Justia Regulation Tracker Department Of Health And Human Services Centers For Medicare & Medicaid Services 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 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims, 20164-20643 [2018-08705]
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 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims, 20164-20643 [2018-08705] Download as PDF
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 412, 413, 424, and 495
[CMS–1694–P]
RIN 0938–AT27
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 2019 Rates;
Proposed Quality Reporting
Requirements for Specific Providers;
Proposed Medicare and Medicaid
Electronic Health Record (EHR)
Incentive Programs (Promoting
Interoperability Programs)
Requirements for Eligible Hospitals,
Critical Access Hospitals, and Eligible
Professionals; Medicare Cost
Reporting Requirements; and
Physician Certification and
Recertification of Claims
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
We are proposing to revise the
Medicare hospital inpatient prospective
payment systems (IPPS) for operating
and capital-related costs of acute care
hospitals to implement changes arising
from our continuing experience with
these systems for FY 2019. Some of
these proposed changes implement
certain statutory provisions contained in
the 21st Century Cures Act and the
Bipartisan Budget Act of 2018, and
other legislation. We also are proposing
to make changes relating to Medicare
graduate medical education (GME)
affiliation agreements for new urban
teaching hospitals. In addition, we are
proposing to 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 2019. We
are proposing to update the payment
policies and the annual payment rates
for the Medicare prospective payment
system (PPS) for inpatient hospital
services provided by long-term care
hospitals (LTCHs) for FY 2019.
In addition, we are proposing to
establish new requirements or revise
existing requirements for quality
reporting by specific Medicare providers
(acute care hospitals, PPS-exempt
cancer hospitals, and LTCHs). We also
are proposing to establish new
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requirements or revise existing
requirements for eligible professionals
(EPs), eligible hospitals, and critical
access hospitals (CAHs) participating in
the Medicare and Medicaid Electronic
Health Record (EHR) Incentive Programs
(now referred to as the Promoting
Interoperability Programs). In addition,
we are proposing changes to the
requirements that apply to States
operating Medicaid Promoting
Interoperability Prrograms. We are
proposing to update policies for the
Hospital Value-Based Purchasing (VBP)
Program, the Hospital Readmissions
Reduction Program, and the HospitalAcquired Condition (HAC) Reduction
Program.
We also are proposing to make
changes relating to the required
supporting documentation for an
acceptable Medicare cost report
submission and the supporting
information for physician certification
and recertification of claims.
DATES: Comment Period: To be assured
consideration, comments must be
received at one of the addresses
provided in the ADDRESSES section, no
later than 5 p.m. on June 25, 2018.
ADDRESSES: In commenting, please refer
to file code CMS–1694–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 submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
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–1694–P, P.O. Box 8011, 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 to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1694–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,
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Operating Prospective Payment, MS–
DRGs, Wage Index, New Medical
Service and Technology Add-On
Payments, Hospital Geographic
Reclassifications, Graduate Medical
Education, Capital Prospective Payment,
Excluded Hospitals, Sole Community
Hospitals, Medicare Disproportionate
Share Hospital (DSH) Payment
Adjustment, Medicare-Dependent Small
Rural Hospital (MDH) Program, and
Low-Volume Hospital Payment
Adjustment Issues.
Michele Hudson, (410) 786–4487,
Mark Luxton, (410) 786–4530, and
Emily Lipkin, (410) 786–3633,
Long-Term Care Hospital Prospective
Payment System and MS–LTC–DRG
Relative Weights Issues.
Siddhartha Mazumdar, (410) 786–
6673, Rural Community Hospital
Demonstration Program Issues.
Jeris Smith, (410) 786–0110, Frontier
Community Health Integration Project
Demonstration Issues.
Cindy Tourison, (410) 786–1093,
Hospital Readmissions Reduction
Program—Readmission Measures for
Hospitals Issues.
James Poyer, (410) 786–2261, Hospital
Readmissions Reduction Program—
Administration Issues.
Elizabeth Bainger, (410) 786–0529,
Hospital-Acquired Condition Reduction
Program Issues.
Joseph Clift, (410) 786–4165,
Hospital-Acquired Condition Reduction
Program—Measures Issues.
Grace Snyder, (410) 786–0700 and
James Poyer, (410) 786–2261, Hospital
Inpatient Quality Reporting and
Hospital Value-Based Purchasing—
Program Administration, Validation,
and Reconsideration Issues.
Reena Duseja, (410) 786–1999 and
Cindy Tourison, (410) 786–1093,
Hospital Inpatient Quality Reporting—
Measures Issues Except Hospital
Consumer Assessment of Healthcare
Providers and Systems Issues; and
Readmission Measures for Hospitals
Issues.
Kim Spalding Bush, (410) 786–3232,
Hospital Value-Based Purchasing
Efficiency Measures Issues.
Elizabeth Goldstein, (410) 786–6665,
Hospital Inpatient Quality Reporting—
Hospital Consumer Assessment of
Healthcare Providers and Systems
Measures Issues.
Joel Andress, (410) 786–5237 and
Caitlin Cromer, (410) 786–3106, PPSExempt Cancer Hospital Quality
Reporting Issues.
Mary Pratt, (410) 786–6867, LongTerm Care Hospital Quality Data
Reporting Issues.
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
Elizabeth Holland, (410) 786-1309,
Promoting Interoperability Programs
Clinical Quality Measure Related Issues.
Kathleen Johnson, (410) 786–3295
and Steven Johnson (410) 786–3332,
Promoting Interoperability Programs
Nonclinical Quality Measure Related
Issues.
Kellie Shannon, (410) 786–0416,
Acceptable Medicare Cost Report
Submissions Issues.
Thomas Kessler, (410) 786–1991,
Physician Certification and
Recertification of Claims.
SUPPLEMENTARY INFORMATION:
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: https://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
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Electronic Access
This Federal Register document is
available from the Federal Register
online database through Federal Digital
System (FDsys), a service of the U.S.
Government Printing Office. This
database can be accessed via the
Internet at: https://www.gpo.gov/fdsys.
Tables Available Only Through the
Internet on the CMS Website
In the past, a majority of the tables
referred to throughout this preamble
and in the Addendum to the proposed
rule and the final rule were published
in the Federal Register as part of the
annual proposed and final rules.
However, beginning in FY 2012, the
majority of the IPPS tables and LTCH
PPS tables are no longer published in
the Federal Register. Instead, these
tables generally will be available only
through the Internet. The IPPS tables for
this proposed rule are available through
the Internet on the CMS website at:
https://www.cms.hhs.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/. Click on
the link on the left side of the screen
titled, ‘‘FY 2019 IPPS Proposed Rule
Home Page’’ or ‘‘Acute Inpatient—Files
for Download’’. The LTCH PPS tables
for this FY 2019 proposed rule are
available through the Internet on the
CMS website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/LongTermCareHospitalPPS/
index.html under the list item for
Regulation Number CMS–1694–P. For
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further details on the contents of the
tables referenced in this proposed rule,
we refer readers to section VI. of the
Addendum to this proposed rule.
Readers who experience any problems
accessing any of the tables that are
posted on the CMS websites identified
above should contact Michael Treitel at
(410) 786–4552.
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background Summary
C. Summary of Provisions of Recent
Legislation Proposed To Be Implemented
in This Proposed Rule
D. Summary of Provisions of This
Proposed Rule
II. Proposed Changes to Medicare Severity
Diagnosis-Related Group (MS–DRG)
Classifications and Relative Weights
A. Background
B. MS–DRG Reclassifications
C. Adoption of the MS–DRGs in FY 2008
D. Proposed FY 2019 MS–DRG
Documentation and Coding Adjustment
E. Refinement of the MS–DRG Relative
Weight Calculation
F. Proposed Changes to Specific MS–DRG
Classifications
G. Recalibration of the Proposed FY 2019
MS–DRG Relative Weights
H. Proposed Add-On Payments for New
Services and Technologies for FY 2019
III. Proposed Changes to the Hospital Wage
Index for Acute Care Hospitals
A. Background
B. Worksheet S–3 Wage Data for the
Proposed FY 2019 Wage Index
C. Verification of Worksheet S–3 Wage
Data
D. Method for Computing the Proposed FY
2019 Unadjusted Wage Index
E. Proposed Occupational Mix Adjustment
to the FY 2019 Wage Index
F. Analysis and Implementation of the
Proposed Occupational Mix Adjustment
and the Proposed FY 2019 Occupational
Mix Adjusted Wage Index
G. Proposed Application of the Rural,
Imputed, and Frontier Floors
H. Proposed FY 2019 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 and
Proposed Change to Lock-In Date
L. Process for Requests for Wage Index
Data Corrections
M. Proposed Labor-Related Share for the
Proposed FY 2019 Wage Index
N. Request for Public Comments on Wage
Index Disparities
IV. Other Decisions and Proposed Changes to
the IPPS for Operating System
A. Proposed Changes to MS–DRGs Subject
to Postacute Care Transfer Policy and
MS-DRG Special Payment Policies
(§ 412.4)
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B. Proposed Changes in the Inpatient
Hospital Updates for FY 2019
(§ 412.64(d))
C. Rural Referral Centers (RRCs) Proposed
Annual Updates to Case-Mix Index and
Discharge Criteria (§ 412.96)
D. Proposed Payment Adjustment for LowVolume Hospitals (§ 412.101)
E. Indirect Medical Education (IME)
Payment Adjustment Factor (§ 412.105)
F. Proposed Payment Adjustment for
Medicare Disproportionate Share
Hospitals (DSHs) for FY 2019 (§ 412.106)
G. Sole Community Hospitals (SCHs) and
Medicare-Dependent, Small Rural
Hospitals (MDHs) (§§ 412.90, 412.92, and
412.108)
H. Hospital Readmissions Reduction
Program: Proposed Updates and Changes
(§§ 412.150 Through 412.154)
I. Hospital Value-Based Purchasing (VBP)
Program: Proposed Policy Changes
J. Hospital-Acquired Condition (HAC)
Reduction Program
K. Payments for Indirect and Direct
Graduate Medical Education Costs
(§§ 412.105 and 413.75 Through 413.83)
L. Rural Community Hospital
Demonstration Program
M. Proposed Revision of Hospital Inpatient
Admission Orders Documentation
Requirements Under Medicare Part A
V. Proposed Changes to the IPPS for CapitalRelated Costs
A. Overview
B. Additional Provisions
C. Proposed Annual Update for FY 2019
VI. Proposed Changes for Hospitals Excluded
From the IPPS
A. Proposed Rate-of-Increase in Payments
to Excluded Hospitals for FY 2019
B. Proposed Changes to Regulations
Governing Satellite Facilities
C. Proposed Changes to Regulations
Governing Excluded Units of Hospitals
D. Critical Access Hospitals (CAHs)
VII. Proposed Changes to the Long-Term Care
Hospital Prospective Payment System
(LTCH PPS) for FY 2019
A. Background of the LTCH PPS
B. Proposed Medicare Severity Long-Term
Care Diagnosis-Related Group (MS–LTC–
DRG) Classifications and Relative
Weights for FY 2019
C. Proposed Modifications to the
Application of the Site Neutral Payment
Rate (§ 412.522)
D. Proposed Changes to the LTCH PPS
Payment Rates and Other Proposed
Changes to the LTCH PPS for FY 2019
E. Proposed Elimination of the ‘‘25-Percent
Threshold Policy’’ Adjustment
(§ 412.538)
VIII. Quality Data Reporting Requirements for
Specific Providers and Suppliers
A. Hospital Inpatient Quality Reporting
(IQR) Program
B. PPS-Exempt Cancer Hospital Quality
Reporting (PCHQR) Program
C. Long-Term Care Hospital Quality
Reporting Program (LTCH QRP)
D. Proposed Changes to the Medicare and
Medicaid EHR Incentive Programs (Now
Referred to as the Medicare and
Medicaid Promoting Interoperability
Programs)
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IX. Proposed Revisions of the Supporting
Documentation Required for Submission
of an Acceptable Medicare Cost Report
X. Requirements for Hospitals To Make
Public a List of Their Standard Charges
via the Internet
XI. Proposed Revisions Regarding Physician
Certification and Recertification of
Claims
XII. Request for Information on Promoting
Interoperability and Electronic
Healthcare Information Exchange
Through Possible Revisions to the CMS
Patient Health and Safety Requirements
for Hospitals and Other Medicare- and
Medicaid-Participating Providers and
Suppliers
XIII. MedPAC Recommendations
XIV. Other Required Information
A. Publicly Available Data
B. Collection of Information Requirements
C. Response to Public Comments
Regulation Text
Addendum—Proposed Schedule of Proposed
Standardized Amounts, Update Factors,
Rate-of-Increase Percentages Effective
With Cost Reporting Periods Beginning
on or After October 1, 2018, and
Payment Rates for LTCHs Effective for
Discharges Occurring on or After October
1, 2018
I. Summary and Background
II. Proposed Changes to the Prospective
Payment Rates for Hospital Inpatient
Operating Costs for Acute Care Hospitals
for FY 2019
A. Calculation of the Adjusted
Standardized Amount
B. Proposed Adjustments for Area Wage
Levels and Cost-of-Living
C. Calculation of the Prospective Payment
Rates
III. Proposed Changes to Payment Rates for
Acute Care Hospital Inpatient
Capital-Related Costs for FY 2019
A. Determination of Federal Hospital
Inpatient Capital-Related Prospective
Payment Rate Update for FY 2019
B. Calculation of the Inpatient
Capital-Related Prospective Payments for
FY 2019
C. Capital Input Price Index
IV. Proposed Changes to Payment Rates for
Excluded Hospitals: Rate-of-Increase
Percentages for FY 2019
V. Proposed Changes to the Payment Rates
for the LTCH PPS for FY 2019
A. Proposed LTCH PPS Standard Federal
Payment Rate for FY 2019
B. Proposed Adjustment for Area Wage
Levels Under the LTCH PPS for FY 2019
C. Proposed LTCH PPS Cost-of-Living
Adjustment (COLA) for LTCHs Located
in Alaska and Hawaii
D. Proposed Adjustment for LTCH PPS
High-Cost Outlier (HCO) Cases
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 2019
VI. Tables Referenced in This Proposed Rule
Generally Available Only Through the
Internet on the CMS Website
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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 Proposed
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
Programs
O. Alternatives Considered
P. Reducing Regulation and Controlling
Regulatory Costs
Q. Overall Conclusion
R. Regulatory Review Costs
II. Accounting Statements and Tables
A. Acute Care Hospitals
B. LTCHs
III. Regulatory Flexibility Act (RFA) Analysis
IV. Impact on Small Rural Hospitals
V. Unfunded Mandate Reform Act (UMRA)
Analysis
VI. Executive Order 13175
VII. Executive Order 12866
Appendix B—Recommendation of Update
Factors for Operating Cost Rates of
Payment for Inpatient Hospital Services
I. Background
II. Inpatient Hospital Update for FY 2019
A. Proposed FY 2019 Inpatient Hospital
Update
B. Proposed Update for SCHs and MDHs
for FY 2019
C. Proposed FY 2019 Puerto Rico Hospital
Update
D. Proposed Update for Hospitals Excluded
From the IPPS for FY 2019
E. Proposed Update for LTCHs for FY 2019
III. Secretary’s Recommendation
IV. MedPAC Recommendation for Assessing
Payment Adequacy and Updating
Payments in Traditional Medicare
I. Executive Summary and Background
A. Executive Summary
1. Purpose and Legal Authority
This 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
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hospitals as well as for certain hospitals
and hospital units excluded from the
IPPS. In addition, it would make
payment and policy changes for
inpatient hospital services provided by
long-term care hospitals (LTCHs) under
the long-term care hospital prospective
payment system (LTCH PPS). This
proposed rule also would make policy
changes to programs associated with
Medicare IPPS hospitals, IPPS-excluded
hospitals, and LTCHs.
We are proposing to establish new
requirements and revise existing
requirements for quality reporting by
specific providers (acute care hospitals,
PPS-exempt cancer hospitals, and
LTCHs) that are participating in
Medicare. We also are proposing to
establish new requirements and revise
existing requirements for eligible
professionals (EPs), eligible hospitals,
and CAHs participating in the Medicare
and Medicaid Promoting
Interoperability Programs. We are
proposing to update policies for the
Hospital Value-Based Purchasing (VBP)
Program, the Hospital Readmissions
Reduction Program, and the HospitalAcquired Condition (HAC) Reduction
Program.
We also are proposing to make
changes relating to the supporting
documentation required for an
acceptable Medicare cost report
submission and the supporting
information for physician certification
and recertification of claims.
Under various statutory authorities,
we are proposing to make changes to the
Medicare IPPS, to the LTCH PPS, and to
other related payment methodologies
and programs for FY 2019 and
subsequent fiscal years. These statutory
authorities include, but are not limited
to, the following:
• Section 1886(d) of the Social
Security Act (the Act), which sets forth
a system of payment for the operating
costs of acute care hospital inpatient
stays under Medicare Part A (Hospital
Insurance) based on prospectively set
rates. Section 1886(g) of the Act requires
that, instead of paying for capital-related
costs of inpatient hospital services on a
reasonable cost basis, the Secretary use
a prospective payment system (PPS).
• Section 1886(d)(1)(B) of the Act,
which specifies that certain hospitals
and hospital units are excluded from the
IPPS. These hospitals and units are:
Rehabilitation hospitals and units;
LTCHs; psychiatric hospitals and units;
children’s hospitals; cancer hospitals;
extended neoplastic disease care
hospitals, and hospitals located outside
the 50 States, the District of Columbia,
and Puerto Rico (that is, hospitals
located in the U.S. Virgin Islands,
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Guam, the Northern Mariana Islands,
and American Samoa). Religious
nonmedical health care institutions
(RNHCIs) are also excluded from the
IPPS.
• Sections 123(a) and (c) of the BBRA
(Pub. L. 106-113) and section 307(b)(1)
of the BIPA (Pub. L. 106-554) (as
codified under section 1886(m)(1) of the
Act), which provide for the
development and implementation of a
prospective payment system for
payment for inpatient hospital services
of LTCHs described in section
1886(d)(1)(B)(iv) of the Act.
• Sections 1814(l), 1820, and 1834(g)
of the Act, which specify that payments
are made to critical access hospitals
(CAHs) (that is, rural hospitals or
facilities that meet certain statutory
requirements) for inpatient and
outpatient services and that these
payments are generally based on 101
percent of reasonable cost.
• Section 1866(k) of the Act, as added
by section 3005 of the Affordable Care
Act, which establishes a quality
reporting program for hospitals
described in section 1886(d)(1)(B)(v) of
the Act, referred to as ‘‘PPS-exempt
cancer hospitals.’’
• Section 1886(a)(4) of the Act, which
specifies that costs of approved
educational activities are excluded from
the operating costs of inpatient hospital
services. Hospitals with approved
graduate medical education (GME)
programs are paid for the direct costs of
GME in accordance with section 1886(h)
of the Act.
• Section 1886(b)(3)(B)(viii) of the
Act, which requires the Secretary to
reduce the applicable percentage
increase that would otherwise apply to
the standardized amount applicable to a
subsection (d) hospital for discharges
occurring in a fiscal year if the hospital
does not submit data on measures in a
form and manner, and at a time,
specified by the Secretary.
• Section 1886(o) of the Act, which
requires the Secretary to establish a
Hospital Value-Based Purchasing (VBP)
Program under which value-based
incentive payments are made in a fiscal
year to hospitals meeting performance
standards established for a performance
period for such fiscal year.
• Section 1886(p) of the Act, as added
by section 3008 of the Affordable Care
Act, which establishes a HospitalAcquired Condition (HAC) Reduction
Program, under which payments to
applicable hospitals are adjusted to
provide an incentive to reduce hospitalacquired conditions.
• Section 1886(q) of the Act, as added
by section 3025 of the Affordable Care
Act and amended by section 10309 of
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the Affordable Care Act and 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’’ under section 1886(d) of the
Act will be reduced to account for
certain excess readmissions. Section
15002 of the 21st Century Cures Act
requires the Secretary to compare
cohorts of hospitals to each other in
determining the extent of excess
readmissions.
• Section 1886(r) of the Act, as added
by section 3133 of the Affordable Care
Act, which provides for a reduction to
disproportionate share hospital (DSH)
payments under section 1886(d)(5)(F) of
the Act and for a new uncompensated
care payment to eligible hospitals.
Specifically, section 1886(r) of the Act
requires that, for fiscal year 2014 and
each subsequent fiscal year, subsection
(d) hospitals that would otherwise
receive a DSH payment made under
section 1886(d)(5)(F) of the Act will
receive two separate payments: (1) 25
percent of the amount they previously
would have received under section
1886(d)(5)(F) of the Act for DSH (‘‘the
empirically justified amount’’), and (2)
an additional payment for the DSH
hospital’s proportion of uncompensated
care, determined as the product of three
factors. These three factors are: (1) 75
percent of the payments that would
otherwise be made under section
1886(d)(5)(F) of the Act; (2) 1 minus the
percent change in the percent of
individuals who are uninsured (minus
0.2 percentage point for FY 2018
through FY 2019); and (3) a hospital’s
uncompensated care amount relative to
the uncompensated care amount of all
DSH hospitals expressed as a
percentage.
• Section 1886(m)(6) of the Act, as
added by section 1206(c) of the Pathway
for Sustainable Growth Rate (SGR)
Reform Act of 2013 (Pub. L. 113–67) and
amended by section 51005(a) of the
Bipartisan Budget Act of 2018 (Pub. L.
115–123), which provided for the
establishment of site neutral payment
rate criteria under the LTCH PPS with
implementation beginning in FY 2016,
and provides for a 4-year transitional
blended payment rate for discharges
occurring in LTCH cost reporting
periods beginning in FYs 2016 through
2019. Section 51005(b) of the Bipartisan
Budget Act of 2018 amended section
1886(m)(6)(B)(ii) by adding new clause
(iv), which specifies that the IPPS
comparable amount defined in
subclause (I) shall be reduced by 4.6
percent for FYs 2018 through 2026.
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• Section 1886(m)(6) of the Act, as
amended by section 15009 of the 21st
Century Cures Act (Pub. L. 114–255),
which provides for a temporary
exception to the application of the site
neutral payment rate under the LTCH
PPS for certain spinal cord specialty
hospitals for discharges in cost reporting
periods beginning during FYs 2018 and
2019.
• Section 1886(m)(6) of the Act, as
amended by section 15010 of the 21st
Century Cures Act (Pub. L. 114–255),
which provides for a temporary
exception to the application of the site
neutral payment rate under the LTCH
PPS for certain LTCHs with certain
discharges with severe wounds
occurring in cost reporting periods
beginning during FY 2018.
• Section 1886(m)(5)(D)(iv) of the
Act, as added by section 1206(c) of the
Pathway for Sustainable Growth Rate
(SGR) Reform Act of 2013 (Pub. L. 113–
67), which provides for the
establishment of a functional status
quality measure in the LTCH QRP for
change in mobility among inpatients
requiring ventilator support.
• Section 1899B of the Act, as added
by section 2(a) of the Improving
Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT
Act, Pub. L. 113–185), which provides
for the establishment of standardized
data reporting for certain post-acute care
providers, including LTCHs.
2. Improving Patient Outcomes and
Reducing Burden Through Meaningful
Measures
Regulatory reform and reducing
regulatory burden are high priorities for
CMS. To reduce the regulatory burden
on the healthcare industry, lower health
care costs, and enhance patient care, in
October 2017, we launched the
Meaningful Measures Initiative.1 This
initiative is one component of our
agency-wide Patients Over Paperwork
Initiative,2 which is aimed at evaluating
and streamlining regulations with a goal
to reduce unnecessary cost and burden,
increase efficiencies, and improve
beneficiary experience. The Meaningful
Measures Initiative is aimed at
identifying the highest priority areas for
quality measurement and quality
improvement in order to assess the core
quality of care issues that are most vital
1 Meaningful Measures webpage: https://
www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/QualityInitiativesGenInfo/
MMF/General-info-Sub-Page.html.
2 Remarks by Administrator Seema Verma at the
Health Care Payment Learning and Action Network
(LAN) Fall Summit, as prepared for delivery on
October 30, 2017. Available at: https://
www.cms.gov/Newsroom/MediaReleaseDatabase/
Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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to advancing our work to improve
patient outcomes. The Meaningful
Measures Initiative represents a new
approach to quality measures that will
foster operational efficiencies and will
reduce costs, including collection and
reporting burden while producing
quality measurement that is more
focused on meaningful outcomes.
The Meaningful Measures framework
has the following objectives:
• Address high-impact measure areas
that safeguard public health;
• Patient-centered and meaningful to
patients;
• Outcome-based where possible;
• Fulfill each program’s statutory
requirements;
• Minimize the level of burden for
health care providers (for example,
through a preference for EHR-based
measures where possible, such as
electronic clinical quality measures; 3
Quality priority
Meaningful measure area
Making Care Safer by Reducing Harm Caused in the Delivery of Care
Strengthen Person and Family Engagement as Partners in Their Care
Promote Effective Communication and Coordination of Care .................
Promote Effective Prevention and Treatment of Chronic Disease ..........
Work with Communities to Promote Best Practices of Healthy Living ....
Make Care Affordable ..............................................................................
By including Meaningful Measures in
our programs, we believe that we can
also address the following cross-cutting
measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and
impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural
communities; and
• Reducing burden.
We believe that the Meaningful
Measures Initiative will improve
outcomes for patients, their families,
and health care providers while
reducing burden and costs for clinicians
and providers as well as promoting
operational efficiencies.
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• Significant opportunity for
improvement;
• Address measure needs for
population based payment through
alternative payment models; and
• Align across programs and/or with
other payers.
In order to achieve these objectives,
we have identified 19 Meaningful
Measures areas and mapped them to six
overarching quality priorities as shown
in the following table:
Healthcare-Associated Infections
Preventable Healthcare Harm
Care is Personalized and Aligned with Patient’s Goals
End of Life Care According to Preferences
Patient’s Experience of Care
Patient Reported Functional Outcomes
Medication Management
Admissions and Readmissions to Hospitals
Transfer of Health Information and Interoperability
Preventive Care
Management of Chronic Conditions
Prevention, Treatment, and Management of Mental Health
Prevention and Treatment of Opioid and Substance Use Disorders
Risk Adjusted Mortality
Equity of Care
Community Engagement
Appropriate Use of Healthcare
Patient-focused Episode of Care
Risk Adjusted Total Cost of Care
a. MS–DRG Documentation and Coding
Adjustment
3. Summary of the Major Provisions
Below we provide 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 included in this proposed rule
is presented below in section I.D. of this
preamble.
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
3 Refer to section VIII.A.9.c.of the preamble of this
proposed rule where we are seeking public
adjustment was subsequently adjusted
to 0.4588 percent by section 15005 of
the 21st Century Cures Act.) Therefore,
for FY 2019, we are proposing to make
an adjustment of +0.5 percent to the
standardized amount.
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b. Expansion of the Postacute Care
Transfer Policy
Section 53109 of the Bipartisan
Budget Act of 2018 amended section
1886(d)(5)(J)(ii) of the Act to also
include discharges to hospice care by a
hospice program as a qualified
discharge, effective for discharges
occurring on or after October 1, 2018.
Accordingly, we are proposing to make
conforming amendments to § 412.4(c) of
the regulation, effective for discharges
on or after October 1, 2018, to specify
that if a discharge is assigned to one of
the MS–DRGs subject to the postacute
care transfer policy and the individual
is transferred to hospice care by a
hospice program, the discharge would
be subject to payment as a transfer case.
c. DSH Payment Adjustment and
Additional Payment for Uncompensated
Care
Section 3133 of the Affordable Care
Act modified the Medicare
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disproportionate share hospital (DSH)
payment methodology beginning in FY
2014. Under section 1886(r) of the Act,
which was added by section 3133 of the
Affordable Care Act, starting in FY
2014, DSHs receive 25 percent of the
amount they previously would have
received under the statutory formula for
Medicare DSH payments in section
1886(d)(5)(F) of the Act. The remaining
amount, equal to 75 percent of the
amount that otherwise would have been
paid as Medicare DSH payments, is paid
as additional payments after the amount
is reduced for changes in the percentage
of individuals that are uninsured. Each
Medicare DSH will receive an
additional payment based on its share of
the total amount of uncompensated care
for all Medicare DSHs for a given time
period.
In this proposed rule, we are
proposing to update our estimates of the
three factors used to determine
uncompensated care payments for FY
2019. We are continuing to use
uninsured estimates produced by CMS’
Office of the Actuary (OACT) as part of
the development of the National Health
Expenditure Accounts (NHEA) in the
calculation of Factor 2. We also are
continuing to incorporate data from
Worksheet S–10 in the calculation of
hospitals’ share of the aggregate amount
of uncompensated care by combining
data on uncompensated care costs from
Worksheet S–10 for FYs 2014 and 2015
with proxy data regarding a hospital’s
share of low-income insured days for FY
2013 to determine Factor 3 for FY 2019.
In addition, we are proposing to use
only data regarding low-income insured
days for FY 2013 to determine the
amount of uncompensated care
payments for Puerto Rico hospitals,
Indian Health Service and Tribal
hospitals, and all-inclusive rate
providers. For this proposed rule, we
also are proposing the following
policies: (1) For providers with multiple
cost reports beginning in the same fiscal
year, to use the longest cost report and
annualize Medicaid data and
uncompensated care data if a hospital’s
cost report does not equal 12 months of
data; (2) in the rare case where a
provider has multiple cost reports
beginning in the same fiscal year, but
one report also spans the entirety of the
following fiscal year such that the
hospital has no cost report for that fiscal
year, the cost report that spans both
fiscal years would be used for the latter
fiscal year; and (3) to apply statistical
trim methodologies to potentially
aberrant cost-to-charge ratios (CCRs) and
potentially aberrant uncompensated
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care costs reported on the Worksheet S–
10.
d. Proposed Changes to the LTCH PPS
In 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 2019. In addition, we
are proposing to eliminate the 25percent threshold policy, and under this
proposal we would apply a one-time
permanent adjustment of approximately
¥0.9 percent to the LTCH PPS standard
Federal payment rate to ensure this
proposed elimination of the 25-percent
threshold policy is budget neutral.
e. Reduction of Hospital Payments for
Excess Readmissions
We are proposing to make changes to
policies for the Hospital Readmissions
Reduction Program, which is
established under section 1886(q) of the
Act, as added by section 3025 of the
Affordable Care Act, as amended by
section 10309 of the Affordable Care Act
and further amended by section 15002
of the 21st Century Cures Act. The
Hospital Readmissions Reduction
Program requires a reduction to a
hospital’s base operating DRG payment
to account for excess readmissions of
selected applicable conditions. For FY
2018 and subsequent years, the
reduction is based on a hospital’s riskadjusted readmission rate during a 3year period for acute myocardial
infarction (AMI), heart failure (HF),
pneumonia, chronic obstructive
pulmonary disease (COPD), total hip
arthroplasty/total knee arthroplasty
(THA/TKA), and coronary artery bypass
graft (CABG). In this proposed rule, we
are proposing to establish the applicable
periods for FY 2019, FY 2020, and FY
2021. We are also proposing to codify
the definitions of dual-eligible patients,
the proportion of dual-eligibles, and the
applicable period for dual-eligibility.
f. Hospital Value-Based Purchasing
(VBP) Program
Section 1886(o) of the Act requires the
Secretary to establish a Hospital VBP
Program under which value-based
incentive payments are made in a fiscal
year to hospitals based on their
performance on measures established
for a performance period for such fiscal
year. As part of agency-wide efforts
under the Meaningful Measures
Initiative to use a parsimonious set of
the most meaningful measures for
patients, clinicians, and providers in
our quality programs and the Patients
Over Paperwork Initiative to reduce
costs and burden and program
complexity as discussed in section
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I.A.2. of the preamble of this proposed
rule, we are proposing to remove a total
of 10 measures from the Hospital VBP
Program, all of which would continue to
be used in the Hospital IQR Program or
the HAC Reduction Program, in order to
reduce the costs and complexity of
tracking these measures in multiple
programs. We also are proposing to
adopt measure removal factors for the
Hospital VBP Program. Specifically, we
are proposing to remove six measures
beginning with the FY 2021 program
year: (1) Elective Delivery (NQF #0469)
(PC–01); (2) National Healthcare Safety
Network (NHSN) Catheter-Associated
Urinary Tract Infection (CAUTI)
Outcome Measure (NQF #0138); (3)
National Healthcare Safety Network
(NHSN) Central Line-Associated
Bloodstream Infection (CLABSI)
Outcome Measure (NQF #0139); (4)
American College of Surgeons-Centers
for Disease Control and Prevention
(ACS–CDC) Harmonized Procedure
Specific Surgical Site Infection (SSI)
Outcome Measure (NQF #0753); (5)
National Healthcare Safety Network
(NHSN) Facility-wide Inpatient
Hospital-onset Methicillin-resistant
Staphylococcus aureus Bacteremia
(MRSA) Outcome Measure (NQF
#1716); and (6) National Healthcare
Safety Network (NHSN) Facility-wide
Inpatient Hospital-onset Clostridium
difficile Infection (CDI) Outcome
Measure (NQF #1717). We are also
proposing to remove four measures from
the Hospital VBP Program effective with
the effective date of the FY 2019 IPPS/
LTCH PPS final rule: (1) Patient Safety
and Adverse Events (Composite) (NQF
#0531) (PSI 90); (2) Hospital-Level, RiskStandardized Payment Associated With
a 30-Day Episode-of-Care for Acute
Myocardial Infarction (NQF #2431)
(AMI Payment); (3) Hospital-Level, RiskStandardized Payment Associated With
a 30-Day Episode-of-Care for Heart
Failure (NQF #2436) (HF Payment); and
(4) Hospital-Level, Risk-Standardized
Payment Associated With a 30-Day
Episode-of-Care for Pneumonia (PN
Payment) (NQF #2579). In addition, we
are proposing to rename the Clinical
Care domain as the Clinical Outcomes
domain beginning with the FY 2020
program year; we are proposing to
remove the Safety domain from the
Hospital VBP Program, if our proposals
to removal all of the measures in this
domain are finalized, and to weight the
three remaining domains as follows:
Clinical Outcomes domain—50 percent;
Person and Community Engagement
domain—25 percent; and Efficiency and
Cost Reduction domain—25 percent.
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g. Hospital-Acquired Condition (HAC)
Reduction Program
Section 1886(p) of the Act, as added
under section 3008(a) of the Affordable
Care Act, establishes an incentive to
hospitals to reduce the incidence of
hospital-acquired conditions by
requiring the Secretary to make an
adjustment to payments to applicable
hospitals effective for discharges
beginning on October 1, 2014. This 1percent payment reduction applies to a
hospital whose ranking in the worstperforming quartile (25 percent) of all
applicable hospitals, relative to the
national average, of conditions acquired
during the applicable period and on all
of the hospital’s discharges for the
specified fiscal year. As part of our
agency-wide Patients over Paperwork
and Meaningful Measures Initiatives,
discussed in section I.A.2. of the
preamble of this proposed rule, we are
proposing that the measures currently
included in the HAC Reduction Program
should be retained because the
measures address a performance gap in
patient safety and reducing harm caused
in the delivery of care. In this proposed
rule, we are proposing to: (1) Establish
administrative policies to collect,
validate, and publicly report NHSN
healthcare-associated infection (HAI)
quality measure data that facilitate a
seamless transition, independent of the
Hospital IQR Program, beginning with
January 1, 2019 infectious events; (2)
change the scoring methodology by
removing domains and assigning equal
weighting to each measure for which a
hospital has a measure; and (3) establish
the applicable period for FY 2021. In
addition, we are seeking stakeholder
comment regarding the potential future
inclusion of additional measures,
including eCQMs.
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h. Hospital Inpatient Quality Reporting
(IQR) Program
Under section 1886(b)(3)(B)(viii) of
the Act, subsection (d) hospitals are
required to report data on measures
selected by the Secretary for a fiscal year
in order to receive the full annual
percentage increase that would
otherwise apply to the standardized
amount applicable to discharges
occurring in that fiscal year.
In this proposed rule, we are
proposing several changes. As part of
agency-wide efforts under the
Meaningful Measures Initiative to use a
parsimonious set of the most
meaningful measures for patients and
clinicians in our quality programs and
the Patients Over Paperwork initiative
to reduce burden, cost, and program
complexity as discussed in section
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I.A.2. of the preamble of this proposed
rule, we are proposing to add a new
measure removal factor and to remove a
total of 39 measures from the Hospital
IQR Program. For a full list of measures
proposed for removal, we refer readers
to section VIII.A.4.b. of the preamble of
this proposed rule. Beginning with the
CY 2018 reporting period/FY 2020
payment determination and subsequent
years, we are proposing to remove 17
claims-based measures and two
structural measures. Beginning with the
CY 2019 reporting period/FY 2021
payment determination and subsequent
years, we are proposing to remove eight
chart-abstracted measures and two
claims-based measures. Beginning with
the CY 2020 reporting period/FY 2022
payment determination and subsequent
years, we are proposing to remove one
chart-abstracted measure, one
claims-based measure, and seven
eCQMs from the Hospital IQR Program
measure set. Beginning with the CY
2021 reporting period/FY 2023 payment
determination, we are proposing to
remove one claims-based measure.
In addition, for the CY 2019 reporting
period/FY 2021 payment determination,
we are proposing to: (1) Require the
same eCQM reporting requirements that
were adopted for the CY 2018 reporting
period/FY 2020 payment determination
(82 FR 38355 through 38361), such that
hospitals submit one, self-selected
calendar quarter of 2019 discharge data
for 4 eCQMs in the Hospital IQR
Program measure set; and (2) require
that hospitals use the 2015 Edition
certification criteria for CEHRT. These
proposals are in alignment with
proposals or current established policies
under the Medicare and Medicaid
Promoting Interoperability Programs
(previously known as the Medicare and
Medicaid EHR Incentive Programs). In
addition, we are seeking public
comment on two measures for potential
future inclusion in the Hospital IQR
Program, as well as the potential future
development and adoption of electronic
clinical quality measures generally.
i. Long-Term Care Hospital Quality
Reporting Program (LTCH QRP)
The LTCH QRP is authorized by
section 1886(m)(5) of the Act and
applies to all hospitals certified by
Medicare as long-term care hospitals
(LTCHs). Under the LTCH QRP, the
Secretary reduces by 2 percentage
points the annual update to the LTCH
PPS standard Federal rate for discharges
for an LTCH during a fiscal year if the
LTCH fails to submit data in accordance
with the LTCH QRP requirements
specified for that fiscal year. As part of
agency-wide efforts under the
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Meaningful Measures Initiative to use a
parsimonious set of the most
meaningful measures for patients and
clinicians in our quality programs and
the Patients Over Paperwork Initiative
to reduce cost and burden and program
complexity as discussed in section
I.A.2. of the preamble of this proposed
rule, we are proposing to remove three
measures from the LTCH QRP. We also
are proposing to adopt a new measure
removal factor and are proposing to
codify the measure removal factors in
our regulations. In addition, we are
proposing to update our regulations to
change methods by which an LTCH is
notified of noncompliance with the
requirements of the LTCH QRP for a
program year; and how CMS will notify
an LTCH of a reconsideration decision.
4. Summary of Costs and Benefits
• Adjustment for MS–DRG
Documentation and Coding Changes.
Section 414 of the MACRA replaced the
single positive adjustment we intended
to make in FY 2018 once the
recoupment required by section 631 of
the ATRA was complete with a 0.5
percent positive adjustment to the
standardized amount of Medicare
payments to acute care hospitals for FYs
2018 through 2023. (The FY 2018
adjustment was subsequently adjusted
to 0.4588 percent by section 15005 of
the 21st Century Cures Act.) For FY
2019, we are proposing to make an
adjustment of +0.5 percent to the
standardized amount consistent with
the MACRA.
• Expansion of the Postacute Care
Transfer Policy. Section 53109 of the
Bipartisan Budget Act of 2018 amended
section 1886(d)(5)(J)(ii) of the Act to also
include discharges to hospice care by a
hospice program as a qualified
discharge, effective for discharges
occurring on or after October 1, 2018.
Accordingly, we are proposing to make
conforming amendments to § 412.4(c) of
the regulation to specify that, effective
for discharges on or after October 1,
2018, if a discharge is assigned to one
of the MS–DRGs subject to the postacute
care transfer policy and the individual
is transferred to hospice care by a
hospice program, the discharge would
be subject to payment as a transfer case.
We estimate that this statutory
expansion to the postacute care transfer
policy will reduce Medicare payments
under the IPPS by approximately $240
million in FY 2019.
• Proposed Medicare DSH Payment
Adjustment and Additional Payment for
Uncompensated Care. Under section
1886(r) of the Act (as added by section
3133 of the Affordable Care Act), DSH
payments to hospitals under section
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1886(d)(5)(F) of the Act are reduced and
an additional payment for
uncompensated care is made to eligible
hospitals beginning in FY 2014.
Hospitals that receive Medicare DSH
payments receive 25 percent of the
amount they previously would have
received under the statutory formula for
Medicare DSH payments in section
1886(d)(5)(F) of the Act. The remainder,
equal to an estimate of 75 percent of
what otherwise would have been paid
as Medicare DSH payments, is the basis
for determining the additional payments
for uncompensated care after the
amount is reduced for changes in the
percentage of individuals that are
uninsured and additional statutory
adjustments. Each hospital that receives
Medicare DSH payments will receive an
additional payment for uncompensated
care based on its share of the total
uncompensated care amount reported
by Medicare DSHs. The reduction to
Medicare DSH payments is not budget
neutral.
For FY 2019, we are proposing to
update our estimates of the three factors
used to determine uncompensated care
payments. We are continuing to use
uninsured estimates produced by OACT
as part of the development of the NHEA
in the calculation of Factor 2. We also
are continuing to incorporate data from
Worksheet S–10 in the calculation of
hospitals’ share of the aggregate amount
of uncompensated care by combining
data on uncompensated care costs from
Worksheet S–10 for FY 2014 and FY
2015 with proxy data regarding a
hospital’s share of low-income insured
days for FY 2013 to determine Factor 3
for FY 2019. To determine the amount
of uncompensated care for Puerto Rico
hospitals, Indian Health Service and
Tribal hospitals, and all-inclusive rate
providers, we are proposing to use only
the data regarding low-income insured
days for FY 2013. In addition, in this
proposed rule, we are proposing the
following policies: (1) For providers
with multiple cost reports beginning in
the same fiscal year, to use the longest
cost report and annualize Medicaid data
and uncompensated care data if a
hospital’s cost report does not equal 12
months of data; (2) in the rare case
where a provider has multiple cost
reports beginning in the same fiscal
year, but one report also spans the
entirety of the following fiscal year such
that the hospital has no cost report for
that fiscal year, the cost report that
spans both fiscal years would be used
for the latter fiscal year; and (3) to apply
statistical trim methodologies to
potentially aberrant CCRs and
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potentially aberrant uncompensated
care costs.
We are projecting that proposed
estimated Medicare DSH payments, and
additional payments for uncompensated
care made for FY 2019, would increase
payments overall by approximately 1.3
percent as compared to the estimate of
overall payments, including Medicare
DSH payments and uncompensated care
payments that will be distributed in FY
2018. The additional payments have
redistributive effects based on a
hospital’s uncompensated care amount
relative to the uncompensated care
amount for all hospitals that are
estimated to receive Medicare DSH
payments, and the calculated payment
amount is not directly tied to a
hospital’s number of discharges.
• Proposed Update to the LTCH PPS
Payment Rates and Other Payment
Policies. Based on the best available
data for the 409 LTCHs in our database,
we estimate that the proposed changes
to the payment rates and factors that we
are presenting in the preamble and
Addendum of this proposed rule, which
reflects the continuation of the
transition of the statutory application of
the site neutral payment rate, the update
to the LTCH PPS standard Federal
payment rate for FY 2019, and the
proposed one-time permanent
adjustment of approximately-0.9 percent
to the LTCH PPS standard Federal
payment rate to ensure this proposed
elimination of the 25-percent threshold
policy is budget neutral would result in
an estimated decrease in payments in
FY 2019 of approximately $5 million.
• Proposed Changes to the Hospital
Readmissions Reduction Program. For
FY 2019 and subsequent years, the
reduction is based on a hospital’s riskadjusted readmission rate during a 3year period for acute myocardial
infarction (AMI), heart failure (HF),
pneumonia, chronic obstructive
pulmonary disease (COPD), total hip
arthroplasty/total knee arthroplasty
(THA/TKA), and coronary artery bypass
graft (CABG). Overall, in this proposed
rule, we estimate that 2,610 hospitals
would have their base operating DRG
payments reduced by their determined
proposed proxy FY 2019 hospitalspecific readmission adjustment. As a
result, we estimate that the Hospital
Readmissions Reduction Program would
save approximately $566 million in FY
2019.
• Value-Based Incentive Payments
under the Hospital VBP Program. We
estimate that there will be no net
financial impact to the Hospital VBP
Program for the FY 2019 program year
in the aggregate because, by law, the
amount available for value-based
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incentive payments under the program
in a given year must be equal to the total
amount of base operating MS–DRG
payment amount reductions for that
year, as estimated by the Secretary. The
estimated amount of base operating MS–
DRG payment amount reductions for the
FY 2019 program year and, therefore,
the estimated amount available for
value-based incentive payments for FY
2019 discharges is approximately $1.9
billion.
• Proposed Changes to the HAC
Reduction Program. A hospital’s Total
HAC score and its ranking in
comparison to other hospitals in any
given year depend on several different
factors. Any significant impact due to
the proposed HAC Reduction Program
changes for FY 2019, including which
hospitals would receive the adjustment,
would depend on actual experience.
The proposed removal of NHSN HAI
measures from the Hospital IQR
Program and the subsequent cessation of
its validation processes for NHSN HAI
measures and proposed creation of a
validation process for the HAC
Reduction program represent no net
change in reporting burden across CMS
hospital quality programs. However, if
our proposal to remove HAI chartabstracted measures from the Hospital
IQR Program is finalized, we anticipate
a total burden shift of 43,200 hours and
approximately $1.6 million as a result of
no longer needing to validate those HAI
measures under the Hospital IQR
Program and beginning the validation
process under the HAC Reduction
Program.
• Proposed Changes to the Hospital
Inpatient Quality Reporting (IQR)
Program. Across 3,300 IPPS hospitals,
we estimate that our proposed
requirements for the Hospital IQR
Program would result in the following
changes to costs and burdens related to
information collection for this program
compared to previously adopted
requirements: (1) A total collection of
information burden reduction of
1,046,071 hours and a total cost
reduction of approximately $38.3
million for the CY 2019 reporting
period/FY 2021 payment determination,
due to the proposed removal of ED–1,
IMM–2, and VTE–6 measures; and (2) a
total collection of information burden
reduction of 901,200 hours and a total
cost reduction of $33 million for the CY
2020 reporting period/FY 2022 payment
determination, due to: (a) The proposed
removal of ED–2, and (b) validation of
the NHSN HAI measures no longer
being conducted under the Hospital IQR
Program once the HAC Reduction
Program begins validating these
measures, as proposed in the preamble
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of this proposed rule for the HAC
Reduction Program.
Further, we anticipate that the
proposed removal of 39 measures would
result in a reduction in costs unrelated
to information collection. For example,
it may be costly for health care
providers to track the confidential
feedback, preview reports, and publicly
reported information on a measure
where we use the measure in more than
one program. Also, when measures are
in multiple programs, maintaining the
specifications for those measures, as
well as the tools we need to collect,
validate, analyze, and publicly report
the measure data may result in costs to
CMS. In addition, beneficiaries may find
it confusing to see public reporting on
the same measure in different programs.
We anticipate that our proposals will
reduce the above-described costs.
• Proposed Changes Related to the
LTCH QRP. In this proposed rule, we
are proposing to remove three measures
from the LTCH QRP, two measures
beginning with the FY 2020 LTCH QRP
and one measure beginning with the FY
2021 LTCH QRP. We also are proposing
a new quality measure removal factor
for the LTCH QRP. We estimate that the
impact of these proposed changes is a
reduction in costs of approximately
$1,148 per LTCH annually or
approximately $482,469 for all LTCHs
annually.
B. Background Summary
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1. Acute Care Hospital Inpatient
Prospective Payment System (IPPS)
Section 1886(d) of the Social Security
Act (the Act) sets forth a system of
payment for the operating costs of acute
care hospital inpatient stays under
Medicare Part A (Hospital Insurance)
based on prospectively set rates. Section
1886(g) of the Act requires the Secretary
to use a prospective payment system
(PPS) to pay for the capital-related costs
of inpatient hospital services for these
‘‘subsection (d) hospitals.’’ Under these
PPSs, Medicare payment for hospital
inpatient operating and capital-related
costs is made at predetermined, specific
rates for each hospital discharge.
Discharges are classified according to a
list of diagnosis-related groups (DRGs).
The base payment rate is comprised of
a standardized amount that is divided
into a labor-related share and a
nonlabor-related share. The laborrelated share is adjusted by the wage
index applicable to the area where the
hospital is located. If the hospital is
located in Alaska or Hawaii, the
nonlabor-related share is adjusted by a
cost-of-living adjustment factor. This
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base payment rate is multiplied by the
DRG relative weight.
If the hospital treats a high percentage
of certain low-income patients, it
receives a percentage add-on payment
applied to the DRG-adjusted base
payment rate. This add-on payment,
known as the disproportionate share
hospital (DSH) adjustment, provides for
a percentage increase in Medicare
payments to hospitals that qualify under
either of two statutory formulas
designed to identify hospitals that serve
a disproportionate share of low-income
patients. For qualifying hospitals, the
amount of this adjustment varies based
on the outcome of the statutory
calculations. The Affordable Care Act
revised the Medicare DSH payment
methodology and provides for a new
additional Medicare payment that
considers the amount of uncompensated
care beginning on October 1, 2013.
If the hospital is training residents in
an approved residency program(s), it
receives a percentage add-on payment
for each case paid under the IPPS,
known as the indirect medical
education (IME) adjustment. This
percentage varies, depending on the
ratio of residents to beds.
Additional payments may be made for
cases that involve new technologies or
medical services that have been
approved for special add-on payments.
To qualify, a new technology or medical
service must demonstrate that it is a
substantial clinical improvement over
technologies or services otherwise
available, and that, absent an add-on
payment, it would be inadequately paid
under the regular DRG payment.
The costs incurred by the hospital for
a case are evaluated to determine
whether the hospital is eligible for an
additional payment as an outlier case.
This additional payment is designed to
protect the hospital from large financial
losses due to unusually expensive cases.
Any eligible outlier payment is added to
the DRG-adjusted base payment rate,
plus any DSH, IME, and new technology
or medical service add-on adjustments.
Although payments to most hospitals
under the IPPS are made on the basis of
the standardized amounts, some
categories of hospitals are paid in whole
or in part based on their hospitalspecific rate, which is determined from
their costs in a base year. For example,
sole community hospitals (SCHs)
receive the higher of a hospital-specific
rate based on their costs in a base year
(the highest of FY 1982, FY 1987, FY
1996, or FY 2006) or the IPPS Federal
rate based on the standardized amount.
SCHs are the sole source of care in their
areas. Specifically, section
1886(d)(5)(D)(iii) of the Act defines an
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SCH as a hospital that is located more
than 35 road miles from another
hospital or that, by reason of factors
such as isolated location, weather
conditions, travel conditions, or absence
of other like hospitals (as determined by
the Secretary), is the sole source of
hospital inpatient services reasonably
available to Medicare beneficiaries. In
addition, certain rural hospitals
previously designated by the Secretary
as essential access community hospitals
are considered SCHs.
Under current law, the Medicaredependent, small rural hospital (MDH)
program is effective through FY 2022.
Through and including FY 2006, an
MDH received the higher of the Federal
rate or the Federal rate plus 50 percent
of the amount by which the Federal rate
was exceeded by the higher of its FY
1982 or FY 1987 hospital-specific rate.
For discharges occurring on or after
October 1, 2007, but before October 1,
2022, an MDH receives the higher of the
Federal rate or the Federal rate plus 75
percent of the amount by which the
Federal rate is exceeded by the highest
of its FY 1982, FY 1987, or FY 2002
hospital-specific rate. MDHs are a major
source of care for Medicare beneficiaries
in their areas. Section 1886(d)(5)(G)(iv)
of the Act defines an MDH as a hospital
that is located in a rural area (or, as
amended by the Bipartisan Budget Act
of 2018, a hospital located in a State
with no rural area that meets certain
statutory criteria), has not more than
100 beds, is not an SCH, and has a high
percentage of Medicare discharges (not
less than 60 percent of its inpatient days
or discharges in its cost reporting year
beginning in FY 1987 or in two of its
three most recently settled Medicare
cost reporting years).
Section 1886(g) of the Act requires the
Secretary to pay for the capital-related
costs of inpatient hospital services in
accordance with a prospective payment
system established by the Secretary. The
basic methodology for determining
capital prospective payments is set forth
in our regulations at 42 CFR 412.308
and 412.312. Under the capital IPPS,
payments are adjusted by the same DRG
for the case as they are under the
operating IPPS. Capital IPPS payments
are also adjusted for IME and DSH,
similar to the adjustments made under
the operating IPPS. In addition,
hospitals may receive outlier payments
for those cases that have unusually high
costs.
The existing regulations governing
payments to hospitals under the IPPS
are located in 42 CFR part 412, subparts
A through M.
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2. Hospitals and Hospital Units
Excluded From the IPPS
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Under section 1886(d)(1)(B) of the
Act, as amended, certain hospitals and
hospital units are excluded from the
IPPS. These hospitals and units are:
Inpatient rehabilitation facility (IRF)
hospitals and units; long-term care
hospitals (LTCHs); psychiatric hospitals
and units; children’s hospitals; cancer
hospitals; extended neoplastic disease
care hospitals, and hospitals located
outside the 50 States, the District of
Columbia, and Puerto Rico (that is,
hospitals located in the U.S. Virgin
Islands, Guam, the Northern Mariana
Islands, and American Samoa).
Religious nonmedical health care
institutions (RNHCIs) are also excluded
from the IPPS. Various sections of the
Balanced Budget Act of 1997 (BBA, Pub.
L. 105–33), the Medicare, Medicaid and
SCHIP [State Children’s Health
Insurance Program] Balanced Budget
Refinement Act of 1999 (BBRA, Pub. L.
106–113), and the Medicare, Medicaid,
and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA, Pub. L.
106–554) provide for the
implementation of PPSs for IRF
hospitals and units, LTCHs, and
psychiatric hospitals and units (referred
to as inpatient psychiatric facilities
(IPFs)). (We note that the annual
updates to the LTCH PPS are included
along with the IPPS annual update in
this document. Updates to the IRF PPS
and IPF PPS are issued as separate
documents.) Children’s hospitals,
cancer hospitals, hospitals located
outside the 50 States, the District of
Columbia, and Puerto Rico (that is,
hospitals located in the U.S. Virgin
Islands, Guam, the Northern Mariana
Islands, and American Samoa), and
RNHCIs continue to be paid solely
under a reasonable cost-based system
subject to a rate-of-increase ceiling on
inpatient operating costs. Similarly,
extended neoplastic disease care
hospitals are paid on a reasonable cost
basis subject to a rate-of-increase ceiling
on inpatient operating costs.
The existing regulations governing
payments to excluded hospitals and
hospital units are located in 42 CFR
parts 412 and 413.
3. Long-Term Care Hospital Prospective
Payment System (LTCH PPS)
The Medicare prospective payment
system (PPS) for LTCHs applies to
hospitals described in section
1886(d)(1)(B)(iv) of the Act effective for
cost reporting periods beginning on or
after October 1, 2002. The LTCH PPS
was established under the authority of
sections 123 of the BBRA and section
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307(b) of the BIPA (as codified under
section 1886(m)(1) of the Act). During
the 5-year (optional) transition period, a
LTCH’s payment under the PPS was
based on an increasing proportion of the
LTCH Federal rate with a corresponding
decreasing proportion based on
reasonable cost principles. Effective for
cost reporting periods beginning on or
after October 1, 2006 through September
30, 2016, all LTCHs were paid 100
percent of the Federal rate. Section
1206(a) of the Pathway for SGR Reform
Act of 2013 (Pub. L. 113–67) established
the site neutral payment rate under the
LTCH PPS, which made the LTCH PPS
a dual rate payment system beginning in
FY 2016. Under this statute, based on a
rolling effective date that is linked to the
date on which a given LTCH’s Federal
FY 2016 cost reporting period begins,
LTCHs are generally paid for discharges
at the site neutral payment rate unless
the discharge meets the patient criteria
for payment at the LTCH PPS standard
Federal payment rate. The existing
regulations governing payment under
the LTCH PPS are located in 42 CFR
part 412, subpart O. Beginning October
1, 2009, we issue the annual updates to
the LTCH PPS in the same documents
that update the IPPS (73 FR 26797
through 26798).
4. Critical Access Hospitals (CAHs)
Under sections 1814(l), 1820, and
1834(g) of the Act, payments made to
critical access hospitals (CAHs) (that is,
rural hospitals or facilities that meet
certain statutory requirements) for
inpatient and outpatient services are
generally based on 101 percent of
reasonable cost. Reasonable cost is
determined under the provisions of
section 1861(v) of the Act and existing
regulations under 42 CFR part 413.
5. Payments for Graduate Medical
Education (GME)
Under section 1886(a)(4) of the Act,
costs of approved educational activities
are excluded from the operating costs of
inpatient hospital services. Hospitals
with approved graduate medical
education (GME) programs are paid for
the direct costs of GME in accordance
with section 1886(h) of the Act. The
amount of payment for direct GME costs
for a cost reporting period is based on
the hospital’s number of residents in
that period and the hospital’s costs per
resident in a base year. The existing
regulations governing payments to the
various types of hospitals are located in
42 CFR part 413.
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C. Summary of Provisions of Recent
Legislation Proposed To Be
Implemented in This Proposed Rule
1. Pathway for SGR Reform Act of 2013
(Pub. L. 113–67)
The Pathway for SGR Reform Act of
2013 (Pub. L. 113–67) introduced new
payment rules in the LTCH PPS. Under
section 1206 of this law, discharges in
cost reporting periods beginning on or
after October 1, 2015 under the LTCH
PPS will receive payment under a site
neutral rate unless the discharge meets
certain patient-specific criteria. In this
proposed rule, we are continuing to
update certain policies that
implemented provisions under section
1206 of the Pathway for SGR Reform
Act.
2. Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT
Act) (Pub. L. 113–185)
The Improving Medicare Post-Acute
Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113–185),
enacted on October 6, 2014, made a
number of changes that affect the LongTerm Care Hospital Quality Reporting
Program (LTCH QRP). In this proposed
rule, we are proposing to continue to
implement portions of section 1899B of
the Act, as added by section 2(a) of the
IMPACT Act, which, in part, requires
LTCHs, among other postacute care
providers, to report standardized patient
assessment data, data on quality
measures, and data on resource use and
other measures.
3. The Medicare Access and CHIP
Reauthorization Act of 2015 (Pub. L.
114–10)
Section 414 of the Medicare Access
and CHIP Reauthorization Act of 2015
(MACRA, Pub. L. 114–10) specifies a 0.5
percent positive adjustment to the
standardized amount of Medicare
payments to acute care hospitals for FYs
2018 through 2023. These adjustments
follow the recoupment adjustment to
the standardized amounts under section
1886(d) of the Act based upon the
Secretary’s estimates for discharges
occurring from FYs 2014 through 2017
to fully offset $11 billion, in accordance
with section 631 of the ATRA. The FY
2018 adjustment was subsequently
adjusted to 0.4588 percent by section
15005 of the 21st Century Cures Act.
4. The 21st Century Cures Act (Pub. L.
114–255)
The 21st Century Cures Act (Pub. L.
114–255), enacted on December 13,
2016, contained the following provision
affecting payments under the Hospital
Readmissions Reduction Program,
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which we are proposing to continue to
implement in this proposed rule:
• Section 15002, which amended
section 1886(q)(3) of the Act by adding
subparagraphs (D) and (E), which
requires the Secretary to develop a
methodology for calculating the excess
readmissions adjustment factor for the
Hospital Readmissions Reduction
Program based on cohorts defined by
the percentage of dual-eligible patients
(that is, patients who are eligible for
both Medicare and full-benefit Medicaid
coverage) cared for by a hospital. In this
proposed rule, we are proposing to
continue to implement changes to the
payment adjustment factor to assess
penalties based on a hospital’s
performance relative to other hospitals
treating a similar proportion of dualeligible patients.
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5. The Bipartisan Budget Act of 2018
(Pub. L. 115–123)
The Bipartisan Budget Act of 2018
(Pub. L. 115–123), enacted on February
9, 2018, contains provisions affecting
payments under the IPPS and the LTCH
PPS, which we are proposing to
implement or continue to implement in
this proposed rule:
• Section 50204 amended section
1886(d)(12) of the Act to provide for
certain temporary changes to the lowvolume hospital payment adjustment
policy for FYs 2018 through 2022. For
FY 2018, this provision extends the
qualifying criteria and payment
adjustment formula that applied for FYs
2011 through 2017. For FYs 2019
through 2022, this provision modifies
the discharge criterion and payment
adjustment formula. In FY 2023 and
subsequent fiscal years, the qualifying
criteria and payment adjustment revert
to the requirements that were in effect
for FYs 2005 through 2010.
• Section 50205 extends the MDH
program through FY 2022. It also
provides for an eligible hospital that is
located in a State with no rural area to
qualify for MDH status under an
expanded definition if the hospital
satisfies any of the statutory criteria at
section 1886(d)(8)(E)(ii)(I), (II) (as of
January 1, 2018), or (III) of the Act to be
reclassified as rural.
• Section 51005(a) modified section
1886(m)(6) of the Act by extending the
blended payment rate for site neutral
payment rate LTCH discharges for cost
reporting periods beginning in FY 2016
by an additional 2 years (FYs 2018 and
2019). In addition, section 51005(b)
reduces the LTCH IPPS comparable per
diem amount used in the site neutral
payment rate for FYs 2018 through 2026
by 4.6 percent. In this proposed rule, we
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are proposing to make conforming
changes to the existing regulations.
• Section 53109 modified section
1886(d)(5)(J) of the Act to require that,
beginning in FY 2019, discharges to
hospice care will also qualify as a
postacute care transfer and be subject to
payment adjustments.
D. Summary of the Provisions of This
Proposed Rule
In this proposed rule, we are setting
forth proposed payment and policy
changes to the Medicare IPPS for FY
2019 operating costs and for capitalrelated costs of acute care hospitals and
certain hospitals and hospital units that
are excluded from IPPS. In addition, we
are setting forth proposed changes to the
payment rates, factors, and other
payment and policy-related changes to
programs associated with payment rate
policies under the LTCH PPS for FY
2019.
Below is a general summary of the
proposed changes included 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 2019.
• Proposed adjustment to the
standardized amounts under section
1886(d) of the Act for FY 2019 in
accordance with the amendments made
to section 7(b)(1)(B) of Public Law 110–
90 by section 414 of the MACRA.
• Proposed recalibration of the MS–
DRG relative weights.
• A discussion of the proposed FY
2019 status of new technologies
approved for add-on payments for FY
2018 and a presentation of our
evaluation and analysis of the FY 2019
applicants for add-on payments for
high-cost new medical services and
technologies (including public input, as
directed by Pub. L. 108–173, obtained in
a town hall meeting).
2. Proposed Changes to the Hospital
Wage Index for Acute Care Hospitals
In section III. of the preamble to 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 are not limited
to, the following:
• The proposed FY 2019 wage index
update using wage data from cost
reporting periods beginning in FY 2015.
• Proposal regarding other wagerelated costs in the wage index.
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• Calculation of the proposed
occupational mix adjustment for FY
2019 based on the 2016 Occupational
Mix Survey.
• Analysis and implementation of the
proposed FY 2019 occupational mix
adjustment to the wage index for acute
care hospitals.
• Proposed application of the rural
floor and the frontier State floor and the
proposed expiration of the imputed
floor.
• Proposals to codify policies
regarding multicampus hospitals.
• Proposed revisions to the wage
index for acute care hospitals based on
hospital redesignations and
reclassifications under sections
1886(d)(8)(B), (d)(8)(E), and (d)(10) of
the Act.
• The proposed adjustment to the
wage index for acute care hospitals for
FY 2019 based on commuting patterns
of hospital employees who reside in a
county and work in a different area with
a higher wage index.
• Determination of the labor-related
share for the proposed FY 2019 wage
index.
• Public comment solicitation on
wage index disparities.
3. Other Decisions and Proposed
Changes to the IPPS for Operating Costs
In section IV. of the preamble of this
proposed rule, we discuss proposed
changes or clarifications of a number of
the provisions of the regulations in 42
CFR parts 412 and 413, including the
following:
• Proposed changes to MS–DRGs
subject to the postacute care transfer
policy and special payment policy and
implementation of the statutory changes
to the postacute care transfer policy.
• Proposed changes to the inpatient
hospital update for FY 2019.
• Proposed changes related to the
statutory changes to the low-volume
hospital payment adjustment policy.
• Proposed updated national and
regional case-mix values and discharges
for purposes of determining RRC status.
• The statutorily required IME
adjustment factor for FY 2019.
• Proposed changes to the
methodologies for determining
Medicare DSH payments and the
additional payments for uncompensated
care.
• Proposed changes to the effective
date of SCH and MDH classification
status determinations.
• Proposed changes related to the
extension of the MDH program.
• Proposed changes to the rules for
payment adjustments under the
Hospital Readmissions Reduction
Program based on hospital readmission
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measures and the process for hospital
review and correction of those rates for
FY 2019.
• Proposed changes to the
requirements and provision of valuebased incentive payments under the
Hospital Value-Based Purchasing
Program.
• Proposed requirements for payment
adjustments to hospitals under the HAC
Reduction Program for FY 2019.
• Proposed changes to Medicare GME
affiliation agreements for new urban
teaching hospitals.
• Discussion of and proposals relating
to the implementation of the Rural
Community Hospital Demonstration
Program in FY 2019.
• Proposed revisions of the hospital
inpatient admission orders
documentation requirements.
4. Proposed FY 2019 Policy Governing
the IPPS for Capital-Related Costs
In section V. of the preamble to this
proposed rule, we discuss the proposed
payment policy requirements for
capital-related costs and capital
payments to hospitals for FY 2019.
5. Proposed Changes to the Payment
Rates for Certain Excluded Hospitals:
Rate-of-Increase Percentages
In section VI. of the preamble of this
proposed rule, we discuss—
• Proposed changes to payments to
certain excluded hospitals for FY 2019.
• Proposed changes to the regulations
governing satellite facilities.
• Proposed changes to the regulations
governing excluded units of hospitals.
• Proposed continued
implementation of the Frontier
Community Health Integration Project
(FCHIP) Demonstration.
6. Proposed Changes to the LTCH PPS
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In section VII. of the preamble of the
proposed rule, we set forth—
• Proposed changes to the LTCH PPS
Federal payment rates, factors, and
other payment rate policies under the
LTCH PPS for FY 2019.
• Proposed changes to the blended
payment rate for site neutral payment
rate cases.
• Proposed elimination of the 25percent threshold policy.
7. Proposed Changes Relating to Quality
Data Reporting for Specific Providers
and Suppliers
In section VIII. of the preamble of the
proposed rule, we address—
• Proposed requirements for the
Hospital Inpatient Quality Reporting
(IQR) Program.
• Proposed changes to the
requirements for the quality reporting
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program for PPS-exempt cancer
hospitals (PCHQR Program).
• Proposed changes to the
requirements under the LTCH Quality
Reporting Program (LTCH QRP).
• Proposed changes to requirements
pertaining to the clinical quality
measurement for eligible hospitals and
CAHs participating in the Medicare and
Medicaid Promoting Interoperability
Programs.
8. Proposed Revision to the Supporting
Documentation Requirements for an
Acceptable Medicare Cost Report
Submission
In section IX. of the preamble of this
proposed rule, we set forth proposed
revisions to the supporting
documentation required for an
acceptable Medicare cost report
submission.
9. Requirements for Hospitals To Make
Public List of Standard Charges
In section X. of the preamble of this
proposed rule, we discuss our efforts to
further improve the public accessibility
of hospital standard charge information,
effective January 1, 2019, in accordance
with section 2718(e) of the Public
Health Service Act.
10. Proposed Revisions Regarding
Physician Certification and
Recertification of Claims
In section XI. of the preamble of this
proposed rule, we set forth proposed
revisions to the requirements for
supporting information used for
physician certification and
recertification of claims.
11. Request for Information
In section XII. of the preamble of this
proposed rule, we include a request for
information on possible establishment
of CMS patient health and safety
requirements for hospitals and other
Medicare- and Medicaid-participating
providers and suppliers for
interoperable electronic health records
and systems for electronic health care
information exchange.
12. Determining Prospective Payment
Operating and Capital Rates and
Rate-of-Increase Limits for Acute Care
Hospitals
In section V. of the Addendum to this
proposed rule, we set forth proposed
changes to the amounts and factors for
determining the proposed FY 2019
prospective payment rates for operating
costs and capital-related costs for acute
care hospitals. We are proposing to
establish the threshold amounts for
outlier cases. In addition, we address
the update factors for determining the
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rate-of-increase limits for cost reporting
periods beginning in FY 2019 for certain
hospitals excluded from the IPPS.
13. Determining Prospective Payment
Rates for LTCHs
In section V. of the Addendum to this
proposed rule, we set forth proposed
changes to the amounts and factors for
determining the proposed FY 2019
LTCH PPS standard Federal payment
rate and other factors used to determine
LTCH PPS payments under both the
LTCH PPS standard Federal payment
rate and the site neutral payment rate in
FY 2019. We are proposing to establish
the adjustments for wage levels, the
labor-related share, the cost-of-living
adjustment, and high-cost outliers,
including the applicable fixed-loss
amounts and the LTCH cost-to-charge
ratios (CCRs) for both payment rates.
14. Impact Analysis
In Appendix A of this proposed rule,
we set forth an analysis of the impact
that the proposed changes would have
on affected acute care hospitals, CAHs,
LTCHs, and PCHs.
15. Recommendation of Update Factors
for Operating Cost Rates of Payment for
Hospital Inpatient Services
In Appendix B of this proposed rule,
as required by sections 1886(e)(4) and
(e)(5) of the Act, we provide our
recommendations of the appropriate
percentage changes for FY 2019 for the
following:
• A single average standardized
amount for all areas for hospital
inpatient services paid under the IPPS
for operating costs of acute care
hospitals (and hospital-specific rates
applicable to SCHs and MDHs).
• Target rate-of-increase limits to the
allowable operating costs of hospital
inpatient services furnished by certain
hospitals excluded from the IPPS.
• The LTCH PPS standard Federal
payment rate and the site neutral
payment rate for hospital inpatient
services provided for LTCH PPS
discharges.
16. Discussion of Medicare Payment
Advisory Commission
Recommendations
Under section 1805(b) of the Act,
MedPAC is required to submit a report
to Congress, no later than March 15 of
each year, in which MedPAC reviews
and makes recommendations on
Medicare payment policies. MedPAC’s
March 2018 recommendations
concerning hospital inpatient payment
policies address the update factor for
hospital inpatient operating costs and
capital-related costs for hospitals under
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the IPPS. We address these
recommendations in Appendix B of this
proposed rule. For further information
relating specifically to the MedPAC
March 2018 report or to obtain a copy
of the report, contact MedPAC at (202)
220–3700 or visit MedPAC’s website at:
https://www.medpac.gov.
II. Proposed Changes to Medicare
Severity Diagnosis-Related Group (MS–
DRG) Classifications and Relative
Weights
A. Background
Section 1886(d) of the Act specifies
that the Secretary shall establish a
classification system (referred to as
diagnosis-related groups (DRGs)) for
inpatient discharges and adjust
payments under the IPPS based on
appropriate weighting factors assigned
to each DRG. Therefore, under the IPPS,
Medicare pays for inpatient hospital
services on a rate per discharge basis
that varies according to the DRG to
which a beneficiary’s stay is assigned.
The formula used to calculate payment
for a specific case multiplies an
individual hospital’s payment rate per
case by the weight of the DRG to which
the case is assigned. Each DRG weight
represents the average resources
required to care for cases in that
particular DRG, relative to the average
resources used to treat cases in all
DRGs.
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.
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B. MS–DRG Reclassifications
For general information about the
MS–DRG system, including yearly
reviews and changes to the MS–DRGs,
we refer readers to the previous
discussions in the FY 2010 IPPS/RY
2010 LTCH PPS final rule (74 FR 43764
through 43766) and the FYs 2011
through 2018 IPPS/LTCH PPS final
rules (75 FR 50053 through 50055; 76
FR 51485 through 51487; 77 FR 53273;
78 FR 50512; 79 FR 49871; 80 FR 49342;
81 FR 56787 through 56872; and 82 FR
38010 through 38085, respectively).
C. Adoption of the MS–DRGs in FY 2008
For information on the adoption of
the MS–DRGs in FY 2008, we refer
readers to the FY 2008 IPPS final rule
with comment period (72 FR 47140
through 47189).
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D. Proposed FY 2019 MS–DRG
Documentation and Coding Adjustment
1. Background on the Prospective MS–
DRG Documentation and Coding
Adjustments for FY 2008 and FY 2009
Authorized by Public Law 110–90 and
the Recoupment or Repayment
Adjustment Authorized by Section 631
of the American Taxpayer Relief Act of
2012 (ATRA)
In the FY 2008 IPPS final rule with
comment period (72 FR 47140 through
47189), we adopted the MS–DRG
patient classification system for the
IPPS, effective October 1, 2007, to better
recognize severity of illness in Medicare
payment rates for acute care hospitals.
The adoption of the MS–DRG system
resulted in the expansion of the number
of DRGs from 538 in FY 2007 to 745 in
FY 2008. By increasing the number of
MS–DRGs and more fully taking into
account patient severity of illness in
Medicare payment rates for acute care
hospitals, MS–DRGs encourage
hospitals to improve their
documentation and coding of patient
diagnoses.
In the FY 2008 IPPS final rule with
comment period (72 FR 47175 through
47186), we indicated that the adoption
of the MS–DRGs had the potential to
lead to increases in aggregate payments
without a corresponding increase in
actual patient severity of illness due to
the incentives for additional
documentation and coding. In that final
rule with comment period, we exercised
our authority under section
1886(d)(3)(A)(vi) of the Act, which
authorizes us to maintain budget
neutrality by adjusting the national
standardized amount, to eliminate the
estimated effect of changes in coding or
classification that do not reflect real
changes in case-mix. Our actuaries
estimated that maintaining budget
neutrality required an adjustment of
¥4.8 percentage points to the national
standardized amount. We provided for
phasing in this ¥4.8 percentage point
adjustment over 3 years. Specifically,
we established prospective
documentation and coding adjustments
of ¥1.2 percentage points for FY 2008,
¥1.8 percentage points for FY 2009,
and ¥1.8 percentage points for FY
2010.
On September 29, 2007, Congress
enacted the TMA [Transitional Medical
Assistance], Abstinence Education, and
QI [Qualifying Individuals] Programs
Extension Act of 2007 (Pub. L. 110–90).
Section 7(a) of Public Law 110–90
reduced the documentation and coding
adjustment made as a result of the MS–
DRG system that we adopted in the FY
2008 IPPS final rule with comment
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period to ¥0.6 percentage point for FY
2008 and ¥0.9 percentage point for FY
2009.
As discussed in prior year
rulemakings, and most recently in the
FY 2017 IPPS/LTCH PPS final rule (81
FR 56780 through 56782), we
implemented a series of adjustments
required under sections 7(b)(1)(A) and
7(b)(1)(B) of Public Law 110–90, based
on a retrospective review of FY 2008
and FY 2009 claims data. We completed
these adjustments in FY 2013, but
indicated in the FY 2013 IPPS/LTCH
PPS final rule (77 FR 53274 through
53275) that delaying full
implementation of the adjustment
required under section 7(b)(1)(A) of
Public Law 110–90 until FY 2013
resulted in payments in FY 2010
through FY 2012 being overstated, and
that these overpayments could not be
recovered under Public Law 110–90.
In addition, as discussed in prior
rulemakings and most recently in the
FY 2018 IPPS/LTCH PPS final rule (82
FR 38008 through 38009), section 631 of
the ATRA amended section 7(b)(1)(B) of
Public Law 110–90 to require the
Secretary to make a recoupment
adjustment or adjustments totaling $11
billion by FY 2017. This adjustment
represented the amount of the increase
in aggregate payments as a result of not
completing the prospective adjustment
authorized under section 7(b)(1)(A) of
Public Law 110–90 until FY 2013.
2. Adjustment Made for FY 2018 as
Required Under Section 414 of Public
Law 114–10 (MACRA) and Section
15005 of Public Law 114–255
As stated in the FY 2017 IPPS/LTCH
PPS final rule (81 FR 56785), once the
recoupment required under section 631
of the ATRA was complete, we had
anticipated making a single positive
adjustment in FY 2018 to offset the
reductions required to recoup the $11
billion under section 631 of the ATRA.
However, section 414 of the MACRA
(which was enacted on April 16, 2015)
replaced the single positive adjustment
we intended to make in FY 2018 with
a 0.5 percentage point positive
adjustment for each of FYs 2018 through
2023. In the FY 2017 rulemaking, we
indicated that we would address the
adjustments for FY 2018 and later fiscal
years in future rulemaking. Section
15005 of the 21st Century Cures Act
(Pub. L. 114–255), which was enacted
on December 13, 2016, amended section
7(b)(1)(B) of the TMA, as amended by
section 631 of the ATRA and section
414 of the MACRA, to reduce the
adjustment for FY 2018 from a 0.5
percentage point to a 0.4588 percentage
point. As we discussed in the FY 2018
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rulemaking, we believe the directive
under section 15005 of Public Law 114–
255 is clear. Therefore, in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38009)
for FY 2018, we implemented the
required +0.4588 percentage point
adjustment to the standardized amount.
This is a permanent adjustment to
payment rates. While we did not
address future adjustments required
under section 414 of the MACRA and
section 15005 of Public Law 114–255 at
that time, we stated that we expected to
propose positive 0.5 percentage point
adjustments to the standardized
amounts for FYs 2019 through 2023.
the proposed MS–DRG relative weights
for FY 2019 is included in section II.G.
of the preamble to this FY 2019 IPPS/
LTCH PPS proposed rule. As we did
with the FY 2018 IPPS/LTCH PPS final
rule, for this proposed rule, we are
providing the version of the HCRIS from
which we calculated these proposed 19
CCRs on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/. Click on
the link on the left side of the screen
titled ‘‘FY 2019 IPPS Proposed Rule
Home Page’’ or ‘‘Acute Inpatient Files
for Download.’’
3. Proposed Adjustment for FY 2019
F. Proposed Changes to Specific MS–
DRG Classifications
Consistent with the requirements of
section 414 of the MACRA, we are
proposing to implement a positive 0.5
percentage point adjustment to the
standardized amount for FY 2019. This
would be a permanent adjustment to
payment rates. We plan to propose
future adjustments required under
section 414 of the MACRA for FYs 2020
through 2023 in future rulemaking.
E. Refinement of the MS–DRG Relative
Weight Calculation
1. Background
Beginning in FY 2007, we
implemented relative weights for DRGs
based on cost report data instead of
charge information. We refer readers to
the FY 2007 IPPS final rule (71 FR
47882) for a detailed discussion of our
final policy for calculating the
cost-based DRG relative weights and to
the FY 2008 IPPS final rule with
comment period (72 FR 47199) for
information on how we blended relative
weights based on the CMS DRGs and
MS–DRGs. We also refer readers to the
FY 2017 IPPS/LTCH PPS final rule (81
FR 56785 through 56787) for a detailed
discussion of the history of changes to
the number of cost centers used in
calculating the DRG relative weights.
Since FY 2014, we calculate the IPPS
MS–DRG relative weights using 19
CCRs, which now include distinct CCRs
for implantable devices, MRIs, CT scans,
and cardiac catheterization.
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2. Discussion of Policy for FY 2019
Consistent with our established
policy, we are calculating the proposed
MS–DRG relative weights for FY 2019
using two data sources: The MedPAR
file as the claims data source and the
HCRIS as the cost report data source.
We adjusted the charges from the claims
to costs by applying the 19 national
average CCRs developed from the cost
reports. The description of the
calculation of the proposed 19 CCRs and
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1. Discussion of Changes to Coding
System and Basis for Proposed FY 2019
MS–DRG Updates
a. Conversion of MS–DRGs to the
International Classification of Diseases,
10th Revision (ICD–10)
As of October 1, 2015, providers use
the International Classification of
Diseases, 10th Revision (ICD–10) coding
system to report diagnoses and
procedures for Medicare hospital
inpatient services under the MS–DRG
system instead of the ICD–9–CM coding
system, which was used through
September 30, 2015. The ICD–10 coding
system includes the International
Classification of Diseases, 10th
Revision, Clinical Modification (ICD–
10–CM) for diagnosis coding and the
International Classification of Diseases,
10th Revision, Procedure Coding
System (ICD–10–PCS) for inpatient
hospital procedure coding, as well as
the ICD–10–CM and ICD–10–PCS
Official Guidelines for Coding and
Reporting. For a detailed discussion of
the conversion of the MS–DRGs to ICD–
10, we refer readers to the FY 2017
IPPS/LTCH PPS final rule (81 FR 56787
through 56789).
b. Basis for Proposed FY 2019 MS–DRG
Updates
CMS has previously encouraged input
from our stakeholders concerning the
annual IPPS updates when that input
was made available to us by December
7 of the year prior to the next annual
proposed rule update. As discussed in
the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38010), as we work with the
public to examine the ICD–10 claims
data used for updates to the ICD–10 MS
DRGs, we would like to examine areas
where the MS–DRGs can be improved,
which will require additional time for
us to review requests from the public to
make specific updates, analyze claims
data, and consider any proposed
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updates. Given the need for more time
to carefully evaluate requests and
propose updates, we changed the
deadline to request updates to the MS–
DRGs to November 1 of each year. This
will provide an additional 5 weeks for
the data analysis and review process.
Interested parties had to submit any
comments and suggestions for FY 2019
by November 1, 2017, and are
encouraged to submit any comments
and suggestions for FY 2020 by
November 1, 2018 via the CMS MS–
DRG Classification Change Request
Mailbox located at:
MSDRGClassificationChange@
cms.hhs.gov. The comments that were
submitted in a timely manner for FY
2019 are discussed in this section of the
preamble of this proposed rule.
Following are the changes that we are
proposing to the MS–DRGs for FY 2019
in this FY 2019 IPPS/LTCH PPS
proposed rule. 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.
For this FY 2019 IPPS/LTCH PPS
proposed rule, our MS–DRG analysis
was based on ICD–10 claims data from
the September 2017 update of the FY
2017 MedPAR file, which contains
hospital bills received through
September 30, 2017, for discharges
occurring through September 30, 2017.
In our discussion of the proposed MS–
DRG reclassification changes, we refer
to our analysis of claims data from the
‘‘September 2017 update of the FY 2017
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
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between the cases we select for review
and the remainder of cases in the MS–
DRG. We also consider variation in costs
within these groups; that is, whether
observed average differences are
consistent across patients or attributable
to cases that are extreme in terms of
costs or length of stay, or both. Further,
we consider the number of patients who
will have a given set of characteristics
and generally prefer not to create a new
MS–DRG unless it would include a
substantial number of cases.
