
There was no relationship between best response and baseline BCMA
expression level or weight-adjusted CAR T-cells infused.\105\
The applicant asserts that of patients in the LEGEND-2 study with
CR, 39 of 42 were minimal residual disease negative (MRD-neg) and
remained RRMM progression-free. The median PFS rate for all treated
patients was 20 months; median PFS for MRD-neg patients with CR was 28
months. At 18 months, the PFS rate was 50% for all patients and 71% for
MRD-neg patients with CR. Seventeen patients died during the study and
the follow-up period. The causes of death included progressive disease
(PD; n=11), disease relapse, PD with lung infection, suicide after PD,
esophageal carcinoma, infection, pulmonary embolism and acute coronary
syndrome (n=1 each). Of these, 4 did not achieve partial response (PR)
or better; and 1 was not evaluable.
From the LEGEND-2 study, the median time to onset of CRS was 9 days
(range, 1-19) with a median duration of 9 days (range, 3-57); all but 1
CRS events resolved. Tocilizumab (46%), oxygen (35%), vasopressor
(11%), and intubation (1 patient) were used to treat CRS. Neurotoxicity
with grade 1 aphasia, agitation and seizure-like activity was observed
in 1 patient in the LEGEND-2 study. The applicant believes that since
ciltacabtagene autoleucel displayed a manageable CRS safety profile
that it represents a substantial clinical improvement over existing
therapies.
After reviewing the information submitted by the applicant as part
of its FY 2022 new technology add-on payment application for
ciltacabtagene autoleucel, we note that there are no head-to-head
comparisons of ciltacabtagene autoleucel and other CAR T-cell therapies
and BCMA-targeted
[[Page 25239]]
therapies. We also note that the applicant chose to use ORR data as a
measure of substantial clinical improvement rather than the available,
and more clinically relevant, OS data.
We are inviting public comment on whether ciltacabtagene autolecuel
meets the substantial clinical improvement criterion.
We did not receive any written comments in response to the New
Technology Town Hall meeting notice published in the Federal Register
regarding the substantial clinical improvement criterion for
ciltacabtagene autoleucel.
e. COSELA (trilaciclib)
G1 Therapeutics submitted an application for new technology add-on
payments for Trilaciclib for FY 2022. COSELA (trilaciclib) is indicated
to decrease the incidence of chemotherapy-induced myelosuppression in
adult patients when administered prior to a platinum/etoposide-
containing regimen or topotecan-containing regimen for extensive-stage
small cell lung cancer (ES-SCLC).\130\
---------------------------------------------------------------------------
\130\ G1 Therapeutics Inc., Rev. 2/2021, COSELA prescribing
information: https://www.g1therapeutics.com/cosela/pi/
#:~:text=COSELA%20is%20indicated%20to%20decrease,cancer%20(ES%2DSCLC)
.&text=The%20recommended%20dose%20of%20COSELA%20is%20240%20mg%2Fm2%20
per%20dose.
---------------------------------------------------------------------------
According to the applicant, Trilaciclib is a first-in-class
myelopreservation therapy that has the potential to mitigate
chemotherapy-induced myelosuppression (CIM). Trilaciclib is a
selective, transient inhibitor of cyclin dependent kinases 4 and 6
(CDK4/6) with potential antineoplastic and chemoprotective activities.
CDK4 and CDK6 are key regulators of the G1 cell-cycle checkpoint and
play important roles in cell proliferation and associated biological
processes. One of the most common pathways dysregulated in cancer is
the cyclin D-cyclin-dependent kinase four or six (CDK4/6)-
retinoblastoma (RB) pathway. Trilaciclib arrests hematopoietic stem and
progenitor (HSPCs) bone marrow cells in the G1 phase of the cell cycle
during chemotherapy exposure, protecting them from chemotherapy-induced
damage.
According to the applicant, the defining characteristic of cancer
is uncontrolled cellular proliferation, a phenomenon that requires
tumor cells to avoid or disable normal, physiologic cell-cycle
regulation. While there are both CDK 4/6 independent and dependent
cells, HSPCs and immune cells are CDK 4/6 dependent whereas SCLC cells
are CDK 4/6 independent. According to the applicant, the transient
arrest of HSPCs and lymphocytes by trilaciclib during the
administration of chemotherapy is thought to have a number of
beneficial effects, including a reduction in chemotherapy-induced
myelosuppression and preservation of immune function, as well as an
enhanced immune response.131 132 133 Specifically, SCLC
cells replicate independently of CDK 4/6 and therefore these cells are
damaged by chemotherapy. Because HSPCs and lymphocytes are CDK 4/6
dependent, trilaciclib's mechanism of action is believed to preserve
these cells by temporarily arresting their proliferation during
chemotherapy. In this way, trilaciclib reduces chemotherapy-induced
myelosuppression in patients with extensive-stage small-cell lung
cancer (ES-SCLC).\134\ The applicant also asserted that in preclinical
models, CDK4/6 inhibition by trilaciclib also alters the tumor immune
microenvironment through transient inhibition of the immune cells known
as lymphocytes that are also dependent on CDK4/6 activity for
proliferation.\135\
---------------------------------------------------------------------------
\131\ Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T)
decreases myelosuppression in extensive-stage small cell lung cancer
(ES-SCLC) patients receiving first-line chemotherapy plus
atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD: https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf.
\132\ Weiss JM, Csoszi T, Maglakelidze M, et al.
Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients
with small-cell lung cancer receiving first-line chemotherapy: a
phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-
1621.
\133\ Hart LL, Andric ZG, Hussein MA, et al. Effect of
trilaciclib, a CDK 4/6 inhibitor, on myelosuppression in patients
with previously treated extensive-stage small cell lung cancer
receiving topotecan. J Clin Oncol. 2019;37(15_suppl): Abstract 8505:
https://www.g8501therapeutics.com/file.cfm/8534/docs/tr-G8501T8528-8503%8520ASCO%202019%202020Oral%202020Presentation%20060119-20060111.pdf.
\134\ Donjerkovic D, Scott DW. Regulation of the G1 phase of the
mammalian cell cycle. Cell Res. 2000;10(1):1-16.
\135\ Lai AY, Sorrentino JA, Dragnev KH, et al. CDK4/6
inhibition enhances antitumor efficacy of chemotherapy and immune
checkpoint inhibitor combinations in preclinical models and enhances
T-cell activation in patients with SCLC receiving chemotherapy. J
Immunother Cancer. 2020;0:e000847. doi:10.1136/jitc-2020-000847.
---------------------------------------------------------------------------
According to the applicant, chemotherapy remains the cornerstone of
treatment for extensive stage small cell lung cancer (ES-SCLC). The
applicant asserted that almost all of the ~18,600 ES-SCLC patients
diagnosed each year are treated with platinum/etoposide-containing or
topotecan-containing chemotherapy regimens. Chemotherapy drugs target
cells at different phases of the cell cycle. According to the
applicant, systemic chemotherapy, alone or in combination with immune
checkpoint inhibitors, is the standard of care for patients with
advanced SCLC. Additionally, per the applicant, rescue interventions,
including growth factors and blood transfusions, are commonly routine
therapies for SCLC. The applicant also indicated that granulocyte
colony-stimulating factors (G-CSFs) only address neutropenia, while
erythropoiesis stimulating agent (ESAs) and red blood cell (RBC)
transfusions only address anemia, and there is no available treatment
that broadly mitigates myelosuppressive effects and their corresponding
impact on patient well-being before chemotherapy damage occurs.
COSELA (trilaciclib) received FDA's New Drug Application approval
on February 12, 2021. COSELA is for intravenous use only. The
recommended dose of COSELA is 240 mg/m2 as a 30-minute intravenous
infusion completed within four hours prior to the start of chemotherapy
on each day chemotherapy is administered.\136\ The applicant also
stated that in 2019, trilaciclib was granted Breakthrough Therapy
Designation for the mitigation of clinically significant chemotherapy-
induced myelosuppression in adult patients with SCLC. The applicant
submitted a request for a new ICD-10-PCS code as the applicant states
that there are no existing ICD-10-PCS codes that uniquely identify the
administration of trilaciclib.
---------------------------------------------------------------------------
\136\ G1 Therapeutics Inc., Rev. 2/2021, COSELA prescribing
information: https://www.g1therapeutics.com/cosela/pi/
#:~:text=COSELA%20is%20indicated%20to%20decrease,cancer%20(ES%2DSCLC)
.&text=The%20recommended%20dose%20of%20COSELA%20is%20240%20mg%2Fm2%20
per%20dose.
---------------------------------------------------------------------------
As previously discussed, 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 respect to the first criterion, whether a product uses the
same or a similar mechanism of action to achieve a therapeutic outcome,
the applicant asserted that trilaciclib, also referred to as G1T28, has
a unique mechanism of action as a small molecule, competitive inhibitor
of CDK4/6, with potential antineoplastic and chemoprotective
activities. The applicant stated that upon administration, trilaciclib
binds to and inhibits the activity of CDK4/6, thereby blocking the
phosphorylation of
[[Page 25240]]
the retinoblastoma protein (Rb) in early G1. This prevents G1/S phase
transition, causing cell cycle arrest in the G1 phase and induced
apoptosis, which inhibits the proliferation of CDK4/6-overexpressing
tumor cells. In patients with CDK4/6-independent tumor cells, G1T28 may
protect against multi-lineage chemotherapy-induced myelosuppression
(CIM) by transiently and reversibly inducing G1 cell cycle arrest in
hematopoietic stem and progenitor cells (HSPCs) and preventing
transition to the S phase. Per the applicant, this protects all
hematopoietic lineages, including red blood cells, platelets,
neutrophils and lymphocytes, from the DNA-damaging effects of certain
chemotherapeutics and preserves the function of the bone marrow and the
immune system.
The applicant stated that the cell cycle consists of four distinct
phases, Gap 1 phase (G1), S phase, Gap 2 (G2)
post-synthesis phase, and the M phase.\137\ Regulation of this process
is maintained by a series of highly conserved proteins referred to as
cyclins, and their catalytic binding partners, CDKs. The CDKs are a
family of enzymes that control several cellular processes in mammalian
cells, including the modulation of the cell cycle via binding to
cyclins A-E, which results in the activation of transcription factors
that regulate the cellular transition from G1 (growth phase) to S (DNA
replication) and G2 (growth phase) to M (mitosis).\138\
---------------------------------------------------------------------------
\137\ Ferrarotto R, Anderson I, Medgyasszay B, et al.
Trilaciclib reduces the need for growth factors and red blood cell
transfusions to manage chemotherapy-induced myelosuppression. Poster
presented at: IASLC: 2020 North America Conference on Lung Cancer;
October 16-17, 2020; Virtual congress.
\138\ Asghar U, Witkiewicz AK, Turner NC, Knudsen ES. The
history and future of targeting cyclin-dependent kinases in cancer
therapy. Nat Rev Drug Discov. 2015;14(2):130-146.
---------------------------------------------------------------------------
According to the applicant, the G1-to-S checkpoint is a critical
restriction point in the process of cell division. Cells are maintained
in a quiescent state until the proper signal is achieved for reentry
into the cell cycle. Throughout G1, expression of the D-type cyclins
(D1, D2, D3) increases until active complexes with CDK4/6 are formed.
Active CDK4/6 complexes partially phosphorylate RB, which allows
partial depression of the transcription factor E2F. This induces
additional transcript production of cyclin E1, which binds CDK2 to form
active complexes that result in the hyperphosphorylation of RB and
drives the cells through late G1 into S phase. Inhibition of cyclin D-
CDK4/6 by the tumor suppressor CDKN2A leads to a G1 arrest and cell-
cycle progression is halted.\139\
---------------------------------------------------------------------------
\139\ Donjerkovic D, Scott DW. Regulation of the G1 phase of the
mammalian cell cycle. Cell Res. 2000;10(1):1-16.
---------------------------------------------------------------------------
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant asserted that
trilaciclib will be assigned the same MS-DRG as existing technologies.
The applicant did not explicitly state to which MS-DRG(s) trilaciclib
would be assigned, but included MS-DRGs 180 (Respiratory Neoplasms with
MCC), 181 (Respiratory Neoplasms with CC), and 182 (Respiratory
Neoplasms without CC/MCC) in its cost analysis.
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 when compared to an
existing technology, the applicant stated that trilaciclib is the only
proactive (preventive) multilineage (erythrocytes, leukocytes, and
thrombocytes, neutrophils and lymphocytes) therapy given as a 30-minute
infusion administered prior to chemotherapy on each day of
chemotherapy. Due to its mechanism of action, trilaciclib's benefit is
coupled to its administration schedule (that is, trilaciclib must be
administered prior to chemotherapy to ensure G1 arrest of HSPCs when
those cells are exposed to cytotoxic chemotherapy). According to the
applicant, this therapeutic paradigm contrasts with standard available
treatment options and interventions that are administered after
chemotherapy to reactively reduce or treat chemotherapy side effects.
The applicant asserted that typical supportive care rescue
interventions such as growth factors (G-CSFs, ESAs) and red blood cell
(RBC) transfusions are used after chemotherapy causes damage to stem
cells. Current supportive care therapies are used reactively to treat
single cell lineage specific (leukocytes and erythrocytes)
complications,\140\ such as neutropenia and anemia. Additionally, the
applicant indicated that growth factor and RBC transfusion use are
known to carry a number of risks and cause complications and adverse
events.
---------------------------------------------------------------------------
\140\ National Comprehensive Cancer Network. NCCN Clinical
Practice Guidelines in Oncology. Hematopoietic Growth Factors.
Version 1.2020. 27 January. 2020.
---------------------------------------------------------------------------
We note that the information provided by the applicant in response
to whether trilaciclib treats the same or similar type of disease or
the same or similar patient population, appears to only speak to the
first criterion and whether trilaciclib has a mechanism of action that
is different than existing technologies; however, we believe
trilaciclib appears to treat the same patient population and disease as
existing therapies. We are inviting public comments on whether
trilaciclib is substantially similar to an existing technology and
whether it meets the newness criterion.
With respect to the cost criterion, the applicant conducted the
following analysis to demonstrate that trilaciclib meets the cost
criterion. In identifying the cost of trilaciclib, the applicant stated
that dosing is based on body surface area, 240 mg/m\2\ with an average
of two vials (300mg each) per patient per dose. To identify cases that
may be eligible for the use of trilaciclib, the applicant searched the
FY 2019 MedPAR LDS file for claims reporting an ICD-10-PCS code of
category C34 through C34.92 (Malignant neoplasm related to the
bronchus, lobe, or lung) as noted in the following table.
[[Page 25241]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.147
[GRAPHIC] [TIFF OMITTED] TP10MY21.148
According to the applicant, based on the advice of clinical
experts, it limited case selection criteria to claims that included one
of MS-DRGs 180, 181, or 182. The applicant then randomly selected 15%
of the claims from the sample to account for the fact that SCLC
comprises 15% of lung cancer cases.\141\ Based on the FY 2019 MedPAR
LDS file, the applicant identified 3,500 cases. The applicant noted
that 2,346 cases mapped to MS-DRG 180; 1,085 cases
[[Page 25242]]
mapped to MS-DRG 181; and 69 cases mapped to MS-DRG 182.
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\141\ Govindan R, et al. J Clin Oncol. 2006;24:4539-44. Byers
LA, Rudin CM. Cancer. 2015;121:664-72.
---------------------------------------------------------------------------
Using these 3,500 cases, the applicant then calculated the
unstandardized average charges per case for each MS-DRG. Because the
use of trilaciclib results in approximately half of patients no longer
needing drugs used to counter the effects of chemotherapy during the
inpatient stay, the applicant removed 50% of the drug charges for the
technology being replaced.
The applicant then standardized the charges using the 2019 IPPS/
LTCH PPS final rule impact file and inflated the charges by 1.13218 or
13.2 percent, the same inflation factor used by CMS to update the
outlier threshold in the FY 2021 IPPS/LTCH PPS final rule. The
applicant then added the charges for trilaciclib by converting the
costs to a charge by dividing the cost by the national average cost-to-
charge ratio of 0.187 for pharmacy from the FY 2021 IPPS/LTCH PPS final
rule.
Using the data file thresholds associated with the FY 2021 IPPS/
LTCH PPS final rule correction notice, the average case-weighted
threshold amount was $57,031. In the applicant's analysis, the final
inflated average case-weighted standardized charge per case was
$95,701. 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.
With respect to the cost criterion, we note that in listing the
codes it used to identify cases that may be eligible for the use of
trilaciclib, the applicant provided several ICD-10 codes that lack four
digits and thus, are considered invalid. We would be interested in
understanding the basis for the applicant's choice of codes. We also
note that in its analysis, the applicant randomly selected 15% of the
claims from the sample to account for the fact that SCLC comprises 15%
of lung cancer cases. In so doing, the applicant is making the
assumption that SCLC cases are randomly distributed amongst all cases
from which the applicant sampled. By randomly sampling the population,
the applicant is selecting a subsample that is ideally similar to the
population with less variance. It may be the case that SCLC cases are
systematically different from other cases in the population. If this is
true, then a random sample may not be appropriate. Accordingly, we
question the appropriateness of the sampling used and whether it
accurately represents cases that would use the technology.
Finally, with respect to pricing, it appears that the applicant's
final inflated average case-weighted standardized charge per case
reflects pricing prior to the availability of more current total
wholesale acquisition cost. We therefore request that the applicant
update its cost analysis to reflect the final inflated average case
weighted standardized charge per case based on this more current
information. We are inviting public comment on whether trilaciclib
meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that trilaciclib represents a substantial clinical
improvement over existing technologies because it offers a treatment
option for patients unresponsive to or ineligible for currently
available treatments and improves clinical outcomes for a patient
population as compared to currently available treatments. The applicant
stated that chemotherapy-induced myelosuppression (CIM) is typically
managed with treatment dose delays and reductions due to the slow
recovery of bone marrow after a course of chemotherapy.\142\ The
applicant also stated that CIM is managed with rescue interventions
including hematopoietic growth factors (G-CSFs and ESAs) and by RBC and
platelet transfusions.143 144 Per the applicant, despite the
availability and use of these treatment options, CIM continues to be of
clinical significance and remains a central concern in the delivery of
chemotherapy.145 146 The applicant further stated that
myelosuppression results in dose reductions, dose delays, and/or dose
discontinuations, affecting the dose intensity and intended antitumor
efficacy of chemotherapy.\147\ Per the applicant, the supportive care
interventions for treatment of myelosuppression are suboptimal and are
often administered reactively, do not protect the bone marrow from
chemotherapy-induced cytotoxic effects, are specific to single
hematopoietic lineages, and impart their own risks for adverse
reactions.\148\ The applicant concluded by stating that new approaches
that proactively prevent chemotherapy-induced damage and its associated
consequences, whilst not decreasing the efficacy of chemotherapy, are
urgently needed to improve care of patients with ES-SCLC.\149\
---------------------------------------------------------------------------
\142\ Crawford J, Dale DC, Lyman GH. Chemotherapy-induced
neutropenia: Risks, consequences, and new directions for its
management. Cancer. 2004;100(2):228.
\143\ Kurtin S. Myeloid Toxicity of Cancer Treatment. J Adv
Pract Oncol 2012;3:209-24.
\144\ Asghar U, Witkiewicz AK, Turner NC, Knudsen ES. The
history and future of targeting cyclin-dependent kinases in cancer
therapy. Nat Rev Drug Discov. 2015;14(2):130-46.
\145\ Crawford J, Dale DC, Lyman GH. Chemotherapy-induced
neutropenia: Risks, consequences, and new directions for its
management. Cancer. 2004;100(2):228.
\146\ Lyman GH. Chemotherapy dose intensity and quality cancer
care. Oncology (Williston Park). 2006;20(14 Suppl 9):16-25.
\147\ Smith RE. Trends in recommendations for myelosuppressive
chemotherapy for the treatment of solid tumors. J Natl Compr Canc
Netw. 2006;4(7):649-58.
\148\ Bisi JE, Sorrentino JA, Roberts PJ, Tavares FX, Strum JC.
Preclinical characterization of G1T28: a novel CDK4/6 inhibitor for
reduction of chemotherapy-induced myelosuppression. Mol Cancer Ther.
2016;15(5):783-93.
\149\ Nurgali K, Jagoe T, Raquel Abalo R. Editorial: Adverse
Effects of Cancer Chemotherapy: Anything New to Improve Tolerance
and Reduce Sequelae? Front Pharmacol. 2018;9:245.
---------------------------------------------------------------------------
In regard to the claim that the use of trilaciclib significantly
improves clinical outcomes for a patient population as compared to
currently available treatments, the applicant stated that the
administration of trilaciclib prior to chemotherapy in patients with
SCLC prevented chemotherapy-induced neutropenia, reduced chemotherapy-
induced anemia, reduced CIM or sepsis-related hospitalizations, and has
the potential to improve the management and quality of life of patients
receiving myelosuppressive chemotherapy as compared to placebo.\150\
---------------------------------------------------------------------------
\150\ Ferrarotto R, Anderson I, Medgyasszay B, et al.
Trilaciclib reduces the need for growth factors and red blood cell
transfusions to manage chemotherapy-induced myelosuppression. Poster
presented at: IASLC: 2020 North America Conference on Lung Cancer;
October 16-17, 2020; Virtual congress.
---------------------------------------------------------------------------
The applicant presented eight claims in support of the assertion
that trilaciclib represents substantial clinical improvement over
existing technologies in the mitigation of clinically significant
chemotherapy-induced myelosupression in adult patients with SCLC.
In its first and second claims, the applicant asserted that
trilaciclib reduces the mean duration of severe G4 neutropenia in cycle
1 of chemotherapy and reduces the proportion of patients experiencing
severe G4 neutropenia in comparison to placebo. The applicant submitted
three sources in support of these claims. First, the applicant
submitted a poster presentation from Daniel, et. al., describing a
global, randomized, double-blind, placebo-controlled, multicenter,
phase 2 study that assessed the potential of trilaciclib to reduce the
incidence and consequences of chemotherapy-induced myelosuppression in
patients with newly diagnosed ES-SCLC treated with etoposide,
carboplatin, and atezolizumab. One hundred seven eligible patients were
randomized to
[[Page 25243]]
receive trilaciclib (n = 53) or placebo (n = 54). The primary endpoints
were mean duration of severe neutropenia (SN) in cycle 1 and percent of
patients with grade 4 SN. Results summarized mean duration of SN in
cycle 1 as 0 days with trilaciclib and 4 days with placebo, and percent
of patients with grade 4 SN as 1.9% vs 49.1%, respectively.\151\
---------------------------------------------------------------------------
\151\ Daniel D, Kuchava V, Bondarenko I et al. Trilaciclib
Decreases Myelosuppression in Extensive-Stage Small Cell Lung Cancer
(ES-SCLC) Patients Receiving First-Line Chemotherapy Plus
Atezolizumab [Poster Presentation]. European Society of Medical
Oncology (ESMO). October, 2019; Barcelona, Spain.
---------------------------------------------------------------------------
Second, the applicant submitted an article by Weiss, et. al.,
summarizing a phase II randomized, double-blind placebo-controlled
study of the safety, efficacy and pharmacokinetics (PK) of trilaciclib
in combination with etoposide/carboplatin (E/P) therapy for treatment-
naive extensive-stage small-cell lung cancer patients. Thirty-nine
patients were included in the trilaciclib group versus 38 in the
placebo group. The applicant stated that treatment with trilaciclib
resulted in a reduced mean duration of severe G4 neutropenia in cycle 1
(0 days versus 3 days in placebo) and reduced proportion of patients
experiencing severe G4 neutropenia for trilaciclib (5% versus
43%).\152\
---------------------------------------------------------------------------
\152\ Weiss JM, Csoszi T, Maglakelidze M et al.
Myelopreservation with the CDK4/6 inhibitor Trilaciclib in Patients
with Small-Cell Lung Cancer Receiving First-Line Chemotherapy: A
Phase Ib/Randomized Phase II Trial. Ann Oncol. 2019 ;30(10):1613-
1621.
---------------------------------------------------------------------------
Third, the applicant submitted a presentation from Hart, et. al.,
describing a randomized, double-blind, placebo-controlled, phase 2
study to compare the results of 32 patients receiving Trilaciclib
versus 28 receiving placebo in patients being treated with topotecan
for previously treated ES-SCLC. Primary endpoints were mean duration of
SN in cycle 1 and the percentage of patients with SN. Results
demonstrated that the mean duration of severe G4 neutropenia in cycle 1
was reported at 2 days for trilaciclib versus eight days for placebo.
The proportion of patients experiencing severe G4 neutropenia was
reported at 41% for trilaciclib versus 76% for placebo.\153\
---------------------------------------------------------------------------
\153\ Hart LL, Andric ZG, Hussein MA et al. Effect of
Trilaciclib, a CDK4/6 Inhibitor, on Myelosuppression in Patients
with Previously Treated Extensive-Stage Small Cell Lung Cancer [Oral
Presentation]. Presented at: American Society of Clinical Oncology
(ASCO). June 2019; Chicago, US.
---------------------------------------------------------------------------
In the third claim, the applicant asserted that trilaciclib reduces
the proportion of patients experiencing febrile neutropenia treatment
emergent adverse events (TEAE) in comparison to placebo. In the fourth
claim, the applicant asserted that trilaciclib decreases the rate of
therapeutic intervention with G-CSF in comparison to placebo, noting
that growth factors are known to carry a number of risks, cause
complications and adverse events. In the fifth claim, the applicant
asserted that trilaciclib reduces the proportion of patients
experiencing grade 3/4 anemia in comparison to placebo. In the sixth
claim, the applicant asserted that trilaciclib decreases the rate of
therapeutic intervention with red blood cell transfusions in comparison
to placebo. To support these claims, the applicant submitted a 2020
poster presentation from Weiss, et. al., describing a pooled analysis
across three RCTs that compared the proportion of ES-SCLC patients
experiencing febrile neutropenia between trilaciclib and placebo. The
trilaciclib group included 122 patients and the placebo group included
118 patients. The presentation reflected the following results: The
proportion of patients experiencing febrile neutropenia for trilaciclib
was 3% versus placebo at 9%; the rate of therapeutic intervention with
G-CSF for trilaciclib at 29% versus 56% for placebo; the proportion of
patients experiencing grade 3/4 anemia for trilaciclib at 20% versus
32% for placebo; and the rate of therapeutic intervention with red
blood cell transfusions for trilaciclib at 15% versus 26% for
placebo.\154\
---------------------------------------------------------------------------
\154\ Weiss J, Goldschmidt J, Andric Z et al. Myelopreservation
and Reduced Use of Supportive Care with Trilaciclib in Patients with
Small Cell Lung Cancer [Poster Presentation]. Presented at: American
Society of Clinical Oncology (ASCO). May 2020.
---------------------------------------------------------------------------
In the seventh claim, the applicant asserted that trilaciclib
delays time to deterioration in symptoms and functioning domains of
patient-reported quality of life measures on Functional Assessment of
Cancer Therapy (FACT) scores. The applicant submitted a 2019
presentation from Weiss, et. al., describing a pooled analysis across
three RCTs. The applicant stated that trilaciclib delays time to
confirmed deterioration in a variety of symptoms and functioning
domains compared to placebo, for example: median of 4.7 months delay to
deterioration for fatigue; median of 3.5 months delay for anemia; and
median of 4 months delay for functional well-being.\155\
---------------------------------------------------------------------------
\155\ Weiss J, Skaltsa K, Gwaltney C, et al: Results from three
phase 2 randomized, double-blind, placebo-controlled small cell lung
cancer trials. 2019 Multinational Association of Supportive Care in
Cancer/International Society of Oral Oncology International
Symposium on Supportive Care in Cancer. Abstract eP723. Presented
June 21, 2019.
---------------------------------------------------------------------------
In the eighth claim, the applicant asserted that trilaciclib
decreases the number of hospitalizations due to myelosuppression or
sepsis. The applicant submitted a conference agenda referring to an
oral presentation by Ferrarotto, et. al., at the North America
Conference on Lung Cancer, October 16, 2020. The applicant stated that
hospitalizations due to myelosuppression or sepsis occurred in
significantly fewer patients and significantly less often among
patients receiving trilaciclib prior to chemotherapy versus placebo
though we were unable to locate support for this claim in the
conference agenda submitted with the application.\156\
---------------------------------------------------------------------------
\156\ Ferrarotto R, Anderson I, Medgyasszay B, et al.