In our examination of the claims data,
we apply the following criteria
established in FY 2008 (72 FR 47169) to
determine if the creation of a new
complication or comorbidity (CC) or
major complication or comorbidity
(MCC) subgroup within a base MS–DRG
is warranted:
• A reduction in variance of costs of
at least 3 percent;
• At least 5 percent of the patients in
the MS–DRG fall within the CC or MCC
subgroup;
• At least 500 cases are in the CC or
MCC subgroup;
• There is at least a 20-percent
difference in average costs between
subgroups; and
• There is a $2,000 difference in
average costs between subgroups.
In order to warrant creation of a CC
or MCC subgroup within a base MS–
DRG, the subgroup must meet all five of
the criteria.
2. Pre-MDC
a. Heart Transplant or Implant of Heart
Assist System
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38012), we stated our intent
to review the ICD–10 logic for Pre-MDC
MS–DRGs 001 and 002 (Heart
Transplant or Implant of Heart Assist
System with and without MCC,
respectively), as well as MS–DRG 215
ICD–10–PCS
code
02HA0QZ .............
02HA3QZ .............
02HA4QZ .............
Code description
Insertion of implantable heart assist system into heart, open approach.
Insertion of implantable heart assist system into heart, percutaneous approach.
Insertion of implantable heart assist system into heart, percutaneous endoscopic approach.
In addition to these three procedure
codes, there are also 33 pairs of code
combinations or procedure code
‘‘clusters’’ that, when reported together,
satisfy the logic for assignment to MS–
DRGs 001 and 002. The code
combinations are represented by two
procedure codes and include either one
code for the insertion of the device with
one code for removal of the device or
Code
Code description
02HA0RS ...........
Insertion of biventricular short-term external
heart assist system into heart, open approach.
Insertion of biventricular short-term external
heart assist system into heart, open approach.
Insertion of biventricular short-term external
heart assist system into heart, open approach.
Insertion of short-term external heart assist
system into heart, open approach.
Insertion of short-term external heart assist
system into heart, open approach.
Insertion of short-term external heart assist
system into heart, open approach.
Insertion of biventricular
heart assist system into
approach.
Insertion of biventricular
heart assist system into
approach.
Insertion of biventricular
heart assist system into
approach.
Insertion of biventricular
heart assist system into
endoscopic approach.
02HA0RS ...........
02HA0RS ...........
02HA0RZ ...........
02HA0RZ ...........
02HA0RZ ...........
02HA3RS ...........
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02HA3RS ...........
02HA3RS ...........
02HA4RS ...........
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(Other Heart Assist System Implant) and
MS–DRGs 268 and 269 (Aortic and
Heart Assist Procedures Except
Pulsation Balloon with and without
MCC, respectively) where procedures
involving heart assist devices are
currently assigned. We also encouraged
the public to submit any comments on
restructuring the MS–DRGs for heart
assist system procedures to the CMS
MS–DRG Classification Change Request
Mailbox located at:
MSDRGClassificationChange@
cms.hhs.gov by November 1, 2017.
The logic for Pre-MDC MS–DRGs 001
and 002 is comprised of two lists. The
first list includes procedure codes
identifying a heart transplant procedure,
and the second list includes procedure
codes identifying the implantation of a
heart assist system. The list of
procedure codes identifying the
implantation of a heart assist system
includes the following three codes.
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one code for the revision of the device
with one code for the removal of the
device. The 33 pairs of code
combinations are listed below.
Code
Code description
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, open approach.
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
with
02PA4RZ ..........
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
short-term external
heart, percutaneous
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
short-term external
heart, percutaneous
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
short-term external
heart, percutaneous
with
02PA4RZ ..........
short-term external
heart, percutaneous
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
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Code
Code description
02HA4RS ...........
Insertion of biventricular short-term external
heart assist system into heart, percutaneous
endoscopic approach.
Insertion of biventricular short-term external
heart assist system into heart, percutaneous
endoscopic approach.
Insertion of short-term external heart assist
system into heart, percutaneous endoscopic
approach.
Insertion of short-term external heart assist
system into heart, percutaneous endoscopic
approach.
Insertion of short-term external heart assist
system into heart, percutaneous endoscopic
approach.
Revision of implantable heart assist system in
heart, open approach.
Revision of implantable heart assist system in
heart, open approach.
Revision of implantable heart assist system in
heart, open approach.
02HA4RS ...........
02HA4RZ ...........
02HA4RZ ...........
02HA4RZ ...........
02WA0QZ ..........
02WA0QZ ..........
02WA0QZ ..........
02WA0RZ ...........
02WA0RZ ...........
02WA0RZ ...........
02WA3QZ ..........
02WA3QZ ..........
02WA3QZ ..........
02WA3RZ ...........
02WA3RZ ...........
02WA3RZ ...........
02WA4QZ ..........
02WA4QZ ..........
02WA4QZ ..........
02WA4RZ ...........
02WA4RZ ...........
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02WA4RZ ...........
Code
Code description
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
with
02PA4RZ ..........
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
with
02PA4RZ ..........
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
external heart assist
approach.
external heart assist
approach.
external heart assist
approach.
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
Revision of implantable heart assist system in
heart, percutaneous approach.
Revision of implantable heart assist system in
heart, percutaneous approach.
Revision of implantable heart assist system in
heart, percutaneous approach.
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
Revision
system
Revision
system
Revision
system
of short-term external heart assist
in heart, percutaneous approach.
of short-term external heart assist
in heart, percutaneous approach.
of short-term external heart assist
in heart, percutaneous approach.
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
Revision of implantable heart assist system in
heart, percutaneous endoscopic approach.
Revision of implantable heart assist system in
heart, percutaneous endoscopic approach.
Revision of implantable heart assist system in
heart, percutaneous endoscopic approach.
with
02PA0RZ ..........
with
02PA3RZ ..........
with
02PA4RZ ..........
Revision of
system in
approach.
Revision of
system in
approach.
Revision of
system in
approach.
short-term external heart assist
heart, percutaneous endoscopic
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
short-term external heart assist
heart, percutaneous endoscopic
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
short-term external heart assist
heart, percutaneous endoscopic
with
02PA4RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
2018 IPPS/LTCH PPS final rule (82 FR
38011 through 38012) involving MS–
DRG 215 (Other Heart Assist System
Implant), the commenters provided
examples of common clinical scenarios
involving a left ventricular assist device
(LVAD) and included the procedure
codes that were reported under the ICD–
9 based MS–DRGs in comparison to the
procedure codes reported under the
ICD–10 MS–DRGs, which are reflected
in the following table.
Revision
system
Revision
system
Revision
system
of short-term
in heart, open
of short-term
in heart, open
of short-term
in heart, open
In response to our solicitation for
public comments on restructuring the
MS–DRGs for heart assist system
procedures, commenters recommended
that CMS maintain the current logic
under the Pre-MDC MS–DRGs 001 and
002. Similar to the discussion in the FY
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Procedure
ICD–9–CM
procedure code
New LVAD inserted ..........
37.66 (Insertion of
implantable heart assist
system).
001 or 002
LVAD Exchange—existing
LVAD is removed and
replaced with either new
LVAD system or new
LVAD pump.
37.63 (Repair of heart assist system).
215
LVAD revision and repair—existing LVAD is
adjusted or repaired
without removing the existing LVAD device.
37.63 (Repair of heart assist system).
215
The commenters noted that, for PreMDC MS–DRGs 001 and 002, the
procedures involving the insertion of an
implantable heart assist system, such as
the insertion of a LVAD, and the
procedures involving exchange of an
LVAD (where an existing LVAD is
removed and replaced with either a new
LVAD or a new LVAD pump)
demonstrate clinical similarities and
utilize similar resources. Although the
commenters recommended that CMS
maintain the current logic under the
Pre-MDC MS–DRGs 001 and 002, they
also recommended that CMS continue
to monitor the data in these MS–DRGs
for future consideration of distinctions
(for example, different approaches and
evolving technologies) that may impact
the clinical and resource use of patients
undergoing procedures utilizing heart
assist devices. The commenters also
ICD–9
MS–DRG
ICD–10
MS–DRG
ICD–10–PCS codes
02WA0QZ (Insertion of implantable heart assist system into heart, open approach).
02WA3QZ (Insertion of implantable heart assist system into heart, percutaneous approach).
02WA4QZ (Insertion of implantable heart assist system into heart, percutaneous endoscopic approach).
02PA0QZ (Removal of implantable heart assist system from heart, open approach).
02PA3QZ (Removal of implantable heart assist system from heart, percutaneous approach).
02PA4QZ (Removal of implantable heart assist system from heart, percutaneous endoscopic approach) and.
02WA0QZ (Insertion of implantable heart assist system into heart, open approach).
02WA3QZ (Insertion of implantable heart assist system into heart, percutaneous approach).
02WA4QZ (Insertion of implantable heart assist system into heart, percutaneous endoscopic approach).
02WA0QZ (Revision of implantable heart assist system in heart, open approach).
02WA3QZ (Revision of implantable heart assist system in heart, percutaneous approach).
02WA4QZ (Revision of implantable heart assist system in heart, percutaneous endoscopic approach).
requested that coding guidance be
issued for assignment of the correct
ICD–10–PCS procedure codes
describing LVAD exchanges to
encourage accurate reporting of these
procedures.
We agree with the commenters that
we should continue to monitor the data
in Pre-MDC MS–DRGs 001 and 002 for
future consideration of distinctions (for
example, different approaches and
evolving technologies) that may impact
the clinical and resource use of patients
undergoing procedures utilizing heart
assist devices. In response to the request
that coding guidance be issued for
assignment of the correct ICD–10–PCS
procedure codes describing LVAD
exchanges to encourage accurate
reporting of these procedures, as we
noted in the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38012), coding advice
001 or 002
001 or 002
215
is issued independently from payment
policy. We also noted that, historically,
we have not provided coding advice in
rulemaking with respect to policy (82
FR 38045). We collaborate with the
American Hospital Association (AHA)
through the Coding Clinic for ICD–10–
CM and ICD–10–PCS to promote proper
coding. We recommend that the
requestor and other interested parties
submit any questions pertaining to
correct coding for these technologies to
the AHA.
In response to the public comments
we received on this topic, we are
providing the results of our claims
analysis from the September 2017
update of the FY 2017 MedPAR file for
cases in Pre-MDC MS–DRGs 001 and
002. Our findings are shown in the
following table.
MS–DRGS FOR HEART TRANSPLANT OR IMPLANT OF HEART ASSIST SYSTEM
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 001—All cases ............................................................................................................
MS–DRG 002—All cases ............................................................................................................
As shown in this table, for MS–DRG
001, there were a total of 1,993 cases
with an average length of stay of 35.6
days and average costs of $185,660. For
MS–DRG 002, there were a total of 179
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
cases with an average length of stay of
18.3 days and average costs of $99,635.
We then examined claims data in PreMDC MS–DRGs 001 and 002 for cases
that reported one of the three procedure
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
1,993
179
Average
length
of stay
35.6
18.3
Average
costs
$185,660
99,635
codes identifying the implantation of a
heart assist system such as the LVAD.
Our findings are shown in the following
table.
E:\FR\FM\07MYP2.SGM
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MS–DRGS FOR HEART TRANSPLANT OR IMPLANT OF HEART ASSIST SYSTEM
MS–DRG 001—All cases ............................................................................................................
MS–DRG 001—Cases with procedure code 02HA0QZ (Insertion of implantable heart assist
system into heart, open approach) ..........................................................................................
MS–DRG 001—Cases with procedure code 02HA3QZ (Insertion of implantable heart assist
system into heart, percutaneous approach) ............................................................................
MS–DRG 001—Cases with procedure code 02HA4QZ (Insertion of implantable heart assist
system into heart, percutaneous endoscopic approach) .........................................................
MS–DRG 002—All cases ............................................................................................................
MS–DRG 002—Cases with procedure code 02HA0QZ (Insertion of implantable heart assist
system into heart, open approach) ..........................................................................................
MS–DRG 002—Cases with procedure code 02HA3QZ (Insertion of implantable heart assist
system into heart, percutaneous approach) ............................................................................
MS–DRG 002—Cases with procedure code 02HA4QZ (Insertion of implantable heart assist
system into heart, percutaneous endoscopic approach) .........................................................
As shown in this table, for MS–DRG
001, there were a total of 1,260 cases
reporting procedure code 02HA0QZ
(Insertion of implantable heart assist
system into heart, open approach) with
an average length of stay of 35.5 days
and average costs of $206,663. There
was one case that reported procedure
code 02HA3QZ (Insertion of
implantable heart assist system into
heart, percutaneous approach) with an
average length of stay of 8 days and
average costs of $33,889. There were no
cases reporting procedure code
02HA4QZ (Insertion of implantable
Average
length
of stay
Number
of cases
MS–DRG
heart assist system into heart,
percutaneous endoscopic approach). For
MS–DRG 002, there were a total of 82
cases reporting procedure code
02HA0QZ (Insertion of implantable
heart assist system into heart, open
approach) with an average length of stay
of 19.9 days and average costs of
$131,957. There were no cases reporting
procedure codes 02HA3QZ (Insertion of
implantable heart assist system into
heart, percutaneous approach) or
02HA4QZ (Insertion of implantable
heart assist system into heart,
percutaneous endoscopic approach).
Average
costs
1,993
35.6
$185,660
1,260
35.5
206,663
1
8
33,889
0
179
0
18.3
0
99,635
82
19.9
131,957
0
0
0
0
0
0
We also examined the cases in MS–
DRGs 001 and 002 that reported one of
the possible 33 pairs of code
combinations or clusters. Our findings
are shown in the following 8 tables. The
first table provides the total number of
cases reporting a procedure code
combination (or cluster) compared to all
of the cases in the respective MS–DRG,
followed by additional detailed tables
showing the number of cases, average
length of stay, and average costs for each
specific code combination that was
reported in the claims data.
HEART TRANSPLANT OR IMPLANT OF HEART ASSIST SYSTEM
MS–DRG
MS–DRG
MS–DRG
MS–DRG
Average
length
of stay
Number
of cases
MS–DRG 001 and 002
001—All cases ............................................................................................................
001—Cases with a procedure code combination (cluster) .........................................
002—All cases ............................................................................................................
002—Cases with a procedure code combination (cluster) .........................................
1,993
149
179
6
Average
costs
35.6
28.4
18.3
3.8
$185,660
179,607
99,635
57,343
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
daltland on DSKBBV9HB2PROD with PROPOSALS2
Cases with a procedure code combination of 02HA0RS (Insertion of biventricular short-term
external heart assist system into heart, open approach) with 02PA0RZ (Removal of shortterm external heart assist system from heart, open approach) ..............................................
Cases with a procedure code combination of 02HA0RS (Insertion of biventricular short-term
external heart assist system into heart, open approach) with 02PA3RZ (Removal of shortterm external heart assist system from heart, percutaneous approach) .................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
VerDate Sep<11>2014
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Jkt 244001
PO 00000
Average
length
of stay
Number
of cases
MS–DRG 001
Frm 00019
Fmt 4701
Sfmt 4702
E:\FR\FM\07MYP2.SGM
Average
costs
3
20.3
$121,919
2
5
12
17
114,688
119,027
07MYP2
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PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
Average
length
of stay
Number
of cases
Average
costs
MS–DRG 001
Cases with a procedure code combination of 02HA0RZ (Insertion of short-term external heart
assist system into heart, open approach) with 02PA0RZ (Removal of short-term external
heart assist system from heart, open approach) .....................................................................
Cases with a procedure code combination of 02HA0RZ (Insertion of short-term external heart
assist system into heart, open approach) with 02PA3RZ (Removal of short-term external
heart assist system from heart, percutaneous approach) .......................................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
30
55.6
$351,995
19
49
29.8
45.6
191,163
289,632
1
4
48,212
2
3
4.5
4.3
66,386
60,328
52
43.3
276,403
MS–DRG 002
Cases with a procedure code combination of 02HA0RZ (Insertion of short-term external heart
assist system into heart, open approach) with 02PA0RZ (Removal of short-term external
heart assist system from heart, open approach) .....................................................................
Cases with a procedure code combination of 02HA0RZ (Insertion of short-term external heart
assist system into heart, open approach) with 02PA3RZ (Removal of short-term external
heart assist system from heart, percutaneous approach) .......................................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 002
All cases reporting one or more of the above procedure code combinations across both MS–
DRGs 001 and 002 ..................................................................................................................
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
Average
length
of stay
Number
of cases
Average
costs
MS–DRG 001
Cases with a procedure code combination of 02HA3RS (Insertion of biventricular short-term
external heart assist system into heart, percutaneous approach) with 02PA0RZ (Removal
of short-term external heart assist system from heart, open approach) .................................
Cases with a procedure code combination of 02HA3RS (Insertion of biventricular short-term
external heart assist system into heart, percutaneous approach) with 02PA3RZ (Removal
of short-term external heart assist system from heart, percutaneous approach) ...................
Cases with a procedure code combination of 02HA3RS (Insertion of biventricular short-term
external heart assist system into heart, percutaneous approach) with 02PA4RZ (Removal
of short-term external heart assist system from heart, percutaneous endoscopic approach)
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
3
43.3
$233,330
24
14.8
113,955
1
28
44
18.9
153,284
128,150
2
2
4
4
$30,954
30,954
30
17.9
121,670
MS–DRG 002
Cases with a procedure code combination of 02HA3RS (Insertion of biventricular short-term
external heart assist system into heart, percutaneous approach) with 02PA3RZ (Removal
of short-term external heart assist system from heart, percutaneous approach) ...................
All cases reporting one of the above procedure code combinations in MS–DRG 002 ..............
All cases reporting one or more of the above procedure code combinations across both
MS-DRGs 001 and 002 ...........................................................................................................
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
daltland on DSKBBV9HB2PROD with PROPOSALS2
Cases with a procedure code combination of 02HA4RZ (Insertion of short-term external heart
assist system into heart, percutaneous endoscopic approach) with 02PA3RZ (Removal of
short-term external heart assist system from heart, percutaneous approach) .......................
Cases with a procedure code combination of 02HA4RZ (Insertion of short-term external heart
assist system into heart, open approach) with 02PA4RZ (Removal of short-term external
heart assist system from heart, percutaneous endoscopic approach) ....................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
PO 00000
Average
length
of stay
Number
of cases
MS–DRG 001
Frm 00020
Fmt 4701
Sfmt 4702
E:\FR\FM\07MYP2.SGM
Average
costs
4
17.3
$154,885
2
6
15.5
16.7
80,852
130,207
07MYP2
20183
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
Average
length
of stay
Number
of cases
MS–DRG 001
Cases with a procedure code combination of 02WA0QZ (Revision of implantable heart assist
system in heart, open approach) with 02PA0RZ (Removal of short-term external heart assist system from heart, open approach) ..................................................................................
1
Average
costs
105
$516,557
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
Average
length
of stay
Number
of cases
MS–DRG 001
Cases with a procedure code combination of 02WA0RZ (Revision of short-term external
heart assist system in heart, open approach) with 02PA0RZ (Removal of short-term external heart assist system from heart, open approach) ...............................................................
Cases with a procedure code combination of 02WA0RZ (Revision of short-term external
heart assist system in heart, open approach) with 02PA03Z (Removal of short-term external heart assist system from heart, percutaneous approach) .................................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
Average
costs
2
40
$285,818
1
3
43
41
372,673
314,770
PROCEDURE CODE COMBINATIONS FOR IMPLANT OF HEART ASSIST SYSTEM
Average
length
of stay
Number
of cases
Average
costs
MS–DRG 001
Cases with a procedure code combination of 02WA3RZ (Revision of short-term external
heart assist system in heart, percutaneous approach) with 02PA0RZ (Removal of shortterm external heart assist system from heart, open approach) ..............................................
Cases with a procedure code combination of 02WA3RZ (Revision of short-term external
heart assist system in heart, percutaneous approach) with 02PA3RZ (Removal of shortterm external heart assist system from heart, percutaneous approach) .................................
All cases reporting one or more of the above procedure code combinations in MS–DRG 001
2
24
$123,084
55
57
14.7
15
104,963
105,599
1
2
101,168
58
14.8
105,522
1
10
112,698
MS–DRG 002
Cases with a procedure code combination of 02WA3RZ (Revision of short-term external
heart assist system in heart, percutaneous approach) with 02PA3RZ (Removal of shortterm external heart assist system from heart, percutaneous approach) .................................
All cases reporting one or more of the above procedure code combinations across both MS–
DRGs 001 and 002 ..................................................................................................................
MS–DRG 001
Cases with a procedure code combination of 02WA4RZ (Revision of short-term external
heart assist system in heart, percutaneous endoscopic approach) with 02PA0RZ (Removal
of short-term external heart assist system from heart, open approach) .................................
We did not find any cases reporting
the following procedure code
02HA4RS ...........
daltland on DSKBBV9HB2PROD with PROPOSALS2
02HA4RS ...........
02HA4RS ...........
02WA3QZ ..........
02WA3QZ ..........
VerDate Sep<11>2014
combinations (clusters) in the claims
data.
Insertion of biventricular short-term external
heart assist system into heart, percutaneous
endoscopic approach.
Insertion of biventricular short-term external
heart assist system into heart, percutaneous
endoscopic approach.
Insertion of biventricular short-term external
heart assist system into heart, percutaneous
endoscopic approach.
Revision of implantable heart assist system in
heart, percutaneous approach.
Revision of implantable heart assist system in
heart, percutaneous approach.
20:30 May 04, 2018
Jkt 244001
PO 00000
Frm 00021
with
02PA0RZ ..........
Removal of short-term external heart assist
system from heart, open approach.
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous approach.
with
02PA4RZ ..........
with
02PA0RZ ..........
with
02PA3RZ ..........
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
Removal of short-term external heart assist
system from heart, open approach.
Removal of short-term external heart assist
system from heart, percutaneous approach.
Fmt 4701
Sfmt 4702
E:\FR\FM\07MYP2.SGM
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
02WA3QZ ..........
Revision of implantable heart assist system in
heart, percutaneous approach.
The data show that there are
differences in the average length of stay
and average costs for cases in Pre-MDC
MS–DRGs 001 and 002 according to the
type of procedure (insertion, revision, or
removal), the type of device
(biventricular short-term external heart
assist system, short-term external heart
assist system or implantable heart assist
system), and the approaches that were
utilized (open, percutaneous, or
percutaneous endoscopic). We agree
with the commenters’ recommendation
to maintain the structure of Pre-MDC
MS–DRGs 001 and 002 for FY 2019 and
with
02PA4RZ ..........
will continue to analyze the claims data.
We are inviting public comments on our
decision to maintain the current
structure of Pre-MDC MS–DRGs 001 and
002 for FY 2019.
Commenters also suggested that CMS
maintain the current logic for MS–DRG
215 (Other Heart Assist System
Implant), but they recommended that
CMS continue to monitor the data in
MS–DRG 215 for future consideration of
distinctions (for example, different
approaches and evolving technologies)
that may impact the clinical and
resource use of procedures utilizing
heart assist devices. We also received a
Removal of short-term external heart assist
system from heart, percutaneous endoscopic
approach.
request to review claims data for
procedures involving extracorporeal
membrane oxygenation (ECMO) in
combination with the insertion of a
percutaneous short-term external heart
assist device to determine if the current
MS–DRG assignment is appropriate.
The logic for MS–DRG 215 is
comprised of the procedure codes
shown in the following table, for which
we examined claims data in the
September 2017 update of the FY 2017
MedPAR file in response to the
commenters’ requests. Our findings are
shown in the following table.
MS–DRG 215
[Other heart assist system implant]
Average
length
of stay
daltland on DSKBBV9HB2PROD with PROPOSALS2
Number
of cases
All cases ......................................................................................................................................
Cases with procedure code 02HA0RJ (Insertion of short-term external heart assist system
into heart, intraoperative, open approach) ...............................................................................
Cases with procedure code 02HA0RS (Insertion of biventricular short-term external heart assist system into heart, open approach) ...................................................................................
Cases with procedure code 02HA0RZ (Insertion of short-term external heart assist system
into heart, open approach) .......................................................................................................
Cases with procedure code 02HA3RJ (Insertion of short-term external heart assist system
into heart, intraoperative, percutaneous approach) .................................................................
Cases with procedure code 02HA3RS (Insertion of biventricular short-term external heart assist system into heart, percutaneous approach) ......................................................................
Cases with procedure code 02HA3RZ (Insertion of short-term external heart assist system
into heart, percutaneous approach) .........................................................................................
Cases with procedure code 02HA4RJ (Insertion of short-term external heart assist system
into heart, intraoperative, percutaneous endoscopic approach) .............................................
Cases with procedure code 02HA4RS (Insertion of biventricular short-term external heart assist system into heart, percutaneous endoscopic approach) ..................................................
Cases with procedure code 02HA4RZ (Insertion of short-term external heart assist system
into heart, percutaneous endoscopic approach) .....................................................................
Cases with procedure code 02WA0JZ (Revision of synthetic substitute in heart, open approach) .....................................................................................................................................
Cases with procedure code 02WA0QZ (Revision of implantable heart assist system in heart,
open approach) ........................................................................................................................
Cases with procedure code 02WA0RS (Revision of biventricular short-term external heart assist system in heart, open approach) ......................................................................................
Cases with procedure code 02WA0RZ (Revision of short-term external heart assist system in
heart, open approach) ..............................................................................................................
Cases with procedure code 02WA3QZ (Revision of implantable heart assist system in heart,
percutaneous approach) ..........................................................................................................
Cases with procedure code 02WA3RS (Revision of biventricular short-term external heart assist system in heart, percutaneous approach) .........................................................................
Cases with procedure code 02WA3RZ (Revision of short-term external heart assist system in
heart, percutaneous approach) ................................................................................................
Cases with procedure code 02WA4QZ (Revision of implantable heart assist system in heart,
percutaneous endoscopic approach) .......................................................................................
Cases with procedure code 02WA4RS (Revision of biventricular short-term external heart assist system in heart, percutaneous endoscopic approach) .....................................................
Cases with procedure code 02WA4RZ (Revision of short-term external heart assist system in
heart, percutaneous endoscopic approach) ............................................................................
As shown in this table, for MS–DRG
215, we found a total of 3,428 cases with
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
an average length of stay of 8.7 days and
average costs of $68,965. For procedure
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
Average
costs
3,428
8.7
$68,965
0
0
0
9
10
118,361
66
11.5
99,107
0
0
0
117
7.2
64,302
3,136
8.4
67,670
0
0
0
1
2
43,988
31
5.3
57,042
1
84
366,089
56
25.1
123,410
0
0
0
8
13.5
99,378
0
0
0
0
0
0
80
10
71,077
0
0
0
0
0
0
0
0
0
codes describing the insertion of a
biventricular short-term external heart
E:\FR\FM\07MYP2.SGM
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
assist system with open, percutaneous
or percutaneous endoscopic approaches,
we found a total of 127 cases with an
average length of stay ranging from 2 to
10 days and average costs ranging from
$43,988 to $118,361. For procedure
codes describing the insertion of a shortterm external heart assist system with
open, percutaneous or percutaneous
endoscopic approaches, we found a
total of 3,233 cases with an average
length of stay ranging from 5.3 days to
11.5 days and average costs ranging
from $57,042 to $99,107. For procedure
codes describing the revision of a shortterm external heart assist system with
open or percutaneous approaches, we
found a total of 88 cases with an average
length of stay ranging from 10 to 13.5
days and average costs ranging from
$71,077 to $99,378. We found 1 case
reporting procedure code 02WA0JZ
(Revision of synthetic substitute in
heart, open approach), with an average
length of stay of 84 days and average
costs of $366,089. Lastly, we found 56
cases reporting procedure code
02WA0QZ (Revision of implantable
heart assist system in heart, open
approach) with an average length of stay
of 25.1 days and average costs of
$123,410.
As the data show, there is a wide
range in the average length of stay and
the average costs for cases reporting
procedures that involve a biventricular
short-term external heart assist system
versus a short-term external heart assist
system. There is an even greater range
in the average length of stay and the
average costs when comparing the
revision of a short-term external heart
assist system to the revision of a
synthetic substitute in the heart or to the
revision an implantable heart assist
system.
We agree with the commenters that
continued monitoring of the data and
further analysis is necessary prior to
proposing any modifications to MS–
DRG 215. As stated in the FY 2018
IPPS/LTCH PPS final rule (82 FR
38012), we are aware that the AHA
ICD–10–PCS
code
02HA0RJ ..............
02HA3RJ ..............
02HA4RJ ..............
published Coding Clinic advice that
clarified coding and reporting for
certain external heart assist devices due
to the technology being approved for
new indications. The current claims
data do not yet reflect that updated
guidance. We also note that there have
been recent updates to the descriptions
of the codes for heart assist devices in
the past year. For example, the qualifier
‘‘intraoperative’’ was added effective
October 1, 2017 (FY 2018) to the
procedure codes describing the
insertion of short-term external heart
assist system procedures to distinguish
between procedures where the device
was only used intraoperatively and was
removed at the conclusion of the
procedure versus procedures where the
device was not removed at the
conclusion of the procedure and for
which that qualifier would not be
reported. The current claims data do not
yet reflect these new procedure codes,
which are displayed in the following
table and are assigned to MS–DRG 215.
Code description
Insertion of short-term external heart assist system into heart, intraoperative, open approach.
Insertion of short-term external heart assist system into heart, intraoperative, percutaneous approach.
Insertion of short-term external heart assist system into heart, intraoperative, percutaneous endoscopic approach.
Our clinical advisors agree that
additional claims data are needed for
analysis prior to proposing any changes
to MS–DRG 215. Therefore, we are
proposing not to make any
modifications to MS–DRG 215 for FY
2019. We are inviting public comments
on our proposal.
As stated earlier in this section, we
also received a request to review cases
reporting the use of ECMO in
combination with the insertion of a
percutaneous short-term external heart
assist device. Under ICD–10–PCS,
ECMO is identified with procedure code
5A15223 (Extracorporeal membrane
oxygenation, continuous) and the
insertion of a percutaneous short-term
external heart assist device is identified
with procedure code 02HA3RZ
(Insertion of short-term external heart
assist system into heart, percutaneous
approach). According to the commenter,
when ECMO procedures are performed
percutaneously, they are less invasive
and less expensive than traditional
ECMO. The commenter also noted that,
currently under ICD–10–PCS, there is
not a specific procedure code to identify
percutaneous ECMO, and providers are
only able to report ICD–10–PCS
procedure code 5A15223, which may be
inappropriately resulting in a higher
paying MS–DRG. Therefore, the
commenter submitted a separate request
to create a new ICD–10–PCS procedure
code specifically for percutaneous
ECMO which was discussed at the
March 6–7, 2018 ICD–10 Coordination
and Maintenance Committee Meeting.
We refer readers to section II.F.18. of the
preamble of this proposed rule for
further information regarding this
meeting and the discussion for a new
procedure code.
The requestor suggested that cases
reporting a procedure code for ECMO in
combination with the insertion of a
percutaneous short-term external heart
assist device could be reassigned from
Pre-MDC MS–DRG 003 (ECMO or
Tracheostomy with Mechanical
Ventilation >96 Hours or Principal
Diagnosis Except Face, Mouth and Neck
with Major O.R. Procedure) to MS–DRG
215. Our analysis involved examining
cases in Pre-MDC MS–DRG 003 in the
September 2017 update of the FY 2017
MedPAR file for cases reporting ECMO
with and without the insertion of a
percutaneous short-term external heart
assist device. Our findings are shown in
the following table.
daltland on DSKBBV9HB2PROD with PROPOSALS2
ECMO AND PERCUTANEOUS SHORT-TERM EXTERNAL HEART ASSIST DEVICE
MS–DRG 003—All cases ............................................................................................................
MS–DRG 003—Cases with procedure code 5A15223 (Extracorporeal membrane oxygenation, continuous) .....................................................................................................................
MS–DRG 003—Cases with procedure code 5A15223 (Extracorporeal membrane oxygenation, continuous) and 02HA3RZ (Insertion of short-term external heart assist system into
heart, percutaneous approach) ................................................................................................
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Average
length
of stay
Number
of cases
Pre-MDC MS–DRG
Fmt 4701
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Average
costs
14,383
29.5
$118,218
1,786
19
119,340
94
11.4
110,874
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ECMO AND PERCUTANEOUS SHORT-TERM EXTERNAL HEART ASSIST DEVICE—Continued
MS–DRG 003—Cases with procedure code 5A15223 (Extracorporeal membrane oxygenation, continuous) and 02HA4RZ (Insertion of short-term external heart assist system into
heart, percutaneous endoscopic approach) ............................................................................
As shown in this table, we found a
total of 14,383 cases with an average
length of stay of 29.5 days and average
costs of $118,218 in Pre-MDC MS–DRG
003. We found 1,786 cases reporting
procedure code 5A15223
(Extracorporeal membrane oxygenation,
continuous) with an average length of
stay of 19 days and average costs of
Average
length
of stay
Number
of cases
Pre-MDC MS–DRG
$119,340. We found 94 cases reporting
procedure code 5A15223 and 02HA3RZ
(Insertion of short-term external heart
assist system into heart, percutaneous
approach) with an average length of stay
of 11.4 days and average costs of
$110,874. Lastly, we found 1 case
reporting procedure code 5A15223 and
02HA4RZ (Insertion of short-term
Average
costs
1
1
64,319
external heart assist system into heart,
percutaneous endoscopic approach)
with an average length of stay of 1 day
and average costs of $64,319.
We also reviewed the cases in MS–
DRG 215 for procedure codes 02HA3RZ
and 02HA4RZ. Our findings are shown
in the following table.
PERCUTANEOUS SHORT-TERM EXTERNAL HEART ASSIST DEVICE
MS–DRG 215—All cases ............................................................................................................
MS–DRG 215—Cases with procedure code 02HA3RZ (Insertion of short-term external heart
assist system into heart, percutaneous approach) ..................................................................
MS–DRG 215—Cases with procedure code 02HA4RZ (Insertion of short-term external heart
assist system into heart, percutaneous endoscopic approach) ..............................................
As shown in this table, we found a
total of 3,428 cases with an average
length of stay of 8.7 days and average
costs of $68,965. We found a total of
3,136 cases reporting procedure code
02HA3RZ with an average length of stay
of 8.4 days and average costs of $67,670.
We found a total of 31 cases reporting
procedure code 02HA4RZ with an
average length of stay of 5.3 days and
average costs of $57,042.
For Pre-MDC MS–DRG 003, while the
average length of stay and average costs
for cases where procedure code
5A15223 was reported with procedure
code 02HA3RZ or procedure code
02HA4RZ are lower than the average
length of stay and average costs for cases
where procedure code 5A15223 was
reported alone, we are unable to
determine from the data if those ECMO
procedures were performed
Average
length
of stay
Number
of cases
MS–DRG
percutaneously in the absence of a
unique code. In addition, the one case
reporting procedure code 5A15223 with
02HA4RZ only had a 1 day length of
stay and it is unclear from the data what
the circumstances of that case may have
involved. For example, the patient may
have been transferred or may have
expired. Therefore, we are proposing to
not reassign cases reporting procedure
code 5A15223 when reported with
procedure code 02HA3RZ or procedure
code 02HA4RZ for FY 2019. Our
clinical advisors agree that until there is
a way to specifically identify
percutaneous ECMO in the claims data
to enable further analysis, a proposal at
this time is not warranted. We are
inviting public comments on our
proposal.
A commenter also suggested that CMS
maintain the current logic for MS–DRGs
Average
costs
3,428
8.7
$68,965
3,136
8.4
67,670
31
5.3
57,042
268 and 269 (Aortic and Heart Assist
Procedures Except Pulsation Balloon
with and without MCC, respectively),
but recommended that CMS continue to
monitor the data in these MS–DRGs for
future consideration of distinctions (for
example, different approaches and
evolving technologies) that may impact
the clinical and resource use of
procedures involving heart assist
devices.
The logic for heart assist system
devices in MS–DRGs 268 and 269 is
comprised of the procedure codes
shown in the following table, for which
we examined claims data in the
September 2017 update of the FY 2017
MedPAR file in response to the
commenter’s request. Our findings are
shown in the following table.
MS–DRGS FOR AORTIC AND HEART ASSIST PROCEDURES EXCEPT PULSATION BALLOON
Average
length
of stay
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Number
of cases
MS–DRG 268—All cases ............................................................................................................
MS–DRG 268—Cases with procedure code 02PA0QZ (Removal of implantable heart assist
system from heart, open approach) .........................................................................................
MS–DRG 268—Cases with procedure code 02PA0RS (Removal of biventricular short-term
external heart assist system from heart, open approach) .......................................................
MS–DRG 268—Cases with procedure code 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach) ..............................................................................
MS–DRG 268—Cases with procedure code 02PA3QZ (Removal of implantable heart assist
system from heart, percutaneous approach) ...........................................................................
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Average
costs
3,798
9.6
$49,122
16
23.4
79,850
0
0
0
0
0
0
28
10.5
31,797
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MS–DRGS FOR AORTIC AND HEART ASSIST PROCEDURES EXCEPT PULSATION BALLOON—Continued
Average
length
of stay
Number
of cases
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MS–DRG 268—Cases with procedure code 02PA3RS (Removal of biventricular short-term
external heart assist system from heart, percutaneous approach) .........................................
MS–DRG 268—Cases with procedure code 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach) ................................................................
MS–DRG 268—Cases with procedure code 02PA4QZ (Removal of implantable heart assist
system from heart, percutaneous endoscopic approach) .......................................................
MS–DRG 268—Cases with procedure code 02PA4RS (Removal of biventricular short-term
external heart assist system from heart, percutaneous endoscopic approach) ......................
MS–DRG 268—Cases with procedure code 02PA4RZ (Removal of short-term external heart
assist system from heart, percutaneous endoscopic approach) .............................................
MS–DRG 269—All cases ............................................................................................................
MS–DRG 269—Cases with procedure code 02PA0QZ (Removal of implantable heart assist
system from heart, open approach) .........................................................................................
MS–DRG 269—Cases with procedure code 02PA0RS (Removal of biventricular short-term
external heart assist system from heart, open approach) .......................................................
MS–DRG 269—Cases with procedure code 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach) ..............................................................................
MS–DRG 269—Cases with procedure code 02PA3QZ (Removal of implantable heart assist
system from heart, percutaneous approach) ...........................................................................
MS–DRG 269—Cases with procedure code 02PA3RS (Removal of biventricular short-term
external heart assist system from heart, percutaneous approach) .........................................
MS–DRG 269—Cases with procedure code 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach) ................................................................
MS–DRG 269—Cases with procedure code 02PA4QZ (Removal of implantable heart assist
system from heart, percutaneous endoscopic approach) .......................................................
MS–DRG 269—Cases with procedure code 02PA4RS (Removal of biventricular short-term
external heart assist system from heart, percutaneous endoscopic approach) ......................
MS–DRG 269—Cases with procedure code 02PA4RZ (Removal of short-term external heart
assist system from heart, percutaneous endoscopic approach) .............................................
As shown in this table, for MS–DRG
268, there were a total of 3,798 cases,
with an average length of stay of 9.6
days and average costs of $49,122. There
were 16 cases reporting procedure code
02PA0QZ (Removal of implantable heart
assist system from heart, open
approach), with an average length of
stay of 23.4 days and average costs of
$79,850. There were no cases that
reported procedure codes 02PA0RS
(Removal of biventricular short-term
external heart assist system from heart,
open approach), 02PA0RZ (Removal of
short-term external heart assist system
from heart, open approach), 02PA3RS
(Removal of biventricular short-term
external heart assist system from heart,
percutaneous approach), 02PA4RS
(Removal of biventricular short-term
external heart assist system from heart,
percutaneous endoscopic approach) or
02PA4RZ (Removal of short-term
external heart assist system from heart,
percutaneous endoscopic approach).
There were 28 cases reporting procedure
code 02PA3QZ (Removal of implantable
heart assist system from heart,
percutaneous approach), with an
average length of stay of 10.5 days and
average costs of $31,797. There were 96
cases reporting procedure code
02PA3RZ (Removal of short-term
external heart assist system from heart,
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percutaneous approach), with an
average length of stay of 12.4 days and
average costs of $51,469. There were 5
cases reporting procedure code
02PA4QZ (Removal of implantable heart
assist system from heart, percutaneous
endoscopic approach), with an average
length of stay of 7.8 days and average
costs of $37,592. For MS–DRG 269,
there were a total of 16,900 cases, with
an average length of stay of 2.4 days and
average costs of $30,793. There were 10
cases reporting procedure code
02PA0QZ (Removal of implantable heart
assist system from heart, open
approach), with an average length of
stay of 8 days and average costs of
$23,741. There were no cases reporting
procedure codes 02PA0RS (Removal of
biventricular short-term external heart
assist system from heart, open
approach), 02PA0RZ (Removal of shortterm external heart assist system from
heart, open approach), 02PA3RS
(Removal of biventricular short-term
external heart assist system from heart,
percutaneous approach), 02PA4RS
(Removal of biventricular short-term
external heart assist system from heart,
percutaneous endoscopic approach) or
02PA4RZ (Removal of short-term
external heart assist system from heart,
percutaneous endoscopic approach).
There were 6 cases reporting procedure
PO 00000
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Average
costs
0
0
0
96
12.4
51,469
5
7.8
37,592
0
0
0
0
16,900
0
2.4
0
30,793
10
8
23,741
0
0
0
0
0
0
6
5
19,421
0
0
0
11
4
25,719
1
3
14,415
0
0
0
0
0
0
code 02PA3QZ (Removal of implantable
heart assist system from heart,
percutaneous approach), with an
average length of stay of 5 days and
average costs of $19,421. There were 11
cases reporting procedure code
02PA3RZ (Removal of short-term
external heart assist system from heart,
percutaneous approach), with an
average length of stay of 4 days and
average costs of $25,719. There was 1
case reporting procedure code 02PA4QZ
(Removal of implantable heart assist
system from heart, percutaneous
endoscopic approach), with an average
length of stay of 3 days and average
costs of $14,415.
The data show that there are
differences in the average length of stay
and average costs for cases in MS–DRGs
268 and 269 according to the type of
device (short-term external heart assist
system or implantable heart assist
system), and the approaches that were
utilized (open, percutaneous, or
percutaneous endoscopic). We agree
with the recommendation to maintain
the structure of MS–DRGs 268 and 269
for FY 2019 and will continue to
analyze the claims data for possible
future updates. As such, we are
proposing to not make any changes to
the structure of MS–DRGs 268 and 269
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for FY 2019. We are inviting public
comments on our proposal.
b. Brachytherapy
We received a request to create a new
Pre-MDC MS–DRG for all procedures
involving the CivaSheet® technology,
an implantable, planar brachytherapy
source designed to enable delivery of
radiation to the site of the cancer tumor
excision or debulking, while protecting
neighboring tissue. The requestor stated
that physicians have used the
CivaSheet® technology for a number of
indications, such as colorectal,
gynecological, head and neck, soft tissue
sarcomas and pancreatic cancer. The
requestor noted that potential uses also
include nonsmall-cell lung cancer,
ocular melanoma, and atypical
meningioma. Currently, procedures
involving the CivaSheet® technology
are reported using ICD–10–PCS Section
D—Radiation Therapy codes, with the
root operation ‘‘Brachytherapy.’’ These
codes are non-O.R. codes and group to
the MS–DRG to which the principal
diagnosis is assigned.
In response to this request, we have
analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for cases representing
patients who received treatment that
reported low dose rate (LDR)
brachytherapy procedure codes across
all MS–DRGs. We refer readers to Table
6P.—ICD–10–CM and ICD–10–PCS
Codes for Proposed MS–DRG Changes
associated with this proposed rule,
which is available via the Internet on
the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/. A
detailed list of these procedure codes
are shown in Table 6P.1. Our findings
are reflected in the following table.
CASES REPORTING LOW DOSE RATE (LDR) BRACHYTHERAPY PROCEDURE CODES ACROSS ALL MS–DRGS
MS–DRG 129 (Major Head and Neck Procedures with CC/MCC or Major Device)—Cases
with procedure code D710BBZ (Low dose rate (LDR) brachytherapy of bone marrow using
Palladium-103 (Pd-103)) ..........................................................................................................
MS–DRG 724 (Malignancy, Male Reproductive System without CC/MCC)—Cases with procedure code DV10BBZ (Low dose rate (LDR) brachytherapy of prostate using Palladium-103 (Pd-103)) ..................................................................................................................
MS–DRG 129—Cases with procedure code DW11BBZ (Low dose rate (LDR) brachytherapy
of head and neck using Palladium-103 (Pd-103)) ...................................................................
MS–DRG 330 (Major Small and Large Bowel Procedures with CC)—Cases with procedure
code DW16BBZ (Low dose rate (LDR) brachytherapy of pelvic region using Palladium-103
(Pd-103)) ..................................................................................................................................
As shown in the immediately
preceding table, we identified 4 cases
reporting one of these LDR
brachytherapy procedure codes across
all MS–DRGs, with an average length of
stay of 6.3 days and average costs of
$39,853. We believe that creating a new
Pre-MDC MS–DRG based on such a
small number of cases could lead to
distortion in the relative payment
weights for the Pre-MDC MS–DRG.
Having a larger number of clinically
cohesive cases within the Pre-MDC MS–
DRG provides greater stability for
annual updates to the relative payment
weights. Therefore, we are not
proposing to create a new Pre-MDC MS–
DRG for procedures involving the
CivaSheet® technology for FY 2019. We
are inviting public comments on our
proposal to maintain the current
MS-DRG structure for procedures
involving the CivaSheet® technology.
daltland on DSKBBV9HB2PROD with PROPOSALS2
c. Laryngectomy
The logic for case assignment to PreMDC MS–DRGs 11, 12, and 13
(Tracheostomy for Face, Mouth and
Neck Diagnoses with MCC, with CC,
and without CC/MCC, respectively) as
displayed in the ICD–10 MS–DRG
Version 35 Definitions Manual, which is
available via the Internet on the CMS
website at: https://www.cms.gov/
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Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/FY2018IPPS-Final-Rule-Home-Page-Items/
FY2018-IPPS-Final-Rule-DataFiles.html?DLPage=1&DLEntries=
10&DLSort=0&DLSortDir=ascending, is
comprised of a list of procedure codes
for laryngectomies, a list of procedure
codes for tracheostomies, and a list of
diagnosis codes for conditions involving
the face, mouth, and neck. The
procedure codes for laryngectomies are
listed separately and are reported
differently from the procedure codes
listed for tracheostomies. The procedure
codes listed for tracheostomies must be
reported with a diagnosis code
involving the face, mouth, or neck as a
principal diagnosis to satisfy the logic
for assignment to Pre-MDC MS–DRG 11,
12, or 13. Alternatively, any principal
diagnosis code reported with a
procedure code from the list of
procedure codes for laryngectomies will
satisfy the logic for assignment to
Pre-MDC MS–DRG 11, 12, or 13.
To improve the manner in which the
logic for assignment is displayed in the
ICD–10 MS–DRG Definitions Manual
and to clarify how it is applied for
grouping purposes, we are proposing to
reorder the lists of the diagnosis and
procedure codes. The list of principal
diagnosis codes for face, mouth, and
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Average
length
of stay
Number
of cases
ICD–10–PCS procedures
Fmt 4701
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Average
costs
1
7
$10,357
1
7
32,298
1
3
42,565
1
8
74,190
neck would be sequenced first, followed
by the list of the tracheostomy
procedure codes and, lastly, the list of
laryngectomy procedure codes.
We also are proposing to revise the
titles of Pre-MDC MS–DRGs 11, 12, and
13 from ‘‘Tracheostomy for Face, Mouth
and Neck Diagnoses with MCC, with CC
and without CC/MCC, respectively’’ to
‘‘Tracheostomy for Face, Mouth and
Neck Diagnoses or Laryngectomy with
MCC’’, ‘‘Tracheostomy for Face, Mouth
and Neck Diagnoses or Laryngectomy
with CC’’, and ‘‘Tracheostomy for Face,
Mouth and Neck Diagnoses or
Laryngectomy without CC/MCC’’,
respectively, to reflect that
laryngectomy procedures may also be
assigned to these MS–DRGs.
We are inviting public comments on
our proposals.
d. Chimeric Antigen Receptor (CAR) TCell Therapy
Chimeric Antigen Receptor (CAR) Tcell therapy is a cell-based gene therapy
in which a patient’s own T-cells are
genetically engineered in a laboratory
and used to assist in the patient’s
treatment to attack certain cancerous
cells. Blood is drawn from the patient
and the T-cells are separated. The
laboratory then utilizes the CAR process
to genetically engineer the T-cells,
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resulting in the addition of a chimeric
antigen receptor that will bind to a
certain protein on the patient’s
cancerous cells. The CAR T-cells are
then administered to the patient by
infusion.
Two CAR T-cell therapy drugs
received FDA approval in 2017.
KYMRIAHTM (manufactured by Novartis
Pharmaceuticals Corporation) was
approved for the use in the treatment of
patients up to 25 years of age with Bcell precursor acute lymphoblastic
leukemia (ALL) that is refractory or in
second or later relapse. YESCARTATM
(manufactured by Kite Pharma, Inc.)
was approved for use in the treatment
of adult patients with relapsed or
refractory large B-cell lymphoma and
who have not responded to or who have
relapsed after at least two other kinds of
treatment.
Procedures involving the CAR T-cell
therapy drugs are currently identified
with ICD–10–PCS procedure codes
XW033C3 (Introduction of engineered
autologous chimeric antigen receptor tcell immunotherapy into peripheral
vein, percutaneous approach, new
technology group 3) and XW043C3
(Introduction of engineered autologous
chimeric antigen receptor t-cell
immunotherapy into central vein,
percutaneous approach, new technology
group 3), which both became effective
October 1, 2017. Procedures described
by these two ICD–10–PCS procedure
codes are designated as non-O.R.
procedures that have no impact on MS–
DRG assignment.
We have received many inquiries
from the public regarding payment of
CAR T-cell therapy under the IPPS.
Suggestions for the MS–DRG assignment
for FY 2019 ranged from assigning ICD–
10–PCS procedure codes XW033C3 and
XW043C3 to an existing MS–DRG to the
creation of a new MS–DRG for CAR
T-cell therapy. In the context of the
recommendation to create a new MS–
DRG for FY 2019, we also received
suggestions that payment should be
established in a way that promotes
comparability between the inpatient
setting and outpatient setting.
As part of our review of these
suggestions, we examined the existing
MS–DRGs to identify the MS–DRGs that
represent cases most clinically similar
to those cases in which the CAR T-cell
therapy procedures would be reported.
The CAR T-cell procedures involve a
type of autologous immunotherapy in
which the patient’s cells are genetically
transformed and then returned to that
patient after the patient undergoes cell
depleting chemotherapy. Our clinical
advisors believe that patients receiving
treatment utilizing CAR T-cell therapy
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procedures would have similar clinical
characteristics and comorbidities to
those seen in cases representing patients
receiving treatment for other
hematopoietic carcinomas who are
treated with autologous bone marrow
transplant therapy that are currently
assigned to MS–DRG 016 (Autologous
Bone Marrow Transplant with CC/
MCC). Therefore, after consideration of
the inquiries received as to how the
IPPS can appropriately group cases
reporting the use of CAR T-cell therapy,
we are proposing to assign ICD–10–PCS
procedure codes XW033C3 and
XW043C3 to Pre-MDC MS–DRG 016 for
FY 2019. In addition, we are proposing
to revise the title of MS–DRG 016 from
‘‘Autologous Bone Marrow Transplant
with CC/MCC’’ to ‘‘Autologous Bone
Marrow Transplant with CC/MCC or Tcell Immunotherapy.’’
However, we note that, as discussed
in greater detail in section II.H.5.a. of
the preamble of this proposed rule, the
manufacturer of KYMRIAHTM and the
manufacturer of YESCARTATM
submitted applications for new
technology add-on payments for FY
2019. We also recognize that many
members of the public have noted that
the combination of the new technology
add-on payment applications, the
extremely high-cost of these CAR T-cell
therapy drugs, and the potential for
volume increases over time present
unique challenges with respect to the
MS–DRG assignment for procedures
involving the utilization of CAR T-cell
therapy drugs and cases representing
patients receiving treatment involving
CAR T-cell therapy. We believe that, in
the context of these pending new
technology add-on payment
applications, there may also be merit in
the alternative suggestion we received to
create a new MS–DRG for procedures
involving the utilization of CAR T-cell
therapy drugs and cases representing
patients receiving treatment involving
CAR T-cell therapy to which we could
assign ICD–10–PCS procedure codes
XW033C3 and XW043C3, effective for
discharges occurring in FY 2019. As
noted in section II.H.5.a. of the
preamble of this proposed rule, if a new
MS–DRG were to be created then
consistent with section 1886(d)(5)(K)(ix)
of the Act there may no longer be a need
for a new technology add-on payment
under section 1886(d)(5)(K)(ii)(III) of the
Act.
We are inviting public comments on
our proposed approach of assigning
ICD–10–PCS procedure codes XW033C3
and XW043C3 to Pre-MDC MS–DRG 016
for FY 2019. We also are inviting public
comments on alternative approaches,
including in the context of the pending
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20189
KYMRIAHTM and YESCARTATM new
technology add-on payment
applications, and the most appropriate
way to establish payment for FY 2019
under any alternative approaches. Such
payment alternatives may include using
a CCR of 1.0 for charges associated with
ICD–10–PCS procedure codes XW033C3
and XW043C3, given that many public
inquirers believed that hospitals would
be unlikely to set charges different from
the costs for KYMRIAHTM and
YESCARTATM CAR T-cell therapy
drugs, as discussed further in section
II.A.4.g.2. of the Addendum of this
proposed rule. These payment
alternatives, including payment under
any potential new MS–DRG, also could
take into account an appropriate portion
of the average sales price (ASP) for these
drugs, including in the context of the
pending new technology add-on
payment applications.
We are inviting comments on how
these payment alternatives would affect
access to care, as well as how they affect
incentives to encourage lower drug
prices, which is a high priority for this
Administration. In addition, we are
considering approaches and authorities
to encourage value-based care and lower
drug prices. We solicit comments on
how the payment methodology
alternatives may intersect and affect
future participation in any such
alternative approaches.
As stated in section II.F.1.b. of the
preamble of this proposed rule, we
described the criteria used to establish
new MS–DRGs. In particular, we
consider whether the resource
consumption and clinical characteristics
of the patients with a given set of
conditions are significantly different
than the remaining patients in the MS–
DRG. We evaluate patient care costs
using average costs and lengths of stay
and rely on the judgment of our clinical
advisors to decide whether patients are
clinically distinct or similar to other
patients in the MS–DRG. In evaluating
resource costs, we consider both the
absolute and percentage differences in
average costs between the cases we
select for review and the remainder of
cases in the MS–DRG. We also consider
whether observed average differences
are consistent across patients or
attributable to cases that were extreme
in terms of costs or length of stay, or
both. Further, we consider the number
of patients who will have a given set of
characteristics and generally prefer not
to create a new MS–DRG unless it
would include a substantial number of
cases. Based on the principles typically
used to establish a new MS–DRG, we
are soliciting comments on how the
administration of the CAR T-cell
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therapy drugs and associated services
meet the criteria for the creation of a
new MS–DRG. Also, section
1886(d)(4)(C)(iii) of the Act specifies
that, beginning in FY 1991, the annual
DRG reclassification and recalibration of
the relative weights must be made in a
manner that ensures that aggregate
payments to hospitals are not affected.
Given that a new MS–DRG must be
established in a budget neutral manner,
we are concerned with the redistributive
effects away from core hospital services
over time toward specialized hospitals
and how that may affect payment for
these core services. Therefore, we are
soliciting public comments on our
concerns with the payment alternatives
that we are considering for CAR T-cell
therapy drugs and therapies.
3. MDC 1 (Diseases and Disorders of the
Nervous System)
a. Epilepsy With Neurostimulator
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38015 through 38019), based
on a request we received and our review
of the claims data, the advice of our
clinical advisors, and consideration of
public comments, we finalized our
proposal to reassign all cases reporting
a principal diagnosis of epilepsy and
one of the following ICD–10–PCS code
combinations, which capture cases
involving neurostimulator generators
inserted into the skull (including cases
involving the use of the RNS©
neurostimulator), to retitled MS–DRG
023 (Craniotomy with Major Device
Implant or Acute Complex Central
Nervous System (CNS) Principal
Diagnosis (PDX) with MCC or
Chemotherapy Implant or Epilepsy with
Neurostimulator), even if there is no
MCC reported:
• 0NH00NZ (Insertion of
neurostimulator generator into skull,
open approach), in combination with
00H00MZ (Insertion of neurostimulator
lead into brain, open approach);
• 0NH00NZ (Insertion of
neurostimulator generator into skull,
open approach), in combination with
00H03MZ (Insertion of neurostimulator
lead into brain, percutaneous approach);
and
• 0NH00NZ (Insertion of
neurostimulator generator into skull,
open approach), in combination with
00H04MZ (Insertion of neurostimulator
lead into brain, percutaneous
endoscopic approach).
The finalized listing of epilepsy
diagnosis codes (82 FR 38018 through
38019) contained codes provided by the
requestor (82 FR 38016), in addition to
diagnosis codes organized in
subcategories G40.A– and G40.B– as
recommended by a commenter in
response to the proposed rule (82 FR
38018) because the diagnosis codes
organized in these subcategories also are
representative of diagnoses of epilepsy.
For FY 2019, we received a request to
include two additional diagnosis codes
organized in subcategory G40.1– in the
listing of epilepsy diagnosis codes for
cases assigned to MS–DRG 023 because
these diagnosis codes also represent
diagnoses of epilepsy. The two
additional codes identified by the
requestor are:
• G40.109 (Localization-related
(focal) (partial) symptomatic epilepsy
and epileptic syndromes with simple
partial seizures, not intractable, without
status epilepticus); and
• G40.111 (Localization-related
(focal) (partial) symptomatic epilepsy
and epileptic syndromes with simple
partial seizures, intractable, with status
epilepticus).
We agree with the requestor that
diagnosis codes G40.109 and G40.111
also are representative of epilepsy
diagnoses and should be added to the
listing of epilepsy diagnosis codes for
cases assigned to MS–DRG 023 because
they also capture a type of epilepsy. Our
clinical advisors reviewed this issue and
agree that adding the two additional
epilepsy diagnosis codes is appropriate.
Therefore, we are proposing to add ICD–
10–CM diagnosis codes G40.109 and
G40.111 to the listing of epilepsy
diagnosis codes for cases assigned to
MS–DRG 023, effective October 1, 2018.
We are inviting public comments on
our proposal.
b. Neurological Conditions With
Mechanical Ventilation
We received two separate, but related
requests to create new MS–DRGs for
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
061
062
063
064
065
066
VerDate Sep<11>2014
cases that identify patients who have
been diagnosed with neurological
conditions classified under MDC 1
(Diseases and Disorders of the Nervous
System) and who require mechanical
ventilation with and without a
thrombolytic and in the absence of an
O.R. procedure. The requestors
suggested that CMS consider when
mechanical ventilation is reported with
a neurological condition for the ICD–10
MS–DRG GROUPER assignment logic,
similar to the current logic for MS–
DRGs 207 and 208 (Respiratory System
Diagnosis with Ventilator Support >96
Hours and <=96 Hours, respectively)
under MDC 4 (Diseases and Disorders of
the Respiratory System), which consider
respiratory conditions that require
mechanical ventilation and are assigned
a higher relative weight.
The requestors stated that patients
with a principal diagnosis of respiratory
failure requiring mechanical ventilation
are currently assigned to MS–DRG 207
(Respiratory System Diagnoses with
Ventilator Support >96 Hours), which
has a relative weight of 5.4845, and to
MS–DRG 208 (Respiratory System
Diagnoses with Ventilator Support <=96
Hours), which has a relative weight of
2.3678. The requestors also stated that
patients with a principal diagnosis of
ischemic cerebral infarction who
received a thrombolytic agent during the
hospital stay and did not undergo an
O.R. procedure are assigned to MS–
DRGs 061, 062, and 063 (Ischemic
Stroke, Precerebral Occlusion or
Transient Ischemia with Thrombolytic
Agent with MCC, with CC, and without
CC/MCC, respectively) under MDC 1,
while patients with a principal
diagnosis of intracranial hemorrhage or
ischemic cerebral infarction who did
not receive a thrombolytic agent during
the hospital stay and did not undergo an
O.R. procedure are assigned to MS–
DRGs 064, 065 and 66 (Intracranial
Hemorrhage or Cerebral Infarction with
MCC, with CC or TPA in 24 Hours, and
without CC/MCC, respectively) under
MDC 1.
The requestors provided the current
FY 2018 relative weights for these MS–
DRGs as shown in the following table.
Relative
weight
MS–DRG title
.......
.......
.......
.......
.......
.......
Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent with MCC ..............
Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent with CC .................
Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent without CC/MCC ..
Intracranial Hemorrhage or Cerebral Infarction with MCC ...............................................................................
Intracranial Hemorrhage or Cerebral Infarction with CC or TPA in 24 hours ..................................................
Intracranial Hemorrhage or Cerebral Infarction with MCC ...............................................................................
20:30 May 04, 2018
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l.9321
l.6169
l.7685
1.0311
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The requestors stated that although
the ICD–10–CM Official Guidelines for
Coding and Reporting allow sequencing
of acute respiratory failure as the
principal diagnosis when it is jointly
responsible (with an acute neurologic
event) for admission, which would
result in assignment to MS–DRGs 207 or
208 when the patient requires
mechanical ventilation, it would not be
appropriate to sequence acute
respiratory failure as the principal
diagnosis when it is secondary to
intracranial hemorrhage or ischemic
cerebral infarction.
The requestors also stated that
reporting for other purposes, such as
quality measures, clinical trials, and
Joint Commission and State certification
or survey cases, is based on the
principal diagnosis, and it is important,
from a quality of care perspective, that
the intracranial hemorrhage or cerebral
infarction codes continue to be
sequenced as principal diagnosis. The
requestors believed that cases of
patients who present with cerebral
infarction or cerebral hemorrhage and
acute respiratory failure are currently in
conflict for principal diagnosis
sequencing because the cerebral
infarction or cerebral hemorrhage code
is needed as the principal diagnosis for
quality reporting and other purposes.
However, acute respiratory failure is
needed as the principal diagnosis for
purposes of appropriate payment under
the MS–DRGs.
The requestors stated that by creating
new MS–DRGs for neurological
conditions with mechanical ventilation,
those patients who require mechanical
ventilation for airway protection on
admission and those patients who
develop acute respiratory failure
requiring mechanical ventilation after
admission can be grouped to MS–DRGs
that provide appropriate payment for
the mechanical ventilation resources.
The requestors suggested two new MS–
DRGs, citing as support that new MS–
DRGs were created for patients with
sepsis requiring mechanical ventilation
greater than and less than 96 hours.
As discussed earlier in this section,
the requests we received were separate,
but related requests. The first request
was to specifically identify patients
ICD–10–PCS
code
5A1935Z ...............
5A1945Z ...............
5A1955Z ...............
Respiratory ventilation, less than 96 consecutive hours.
Respiratory ventilation, 24–96 consecutive hours.
Respiratory ventilation, greater than 96 consecutive hours.
example, TPA) during the current
episode of care and did not undergo an
O.R. procedure.
For the first subset of patients, we
analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for MS–DRGs 061, 062,
and 063 because cases that are assigned
to these MS–DRGs specifically identify
patients who were diagnosed with a
cerebral infarction and received a
thrombolytic. The 90 ICD–10–CM
diagnosis codes that specify a cerebral
daltland on DSKBBV9HB2PROD with PROPOSALS2
ICD–10–PCS code
...............
...............
...............
...............
...............
...............
...............
...............
...............
...............
infarction and were included in our
analysis are listed in Table 6P.1a
associated with this proposed rule
(which is available via the Internet on
the CMS website at: https://
www.cms.hhs.gov/Medicare/MedicareFee-for-Service-Payment/
AcuteInpatientPPS/).
The ICD–10–PCS procedure codes
displayed in the following table
describe use of a thrombolytic agent.
Code description
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
Introduction
of
of
of
of
of
of
of
of
of
of
other
other
other
other
other
other
other
other
other
other
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
thrombolytic
We examined claims data in MS–
DRGs 061, 062, and 063 and identified
cases that reported mechanical
VerDate Sep<11>2014
presenting with intracranial hemorrhage
or cerebral infarction with mechanical
ventilation and create two new MS–
DRGs as follows:
• Suggested new MS–DRG XXX
(Intracranial Hemorrhage or Cerebral
Infarction with Mechanical Ventilation
>96 Hours); and
• Suggested new MS–DRG XXX
(Intracranial Hemorrhage or Cerebral
Infarction with Mechanical Ventilation
<=96 Hours).
The second request was to consider
any principal diagnosis under the
current GROUPER logic for MDC 1 with
mechanical ventilation and create two
new MS–DRGs as follows:
• Suggested New MS–DRG XXX
(Neurological System Diagnosis with
Mechanical Ventilation 96+ Hours); and
• Suggested New MS–DRG XXX
(Neurological System Diagnosis with
Mechanical Ventilation ≤96 Hours).
Both requesters suggested that CMS
use the three ICD–10–PCS codes
identifying mechanical ventilation to
assign cases to the respective suggested
new MS–DRGs. The three ICD–10–PCS
codes are shown in the following table.
Code description
Below we discuss the different
aspects of each request in more detail.
The first request involved two
aspects: (1) Analyzing patients
diagnosed with cerebral infarction and
required mechanical ventilation who
received a thrombolytic (for example,
TPA) and did not undergo an O.R.
procedure; and (2) analyzing patients
diagnosed with intracranial hemorrhage
or ischemic cerebral infarction and
required mechanical ventilation who
did not receive a thrombolytic (for
3E03017
3E03317
3E04017
3E04317
3E05017
3E05317
3E06017
3E06317
3E08017
3E08317
20191
20:30 May 04, 2018
Jkt 244001
into
into
into
into
into
into
into
into
into
into
peripheral vein, open approach.
peripheral vein, percutaneous approach.
central vein, open approach.
central vein, percutaneous approach.
peripheral artery, open approach.
peripheral artery, percutaneous approach.
central artery, open approach.
central artery, percutaneous approach.
heart, open approach.
heart, percutaneous approach.
ventilation of any duration with a
principal diagnosis of cerebral
infarction where a thrombolytic agent
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
was administered and the patient did
not undergo an O.R. procedure. Our
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findings are shown in the following
table.
CEREBRAL INFARCTION WITH THROMBOLYTIC AND MV
MS–DRG 061—All cases ............................................................................................................
MS–DRG 061—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 061—Cases with principal diagnosis of cerebral infarction and mechanical ventilation =24–96 hours ....................................................................................................................
MS–DRG 061—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <24 hours ..........................................................................................................................
MS–DRG 062—All cases ............................................................................................................
MS–DRG 062—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 062—Cases with principal diagnosis of cerebral infarction and mechanical ventilation =24–96 hours ....................................................................................................................
MS–DRG 062—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <24 hours ..........................................................................................................................
MS–DRG 063—All cases ............................................................................................................
MS–DRG 063—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 063—Cases with principal diagnosis of cerebral infarction and mechanical ventilation =24–96 hours ....................................................................................................................
MS–DRG 063—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <24 hours ..........................................................................................................................
As shown in this table, there were a
total of 5,192 cases in MS–DRG 061
with an average length of stay of 6.4
days and average costs of $20,097. There
were a total of 758 cases reporting the
use of mechanical ventilation in MS–
DRG 061 with an average length of stay
ranging from 4.9 days to 12.8 days and
average costs ranging from $19,795 to
$41,691. For MS–DRG 062, there were a
total of 9,730 cases with an average
length of stay of 3.9 days and average
costs of $13,865. There were a total of
33 cases reporting the use of mechanical
Average
length
of stay
Number of
cases
MS–DRG
ventilation in MS–DRG 062 with an
average length of stay ranging from 3.8
days to 5.3 days and average costs
ranging from $14,026 to $19,817. For
MS-DRG 063, there were a total of 1,984
cases with an average length of stay of
2.7 days and average costs of $11,771.
There were a total of 8 cases reporting
the use of mechanical ventilation in
MS–DRG 063 with an average length of
stay ranging from 2.0 days to 2.7 days
and average costs ranging from $11,195
to $14,588.
We then compared the total number
of cases in MS–DRGs 061, 062, and 063
Average
costs
5,192
6.4
$20,097
166
12.8
41,691
378
7.5
26,368
214
9,730
4.9
3.9
19,795
13,865
0
0.0
0
10
5.3
19,817
23
1,984
3.8
2.7
14,026
11,771
0
0.0
0
3
2.7
14,588
5
2.0
11,195
specifically reporting mechanical
ventilation >96 hours with a principal
diagnosis of cerebral infarction where a
thrombolytic agent was administered
and the patient did not undergo an O.R.
procedure against the total number of
cases reporting mechanical ventilation
<=96 hours with a principal diagnosis of
cerebral infarction where a thrombolytic
agent was administered and the patient
did not undergo an O.R. procedure. Our
findings are shown in the following
table.
CEREBRAL INFARCTION WITH THROMBOLYTIC AND MV
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 061—All cases ............................................................................................................
MS–DRG 061—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 061—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <=96 hours ........................................................................................................................
MS–DRG 062—All cases ............................................................................................................
MS–DRG 062—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 062—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <=96 hours ........................................................................................................................
MS–DRG 063—All cases ............................................................................................................
MS–DRG 063—Cases with principal diagnosis of cerebral infarction and mechanical ventilation >96 hours ..........................................................................................................................
MS–DRG 063—Cases with principal diagnosis of cerebral infarction and mechanical ventilation <=96 hours ........................................................................................................................
As shown in this table, the total
number of cases reported in MS–DRG
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
061 was 5,192, with an average length
of stay of 6.4 days and average costs of
PO 00000
Average
length
of stay
Number of
cases
MS–DRG
Frm 00030
Fmt 4701
Sfmt 4702
Average
costs
5,192
6.4
$20,097
166
12.8
41,691
594
9,730
6.5
3.9
23,780
13,865
0
0.0
0
34
1,984
4.2
2.7
15,558
11,771
0
0.0
$0
8
2.3
12,467
$20,097. There were 166 cases that
reported mechanical ventilation >96
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hours, with an average length of stay of
12.8 days and average costs of $41,691.
There were 594 cases that reported
mechanical ventilation <=96 hours,
with an average length of stay of 6.5
days and average costs of $23,780.
The total number of cases reported in
MS–DRG 062 was 9,730, with an
average length of stay of 3.9 days and
average costs of $13,865. There were no
cases identified in MS–DRG 062 where
mechanical ventilation >96 hours was
reported. However, there were 34 cases
that reported mechanical ventilation
<=96 hours, with an average length of
stay of 4.2 days and average costs of
$15,558.
The total number of cases reported in
MS–DRG 63 was 1,984 with an average
length of stay of 2.7 days and average
costs of $11,771. There were no cases
identified in MS–DRG 063 where
mechanical ventilation >96 hours was
reported. However, there were 8 cases
that reported mechanical ventilation
<=96 hours, with an average length of
stay of 2.3 days and average costs of
$12,467.
For the second subset of patients, we
examined claims data for MS–DRGs
064, 065, and 066. We identified cases
reporting mechanical ventilation of any
duration with a principal diagnosis of
cerebral infarction or intracranial
hemorrhage where a thrombolytic agent
was not administered during the current
hospital stay and the patient did not
undergo an O.R. procedure. The 33 ICD–
10–CM diagnosis codes that specify an
intracranial hemorrhage and were
included in our analysis are listed in
Table 6P.1b associated with this
proposed rule (which is available via
the Internet on the CMS website at:
https://www.cms.hhs.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/).
We also used the list of 90 ICD–10–
CM diagnosis codes that specify a
cerebral infarction listed in Table 6P.1a
associated with this proposed rule for
our analysis. We note that the
GROUPER logic for case assignment to
MS–DRG 065 includes that a
thrombolytic agent (for example, TPA)
was administered within 24 hours of the
current hospital stay. The ICD–10–CM
diagnosis code that describes this
scenario is Z92.82 (Status post
administration of tPA (rtPA) in a
different facility within the last 24 hours
prior to admission to current facility).
We did not review the cases reporting
that diagnosis code for our analysis. Our
findings are shown in the following
table.
CEREBRAL INFARCTION OR INTRACRANIAL HEMORRHAGE WITH MV AND WITHOUT THROMBOLYTIC
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 064—All cases ............................................................................................................
MS–DRG 064—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 064—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation =24–96 hours .....................................................................
MS–DRG 064—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <24 hours ...........................................................................
MS–DRG 065—All cases ............................................................................................................
MS–DRG 065—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 065—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation =24–96 hours .....................................................................
MS–DRG 065—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <24 hours ...........................................................................
MS–DRG 066—All cases ............................................................................................................
MS–DRG 066—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 066—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation =24–96 hours .....................................................................
MS–DRG 066—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <24 hours ...........................................................................
The total number of cases reported in
MS–DRG 064 was 76,513, with an
average length of stay of 6.0 days and
average costs of $12,574. There were a
total of 10,997 cases reporting the use of
mechanical ventilation in MS–DRG 064
with an average length of stay ranging
from 3.1 days to 13.4 days and average
costs ranging from $8,675 to $38,262.
For MS–DRG 065, there were a total of
106,554 cases with an average length of
stay of 3.7 days and average costs of
$7,236. There were a total of 450 cases
reporting the use of mechanical
ventilation in MS–DRG 065 with an
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
average length of stay ranging from 2.1
days to 10.2 days and average costs
ranging from $6,145 to $20,759. For
MS–DRG 066, there were a total of
34,689 cases with an average length of
stay of 2.5 days and average costs of
$5,321. There were a total of 195 cases
reporting the use of mechanical
ventilation in MS–DRG 066 with an
average length of stay ranging from 1.4
days to 4.0 days and average costs
ranging from $3,426 to $10,364.
We then compared the total number
of cases in MS–DRGs 064, 065, and 066
specifically reporting mechanical
PO 00000
Average
length
of stay
Number of
cases
MS–DRG
Frm 00031
Fmt 4701
Sfmt 4702
Average
costs
76,513
6.0
$12,574
2,153
13.4
38,262
4,843
6.6
18,119
4,001
106,554
3.1
3.7
8,675
7,236
22
10.2
20,759
127
4.2
12,688
301
34,689
2.1
2.5
6,145
5,321
1
4.0
3,426
31
3.7
10,364
163
1.4
4,148
ventilation >96 hours with a principal
diagnosis of cerebral infarction or
intracranial hemorrhage where a
thrombolytic agent was not
administered and the patient did not
undergo an O.R. procedure against the
total number of cases reporting
mechanical ventilation <=96 hours with
a principal diagnosis of cerebral
infarction or intracranial hemorrhage
where a thrombolytic agent was not
administered and the patient did not
undergo an O.R. procedure. Our
findings are shown in the following
table.
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CEREBRAL INFARCTION OR INTRACRANIAL HEMORRHAGE WITH MV AND WITHOUT THROMBOLYTIC
MS–DRG 064—All cases ............................................................................................................
MS–DRG 064—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 064—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <=96 hours .........................................................................
MS–DRG 065—All cases ............................................................................................................
MS–DRG 065—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 065—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <=96 hours .........................................................................
MS–DRG 066—All cases ............................................................................................................
MS–DRG 066—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation >96 hours ...........................................................................
MS–DRG 066—Cases with principal diagnosis of cerebral infarction or intracranial hemorrhage and mechanical ventilation <=96 hours .........................................................................
The total number of cases reported in
MS–DRG 064 was 76,513, with an
average length of stay of 6.0 days and
average costs of $12,574. There were
2,153 cases that reported mechanical
ventilation >96 hours, with an average
length of stay of 13.4 days and average
costs of $38,262, and there were 8,794
cases that reported mechanical
ventilation <=96 hours, with an average
length of stay of 4.9 days and average
costs of $13,704.
The total number of cases reported in
MS–DRG 65 was 106,554, with an
average length of stay of 3.7 days and
average costs of $7,236. There were 22
Average
length
of stay
Number
of cases
MS–DRG
cases that reported mechanical
ventilation >96 hours, with an average
length of stay of 10.2 days and average
costs of $20,759, and there were 428
cases that reported mechanical
ventilation<=96 hours, with an average
length of stay of 2.7 days and average
costs of $8,086.
The total number of cases reported in
MS–DRG 66 was 34,689, with an
average length of stay of 2.5 days and
average costs of $5,321. There was one
case that reported mechanical
ventilation >96 hours, with an average
length of stay of 4.0 days and average
costs of $3,426, and there were 194
Average
costs
76,513
6.0
$12,574
2,153
13.4
38,262
8,794
106,554
4.9
3.7
13,704
7,236
22
10.2
20,759
428
34,689
2.7
2.5
8,086
5,321
1
4.0
3,426
194
1.8
5,141
cases that reported mechanical
ventilation <=96 hours, with an average
length of stay of 1.8 days and average
costs of $5,141.
We also analyzed claims data for MS–
DRGs 207 and 208. As shown in the
following table, there were a total of
19,471cases found in MS–DRG 207 with
an average length of stay of 13.8 days
and average costs of $38,124. For MS–
DRG 208, there were a total of 55,802
cases found with an average length of
stay of 6.7 days and average costs of
$17,439.
RESPIRATORY SYSTEM DIAGNOSIS WITH VENTILATOR SUPPORT
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 207—All cases ............................................................................................................
MS–DRG 208—All cases ............................................................................................................
Our analysis of claims data relating to
the first request for MS–DRGs 061, 062,
063, 064, 065, and 066 and consultation
with our clinical advisors do not
support creating new MS–DRGs for
cases that identify patients diagnosed
with cerebral infarction or intracranial
hemorrhage who require mechanical
ventilation with or without a
thrombolytic and in the absence of an
O.R. procedure.
For the first subset of patients (in MS–
DRGs 061, 062 and 063), our data
findings for MS–DRG 061 demonstrate
the 166 cases that reported mechanical
ventilation >96 hours had a longer
average length of stay (12.8 days versus
6.4 days) and higher average costs
($41,691 versus $20,097) compared to
all the cases in MS–DRG 061. However,
there were no cases that reported
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
mechanical ventilation >96 hours for
MS–DRG 062 or MS–DRG 063. For the
594 cases that reported mechanical
ventilation <=96 hours in MS-DRG 061,
the data show that the average length of
stay was consistent with the average
length of stay of all of the cases in MS–
DRG 061 (6.5 days versus 6.4 days) and
the average costs were also consistent
with the average costs of all of the cases
in MS-DRG 061 ($23,780 versus
$20,097). For the 34 cases that reported
mechanical ventilation <=96 hours in
MS–DRG 062, the data show that the
average length of stay was consistent
with the average length of stay of all of
the cases in MS–DRG 062 (4.2 days
versus 3.9 days) and the average costs
were also consistent with the average
costs of all of the cases in MS DRG 062
($15,558 versus $13,865). Lastly, for the
PO 00000
Frm 00032
Fmt 4701
Sfmt 4702
19,471
55,802
Average
length
of stay
13.8
6.7
Average
costs
$38,124
17,439
8 cases that reported mechanical
ventilation <=96 hours in MS–DRG 063,
the data show that the average length of
stay was consistent with the average
length of stay of all of the cases in MS–
DRG 063 (2.3 days versus 2.7 days) and
the average costs were also consistent
with the average costs of all of the cases
in MS DRG 063 ($12,467 versus
$11,771).
For the second subset of patients (in
MS–DRGs 064, 065 and 066), the data
findings for the 2,153 cases that
reported mechanical ventilation >96
hours in MS–DRG 064 showed a longer
average length of stay (13.4 days versus
6.0 days) and higher average costs
($38,262 versus $12,574) compared to
all of the cases in MS–DRG 064.
However, the 2,153 cases represent only
2.8 percent of all the cases in MS–DRG
E:\FR\FM\07MYP2.SGM
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064. For the 22 cases that reported
mechanical ventilation >96 hours in
MS–DRG 065, the data showed a longer
average length of stay (10.2 days versus
3.7 days) and higher average costs
($20,759 versus $7,236) compared to all
of the cases in MS–DRG 065. However,
the 22 cases represent only 0.02 percent
of all the cases in MS–DRG 065. For the
one case that reported mechanical
ventilation >96 hours in MS–DRG 066,
the data showed a longer average length
of stay (4.0 days versus 2.5 days) and
lower average costs ($3,426 versus
$5,321) compared to all of the cases in
MS–DRG 066. For the 8,794 cases that
reported mechanical ventilation <=96
hours in MS–DRG 064, the data showed
that the average length of stay was
shorter than the average length of stay
for all of the cases in MS–DRG 064 (4.9
days versus 6.0 days) and the average
costs were consistent with the average
costs of all of the cases in MS–DRG 064
($13,704 versus $12,574). For the 428
cases that reported mechanical
ventilation <=96 hours in MS–DRG 065,
the data showed that the average length
of stay was shorter than the average
length of stay for all of the cases in MS–
DRG 065 (2.7 days versus 3.7 days) and
the average costs were consistent with
the average costs of all the cases in MS–
DRG 065 ($8,086 versus $7,236). For the
194 cases that reported mechanical
ventilation <=96 hours in MS–DRG 066,
the data showed that the average length
of stay was shorter than the average
length of stay for all of the cases in MS–
DRG 066 (1.8 days versus 2.5 days) and
the average costs were less than the
average costs of all of the cases in MS–
DRG 066 ($5,141 versus $5,321).
Based on the analysis described
above, the current MS–DRG assignment
for the cases in MS–DRGs 061, 062, 063,
064, 065 and 066 that identify patients
diagnosed with cerebral infarction or
intracranial hemorrhage who require
mechanical ventilation with or without
a thrombolytic and in the absence of an
O.R. procedure appears appropriate.
Our clinical advisors also noted that
patients requiring mechanical
ventilation (in the absence of an O.R.
procedure) are known to be more
resource intensive and it would not be
practical to create new MS–DRGs
specifically for this subset of patients
diagnosed with an acute neurologic
event, given the various indications for
which mechanical ventilation may be
utilized. If we were to create new MS–
DRGs for patients diagnosed with an
intracranial hemorrhage or cerebral
infarction who require mechanical
ventilation, it would not address all of
the other patients who also utilize
mechanical ventilation resources. It
would also necessitate further extensive
analysis and evaluation for several other
conditions that require mechanical
ventilation across each of the 25 MDCs
under the ICD–10 MS–DRGs.
To evaluate the frequency in which
the use of mechanical ventilation is
reported for different clinical scenarios,
we examined claims data across each of
the 25 MDCs to determine the number
of cases reporting the use of mechanical
ventilation >96 hours. Our findings are
shown in the table below.
MECHANICAL VENTILATION >96 HOURS ACROSS ALL MDCS
daltland on DSKBBV9HB2PROD with PROPOSALS2
All cases with mechanical ventilation >96 hours .........................................................................
MDC 1 (Diseases and Disorders of the Nervous System)—Cases with mechanical ventilation
>96 hours .................................................................................................................................
MDC 2 (Disease and Disorders of the Eye)—Cases with mechanical ventilation >96 hours ....
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and Throat)—Cases with mechanical ventilation >96 hours .........................................................................................................
MDC 4 (Diseases and Disorders of the Respiratory System)—Cases with mechanical ventilation >96 hours ..........................................................................................................................
MDC 5 (Diseases and Disorders of the Circulatory System)—Cases with mechanical ventilation >96 hours ..........................................................................................................................