Trilaciclib reduces the need for growth factors and red blood cell
transfusions to manage chemotherapy-induced myelosuppression. [Oral
Presentation]. Presented at: North America Conference on Lung
Cancer, October 2020. https://naclc2020.iaslc.org/program-at-a-glance/.
---------------------------------------------------------------------------
With respect to the substantial clinical improvement criterion, we
note that the data submitted by the applicant included one published
peer reviewed article from Weiss, et. al.,\157\ abstracts from Daniel,
et. al.,\158\ and Hart, et. al.,\159\ and references to trials
exploring broader cohorts of small cell lung cancer, breast cancer and
colon cancer patients. In addition, as summarized previously, we note
that most of the studies submitted by the applicant had sample sizes
fewer than 100 participants which may limit generalizability of the
studies. With respect to the Weiss, et. al., study, we note that
trilaciclib was compared with placebo at a significance level of two-
sided [alpha] = 0.2 which is much lower than the typical cutoff of 0.05
and may have increased the risk of false positives and interfered with
the ability to draw conclusions that are based on statistical methods.
We also note the lack of any statistical correction for multiple
comparisons. We note that
[[Page 25244]]
in sources provided by the applicant, mean duration of severe
neutropenia was assessed in day increments.160 161 162 163
However, it is not clear that zero days would indicate that those
patients experienced no severe neutropenia. Specifically, we question
whether mean hours in severe neutropenia was evaluated or whether, in
addition to the groupings by days, one day or less would be an
appropriate value for inclusion. Finally, while the applicant referred
to decreases in the number of hospitalizations, we note that the source
provided was limited to a conference agenda that only linked to an
abstract pertaining to reductions in utilization of supportive care
interventions but did not reflect hospitalization rates.\164\
---------------------------------------------------------------------------
\157\ Weiss JM, Csoszi T, Maglakelidze M, et al.
Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients
with small-cell lung cancer receiving first-line chemotherapy: A
phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-
1621.
\158\ Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T)
decreases myelosuppression in extensive-stage small cell lung cancer
(ES-SCLC) patients receiving first-line chemotherapy plus
atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD. https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf.
\159\ Hart LL, Andric ZG, Hussein MA, et al. Effect of
trilaciclib, a CDK \4/6\ inhibitor, on myelosuppression in patients
with previously treated extensive-stage small cell lung cancer
receiving topotecan. J Clin Oncol. 2019;37(15_suppl): Abstract 8505:
https://www.g8501therapeutics.com/file.cfm/8534/docs/tr-G8501T8528-8503%8520ASCO%202019%202020Oral%202020Presentation%20060119-20060111.pdf.
\160\ Weiss JM, Csoszi T, Maglakelidze M, et al.
Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients
with small-cell lung cancer receiving first-line chemotherapy: A
phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-
1621.
\161\ Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T)
decreases myelosuppression in extensive-stage small cell lung cancer
(ES-SCLC) patients receiving first-line chemotherapy plus
atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD: https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf.
\162\ Hart LL, Andric ZG, Hussein MA et al. Effect of
Trilaciclib, a CDK4/6 Inhibitor, on Myelosuppression in Patients
with Previously Treated Extensive-Stage Small Cell Lung Cancer [Oral
Presentation]. Presented at: American Society of Clinical Oncology
(ASCO). June 2019; Chicago, US.
\163\ Weiss J, Goldschmidt J, Andric Z et al. Myelopreservation
and Reduced Use of Supportive Care with Trilaciclib in Patients with
Small Cell Lung Cancer [Poster Presentation]. Presented at: American
Society of Clinical Oncology (ASCO). May 2020.
\164\ Ferrarotto R, Anderson I, Medgyasszay B, et al.
Trilaciclib reduces the need for growth factors and red blood cell
transfusions to manage chemotherapy-induced myelosuppression. [Oral
Presentation]. Presented at: North America Conference on Lung
Cancer, October 2020. https://naclc2020.iaslc.org/program-at-a-glance/.
---------------------------------------------------------------------------
We invite public comments as to whether trilaciclib meets the
substantial clinical improvement criterion.
We did not receive any written comments in response to the New
Technology Town Hall meeting notice published in the Federal Register
regarding the substantial clinical improvement criterion for
trilaciclib.
f. Ellipsys[supreg] Vascular Access System
Avenu Medical, Inc. submitted an application for new technology
add-on payments for the Ellipsys[supreg] Vascular Access System
(``Ellipsys'') for FY 2022. Ellipsys is a device that enables
percutaneous creation of an arteriovenous fistula (AVF), which is used
to access the bloodstream for hemodialysis for the treatment of end-
stage renal disease (ESRD). According to the applicant, to create the
fistula, a physician inserts a crossing needle through the perforating
vein and into the proximal radial artery in the forearm. A specialized
catheter is then used to bring the artery and vein together. The two
vessels are ``welded'' together with thermal resistance energy,
creating an anastomosis. According to the applicant, the only means of
creating an AVF was through open surgery before the approval of
Ellipsys, and percutaneous AVF (pAVF) offers a number of advantages
over surgical AVF (sAVF).
With respect to the newness criterion, the applicant for Ellipsys
received 510(k) clearance from the FDA on August 9, 2019, with an
indication for the creation of a proximal radial artery to perforating
vein anastomosis via a retrograde venous access approach in patients
with a minimum vessel diameter of 2.0mm and less than 1.5mm of
separation between the artery and vein at the fistula creation site who
have chronic kidney disease requiring dialysis.\165\ The subject of
this 510(k) clearance was an update to the Instructions for Use (IFU)
to allow an additional procedural step for balloon dilation of the
anastomosis junction at the radial artery and adjacent outflow vein of
the AVF immediately after creation with the Ellipsys catheter. Per the
applicant, the device was immediately available on the market. The
applicant further stated that the device was originally approved under
a De Novo clearance on June 22, 2018. Ellipsys also received two
additional 510(k) clearances dated January 25, 2019 (minor change in
the packaging of components) and October 5, 2018 (minor technological
differences in the power control unit and minor enhancements to the
catheter design) but the applicant states they are not regarded as
material for this application. The FDA has classified Ellipsys as a
Class II device under the generic name percutaneous catheter for
creation of an arteriovenous fistula for hemodialysis access. The
applicant stated that currently, two ICD-10-PCS codes identify
procedures using Ellipsys: 031B3ZF (Bypass right radial artery to lower
arm vein, percutaneous approach); and 031C3ZF (Bypass left radial
artery to lower arm vein, percutaneous approach). However, since these
codes also identify the WavelinQTM EndoAVF System
(``WavelinQ''), another percutaneous fistula device, Avenu Medical
submitted a code request for a unique ICD-10-PCS code to distinctly
identify Ellipsys beginning in FY 2022. The applicant stated this
technology was first assigned HCPCS code C9754 on January 1, 2019,
which was then replaced by HCPCS code G2170 on July 1, 2020. Per the
applicant, WavelinQ was assigned HCPCS codes (C9755 replaced by G2171)
with the same timing, and the codes for the 2 pAVF technologies are
differentiated by the use of thermal resistance energy for Ellipsys and
the use of radiofrequency energy for WavelinQ.
---------------------------------------------------------------------------
\165\ U.S. Food and Drug Administration (FDA). Center for
Devices and Radiological Health. 510(k) Summary No. K1191114. 2019.
Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191114.pdf.
---------------------------------------------------------------------------
The applicant stated that hemodialysis access for the treatment of
ESRD can be provided by catheter, graft, or AVF, of which AVF is
generally preferred for patients whose vascular anatomy and condition
permit it. Per the applicant, the only method for creating an AVF was
through an open surgical approach until the introduction of Ellipsys
and WavelinQ, two devices that use a percutaneous approach.
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 similar mechanism of action to achieve a therapeutic outcome, the
applicant asserted that Ellipsys uses a new mechanism of action
compared to its initial clearance. Per the applicant, the current
device included an additional step in the IFU, creating a different
procedure profile and a different mechanism of action. The applicant
states that the addition of this step, a balloon angioplasty performed
within the same operative session as the creation of the pAVF, instead
of days or weeks later, typically contributes to decreased time to
maturation, improved initial flow, and helps avoid early thrombosis of
the newly-created access, in addition to decreasing the number of
secondary procedures required for maturation and maintenance. According
to the applicant, the explicit inclusion of the step in the IFU, where
it was not previously explicitly included, represents a new mechanism
of action.
With respect to the second criterion, whether a product is assigned
to the same or different MS-DRG, the applicant generally stated that
Ellipsys is assigned to the same MS-DRGs as existing technologies.
According to information provided by the applicant,
[[Page 25245]]
these MS-DRGs appear to be MS-DRGs 264, 356, 357, 358, 628, 629, 630,
673, 674, 675, 907, 908, 909, 981, 982, and 983. 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 generally stated that
Ellipsys will 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.
In summary, the applicant believes that Ellipsys is not
substantially similar to other currently available therapies and/or
technologies because it uses a new mechanism of action and that
therefore, the technology meets the ``newness'' criterion. However, we
believe that the mechanism of action for Ellipsys may be the same or
similar to the original version of the Ellipsys system, which received
FDA approval on June 22, 2018. Though the current IFU includes an
additional procedure as part of the index procedure, it is not clear
that this step of balloon angioplasty done concurrently changes the
mechanism of action of the Ellipsys system. Per the FDA's 510(k)
summary, compared to the predicate device, there were no changes to the
device or the manner in which it creates a percutaneous anastomosis,
and other than the additional procedural step of balloon dilation, all
characteristics remain unchanged.\166\ In addition, clinicians were not
precluded from performing this step before the change in the IFU, and
in fact, balloon dilation was already performed during the index
procedure in some cases.\167\ Though the applicant maintains that
performing this additional step in all cases, as opposed to some, leads
to superior clinical outcomes, we are unclear if this has any bearing
on newness for this technology or if it represents a change in the
mechanism of action of this device. We note that if the current device
is substantially similar to the original version of Ellipsys, we
believe the newness period for this technology would begin on June 22,
2018 with the De Novo approval date and, therefore, because the 3-year
anniversary date of the technology's entry onto the U.S. market (June
22, 2021) would occur in FY 2021, the technology would no longer be
considered new and would not be eligible for new technology add-on
payments for FY 2022. We welcome public comments on whether the change
in the Ellipsys IFU represents a change to the device's mechanism of
action.
---------------------------------------------------------------------------
\166\ U.S. Food and Drug Administration (FDA). Center for
Devices and Radiological Health. 510(k) Summary No. K1191114. 2019.
Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191114.pdf.
\167\ Hull JE, Jennings W, et al., ``The Pivotal Multicenter
Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula
Creation for Hemodialysis Access,'' Journal of Vascular and
Interventional Radiology 2018; 29: 149-158.
---------------------------------------------------------------------------
We also note that differences in mechanism of action between
Ellipsys and WavelinQ were not included. We note that CMS stated in the
FY 2021 IPPS/LTCH PPS final rule (85 FR 58702) that WavelinQ uses a
unique mechanism of action that differed from that of other
commercially available devices.
We are inviting public comments on whether Ellipsys is
substantially similar to other currently available therapies and/or
technologies and whether this technology 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 searched the FY 2019 MedPAR claims data file with the
FY 2019 IPPS/LTCH PPS final rule correction notice IPPS Impact File to
identify potential cases representing patients who may be eligible for
treatment using the Ellipsys. The applicant stated that currently,
there are two ICD-10-PCS procedure codes that describe percutaneous AVF
in the radial artery: 031B3ZF (Bypass right radial artery to lower arm
vein, percutaneous approach) and 031C3ZF (Bypass left radial artery to
lower arm vein, percutaneous approach). The applicant stated that these
codes are not specific to percutaneous AVF formation using thermal
energy. We note that the applicant submitted a request for approval for
a unique ICD-10-PCS code for the use of the Ellipsys beginning FY 2022.
The applicant stated that if the procedure were reported with the
previously mentioned procedure codes, Ellipsys would be mapped to the
following MS-DRGs:
[GRAPHIC] [TIFF OMITTED] TP10MY21.149
The applicant added that ICD-10 codes 031B3ZF and 031C3ZF were new
effective October 1, 2019 and therefore do not appear in the 2019
claims data. According to the applicant, the most common MS-DRGs for
patients admitted with chronic kidney disease and who received an open
procedure for creation of an AVF are shown below.
[[Page 25246]]
[GRAPHIC] [TIFF OMITTED] TP10MY21.150
The applicant has not made a request for Ellipsys to be mapped to a
new MS-DRG for FY 2022.
The applicant stated that claims which had a diagnosis code for
Chronic Kidney Disease (CKD) stage IV, CKD stage V, or ESRD and which
included an open bypass of the subclavian artery to upper arm vein or
the radial artery to lower arm vein during the same stage were included
in the cost analysis. The applicant stated they used the following ICD-
10 codes in their analysis to identify claims.
[GRAPHIC] [TIFF OMITTED] TP10MY21.151
Cases mapping to the top five MS-DRGs by volume were selected,
which resulted in 689 cases or 79% of case volume.
The applicant determined an average unstandardized case weighted
charge per case of $91,190.
The applicant did not remove charges for prior technology because
the cases identified included an open procedure that is not performed
using a specific device. However, the applicant stated that all charges
for the operating room (OR) were removed as the procedures involving
the technology would not always be performed in an OR. The applicant
stated that departmental charges were standardized using the factors
from the standardization file released with the FY 2021 final rule. The
applicant then standardized the charges using the FY 2019 Final Rule
with Correction Notice Impact File. Next, the applicant applied the 2-
year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to
calculate outlier threshold charges (1.13218). To calculate the charges
for the technology, the applicant used the national average CCR for the
Supplies and Equipment cost center of 0.297 from the FY 2021 IPPS/LTCH
PPS final rule. The applicant added charges for other items and
services related to the technology; half of the average departmental
charges for the OR removed in a prior step were added back to the per
case charge, by MS-DRG, as procedures using the technology would
sometimes be performed in an OR. The applicant calculated a final
inflated average case-weighted standardized charge per case of
$119,158, which exceeded the average case-weighted threshold amount of
$91,190 by $27,967. The applicant stated that because the final
inflated average case-weighted standardized charge per case exceeded
the average case-weighted threshold amount, the therapy meets the cost
criterion.