MDC 6 (Diseases and Disorders of the Digestive System)—Cases with mechanical ventilation >96 hours ..........................................................................................................................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and Pancreas)—Cases with
mechanical ventilation >96 hours ............................................................................................
MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)—
Cases with mechanical ventilation >96 hours .........................................................................
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast)—Cases with
mechanical ventilation >96 hours ............................................................................................
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and Disorders)—Cases with mechanical ventilation >96 hours .................................................................................................
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)—Cases with mechanical
ventilation >96 hours ................................................................................................................
MDC 12 (Diseases and Disorders of the Male Reproductive System)—Cases with mechanical ventilation >96 hours .........................................................................................................
MDC 13 (Diseases and Disorders of the Female Reproductive System)—Cases with mechanical ventilation >96 hours .................................................................................................
MDC 14 (Pregnancy, Childbirth and the Puerperium)—Cases with mechanical ventilation >96
hours ........................................................................................................................................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, Immunologic Disorders)—Cases with mechanical ventilation >96 hours ..........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms)—
Cases with mechanical ventilation >96 hours .........................................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or Unspecified Sites)—Cases with mechanical ventilation >96 hours .................................................................................................
MDC 19 (Mental Diseases and Disorders)—Cases with mechanical ventilation >96 hours ......
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental Disorders)—Cases
with mechanical ventilation >96 hours .....................................................................................
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PO 00000
Average
length
of stay
Number
of cases
MDC
Frm 00033
Fmt 4701
Sfmt 4702
Average
costs
127,626
18.4
$61,056
13,668
33
18.3
22.7
61,234
79,080
602
20.3
62,625
27,793
16.6
48,869
16,923
20.7
84,565
6,401
22.4
73,759
1,803
24.5
80,477
2,780
22.3
83,271
390
22.2
68,288
1,168
20.9
60,682
2,325
19.6
57,893
54
26.8
95,204
89
24.6
83,319
22
17.4
56,981
468
20.1
68,658
538
29.7
99,968
48,176
54
17.3
29.3
55,022
52,749
312
20.5
47,637
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MECHANICAL VENTILATION >96 HOURS ACROSS ALL MDCS—Continued
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)—Cases with mechanical ventilation
>96 hours .................................................................................................................................
MDC 22 (Burns)—Cases with mechanical ventilation >96 hours ...............................................
MDC 23 (Factors Influencing Health Status and Other Contacts with Health Services)—
Cases with mechanical ventilation >96 hours .........................................................................
MDC 24 (Multiple Significant Trauma)—Cases with mechanical ventilation >96 hours .............
MDC 25 (Human Immunodeficiency Virus Infections)—Cases with mechanical ventilation >96
hours ........................................................................................................................................
As shown in the table, the top 5 MDCs
with the largest number of cases
reporting mechanical ventilation >96
hours are MDC 18, with 48,176 cases;
MDC 4, with 27,793 cases; MDC 5, with
16,923 cases; MDC 1, with 13,668 cases;
and MDC 6, with 6,401 cases. We note
that the claims data demonstrate that
the average length of stay is consistent
with what we would expect for cases
reporting the use of mechanical
ventilation >96 hours across each of the
Average
length
of stay
Number
of cases
MDC
25 MDCs. The top 5 MDCs with the
highest average costs for cases reporting
mechanical ventilation >96 hours were
MDC 22, with average costs of $188,704;
MDC 17, with average costs of $99,968;
MDC 12, with average costs of $95,204;
MDC 5, with average costs of $84,565;
and MDC 13, with average costs of
$83,319. We note that the data for MDC
8 demonstrated similar results
compared to MDC 13 with average costs
of $83,271 for cases reporting
Average
costs
2,436
242
18.2
34.8
57,712
188,704
64
922
17.7
17.6
50,821
72,358
363
19.1
56,688
mechanical ventilation >96 hours. In
summary, the claims data reflect a wide
variance with regard to the frequency
and average costs for cases reporting the
use of mechanical ventilation >96
hours.
We also examined claims data across
each of the 25 MDCs for the number of
cases reporting the use of mechanical
ventilation <=96 hours. Our findings are
shown in the table below.
MECHANICAL VENTILATION <=96 HOURS ACROSS ALL MDCS
daltland on DSKBBV9HB2PROD with PROPOSALS2
All cases with mechanical ventilation <=96 hours ......................................................................
MDC 1 (Diseases and Disorders of the Nervous System)—Cases with mechanical ventilation
<=96 hours ...............................................................................................................................
MDC 2 (Disease and Disorders of the Eye)—Cases with mechanical ventilation <=96 hours ..
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and Throat)—Cases with mechanical ventilation <=96 hours .......................................................................................................
MDC 4 (Diseases and Disorders of the Respiratory System)—Cases with mechanical ventilation <=96 hours ........................................................................................................................
MDC 5 (Diseases and Disorders of the Circulatory System)—Cases with mechanical ventilation <=96 hours ........................................................................................................................
MDC 6 (Diseases and Disorders of the Digestive System)—Cases with mechanical ventilation <=96 hours ........................................................................................................................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and Pancreas)—Cases with
mechanical ventilation <=96 hours ..........................................................................................
MDC 8 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)—
Cases with mechanical ventilation <=96 hours .......................................................................
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast)—Cases with
mechanical ventilation <=96 hours ..........................................................................................
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and Disorders)—Cases with mechanical ventilation <=96 hours ...............................................................................................
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)—Cases with mechanical
ventilation <=96 hours ..............................................................................................................
MDC 12 (Diseases and Disorders of the Male Reproductive System)—Cases with mechanical ventilation <=96 hours .......................................................................................................
MDC 13 (Diseases and Disorders of the Female Reproductive System)—Cases with mechanical ventilation <=96 hours ...............................................................................................
MDC 14 (Pregnancy, Childbirth and the Puerperium)—Cases with mechanical ventilation
<=96 hours ...............................................................................................................................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, Immunologic Disorders)—Cases with mechanical ventilation <=96 hours ........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly Differentiated Neoplasms)—
Cases with mechanical ventilation <=96 hours .......................................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or Unspecified Sites)—Cases with mechanical ventilation <=96 hours ...............................................................................................
MDC 19 (Mental Diseases and Disorders)—Cases with mechanical ventilation <=96 hours ....
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental Disorders)—Cases
with mechanical ventilation <=96 hours ...................................................................................
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)—Cases with mechanical ventilation
<=96 hours ...............................................................................................................................
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PO 00000
Average
length
of stay
Number
of cases
MDC
Frm 00034
Fmt 4701
Sfmt 4702
Average
costs
266,583
8.5
$26,668
29,896
60
7.4
8.4
22,838
29,708
1,397
9.8
29,479
64,861
7.8
20,929
45,147
8.8
35,818
15,629
11.3
33,660
4,678
10.5
31,565
7,140
10.4
40,183
1,036
10.7
26,809
3,591
9.0
23,863
5,506
10.2
27,951
168
11.5
35,009
310
10.8
32,382
55
7.6
21,785
1,171
8.7
26,138
1,178
15.3
46,335
69,826
264
8.5
10.4
25,253
18,805
918
8.3
19,376
10,842
6.5
17,843
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MECHANICAL VENTILATION <=96 HOURS ACROSS ALL MDCS—Continued
Number
of cases
MDC
daltland on DSKBBV9HB2PROD with PROPOSALS2
MDC 22 (Burns)—Cases with mechanical ventilation <=96 hours .............................................
MDC 23 (Factors Influencing Health Status and Other Contacts with Health Services)—
Cases with mechanical ventilation <=96 hours .......................................................................
MDC 24 (Multiple Significant Trauma)—Cases with mechanical ventilation <=96 hours ...........
MDC 25 (Human Immunodeficiency Virus Infections)—Cases with mechanical ventilation
<=96 hours ...............................................................................................................................
As shown in the table, the top 5 MDCs
with the largest number of cases
reporting mechanical ventilation <=96
hours are MDC 18, with 69,826 cases;
MDC 4, with 64,861 cases; MDC 5, with
45,147 cases; MDC 1, with 29,896 cases;
and MDC 6, with 15,629 cases. We note
that the claims data demonstrate that
the average length of stay is consistent
with what we would expect for cases
reporting the use of mechanical
ventilation <=96 hours across each of
the 25 MDCs. The top 5 MDCs with the
highest average costs for cases reporting
mechanical ventilation <=96 hours are
MDC 17, with average costs of $46,335;
MDC 22, with average costs of $45,557;
MDC 8, with average costs of $40,183;
MDC 24, with average costs of $36,475;
and MDC 5, with average costs of
$35,818. Similar to the cases reporting
mechanical ventilation >96 hours, the
claims data for cases reporting the use
of mechanical ventilation <=96 hours
also reflect a wide variance with regard
to the frequency and average costs.
Depending on the number of cases in
each MS–DRG, it may be difficult to
detect patterns of complexity and
resource intensity.
With respect to the requestor’s
statement that reporting for other
purposes, such as quality measures,
clinical trials, and Joint Commission
and State certification or survey cases,
is based on the principal diagnosis, and
their belief that patients who present
with cerebral infarction or cerebral
hemorrhage and acute respiratory
failure are currently in conflict for
principal diagnosis sequencing because
the cerebral infarction or cerebral
hemorrhage code is needed as the
principal diagnosis for quality reporting
and other purposes (however, acute
respiratory failure is needed as the
principal diagnosis for purposes of
appropriate payment under the MS–
DRGs), we note that providers are
required to assign the principal
diagnosis according to the ICD–10–CM
Official Guidelines for Coding and
Reporting and these assignments are not
based on factors such as quality
measures or clinical trials indications.
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Furthermore, we do not base MS–DRG
reclassification decisions on those
factors. If the cerebral hemorrhage or
ischemic cerebral infarction is the
reason for admission to the hospital, the
cerebral hemorrhage or ischemic
cerebral infarction diagnosis code
should be assigned as the principal
diagnosis.
We acknowledge that new MS–DRGs
were created for cases of patients with
sepsis requiring mechanical ventilation
greater than and less than 96 hours.
However, those MS–DRGs (MS–DRG
575 (Septicemia with Mechanical
Ventilation 96+ Hours Age >17) and
MS–DRG 576 (Septicemia without
Mechanical Ventilation 96+ Hours Age
>17)) were created several years ago, in
FY 2007 (71 FR 47938 through 47939)
in response to public comments
suggesting alternatives for the need to
recognize the treatment for that subset
of patients with severe sepsis who
exhibit a greater degree of severity and
resource consumption as septicemia is a
systemic condition, and also as a
preliminary step in the transition from
the CMS DRGs to MS–DRGs.
We believe that additional analysis
and efforts toward a broader approach to
refining the MS–DRGs for cases of
patients requiring mechanical
ventilation across the MDCs involves
carefully examining the potential for
instability in the relative weights and
disrupting the integrity of the MS–DRG
system based on the creation of separate
MS-DRGs involving small numbers of
cases for various indications in which
mechanical ventilation may be required.
The second request focused on
patients diagnosed with any
neurological condition classified under
MDC 1 requiring mechanical ventilation
in the absence of an O.R. procedure and
without having received a thrombolytic
agent. Because the first request
specifically involved analysis for the
acute neurological conditions of
cerebral infarction and intracranial
hemorrhage under MDC 1 and our
findings do not support creating new
MS–DRGs for those specific conditions,
we did not perform separate claims
PO 00000
Frm 00035
Fmt 4701
Sfmt 4702
Average
length
of stay
Average
costs
353
9.7
45,557
307
1,709
6.6
8.8
16,159
36,475
541
10.4
29,255
analysis for other conditions classified
under MDC 1.
Therefore, we are not proposing to
create new MS–DRGs for cases that
identify patients diagnosed with
neurological conditions classified under
MDC 1 who require mechanical
ventilation with or without a
thrombolytic and in the absence of an
O.R. procedure. We are inviting public
comments on our proposal.
4. MDC 5 (Diseases and Disorders of the
Circulatory System)
a. Pacemaker Insertions
In the FY 2017 IPPS/LTCH PPS final
rule (81 FR 56804 through 56809), we
discussed a request to examine the ICD–
10–PCS procedure code combinations
that describe procedures involving
pacemaker insertions to determine if
some procedure code combinations
were excluded from the Version 33 ICD–
10 MS–DRG assignments for MS–DRGs
242, 243, and 244 (Permanent Cardiac
Pacemaker Implant with MCC, with CC,
and without CC/MCC, respectively)
under MDC 5. We finalized our proposal
to modify the Version 34 ICD–10 MS–
DRG GROUPER logic so the specified
procedure code combinations were no
longer required for assignment into
those MS–DRGs. As a result, the logic
for pacemaker insertion procedures was
simplified by separating the procedure
codes describing cardiac pacemaker
device insertions into one list and
separating the procedure codes
describing cardiac pacemaker lead
insertions into another list. Therefore,
when any ICD–10–PCS procedure code
describing the insertion of a pacemaker
device is reported from that specific
logic list with any ICD–10–PCS
procedure code describing the insertion
of a pacemaker lead from that specific
logic list (81 FR 56804 through 56806),
the case is assigned to MS–DRGs 242,
243, and 244 under MDC 5.
We then discussed our examination of
the Version 33 GROUPER logic for
MS-DRGs 258 and 259 (Cardiac
Pacemaker Device Replacement with
and without MCC, respectively) because
assignment of cases to these MS–DRGs
E:\FR\FM\07MYP2.SGM
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also included qualifying ICD–10–PCS
procedure code combinations involving
pacemaker insertions (81 FR 56806
through 56808). Specifically, the logic
for Version 33 ICD–10 MS–DRGs 258
and 259 included ICD–10–PCS
procedure code combinations describing
the removal of pacemaker devices and
the insertion of new pacemaker devices.
We finalized our proposal to modify the
Version 34 ICD–10 MS–DRG GROUPER
logic for MS–DRGs 258 and 259 to
establish that a case reporting any
procedure code from the list of ICD–10–
PCS procedure codes describing
procedures involving pacemaker device
insertions without any other procedure
codes describing procedures involving
pacemaker leads reported would be
assigned to MS–DRGs 258 and 259 (81
FR 56806 through 56807) under MDC 5.
In addition, we pointed out that a
limited number of ICD–10–PCS
procedure codes describing pacemaker
insertion are classified as non-operating
room (non-O.R.) codes within the MS–
DRGs and that the Version 34 ICD–10
MS–DRG GROUPER logic would
continue to classify these procedure
codes as non-O.R. codes. We noted that
a case reporting any one of these nonO.R. procedure codes describing a
pacemaker device insertion without any
other procedure code involving a
pacemaker lead would be assigned to
MS–DRGs 258 and 259. Therefore, the
listed procedure codes describing a
pacemaker device insertion under MS–
DRGs 258 and 259 are designated as
non-O.R. affecting the MS–DRG.
Lastly, we discussed our examination
of the Version 33 GROUPER logic for
MS–DRGs 260, 261, and 262 (Cardiac
Pacemaker Revision Except Device
Replacement with MCC, with CC, and
without CC/MCC, respectively), and
noted that cases assigned to these MS–
DRGs also included lists of procedure
code combinations describing
procedures involving the removal of
pacemaker leads and the insertion of
new leads, in addition to lists of single
procedure codes describing procedures
involving the insertion of pacemaker
leads, removal of cardiac devices, and
revision of cardiac devices (81 FR
56808). We finalized our proposal to
modify the ICD–10 MS–DRG GROUPER
logic for MS–DRGs 260, 261, and 262 so
that cases reporting any one of the listed
ICD–10–PCS procedure codes
describing procedures involving
pacemakers and related procedures and
associated devices are assigned to MS
DRGs 260, 261, and 262 under MDC 5.
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Therefore, the GROUPER logic that
required a combination of procedure
codes be reported for assignment into
MS–DRGs 260, 261 and 262 under
Version 33 was no longer required
effective with discharges occurring on
or after October 1, 2016 (FY 2017) under
Version 34 of the ICD–10 MS–DRGs.
We note that while the discussion in
the FY 2017 IPPS/LTCH PPS final rule
focused on the MS–DRGs involving
pacemaker procedures under MDC 5,
similar GROUPER logic exists in
Version 33 of the ICD–10 MS–DRGs
under MDC 1 (Diseases and Disorders of
the Nervous System) in MS–DRGs 040,
041 and 042 (Peripheral, Cranial Nerve
and Other Nervous System Procedures
with MCC, with CC or Peripheral
Neurostimulator and without CC/MCC,
respectively) and MDC 21 (Injuries,
Poisonings and Toxic Effects of Drugs)
in MS–DRGs 907, 908, and 909 (Other
O.R. Procedures for Injuries with MCC,
with CC, and without MCC,
respectively) where procedure code
combinations involving cardiac
pacemaker device insertions or
removals and cardiac pacemaker lead
insertions or removals are required to be
reported together for assignment into
those MS–DRGs. We also note that, with
the exception of when a principal
diagnosis is reported from MDC 1, MDC
5, or MDC 21, the procedure codes
describing the insertion, removal,
replacement, or revision of pacemaker
devices are assigned to a medical MS–
DRG in the absence of another O.R.
procedure according to the GROUPER
logic. We refer the reader to the ICD–10
MS–DRG Definitions Manual Version
33, which is available via the Internet
on the CMS Web site at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatient
PPS/FY2016-IPPS-Final-Rule-HomePage-Items/FY2016-IPPS-Final-RuleData-Files.html?DLPage=1&DLEntries
=10&DLSort=0&DLSortDir=ascending
for complete documentation of the
GROUPER logic that was in effect at that
time for the Version 33 ICD–10 MS–
DRGs discussed earlier.
For FY 2019, we received a request to
assign all procedures involving the
insertion of pacemaker devices to
surgical MS–DRGs, regardless of the
principal diagnosis. The requestor
recommended that procedures involving
pacemaker insertion be grouped to
surgical MS–DRGs within the MDC to
which the principal diagnosis is
assigned, or that they group to MS–
DRGs 981, 982, and 983 (Extensive O.R.
PO 00000
Frm 00036
Fmt 4701
Sfmt 4702
Procedure Unrelated to Principal
Diagnosis with MCC, with CC and
without CC/MCC, respectively).
Currently, in Version 35 of the ICD–10
MS–DRGs, procedures involving
pacemakers are assigned to MS–DRGs
040, 041, and 042 (Peripheral, Cranial
Nerve and Other Nervous System
Procedures with MCC, with CC or
Peripheral Neurostimulator and without
CC/MCC, respectively) under MDC 1
(Diseases and Disorders of the Nervous
System), to MS–DRGs 242, 243, and 244
(Permanent Cardiac Pacemaker Implant
with MCC, with CC, and without CC/
MCC, respectively), MS–DRGs 258 and
259 (Cardiac Pacemaker Device
Replacement with MCC and without
MCC, respectively), and MS–DRGs 260,
261 and 262 (Cardiac Pacemaker
Revision Except Device Replacement
with MCC, with CC, and without CC/
MCC, respectively) under MDC 5
(Diseases and Disorders of the
Circulatory System), and to MS–DRGs
907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with
CC, and without CC/MCC, respectively),
under MDC 21 (Injuries, Poisoning and
Toxic Effects of Drugs), with all other
unrelated principal diagnoses resulting
in a medical MS–DRG assignment.
According to the requestor, the medical
MS–DRGs do not provide adequate
payment for the pacemaker device,
specialized operating suites, time, skills,
and other resources involved for
pacemaker insertion procedures.
Therefore, the requestor recommended
that procedures involving pacemaker
insertions be grouped to surgical MS–
DRGs. We refer readers to the ICD–10
MS–DRG Definitions Manual Version
35, which is available via the Internet
on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatient
PPS/FY2018-IPPS-Final-Rule-HomePage-Items/FY2018-IPPS-Final-RuleData-Files.html?DLPage=1&DL
Entries=10&DLSort=0&DLSortDir=
ascending for complete documentation
of the GROUPER logic for the MS–DRGs
discussed earlier.
The following procedure codes
describe procedures involving the
insertion of a cardiac rhythm related
device which are classified as a type of
pacemaker insertion under the ICD–10
MS–DRGs. These four codes are
assigned to MS–DRGs 040, 041, and
042, as well as MS–DRGs 907, 908, and
909, and are designated as O.R.
procedures.
E:\FR\FM\07MYP2.SGM
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ICD–10–PCS
code
0JH60PZ
0JH63PZ
0JH80PZ
0JH83PZ
..............
..............
..............
..............
Code description
Insertion
Insertion
Insertion
Insertion
of
of
of
of
cardiac
cardiac
cardiac
cardiac
rhythm
rhythm
rhythm
rhythm
We examined cases from the
September update of the FY 2017
MedPAR claims data for cases involving
related
related
related
related
device
device
device
device
into
into
into
into
chest subcutaneous tissue and fascia, open approach.
chest subcutaneous tissue and fascia, percutaneous approach.
abdomen subcutaneous tissue and fascia, open approach.
abdomen subcutaneous tissue and fascia, percutaneous approach.
pacemaker insertion procedures
reporting the above ICD–10–PCS codes
in MS–DRGs 040, 041 and 042 under
MDC 1. Our findings are shown in the
following table.
CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 1
Number
of
cases
MS–DRG in MDC 1
MS–DRG 040—All cases ............................................................................................................
MS–DRG 040—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 040—Cases with procedure code 0JH63PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach) .............................
MS–DRG 040—Cases with procedure code 0JH80PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, open approach) ....................................
MS–DRG 040—Cases with procedure code 0JH83PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, percutaneous approach) ......................
MS–DRG 041—All cases ............................................................................................................
MS–DRG 041—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 041—Cases with procedure code 0JH63PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach) .............................
MS–DRG 041—Cases with procedure code 0JH80PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, open approach) ....................................
MS–DRG 041—Cases with procedure code 0JH83PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, percutaneous approach) ......................
MS–DRG 042—All cases ............................................................................................................
MS–DRG 042—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 042—Cases with procedure code 0JH83PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, percutaneous approach) ......................
MS–DRG 042—Cases with procedure code 0JH80PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, open approach) ....................................
MS–DRG 042—Cases with procedure code 0JH83PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, percutaneous approach) ......................
The following table is a summary of
the findings shown above from our
review of MS–DRGs 040, 041 and 042
Average
length
of stay
Average
costs
4,462
10.4
$26,877
13
14.2
55,624
2
3.5
15,826
0
0
0
0
5,648
0
5.2
0
16,927
12
6.4
22,498
4
5
17,238
0
0
0
0
2,154
0
3.1
0
13,730
5
8
18,183
0
0
0
0
0
0
0
0
0
and the total number of cases reporting
a pacemaker insertion procedure.
MS–DRGS FOR CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 1
Number
of
cases
MS–DRG in MDC 1
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRGs 040, 041, and 042—All cases ...................................................................................
MS–DRGs 040, 041, and 042—Cases with a pacemaker insertion procedure .........................
We found a total of 12,264 cases in
MS–DRGs 040, 041, and 042 with an
average length of stay of 6.7 days and
average costs of $19,986. We found a
total of 36 cases in MS–DRGs 040, 041,
and 042 reporting procedure codes
VerDate Sep<11>2014
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describing the insertion of a pacemaker
device with an average length of stay of
9.1 days and average costs of $32,906.
We then examined cases involving
pacemaker insertion procedures
reporting those same four ICD–10–PCS
PO 00000
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Sfmt 4702
12,264
36
Average
length
of stay
Average
costs
6.7
9.1
$19,986
32,906
procedure codes 0JH60PZ, 0JH63PZ,
0JH80PZ and 0JH83PZ in MS–DRGs
907, 908, and 909 under MDC 21. Our
findings are shown in the following
table.
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MS–DRGS FOR CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 21
MS–DRG 907—All cases ............................................................................................................
MS–DRG 907—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 908—All cases ............................................................................................................
MS–DRG 908—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 909—All cases ............................................................................................................
MS–DRG 909—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
We note that there were no cases
found where procedure codes 0JH63PZ,
0JH80PZ or 0JH83PZ were reported in
MS–DRGs 907, 908 and 909 under MDC
Average
length
of stay
Number
of cases
MS–DRG in MDC 21
21 and, therefore, they are not displayed
in the table.
The following table is a summary of
the findings shown above from our
Average
costs
7,405
10.1
$28,997
7
8,519
11.1
5.2
60,141
14,282
4
3,224
3.8
3.1
35,678
9,688
2
2
42,688
review of MS–DRGs 907, 908, and 909
and the total number of cases reporting
a pacemaker insertion procedure.
MS–DRGS FOR CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 21
Number
of cases
MS–DRG in MDC 21
MS–DRGs 907, 908 and 909—All cases ....................................................................................
MS–DRGs 907, 908 and 909—Cases with a pacemaker insertion procedure ..........................
We found a total of 19,148 cases in
MS–DRGs 907, 908, and 909 with an
average length of stay of 6.7 days and
average costs of $19,199. We found a
total of 13 cases in MS–DRGs 907, 908,
and 909 reporting pacemaker insertion
procedures with an average length of
stay of 7.5 days and average costs of
$49,929.
ICD–10–PCS
code
0JH604Z
0JH605Z
0JH606Z
0JH607Z
...............
...............
...............
...............
0JH60PZ ..............
0JH634Z ...............
0JH635Z ...............
0JH636Z ...............
0JH637Z ...............
0JH63PZ ..............
0JH804Z ...............
0JH805Z ...............
0JH806Z ...............
0JH807Z ...............
0JH80PZ ..............
0JH834Z ...............
0JH835Z ...............
daltland on DSKBBV9HB2PROD with PROPOSALS2
0JH836Z ...............
0JH837Z ...............
0JH83PZ ..............
Average
costs
6.7
7.5
$19,199
49,929
We also examined cases involving
pacemaker insertion procedures
reporting the following procedure codes
that are assigned to MS–DRGs 242, 243,
and 244 under MDC 5.
Code description
Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, open approach.
Insertion of cardiac resynchronization pacemaker pulse generator into chest subcutaneous tissue and fascia, open approach.
Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, percutaneous approach.
Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, percutaneous approach.
Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, percutaneous approach.
Insertion of cardiac resynchronization pacemaker pulse generator into chest subcutaneous tissue and fascia, percutaneous
approach.
Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach.
Insertion of pacemaker, single chamber into abdomen subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, single chamber rate responsive into abdomen subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, open approach.
Insertion of cardiac resynchronization pacemaker pulse generator into abdomen subcutaneous tissue and fascia, open approach.
Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, open approach.
Insertion of pacemaker, single chamber into abdomen subcutaneous tissue and fascia, percutaneous approach.
Insertion of pacemaker, single chamber rate responsive into abdomen subcutaneous tissue and fascia, percutaneous approach.
Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, percutaneous approach.
Insertion of cardiac resynchronization pacemaker pulse generator into abdomen subcutaneous tissue and fascia,
percutaneous approach.
Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, percutaneous approach.
Our data findings are shown in the
following table. We note that procedure
codes displayed with an asterisk (*) in
VerDate Sep<11>2014
19,148
13
Average
length
of stay
20:30 May 04, 2018
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the table are designated as non-O.R.
procedures affecting the MS–DRG.
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CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 5
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 242—All cases ............................................................................................................
MS–DRG 242—Cases with procedure code 0JH604Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, open approach) ............................................
MS–DRG 242—Cases with procedure code 0JH605Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, open approach) ..................
MS–DRG 242—Cases with procedure code 0JH606Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, open approach) ............................................
MS–DRG 242—Cases with procedure code 0JH607Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest subcutaneous tissue and fascia, open approach) .....
MS–DRG 242—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 242—Cases with procedure code 0JH634Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 242—Cases with procedure code 0JH635Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, percutaneous approach) ....
MS–DRG 242—Cases with procedure code 0JH636Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 242—Cases with procedure code 0JH637Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest Subcutaneous tissue and fascia, percutaneous approach) .....................................................................................................................................
MS–DRG 242—Cases with procedure code 0JH63PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach) .............................
MS–DRG 242—Cases with procedure code 0JH804Z* (Insertion of pacemaker, single chamber into abdomen subcutaneous tissue and fascia, open approach) .....................................
MS–DRG 242—Cases with procedure code 0JH805Z* (Insertion of pacemaker, single chamber rate responsive into abdomen subcutaneous tissue and fascia, open approach) ...........
MS–DRG 242—Cases with procedure code 0JH806Z* (Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, open approach) .....................................
MS–DRG 242—Cases with procedure code 0JH807Z (Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen subcutaneous tissue and fascia, open approach)
MS–DRG 242—Cases with procedure code 0JH836Z (Insertion of pacemaker, dual chamber
into abdomen subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 243—All cases ............................................................................................................
MS–DRG 243—Cases with procedure code 0JH604Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, open approach) ............................................
MS–DRG 243—Cases with procedure code 0JH605Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, open approach) ..................
MS–DRG 243—Cases with procedure code 0JH606Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, open approach) ............................................
MS–DRG 243—Cases with procedure code 0JH607Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest subcutaneous tissue and fascia, open approach) .....
MS–DRG 243—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 243—Cases with procedure code 0JH634Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 243—Cases with procedure code 0JH635Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, percutaneous approach) ....
MS–DRG 243—Cases with procedure code 0JH636Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 243—Cases with procedure code 0JH637Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest subcutaneous tissue and fascia, percutaneous approach) .....................................................................................................................................
MS–DRG 243—Cases with procedure code 0JH63PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach) .............................
MS–DRG 243—Cases with procedure code 0JH804Z* (Insertion of pacemaker, single chamber into abdomen subcutaneous tissue and fascia, open approach) .....................................
MS–DRG 243—Cases with procedure code 0JH805Z* (Insertion of pacemaker, single chamber rate responsive into abdomen subcutaneous tissue and fascia, open approach) ...........
MS–DRG 243—Cases with procedure code 0JH806Z* (Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, open approach) .....................................
MS–DRG 243—Cases with procedure code 0JH807Z (Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen subcutaneous tissue and fascia, open approach)
MS–DRG 243—Cases with procedure code 0JH80PZ (Insertion of cardiac rhythm related device into abdomen subcutaneous tissue and fascia, open approach) ....................................
MS–DRG 243—Cases with procedure code 0JH836Z* (Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, percutaneous approach) ........................
MS–DRG 244—All cases ............................................................................................................
MS–DRG 244—Cases with procedure code 0JH604Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, open approach) ............................................
VerDate Sep<11>2014
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Frm 00039
Average
length of
stay
Number
of cases
MS–DRG in MDC 5
Fmt 4701
Sfmt 4702
Average
costs
18,205
6.9
$26,414
2,518
7.7
25,004
306
7.7
24,454
13,323
6.7
25,497
1,528
8.1
37,060
5
16.6
59,334
65
8.5
26,789
10
7
35,104
313
6.4
23,699
82
7.1
35,382
2
12.5
32,405
25
14.4
43,080
2
4
26,949
50
6.8
25,306
5
21.2
67,908
1
24,586
5
4
36,111
18,669
2,537
4.7
17,118
271
4.4
17,268
19,921
3.9
18,306
1,236
4.4
28,658
6
4.2
20,994
55
5.2
16,784
15
4.1
17,938
431
3.7
16,164
58
5
28,926
3
8.3
23,717
10
8.2
20,871
1
4
15,739
57
4.4
18,787
3
4
19,653
1
7
16,224
1
15,974
2
2.7
14,005
15,670
1,045
3.2
14,541
E:\FR\FM\07MYP2.SGM
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 5—Continued
MS–DRG 244—Cases with procedure code 0JH605Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, open approach) ..................
MS–DRG 244—Cases with procedure code 0JH606Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, open approach) ............................................
MS–DRG 244—Cases with procedure code 0JH607Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest subcutaneous tissue and fascia, open approach) .....
MS–DRG 244—Cases with procedure code 0JH60PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, open approach) ...........................................
MS–DRG 244—Cases with procedure code 0JH634Z* (Insertion of pacemaker, single chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 244—Cases with procedure code 0JH635Z* (Insertion of pacemaker, single chamber rate responsive into chest subcutaneous tissue and fascia, percutaneous approach) ....
MS–DRG 244—Cases with procedure code 0JH636Z* (Insertion of pacemaker, dual chamber into chest subcutaneous tissue and fascia, percutaneous approach) ..............................
MS–DRG 244—Cases with procedure code 0JH637Z (Insertion of cardiac resynchronization
pacemaker pulse generator into chest subcutaneous tissue and fascia, percutaneous approach) .....................................................................................................................................
MS–DRG 244—Cases with procedure code 0JH63PZ (Insertion of cardiac rhythm related device into chest subcutaneous tissue and fascia, percutaneous approach) .............................
MS–DRG 244—Cases with procedure code 0JH805Z* (Insertion of pacemaker, single chamber rate responsive into abdomen subcutaneous tissue and fascia, open approach) ...........
MS–DRG 244—Cases with procedure code 0JH806Z* (Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, open approach) .....................................
MS–DRG 244—Cases with procedure code 0JH836Z* (Insertion of pacemaker, dual chamber into abdomen subcutaneous tissue and fascia, percutaneous approach) ........................
The following table is a summary of
the findings shown above from our
review of MS–DRGs 242, 243, and 244
Average
length of
stay
Number
of cases
MS–DRG in MDC 5
Average
costs
127
3
13,208
14,092
2.7
15,596
303
2.8
26,221
2
4.5
9,248
32
2.8
11,525
1
2
30,100
320
2.6
13,670
20
2.7
19,218
1
3
12,120
1
1
21,604
36
3.2
16,492
1
3
12,160
and the total number of cases reporting
a pacemaker insertion procedure.
CASES INVOLVING PACEMAKER INSERTION PROCEDURES IN MDC 5
Number
of cases
MS–DRG in MDC 5
MS–DRGs 242, 243 and 244—All cases ....................................................................................
MS–DRGs 242, 243, and 244—Cases with a pacemaker insertion procedure .........................
Average
length of
stay
58,765
* 58,822
Average
costs
4.6
4.6
$20,253
20,270
* The figure is not adjusted for cases reporting more than one pacemaker insertion procedure code. The figure represents the frequency in
which the number of pacemaker insertion procedures was reported.
We found a total of 58,765 cases in
MS–DRGs 242, 243, and 244 with an
average length of stay of 4.6 days and
average costs of $20,253. We found a
total of 58,822 cases reporting
pacemaker insertion procedures in MS–
DRGs 242, 243, and 244 with an average
length of stay of 4.6 days and average
costs of $20,270. We note that the
analysis performed is by procedure
code, and because multiple pacemaker
insertion procedures may be reported on
a single claim, the total number of these
pacemaker insertion procedure cases
exceeds the total number of all cases
found across MS–DRGs 242, 243, and
244 (58,822 procedures versus 58,765
cases).
We then analyzed claims for cases
reporting a procedure code describing
(1) the insertion of a pacemaker device
only, (2) the insertion of a pacemaker
lead only, and (3) both the insertion of
a pacemaker device and a pacemaker
lead across all the MDCs except MDC 5
to determine the number of cases
currently grouping to medical MS–DRGs
and the potential impact of these cases
moving into the surgical unrelated MS–
DRGs 981, 982 and 983 (Extensive O.R.
Procedure Unrelated to Principal
Diagnosis with MCC, with CC and
without CC/MCC, respectively). Our
findings are shown in the following
table.
daltland on DSKBBV9HB2PROD with PROPOSALS2
PACEMAKER INSERTION PROCEDURES IN MEDICAL MS–DRGS
Number
of cases
All MDCs except MDC 5
Procedures for insertion of pacemaker device ............................................................................
Procedures for insertion of pacemaker lead ...............................................................................
Procedures for insertion of pacemaker device with insertion of pacemaker lead ......................
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2,747
2,831
2,709
07MYP2
Average
length
of
stay
Average
costs
9.5
9.4
9.4
$29,389
29,240
29,297
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
We found a total of 2,747 cases
reporting the insertion of a pacemaker
device in 177 medical MS–DRGs with
an average length of stay of 9.5 days and
average costs of $29,389 across all the
MDCs except MDC 5. We found a total
of 2,831 cases reporting the insertion of
a pacemaker lead in 175 medical MS–
DRGs with an average length of stay of
9.4 days and average costs of $29,240
across all the MDCs except MDC 5. We
found a total of 2,709 cases reporting
both the insertion of a pacemaker device
and the insertion of a pacemaker lead in
170 medical MS–DRGs with an average
length of stay of 9.4 days and average
costs of $29,297 across all the MDCs
except MDC 5.
20203
We also analyzed claims for cases
reporting a procedure code describing
the insertion of a pacemaker device with
a procedure code describing the
insertion of a pacemaker lead in all the
surgical MS–DRGs across all the MDCs
except MDC 5. Our findings are shown
in the following table.
PACEMAKER INSERTION PROCEDURES IN MEDICAL MS–DRGS
Number
of cases
Average
length of
stay
Average
costs
Procedures for insertion of pacemaker device with insertion of pacemaker lead ......................
daltland on DSKBBV9HB2PROD with PROPOSALS2
All MDCs except MDC 5
3,667
12.8
$48,856
We found a total of 3,667 cases
reporting the insertion of a pacemaker
device and the insertion of a pacemaker
lead in 194 surgical MS–DRGs with an
average length of stay of 12.8 days and
average costs of $48,856 across all the
MDCs except MDC 5.
For cases where the insertion of a
pacemaker device, the insertion of a
pacemaker lead or the insertion of both
a pacemaker device and lead were
reported on a claim grouping to a
medical MS–DRG, the average length of
stay and average costs were generally
higher for these cases when compared to
the average length of stay and average
costs for all the cases in their assigned
MS–DRGs. For example, we found 113
cases reporting both the insertion of a
pacemaker device and lead in MS–DRG
378 (G.I. Hemorrhage with CC), with an
average length of stay of 7.1 days and
average costs of $23,711. The average
length of stay for all cases in MS–DRG
378 was 3.6 days and the average cost
for all cases in MS–DRG 378 was
$7,190. The average length of stay for
cases reporting both the insertion of a
pacemaker device and lead were twice
as long as the average length of stay for
all the cases in MS–DRG 378 (7.1 days
versus 3.6 days). In addition, the
average costs for the cases reporting
both the insertion of a pacemaker device
and lead were approximately $16,500
higher than the average costs of all the
cases in MS–DRG 378 ($23,711 versus
$7,190). We refer readers to Table 6P.1c
associated with this proposed rule
(which is available via the internet on
the CMS website) for the detailed report
of our findings across the other medical
MS–DRGs. We note that the average
costs and average length of stay for cases
reporting the insertion of a pacemaker
device, the insertion of a pacemaker
lead or the insertion of both a
pacemaker device and lead are reflected
in Columns D and E, while the average
costs and average length of stay for all
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
cases in the respective MS–DRG are
reflected in Columns I and J.
The claims data results from our
analysis of this request showed that if
we were to support restructuring the
GROUPER logic so that pacemaker
insertion procedures that include a
combination of the insertion of the
pacemaker device with the insertion of
the pacemaker lead are designated as an
O.R. procedure across all the MDCs, we
would expect approximately 2,709 cases
to move or ‘‘shift’’ from the medical
MS–DRGs where they are currently
grouping into the surgical unrelated
MS–DRGs 981, 982, and 983.
Our clinical advisors reviewed the
data results and recommended that
pacemaker insertion procedures
involving a complete pacemaker system
(insertion of pacemaker device
combined with insertion of pacemaker
lead) warrant classification into surgical
MS–DRGs because the patients
receiving these devices demonstrate
greater treatment difficulty and
utilization of resources when compared
to procedures that involve the insertion
of only the pacemaker device or the
insertion of only the pacemaker lead.
We note that the request we addressed
in the FY 2017 IPPS/LTCH PPS
proposed rule (81 FR 24981 through
24984) was to determine if some
procedure code combinations were
excluded from the ICD–10 MS–DRG
assignments for MS–DRGs 242, 243, and
244. We proposed and, upon
considering public comments received,
finalized an alternate approach that we
believed to be less complicated. We also
stated in the FY 2017 IPPS/LTCH PPS
final rule (81 FR 56806) that we would
continue to monitor the MS–DRGs for
pacemaker insertion procedures as we
receive ICD–10 claims data. Upon
further review, we believe that
recreating the procedure code
combinations for pacemaker insertion
procedures would allow for the
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Fmt 4701
Sfmt 4702
grouping of these procedures to the
surgical MS–DRGs, which we believe is
warranted to better recognize the
resources and complexity of performing
these procedures. Therefore, we are
proposing to recreate pairs of procedure
code combinations involving both the
insertion of a pacemaker device with the
insertion of a pacemaker lead to act as
procedure code combination pairs or
‘‘clusters’’ in the GROUPER logic that
are designated as O.R. procedures
outside of MDC 5 when reported
together. We are inviting public
comments on our proposal.
We also are proposing to designate all
the procedure codes describing the
insertion of a pacemaker device or the
insertion of a pacemaker lead as nonO.R. procedures when reported as a
single, individual stand-alone code
based on the recommendation of our
clinical advisors as noted earlier in this
section and consistent with how these
procedures were classified under the
Version 33 ICD–10 MS–DRG GROUPER
logic. We are inviting public comments
on our proposal.
We refer readers to Table 6P.1d, 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.hhs.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/) for (1) a
complete list of the proposed procedure
code combinations or ‘‘pairs’’; (2) a
complete list of the procedure codes
describing the insertion of a pacemaker
device; and (3) a complete list of the
procedure codes describing the
insertion of a pacemaker lead. We are
inviting public comments on our lists of
procedure codes that we are proposing
to include for restructuring the ICD–10
MS–DRG GROUPER logic for pacemaker
insertion procedures.
In addition, we are proposing to
maintain the current GROUPER logic for
MS–DRGs 258 and 259 (Cardiac
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Pacemaker Device Replacement with
MCC and without MCC, respectively)
where the listed procedure codes as
shown in the ICD–10 MS–DRG
Definitions Manual Version 35, which is
available via the internet on the CMS
website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/FY2018IPPS-Final-Rule-Home-Page-Items/
FY2018-IPPS-Final-Rule-DataFiles.html?DLPage=1&DLEntries=
10&DLSort=0&DLSortDir=ascending,
describing a pacemaker device
insertion, continue to be designated as
‘‘non-O.R. affecting the MS–DRG’’
because they are reported when a
pacemaker device requires replacement
and have a corresponding diagnosis
from MDC 5. Also, we are proposing to
maintain the current GROUPER logic for
MS–DRGs 260, 261, and 262 (Cardiac
Pacemaker Revision Except Device
Replacement with MCC, with CC, and
without CC/MCC, respectively) so that
cases reporting any one of the listed
ICD–10–PCS procedure codes as shown
in the ICD–10 MS–DRG Definitions
Manual Version 35 describing
procedures involving pacemakers and
ICD–10–PCS code
02PA0MZ .............
02PA3MZ .............
02PA4MZ .............
02WA0MZ ............
02WA3MZ ............
02WA4MZ ............
0JPT0PZ ..............
0JPT3PZ ..............
0JWT0PZ .............
0JWT3PZ .............
Code description
Removal of cardiac lead from heart, open approach.
Removal of cardiac lead from heart, percutaneous approach.
Removal of cardiac lead from heart, percutaneous endoscopic approach.
Revision of cardiac lead in heart, open approach.
Revision of cardiac lead in heart, percutaneous approach.
Revision of cardiac lead in heart, percutaneous endoscopic approach.
Removal of cardiac rhythm related device from trunk subcutaneous tissue and fascia, open approach.
Removal of cardiac rhythm related device from trunk subcutaneous tissue and fascia, percutaneous approach.
Revision of cardiac rhythm related device in trunk subcutaneous tissue and fascia, open approach.
Revision of cardiac rhythm related device in trunk subcutaneous tissue and fascia, percutaneous approach.
We are soliciting public comments on
whether these procedure codes
describing the removal or revision of a
cardiac lead and removal or revision of
a cardiac rhythm related (pacemaker)
device should also be designated as
non-O.R. procedure codes for FY 2019
when reported as a single, individual
stand-alone code with a principal
diagnosis outside of MDC 5 for
consistency in the classification among
these devices.
We also note that, while the requestor
did not include the following procedure
codes in its request, the codes in the
following table became effective October
1, 2016 (FY 2017) and also describe
procedures involving the insertion of a
ICD–10–PCS code
daltland on DSKBBV9HB2PROD with PROPOSALS2
02H40NZ ..............
02H43NZ ..............
02H44NZ ..............
02H60NZ ..............
02H63NZ ..............
02H64NZ ..............
02H70NZ ..............
02H73NZ ..............
02H74NZ ..............
02HK0NZ .............
02HK3NZ .............
02HK4NZ .............
02HL0NZ ..............
02HL3NZ ..............
02HL4NZ ..............
02WA0NZ .............
02WA3NZ .............
02WA4NZ .............
02WAXNZ ............
02H40NZ ..............
02H43NZ ..............
pacemaker. Specifically, the following
list includes procedure codes that
describe an intracardiac or ‘‘leadless’’
pacemaker. These procedure codes are
designated as O.R. procedure codes and
are currently assigned to MS–DRGs 228
and 229 (Other Cardiothoracic
Procedures with MCC and without
MCC, respectively) under MDC 5.
Code description
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Revision
Revision
Revision
Revision
Insertion
Insertion
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
intracardiac
We examined claims data for
procedures involving an intracardiac
pacemaker reporting any of the above
VerDate Sep<11>2014
related procedures and associated
devices will continue to be assigned to
those MS–DRGs under MDC 5 because
they are reported when a pacemaker
device requires revision and they have
a corresponding circulatory system
diagnosis. We are inviting public
comments on our proposal.
We note that, while the requestor did
not include the following procedure
codes in its request, these codes are also
currently designated as O.R. procedure
codes and are assigned to MS–DRGs
260, 261, and 262 under MDC 5.
20:30 May 04, 2018
Jkt 244001
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
pacemaker
into coronary vein, open approach.
into coronary vein, percutaneous approach.
into coronary vein, percutaneous endoscopic approach.
into right atrium, open approach.
into right atrium, percutaneous approach.
into right atrium, percutaneous endoscopic approach.
into left atrium, open approach.
into left atrium, percutaneous approach.
into left atrium, percutaneous endoscopic approach.
into right ventricle, open approach.
into right ventricle, percutaneous approach.
into right ventricle, percutaneous endoscopic approach.
into left ventricle, open approach.
into left ventricle, percutaneous Approach.
into left ventricle, percutaneous endoscopic approach.
in heart, open approach.
in heart, percutaneous approach.
in heart, percutaneous endoscopic approach.
in heart, external approach.
into coronary vein, open approach.
into coronary vein, percutaneous approach.
codes across all MS–DRGs. Our findings
are shown in the following table.
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20205
INTRACARDIAC PACEMAKER PROCEDURES
Across all MS–DRGs
Number
of cases
Average
length
of stay
Average
costs
Procedures for intracardiac pacemaker ......................................................................................
1,190
8.6
$38,576
We found 1,190 cases reporting a
procedure involving an intracardiac
pacemaker with an average length of
stay of 8.6 days and average costs of
$38,576. Of these 1,190 cases, we found
1,037 cases in MS–DRGs under MDC 5.
We also found that the 153 cases that
grouped to MS–DRGs outside of MDC 5
grouped to surgical MS–DRGs;
therefore, another O.R. procedure was
also reported on the claim. However, we
are soliciting public comments on
whether these procedure codes
describing the insertion and revision of
intracardiac pacemakers should also be
considered for classification into all
surgical unrelated MS–DRGs outside of
MDC 5 for FY 2019.
b. Drug-Coated Balloons in
Endovascular Procedures
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38111), we discontinued
new technology add-on payments for
the LUTONIX® and IN.PACTTM
AdmiralTM drug-coated balloon (DCB)
technologies, effective for FY 2018,
because the technology no longer met
the newness criterion for new
technology add-on payments. For FY
2019, we received a request to reassign
cases that utilize a drug-coated balloon
in the performance of an endovascular
procedure involving the treatment of
superficial femoral arteries for
peripheral arterial disease from the
lower severity level MS–DRG 254 (Other
Vascular Procedures without CC/MCC)
and MS–DRG 253 (Other Vascular
Procedures with CC) to the highest
severity level MS–DRG 252 (Other
Vascular Procedures with MCC). We
also received a request to revise the title
of MS–DRG 252 to ‘‘Other Vascular
Procedures with MCC or Drug-Coated
Balloon Implant’’.
There are currently 36 ICD–10–PCS
procedure codes that describe the
performance of endovascular
procedures involving treatment of the
superficial femoral arteries that utilize a
drug-coated balloon, which are listed in
the following table.
ICD–10–PCS code
Code description
047K041 ...............
047K0D1 ..............
047K0Z1 ...............
047K341 ...............
047K3D1 ..............
047K3Z1 ...............
047K441 ...............
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, open approach.
Dilation of right femoral artery using drug-coated balloon, open approach.
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery using drug-coated balloon, percutaneous approach.
Dilation of right femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right femoral artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, open approach.
Dilation of left femoral artery using drug-coated balloon, open approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery using drug-coated balloon, percutaneous approach.
Dilation of left femoral artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left femoral artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left femoral artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, open approach.
Dilation of right popliteal artery using drug-coated balloon, open approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery using drug-coated balloon, percutaneous approach.
Dilation of right popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic
approach.
Dilation of right popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of right popliteal artery using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, open approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, open approach.
Dilation of left popliteal artery using drug-coated balloon, open approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery using drug-coated balloon, percutaneous approach.
Dilation of left popliteal artery with drug-eluting intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left popliteal artery with intraluminal device using drug-coated balloon, percutaneous endoscopic approach.
Dilation of left popliteal artery using drug-coated balloon, percutaneous endoscopic approach.
047K4D1 ..............
047K4Z1 ...............
047L041 ...............
047L0D1 ...............
047L0Z1 ...............
047L341 ...............
047L3D1 ...............
047L3Z1 ...............
047L441 ...............
daltland on DSKBBV9HB2PROD with PROPOSALS2
047L4D1 ...............
047L4Z1 ...............
047M041 ..............
047M0D1 ..............
047M0Z1 ..............
047M341 ..............
047M3D1 ..............
047M3Z1 ..............
047M441 ..............
047M4D1 ..............
047M4Z1 ..............
047N041 ...............
047N0D1 ..............
047N0Z1 ..............
047N341 ...............
047N3D1 ..............
047N3Z1 ..............
047N441 ...............
047N4D1 ..............
047N4Z1 ..............
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The requestor performed its own
analysis of claims data and expressed
concern that it found that the average
costs of cases using a drug-coated
balloon in the performance of
percutaneous endovascular procedures
involving treatment of patients who
have been diagnosed with peripheral
arterial disease are significantly higher
than the average costs of all of the cases
in the MS–DRGs where these
procedures are currently assigned. The
requestor also expressed concern that
payments may no longer be adequate
because the new technology add-on
payments have been discontinued and
may affect patient access to these
procedures.
We first examined claims data from
the September 2017 update of the FY
2017 MedPAR file for cases reporting
any 1 of the 36 ICD–10–PCS procedure
codes listed in the immediately
preceding table that describe the use of
a drug-coated balloon in the
performance of endovascular
procedures in MS–DRGs 252, 253, and
254. Our findings are shown in the
following table.
MS–DRGS FOR OTHER VASCULAR PROCEDURES WITH DRUG-COATED BALLOON
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
252—All cases ............................................................................................................
252—Cases with drug-coated balloon ........................................................................
253—All cases ............................................................................................................
253—Cases with drug-coated balloon ........................................................................
254—All cases ............................................................................................................
254—Cases with drug-coated balloon ........................................................................
As shown in this table, there were a
total of 33,583 cases in MS–DRG 252,
with an average length of stay of 7.6
days and average costs of $23,906. There
were 870 cases in MS–DRG 252
reporting the use of a drug-coated
balloon in the performance of an
endovascular procedure, with an
average length of stay of 8.8 days and
average costs of $30,912. The total
number of cases in MS–DRG 253 was
25,714, with an average length of stay of
5.4 days and average costs of $18,986.
There were 1,532 cases in MS–DRG 253
reporting the use of a DCB in the
performance of an endovascular
procedure, with an average length of
stay of 5.4 days and average costs of
$23,051. The total number of cases in
MS–DRG 254 was 12,344, with an
average length of stay of 2.8 days and
average costs of $13,287. There were
488 cases in MS–DRG 254 reporting the
use of a DCB in the performance of an
endovascular procedure, with an
average length of stay of 2.4 days and
average costs of $17,445.
The results of our data analysis show
that there is not a very high volume of
cases reporting the use of a drug-coated
balloon in the performance of
endovascular procedures compared to
all of the cases in the assigned MS–
DRGs. The data results also show that
the average length of stay for cases
reporting the use of a drug-coated
balloon in the performance of
endovascular procedures in MS–DRGs
253 and 254 is lower compared to the
average length of stay for all of the cases
in the assigned MS–DRGs, while the
average length of stay for cases reporting
the use of a drug-coated balloon in the
performance of endovascular
procedures in MS–DRG 252 is slightly
higher compared to all of the cases in
MS–DRG 252 (8.8 days versus 7.6 days).
Lastly, the data results showed that the
average costs for cases reporting the use
of a drug-coated balloon in the
performance of percutaneous
endovascular procedures were higher
compared to all of the cases in the
assigned MS–DRGs. Specifically, for
Average
length
of stay
33,583
870
25,714
1,532
12,344
488
Average
costs
7.6
8.8
5.4
5.4
2.8
2.4
$23,906
30,912
18,986
23,051
13,287
17,445
MS–DRG 252, the average costs for cases
reporting the use of a DCB in the
performance of endovascular
procedures were $30,912 versus the
average costs of $23,906 for all cases in
MS–DRG 252, a difference of $7,006.
For MS–DRG 253, the average costs for
cases reporting the use of a drug-coated
balloon in the performance of
endovascular procedures were $23,051
versus the average costs of $18,986 for
all cases in MS–DRG 253, a difference
of $4,065. For MS–DRG 254, the average
costs for cases reporting the use of a
drug-coated balloon in the performance
of endovascular procedures were
$17,445 versus the average costs of
$13,287 for all cases in MS–DRG 254, a
difference of $4,158.
The following table is a summary of
the findings discussed above from our
review of MS–DRGs 252, 253 and 254
and the total number of cases that used
a drug-coated balloon in the
performance of the procedure across
MS–DRGs 252, 253, and 254.
MS–DRGS FOR OTHER VASCULAR PROCEDURES AND CASES WITH DRUG-COATED BALLOON
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRGs 252, 253, and 254—All cases ...................................................................................
MS–DRGs 252, 253, and 254—Cases with drug-coated balloon ..............................................
As shown in this table, there were a
total of 71,641 cases across MS–DRGs
252, 253, and 254, with an average
length of stay of 6.0 days and average
costs of $20,310. There were a total of
2,890 cases across MS–DRGs 252, 253,
and 254 reporting the use of a drug-
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20:30 May 04, 2018
Jkt 244001
coated balloon in the performance of the
procedure, with an average length of
stay of 6.0 days and average costs of
$24,569. The data analysis showed that
cases reporting the use of a drug-coated
balloon in the performance of the
procedure across MS–DRGs 252, 253
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Sfmt 4702
71,641
2,890
Average
Length
of stay
Average
costs
6.0
6.0
$20,310
24,569
and 254 have similar lengths of stay (6.0
days) compared to the average length of
stay for all of the cases in MS–DRGs
252, 253, and 254. The data results also
showed that the cases reporting the use
of a drug-coated balloon in the
performance of the procedure across
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these MS–DRGs have higher average
costs ($24,569 versus $20,310)
compared to the average costs for all of
the cases across these MS–DRGs.
The results of our claims data analysis
and the advice from our clinical
advisors do not support reassigning
cases reporting the use of a drug-coated
balloon in the performance of these
procedures from the lower severity level
MS–DRGs 253 and 254 to the highest
severity level MS–DRG 252 at this time.
If we were to reassign cases that utilize
a drug-coated balloon in the
performance of these types of
procedures from MS–DRG 254 to MS–
DRG 252, the cases would result in
overpayment and also would have a
shorter length of stay compared to all of
the cases in MS–DRG 252. While the
cases reporting the use of a drug-coated
balloon in the performance of these
procedures are higher compared to the
average costs for all cases in their
assigned MS–DRGs, it is not by a
significant amount. We believe that as
use of a drug-coated balloon becomes
more common, the costs will be
reflected in the data. Our clinical
advisors also agreed that it would not be
clinically appropriate to reassign cases
for patients from the lowest severity
level (without CC/MCC) MS–DRG to the
highest severity level (with MCC) MS–
DRG in the absence of additional data to
better determine the resource utilization
for this subset of patients. Therefore, for
these reasons, we are proposing to not
reassign cases reporting the use of a
drug-coated balloon in the performance
of endovascular procedures from MS–
DRGs 253 and 254 to MS–DRG 252. We
are inviting public comments on our
proposal.
We note that because 24 of the 36
ICD–10–PCS procedure codes
describing the use of a drug-coated
balloon in the performance of
endovascular procedures also include
the use of an intraluminal device, we
conducted further analysis to determine
the number of cases reporting an
intraluminal device with the use of a
drug-coated balloon in the performance
of the procedure versus the number of
cases reporting the use of a drug-coated
balloon alone. We analyzed the number
of cases across MS–DRGs 252, 253, and
254 reporting: (1) The use of an
intraluminal device (stent) with use of
a drug-coated balloon in the
performance of the procedure; (2) the
use of a drug-eluting intraluminal
device (stent) with the use of a drugcoated balloon in the performance of the
procedure; and (3) the use of a drugcoated balloon only in the performance
of the procedure. Our findings are
shown in the following table.
MS–DRGS FOR OTHER VASCULAR PROCEDURES AND CASES WITH DRUG-COATED BALLOON
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRGs 252, 253 and 254—All cases ....................................................................................
MS–DRGs 252, 253 and 254—Cases with intraluminal device with drug-coated balloon .........
MS–DRGs 252, 253 and 254—Cases with drug-eluting intraluminal device with drug-coated
balloon ......................................................................................................................................
MS–DRGs 252, 253 and 254—Cases with drug-coated balloon only ........................................
As shown in this table, there were a
total of 71,641 cases across MS–DRGs
252, 253, and 254, with an average
length of stay of 6.0 days and average
costs of $20,310. There were 522 cases
across MS–DRGs 252, 253, and 254
reporting the use of an intraluminal
device with use of a drug-coated balloon
in the performance of the procedure,
with an average length of stay of 6.0
days and average costs of $28,418. There
were 447 cases across MS–DRGs 252,
253, and 254 reporting the use of a
drug-eluting intraluminal device with
use of a drug-coated balloon in the
performance of the procedure, with an
average length of stay of 6.0 days and
average costs of $26,098. Lastly, there
were 2,705 cases across MS–DRGs 252,
253, and 254 reporting the use of a drugcoated balloon alone in the performance
of the procedure, with an average length
of stay of 6.1 days and average costs of
$24,553.
The data showed that the 2,705 cases
in MS–DRGs 252, 253, and 254
reporting the use of a drug-coated
balloon alone in the performance of the
procedure have lower average costs
compared to the 969 cases in MS–DRGs
252, 253, and 254 reporting the use of
an intraluminal device (522 cases) or a
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
drug-eluting intraluminal device (447
cases) with a drug-coated balloon in the
performance of the procedure ($24,553
versus $28,418 and $26,098,
respectively). The data also showed that
the cases reporting the use of a drugcoated balloon alone in the performance
of the procedure have a comparable
average length of stay compared to the
cases reporting the use of an
intraluminal device or a drug-eluting
intraluminal device with a drug-coated
balloon in the performance of the
procedure (6.1 days versus 6.0 days).
In summary, we believe that further
analysis of endovascular procedures
involving the treatment of superficial
femoral arteries for peripheral arterial
disease that utilize a drug-coated
balloon in the performance of the
procedure would be advantageous. As
additional claims data become available,
we will be able to more fully evaluate
the differences in cases where a
procedure utilizes a drug-coated balloon
alone in the performance of the
procedure versus cases where a
procedure utilizes an intraluminal
device or a drug-eluting intraluminal
device in addition to a drug-coated
balloon in the performance of the
procedure.
PO 00000
Frm 00045
Fmt 4701
Sfmt 4702
Average
length
of stay
Average
costs
71,641
522
6.0
6.0
$20,310
28,418
447
2,705
6.0
6.1
26,098
24,553
5. MDC 6 (Diseases and Disorders of the
Digestive System)
a. Benign Lipomatous Neoplasm of
Kidney
We received a request to reassign
ICD–10–CM diagnosis code D17.71
(Benign lipomatous neoplasm of kidney)
from MDC 06 (Diseases and Disorders of
the Digestive System) to MDC 11
(Diseases and Disorders of the Kidney
and Urinary Tract). The requestor stated
that this diagnosis code is used to
describe a kidney neoplasm and
believed that because the ICD–10–CM
code is specific to the kidney, a more
appropriate assignment would be under
MDC 11. In FY 2015, under the ICD–9–
CM classification, there was not a
specific diagnosis code for a benign
lipomatous neoplasm of the kidney. The
only diagnosis code available was ICD–
9–CM diagnosis code 214.3 (Lipoma of
intra-abdominal organs), which was
assigned to MS–DRGs 393, 394, and 395
(Other Digestive System Diagnoses with
MCC, with CC, and without CC/MCC,
respectively) under MDC 6. Therefore,
when we converted from the ICD–9
based MS-DRGs to the ICD-10 MS-DRGs,
there was not a specific code available
that identified the kidney from which to
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replicate. As a result, ICD–10–CM
diagnosis code D17.71 was assigned to
those same MS–DRGs (MS–DRGs 393,
394, and 395) under MDC 6.
While reviewing the MS–DRG
classification of ICD–10–CM diagnosis
code D17.71, we also reviewed the MS–
DRG classification of another diagnosis
code organized in subcategory D17.7,
ICD–10–CM diagnosis code D17.72
(Benign lipomatous neoplasm of other
genitourinary organ). ICD–10–CM
diagnosis code D17.72 is currently
assigned under MDC 09 (Diseases and
Disorders of the Skin, Subcutaneous
Tissue and Breast) to MS–DRGs 606 and
607 (Minor Skin Disorders with and
without MCC, respectively). Similar to
the replication issue with ICD–10–CM
diagnosis code D17.71, with ICD–10–
CM diagnosis code D17.72, under the
ICD–9–CM classification, there was not
a specific diagnosis code to identify a
benign lipomatous neoplasm of
genitourinary organ. The only diagnosis
code available was ICD–9–CM diagnosis
code 214.8 (Lipoma of other specified
sites), which was assigned to MS–DRGs
606 and 607 under MDC 09. Therefore,
when we converted from the ICD–9
based MS-DRGs to the ICD–10
MS-DRGs, there was not a specific code
available that identified another
genitourinary organ (other than the
kidney) from which to replicate. As a
result, ICD–10–CM diagnosis code
D17.72 was assigned to those same MS–
DRGs (MS–DRGs 606 and 607) under
MDC 9.
We are proposing to reassign ICD–10–
CM diagnosis code D17.71 from MS–
DRGs 393, 394, and 395 (Other Digestive
System Diagnoses with MCC, with CC,
and without CC/MCC, respectively)
under MDC 06 to MS–DRGs 686, 687,
and 688 (Kidney and Urinary Tract
Neoplasms with MCC, with CC, and
without CC/MCC, respectively) under
MDC 11 because this diagnosis code is
used to describe a kidney neoplasm. We
also are proposing to reassign ICD–10–
CM diagnosis code D17.72 from MS–
DRGs 606 and 607 under MDC 09 to
MS–DRGs 686, 687, and 688 under MDC
11 because this diagnosis code is used
to describe other types of neoplasms
ICD–10–PCS
code
0DSK0ZZ .............
0DKL4ZZ ..............
0DSL0ZZ ..............
0DSL4ZZ ..............
0DSM0ZZ .............
0DSM4ZZ .............
0DSN0ZZ .............
0DSN4ZZ .............
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
that group to MS–DRGs 329, 330, and
331, such as repositioning of the large
intestine (unspecified segment).
We analyzed the claims data from the
September 2017 update of the FY 2017
daltland on DSKBBV9HB2PROD with PROPOSALS2
cases
cases
cases
cases
cases
cases
Med PAR file for MS–DRGs 344, 345
and 346 for all cases reporting the 8
ICD-10–PCS procedure codes listed in
the table above. Our findings are shown
in the following table:
Number of
cases
............................................................................................................
with a specific large bowel reposition procedure ..............................
............................................................................................................
with a specific large bowel reposition ................................................
............................................................................................................
with a specific large bowel reposition procedure ..............................
The data showed that the average
length of stay and average costs for cases
that reported a specific large bowel
reposition procedure were generally
consistent with the average length of
VerDate Sep<11>2014
We received a request to reassign the
following 8 ICD–10–PCS procedure
codes that describe repositioning of the
colon and takedown of end colostomy
from MS–DRGs 344, 345, and 346
(Minor Small and Large Bowel
Procedures with MCC, with CC, and
without CC/MCC, respectively) to MS–
DRGs 329, 330, and 331 (Major Small
and Large Bowel Procedures with MCC,
with CC, and without CC/MCC,
respectively):
ascending colon, open approach.
ascending colon, percutaneous endoscopic approach.
transverse colon, open approach.
transverse colon, percutaneous endoscopic approach.
descending colon, open approach.
descending colon, percutaneous endoscopic approach.
sigmoid colon, open approach.
sigmoid colon, percutaneous endoscopic approach.
MS–DRG
344—All
344—All
345—All
345—All
346—All
346—All
b. Bowel Procedures
Code description
The requestor indicated that the
resources required for procedures
identifying repositioning of specified
segments of the large bowel are more
closely aligned with other procedures
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
classified to the genitourinary tract that
do not have a specific code identifying
the site. Our clinical advisors agree that
the conditions described by the ICD–10–
CM diagnosis codes provide specific
anatomic detail involving the kidney
and genitourinary tract and, therefore, if
reclassified under this proposed MDC
and reassigned to these MS–DRGs,
would improve the clinical coherence of
the patients assigned to these groups.
We are inviting public comments on
our proposals.
20:30 May 04, 2018
Jkt 244001
stay and average costs for all of the cases
in their assigned MS–DRG.
We then examined the claims data in
the September 2017 update of the FY
2017 MedPAR file for MS–DRGs 329,
PO 00000
Frm 00046
Fmt 4701
Sfmt 4702
1,452
52
2,674
246
990
223
Average
length
of stay
Average
costs
9.5
9.6
5.6
6
3.8
4.5
$20,609
23,409
11,552
14,915
8,977
12,279
330 and 331. Our findings are shown in
the following table.
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Number of
cases
MS–DRG
MS–DRGs 329, 330, and
MS–DRG 329—All cases
MS–DRG 330—All cases
MS–DRG 331—All cases
331—All cases ...................................................................................
............................................................................................................
............................................................................................................
............................................................................................................
As shown in this table, across MS–
DRGs 329, 330, and 331, we found a
total of 112,388 cases, with an average
length of stay of 8.4 days and average
costs of $21,382. The results of our
analysis indicate that the resources
required for cases reporting the specific
large bowel repositioning procedures
are more aligned with those resources
required for all cases assigned to MS–
DRGs 344, 345, and 346, with the
average costs being lower than the
average costs for all cases assigned to
MS–DRGs 329, 330, and 331. Our
clinical advisors also indicated that the
8 specific bowel repositioning
procedures are best aligned with those
in MS–DRGs 344, 345, and 346.
Therefore, we are proposing to maintain
the current assignment of the 8 specific
ICD–10–PCS
code
0DQK0ZZ
0DQK4ZZ
0DQL0ZZ
0DQL4ZZ
0DQM0ZZ
0DQM4ZZ
0DQN0ZZ
0DQN4ZZ
0DSB0ZZ
0DSB4ZZ
0DSE0ZZ
0DSE4ZZ
.............
.............
.............
.............
............
............
.............
.............
.............
.............
.............
.............
$21,382
34,015
17,896
12,132
bowel repositioning procedures in
MS-DRGs 344, 345, and 346 for FY
2019. We are inviting public comments
on this proposal.
In conducting our analysis of MS–
DRGs 329, 330, and 331, we also
examined the subset of cases reporting
one of the bowel procedures listed in
the following table as the only O.R.
procedure.
Repair ascending colon, open approach.
Repair ascending colon, percutaneous endoscopic approach.
Repair transverse colon, open approach.
Repair transverse colon, percutaneous endoscopic approach.
Repair descending colon, open approach.
Repair descending colon, percutaneous endoscopic approach.
Repair sigmoid colon, open approach.
Repair sigmoid colon, percutaneous endoscopic approach.
Reposition ileum, open approach.
Reposition ileum, percutaneous endoscopic approach.
Reposition large intestine, open approach.
Reposition large intestine, percutaneous endoscopic approach.
resource use. As shown in the following
table, we identified 398 cases reporting
a bowel procedure as the only O.R.
procedure, with an average length of
stay of 6.3 days and average costs of
$13,595 across MS–DRGs 329, 330, and
MS–DRGs 329, 330 and 331—All cases ....................................................................................
MS–DRGs 329, 330 and 331—All cases with a bowel procedure as only O.R. procedure ......
MS–DRG 329—All cases ............................................................................................................
MS–DRG 329—Cases with a bowel procedure as only O.R. procedure ...................................
MS–DRG 330—All cases ............................................................................................................
MS–DRG 330—Cases with a bowel procedure as only O.R. procedure ...................................
MS–DRG 331—All cases ............................................................................................................
MS–DRG 331—Cases with a bowel procedure as only O.R. procedure ...................................
The resources required for these cases
are more aligned with the resources
required for cases assigned to MS–DRGs
344, 345, and 346 than with the
resources required for cases assigned to
MS–DRGs 329, 330, and 331. Our
clinical advisors also agreed that these
cases are more clinically aligned with
cases in MS–DRGs 344, 345, and 346, as
they are minor procedures relative to
20:30 May 04, 2018
Jkt 244001
the major bowel procedures assigned to
MS–DRGs 329, 330, and 331. Therefore,
we are proposing to reassign the 12
ICD–10–PCS procedure codes listed
above from MS–DRGs 329, 330, and 331
to MS–DRGs 344, 345, and 346. We are
inviting public comments on this
proposal.
PO 00000
331, compared to the overall average
length of stay of 8.4 days and average
costs of $21,382 for all cases in MS–
DRGs 329, 330, and 331.
Number of
cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
8.4
13.3
7.3
4.1
Average
costs
Code description
This approach can be useful in
determining whether resource use is
truly associated with a particular
procedure or whether the procedure
frequently occurs in cases with other
procedures with higher than average
VerDate Sep<11>2014
112,388
33,640
52,644
26,104
Average
length
of stay
Frm 00047
Fmt 4701
Sfmt 4702
112,388
398
33,640
86
52,644
183
26,104
129
Average
length
of stay
8.4
6.3
13.3
8.3
7.3
6.9
4.1
4.3
Average
costs
$21,382
13,595
34,015
19,309
17,896
13,617
12,132
9,754
6. MDC 8 (Diseases and Disorders of the
Musculoskeletal System and Connective
Tissue): Spinal Fusion
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38036), we announced our
plans to review the ICD–10 logic for the
MS–DRGs where procedures involving
spinal fusion are currently assigned for
FY 2019. After publication of the FY
2018 IPPS/LTCH PPS final rule, we
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received a comment suggesting that
CMS publish findings from this review
and discuss possible future actions. The
commenter agreed that it is important to
be able to fully evaluate the MS–DRGs
to which all spinal fusion procedures
are currently assigned with additional
claims data, particularly considering the
33 clinically invalid codes that were
identified through the rulemaking
process (82 FR 38034 through 38035)
and the 87 codes identified from the
upper and lower joint fusion tables in
the ICD–10–PCS classification and
discussed at the September 12, 2017
ICD–10 Coordination and Maintenance
Committee that were proposed to be
deleted effective October 1, 2018 (FY
2019). The agenda and handouts from
that meeting can be obtained from the
CMS website at: https://www.cms.gov/
Medicare/Coding/
ICD9ProviderDiagnosticCodes/ICD-9CM-C-and-M-Meeting-Materials.html.
According to the commenter, deleting
the 33 procedure codes describing
clinically invalid spinal fusion
procedures for FY 2018 partially
resolves the issue for data used in
setting the FY 2020 payment rates.
However, the commenter also noted that
the problem will not be fully resolved
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
453
454
455
456
457
458
459
460
471
472
473
Description
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
.......................
Combined Anterior/Posterior Spinal Fusion with MCC.
Combined Anterior/Posterior Spinal Fusion with CC.
Combined Anterior/Posterior Spinal Fusion without CC/MCC.
Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with MCC.
Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with CC.
Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions without CC/MCC.
Spinal Fusion Except Cervical with MCC.
Spinal Fusion Except Cervical without MCC.
Cervical Spinal Fusion with MCC.
Cervical Spinal Fusion with CC.
Cervical Spinal Fusion without CC/MCC.
In addition, the commenter noted that
it also identified a number of discharges
for the 33 clinically invalid codes we
identified in the FY 2018 IPPS/LTCH
PPS final rule in the same MS–DRGs
listed above. According to the
commenter, its findings of these invalid
spinal fusion procedure codes in the FY
2016 claims data comprise
approximately 30 percent of all
discharges for spinal fusion procedures.
The commenter expressed its
appreciation that CMS is making efforts
to address coding inaccuracies within
the classification and suggested that
CMS publish findings from its own
review of spinal fusion coding issues in
those MS–DRGs where cases reporting
spinal fusion procedures are currently
assigned and include a discussion of
possible future actions in the FY 2019
IPPS/LTCH PPS proposed rule. The
commenter believed that such an
approach would allow time for
stakeholder input on any possible
proposals along with time for the
invalid codes to be worked out of the
datasets. The commenter also noted that
publishing CMS’ findings will put the
agency, as well as the public, in a better
position to address any potential
payment issues for these services
beginning in FY 2021.
We thank the commenter for
acknowledging the steps we have taken
in our efforts to address coding
VerDate Sep<11>2014
until the FY 2019 claims are available
for FY 2021 ratesetting (due to the 87
codes identified at the ICD–10
Coordination and Maintenance
Committee meeting for deletion
effective October 1, 2018 (FY 2019)).
The commenter noted that it analyzed
claims data from the FY 2016 MedPAR
data set and was surprised to discover
a significant number of discharges
reporting 1 of the 87 clinically invalid
codes that were identified and
discussed by the ICD–10 Coordination
and Maintenance Committee among the
following spinal fusion MS–DRGs.
20:30 May 04, 2018
Jkt 244001
inaccuracies within the classification as
we continue to refine the ICD–10 MS–
DRGs. We are not proposing any
changes to the MS–DRGs involving
spinal fusion procedures for FY 2019.
However, in response to the
commenter’s suggestion and findings,
we are providing the results from our
analysis of the September 2017 update
of the FY 2017 MedPAR claims data for
the MS–DRGs involving spinal fusion
procedures.
We note that while the commenter
stated that 87 codes were identified
from the upper and lower joint fusion
tables in the ICD–10–PCS classification
and discussed at the September 12, 2017
ICD–10 Coordination and Maintenance
Committee meeting to be deleted
effective October 1, 2018 (FY 2019),
there were 99 spinal fusion codes
identified in the meeting materials, as
shown in Table 6P.1g associated with
this proposed rule (which is available
via the Internet on the CMS website at:
https://www.cms.hhs.gov/Medicare/
Medicare-Fee-for-Service-Payment/
AcuteInpatientPPS/).
As shown in Table 6P.1g associated
with this proposed rule, the 99
procedure codes describe spinal fusion
procedures that have device value ‘‘Z’’
representing No Device for the 6th
character in the code. Because a spinal
fusion procedure always requires some
type of device (for example,
PO 00000
Frm 00048
Fmt 4701
Sfmt 4702
instrumentation with bone graft or bone
graft alone) to facilitate the fusion of
vertebral bones, these codes are
considered clinically invalid and were
proposed for deletion at the September
12, 2017 ICD–10 Coordination and
Maintenance Committee meeting. We
received public comments in support of
the proposal to delete the 99 codes
describing a spinal fusion without a
device, in addition to receiving support
for the deletion of other procedure
codes describing fusion of body sites
other than the spine. A total of 213
procedure codes describing fusion of a
specific body part with device value
‘‘Z’’ No Device are being deleted
effective October 1, 2018 (FY 2019) as
shown in Table 6D.—Invalid Procedure
Codes associated with this proposed
rule (which is available via the Internet
on the CMS website at: https://
www.cms.hhs.gov/Medicare/MedicareFee-for-Service-Payment/
AcuteInpatientPPS/).
We examined claims data from the
September 2017 update of the FY 2017
MedPAR file for cases reporting any of
the clinically invalid spinal fusion
procedures with device value ‘‘Z’’ No
Device in MS–DRGs 028 (Spinal
Procedures with MCC), 029 (Spinal
Procedures with CC or Spinal
Neurostimulators), and 030 (Spinal
Procedures without CC/MCC) under
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MDC 1 and MS–DRGs 453, 454, 455,
456, 457, 458, 459, 460, 471, 472, and
473 under MDC 8 (that are listed and
shown earlier in this section). Our
findings are shown in the following
tables.
SPINAL FUSION PROCEDURES
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
028—All cases ............................................................................................................
028—Cases with invalid spinal fusion procedures .....................................................
029—All cases ............................................................................................................
029—Cases with invalid spinal fusion procedures .....................................................
030—All cases ............................................................................................................
030—Cases with invalid spinal fusion procedures .....................................................
453—All cases ............................................................................................................
453—Cases with invalid spinal fusion procedures .....................................................
454—All cases ............................................................................................................
454—Cases with invalid spinal fusion procedures .....................................................
455—All cases ............................................................................................................
455—Cases with invalid spinal fusion procedures .....................................................
456—All cases ............................................................................................................
456—Cases with invalid spinal fusion procedures .....................................................
457—All cases ............................................................................................................
457—Cases with invalid spinal fusion procedures .....................................................
458—All cases ............................................................................................................
458—Cases with invalid spinal fusion procedures .....................................................
459—All cases ............................................................................................................
459—Cases with invalid spinal fusion procedures .....................................................
460—All cases ............................................................................................................
460—Cases with invalid spinal fusion procedures .....................................................
471—All cases ............................................................................................................
471—Cases with invalid spinal fusion procedures .....................................................
472—All cases ............................................................................................................
472—Cases with invalid spinal fusion procedures .....................................................
473—All cases ............................................................................................................
473—Cases with invalid spinal fusion procedures .....................................................
1,927
132
3,426
171
1,578
52
2,891
823
12,288
2,473
12,751
2,332
1,439
404
3,644
960
1,368
244
4,904
726
59,459
5,311
3,568
389
15,414
1,270
18,095
1,185
Average
length
of stay
Average
costs
11.7
13
5.7
7.4
3
2.6
9.5
10.1
4.7
5.4
3
3.2
11.5
12.5
6
6.7
3.6
4.1
7.8
9
3.4
3.9
8.4
9.9
3.2
4
1.8
2.3
$37,524
52,034
22,525
33,668
15,984
22,471
70,005
84,829
47,334
59,814
37,440
45,888
66,447
71,385
48,595
53,298
37,804
43,182
43,862
49,387
29,870
31,936
36,272
43,014
21,836
25,780
17,694
19,503
SUMMARY TABLE FOR SPINAL FUSION PROCEDURES
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and 473—All
cases ........................................................................................................................................
MS–DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and 473—
Cases with invalid spinal fusion procedures ............................................................................
As shown in this summary table, we
found a total of 142,752 cases in MS–
DRGs 028, 029, 030, 453, 454, 455, 456,
457, 458, 459, 460, 471, 472, and 473
with an average length of stay of 3.9
days and average costs of $31,788. We
found a total of 16,472 cases reporting
a procedure code for an invalid spinal
fusion procedure with device value ‘‘Z’’
No Device across MS–DRGs 028, 029,
and 030 under MDC 1 and MS–DRGs
453, 454, 455, 456, 457, 458, 459, 460,
471, 472, and 473 under MDC 8, with
an average length of stay of 5.1 days and
average costs of $42,929. The results of
the data analysis demonstrate that these
invalid spinal fusion procedures
represent approximately 12 percent of
all discharges across the spinal fusion
MS–DRGs. Because these procedure
codes describe clinically invalid
procedures, we would not expect these
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codes to be reported on any claims data.
It is unclear why providers assigned
procedure codes for spinal fusion
procedures with the device value ‘‘Z’’
No Device. Our analysis did not
examine whether these claims were
isolated to a specific provider or
whether this inaccurate reporting was
widespread among a number of
providers.
With regard to possible future action,
we will continue to monitor the claims
data for resolution of the coding issues
previously identified. Because the
procedure codes that we analyzed and
presented findings for in this FY 2019
IPPS/LTCH PPS proposed rule are no
longer in the classification effective
October 1, 2018 (FY 2019), the claims
data that we examine for FY 2020 may
still contain claims with the invalid
codes. As such, we will continue to
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Average
length
of stay
Average
costs
142,752
3.9
$31,788
16,472
5.1
42,929
collaborate with the AHA as one of the
four Cooperating Parties through the
AHA’s Coding Clinic for ICD–10–CM/
PCS and provide further education on
spinal fusion procedures and the proper
reporting of the ICD–10–PCS spinal
fusion procedure codes. We agree with
the commenter that until these coding
inaccuracies are no longer reflected in
the claims data, it would be premature
to propose any MS–DRG modifications
for spinal fusion procedures. Possible
MS–DRG modifications may include
taking into account the approach that
was utilized in performing the spinal
fusion procedure (for example, open
versus percutaneous).
For the reasons described, stated
earlier in our discussion, we are
proposing to not make any changes to
the spinal fusion MS–DRGs for FY 2019.
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We are inviting public comments on our
proposal.
7. MDC 9 (Diseases and Disorders of the
Skin, Subcutaneous Tissue and Breast):
Cellulitis With Methicillin Resistant
Staphylococcus Aureus (MSRA)
Infection
We received a request to reassign
ICD–10–CM diagnosis codes reported
with a primary diagnosis of cellulitis
and a secondary diagnosis code of
B95.62 (Methicillin resistant
Staphylococcus aureus infection as the
cause of diseases classified elsewhere)
or A49.02 (Methicillin resistant
Staphylococcus aureus infection,
unspecified site). Currently, these cases
are assigned to MS–DRG 602 (Cellulitis
with MCC) and MS–DRG 603 (Cellulitis
without MCC) in MDC 9. The requestor
believed that cases of cellulitis with
MSRA infection should be reassigned to
MS–DRG 867 (Other Infectious and
Parasitic Diseases Diagnoses with MCC)
because MS–DRGs 602 and 603 include
cases that do not accurately reflect the
severity of illness or risk of mortality for
patients diagnosed with cellulitis and
MRSA. The requestor acknowledged
that the organism is not to be coded
before the localized infection, but stated
in its request that patients diagnosed
with cellulitis and MRSA are entirely
different from patients diagnosed only
with cellulitis. The requestor stated that
Number
of cases
MS–DRG
MS–DRG 602—All cases ............................................................................................................
MS–DRG 603—All cases ............................................................................................................
MS–DRGs 602 and 603—Cases reported with a primary diagnosis of cellulitis and a secondary diagnosis of B95.62 .....................................................................................................
MS–DRGs 602 and 603—Cases reported with a primary diagnosis of cellulitis and a secondary diagnosis of A49.02 .....................................................................................................
As shown in this table, we examined
the subsets of cases in MS–DRGs 602
and 603 reported with a primary
diagnosis of cellulitis and a secondary
diagnosis code B95.62 or A49.02. Both
of these subsets of cases had an average
length of stay that was comparable to
the average length of stay for all cases
in MS–DRG 602 and greater than the
average length of stay for all cases in
MS–DRG 603, and average costs that
were lower than the average costs of all
cases in MS–DRG 602 and higher than
there is a genuine threat to life or limb
in these cases. The requestor further
stated that, with the opioid crisis and
the frequency of MRSA infection among
this population, cases of cellulitis with
MRSA should be identified with a
specific combination code and assigned
to MS–DRG 867.
We analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for all cases assigned to
MS–DRGs 602 and 603 and subsets of
these cases reporting a primary ICD–10–
CM diagnosis of cellulitis and a
secondary diagnosis code of B95.62 or
A49.02. Our findings are shown in the
following table.
the average costs of all cases in MS–
DRG 603. As we have discussed in prior
rulemaking (77 FR 53309), it is a
fundamental principle of an averaged
payment system that half of the
procedures in a group will have above
average costs. It is expected that there
will be higher cost and lower cost
subsets, especially when a subset has
low numbers.
To examine the request to reassign
ICD–10–CM diagnosis codes reported
with a primary diagnosis of cellulitis
5.8
3.9
$10,034
6,128
5,364
5.3
8,245
309
5.4
8,832
and a secondary diagnosis code of
B95.62 or A49.02 from MS–DRGs 602
and 603 to MS–DRG 867 (which would
typically involve also reassigning those
cases to the two other severity level
MS–DRGs 868 and 869 (Other Infectious
and Parasitic Diseases Diagnoses with
CC and Other Infectious and Parasitic
Diseases Diagnoses without CC/MCC,
respectively)), we then analyzed the
data for all cases in MS–DRGs 867, 868
and 869. The results of our analysis are
shown in the following table.
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MS–DRG 867–All cases ..............................................................................................................
MS–DRG 868–All cases ..............................................................................................................
MS–DRG 869–All cases ..............................................................................................................
We compared the average length of
stay and average costs for MS–DRGs
867, 868, and 869 to the average length
of stay and average costs for the subsets
of cases in MS–DRGs 602 and 603
reported with a primary diagnosis of
cellulitis and a secondary diagnosis
code of B95.62 or A49.02. We found that
the average length of stay for these
subsets of cases was shorter and the
average costs were lower than those for
all cases in MS–DRG 867, but that the
average length of stay and average costs
were higher than those for all cases in
MS–DRG 868 and MS–DRG 869. Our
findings from the analysis of claims data
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do not support reassigning cellulitis
cases reported with ICD–10–CM
diagnosis code B95.62 or A49.02 from
MS–DRGs 602 and 603 to MS–DRGs
867, 868 and 869. Our clinical advisors
noted that when a primary diagnosis of
cellulitis is accompanied by a secondary
diagnosis of B95.62 or A49.02 in MS–
DRGs 602 or 603, the combination of
these primary and secondary diagnoses
is the reason for the hospitalization, and
the level of acuity of these subsets of
patients is similar to other patients in
MS–DRGs 602 and 603. Therefore, these
cases are more clinically aligned with
all cases in MS–DRGs 602 and 603. For
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Average
costs
26,244
104,491
Number
of cases
MS–DRG
Average
length
of stay
2,653
2,096
499
Average
length
of stay
Average
costs
7.5
4.4
3.3
$14,762
7,532
5,624
these reasons, we are not proposing to
reassign cellulitis cases reported with
ICD–10–CM diagnosis code of B95.62 or
A49.02 to MS–DRG 867, 868, or 869 for
FY 2019. We are inviting public
comments on our proposal to maintain
the current MS–DRG assignment for
ICD–10–CM codes B95.62 and A49.02
when reported as secondary diagnoses
with a primary diagnosis of cellulitis.
8. MDC 10 (Endocrine, Nutritional and
Metabolic Diseases and Disorders):
Acute Intermittent Porphyria
We received a request to revise the
MS–DRG classification for cases of
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patients diagnosed with porphyria and
reported with ICD–10–CM diagnosis
code E80.21 (Acute intermittent
(hepatic) porphyria) to recognize the
resource requirements in caring for
these patients, to ensure appropriate
payment for these cases, and to preserve
patient access to necessary treatments.
Porphyria is defined as a group of rare
disorders (‘‘porphyrias’’) that interfere
with the production of hemoglobin that
is needed for red blood cells. While
some of these disorders are genetic
(inborn) and others are acquired, they
all result in the abnormal accumulation
of hemoglobin building blocks, called
porphyrins, which can be deposited in
the tissues where they particularly
interfere with the functioning of the
nervous system and the skin. Treatment
for patients suffering from disorders of
porphyrin metabolism consists of an
intravenous injection of Panhematin®
(hemin for injection). ICD–10–CM
diagnosis code E80.21 is currently
assigned to MS–DRG 642 (Inborn and
Other Disorders of Metabolism). (We
note that this issue has been discussed
previously in the FY 2013 IPPS/LTCH
PPS proposed and final rules (77 FR
27904 through 27905 and 77 FR 53311
through 53313, respectively) and the FY
2015 IPPS/LTCH PPS proposed and
final rules (79 FR 28016 and 79 FR
49901, respectively).)
We analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for cases assigned to MS–
DRG 642. Our findings are shown in the
following table.
Number
of cases
MS–DRG
MS–DRG 642—All cases ............................................................................................................
MS–DRG 642—Cases reporting diagnosis code E80.21 as principal diagnosis .......................
MS–DRG 642—Cases not reporting diagnosis code E80.21 as principal diagnosis .................
As shown in this table, cases
reporting diagnosis code E80.21 as the
principal diagnosis in MS–DRG 642 had
higher average costs and longer average
lengths of stay compared to the average
costs and lengths of stay for all other
cases in MS–DRG 642.
To examine the request to reassign
cases with ICD–10–CM diagnosis code
E80.21 as the principal diagnosis, we
analyzed claims data for all cases in
MS–DRGs for endocrine disorders,
including MS–DRG 643 (Endocrine
Disorders with MCC), MS-DRG 644
MS–DRG 643—All cases ............................................................................................................
MS–DRG 644—All cases ............................................................................................................
MS–DRG 645—All cases ............................................................................................................
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The data results showed that the
average length of stay for the subset of
cases reporting ICD–10–CM diagnosis
code E80.21 as the principal diagnosis
in MS–DRG 642 is lower than the
average length of stay for all cases in
MS–DRG 643, but higher than the
average length of stay for all cases in
MS–DRGs 644 and 645. The average
costs for the subset of cases reporting
ICD–10–CM diagnosis code E80.21 as
the principal diagnosis in MS–DRG 642
are much higher than the average costs
for all cases in MS–DRGs 643, 644, and
645. However, after considering these
findings in the context of the current
MS–DRG structure, we were unable to
identify an MS–DRG that would more
closely parallel these cases with respect
to average costs and length of stay that
would also be clinically aligned. Our
clinical advisors believe that, in the
current MS–DRG structure, the clinical
characteristics of patients in these cases
are most closely aligned with the
clinical characteristics of patients in all
cases in MS–DRG 642. Moreover, given
the small number of porphyria cases, we
do not believe there is justification for
creating a new MS–DRG. Basing a new
MS–DRG on such a small number of
cases could lead to distortions in the
relative payment weights for the MS–
DRG because several expensive cases
could impact the overall relative
payment weight. Having larger clinical
cohesive groups within an MS–DRG
provides greater stability for annual
ICD–10–CM
code
Z49.01
Z49.02
Z49.31
Z49.32
..................
..................
..................
..................
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1,801
183
1,618
9,337
11,306
4,297
20:30 May 04, 2018
for
for
for
for
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$9,157
19,244
8,016
Average
length
of stay
Average
costs
6.3
4.2
3.2
$11,268
7,154
5,406
9. MDC 11 (Diseases and Disorders of
the Kidney and Urinary Tract): Admit
for Renal Dialysis
We received a request to review the
codes assigned to MS–DRG 685 (Admit
for Renal Dialysis) to determine if the
MS–DRG should be deleted, or if it
should remain as a valid MS–DRG.
Currently, the ICD–10–CM diagnosis
codes shown in the table below are
assigned to MS–DRG 685:
fitting and adjustment of extracorporeal dialysis catheter.
fitting and adjustment of peritoneal dialysis catheter.
adequacy testing for hemodialysis.
adequacy testing for peritoneal dialysis.
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4.3
5.6
4.1
updates to the relative payment weights.
In summary, we are not proposing to
revise the MS–DRG classification for
porphyria cases. We are inviting public
comments on our proposal to maintain
porphyria cases in MS–DRG 642.
ICD–CM code title
Encounter
Encounter
Encounter
Encounter
Average
costs
(Endocrine Disorders with CC), and
MS–DRG 645 (Endocrine Disorders
without CC/MCC). The results of our
analysis are shown in the following
table.
Number
of cases
MS–DRG
Average
length
of stay
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The requestor stated that, under ICD–
9–CM, diagnosis code V56.0 (Encounter
for extracorporeal dialysis) was reported
as the principal diagnosis to identify
patients who were admitted for an
encounter for dialysis. However, under
ICD–10–CM, there is no comparable
code in which to replicate such a
diagnosis. The requestor noted that,
while patients continue to be admitted
under inpatient status (under certain
circumstances) for dialysis services,
there is no existing ICD–10–CM
diagnosis code within the classification
that specifically identifies a patient
being admitted for an encounter for
dialysis services.
The requestor also noted that three of
the four ICD–10–CM diagnosis codes
currently assigned to MS–DRG 685 are
on the ‘‘Unacceptable Principal
Diagnosis’’ edit code list in the
Medicare Code Editor (MCE). Therefore,
these codes are not allowed to be
reported as a principal diagnosis for an
inpatient admission.
We examined claims data from the
September 2017 update of the FY 2017
MedPAR file for cases reporting ICD–
10–CM diagnosis codes Z49.01, Z49.02,
Z49.31, and Z49.32. Our findings are
shown in the following table.
ADMIT FOR RENAL DIALYSIS ENCOUNTER
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MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
685—All cases ............................................................................................................
685—Cases reporting ICD–10–CM diagnosis code Z49.01 ......................................
685—Cases reporting ICD–10–CM diagnosis code Z49.02 ......................................
685—Cases reporting ICD–10–CM diagnosis code Z49.31 ......................................
685—Cases reporting ICD–10–CM diagnosis code Z49.32 ......................................
As shown in the table above, for MS–
DRG 685, there were a total of 78 cases
reporting ICD–10–CM diagnosis code
Z49.01, with an average length of stay
of 4 days and average costs of $8,871.
There were no cases reporting ICD–10–
CM diagnosis code Z49.02, Z49.31, or
Z49.32.
Our clinical advisors reviewed the
clinical issues, as well as the claims
data for MS–DRG 685. Based on their
review of the data analysis, our clinical
advisors recommended that MS–DRG
685 be deleted and ICD–10–CM
diagnosis codes Z49.01, Z49.02, Z49.31,
and Z49.32 be reassigned. Historically,
patients were admitted as inpatients to
receive hemodialysis services. However,
over time, that practice has shifted to
outpatient and ambulatory settings.
Because of this change in medical
practice, we do not believe that it is
appropriate to maintain a vestigial MS–
DRG, particularly due to the fact that the
transition to ICD–10 has resulted in
three out of four codes that map to the
MS–DRG being precluded from being
used as principal diagnosis codes on the
claim. In addition, our clinical advisors
believe that reassigning the ICD–10–CM
diagnosis codes from MS–DRG 685 to
MS–DRGs 698, 699, and 700 (Other
Kidney and Urinary Tract Diagnoses
with MCC, with CC, and without
CC\MCC, respectively) is clinically
appropriate because the reassignment
will result in an accurate MS–DRG
assignment of a specific case or
inpatient service and encounter based
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on acceptable principal diagnosis codes
under these MS–DRGs.
Therefore, for FY 2019, because there
is no existing ICD–10–CM diagnosis
code within the classification system
that specifically identifies a patient
being admitted for an encounter for
dialysis services and three of the four
ICD–10–CM diagnosis codes, Z49.02,
Z49.31, and Z49.32, currently assigned
to MS–DRG 685 are on the Unacceptable
Principal Diagnosis edit code list in the
Medicare Code Editor (MCE), we are
proposing to delete MS–DRG 685 and
reassign ICD–10–CM diagnosis codes
Z49.01, Z49.02, Z49.31, and Z49.32
from MS–DRG 685 to MS–DRGs 698,
699, and 700.
We are inviting public comments on
our proposals.
10. MDC 14 (Pregnancy, Childbirth and
the Puerperium)
In the FY 2018 IPPS/LTCH PPS
proposed rule (82 FR 19834) and final
rule (82 FR 38036 through 38037), we
noted that the MS–DRG logic involving
a vaginal delivery under MDC 14 is
technically complex as a result of the
requirements that must be met to satisfy
assignment to the affected MS–DRGs. As
a result, we solicited public comments
on further refinement to the following
four MS–DRGs related to vaginal
delivery: MS–DRG 767 (Vaginal
Delivery with Sterilization and/or D&C);
MS–DRG 768 (Vaginal Delivery with
O.R. Procedure Except Sterilization and/
or D&C); MS–DRG 774 (Vaginal Delivery
with Complicating Diagnosis); and MS–
DRG 775 (Vaginal Delivery without
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length
of stay
Number
of cases
MS–DRG
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78
78
0
0
0
Average
costs
4
4
0
0
0
$8,871
8,871
0
0
0
Complicating Diagnosis). In addition,
we sought public comments on further
refinements to the conditions defined as
a complicating diagnosis in MS–DRG
774 and MS–DRG 781 (Other
Antepartum Diagnoses with Medical
Complications). We indicated that we
would review public comments
received in response to the solicitation
as we continued to evaluate these MS–
DRGs under MDC 14 and, if warranted,
we would propose refinements for FY
2019. Commenters were instructed to
direct comments for consideration to the
CMS MS–DRG Classification Change
Request Mailbox located at
MSDRGClassificationChange@
cms.hhs.gov by November 1, 2017.
In response to our solicitation for
public comments on the MS–DRGs
related to vaginal delivery, one
commenter recommended that CMS
convene a workgroup that would
include hospital staff and physicians to
systematically review the MDC 14
MS–DRGs and to identify which
conditions should appropriately be
considered complicating diagnoses. As
an interim step, this commenter
recommended that CMS consider the
following suggestions as a result of its
own evaluation of MS–DRGs 767, 774
and 775.
For MS–DRG 767, the commenter
recommended that the following ICD–
10–CM diagnosis codes and ICD–10–
PCS procedure code be removed from
the GROUPER logic and provided the
rationale for why the commenter
suggested removing each code.
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20215
SUGGESTIONS FOR MS–DRG 767
[Vaginal delivery with sterilization and/or D&C]
ICD–10–CM
code
Code description
Rationale for removing code
from MS–DRG 767
O66.41 ...................
Failed attempted vaginal birth after previous cesarean delivery.
Rupture of uterus before onset of labor, unspecified trimester.
This code indicates that the attempt at vaginal delivery has
failed.
This code indicates that the uterus has ruptured before
onset of labor and therefore, a vaginal delivery would not
be possible.
This code indicates the encounter is for a cesarean delivery.
This code indicates this is a cesarean delivery.
O71.00 ...................
O82 ........................
Encounter for cesarean delivery without indication ...............
O75.82 ...................
Onset (spontaneous) of labor after 37 weeks of gestation
but before 39 completed weeks, with delivery by
(planned) C-section.
SUGGESTIONS FOR MS–DRG 767
[Vaginal delivery with sterilization and/or D&C]
ICD–10–PCS
code
Code description
Rationale for removing code
from MS–DRG 767
10A07Z6 ................
Abortion of products of conception, vacuum, via natural or
artificial opening.
This code indicates the procedure to be an abortion rather
than a vaginal delivery.
For MS–DRG 774, the commenter
recommended that the following ICD–
10–CM diagnosis codes be removed
from the GROUPER logic and provided
the rationale for why the commenter
suggested removing each code.
SUGGESTIONS FOR MS–DRG 774
[Vaginal delivery with Complicating Diagnoses]
ICD–10–CM
code
Code description
Rationale for removing code
from MS–DRG 774
O66.41 ...................
Failed attempted vaginal birth after previous cesarean delivery.
Rupture of uterus before onset of labor, unspecified trimester.
This code indicates that the attempt at vaginal delivery has
failed.
This code indicates that the uterus has ruptured before
onset of labor and therefore, a vaginal delivery would not
be possible.
This code indicates this is a planned cesarean delivery.
O71.00 ...................
O75.82 ...................
O82 ........................
Onset (spontaneous) of labor after 37 weeks of gestation
but before 39 completed weeks, with delivery by
(planned) C-section.
Encounter for cesarean delivery without indication ...............
O80 ........................
Encounter for full-term uncomplicated delivery ......................
For MS–DRG 775, the commenter
recommended that the following ICD–
10–CM diagnosis codes and ICD–10–
This code indicates the encounter is for a cesarean delivery.
According to the Official Guidelines for Coding and Reporting, ‘‘Code O80 should be assigned when a woman is admitted for a full term normal delivery and delivers a single, healthy infant without any complications antepartum,
during the delivery, or postpartum during the delivery episode.’’
PCS procedure code be removed from
the GROUPER logic and provided the
rationale for why the commenter
suggested removing each code.
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SUGGESTIONS FOR MS–DRG 775
[Vaginal delivery without complicating diagnoses]
ICD–10–CM
code
Code description
Rationale for removing code
from MS–DRG 775
O66.41 ...................
Failed attempted vaginal birth after previous cesarean delivery.
Labor and delivery complicated by vasa previa, not applicable or unspecified.
This code indicates that the attempt at vaginal delivery has
failed.
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
O69.4XX0 ..............
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SUGGESTIONS FOR MS–DRG 775—Continued
[Vaginal delivery without complicating diagnoses]
ICD–10–CM
code
Code description
Rationale for removing code
from MS–DRG 775
O69.4XX2 ..............
Labor and delivery complicated by vasa previa, fetus 2 .......
O69.4XX3 ..............
Labor and delivery complicated by vasa previa, fetus 3 .......
O69.4XX4 ..............
Labor and delivery complicated by vasa previa, fetus 4 .......
O69.4XX5 ..............
Labor and delivery complicated by vasa previa, fetus 5 .......
O69.4XX9 ..............
Labor and delivery complicated by vasa previa, other fetus
O71.00 ...................
Rupture of uterus before onset of labor, unspecified trimester.
O82 ........................
Encounter for cesarean delivery without indication ...............
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
According to the physicians consulted, vasa previa always
results in C-section. Research indicates that when vasa
previa is diagnosed, C-section before labor begins can
save the baby’s life.
This code indicates that the uterus has ruptured before
onset of labor and therefore, a vaginal delivery would not
be possible.
This code indicates the encounter is for a cesarean delivery.
SUGGESTIONS FOR MS–DRG 775
[Vaginal delivery without Complicating Diagnosis]
ICD–10–CM
code
Code description
Rationale for removing code
from MS–DRG 775
10A07Z6 ................
Abortion of Products of Conception, Vacuum, Via Natural or
Artificial Opening.
This code indicates the procedure to be an abortion rather
than a vaginal delivery.
Another commenter agreed that the
MS–DRG logic for a vaginal delivery
under MDC 14 is technically complex
and provided examples to illustrate
these facts. For instance, the commenter
noted that the GROUPER logic code lists
appear redundant with several of the
same codes listed for different MS–
DRGs and that the GROUPER logic code
list for a vaginal delivery in MS–DRG
774 is comprised of diagnosis codes
while the GROUPER logic code list for
a vaginal delivery in MS–DRG 775 is
comprised of procedure codes. The
commenter also noted that several of the
ICD–10–CM diagnosis codes shown in
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ICD–10–CM
code
O11.4 ...................
O11.5 ...................
012.04 ..................
012.05 ..................
012.14 ..................
012.15 ..................
012.24 ..................
012.25 ..................
O13.4 ...................
O13.5 ...................
O14.04 .................
O14.05 .................
O14.14 .................
O14.15 .................
O14.24 .................
O14.25 .................
O14.94 .................
O14.95 .................
O15.00 .................
VerDate Sep<11>2014
the table below that became effective
with discharges on and after October 1,
2016 (FY 2017) or October 1, 2017 (FY
2018) appear to be missing from the
GROUPER logic code lists for MS–DRGs
781 and 774.
Code description
Pre-existing hypertension with pre-eclampsia, complicating childbirth.
Pre-existing hypertension with pre-eclampsia, complicating the puerperium.
Gestational edema, complicating childbirth.
Gestational edema, complicating the puerperium.
Gestational proteinuria, complicating childbirth.
Gestational proteinuria, complicating the puerperium.
Gestational edema with proteinuria, complicating childbirth.
Gestational edema with proteinuria, complicating the puerperium.
Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating childbirth.
Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating the puerperium.
Mild to moderate pre-eclampsia, complicating childbirth.
Mild to moderate pre-eclampsia, complicating the puerperium.
Severe pre-eclampsia, complicating childbirth.
Severe pre-eclampsia, complicating the puerperium.
HELLP syndrome, complicating childbirth.
HELLP syndrome, complicating the puerperium.
Unspecified pre-eclampsia, complicating childbirth.
Unspecified pre-eclampsia, complicating the puerperium.
Eclampsia complicating pregnancy, unspecified trimester.
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ICD–10–CM
code
daltland on DSKBBV9HB2PROD with PROPOSALS2
O15.02 .................
O15.03 .................
O15.1 ...................
O15.2 ...................
O16.4 ...................
O16.5 ...................
O24.415 ...............
O24.425 ...............
O24.435 ...............
O44.20 .................
O44.21 .................
O44.22 .................
O44.23 .................
O44.30 .................
O44.31 .................
O44.32 .................
O44.33 .................
O44.40 .................
O44.41 .................
O44.42 .................
O44.43 .................
O44.50 .................
O44.51 .................
O44.52 .................
O44.53 .................
O70.20 .................
O70.21 .................
O70.22 .................
O70.23 .................
O86.11 .................
O86.12 .................
O86.13 .................
O86.19 .................
O86.20 .................
O86.21 .................
O86.22 .................
O86.29 .................
O86.81 .................
O86.89 .................
Code description
Eclampsia complicating pregnancy, second trimester.
Eclampsia complicating pregnancy, third trimester.
Eclampsia complicating labor.
Eclampsia complicating puerperium, second trimester.
Unspecified maternal hypertension, complicating childbirth.
Unspecified maternal hypertension, complicating the puerperium.
Gestational diabetes mellitus in pregnancy, controlled by oral hypoglycemic drugs.
Gestational diabetes mellitus in childbirth, controlled by oral hypoglycemic drugs.
Gestational diabetes mellitus in puerperium, controlled by oral hypoglycemic drugs.
Partial placenta previa NOS or without hemorrhage, unspecified trimester.
Partial placenta previa NOS or without hemorrhage, first trimester.
Partial placenta previa NOS or without hemorrhage, second trimester.
Partial placenta previa NOS or without hemorrhage, third trimester.
Partial placenta previa with hemorrhage, unspecified trimester.
Partial placenta previa with hemorrhage, first trimester.
Partial placenta previa with hemorrhage, second trimester.
Partial placenta previa with hemorrhage, third trimester.
Low lying placenta NOS or without hemorrhage, unspecified trimester.
Low lying placenta NOS or without hemorrhage, first trimester.
Low lying placenta NOS or without hemorrhage, second trimester.
Low lying placenta NOS or without hemorrhage, third trimester.
Low lying placenta with hemorrhage, unspecified trimester.
Low lying placenta with hemorrhage, first trimester.
Low lying placenta with hemorrhage, second trimester.
Low lying placenta with hemorrhage, third trimester.
Third degree perineal laceration during delivery, unspecified.
Third degree perineal laceration during delivery, IIIa.
Third degree perineal laceration during delivery, IIIb.
Third degree perineal laceration during delivery, IIIc.
Cervicitis following delivery.
Endometritis following delivery.
Vaginitis following delivery.
Other infection of genital tract following delivery.
Urinary tract infection following delivery, unspecified.
Infection of kidney following delivery.
Infection of bladder following delivery.
Other urinary tract infection following delivery.
Puerperal septic thrombophlebitis.
Other specified puerperal infections.
Lastly, the commenter stated that the
list of ICD–10–PCS procedure codes
appears comprehensive, but indicated
that inpatient coding is not their
expertise. We note that it was not clear
which list of procedure codes the
commenter was specifically referencing.
The commenter did not provide a list of
any procedure codes for CMS to review
or reference a specific MS–DRG in its
comment.
Another commenter expressed
concern that ICD–10–PCS procedure
codes 10D17Z9 (Manual extraction of
products of conception, retained, via
natural or artificial opening) and
10D18Z9 (Manual extraction of products
of conception, retained, via natural or
artificial opening endoscopic) are not
assigned to the appropriate MS–DRG.
ICD–10–PCS procedure codes 10D17Z9
and 10D18Z9 describe the manual
removal of a retained placenta and are
currently assigned to MS–DRG 767
(Vaginal Delivery with Sterilization
and/or D&C). According to the
commenter, a patient that has a vaginal
delivery with manual removal of a
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retained placenta is not having a
sterilization or D&C procedure. The
commenter noted that, under ICD–9–
CM, a vaginal delivery with manual
removal of retained placenta grouped to
MS–DRG 774 (Vaginal Delivery with
Complicating Diagnosis) or MS–DRG
775 (Vaginal Delivery without
Complicating Diagnosis). The
commenter suggested CMS review these
procedure codes for appropriate MS–
DRG assignment under the ICD–10 MS–
DRGs.
We thank the commenters and
appreciate the recommendations and
suggestions provided in response to our
solicitation for comments on the
GROUPER logic for the MS–DRGs
involving a vaginal delivery or
complicating diagnosis under MDC 14.
With regard to the commenter who
recommended that we convene a
workgroup that would include hospital
staff and physicians to systematically
review the MDC 14 MS–DRGs and to
identify which conditions should
appropriately be considered
complicating diagnoses, we note that we
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formed an internal workgroup
comprised of clinical advisors that
included physicians, coding specialists,
and other IPPS policy staff that assisted
in our review of the GROUPER logic for
a vaginal delivery and complicating
diagnoses. We also received clinical
input from 3M/Health Information
Systems (HIS) staff, which, under
contract with CMS, is responsible for
updating and maintaining the
GROUPER program. We note that our
analysis involved other MS–DRGs under
MDC 14, in addition to those for which
we specifically solicited public
comments. As one of the other
commenters correctly pointed out, there
is redundancy, with several of the same
codes listed for different MS–DRGs.
Below we provide a summary of our
internal analysis with responses to the
commenters’ recommendations and
suggestions incorporated into the
applicable sections. We refer readers to
the ICD–10 MS–DRG Version 35
Definitions Manual located via the
Internet on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Fee-
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for-Service-Payment/
AcuteInpatientPPS/FY2018-IPPS-FinalRule-Home-Page-Items/FY2018-IPPSFinal-Rule-Data-Files.html?DLPage=
1&DLEntries=10&DLSort=0&DLSortDir=
ascending for documentation of the
GROUPER logic associated with the
MDC 14 MS–DRGs to assist in the
review of our discussion that follows.
We started our evaluation of the
GROUPER logic for the MS–DRGs under
MDC 14 by first reviewing the current
concepts that exist. For example, there
are ‘‘groups’’ for cesarean section
procedures, vaginal delivery
procedures, and abortions. There also
are groups where no delivery occurs,
and lastly, there are groups for after the
delivery occurs, or the ‘‘postpartum’’
period. These groups are then further
subdivided based on the presence or
absence of complicating conditions or
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
765
766
769
770
776
777
778
779
780
782
Description
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
Cesarean Section with CC/MCC.
Cesarean Section without CC/MCC.
Postpartum and Post Abortion Diagnoses with O.R. Procedure.
Abortion with D&C, Aspiration Curettage or Hysterotomy.
Postpartum and Post Abortion Diagnoses without O.R. Procedure.
Ectopic Pregnancy.
Threatened Abortion.
Abortion without D&C.
False Labor.
Other Antepartum Diagnoses without Medical Complications.
The first issue we reviewed was the
GROUPER logic for complicating
conditions (MS–DRGs 774 and 781).
Because one of the main objectives in
our transition to the MS–DRGs was to
better recognize the severity of illness of
a patient, we believed we could
structure the vaginal delivery and other
MDC 14 MS–DRGs in a similar way.
Therefore, we began working with the
concept of vaginal delivery ‘‘with MCC,
with CC and without CC/MCC’’ to
replace the older, ‘‘complicating
conditions’’ logic.
Next, we compared the additional
GROUPER logic that exists between the
vaginal delivery and the cesarean
section MS–DRGs (MS–DRGs 765, 766,
767, 774, and 775). Currently, the
vaginal delivery MS–DRGs take into
account a sterilization procedure;
however, the cesarean section MS–DRGs
do not. Because a patient can have a
sterilization procedure performed along
with a cesarean section procedure, we
adopted a working concept of ‘‘cesarean
section with and without sterilization
with MCC, with CC and without CC/
MCC’’, as well as ‘‘vaginal delivery with
and without sterilization with MCC,
with CC and without CC/MCC’’.
We then reviewed the GROUPER logic
for the MS–DRGs involving abortion
and where no delivery occurs (MS–
DRGs 770, 777, 778, 779, 780, and 782).
We believed that we could consolidate
the groups in which no delivery occurs.
Finally, we considered the GROUPER
logic for the MS–DRGs related to the
postpartum period (MS–DRGs 769 and
776) and determined that the structure
of these MS–DRGs did not appear to
require modification.
VerDate Sep<11>2014
the presence of another procedure. We
examined how we could simplify some
of the older, complex GROUPER logic
and remain consistent with the structure
of other ICD–10 MS–DRGs. We
identified the following MS–DRGs for
closer review, in addition to MS–DRG
767, MS–DRG 768, MS–DRG 774, MS–
DRG 775 and MS–DRG 781.
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After we established those initial
working concepts for the MS–DRGs
discussed above, we examined the list
of the ICD–10–PCS procedure codes that
comprise the sterilization procedure
GROUPER logic for the vaginal delivery
MS–DRG 767. We identified the two
manual extraction of placenta codes that
the commenter had brought to our
attention (ICD–10–PCS codes 10D17Z9
and 10D18Z9). We also identified two
additional procedure codes, ICD–10–
PCS codes 10D17ZZ (Extraction of
products of conception, retained, via
natural or artificial opening) and
10D18ZZ (Extraction of products of
conception, retained, via natural or
artificial opening endoscopic) in the list
that are not sterilization procedures.
Two of the four procedure codes
describe manual extraction (removal) of
retained placenta and the other two
procedure codes describe dilation and
curettage procedures. We then
identified four more procedure codes in
the list that do not describe sterilization
procedures. ICD–10–PCS procedure
codes 0UDB7ZX (Extraction of
endometrium, via natural or artificial
opening, diagnostic), 0UDB7ZZ
(Extraction of endometrium, via natural
or artificial opening), 0UDB8ZX
(Extraction of endometrium, via natural
or artificial opening endoscopic,
diagnostic), and 0UDB8ZZ (Extraction
of endometrium, via natural or artificial
opening endoscopic) describe dilation
and curettage procedures that can be
performed for diagnostic or therapeutic
purposes. We believe that these ICD–
10–PCS procedure codes would be more
appropriately assigned to MDC 13
(Diseases and Disorders of the Female
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Reproductive System) in MS–DRGs 744
and 745 (D&C, Conization, Laparascopy
and Tubal Interruption with and
without CC/MCC, respectively) and,
therefore, removed them from our
working list of sterilization and/or D&C
procedures. Because the GROUPER
logic for MS–DRG 767 includes both
sterilization and/or D&C, we agreed that
all the other procedure codes currently
included under that logic list of
sterilization procedures should remain,
with the exception of the two identified
by the commenter. Therefore, we agree
with the commenter that the manual
extraction of retained placenta
procedure codes should be reassigned to
a more clinically appropriate vaginal
delivery MS–DRG because they are not
describing sterilization procedures.
Our attention then turned to other
MDC 14 GROUPER logic code lists
starting with the ‘‘CC for C-section’’ list
under MS–DRGs 765 and 766 (Cesarean
Section with and without CC/MCC,
respectively). As noted earlier in this
section, in conducting our review, we
considered how we could utilize the
severity level concept (with MCC, with
CC, and without CC/MCC) where
applicable. Consistent with this
approach, we removed the ‘‘CC for Csection’’ logic from these MS–DRGs as
part of our working concept and efforts
to refine MDC 14. We determined it
would be less complicated to simply
allow the existing ICD–10 MS-DRG CC
and MCC code list logic to apply for
these MS–DRGs. Next, we reviewed the
logic code lists for ‘‘Malpresentation’’
and ‘‘Twins’’ and concluded that this
logic was not necessary for the cesarean
section MS–DRGs because these are
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describing antepartum conditions and it
is the procedure of the cesarean section
that determines whether or not a patient
would be classified to these MS–DRGs.
Therefore, those code lists were also
removed for purposes of our working
concept. With regard to the ‘‘Operating
Room Procedure’’ code list, we agreed
there should be no changes. However,
we note that the title to ICD–10–PCS
procedure code 10D00Z0 (Extraction of
products of conception, classical, open
approach) is being revised effective
October 1, 2018, to replace the term
‘‘classical’’ with ‘‘high’’ and ICD–10–
PCS procedure code 10D00Z1
(Extraction of products of conception,
low cervical, open approach) is being
revised to replace the term ‘‘low
cervical’’ to ‘‘low’’. These revisions are
also shown in Table 6F—Revised
Procedure Code Titles available via the
Internet on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/.
Next, we reviewed the ‘‘Delivery
Procedure’’ and ‘‘Delivery Outcome’’
GROUPER logic code lists for the
vaginal delivery MS–DRGs 767, 768,
774, and 775. We identified ICD–10–
PCS procedure code 10A0726 (Abortion
of products of conception, vacuum, via
natural or artificial opening) and ICD–
10–PCS procedure code 10S07ZZ
(Reposition products of conception, via
natural or artificial opening) under the
‘‘Delivery Procedure’’ code list as
procedure codes that should not be
included because ICD–10–PCS
procedure code 10A07Z6 describes an
abortion procedure and ICD–10–PCS
procedure code 10S07ZZ describes
repositioning of the fetus and does not
indicate a delivery took place. We also
note that, as described earlier in this
discussion, a commenter recommended
ICD–10–PCS
code
daltland on DSKBBV9HB2PROD with PROPOSALS2
0DQP7ZZ
0DQQ0ZZ
0DQQ3ZZ
0DQQ4ZZ
0DQQ7ZZ
0DQQ8ZZ
0DQR0ZZ
0DQR3ZZ
0DQR4ZZ
.............
.............
.............
.............
.............
.............
.............
.............
.............
that ICD–10–PCS procedure code
10A07Z6 be removed from the
GROUPER logic specifically for MS–
DRGs 767 and 775. Therefore, we
removed these two procedure codes
from the logic code list for ‘‘Delivery
Procedure’’ in MS–DRGs 767, 768, 774,
and 775. We agreed with the commenter
that ICD–10–PCS procedure code
10A07Z6 would be more appropriately
assigned to one of the Abortion MS–
DRGs. For the remaining procedures
currently included in the ‘‘Delivery
Procedure’’ code list we considered
which procedures would be expected to
be performed during the course of a
standard, uncomplicated delivery
episode versus those that would
reasonably be expected to require
additional resources outside of the
delivery room. The list of procedure
codes we reviewed is shown in the
following table.
Code description
Repair
Repair
Repair
Repair
Repair
Repair
Repair
Repair
Repair
rectum, via natural or artificial opening.
anus, open approach.
anus, percutaneous approach.
anus, percutaneous endoscopic approach.
anus, via natural or artificial opening.
anus, via natural or artificial opening endoscopic.
anal sphincter, open approach.
anal sphincter, percutaneous approach.
anal sphincter, percutaneous endoscopic approach.
While we acknowledge that these
procedures may be performed to treat
obstetrical lacerations as discussed in
prior rulemaking (81 FR 56853), we also
believe that these procedures would
reasonably be expected to require a
separate operative episode and would
not be performed immediately at the
time of the delivery. Therefore, we
removed those procedure codes
describing repair of the rectum, anus,
and anal sphincter shown in the table
above from our working concept list of
procedures to consider for a vaginal
delivery. Our review of the list of
diagnosis codes for the ‘‘Delivery
Outcome’’ as a secondary diagnosis did
not prompt any changes. We agreed that
the current list of diagnosis codes
continues to appear appropriate for
describing the outcome of a delivery.
As the purpose of our analysis and
this review was to clarify what
constitutes a vaginal delivery to satisfy
the ICD–10 MS–DRG logic for the
vaginal delivery MS–DRGs, we believed
it was appropriate to expect that a
procedure code describing the vaginal
delivery or extraction of ‘‘products of
conception’’ procedure and a diagnosis
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code describing the delivery outcome
should be reported on every claim in
which a vaginal delivery occurs. This is
also consistent with Section I.C.15.b.5 of
the ICD–10–CM Official Guidelines for
Coding and Reporting, which states ‘‘A
code from category Z37, Outcome of
delivery, should be included on every
maternal record when a delivery has
occurred. These codes are not to be used
on subsequent records or on the
newborn record.’’ Therefore, we
adopted the working concept that,
regardless of the principal diagnosis, if
there is a procedure code describing the
vaginal delivery or extraction of
‘‘products of conception’’ procedure and
a diagnosis code describing the delivery
outcome, this logic would result in
assignment to a vaginal delivery MS–
DRG. We note that, as a result of this
working concept, there would no longer
be a need to maintain the ‘‘third
condition’’ list under MS–DRG 774. In
addition, as noted earlier in this
discussion, because we were working
with the concept of vaginal delivery
‘‘with MCC, with CC, and without
CC/MCC’’ to replace the older,
‘‘complicating conditions’’ logic, there
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would no longer be a need to maintain
the ‘‘second condition’’ list of
complicating diagnosis under MS–DRG
774.
We then reviewed the GROUPER logic
code list of ‘‘Or Other O.R. procedures’’
(MS–DRG 768) to determine if any
changes to these lists were warranted.
Similar to our analysis of the procedures
listed under the ‘‘Delivery Procedure’’
logic code list, our examination of the
procedures currently described in the
‘‘Or Other O.R. procedures’’ procedure
code list also considered which
procedures would be expected to be
performed during the course of a
standard, uncomplicated delivery
episode versus those that would
reasonably be expected to require
additional resources outside of the
delivery room. Our analysis of all the
procedures resulted in the working
concept to allow all O.R. procedures to
be applicable for assignment to MS–
DRG 768, with the exception of the
procedure codes for sterilization and/or
D&C and ICD–10–PCS procedure codes
0KQM0ZZ (Repair perineum muscle,
open approach) and 0UJM0ZZ
(Inspection of vulva, open approach),
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which we determined would be
reasonably expected to be performed
during a standard delivery episode and,
therefore, assigned to MS–DRG 774 or
MS–DRG 775. We also note that, this
working concept for MS–DRG 768
would eliminate vaginal delivery cases
with an O.R. procedure grouping to the
unrelated MS-DRGs because all O.R.
procedures would be included in the
GROUPER logic procedure code list for
‘‘Or Other O.R. Procedures’’.
The next set of MS–DRGs we
examined more closely included MS–
DRGs 777, 778, 780, 781, and 782. We
believed that, because the conditions in
these MS–DRGs are all describing
antepartum related conditions, we could
group the conditions together clinically.
Diagnoses described as occurring during
pregnancy and diagnoses specifying a
trimester or maternal care in the absence
of a delivery procedure reported were
considered antepartum conditions. We
also believed we could better classify
these groups of patients based on the
presence or absence of a procedure.
Therefore, we worked with the concept
of ‘‘antepartum diagnoses with and
without O.R. procedure’’.
As noted earlier in the discussion, we
adopted a working concept of ‘‘cesarean
section with and without sterilization
with MCC, with CC, and without CC/
MCC.’’ This concept is illustrated in the
following table and includes our
suggested modifications.
SUGGESTED MODIFICATIONS TO MS–
DRGS FOR MDC 14
[Pregnancy, childbirth and the puerperium]
DELETE 2 MS–DRGs:
MS–DRG 765 (Cesarean Section with CC/MCC).
MS–DRG 766 (Cesarean Section without CC/
MCC).
CREATE 6 MS–DRGs:
MS–DRG XXX (Cesarean Section with Sterilization with MCC).
MS–DRG XXX (Cesarean Section with Sterilization with CC).
MS–DRG XXX (Cesarean Section with Sterilization without CC/MCC).
MS–DRG XXX (Cesarean Section without Sterilization with MCC).
SUGGESTED MODIFICATIONS TO MS–
DRGS FOR MDC 14—Continued
[Pregnancy, childbirth and the puerperium]
MS–DRG XXX (Cesarean Section without Sterilization with CC).
MS–DRG XXX (Cesarean Section without Sterilization without CC/MCC).
As shown in the table, we suggest
deleting MS–DRGs 765 and 766. We
also suggest creating 6 new MS–DRGs
that are subdivided by a 3-way severity
level split that includes ‘‘with
Sterilization’’ and ‘‘without
Sterilization’’.
We also adopted a working concept of
‘‘vaginal delivery with and without
sterilization with MCC, with CC, and
without CC/MCC’’. This concept is
illustrated in the following table and
includes our suggested modifications.
SUGGESTED MODIFICATIONS TO MS–
DRGS FOR MDC 14
[Pregnancy, childbirth and the puerperium]
DELETE 3 MS–DRGs:
MS–DRG 767 (Vaginal Delivery with Sterilization
and/or D&C).
MS–DRG 774 (Vaginal Delivery with Complicating
Diagnosis).
MS–DRG 775 (Vaginal Delivery without Complicating Diagnosis).
CREATE 6 MS–DRGs:
MS–DRG XXX (Vaginal Delivery with Sterilization/
D&C with MCC).
MS–DRG XXX (Vaginal Delivery with Sterilization/
D&C with CC).
MS–DRG XXX (Vaginal Delivery with Sterilization/
D&C without CC/MCC).
MS–DRG XXX (Vaginal Delivery without Sterilization/D&C with MCC).
MS–DRG XXX (Vaginal Delivery without Sterilization/D&C with CC).
MS–DRG XXX (Vaginal Delivery without Sterilization/D&C without CC/MCC).
As shown in the table, we suggest
deleting MS–DRGs 767, 774, and 775.
We also suggest creating 6 new MS–
DRGs that are subdivided by a 3-way
severity level split that includes ‘‘with
Sterilization/D&C’’ and ‘‘without
Sterilization/D&C’’.
In addition, as indicated above, we
believed that we could consolidate the
groups in which no delivery occurs. We
believe that consolidating MS–DRGs
where clinically coherent conditions
exist is consistent with our approach to
MS–DRG reclassification and our
continued refinement efforts. This
concept is illustrated in the following
table and includes our suggested
modifications.
SUGGESTED MODIFICATIONS TO MS–
DRGS FOR MDC 14
[Pregnancy, childbirth and the puerperium]
DELETE 5 MS–DRGs:
MS–DRG 777 (Ectopic Pregnancy).
MS–DRG 778 (Threatened Abortion).
MS–DRG 780 (False Labor).
MS–DRG 781 (Other Antepartum Diagnoses with
Medical Complications).
MS–DRG 782 (Other Antepartum Diagnoses without Medical Complications).
CREATE 6 MS–DRGs:
MS–DRG XXX (Other Antepartum Diagnoses with
O.R. Procedure with MCC).
MS–DRG XXX (Other Antepartum Diagnoses with
O.R. Procedure with CC).
MS–DRG XXX (Other Antepartum Diagnoses with
O.R. Procedure without CC/MCC).
MS–DRG XXX (Other Antepartum Diagnoses
without O.R. Procedure with MCC).
MS–DRG XXX (Other Antepartum Diagnoses
without O.R. Procedure with CC).
MS–DRG XXX (Other Antepartum Diagnoses
without O.R. Procedure without CC/MCC).
As shown in the table, we suggest
deleting MS–DRGs 777, 778, 780, 781,
and 782. We also suggest creating 6 new
MS–DRGs that are subdivided by a 3way severity level split that includes
‘‘with O.R. Procedure’’ and ‘‘without
O.R. Procedure’’.
Once we established each of these
fundamental concepts from a clinical
perspective, we were able to analyze the
data to determine if our initial suggested
modifications were supported.
To analyze our suggested
modifications for the cesarean section
and vaginal delivery MS–DRGs, we
examined the claims data from the
September 2017 update of the FY 2017
MedPAR file for MS–DRGs 765, 766,
767, 768, 774, and 775.
MS–DRGS FOR MDC 14 PREGNANCY, CHILDBIRTH AND THE PUERPERIUM
Number
of cases
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
MS–DRG 765 (Cesarean Section with CC/MCC)—All cases .....................................................
MS–DRG 766 (Cesarean Section without CC/MCC)—All cases ................................................
MS–DRG 767 (Vaginal Delivery with Sterilization and/or D&C)—All cases ...............................
MS–DRG 768 (Vaginal Delivery with O.R. Procedure Except Sterilization and/or D&C)—All
cases ........................................................................................................................................
MS–DRG 774 (Vaginal Delivery with Complicating Diagnosis)—All cases ................................
MS–DRG 775 (Vaginal Delivery without Complicating Diagnosis)—All cases ...........................
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Average
length
of stay
Average
costs
3,494
1,974
351
4.6
3.1
3.2
$8,929
6,488
7,886
17
1,650
4,676
6.2
3.3
2.4
26,164
6,046
4,769
07MYP2
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As shown in the table, there were a
total of 3,494 cases in MS–DRG 765,
with an average length of stay of 4.6
days and average costs of $8,929. For
MS–DRG 766, there were a total of 1,974
cases, with an average length of stay of
3.1 days and average costs of $6,488. For
MS–DRG 767, there were a total of 351
cases, with an average length of stay of
3.2 days and average costs of $ 7,886.
For MS–DRG 768, there were a total of
17 cases, with an average length of stay
of 6.2 days and average costs of $26,164.
For MS–DRG 774, there were a total of
1,650 cases, with an average length of
stay of 3.3 days and average costs of
$6,046. Lastly, for MS–DRG 775, there
were a total of 4,676 cases, with an
average length of stay of 2.4 days and
average costs of $4,769.
To compare and analyze the impact of
our suggested modifications, we ran a
simulation using the Version 35 ICD–10
MS–DRG GROUPER. The following
table reflects our findings for the
suggested Cesarean Section MS–DRGs
with a 3-way severity level split.
SUGGESTED MS–DRGS FOR CESAREAN SECTION
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
783
784
785
786
787
788
(Cesarean
(Cesarean
(Cesarean
(Cesarean
(Cesarean
(Cesarean
Section
Section
Section
Section
Section
Section
with Sterilization with MCC) ..................................................
with Sterilization with CC) .....................................................
with Sterilization without CC/MCC) ......................................
without Sterilization with MCC) .............................................
without Sterilization with CC) ................................................
without Sterilization without CC/MCC) .................................
As shown in the table, there were a
total of 178 cases for the cesarean
section with sterilization with MCC
group, with an average length of stay of
6.4 days and average costs of $12,977.
There were a total of 511 cases for the
cesarean section with sterilization with
CC group, with an average length of stay
of 4.1 days and average costs of $8,042.
There were a total of 475 cases for the
cesarean section with sterilization
without CC/MCC group, with an average
length of stay of 3.0 days and average
costs of $6,259. For the cesarean section
without sterilization with MCC group
there were a total of 707 cases, with an
average length of stay of 5.9 days and
average costs of $11,515. There were a
total of 1,887 cases for the cesarean
section without sterilization with CC
group, with an average length of stay of
4.2 days and average costs of $7,990.
Average
Length
of stay
178
511
475
707
1,887
1,710
Average
costs
6.4
4.1
3.0
5.9
4.2
3.3
$12,977
8,042
6,259
11,515
7,990
6,663
Lastly, there were a total of 1,710 cases
for the cesarean section without
sterilization without CC/MCC group,
with an average length of stay of 3.3
days and average costs of $6,663.
The following table reflects our
findings for the suggested Vaginal
Delivery MS–DRGs with a 3-way
severity level split.
SUGGESTED MS–DRGS FOR VAGINAL DELIVERY
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
796
797
798
805
806
807
(Vaginal
(Vaginal
(Vaginal
(Vaginal
(Vaginal
(Vaginal
Delivery
Delivery
Delivery
Delivery
Delivery
Delivery
with Sterilization/D&C with MCC) ............................................
with Sterilization/D&C with CC) ...............................................
with Sterilization/D&C without CC/MCC) .................................
without Sterilization/D&C with MCC) .......................................
without Sterilization/D&C with CC) ..........................................
without Sterilization/D&C without CC/MCC) ............................
daltland on DSKBBV9HB2PROD with PROPOSALS2
As shown in the table, there were a
total of 25 cases for the vaginal delivery
with sterilization/D&C with MCC group,
with an average length of stay of 6.7
days and average costs of $11,421. There
were a total of 63 cases for the vaginal
delivery with sterilization/D&C with CC
group, with an average length of stay of
2.4 days and average costs of $6,065.
There were a total of 126 cases for
vaginal delivery with sterilization/D&C
without CC/MCC group, with an average
length of stay of 2.3 days and average
costs of $6,697. There were a total of
406 cases for the vaginal delivery
without sterilization/D&C with MCC
group, with an average length of stay of
5.0 days and average costs of $9,605.
There were a total of 1,952 cases for the
vaginal delivery without sterilization/
D&C with CC group, with an average
length of stay of 2.9 days and average
costs of $5,506. There were a total of
4,105 cases for the vaginal delivery
Average
length
of stay
25
63
126
406
1,952
4,105
Average
costs
6.7
2.4
2.3
5.0
2.9
2.3
$11,421
6,065
6,697
9,605
5,506
4,601
without sterilization/D&C without
CC/MCC group, with an average length
of stay of 2.3 days and average costs of
$4,601.
We then reviewed the claims data
from the September 2017 update of the
FY 2017 MedPAR file for MS–DRGs
777, 778, 780, 781, and 782. Our
findings are shown in the following
table.
MS–DRGS FOR MDC 14 PREGNANCY, CHILDBIRTH AND THE PUERPERIUM
Number
of cases
MS–DRG
MS–DRG 777 (Ectopic Pregnancy)—All cases ..........................................................................
MS–DRG 778 (Threatened Abortion)—All cases ........................................................................
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72
205
07MYP2
Average
length
of stay
Average
costs
1.9
2.7
$7,149
4,001
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MS–DRGS FOR MDC 14 PREGNANCY, CHILDBIRTH AND THE PUERPERIUM—Continued
Number
of cases
MS–DRG
MS–DRG 780 (False Labor)—All cases .....................................................................................
MS–DRG 781 (Other Antepartum Diagnoses with Medical Complications)—All cases .............
MS–DRG 782 (Other Antepartum Diagnoses without Medical Complications)—All cases ........
As shown in the table, there were a
total of 72 cases in MS–DRG 777, with
an average length of stay of 1.9 days and
average costs of $7,149. For MS–DRG
778, there were a total of 205 cases, with
an average length of stay of 2.7 days and
average costs of $4,001. For MS–DRG
780, there were a total of 41 cases, with
an average length of stay of 2.1 days and
average costs of $3,045. For MS–DRG
781, there were a total of 2,333 cases,
with an average length of stay of 3.7
days and average costs of $5,817. Lastly,
for MS–DRG 782, there were a total of
70 cases, with an average length of stay
of 2.1 days and average costs of $3,381.
To compare and analyze the impact of
deleting those 5 MS–DRGs and creating
Average
length
of stay
41
2,333
70
Average
costs
2.1
3.7
2.1
3,045
5,817
3,381
6 new MS–DRGs, we ran a simulation
using the Version 35 ICD–10 MS–DRG
GROUPER. Our findings below
represent what we found and would
expect under the suggested
modifications. The following table
reflects the MS–DRGs for the suggested
Other Antepartum Diagnoses MS–DRGs
with a 3-way severity level split.
SUGGESTED MS–DRGS FOR OTHER ANTEPARTUM DIAGNOSES
Number
of cases
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
817
818
819
831
832
833
(Other
(Other
(Other
(Other
(Other
(Other
Antepartum
Antepartum
Antepartum
Antepartum
Antepartum
Antepartum
Diagnoses
Diagnoses
Diagnoses
Diagnoses
Diagnoses
Diagnoses
with O.R. Procedure with MCC) .........................
with O.R. Procedure with CC) ............................
with O.R. Procedure without CC/MCC) ..............
without O.R. Procedure with MCC) ....................
without O.R. Procedure with CC) .......................
without O.R. Procedure without CC/MCC) .........
Our analysis of claims data from the
September 2017 update of the FY 2017
MedPAR file recognized that when the
criteria to create subgroups were
applied for the 3-way severity level
splits for the suggested MS–DRGs, those
criteria were not met in all instances.
For example, the criteria that there are
at least 500 cases in the MCC or CC
group was not met for the suggested
Vaginal Delivery with Sterilization/D&C
3-way severity level split or the
suggested Other Antepartum Diagnoses
with O.R. Procedure 3-way severity
level split.
However, as we have noted in prior
rulemaking (72 FR 47152), we cannot
adopt the same approach to refine the
maternity and newborn MS–DRGs
because of the extremely low volume of
Medicare patients there are in these
DRGs. While there is not a high volume
of these cases represented in the
Medicare data, and while we generally
advise that other payers should develop
MS–DRGs to address the needs of their
patients, we believe that our suggested
3-way severity level splits would
Average
length
of stay
60
66
44
786
910
855
Average
costs
5.1
4.2
1.7
4.3
3.5
2.7
$13,117
10,483
5,904
7,248
4,994
3,843
address the complexity of the current
MDC 14 GROUPER logic for a vaginal
delivery and takes into account the new
and different clinical concepts that exist
under ICD–10 for this subset of patients
while also maintaining the existing MS–
DRG structure for identifying severity of
illness, utilization of resources and
complexity of service.
However, as an alternative option, we
also performed analysis for a 2-way
severity level split for the suggested
MS–DRGs. Our findings are shown in
the following tables.
SUGGESTED MS–DRGS FOR CESAREAN SECTION
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
XXX
XXX
XXX
XXX
(Cesarean
(Cesarean
(Cesarean
(Cesarean
Section
Section
Section
Section
with Sterilization with CC/MCC) ..........................................
with Sterilization without CC/MCC) .....................................
without Sterilization with MCC) ...........................................
without Sterilization without CC/MCC) ................................
Average
length
of stay
689
475
2,594
1,710
Average
costs
4.7
3.0
4.7
3.3
$9,317
6,259
8,951
6,663
SUGGESTED MS–DRGS FOR VAGINAL DELIVERY
Number
of cases
MS–DRG
MS–DRG XXX (Vaginal Delivery with Sterilization/D&C with CC/MCC) ....................................
MS–DRG XXX (Vaginal Delivery with Sterilization/D&C without CC/MCC) ...............................
MS–DRG XXX (Vaginal Delivery without Sterilization/D&C with MCC) ......................................
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88
126
2,358
07MYP2
Average
length
of stay
Average
costs
3.6
2.3
3.2
$7,586
6,697
6,212
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SUGGESTED MS–DRGS FOR VAGINAL DELIVERY—Continued
Number
of cases
MS–DRG
MS–DRG XXX (Vaginal Delivery without Sterilization/D&C without CC/MCC) ..........................
Average
length
of stay
4,105
Average
costs
2.3
4,601
SUGGESTED MS–DRGS FOR OTHER ANTEPARTUM DIAGNOSES
Number
of cases
MS–DRG
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
MS–DRG
MS–DRG
MS–DRG
XXX
XXX
XXX
XXX
(Other
(Other
(Other
(Other
Antepartum
Antepartum
Antepartum
Antepartum
Diagnoses
Diagnoses
Diagnoses
Diagnoses
with O.R. Procedure with MCC) ........................
with O.R. Procedure without CC/MCC) .............
without O.R. Procedure with MCC) ...................
without O.R. Procedure without CC/MCC) ........
Similar to the analysis performed for
the 3-way severity level split, we
acknowledge that when the criteria to
create subgroups was applied for the
alternative 2-way severity level splits for
the suggested MS–DRGs, those criteria
were not met in all instances. For
example, the suggested Vaginal Delivery
with Sterilization/D&C and the Other
Antepartum Diagnoses with O.R.
Procedure alternative option 2-way
severity level splits did not meet the
criteria for 500 or more cases in the
MCC or CC group.
Based on our review, which included
support from our clinical advisors, and
the analysis of claims data described
above, we are proposing the deletion of
10 MS–DRGs and the creation of 18 new
MS–DRGs (as shown below). This
proposal is based on the approach
described above, which involves
consolidating specific conditions and
concepts into the structure of existing
logic and making additional
modifications, such as adding severity
levels, as part of our refinement efforts
for the ICD–10 MS–DRGs. Our proposals
are intended to address the vaginal
delivery ‘‘complicating diagnosis’’ logic
and antepartum diagnoses with
‘‘medical complications’’ logic with the
proposed addition of the existing and
familiar severity level concept (with
MCC, with CC, and without CC/MCC) to
the MDC 14 MS–DRGs to provide the
ability to distinguish the varying
resource requirements for this subset of
patients and allow the opportunity to
make more meaningful comparisons
with regard to severity across the MS–
DRGs. Our proposals, as set forth below,
would also simplify the vaginal delivery
procedure logic that we identified and
commenters acknowledged as
technically complex by eliminatng the
extensive diagnosis and procedure code
lists for several conditions that must be
met for assignment to the vaginal
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delivery MS–DRGs. Our proposals are
also intended to respond to issues
identified and brought to our attention
through public comments for
consideration in updating the
GROUPER logic code lists in MDC 14.
Specifically, we are proposing to
delete the following 10 MS–DRGs under
MDC 14:
• MS–DRG 765 (Cesarean Section
with CC/MCC);
• MS–DRG 766 (Cesarean Section
without CC/MCC);
• MS–DRG 767 (Vaginal Delivery
with Sterilization and/or D&C);
• MS–DRG 774 (Vaginal Delivery
with Complicating Diagnosis);
• MS–DRG 775 (Vaginal Delivery
without Complicating Diagnosis);
• MS–DRG 777 (Ectopic Pregnancy);
• MS–DRG 778 (Threatened
Abortion);
• MS–DRG 780 (False Labor);
• MS–DRG 781 (Other Antepartum
Diagnoses with Medical Complications);
and
• MS–DRG 782 (Other Antepartum
Diagnoses without Medical
Complications).
We are proposing to create the
following new 18 MS–DRGs under MDC
14:
• Proposed new MS–DRG 783
(Cesarean Section with Sterilization
with MCC);
• Proposed new MS–DRG 784
(Cesarean Section with Sterilization
with CC);
• Proposed new MS–DRG 785
(Cesarean Section with Sterilization
without CC/MCC);
• Proposed new MS–DRG 786
(Cesarean Section without Sterilization
with MCC);
• Proposed new MS–DRG 787
(Cesarean Section without Sterilization
with CC);
• Proposed new MS–DRG 788
Cesarean Section without Sterilization
without CC/MCC);
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44
1,696
855
Average
length
of stay
Average
costs
4.7
1.7
3.9
2.7
$11,737
5,904
6,039
3,843
• Proposed new MS–DRG 796
(Vaginal Delivery with Sterilization/
D&C with MCC);
• Proposed new MS–DRG 797
(Vaginal Delivery with Sterilization/
D&C with CC);
• Proposed new MS–DRG 798
(Vaginal Delivery with Sterilization/
D&C without CC/MCC);
• Proposed new MS–DRG 805
(Vaginal Delivery without Sterilization/
D&C with MCC);
• Proposed new MS–DRG 806
(Vaginal Delivery without Sterilization/
D&C with CC);
• Proposed new MS–DRG 807
(Vaginal Delivery without Sterilization/
D&C without CC/MCC);
• Proposed new MS–DRG 817 (Other
Antepartum Diagnoses with O.R.
Procedure with MCC);
• Proposed new MS–DRG 818 (Other
Antepartum Diagnoses with O.R.
Procedure with CC);
• Proposed new MS–DRG 819 (Other
Antepartum Diagnoses with O.R.
Procedure without CC/MCC);
• Proposed new MS–DRG 831 (Other
Antepartum Diagnoses without O.R.
Procedure with MCC);
• Proposed new MS–DRG 832 (Other
Antepartum Diagnoses without O.R.
Procedure with CC); and
• Proposed new MS–DRG 833 (Other
Antepartum Diagnoses without O.R.
Procedure without CC/MCC).
The diagrams below illustrate how the
proposed MS–DRG logic for MDC 14
would function. The first diagram
(Diagram 1.) begins by asking if there is
a principal diagnosis from MDC 14. If
no, the GROUPER logic directs the case
to the appropriate MDC based on the
principal diagnosis reported. Next, the
logic asks if there is a cesarean section
procedure reported on the claim. If yes,
the logic asks if there was a sterilization
procedure reported on the claim. If yes,
the logic assigns the case to one of the
proposed new MS–DRGs 783, 784, or
E:\FR\FM\07MYP2.SGM
07MYP2
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
785. If no, the logic assigns the case to
one of the proposed new MS–DRGs 786,
787, or 788. If there was not a cesarean
section procedure reported on the claim,
the logic asks if there was a vaginal
delivery procedure reported on the
claim. If yes, the logic asks if there was
another O.R. procedure other than
the logic assigns the case to one of the
proposed new MS–DRGs 805, 806, or
807. If there was not a vaginal delivery
procedure reported on the claim, the
GROUPER logic directs you to the other
non-delivery MS–DRGs as shown in
Diagram 2.
sterilization, D&C, delivery procedure or
a delivery inclusive O.R. procedure. If
yes, the logic assigns the case to existing
MS–DRG 768. If no, the logic asks if
there was a sterilization and/or D&C
reported on the claim. If yes, the logic
assigns the case to one of the proposed
new MS–DRGs 796, 797, or 798. If no,
BILLING CODE 4120–01–P
MS–DRG 770. If no, the logic assigns the
case to existing MS–DRG 779. If there
was not a principal diagnosis of
abortion reported on the claim, the logic
asks if there was a principal diagnosis
of an antepartum condition reported on
the claim. If yes, the logic then asks if
there was an O.R. procedure reported on
the claim. If yes, the logic assigns the
case to one of the proposed new MS–
DRGs 817, 818, or 819. If no, the logic
assigns the case to one of the proposed
new MS–DRGs 831, 832, or 833. If there
was not a principal diagnosis of an
The logic for Diagram 2. begins by
asking if there is a principal diagnosis
of abortion reported on the claim. If yes,
the logic then asks if there was a D&C,
aspiration curettage or hysterotomy
procedure reported on the claim. If yes,
the logic assigns the case to existing
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Diagram 1.
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
20225
a principal diagnosis describing
childbirth, delivery or an intrapartum
condition reported on the claim without
any other procedures, and assigns the
case to existing MS–DRG 998 (Principal
Diagnosis Invalid as Discharge
Diagnosis).
To assist in detecting coding and MS–
DRG assignment errors for MS–DRG 998
that could result when a provider does
not report the procedure code for either
a cesarean section or a vaginal delivery
along with an outcome of delivery
diagnosis code, as discussed in section
II.F.13.d., we are proposing to add a
new Questionable Obstetric Admission
edit under the MCE. We are inviting
public comments on this proposed MCE
edit and we also are inviting public
comments on the need for any
additional MCE considerations with
regard to the proposed changes for the
MDC 14 MS–DRGs.
BILLING CODE 4120–01–C
diagnosis and procedure codes that we
are proposing to assign to the GROUPER
logic for the proposed new MS–DRGs
and the existing MS–DRGs under MDC
We refer readers to Tables 6P.1h
through 6P.1k for the lists of the
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antepartum condition reported on the
claim, the logic asks if there was a
principal diagnosis of a postpartum
condition reported on the claim. If yes,
the logic then asks if there was an O.R.
procedure reported on the claim. If yes,
the logic assigns the case to existing
MS–DRG 769. If no, the logic assigns the
case to existing MS–DRG 776. If there
was not a principal diagnosis of a
postpartum condition reported on the
claim, the logic identifies that there was
20226
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
14. We are inviting public comments on
our proposed list of diagnosis codes,
which also addresses the list of
diagnosis codes that a commenter
identified as missing from the
GROUPER logic. We note that, as a
result of our proposed GROUPER logic
changes to the vaginal delivery MS–
DRGs, which would only take into
account the procedure codes for a
vaginal delivery and the outcome of
delivery secondary diagnosis codes,
there is no longer a need to maintain a
specific principal diagnosis logic list for
those MS–DRGs. Therefore, while we
appreciate the detailed suggestions and
rationale submitted by the commenter
for why specific diagnosis codes should
be removed from the vaginal delivery
principal diagnosis logic as displayed
earlier in this discussion, we are
proposing to remove that logic. We are
inviting public comments on our
proposal.
We also are inviting public comments
on our proposal to reassign ICD–10–PCS
procedure codes 0UDB7ZX, 0UDB7ZZ,
0UDB8ZX, and 0UDB8ZZ that describe
dilation and curettage procedures from
MS–DRG 767 under MDC 14 to MS–
DRGs 744 and 745 under MDC 13.
In addition, we are inviting public
comments on our proposed list of
procedure codes for the proposed
revised MDC 14 MS–DRG logic, which
would require a procedure code for case
assignment. Finally, we are inviting
public comments on the proposed
deletion of the 10 MS–DRGs and the
proposed creation of 18 new MS–DRGs
with a 3-way severity level split listed
above in this section, as well as on the
potential alternative new MS–DRGs
using a 2-way severity level split as also
presented above.
11. MDC 18 (Infectious and Parasitic
Diseases (Systematic or Unspecified
Sites): Systemic Inflammatory Response
Syndrome (SIRS) of Non-Infectious
Origin
ICD–10–CM diagnosis codes R65.10
(Systemic Inflammatory Response
Syndrome (SIRS) of non-infectious
origin without acute organ dysfunction)
and R65.11 (Systemic Inflammatory
Response Syndrome (SIRS) of noninfectious origin with acute organ
dysfunction) are currently assigned to
MS–DRGs 870 (Septicemia or Severe
Sepsis with Mechanical Ventilation >96
Hours), 871 (Septicemia or Severe
Sepsis with Mechanical Ventilation >96
Hours with MCC), and 872 (Septicemia
or Severe Sepsis with Mechanical
Ventilation >96 Hours without MCC)
under MDC 18 (Infectious and Parasitic
Diseases, Systemic or Unspecified
Sites). Our clinical advisors noted that
these diagnosis codes are specifically
describing conditions of a noninfectious origin, and recommended
that they be reassigned to a more
clinically appropriate MS–DRG.
We examined claims data from the
September 2017 update of the FY 2017
MedPAR file for cases in MS–DRGs 870,
871, and 872. Our findings are shown in
the following table.
SEPTICEMIA OR SEVERE SEPSIS WITH AND WITHOUT MECHANICAL VENTILATION >96 HOURS WITH AND WITHOUT MCC
Number
of cases
MS–DRG
MS–DRG 870—All cases ............................................................................................................
MS–DRG 871—All cases ............................................................................................................
MS–DRG 872—All cases ............................................................................................................
As shown in this table, we found a
total of 31,658 cases in MS–DRG 870,
with an average length of stay of 14.3
days and average costs of $42,981. We
found a total of 566,531 cases in MS–
DRG 871, with an average length of stay
of 6.3 days and average costs of $13,002.
Lastly, we found a total of 150,437 cases
in MS–DRG 872, with an average length
of stay of 4.3 days and average costs of
$7,532.
Average
length
of stay
31,658
566,531
150,437
Average
costs
14.3
6.3
4.3
$42,981
13,002
7,532
We then examined claims data in
MS–DRGs 870, 871, or 872 for cases
reporting an ICD–10–CM diagnosis code
of R65.10 or R65.11. Our findings are
shown in the following table.
SIRS OF NON-INFECTIOUS ORIGIN WITH AND WITHOUT ACUTE ORGAN DYSFUNCTION
Number
of cases
MS–DRGs 870, 871 and 872
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRGs
MS–DRGs
MS–DRGs
MS–DRGs
870,
870,
870,
870,
871,
871,
871,
871,
and
and
and
and
872—Cases
872—Cases
872—Cases
872—Cases
reporting
reporting
reporting
reporting
As shown in this table, we found a
total of 1,254 cases reporting a principal
diagnosis code of R65.10 in MS–DRGs
870, 871, and 872, with an average
length of stay of 3.8 days and average
costs of $6,615. We found a total of 138
cases reporting a principal diagnosis
code of R65.11 in MS–DRGs 870, 871,
and 872, with an average length of stay
of 4.8 days and average costs of $9,655.
We found a total of 1,232 cases
reporting a secondary diagnosis code of
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a
a
a
a
principal diagnosis code of R65.10 ............
principal diagnosis code of R65.11 ............
secondary diagnosis code of R65.10 ........
secondary diagnosis code of R65.11 ........
R65.10 in MS–DRGs 870, 871, and 872,
with an average length of stay of 5.5
days and average costs of $10,670.
Lastly, we found a total of 117 cases
reporting a secondary diagnosis code of
R65.11 in MS–DRGs 870, 871, and 872,
with an average length of stay of 6.2
days and average costs of $12,525.
The claims data included a total of
1,392 cases in MS–DRGs 870, 871, and
872 that reported a principal diagnosis
code of R65.10 or R65.11. We note that
PO 00000
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Fmt 4701
Sfmt 4702
1,254
138
1,232
117
Average
length
of stay
Average
costs
3.8
4.8
5.5
6.2
$6,615
9,655
10,670
12,525
these 1,392 cases appear to have been
coded inaccurately according to the
ICD–10–CM Official Guidelines for
Coding and Reporting at Section
I.C.18.g., which specifically state: ‘‘The
systemic inflammatory response
syndrome (SIRS) can develop as a result
of certain non-infectious disease
processes, such as trauma, malignant
neoplasm, or pancreatitis. When SIRS is
documented with a non-infectious
condition, and no subsequent infection
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
is documented, the code for the
underlying condition, such as an injury,
should be assigned, followed by code
R65.10, Systemic inflammatory
response syndrome (SIRS) of noninfectious origin without acute organ
dysfunction or code R65.11, Systemic
inflammatory response syndrome (SIRS)
of non-infectious origin with acute
organ dysfunction.’’ Therefore,
according to the Coding Guidelines,
ICD–10–CM diagnosis codes R65.10 and
R65.11 should not be reported as the
principal diagnosis on an inpatient
claim.
We have acknowledged in past
rulemaking the challenges with coding
for SIRS (and sepsis) (71 FR 24037). In
addition, we note that there has been
confusion with regard to how these
codes are displayed in the ICD–10 MS–
DRG Definitions Manual under MS–
DRGs 870, 871, and 872, which may
also impact the reporting of these
conditions. For example, in Version 35
of the ICD–10 MS–DRG Definitions
Manual (which is available via the
Internet on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatient
PPS/FY2018-IPPS-Final-Rule-HomePage-Items/FY2018-IPPS-Final-RuleData-Files.html?DLPage=1&DLEntries=
10&DLSort=0&DLSortDir=ascending,
the logic for case assignment to MS–
DRGs 870, 871, and 872 is comprised of
a list of several diagnosis codes, of
which ICD–10–CM diagnosis codes
R65.10 and R65.11 are included.
Because these codes are listed under the
heading of ‘‘Principal Diagnosis’’, it may
appear that these codes are to be
reported as a principal diagnosis for
assignment to MS–DRGs 870, 871, or
872. However, the Definitions Manual
display of the GROUPER logic
assignment for each diagnosis code is
for grouping purposes only. The
GROUPER (and, therefore,
documentation in the MS–DRG
Definitions Manual) was not designed to
account for coding guidelines or
coverage policies. Since the inception of
the IPPS, the data editing function has
been a separate and independent step in
the process of determining a DRG
assignment. Except for extreme data
integrity issues that prevent a DRG from
being assigned, such as an invalid
principal diagnosis, the DRG assignment
GROUPER does not edit for data
integrity. Prior to assigning the MS–DRG
to a claim, the MACs apply a series of
data integrity edits using programs such
as the Medicare Code Editor (MCE). The
MCE is designed to identify cases that
require further review before
classification into an MS–DRG. These
data integrity edits address issues such
as data validity, coding rules, and
20227
coverage policies. The separation of the
MS–DRG grouping and data editing
functions allows the MS–DRG
GROUPER to remain stable during a
fiscal year even though coding rules and
coverage policies may change during the
fiscal year. As such, in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38050
through 38051), we finalized our
proposal to add ICD–10–CM diagnosis
codes R65.10 and R65.11 to the
Unacceptable Principal Diagnosis edit
in the MCE as a result of the Official
Guidelines for Coding and Reporting
related to SIRS, in efforts to improve
coding accuracy for these types of cases.
To address the issue of determining a
more appropriate MS–DRG assignment
for ICD–10–CM diagnosis codes R65.10
and R65.11, we reviewed alternative
options under MDC 18. Our clinical
advisors determined the most
appropriate option is MS–DRG 864
(Fever) because the conditions that are
assigned here describe conditions of a
non-infectious origin.
Therefore, we are proposing to
reassign ICD–10–CM diagnosis codes
R65.10 and R65.11 to MS–DRG 864 and
to revise the title of MS–DRG 864 to
‘‘Fever and Inflammatory Conditions’’ to
better reflect the diagnoses assigned
there.
PROPOSED REVISED MS–DRG 864 (FEVER AND INFLAMMATORY CONDITIONS)
MS–DRG
Number of
cases
Average
length
of stay
Average costs
MS–DRG 864—All cases ............................................................................................................
12,144
3.4
$6,232
We are inviting public comments on
our proposals.
daltland on DSKBBV9HB2PROD with PROPOSALS2
12. MDC 21 (Injuries, Poisonings and
Toxic Effects of Drugs): Corrosive Burns
ICD–10–CM Coding Guidelines
include ‘‘Code first’’ sequencing
instructions for cases reporting a
primary diagnosis of toxic effect (ICD–
10–CM codes T51 through T65) and a
secondary diagnosis of corrosive burn
(ICD–10–CM codes T21.40 through
T21.79). We received a request to
reassign these cases from MS–DRGs 901
(Wound Debridements for Injuries with
MCC), 902 (Wound Debridements for
Injuries with CC), 903 (Wound
Debridements for Injuries without CC/
MCC), 904 (Skin Grafts for Injuries with
CC/MCC), 905 (Skin Grafts for Injuries
without CC/MCC), 917 (Poisoning and
Toxic Effects of Drugs with MCC), and
918 (Poisoning and Toxic Effects of
Drugs without MCC) to MS–DRGs 927
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(Extensive Burns or Full Thickness
Burns with Mechanical Ventilation >96
Hours with Skin Graft), 928 (Full
Thickness Burn with Skin Graft or
Inhalation Injury with CC/MCC), 929
(Full Thickness Burn with Skin Graft or
Inhalation Injury without CC/MCC), 933
(Extensive Burns or Full Thickness
Burns with Mechanical Ventilation >96
Hours without Skin Graft), 934 (Full
Thickness Burn without Skin Graft or
Inhalation Injury), and 935
(Nonextensive Burns).
The requestor noted that, for
corrosion burns codes T21.40 through
T21.79, ICD-10–CM Coding Guidelines
instruct to ‘‘Code first (T51 through T65)
to identify chemical and intent.’’
Because code first notes provide
sequencing directive, when patients are
admitted with corrosive burns (which
can be full thickness and extensive),
toxic effect codes T51 through T65 must
be sequenced first followed by codes for
PO 00000
Frm 00065
Fmt 4701
Sfmt 4702
the corrosive burns. This causes fullthickness and extensive burns to group
to MS–DRGs 901 through 905 when
excisional debridement and split
thickness skin grafts are performed, and
to MS–DRGs 917 and 918 when
procedures are not performed. This is in
contrast to cases reporting a primary
diagnosis of corrosive burn, which
group to MS-DRGs 927 through 935.
The requestor stated that MS–DRGs
456 (Spinal Fusion except Cervical with
Spinal Curvature or Malignancy or
Infection or Extensive Fusions with
MCC), 457 (Spinal Fusion Except
Cervical with Spinal Curvature or
Malignancy or Infection or Extensive
Fusions with CC), and 458 (Spinal
Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions without CC/MCC) are
grouped based on the procedure
performed in combination with the
principal diagnosis or secondary
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
diagnosis (secondary scoliosis). The
requestor stated that when codes for
corrosive burns are reported as
secondary diagnoses in conjunction
with principal diagnoses codes T5l
through T65, particularly when skin
grafts are performed, they would be
more appropriately assigned to MS–
DRGs 927 through 935.
We analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for all cases assigned to
MS–DRGs 901, 902, 903, 904, 905, 917,
and 918, and subsets of these cases with
primary diagnosis of toxic effect with
secondary diagnosis of corrosive burn.
We note that we found no cases from
this subset in MS-DRGs 903, 907, 908,
and 909 and, therefore, did not include
the results for these MS-DRGs in the
table below. We also analyzed all cases
assigned to MS–DRGs 927, 928, 929,
933, 934, and 935 and those cases that
reported a primary diagnosis of
corrosive burn. Our findings are shown
in the following two tables.
MDC 21 INJURIES, POISONINGS AND TOXIC EFFECTS OF DRUGS
All Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn—
Across all MS–DRGs ...............................................................................................................
MS–DRG 901—All cases ............................................................................................................
MS–DRG 901—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 902—All cases ............................................................................................................
MS–DRG 902—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 904—All cases ............................................................................................................
MS–DRG 904—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 905—All cases ............................................................................................................
MS–DRG 905—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 906—All cases ............................................................................................................
MS–DRG 906—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 917—All cases ............................................................................................................
MS–DRG 917—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
MS–DRG 918—All cases ............................................................................................................
MS–DRG 918—Cases with primary diagnosis of toxic effect and secondary diagnosis of corrosive burn ...............................................................................................................................
As shown in this table, there were a
total of 55 cases with a primary
diagnosis of toxic effect and a secondary
diagnosis of corrosive burn across MS–
DRGs 901, 902, 903, 904, 905, 917, and
918. When comparing this subset of
codes relative to those of each MS–DRG
as a whole, we noted that, in most of
these MS–DRGs, the average costs and
average length of stay for this subset of
cases were roughly equivalent to or
lower than the average costs and average
length of stay for cases in the MS–DRG
as a whole, while in one case, they were
higher. As we have noted in prior
Average
length
of stay
Number
of cases
MS–DRG
rulemaking (77 FR 53309) and
elsewhere in this rule, it is a
fundamental principle of an averaged
payment system that half of the
procedures in a group will have above
average costs. It is expected that there
will be higher cost and lower cost
subsets, especially when a subset has
low numbers. The results of this
analysis indicate that these cases are
appropriately placed within their
current MDC.
Our clinical advisors reviewed this
request and indicated that patients with
a primary diagnosis of toxic effect and
Average
costs
55
968
5.5
13
$18,077
31,479
1
1,775
8
6.6
12,388
14,206
8
905
10.3
9.8
20,940
23,565
8
263
6.4
4.9
22,624
13,291
2
458
2.5
4.8
7,682
13,555
1
31,730
5
4.8
7,409
10,280
6
19,819
4.8
3
7,336
5,529
28
3.5
5,643
a secondary diagnosis of corrosive burn
have been exposed to an irritant or
corrosive substance and, therefore, are
clinically similar to those patients in
MDC 21. Furthermore, our clinical
advisors do not believe that the size of
this subset of cases justifies the
significant changes to the GROUPER
logic that would be required to address
the commenter’s request, which would
involve rerouting cases when the
primary and secondary diagnoses are in
different MDCs.
MDC 22 BURNS
Number
of cases
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MS–DRG
All cases with primary diagnosis of corrosive burn—Across all MS–DRGs ...............................
MS–DRG 927—All cases ............................................................................................................
MS–DRG 927—Cases with primary diagnosis of corrosive burn ...............................................
MS–DRG 928—All cases ............................................................................................................
MS–DRG 928—Cases with primary diagnosis of corrosive burn ...............................................
MS–DRG 929—All cases ............................................................................................................
MS–DRG 929—Cases with primary diagnosis of corrosive burn ...............................................
MS–DRG 933—All cases ............................................................................................................
MS–DRG 933—Cases with primary diagnosis of corrosive burn ...............................................
MS–DRG 934—All cases ............................................................................................................
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Frm 00066
Fmt 4701
Sfmt 4702
E:\FR\FM\07MYP2.SGM
60
159
1
1,021
13
295
4
121
1
503
07MYP2
Average
length
of stay
8.5
28.1
41
15.1
13.2
7.9
12.5
4.6
7
6.1
Average
costs
$19,456
128,960
75,985
42,868
31,118
21,600
18,527
21,291
91,779
13,286
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
MDC 22 BURNS—Continued
Number
of cases
MS–DRG
MS–DRG 934—Cases with primary diagnosis of corrosive burn ...............................................
MS–DRG 935—All cases ............................................................................................................
MS–DRG 935—Cases with primary diagnosis of corrosive burn ...............................................
To address the request of reassigning
cases with a primary diagnosis of toxic
effect and secondary diagnosis of
corrosive burn, we reviewed the data for
all cases in MS–DRGs 927, 928, 929,
933, 934, and 935 and those cases
reporting a primary diagnosis of
corrosive burn. We found a total of 60
cases reporting a primary diagnosis of
corrosive burn, with an average length
of stay of 8.5 days and average costs of
$19,456. Our clinical advisors believe
that these cases reporting a primary
diagnosis of corrosive burn are
appropriately placed in MDC 22 as they
are clinically aligned with other patients
in this MDC. In summary, the results of
our claims data analysis and the advice
from our clinical advisors do not
support reassigning cases in MS–DRGs
901, 902, 903, 904, 905, 917, and 918
reporting a primary diagnosis of toxic
effect and a secondary diagnosis of
corrosive burn to MS–DRGs 927, 928,
929, 933, 934 and 935. Therefore, we are
not proposing to reassign these cases.
We are inviting public comments on our
proposal to maintain the current
MS-DRG structure for these cases.
13. 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 2018 IPPS/
LTCH PPS final rule (82 FR 38045), we
made available the FY 2018 ICD–10
MCE Version 35 manual file. The link
to this MCE manual file, along with the
link to the mainframe and computer
software for the MCE Version 35 (and
ICD–10 MS–DRGs) are posted on the
CMS website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
through the FY 2018 IPPS Final Rule
Home Page.
For this FY 2019 IPPS/LTCH PPS
proposed rule, below we address the
MCE requests we received by the
November 1, 2017 deadline. We also
discuss the proposals we are making
based on our internal review and
analysis.
a. Age Conflict Edit
In the MCE, the Age Conflict edit
exists to detect inconsistencies between
a patient’s age and any diagnosis on the
patient’s record; for example, a 5-yearold patient with benign prostatic
hypertrophy or a 78-year-old patient
coded with a delivery. In these cases,
the diagnosis is clinically and virtually
impossible for a patient of the stated
age. Therefore, either the diagnosis or
the age is presumed to be incorrect.
Currently, in the MCE, the following
four age diagnosis categories appear
under the Age Conflict edit and are
listed in the manual and written in the
software program:
• Perinatal/Newborn—Age of 0 years
only; a subset of diagnoses which will
only occur during the perinatal or
newborn period of age 0 (for example,
tetanus neonatorum, health examination
for newborn under 8 days old).
daltland on DSKBBV9HB2PROD with PROPOSALS2
ICD–10–CM
code
Z05.0 ....................