We note that the applicant used claims with open subclavian artery
bypass to upper arm vein, in addition to radial lower arm fistulas, as
a proxy for Ellipsys cases. The applicant stated that Ellipsys may
provide an alternative to these cases in some instances where AVF
placement in the radial arteries is possible but the surgeons are
unfamiliar with the procedure. However, we question if these are the
most appropriate proxy, as Ellipsys should not replace radiocephalic
fistulas, per standard guidelines that recommend wrist fistulas first;
and it would be more likely that surgeons would use Ellipsys over upper
arm fistulas than a subclavian fistula, which is used rarely in
standard practice.
We are inviting public comments on whether the Ellipsys[supreg]
Vascular Access System meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the Ellipsys[supreg] Vascular Access System
represents a substantial clinical improvement over existing
technologies. Broadly, the applicant outlined three comparators with
respect to which it asserted Ellipsys provides a substantial clinical
improvement: (1) Percutaneous AVF with the WavelinQTM (4F)
EndoAVF System; (2) percutaneous AVF (pAVF) with the prior version of
Ellipsys; and (3) surgical AVF (sAVF).
With respect to the first comparison, Ellipsys as compared to
WavelinQ, the applicant stated that Ellipsys has improved outcomes
including technical success and cumulative patency. The applicant cited
the following to support superiority of Ellipsys over WavelinQ: (1)
Higher fraction of cases with clinically functional AVFs; (2) speedier
maturation; (3) more durable AVFs; and (4) smaller failure rate.
According to the applicant, no head-to-head clinical trial is
available, but they provided one retrospective study that provides a
direct comparison between the two pAVF systems to support their claims.
Shahverdyan et al. performed a retrospective review of 100 patients
undergoing percutaneous fistula creation at a single site in Germany
between December 2017 and December 2019 to compare outcomes with pAVF
[[Page 25247]]
creation using the Ellipsys and WavelinQ systems.\168\ In this single-
operator, comparative case series, 65 Ellipsys procedures and 35
WavelinQ procedures were completed, following a procedure sequence
algorithm for selecting the type of vascular access. Per the study,
wrist sAVF was the first choice as per standard practice guidelines,
followed by proximal forearm pAVF, resulting in 100 pAVFs using
Ellipsys (n=65) and WavelinQ (n=35). Demographics for the study
patients included 69 percent male and median age of 64.1 years. There
were no significant differences between WavelinQ and Ellipsys patients
in age, Body Mass Index (BMI), Chronic Kidney Disease (CKD) status, AVF
history, or presence of diabetes, though the WavelinQ group had a
higher proportion of males. The primary endpoints were technical
success, time to maturation, functional patency, and time to first
clinical use, and median follow-up was 186.5 days. The study reported
technical success, defined as post-procedure ultrasound examination
demonstrating a patent anastomosis and fistula flow, with Ellipsys at
100 percent vs. 97 percent with WavelinQ (p=0.35). Interventions were
performed in approximately 27 percent of cases for both technologies,
and the number of interventions per patient-year was 0.96 vs. 0.46,
respectively.
---------------------------------------------------------------------------
\168\ Shahverdyan et al., ``Comparison of Outcomes of
Percutaneous Arteriovenous Fistulae Creation by Ellipsys and
WavelinQ Devices,'' Journal of Vascular and Interventional Radiology
2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
---------------------------------------------------------------------------
Per the applicant, the study demonstrated a higher fraction of
cases with clinically functional AVFs using Ellipsys, as fistula
maturation at four weeks was 68.3 percent with Ellipsys vs. 54.3
percent with WavelinQ (p=0.1709), and at the end of the study period,
83.3% and 71.4% respectively. In addition, the applicant stated that
successful dialysis access was achieved in 79.5 percent of Ellipsys
cases vs. 60.9 percent for WavelinQ cases among patients on dialysis
(p=0.0711). The applicant also stated that the study demonstrated that
Ellipsys results in speedier maturation with Ellipsys demonstrating a
median time to cannulation of 60 days vs. 90 days with WavelinQ
(p=0.3676). Next, the applicant stated that use of Ellipsys
demonstrated more durable AVFs, with a secondary patency rate (the time
from fistula creation to fistula abandonment, including any
interventions) at 12 months of 82 percent as compared to 60 percent
with WavelinQ, and a functional patency rate of 100% vs 85.7%,
respectively. We note that primary patency (the time from fistula
creation to the first intervention) between groups was not
significantly different. Lastly, access failure occurred in 15.4
percent of Ellipsys patients vs 37.1 percent of WavelinQ patients
(p=0.0137), which demonstrated that use of Ellipsys results in a
smaller failure rate, according to the applicant.
With regard to the second comparison, Ellipsys compared to the
previous version of the technology, the applicant states that since the
IFU dated 8/9/19 now states that balloon angioplasty should be
performed at the time of the creation procedure, they believe that
Ellipsys should be considered a different device. Per the applicant,
this subtle difference is of key clinical importance to successful use
of Ellipsys, as this method decreases the time to two-needle
cannulation (2NC) and also improves initial flow, resolving vascular
spasm at the time of the procedure and reducing early thrombosis. The
applicant further states that performing balloon angioplasty 100
percent of the time also decreases the number of secondary procedures.
To support these claims, the applicant compared results from the
Ellipsys pivotal trial that used the earlier IFU, in which angioplasty
was performed simultaneously on 19% of patients, with the Ellipsys
post-market registry that implemented the change and performed the
additional step on 100% of patients.
Ellipsys's pivotal trial was a prospective, single-arm, non-
inferiority study of 107 patients at five sites to compare Ellipsys
with a 90-day performance goal based on a meta-analysis of surgical
results from the literature.\169\ Inclusion criteria included vascular
anatomy specific to the indications for Ellipsys, age between 18 and 80
years old, and CKD stage IV or V. Exclusion criteria included recent
surgery or major illness within 6 weeks, acute or active infection, and
use of immunosuppressive medication. Of 261 patients evaluated, a total
of 117 met inclusion and exclusion criteria, with 28 percent excluded
due to unsuitable anatomy. 107 were included in the intent to treat
(ITT) population after each study site completed 2 proctored
procedures. Demographics included 73 percent male, mean patient age of
56.7 years, and mean BMI of 31.2 percent. All patients in the ITT
population received a pAVF with Ellipsys between the proximal radial
artery and perforating vein, followed by separate maturation
procedures. The primary efficacy endpoint of the study was maturation
success, defined as brachial artery flow volume greater than or equal
to 500ml/min and target vein diameter greater than or equal to 4mm in
more than 49 percent of patients at 90 days. This performance goal was
obtained from a meta-analysis of 8 studies of open sAVF, where the
weighted least squares mean success rate was 62 percent, and the lower
bound from a 2-sided 95 percent lower confidence interval was 49
percent. The primary safety endpoint was the absence of device-related
complications at 90 days. Access failure occurred in 4/107, with a
technical success rate of 95 percent. The primary endpoint was met by
86 percent at 90 days (the 97.5 percent lower confidence interval was
77.9 percent), exceeding the 49 percent performance goal (p 66.2 (34-345 days). Per the authors, spasm of the perforating
vein was easily treated with vasodilators and balloon dilation as a
matter of routine care. Nineteen percent of patients (20/107) received
balloon dilation during the index procedure, and second stage
maturation procedures included 113 balloon dilations in 77 patients. A
total of 205 maturation procedures were performed on 99 patients at a
mean of 35.1 days. An additional 66 maintenance procedures were
performed in 35 patients at a mean of 17 days, for a total of 271
secondary procedures during the 12 months of the study (2.7 per patient
year).
---------------------------------------------------------------------------
\169\ Hull JE, Jennings W, et al., ``The Pivotal Multicenter
Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula
Creation for Hemodialysis Access,'' Journal of Vascular and
Interventional Radiology 2018; 29: 149-158.et al.,
---------------------------------------------------------------------------
The Ellipsys post-market registry by Hull et al. was a prospective
single-operator study of 60 patients receiving a pAVF with Ellipsys at
a single outpatient US site in an attempt to understand patient
selection, maturation, and cannulation with pAVFs.\170\ Patient
demographics included 57 percent male, mean age of 64, and mean BMI of
30.7. 123 patients with ESRD stages IV and V were evaluated by
ultrasound to determine suitability for AVF. Ninety-two percent were
eligible for sAVF and 61 percent
[[Page 25248]]
were eligible for pAVF. Of the 95 patients who received an AVF, 63
percent (60) received pAVF and 37 percent (35) received sAVF. All 60
pAVF patients underwent pAVF creation under ultrasound guidance,
followed by balloon dilation, as compared to the pivotal trial where
only 19 percent had balloon dilation as part of the index procedure.
After 4 weeks, maturation and suitability for dialysis were assessed.
The fistulas were considered suitable when palpable on examination and
the target vein had 500ml/min flow volume and 5mm diameter. Fifty-two
additional maturation procedures, including balloon dilation in 62
percent, were performed in 40 of 60 patients to achieve adequate flow
volume and diameter in the target vein. Physiologic maturation was
achieved in 93 percent (56 of 60 patients) with a mean time of 40.4
days 4.3, and of the remaining 4 patients, one thrombosed
and three died prior to maturation. In the 54 patients requiring
dialysis, 87 percent achieved 2NC at a mean of 76.8 days. Six month
cumulative patency and functional patency were both 94 percent. 70
maintenance procedures were performed in 63 percent. Only 2 patients
achieved 2NC without an additional procedure. The authors noted that
this study is limited by a modest sample size and single-site study
with surgeons experienced in pAVF creation, and that results were not
compared to surgery.
---------------------------------------------------------------------------
\170\ Hull JE, Deitrick J, Groome K, ``Maturation for
Hemodialysis in the Ellipsys[supreg] EndoAVF Post-Market Registry,''
Journal of Vascular and Interventional Radiology 2020; 31(9): 1373-
1381. (Published on-line August 13, 2020.)
---------------------------------------------------------------------------
According to the applicant, the post-market registry demonstrated
the significant clinical differences between performing balloon
angioplasty as part of the index procedure 19 percent of the time (as
seen in the pivotal trial) compared to 100 percent of the time. The
results showed that the average time to 2NC decreased from 100 days to
70 days. The study also compared initial AVF flow between the studies,
which increased to 649 ml/min from 330.4 ml/min, attributed to the
reduction in instances of venospasm due to balloon dilation.\171\
According to the study investigators, this decrease in venospasm and
higher flow led to a reduction in early thrombosis from 11 percent to 2
percent. Lastly, the applicant compared the number of secondary
procedures between the two studies with the following table:
---------------------------------------------------------------------------
\171\ Hull JE, Deitrick J, Groome K, ``Maturation for
Hemodialysis in the Ellipsys[supreg] EndoAVF Post-Market Registry,''
Journal of Vascular and Interventional Radiology 2020; 31(9): 1373-
1381. (Published on-line August 13, 2020.)
[GRAPHIC] [TIFF OMITTED] TP10MY21.152
Per the applicant, despite the higher standard for maturation in
the second study (5mm target vein diameter vs 4mm in the pivotal
study), the number of maturation procedures decreased, while
maintenance procedures increased. Overall, secondary procedures
decreased with the new protocol, as described in the table submitted by
the applicant.
With respect to the third comparison, Ellipsys as compared to sAVF,
the applicant stated that Ellipsys creates a side-to-side fistula with
a percutaneous approach while sAVFs for the most part create end-to-
side fistulas. According to the applicant, in patients that have
suitable anatomy for pAVF creation, this method of fistula creation
contributes to improved outcomes in five ways: (1) Higher fraction of
cases with clinically functional AVFs; (2) decreased time to two-needle
cannulation; (3) more durable AVFs; (4) decreased need for secondary
interventions; and (5) patient satisfaction with Ellipsys AVFs.
According to the applicant, no head-to-head studies or randomized
trials between Ellipsys and sAVFs are available, and instead, results
of key variables of interest were compared using studies with
comparable results for sAVFs from published literature. The applicant
provided 2 prospective single-arm studies and 5 retrospective studies,
including the studies previously discussed, to support these claims.
They also submitted data from one unpublished study. Aside from the
Ellipsys pivotal trial, the Ellipsys post-market registry, and the
comparison study with WavelinQ already summarized, the remaining
studies are summarized below.
The 2-year results of the pivotal trial were analyzed
retrospectively by Beathard.\172\ 105 patients with 2 year follow-up
data were included, and of these, 103 had functioning fistulas and all
were receiving dialysis except 3. Cumulative patency at 18 and 24
months was 92.8 percent and 91.6 percent, respectively. Patient
experience with pAVF was assessed among those who had received a
previous access procedure (\1/3\). When compared to their previous
procedure, patients rated Ellipsys as the same in 68 percent, better or
much better in 29 percent, and worse in 3 percent. Patients mentioned
difficulty with cannulation due to unfamiliarity of dialysis staff with
pAVF, but commented on the lack of surgical scar and short recovery
time. Among all patients who responded, 93 percent rated their access
as very good or excellent.
---------------------------------------------------------------------------
\172\ Beathard et al., ``Two-year cumulative patency of
endovascular AVF'' JVA 2020; 21: 350-356.
---------------------------------------------------------------------------
A retrospective review of 34 patients who received pAVF between May
2017 and November 2018 at a clinic in France was submitted.\173\
Patients included had ESRD, were not candidates for wrist fistulas, and
met the anatomic criteria for use of Ellipsys. Demographics included
patients that were 58 percent male, 65 percent Caucasian and 35 percent
African, and a mean age of 62 years old. After fistula creation with
Ellipsys, all anastomoses received balloon dilation. Twenty-four of 34
patients had successful 2NC within 6 weeks. Forty-four percent of
patients did not require secondary interventions, and 12 percent
required additional dilation within 4 weeks to improve maturation. Two
patients converted to a surgical fistula due to cannulation
difficulties. No patients developed steal syndrome or aneurysmal
changes in the one year follow-up period. Study authors noted that one
benefit of pAVF over sAVF is the potential for multiple outflow
cannulation veins, as compared to a sAVF in the same location, where
the median cubital vein is ligated to augment flow into a single
vessel.