Z05.1 ....................
Z05.2 ....................
Z05.3 ....................
Z05.41 ..................
Z05.42 ..................
Z05.43 ..................
Z05.5 ....................
Z05.6 ....................
Z05.71 ..................
VerDate Sep<11>2014
11
1,705
29
Average
length
of stay
Average
costs
5.8
5.2
5
• Pediatric—Age is 0–17 years
inclusive (for example, Reye’s
syndrome, routine child health exam).
• Maternity—Age range is 12–55
years inclusive (for example, diabetes in
pregnancy, antepartum pulmonary
complication).
• Adult—Age range is 15–124 years
inclusive (for example, senile delirium,
mature cataract).
(1) Perinatal/Newborn Diagnoses
Category
Under the ICD–10 MCE, the Perinatal/
Newborn Diagnoses category under the
Age Conflict edit considers the age of 0
years only; a subset of diagnoses which
will only occur during the perinatal or
newborn period of age 0 to be inclusive.
This includes conditions that have their
origin in the fetal or perinatal period
(before birth through the first 28 days
after birth) even if morbidity occurs
later. For that reason, the diagnosis
codes on this Age Conflict edit list
would be expected to apply to
conditions or disorders specific to that
age group only.
In the ICD–10–CM classification,
there are 14 diagnosis codes that
describe specific suspected conditions
that have been evaluated and ruled out
during the newborn period and are
currently not on the Perinatal/Newborn
Diagnoses Category edit code list. We
consulted with staff at the Centers for
Disease Control’s (CDC’s) National
Center for Health Statistics (NCHS)
because NCHS has the lead
responsibility for the ICD–10–CM
diagnosis codes. The NCHS’ staff
confirmed that the following diagnosis
codes are appropriate to add to the edit
code list for the Perinatal/Newborn
Diagnoses Category.
Code description
Observation
Observation
Observation
Observation
Observation
Observation
Observation
Observation
Observation
Observation
20:30 May 04, 2018
and
and
and
and
and
and
and
and
and
and
evaluation
evaluation
evaluation
evaluation
evaluation
evaluation
evaluation
evaluation
evaluation
evaluation
Jkt 244001
of
of
of
of
of
of
of
of
of
of
newborn
newborn
newborn
newborn
newborn
newborn
newborn
newborn
newborn
newborn
PO 00000
for
for
for
for
for
for
for
for
for
for
Frm 00067
suspected
suspected
suspected
suspected
suspected
suspected
suspected
suspected
suspected
suspected
Fmt 4701
cardiac condition ruled out.
infectious condition ruled out.
neurological condition ruled out.
respiratory condition ruled out.
genetic condition ruled out.
metabolic condition ruled out.
immunologic condition ruled out.
gastrointestinal condition ruled out.
genitourinary condition ruled out.
skin and subcutaneous tissue condition ruled out.
Sfmt 4702
13,280
13,065
9,822
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
ICD–10–CM
code
Z05.72 ..................
Z05.73 ..................
Z05.8 ....................
Z05.9 ....................
Code description
Observation
Observation
Observation
Observation
and
and
and
and
evaluation
evaluation
evaluation
evaluation
Therefore, we are proposing to add
the ICD–10–CM diagnosis codes listed
in the table above to the Age Conflict
edit under the Perinatal/Newborn
Diagnoses Category edit code list. We
also are proposing to continue to
include the existing diagnosis codes
currently listed under the Perinatal/
Newborn Diagnoses Category edit code
list. We are inviting public comments
on our proposals.
(2) Pediatric Diagnoses Category
Under the ICD–10 MCE, the Pediatric
Diagnoses Category for the Age Conflict
edit considers the age range of 0 to 17
years inclusive. For that reason, the
diagnosis codes on this Age Conflict
edit list would be expected to apply to
conditions or disorders specific to that
age group only.
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6C.—Invalid Diagnosis Codes associated
with this proposed rule (which is
available via the Internet on the CMS
of
of
of
of
newborn
newborn
newborn
newborn
for
for
for
for
suspected musculoskeletal condition ruled out.
suspected connective tissue condition ruled out.
other specified suspected condition ruled out.
unspecified suspected condition ruled out.
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html) lists the diagnoses that are
no longer effective as of October 1, 2018.
Included in this table is an ICD–10–CM
diagnosis code currently listed on the
Pediatric Diagnoses Category edit code
list, ICD–10–CM diagnosis code Z13.4
(Encounter for screening for certain
developmental disorders in childhood).
We are proposing to remove this code
from the Pediatric Diagnoses Category
edit code list. We also are proposing to
continue to include the other existing
diagnosis codes currently listed under
the Pediatric Diagnoses Category edit
code list. We are inviting public
comments on our proposals.
(3) Maternity Diagnoses
Under the ICD–10 MCE, the Maternity
Diagnoses Category for the Age Conflict
edit considers the age range of 12 to 55
years inclusive. For that reason, the
diagnosis codes on this Age Conflict
edit list would be expected to apply to
conditions or disorders specific to that
age group only.
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6A.—New Diagnosis Codes associated
with this proposed rule (which is
available via the Internet on the CMS
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html) lists the new diagnoses
codes that have been approved to date,
which will be effective with discharges
occurring on and after October 1, 2018.
The following table lists the new ICD–
10–CM diagnosis codes included in
Table 6A associated with pregnancy and
maternal care that we believe are
appropriate to add to the Maternity
Diagnoses Category edit code list under
the Age Conflict edit. Therefore, we are
proposing to add these codes to the
Maternity Diagnoses Category edit code
list under the Age Conflict edit.
ICD–10–CM
code
Code description
F53.0 ....................
F53.1 ....................
O30.131 ...............
O30.132 ...............
O30.133 ...............
O30.139 ...............
O30.231 ...............
O30.232 ...............
O30.233 ...............
O30.239 ...............
O30.831 ...............
O30.832 ...............
Postpartum depression.
Puerperal psychosis.
Triplet pregnancy, trichorionic/triamniotic, first trimester.
Triplet pregnancy, trichorionic/triamniotic, second trimester.
Triplet pregnancy, trichorionic/triamniotic, third trimester.
Triplet pregnancy, trichorionic/triamniotic, unspecified trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, first trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, second trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, third trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, unspecified trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, first trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, second trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, third trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, unspecified
trimester.
Infection of obstetric surgical wound, unspecified.
Infection of obstetric surgical wound, superficial incisional site.
Infection of obstetric surgical wound, deep incisional site.
Infection of obstetric surgical wound, organ and space site.
Sepsis following an obstetrical procedure.
Infection of obstetric surgical wound, other surgical site.
O30.833 ...............
O30.839 ...............
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O86.00
O86.01
O86.02
O86.03
O86.04
O86.09
.................
.................
.................
.................
.................
.................
In addition, as discussed in section
II.F.15. of the preamble of this proposed
rule, Table 6C.—Invalid Diagnosis
Codes associated with this proposed
rule (which is available via the Internet
on the CMS website at: https://
www.cms.hhs.gov/Medicare/MedicareFee-for-Service-Payment/AcuteInpatient
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PPS/) lists the diagnosis
codes that are no longer effective as of
October 1, 2018. Included in this table
are two ICD–10–CM diagnosis codes
currently listed on the Maternity
Diagnoses Category edit code list: ICD–
10–CM diagnosis codes F53 (Puerperal
psychosis) and O86.0 (Infection of
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obstetric surgical wound). We are
proposing to remove these codes from
the Maternity Diagnoses Category Edit
code list. We also are proposing to
continue to include the other existing
diagnosis codes currently listed under
the Maternity Diagnoses Category edit
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code list. We are inviting public
comments on our proposals.
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.
b. Sex Conflict Edit
In the MCE, the Sex Conflict edit
detects inconsistencies between a
patient’s sex and any diagnosis or
procedure on the patient’s record; for
ICD–10–CM
code
Z30.015 ................
Z31.7 ....................
Z98.891 ................
20231
(1) Diagnoses for Females Only Edit
We received a request to consider the
addition of the following ICD–10–CM
diagnosis codes to the list for the
Diagnoses for Females Only edit.
Code description
Encounter for initial prescription of vaginal ring hormonal contraceptive.
Encounter for procreative management and counseling for gestational carrier.
History of uterine scar from previous surgery.
The requestor noted that, currently,
ICD–10–CM diagnosis code Z30.44
(Encounter for surveillance of vaginal
ring hormonal contraceptive device) is
on the Diagnoses for Females Only edit
code list and suggested that ICD–10–CM
diagnosis code Z30.015, which also
describes an encounter involving a
vaginal ring hormonal contraceptive, be
added to the Diagnoses for Females
Only edit code list as well. In addition,
the requestor suggested that ICD–10–CM
diagnosis codes Z31.7 and Z98.891 be
added to the Diagnoses for Females
Only edit code list.
We reviewed ICD–10–CM diagnosis
codes Z30.015, Z31.7, and Z98.891, and
we agree with the requestor that it is
clinically appropriate to add these three
ICD–10–CM diagnosis codes to the
Diagnoses for Females Only edit code
list because the conditions described by
these codes are specific to and
consistent with the female sex.
In addition, as discussed in section
II.F.15. of the preamble of this proposed
rule, Table 6A.—New Diagnosis Codes
associated with this proposed rule
(which is available via the Internet on
the CMS website at: https://
www.cms.hhs.gov/Medicare/MedicareFee-for-Service-Payment/
AcuteInpatientPPS/) lists the
new diagnosis codes that have been
approved to date, which will be
effective with discharges occurring on
and after October 1, 2018. The following
table lists the new diagnosis codes that
are associated with conditions
consistent with the female sex. We are
proposing to add these ICD–10–CM
diagnosis codes to the Diagnoses for
Females Only edit code list under the
Sex Conflict edit.
ICD–10–CM
code
Code description
F53.0 ....................
F53.1 ....................
N35.82 ..................
N35.92 ..................
O30.131 ...............
O30.132 ...............
O30.133 ...............
O30.139 ...............
O30.231 ...............
O30.232 ...............
O30.233 ...............
O30.239 ...............
O30.831 ...............
O30.832 ...............
Postpartum depression.
Puerperal psychosis.
Other urethral stricture, female.
Unspecified urethral stricture, female.
Triplet pregnancy, trichorionic/triamniotic, first trimester.
Triplet pregnancy, trichorionic/triamniotic, second trimester.
Triplet pregnancy, trichorionic/triamniotic, third trimester.
Triplet pregnancy, trichorionic/triamniotic, unspecified trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, first trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, second trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, third trimester.
Quadruplet pregnancy, quadrachorionic/quadra-amniotic, unspecified trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, first trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, second trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, third trimester.
Other specified multiple gestation, number of chorions and amnions are both equal to the number of fetuses, unspecified
trimester.
Infection of obstetric surgical wound, unspecified.
Infection of obstetric surgical wound, superficial incisional site.
Infection of obstetric surgical wound, deep incisional site.
Infection of obstetric surgical wound, organ and space site.
Sepsis following an obstetrical procedure.
Infection of obstetric surgical wound, other surgical site.
Other doubling of uterus, unspecified.
Other complete doubling of uterus.
Other partial doubling of uterus.
Other doubling of uterus, other specified.
Encounter for screening for maternal depression.
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O30.833 ...............
O30.839 ...............
O86.00
O86.01
O86.02
O86.03
O86.04
O86.09
Q51.20
Q51.21
Q51.22
Q51.28
Z13.32
.................
.................
.................
.................
.................
.................
.................
.................
.................
.................
..................
We are inviting public comments on
our proposals.
In addition, as discussed in section
II.F.15. of the preamble of this proposed
rule, Table 6C.—Invalid Diagnosis
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Codes associated with this proposed
rule (which is available via the internet
on the CMS website at: https://
www.cms.hhs.gov/Medicare/Medicare-
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Fee-for-Service-Payment/
AcuteInpatientPPS/) lists the
diagnosis codes that are no longer
effective as of October 1, 2018. Included
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in this table are the following three ICD–
10–CM diagnosis codes currently listed
on the Diagnoses for Females Only edit
code list.
ICD–10–CM
code
F53 .......................
O86.00 .................
Q51.20 .................
Code description
Puerperal psychosis.
Infection of obstetric surgical wound.
Other doubling of uterus, unspecified.
Because these three ICD–10–CM
diagnosis codes will no longer be
effective as of October 1, 2018, we are
proposing to remove them from the
Diagnoses for Females Only edit code
list under the Sex Conflict edit. We are
inviting public comments on our
proposal.
(2) Procedures for Females Only Edit
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6B.—New Procedure Codes associated
with this proposed rule (which is
available via the Internet on the CMS
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
ICD–10–CM code
0UY90Z0 ..............
0UY90Z1 ..............
0UY90Z2 ..............
Code description
Transplantation of uterus, allogeneic, open approach.
Transplantation of uterus, syngeneic, open approach.
Transplantation of uterus, zooplastic, open approach.
We also are proposing to continue to
include the existing procedure codes
currently listed under the Procedures
for Females Only edit code list. We are
inviting public comments on our
proposals.
(3) Diagnoses for Males Only Edit
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6A.—New Diagnosis Codes associated
with this proposed rule (which is
available via the Internet on the CMS
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html) lists the new diagnosis
codes that have been approved to date,
which will be effective with discharges
ICD–10–CM
code
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N35.016
N35.116
N35.811
N35.812
N35.813
N35.814
N35.816
N35.819
N35.911
N35.912
N35.913
N35.914
N35.916
N35.919
N99.116
R93.811
R93.812
R93.813
R93.819
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
................
occurring on and after October 1, 2018.
The following table lists the new
diagnosis codes that are associated with
conditions consistent with the male sex.
We are proposing to add these ICD–10–
CM diagnosis codes to the Diagnoses for
Males Only edit code list under the Sex
Conflict edit.
Code description
Post-traumatic urethral stricture, male, overlapping sites.
Postinfective urethral stricture, not elsewhere classified, male, overlapping sites.
Other urethral stricture, male, meatal.
Other urethral bulbous stricture, male.
Other membranous urethral stricture, male.
Other anterior urethral stricture, male, anterior.
Other urethral stricture, male, overlapping sites.
Other urethral stricture, male, unspecified site.
Unspecified urethral stricture, male, meatal.
Unspecified bulbous urethral stricture, male.
Unspecified membranous urethral stricture, male.
Unspecified anterior urethral stricture, male.
Unspecified urethral stricture, male, overlapping sites.
Unspecified urethral stricture, male, unspecified site.
Postprocedural urethral stricture, male, overlapping sites.
Abnormal radiologic findings on diagnostic imaging of right testicle.
Abnormal radiologic findings on diagnostic imaging of left testicle.
Abnormal radiologic findings on diagnostic imaging of testicles, bilateral.
Abnormal radiologic findings on diagnostic imaging of unspecified testicle.
We also are proposing to continue to
include the existing diagnosis codes
currently listed under the Diagnoses for
Males Only edit code list. We are
inviting public comments on our
proposals.
VerDate Sep<11>2014
index.html) lists the procedure codes
that have been approved to date, which
will be effective with discharges
occurring on and after October 1, 2018.
We are proposing to add the three ICD–
10–PCS procedure codes in the
following table describing procedures
associated with the female sex to the
Procedures for Females Only edit code
list.
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c. Manifestation Code as Principal
Diagnosis Edit
In the ICD–10–CM classification
system, manifestation codes describe
the manifestation of an underlying
disease, not the disease itself and,
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therefore, should not be used as a
principal diagnosis.
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6A.—New Diagnosis Codes associated
with this proposed rule (which is
available via the Internet on the CMS
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website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html) lists the new diagnosis
codes that have been approved to date
which will be effective with discharges
occurring on and after October 1, 2018.
Included in this table are ICD–10–CM
diagnosis codes K82.A1 (Gangrene of
gallbladder in cholecystitis) and K82.A2
(Perforation of gallbladder in
cholecystitis). We are proposing to add
these two ICD–10–CM diagnosis codes
to the Manifestation Code as Principal
Diagnosis edit code list because the type
of cholecystitis would be required to be
reported first. We also are proposing to
continue to include the existing
diagnosis codes currently listed under
the Manifestation Code as Principal
Diagnosis edit code list. We are inviting
public comments on our proposals.
d. Questionable Admission Edit
In the MCE, some diagnoses are not
usually sufficient justification for
admission to an acute care hospital. For
example, if a patient is assigned ICD–
10–CM diagnosis code R03.0 (Elevated
blood pressure reading, without
diagnosis of hypertension), the patient
would have a questionable admission
because an elevated blood pressure
reading is not normally sufficient
justification for admission to a hospital.
As discussed in section II.F.10. of the
preamble of this proposed rule, we are
proposing several modifications to the
MS–DRGs under MDC 14 (Pregnancy,
Childbirth and the Puerperium). One
aspect of these proposed modifications
involves the GROUPER logic for the
cesarean section and vaginal delivery
MS–DRGs. We refer readers to section
II.F.10. of the preamble of this proposed
rule for a detailed discussion of the
proposals regarding these MS–DRG
modifications under MDC 14 and the
relation to the MCE.
If a patient presents to the hospital
and either a cesarean section or a
vaginal delivery occurs, it is expected
that, in addition to the specific type of
delivery code, an outcome of delivery
code is also assigned and reported on
the claim. The outcome of delivery
codes are ICD–10–CM diagnosis codes
that are to be reported as secondary
diagnoses as instructed in Section
I.C.15.b.5 of the ICD–10–CM Official
Guidelines for Coding and Reporting
which states: ‘‘A code from category
Z37, Outcome of delivery, should be
included on every maternal record
when a delivery has occurred. These
codes are not to be used on subsequent
records or on the newborn record.’’
Therefore, to encourage accurate coding
and appropriate MS–DRG assignment in
alignment with the proposed
modifications to the delivery MS–DRGs,
we are proposing to create a new
‘‘Questionable Obstetric Admission
Edit’’ under the Questionable
Admission edit to read as follows:
20233
10D07Z5 Extraction of Products of
Conception, High Forceps, Via Natural or
Artificial Opening
10D07Z6 Extraction of Products of
Conception, Vacuum, Via Natural or
Artificial Opening
10D07Z7 Extraction of Products of
Conception, Internal Version, Via
Natural or Artificial Opening
10D07Z8 Extraction of Products of
Conception, Other, Via Natural or
Artificial Opening
10D17Z9 Manual Extraction of Products of
Conception, Retained, Via Natural or
Artificial Opening
10D18Z9 Manual Extraction of Products of
Conception, Retained, Via Natural or
Artificial Opening Endoscopic
10E0XZZ Delivery of Products of
Conception, External Approach
Secondary diagnosis code list for outcome of
delivery
Procedure code list for cesarean section
10D00Z0 Extraction of Products of
Conception, High, Open Approach
10D00Z1 Extraction of Products of
Conception, Low, Open Approach
10D00Z2 Extraction of Products of
Conception, Extraperitoneal, Open
Approach
Z37.0 Single live birth
Z37.1 Single stillbirth
Z37.2 Twins, both liveborn
Z37.3 Twins, one liveborn and one stillborn
Z37.4 Twins, both stillborn
Z37.50 Multiple births, unspecified, all
liveborn
Z37.51 Triplets, all liveborn
Z37.52 Quadruplets, all liveborn
Z37.53 Quintuplets, all liveborn
Z37.54 Sextuplets, all liveborn
Z37.59 Other multiple births, all liveborn
Z37.60 Multiple births, unspecified, some
liveborn
Z37.61 Triplets, some liveborn
Z37.62 Quadruplets, some liveborn
Z37.63 Quintuplets, some liveborn
Z37.64 Sextuplets, some liveborn
Z37.69 Other multiple births, some liveborn
Z37.7 Other multiple births, all stillborn
Z37.9 Outcome of delivery, unspecified’’
Procedure code list for vaginal delivery
10D07Z3 Extraction of Products of
Conception, Low Forceps, Via Natural or
Artificial Opening
10D07Z4 Extraction of Products of
Conception, Mid Forceps, Via Natural or
Artificial Opening
We are proposing that the three ICD–
10–PCS procedure codes listed in the
following table would be used to
establish the list of codes for the
proposed Questionable Obstetric
Admission edit logic for cesarean
section.
‘‘b. Questionable obstetric admission
ICD–10–PCS procedure codes describing a
cesarean section or vaginal delivery are
considered to be a questionable
admission except when reported with a
corresponding secondary diagnosis code
describing the outcome of delivery.
ICD–10–PCS PROCEDURE CODES FOR CESAREAN SECTION UNDER THE PROPOSED QUESTIONABLE OBSTETRIC
ADMISSION EDIT CODE LIST IN THE MCE
ICD–10–CM
code
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10D00Z0 ..............
10D00Z1 ..............
10D00Z2 ..............
Code description
Extraction of products of conception, high, open approach.
Extraction of products of conception, low, open approach.
Extraction of products of conception, extraperitoneal, open approach.
We are proposing that the nine ICD–
10–PCS procedure codes listed in the
following table would be used to
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proposed new Questionable Obstetric
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Admission edit logic for vaginal
delivery.
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ICD–10–PCS PROCEDURE CODES FOR VAGINAL DELIVERY UNDER THE PROPOSED QUESTIONABLE OBSTETRIC
ADMISSION EDIT CODE LIST IN THE MCE
ICD–10–CM
code
10D07Z3
10D07Z4
10D07Z5
10D07Z6
10D07Z7
10D07Z8
10D17Z9
10D18Z9
10E0XZZ
..............
..............
..............
..............
..............
..............
..............
..............
..............
Code description
Extraction of products of conception, low forceps, via natural or artificial opening.
Extraction of products of conception, mid forceps, via natural or artificial opening.
Extraction of products of conception, high forceps, via natural or artificial opening.
Extraction of products of conception, vacuum, via natural or artificial opening.
Extraction of products of conception, internal version, via natural or artificial opening.
Extraction of products of conception, other, via natural or artificial opening.
Manual extraction of products of conception, retained, via natural or artificial opening.
Manual extraction of products of conception, retained, via natural or artificial opening.
Delivery of products of conception, external approach.
We are proposing that the 19 ICD–10–
CM diagnosis codes listed in the
following table would be used to
establish the list of secondary diagnosis
codes for the proposed new
Questionable Obstetric Admission edit
logic for outcome of delivery.
ICD–10–CM SECONDARY DIAGNOSIS CODES FOR OUTCOME OF DELIVERY UNDER THE PROPOSED QUESTIONABLE
OBSTETRIC ADMISSION EDIT CODE LIST IN THE MCE
ICD–10–CM
code
Z37.0 ....................
Z37.1 ....................
Z37.2 ....................
Z37.3 ....................
Z37.4 ....................
Z37.50 ..................
Z37.51 ..................
Z37.52 ..................
Z37.53 ..................
Z37.54 ..................
Z37.59 ..................
Z37.60 ..................
Z37.61 ..................
Z37.62 ..................
Z37.63 ..................
Z37.64 ..................
Z37.69 ..................
Z37.7 ....................
Z37.9 ....................
Code description
Single live birth.
Single stillbirth.
Twins, both liveborn.
Twins, one liveborn and one stillborn.
Twins, both stillborn.
Multiple births, unspecified, all liveborn.
Triplets, all liveborn.
Quadruplets, all liveborn.
Quintuplets, all liveborn.
Sextuplets, all liveborn.
Other multiple births, all liveborn.
Multiple births, unspecified, some liveborn.
Triplets, some liveborn.
Quadruplets, some liveborn.
Quintuplets, some liveborn.
Sextuplets, some liveborn.
Other multiple births, some liveborn.
Other multiple births, all liveborn.
Outcome of delivery, unspecified.
We are inviting public comments on
our proposal to create this new
Questionable Obstetric Admission edit.
We also are inviting public comments
on the lists of diagnosis and procedure
codes that we are proposing to include
for this edit.
daltland on DSKBBV9HB2PROD with PROPOSALS2
e. Unacceptable Principal Diagnosis Edit
In the MCE, there are select codes that
describe a circumstance which
influences an individual’s health status,
but does not actually describe a current
illness or injury. There also are codes
that are not specific manifestations, but
may be due to an underlying cause.
These codes are considered
unacceptable as a principal diagnosis. In
limited situations, there are a few codes
on the MCE Unacceptable Principal
Diagnosis edit code list that are
considered ‘‘acceptable’’ when a
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specified secondary diagnosis is also
coded and reported on the claim.
As discussed in section II.F.9. of the
preamble of this proposed rule, ICD–10–
CM diagnosis codes Z49.02 (Encounter
for fitting and adjustment of peritoneal
dialysis catheter), Z49.31 (Encounter for
adequacy testing for hemodialysis), and
Z49.32 (Encounter for adequacy testing
for peritoneal dialysis) are currently on
the Unacceptable Principal Diagnosis
edit code list. We are proposing to add
diagnosis code Z49.01 (Encounter for
fitting and adjustment of extracorporeal
dialysis catheter) to the Unacceptable
Principal Diagnosis edit code list
because this is an encounter code that
would more likely be performed in an
outpatient setting.
As discussed in section II.F.15. of the
preamble of this proposed rule, Table
6C.—Invalid Diagnosis Codes associated
with this proposed rule (which is
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available via the Internet on the CMS
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html) lists the diagnosis codes
that are no longer effective as of October
1, 2018. As previously noted, included
in this table is an ICD–10–CM diagnosis
code Z13.4 (Encounter for screening for
certain developmental disorders in
childhood) which is currently listed on
the Unacceptable Principal diagnoses
Category edit code list. We are
proposing to remove this code from the
Unacceptable Principal Diagnoses
Category edit code list.
We also are proposing to continue to
include the other existing diagnosis
codes currently listed under the
Unacceptable Principal Diagnosis edit
code list. We are inviting public
comments on our proposals.
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f. Future Enhancement
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In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38053 through 38054), we
noted the importance of ensuring
accuracy of the coded data from the
reporting, collection, processing,
coverage, payment, and analysis
aspects. We have engaged a contractor
to assist in the review of the limited
coverage and noncovered procedure
edits in the MCE that may also be
present in other claims processing
systems that are utilized by our MACs.
The MACs must adhere to criteria
specified within the National Coverage
Determinations (NCDs) and may
implement their own edits in addition
to what are already incorporated into
the MCE, resulting in duplicate edits.
The objective of this review is to
identify where duplicate edits may exist
and to determine what the impact might
be if these edits were to be removed
from the MCE.
We have noted that the purpose of the
MCE is to ensure that errors and
inconsistencies in the coded data are
recognized during Medicare claims
processing. We are considering whether
the inclusion of coverage edits in the
MCE necessarily aligns with that
specific goal because the focus of
coverage edits is on whether or not a
particular service is covered for
payment purposes and not whether it
was coded correctly.
As we continue to evaluate the
purpose and function of the MCE with
respect to ICD–10, we encourage public
input for future discussion. As we
discussed in the FY 2018 IPPS/LTCH
PPS final rule, we recognize a need to
further examine the current list of edits
and the definitions of those edits. We
continue to encourage public comments
on whether there are additional
concerns with the current edits,
including specific edits or language that
should be removed or revised, edits that
should be combined, or new edits that
should be added to assist in detecting
errors or inaccuracies in the coded data.
Comments should be directed to the
MS–DRG Classification Change
Mailbox located at:
MSDRGClassificationChange@
cms.hhs.gov by November 1, 2018 for
FY 2020.
14. 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
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decision rule within the GROUPER by
which these cases are assigned to a
single MS–DRG. The surgical hierarchy,
an ordering of surgical classes from
most resource-intensive to least
resource-intensive, performs that
function. Application of this hierarchy
ensures that cases involving multiple
surgical procedures are assigned to the
MS–DRG associated with the most
resource-intensive surgical class.
A surgical class can be composed of
one or more MS–DRGs. For example, in
MDC 11, the surgical class ‘‘kidney
transplant’’ consists of a single MS–DRG
(MS–DRG 652) and the class ‘‘major
bladder procedures’’ consists of three
MS–DRGs (MS–DRGs 653, 654, and
655). Consequently, in many cases, the
surgical hierarchy has an impact on
more than one MS–DRG. The
methodology for determining the most
resource–intensive surgical class
involves weighting the average
resources for each MS–DRG by
frequency to determine the weighted
average resources for each surgical class.
For example, assume surgical class A
includes MS–DRGs 001 and 002 and
surgical class B includes MS–DRGs 003,
004, and 005. Assume also that the
average costs of MS–DRG 001 are higher
than that of MS–DRG 003, but the
average costs of MS–DRGs 004 and 005
are higher than the average costs of MS–
DRG 002. To determine whether
surgical class A should be higher or
lower than surgical class B in the
surgical hierarchy, we would weigh the
average costs of each MS–DRG in the
class by frequency (that is, by the
number of cases in the MS–DRG) to
determine average resource
consumption for the surgical class. The
surgical classes would then be ordered
from the class with the highest average
resource utilization to that with the
lowest, with the exception of ‘‘other
O.R. procedures’’ as discussed in this
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.
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20235
procedures’’ surgical class is uniformly
ordered last in the surgical hierarchy of
each MDC in which it occurs, regardless
of the fact that the average costs for the
MS–DRG or MS–DRGs in that surgical
class may be higher than those for other
surgical classes in the MDC. The ‘‘other
O.R. procedures’’ class is a group of
procedures that are only infrequently
related to the diagnoses in the MDC, but
are still occasionally performed on
patients with cases assigned to the MDC
with these diagnoses. Therefore,
assignment to these surgical classes
should only occur if no other surgical
class more closely related to the
diagnoses in the MDC is appropriate.
A second example occurs when the
difference between the average costs for
two surgical classes is very small. We
have found that small differences
generally do not warrant reordering of
the hierarchy because, as a result of
reassigning cases on the basis of the
hierarchy change, the average costs are
likely to shift such that the
higher-ordered surgical class has lower
average costs than the class ordered
below it.
Based on the changes that we are
proposing to make in this FY 2019 IPPS/
LTCH PPS proposed rule, as discussed
in section II.F.10. of the preamble of this
proposed rule, we are proposing to
revise the surgical hierarchy for MDC 14
(Pregnancy, Childbirth & the
Puerperium) as follows: In MDC 14, we
are proposing to delete MS–DRGs 765
and 766 (Cesarean Section with and
without CC/MCC, respectively) and
MS–DRG 767 (Vaginal Delivery with
Sterilization and/or D&C) from the
surgical hierarchy. We are proposing to
sequence proposed new MS–DRGs 783,
784, and 785 (Cesarean Section with
Sterilization with MCC, with CC and
without CC/MCC, respectively) above
proposed new MS–DRGs 786, 787, and
788 (Cesarean Section without
Sterilization with MCC, with CC and
without CC/MCC, respectively). We are
proposing to sequence proposed new
MS–DRGs 786, 787, and 788 (Cesarean
Section without Sterilization with MCC,
with CC and without CC/MCC,
respectively) above MS–DRG 768
(Vaginal Delivery with O.R. Procedure
Except Sterilization and/or D&C). We
also are proposing to sequence proposed
new MS–DRGs 796, 797, and 798
(Vaginal Delivery with Sterilization/
D&C with MCC, with CC and without
CC/MCC, respectively) below MS–DRG
768 and above MS–DRG 770 (Abortion
with D&C, Aspiration Curettage or
Hysterotomy). Finally, we are proposing
to sequence proposed new MS–DRGs
817, 818, and 819 (Other Antepartum
Diagnoses with O.R. procedure with
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MCC, with CC and without CC/MCC,
respectively) below MS–DRG 770 and
above MS–DRG 769 (Postpartum and
Post Abortion Diagnoses with O.R.
Procedure). Our proposals for Appendix
D MS–DRG Surgical Hierarchy by MDC
and MS–DRG of the ICD–10 MS–DRG
Definitions Manual Version 36 are
illustrated in the following table.
PROPOSED SURGICAL HIERARCHY: MDC 14
[Pregnancy, childbirth and the puerperium]
Proposed
Proposed
MS–DRG
Proposed
MS–DRG
Proposed
MS–DRG
New MS–DRGs 783–785 ........................................................
New MS–DRGs 786–788 ........................................................
768 ...........................................................................................
New MS–DRGs 796–798 ........................................................
770 ...........................................................................................
New MS–DRGs 817–819 ........................................................
769 ...........................................................................................
We are inviting public comments on
our proposals.
As with other MS–DRG related issues,
we encourage commenters to submit
requests to examine ICD–10 claims
pertaining to the surgical hierarchy via
the CMS MS-DRG Classification Change
Request Mailbox located at:
MSDRGClassificationChange@
cms.hhs.gov by November 1, 2018 for
FY 2020 consideration.
15. Proposed Changes to the MS–DRG
Diagnosis Codes for FY 2019
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a. Background of the CC List and the CC
Exclusions List
Under the IPPS MS–DRG
classification system, we have
developed a standard list of diagnoses
that are considered CCs. Historically, we
developed this list using physician
panels that classified each diagnosis
code based on whether the diagnosis,
when present as a secondary condition,
would be considered a substantial
complication or comorbidity. A
substantial complication or comorbidity
was defined as a condition that, because
of its presence with a specific principal
diagnosis, would cause an increase in
the length-of-stay by at least 1 day in at
least 75 percent of the patients.
However, depending on the principal
diagnosis of the patient, some diagnoses
on the basic list of complications and
comorbidities may be excluded if they
are closely related to the principal
diagnosis. In FY 2008, we evaluated
each diagnosis code to determine its
impact on resource use and to
determine the most appropriate CC
subclassification (non-CC, CC, or MCC)
assignment. We refer readers to sections
II.D.2. and 3. of the preamble of the FY
2008 IPPS final rule with comment
period for a discussion of the refinement
of CCs in relation to the MS-DRGs we
adopted for FY 2008 (72 FR 47152
through 47171).
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Cesarean Section with Sterilization.
Cesarean Section without Sterilization.
Vaginal Delivery with O.R. Procedures.
Vaginal Delivery with Sterilization/D&C.
Abortion with D&C, Aspiration Curettage or Hysterotomy.
Other Antepartum Diagnoses with O.R. Procedure.
Postpartum and Post Abortion Diagnoses with O.R. Procedure.
b. Proposed Additions and Deletions to
the Diagnosis Code Severity Levels for
FY 2019
The following tables identifying the
proposed additions and deletions to the
MCC severity levels list and the
proposed additions and deletions to the
CC severity levels list for FY 2019 are
available via the Internet on the CMS
website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html.
Table 6I.1—Proposed Additions to the
MCC List—FY 2019;
Table 6I.2—Proposed Deletions to the
MCC List—FY 2019;
Table 6J.1—Proposed Additions to the
CC List—FY 2019; and
Table 6J.2—Proposed Deletions to the
CC List—FY 2019.
We are inviting public comments on
our proposed severity level designations
for the diagnosis codes listed in Table
6I.1. and Table 6J.1. We note that, for
Table 6I.2. and Table 6J.2., the proposed
deletions are a result of code
expansions, with the exception of
diagnosis codes B20 and J80, which are
the result of proposed severity level
designation changes. Therefore, the
diagnosis codes on these lists will no
longer be valid codes, effective FY 2019.
We refer readers to the Tables 6I.1,
6I.2, 6J.1, and 6J.2 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/.
c. Principal Diagnosis Is Its Own CC or
MCC
In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38060), we provided the
public with notice of our plans to
conduct a comprehensive review of the
CC and MCC lists for FY 2019. In the FY
2018 IPPS/LTCH PPS final rule (82 FR
38056 through 38057), we also finalized
our proposal to maintain the existing
lists of principal diagnosis codes in
Table 6L.—Principal Diagnosis Is Its
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Own MCC List and Table 6M.—
Principal Diagnosis Is Its Own CC List
for FY 2018, without any changes to the
existing lists, noting our plans to
conduct a comprehensive review of the
CC and MCC lists for FY 2019 (82 FR
38060). We stated that having multiple
lists for CC and MCC diagnoses when
reported as a principal and/or secondary
diagnosis may not provide an accurate
representation of resource utilization for
the MS–DRGs.
We also stated that the purpose of the
Principal Diagnosis Is Its Own CC or
MCC Lists was to ensure consistent MS–
DRG assignment between the ICD–9–CM
and ICD–10 MS–DRGs. The Principal
Diagnosis Is Its Own CC or MCC Lists
were developed for the FY 2016
implementation of the ICD–10 version
of the MS–DRGs to facilitate replication
of the ICD–9–CM MS–DRGs. As part of
our efforts to replicate the ICD–9–CM
MS–DRGs, we implemented logic that
may have increased the complexity of
the MS–DRG assignment hierarchy and
altered the format of the ICD–10 MS–
DRG Definitions Manual. Two examples
of workarounds used to facilitate
replication are the proliferation of
procedure clusters in the surgical MS–
DRGs and the creation of the Principal
Diagnosis Is Its Own CC or MCC Lists
special logic.
The following paragraph was added to
the Version 33 ICD–10 MS–DRG
Definitions Manual to explain the use of
the Principal Diagnosis Is Its Own CC or
MCC Lists: ‘‘A few ICD–10–CM
diagnosis codes express conditions that
are normally coded in ICD–9–CM using
two or more ICD–9–CM diagnosis codes.
In the interest of ensuring that the ICD–
10 MS–DRGs Version 33 places a
patient in the same DRG regardless
whether the patient record were to be
coded in ICD–9–CM or ICD–10–CM/
PCS, whenever one of these ICD–10–CM
combination codes is used as principal
diagnosis, the cluster of ICD–9–CM
codes that would be coded on an ICD–
9–CM record is considered. If one of the
ICD–9–CM codes in the cluster is a CC
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or MCC, then the single ICD–10–CM
combination code used as a principal
diagnosis must also imply the CC or
MCC that the ICD–9–CM cluster would
have presented. The ICD–10–CM
diagnoses for which this implication
must be made are listed here.’’ Versions
34 and 35 of the ICD–10 MS–DRG
Definitions Manual also include this
special logic for the MS–DRGs.
The Principal Diagnosis Is Its Own CC
or MCC Lists were developed in the
absence of ICD–10 coded data by
mapping the ICD–9–CM diagnosis codes
to the new ICD–10–CM combination
codes. CMS has historically used
clinical judgment combined with data
analysis to assign a principal diagnosis
describing a complex or severe
condition to the appropriate DRG or
MS–DRG. The initial ICD–10 version of
the MS-DRGs replicated from the ICD–
9 version can now be evaluated using
clinical judgment combined with ICD–
10 coded data because it is no longer
necessary to replicate MS–DRG
assignment across the ICD–9 and ICD–
10 versions of the MS–DRGs for
purposes of calculating relative weights.
Now that ICD–10 coded data are
available, in addition to using the data
for calculating relative weights, ICD–10
data can be used to evaluate the
effectiveness of the special logic for
assigning a severity level to a principal
diagnosis, as an indicator of resource
utilization. To evaluate the effectiveness
of the special logic, we have conducted
analysis of the ICD–10 coded data
combined with clinical review to
determine whether to propose to keep
the special logic for assigning a severity
level to a principal diagnosis, or to
propose to remove the special logic and
use other available means of assigning a
complex principal diagnosis to the
appropriate MS-DRG.
Using claims data from the September
2017 update of the FY 2017 MedPAR
file, we employed the following method
to determine the impact of removing the
special logic used in the current Version
35 GROUPER to process claims
containing a code on the Principal
Diagnosis Is Its Own CC or MCC Lists.
Edits and cost estimations used for
relative weight calculations were
applied, resulting in 9,070,073 IPPS
claims analyzed for this special logic
impact evaluation. We refer readers to
section II.G. of the preamble of this
proposed rule for further information
regarding the methodology for
calculation of the proposed relative
weights.
First, we identified the number of
cases potentially impacted by the
special logic. We identified 310,184
cases reporting a principal diagnosis on
the Principal Diagnosis Is Its Own CC or
MCC lists. Of the 310,184 total cases
that reported a principal diagnosis code
on the Principal Diagnosis Is Its Own CC
or MCC Lists, 204,749 cases also
reported a secondary diagnosis code at
the same severity level or higher
severity level, and therefore the special
logic had no impact on MS–DRG
assignment. However, of the 310,184
total cases, there were 105,435 cases
that did not report a secondary
diagnosis code at the same severity level
20237
or higher severity level, and therefore
the special logic could potentially
impact MS–DRG assignment, depending
on the specific severity leveling
structure of the base DRG.
Next, we removed the special logic in
the GROUPER that is used for
processing claims reporting a principal
diagnosis on the Principal Diagnosis Is
Its Own CC or MCC Lists, thereby
creating a Modified Version 35
GROUPER. Using this Modified Version
35 GROUPER, we reprocessed the
105,435 claims for which the principal
diagnosis code was the sole source of a
MCC or CC on the case, to obtain data
for comparison showing the effect of
removing the special logic.
After removing the special logic in the
Version 35 GROUPER for processing
claims containing diagnosis codes on
the Principal Diagnosis Is Its Own CC or
MCC Lists, and reprocessing the claims
using the Modified Version 35
GROUPER software, we found that
18,596 (6 percent) of the 310,184 cases
reporting a principal diagnosis on the
Principal Diagnosis Is Its Own CC or
MCC Lists resulted in a different MS–
DRG assignment. Overall, the number of
claims impacted by removal of the
special logic (18,596) represents 0.2
percent of the 9,070,073 IPPS claims
analyzed.
Below we provide a summary of the
steps that we followed for the analysis
performed.
Step 1. We analyzed 9,070,073 claims
to determine the number of cases
impacted by the special logic.
WITH SPECIAL LOGIC—9,070,073 CLAIMS ANALYZED
Number of cases reporting a principal diagnosis from the Principal Diagnosis Is Its Own CC/MCC lists (special logic) .................
Number of cases reporting an additional CC/MCC secondary diagnosis code at or above the level of the designated severity
level of the principal diagnosis .........................................................................................................................................................
Number of cases not reporting an additional CC/MCC secondary diagnosis code ...........................................................................
Step 2. We removed special logic from
GROUPER and created a modified
GROUPER.
310,184
204,749
105,435
Step 3. We reprocessed 105,435
claims with modified GROUPER.
WITHOUT SPECIAL LOGIC—105,435 CLAIMS ANALYZED
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Number of cases reporting a principal diagnosis from the Principal Diagnosis Is Its Own CC/MCC lists .........................................
Number of cases resulting in different MS–DRG assignment ............................................................................................................
To estimate the overall financial
impact of removing the special logic
from the GROUPER, we calculated the
aggregate change in estimated payment
for the MS–DRGs by comparing average
costs for each MS–DRG affected by the
change, before and after removing the
special logic. Before removing the
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special logic in the Version 35
GROUPER, the cases impacted by the
special logic had an estimated average
payment of $58 million above the
average costs for all the MS–DRGs to
which the claim was originally
assigned. After removing the special
logic in the Version 35 GROUPER, the
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310,184
18,596
18,596 cases impacted by the special
logic had an estimated average payment
of $39 million below the average costs
for the newly assigned MS–DRGs.
We performed regression analysis to
compare the proportion of variance in
the MS–DRGs with and without the
special logic. The results of the
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regression analysis showed a slight
decrease in variance when the logic was
removed. While the decrease itself was
not statistically significant (an Rsquared of 36.2603 percent after the
special logic was removed, compared
with an R-squared of 36.2501 percent in
the current version 35 GROUPER), we
note that the proportion of variance
across the MS–DRGs essentially stayed
the same, and certainly did not increase,
when the special logic was removed.
We further examined the 18,596
claims that were impacted by the
special logic in the GROUPER for
processing claims containing a code on
the Principal Diagnosis Is Its Own CC or
MCC Lists. The 18,596 claims were
analyzed by the principal diagnosis
code and the MS–DRG assigned,
resulting in 588 principal diagnosis and
MS–DRG combinations or subsets. Of
the 588 subsets of cases that utilized the
special logic, 556 of the 588 subsets (95
percent) had fewer than 100 cases, 529
of the 588 subsets (90 percent) had
fewer than 50 cases, and 489 of the 588
subsets (83 percent) had fewer than 25
cases.
We examined the 32 subsets of cases
(5 percent of the 588 subsets) that
utilized the special logic and had 100 or
more cases. Of the 32 subsets of cases,
18 (56 percent) are similar in terms of
average costs and length of stay to the
MS–DRG assignment that results when
the special logic is removed, and 14 of
the 32 subsets of cases (44 percent) are
similar in terms of average costs and
length of stay to the MS–DRG
assignment that results when the special
logic is utilized.
The table below contains examples of
four subsets of cases that utilize the
special logic, comparing average length
of stay and average costs between two
MS–DRGs within a base DRG,
corresponding to the MS–DRG assigned
when the special logic is removed and
the MS–DRG assigned when the special
logic is utilized. All four subsets of
cases involve the principal diagnosis
code E11.52 (Type 2 diabetes mellitus
with diabetic peripheral angiopathy
with gangrene). There are four subsets of
cases in this example because the
records involving the principal
diagnosis code E11.52 are assigned to
four different base DRGs, one medical
MS–DRG and three surgical MS-DRGs,
depending on the procedure code(s)
reported on the claim. All subsets of
cases contain more than 100 claims. In
three of the four subsets, the cases are
similar in terms of average length of stay
and average costs to the MS–DRG
assignment that results when the special
logic is removed, and in one of the four
subsets, the cases are similar in terms of
average length of stay and average costs
to the MS–DRG assignment that results
when the special logic is utilized.
As shown in the following table,
using ICD–10–CM diagnosis code
E11.52 (Type 2 diabetes mellitus with
diabetic peripheral angiopathy with
gangrene) as our example, the data
findings show four different MS–DRG
pairs for which code E11.52 was the
principal diagnosis on the claim and
where the special logic impacted MS–
DRG assignment. For the first MS–DRG
pair, we examined MS–DRGs 240 and
241 (Amputation for Circulatory System
Disorders Except Upper Limb and Toe
with CC and without CC/MCC,
respectively). We found 436 cases
reporting diagnosis code E11.52 as the
principal diagnosis, with an average
length of stay of 5.5 days and average
costs of $11,769. These 436 cases are
assigned to MS–DRG 240 with the
special logic utilized, and assigned to
MS–DRG 241 with the special logic
removed. The total number of cases
reported in MS–DRG 240 was 7,675,
with an average length of stay of 8.3
days and average costs of $17,876. The
total number of cases reported in MS–
DRG 241 was 778, with an average
length of stay of 5.0 days and average
costs of $10,882. The 436 cases are more
similar to MS–DRG 241 in terms of
length of stay and average cost and less
similar to MS–DRG 240.
For the second MS–DRG pair, we
examined MS–DRGs 256 and 257
(Upper Limb and Toe Amputation for
Circulatory System Disorders with CC
and without CC/MCC, respectively). We
found 193 cases reporting ICD–10–CM
diagnosis code E11.52 as the principal
diagnosis, with an average length of stay
of 4.2 days and average costs of $8,478.
These 193 cases are assigned to MS–
DRG 256 with the special logic utilized,
and assigned to MS–DRG 257 with the
special logic removed. The total number
of cases reported in MS–DRG 256 was
2,251, with an average length of stay of
6.1 days and average costs of $11,987.
The total number of cases reported in
MS–DRG 257 was 115, with an average
length of stay of 4.6 days and average
costs of $7,794. These 193 cases are
more similar to MS–DRG 257 in terms
of average length of stay and average
costs and less similar to MS–DRG 256.
For the third MS–DRG pair, we
examined MS–DRGs 300 and 301
(Peripheral Vascular Disorders with CC
and without CC/MCC, respectively). We
found 185 cases reporting ICD–10–CM
diagnosis code E11.52 as the principal
diagnosis, with an average length of stay
of 3.6 days and average costs of $5,981.
These 185 cases are assigned to MS–
DRG 300 with the special logic utilized,
and assigned to MS–DRG 301 with the
special logic removed. The total number
of cases reported in MS–DRG 300 was
29,327, with an average length of stay of
4.1 days and average costs of $7,272.
The total number of cases reported in
MS–DRG 301 was 9,611, with an
average length of stay of 2.8 days and
average costs of $5,263. These 185 cases
are more similar to MS–DRG 301 in
terms of average length of stay and
average costs and less similar to MS–
DRG 300.
For the fourth MS–DRG pair, we
examined MS–DRGs 253 and 254 (Other
Vascular Procedures with CC and
without CC/MCC, respectively). We
found 225 cases reporting diagnosis
code E11.52 as the principal diagnosis,
with an average length of stay of 5.2
days and average costs of $17,901.
These 225 cases are assigned to MS–
DRG 253 with the special logic utilized,
and assigned to MS–DRG 254 with the
special logic removed. The total number
of cases reported in MS–DRG 253 was
25,714, with an average length of stay of
5.4 days and average costs of $18,986.
The total number of cases reported in
MS–DRG 254 was 12,344, with an
average length of stay of 2.8 days and
average costs of $13,287. Unlike the
previous three MS–DRG pairs, these 225
cases are more similar to MS–DRG 253
in terms of average length of stay and
average costs and less similar to MS–
DRG 254.
MS–DRG PAIRS FOR PRINCIPAL DIAGNOSIS ICD–10–CM CODE E11.52 WITH AND WITHOUT SPECIAL MS–DRG LOGIC
Number
of cases
MS–DRG
MS–DRGs 240 and 241—Special logic impacted cases with ICD–10–CM code E11.52 as
principal diagnosis ....................................................................................................................
MS–DRG 240—All cases ............................................................................................................
MS–DRG 241—All cases ............................................................................................................
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436
7,675
778
07MYP2
Average
length
of stay
Average
costs
5.5
8.3
5.0
$11,769
17,876
10,882
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MS–DRG PAIRS FOR PRINCIPAL DIAGNOSIS ICD–10–CM CODE E11.52 WITH AND WITHOUT SPECIAL MS–DRG LOGIC—
Continued
Number
of cases
MS–DRG
MS–DRGs 253 and 254—Special logic impacted cases with ICD–10–CM E11.52 as principal
diagnosis ..................................................................................................................................
MS–DRG 253—All cases ............................................................................................................
MS–DRG 254—All cases ............................................................................................................
MS–DRGs 256 and 257—Special logic impacted cases with ICD–10–CM E11.52 as principal
diagnosis ..................................................................................................................................
MS–DRG 256—All cases ............................................................................................................
MS–DRG 257—All cases ............................................................................................................
MS–DRGs 300 and 301—Special logic impacted cases with ICD–10–CM E11.52 as principal
diagnosis ..................................................................................................................................
MS–DRG 300—All cases ............................................................................................................
MS–DRG 301—All cases ............................................................................................................
daltland on DSKBBV9HB2PROD with PROPOSALS2
Based on our analysis of the data, we
believe that there may be more effective
indicators of resource utilization than
the Principal Diagnosis Is Its Own CC or
MCC Lists and the special logic used to
assign clinical severity to a principal
diagnosis. As stated earlier in this
discussion, it is no longer necessary to
replicate MS–DRG assignment across
the ICD–9 and ICD–10 versions of the
MS–DRGs. The available ICD–10 data
can now be used to evaluate other
indicators of resource utilization.
Therefore, as an initial
recommendation from the first phase in
our comprehensive review of the CC
and MCC lists, we are proposing to
remove the special logic in the
GROUPER for processing claims
containing a diagnosis code from the
Principal Diagnosis Is Its Own CC or
MCC Lists, and we are proposing to
delete the tables containing the lists of
principal diagnosis codes, Table 6L.—
Principal Diagnosis Is Its Own MCC List
and Table 6M.—Principal Diagnosis Is
Its Own CC List, from the ICD–10 MS–
DRG Definitions Manual for FY 2019.
We are inviting public comments on our
proposals.
d. Proposed CC Exclusions List for FY
2019
In the September 1, 1987 final notice
(52 FR 33143) concerning changes to the
DRG classification system, we modified
the GROUPER logic so that certain
diagnoses included on the standard list
of CCs would not be considered valid
CCs in combination with a particular
principal diagnosis. We created the CC
Exclusions List for the following
reasons: (1) To preclude coding of CCs
for closely related conditions; (2) to
preclude duplicative or inconsistent
coding from being treated as CCs; and
(3) to ensure that cases are appropriately
classified between the complicated and
uncomplicated DRGs in a pair.
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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.
In this proposed rule, for FY 2019, we
are proposing changes to the ICD–10
MS–DRGs Version 36 CC Exclusion List.
Therefore, we developed Table 6G.1.—
Proposed Secondary Diagnosis Order
Additions to the CC Exclusions List—
FY 2019; Table 6G.2.—Proposed
Principal Diagnosis Order Additions to
the CC Exclusions List—FY 2019; Table
6H.1.—Proposed Secondary Diagnosis
Order Deletions to the CC Exclusions
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Average
length
of stay
Average
costs
225
25,714
12,344
5.2
5.4
2.8
17,901
18,986
13,287
193
2,251
115
4.2
6.1
4.6
8,478
11,987
7,794
185
29,327
9,611
3.6
4.1
2.8
5,981
7,272
5,263
List—FY 2019; and Table 6H.2.—
Proposed Principal Diagnosis Order
Deletions to the CC Exclusions List—FY
2019. For Table 6G.1, each secondary
diagnosis code proposed for addition to
the CC Exclusion List is shown with an
asterisk and the principal diagnoses
proposed to exclude the secondary
diagnosis code are provided in the
indented column immediately following
it. For Table 6G.2, each of the principal
diagnosis codes for which there is a CC
exclusion is shown with an asterisk and
the conditions proposed for addition to
the CC Exclusion List that will not
count as a CC are provided in an
indented column immediately following
the affected principal diagnosis. For
Table 6H.1, each secondary diagnosis
code proposed for deletion from the CC
Exclusion List is shown with an asterisk
followed by the principal diagnosis
codes that currently exclude it. For
Table 6H.2, each of the principal
diagnosis codes is shown with an
asterisk and the proposed deletions to
the CC Exclusions List are provided in
an indented column immediately
following the affected principal
diagnosis. Tables 6G.1., 6G.2., 6H.1.,
and 6H.2. associated with this proposed
rule are available via the Internet on the
CMS website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html.
To identify new, revised and deleted
diagnosis and procedure codes, for FY
2019, we developed Table 6A.—New
Diagnosis Codes, Table 6B.—New
Procedure Codes, Table 6C.—Invalid
Diagnosis Codes, Table 6D.—Invalid
Procedure Codes, Table 6E.—Revised
Diagnosis Code Titles, and Table 6F.—
Revised Procedure Code Titles for this
proposed rule.
These tables are not published in the
Addendum to the proposed rule but are
available via the Internet on the CMS
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website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
as described in section VI. of the
Addendum to this proposed rule. As
discussed in section II.F.18. 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 process.
Therefore, although we publish the code
titles in the IPPS proposed and final
rules, they are not subject to comment
in the proposed or final rules.
In this FY 2019 IPPS/LTCH PPS
proposed rule, we are inviting public
comments on the MDC and MS–DRG
assignments for the new diagnosis and
procedure codes as set forth in Table
6A.—New Diagnosis Codes and Table
6B.—New Procedure Codes. In addition,
we are inviting public comments on the
proposed severity level designations for
the new diagnosis codes as set forth in
Table 6A. and the proposed O.R. status
for the new procedure codes as set forth
in Table 6B.
We are making available on the CMS
website at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
the following tables associated with this
proposed rule:
• Table 6A.—New Diagnosis Codes—
FY 2019;
• Table 6B.—New Procedure Codes—
FY 2019;
• Table 6C.—Invalid Diagnosis
Codes—FY 2019;
• Table 6D.—Invalid Procedure
Codes—FY 2019;
• Table 6E.—Revised Diagnosis Code
Titles—FY 2019;
• Table 6F.—Revised Procedure Code
Titles—FY 2019;
• Table 6G.1.—Proposed Secondary
Diagnosis Order Additions to the CC
Exclusions List—FY 2019;
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Code
Diagnosis
20:30 May 04, 2018
16. Comprehensive Review of CC List
for FY 2019
a. Overview of Comprehensive CC/MCC
Analysis
In the FY 2008 IPPS/LTCH PPS final
rule (72 FR 47159), we described our
process for establishing three different
levels of CC severity into which we
would subdivide the diagnosis codes.
The categorization of diagnoses as an
MCC, CC, or non-CC was accomplished
using an iterative approach in which
each diagnosis was evaluated to
determine the extent to which its
presence as a secondary diagnosis
resulted in increased hospital resource
use. We refer readers to the FY 2008
IPPS/LTCH PPS final rule (72 FR 47159)
for a complete discussion of our
approach. Since this comprehensive
analysis was completed for FY 2008, we
have evaluated diagnosis codes
individually when receiving requests to
change the severity level of specific
diagnosis codes. However, given the
Cnt1
Count (Cnt) is the number of patients
in each subset and C1, C2, and C3 are
a measure of the impact on resource use
of patients in each of the subsets. The
C1, C2, and C3 values are a measure of
the ratio of average costs for patients
with these conditions to the expected
average cost across all cases. The C1
value reflects a patient with no other
secondary diagnosis or with all other
secondary diagnoses that are non-CCs.
The C2 value reflects a patient with at
least one other secondary diagnosis that
is a CC but none that is a major CC. The
C3 value reflects a patient with at least
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• Table 6G.2.—Proposed Principal
Diagnosis Order Additions to the CC
Exclusions List—FY 2019;
• Table 6H.1.—Proposed Secondary
Diagnosis Order Deletions to the CC
Exclusions List—FY 2019;
• Table 6H.2.—Proposed Principal
Diagnosis Order Deletions to the CC
Exclusions List—FY 2019;
• Table 6I.1.—Proposed Additions to
the MCC List—FY 2019;
• Table 6I.2.—Proposed Deletions to
the MCC List—FY 2019;
• Table 6J.1.—Proposed Additions to
the CC List—FY 2019; and
• Table 6J.2.—Proposed Deletions to
the CC List—FY 2019.
We note that, as discussed in section
II.F.15.c. of the preamble of this
proposed rule, we are proposing to
delete Table 6L. and Table 6M. from the
ICD–10 MS–DRG Definitions Manual for
FY 2019.
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C1
Cnt2
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Value
Meaning
0 ..........
Significantly below expected value
for the non-CC subgroup.
Approximately equal to expected
value for the non-CC subgroup.
Approximately equal to expected
value for the CC subgroup.
Approximately equal to expected
value for the MCC subgroup.
Significantly above the expected
value for the MCC subgroup.
1 ..........
2 ..........
3 ..........
4 ..........
Each diagnosis for which Medicare
data were available was evaluated to
determine its impact on resource use
and to determine the most appropriate
CC subclass (non-CC, CC, or MCC)
assignment. In order to make this
determination, the average cost for each
subset of cases was compared to the
expected cost for cases in that subset.
The following format was used to
evaluate each diagnosis:
C2
one other secondary diagnosis that is a
major CC. A value close to 1.0 in the C1
field would suggest that the code
produces the same expected value as a
non-CC diagnosis. That is, average costs
for the case are similar to the expected
average costs for that subset and the
diagnosis is not expected to increase
resource usage. A higher value in the C1
(or C2 and C3) field suggests more
resource usage is associated with the
diagnosis and an increased likelihood
that it is more like a CC or major CC
than a non-CC. Thus, a value close to
2.0 suggests the condition is more like
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transition to ICD–10–CM and the
significant changes that have occurred
to diagnosis codes since this review, we
believe it is necessary to conduct a
comprehensive analysis once again. We
have begun this analysis and will
discuss our findings in future
rulemaking. We are currently using the
same methodology utilized in FY 2008
and described below to conduct this
analysis.
For each secondary diagnosis, we
measured the impact in resource use for
the following three subsets of patients:
(1) Patients with no other secondary
diagnosis or with all other secondary
diagnoses that are non-CCs.
(2) Patients with at least one other
secondary diagnosis that is a CC but
none that is an MCC.
(3) Patients with at least one other
secondary diagnosis that is an MCC.
Numerical resource impact values
were assigned for each diagnosis as
follows:
Cnt3
C3
a CC than a non-CC but not as
significant in resource usage as an MCC.
A value close to 3.0 suggests the
condition is expected to consume
resources more similar to an MCC than
a CC or non-CC. For example, a C1 value
of 1.8 for a secondary diagnosis means
that for the subset of patients who have
the secondary diagnosis and have either
no other secondary diagnosis present, or
all the other secondary diagnoses
present are non-CCs, the impact on
resource use of the secondary diagnoses
is greater than the expected value for a
non-CC by an amount equal to 80
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percent of the difference between the
expected value of a CC and a non-CC
(that is, the impact on resource use of
the secondary diagnosis is closer to a CC
than a non-CC).
These mathematical constructs are
used as guides in conjunction with the
judgment of our clinical advisors to
classify each secondary diagnosis
reviewed as an MCC, CC or non-CC. Our
clinical panel reviews the resource use
impact reports and suggests
modifications to the initial CC subclass
assignments when clinically
appropriate.
b. Requested Changes to Severity Levels
ICD–10–CM diagnosis code B20 (Human
immunodeficiency virus [HIV] disease)
from an MCC to a CC. We used the
approach outlined above to evaluate this
request. The table below contains the
data that were evaluated for this request.
(1) Human Immunodeficiency Virus
[HIV] Disease
We received a request that we
consider changing the severity level of
ICD–10–CM diagnosis code
Cnt1
C1
Cnt2
C2
Cnt3
C3
Current
CC
subclass
Proposed
CC
subclass
B20 (Human immunodeficiency virus [HIV]
disease) ........................................................
2,918
0.9946
8,938
2.1237
11,479
3.0960
MCC
CC
While the data did not strongly
suggest that the categorization of HIV as
an MCC was inaccurate, our clinical
advisors indicated that, for many
patients with HIV disease, symptoms
are well controlled by medications. Our
clinical advisors stated that if these
patients have an HIV-related
complicating disease, that complicating
disease would serve as a CC or an MCC.
Therefore, they advised us that ICD–10–
CM diagnosis code B20 is more similar
to a CC than an MCC. Based on the data
results and the advice of our clinical
advisors, we are proposing to change the
severity level of ICD–10–CM diagnosis
code B20 from an MCC to a CC. We are
inviting public comments on our
proposal.
(2) Acute Respiratory Distress Syndrome
We also received a request to change
the severity level for ICD–10–CM
diagnosis code J80 (Acute respiratory
distress syndrome) from a CC to a MCC.
We used the approach outlined above to
evaluate this request. The following
table contains the data that were
evaluated for this request.
ICD–10–CM diagnosis code
Cnt1
C1
Cnt2
C2
Cnt3
C3
Current
CC
subclass
Proposed
CC
subclass
J80 (Acute respiratory distress syndrome) ......
1,840
1.7704
6,818
2.5596
18,376
3.3428
CC
MCC
The data suggest that the resources
involved in caring for a patient with this
condition are 77 percent greater than
expected when the patient has either no
other secondary diagnosis present, or all
the other secondary diagnoses present
are non-CCs. The resources are 56
percent greater than expected when
reported in conjunction with another
secondary diagnosis that is a CC, and 34
percent greater than expected when
reported in conjunction with another
secondary diagnosis code that is an
MCC. Our clinical advisors agree that
the resources required to care for a
patient with this secondary diagnosis
are consistent with those of an MCC.
Therefore, we are proposing to change
the severity level of ICD–10–CM
diagnosis code J80 from a CC to an
MCC. We are inviting public comments
on our proposal.
(3) Encephalopathy
We also received a request to change
the severity level for ICD–10–CM
diagnosis code G93.40 (Encephalopathy,
unspecified) from an MCC to a non-CC.
The requestor pointed out that the
nature of the encephalopathy or its
underlying cause should be coded. The
requestor also noted that unspecified
heart failure is a non-CC. We used the
approach outlined earlier to evaluate
this request. The following table
contains the data that were evaluated for
this request.
Cnt1
C1
Cnt2
C2
Cnt3
C3
Current
CC
subclass
Proposed
CC
subclass
G93.40 (Encephalopathy, unspecified) ............
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ICD–10–CM diagnosis code
1.840
16,306
1.8471
80,222
2.4901
139,066
MCC
MCC
The data suggest that the resources
involved in caring for a patient with this
condition are 84 percent greater than
expected when the patient has either no
other secondary diagnosis present, or all
the other secondary diagnoses present
are non-CCs. The resources are 15
percent lower than expected when
reported in conjunction with another
secondary diagnosis that is a CC, and 49
percent greater than expected when
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reported in conjunction with another
secondary diagnosis code that is an
MCC. We note that the pattern observed
in resource use for the condition of
unspecified heart failure (ICD–10–CM
diagnosis code I50.9) differs from that of
unspecified encephalopathy. Our
clinical advisors reviewed this request
and agree that the resources involved in
caring for a patient with this condition
are aligned with those of an MCC.
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Therefore, we are not proposing a
change to the severity level for ICD–10–
CM diagnosis code G93.40. We are
inviting public comments on our
proposal.
17. Review of Procedure Codes in MS
DRGs 981 Through 983 and 987
Through 989
Each year, we review cases assigned
to MS–DRGs 981, 982, and 983
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(Extensive O.R. Procedure Unrelated to
Principal Diagnosis with MCC, with CC,
and without CC/MCC, respectively) and
MS–DRGs 987, 988, and 989
(Nonextensive O.R. Procedure Unrelated
to Principal Diagnosis with MCC, with
CC, and without CC/MCC, respectively)
to determine whether it would be
appropriate to change the procedures
assigned among these MS–DRGs. MS–
DRGs 981 through 983 and 987 through
989 are reserved for those cases in
which none of the O.R. procedures
performed are related to the principal
diagnosis. These MS–DRGs are intended
to capture atypical cases, that is, those
cases not occurring with sufficient
frequency to represent a distinct,
recognizable clinical group.
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a. Moving Procedure Codes From MS–
DRGs 981 Through 983 or MS–DRGs
987 Through 989 Into MDCs
We annually conduct a review of
procedures producing assignment to
MS–DRGs 981 through 983 (Extensive
O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and
without CC/MCC, respectively) or MS–
DRGs 987 through 989 (Nonextensive
O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and
without CC/MCC, respectively) on the
basis of volume, by procedure, to see if
it would be appropriate to move
procedure codes out of these MS–DRGs
into one of the surgical MS–DRGs for
the MDC into which the principal
diagnosis falls. The data are arrayed in
two ways for comparison purposes. We
look at a frequency count of each major
operative procedure code. We also
compare procedures across MDCs by
volume of procedure codes within each
MDC.
We identify those procedures
occurring in conjunction with certain
principal diagnoses with sufficient
frequency to justify adding them to one
of the surgical MS–DRGs for the MDC in
which the diagnosis falls. Based on the
results of our review of the claims data
from the September 2017 update of the
FY 2017 MedPAR file, we are not
proposing to move any procedures from
MS–DRGs 981 through 983 or MS–DRGs
987 through 989 into one of the surgical
MS–DRGs for the MDC into which the
principal diagnosis is assigned. We are
inviting public comments on our
proposal to maintain the current
structure of these MS–DRGs.
b. Reassignment of Procedures Among
MS–DRGs 981 Through 983 and 987
Through 989
We also review the list of ICD–10–
PCS procedures that, when in
combination with their principal
diagnosis code, result in assignment to
MS–DRGs 981 through 983, or 987
through 989, to ascertain whether any of
those procedures should be reassigned
from one of those two groups of MS–
DRGs to the other group of MS–DRGs
based on average costs and the length of
stay. We look at the data for trends such
as shifts in treatment practice or
reporting practice that would make the
resulting MS–DRG assignment illogical.
If we find these shifts, we would
propose to move cases to keep the MS–
DRGs clinically similar or to provide
payment for the cases in a similar
manner. Generally, we move only those
procedures for which we have an
adequate number of discharges to
analyze the data.
Based on the results of our review of
the September 2017 update of the FY
2017 MedPAR file, we are proposing to
maintain the current structure of MS–
DRGs 981 through 983 and MS–DRGs
987 through 989.
We are inviting public comments on
our proposal.
c. Adding Diagnosis or Procedure Codes
to MDCs
We received a request recommending
that CMS reassign cases for congenital
pectus excavatum (congenital
depression of the sternum or concave
chest) when reported with a procedure
describing repositioning of the sternum
(the Nuss procedure) from MS–DRGs
981, 982, and 983 (Extensive O.R.
Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and
without CC/MCC, respectively) to MS–
DRGs 515, 516, and 517 (Other
Musculoskeletal System and Connective
Tissue O.R. Procedures with MCC, with
CC, and without CC/MCC, respectively).
ICD–10–CM diagnosis code Q67.6
(Pectus excavatum) is reported for this
ICD–10–CM
code
Q67.7
Q76.6
Q76.7
Q76.8
Q76.9
Q77.2
...................
...................
...................
...................
...................
...................
VerDate Sep<11>2014
congenital condition and is currently
assigned to MDC 4 (Diseases and
Disorders of the Respiratory System).
ICD–10–PCS procedure code 0PS044Z
(Reposition sternum with internal
fixation device, percutaneous
endoscopic approach) may be reported
to identify the Nuss procedure and is
currently assigned to MDC 8 (Diseases
and Disorders of the Musculoskeletal
System and Connective Tissue) in MS–
DRGs 515, 516, and 517. The requester
noted that acquired pectus excavatum
(ICD–10–CM diagnosis code M95.4)
groups to MS–DRGs 515, 516, and 517
when reported with a ICD–10–PCS
procedure code describing repositioning
of the sternum and requested that cases
involving diagnoses describing
congenital pectus excavatum also group
to those MS–DRGs when reported with
a ICD–10–PCS procedure code
describing repositioning of the sternum.
Our analysis of this grouping issue
confirmed that, when pectus excavatum
(ICD–10–CM diagnosis code Q67.6) is
reported as a principal diagnosis with a
procedure such as the Nuss procedure
(ICD–10–PCS procedure code 0PS044Z),
these cases group to MS–DRGs 981, 982,
and 983. The reason for this grouping is
because whenever there is a surgical
procedure reported on a claim, which is
unrelated to the MDC to which the case
was assigned based on the principal
diagnosis, it results in an MS–DRG
assignment to a surgical class referred to
as ‘‘unrelated operating room
procedures.’’ In the example provided,
because the ICD–10–CM diagnosis code
Q67.6 describing pectus excavatum is
classified to MDC 4 and the ICD–10–
PCS procedure code 0PS044Z is
classified to MDC 8, the GROUPER logic
assigns this case to the ‘‘unrelated
operating room procedures’’ set of MS–
DRGs.
During our review of ICD–10–CM
diagnosis code Q67.6, we also reviewed
additional ICD–10–CM diagnosis codes
in the Q65 through Q79 code range to
determine if there might be other
conditions classified to MDC 4 that
describe congenital malformations and
deformities of the musculoskeletal
system. We identified the following six
ICD–10–CM diagnosis codes:
Code description
Pectus carinatum.
Other congenital malformations of ribs.
Congenital malformation of sternum.
Other congenital malformations of bony thorax.
Congenital malformation of bony thorax, unspecified.
Short rib syndrome.
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We are proposing to reassign ICD–10–
CM diagnosis code Q67.6, as well as the
additional six ICD–10–CM diagnosis
codes above describing congenital
musculoskeletal conditions, from MDC
4 to MDC 8 where other related
congenital conditions that correspond to
the musculoskeletal system are
classified, as discussed further below.
We identified other related ICD–10–
CM diagnosis codes that are currently
assigned to MDC 8 in categories Q67
(Congenital musculoskeletal deformities
ICD–10–CM
code
Q67.0 ...................
Q67.1 ...................
Q67.2 ...................
Q67.3 ...................
Q67.4 ...................
Q67.5 ...................
Q67.8 ...................
Q76.1 ...................
Q76.2 ...................
Q76.3 ...................
Q76.411 ...............
Q76.412 ...............
Q76.413 ...............
Q76.414 ...............
Q76.415 ...............
Q76.419 ...............
Q76.425 ...............
Q76.426 ...............
Q76.427 ...............
Q76.428 ...............
Q76.429 ...............
Q76.49 .................
Q76.5 ...................
Q77.0 ...................
Q77.1 ...................
Q77.3 ...................
Q77.4 ...................
Q77.5 ...................
Q77.6 ...................
Q77.7 ...................
Q77.8 ...................
Q77.9 ...................
Congenital facial asymmetry.
Congenital compression facies.
Dolichocephaly.
Plagiocephaly.
Other congenital deformities of skull, face and jaw.
Congenital deformity of spine.
Other congenital deformities of chest.
Klippel-Feil syndrome.
Congenital spondylolisthesis.
Congenital scoliosis due to congenital bony malformation.
Congenital kyphosis, occipito-atlanto-axial region.
Congenital kyphosis, cervical region.
Congenital kyphosis, cervicothoracic region.
Congenital kyphosis, thoracic region.
Congenital kyphosis, thoracolumbar region.
Congenital kyphosis, unspecified region.
Congenital lordosis, thoracolumbar region.
Congenital lordosis, lumbar region.
Congenital lordosis, lumbosacral region.
Congenital lordosis, sacral and sacrococcygeal region.
Congenital lordosis, unspecified region.
Other congenital malformations of spine, not associated with scoliosis.
Cervical rib.
Achondrogenesis.
Thanatophoric short stature.
Chondrodysplasia punctate.
Achondroplasia.
Diastrophic dysplasia.
Chondroectodermal dysplasia.
Spondyloepiphyseal dysplasia.
Other osteochondrodysplasia with defects of growth of tubular bones and spine.
Osteochondrodysplasia with defects of growth of tubular bones and spine, unspecified.
following conditions are assigned to
MS–DRGs 551 and 552 (Medical Back
ICD–10–CM
code
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Congenital spondylolisthesis.
Congenital kyphosis, occipito-atlanto-axial region.
Congenital kyphosis, cervical region.
Congenital kyphosis, cervicothoracic region.
Congenital kyphosis, thoracic region.
Congenital kyphosis, thoracolumbar region.
Congenital kyphosis, unspecified region.
Other congenital malformations of spine, not associated with scoliosis.
System and Connective Tissue
Diagnoses with MCC, with CC, and
ICD–10–CM
code
...................
...................
...................
...................
VerDate Sep<11>2014
Problems with and without MCC,
respectively) under MDC 8.
Code description
The remaining conditions shown
below are assigned to MS–DRGs 564,
565, and 566 (Other Musculoskeletal
Q67.0
Q67.1
Q67.2
Q67.3
of head, face, spine and chest), Q76
(Congenital malformations of spine and
bony thorax), and Q77
(Osteochondrodysplasia with defects of
growth of tubular bones and spine) that
are listed in the following table.
Code description
Next, we analyzed the MS–DRG
assignments for the related codes listed
above and found that cases with the
Q76.2 ...................
Q76.411 ...............
Q76.412 ...............
Q76.413 ...............
Q76.414 ...............
Q76.415 ...............
Q76.419 ...............
Q76.49 .................
20243
without CC/MCC, respectively) under
MDC 8.
Code description
Congenital facial asymmetry.
Congenital compression facies.
Dolichocephaly.
Plagiocephaly.
20:30 May 04, 2018
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E:\FR\FM\07MYP2.SGM
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ICD–10–CM
code
Q67.4 ...................
Q67.5 ...................
Q67.8 ...................
Q76.1 ...................
Q76.3 ...................
Q76.425 ...............
Q76.426 ...............
Q76.427 ...............
Q76.428 ...............
Q76.429 ...............
Q76.5 ...................
Q77.0 ...................
Q77.1 ...................
Q77.3 ...................
Q77.4 ...................
Q77.5 ...................
Q77.6 ...................
Q77.7 ...................
Q77.8 ...................
Q77.9 ...................
Code description
Other congenital deformities of skull, face and jaw.
Congenital deformity of spine.
Other congenital deformities of chest.
Klippel-Feil syndrome.
Congenital scoliosis due to congenital bony malformation.
Congenital lordosis, thoracolumbar region.
Congenital lordosis, lumbar region.
Congenital lordosis, lumbosacral region.
Congenital lordosis, sacral and sacrococcygeal region.
Congenital lordosis, unspecified region.
Cervical rib.
Achondrogenesis.
Thanatophoric short stature.
Chondrodysplasia punctate.
Achondroplasia.
Diastrophic dysplasia.
Chondroectodermal dysplasia.
Spondyloepiphyseal dysplasia.
Other osteochondrodysplasia with defects of growth of tubular bones and spine.
Osteochondrodysplasia with defects of growth of tubular bones and spine, unspecified.
As a result of our review, we are
proposing to reassign ICD–10–CM
diagnosis code Q67.6, as well as the
additional six ICD–10–CM diagnosis
codes above describing congenital
musculoskeletal conditions, from MDC
4 to MDC 8 in MS–DRGs 564, 565, and
566. Our clinical advisors agree with
this proposed reassignment because it is
clinically appropriate and consistent
with the other related ICD–10–CM
diagnosis codes grouped in the Q65
through Q79 range that describe
congenital malformations and
deformities of the musculoskeletal
system that are classified under MDC 8
in MS–DRGs 564, 565, and 566. By
reassigning ICD–10–CM diagnosis code
Q67.6 and the additional six ICD–10–
CM diagnosis codes listed in the table
above from MDC 4 to MDC 8, cases
reporting these ICD–10–CM diagnosis
codes in combination with the
respective ICD–10–PCS procedure code
will reflect a more appropriate grouping
from a clinical perspective because they
will now be classified under a surgical
musculoskeletal system related MS–
DRG and will no longer result in an
MS–DRG assignment to the ‘‘unrelated
operating room procedures’’ surgical
class.
In summary, we are proposing to
reassign ICD–10–CM diagnosis codes
Q67.6, Q67.7, Q76.6, Q76.7, Q76.8,
Q76.9, and Q77.2 from MDC 4 to MDC
8 in MS–DRGs 564, 565, and 566 (Other
Musculoskeletal System and Connective
Tissue Diagnoses with MCC, with CC,
and without CC/MCC, respectively). We
are inviting public comments on our
proposals.
We also received a request
recommending that CMS reassign cases
for sternal fracture repair procedures
from MS–DRGs 981, 982, and 983 and
from MS–DRGs 166, 167 and 168 (Other
Respiratory System O.R. Procedures
with MCC, with CC and without CC/
MCC, respectively) under MDC 4 to
MS–DRGs 515, 516, and 517 under MDC
ICD–10–PCS
code
daltland on DSKBBV9HB2PROD with PROPOSALS2
0PS000Z
0PS004Z
0PS00ZZ
0PS030Z
0PS034Z
..............
..............
..............
..............
..............
Code description
Reposition
Reposition
Reposition
Reposition
Reposition
sternum with rigid plate internal fixation device, open approach.
sternum with internal fixation device, open approach.
sternum, open approach.
sternum with rigid plate internal fixation device, percutaneous approach.
sternum with internal fixation device, percutaneous approach.
We note that the above five ICD–10–
PCS procedure codes that may be
reported to describe a sternal fracture
repair are already assigned to MS–DRGs
515, 516, and 517 under MDC 8. In
addition, ICD–10–PCS procedure codes
0PS000Z and 0PS030Z are assigned to
MS–DRGs 166, 167 and 168 under
MDC 4.
VerDate Sep<11>2014
8. The requester noted that clavicle
fracture repair procedures with an
internal fixation device group to MS–
DRGs 515, 516, and 517 when reported
with an ICD–10–CM diagnosis code
describing a fractured clavicle.
However, sternal fracture repair
procedures with an internal fixation
device group to MS–DRGs 981, 982, and
983 or MS–DRGs 166, 167 and 168
when reported with an ICD–10–CM
diagnosis code describing a fracture of
the sternum. According to the requestor,
because the clavicle and sternum are in
the same anatomical region of the body,
it would appear that assignment to MS–
DRGs 515, 516, and 517 would be more
appropriate for sternal fracture repair
procedures.
The requestor provided the following
list of ICD–10–PCS procedure codes in
its request for consideration to reassign
to MS–DRGs 515, 516 and 517 when
reported with an ICD–10–CM diagnosis
code for sternal fracture.
20:30 May 04, 2018
Jkt 244001
As noted in the previous discussion,
whenever there is a surgical procedure
reported on a claim, which is unrelated
to the MDC to which the case was
assigned based on the principal
diagnosis, it results in an MS–DRG
assignment to a surgical class referred to
as ‘‘unrelated operating room
procedures.’’ In the examples provided
PO 00000
Frm 00082
Fmt 4701
Sfmt 4702
by the requestor, when the ICD–10–CM
diagnosis code describing a sternal
fracture is classified under MDC 4 and
the ICD–10–PCS procedure code
describing a sternal fracture repair
procedure is classified under MDC 8,
the GROUPER logic assigns these cases
to the ‘‘unrelated operating room
procedures’’ group of MS–DRGs (981,
E:\FR\FM\07MYP2.SGM
07MYP2
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982, and 983) and when the ICD–10–CM
diagnosis code describing a sternal
fracture is classified under MDC 4 and
the ICD–10–PCS procedure code
describing a sternal repair procedure is
also classified under MDC 4, the
GROUPER logic assigns these cases to
MS–DRG 166, 167, or 168.
For our review of this grouping issue
and the request to have procedures for
sternal fracture repairs assigned to MDC
8, we analyzed the ICD–10–CM
diagnosis codes describing a sternal
ICD–10–CM
code
S22.20XA
S22.20XB
S22.21XA
S22.21XB
S22.22XA
S22.22XB
S22.23XA
S22.23XB
S22.24XA
S22.24XB
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
Unspecified fracture of sternum, initial encounter for closed fracture.
Unspecified fracture of sternum, initial encounter for open fracture.
Fracture of manubrium, initial encounter for closed fracture.
Fracture of manubrium, initial encounter for open fracture.
Fracture of body of sternum, initial encounter for closed fracture.
Fracture of body of sternum, initial encounter for open fracture.
Sternal manubrial dissociation, initial encounter for closed fracture.
Sternal manubrial dissociation, initial encounter for open fracture.
Fracture of xiphoid process, initial encounter for closed fracture.
Fracture of xiphoid process, initial encounter for open fracture.
above from MDC 4 is reported as a
principal diagnosis with an ICD–10–
PCS procedure code for a sternal repair
procedure from MDC 4, these cases
group to MS–DRG 166, 167 or 168.
Our clinical advisors agree with the
requested reclassification of ICD–10–CM
diagnosis codes S22.20XA, S22.20XB,
S22.21XA, S22.21XB, S22.22XA,
S22.22XB, S22.23XA, S22.23XB,
S22.24XA, and S22.24XB describing a
sternal fracture with an initial encounter
ICD–10–CM
code
daltland on DSKBBV9HB2PROD with PROPOSALS2
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
from MDC 4 to MDC 8. They advised
that this requested reclassification is
clinically appropriate because it is
consistent with the other related ICD–
10–CM diagnosis codes that describe
fractures of the sternum and which are
classified under MDC 8. The ICD–10–
CM diagnosis codes describing a sternal
fracture currently classified under MDC
8 to MS–DRGs 564, 565, and 566 are
listed in the following table.
Code description
Unspecified fracture of sternum, subsequent encounter for fracture with routine healing.
Unspecified fracture of sternum, subsequent encounter for fracture with delayed healing.
Unspecified fracture of sternum, subsequent encounter for fracture with nonunion.
Unspecified fracture of sternum, sequela.
Fracture of manubrium, subsequent encounter for fracture with routine healing.
Fracture of manubrium, subsequent encounter for fracture with delayed healing.
Fracture of manubrium, subsequent encounter for fracture with nonunion.
Fracture of manubrium, sequela.
Fracture of body of sternum, subsequent encounter for fracture with routine healing.