---------------------------------------------------------------------------
\173\ Hebibi et al, ``Clinical hemodialysis experience with
percutaneous arteriovenous fistulas created using the
Ellipsys[supreg] vascular access system,'' Hemodialysis
International 2019; 23(2): 168-172.
---------------------------------------------------------------------------
Another study provided was a retrospective cohort study of 232
[[Page 25249]]
consecutive patients who underwent pAVF creation with Ellipsys at a
single center in France.\174\ An Ellipsys pAVF was the second choice
after a radiocephalic surgical wrist fistula. Patients were 63 percent
male, with a mean age of 64 years old (25-92). Balloon angioplasty was
considered part of the index procedure and performed in all cases.
Technical success was achieved in 99 percent. At 1 year, the primary
patency rate was 54 percent and the secondary patency rate was 96
percent with a mean follow up of 252 days. The most frequent
intervention (35 percent of patients) was additional balloon
angioplasty. Eleven percent of patients underwent procedures for
superficialization of deep veins. Average maturation time by clinical
or ultrasound criteria was 4 weeks, and successful cannulation was
established in less than 2 weeks in 10 percent of patients. No
significant adverse events related to the procedures occurred. Three
patients (1 percent) required later conversion to sAVF, two due to
occlusion of the anastomosis and one due to rupture of the perforator
during an angioplasty procedure and pseudoaneurysm. The authors
conclude that pAVFs have reduced need for reinterventions and result in
a moderate-flow fistula with shared venous drainage. They further state
that minimally invasive AVF creation with the low risk of complications
seen using Ellipsys can be particularly beneficial in older patients,
especially since the lower flow fistula as compared to brachial artery
inflow AVFs decreases the risk of cardiac issues. They conclude that
large-scale randomized studies are needed to confirm their findings.
---------------------------------------------------------------------------
\174\ Mallios et al., ``Mid-term results of percutaneous
arteriovenous fistula creation with Ellipsys vascular access system,
technical recommendations and an algorithm for maintenance,''
Journal of Vascular Surgery 2020; 72(6): 2097-2106. (Published on-
line April 7, 2020.).
---------------------------------------------------------------------------
In another study, a case series of 14 patients who achieved early
cannulation with an Ellipsys pAVF underwent retrospective review at an
outpatient department in Europe.\175\ In these patients, cannulation
within 14 days post creation was performed using plastic cannulas in
order to avoid catheter insertion or replacement for dialysis. The
procedure was successful in all except one case. Primary patency at 12
months was 66 percent and cumulative patency was 100 percent, with the
authors concluding that this success suggests that pAVF could serve as
an alternative to catheter for immediate dialysis.
---------------------------------------------------------------------------
\175\ Mallios et al., ``Early cannulation of percutaneously
created AVFs'', Journal of Vascular Access 2020; 21(6): 997-1002.
(Published on-line December 19, 2019.)
---------------------------------------------------------------------------
The applicant also submitted preliminary unpublished results from a
3-year follow up of 99 of the pivotal trial patients, stating that
while Ellipsys AVFs required more maturation procedures, in the 2 years
following creation they required fewer maintenance procedures as
compared to results for sAVF reported in the literature, with an
average of 0.83 vs. 3.41, respectively. Additionally, they stated that
at every follow-up period, Ellipsys showed improved cumulative patency
over sAVF results from the literature, with rates of 90 percent vs 46
percent at 36 months.
The applicant summarized results from all of the studies to support
each claim of Ellipsys's superiority over sAVF by comparing to
historical controls in the literature. For the claim of more clinically
functional AVFs, the applicant summarized results from 4 studies,
demonstrating 2NC in 88 percent at one year and 95 percent at 2 years,
87 percent with an average follow up of 282 days, and 82 percent within
6 weeks.176 177 178 179 This was compared to a value of 53.4
percent successful cannulation for sAVF from a study that looked at the
effect of age over 65 on clinical outcomes for radiocephalic and
brachiocephalic AVF.\180\ For the claim of decreased time to 2NC, the
applicant summarized the results from 5 studies, demonstrating a mean
time to 2NC for Ellipsys of 100.2 days, 65.5 45.7 days, a
range of 10 days to 6 weeks, 4 weeks, and 60
days.181 182 183 184 185 This was compared to a mean of 136
days for sAVFs, taken from the United States Renal Data System.\186\
For the claim of more durable AVFs, the applicant summarized results
from 5 studies demonstrating Ellipsys's cumulative patency at 12
months, ranging from 82 percent to 100 percent, and 91.6 percent at 24
months.187 188 189 190 The applicant compared these results
to a patency rate of 65 percent for sAVFs found in the USRDS
database.\191\ The applicant further stated that preliminary results
from the pivotal trial 3 year follow-up reinforce this claim, as they
found that the cumulative patency using Ellipsys was 90 percent at 36
months, compared to a historical value of 46 percent for sAVFs. For the
claim of decreased secondary interventions (including maturation and
maintenance procedures), the applicant summarized outcomes from 3
studies demonstrating 0.96 secondary interventions per patient year in
the study by Shahverdyan et al.; 2.63 interventions per year in the
pivotal trial; and an average of 0.83 maintenance inventions per
patient in the 2 years following creation in the preliminary results of
the 3 year follow-up by Hull et al. The applicant stated that a
comparable value for sAVFs is
[[Page 25250]]
3.41 over 2 years.\192\ Finally, for the claim of patient satisfaction,
the applicant cited results of the patient survey performed by Beathard
et al., stating that the survey indicated a high level of satisfaction
with Ellipsys, with 93 percent rating their access as very good or
excellent, and 95 percent rating their lack of pain as very good or
excellent. Additionally, patients noted the lack of scar, short
recovery time, and ease of use with Ellipsys.\193\
---------------------------------------------------------------------------
\176\ Hull JE, Jennings W, et al., ``The Pivotal Multicenter
Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula
Creation for Hemodialysis Access,'' Journal of Vascular and
Interventional Radiology 2018; 29: 149-158.
\177\ Beathard GA, et al., ``Two-year cumulative patency of
endovascular arteriovenous fistula,'' Journal of Vascular Access
2020; 21: 350-356.
\178\ Hull JE, Deitrick J, Groome K, ``Maturation for
Hemodialysis in the Ellipsys[supreg] EndoAVF Post-Market Registry,''
Journal of Vascular and Interventional Radiology 2020; 31(9): 1373-
1381. (Published on-line August 13, 2020.)
\179\ Hebibi H, et al., ``Clinical hemodialysis experience with
percutaneous arteriovenous fistulas created using the
Ellipsys[supreg] vascular access system,'' Hemodialysis
International 2019; 23(2): 16 8-172.
\180\ Weale A, et al., ``Radiocephalic and Brachiocephalic
Arteriovenous Fistula Outcomes in the Elderly,'' Journal of Vascular
Surgery 2008; 47(1): 144-150.
\181\ Hull JE, Jennings W, et al., ``The Pivotal Multicenter
Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula
Creation for Hemodialysis Access,'' Journal of Vascular and
Interventional Radiology 2018; 29: 149-158.
\182\ Hull JE, Deitrick J, Groome K, ``Maturation for
Hemodialysis in the Ellipsys[supreg] EndoAVF Post-Market Registry,''
Journal of Vascular and Interventional Radiology 2020; 31(9): 1373-
1381. (Published on-line August 13, 2020.)
\183\ Hebibi H, et al., ``Clinical hemodialysis experience with
percutaneous arteriovenous fistulas created using the
Ellipsys[supreg] vascular access system,'' Hemodialysis
International 2019; 23(2): 168-172.
\184\ Mallios A, Bourquelot P, Franco G, et al., ``Mid-term
results of percutaneous arteriovenous fistula creation with Ellipsys
vascular access system, technical recommendations and an algorithm
for maintenance,'' Journal of Vascular Surgery 2020; 72(6): 2097-
2106. (Published on-line April 7, 2020.)
\185\ Shahverdyan R, et al., ``Comparison of Outcomes of
Percutaneous Arteriovenous Fistulae Creation by Ellipsys and
WavelinQ Devices,'' Journal of Vascular and Interventional Radiology
2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
\186\ United States Renal Data System. 2016 USRDS Annual Data
Report: Epidemiology of kidney disease in the United States.
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, Bethesda, MD, 2016.
\187\ Beathard GA, et al., ``Two-year cumulative patency of
endovascular arteriovenous fistula,'' Journal of Vascular Access
2020; 21: 350-356.
\188\ Mallios A, Bourquelot P, Franco G, et al., ``Mid-term
results of percutaneous arteriovenous fistula creation with Ellipsys
vascular access system, technical recommendations and an algorithm
for maintenance,'' Journal of Vascular Surgery 2020; 72(6): 2097-
2106. (Published on-line April 7, 2020.)
\189\ Shahverdyan R, et al., ``Comparison of Outcomes of
Percutaneous Arteriovenous Fistulae Creation by Ellipsys and
WavelinQ Devices,'' Journal of Vascular and Interventional Radiology
2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
\190\ Mallios A, et al., ``Early cannulation of percutaneously
created arteriovenous hemodialysis fistulae,'' Journal of Vascular
Access 2020; 21(6): 997-1002. (Published on-line December 19, 2019.)
\191\ Al-Jaishi, Ahmed A., et al. ``Patency rates of the
arteriovenous fistula for hemodialysis: a systematic review and
meta-analysis.'' American Journal of Kidney Diseases (2014) 63(3):
464-47.
\192\ Lee T, et al., ``Long-Term Outcomes of Arteriovenous
Fistulas with Unassisted versus Assisted Maturation: A Retrospective
National Hemodialysis Cohort Study,'' Journal on American Nephrology
2019; 30(11):2209-2218.
\193\ Beathard GA, et al., ``Two-year cumulative patency of
endovascular arteriovenous fistula,'' Journal of Vascular Access
2020; 21: 350-356.
---------------------------------------------------------------------------
We note that only one of the studies submitted by the applicant in
support of a finding of substantial clinical improvement for Ellipsys
has a comparator arm (retrospective comparison), and none were created
with a methodology to demonstrate superiority. In addition, some
studies may be limited by potential bias due to single operator and/or
single site design, and comparisons to sAVF were made using various
historical controls from different studies with no statistical
analyses, making it difficult to account for confounding variables. We
further note that the studies used physiologic endpoints as a surrogate
outcome for fistula maturity instead of a clinically functional fistula
as determined by successful 2-needle cannulation. Of interest, a number
of the studies submitted concluded that there is a further need for
head-to-head, larger scale, or longer trials to confirm claims of
superiority of pAVF over surgical AVF and other pAVF devices. We note
that the applicant provided one retrospective study with a small sample
size to support the claim of superiority of Ellipsys over WavelinQ.
Though this study by Shahverdyan et al. demonstrated numerically better
outcomes for multiple endpoints with Ellipsys, we note that outcomes
did not reach statistical significance for primary patency, technical
success, maturation rates, time to cannulation, or fistula success, and
we note the potential for bias with the single operator/single site
study design.
We note that the decreased interventions and time to 2NC using
Ellipsys were reported from studies performed outside of the US, where
practice patterns are different. Per the Hull et al. study, practice in
the US is to direct flow into a single upper arm vein to meet
established guidelines for fistula flow diameter depth and length,
whereas in the European studies, multiple outflow veins were
accepted.\194\ The authors further state that allowing multiple outflow
veins decreases the number of secondary maturation procedures used to
direct flow, but requires advanced cannulation techniques, ultrasound
guidance, and plastic access cannulas that are not available in the US.
These techniques and the use of plastic cannulas also allow for early
cannulation of the fistula in European studies. For these reasons, we
question whether the European results are generalizable to the US
population.
---------------------------------------------------------------------------
\194\ Hull et al., ``Maturation for Hemodialysis in the Ellipsys
EndoAVF Post-Market Registry,'' Journal of Vascular and
Interventional Radiology 2020; 31(9): 1373-1381. (Published on-line
August 13, 2020.)
---------------------------------------------------------------------------
When comparing the new protocol for Ellipsys (always performing
balloon angioplasty) to the De Novo protocol (sometimes performing
balloon angioplasty), Ellipsys demonstrated a reduced number of
maturation procedures and faster time to cannulation; however, more
maintenance procedures were required than the De Novo protocol. In
addition, the investigators did not account for potential confounding
variables between the different studies, which could have affected
outcomes in order to compare the two studies used to claim superiority.
We further note that previously, balloon angioplasty was nearly always
performed, whether as part of the index procedure, as a maturation
procedure, or as a maintenance procedure, and it continued to be a
necessary secondary intervention after adoption of the new procedural
step.
We are inviting public comments on whether the Ellipsys[supreg]
Vascular Access System demonstrates improvement over each of the three
comparators and meets the substantial clinical improvement criterion.
We received public comments in response to the New Technology Town
Hall meeting regarding the application of the Ellipsys[supreg] Vascular
Access System for new technology add-on payments.
Comment: The applicant submitted a public comment providing an
additional study and addressing questions posed at the town hall
meeting. The study provided is a single-center retrospective comparison
article in press of Ellipsys and sAVF by Harika et al. 107 patients who
received pAVF with Ellipsys at this center between May 2017 and May
2018 were compared to an equal number of consecutive patients who
received a surgical fistula in the same time period. Patients with
grafts or lower extremity fistulae were excluded and baseline
characteristics and demographics were comparable between groups. All
pAVFs were created by a single surgeon, while the sAVFs were created by
4 surgeons. Primary outcomes were primary and secondary patency rates,
as well as maturation as determined by AVF utilization, or >4mm
diameter and >500ml/lt flow for pre-dialysis patients. Secondary
outcomes assessed secondary interventions and rate of complications.
Per the applicant, at 6 weeks, pAVF maturation rates were higher
compared to the sAVF arm (65 percent vs 50 percent, p=0.01). In
addition, primary patency in the sAVF group was higher than pAVF at 12
months (86 percent vs 61 percent, phttps://wearesrna.org/living-with-myelitis/disease-information/neuromyelitis-optica-spectrum-disorder/diagnosis/#nmosd. Accessed August 19, 2020.
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\209\ Siegel Rare Neuroimmune Association. Neuromyelitis Optica
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\210\ National Organization for Rare Disorders (NORD[supreg]).
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\211\ Wingerchuk DM. Diagnosis and Treatment of Neuromyelitis
Optica. Neurologist 2007;13(1)2-11. doi:10.1097/
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\212\ Wingerchuk DM, Lennon VA, Lucchinetti CF, et al. The
spectrum of neuromyelitis optica. Lancet Neurol. 2007;6(9)805-815.
doi:10.1016/s1474-4422(07)70216-8.
\213\ Jarius S, Ruprecht K, Wildemann B, et al. Contrasting
disease patterns in seropositive and seronegative neuromyelitis
optica: A multicentre study of 175 patients. J. Neuroinflammation
2012;9(1) doi:10.1186/1742-2094-9-14.
---------------------------------------------------------------------------
According to the applicant, the negative impact of NMOSD on patient
quality of life (QoL) is predominantly a result of physical disability,
pain, vision impairment, and bowel and bladder dysfunction.\214\
Disease-induced disability and symptoms have a considerable impact on
patients' ability to work and thrive in social activities and personal
relationships.\215\ The applicant added that the loss of motor and
sensory function leads to approximately 50% of patients requiring a
wheelchair \216\ and 62% of patients becoming functionally blind \217\
within 5 years of diagnosis.\218\ Therefore, according to the
applicant, it is critical that treatments that consistently and
effectively reduce the risk of relapse are initiated rapidly in
patients diagnosed with NMOSD.
---------------------------------------------------------------------------
\214\ Beekman J, Keisler A, Pedraza O, et al. Neuromyelitis
optica spectrum disorder. Neurol.-Neuroimmunol. Neuroinflammation
2019;6(4)e580. doi:10.1212/nxi.0000000000000580.
\215\ Ibid.
\216\ Kessler RA, Mealy MA, Levy M. Treatment of Neuromyelitis
Optica Spectrum Disorder: Acute, Preventive, and Symptomatic. Curr.
Treat. Options Neurol. 2015;18(1) doi:10.1007/s11940-015-0387-9.
\217\ Wingerchuk DM, Hogancamp WF, O'Brien PC, et al. The
clinical course of neuromyelitis optica (Devic's syndrome).
Neurology 2012;53(5)1107-1107. doi:10.1212/wnl.53.5.1107.
\218\ Wingerchuk DM, Weinshenker BG. Neuromyelitis optica:
Clinical predictors of a relapsing course and survival. Neurology
2012;60(5)848-853. doi:10.1212/01.wnl.0000049912.02954.2c.
---------------------------------------------------------------------------
With respect to the newness criterion, ENSPRYNG received FDA BLA
approval on August 14, 2020. The applicant added that ENSPRYNG was
granted Fast Track designation \219\ and Breakthrough Therapy
designation \220\ by the FDA. The applicant stated that ENSPRYNG was
not commercially available until August 24, 2020 because the applicant
had to wait for final approval for printing and labeling as well as
customs and importation. The recommended loading dosage of ENSPRYNG for
the first three administrations is 120 mg by subcutaneous injection at
Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every
four weeks. The applicant submitted a request for an ICD-10-PCS code to
uniquely identify the administration of ENSPRYNG beginning FY 2022.
---------------------------------------------------------------------------
\219\ US Department of Health and Human Services. FDA Approves
Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord.
https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-disease-affecting-optic-nerves-spinal-cord. Accessed
September 10, 2020.
\220\ Genentech, USA Inc. FDA Approves Genentech's Enspryng for
Neuromyelitis Optica Spectrum Disorder. https://www.gene.com/media/press-releases/14873/2020-08-14/fda-approves-genentechs-enspryng-for-neu. Accessed September 10, 2020.
---------------------------------------------------------------------------
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 purposed of new technology add-on payments. The applicant stated
that there are limited treatment guidelines available for NMOSD with
the most recent US guidelines published in 2012. These US NMOSD
treatment guidelines exclusively recommend off-label drugs:
Azathioprine, with or without prednisone; mycophenolate mofetil, with
or without prednisone; rituximab; or prednisone alone.\221\ The
applicant stated that there are presently two other FDA-approved
therapies for patients with AQP4-IgG positive NMOSD: SOLIRIS
(eculizumab),\222\ which was approved in 2019, and UPLIZNA
(inebilizumab-cdon), which was approved in 2020.\223\
---------------------------------------------------------------------------
\221\ Kimbrough DJ, Fujihara K, Jacob A, et al. Treatment of
Neuromyelitis Optica: Review And Recommendations. Mult Scler Relat
Disord. 2012;1(4):180-187. doi:10.1016/j.msard.2012.06.002.
\222\ SOLIRIS (eculizumab) [prescribing information]. Boston,
MA: Alexion Pharmaceuticals, Inc.; 2019.
\223\ UPLIZNA (inebilizumab) [prescribing information].
Gaithersburg, MD: Viela Bio, Inc.; 2020.
---------------------------------------------------------------------------
With regard to the first criterion, whether a product uses the same
or similar mechanism of action to achieve a therapeutic outcome, the
application stated that ENSPRYNG is an interleukin-6 (IL-6) receptor
antagonist indicated for the treatment of NMOSD in adult patients who
are AQP4-IgG positive.\224\ According to the applicant, ENSPRYNG
targets soluble and membrane-bound IL-6 receptors to inhibit IL-6
signaling and subsequently disrupt downstream inflammatory
[[Page 25253]]
effects that contribute to the pathophysiology of NMOSD; \225\ ENSPRYNG
dissociates from the IL-6 receptor at an acidic pH within endosomes and
is recycled to circulation, prolonging the plasma half-life of the
drug.\226\
---------------------------------------------------------------------------
\224\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
\225\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
\226\ Igawa T, Ishii S, Tachibana T, et al. Antibody Recycling
By Engineered Ph-Dependent Antigen Binding Improves The Duration of
Antigen Neutralization. Nat Biotechnol. 2010;28(11):1203-1207.
doi:10.1038/nbt.1691. Heo Y. Satralizumab: First Approval. Drugs
2020;80(14)1477-1482. doi:10.1007/s40265-020-01380-2.
---------------------------------------------------------------------------
The applicant next identified other drugs used to treat NMOSD and
their corresponding mechanisms of action. According to the applicant,
these current treatments include: SOLIRIS, for which a precise
mechanism of action is unknown but is presumed to involve inhibition of
AQP4-IgG-induced terminal complement C5b-9 deposition; \227\ UPLIZNA,
for which a precise mechanism of action is unknown but is presumed to
involve binding to CD19, a surface antigen present on pre-B and mature
B cells; \228\ azathioprine, for which a precise mechanism of action is
unknown; \229\ Rituxan, which targets CD20 antigen on B cells and leads
to profound B cell depletion, principally over an antibody-dependent
cell cytotoxicity mechanism; \230\ mycophenolate mofetil, which is an
immunosuppressive and an inhibitor of inosine monophosphate
dehydrogenase and therefore of the guanosine nucleotide synthesis
pathway upon which T and B cells depend; \231\ and prednisone, which is
a synthetic adrenocortical steroid drug with predominately
corticosteroid properties.\232\ The applicant concluded that none of
these current drugs are characterized by their binding and blocking of
soluble and membrane-bound IL-6 receptors to inhibit IL-6 signaling.
Therefore, the applicant believes ENSPRYNG has a unique and distinct
mechanism of action.
---------------------------------------------------------------------------
\227\ SOLIRIS (eculizumab) [prescribing information]. Boston,
MA: Alexion Pharmaceuticals, Inc.; 2019.
\228\ UPLIZNA (inebilizumab) [prescribing information].
Gaithersburg, MD: Viela Bio, Inc.; 2020.
\229\ IMURAN (azathioprine) [prescribing information]. Roswell,
GA: Sebela Pharmaceuticals Inc.; 2018.
\230\ RITUXAN (rituximab) [prescribing information]. South San
Francisco, CA: Genentech, Inc.; 2019.
\231\ Allison AC, Eugui EM. Mycophenolate Mofetil And Its
Mechanisms of Action. Immunopharmacology 2000;47(2-3)85-118.
doi:10.1016/s0162-3109(00)00188-0.
\232\ RAYOS (prednisone) [prescribing information]. Lake Forest,
IL: Horizon Therapeutics USA, Inc.; 2019.
---------------------------------------------------------------------------
With respect to the second criterion, whether a product is assigned
to the same or different MS-DRG, the applicant acknowledged that
ENSPRYNG may be assigned to the same MS-DRG when compared to existing
technology. Per the applicant, cases representing patients who may be
eligible for treatment with ENSPRYNG map to MS-DRGs 058, 059, and 060.
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
stated that the use of ENSPRYNG may not involve the treatment of the
same or similar patient population when compared with an existing
technology because: (1) Current technologies such as SOLIRIS may be
contraindicated in patients with unresolved serious Neisseria
meningitidis infections; and (2) SOLIRIS and UPLIZNA are administered
as IV infusions which not all patients may be willing to receive.
In summary, the applicant asserts ENSPRYNG meets the newness
criterion because it is the only treatment for NMOSD that works
specifically by suppressing IL-6 signaling, and because it may not
involve the treatment of the same or similar patient population as
existing technology. We note that the applicant states that the use of
ENSPRYNG may not involve treatment of the same or similar patient
population when compared to SOLIRIS with regard to the treatment of
patients with unresolved serious Neisseria meningitidis infection and
with regard to the treatment of patients unwilling to receive an IV
infusion. However, we question if UPLIZNA may also be a treatment
option for patients with meningococcal disease. We further question
whether patients who are unwilling to receive an IV infusion would
constitute a new patient population for NMOSD. We invite public comment
on whether ENSPRYNG involves the treatment of the same or similar
patient population when compared to existing technologies.
We are inviting public comments on whether ENSPRYNG is
substantially similar to other technologies and whether ENSPRYNG meets
the newness criterion. With regard to the cost criterion, the applicant
provided two cost analyses, with the first being an update of the
analysis used in FY 2021 by the applicant for SOLIRIS, which is also
indicated for NMOSD, and the second which is specific to ENSPRYNG.
Under the first analysis, the applicant searched the FY 2019 MedPAR
database for cases reporting ICD-10-CM code G36.0 in the primary and/or
admitting position, which resulted in 583 cases. The applicant imputed
one case where an MS-DRG had a case volume lower than 11, resulting in
556 cases mapping to 30 MS-DRGs. The applicant stated that it
restricted the analysis to MS-DRGs 058, 059, and 060, which accounted
for 92.1% of all cases identified. The applicant also excluded cases
that were not included in the FY 2021 Proposed Rule Impact File from
this analysis, resulting in a final case count of 466 cases mapping to
three MS-DRGs. Using a CCR of 0.343 (national other services average
CCR), the applicant then removed all charges in the drug cost center,
all charges in the blood cost center, and an additional $12,000 of cost
for plasma exchange procedural costs for cases with non-zero charges in
the blood cost center, for charges for related and prior technologies.
The applicant applied an inflation factor of 13.1%, which per the
applicant is the outlier charge inflation factor used in the FY 2021
IPPS/LTCH PPS final rule, to update the standardized charges from FY
2019 to FY 2021. We note that the applicant appears to have used the FY
2021 IPPS/LTCH PPS proposed rule inflation factor rather than the 2-
year inflation factor from the FY 2021 IPPS/LTCH PPS final rule of 13.2
percent (85 FR 59038), which would have increased the inflated charges.
Finally, the applicant added charges for the technology by multiplying
the cost of ENSPRYNG, based on an average of 1.22 doses per patient, by
the inverse of the national average drug CCR of 0.187 from the FY 2021
IPPS/LTCH PPS final rule (85 FR 58601). The applicant calculated a
final inflated average case-weighted standardized charge per case of
$150,154, which exceeds the case-weighted threshold of $47,813.
For the second analysis, the applicant used the same sample of
cases (466) from the first analysis, as identified in the FY 2019
MedPAR database with the ICD-10-CM code G36.0 and with the same sample
restrictions. In this analysis, the applicant did not remove charges
for related or prior technologies because, per the applicant, ENSPRYNG
is anticipated to neither replace plasma exchange nor be used as a
monotherapy in all patients. The applicant standardized and inflated
the charges, as well as added charges for ENSPRYNG using the same
methodology as the first analysis, described previously. The applicant
calculated a final inflated
[[Page 25254]]
average case-weighted standardized charge per case of $175,021, which
exceeded the case-weighted threshold of $47,813. The applicant asserted
that ENSPRYNG meets the cost criterion based on these analyses.
Based on the information provided by the applicant, it is uncertain
to us why the national other services average CCR was used to inflate
costs to charges in the first analysis when the applicant indicated
that it removed charges from the drugs cost center and blood cost
center. We are seeking public comment on whether this or another CCR,
such as a CCR for drugs or blood and blood products, would be more
appropriate. Furthermore, in the event that a MS-DRG has fewer than 11
cases, the applicant should impute a minimum case number of 11. We are
inviting public comments on whether ENSPRYNG meets the cost criterion,
including whether the use of another CCR would substantially alter the
results of the applicant's analysis.
With regard to the substantial clinical improvement criterion, the
applicant asserts that ENSPRYNG represents a substantial clinical
improvement in the following ways: (1) It significantly improves
clinical outcomes relative to services or technologies previously
available for the treatment of NMOSD in adult patients who are AQP4-IgG
positive; (2) these improvements are not accompanied by serious safety
concerns; (3) ENSPRYNG is the only FDA-approved treatment for NMOSD
that is subcutaneously administered; \233\ and (4) the totality of
circumstances demonstrates ENSPRYNG, relative to technologies
previously available, substantially improves the treatment of Medicare
beneficiaries. The applicant submitted two recent studies to support
their claims of substantial clinical improvement over existing
technologies.