Fracture of body of sternum, subsequent encounter for fracture with delayed healing.
Fracture of body of sternum, subsequent encounter for fracture with nonunion.
Fracture of body of sternum, sequela.
Sternal manubrial dissociation, subsequent encounter for fracture with routine healing.
Sternal manubrial dissociation, subsequent encounter for fracture with delayed healing.
Sternal manubrial dissociation, subsequent encounter for fracture with nonunion.
Sternal manubrial dissociation, sequela.
Fracture of xiphoid process, subsequent encounter for fracture with routine healing.
Fracture of xiphoid process, subsequent encounter for fracture with delayed healing.
Fracture of xiphoid process, subsequent encounter for fracture with nonunion.
Fracture of xiphoid process, sequela.
By reclassifying the 10 ICD–10–CM
diagnosis codes listed in the table
earlier in this section describing sternal
fracture codes with an ‘‘initial
encounter’’ from MDC 4 to MDC 8, the
cases reporting these ICD–10–CM
diagnosis codes in combination with the
respective ICD–10–PCS procedure codes
will reflect a more appropriate grouping
from a clinical perspective and will no
VerDate Sep<11>2014
fracture currently classified under MDC
4. We identified 10 ICD–10–CM
diagnosis codes describing a sternal
fracture with an ‘‘initial encounter’’
classified under MDC 4 that are listed in
the following table.
Code description
Our analysis of this grouping issue
confirmed that when 1 of the 10 ICD–
10–CM diagnosis codes describing a
sternal fracture listed in the table above
from MDC 4 is reported as a principal
diagnosis with an ICD–10–PCS
procedure code for a sternal repair
procedure from MDC 8, these cases
group to MS–DRG 981, 982, or 983. We
also confirmed that when 1 of the 10
ICD–10–CM diagnosis codes describing
a sternal fracture listed in the table
S22.20XD
S22.20XG
S22.20XK
S22.20XS
S22.21XD
S22.21XG
S22.21XK
S22.21XS
S22.22XD
S22.22XG
S22.22XK
S22.22XS
S22.23XD
S22.23XG
S22.23XK
S22.23XS
S22.24XD
S22.24XG
S22.24XK
S22.24XS
20245
20:30 May 04, 2018
Jkt 244001
longer result in an MS–DRG assignment
to the ‘‘unrelated operating room
procedures’’ surgical class when
reported with a surgical procedure
classified under MDC 8.
Therefore, we are proposing to
reassign ICD–10–CM diagnosis codes
S22.20XA, S22.20XB, S22.21XA,
S22.21XB, S22.22XA, S22.22XB,
S22.23XA, S22.23XB, S22.24XA, and
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Fmt 4701
Sfmt 4702
S22.24XB from under MDC 4 to MDC 8
to MS–DRGs 564, 565, and 566. We are
inviting public comments on our
proposals.
In addition, we received a request
recommending that CMS reassign cases
for rib fracture repair procedures from
MS–DRGs 981, 982, and 983, and from
MS–DRGs 166, 167 and 168 (Other
Respiratory System O.R. Procedures
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
with MCC, with CC, and without CC/
MCC, respectively) under MDC 4 to
MS–DRGs 515, 516, and 517 under MDC
8. The requestor noted that clavicle
fracture repair procedures with an
internal fixation device group to MS–
DRGs 515, 516, and 517 when reported
with an ICD–10–CM diagnosis code
describing a fractured clavicle.
However, rib fracture repair procedures
with an internal fixation device group to
MS–DRGs 981, 982, and 983 or to MS–
DRGs 166, 167 and 168 when reported
with an ICD–10–CM diagnosis code
describing a rib fracture. According to
the requestor, because the clavicle and
ribs are in the same anatomical region
of the body, it would appear that
ICD–10–PCS
code
0PH104Z
0PH134Z
0PH144Z
0PH204Z
0PH234Z
0PH244Z
0PS104Z
0PS134Z
0PS204Z
0PS234Z
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
Code description
Insertion of internal fixation device into 1 to 2 ribs, open approach.
Insertion of internal fixation device into 1 to 2 ribs, percutaneous approach.
Insertion of internal fixation device into 1 to 2 ribs, percutaneous endoscopic approach.
Insertion of internal fixation device into 3 or more ribs, open approach.
Insertion of internal fixation device into 3 or more ribs, percutaneous approach.
Insertion of internal fixation device into 3 or more ribs, percutaneous endoscopic approach.
Reposition 1 to 2 ribs with internal fixation device, open approach.
Reposition 1 to 2 ribs with internal fixation device, percutaneous approach.
Reposition 3 or more ribs with internal fixation, device, open approach.
Reposition 3 or more ribs with internal fixation device, percutaneous approach.
We note that the above 10 ICD–10–
PCS procedure codes that may be
reported to describe a rib fracture repair
are already assigned to MS–DRGs 515,
516, and 517 under MDC 8. In addition,
6 of the 10 ICD 10–PCS procedure codes
listed above (0PH104Z, 0PH134Z,
0PH144Z, 0PH204Z, 0PH234Z and
0PH244Z) are also assigned to MS–
DRGs 166, 167, and 168 under MDC 4.
As noted in the previous discussions
above, whenever there is a surgical
procedure reported on a claim, which is
unrelated to the MDC to which the case
was assigned based on the principal
diagnosis, it results in an MS–DRG
assignment to a surgical class referred to
as ‘‘unrelated operating room
procedures.’’ In the examples provided
by the requestor, when the ICD–10–CM
diagnosis code describing a rib fracture
is classified under MDC 4 and the ICD–
10–PCS procedure code describing a rib
fracture repair procedure is classified
under MDC 8, the GROUPER logic
assigns these cases to the ‘‘unrelated
operating room procedures’’ group of
MS–DRGs (981, 982, and 983) and when
the ICD–10–CM diagnosis code
describing a rib fracture is classified
under MDC 4 and the ICD–10–PCS
procedure code describing a rib repair
procedure is also classified under MDC
4, the GROUPER logic assigns these
cases to MS–DRG 166, 167, or 168.
ICD–10–PCS
code
daltland on DSKBBV9HB2PROD with PROPOSALS2
S2231XA
S2231XB
S2232XA
S2232XB
S2239XA
S2239XB
S2241XA
S2241XB
S2242XA
S2242XB
S2243XA
S2243XB
S2249XA
S2249XB
S225XXA
S225XXB
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
For our review of this grouping issue
and the request to have procedures for
rib fracture repairs assigned to MDC 8,
we analyzed the ICD–10–CM diagnosis
codes describing a rib fracture and
found that, while some rib fracture ICD–
10–CM diagnosis codes are classified
under MDC 8 (which would result in
those cases grouping appropriately to
MS–DRGs 515, 516, and 517), there are
other ICD–10–CM diagnosis codes that
are currently classified under MDC 4.
We identified the following ICD–10–CM
diagnosis codes describing a rib fracture
with an initial encounter classified
under MDC 4, as listed in the following
table.
Code description
Fracture of one rib, right side, initial encounter for closed fracture.
Fracture of one rib, right side, initial encounter for open fracture.
Fracture of one rib, left side, initial encounter for closed fracture.
Fracture of one rib, left side, initial encounter for open fracture.
Fracture of one rib, unspecified side, initial encounter for closed fracture.
Fracture of one rib, unspecified side, initial encounter for open fracture.
Multiple fractures of ribs, right side, initial encounter for closed fracture.
Multiple fractures of ribs, right side, initial encounter for open fracture.
Multiple fractures of ribs, left side, initial encounter for closed fracture.
Multiple fractures of ribs, left side, initial encounter for open fracture.
Multiple fractures of ribs, bilateral, initial encounter for closed fracture.
Multiple fractures of ribs, bilateral, initial encounter for open fracture.
Multiple fractures of ribs, unspecified side, initial encounter for closed fracture.
Multiple fractures of ribs, unspecified side, initial encounter for open fracture.
Flail chest, initial encounter for closed fracture.
Flail chest, initial encounter for open fracture.
Our analysis of this grouping issue
confirmed that, when one of the
following four ICD–10–PCS procedure
codes identified by the requestor (and
listed in the table earlier in this section)
from MDC 8 (0PS104Z, 0PS134Z,
VerDate Sep<11>2014
assignment to MS–DRGs 515, 516, and
517 would be more appropriate for rib
fracture repair procedures.
The requestor provided the following
list of 10 ICD–10–PCS procedure codes
in its request for consideration for
reassignment to MS–DRGs 515, 516 and
517 when reported with an ICD–10–CM
diagnosis code for rib fracture.
20:30 May 04, 2018
Jkt 244001
0PS204Z, or 0PS234Z) is reported to
describe a rib fracture repair procedure
with a principal diagnosis code for a rib
fracture with an initial encounter listed
in the table above from MDC 4, these
PO 00000
Frm 00084
Fmt 4701
Sfmt 4702
cases group to MS–DRG 981, 982, or
983.
During our review of those four
repositioning of the rib procedure codes,
we also identified the following four
ICD–10–PCS procedure codes classified
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to MDC 8 that describe repositioning of
the ribs.
ICD–10–PCS
code
0PS10ZZ
0PS144Z
0PS20ZZ
0PS244Z
..............
..............
..............
..............
Code description
Reposition
Reposition
Reposition
Reposition
1
1
3
3
to 2 ribs, open approach.
to 2 ribs with internal fixation device, percutaneous endoscopic approach.
or more ribs, open approach.
or more ribs with internal fixation device, percutaneous endoscopic approach.
We confirmed that when one of the
above four procedure codes is reported
with a principal diagnosis code for a rib
fracture listed in the table above from
MDC 4, these cases also group to MS–
DRG 981, 982, or 983.
Lastly, we confirmed that when one of
the six ICD–10–PCS procedure codes
describing a rib fracture repair listed in
the previous table above from MDC 4 is
reported with a principal diagnosis code
for a rib fracture with an initial
encounter from MDC 4, these cases
group to MS–DRG 166, 167, or 168.
In response to the request to reassign
the procedure codes that describe a rib
fracture repair procedure from MS–
DRGs 981, 982, and 983 and from MS–
DRGs 166, 167, and 168 under MDC 4
to MS–DRGs 515, 516, and 517 under
MDC 8, as discussed above, the 10 ICD–
10–PCS procedure codes submitted by
the requestor that may be reported to
describe a rib fracture repair are already
assigned to MS–DRGs 515, 516, and 517
under MDC 8 and 6 of those 10
procedure codes (0PH104Z, 0PH134Z,
0PH144Z, 0PH204Z, 0PH234Z, and
0PH244Z) are also assigned to MS–
DRGs 166, 167, and 168 under MDC 4.
We analyzed claims data from the
September 2017 update of the FY 2017
MedPAR file for cases reporting a
principal diagnosis of a rib fracture
(initial encounter) from the list of
diagnosis codes shown in the table
above with one of the six ICD–10–PCS
procedure codes describing the
insertion of an internal fixation device
into the rib (0PH104Z, 0PH134Z,
0PH144Z, 0PH204Z, 0PH234Z, and
0PH244Z) in MS–DRGs 166, 167, and
168 under MDC 4. Our findings are
shown in the table below.
MS–DRGS FOR OTHER RESPIRATORY SYSTEM O.R. PROCEDURES
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG 166—All cases ............................................................................................................
MS–DRG 166—Cases with principal diagnosis of rib fracture(s) and insertion of internal fixation device for the rib(s) ...........................................................................................................
MS–DRG 167—All cases ............................................................................................................
MS–DRG 167—Cases with principal diagnosis of rib fracture(s) and insertion of internal fixation device for the rib(s) ...........................................................................................................
MS–DRG 168—All cases ............................................................................................................
MS–DRG 168—Cases with principal diagnosis of rib fracture(s) and insertion of internal fixation device for the rib(s) ...........................................................................................................
As shown in this table, there were a
total of 22,938 cases in MS–DRG 166,
with an average length of stay of 10.2
days and average costs of $24,299. In
MS–DRG 166, we found 40 cases
reporting a principal diagnosis of a rib
fracture(s) with insertion of an internal
fixation device for the rib(s), with an
average length of stay of 11.4 days and
average costs of $43,094. There were a
total of 10,815 cases in MS–DRG 167,
with an average length of stay of 5.7
days and average costs of $13,252. In
MS–DRG 167, we found 10 cases
reporting a principal diagnosis of a rib
fracture(s) with insertion of an internal
fixation device for the rib(s), with an
average length of stay of 6.7 days and
average costs of $30,617. There were a
total of 3,242 cases in MS–DRG 168,
with an average length of stay of 3.1
days and average costs of $9,708. In
MS–DRG 168, we found 4 cases
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
reporting a principal diagnosis of a rib
fracture(s) with insertion of an internal
fixation device for the rib(s), with an
average length of stay of 2 days and
average costs of $21,501. Overall, for
MS–DRGs 166, 167, and 168, there were
a total of 54 cases reporting a principal
diagnosis of a rib fracture(s) with
insertion of an internal fixation device
for the rib(s), demonstrating that while
rib fractures may require treatment, they
are not typically corrected surgically.
Our clinical advisors agree with the
current assignment of procedure codes
to MS–DRGs 166, 167, and 168 that may
be reported to describe repair of a rib
fracture under MDC 4, as well as the
current assignment of procedure codes
to MS–DRGs 515, 516, and 517 that may
be reported to describe repair of a rib
fracture under MDC 8. Our clinical
advisors noted that initial, acute rib
fractures can cause numerous
PO 00000
Average
length
of stay
Number
of cases
MS–DRG
Frm 00085
Fmt 4701
Sfmt 4702
Average
costs
22,938
10.2
$24,299
40
10,815
11.4
5.7
43,094
13,252
10
3,242
6.7
3.1
30,617
9,708
4
2
21,501
respiratory related issues requiring
various treatments and problems with
the healing of a rib fracture are
considered musculoskeletal issues.
We also note that the procedure codes
submitted by the requestor may be
reported for other indications and they
are not restricted to reporting for repair
of a rib fracture. Therefore, assignment
of these codes to the MDC 4 MS–DRGs
and the MDC 8 MS–DRGs is clinically
appropriate.
To address the cases reporting
procedure codes describing the
repositioning of a rib(s) that are
grouping to MS–DRGs 981, 982, and 983
when reported with a principal
diagnosis of a rib fracture (initial
encounter), we are proposing to add the
following eight ICD–10–PCS procedure
codes currently assigned to MDC 8 into
MDC 4, in MS–DRGs 166, 167 and 168.
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ICD–10–PCS
code
0PS104Z
0PS10ZZ
0PS134Z
0PS144Z
0PS204Z
0PS20ZZ
0PS234Z
0PS244Z
..............
..............
..............
..............
..............
..............
..............
..............
Code description
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
1
1
1
1
3
3
3
3
to 2 ribs with internal fixation device, open approach.
to 2 ribs, open approach.
to 2 ribs with internal fixation device, percutaneous approach.
to 2 ribs with internal fixation device, percutaneous endoscopic approach.
or more ribs with internal fixation device, open approach.
or more ribs, open approach.
or more ribs with internal fixation device, percutaneous approach.
or more ribs with internal fixation device, percutaneous endoscopic approach.
Our clinical advisors agree with this
proposed addition to the classification
structure because it is clinically
appropriate and consistent with the
other related ICD–10–PCS procedure
codes that may be reported to describe
rib fracture repair procedures with the
insertion of an internal fixation device
and are classified under MDC 4.
By adding the eight ICD–10–PCS
procedure codes describing
repositioning of the rib(s) that may be
reported to describe a rib fracture repair
procedure under the classification
structure for MDC 4, these cases will no
longer result in an MS–DRG assignment
to the ‘‘unrelated operating room
procedures’’ surgical class when
reported with a diagnosis code under
MDC 4.
We are inviting public comments on
our proposals.
daltland on DSKBBV9HB2PROD with PROPOSALS2
18. Proposed Changes to the ICD–10–
CM and ICD–10–PCS Coding Systems
In September 1985, the ICD-9-CM
Coordination and Maintenance
Committee was formed. This is a
Federal interdepartmental committee,
co-chaired by the National Center for
Health Statistics (NCHS), the Centers for
Disease Control and Prevention (CDC),
and CMS, charged with maintaining and
updating the ICD-9-CM system. The
final update to ICD–9–CM codes was
made on October 1, 2013. Thereafter,
the name of the Committee was changed
to the ICD–10 Coordination and
Maintenance Committee, effective with
the March 19–20, 2014 meeting. The
ICD–10 Coordination and Maintenance
Committee addresses updates to the
ICD–10–CM and ICD–10–PCS coding
systems. The Committee is jointly
responsible for approving coding
changes, and developing errata,
addenda, and other modifications to the
coding systems to reflect newly
developed procedures and technologies
and newly identified diseases. The
Committee is also responsible for
promoting the use of Federal and
non-Federal educational programs and
other communication techniques with a
view toward standardizing coding
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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: https://cms.hhs.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/
codes.html. The official list of ICD–10–
CM and ICD–10–PCS codes can be
found on the CMS website at: https://
www.cms.gov/Medicare/Coding/ICD10/
index.html.
The NCHS has lead responsibility for
the ICD–10–CM and ICD–9–CM
diagnosis codes included in the Tabular
List and Alphabetic Index for Diseases,
while CMS has lead responsibility for
the ICD–10–PCS and ICD–9–CM
procedure codes included in the
Tabular List and Alphabetic Index for
Procedures.
The Committee encourages
participation in the previously
mentioned process by health-related
organizations. In this regard, the
Committee holds public meetings for
discussion of educational issues and
proposed coding changes. These
meetings provide an opportunity for
representatives of recognized
organizations in the coding field, such
as the American Health Information
Management Association (AHIMA), the
American Hospital Association (AHA),
and various physician specialty groups,
as well as individual physicians, health
information management professionals,
and other members of the public, to
contribute ideas on coding matters.
After considering the opinions
expressed at the public meetings and in
writing, the Committee formulates
recommendations, which then must be
approved by the agencies.
The Committee presented proposals
for coding changes for implementation
in FY 2019 at a public meeting held on
September 12–13, 2017, and finalized
the coding changes after consideration
of comments received at the meetings
and in writing by November 13, 2017.
The Committee held its 2018 meeting
on March 6–7, 2018. The deadline for
submitting comments on these code
proposals is scheduled for April 6, 2018.
It was announced at this meeting that
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any new ICD–10–CM/PCS codes for
which there was consensus of public
support and for which complete tabular
and indexing changes would be made
by May 2018 would be included in the
October 1, 2018 update to ICD–10–CM/
ICD–10–PCS. As discussed in earlier
sections of the preamble of the 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, Table 6E.—Revised Diagnosis
Code Titles, and Table 6F.—Revised
Procedure Code Titles for this proposed
rule, which are available via the Internet
on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/. 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. We
are inviting public comments on the
MDC and MS–DRG assignments for the
new diagnosis and procedure codes as
set forth in Table 6A—New Diagnosis
Codes and Table 6B.—New Procedure
Codes. In addition, we are inviting
public comments on the proposed
severity level designations for the new
diagnosis codes as set forth in Table 6A.
and the proposed O.R. status for the
new procedure codes as set forth in
Table 6B. Because of the length of these
tables, they are not published in the
Addendum to this proposed rule.
Rather, they are available via the
Internet as discussed in section VI. of
the Addendum to this proposed rule.
Live Webcast recordings of the
discussions of procedure codes at the
Committee’s September 12–13, 2017
meeting and March 6–7, 2018 meeting
can be obtained from the CMS website
at: https://cms.hhs.gov/Medicare/Coding/
ICD9ProviderDiagnosticCodes/
index.html?redirect=/
icd9ProviderDiagnosticCodes/
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03_meetings.asp. The minutes of the
discussions of diagnosis codes at the
September 12–13, 2017 meeting and
March 6–7, 2018 meeting can be found
at: https://www.cdc.gov/nchs/icd/
icd10cm_maintenance.html. These
websites also provide detailed
information about the Committee,
including information on requesting a
new code, attending a Committee
meeting, and timeline requirements and
meeting dates.
We encourage commenters to address
suggestions on coding issues involving
diagnosis codes to: Donna Pickett,
Co-Chairperson, ICD–10 Coordination
and Maintenance Committee, NCHS,
Room 2402, 3311 Toledo Road,
Hyattsville, MD 20782. Comments may
be sent by E-mail to: nchsicd10cm@
cdc.gov.
Questions and comments concerning
the procedure codes should be
submitted via E-mail to:
ICDProcedureCodeRequest@
cms.hhs.gov.
In the September 7, 2001 final rule
implementing the IPPS new technology
add-on payments (66 FR 46906), we
indicated we would attempt to include
proposals for procedure codes that
would describe new technology
discussed and approved at the Spring
meeting as part of the code revisions
effective the following October.
Section 503(a) of Public Law 108-173
included a requirement for updating
diagnosis and procedure codes twice a
year instead of a single update on
October 1 of each year. This
requirement was included as part of the
amendments to the Act relating to
recognition of new technology under the
IPPS. Section 503(a) amended section
1886(d)(5)(K) of the Act by adding a
clause (vii) which states that the
Secretary shall provide for the addition
of new diagnosis and procedure codes
on April 1 of each year, but the addition
of such codes shall not require the
Secretary to adjust the payment (or
diagnosis-related group classification)
until the fiscal year that begins after
such date. This requirement improves
the recognition of new technologies
under the IPPS by providing
information on these new technologies
at an earlier date. Data will be available
6 months earlier than would be possible
with updates occurring only once a year
on October 1.
While section 1886(d)(5)(K)(vii) of the
Act states that the addition of new
diagnosis and procedure codes on April
1 of each year shall not require the
Secretary to adjust the payment, or DRG
classification, under section 1886(d) of
the Act until the fiscal year that begins
after such date, we have to update the
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DRG software and other systems in
order to recognize and accept the new
codes. We also publicize the code
changes and the need for a mid-year
systems update by providers to identify
the new codes. Hospitals also have to
obtain the new code books and encoder
updates, and make other system changes
in order to identify and report the new
codes.
The ICD–10 (previously the ICD–9–
CM) Coordination and Maintenance
Committee holds its meetings in the
spring and fall in order to update the
codes and the applicable payment and
reporting systems by October 1 of each
year. Items are placed on the agenda for
the Committee meeting if the request is
received at least 2 months prior to the
meeting. This requirement allows time
for staff to review and research the
coding issues and prepare material for
discussion at the meeting. It also allows
time for the topic to be publicized in
meeting announcements in the Federal
Register as well as on the CMS website.
Final decisions on code title revisions
are currently made by March 1 so that
these titles can be included in the IPPS
proposed rule. A complete addendum
describing details of all diagnosis and
procedure coding changes, both tabular
and index, is published on the CMS and
NCHS websites in June of each year.
Publishers of coding books and software
use this information to modify their
products that are used by health care
providers. This 5-month time period has
proved to be necessary for hospitals and
other providers to update their systems.
A discussion of this timeline and the
need for changes are included in the
December 4–5, 2005 ICD–9–CM
Coordination and Maintenance
Committee Meeting minutes. The public
agreed that there was a need to hold the
fall meetings earlier, in September or
October, in order to meet the new
implementation dates. The public
provided comment that additional time
would be needed to update hospital
systems and obtain new code books and
coding software. There was considerable
concern expressed about the impact this
April update would have on providers.
In the FY 2005 IPPS final rule, we
implemented section 1886(d)(5)(K)(vii)
of the Act, as added by section 503(a)
of Public Law 108–173, by developing a
mechanism for approving, in time for
the April update, diagnosis and
procedure code revisions needed to
describe new technologies and medical
services for purposes of the new
technology add-on payment process. We
also established the following process
for making these determinations. Topics
considered during the Fall ICD–10
(previously ICD–9–CM) Coordination
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and Maintenance Committee meeting
are considered for an April 1 update if
a strong and convincing case is made by
the requester at the Committee’s public
meeting. The request must identify the
reason why a new code is needed in
April for purposes of the new
technology process. The participants at
the meeting and those reviewing the
Committee meeting summary report are
provided the opportunity to comment
on this expedited request. All other
topics are considered for the October 1
update. Participants at the Committee
meeting are encouraged to comment on
all such requests. There were not any
requests approved for an expedited
April l, 2018 implementation of a code
at the September 12–13, 2017
Committee meeting. Therefore, there are
not any new codes for implementation
on April 1, 2018.
ICD–9–CM addendum and code title
information is published on the CMS
website at: https://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: https://www.cms.gov/
Medicare/Coding/ICD10/.
CMS also sends copies of all ICD–10–
CM and ICD–10–PCS coding changes to
its Medicare contractors for use in
updating their systems and providing
education to providers.
Information on ICD–10–CM diagnosis
codes, along with the Official ICD–10–
CM Coding Guidelines, can also be
found on the CDC website at: https://
www.cdc.gov/nchs/icd/icd10.htm.
Additionally, information on new,
revised, and deleted ICD–10–CM/ICD–
10–PCS codes is provided to the AHA
for publication in the Coding Clinic for
ICD–10. AHA also distributes coding
update information to publishers and
software vendors.
The following chart shows the
number of ICD–10–CM and ICD–10–PCS
codes and code changes since FY 2016
when ICD–10 was implemented.
TOTAL NUMBER OF CODES AND
CHANGES IN TOTAL NUMBER OF
CODES PER FISCAL YEAR ICD–10–
CM AND ICD–10–PCS CODES
Fiscal year
FY 2016:
ICD–10–CM ..............
ICD–10–PCS .............
FY 2017:
ICD–10–CM ..............
ICD–10–PCS .............
E:\FR\FM\07MYP2.SGM
07MYP2
Number
Change
69,823
71,974
..............
..............
71,486
75,789
+1,663
+3,815
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TOTAL NUMBER OF CODES AND
CHANGES IN TOTAL NUMBER OF
CODES PER FISCAL YEAR ICD–10–
CM AND ICD–10–PCS CODES—
Continued
Fiscal year
Number
FY 2018:
ICD–10–CM ..............
ICD–10–PCS .............
Proposed FY 2019:
ICD–10–CM ..............
ICD–10–PCS .............
Change
71,704
78,705
+218
+2,916
71,902
78,533
+198
¥172
As mentioned previously, the public
is provided the opportunity to comment
on any requests for new diagnosis or
procedure codes discussed at the ICD–
10 Coordination and Maintenance
Committee meeting.
At the September 12–13, 2017 and
March 6–7, 2018 Committee meetings,
we discussed any requests we had
received for new ICD–10–CM diagnosis
codes and ICD–10–PCS procedure codes
that were to be implemented on October
1, 2018. We invited public comments on
any code requests discussed at the
September 12–13, 2017 and March 6–7,
MDC
daltland on DSKBBV9HB2PROD with PROPOSALS2
19. Proposed 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
MS–DRG
001
002
023
1
1
1
1
1
1
1
3
3
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
024
025
026
027
040
041
042
129
130
215
216
217
218
219
220
221
222
223
224
225
226
227
242
243
244
245
258
259
260
261
262
265
266
267
268
269
270
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
20:30 May 04, 2018
hospital received a credit for a replaced
device equal to 50 percent or more of
the cost of the device.
In the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51556 through 51557), we
clarified this policy to state that the
policy applies if the hospital received a
credit equal to 50 percent or more of the
cost of the replacement device and
issued instructions to hospitals
accordingly.
b. Proposed Changes for FY 2019
In this FY 2019 IPPS/LTCH PPS
proposed rule, for FY 2019, we are not
proposing 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 table
below.
We are soliciting public comments on
our proposal to continue to include the
existing MS–DRGs currently subject to
the policy for replaced devices offered
without cost or with credit and to not
add any additional MS–DRGs to the
policy.
MS–DRG title
Pre-MDC ...........
Pre-MDC ...........
1 ........................
VerDate Sep<11>2014
2018 Committee meetings for
implementation as part of the October 1,
2018 update. The deadline for
commenting on code proposals
discussed at the September 12–13, 2017
Committee meeting was November 13,
2017. The deadline for commenting on
code proposals discussed at the March
6–7, 2018 Committee meeting was April
6, 2018.
Heart Transplant or Implant of Heart Assist System with MCC.
Heart Transplant or Implant of Heart Assist System without MCC.
Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator.
Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis without MCC.
Craniotomy & Endovascular Intracranial Procedures with MCC.
Craniotomy & Endovascular Intracranial Procedures with CC.
Craniotomy & Endovascular Intracranial Procedures without CC/MCC.
Peripheral, Cranial Nerve & Other Nervous System Procedures with MCC.
Peripheral, Cranial Nerve & Other Nervous System Procedures with CC or Peripheral Neurostimulator.
Peripheral, Cranial Nerve & Other Nervous System Procedures without CC/MCC.
Major Head & Neck Procedures with CC/MCC or Major Device.
Major Head & Neck Procedures without CC/MCC.
Other Heart Assist System Implant.
Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization with MCC.
Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization with CC.
Cardiac Valve & Other Major Cardiothoracic Procedure with Cardiac Catheterization without CC/MCC.
Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization with MCC.
Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization with CC.
Cardiac Valve & Other Major Cardiothoracic Procedure without Cardiac Catheterization without CC/MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/Heart Failure/Shock with MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization with AMI/Heart Failure/Shock without MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/Heart Failure/Shock with MCC.
Cardiac Defibrillator Implant with Cardiac Catheterization without AMI/Heart Failure/Shock without MCC.
Cardiac Defibrillator Implant without Cardiac Catheterization with MCC.
Cardiac Defibrillator Implant without Cardiac Catheterization without MCC.
Permanent Cardiac Pacemaker Implant with MCC.
Permanent Cardiac Pacemaker Implant with CC.
Permanent Cardiac Pacemaker Implant without CC/MCC.
AICD Generator Procedures.
Cardiac Pacemaker Device Replacement with MCC.
Cardiac Pacemaker Device Replacement without MCC.
Cardiac Pacemaker Revision Except Device Replacement with MCC.
Cardiac Pacemaker Revision Except Device Replacement with CC.
Cardiac Pacemaker Revision Except Device Replacement without CC/MCC.
AICD Lead Procedures.
Endovascular Cardiac Valve Replacement with MCC.
Endovascular Cardiac Valve Replacement without MCC.
Aortic and Heart Assist Procedures Except Pulsation Balloon with MCC.
Aortic and Heart Assist Procedures Except Pulsation Balloon without MCC.
Other Major Cardiovascular Procedures with MCC.
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MDC
5
5
8
8
8
8
8
8
MS–DRG
MS–DRG title
........................
........................
........................
........................
........................
........................
........................
........................
271
272
461
462
466
467
468
469
8 ........................
470
Other Major Cardiovascular Procedures with CC.
Other Major Cardiovascular Procedures without CC/MCC.
Bilateral or Multiple Major Joint Procedures of Lower Extremity with MCC.
Bilateral or Multiple Major Joint Procedures of Lower Extremity without MCC.
Revision of Hip or Knee Replacement with MCC.
Revision of Hip or Knee Replacement with CC.
Revision of Hip or Knee Replacement without CC/MCC.
Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with MCC or Total Ankle Replacement.
Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC.
20. Other Policy Changes: Other
Operating Room (O.R.) and Non-O.R.
Issues
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
cases where we are proposing to change
the designation of procedure codes from
non-O.R. 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. We generally
examine the MS–DRG assignment for
similar procedures, such as the other
approaches for that procedure, to
determine the most appropriate MS–
DRG assignment for procedures newly
designated as O.R. procedures. We are
inviting public comments on these
proposed MS–DRG assignments.
We also 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 below. Instead, we only
discuss MS–DRGs that require explicitly
adding the relevant procedures codes to
the GROUPER logic in order for those
procedure codes to affect the MS–DRG
assignment as intended. In addition,
cases that contain O.R. procedures will
map to MS–DRGs 981, 982, or 983
(Extensive O.R. Procedure Unrelated to
Principal Diagnosis with MCC, with CC,
and without CC/MCC, respectively) or
MS–DRGs 987, 988, or 989 (NonExtensive O.R. Procedure Unrelated to
Principal Diagnosis with MCC, with CC,
and without CC/MCC, respectively)
when they do not contain a principal
daltland on DSKBBV9HB2PROD with PROPOSALS2
ICD–10–PCS
procedure code
00B03ZX
00B13ZX
00B23ZX
00B63ZX
00B73ZX
00B83ZX
00B93ZX
00BA3ZX
00BB3ZX
00BC3ZX
00BD3ZX
00B04ZX
00B14ZX
00B24ZX
00B64ZX
00B74ZX
00B84ZX
00B94ZX
00BA4ZX
00BB4ZX
00BC4ZX
00BD4ZX
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
diagnosis that corresponds to one of the
MDCs to which that procedure is
assigned. These procedures need not be
assigned to MS–DRGs 981 through 989
in order for this to occur. Therefore, if
requestors included some or all of MS–
DRGs 981 through 989 in their request
or included MS–DRGs that require the
presence of any O.R. procedure, we did
not specifically address that aspect in
summarizing their request or our
response to the request in the section
below.
a. Percutaneous and Percutaneous
Endoscopic Excision of Brain and
Cerebral Ventricle
One requestor identified 22 ICD–10–
PCS procedure codes that describe
procedures involving transcranial brain
and cerebral ventricle excision that the
requestor stated would generally require
the resources of an operating room. The
22 procedure codes are listed in the
following table.
Code description
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
Excision
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
brain, percutaneous approach, diagnostic.
cerebral meninges, percutaneous approach, diagnostic.
dura mater, percutaneous approach, diagnostic.
cerebral ventricle, percutaneous approach, diagnostic.
cerebral hemisphere, percutaneous approach, diagnostic.
basal ganglia, percutaneous approach, diagnostic.
thalamus, percutaneous approach, diagnostic.
hypothalamus, percutaneous approach, diagnostic.
pons, percutaneous approach, diagnostic.
cerebellum, percutaneous approach, diagnostic.
medulla oblongata, percutaneous approach, diagnostic.
brain, percutaneous endoscopic approach, diagnostic.
cerebral meninges, percutaneous endoscopic approach, diagnostic.
dura mater, percutaneous endoscopic approach, diagnostic.
cerebral ventricle, percutaneous endoscopic approach, diagnostic.
cerebral hemisphere, percutaneous endoscopic approach, diagnostic.
basal ganglia, percutaneous endoscopic approach, diagnostic.
thalamus, percutaneous endoscopic approach, diagnostic.
hypothalamus, percutaneous endoscopic approach, diagnostic.
pons, percutaneous endoscopic approach, diagnostic.
cerebellum, percutaneous endoscopic approach, diagnostic.
medulla oblongata, percutaneous endoscopic approach, diagnostic.
The requestor stated that, although
percutaneous burr hole biopsies are
performed through smaller openings in
the skull than open burr hole biopsies,
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these procedures require drilling or
cutting through the skull using sterile
technique with anesthesia for pain
control. The requestor also noted that
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similar procedures involving
percutaneous drainage of the subdural
space are currently classified as O.R.
procedures in Version 35 of the ICD–10
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MS–DRGs. However, these 22 ICD–10–
PCS procedure codes are not recognized
as O.R. procedures for purposes of MS–
DRG assignment. The requestor
recommended that the 22 ICD–10–PCS
codes be designated as O.R. procedures
and assigned to MS–DRGs 25, 26, and
27 (Craniotomy and Endovascular
Intracranial Procedures with MCC, with
CC, and without CC/MCC, respectively).
We agree with the requestor that these
procedures typically require the
resources of an operating room.
Therefore, we are proposing to add
these 22 ICD–10–PCS procedure codes
to the FY 2019 ICD–10 MS–DRGs
Version 36 Definitions Manual in
Appendix E—Operating Room
Procedures and Procedure Code/MS–
DRG Index as O.R. procedures assigned
to MS–DRGs 25, 26, and 27 in MDC 1
(Diseases and Disorders of the Nervous
System). We are inviting public
comments on our proposal.
ICD–10–PCS
procedure code
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0JC00ZZ ..............
0JC10ZZ ..............
0JC40ZZ ..............
0JC50ZZ ..............
0JC60ZZ ..............
0JC70ZZ ..............
0JC80ZZ ..............
0JC90ZZ ..............
0JCB0ZZ ..............
0JCC0ZZ ..............
0JCD0ZZ ..............
0JCF0ZZ ..............
0JCG0ZZ ..............
0JCH0ZZ ..............
0JCJ0ZZ ...............
0JCK0ZZ ..............
0JCL0ZZ ..............
0JCM0ZZ .............
0JCN0ZZ ..............
0JCP0ZZ ..............
0JCQ0ZZ ..............
0JCR0ZZ ..............
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
Extirpation
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
matter
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
from
scalp subcutaneous tissue and fascia, open approach.
face subcutaneous tissue and fascia, open approach.
right neck subcutaneous tissue and fascia, open approach.
left neck subcutaneous tissue and fascia, open approach.
chest subcutaneous tissue and fascia, open approach.
back subcutaneous tissue and fascia, open approach.
abdomen subcutaneous tissue and fascia, open approach.
buttock subcutaneous tissue and fascia, open approach.
perineum subcutaneous tissue and fascia, open approach.
pelvic region subcutaneous tissue and fascia, open approach.
right upper arm subcutaneous tissue and fascia, open approach.
left upper arm subcutaneous tissue and fascia, open approach.
right lower arm subcutaneous tissue and fascia, open approach.
left lower arm subcutaneous tissue and fascia, open approach.
right hand subcutaneous tissue and fascia, open approach.
left hand subcutaneous tissue and fascia, open approach.
right upper leg subcutaneous tissue and fascia, open approach.
left upper leg subcutaneous tissue and fascia, open approach.
right lower leg subcutaneous tissue and fascia, open approach.
left lower leg subcutaneous tissue and fascia, open approach.
right foot subcutaneous tissue and fascia, open approach.
left foot subcutaneous tissue and fascia, open approach.
(Other Skin, Subcutaneous Tissue and
Breast Procedures with MCC, CC, and
without CC/MCC, respectively).
We disagree with the requestor that
these procedures typically require the
resources of an operating room. Our
clinical advisors indicated that these
open extirpation procedures are minor
procedures that can be performed
outside of an operating room, such as in
a radiology suite with CT or MRI
guidance. We disagree that these
procedures are similar to open drainage
procedures. Therefore, we are proposing
to maintain the status of these 22 ICD–
10–PCS procedure codes as non-O.R.
procedures. We are inviting public
comments on our proposal.
c. Open Scrotum and Breast Procedures
One requestor identified 13 ICD–10–
PCS procedure codes that describe
procedures involving open drainage,
open extirpation, and open
ICD–10–PCS
procedure code
VerDate Sep<11>2014
One requestor identified 22 ICD–10–
PCS procedure codes that describe
procedures involving open extirpation
of subcutaneous tissue and fascia that
the requestor stated would generally
require the resources of an operating
room. The 22 procedure codes are listed
in the following table.
Code description
The requestor stated that these
procedures involve making an open
incision deeper than the skin under
general anesthesia, and that irrigation
and/or excision of devitalized tissue or
cavity are often required and are
considered inherent to the procedure.
The requestor also stated that open
drainage of subcutaneous tissue and
fascia, open excisional debridement of
subcutaneous tissue and fascia, and
open nonexcisional debridement/
extraction of subcutaneous tissue and
fascia are designated as O.R. procedures,
and that these 22 procedures should be
designated as O.R. procedures for the
same reason. In the ICD–10 MS–DRGs
Version 35, these 22 ICD–10–PCS
procedure codes are not recognized as
O.R. procedures for purposes of MS–
DRG assignment. The requestor
recommended that the 22 ICD–10–PCS
procedure codes listed in the table be
assigned to MS–DRGs 579, 580, and 581
0V950ZZ ..............
0VB50ZZ ..............
0VC50ZZ ..............
b. Open Extirpation of Subcutaneous
Tissue and Fascia
debridement/excision of the scrotum
and breast. The requestor stated that the
13 procedures listed in the following
table involve making an open incision
deeper than the skin under general
anesthesia, and that irrigation and/or
excision of devitalized tissue or cavity
are often required and are considered
inherent to the procedure. The requestor
also stated that open drainage of
subcutaneous tissue and fascia, open
excisional debridement of subcutaneous
tissue and fascia, open non-excisional
debridement/extraction of subcutaneous
tissue and fascia, and open excision of
breast are designated as O.R.
procedures, and that these 13
procedures should be designated as O.R.
procedures for the same reason. In the
ICD–10 MS–DRGs Version 35, these 13
ICD–10–PCS procedure codes are not
recognized as O.R. procedures for
purposes of MS–DRG assignment.
Code description
Drainage of scrotum, open approach.
Excision of scrotum, open approach.
Extirpation of matter from scrotum, open approach.
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ICD–10–PCS
procedure code
0H9U0ZZ ..............
0H9T0ZZ ..............
0H9V0ZZ ..............
0H9W0ZZ .............
0H9X0ZZ ..............
0HCT0ZZ .............
0HCU0ZZ .............
0HCV0ZZ .............
0HCW0ZZ ............
0HCX0ZZ .............
Code description
Drainage of left breast, open approach.
Drainage of right breast, open approach.
Drainage of bilateral breast, open approach.
Drainage of right nipple, open approach.
Drainage of left nipple, open approach.
Extirpation of matter from right breast, open approach.
Extirpation of matter from left breast, open approach.
Extirpation of matter from bilateral breast, open approach.
Extirpation of matter from right nipple, open approach.
Extirpation of matter from left nipple, open approach.
The requestor recommended that the
3 ICD–10–PCS scrotal procedure codes
be assigned to MS–DRGs 717 and 718
(Other Male Reproductive System O.R.
Procedures Except Malignancy with CC/
MCC and without CC/MCC,
respectively) and the 10 breast
procedure codes be assigned to MS–
DRGs 584 and 585 (Breast Biopsy, Local
Excision and Other Breast Procedures
with CC/MCC and without CC/MCC,
respectively).
We agree with the requestor that these
procedures typically require the
resources of an operating room due to
the nature of breast and scrotal tissue,
as well as with the MS–DRG
assignments recommended by the
requestor. In addition, we believe that
the scrotal codes should also be
assigned to MS–DRGs 715 and 716
(Other Male Reproductive System O.R.
Procedures for Malignancy with CC/
MCC and without CC/MCC,
respectively). Therefore, we are
proposing to add these 13 ICD–10–PCS
procedure codes to the FY 2019 ICD–10
MS–DRGs Version 36 Definitions
Manual in Appendix E—Operating
Room Procedures and Procedure Code/
MS–DRG Index as O.R. procedures,
assigned to MS–DRGs 715, 716, 717,
and 718 in MDC 12 (Diseases and
Disorders of the Male Reproductive
ICD–10–PCS
procedure code
daltland on DSKBBV9HB2PROD with PROPOSALS2
0C980ZZ ..............
0C990ZZ ..............
0C9G0ZZ .............
0C9H0ZZ ..............
0CC80ZZ ..............
0CC90ZZ ..............
0CCG0ZZ .............
0CCH0ZZ .............
System) for the scrotal procedure codes
and assigned to MS–DRGs 584 and 585
in MDC 9 (Diseases and Disorders of the
Skin, Subcutaneous Tissue & Breast) for
the breast procedure codes. We are
inviting public comments on our
proposal.
d. Open Parotid Gland and
Submaxillary Gland Procedures
One requestor identified eight ICD–
10–PCS procedure codes that describe
procedures involving open drainage and
open extirpation of the parotid or
submaxillary glands, shown in the
following table.
Code description
Drainage of right parotid gland, open approach.
Drainage of left parotid gland, open approach.
Drainage of right submaxillary gland, open approach.
Drainage of left submaxillary gland, open approach.
Extirpation of matter from right parotid gland, open approach.
Extirpation of matter from left parotid gland, open approach.
Extirpation of matter from right submaxillary gland, open approach.
Extirpation of matter from left submaxillary gland, open approach.
The requestor stated that these
procedures involve making an open
incision through subcutaneous tissue,
fascia, and potentially muscle, to reach
and incise the parotid or submaxillary
gland under general anesthesia, and that
irrigation and/or excision of devitalized
tissue or cavity may be required and are
considered inherent to the procedure.
The requestor also stated that open
drainage of subcutaneous tissue and
fascia, open excisional debridement of
subcutaneous tissue and fascia, and
open non-excisional debridement/
extraction of subcutaneous tissue and
fascia are designated as O.R. procedures,
and that these eight procedures should
be designated as O.R. procedures for the
same reason. In the ICD–10 MS–DRGs
Version 35, these eight ICD–10–PCS
procedure codes are not recognized as
VerDate Sep<11>2014
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Jkt 244001
O.R. procedures for purposes of MS–
DRG assignment. The requestor
requested that these procedures be
assigned to MS–DRG 139 (Salivary
Gland Procedures).
We agree with the requestor that these
eight procedures typically require the
resources of an operating room.
Therefore, we are proposing to add
these ICD–10–PCS procedure codes to
the FY 2019 ICD–10 MS–DRGs Version
36 Definitions Manual in Appendix E—
Operating Room Procedures and
Procedure Code/MS–DRG Index as O.R.
procedures assigned to MS–DRG 139 in
MDC 3 (Diseases and Disorders of the
Ear, Nose, Mouth and Throat). We are
inviting public comments on our
proposal.
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e. Removal and Reinsertion of Spacer;
Knee Joint and Hip Joint
One requestor identified four sets of
ICD–10–PCS procedure code
combinations (eight ICD–10–PCS codes)
that describe procedures involving open
removal and insertion of spacers into
the knee or hip joints, shown in the
following table. The requestor stated
that these are invasive procedures
involving removal and reinsertion of
devices into major joints and are
performed in the operating room under
general anesthesia. In the ICD–10 MS–
DRGs Version 35, these four ICD–10–
PCS procedure code combinations are
not recognized as O.R. procedures for
purposes of MS–DRG assignment. The
requestor recommended that CMS
determine the most appropriate surgical
DRGs for these procedures.
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ICD–10–PCS
procedure code
0SPC08Z
0SHC08Z
0SPD08Z
0SHD08Z
0SP908Z
0SH908Z
0SPB08Z
0SHB08Z
..............
.............
..............
.............
..............
..............
..............
..............
Code description
Removal of spacer from right knee joint, open approach.
Insertion of spacer into right knee joint, open approach.
Removal of spacer from left knee joint, open approach.
Insertion of spacer into left knee joint, open approach.
Removal of spacer from right hip joint, open approach.
Insertion of spacer into right hip joint, open approach.
Removal of spacer from left hip joint, open approach.
Insertion of spacer into left hip joint, open approach.
We agree with the requestor that these
procedures typically require the
resources of an operating room.
However, our clinical advisors indicated
that these codes should be designated as
O.R. procedures even when reported as
stand-alone procedures. Therefore, for
the knee procedures, we are proposing
to add these four ICD–10–PCS
procedure codes to the FY 2019 ICD–10
MS–DRGs Version 36 Definitions
Manual in Appendix E—Operating
Room Procedures and Procedure Code/
MS–DRG Index as O.R. procedures
assigned to MS–DRGs 485, 486, and 487
(Knee Procedures with Principal
Diagnosis of Infection with MCC, with
CC, and without CC/MCC, respectively)
or MS–DRGs 488 and 489 (Knee
Procedures without Principal diagnosis
of Infection with CC/MCC and without
CC/MCC, respectively), both in MDC 8
(Diseases and Disorders of the
Musculoskeletal System and Connective
Tissue). For the hip procedures, we are
proposing to add these four ICD–10–
PCS procedure codes to the FY 2019
ICD–10 MS–DRGs Version 36
Definitions Manual in Appendix E—
Operating Room Procedures and
Procedure Code/MS–DRG Index as O.R.
procedures assigned to MS–DRGs 480,
ICD–10–PCS
procedure code
daltland on DSKBBV9HB2PROD with PROPOSALS2
0T778DZ ..............
0T768DZ ..............
0T788DZ ..............
One requestor identified the following
three ICD–10–PCS procedure codes that
describe procedures involving
endoscopic dilation of ureter(s) with
intraluminal device.
Dilation of left ureter with intraluminal device, via natural or artificial opening endoscopic.
Dilation of right ureter with intraluminal device, via natural or artificial opening endoscopic.
Dilation of bilateral ureters with intraluminal device, via natural or artificial opening endoscopic.
Neoplasm with MCC, with CC, and
without CC/MCC, respectively) and
MS–DRGs 659, 660, and 661 (Kidney
and Ureter Procedures for NonNeoplasm with MCC, with CC, and
without CC/MCC, respectively).
We agree with the requestor that these
procedures typically require the
resources of an operating room. In
addition to the MS–DRGs recommended
by the requestor, we believe that these
procedure codes should also be assigned
to other MS–DRGs, consistent with the
assignment of other dilation of ureter
procedures: MS–DRG 907, 908, and 909
(Other O.R. Procedures for Injuries with
MCC, with CC, and without CC/MCC,
respectively) and MS–DRGs 957, 958,
and 959 (Other O.R. Procedures for
Multiple Significant Trauma with MCC,
with CC, and without CC/MCC,
respectively). Therefore, we are
proposing to add the three ICD–10–PCS
procedure codes identified by the
requestor to the FY 2019 ICD–10 MS–
ICD–10–PCS
procedure code
VerDate Sep<11>2014
f. Endoscopic Dilation of Ureter(s) With
Intraluminal Device
Code description
The requestor stated that these
procedures involve the use of
cystoureteroscopy to view the bladder
and ureter and dilation under
visualization, which are often followed
by placement of a ureteral stent. The
requestor also stated that endoscopic
extirpation of matter from ureter,
endoscopic biopsy of bladder,
endoscopic dilation of bladder,
endoscopic dilation of renal pelvis, and
endoscopic dilation of the ureter
without insertion of intraluminal device
are all assigned to surgical DRGs, and
that these three procedures should be
designated as O.R. procedures for the
same reason. In the ICD–10 MS–DRGs
Version 35, these three ICD–10–PCS
procedure codes are not recognized as
O.R. procedures for purposes of MS–
DRG assignment. The requestor
recommended that these procedures be
assigned to MS–DRGs 656, 657, and 658
(Kidney and Ureter Procedures for
0W9D4ZZ .............
0W9D40Z .............
0W9D4ZX .............
481, and 482 (Hip and Femur
Procedures Except Major Joint with
MCC, with CC, and without CC/MCC,
respectively) in MDC 8 (Diseases and
Disorders of the Musculoskeletal System
and Connective Tissue). We are inviting
public comments on our proposal.
DRGs Version 36 Definitions Manual in
Appendix E—Operating Room
Procedures and Procedure Code/MS–
DRG Index as O.R. procedures assigned
to MS–DRGs 656, 657, and 658 in MDC
11 (Diseases and Disorders of the
Kidney and Urinary Tract), MS–DRGs
659, 660, and 661 in MDC 11, MS–DRGs
907, 908, and 909 in MDC 21 (Injuries,
Poisonings and Toxic Effects of Drugs),
and MS–DRGs 957, 958, and 959 in
MDC 24 (Multiple Significant Trauma).
We are inviting public comments on our
proposal.
g. Thoracoscopic Procedures of
Pericardium and Pleura
One requestor identified seven ICD–
10–PCS procedure codes that describe
procedures involving thoracoscopic
drainage of the pericardial cavity or
pleural cavity, or extirpation of matter
from the pleura, as shown in the
following table.
Code description
Drainage of pericardial cavity, percutaneous endoscopic approach.
Drainage of pericardial cavity with drainage device, percutaneous endoscopic approach.
Drainage of pericardial cavity, percutaneous endoscopic approach, diagnostic.
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ICD–10–PCS
procedure code
0W994ZX
0W9B4ZX
0BCP4ZZ
0BCN4ZZ
.............
.............
.............
.............
Code description
Drainage of right pleural cavity, percutaneous endoscopic approach, diagnostic.
Drainage of left pleural cavity, percutaneous endoscopic approach, diagnostic.
Extirpation of matter from left pleura, percutaneous endoscopic approach.
Extirpation of matter from right pleura, percutaneous endoscopic approach.
The requestor stated that these
procedures involve making an incision
through the chest wall and inserting a
thoracoscope for visualization of
thoracic structures during the
procedure. The requestor also stated
that some thoracoscopic procedures are
assigned to surgical MS–DRGs, while
other procedures are assigned to
medical MS–DRGs. In the ICD–10 MS–
DRGs Version 35, these seven ICD–10–
PCS procedure codes are not recognized
as O.R. procedures for purposes of MS–
DRG assignment.
We agree with the requestor that these
procedures typically require the
ICD–10–PCS
procedure code
0BCP0ZZ .............
0BCN0ZZ .............
Extirpation of matter from left pleura, open approach.
Extirpation of matter from right pleura, open approach.
with MCC, with CC, and without CC/
MCC, respectively) in MDC 5 (Diseases
and Disorders of the Circulatory
System); MS–DRGs 820, 821, and 822
(Lymphoma and Leukemia with Major
O.R. Procedure with MCC, with CC, and
without CC/MCC, respectively) in MDC
17 (Myeloproliferative Diseases and
Disorders, Poorly Differentiated
Neoplasms); MS–DRGs 826, 827, and
828 (Myeloproliferative Disorders or
Poorly Differentiated Neoplasms with
Major O.R. Procedure with MCC, with
CC, and without CC/MCC, respectively)
in MDC 17; MS–DRGs 907, 908, and 909
(Other O.R. Procedures for Injuries with
MCC, with CC, and without CC/MCC,
respectively) in MDC 21 (Injuries,
daltland on DSKBBV9HB2PROD with PROPOSALS2
ICD–10–PCS
procedure code
Poisonings and Toxic Effects of Drugs);
and MS–DRGs 957, 958, and 959 (Other
O.R. Procedures for Multiple Significant
Trauma with MCC, with CC, and
without CC/MCC, respectively) in MDC
24 (Multiple Significant Trauma). We
are inviting public comments on our
proposal.
h. Open Insertion of Totally Implantable
and Tunneled Vascular Access Devices
One requestor identified 20 ICD–10–
PCS procedure codes that describe
procedures involving open insertion of
totally implantable and tunneled
vascular access devices. The codes are
identified in the following table.
Code description
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
Insertion
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
of
totally implantable vascular access device into chest subcutaneous tissue and fascia, open approach.
tunneled vascular access device into chest subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into abdomen subcutaneous tissue and fascia, open approach.
tunneled vascular access device into abdomen subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into right upper arm subcutaneous tissue and fascia, open approach.
tunneled vascular access device into right upper arm subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into left upper arm subcutaneous tissue and fascia, open approach.
tunneled vascular access device into left upper arm subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into right lower arm subcutaneous tissue and fascia, open approach.
tunneled vascular access device into right lower arm subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into left lower arm subcutaneous tissue and fascia, open approach.
tunneled vascular access device into left lower arm subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into right upper leg subcutaneous tissue and fascia, open approach.
tunneled vascular access device into right upper leg subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into left upper leg subcutaneous tissue and fascia, open approach.
tunneled vascular access device into left upper leg subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into right lower leg subcutaneous tissue and fascia, open approach.
tunneled vascular access device into right lower leg subcutaneous tissue and fascia, open approach.
totally implantable vascular access device into left lower leg subcutaneous tissue and fascia, open approach.
tunneled vascular access device into left lower leg subcutaneous tissue and fascia, open approach.
The requestor stated that open
procedures to insert totally implantable
VerDate Sep<11>2014
resources of an operating room, as well
as significant time and skill. During our
review, we noted that the following two
related procedures using the open
approach also were not currently
recognized as O.R. procedures:
Code description
Therefore, to be consistent with the
MS–DRGs to which other approaches
for procedures involving drainage or
extirpation of matter from the pleura are
assigned, we are proposing to add these
nine ICD–10–PCS procedure codes to
the FY 2019 ICD–10 MS–DRGs Version
36 Definitions Manual in Appendix E—
Operating Room Procedures and
Procedure Code/MS–DRG Index as O.R.
procedures assigned to one of the
following MS–DRGs: MS–DRGs 163,
164, and 165 (Major Chest Procedures
with MCC, with CC, and without CC/
MCC, respectively) in MDC 4 (Diseases
and Disorders of the Respiratory
System); MS–DRGs 270, 271, and 272
(Other Major Cardiovascular Procedures
0JH60WZ .............
0JH60XZ ..............
0JH80WZ .............
0JH80XZ ..............
0JHD0WZ .............
0JHD0XZ ..............
0JHF0WZ .............
0JHF0XZ ..............
0JHG0WZ ............
0JHG0XZ .............
0JHH0WZ .............
0JHH0XZ ..............
0JHL0WZ .............
0JHL0XZ ..............
0JHM0WZ ............
0JHM0XZ .............
0JHN0WZ .............
0JHN0XZ ..............
0JHP0WZ .............
0JHP0XZ ..............
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vascular access devices (VAD) involve
implantation of a port by open
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approach, cutting through subcutaneous
tissue/fascia, placing the device, and
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then closing tissues so that none of the
device is exposed. The requestor
explained that open procedures to insert
tunneled VADs involve insertion of the
catheter into central vasculature, and
then open incision of subcutaneous
tissue and fascia through which the
device is tunneled. The requestor also
indicated that these procedures require
two ICD–10–PCS codes: One for the
insertion of the VAD or port within the
subcutaneous tissue; and one for
percutaneous insertion of the central
venous catheter that is connected to the
device. The requestor further noted that,
in MDC 11, cases with these procedure
codes are assigned to surgical MS–DRGs
and that insertion of infusion pumps by
open approach groups to surgical MS–
DRGs. The requestor recommended that
these procedures be assigned to surgical
MS–DRGs in MDC 09 as well. We
examined the O.R. designations for this
group of procedures and determined
that they currently are designated as
non-O.R. procedures for MDC 09 and
MDC 11.
We agree with the requestor that
procedures involving open insertion of
totally implantable VAD procedures
typically require the resources of an
operating room. However, we disagree
that the tunneled VAD procedures
typically require the resources of an
operating room. Therefore, we are
proposing to update the FY 2019 ICD–
10 MS–DRGs Version 36 Definitions
Manual in Appendix E—Operating
Room Procedures and Procedure Code/
MS–DRG Index to designate the 10 ICD–
10–PCS procedure codes describing the
totally implantable VAD procedures as
O.R. procedures, which will continue to
be assigned to MS–DRGs 579, 580, and
581 (Other Skin, Subcutaneous Tissue
and Breast Procedures with MCC, with
CC, and without CC/MCC, respectively)
in MDC 9 (Diseases and Disorders of the
ICD–10–PCS
procedure code
0SS034Z ..............
0SS334Z ..............
0SS534Z ..............
0SS634Z ..............
0SS734Z ..............
0SS834Z ..............
0SS934Z ..............
0SSB34Z ..............
0SSC34Z ..............
0SSD34Z ..............
0SSF34Z ..............
0SSG34Z .............
0SSH34Z ..............
0SSJ34Z ..............
0SSK34Z ..............
0SSL34Z ..............
0SSM34Z .............
0SSN34Z ..............
0SSP34Z ..............
0SSQ34Z .............
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
Reposition
daltland on DSKBBV9HB2PROD with PROPOSALS2
VerDate Sep<11>2014
One requestor identified 20 ICD–10–
PCS procedure codes that describe
procedures involving percutaneous joint
reposition with internal fixation device,
shown in the following table.
lumbar vertebral joint with internal fixation device, percutaneous approach.
lumbosacral joint with internal fixation device, percutaneous approach.
sacrococcygeal joint with internal fixation device, percutaneous approach.
coccygeal joint with internal fixation device, percutaneous approach.
right sacroiliac joint with internal fixation device, percutaneous approach.
left sacroiliac joint with internal fixation device, percutaneous approach.
right hip joint with internal fixation device, percutaneous approach.
left hip joint with internal fixation device, percutaneous approach.
right knee joint with internal fixation device, percutaneous approach.
left knee joint with internal fixation device, percutaneous approach.
right ankle joint with internal fixation device, percutaneous approach.
left ankle joint with internal fixation device, percutaneous approach.
right tarsal joint with internal fixation device, percutaneous approach.
left tarsal joint with internal fixation device, percutaneous approach.
right tarsometatarsal joint with internal fixation device, percutaneous approach.
left tarsometatarsal joint with internal fixation device, percutaneous approach.
right metatarsal-phalangeal joint with internal fixation device, percutaneous approach.
left metatarsal-phalangeal joint with internal fixation device, percutaneous approach.
right toe phalangeal joint with internal fixation device, percutaneous approach.
left toe phalangeal joint with internal fixation device, percutaneous approach.
recognized as O.R. procedures for
purposes of MS–DRG assignment.
We disagree with the requestor that
these procedures typically require the
resources of an operating room, as these
procedures are not as invasive as the
bone reposition procedures referenced
by the requestor. Our clinical advisors
advised that these procedures are
typically performed in a radiology suite.
Therefore, we are proposing to maintain
ICD–10–PCS
procedure code
..............
..............
..............
..............
i. Percutaneous Joint Reposition With
Internal Fixation Device
Code description
The requestor stated that reposition of
the sacrum, femur, tibia, fibula, and
other fractures of bone with internal
fixation device by percutaneous
approach are assigned to surgical DRGs,
and that reposition of sacroiliac, hip,
knee, and other joint locations with
internal fixation should therefore also
be assigned to surgical DRGs. In the
ICD–10 MS–DRGs Version 35, these 20
ICD–10–PCS procedure codes are not
0D5A8ZZ
0D5B8ZZ
0D5C8ZZ
0D588ZZ
Skin, Subcutaneous Tissue and Breast)
and MS–DRGs 673, 674, and 675 (Other
Kidney and Urinary Tract Procedures,
with CC, with MCC, and without CC/
MCC, respectively) in MDC 11 (Diseases
and Disorders of the Kidney and
Urinary Tract). We note that these
procedures already affect MS–DRG
assignment to these MS–DRGs.
However, if the procedure is unrelated
to the principal diagnosis, it will be
assigned to MS–DRGs 981, 982, and 983
instead of a medical MS-DRG. We are
inviting public comments on our
proposal.
the status of these 20 ICD–10–PCS
procedure codes as non-O.R.
procedures. We are inviting public
comments on our proposal.
j. Endoscopic Destruction of Intestine
One requestor identified four ICD–10–
PCS procedure codes that describe
procedures involving endoscopic
destruction of the intestine, as shown in
the following table.
Code description
Destruction
Destruction
Destruction
Destruction
20:30 May 04, 2018
of
of
of
of
jejunum, via natural or artificial opening endoscopic.
ileum, via natural or artificial opening endoscopic.
ileocecal valve, via natural or artificial opening endoscopic.
small intestine, via natural or artificial opening endoscopic.
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The requestor stated that these
procedures are rarely performed in the
operating room. In the ICD–10 MS–
DRGs Version 35, these 20 ICD–10–PCS
procedure codes are currently
recognized as O.R. procedures for
purposes of MS–DRG assignment.
We agree with the requestor that these
procedures do not typically require the
resources of an operating room.
Therefore, we are proposing to remove
these four procedure codes from the FY
2019 ICD–10 MS–DRGs Version 36
Definitions Manual in Appendix E—
Operating Room Procedures and
Procedure Code/MS–DRG Index as O.R.
procedures. We are inviting public
comments on our proposal.
ICD–10–PCS
procedure code
0B9J8ZX ..............
0B9F8ZX ..............
We agree with the requestor that these
procedures do not require the resources
of an operating room. In addition, while
we were reviewing this comment, we
identified three additional related
codes:
Code description
Drainage of right middle lung lobe, via natural or artificial opening endoscopic, diagnostic.
Drainage of right upper lung lobe, via natural or artificial opening endoscopic, diagnostic.
Drainage of left upper lung lobe, via natural or artificial opening endoscopic, diagnostic.
In the ICD–10 MS–DRGs Version 35,
these ICD–10–PCS procedure codes are
currently recognized as O.R. procedures
for purposes of MS–DRG assignment.
We are proposing to remove ICD–10–
PCS procedure codes 0B9J8ZX,
0B9F8ZX, 0B9D8ZX, 0B9C8ZX, and
0B9G8ZX from the FY 2019 ICD–10
MS–DRGs Version 36 Definitions
Manual in Appendix E—Operating
Room Procedures and Procedure Code/
MS–DRG Index as O.R. procedures. We
are inviting public comments on our
proposal.
G. Recalibration of the Proposed FY
2019 MS–DRG Relative Weights
1. Data Sources for Developing the
Proposed Relative Weights
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One requestor identified the following
ICD–10–PCS procedure codes that
describe procedures involving
endoscopic drainage of the lung via
natural or artificial opening for
diagnostic purposes.
Drainage of left lower lung lobe, via natural or artificial opening endoscopic, diagnostic.
Drainage of right lower lung lobe, via natural or artificial opening endoscopic, diagnostic.
ICD–10–PCS
procedure code
In developing the proposed FY 2019
system of weights, we are proposing to
use two data sources: Claims data and
cost report data. As in previous years,
the claims data source is the MedPAR
file. This file is based on fully coded
diagnostic and procedure data for all
Medicare inpatient hospital bills. The
FY 2017 MedPAR data used in this
proposed rule include discharges
occurring on October 1, 2016, through
September 30, 2017, based on bills
received by CMS through December 31,
2017, from all hospitals subject to the
IPPS and short-term, acute care
hospitals in Maryland (which at that
time were under a waiver from the
IPPS). The FY 2017 MedPAR file used
in calculating the proposed relative
weights includes data for approximately
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k. Drainage of Lower Lung Via Natural
or Artificial Opening Endoscopic,
Diagnostic
Code description
The requestor stated that these
procedures are rarely performed in the
operating room.
0B9D8ZX ..............
0B9C8ZX ..............
0B9G8ZX .............
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9,652,400 Medicare discharges from
IPPS providers. Discharges for Medicare
beneficiaries enrolled in a Medicare
Advantage managed care plan are
excluded from this analysis. These
discharges are excluded when the
MedPAR ‘‘GHO Paid’’ indicator field on
the claim record is equal to ‘‘1’’ or when
the MedPAR DRG payment field, which
represents the total payment for the
claim, is equal to the MedPAR ‘‘Indirect
Medical Education (IME)’’ payment
field, indicating that the claim was an
‘‘IME only’’ claim submitted by a
teaching hospital on behalf of a
beneficiary enrolled in a Medicare
Advantage managed care plan. In
addition, the December 31, 2017 update
of the FY 2017 MedPAR file complies
with version 5010 of the X12 HIPAA
Transaction and Code Set Standards,
and includes a variable called ‘‘claim
type.’’ Claim type ‘‘60’’ indicates that
the claim was an inpatient claim paid as
fee-for-service. Claim types ‘‘61,’’ ‘‘62,’’
‘‘63,’’ and ‘‘64’’ relate to encounter
claims, Medicare Advantage IME
claims, and HMO no-pay claims.
Therefore, the calculation of the
proposed relative weights for FY 2019
also excludes claims with claim type
values not equal to ‘‘60.’’ The data
exclude CAHs, including hospitals that
subsequently became CAHs after the
period from which the data were taken.
We note that the proposed FY 2019
relative weights are based on the
ICD-10-CM diagnoses and ICD–10–PCS
procedure codes from the FY 2017
MedPAR claims data, grouped through
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the ICD-10 version of the proposed FY
2019 GROUPER (Version 36).
The second data source used in the
cost-based relative weighting
methodology is the Medicare cost report
data files from the HCRIS. Normally, we
use the HCRIS dataset that is 3 years
prior to the IPPS fiscal year.
Specifically, we used cost report data
from the December 31, 2017 update of
the FY 2016 HCRIS for calculating the
proposed FY 2019 cost-based relative
weights.
2. Methodology for Calculation of the
Proposed Relative Weights
As we explain in section II.E.2. of the
preamble of this proposed rule, we
calculated the proposed FY 2019
relative weights based on 19 CCRs, as
we did for FY 2018. The methodology
we are proposing to use to calculate the
FY 2019 MS–DRG cost-based relative
weights based on claims data in the FY
2017 MedPAR file and data from the FY
2016 Medicare cost reports is as follows:
• To the extent possible, all the
claims were regrouped using the
proposed FY 2019 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 proposed relative
weights for heart and heart-lung, liver
and/or intestinal, and lung transplants
(MS–DRGs 001, 002, 005, 006, and 007,
respectively) were limited to those
Medicare-approved transplant centers
that have cases in the FY 2017 MedPAR
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file. (Medicare coverage for heart,
heart-lung, liver and/or intestinal, and
lung transplants is limited to those
facilities that have received approval
from CMS as transplant centers.)
• Organ acquisition costs for kidney,
heart, heart-lung, liver, lung, pancreas,
and intestinal (or multivisceral organs)
transplants continue to be paid on a
reasonable cost basis. Because these
acquisition costs are paid separately
from the prospective payment rate, it is
necessary to subtract the acquisition
charges from the total charges on each
transplant bill that showed acquisition
charges before computing the average
cost for each MS–DRG and before
eliminating statistical outliers.
• Claims with total charges or total
lengths of stay less than or equal to zero
were deleted. Claims that had an
amount in the total charge field that
differed by more than $30.00 from the
sum of the routine day charges,
intensive care charges, pharmacy
charges, implantable devices charges,
supplies and equipment charges,
therapy services charges, operating
room charges, cardiology charges,
laboratory charges, radiology charges,
other service charges, labor and delivery
charges, inhalation therapy charges,
emergency room charges, blood and
blood products charges, anesthesia
charges, cardiac catheterization charges,
CT scan charges, and MRI charges were
also deleted.
• At least 92.5 percent of the
providers in the MedPAR file had
charges for 14 of the 19 cost centers. All
claims of providers that did not have
charges greater than zero for at least 14
of the 19 cost centers were deleted. In
other words, a provider must have no
more than five blank cost centers. If a
provider did not have charges greater
than zero in more than five cost centers,
the claims for the provider were deleted.
• Statistical outliers were eliminated
by removing all cases that were beyond
3.0 standard deviations from the
geometric mean of the log distribution
of both the total charges per case and
the total charges per day for each MS–
DRG.
• Effective October 1, 2008, because
hospital inpatient claims include a POA
indicator field for each diagnosis
present on the claim, only for purposes
of relative weight-setting, the POA
indicator field was reset to ‘‘Y’’ for
‘‘Yes’’ for all claims that otherwise have
an ‘‘N’’ (No) or a ‘‘U’’ (documentation
insufficient to determine if the
condition was present at the time of
inpatient admission) in the POA field.
Under current payment policy, the
presence of specific HAC codes, as
indicated by the POA field values, can
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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
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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 they were not
participating in those models under the
BPCI initiative. We refer readers to the
FY 2013 IPPS/LTCH PPS final rule for
a complete discussion on our final
policy for the treatment of hospitals
participating in the BPCI Initiative in
our ratesetting process.
The participation of hospitals in the
BPCI initiative is set to conclude on
September 30, 2018. The participation
of hospitals in the Bundled Payments
for Care Improvement (BPCI) Advanced
model is set to start on October 1, 2018.
The BPCI Advanced model, tested
under the authority of section 3021 of
the Affordable Care Act (codified at
section 1115A of the Act), is comprised
of a single payment and risk track,
which bundles payments for multiple
services beneficiaries receive during a
Clinical Episode. Acute care hospitals
may participate in BPCI Advanced in
one of two capacities: As a model
Participant or as a downstream Episode
Initiator. Regardless of the capacity in
which they participate in the BPCI
Advanced model, participating acute
care hospitals will continue to receive
IPPS payments under section 1886(d) of
the Act. Acute care hospitals that are
Participants also assume financial and
quality performance accountability for
Clinical Episodes in the form of a
reconciliation payment. For additional
information on the BPCI Advanced
model, we refer readers to the BPCI
Advanced webpage on the CMS Center
for Medicare and Medicaid Innovation’s
website at: https://innovation.cms.gov/
initiatives/bpci-advanced/. For FY 2019,
consistent with how we have treated
hospitals that participated in the BPCI
Initiative, we believe it is appropriate to
include all applicable data from the
subsection (d) hospitals participating in
the BPCI Advanced model in our IPPS
payment modeling and ratesetting
calculations because, as noted above,
these hospitals are still receiving IPPS
payments under section 1886(d) of the
Act.
The charges for each of the proposed
19 cost groups for each claim were
standardized to remove the effects of
differences in proposed area wage
levels, IME and DSH payments, and for
hospitals located in Alaska and Hawaii,
the applicable proposed 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 proposed geographic
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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 proposed 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
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developed from the FY 2016 cost report
data.
The 19 cost centers that we used in
the proposed relative weight calculation
are shown in the following table. The
table shows the lines on the cost report
and the corresponding revenue codes
that we used to create the proposed 19
national cost center CCRs. If
stakeholders have comments about the
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20259
groupings in this table, we may consider
those comments as we finalize our
policy.
We are inviting public comments on
our proposals related to recalibration of
the proposed FY 2019 relative weights
and the changes in relative weights from
FY 2018.
BILLING CODE 4120–01–P
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Codes
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014X
Routine Da s
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Semi-Private
Room
Charges
Pediatrics
(General
Routine Care
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
Form CMS2552-10
Medicare
Charges from
HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
C 1 C5 30
C 1 C6 30
D3 HOS C2 30
I 012X, 013X
and 016X
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Intensive
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C 1 C5 31 I C 1 C6 31 I D3 HOS C2 31
Coronary
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Intensive
Davs
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(Worksheet
C, Part 1,
Column 5
and line
number)
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MedPAR
Charge Field
Cost Report
Line
Descriotion
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
Form CMS2552-10
Medicare
Charges from
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(Worksheet D-3,
Column & line
number)
Form CMS2552-10
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Surgical
Intensive Care
Unit
I C 1 C5 34 I C 1 C6 34 I D3 HOS C2 34
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Drugs
I Charges
I and 063X
I !i~'i
Therapy
IC
1 C5 64
IC
1 C6 64
I D3
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Cost Center
Revenue
Codes
contained in
MedPAR
Chame Field
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
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HOS C2 64
20261
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MedPAR
Char e Field
Revenue
Codes
contained in
MedPAR
Charges
from
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(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
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c
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Supplies and
Eauioment
Medical/Surgical Supply
Charges
0270, 0271,
0272, 0273,
0274, 0277,
0279,and
0621, 0622,
0623
Medical
Supplies
Charged to
Patients
1 C5 73
C 1 C5 71
Ic
1 C6 73
C 1 C6 71
C 1 C7 71
EP07MY18.004
Medicare
Charges from
HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
I D3
HOS
cz
73
D3 HOS C2 71
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Cost Center
Cost from
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(Worksheet
C, Part 1,
Column 5
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number)
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MedPAR
Charge Field
Durable
Medical
Equipment
Charges
0290, 0291,
0292 and
0294-0299
Medicare
Charges from
HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
DME-Rented
I
Cost Report
Line
Description
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
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number)
Form CMS2552-10
C 1 C5 96
C 1 C6 96
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Used Durable
Medical
Charges
0293
DME-Sold
C 1 C5 97
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Implantable
Devices
0275, 0276,
0278,0624
~\
Implantable
Devices
Charged to
~,U Patients
C 1 C6 97
D3 HOS C2 97
C 1 C7 97
C 1 C5 72
C 1 C6 72
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Group Name
(19 total)
Revenue
Codes
contained in
MedPAR
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Cost from
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(Worksheet
C, Part 1,
Column 5
and line
number)
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C 1 C7 72
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Therapy
Services
Charges
042X
~~r\, Therapy
Medicare
Charges from
HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
C 1 C5 66
C 1 C6 66
D3 HOS C2 66
~~~'
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Occupational
Therapy
Char es
043X
C 1 C5 67
C 1 C6 67
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C 1 C7 67
Speech
Pathology
Char es
044X and
047X
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C 1 C7 68
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D3 HOS C2 68
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Codes
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Cost from
HCRIS
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C, Part 1,
Column 5
and line
number)
Form CMS2552-10
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
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Inhalation
Thera
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046X
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Operating
Room
036X
C 1 C5 50 I C 1 C6 50 I D3 HOS C2 50
C 1 C7 50
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Form CMS2552-10
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Labor &
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Cost Center
Revenue
Codes
contained in
MedPAR
Chame Field
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
Form CMS2552-10
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Cardiolo
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Medicare
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Descriotion
Charges
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HCRIS
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C, Part 1,
Column 6 &
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number)
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Codes
contained in
MedPAR
Chame Field
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
Form CMS2552-10
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number)
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HCRIS
(Worksheet D-3,
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number)
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Codes
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MedPAR
Chame Field
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HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
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Radioisotope
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C, Part 1,
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Form CMS2552-10
Medicare
Charges from
HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
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Computed
Tomography
(CT) Scan
CT Scan
Charges
Computed
;, Tomography
(CT) Scan
035X
C 1 C5 57
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D3 HOS C2 57
;
C 1 C7 57
07MYP2
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Resonance
Imaging
(MRI)
MRI Charges
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Imaging (MRI)
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Charge Field
Cost Report
Line
Description
0343 and
344
Cost Center
Group Name
(19 total)
Revenue
Codes
contained in
MedPAR
Charge Field
0335, 0339,
0342
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
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Room
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HCRIS
(Worksheet D-3,
Column & line
number)
Form CMS2552-10
039x
Blood Storing,
Processing, &
Transfusing
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Cost Center
Revenue
Codes
I contained in
MedPAR
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
Form CMS2552-10
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
Form CMS2552-10
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number)
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Other
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Other Service
Char e
07MYP2
Renal
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ESRD
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Revenue
Codes
contained in
MedPAR
Chame Field
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
Form CMS2552-10
I C_1_C7_74
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number)
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Cost Center
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BILLING CODE 4120–01–C
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Cost Report
Line
Description
Cost from
HCRIS
(Worksheet
C, Part 1,
Column 5
and line
number)
Form CMS2552-10
Charges
from
HCRIS
(Worksheet
C, Part 1,
Column 6 &
7 and line
number)
Form CMS2552-10
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
20275
corresponding national average CCR, we
summed the 19 ‘‘costs’’ across each
proposed MS–DRG to produce a total
standardized cost for the proposed MS–
DRG. The average standardized cost for
each proposed MS–DRG was then
computed as the total standardized cost
for the proposed MS–DRG divided by
the transfer-adjusted case count for the
proposed MS–DRG. We calculated the
transfer-adjusted discharges for use in
the calculation of the Version 36 MS–
DRG relative weights using the statutory
expansion of the postacute care transfer
policy to include discharges to hospice
care by a hospice program discussed in
section IV.A.2.b. of the preamble of this
proposed rule. For the purposes of
calculating the normalization factor, we
used the transfer-adjusted discharges
with the expanded postacute care
transfer policy for Version 35 as well.
(When we calculate the normalization
factor, we calculate the transfer-adjusted
case count for the prior GROUPER
version (in this case Version 35) and
multiply by the weights of that
GROUPER. We then compare that pool
to the transfer-adjusted case count using
the new GROUPER version.) The
average cost for each proposed MS–DRG
was then divided by the national
average standardized cost per case to
determine the proposed relative weight.
The proposed FY 2019 cost-based
relative weights were then normalized
by a proposed adjustment factor of
1.760698 so that the average case weight
after recalibration was equal to the
average case weight before recalibration.
The proposed 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 2019 are as follows:
CCR
3. Development of Proposed National
Average CCRs
We developed the proposed national
average CCRs as follows:
Using the FY 2016 cost report data,
we removed CAHs, Indian Health
Service hospitals, all-inclusive rate
hospitals, and cost reports that
represented time periods of less than 1
year (365 days). We included hospitals
located in Maryland because we include
their charges in our claims database. We
then created CCRs for each provider for
each cost center (see prior table for line
items used in the calculations) and
removed any CCRs that were greater
than 10 or less than 0.01. We
normalized the departmental CCRs by
dividing the CCR for each department
by the total CCR for the hospital for the
purpose of trimming the data. We then
took the logs of the normalized cost
center CCRs and removed any cost
center CCRs where the log of the cost
center CCR was greater or less than the
mean log plus/minus 3 times the
standard deviation for the log of that
cost center CCR. Once the cost report
data were trimmed, we calculated a
Medicare-specific CCR. The
Medicare-specific CCR was determined
by taking the Medicare charges for each
line item from Worksheet D–3 and
deriving the Medicare-specific costs by
applying the hospital-specific
departmental CCRs to the
Medicare-specific charges for each line
item from Worksheet D–3. Once each
hospital’s Medicare-specific costs were
established, we summed the total
Medicare-specific costs and divided by
the sum of the total Medicare-specific
charges to produce national average,
charge-weighted CCRs.
After we multiplied the total charges
for each MS–DRG in each of the
proposed 19 cost centers by the
Low-volume
MS–DRG
MS–DRG title
789 .....................
791 .....................
Neonates, Died or Transferred to Another Acute Care Facility.
Extreme Immaturity or Respiratory Distress Syndrome, Neonate.
Prematurity with Major Problems ............
792 .....................
Prematurity without Major Problems .......
793 .....................
Full-Term Neonate with Major Problems
794 .....................
Neonate with Other Significant Problems
795 .....................
Normal Newborn .....................................
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Group
Routine Days ....................................
Intensive Days ..................................
Drugs ................................................
Supplies & Equipment ......................
Implantable Devices .........................
Therapy Services ..............................
Laboratory .........................................
Operating Room ...............................
Cardiology .........................................
Cardiac Catheterization ....................
Radiology ..........................................
MRIs .................................................
CT Scans ..........................................
Emergency Room .............................
Blood and Blood Products ................
Other Services ..................................
Labor & Delivery ...............................
Inhalation Therapy ............................
Anesthesia ........................................
0.451
0.373
0.196
0.299
0.321
0.312
0.116
0.185
0.107
0.115
0.149
0.076
0.037
0.165
0.306
0.355
0.363
0.163
0.081
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 2019. Using data
from the FY 2017 MedPAR file, there
were 7 MS–DRGs that contain fewer
than 10 cases. For FY 2019, because we
do not have sufficient MedPAR data to
set accurate and stable cost relative
weights for these low-volume MS–
DRGs, we are proposing to compute
relative weights for the proposed lowvolume MS–DRGs by adjusting their
final FY 2018 relative weights by the
percentage change in the average weight
of the cases in other MS–DRGs. The
crosswalk table is shown:
Crosswalk to MS–DRG
Frm 00113
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Final FY 2018 relative weight (adjusted
the cases in other MS–DRGs).
Fmt 4701
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by percent change in average weight of
by percent change in average weight of
by percent change in average weight of
by percent change in average weight of
by percent change in average weight of
by percent change in average weight of
by percent change in average weight of
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20276
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
We are inviting public comments on
our proposals.
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H. Proposed Add-On Payments for New
Services and Technologies for FY 2019
1. Background
Sections 1886(d)(5)(K) and (L) of the
Act establish a process of identifying
and ensuring adequate payment for new
medical services and technologies
(sometimes collectively referred to in
this section as ‘‘new technologies’’)
under the IPPS. Section
1886(d)(5)(K)(vi) of the Act specifies
that a medical service or technology will
be considered new if it meets criteria
established by the Secretary after notice
and opportunity for public comment.
Section 1886(d)(5)(K)(ii)(I) of the Act
specifies that a new medical service or
technology may be considered for new
technology add-on payment if, based on
the estimated costs incurred with
respect to discharges involving such
service or technology, the DRG
prospective payment rate otherwise
applicable to such discharges under this
subsection is inadequate. We note that,
beginning with discharges occurring in
FY 2008, CMS transitioned from CMS–
DRGs to MS–DRGs. The regulations at
42 CFR 412.87 implement these
provisions and specify three criteria for
a new medical service or technology to
receive the additional payment: (1) The
medical service or technology must be
new; (2) the medical service or
technology must be costly such that the
DRG rate otherwise applicable to
discharges involving the medical service
or technology is determined to be
inadequate; and (3) the service or
technology must demonstrate a
substantial clinical improvement over
existing services or technologies. Below
we highlight some of the major statutory
and regulatory provisions relevant to the
new technology add-on payment
criteria, as well as other information.