---------------------------------------------------------------------------
\233\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
---------------------------------------------------------------------------
The SAkuraStar (NCT02073279) \234\ study was a Phase 3, double-
blind, placebo-controlled, parallel-group trial at 44 investigational
sites in 13 countries to assess the safety and efficacy of ENSPRYNG
monotherapy in patients with NMOSD. 95 (57%) of 168 screened
participants aged 18-74 years with AQP4-IgG positive or negative NMOSD
met the inclusion criteria and were randomly assigned (2:1) to
treatment with ENSPRYNG 120mg (n=63) or visually matched placebo
(n=32). Inclusion criteria included participants who had experienced at
least one documented NMOSD attack or relapse in the previous 12 months
and had a score of 6.5 or less on the Expanded Disability Status Scale,
while exclusion criteria included clinical relapse 30 days or fewer
before baseline. The primary endpoint was time to the first protocol-
defined relapse, based on the intention-to-treat (ITT) population
(AQP4-IgG positive and negative) (n=95), and analyzed with
stratification for two randomization factors (previous therapy for
prevention of attacks and nature of the most recent attack). Treatment
in both arms was given subcutaneously at weeks 0, 2, 4, and every 4
weeks thereafter. The double-blind phase was due to last until 44
protocol-defined relapses occurred or 1.5 years after random assignment
of the last patient enrolled, whichever occurred first. Participants
could enter an open-label phase after the occurrence of a protocol-
defined relapse or at the end of the double-blind phase. Protocol-
defined relapses occurred in 19 (30%) patients receiving satralizumab
and 16 (50%) receiving placebo (hazard ratio 0.45, 95% CI 0.23-0.89;
p=0.018). 473.9 adverse events per 100 patient-years occurred in the
satralizumab group and 495.2 per 100 patient-years in the placebo
group. The authors noted that the incidence of serious adverse events
and adverse events leading to withdrawal was similar between groups.
---------------------------------------------------------------------------
\234\ Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And
Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica
Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-
Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412.
doi:10.1016/S1474-4422(20)30078-8.
---------------------------------------------------------------------------
According to the applicant, this study demonstrated that the time
to the first relapse was significantly longer in ENSPRYNG-treated
patients compared with patients who received a placebo (risk reduction,
55%; hazard ratio, 0.45 (95% CI 0.23, 0.89); p = 0.0184). In the AQP4-
IgG positive population, there was a 74% risk reduction and a hazard
ratio of 0.26 (95% CI 0.11, 0.63; p = 0.0014). The results in the
subgroup of AQP4-IgG negative patients were not statistically
significant.235 236 The annualized relapse rate for AQP4-IgG
positive patients was 0.1 (95% CI, 0.05-0.2) in the ENSPRYNG group and
0.5 (95% CI, 0.3-0.9) in the placebo group.\237\ The proportion of
relapse-free AQP4-IgG positive patients at week 96 was 77% in the
ENSPRYNG group and 41% in the placebo group.\238\ According to the
applicant, the study concluded that ENSPRYNG monotherapy reduced the
rate of NMOSD relapse compared with placebo in the overall trial
population and had a favorable safety profile.
---------------------------------------------------------------------------
\235\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020. Traboulsee A, et al.
Efficacy of satralizumab monotherapy in prespecified subgroups of
SAkuraStar, a phase 3 study in patients with neuromyelitis optica
spectrum disorder. Oral Presentation at: Annual Americas Committee
for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum;
West Palm Beach, FL, USA; February 27-29, 2020.
\236\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020. Traboulsee A, et al.
Efficacy of satralizumab monotherapy in prespecified subgroups of
SAkuraStar, a phase 3 study in patients with neuromyelitis optica
spectrum disorder. Oral Presentation at: Annual Americas Committee
for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum;
West Palm Beach, FL, USA; February 27-29, 2020.
\237\ Traboulsee A, et al. Efficacy of satralizumab monotherapy
in prespecified subgroups of SAkuraStar, a phase 3 study in patients
with neuromyelitis optica spectrum disorder. Oral Presentation at:
Annual Americas Committee for Treatment and Research in Multiple
Sclerosis (ACTRIMS) Forum; West Palm Beach, FL, USA; February 27-29,
2020.
\238\ Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And
Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica
Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-
Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412.
doi:10.1016/S1474-4422(20)30078-8.
---------------------------------------------------------------------------
In the second Phase 3, randomized, double-blind, placebo controlled
study submitted by the applicant, the SAkuraSky (NCT02028884) \239\
trial, 83 patients with NMOSD who were seropositive or seronegative for
AQP4-IgG were randomly assigned (1:1) to receive either 120 mg of
satralizumab (n=41) or placebo (n=42) administered subcutaneously at
weeks 0, 2, and 4 and every 4 weeks thereafter, in addition to stable
IST. The primary end point was the first protocol-defined relapse in a
time-to-event analysis. Key secondary end points were the change from
baseline to week 24 in the visual-analogue scale (VAS) pain score
(range, 0 to 100, with higher scores indicating more pain) and the
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
score (range, 0 to 52, with lower scores indicating more fatigue).
Safety was also assessed.
---------------------------------------------------------------------------
\239\ US Department of Health and Human Services. Active Study
Neuromyelitis Optica Spectrum Disorder. https://clinicaltrials.gov/ct2/results?cond=&term=NCT02028884&cntry=&state=&city=&dist=. Accessed
August 14, 2020.
---------------------------------------------------------------------------
The results of the SAkuraSky trial demonstrated that the median
treatment duration with satralizumab in the double-blind period was
107.4 weeks. Relapse occurred in 8 patients (20%) receiving
satralizumab and in 18 (43%) receiving placebo (hazard ratio, 0.38; 95%
confidence interval [CI], 0.16 to 0.88). Multiple imputations for
censored data (including patients who discontinued the trial, received
rescue therapy, had a change in baseline treatment, or were continuing
in the
[[Page 25255]]
trial at the data-cutoff date) resulted in hazard ratios ranging from
0.34 to 0.44 (with corresponding P values of 0.01 to 0.04). Among the
55 AQP4-IgG-seropositive patients, relapse occurred in 11% of those in
the satralizumab group and in 43% of those in the placebo group (hazard
ratio, 0.21; 95% CI, 0.06 to 0.75); among 28 AQP4-IgG-seronegative
patients, relapse occurred in 36% and 43%, respectively (hazard ratio,
0.66; 95% CI, 0.20 to 2.24). The between-group difference in the change
in the mean VAS pain score was 4.08 (95% CI, -8.44 to 16.61); the
between-group difference in the change in the mean FACIT-F score was -
3.10 (95% CI, -8.38 to 2.18). The rates of serious adverse events and
infections did not differ between groups.
In support of the applicant's claim that ENSPRYNG significantly
improves clinical outcomes relative to services or technologies
previously available for the treatment of NMOSD in adult patients who
are AQP4-IgG positive, the applicant stated that patients treated with
ENSPRYNG plus IST exhibited a significantly longer time to first
relapse when compared to placebo. This also included a risk reduction
of 62% in patients treated with ENSPRYNG plus IST when compared with
patients who received a placebo plus IST and a 79% risk reduction in
the AQP4-IgG positive population. Results in the AQP4-IgG negative
patient subgroup were not statistically significant.\240\ The
proportion of relapse free AQP4-IgG positive patients at week 96 was
92% in ENSPRYNG plus IST group and 53% in the placebo plus IST
group.\241\
---------------------------------------------------------------------------
\240\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
\241\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
---------------------------------------------------------------------------
According to the applicant's second claim, substantial improvements
in clinical efficacy are not accompanied by serious concerns. In the
SAkuraSky trial, 90% of patients in the ENSPRYNG plus IST group had at
least one adverse event compared to 95% in the placebo plus IST
group.\242\ The safety profile of ENSPRYNG in the OST period was
consistent with the double-blind period. There were no deaths or
anaphylactic reactions, rates of AEs and serious AEs did not increase
with longer exposure to ENSPRYNG; and the most frequently reported AEs
in the OST period were consistent with the double-blind period.\243\
---------------------------------------------------------------------------
\242\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
\243\ Greenberg B, Seze JD, Fox E. et al. Safety of satralizumab
in neuromyelitis optica spectrum disorder (NMOSD): Results from the
open-label extension periods of SAkuraSky and SAkuraStar
Presentation at: Americas Committee for treatment and research in
Multiple Sclerosis (ACTRIMS); September 2020; Virtual.
---------------------------------------------------------------------------
The applicant's third claim concerns the flexibility provided to
patients by the option to self-administer ENSPRYNG. According to the
applicant, ENSPRYNG is the only FDA-approved treatment for NMOSD that
is administered subcutaneously.\244\ Once treatment is initiated during
inpatient hospital admission, upon discharge and having received
adequate training on how to perform the injection, an adult patient/
caregiver may administer all subsequent doses of ENSPRYNG at home if
the treating physician determines that it is appropriate and the adult
patient/caregiver can perform the injection technique. According to the
applicant, self-administration provides the patient the option to
continue the therapy initiated in the hospital while in the convenience
of their own home, with reduced disruption to daily life. The applicant
states that additionally, the option to self-administer provides
flexibility to patients, as they can bring their medication with them
while traveling without having to worry if there is an infusion site
nearby. The applicant claims this may potentially reduce the rate of
hospital readmissions.
---------------------------------------------------------------------------
\244\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
---------------------------------------------------------------------------
In their fourth claim, the applicant states the totality of
circumstances otherwise demonstrate that ENSPRYNG, relative to
technologies previously available, substantially improves the treatment
of Medicare beneficiaries. The applicant asserts that a cross trial
comparison between ENSPRYNG and SOLIRIS (approved for new technology
add-on payment in FY 2021) cannot be made due to differences in trial
design and study population. However, the applicant noted the following
distinctions between ENSPRYNG and SOLIRIS and their clinical trials.
Per the applicant, the first distinction is that in the registrational
study for SOLIRIS, a higher proportion of patients receiving SOLIRIS
than those receiving a placebo discontinued their participation in the
clinical trial (17% vs 6%).\245\ During the double-blind period of
SAkuraSky trial, however, a total of three patients (7%) in the
ENSPRYNG group and 10 patients (24%) in the placebo group discontinued
the trial agent.\246\ The applicant states that discontinuation of
SOLIRIS may be associated with relapse and hospitalization. The second
distinction made by the applicant is that the prescribing information
for ENSPRYNG \247\ does not bear a black-box warning, in contrast to
that of SOLIRIS.\248\ The third distinction is that patients must be
vaccinated against Neisseria meningitidis before receiving SOLIRIS
\249\ and no such requirement applies to ENSPRYNG.\250\ The fourth and
final distinction made by the applicant highlights duration of
treatment. In the SAkuraSky trial, the mean period of treatment in the
double-blind period was 94.172.6 weeks in the ENSPRYNG
group and 66.061.4 weeks in the placebo group.\251\
However, the median trial durations were shorter in the SOLIRIS trial,
at 90.93 and 43.14 weeks (minimum-maximum, 6.4-211.1 and 8.0-208.6) for
the SOLIRIS and placebo groups, respectively.\252\
---------------------------------------------------------------------------
\245\ Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in
Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N.
Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
\246\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
\247\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
\248\ SOLIRIS (eculizumab) [prescribing information]. Boston,
MA: Alexion Pharmaceuticals, Inc.; 2019.
\249\ SOLIRIS (eculizumab) [prescribing information]. Boston,
MA: Alexion Pharmaceuticals, Inc.; 2019.
\250\ ENSPRYNG (satralizumab) [prescribing information]. South
San Francisco, CA: Genentech USA, Inc.; 2020.
\251\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
\252\ Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in
Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N.
Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
---------------------------------------------------------------------------
In connection with the applicant's fourth claim to support
substantial clinical improvement, the applicant stated that both the
SAkuraStar \253\ and SAkuraSky \254\ clinical trials included
comparator arms. In SAkuraStar, an exclusion criterion was IST use,
whereas in SAkuraSky, patients were permitted to continue baseline
treatment with a stable dose of the IST agents in addition to the trial
drug. This allowed the efficacy of ENSPRYNG to be assessed both in
patients who were
[[Page 25256]]
receiving one of the IST agents for their NMOSD and in the others who
were receiving nothing at all. The applicant stated that in contrast,
SOLIRIS was tested only in a single Phase 3 clinical trial where the
primary end point was the first adjudicated relapse in the population
of patients taking stable-dose IST and either SOLIRIS or placebo; the
efficacy of SOLIRIS monotherapy was a sub analysis,\255\ and UPLIZNA
was tested only in a single Phase 3 clinical trial as a monotherapy
with only a 28-week randomized, controlled period.\256\ According to
the applicant, ENSPRYNG has received approval by regulatory authorities
in Japan,\257\ Canada, and Switzerland \258\ for the treatment of both
adults and adolescents (12-17 years of age) with NMOSD. The applicant
asserts that patients in the ENSPRYNG clinical trials likely are
representative of Medicare patients despite their mean ages (45.3 years
for the ENSPRYNG arm of SAkuraStar \259\ and 40.8 years for the
ENSPRYNG arm of SAkuraSky \260\) being less than 65, as NMOSD is so
severe that patients may qualify for disability accompanied by Medicare
benefits regardless of their age.\261\ The applicant explained that a
severe onset attack causing increased disability is reported to occur
in 45% of patients with NMOSD \262\ and that 52.4% of US-based NMOSD
patients report severe problems with mobility,\263\ which is consistent
with definitions of disability used by the Social Security
Administration (SSA).\264\ Per the applicant, SSA maintains a list of
impairments considered severe enough to prevent gainful activity.
Though NMOSD is not listed, multiple sclerosis (MS) is,\265\ and the
two conditions are frequently confused due to similarities between
clinical presentations.\266\ According to the applicant, the SSA is
open to allowing people to qualify for disability by showing their
condition is as severe as one that is on the list.\267\
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\253\ Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And
Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica
Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-
Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412.
doi:10.1016/S1474-4422(20)30078-8.
\254\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019; 381(22)2114-2124. doi:10.1056/nejmoa1901747.
\255\ Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in
Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N.
Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
\256\ Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the
treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a
double-blind, randomised placebo-controlled phase 2/3 trial. Lancet
2019;394(10206)1352-1363. doi:10.1016/s0140-6736(19)31817-3.
\257\ F. Hoffmann-La Roche Ltd. Roche's ENSPRYNG (satralizumab)
Approved In Japan For Adults And Children With Neuromyelitis Optica
Spectrum Disorder. https://www.roche.com/media/releases/med-cor-2020-06-29.htm. Accessed August 14, 2020.
\258\ Heo Y. Satralizumab: First Approval. Drugs
2020;80(14)1477-1482. doi:10.1007/s40265-020-01380-2.
\259\ Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And
Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica
Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-
Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412.
doi:10.1016/S1474-4422(20)30078-8.
\260\ Yamamura T, Kleiter I, Fujihara K, et al. Trial of
Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J.
Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
\261\ Social Security Administration. Medicare Information.
https://www.ssa.gov/disabilityresearch/wi/medicare.htm. Accessed
September 10, 2020.
\262\ Kim S, Mealy MA, Levy M, et al. Racial differences in
neuromyelitis optica spectrum disorder. Neurology 2018;91(22)e2089-
e2099. doi:10.1212/wnl.0000000000006574.
\263\ Mealy MA, Boscoe A, Caro J, et al. Assessment of Patients
with Neuromyelitis Optica Spectrum Disorder Using the EQ-5D. Int. J.
MS Care 2018; 21(3)129-134. doi:10.7224/1537-2073.2017-076.
\264\ Social Security Administration. How You Qualify. https://www.ssa.gov/benefits/disability/qualify.html. Accessed October 2,
2020.
\265\ Social Security Administration. Disability Evaluation
Under Social Security. https://www.ssa.gov/disability/professionals/bluebook/11.00-Neurological-Adult.htm#11_09. Accessed September 10,
2020.
\266\ Etemadifar M, Nasr Z, Khalili B, Taherioun M, Vosoughi R.
Epidemiology of Neuromyelitis Optica In The World: A Systematic
Review And Meta-Analysis. Mult Scler Int. 2015;2015:174720.
doi:10.1155/2015/174720.
\267\ Social Security Administration. How You Qualify. https://www.ssa.gov/benefits/disability/qualify.html. Accessed October 2,
2020.
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After reviewing the information submitted by the applicant as part
of its FY 2022 new technology add-on payment application for ENSPRYNG,
we note that while the applicant provided data comparing ENSPRYNG to
placebo with or without IST, the applicant did not provide data to
demonstrate improved outcomes over existing FDA approved treatments for
NMOSD. While the applicant states reasons why a comparison could not be
made, additional information would help inform our assessment of
whether ENSPRYNG demonstrates a significant clinical improvement over
existing technologies for outcomes such as time to first relapse and
annual relapse rate. In addition, while we understand that there may be
potential benefits related to the self-administrative delivery of
ENSPRYNG, we question if the benefits are related only to the
outpatient administration of the medication and whether they would
demonstrate improved clinical outcomes that represent a substantial
clinical improvement in the inpatient setting. We are inviting public
comments on whether ENSPRYNG meets the substantial clinical improvement
criterion.
We did not receive any written comments in response to the New
Technology Town Hall meeting notice published in the Federal Register
regarding the substantial clinical improvement criterion for ENSPRYNG.
h. ABECMA[supreg] (idecabtagene vicleucel)
Celgene Corporation, a wholly owned subsidiary of Bristol-Myers
Squibb (BMS), submitted an application for new technology add-on
payment for idecabtagene vicleucel for FY 2022. Idecabtagene viclecuel
is a, B-cell maturation antigen (BCMA)-directed genetically modified
autologous chimeric antigen receptor (CAR) T-cell immunotherapy for the
treatment of adult patients with relapsed or refractory (RR) multiple
myeloma (MM) (RRMM) who have received at least four prior therapies
including an immunomodulatory agent (IMiD), a proteasome inhibitor
(PI), and an anti-CD38 antibody (for example, triple-class-exposed).
Idecabtagene vicleucel is expected to be a 5th line plus (5L+)
treatment.
Multiple myeloma (MM) is typically characterized by the neoplastic
proliferation of plasma cells producing a monoclonal immunoglobulin.
The plasma cells proliferate in the bone marrow and can result in
extensive skeletal destruction with osteolytic lesions, osteopenia,
and/or pathologic fractures. The diagnosis of MM is often suspected
because of one (or more) of the following clinical presentations:
Bone pain with lytic lesions discovered on routine skeletal
films or other imaging modalities
An increased total serum protein concentration and/or the
presence of a monoclonal protein in the urine or serum
Systemic signs or symptoms suggestive of malignancy, such as
unexplained anemia
Hypercalcemia, which is either symptomatic or discovered
incidentally
Acute renal failure with a bland urinalysis or rarely
nephrotic syndrome due to concurrent immunoglobulin light chain (AL)
amyloidosis
It is important to distinguish MM both from other causes of these
clinical presentations and from other plasma cell dyscrasias for the
purposes of prognosis and treatment.\268\ Data from the U.S.
Surveillance, Epidemiology, and End Results (SEER) registry estimate
32,000 new cases of MM and
[[Page 25257]]
13,000 deaths from MM annually in the U.S. This correlates with an
annual incidence of approximately 7 per 100,000 men and women per year.
MM is largely a disease of older adults. The median age at diagnosis is
65 to 74 years. MM is also slightly more frequent in men than in women
(approximately 1.4:1). MM is associated with substantial morbidity and
mortality \269\ and approximately 25% of patients have a median
survival of 2 years or less.\270\ With respect to the newness
criterion, idecabtagene vicleucel received FDA approval on March 26,
2021, and has marketing authorization under the name of Abecma[supreg]
and is indicated for the treatment of adult patients with relapsed or
refractory multiple myeloma after four or more prior lines of therapy,
including an immunomodulatory agent, a proteasome inhibitor, and an
anti-CD38 monoclonal antibody. A single dose of idecabtagene vicleucel
contains a cell suspension of 300 to 460 x 106 CAR T-cells.
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\268\ Laubauch, J.P. (2021). Multiple myeloma: Clinical
features, laboratory manifestations, and diagnosis. UptoDate.
Available from https://www.uptodate.com/contents/multiple-myeloma-clinical-features-laboratory-manifestations-and-diagnosis?search=multiple%20myeloma&;source=search_result&selectedTit
le=1~150&usage_type=default&display_rank=1.
\269\ R?owan AJ, Allen C, Barac A, et al. Global Burden of
Multiple Myeloma: A Systematic Analysis for the Global Burden of
Disease Study 2016. JAMA Oncol. 2018;4(9):1221-1227. doi:10.1001/
jamaoncol.2018.2128.
\270\ Biran, N., Jagannath, S., Risk Stratification in Multiple
Myeloma, Part 1: Characterization of High-Risk Disease 2013.
Clinical Adv in Hematology & Oncology 11(8); 489-503.
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The applicant submitted a request for unique ICD-10-PCS codes that
describe the administration of idecabtagene vicleducel at the September
2020 Coordination and Maintenance Committee meeting. The following
codes were approved to describe procedures involving the administration
of idecabtagene vicleucel: XW033L7 (Introduction of idecabtagene
vicleucel immunotherapy into peripheral vein, percutaneous approach,
new technology group 7) and XW043L7 (Introduction of idecabtagene
vicleucel immunotherapy into central vein, percutaneous approach, new
technology group 7). These codes will be effective starting October 1,
2021.
As previously stated, if a technology meets all three of the
substantial similarity criteria as previously described, 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 respect to whether a product uses the same or a similar
mechanism of action when compared to an existing technology to achieve
a therapeutic outcome, the applicant asserts that idecabtagene
viceleucel does not use the same or similar mechanism of action as
other therapies approved to treat 4L+ RRMM or CAR T-cell therapies
approved to treat different diseases. According to the applicant, with
regard to its mechanism of action, idecabtagene viceleucel is a
chimeric antigen receptor (CAR)-positive T cell therapy targeting B-
cell maturation antigen (BCMA), which is expressed on the surface of
normal and malignant plasma cells. The CAR construct includes an anti-
BCMA scFv-targeting domain for antigen specificity, a transmembrane
domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory
domain. Antigen-specific activation of idecabtagene viceleucel results
in CAR-positive T cell proliferation, cytokine secretion, and
subsequent cytolytic killing of BCMA-expressing cells.
According to the applicant, with respect to the non-CAR T-cell
therapies to treat 4L+ RRMM, specifically Xpovio[supreg], Blenrep, and
chemotherapy, idecabtagene vicleucel's mechanism of action is different
because it is a CAR T-cell therapy. The applicant states that the
mechanism of action for Xpovio[supreg] is reversible inhibition of
nuclear export of tumor suppressor proteins (TSPs), growth regulators,
and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1
inhibition by Xpovio[supreg] leads to accumulation of TSPs in the
nucleus, reductions in several oncoproteins, such as c-myc (a ``master
regulator'' which controls many aspects of cellular growth regulation
and cellular metabolism) and cyclin D1, cell cycle arrest, and
apoptosis of cancer cells. The applicant states that Blenrep's
mechanism of action is cell destruction via microtubule inhibition,
where the microtubule inhibitor is conjugated to a BCMA-specific
antibody (antibody-drug conjugate). The applicant further states that
the mechanism of action for chemotherapy regimens generally is
disruption of normal processes required for cell survival, such as
deoxyribonucleic acid (DNA) replication and protein synthesis or
degradation.
With respect to the mechanism of action of other currently FDA
approved CAR T-cell therapies, according to the applicant, there are no
other FDA approved CAR T-cell therapies that are indicated for
treatment of RRMM with the same or similar mechanism of action as
idecabtagene vicleucel. The applicant stated that CAR T-cell therapies
employ a unique mechanism of action which modifies the patient's own T-
cell to express a chimeric antigen receptor (CAR) that programs T-cells
to destroy cells that express a specific target. In the case of
idecabtagene vicleucel, this target is BCMA, which is a protein that is
highly expressed on the surface of MM cells making it an ideal target
for the treatment of MM. The applicant asserts that the key feature
that distinguishes idecabtagene vicleucel from CD-19 directed CAR T-
cell therapies is the BCMA targeting domain. According to the
applicant, idecabtagene vicleucel's BCMA targeting domain means that
idecabtagene vicleucel has a completely different mechanism of action
from other currently FDA approved CAR T-cell therapies. In its
application, the applicant asserted that since there are currently no
FDA approved anti-BCMA CAR T-cell therapies, if approved, idecabtagene
vicleucel is the first CAR T-cell therapy approved for the treatment of
RRMM and the only approved CAR T-cell therapy with a BCMA targeting
domain which makes it unique as compared to other currently approved
FDA therapies used to treat RRMM.
With regard to whether a product is assigned to the same DRG when
compared to an existing technology, the applicant stated that it
expects that cases involving the administration idecabtagene vicleucel
will be assigned to the same MS-DRG, MS-DRG 018 (Chimeric Antigen
Receptor (CAR) T-cell Immunotherapy), as other CAR T-cell therapies.
With regard to 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 when compared to an existing technology, the
applicant asserted that, if FDA approved, idecabtagene vicleucel will
be the first and only anti-BCMA CAR T-cell therapy available to treat
RRMM. The applicant further asserted that idecabtagene vicleucel would
be indicated for a broader population than other currently FDA-approved
available therapies, specifically multiple myeloma patients having
received four prior therapies.
In summary, according to the applicant, because idecabtagene
vicleucel has a unique mechanism of action when compared to other
currently FDA approved treatments for RRMM, and does not involve the
treatment of the same or similar type of disease (RRMM) or the same or
similar patient population (triple-class-exposed adult patients with
RRMM), the technology is not substantially similar to an existing
technology and therefore meets the newness criterion. However, we
question whether idecabtagnene vicleucel's mechanism of action may be
similar to that of ciltacabtagene autoleucel, another CAR T-cell
therapy for which an application for new technology add-on payments was
[[Page 25258]]
submitted for FY 2022 as discussed previously. Both idecabtagene
vicleucel and ciltacabtagene autoleucel seem to be intended for similar
patient populations; multiple myeloma patients with three or more prior
therapies, and would involve the treatment of the same conditions;
adult patients with relapsed or refractory multiple myeloma. We are
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 idecabtagene
vicleucel and ciltacabtagne autoleucel, if approved by July 1, 2021,
are substantially similar to each other and therefore should be
considered as a single application for purposes of new technology add-
on payments.
We are inviting public comments on whether idecabtagene vicleucel
is substantially similar to an existing technology and whether it meets
the newness criterion.
With regard to the cost criterion, the applicant searched the FY
2019 MedPAR correction notice (December 1, 2020) file to identify
potential cases representing patients who may be eligible for treatment
using idecabtagene vicleucel. In its analysis, the applicant identified
a primary cohort to assess whether this therapy met the cost criterion.
The following ICD-10-CM diagnosis codes were used to identify claims
involving multiple myeloma procedures.
[GRAPHIC] [TIFF OMITTED] TP10MY21.153
The applicant chose to limit its analysis to MS-DRG 016 (Autologous
Bone Marrow Transplant W CC/MCC or T-Cell Immunotherapy, MS-DRG 840
(Lymphoma & Non-Acute Leukemia W MCC) and MS-DRG 841 (Lymphoma & Non-
Acute Leukemia W CC). The claim search conducted by the applicant
resulted in 1,955 claims mapped to MS-DRG 016, MS-DRG 840 and MS-DRG
841 using the FY 2019 MedPAR. The applicant determined an average
unstandardized case weighted charge per case of $1,237,393. The
applicant used the MS-DRG-018 New Technology Threshold for FY 2022 from
the FY 2021 IPPS/LTCH PPS final rule.
The applicant removed all charges in the drug cost center for the
prior technology because, according to the applicant, it is not
possible to differentiate between different drugs on inpatient claims.
The applicant added that this is likely an overestimate of the charges
that would be replaced by the use of idecabtagene vicleucel. The
applicant then standardized the charges using the FY 2019 final rule
impact file. Next, the applicant applied the 2-year inflation factor
used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier
threshold charges (1.13218). To calculate the charges for the new
technology, the applicant used a national average CCR for the CAR T-
cell therapies of 0.295. To determine this alternative CCR for CAR T-
cell therapies, the applicant referred to the FY 2021 IPPS/LTCH PPS
final rule AOR/BOR file and calculated an alternative markup percentage
by dividing the AOR drug charges within DRG 018 by the number of cases
to determine a per case drug charge. The applicant then divided the
drug charges per case by $373,000, the acquisition cost of YESCARTA and
KYMRIAH. The applicant calculated a final inflated average case