For a complete discussion on the new
technology add-on payment criteria, we
refer readers to the FY 2012 IPPS/LTCH
PPS final rule (76 FR 51572 through
51574).
Under the first criterion, as reflected
in § 412.87(b)(2), a specific medical
service or technology will be considered
‘‘new’’ for purposes of new medical
service or technology add-on payments
until such time as Medicare data are
available to fully reflect the cost of the
technology in the MS–DRG weights
through recalibration. We note that we
do not consider a service or technology
to be new if it is substantially similar to
one or more existing technologies. That
is, even if a technology receives a new
FDA approval or clearance, it may not
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20:30 May 04, 2018
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necessarily be considered ‘‘new’’ for
purposes of new technology add-on
payments if it is ‘‘substantially similar’’
to a technology that was approved or
cleared by FDA and has been on the
market for more than 2 to 3 years. In the
FY 2010 IPPS/RY 2010 LTCH PPS final
rule (74 FR 43813 through 43814), we
established criteria for evaluating
whether a new technology is
substantially similar to an existing
technology, specifically: (1) Whether a
product uses the same or a similar
mechanism of action to achieve a
therapeutic outcome; (2) whether a
product is assigned to the same or a
different MS–DRG; and (3) whether the
new use of the technology involves the
treatment of the same or similar type of
disease and the same or similar patient
population. If a technology meets all
three of these criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments. For a
detailed discussion of the criteria for
substantial similarity, we refer readers
to the FY 2006 IPPS final rule (70 FR
47351 through 47352), and the FY 2010
IPPS/LTCH PPS final rule (74 FR 43813
through 43814).
Under the second criterion,
§ 412.87(b)(3) further provides that, to
be eligible for the add-on payment for
new medical services or technologies,
the MS–DRG prospective payment rate
otherwise applicable to discharges
involving the new medical service or
technology must be assessed for
adequacy. Under the cost criterion,
consistent with the formula specified in
section 1886(d)(5)(K)(ii)(I) of the Act, to
assess the adequacy of payment for a
new technology paid under the
applicable MS–DRG prospective
payment rate, we evaluate whether the
charges for cases involving the new
technology exceed certain threshold
amounts. Table 10 that was released
with the FY 2018 IPPS/LTCH PPS final
rule contains the final thresholds that
we used to evaluate applications for
new medical service or technology addon payments for FY 2019. We refer
readers to the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
AcuteInpatientPPS/FY2018-IPPS-FinalRule-Home-Page-Items/FY2018-IPPSFinal-Rule-Tables.html to download and
view Table 10.
As previously stated, Table 10 that is
released with each proposed and final
rule contains the thresholds that we use
to evaluate applications for new medical
service and technology add-on
payments for the fiscal year that follows
the fiscal year that is otherwise the
PO 00000
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subject of the rulemaking. For example,
the thresholds in Table 10 released with
the FY 2018 IPPS/LTCH PPS final rule
are applicable to FY 2019 new
technology applications. Beginning with
the thresholds for FY 2020 and future
years, we are proposing to provide the
thresholds that we previously included
in Table 10 as one of our data files
posted via the Internet on the CMS
website at: https://www.cms.hhs.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
index.html, which is the same URL
where the impact data files associated
with the rulemaking for the applicable
fiscal year are posted. We believe that
this proposed change in the
presentation of this information,
specifically in the data files rather than
in a Table 10, will clarify for the public
that the listed thresholds will be used
for new technology add-on payment
applications for the next fiscal year (in
this case, for FY 2020) rather than for
the fiscal year that is otherwise the
subject of the rulemaking (in this case,
for FY 2019), while continuing to
furnish the same information on the
new technology add-on payment
thresholds for applications for the next
fiscal year as has been provided in
previous fiscal years. Accordingly, we
would no longer include Table 10 as
one of our IPPS tables, but would
instead include the thresholds
applicable to the next fiscal year
(beginning with FY 2020) in the data
files associated with the prior fiscal year
(in this case, FY 2019).
In the September 7, 2001 final rule
that established the new technology
add-on payment regulations (66 FR
46917), we discussed the issue of
whether the Health Insurance
Portability and Accountability Act
(HIPAA) Privacy Rule at 45 CFR parts
160 and 164 applies to claims
information that providers submit with
applications for new medical service or
technology add-on payments. We refer
readers to the FY 2012 IPPS/LTCH PPS
final rule (76 FR 51573) for complete
information on this issue.
Under the third criterion,
§ 412.87(b)(1) of our existing regulations
provides that a new technology is an
appropriate candidate for an additional
payment when it represents an advance
that substantially improves, relative to
technologies previously available, the
diagnosis or treatment of Medicare
beneficiaries. For example, a new
technology represents a substantial
clinical improvement when it reduces
mortality, decreases the number of
hospitalizations or physician visits, or
reduces recovery time compared to the
technologies previously available. (We
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refer readers to the September 7, 2001
final rule for a more detailed discussion
of this criterion (66 FR 46902).)
The new medical service or
technology add-on payment policy
under the IPPS provides additional
payments for cases with relatively high
costs involving eligible new medical
services or technologies, while
preserving some of the incentives
inherent under an average-based
prospective payment system. The
payment mechanism is based on the
cost to hospitals for the new medical
service or technology. Under § 412.88, if
the costs of the discharge (determined
by applying cost-to-charge ratios (CCRs)
as described in § 412.84(h)) exceed the
full DRG payment (including payments
for IME and DSH, but excluding outlier
payments), Medicare will make an addon payment equal to the lesser of: (1) 50
percent of the estimated costs of the
new technology or medical service (if
the estimated costs for the case
including the new technology or
medical service exceed Medicare’s
payment); or (2) 50 percent of the
difference between the full DRG
payment and the hospital’s estimated
cost for the case. Unless the discharge
qualifies for an outlier payment, the
additional Medicare payment is limited
to the full MS–DRG payment plus 50
percent of the estimated costs of the
new technology or medical service.
Section 503(d)(2) of Public Law 108–
173 provides that there shall be no
reduction or adjustment in aggregate
payments under the IPPS due to add-on
payments for new medical services and
technologies. Therefore, in accordance
with section 503(d)(2) of Public Law
108–173, add-on payments for new
medical services or technologies for FY
2005 and later years have not been
subjected to budget neutrality.
In the FY 2009 IPPS final rule (73 FR
48561 through 48563), we modified our
regulations at § 412.87 to codify our
longstanding practice of how CMS
evaluates the eligibility criteria for new
medical service or technology add-on
payment applications. That is, we first
determine whether a medical service or
technology meets the newness criterion,
and only if so, do we then make a
determination as to whether the
technology meets the cost threshold and
represents a substantial clinical
improvement over existing medical
services or technologies. We amended
§ 412.87(c) to specify that all applicants
for new technology add-on payments
must have FDA approval or clearance
for their new medical service or
technology by July 1 of the year prior to
the beginning of the fiscal year that the
application is being considered.
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The Council on Technology and
Innovation (CTI) at CMS oversees the
agency’s cross-cutting priority on
coordinating coverage, coding and
payment processes for Medicare with
respect to new technologies and
procedures, including new drug
therapies, as well as promoting the
exchange of information on new
technologies and medical services
between CMS and other entities. The
CTI, composed of senior CMS staff and
clinicians, was established under
section 942(a) of Public Law 108–173.
The Council is co-chaired by the
Director of the Center for Clinical
Standards and Quality (CCSQ) and the
Director of the Center for Medicare
(CM), who is also designated as the
CTI’s Executive Coordinator.
The specific processes for coverage,
coding, and payment are implemented
by CM, CCSQ, and the local Medicare
Administrative Contractors (MACs) (in
the case of local coverage and payment
decisions). The CTI supplements, rather
than replaces, these processes by
working to assure that all of these
activities reflect the agency-wide
priority to promote high-quality,
innovative care. At the same time, the
CTI also works to streamline, accelerate,
and improve coordination of these
processes to ensure that they remain up
to date as new issues arise. To achieve
its goals, the CTI works to streamline
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
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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
CTI@cms.hhs.gov.
We note that applicants for add-on
payments for new medical services or
technologies for FY 2020 must submit a
formal request, including a full
description of the clinical applications
of the medical service or technology and
the results of any clinical evaluations
demonstrating that the new medical
service or technology represents a
substantial clinical improvement, along
with a significant sample of data to
demonstrate that the medical service or
technology meets the high-cost
threshold. Complete application
information, along with final deadlines
for submitting a full application, will be
posted as it becomes available on the
CMS website at: https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/
newtech.html. To allow interested
parties to identify the new medical
services or technologies under review
before the publication of the proposed
rule for FY 2020, the CMS website also
will post the tracking forms completed
by each applicant. We note that the
burden associated with this information
collection requirement is the time and
effort required to collect and submit the
data in the formal request for add-on
payments for new medical services and
technologies to CMS. The
aforementioned burden is subject to the
PRA; it is currently approved under
OMB control number 0938–1347, which
expires on December 31, 2020.
2. Public Input Before Publication of a
Notice of Proposed Rulemaking on AddOn Payments
Section 1886(d)(5)(K)(viii) of the Act,
as amended by section 503(b)(2) of
Public Law 108–173, provides for a
mechanism for public input before
publication of a notice of proposed
rulemaking regarding whether a medical
service or technology represents a
substantial clinical improvement or
advancement. The process for
evaluating new medical service and
technology applications requires the
Secretary to—
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• Provide, before publication of a
proposed rule, for public input
regarding whether a new service or
technology represents an advance in
medical technology that substantially
improves the diagnosis or treatment of
Medicare beneficiaries;
• Make public and periodically
update a list of the services and
technologies for which applications for
add-on payments are pending;
• Accept comments,
recommendations, and data from the
public regarding whether a service or
technology represents a substantial
clinical improvement; and
• Provide, before publication of a
proposed rule, for a meeting at which
organizations representing hospitals,
physicians, manufacturers, and any
other interested party may present
comments, recommendations, and data
regarding whether a new medical
service or technology represents a
substantial clinical improvement to the
clinical staff of CMS.
In order to provide an opportunity for
public input regarding add-on payments
for new medical services and
technologies for FY 2019 prior to
publication of this FY 2019 IPPS/LTCH
PPS proposed rule, we published a
notice in the Federal Register on
December 4, 2017 (82 FR 57275), and
held a town hall meeting at the CMS
Headquarters Office in Baltimore, MD,
on February 13, 2018. In the
announcement notice for the meeting,
we stated that the opinions and
presentations provided during the
meeting would assist us in our
evaluations of applications by allowing
public discussion of the substantial
clinical improvement criterion for each
of the FY 2019 new medical service and
technology add-on payment
applications before the publication of
this FY 2019 IPPS/LTCH PPS proposed
rule.
Approximately 150 individuals
registered to attend the town hall
meeting in person, while additional
individuals listened over an open
telephone line. We also live-streamed
the town hall meeting and posted the
town hall on the CMS YouTube web
page at: https://www.youtube.com/
watch?v=9niqfxXe4oA&t=217s. We
considered each applicant’s
presentation made at the town hall
meeting, as well as written comments
submitted on the applications that were
received by the due date of February 23,
2018, in our evaluation of the new
technology add-on payment
applications for FY 2019 in this FY 2019
IPPS/LTCH PPS proposed rule.
In response to the published notice
and the February 13, 2018 New
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Technology Town Hall meeting, we
received written comments regarding
the applications for FY 2019 new
technology add-on payments. We note
that we do not summarize comments
that are unrelated to the ‘‘substantial
clinical improvement’’ criterion. As
explained earlier and in the Federal
Register notice announcing the New
Technology Town Hall meeting (82 FR
57275 through 57277), the purpose of
the meeting was specifically to discuss
the substantial clinical improvement
criterion in regard to pending new
technology add-on payment
applications for FY 2019. Therefore, we
are not summarizing those written
comments in this proposed rule. 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, at the end of
each discussion of the individual
applications.
Comment: One commenter
recommended that the specific criteria
that CMS uses in making substantial
clinical improvement determinations be
codified in the regulations to more
explicitly clarify that the new medical
service or technology will meet the
substantial clinical improvement
criterion if it: (a) Results in a reduction
of the length of a hospital stay; (b)
improves patient quality of life; (c)
creates long-term clinical efficiencies in
treatment; (d) addresses patientcentered objectives as defined by the
Secretary; or (e) meets such other
criteria as the Secretary may specify.
The commenter stated that criteria
similar to these were defined in the
September 2001 New Technology Final
Rule (66 FR 46913 through 46914). The
commenter also recommended that final
decisions on new technology add-on
payment applications should explicitly
discuss how a technology or treatment
meets or fails to meet these specific
criteria.
Response: We appreciate the
commenter’s recommendation.
However, in the September 2001 New
Technology Final Rule (66 FR 46913
through 46914), we explained how we
evaluate if a new medical service or
technology would meet the substantial
clinical improvement criterion.
Specifically, we stated that we evaluate
a request for new technology payments
against the following criteria to
determine if the new medical service or
technology would represent a
substantial clinical improvement over
existing technologies:
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• The device offers a treatment option
for a patient population unresponsive
to, or ineligible for, currently available
treatments.
• The device 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. There must also be evidence
that use of the device to make a
diagnosis affects the management of the
patient.
• Use of the device significantly
improves clinical outcomes for a patient
population as compared to currently
available treatments.
We typically require the applicant to
submit evidence that the technology
meets one or more of these standards.
Regarding whether the use of the device
significantly improves clinical outcomes
for a patient population as compared to
currently available treatments, we
provided examples of improved clinical
outcomes.
In response to the commenter’s
recommendation that final decisions on
new technology add-on applications
explicitly discuss how a technology or
treatment meets or fails to meet these
specific standards, we believe that we
provide this explanation when
approving or denying an application for
new technology add-on payments in the
final rule.
Comment: One commenter stated that
the United States Food and Drug
Administration Modernization Act
(FDAMA) of 1997 established a category
of medical devices and diagnostics that
are eligible for priority FDA review. The
commenter explained that, to qualify,
products must be designated by the FDA
as offering the potential for significant
improvements in the diagnosis or
treatment of the most serious illnesses,
including those that are life-threatening
or irreversibly debilitating. The
commenter indicated that the processes
by which products meeting the statutory
standard for priority treatment are
considered by the FDA are spelled out
in greater detail in FDA’s Expedited
Access Program (EAP), and in the 21st
Century Cures Act. The commenter
believed that the criteria for priority
FDA review are very similar to the
substantial clinical improvement
criteria and, therefore, devices used in
the inpatient setting determined to be
eligible for expedited review and
approved by the FDA should
automatically be considered as meeting
the substantial clinical improvement
criterion, without further consideration
by CMS.
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Another commenter stated that CMS
historically has noted that a new
technology is an appropriate candidate
for an additional payment ‘‘when it
represents an advance that substantially
improves, relative to technologies
previously available, the diagnosis or
treatment of Medicare beneficiaries.’’
The commenter believed that this
standard was created for medical
devices because they dominated new
technology of the time. The commenter
recommended that this standard not be
applied to regenerative medicine
therapies because it believed these
criteria are likely outside Congressional
intent and inconsistent with some of the
congressionally-created FDA approval
rules related to expedited approval
programs. The commenter explained
that the FDA defines congressionallycreated ‘‘breakthrough therapy’’ and
designates a therapy as such if it ‘‘may
demonstrate substantial improvement
over existing therapies.’’ In addition, the
commenter stated that the Regenerative
Medicine Advanced Therapy (RMAT)
designation is granted to products that
are intended to treat, modify, reverse, or
cure a serious or life-threatening disease
or condition, and if clinical evidence
shows that it has the potential to meet
an unmet medical need.
Response: The FDA provides a
number of different types of approvals
and designations for devices, drugs, and
other medical products. As required by
section 1886(d)(5)(K)(viii) of the Act,
CMS provides a mechanism for public
input, before the publication of the
proposed rule, regarding whether a new
service or technology represents an
advance in medical technology that
substantially improves the diagnosis or
treatment of individuals entitled to
benefits under Medicare Part A. We
believe that the criteria explained in the
September 2001 New Technology Final
Rule (66 FR 46914) are consistent with
the statutory requirements for
evaluating new medical services and
technologies and continue to be relevant
to determining whether a new medical
service or technology represents a
substantial clinical improvement over
existing technologies. If the technology
has a status designated by the FDA that
is similar to the standards and
conditions required to demonstrate
substantial clinical improvement under
the new technology add-on payment
criterion, or is designated as a
breakthrough therapy, the technology
should be able to demonstrate with
evidence that it meets the new
technology add-on payment substantial
clinical improvement criterion. Finally,
we do take FDA approvals into
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consideration in our evaluation and
determination of approvals and denials
of new technology add-on payment
applications.
Comment: One commenter stated that,
for technologies without a special FDA
designation, the substantial clinical
improvement standard is an
inappropriate clinical standard for the
family of regenerative therapies because
it creates a threshold that is too high
and unrealistic to meet. The commenter
believed that requiring a vague standard
such as ‘‘substantial clinical
improvement’’ ignores that innovation
is achieved incrementally. The
commenter asserted that by only
approving new technologies that can
achieve this standard for new
technology add-on payments, CMS’
policy is at cross-purposes with
promoting innovation because many
worthy technologies will not be
approved by CMS, which denies the
general population the opportunity of
having the chance to learn and
otherwise benefit from those
technologies.
The commenter also stated that CMS
has questioned how substantial clinical
improvement can be measured and
achieved via small clinical trials with
FDA approval. The commenter stated
that it is concerned that this view sets
a dangerous precedent by significantly
undervaluing new transformative
therapies. The commenter added that
the FDA often only requires single-arm
trials with small numbers of patients for
these products because it is often not
feasible for product developers to
provide data on a large number of
patients, especially those working in
rare diseases as many regenerative and
advanced therapeutic developers are.
The commenter stated that, given the
transformative nature of the products,
this should not be a reason for CMS to
deny a new medical service or
technology add-on payment.
Response: We believe that the
September 2001 New Technology Final
Rule (66 FR 46914) clearly defines the
criteria that CMS uses to evaluate and
determine if a new medical service or
technology represents a substantial
clinical improvement. In addition, we
accept different types of data (for
example, peer-reviewed articles, study
results, or letters from major
associations, among others) that
demonstrate and support the substantial
clinical improvement associated with
the new medical service or technology’s
use. In addition to clinical data, we will
consider any evidence that would
support the conclusion of a substantial
clinical improvement associated with a
new medical service or technology.
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Therefore, we believe that we consider
an appropriate range of evidence.
Comment: One commenter stated that
CMS should consider FDA approval and
the associated evidence base leading to
such an approval as a standard for
meeting the substantial clinical
improvement criterion. The commenter
believed that additional factors such as
improvements in patient quality of life,
creation of long-term clinical
efficiencies in care, reductions in the
use of other healthcare services, or other
such criteria should be incorporated
into the CMS determination process for
whether a new medical service or
technology demonstrates or represents a
substantial clinical improvement over
existing technologies. The commenter
believed that, by including these
additional factors, CMS would align
payment rates such that patients would
have access to the highest standard of
treatment for all transformative
therapies representing a substantial
clinical improvement for the patient
populations they serve, and it would be
recognized as such by the receipt of new
technology add-on payments.
Response: As stated earlier, one of the
standards we use to determine whether
a new medical service or technology
represents a substantial clinical
improvement over existing technologies
is to evaluate whether the use of the
device, drug, service, or technology
significantly improves clinical outcomes
for a patient population as compared to
currently available treatments, and we
provided examples of improved clinical
outcomes in the September 2001 New
Technology Final Rule (66 FR 46913
through 46914).
Comment: One commenter
encouraged CMS to ensure appropriate
implementation of the substantial
clinical improvement criterion under
the applicable Medicare statutory
provisions and regulations, as applied to
radiopharmaceuticals and other nuclear
medicine technologies that can lead to
significant benefits and advances in the
diagnosis and treatment of many
diseases. The commenter recommended
that CMS apply an appropriately
flexible standard for purposes of
assessing whether a technology
represents a substantial clinical
improvement over other existing,
available therapies. The commenter
asserted that a flexible standard for this
purpose must include new products and
new formulations of products that
increase the safety or efficacy, or both,
relative to current treatments. The
commenter believed that failing to
recognize a technology that enhances
the safety and/or efficacy of existing
options as both ‘‘new’’ and a
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‘‘substantial clinical improvement’’ over
existing options would be a disservice
to Medicare beneficiaries and to the
mission of the Medicare program.
The commenter encouraged CMS to
give consideration to the importance of
technologies that make radiotherapies
safer, as well as those that lead to
increased efficacy. The commenter
explained that minimizing a patient’s
exposure to radiation, while also
maximizing the effectiveness of the
radiotherapy dose results in highly
significant clinical improvements for
patients, including in specific areas that
CMS has expressly identified as relevant
to the substantial clinical improvement
criterion.
Response: As stated earlier, we
believe that the criteria explained in the
September 2001 New Technology Final
Rule (66 FR 46914) are consistent with
the statutory requirements for
evaluating new medical services and
technologies and continue to be relevant
to determining whether a new medical
service or technology represents a
substantial clinical improvement over
existing technologies.
We believe that it is important to
maintain an open dialogue regarding the
IPPS new technology add-on payment
process, and we appreciate all of the
commenters’ input and
recommendations.
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3. ICD–10–PCS Section ‘‘X’’ Codes for
Certain New Medical Services and
Technologies
As discussed in the FY 2016 IPPS/
LTCH final rule (80 FR 49434), the ICD–
10–PCS includes a new section
containing the new Section ‘‘X’’ codes,
which began being used with discharges
occurring on or after October 1, 2015.
Decisions regarding changes to ICD–10–
PCS Section ‘‘X’’ codes will be handled
in the same manner as the decisions for
all of the other ICD–10–PCS code
changes. That is, proposals to create,
delete, or revise Section ‘‘X’’ codes
under the ICD–10–PCS structure will be
referred to the ICD–10 Coordination and
Maintenance Committee. In addition,
several of the new medical services and
technologies that have been, or may be,
approved for new technology add-on
payments may now, and in the future,
be assigned a Section ‘‘X’’ code within
the structure of the ICD–10–PCS. We
posted ICD–10–PCS Guidelines on the
CMS website at: https://www.cms.gov/
Medicare/Coding/ICD10/2016-ICD-10PCS-and-GEMs.html, including
guidelines for ICD–10–PCS Section ‘‘X’’
codes. We encourage providers to view
the material provided on ICD–10–PCS
Section ‘‘X’’ codes.
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4. Proposed FY 2019 Status of
Technologies Approved for FY 2018
Add-On Payments
a. Defitelio® (Defibrotide)
Jazz Pharmaceuticals submitted an
application for new technology add-on
payments for FY 2017 for defibrotide
(Defitelio®), a treatment for patients
diagnosed with hepatic veno-occlusive
disease (VOD) with evidence of
multiorgan dysfunction. VOD, also
known as sinusoidal obstruction
syndrome (SOS), is a potentially lifethreatening complication of
hematopoietic stem cell transplantation
(HSCT), with an incidence rate of 8
percent to 15 percent. Diagnoses of VOD
range in severity from what has been
classically defined as a disease limited
to the liver (mild) and reversible, to a
severe syndrome associated with multiorgan dysfunction or failure and death.
Patients treated with HSCT who
develop VOD with multi-organ failure
face an immediate risk of death, with a
mortality rate of more than 80 percent
when only supportive care is used. The
applicant asserted that Defitelio®
improves the survival rate of patients
diagnosed with VOD with multi-organ
failure by 23 percent.
Defitelio® received Orphan Drug
Designation for the treatment of VOD in
2003 and for the prevention of VOD in
2007. It has been available to patients as
an investigational drug through an
expanded access program since 2006.
The applicant’s New Drug Application
(NDA) for Defitelio® received FDA
approval on March 30, 2016. The
applicant confirmed that Defitelio® was
not available on the U.S. market as of
the FDA NDA approval date of March
30, 2016. According to the applicant,
commercial packaging could not be
completed until the label for Defitelio®
was finalized with FDA approval, and
that commercial shipments of Defitelio®
to hospitals and treatment centers began
on April 4, 2016. Therefore, we agreed
that, based on this information, the
newness period for Defitelio® begins on
April 4, 2016, the date of its first
commercial availability.
The applicant received approval to
use unique ICD–10–PCS procedure
codes to describe the use of Defitelio®,
with an effective date of October 1,
2016. The approved ICD–10PCS
procedure codes are: XW03392
(Introduction of defibrotide sodium
anticoagulant into peripheral vein,
percutaneous approach); and XW04392
(Introduction of defibrotide sodium
anticoagulant into central vein,
percutaneous approach).
After evaluation of the newness, costs,
and substantial clinical improvement
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criteria for new technology add-on
payments for Defitelio® and
consideration of the public comments
we received in response to the FY 2017
IPPS/LTCH PPS proposed rule, we
approved Defitelio® for new technology
add-on payments for FY 2017 (81 FR
56906). With the new technology addon payment application, the applicant
estimated that the average Medicare
beneficiary would require a dosage of 25
mg/kg/day for a minimum of 21 days of
treatment. The recommended dose is
6.25 mg/kg given as a 2-hour
intravenous infusion every 6 hours.
Dosing should be based on a patient’s
baseline body weight, which is assumed
to be 70 kg for an average adult patient.
All vials contain 200 mg at a cost of
$825 per vial. Therefore, we determined
that cases involving the use of the
Defitelio® technology would incur an
average cost per case of $151,800 (70 kg
adult × 25 mg/kg/day × 21 days = 36,750
mg per patient/200 mg vial = 184 vials
per patient × $825 per vial = $151,800).
Under § 412.88(a)(2), we limit new
technology add-on payments to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment
amount for a case involving the use of
Defitelio® is $75,900.
Our policy is that a medical service or
technology may continue to be
considered ‘‘new’’ for purposes of new
technology add-on payments within 2 or
3 years after the point at which data
begin to become available reflecting the
inpatient hospital code assigned to the
new service or technology. Our practice
has been to begin and end new
technology add-on payments on the
basis of a fiscal year, and we have
generally followed a guideline that uses
a 6-month window before and after the
start of the fiscal year to determine
whether to extend the new technology
add-on payment for an additional fiscal
year. In general, we extend new
technology add-on payments for an
additional year only if the 3-year
anniversary date of the product’s entry
onto the U.S. market occurs in the latter
half of the fiscal year (70 FR 47362).
With regard to the newness criterion
for Defitelio®, we considered the
beginning of the newness period to
commence on the first day Defitelio®
was commercially available (April 4,
2016). Because the 3-year anniversary
date of the entry of the Defitelio® onto
the U.S. market (April 4, 2019) will
occur in the latter half of FY 2019, we
are proposing to continue new
technology add-on payments for this
technology for FY 2019. We are
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proposing that the maximum payment
for a case involving Defitelio® would
remain at $75,900 for FY 2019. We are
inviting public comments on our
proposal to continue new technology
add-on payments for Defitelio® for FY
2019.
b. EDWARDS INTUITY EliteTM Valve
System (INTUITY) and LivaNova
Perceval Valve (Perceval)
Two manufacturers, Edwards
Lifesciences and LivaNova, submitted
applications for new technology add-on
payments for FY 2018 for the INTUITY
EliteTM Valve System (INTUITY) and
the Perceval Valve (Perceval),
respectively. Both of these technologies
are prosthetic aortic valves inserted
using surgical aortic valve replacement
(AVR). Aortic valvular disease is
relatively common, primarily
manifested by aortic stenosis. Most
aortic stenosis is due to calcification of
the valve, either on a normal tri-leaflet
valve or on a congenitally bicuspid
valve. The resistance to outflow of blood
is progressive over time, and as the size
of the aortic orifice narrows, the heart
must generate increasingly elevated
pressures to maintain blood flow.
Symptoms such as angina, heart failure,
and syncope eventually develop, and
portend a very serious prognosis. There
is no effective medical therapy for aortic
stenosis, so the diseased valve must be
replaced or, less commonly, repaired.
According to both applicants, the
INTUITY valve and the Perceval valve
are the first sutureless, rapid
deployment aortic valves that can be
used for the treatment of patients who
are candidates for surgical AVR.
Because potential cases representing
patients who are eligible for treatment
using the INTUITY and the Perceval
aortic valve devices would group to the
same MS–DRGs, and we believe that
these devices are intended to treat the
same or similar disease in the same or
similar patient population, and are
purposed to achieve the same
therapeutic outcome using the same or
similar mechanism of action, we
determined these two devices are
substantially similar to each other and
that it was appropriate to evaluate both
technologies as one application for new
technology add-on payments under the
IPPS.
With respect to the newness criterion,
the INTUITY valve received FDA
approval on August 12, 2016, and was
commercially available on the U.S.
market on August 19, 2016. The
Perceval valve received FDA approval
on January 8, 2016, and was
commercially available on the U.S.
market on February 29, 2016. In
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accordance with our policy, we stated in
the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38120) that we believe it is
appropriate to use the earliest market
availability date submitted as the
beginning of the newness period.
Accordingly, for both devices, we stated
that the beginning of the newness
period is February 29, 2016, when the
Perceval valve became commercially
available. The ICD–10–PCS code
approved to identify procedures
involving the use of both devices when
surgically implanted is ICD–10–PCS
code X2RF032 (Replacement of aortic
valve using zooplastic tissue, rapid
deployment technique, open approach,
new technology group 2).
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for the INTUITY and Perceval
valves and consideration of the public
comments we received in response to
the FY 2018 IPPS/LTCH PPS proposed
rule, we approved the INTUITY and
Perceval valves for new technology addon payments for FY 2018 (82 FR 38125).
We stated that we believed that the use
of a weighted-average of the cost of the
standard valves based on the projected
number of cases involving each
technology to determine the maximum
new technology add-on payment was
most appropriate. To compute the
weighted-cost average, we summed the
total number of projected cases for each
of the applicants, which equaled 2,429
cases (1,750 plus 679). We then divided
the number of projected cases for each
of the applicants by the total number of
cases, which resulted in the following
case-weighted percentages: 72 percent
for the INTUITY and 28 percent for the
Perceval valve. We then multiplied the
cost per case for the manufacturer
specific valve by the case-weighted
percentage (0.72 * $12,500 = $9,005.76
for INTUITY and 0.28 * $11,500 =
$3,214.70 for the Perceval valve). This
resulted in a case-weighted average cost
of $12,220.46 for the valves. Under
§ 412.88(a)(2), we limit new technology
add-on payments to the lesser of 50
percent of the average cost of the device
or 50 percent of the costs in excess of
the MS–DRG payment for the case. As
a result, the maximum new technology
add-on payment for a case involving the
INTUITY or Perceval valves is $6,110.23
for FY 2018.
With regard to the newness criterion
for the INTUITY and Perceval valves,
we considered the newness period for
the INTUITY and Perceval valves to
begin February 29, 2016. As discussed
previously in this section, in general, we
extend new technology add-on
payments for an additional year only if
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the 3-year anniversary date of the
product’s entry onto the U.S. market
occurs in the latter half of the upcoming
fiscal year. Because the 3-year
anniversary date of the entry of the
technology onto the U.S. market
(February 29, 2019) will occur in the
first half of FY 2019, we are proposing
to discontinue new technology add-on
payments for the INTUITY and Perceval
valves for FY 2019. We are inviting
public comments on our proposal to
discontinue new technology add-on
payments for the INTUITY and Perceval
valves.
c. GORE® EXCLUDER® Iliac Branch
Endoprosthesis (Gore IBE Device)
W. L. Gore and Associates, Inc.
submitted an application for new
technology add-on payments for the
GORE® EXCLUDER® Iliac Branch
Endoprosthesis (GORE IBE device) for
FY 2017. The device consists of two
components: The Iliac Branch
Component (IBC) and the Internal Iliac
Component (IIC). The applicant
indicated that each endoprosthesis is
pre-mounted on a customized delivery
and deployment system allowing for
controlled endovascular delivery via
bilateral femoral access. According to
the applicant, the device is designed to
be used in conjunction with the GORE®
EXCLUDER® AAA Endoprosthesis for
the treatment of patients requiring
repair of common iliac or aortoiliac
aneurysms. When deployed, the GORE
IBE device excludes the common iliac
aneurysm from systemic blood flow,
while preserving blood flow in the
external and internal iliac arteries.
With regard to the newness criterion,
the applicant received pre-market FDA
approval of the GORE IBE device on
February 29, 2016. The following
procedure codes describe the use of this
technology: 04VC0EZ (Restriction of
right common iliac artery with branched
or fenestrated intraluminal device, one
or two arteries, open approach);
04VC3EZ (Restriction of right common
iliac artery with branched or fenestrated
intraluminal device, one or two arteries,
percutaneous approach); 04VC4EZ
(Restriction of right common iliac artery
with branched or fenestrated
intraluminal device, one or two arteries,
percutaneous approach); 04VD0EZ
(Restriction of left common iliac artery
with branched or fenestrated
intraluminal device, one or two arteries,
open approach); 04VD3EZ (Restriction
of left common iliac artery with
branched or fenestrated intraluminal
device, one or two arteries,
percutaneous approach); 04VD4EZ
(Restriction of left common iliac artery
with branched or fenestrated
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intraluminal device, one or two arteries,
percutaneous endoscopic approach).
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for the GORE IBE device and
consideration of the public comments
we received in response to the FY 2017
IPPS/LTCH PPS proposed rule, we
approved the GORE IBE device for new
technology add-on payments for FY
2017 (81 FR 56909). With the new
technology add-on payment application,
the applicant indicated that the total
operating cost of the GORE IBE device
is $10,500. Under § 412.88(a)(2), we
limit new technology add-on payments
to the lesser of 50 percent of the average
cost of the device or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment for a
case involving the GORE IBE device is
$5,250.
With regard to the newness criterion
for the GORE IBE device, we considered
the beginning of the newness period to
commence when the GORE IBE device
received FDA approval on February 29,
2016. As discussed previously in this
section, in general, we extend new
technology add-on payments for an
additional year only if the 3-year
anniversary date of the product’s entry
onto the U.S. market occurs in the latter
half of the upcoming fiscal year.
Because the 3-year anniversary date of
the entry of the GORE IBE device onto
the U.S. market (February 28, 2019) will
occur in the first half of FY 2019, we are
proposing to discontinue new
technology add-on payments for this
technology for FY 2019. We are inviting
public comments on our proposal to
discontinue new technology add-on
payments for the GORE IBE device.
d. Idarucizumab
Boehringer Ingelheim
Pharmaceuticals, Inc. submitted an
application for new technology add-on
payments for FY 2017 for Idarucizumab,
a product developed as an antidote to
reverse the effects of PRADAXAR
(Dabigatran), which is also
manufactured by Boehringer Ingelheim
Pharmaceuticals, Inc.
Dabigatran is an oral direct thrombin
inhibitor currently indicated: (1) To
reduce the risk of stroke and systemic
embolism in patients who have been
diagnosed with nonvalvular atrial
fibrillation (NVAF); (2) for the treatment
of deep venous thrombosis (DVT) and
pulmonary embolism (PE) in patients
who have been administered a
parenteral anticoagulant for 5 to 10
days; (3) to reduce the risk of recurrence
of DVT and PE in patients who have
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been previously treated; and (4) for the
prophylaxis of DVT and PE in patients
who have undergone hip replacement
surgery. Currently, unlike the
anticoagulant Warfarin, there is no
specific way to reverse the anticoagulant
effect of Dabigatran in the event of a
major bleeding episode. Idarucizumab is
a humanized fragment antigen binding
(Fab) molecule, which specifically binds
to Dabigatran to deactivate the
anticoagulant effect, thereby allowing
thrombin to act in blood clot formation.
The applicant stated that Idarucizumab
represents a new pharmacologic
approach to neutralizing the specific
anticoagulant effect of Dabigatran in
emergency situations.
Idarucizumab was approved by the
FDA on October 16, 2015. Idarucizumab
is indicated for the use in the treatment
of patients who have been administered
Pradaxa when reversal of the
anticoagulant effects of dabigatran is
needed for emergency surgery or urgent
medical procedures or in lifethreatening or uncontrolled bleeding.
The applicant was granted approval to
use unique ICD–10–PCS procedure
codes that became effective October 1,
2016, to describe the use of this
technology. The approved ICD–10–PCS
procedure codes are: XW03331
(Introduction of Idarucizumab,
Dabigatran reversal agent into
peripheral vein, percutaneous approach,
new technology group 1); and XW04331
(Introduction of Idarucizumab,
Dabigatran reversal agent into central
vein, percutaneous approach, new
technology group 1).
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for Idarucizumab and
consideration of the public comments
we received in response to the FY 2017
IPPS/LTCH PPS proposed rule, we
approved Idarucizumab for new
technology add-on payments for FY
2017 (81 FR 56897). With the new
technology add-on payment application,
the applicant indicated that the total
operating cost of Idarucizumab is
$3,500. Under § 412.88(a)(2), we limit
new technology add-on payments to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment for a
case involving Idarucizumab is $1,750.
With regard to the newness criterion
for Idarucizumab, we considered the
beginning of the newness period to
commence when Idarucizumab was
approved by the FDA on October 16,
2015. As discussed previously in this
section, in general, we extend new
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technology add-on payments for an
additional year only if the 3-year
anniversary date of the product’s entry
onto the U.S. market occurs in the latter
half of the upcoming fiscal year.
Because the 3-year anniversary date of
the entry of Idarucizumab onto the U.S.
market will occur in the first half of FY
2019 (October 15, 2018), we are
proposing to discontinue new
technology add-on payments for this
technology for FY 2019. We are inviting
public comments on our proposal to
discontinue new technology add-on
payments for Idarucizumab.
e. Ustekinumab (Stelara®)
Janssen Biotech submitted an
application for new technology add-on
payments for the Stelara® induction
therapy for FY 2018. Stelara® received
FDA approval as an intravenous (IV)
infusion treatment of Crohn’s disease
(CD) on September 23, 2016, which
added a new indication for the use of
Stelara® and route of administration for
this monoclonal antibody. IV infusion of
Stelara® is indicated for the treatment
of adult patients (18 years and older)
diagnosed with moderately to severely
active CD who have: (1) Failed or were
intolerant to treatment using
immunomodulators or corticosteroids,
but never failed a tumor necrosis factor
(TNF) blocker; or (2) failed or were
intolerant to treatment using one or
more TNF blockers. Stelara® for IV
infusion has only one purpose,
induction therapy. Stelara® must be
administered intravenously by a health
care professional in either an inpatient
hospital setting or an outpatient hospital
setting.
Stelara® for IV infusion is packaged
in single 130 mg vials. Induction
therapy consists of a single IV infusion
dose using the following weight-based
dosing regimen: Patients weighing less
than (<)55 kg are administered 260 mg
of Stelara® (2 vials); patients weighing
more than (>)55 kg, but less than (<)85
kg are administered 390 mg of Stelara®
(3 vials); and patients weighing more
than (>)85 kg are administered 520 mg
of Stelara® (4 vials). An average dose of
Stelara® administered through IV
infusion is 390 mg (3 vials).
Maintenance doses of Stelara® are
administered at 90 mg, subcutaneously,
at 8-week intervals and may occur in the
outpatient hospital setting.
CD is an inflammatory bowel disease
of unknown etiology, characterized by
transmural inflammation of the
gastrointestinal (GI) tract. Symptoms of
CD may include fatigue, prolonged
diarrhea with or without bleeding,
abdominal pain, weight loss and fever.
CD can affect any part of the GI tract
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including the mouth, esophagus,
stomach, small intestine, and large
intestine. Conventional pharmacologic
treatments of CD include antibiotics,
mesalamines, corticosteroids,
immunomodulators, tumor necrosis
alpha (TNFa) inhibitors, and antiintegrin agents. Surgery may be
necessary for some patients diagnosed
with CD in which conventional
therapies have failed.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for Stelara® and
consideration of the public comments
we received in response to the FY 2018
IPPS/LTCH PPS proposed rule, we
approved Stelara® for new technology
add-on payments for FY 2018 (82 FR
38129). Cases involving Stelara® that
are eligible for new technology add-on
payments are identified by ICD–10–PCS
procedure code XW033F3 (Introduction
of other New Technology therapeutic
substance into peripheral vein,
percutaneous approach, new technology
group 3). With the new technology addon payment application, the applicant
estimated that the average Medicare
beneficiary would require a dosage of
390 mg (3 vials) at a hospital acquisition
cost of $1,600 per vial (for a total of
$4,800). Under § 412.88(a)(2), we limit
new technology add-on payments to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment
amount for a case involving the use of
Stelara® is $2,400.
With regard to the newness criterion
for Stelara®, we considered the
beginning of the newness period to
commence when Stelara® received FDA
approval as an IV infusion treatment of
Crohn’s disease (CD) on September 23,
2016. Because the 3-year anniversary
date of the entry of Stelara® onto the
U.S. market (September 23, 2019) will
occur after FY 2019, we are proposing
to continue new technology add-on
payments for this technology for FY
2019. We are proposing that the
maximum payment for a case involving
Stelara® would remain at $2,400 for FY
2019. We are inviting public comments
on our proposal to continue new
technology add-on payments for
Stelara® for FY 2019.
f. VistogardTM (Uridine Triacetate)
BTG International Inc. submitted an
application for new technology add-on
payments for the VistogardTM for FY
2017. VistogardTM was developed as an
emergency treatment for Fluorouracil
toxicity.
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Chemotherapeutic agent 5fluorouracil (5–FU) is used to treat
specific solid tumors. It acts upon
deoxyribonucleic acid (DNA) and
ribonucleic acid (RNA) in the body, as
uracil is a naturally occurring building
block for genetic material. Fluorouracil
is a fluorinated pyrimidine. As a
chemotherapy agent, Fluorouracil is
absorbed by cells and causes the cell to
metabolize into byproducts that are
toxic and used to destroy cancerous
cells. According to the applicant, the
byproducts fluorodoxyuridine
monophosphate (F–dUMP) and
floxuridine triphosphate (FUTP) are
believed to do the following: (1) Reduce
DNA synthesis; (2) lead to DNA
fragmentation; and (3) disrupt RNA
synthesis. Fluorouracil is used to treat a
variety of solid tumors such as
colorectal, head and neck, breast, and
ovarian cancer. With different tumor
treatments, different dosages, and
different dosing schedules, there is a
risk for toxicity in these patients.
Patients may suffer from fluorouracil
toxicity/death if 5–FU is delivered in
slight excess or at faster infusion rates
than prescribed. The cause of overdose
can happen for a variety of reasons
including: Pump malfunction, incorrect
pump programming or miscalculated
doses, and accidental or intentional
ingestion.
VistogardTM is an antidote to
Fluorouracil toxicity and is a prodrug of
uridine. Once the drug is metabolized
into uridine, it competes with the toxic
byproduct FUTP in binding to RNA,
thereby reducing the impact FUTP has
on cell death.
With regard to the newness criterion,
VistogardTM received FDA approval on
December 11, 2015. However, as
discussed in the FY 2017 IPPS/LTCH
PPS final rule (81 FR 56910), due to the
delay in VistogardTM’s commercial
availability, we considered the newness
period to begin March 2, 2016, instead
of December 11, 2015. The applicant
noted that the VistogardTM is the first
FDA-approved antidote used to reverse
fluorouracil toxicity. The applicant
submitted a request for a unique ICD–
10–PCS procedure code and was
granted approval for the following
procedure code: XW0DX82
(Introduction of Uridine Triacetate into
Mouth and Pharynx, External Approach,
new technology group 2). The new code
became effective on October 1, 2016.
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for VistogardTM and
consideration of the public comments
we received in response to the FY 2017
IPPS/LTCH PPS proposed rule, we
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approved VistogardTM for new
technology add-on payments for FY
2017 (81 FR 56912). With the new
technology add-on payment application,
the applicant stated that the total
operating cost of VistogardTM is $75,000.
Under § 412.88(a)(2), we limit new
technology add-on payments to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment for a
case involving VistogardTM is $37,500.
With regard to the newness criterion
for the VistogardTM, we considered the
beginning of the newness period to
commence upon the entry of
VistogardTM onto the U.S. market on
March 2, 2016. As discussed previously
in this section, in general, we extend
new technology add-on payments for an
additional year only if the 3-year
anniversary date of the product’s entry
onto the U.S. market occurs in the latter
half of the upcoming fiscal year.
Because the 3-year anniversary date of
the entry of the VistogardTM onto the
U.S. market (March 2, 2019) will occur
in the first half of FY 2019, we are
proposing to discontinue new
technology add-on payments for this
technology for FY 2019. We are inviting
public comments on our proposal to
discontinue new technology add-on
payments for the VistogardTM.
g. Bezlotoxumab (ZINPLAVATM)
Merck & Co., Inc. submitted an
application for new technology add-on
payments for ZINPLAVATM for FY 2018.
ZINPLAVATM is indicated to reduce
recurrence of Clostridium difficile
infection (CDI) in adult patients who are
receiving antibacterial drug treatment
for a diagnosis of CDI who are at high
risk for CDI recurrence. ZINPLAVATM is
not indicated for the treatment of the
presenting episode of CDI and is not an
antibacterial drug.
Clostridium difficile (C-diff) is a
disease-causing anaerobic, spore
forming bacteria that can affect the
gastrointestinal (GI) tract. Some people
carry the C-diff bacterium in their
intestines, but never develop symptoms
of an infection. The difference between
asymptomatic colonization and
pathogenicity is caused primarily by the
production of an enterotoxin (Toxin A)
and/or a cytotoxin (Toxin B). The
presence of either or both toxins can
lead to symptomatic CDI, which is
defined as the acute onset of diarrhea
with a documented infection with
toxigenic C-diff, or the presence of
either toxin A or B. The GI tract
contains millions of bacteria, commonly
referred to as ‘‘normal flora’’ or ‘‘good
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bacteria,’’ which play a role in
protecting the body from infection.
Antibiotics can kill these good bacteria
and allow the C-diff bacteria to multiply
and release toxins that damage the cells
lining the intestinal wall, resulting in a
CDI. CDI is a leading cause of hospitalassociated gastrointestinal illnesses.
Persons at increased risk for CDI include
people who are treated with current or
recent antibiotic use, people who have
encountered current or recent
hospitalization, people who are older
than 65 years, immunocompromised
patients, and people who have recently
had a diagnosis of CDI. CDI symptoms
include, but are not limited to, diarrhea,
abdominal pain, and fever. CDI
symptoms range in severity from mild
(abdominal discomfort, loose stools) to
severe (profuse, watery diarrhea, severe
pain, and high fevers). Severe CDI can
be life-threatening and, in rare cases,
can cause bowel rupture, sepsis and
organ failure. CDI is responsible for
14,000 deaths per year in the United
States.
C-diff produces two virulent, proinflammatory toxins, Toxin A and Toxin
B, which target host colonocytes (that is,
large intestine endothelial cells) by
binding to endothelial cell surface
receptors via combined repetitive
oligopeptide (CROP) domains. These
toxins cause the release of inflammatory
cytokines leading to intestinal fluid
secretion and intestinal inflammation.
The applicant asserted that
ZINPLAVATM targets Toxin B sites
within the CROP domain rather than the
C-diff organism itself. According to the
applicant, by targeting C-diff Toxin B,
ZINPLAVATM neutralizes Toxin B,
prevents large intestine endothelial cell
inflammation, symptoms associated
with CDI, and reduces the recurrence of
CDI.
ZINPLAVATM received FDA approval
on October 21, 2016, for reduction of
recurrence of CDI in patients receiving
antibacterial drug treatment for CDI and
who are at high risk of CDI recurrence.
ZINPLAVATM became commercially
available on February 10, 2017.
Therefore, the newness period for
ZINPLAVATM began on February 10,
2017. The applicant submitted a request
for a unique ICD–10–PCS procedure
code and was granted approval for the
following procedure codes: XW033A3
(Introduction of bezlotoxumab
monoclonal antibody, into peripheral
vein, percutaneous approach, new
technology group 3) and XW043A3
(Introduction of bezlotoxumab
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monoclonal antibody, into central vein,
percutaneous approach, new technology
group 3).
After evaluation of the newness, costs,
and substantial clinical improvement
criteria for new technology add-on
payments for ZINPLAVATM and
consideration of the public comments
we received in response to the FY 2018
IPPS/LTCH PPS proposed rule, we
approved ZINPLAVATM for new
technology add-on payments for FY
2018 (82 FR 38119). With the new
technology add-on payment application,
the applicant estimated that the average
Medicare beneficiary would require a
dosage of 10 mg/kg of ZINPLAVATM
administered as an IV infusion over 60
minutes as a single dose. According to
the applicant, the WAC for one dose is
$3,800. Under § 412.88(a)(2), we limit
new technology add-on payments to the
lesser of 50 percent of the average cost
of the technology or 50 percent of the
costs in excess of the MS–DRG payment
for the case. As a result, the maximum
new technology add-on payment
amount for a case involving the use of
ZINPLAVATM is $1,900.
With regard to the newness criterion
for ZINPLAVATM, we considered the
beginning of the newness period to
commence on February 10, 2017.
Because the 3-year anniversary date of
the entry of ZINPLAVATM onto the U.S.
market (February 10, 2020) will occur
after FY 2019, we are proposing to
continue new technology add-on
payments for this technology for FY
2019. We are proposing that the
maximum payment for a case involving
ZINPLAVATM would remain at $1,900
for FY 2019. We are inviting public
comments on our proposal to continue
new technology add-on payments for
ZINPLAVATM for FY 2019.
5. FY 2019 Applications for New
Technology Add-On Payments
We received 15 applications for new
technology add-on payments for FY
2019. In accordance with the regulations
under § 412.87(c), applicants for new
technology add-on payments must have
FDA approval or clearance by July 1 of
the year prior to the beginning of the
fiscal year that the application is being
considered. A discussion of the 15
applications is presented below.
a. KYMRIAHTM (Tisagenlecleucel) and
YESCARTATM (Axicabtagene
Ciloleucel)
Two manufacturers, Novartis
Pharmaceuticals Corporation and Kite
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Pharma, Inc. submitted separate
applications for new technology add-on
payments for FY 2019 for KYMRIAHTM
(tisagenlecleucel) and YESCARTATM
(axicabtagene ciloleucel), respectively.
Both of these technologies are CD–19directed T-cell immunotherapies used
for the purposes of treating patients
with aggressive variants of non-Hodgkin
lymphoma (NHL). We note that
KYMRIAHTM was approved by the FDA
on August 30, 2017, for use in the
treatment of patients up to 25 years of
age with B-cell precursor acute
lymphoblastic leukemia (ALL) that is
refractory or in second or later relapse,
which is a different indication and
patient population than the new
indication and targeted patient
population for which the applicant
submitted a request for approval of new
technology add-on payments for FY
2019. Specifically, and as summarized
in the following table, the new
indication for which Novartis
Pharmaceuticals Corporation is
requesting approval for new technology
add-on payments for KYMRIAHTM is as
an autologous T-cell immune therapy
indicated for use in the treatment of
patients with relapsed/refractory (R/R)
Diffuse Large B-Cell Lymphoma
(DLBCL) not eligible for autologous stem
cell transplant (ASCT). As of the time of
the development of this proposed rule,
Novartis Pharmaceuticals Corporation
has been granted a Breakthrough
Therapy designation by the FDA, and is
awaiting FDA approval for the use of
KYMRIAHTM under this new indication.
We also note that Kite Pharma, Inc.
previously submitted an application for
approval for new technology add-on
payments for FY 2018 for KTE–C19 for
use as an autologous T-cell immune
therapy in the treatment of adult
patients with R/R aggressive B-cell NHL
who are ineligible for ASCT. However,
Kite Pharma, Inc. withdrew its
application for KTE–C19 prior to
publication of the FY 2018 IPPS/LTCH
PPS final rule. Kite Pharma, Inc. has
resubmitted an application for approval
for new technology add-on payments for
FY 2019 for KTE–C19 under a new
name, YESCARTATM, for the same
indication. Kite Pharma, Inc. received
FDA approval for this original
indication and treatment use of
YESCARTATM on October 18, 2017. (We
refer readers to the following table for a
comparison of the indications and FDA
approvals for KYMRIAHTM and
YESCARTATM.)
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COMPARISON OF INDICATION AND FDA APPROVAL FOR KYMRIAHTM AND YESCARTATM
FY 2019 applicant
technology name
Description of indication for which new technology add-on
payments are being requested
FDA approval
status
KYMRIAHTM (Novartis Pharmaceuticals Corporation).
YESCARTATM (Kite Pharma,
Inc.).
KYMRIAHTM: Autologous T-cell immune therapy indicated for use in the treatment
of patients with relapsed/refractory (R/R) Diffuse Large B Cell Lymphoma
(DLBCL) not eligible for autologous stem cell transplant (ASCT).
YESCARTATM: Autologous T-cell immune therapy indicated for use in the treatment of adult patients with R/R large B-cell lymphoma after two or more lines of
systemic therapy, including DLBCL not otherwise specified, primary mediastinal
large B-cell, high grade B-cell lymphoma, and DLBCL arising from follicular
lymphoma.
Breakthrough Therapy designation granted by FDA;
FDA approval pending.
FDA approval received
10/18/2017.
Technology approved for
other indications
Description of other indication
FDA approval of other
indication
KYMRIAHTM (Novartis Pharmaceuticals Corporation).
KYMRIAHTM: CD–19-directed T-cell immunotherapy indicated for the use in the
treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.
None .............................................................................................................................
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YESCARTATM (Kite Pharma,
Inc.).
We note that procedures involving the
KYMRIAHTM and YESCARTATM
therapies are both reported using the
following ICD–10–PCS procedure codes:
XW033C3 (Introduction of engineered
autologous chimeric antigen receptor tcell immunotherapy into peripheral
vein, percutaneous approach, new
technology group 3); and XW043C3
(Introduction of engineered autologous
chimeric antigen receptor t-cell
immunotherapy into central vein,
percutaneous approach, new technology
group 3). We further note that, in
section II.F.2.d. of the preamble of this
proposed rule, we are proposing to
assign cases reporting these ICD–10–
PCS procedure codes to Pre-MDC MS–
DRG 016 (Autologous Bone Marrow
Transplant with CC/MCC) for FY 2019.
We refer readers to section II.F.2.d. of
this proposed rule for a complete
discussion of the proposed assignment
of cases reporting these procedure codes
to Pre-MDC MS–DRG 016, which also
includes a proposal to revise the title of
MS–DRG 016 to reflect the proposed
assignments.
According to the applicants, patients
with NHL represent a heterogeneous
group of B-cell malignancies with
varying patterns of behavior and
response to treatment. B-cell NHL can
be classified as either an aggressive, or
indolent disease, with aggressive
variants including DLBCL; primary
mediastinal large B-cell lymphoma
(PMBCL); and transformed follicular
lymphoma (TFL). Within diagnoses of
NHL, DLBCL is the most common
subtype of NHL, accounting for
approximately 30 percent of patients
who have been diagnosed with NHL,
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and survival without treatment is
measured in months.4 Despite improved
therapies, only 50 to 70 percent of
newly diagnosed patients are cured by
standard first-line therapy alone.
Furthermore, R/R disease continues to
carry a poor prognosis because only 50
percent of patients are eligible for
autologous stem cell transplantation
(ASCT) due to advanced age, poor
functional status, comorbidities,
inadequate social support for recovery
after ASCT, and provider or patient
choice.5 6 7 8 Of the roughly 50 percent of
patients that are eligible for ASCT,
nearly 50 percent fail to respond to
prerequisite salvage chemotherapy and
cannot undergo ASCT.9 10 11 12 Second4 Chaganti, S., et al., ‘‘Guidelines for the
management of diffuse large B-cell lymphoma,’’ BJH
Guideline, 2016. Available at: www.bit.do/bshguidelines.
5 Matasar, M., et al., ‘‘Ofatumumab in
combination with ICE or DHAP chemotherapy in
relapsed or refractory intermediate grade B-cell
lymphoma,’’ Blood, 25 July 2013, vol. 122, No 4.
6 Hitz, F., et al., ‘‘Outcome of patients with
chemotherapy refractory and early progressive
diffuse large B cell lymphoma after R–CHOP
treatment,’’ Blood (American Society of Hematology
(ASH) annual meeting abstracts, poster session),
2010, pp. 116 (abstract #1751).
7 Telio, D., et al., ‘‘Salvage chemotherapy and
autologous stem cell transplant in primary
refractory diffuse large B-cell lymphoma: outcomes
and prognostic factors,’’ Leukemia & Lymphoma,
2012, vol. 53(5), pp. 836–41.
8 Moskowitz, C.H., et al., ‘‘Ifosfamide, carboplatin,
and etoposide: a highly effective cytoreduction and
peripheral-blood progenitor-cell mobilization
regimen for transplant-eligible patients with nonHodgkin’s lymphoma,’’ Journal of Clinical
Oncology, 1999, vol. 17(12), pp. 3776–85.
9 Crump, M., et al., ‘‘Outcomes in patients with
refractory aggressive diffuse large B-cell lymphoma
(DLBCL): results from the international scholar-1
study,’’ Abstract and poster presented at Pan Pacific
Lymphoma Conference (PPLC), July 2016.
PO 00000
Frm 00123
Fmt 4701
Sfmt 4702
FDA approval received
8/30/2017.
N/A.
line chemotherapy regimens studied to
date include rituximab, ifosfamide,
carboplatin and etoposide (R–ICE), and
rituximab, dexamethasone, cytarabine,
and cisplatin (R–DHAP), followed by
consolidative high-dose therapy (HDT)/
ASCT. Both regimens offer similar
overall response rates (ORR) of 51
percent with 1 in 4 patients achieving
long-term complete response (CR) at the
expense of increased toxicity.13 Secondline treatment with dexamethasone,
high-dose cytarabine, and cisplatin
(DHAP) is considered a standard
chemotherapy regimen, but is associated
with substantial treatment-related
toxicity.14 For patients who experience
disease progression during or after
primary treatment, the combination of
HDT/ASCT remains the only curative
option.15 According to the applicants,
10 Gisselbrecht, C., et al., ‘‘Results from
SCHOLAR–1: outcomes in patients with refractory
aggressive diffuse large B-cell lymphoma (DLBCL),’’
Oral presentation at European Hematology
Association conference, July 2016.
11 Iams, W., Reddy, N., ‘‘Consolidative autologous
hematopoietic stem-cell transplantation in first
remission for non-Hodgkin lymphoma: current
indications and future perspective,’’ Ther Adv
Hematol, 2014, vol. 5(5), pp. 153–67.
12 Kantoff, P.W., et al., ‘‘Sipuleucel-T
immunotherapy for castration-resistant prostate
cancer,’’ N Engl J Med, 2010, vol. 363, pp. 411–422.
13 Rovira, J., Valera, A., Colomo, L., et al.,
‘‘Prognosis of patients with diffuse large B cell
lymphoma not reaching complete response or
relapsing after frontline chemotherapy or
immunochemotherapy,’’ Ann Hematol, 2015, vol.
94(5), pp. 803–812.
14 Swerdlow, S.H., Campo, E., Pileri, S.A., et al.,
‘‘The 2016 revision of the World Health
Organization classification of lymphoid
neoplasms,’’ Blood, 2016, vol. 127(20), pp. 2375–
2390.
15 Koristka, S., Cartellieri, M., Arndt, C., et al.,
‘‘Tregs activated by bispecific antibodies: killers or
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given the modest response to
second-line therapy and/or HDT/ASCT,
the population of patients with the
highest unmet need is those with
chemorefractory disease, which include
DLBCL, PMBCL, and TFL. These
patients are defined as either
progressive disease (PD) as best
response to chemotherapy, stable
disease as best response following
greater than or equal to 4 cycles of firstline or 2 cycles of later-line therapy, or
relapse within less than or equal to 12
months of ASCT.16 Based on these
definitions and available data from a
multi-center retrospective study
(SCHOLAR–1), chemorefractory disease
treated with current and historical
standards of care has consistently poor
outcomes with an ORR of 26 percent
and median overall survival (OS) of 6.3
months.17
According to Novartis
Pharmaceuticals Corporation, upon FDA
approval of the additional indication,
KYMRIAHTM will also be used for the
treatment of patients with R/R DLBCL
who are not eligible for ASCT. Novartis
Pharmaceuticals Corporation describes
KYMRIAHTM as a CD-19-directed
genetically modified autologous T-cell
immunotherapy which utilizes
peripheral blood T-cells, which have
been reprogrammed with a transgene
encoding, a chimeric antigen receptor
(CAR), to identify and eliminate CD–19expressing malignant and normal cells.
Upon binding to CD–19-expressing
cells, the CAR transmits a signal to
promote T-cell expansion, activation,
target cell elimination, and persistence
of KYMRIAHTM cells. The transduced
T-cells expand in vivo to engage and
eliminate CD–19-expressing cells and
may exhibit immunological endurance
to help support long-lasting remission.
18 19 20 21 According to the applicant, no
other agent currently used in the
treatment of patients with R/R DLBCL
suppressors?,’’ OncoImmunology, 2015, vol.
(3):e994441, DOI: 10.4161/2162402X.2014.994441.
16 Crump, M., Neelapu, S.S., Farooq, U., et al.,
‘‘Outcomes in refractory diffuse large B-cell
lymphoma: results from the international
SCHOLAR–1 study,’’ Blood, Published online:
August 3, 2017, doi: 10.1182/blood-2017-03-69620.
17 Ibid.
18 KYMRIAHTM [prescribing information], East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2017.
19 Kalos, M., Levine, B.L., Porter, D.L., et al.,
‘‘T-cells with chimeric antigen receptors have
potent antitumor effects and can establish memory
in patients with advanced leukemia,’’ Sci Transl
Med, 2011, vol. 3(95), pp, 95ra73.
20 FDA Briefing Document. Available at: https://
www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
UCM566168.pdf.
21 Wang, X., Riviere, I., ‘‘Clinical manufacturing
of CART cells: foundation of a promising therapy,’’
Mol Ther Oncolytics, 2016, vol. 3, pp. 16015.
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20:30 May 04, 2018
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employs gene modified autologous cells
to target and eliminate malignant cells.
According to Kite Pharma, Inc.,
YESCARTATM is indicated for the use in
the treatment of adult patients with
R/R large B-cell lymphoma after two or
more lines of systemic therapy,
including DLBCL not otherwise
specified, PMBCL, high grade B-cell
lymphoma, and DLBCL arising from
follicular lymphoma. YESCARTA is not
indicated for the treatment of patients
with primary central nervous system
lymphoma. The applicant for
YESCARTATM described the technology
as a CD–19-directed genetically
modified autologous T-cell
immunotherapy that binds to CD–19expressing cancer cells and normal
B-cells. These normal B-cells are
considered to be non-essential tissue, as
they are not required for patient
survival. According to the applicant,
studies demonstrated that following
anti-CD–19 CAR T-cell engagement with
CD–19-expressing target cells, the CD–
28 and CD–3-zeta co-stimulatory
domains activate downstream signaling
cascades that lead to T-cell activation,
proliferation, acquisition of effector
functions and secretion of inflammatory
cytokines and chemokines. This
sequence of events leads to the
elimination of CD–19-expressing tumor
cells.
Both applicants expressed that their
technology is the first treatment of its
kind for the targeted adult population.
In addition, both applicants asserted
that their technology is new and does
not use a substantially similar
mechanism of action or involve the
same treatment indication as any other
currently FDA-approved technology. We
note that, at the time each applicant
submitted its new technology add-on
payment application, neither technology
had received FDA approval for the
indication for which the applicant
requested approval for the new
technology add-on payment;
KYMRIAHTM has been granted
Breakthrough Therapy designation for
the use in the treatment of patients for
the additional indication that is the
subject of its new technology add-on
application and, as of the time of the
development of this proposed rule, is
awaiting FDA approval. However, as
stated earlier, YESCARTATM received
FDA approval for use in the treatment
of patients and the indication stated in
its application on October 18, 2017,
after each applicant submitted its new
technology add-on payment application.
As noted, according to both
applicants, KYMRIAHTM and
YESCARTATM are the first CAR T
immunotherapies of their kind. Because
PO 00000
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Sfmt 4702
potential cases representing patients
who may be eligible for treatment using
KYMRIAHTM and YESCARTATM would
group to the same MS–DRGs (because
the same ICD–10–CM diagnosis codes
and ICD–10–PCS procedures codes are
used to report treatment using either
KYMRIAHTM or YESCARTATM), and we
believe that these technologies are
intended to treat the same or similar
disease in the same or similar patient
population, and are purposed to achieve
the same therapeutic outcome using the
same or similar mechanism of action,
we disagree with the applicants and
believe these two technologies are
substantially similar to each other and
that it is appropriate to evaluate both
technologies as one application for new
technology add-on payments under the
IPPS. For these reasons, and as
discussed further below, we would
intend to make one determination
regarding approval for new technology
add-on payments that would apply to
both applications, and in accordance
with our policy, would use the earliest
market availability date submitted as the
beginning of the newness period for
both KYMRIAHTM and YESCARTATM.
We are inviting public comments on
whether KYMRIAHTM and
YESCARTATM are substantially similar.
With respect to the newness criterion,
as previously stated, YESCARTATM
received FDA approval on October 18,
2017. According to the applicant, prior
to FDA approval, YESCARTATM had
been available in the U.S. only on an
investigational basis under an
investigational new drug (IND)
application. For the same IND patient
population, and until commercial
availability, YESCARTATM was
available under an Expanded Access
Program (EAP) which started on May
17, 2017. The applicant stated that it did
not recover any costs associated with
the EAP. According to the applicant, the
first commercial shipment of
YESCARTATM was received by a
certified treatment center on November
22, 2017. As previously indicated,
KYMRIAHTM is not currently approved
by the FDA for use in the treatment of
patients with R/R DLBCL that are not
eligible for ASCT; the technology has
been granted Breakthrough Therapy
designation by the FDA. The applicant
anticipates receipt of FDA approval to
occur in the second quarter of 2018. We
believe that, in accordance with our
policy, if these technologies are
substantially similar to each other, it is
appropriate to use the earliest market
availability date submitted as the
beginning of the newness period for
both technologies. Therefore, based on
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our policy, with regard to both
technologies, if the technologies are
approved for new technology add-on
payments, we believe that the beginning
of the newness period would be
November 22, 2017.
We previously stated that, because we
believe these two technologies are
substantially similar to each other, we
believe it is appropriate to evaluate both
technologies as one application for new
technology add-on payments under the
IPPS. The applicants submitted separate
cost and clinical data, and we reviewed
and discuss each set of data separately.
However, we would intend to make one
determination regarding new technology
add-on payments that would apply to
both applications. We believe that this
is consistent with our policy statements
in the past regarding substantial
similarity. Specifically, we have noted
that approval of new technology add-on
payments would extend to all
technologies that are substantially
similar (66 FR 46915), and we believe
that continuing our current practice of
extending new technology add-on
payments without a further application
from the manufacturer of the competing
product, or a specific finding on cost
and clinical improvement if we make a
finding of substantial similarity among
two products is the better policy
because we avoid—
• Creating manufacturer-specific
codes for substantially similar products;
• Requiring different manufacturers
of substantially similar products to
submit separate new technology add-on
payment applications;
• Having to compare the merits of
competing technologies on the basis of
substantial clinical improvement; and
• Bestowing an advantage to the first
applicant representing a particular new
technology to receive approval (70 FR
47351).
If substantially similar technologies
are submitted for review in different
(and subsequent) years, rather than the
same year, we would evaluate and make
a determination on the first application
and apply that same determination to
the second application. However,
because the technologies have been
submitted for review in the same year,
and because we believe they are
substantially similar to each other, we
believe that it is appropriate to consider
both sets of cost data and clinical data
in making a determination, and we do
not believe that it is possible to choose
one set of data over another set of data
in an objective manner. We are inviting
public comments on our proposal to
evaluate KYMRIAHTM and
YESCARTATM as one application for
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20:30 May 04, 2018
Jkt 244001
new technology add-on payments under
the IPPS.
As stated earlier, we believe that
KYMRIAHTM and YESCARTATM are
substantially similar to each other for
purposes of analyzing these two
applications as one application. We also
need to determine whether
KYMRIAHTM and YESCARTATM are
substantially similar to existing
technologies prior to their approval by
the FDA and their release onto the U.S.
market. As discussed earlier, if a
technology meets all three of the
substantial similarity criteria, it would
be considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With respect to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, the applicant for
KYMRIAHTM asserted that its unique
design, which utilizes features that were
not previously included in traditional
cytotoxic chemotherapeutic or
immunotherapeutic agents, constitutes a
new mechanism of action. The
deployment mechanism allows for
identification and elimination of CD–19expressing malignant and nonmalignant cells, as well as possible
immunological endurance to help
support long-lasting remission.22 23 24 25
The applicant provided context
regarding how KYMRIAHTM’s unique
design contributes to a new mechanism
of action by explaining that peripheral
blood T-cells, which have been
reprogrammed with a transgene
encoding, a CAR, identify and eliminate
CD-19-expressing malignant and
nonmalignant cells. As explained by the
applicant, upon binding to CD–19expressing cells, the CAR transmits a
signal to promote T-cell expansion,
activation, target cell elimination, and
persistence of KYMRIAHTM cells.26 27 28
22 KYMRIAH [prescribing information]. East
Hanover, NJ: Novartis Pharmaceuticals Corp; 2017.
23 Kalos, M., Levine, B.L., Porter, D.L., et al., ‘‘T
cells with chimeric antigen receptors have potent
antitumor effects and can establish memory in
patients with advanced leukemia,’’ Sci Transl Med,
2011, vol. 3(95), pp. 95ra73.
24 FDA Briefing Document. Available at: https://
www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
UCM566168.pdf.
25 Maude, S.L., Frey, N., Shaw, P.A., et al.,
‘‘Chimeric antigen receptor T cells for sustained
remissions in leukemia,’’ N Engl J Med, 2014, vol.
371(16), pp. 1507–1517.
26 KYMRIAHTM [prescribing information], East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2017.
27 Kalos, M., Levine, B.L., Porter, D.L., et al.,
‘‘T-cells with chimeric antigen receptors have
potent antitumor effects and can establish memory
in patients with advanced leukemia,’’ Sci Transl
Med, 2011, 3(95), pp, 95ra73.
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Sfmt 4702
20287
According to the applicant, transduced
T-cells expand in vivo to engage and
eliminate CD–19-expressing cells and
may exhibit immunological endurance
to help support long-lasting
remission.29 30 31
The applicant for YESCARTATM
stated that YESCARTATM is the first
engineered autologous cellular
immunotherapy comprised of CAR
T-cells that recognizes CD–19 express
cancer cells and normal B-cells with
efficacy in patients with R/R large B-cell
lymphoma after two or more lines of
systemic therapy, including DLBCL not
otherwise specified, PMBCL, high grade
B-cell lymphoma, and DLBCL arising
from follicular lymphoma as
demonstrated in a multi-centered
clinical trial. Therefore, the applicant
believed that YESCARTATM’s
mechanism of action is distinct and
unique from any other cancer drug or
biologic that is currently approved for
use in the treatment of patients who
have been diagnosed with aggressive Bcell NHL, namely single-agent or
combination chemotherapy regimens.
The applicant also pointed out that
YESCARTATM is the only available
therapy that has been granted FDA
approval for the treatment of adult
patients with R/R large B-cell
lymphoma after two or more lines of
systemic therapy, including DLBCL not
otherwise specified, PMBCL, high grade
B-cell lymphoma, and DLBCL arising
from follicular lymphoma.
With respect to the second and third
criteria, whether a product is assigned
to the same or a different MS–DRG and
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, the applicant
for KYMRIAHTM indicated that the
technology is used in the treatment of
the same patient population, and
potential cases representing patients
that may be eligible for treatment using
KYMRIAHTM would be assigned to the
same MS–DRGs as cases involving
28 FDA Briefing Document. Available at: https://
www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
UCM566168.pdf.
29 Kalos, M., Levine, B.L., Porter, D.L., et al., ‘‘T
cells with chimeric antigen receptors have potent
antitumor effects and can establish memory in
patients with advanced leukemia,’’ Sci Transl Med,
2011, vol. 3(95), pp. 95rs73.
30 FDA Briefing Document. Available at: https://
www.fda.gov/downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
UCM566168.pdf.
31 Maude, S.L., Frey, N., Shaw, P.A., et al.,
‘‘Chimeric antigen receptor T-cells for sustained
remissions in leukemia,’’ N Engl J Med, 2014, vol.
371(16), pp. 1507–1517.
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patients with a DLBCL diagnosis.
Potential cases representing patients
that may be eligible for treatment using
KYMRIAHTM map to 437 separate MS–
DRGs, with the top 20 MS–DRGs
covering approximately 68 percent of all
patients who have been diagnosed with
DLBCL. For patients with DLBCL and
who have received chemotherapy
during their hospital stay, the target
population mapped to 8 separate MS–
DRGs, with the top 2 MS–DRGs
covering over 95 percent of this
population: MS–DRGs 847
(Chemotherapy without Acute
Leukemia as Secondary Diagnosis with
CC), and 846 (Chemotherapy without
Acute Leukemia as Secondary Diagnosis
with MCC). The applicant for
YESCARTATM submitted findings that
potential cases representing patients
that may be eligible for treatment using
YESCARTATM span 15 unique MS–
DRGs, 8 of which contain more than 10
cases. The most common MS–DRGs
were: MS–DRGs 840 (Lymphoma and
Non-Acute Leukemia with MCC), 841
(Lymphoma and Non-Acute Leukemia
with CC), and 823 (Lymphoma and NonAcute Leukemia with other O.R.
Procedures with MCC). These 3 MS–
DRGs accounted for 628 (76 percent) of
the 827 cases. While the applicants for
KYMRIAHTM and YESCARTATM
submitted different findings regarding
the most common MS–DRGs to which
potential cases representing patients
who may be eligible for treatment
involving their technology would map,
we believe that, under the current MS–
DRGs (FY 2018), potential cases
representing patients who may be
eligible for treatment involving either
KYMRIAHTM or YESCARTATM would
map to the same MS–DRGs because the
same ICD–10–CM diagnosis codes and
ICD–10–PCS procedures codes would be
used to report cases for patients who
may be eligible for treatment involving
KYMRIAHTM and YESCARTATM.
Furthermore, as noted above, we are
proposing that cases reporting these
ICD–10–PCS procedure codes would be
assigned to MS–DRG 016 for FY 2019.
Therefore, under this proposal, for FY
2019, cases involving the utilization of
KYMRIAHTM and YESCARTATM would
continue to map to the same MS–DRGs.
The applicant for YESCARTATM also
addressed the concern expressed by
CMS in the FY 2018 IPPS/LTCH PPS
proposed rule regarding Kite Pharma
Inc.’s FY 2018 new technology add-on
payment application for the KTE–C19
technology (82 FR 19888). At the time,
CMS expressed concern that KTE–C19
may use the same or similar mechanism
of action as the Bi-Specific T-Cell
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engagers (BiTE) technology. The
applicant for YESCARTATM explained
that YESCARTATM has a unique and
distinct mechanism of action that is
substantially different from BiTE’s or
any other drug or biologic currently
assigned to any MS–DRG in the FY 2016
MedPAR Hospital Limited Data Set. In
providing more detail regarding how
YESCARTATM is different from the BiTE
technology, the applicant explained that
the BiTE technology is not an
engineered autologous T-cell
immunotherapy derived from a patient’s
own T-cells. Instead, it is a bi-specific
T-cell engager that recognizes CD–19
and CD–3 cancer cells. Unlike
engineered T-cell therapy, BiTE does
not have the ability to enhance the
proliferative and cytolytic capacity of Tcells through ex-vivo engineering.
Further, BiTE is approved for the
treatment of patients who have been
diagnosed with Philadelphia
chromosome-negative relapsed or
refractory B-cell precursor acute
lymphoblastic leukemia (ALL) and is
not approved for patients with relapsed
or refractory large B-cell lymphoma,
whereas YESCARTATM is indicated for
use in the treatment of adult patients
with R/R aggressive B-cell NHL who are
ineligible for ASCT.
The applicant for YESCARTATM also
indicated that its mechanism of action
is not the same or similar to the
mechanism of action used by
KYMRIAHTM’s currently available
FDA-approved CD–19-directed
genetically modified autologous T-cell
immunotherapy indicated for use in the
treatment of patients up to 25 years of
age with B-cell precursor acute
lymphoblastic leukemia (ALL) that is
refractory or in second or later relapse.32
The applicant for YESCARTATM stated
that the mechanism of action is different
from KYMRIAHTM’s FDA-approved
therapy because the spacer,
transmembrane and co-stimulatory
domains of YESCARTATM are different
from those of KYMRIAHTM. The
applicant explained that YESCARTATM
is comprised of a CD–28 co-stimulatory
domain and KYMRIAHTM has 4–1BB costimulatory domain. Further, the
applicant stated the manufacturing
processes of the two immunotherapies
are also different, which may result in
cell composition differences leading to
possible efficacy and safety differences.
While the applicant for YESCARTATM
stated how its technology is different
from KYMRIAHTM, because both
technologies are CD–19-directed T-cell
immunotherapies used for the purpose
32 Food and Drug Administration. Available at:
www.accessdata.fda.gov/scripts/opdlisting/oopd/.
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of treating patients with aggressive
variants of NHL, we believe that
YESCARTATM and KYMRIAHTM are
substantially similar treatment options.
Furthermore, we also are concerned that
there may be an age overlap (18 to 25)
between the two different patient
populations for the currently approved
KYMRIAHTM technology and
YESCARTATM technology. The
currently approved KYMRIAHTM
technology is indicated for use in the
treatment of patients who are up to 25
years of age and YESCARTATM
technology is indicated for use in the
treatment of adult patients.
As noted earlier, the applicant has
asserted that YESCARTATM is not
substantially similar to KYMRIAHTM.
Under this scenario, if both
YESCARTATM and KYMRIAHTM meet
all of the new technology add-on
payment criteria and are approved for
new technology add-on payments for FY
2019, for purposes of making the new
technology add-on payment, because
procedures utilizing either
YESCARTATM or KYMRIAHTM CAR Tcell therapy drugs are reported using the
same ICD–10–PCS procedure codes, in
order to accurately pay the new
technology add-on payment to hospitals
that perform procedures utilizing either
technology, it may be necessary to use
alternative coding mechanisms to make
the new technology add-on payments.
CMS is inviting comments on
alternative coding mechanisms to make
the new technology add-on payments, if
necessary.
We are inviting public comments on
whether KYMRIAHTM and
YESCARTATM are substantially similar
to existing technologies and whether the
technologies meet the newness
criterion.
As we stated above, each applicant
submitted separate analysis regarding
the cost criterion for each of their
products, and both applicants
maintained that their product meets the
cost criterion. We summarize each
analysis below.
With regard to the cost criterion, the
applicant for KYMRIAHTM searched the
FY 2016 MedPAR claims data file to
identify potential cases representing
patients who may be eligible for
treatment using KYMRIAHTM. 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
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limb); C83.36 (DLBCL, intrapelvic
lymph nodes); C83.37 (DLBCL, spleen);
C83.38 (DLBCL, lymph nodes of
multiple sites); or C83.39 (DLBCL,
extranodal and solid organ sites). The
applicant also identified potential cases
where patients received chemotherapy
using two encounter codes, Z51.11
(Antineoplastic chemotherapy) and
Z51.12 (Antineoplastic
immunotherapy), in conjunction with
DLBCL diagnosis codes.
Applying the parameters above, the
applicant for KYMRIAHTM identified a
total of 22,589 DLBCL potential cases
that mapped to 437 MS–DRGs. The
applicant chose the top 20 MS–DRGs
which made up a total of 15,451
potential cases at 68 percent of total
cases. Of the 22,589 total DLBCL
potential cases, the applicant also
provided a breakdown of DLBCL
potential cases where chemotherapy
was used, and DLBCL potential cases
where chemotherapy was not used. Of
the 6,501 DLBCL potential cases where
chemotherapy was used, MS–DRGs 846
and 847 accounted for 6,181 (95
percent) of the 6,501 cases. Of the
16,088 DLBCL potential cases where
chemotherapy was not used, the
applicant chose the top 20 MS–DRGs
which made up a total of 9,333 potential
cases at 58 percent of total cases. The
applicant believed the distribution of
patients that may be eligible for
treatment using KYMRIAHTM will
include a wide variety of MS–DRGs. As
such, the applicant conducted an
analysis of three scenarios: Potential
DLBCL cases, potential DLBCL cases
with chemotherapy, and potential
DLBCL cases without chemotherapy.
The applicant removed reported
historic charges that would be avoided
through the use of KYMRIAHTM. Next,
the applicant removed 50 percent of the
chemotherapy pharmacy charges that
would not be required for patients that
may be eligible to receive treatment
using KYMRIAHTM. The applicant
standardized the charges and then
applied an inflation factor of 1.09357,
which is the 2-year inflation factor in
the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38527), to update the charges
from FY 2016 to FY 2018. The applicant
did not add charges for KYMRIAHTM to
its analysis. However, the applicant
provided a cost analysis related to the
three categories of claims data it
previously researched (that is, potential
DLBCL cases, potential DLBCL cases
with chemotherapy, and potential
DLBCL cases without chemotherapy).
The applicant’s analysis showed the
inflated average case-weighted
standardized charge per case for
potential DLBCL cases, potential DLBCL
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cases with chemotherapy, and potential
DLBCL cases without chemotherapy
was $63,271, $39,723, and $72,781,
respectively. The average case-weighted
threshold amount for potential DLBCL
cases, potential DLBCL cases with
chemotherapy, and potential DLBCL
cases without chemotherapy was
$58,278, $48,190, and $62,355
respectively. While the inflated average
case-weighted standardized charge per
case ($39,723) is lower than the average
case-weighted threshold amount
($48,190) for potential DLBCL cases
with chemotherapy, the applicant
expects the cost of KYMRIAHTM to be
higher than the new technology add-on
payment threshold amount for all three
cohorts. Therefore, the applicant
maintained that it meets the cost
criterion.
We note that, as discussed earlier, in
section II.F.2.d. of the preamble of this
proposed rule, we are proposing to
assign the ICD–10–PCS procedure codes
that describe procedures involving the
utilization of these CAR T-cell therapy
drugs and cases representing patients
receiving treatment involving CAR
T-cell therapy procedures to Pre-MDC
MS–DRG 016 for FY 2019. Therefore, in
addition to the analysis above, we
compared the inflated average
case-weighted standardized charge per
case from all three cohorts above to the
average case-weighted threshold amount
for MS–DRG 016. The average caseweighted threshold amount for MS–
DRG 016 from Table 10 in the FY 2018
IPPS/LTCH PPS final rule is $161,058.
Although the inflated average caseweighted standardized charge per case
for all three cohorts ($63,271, $39,723,
and $72,781) is lower than the average
case-weighted threshold amount for
MS–DRG 016, similar to above, the
applicant expects the cost of
KYMRIAHTM to be higher than the new
technology add-on payment threshold
amount for MS–DRG 016. Therefore, it
appears that KYMRIAHTM would meet
the cost criterion under this scenario as
well.
We appreciate the applicant’s
analysis. However, we note that the
applicant did not provide information
regarding which specific historic
charges were removed in conducting its
cost analysis. Nonetheless, we believe
that even if historic charges were
identified and removed, the applicant
would meet the cost criterion because,
as indicated, the applicant expects the
cost of KYMRIAHTM to be higher than
the new technology add-on payment
threshold amounts listed earlier.
We are inviting public comments on
whether KYMRIAHTM meets the cost
criterion.
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With regard to the cost criterion in
reference to YESCARTATM, the
applicant conducted the following
analysis. The applicant examined FY
2016 MedPAR claims data restricted to
patients discharged in FY 2016. The
applicant included potential cases
reporting an ICD–10 diagnosis code of
C83.38. Noting that only MS–DRGs 820
(Lymphoma and Leukemia with Major
O.R. Procedure with MCC), 821
(Lymphoma and Leukemia with Major
O.R. Procedure with CC), 823 and 824
(Lymphoma and Non-Acute Leukemia
with Other O.R. Procedure with MCC,
with CC, respectively), 825 (Lymphoma
and Non Acute Leukemia with Other
O.R Procedure without CC/MCC), and
840, 841 and 842 (Lymphoma and NonAcute Leukemia with MCC, with CC
and without CC/MCC, respectively)
consisted of 10 or more cases, the
applicant limited its analysis to these 8
MS–DRGs. The applicant identified 827
potential cases across these MS–DRGs.
The average case-weighted
unstandardized charge per case was
$126,978. The applicant standardized
charges using FY 2016 standardization
factors and applied an inflation factor of
1.09357 from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38527). The
applicant for YESCARTATM did not
include the cost of its technology in its
analysis.
Included in the average case-weighted
standardized charge per case were
charges for the current treatment
components. Therefore, the applicant
for YESCARTATM removed 20 percent
of radiology charges to account for
chemotherapy, and calculated the
adjusted average case-weighted
standardized charge per case by
subtracting these charges from the
standardized charge per case. Based on
the distribution of potential cases
within the eight MS–DRGs, the
applicant case-weighted the final
inflated average case-weighted
standardized charge per case. This
resulted in an inflated average caseweighted standardized charge per case
of $118,575. Using the FY 2018 IPPS
Table 10 thresholds, the average caseweighted threshold amount was
$72,858. Even without considering the
cost of its technology, the applicant
maintained that because the inflated
average case-weighted standardized
charge per case exceeds the average
case-weighted threshold amount, the
technology meets the cost criterion.
We note that, as discussed earlier, in
section II.F.2.d. of the preamble of this
proposed rule, we are proposing to
assign the ICD–10–PCS procedure codes
that describe procedures involving the
utilization of these CAR T-cell therapy
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drugs and cases representing patients
receiving treatment involving CAR
T-cell therapy procedures to Pre-MDC
MS–DRG 016 for FY 2019. Therefore, in
addition to the analysis above, we
compared the inflated average caseweighted standardized charge per case
($118,575) to the average case-weighted
threshold amount for MS–DRG 016. The
average case-weighted threshold amount
for MS–DRG 016 from Table 10 in the
FY 2018 IPPS/LTCH PPS final rule is
$161,058. Although the inflated average
case-weighted standardized charge per
case is lower than the average caseweighted threshold amount for MS–
DRG 016, the applicant expects the cost
of YESCARTATM to be higher than the
new technology add-on payment
threshold amount for MS–DRG 016.
Therefore, it appears that YESCARTATM
would meet the cost criterion under this
scenario as well.
We are inviting public comments on
whether YESCARTATM technology
meets the cost criterion.
With regard to substantial clinical
improvement for KYMRIAHTM, the
applicant asserted that several aspects of
the treatment represent a substantial
clinical improvement over existing
technologies. The applicant believed
that KYMRIAHTM allows access for a
treatment option for those patients who
are unable to receive standard of care
treatment. The applicant stated in its
application that there are no currently
FDA-approved treatment options for
patients with R/R DLBCL who are
ineligible for or who have failed ASCT.
Additionally, the applicant maintained
that KYMRIAHTM significantly
improves clinical outcomes, including
ORR, CR, OS, and durability of
response, and allows for a manageable
safety profile. The applicant asserted
that, when compared to the historical
control data (SCHOLAR–1) and the
currently available treatment options, it
is clear that KYMRIAHTM significantly
improves clinical outcomes for patients
with R/R DLBCL who are not eligible for
ASCT. The applicant conveyed that,
given that the patient population has no
other available treatment options and an
expected very short lifespan without
therapy, there are no randomized
controlled trials of the use of
KYMRIAHTM in patients with R/R
DLBCL and, therefore, efficacy
assessments must be made in
comparison to historical control data.
The SCHOLAR–1 study is the most
comprehensive evaluation of the
outcome of patients with refractory
DLBCL. SCHOLAR–1 includes patients
from two large randomized controlled
trials (Lymphoma Academic Research
Organization-CORAL and Canadian
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Cancer Trials Group LY.12) and two
clinical databases (MD Anderson Cancer
Center and University of Iowa/Mayo
Clinic Lymphoma Specialized Program
of Research Excellence).33
The applicant for KYMRIAHTM
conveyed that the PARMA study
established high-dose chemotherapy
and ASCT as the standard treatment for
patients with R/R DLBCL.34 However,
according to the applicant, many
patients with R/R DLBCL are ineligible
for ASCT because of medical frailty.
Patients who are ineligible for ASCT
because of medical frailty would also be
adversely affected by high-dose
chemotherapy regimens.35 Lowering the
toxicity of chemotherapy regimens
becomes the only treatment option,
leaving patients with little potential for
therapeutic outcomes. According to the
applicant, the lack of efficacy of these
aforementioned salvage regimens was
demonstrated in nine studies evaluating
combined chemotherapeutic regimens
in patients who were either refractory to
first-line or first salvage. Chemotherapy
response rates ranged from 0 percent to
23 percent with OS less than 10 months
in all studies.36 For patients who do not
respond to combined therapy regimens,
the National Comprehensive Cancer
Network (NCCN) offers only clinical
trials or palliative care as therapeutic
options.37
According to the applicant for
KYMRIAHTM, the immunomodulatory
agent Lenalidomide was only able to
show an ORR of 30 percent, a CR rate
of 8 percent, and a 4.6-month median
duration of response.38 M-tor inhibitors
33 Crump, M., Neelapu, S.S., Farooq, U., et al.,
‘‘Outcomes in refractory diffuse large B-cell
lymphoma: results from the international
SCHOLAR–1 study,’’ Blood, Published online:
August 3, 2017, doi: 10.1182/blood-2017-03769620.
34 Philip, T., Guglielmi, C., Hagenbeek, A., et al.,
‘‘Autologous bone marrow transplantation as
compared with salvage chemotherapy in relapses of
chemotherapy-sensitive non-Hodgkin’s
lymphoma,’’ N Engl J Med, 1995, vol. 333(23), pp.
1540–1545.
35 Friedberg, J.W., ‘‘Relapsed/refractory diffuse
large B-cell lymphoma,’’ Hematology AM Soc
Hematol Educ Program, 2011, vol. (1), pp. 498–505.
36 Crump, M., Neelapu, S.S., Farooq, U., et al.,
‘‘Outcomes in refractory diffuse large B-cell
lymphoma: results from the international
SCHOLAR–1 study,’’ Blood, Published online:
August 3, 2017, doi: 10.1182/blood-2017-03769620.
37 National Comprehensive Cancer Network,
NCCN Clinical Practice Guidelines in Oncology
(NCCN GuidelinesR), ‘‘B-cell lymphomas: Diffuse
large b-cell lymphoma and follicular lymphoma
(Version 3.2017),’’ May 25, 2017. Available at:
https://www.nccn.org/professionals/physician_gls/
pdf/b-cell_blocks.pdf.
38 Klyuchnikov, E., Bacher, U., Kroll, T., et al.,
‘‘Allogeneic hematopoietic cell transplantation for
diffuse large B cell lymphoma: who, when and
how?,’’ Bone Marrow Transplant, 2014, vol. 49(1),
pp. 1–7.
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such as Everolimus and Temserolimus
have been studied as single agents, or in
combination with Rituximab, as have
newer monoclonal antibodies
Dacetuzumab, Ofatumomab and
Obinutuzumab. However, none induced
a CR rate higher than 20 percent or
showed a median duration of response
longer than 1 year.39
According to the applicant, although
controversial, allogeneic stem cell
transplantation (allo-SCT) has been
proposed for patients who have been
diagnosed with R/R disease. It is
hypothesized that the malignant cell
will be less able to escape the immune
targeting of allogenic T-cells—known as
the graft-vs-lymphoma effect.40 41 The
use of allo-SCT is limited in patients
who are not eligible for ASCT because
of the high rate of morbidity and
mortality. This medically frail
population is generally excluded from
participation. The population most
impacted by this is the elderly, who are
often excluded based on age alone. In
seven studies evaluating allo-SCT in
patients with R/R DLBCL, the median
age at transplant was 43 years old to 52
years old, considerably lower than the
median age of patients with DLBCL of
64 years old. Only two studies included
any patients over 66 years old. In these
studies, allo-SCT provided OS rates
ranging from 18 percent to 52 percent at
3 to 5 years, but was accompanied by
treatment-related mortality rates ranging
from 23 percent to 56 percent.42
According to the applicant, this toxicity
and efficacy profile of allo-SCT
substantially limits its use, especially in
patients 65 years old and older. Given
the high unmet medical need, the
applicant maintained that KYMRIAHTM
represents a substantial clinical
improvement by offering a treatment
option for a patient population
unresponsive to, or ineligible for,
currently available treatments.
To express how KYMRIAHTM has
improved clinical outcomes, including
ORR, CR rate, OS, and durability of
response, the applicant referenced
clinical trials in which KYMRIAHTM
was tested. Study 1 was a single-arm,
open-label, multi-site, global Phase II
study to determine the safety and
efficacy of tisagenlecleucel in patients
39 Ibid.
40 Ibid.
41 Maude, S.L., Teachey, D.T., Porter, D.L., Grupp,
S.A., ‘‘CD19-targeted chimeric antigen receptor Tcell therapy for acute lymphoblastic leukemia,’’
Blood, 2015, vol. 125(26), pp. 4017–4023.
42 Klyuchnikov, E., Bacher, U., Kroll, T., et al.,
‘‘Allogeneic hematopoietic cell transplantation for
diffuse large B cell lymphoma: who, when and
how?,’’ Bone Marrow Transplant, 2014, vol. 49(1),
pp. 1–7.
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with R/R DLBCL (CCTL019C2201/
CT02445248/‘JULIET’ study).43 44 45 Key
inclusion criteria included patients who
were 18 years old and older, patients
with refractory to at least two lines of
chemotherapy and either relapsed post
ASCT or who were ineligible for ASCT,
measurable disease at the time of
infusion, and adequate organ and bone
marrow function. The study was
conducted in three phases. In the
screening phase patient eligibility was
assessed and patient cells collected for
product manufacture. Patients were also
able to receive bridging, cytotoxic
chemotherapy during this time. In the
pre-treatment phase patients underwent
a restaging of disease followed by
lymphodepleting chemotherapy with
fludarabine 25mg/m2 x3 and
cyclophosphamide 250mg/m2/d x3 or
bendamustine 90mg/m2/d x2 days. The
treatment and follow-up phase began 2
to 14 days after lymphodepleting
chemotherapy, when the patient
received a single infusion of
tisagenlecleucel with a target dose of
5x108 CTL019 transduced viable cells.
The primary objective was to assess the
efficacy of tisagenlecleucel, as measured
by the best overall response (BOR),
which was defined as CR or partial
response (PR). It was assessed on the
Chesson 2007 response criteria
amended by Novartis Pharmaceutical
Corporation as confirmed by an
Independent Review Committee (IRC).
One hundred forty-seven patients were
enrolled, and 99 of them were infused
with tisagenlecleucel. Forty-three
patients discontinued prior to infusion
(9 due to inability to manufacture and
34 due to patient-related issues).46 The
median age of treated patients was 56
years old with a range of 24 to 75; 20
percent were older than 65 years old.
Patients had received 2 to 7 prior lines
of therapy, with 60 percent receiving 3
43 Data on file, Oncology clinical trial protocol
CCTL019C2201: ‘‘A Phase II, single-arm,
multi-center trial to determine the efficacy and
safety of CTL019 in adult patients with relapsed or
refractory diffuse large Bcell lymphoma (DLBCL),’’
Novartis Pharmaceutical Corp, 2015.
44 Schuster, S.J., Bishop, M.R., Tam, C., et al.,
‘‘Global trial of the efficacy and safety of CTL019
in adult patients with relapsed or refractory diffuse
large B-cell lymphoma: an interim analysis,’’
Presented at: 22nd Congress of the European
Hematology Association, June 22–25, 2017, Madrid,
Spain.
45 ClinicalTrials.gov, ‘‘Study of efficacy and safety
of CTL019 in adult DLBCL patients (JULIET).’’
Available at: https://clinicaltrials.gov/ct2/show/
NCT02445248.
46 Schuster, S.J., Bishop, M.R., Tam, C., et al.,
‘‘Global trial of the efficacy and safety of CTL019
in adult patients with relapsed or refractory diffuse
large B-cell lymphoma: an interim analysis,’’
Presented at: 22nd Congress of the European
Hematology Association, June 22–25, 2017, Madrid,
Spain.
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or more therapies, and 51 percent
having previously undergone ASCT. A
primary analysis was performed on 81
patients infused and followed for more
than or at least 3 months. In this
primary analysis, the BOR was 53
percent; the study met its primary
objective based on statistical analysis
(that is, testing whether BOR was greater
than 20 percent, a clinically relevant
threshold chosen based on the response
to chemotherapy in a patient with R/R
DLBCL). Forty-three percent (43
percent) of evaluated patients reached a
CR, and 14 percent reached a PR. ORR
evaluated at 3 months was 38 percent
with a distribution of 32 percent CR and
6 percent PR. All patients in CR at 3
months continued to be in CR. ORR was
similar across subgroups including 64.7
percent response in patients who were
older than 65 years old, 61.1 percent
response in patients with Grade III/IV
disease at the time of enrollment, 58.3
percent response in patients with
Activated B-cell, 52.4 percent response
in patients with Germinal Center B-cell
subtype, and 60 percent response in
patients with double and triple hit
lymphoma. Durability of response was
assessed based on relapse free survival
(RFS), which was estimated at 74
percent at 6 months.
The applicant for KYMRIAHTM
reported that Study 2 was a supportive
Phase IIa single institution study of
adults who were diagnosed with
advanced CD19+ NHL conducted at the
University of Pennsylvania.47 48
Tisagenlecleucel cells were produced at
the University of Pennsylvania using the
same genetic construct and a similar
manufacturing technique as employed
in Study 1. Key inclusion criteria
included patients who were at least 18
years old, patients with CD19+
lymphoma with no available curative
options, and measurable disease at the
time of enrollment. Tisagenlecleucel
was delivered in a single infusion 1 to
4 days after restaging and
lymphodepleting chemotherapy. The
median tisagenlecleucel cell dose was
5.0 × 108 transduced cells. The study
enrolled 38 patients; of these, 21 were
diagnosed with DLBCL and 13 received
treatment involving KYMRIAHTM.
47 ClinicalTrials.gov, ‘‘Phase IIa study of
redirected autologous T-cells engineered to contain
anti-CD19 attached to TCRz and 4-signaling
domains in patients with chemotherapy relapsed or
refractory CD19+ lymphomas,’’ Available at:
https://clinicaltrials.gov/ct2/show/NCT02030834.
48 Schuster, S.J., Svoboda, J., Nasta, S.D., et al.,
‘‘Sustained remissions following chimeric antigen
receptor modified T-cells directed against CD–19
(CTL019) in patients with relapsed or refractory
CD19+ lymphomas,’’ Presented at: 57th Annual
Meeting of the American Society of Hematology,
December 6, 2015, Orlando, FL.
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Patients ranged in age from 25 to 77
years old, and had a median of 4 prior
therapies. Thirty-seven percent had
undergone ASCT and 63 percent were
diagnosed with Grade III/IV disease.
ORR at 3 months was 54 percent.
Progression free survival was 43 percent
at a median follow-up of 11.7 months.
Safety and efficacy results are similar to
those of the multi-center study.
The applicant for KYMRIAHTM
reported that Study 3 was a supportive,
patient-level meta-analysis of historical
outcomes in patients who were
diagnosed with refractory DLBCL
(SCHOLAR–1).49 This study included a
pooled data analysis of two Phase III
clinical trials (Lymphoma Academic
Research Organization-CORAL and
Canadian Cancer Trials Group LY.12)
and two observational cohorts (MD
Anderson Cancer Center and University
of Iowa/Mayo Clinic Lymphoma
Specialized Program of Research
Excellence). Refractory disease was
defined as progressive disease or stable
disease as best response to
chemotherapy (received more than or at
least 4 cycles of first-line therapy or 2
cycles of later-line therapy, respectively)
or relapse in less than or at 12 months
post-ASCT. Of 861 abstracted records,
636 were included based on these
criteria. All patients from each data
source who met criteria for diagnosis of
refractory DLBCL, including TFL and
PMBCL, who went on to receive
subsequent therapy were considered for
analysis. Patients who were diagnosed
with TFL and PMBCL were included
because they are histologically similar
and clinically treated as large cell
lymphoma. Response rates were similar
across the 4 datasets, ranging from 20
percent to 31 percent, with a pooled
response rate of 26 percent. CR rates
ranged from 2 percent to 15 percent,
with a pooled CR rate of 7 percent.
Subgroup analyses including patients
with primary refractory, refractory to
second or later-line therapy, and relapse
in less than 12 months post-ASCT
revealed response rates similar to the
pooled analysis, with worst outcomes in
the primary refractory group (20
percent). OS from the commencement of
therapy was 6.3 months and was similar
across subgroup analyses. Achieving a
CR after last salvage chemotherapy
predicted a longer OS of 14.9 months
compared to 4.6 months in
nonresponders. Patients who had not
undergone ASCT had an OS of 5.1
49 Crump, M., Neelapu, S.S., Farooq, U., et al.,
‘‘Outcomes in refractory diffuse large B-cell
lymphoma: results from the international
SCHOLAR–1 study,’’ Blood, Published online:
August 3, 2017, doi: 10.1182/blood-2017-03769620.
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months with a 2 year OS rate of 11
percent.
The applicant asserted that
KYMRIAHTM provides a manageable
safety profile when treatment is
performed by trained medical personnel
and, as opposed to ASCT, KYMRIAHTM
mitigates the need for high-dose
chemotherapy to induce response prior
to infusion. Adverse events were most
common in the 8 weeks following
infusion and were manageable by a
trained staff. Cytokine Relapse
Syndrome (CRS) occurred in 58 percent
of patients with 23 percent having
Grade III or IV events as graded on the
University of Pennsylvania grading
system.50 51 Median time to onset of
CRS was 3 days and median duration
was 7 days with a range of 2 to 30 days.
Twenty-four percent of the patients
required ICU admission. CRS was
managed with supportive care in most
patients. However, 16 percent required
anti-cytokine therapy including
tocilizumab (15 percent) and
corticosteroids (11 percent). Other
adverse events of special interest
include infection in 34 percent (20
percent Grade III or IV) of patients,
cytopenias not resolved by day 28 in 36
percent (27 percent Grade III or IV) of
patients, neurologic events in 21 percent
(12 percent Grade III or IV) of patients,
febrile neutropenia in 13 percent (13
percent Grade III or IV) of patients, and
tumor lysis syndrome 1 percent (1
percent Grade III). No deaths were
attributed to tisagenlecleucel including
no fatal cases of CRS or neurologic
events. No cerebral edema was
observed.52 Study 2 safety results were
consistent to those of Study 1.53
After reviewing the studies provided
by the applicant, we are concerned that
the applicant included patients who
were diagnosed with TFL and PMBCL
in the SCHOLAR–1 data results for their
comparison analysis, possibly skewing
results. Furthermore, the discontinue
rate of the JULIET trial was high. Of 147
patients enrolled for infusion involving
KYMRIAHTM, 43 discontinued prior to
infusion (9 discontinued due to inability
to manufacture, and 34 discontinued
due to patient-related issues). Finally,
the rate of patients who experienced a
diagnosis of CRS was high, 58 percent.54
The applicant for YESCARTATM
stated that YESCARTATM represents a
substantial clinical improvement over
existing technologies when used in the
treatment of patients with aggressive
B-cell NHL. The applicant asserted that
YESCARTATM can benefit the patient
population with the highest unmet
need, patients with R/R disease after
failure of first-line or second-line
therapy, and patients who have failed or
who are ineligible for ASCT. These
patients, otherwise, have adverse
outcomes as demonstrated by historical
control data.
Regarding clinical data for
YESCARTATM, the applicant stated that
historical control data was the only
ethical and feasible comparison
information for these patients with
chemorefractory, aggressive NHL who
have no other available treatment
options and who are expected to have
a very short lifespan without therapy.
According to the applicant, based on
meta-analysis of outcomes in patients
with chemorefractory DLBCL, there are
no curative options for patients with
aggressive B-cell NHL, regardless of
refractory subgroup, line of therapy, and
disease stage with their median OS
being 6.6 months.55
In the applicant’s FY 2018 new
technology add-on payment application
for the KTE–C19 technology, which was
discussed in the FY 2018 IPPS/LTCH
PPS proposed rule (82 FR 19889), the
applicant cited ongoing clinical trials.
The applicant provided updated data
related to these ongoing clinical trials as
part of its FY 2019 application for
YESCARTATM.56 57 58 The updated
50 ClinicalTrials.gov, ‘‘Phase IIa study of
redirected autologous T-cells engineered to contain
anti-CD19 attached to TCRz and 4-signaling
domains in patients with chemotherapy relapsed or
refractory CD19+ lymphomas.’’ Available at:
https://clinicaltrials.gov/ct2/show/NCT02030834.
51 Schuster, S.J., Svoboda, J., Nasta, S.D., et al.,
‘‘Sustained remissions following chimeric antigen
receptor modified T-cells directed against CD–19
(CTL019) in patients with relapsed or refractory
CD19+ lymphomas,’’ Presented at: 57th Annual
Meeting of the American Society of Hematology,
December 6, 2015, Orlando, FL.
52 Schuster, S.J., Bishop, M.R., Tam, C., et al.,
‘‘Global trial of the efficacy and safety of CTL019
in adult patients with relapsed or refractory diffuse
large B-cell lymphoma: an interim analysis,’’
Presented at: 22nd Congress of the European
Hematology Association, June 22–25, 2017, Madrid,
Spain.
53 Ibid.
54 Schuster, S.J., Bishop, M.R., Tam, C., et al.,
‘‘Global trial of the efficacy and safety of CTL019
in adult patients with relapsed or refractory diffuse
large B-cell lymphoma: an interim analysis,’’
Presented at: 22nd Congress of the European
Hematology Association, June 22–25, 2017, Madrid,
Spain.
55 Seshardi, T., et al., ‘‘Salvage therapy for
relapsed/refractory diffuse large B-cell lymphoma,’’
Biol Blood Marrow Transplant, 2008 Mar, vol.
14(3), pp. 259–67.
56 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase 1 of ZUMA–1: A phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
57 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: A pivotal trial of axicabtagene
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analysis of the pivotal Study 1 (ZUMA–
1, KTE–C19–101), Phase I and II
occurred when patients had been
followed for 12 months after infusion of
YESCARTATM. Study 1 is a Phase I–II
multi-center, open-label study
evaluating the safety and efficacy of the
use of YESCARTATM in patients with
aggressive refractory NHL. The trial
consists of two distinct phases designed
as Phase I (n=7) and Phase II (n=101).
Phase II is a multi-cohort open-label
study evaluating the efficacy of
YESCARTATM.59 The applicant noted
that, as of the analysis cutoff date for the
interim analysis, the results of Study 1
demonstrated rapid and substantial
improvement in objective, or ORR. After
6 and 12 months, the ORR was 82 and
83 percent, respectively. Consistent
response rates were observed in both
Study 1, Cohort 1 (DLBCL; n=77) and
Cohort 2 (PMBCL or TFL; n=24) and
across covariates including disease
stage, age, IPI scores, CD–19 status, and
refractory disease subset. In the updated
analysis, results were consistent across
age groups. In this analysis, 39 percent
of patients younger than 65 years old
were in ongoing response, and 50
percent of patients at least 65 years old
or older were in ongoing response.
Similarly, the survival rate at 12 months
was 57 percent among patients younger
than 65 years old and 71 percent among
patients at least 65 years old or older
versus historical control of 26 percent.
The applicant further stated that
evidence of substantial clinical
improvement regarding the efficacy of
YESCARTATM for the treatment of
patients with chemorefractory,
aggressive B-cell NHL is supported by
the CR of YESCARTATM in Study 1,
Phase II (54 percent) versus the
historical control (7 percent).60 61 62 63
ciloretroleucel (axi-cel; KTE–C19) in patients with
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
58 Locke, F.L., et al., ‘‘Phase I results of ZUMA–
1: A multicenter study of KTE–C19 anti-CD19 CAR
T cell therapy in refractory aggressive lymphoma,’’
Mol Ther, vol. 25, No 1, January 2017.
59 Neelapu, S.S., Locke, F.L., et al., 2016, ‘‘KTE–
C19 (anti-CD19 CAR T cells) induces complete
remissions in patients with refractory diffuse large
B-cell lymphoma (DLBCL): Results from the pivotal
Phase II ZUMA–1,’’ Abstract presented at American
Society of Hematology (ASH) 58th Annual Meeting,
December 2016.
60 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase I of ZUMA–1: a phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
61 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: a pivotal trial of axicabtagene
ciloretroleucel (axi-cel; KTE–C19) in patients with
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The applicant noted that CR rates were
observed in both Study 1, Cohort 1. The
applicant reported that, in the updated
analysis, results were in ongoing
response (46 percent of patients at least
65 years old or older were in ongoing
response). Similarly, the survival rate at
12 months was 57 percent among
patients younger than 65 years old and
71 percent among patients at least 65
years old or older.64 65 66 67 The
applicant also provided the following
tables to depict data to support
substantial clinical improvement (we
refer readers to the two tables below).
OVERALL RESPONSE RATES ACROSS ALL YESCARTATM STUDIES VS. SCHOLAR–1
Study 1,
Phase I
n=7
%
Overall Response Rate (%) ........................................................................................
Month 6 (%) .................................................................................................................
Ongoing with >15 Months of follow-up (%) ................................................................
Ongoing with >18 Months of follow-up (%) ................................................................
Study 1,
Phase II
n=101
71
43
43
43
Scholar-1
n=529
83 ...................................
41 ...................................
42 ...................................
Follow-up ongoing .........
26
........................
........................
........................
RESULTS FOR YESCARTATM STUDY 1, PHASE II: COMPLETE RESPONSE
Study 1, Phase II
n=101
Complete Response (%) (95 Percent Confidence Interval) ....................................................................................................
Duration of Response, median (range in months) ..................................................................................................................
Ongoing Responses, CR (%); Median 8.7 months follow-up; median overall survival has not been reached .....................
Ongoing Responses, CR (%); Median 15.3 months follow-up; median overall survival has not been reached ...................
54 (44,64).
not reached.
39.
40.
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According to the applicant, the 6month and 12-month survival rates (95
percent CI) for patients enrolled in the
SCHOLAR–1 study were 53 percent (49
percent, 57 percent) and 28 percent (25
percent, 32 percent).68 In contrast, the
6-month and 12–month survival rates
(95 percent CI) in the Study 1 updated
analysis were 79 percent (70 percent, 86
percent) and 60 percent (50 percent, 69
percent).69 70 71
The applicant also cited safety results
from the pivotal Study 1, Phase II.
According to the applicant, the clinical
trial protocol stipulated that patients
were infused with YESCARTATM in the
hospital inpatient setting and were
monitored in the inpatient setting for at
least 7 days for early identification and
treatment involving YESCARTATMrelated toxicities, which primarily
included CRS diagnoses and
neurotoxicities. The applicant noted
that the interim analysis showed the
length of stay following infusion of
YESCARTATM was a median of 15 days.
Ninety-three percent of patients
experienced CRS diagnoses, 13 percent
of whom experienced Grade III or higher
(severe, life threatening or fatal) CRS
diagnoses. The median time to onset of
CRS diagnosis was 2 days (range 1 to 12
days) and the median time to resolution
was 8 days. Ninety-eight percent of
patients recovered from CRS diagnosis.
Neurologic events occurred in 64
percent of patients, 28 percent of whom
experienced Grade III or higher (severe
or life threatening) events. The median
time to onset of neurologic events was
5 days (range 1 to 17 days). The median
time to resolution was 17 days. Nearly
all patients recovered from neurologic
events. The medications most often
used to treat these complications
included growth factors, blood
products, anti-infectives, steroids,
tocilizumab, and vasopressors. Two
patients died from YESCARTATMrelated adverse events (hemophagocytic
lymphohistiocytosis and cardiac arrest
in the hospital setting as a result of CRS
diagnoses). According to the applicant,
there were no clinically important
differences in adverse event rates across
age groups (younger than 65 years old;
65 years old or older), including CRS
diagnoses and neurotoxicity.72 73
The applicant for YESCARTATM
provided information regarding a safety
expansion cohort, Study 1 Phase II
Safety Expansion Cohort 3 that was
created and carried out in 2017.
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
62 Locke, F.L., et al., ‘‘Phase I results of ZUMA–
1: A multicenter study of KTE–C19 anti-CD19 CAR
T cell therapy in refractory aggressive lymphoma,’’
Mol Ther, vol. 25, No 1, January 2017.
63 Crump, et al., 2017, ‘‘Outcomes in refractory
diffuse large B-cell lymphoma: Results from the
international SCHOLAR–1 study,’’ Blood, vol. 0,
2017, pp. blood-2017-03-769620v1.
64 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase I of ZUMA–1: A phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
65 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: A pivotal trial of axicabtagene
ciloretroleucel (axi-cel; KTE–C19) in patients with
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
66 Locke, F.L., et al., ‘‘Phase I results of ZUMA–
1: A multicenter study of KTE–C19 anti-CD19 CAR
T cell therapy in refractory aggressive lymphoma,’’
Mol Ther, vol. 25, No 1, January 2017.
67 Crump, et al., ‘‘Outcomes in refractory diffuse
large B-cell lymphoma: Results from the
international SCHOLAR–1 study,’’ Blood, vol. 0,
2017, pp. blood-2017-03-769620v1.
68 Crump, et al., ‘‘Outcomes in refractory diffuse
large B-cell lymphoma: results from the
international SCHOLAR–1 study,’’ Blood, vol. 0,
2017, pp. blood-2017-03-769620v1.
69 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase I of ZUMA–1: a phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
70 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: a pivotal trial of axicabtagene
ciloretroleucel (axi-cel; KTE–C19) in patients with
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
71 Locke, F.L., et al., ‘‘Phase I results of ZUMA–
1: a multicenter study of KTE–C19 anti-CD19 CAR
T cell therapy in refractory aggressive lymphoma,’’
Mol Ther, vol. 25, No 1, January 2017.
72 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase I of ZUMA–1: a phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
73 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: a pivotal trial of axicabtagene
ciloretroleucel (axi-cel; KTE–C19) in patients with
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
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According to the applicant, this Safety
Expansion Cohort investigated measures
to mitigate the incidence and/or severity
of anti-CD–19 CAR T therapy and
evaluated an adverse event mitigation
strategy by prophylactically using
levetiracetam (Keppra), an
anticonvulsant, and tocilizumab, an
IL–6 receptor inhibitor. Of the 30
patients treated, 2 patients experienced
Grade III CRS diagnoses; 1 of the 2
patients recovered. In late April 2017,
the other patient also experienced
multi-organ failure and a neurologic
event that subsequently progressed to a
fatal Grade V cerebral edema that was
deemed related to YESCARTATM
treatment. This case of cerebral edema
was observed in a 21 year-old male with
refractory, rapidly progressive,
symptomatic, stage IVB PMBCL.
Analysis of the baseline serum and
cerebrospinal fluid (CSF) obtained prior
to any study treatment demonstrated
high cytokine and chemokine levels.
According to the applicant, this suggests
a significant preexisting underlying
inflammatory process, both systemically
and within the central nervous system.
Rapidly progressing disease, recent
mediastinal XRT (external beam
radiation therapy) and/or CMV
(cytomegalovirus) reactivation may have
contributed to the pre-existing state.
There were no prior cases of cerebral
edema in the 200 patients who have
been treated with YESCARTATM in the
ZUMA clinical development program.
The single patient event from the Study
1 Phase II Safety Expansion Cohort 3
was the first Grade V cerebral edema
event.74 75
After reviewing the information
submitted by the applicant as part of its
FY 2019 new technology add-on
payment application for YESCARTATM,
we are concerned that it does not appear
to include patient mortality data that
was included as part of the applicant’s
FY2018 new technology add-on
payment application for the KTE–C19
technology. In that application, as
discussed in the FY 2018 IPPS/LTCH
PPS proposed rule (82 FR 19890), the
applicant provided that by an earlier
cutoff date for the interim analysis of
74 Locke, F.L., et al., ‘‘Ongoing complete
remissions in Phase I of ZUMA–1: a phase I–II
multicenter study evaluating the safety and efficacy
of KTE–C19 (anti-CD19 CAR T cells) in patients
with refractory aggressive B-cell non-Hodgkin
lymphoma (NHL),’’ Oral presentation (abstract
10480) presented at European Society for Medical
Oncology (ESMO), October 2016.
75 Locke, F.L., et al., ‘‘Primary results from
ZUMA–1: a pivotal trial of axicabtagene
ciloretroleucel (aci-cel; KTE–C19) in patients with
refractory aggressive non-Hodgkins lymphoma
(NHL),’’ Oral presentation, American Association of
Cancer Research (AACR).
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Study 1, among all KTE–C19 treated
patients, 12 patients in Study 1, Phase
II, including 10 from Cohort 1, and 2
from Cohort 2, died. Eight of these
deaths were due to disease progression.
One patient had disease progression
after receiving KTE–C19 treatment and
subsequently had ASCT. After ASCT,
the patient died due to sepsis. Two
patients (3 percent) died due to KTE–
C19-related adverse events (Grade V
hemophagocytic lymphohistiocytosis
event and Grade V anoxic brain injury),
and one died due to an adverse event
deemed unrelated to treatment
involving KTE–C19 (Grade V pulmonary
embolism), without disease progression.
We believe it would be relevant to
include this information because it is
related to the same treatment that is the
subject of the applicant’s FY 2019 new
technology add-on payment application.
We also are concerned that there are
few published results showing any
survival benefits from the use of this
treatment. In addition, we are concerned
with the limited number of patients
(n=108) that were studied after infusion
involving YESCARTATM T-cell
immunotherapy. Finally, we are
concerned about the data related to the
percentage of patients who experience
complications or toxicities related to
YESCARTATM treatment. According to
the applicant, of the patients who
participated in YESCARTATM clinical
trials, 93 percent developed CRS
diagnoses and 64 percent experienced
neurological adverse events.
We are inviting public comments on
whether KYMRIAHTM and
YESCARTATM meet the substantial
clinical improvement criterion.
Finally, we believe that in the context
of these pending new technology add-on
payment applications, there may also be
merit in the suggestions from the public
to create a new MS–DRG for the
assignment of procedures involving the
utilization of CAR T-cell therapy drugs
and cases representing patients who
receive treatment involving CAR T-cell
therapy as an alternative to our
proposed MS–DRG assignment to MS–
DRG 016 for FY 2019, or the suggestions
to allow hospitals to utilize a CCR
specific to procedures involving the
utilization of KYMRIAHTM and
YESCARTATM CAR T-cell therapy drugs
for FY 2019 as part of the determination
of the cost of a case for purposes of
calculating outlier payments for
individual FY 2019 cases, new
technology add-on payments, if
approved, for individual FY 2019 cases,
and payments to IPPS-excluded cancer
hospitals beginning in FY 2019. If as
discussed in section II.F.2.d. of the
preamble of this proposed rule a new
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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. With respect to an alternative
considered for the use of a CCR specific
to procedures involving the utilization
of KYMRIAHTM and YESCARTATM CAR
T-cell therapy drugs for FY 2019 as part
of the determination of the cost of a case
for purposes of calculating outlier
payments for individual FY 2019 cases,
new technology add-on payments, if
approved, for individual FY 2019 cases,
and payments to IPPS-excluded cancer
hospitals beginning in FY 2019, we refer
readers to the discussion in section
II.A.4.g.2. of the Addendum to this
proposed rule.
We are inviting public comments
regarding the most appropriate
mechanism to provide payment to
hospitals for new technologies such as
CAR T-cell therapy drugs, including
through the use of new technology
add-on payments.
We also are inviting public comments
on how these payment alternatives
would affect access to care, as well as
how they affect incentives to encourage
lower drug prices, which is a high
priority for this Administration. In
addition, we are considering alternative
approaches and authorities to encourage
value-based care and lower drug prices.
We solicit comments on how the
payment methodology alternatives may
intersect and affect future participation
in any such alternative approaches.
We did not receive any written public
comments in response to the New
Technology Town Hall meeting notice
published in the Federal Register
regarding the application of
KYMRIAHTM for new technology addon payments for FY 2019.
Below we summarize and respond to
a written public comment we received
during the open comment period
regarding YESCARTATM in response to
the New Technology Town Hall meeting
notice published in the Federal
Register.
Comment: The applicant commented
that the use of YESCARTATM as a
treatment option has resulted in
unprecedented and consistent treatment
for patients with refractory large B-cell
lymphoma who previously did not have
a curative option. In addition, the
applicant summarized the substantial
clinical improvement differences
between YESCARTATM and the results
of KYMRIAHTM’s SCHOLAR–1 study.
The applicant noted that, for the
patients enrolled in the SCHOLAR–1
study, the median overall survival was
6 months and complete remission was
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7 percent. Conversely, the applicant
conveyed that, for the patients enrolled
in YESCARTATM’s Study 1, at median
15.4 months follow-up, responses were
ongoing in 42 percent of the patients
and 40 percent of the patients were in
complete remission.
Response: We appreciate the
applicant’s input. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payments for
YESCARTATM for FY 2019.
We note that the applicant also
provided comments that were unrelated
to the substantial clinical improvement
criterion. As stated earlier, the purpose
of the new technology town hall
meeting is specifically to discuss the
substantial clinical improvement
criterion in regard to pending new
technology add-on payment
applications for FY 2019. Therefore, we
are not summarizing these additional
comments in this proposed rule.
However, the applicant may resubmit its
comments in response to proposals
presented in this proposed rule.
b. VYXEOSTM (Cytarabine and
Daunorubicin Liposome for Injection)
Jazz Pharmaceuticals, Inc. submitted
an application for new technology addon payments for the VYXEOSTM
technology for FY 2019. (We note that
Celator Pharmaceuticals, Inc. submitted
an application for new technology
add-on payments for VYXEOSTM for FY
2018. However, Celator Pharmaceuticals
did not receive FDA approval by the
July 1, 2017 deadline for applications
for FY 2018.) VYXEOSTM was approved
by FDA on August 3, 2017, for the
treatment of adults with newly
diagnosed therapy-related acute
myeloid leukemia (t-AML) or AML with
myelodysplasia-related changes (AML–
MRC).
AML is a type of cancer in which the
bone marrow makes abnormal
myeloblasts (immature bone marrow
white blood cells), red blood cells, and
platelets. If left untreated, AML
progresses rapidly. Normally, the bone
marrow makes blood stem cells that
develop into mature blood cells over
time. Stem cells have the potential to
develop into many different cell types
in the body. Stem cells can act as an
internal repair system, dividing,
essentially without limit, to replenish
other cells. When a stem cell divides,
each new cell has the potential to either
remain a stem cell or become a
specialized cell, such as a muscle cell,
a red blood cell, or a brain cell, among
others. A blood stem cell may become
a myeloid stem cell or a lymphoid stem
cell. Lymphoid stem cells become white
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blood cells. A myeloid stem cell
becomes one of three types of mature
blood cells: (1) Red blood cells that
carry oxygen and other substances to
body tissues; (2) white blood cells that
fight infection; or (3) platelets that form
blood clots and help to control bleeding.
In patients diagnosed with AML, the
myeloid stem cells usually become a
type of myeloblast. The myeloblasts in
patients diagnosed with AML are
abnormal and do not become healthy
white blood cells. Sometimes in patients
diagnosed with AML, too many stem
cells become abnormal red blood cells
or platelets. These abnormal cells are
called leukemia cells or blasts.
AML is defined by the World Health
Organization (WHO) as greater than 20
percent blasts in the bone marrow or
blood. AML can also be diagnosed if the
blasts are found to have a chromosome
change that occurs only in a specific
type of AML diagnosis, even if the blast
percentage does not reach 20 percent.
Leukemia cells can build up in the bone
marrow and blood, resulting in less
room for healthy white blood cells, red
blood cells, and platelets. When this
occurs, infection, anemia, or increased
risk for bleeding may result. Leukemia
cells can spread outside the blood to
other parts of the body, including the
central nervous system (CNS), skin, and
gums.
Treatment of AML diagnoses usually
consists of two phases; remission
induction and post-remission therapy.
Phase one, remission induction, is
aimed at eliminating as many
myeloblasts as possible. The most
common used remission induction
regimens for AML diagnoses are the
‘‘7+3’’ regimens using an antineoplastic
and an anthracycline. Cytarabine and
daunorubicin are two commonly used
drugs for ‘‘7+3’’ remission induction
therapy. Cytarabine is continuously
administered intravenously over the
course of 7 days, while daunorubicin is
intermittently administered
intravenously for the first 3 days. The
‘‘7+3’’ regimen typically achieves a 70
to 80 percent complete remission (CR)
rate in most patients under 60 years of
age.
High rates of CR are not generally
seen in older patients for a number of
reasons, such as different leukemia
biology, much higher incidence of
adverse cytogenetic abnormalities,
higher rate of multidrug resistant
leukemic cells, and comparatively lower
patient performance status (the standard
criteria for measuring how the disease
impacts a patient’s daily living
abilities). Intensive induction therapy
has worse outcomes in this patient
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population.76 The applicant asserted
that many older adults diagnosed with
AML have a poor performance status 77
at presentation and multiple medical
comorbidities that make the use of
intensive induction therapy quite
difficult or contraindicated altogether.
Moreover, the CR rates of poor-risk
patients diagnosed with AML are
substantially lower in patients over 60
years of age; owing to a higher
proportion of secondary AML, disease
developing in the setting of a prior
myeloid disorder, or prior cytotoxic
chemotherapy. Therefore, less than half
of older adults diagnosed with AML
achieve CR with combination induction
regimens.78
According to the applicant, the
combination of cytarabine and an
anthracycline, either as ‘‘7+3’’ regimens
or as part of a different regimen
incorporating other cytotoxic agents,
may be used as so-called ‘‘salvage’’
induction therapy in the treatment of
adults diagnosed with AML who
experience relapse in an attempt to
achieve CR. According to the applicant,
while CR rates of success vary widely
depending on underlying disease
biology and host factors, there is a lower
success rate overall in achievement of
CR with ‘‘7+3’’ regimens compared to
VYXEOSTM therapy. According to the
applicant, ‘‘7+3’’ regimens produce a CR
rate of approximately 50 percent in
younger adult patients who have
relapsed, but were in CR for at least 1
year.79
VYXEOSTM is a nano-scale liposomal
formulation containing a fixed
combination of cytarabine and
daunorubicin in a 5:1 molar ratio. This
formulation was developed by the
applicant using a proprietary system
known as CombiPlex. According to the
applicant, CombiPlex addresses several
fundamental shortcomings of
conventional combination regimens,
specifically the conventional ‘‘7+3’’ free
drug dosing, as well as the challenges
inherent in combination drug
development, by identifying the most
effective synergistic molar ratio of the
76 Juliusson, G., Lazarevic, V., Horstedt, A.S.,
Hagberg, O., Hoglund, M., ‘‘Acute myeloid
leukemia in the real world: why population-based
registries are needed’’, Blood, 2012 Apr 26; vol.
119(17), pp. 3890–9.
77 Stone, R.M., et al., (2004), ‘‘Acute myeloid
leukemia. Hematology’’, Am Soc Hematol Educ
Program, 2004, pp. 98–117.
78 Appelbaum, F.R., Gundacker, H., Head, D.R.,
‘‘Age and acute myeloid leukemia’’, Blood 2006,
vol. 107, pp. 3481–3485.
79 Kantarjian, H., Rayandi, F., O’Brien, S., et al.,
‘‘Intensive chemotherapy does not benefit most
older patients (age 70 years and older) with acute
myeloid leukemia,’’ Blood, 2010, vol. 116(22), pp.
4422.
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drugs being combined in vitro, and
fixing this ratio in a nano-scale drug
delivery complex to maintain the
optimized combination after
administration and ensuring exposure of
this ratio to the tumor.
Cytarabine and daunorubicin are coencapsulated inside the VYXEOSTM
liposome at a fixed ratiometrically,
optimized 5:1 cytarabine:daunorubicin
molar ratio. According to the applicant,
encapsulation maintains the synergistic
ratios, reduces degradation, and
minimizes the impact of drug
transporters and the effect of known
resistant mechanisms. The applicant
stated that the 5:1 molar ratio has been
shown, in vitro, to maximize synergistic
antitumor activity across multiple
leukemic and solid tumor cell lines,
including AML, and in animal model
studies to be optimally efficacious
compared to other
cytarabine:daunorubicin ratios. In
addition, the applicant stated that in
clinical studies, the use of VYXEOSTM
has demonstrated consistently more
efficacious results than the conventional
‘‘7+3’’ free drug dosing. VYXEOSTM is
intended for intravenous administration
after reconstitution with 19 mL sterile
water for injection. VYXEOSTM is
administered as a 90-minute
intravenous infusion on days 1, 3, and
5 (induction therapy), as compared to
the ‘‘7+3’’ free drug dosing, which
consists of two individual drugs
administered on different days,
including 7 days of continuous infusion.
With regard to the newness criterion,
as discussed earlier, if a technology
meets all three of the substantial
similarity criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, the applicant
asserted that VYXEOSTM does not use
the same or similar mechanism of action
to achieve a therapeutic outcome as any
other drug assigned to the same or a
different MS–DRG. The applicant stated
that no other AML treatment is
designed, nor is able, to deliver a fixed,
ratiometrically optimized and
synergistic drug:drug ratio of 5:1
cytarabine to daunorubicin, and
selectively target and accumulate at the
site of malignancy, while minimizing
unwanted exposure, which the
applicant based on the data results of
preclinical and clinical studies of the
use of VYXEOSTM. The applicant
indicated that VYXEOSTM is a nanoscale liposomal formulation of a fixed
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combination of cytarabine and
daunorubicin. Further, the applicant
stated that the rationale for the
development of VYXEOSTM is based on
prolonged delivery of synergistic drug
ratios utilizing the applicant’s
proprietary, ratiometric CombiPlex
technology. According to the applicant,
conventional ‘‘7+3’’ free drug dosing has
no delivery complex, and these
individual drugs are administered
without regard to their ratio dependent
interaction. According to the applicant,
enzymatic inactivation and imbalanced
drug efflux and transporter expression
reduce drug levels in the cell. Further,
decreased cytotoxicity leads to cell
survival, emergence of drug resistant
cells, and decreased overall survival.
The applicant provided the results of
clinical studies to demonstrate that the
CombiPlex technology and the
ratiometric dosing of VYXEOSTM
represent a shift in anticancer agent
delivery, whereby the fixed, optimized
dosing provides less drug to achieve
improved efficacy, while maintaining a
favorable risk-benefit profile. The
results of this ratiometric dosing
approach are in contrast to the typical
combination chemotherapy
development that establishes the
recommended dose of one agent and
then adds subsequent drugs to the
combination at increasing
concentrations until the aggregate
effects of toxicity are considered to be
limiting (the ‘‘7+3’’ drug regimen).
According to the applicant, this current
approach to combination chemotherapy
development assumes that maximum
therapeutic activity will be achieved
with maximum dose intensity for all
drugs in the combination, and ignores
the possibility that more subtle
concentration-dependent drug
interactions could result in frankly
synergistic outcomes.
The applicant maintained that, while
VYXEOSTM contains no novel active
agents, its innovative drug delivery
mechanism appears to be a superior way
to deliver the two active compounds in
an effort to optimize their efficacy in
killing leukemic blasts. However, we are
concerned it is possible that VYXEOSTM
may use a similar mechanism of action
compared to currently available
treatment options because both the
current treatment regimen and
VYXEOSTM are used in the treatment of
AML by intravenous administration of
cytarabine and daunorubicin. We are
concerned that the mechanism of action
of the ratiometrically fixed liposomal
formulation of VYXEOSTM is the same
or similar to that of the current
intravenous administration of
cytarabine and daunorubicin.
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With respect to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, we believe
that potential cases representing
patients who may be eligible for
treatment involving VYXEOSTM would
be assigned to the same MS-DRGs as
cases representing patients who receive
treatment for diagnoses of AML.
With respect to the third criterion,
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, the applicant
asserted that VYXEOSTM is indicated for
use in the treatment of patients who
have been diagnosed with high-risk
AML. The applicant also asserted that
VYXEOSTM is the first and only
approved fixed combination of
cytarabine and daunorubicin and is
designed to uniquely control the
exposure using a nano-scale drug
delivery vehicle leading to statistically
significant improvements in survival in
patients who have been diagnosed with
high-risk AML compared to the
conventional ‘‘7+3’’ free drug dosing.
We believe that VYXEOSTM involves the
treatment of the same patient
population as other AML treatment
therapies.
The following unique ICD–10–PCS
codes were created to describe the
administration of VYXEOSTM:
XW033B3 (Introduction of cytarabine
and caunorubicin liposome
antineoplastic into peripheral vein,
percutaneous approach, new technology
group 3) and XW043B3 (Introduction of
cytarabine and daunorubicin liposome
antineoplastic into central vein,
percutaneous approach, new technology
group 3).
We are inviting public comments on
whether VYXEOSTM is substantially
similar to existing technology, including
whether the mechanism of action of
VYXEOSTM differs from the mechanism
of action of the currently available
treatment regimen. We also are inviting
public comments on whether
VYXEOSTM meets the newness
criterion.
With regard to the cost criterion, the
applicant conducted the following
analysis. The applicant used the FY
2016 MedPAR Hospital Limited Data
Set (LDS) to assess the MS–DRGs to
which cases representing potential
patient hospitalizations that may be
eligible for treatment involving
VYXEOSTM would most likely be
assigned. These potential cases
representing patients who may be
VYXEOSTM candidates were identified
if they: (1) Were diagnosed with acute
myeloid leukemia (AML); and (2)
received chemotherapy during their
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hospital stay. The cohort was further
limited by excluding patients who had
received bone marrow transplants. The
cohort used in the analysis is referred to
in this discussion as the primary cohort.
According to the applicant, the
primary cohort of cases spans 131
unique MS–DRGs, 16 of which
contained more than 10 cases. The most
common MS–DRGs are MS–DRG 837,
834, 838, and 839. These 4 MS–DRGs
account for 4,457 (81 percent) of the
5,483 potential cases in the cohort.
The case-weighted unstandardized
charge per case is approximately
$185,844. The applicant then removed
charges related to other chemotherapy
agents because VYXEOSTM would
replace the need for the use of current
chemotherapy agents. The applicant
explained that charges for
chemotherapy drugs are grouped with
charges for oncology, diagnostic
radiology, therapeutic radiology,
nuclear medicine, CT scans, and other
imaging services in the ‘‘Radiology
Charge Amount.’’ According to the
applicant, removing 100 percent of the
‘‘Radiology Charge Amount’’ would
understate the cost of care for treatment
involving VYXEOSTM for patients who
may be eligible because treatment
involving VYXEOSTM would be unlikely
to replace many of the services captured
in the ‘‘Radiology Charge Amount’’
category. The applicant found that
chemotherapy charges represent less
than 20 percent of the charges
associated with revenue centers grouped
into the ‘‘Radiology Charge Amount’’
and removed 20 percent of the radiology
charge amount in order to capture the
effect of removing chemotherapy
pharmacy charges. The applicant noted
that regardless of the type of induction
chemotherapy, patients being treated for
AML have AML-related complications,
such as bleeding or infection that
require supportive care drug therapy.
For this reason, it is expected that
eligible patients receiving treatment
involving VXYEOSTM will continue to
incur other pharmacy and IV therapy
charges for AML-related complications.
After removing the charges for the
prior technology, the applicant
standardized the charges. The applicant
then applied an inflation factor of
1.09357, the value used in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38527)
to update the charges from FY 2016 to
FY 2018. According to the applicant, for
the primary new technology add-on
payment cohort, the cost criterion was
met without consideration of
VYXEOSTM charges. The average caseweighted standardized charge was
$170,458, which exceeds the average
case-weighted Table 10 MS–DRG
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threshold amount of $82,561 by
$87,897.
The applicant provided additional
analyses with the inclusion of
VYXEOSTM charges under 3-vial, 4-vial,
6-vial, and 10-vial treatment scenarios.
According to the applicant, the cost
criterion was satisfied in each of these
scenarios, with charges in excess of the
average case-weighted threshold
amount.
Finally, the applicant also provided
the following sensitivity analyses (that
did not include charges for VYXEOSTM)
using the methodology above:
• Sensitivity Analysis 1—limits the
cohort to patients who have been
diagnosed with AML without remission
(C92.00 or C92.50) who received
chemotherapy and did not receive bone
marrow transplant.
• Sensitivity Analysis 2—the
modified cohort was limited to patients
who have been diagnosed with relapsed
AML who received chemotherapy and
did not receive bone marrow transplant.
• Sensitivity Analysis 3—the
modified cohort was limited to patients
who have been diagnosed with AML
and who did not receive bone marrow
transplant.
• Sensitivity Analysis 4—the primary
cohort was maintained, but 100 percent
of the charges for revenue centers
grouped into the ‘‘Pharmacy Charge
Amount’’ were excluded.
• Sensitivity Analysis 5—identifies
patients who have been diagnosed with
AML in remission.
The applicant noted that, in all of the
sensitivity analysis scenarios, the
average case-weighted standardized
charge per case exceeded the average
case-weighted Table 10 MS–DRG
threshold amount. Based on all of the
analyses above, the applicant
maintained that VYXEOSTM meets the
cost criterion. We are inviting public
comments on whether VYXEOSTM
meets the cost criterion.
With regard to substantial clinical
improvement, according to the
applicant, clinical data results have
shown that the use of VYXEOSTM
represents a substantial clinical
improvement for the treatment of AML
in newly diagnosed high-risk, older (60
years of age and older) patients, marked
by statistically significant improvements
in overall survival, event free survival
and response rates, and in relapsed
patients age 18 to 65 years of age, where
a statistically significant improvement
in overall survival has been documented
for the poor-risk subset of patients as
defined by the European Prognostic
Index. In both groups of patients, the
applicant stated that there was
significant improvement in survival for
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the high-risk patient group. The
applicant provided the following
specific clinical data results.
• The applicant stated that clinical
data results show that treatment with
VYXEOSTM for older patients (60 years
of age and older) who have been
diagnosed with untreated, high-risk
AML will result in superior survival
rates, as compared to patients treated
with conventional ‘‘7+3’’ free drug
dosing. The applicant provided a
summary of the pivotal Phase III Study
301 in which 309 patients were
enrolled, with 153 patients randomized
to the VYXEOSTM treatment arm and
156 to the ‘‘7+3’’ free drug dosing
treatment arm. Among patients who
were 60 to 69 years old, there were 96
patients in the VYXEOSTM treatment
arm and 102 in the ‘‘7+3’’ free drug
dosing treatment arm. For patients who
were 70 to 75 years old, there were 57
and 54 patients in each treatment arm,
respectively. The applicant noted that
the data results from the Phase III Study
301 demonstrated that first-line
treatment of patients diagnosed with
high-risk AML in the VYXEOSTM
treatment arm resulted in substantially
greater median overall survival of 9.56
months versus 5.95 months in the ‘‘7+3’’
free drug dosing treatment arm (hazard
ratio of 0.69; p =0.005).
• The applicant further asserted that
high-risk, older patients (60 years old
and older) previously untreated for
diagnoses of AML will have a lower risk
of early death when treated with
VYXEOSTM than those treated with the
conventional ‘‘7+3’’ free drug dosing.
The applicant cited Medeiros, et al.,80
which reported a large observational
study of Medicare beneficiaries and
noted the following: The data result of
the study showed that 50 to 60 percent
of elderly patients diagnosed with AML
remain untreated following diagnosis;
treated patients were more likely
younger, male, and married, and less
likely to have secondary diagnoses of
AML, poor performance indicators, and
poor comorbidity scores compared to
untreated patients; and in multivariate
survival analyses, treated patients
exhibited a significant 33 percent lower
risk of death compared to untreated
patients.
Based on data from the Phase III
Study 301,81 the applicant cited the
80 Medeiros, B., et al., ‘‘Big data analysis of
treatment patterns and outcomes among elderly
acute myeloid leukemia patients in the United
States’’, Ann Hematol, 2015, vol. 94(7), pp. 1127–
1138.
81 Lancet, J., et al., ‘‘Final results of a Phase III
randomized trial of VYXEOS (CPX–351) versus 7+3
in older patients with newly diagnosed, high-risk
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following results: The rate of 60-day
mortality was less in the VYXEOSTM
treatment arm (13.7 percent) versus the
‘‘7+3’’ free drug dosing treatment arm
(21.2 percent); the reduction in early
mortality was due to fewer deaths from
refractory AML (3.3 percent versus 11.3
percent), with very similar rates of 60day mortality due to adverse events
(10.4 percent versus 9.9 percent); there
were fewer deaths in the VYXEOSTM
treatment arm versus the ‘‘7+3’’ free
drug dosing treatment arm during the
treatment phase (7.8 percent versus 11.3
percent); and there were fewer deaths in
the VYXEOSTM treatment arm during
the follow-up phase than in the ‘‘7+3’’
free drug dosing treatment arm (59.5
percent versus 71.5 percent).
• The applicant asserted that highrisk, older patients (60 years old and
older) previously untreated for a
diagnosis of AML exhibited statistically
significant improvements in response
rates after treatment with VYXEOSTM
versus treatment with the conventional
‘‘7+3’’ free drug chemotherapy dosing,
suggesting that the use of VYXEOSTM is
a superior pre-transplant induction
treatment versus ‘‘7+3’’ free drug
dosing. Restoration of normal
hematopoiesis is the ultimate goal of
any therapy for AML diagnoses. The
first phase of treatment consists of
induction chemotherapy, in which the
goal is to ‘‘empty’’ the bone marrow of
all hematopoietic elements (both benign
and malignant), and to allow
repopulation of the marrow with normal
cells, thereby yielding remission.
According to the applicant, postinduction response rates were
significantly higher following the use of
VYXEOSTM, which elicited a 47.7
percent total response rate and a 37.3
percent rate for CR, whereas the total
response and CR rates for the ‘‘7+3’’ free
drug dosing arm were 33.3 percent and
25.6 percent, respectively. The CR + CRi
rates for patients who were 60 to 69
years of age were 50.0 percent in the
VYXEOSTM treatment arm and 36.3
percent in the ‘‘7+3’’ free drug dosing
treatment arm, with an odds ratio of
1.76 (95 percent CI, 1.00–3.10). For
patients who were 70 to 75 years old,
the rates of CR + CRi were 43.9 percent
in the VYXEOSTM treatment arm and
27.8 percent in the ‘‘7+3’’ free drug
dosing treatment arm.
• The applicant asserted that
VYXEOSTM treatment will enable
high-risk, older patients (60 years old
and older) to bridge to allogeneic
transplant, and VYXEOSTM treated
(secondary) AML’’. Abstract and oral presentation
at American Society of Clinical Oncology (ASCO),
June 2016.
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responding patients will have markedly
better outcomes following transplant.
The applicant stated that diagnoses of
secondary AML are considered
incurable with standard chemotherapy
approaches and, as with other high-risk
hematological malignancies,
transplantation is a useful treatment
alternative. The applicant further stated
that autologous HSCT has limited
effectiveness and at this time, only
allogeneic HSCT with full intensity
conditioning has been reported to
produce long-term remissions. However,
the applicant stated that the clinical
study by Medeiros, et al. reported that,
while the use of allogeneic HSCT is
considered a potential cure for AML, its
use is limited in older patients because
of significant baseline comorbidities and
increased transplant-related morbidity
and mortality. Patients in either
treatment arm of the Phase III Study 301
responding to induction with a CR or
CR+CRi (n=125) were considered for
allogeneic hematopoietic cell transplant
(HCT) when possible. In total, 91
patients were transplanted: 52 (34
percent) from the VYXEOSTM treatment
arm and 39 (25 percent) from the ‘‘7+3’’
free drug dosing treatment arm. Patient
and AML characteristics were similar
according to randomized arm, including
percentage of patients in each treatment
arm that underwent transplant in
CR+CRi status. However, the applicant
noted that the VYXEOSTM treatment
arm contained a higher percentage of
older patients (70 years old or older)
who were transplanted (VYXEOSTM, 31
percent; ‘‘7+3’’ free drug dosing, 15
percent).82
According to the applicant, patient
outcome following transplant strongly
favored patients in the VYXEOSTM
treatment arm. The Kaplan-Meier
analysis of the 91 transplanted patients
landmarked at the time of HCT showed
that patients in the VYXEOSTM
treatment arm had markedly better
overall survival (hazard ratio 0.46;
p=0.0046). The time-dependent
Adjustment Model (Cox proportional
hazard ratio) was used to evaluate the
contribution of VYXEOSTM treatment to
overall survival rate after adjustment for
transplant and showed that VYXEOSTM
treatment remained a significant
contributor, even after adjusting for
transplant. The time-dependent Cox
hazard ratio for overall survival rates in
the VYXEOSTM treatment arm versus
the ‘‘7+3’’ free drug dosing treatment
arm was 0.51 (95 percent CI, 0.35–0.75;
p=.0007).
82 Stone Hematology 2004; Gordon AACR 2016;
NCI. Available at: www.cancer.gov.
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• The applicant asserted that
VYXEOSTM treatment of previously
untreated older patients (60 years old
and older) diagnosed with high-risk
AML increases the response rate and
improves survival compared to
conventional ‘‘7+3’’ free drug dosing
treatment in patients diagnosed with
FLT3 mutation. The applicant noted the
following: Approximately 20 to 30
percent of AML patients harbor some
form of FLT3 mutation, AML patients
with a FLT3 mutation have a higher
relapse rate and poorer prognosis than
the overall population diagnosed with
AML, and the most common type of
mutation is internal tandem duplication
(ITD) mutation localized to a membrane
region of the receptor.
The applicant cited Gordon, et al.,
2016,83 which reported on the
significant anti-leukemic activity of
VYXEOSTM treatment in AML blasts
exhibiting high-risk characteristics,
including FLT3–ITD, that are typically
associated with poor outcomes when
treated with conventional ‘‘7+3’’ free
drug dosing treatment. To determine
whether the improved complete
remission and overall survival rates of
treatment using VYXEOSTM as
compared to conventional ‘‘7+3’’ free
drug dosing treatment are attributable to
liposome-mediated altered drug PK or
direct cellular interactions with specific
AML blast samples, the authors
evaluated cytotoxicity in 53 AML
patient specimens. Cytotoxicity results
were correlated with patient
characteristics, as well as VYXEOSTM
treatment cellular uptake and molecular
phenotype status including FLT3–ITD,
which is a predictor of poor patient
outcomes to conventional ‘‘7+3’’ free
drug dosing treatment. The applicant
stated that a notable result from this
research was the observation that AML
blasts exhibiting the FLT3–ITD
phenotype exhibited some of the lowest
IC50 (the 50 percent inhibitory
concentration) values and, as a group,
were five-fold more sensitive to the
VYXEOSTM treatment than those with
wild type FLT3. In addition, there was
evidence that increased sensitivity to
VYXEOSTM treatment was associated
with increased uptake of the drug-laden
liposomes by the patient-derived AML
blasts. The applicant noted that Gordon,
et al. 2016, concluded taken together,
the data are consistent with clinical
observations where VYXEOSTM
treatment retains significant anti83 Gordon, M., Tardi, P., Lawrence, M.D., et al.,
‘‘CPX–351 cytotoxicity against fresh AML blasts
increased for FLT3–ITD+ cells and correlates with
drug uptake and clinical outcomes,’’ Abstract 287
and poster presented at AACR (American
Association for Cancer Research), April 2016.
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leukemic activity in AML patients
exhibiting high-risk characteristics. The
applicant also noted that a subanalysis
of Phase III Study 301 identified 22
patients who had been diagnosed with
FLT3 mutation in the VYXEOSTM
treatment arm and 20 in the ‘‘7+3’’ free
drug dosing treatment arm, which
resulted in the following response rates
of FLT3 mutated patients, which were
higher with VYXEOSTM treatments (15
of 22, 68.2 percent) versus ‘‘7+3’’ free
drug dosing treatments (5 of 20, 25.0
percent); and the Kaplan-Meier analysis
of the 42 FLT3 mutated patients showed
that patients in the VYXEOSTM
treatment arm had a trend towards
better overall survival rates (hazard ratio
0.57; p=0.093).
• The applicant asserted that younger
patients (18 to 65 years old) with poor
risk first relapse AML have shown
higher response rates with VYXEOSTM
treatment versus conventional ‘‘salvage’’
chemotherapy. Overall, the applicant
stated that the use of VYXEOSTM had an
acceptable safety profile in this patient
population based on 60-day mortality
data. Study 205 84 was a randomized
study comparing VYXEOSTM treatment
against the investigator’s choice of first
‘‘salvage’’ chemotherapy in patients
who had been diagnosed with relapsed
AML after a first remission lasting
greater than 1 month (VYXEOSTM
treatment arm, n=81 and ‘‘7+3’’ free
drug dosing treatment arm, n=44; 18 to
65 years old). Investigator’s choice was
almost always based on cytarabine +
anthracycline, usually with the addition
of one or two new agents. According to
the applicant, treatment involving
VYXEOSTM demonstrated a higher rate
of morphological leukemia clearance
among all patients, 43.2 percent versus
40.0 percent, and the advantage was
most apparent in poor-risk patients, 78.7
percent versus 44.4 percent, as defined
by the European Prognostic Index (EPI).
In the subset analysis of this EPI
poor-risk patient subset, the applicant
stated there was a significant
improvement in survival rate (6.6 versus
4.2 months median, hazard ratio=0.55,
p=0.02) and improved response rate
(39.3 percent versus 27 percent). The
applicant also noted the following: the
safety profile for the use of VYXEOSTM
was qualitatively similar to that of
control ‘‘salvage’’ therapy, with nearly
identical 60-day mortality rates (14.8
percent versus 15.9 percent); among
VYXEOSTM treated patients, those with
no history of prior HSCT (n=59) had
higher response rates (54.2 percent
versus 37.8 percent) and lower 60-day
mortality (10.2 percent versus 16.2
percent); overall, the use of VYXEOSTM
had acceptable safety based on 60-day
mortality data, with somewhat higher
frequency of neutropenia and
thrombocytopenia-related grade III–IV
adverse events. Even though these
patients are younger (18 to 65 years old)
than the population studied in Phase III
Study 301 (60 years old and older),
Study 205 patients were at a later stage
of the disease and almost all had
responded to first-line therapy
(cytarabine + anthracycline) and had
relapsed. The applicant also cited
Cortes, et al. 2015,85 which reported that
patients who have been diagnosed with
first relapse AML have limited
likelihood of response and short
expected survival following ‘‘salvage’’
treatment with the results from
literature showing that:
• Mitoxantrone, etoposide, and
cytarabine induced response in 23
percent of patients, with median overall
survival of only 2 months.
• Modulation of deoxycitidine kinase
by fludarabine led to the combination of
fludarabine and cytarabine, resulting in
a 36 percent CR rate with median
remission duration of 39 weeks.
• First salvage gemtuzumab
ozogamicin induced CR+CRp (or
CR+CRi) response in 30 percent of
patients with CD33+ AML and, for
patients with short first CR durations,
appeared to be superior to cytarabinebased therapy.
The applicant noted that Study 205
results showed the use of VYXEOSTM
retained greater anti-leukemic efficacy
in patients who have been diagnosed
with poor-risk first relapse AML, and
produced higher morphological
leukemia clearance rates (78.7 percent)
compared to conventional ‘‘salvage’’
therapy (44 percent). The applicant
further noted that, overall, the use of
VYXEOSTM had acceptable safety
profile in this patient population based
on 60-day mortality data.
Based on all of the data presented
above, the applicant concluded that
VYXEOSTM represents a substantial
clinical improvement over existing
technologies. However, we are
concerned that, although there was an
improvement in a number of outcomes
in Phase III Study 301, specifically
overall survival rate, lower risk of early
death, improved response rates, better
84 Cortes, J., et al., ‘‘Significance of prior HSCT on
the outcome of salvage therapy with CPX–351 or
conventional chemotherapy among first relapse
AML patients.’’ Abstract and poster presented at
ASH 2011.
85 Cortes, J., et al., (2015), ‘‘Phase II, multicenter,
randomized trial of CPX–351
(cytarabine:daunorubicin) liposome injection versus
intensive salvage therapy in adults with first relapse
AML,’’ Cancer, January 2015, pp. 234–42.
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outcomes following transplant,
increased response rate and overall
survival in patients diagnosed with
FLT3 mutation, and higher response
rates versus conventional ‘‘salvage’’
chemotherapy in younger patients
diagnosed with poor-risk first relapse,
the improved outcomes may not be
statistically significant. Furthermore, we
are concerned that the overall
improvement in survival from 5.95
months to 9.56 months may not
represent a substantial clinical
improvement. In addition, the rate of
adverse events in both treatment arms of
Study 205, given the theoretical benefit
of reduced toxicity with the liposomal
formulation, was similar for both the
VYXEOSTM and ‘‘7+3’’ free drug
treatment groups. Therefore, we also are
concerned that there is a similar rate of
adverse events, such as febrile
neutropenia (68 percent versus 71
percent), pneumonia (20 percent versus
15 percent), and hypoxia (13 percent
versus 15 percent), with the use of
VYXEOSTM as compared with the
conventional ‘‘7+3’’ free drug regimen.
We are inviting public comments on
whether VYXEOSTM meets the
substantial clinical improvement
criterion.
Below we summarize and respond to
a written public comment we received
regarding the VYXEOSTM during the
open comment period in response to the
New Technology Town Hall meeting
notice published in the Federal
Register.
Comment: The applicant provided a
written comment to provide notification
of the addition of VYXEOSTM to the
Category 1 Clinical Practice Guidelines
in Oncology recommendation by the
National Comprehensive Cancer
Network. The applicant reported that
the resources made available by NCCN
are the NCCN Clinical Practice
Guidelines in Oncology (NCCN
Guidelines®). The intent of the
guidelines is to assist in the decisionmaking process of individuals involved
in cancer treatment and care. According
to the NCCN Guidelines®, Category 1
clinical practices are based upon
high-level evidence, and there is
uniform NCCN consensus that the
intervention is appropriate. The
February 7, 2018 NCCN Guidelines® for
Acute Myeloid Leukemia include a
recommendation for cytarabine and
daunorubicin for the treatment of adult
patients 60 years of age or older who
have been newly diagnosed with
therapy-related AML (t-AML) or AML
with myelodysplasia-related changes
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(AML–RMC) to be included as a
Category 1 clinical practice.86
Response: We appreciate the
applicant’s submission of additional
information. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payments for
VYXEOSTM for FY 2019.
c. VABOMERETM (MeropenemVaborbactam)
daltland on DSKBBV9HB2PROD with PROPOSALS2
Melinta Therapeutics, Inc., submitted
an application for new technology addon payments for VABOMERETM for FY
2019. VABOMERETM is indicated for
use in the treatment of adult patients
who have been diagnosed with
complicated urinary tract infections
(cUTIs), including pyelonephritis,
caused by specific bacteria.
VABOMERETM received FDA approval
on August 29, 2017.
Complicated urinary tract infections
(cUTIs) are defined as chills, rigors, or
fever (temperature of greater than or
equal to 38.0°C); elevated white blood
cell count (greater than 10,000/mm3), or
left shift (greater than 15 percent
immature PMNs); nausea or vomiting;
dysuria, increased urinary frequency, or
urinary urgency; lower abdominal pain
or pelvic pain. Acute pyelonephritis is
defined as chills, rigors, or fever
(temperature of greater than or equal to
38.0°C); elevated white blood cell count
(greater than 10,000/mm3), or left shift
(greater than 15 percent immature
PMNs); nausea or vomiting; dysuria,
increased urinary frequency, or urinary
urgency; flank pain; costo-vertebral
angle tenderness on physical
examination. Risk factors for infection
with drug-resistant organisms do not, on
their own, indicate a cUTI.87 The
increasing incidence of multidrugresistant gram-negative bacteria, such as
carbapenem-resistant Enterobacteriacea
(CRE), has resulted in a critical need for
new antimicrobials.
The applicant reported that it has
developed a beta-lactamase combination
antibiotic, VABOMERETM, to treat
cUTIs, including those caused by
certain carbapenem-resistant organisms.
By combining the carbapenem class
antibiotic meropenem with
vaborbactam, VABOMERETM protects
86 NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®), Acute Myeloid Leukemia,
Version I—2018, February 7, 2018, https://
www.nccn.org/professionals/physician_gls/pdf/
aml.pdf.
87 Hooton, T. and Kalpana, G., 2018, ‘‘Acute
complicated urinary tract infection (including
pyelonephritis) in adults,’’ In A. Bloom (Ed.),
UpToDate. Available at: https://www.uptodate.com/
contents/acute-complicated-urinary-tract-infectionincluding-pyelonephritis-in-adults.
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meropenem from degradation by certain
CRE strains.
The applicant stated that meropenem,
a carbapenem, is a broad spectrum
beta-lactam antibiotic that works by
inhibiting cell wall synthesis of both
gram-positive and gram-negative
bacteria through binding of penicillinbinding proteins (PBP). Carbapenemase
producing strains of bacteria have
become more resistant to beta-lactam
antibiotics, such as meropenem.
However, meropenem in combination
with vaborbactam, inhibits the
carbapenemase activity, thereby
allowing the meropenem to bind PBP
and kill the bacteria.
According to the applicant,
vaborbactam, a boronic acid inhibitor, is
a first-in class beta-lactamase inhibitor.
Vaborbactam blocks the breakdown of
carbapenems, such as meropenem, by
bacteria containing carbapenemases.
Although vaborbactam has no
antibacterial properties, it allows for the
treatment of resistant infections by
increasing bacterial sensitivity to
meropenem. New carbapenemase
producing strains of bacteria have
become more resistant to beta-lactam
antibiotics. However, meropenem in
combination with vaborbactam, can
inhibit the carbapenemase enzyme,
thereby allowing the meropenem to
bind PBP and kill the bacteria. The
applicant stated that the vaborbactem
component of VABOMERETM helps to
protect the meropenem from
degradation by certain beta-lactamases,
such as Klebsiella pneumonia
carbapenemase (KPC). According to the
applicant, VABOMERETM is the first of
a novel class of beta-lactamase
inhibitors. The applicant asserted that
VABOMERETM’s use of vaborbactam to
restore the efficacy of meropenem is a
novel approach to fighting antimicrobial
resistance.
The applicant stated that
VABOMERETM is indicated for use in
the treatment of adult patients 18 years
old and older who have been diagnosed
with cUTIs, including pyelonephritis.
The recommended dosage of
VABOMERETM is 4 grams (2 grams of
meropenem and 2 grams of
vaborbactam) administered every 8
hours by intravenous (IV) infusion over
3 hours with an estimated glomerular
filtration rate (eGFR) greater than or
equal to 50 mL/min/1.73 m2. The
recommended dosage of VABOMERETM
for patients with varying degrees of
renal function is included in the
prescribing information. The duration of
treatment is for up to 14 days.
As discussed earlier, if a technology
meets all three of the substantial
similarity criteria, it would be
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considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, according to the
applicant, VABOMERETM is designed
primarily for the treatment of gramnegative bacteria that are resistant to
other current antibiotic therapies. The
applicant stated that VABOMERETM
does not use the same or similar
mechanism of action to achieve a
therapeutic outcome. The applicant
asserted that the vaborbactam
component of VABOMERETM is a new
class of beta-lactamase inhibitor that
protects meropenem from degradation
by certain enzymes such as
carbapenamases. The applicant
indicated that the structure of
vaborbactam is distinctly optimized for
inhibition of serine carbapenamases and
for combination with a carbapenem
antibiotic. Beta-lactamase inhibitors are
agents that inhibit bacterial enzymes—
enzymes that destroy beta-lactam
antibiotics and result in resistance to
first-line as well as ‘‘last defense’’
antimicrobials used in hospitals.
According to the applicant, in order for
carbapenems to be effective these
enzymes must be inhibited. The
applicant stated that the addition of
vaborbactam as a potent inhibitor
against Class A and C serine betalactamases, particularly KPC, represents
a new mechanism of action. According
to the applicant, VABOMERETM’s use of
vaborbactam to restore the efficacy of
meropenem is a novel approach and
that the FDA’s approval of
VABOMERETM for the treatment of
cUTIs represents a significant label
expansion because mereopenem alone
(without the addition of vaborbactam) is
not indicated for the treatment of
patients with cUTI infections.
Therefore, the applicant maintained that
this technology and resistance-fighting
mechanism involved in the therapeutic
effect achieved by VABOMERETM is
distinct from any other existing product.
The applicant noted that VABOMERETM
was designated as a qualified infectious
disease product (QIDP) in January 2014.
This designation is given to antibacterial
products that treat serious or
life-threatening infections under the
Generating Antibiotic Incentives Now
(GAIN) title of the FDA Safety and
Innovation Act.
We believe that, although the
molecular structure of the vaborbactam
component of VABOMERETM is unique,
the bactericidal action of VABOMERETM
is the same as meropenem alone. In
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addition, we note that there are other
similar beta-lactam/beta-lactamase
inhibitor combination therapies
currently available as treatment options.
We are inviting public comments on
whether VABOMERETM’s mechanism of
action is similar to other existing
technologies.
With respect to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, the
applicant asserted that patients who
may be eligible to receive treatment
involving VABOMERETM include
hospitalized patients who have been
diagnosed with a cUTI. These potential
cases can be identified by a variety of
ICD–10–CM diagnosis codes. Therefore,
potential cases representing patients
who have been diagnosed with a cUTI
who may be eligible for treatment
involving VABOMERETM can be
mapped to multiple MS–DRGs. The
following are the most commonly used
MS–DRGs for patients who have been
diagnosed with a cUTI: MS–DRG 690
(Kidney and Urinary Tract Infections
without MCC); MS–DRG 853 (Infectious
and Parasitic Diseases with O.R.
Procedure with MCC); MS–DRG 870
(Septicemia or Sever Sepsis with
Mechanical Ventilation 96+ Hours);
MS–DRG 871 (Septicemia or Severe
Sepsis without Mechanical Ventilation
96+ Hours with MCC); and MS–DRG
872 (Septicemia or Severe Sepsis
without Mechanical Ventilation 96+
Hours without MCC). Potential cases
representing patients who may be
eligible for treatment with
VABOMERETM would be assigned to the
same MS–DRGs as cases representing
hospitalized patients who have been
diagnosed with a cUTI.
With respect to the third criterion,
whether the use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, the applicant
asserted that the use of VABOMERETM
would treat a different patient
population than existing and currently
available treatment options. According
to the applicant, VABOMERETM’s use of
vaborbactam to restore the efficacy of
meropenem is a novel approach to
fighting the global and national public
health crisis of antimicrobial resistance,
and as such, the use of VABOMERETM
reaches different and expanded patient
populations. The applicant further
asserted that future patient populations
are saved as well because the growth of
resistant infections is slowed. The
applicant believed that, because of the
threat posed by gram-negative bacterial
infections and the limited number of
available treatments currently on the
market or in development, the
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combination structure and development
of VABOMERETM and its potential
expanded use is new. While the
applicant believes that VABOMERETM
treats a different patient population, we
note that VABOMERETM is only
approved for use in the treatment of
adult patients who have been diagnosed
with cUTIs. Therefore, it appears that
VABOMERETM treats the same
population (adult patients with a cUTI)
and there are already other treatment
options available for diagnoses of cUTIs.
We are concerned that VABOMERETM
may be substantially similar to existing
beta-lactam/beta-lactamase inhibitor
combination therapies. As noted above,
we are concerned that VABOMERETM
may have a similar mechanism of
action, treats the same population
(patients with a cUTI) and would be
assigned to the same MS–DRGs (similar
to existing beta-lactam/beta-lactamase
inhibitor combination therapies
currently available as treatment
options). We are inviting public
comments on whether VABOMERETM
meets the substantial similarity criteria
and the newness criterion.
With regard to the cost criterion, the
applicant conducted the following
analysis to demonstrate that the
technology meets the cost criterion. In
order to identify the range of MS–DRGs
to which cases representing potential
patients who may be eligible for
treatment using VABOMERETM may
map, the applicant used the Premier
Research Database from 2nd Quarter
2015 to 4th Quarter 2016. According to
the applicant, Premier is an electronic
laboratory, pharmacy, and billing data
repository that collects data from over
600 hospitals and captures nearly 20
percent of U.S. hospitalizations. The
applicant’s list of most common MS–
DRGs is based on data regarding CRE
from the Premier Research Database.
According to the applicant,
approximately 175 member hospitals
also submit microbiology data, which
allowed the applicant to identify
specific pathogens such as CRE
infections. Using the Premier Research
Database, the applicant identified over
350 MS–DRGs containing data for 2,076
cases representing patients who had
been hospitalized for CRE infections.
The applicant used the top five most
common MS–DRGs: MS–DRG 871
(Septicemia or Severe Sepsis without
Mechanical Ventilation >96 Hours with
MCC), MS–DRG 853 (Infectious and
Parasitic Disease with O.R. Procedure
with MCC), MS–DRG 870 (Septicemia or
Severe Sepsis with Mechanical
Ventilation >96 Hours), MS–DRG 872
(Septicemia or Severe Sepsis without
Mechanical Ventilation >96 Hours
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20301
without MCC), and MS–DRG 690
(Kidney and Urinary Tract Infections
without MCC), to which 627 cases
representing potential patients who may
be eligible for treatment involving
VABOMERETM, or approximately 30.2
percent of the total cases identified,
mapped.
The applicant reported that the
resulting 627 cases from the identified
top 5 MS–DRGs have an average caseweighted unstandardized charge per
case of $74,815. We note that, instead of
using actual charges from the Premier
Research Database, the applicant
computed this amount based on the
average case-weighted threshold
amounts in Table 10 from the FY 2018
IPPS/LTCH PPS final rule. For the rest
of the analysis, the applicant adjusted
the average case-weighted threshold
amounts (referred to above as the
average case-weighted unstandardized
charge per case) rather than the actual
average case-weighted unstandardized
charge per case from the Premier
Research Database. According to the
applicant, based on the Premier data,
$1,999 is the mean antibiotic costs of
treating patients hospitalized with CRE
infections with current therapies. The
applicant explained that it identified 69
different regimens that ranged from 1 to
4 drugs from a study conducted to
understand the current management of
patients diagnosed with CRE infections.
Accordingly, the applicant estimated
the removal of charges for a prior
technology of $1,999. The applicant
then standardized the charges. The
applicant applied an inflation factor of
9.357 percent from the FY 2018 IPPS/
LTCH PPS final rule (82 FR 38527) to
inflate the charges. The applicant noted
that it does not yet have sufficient
charge data from hospitals and will
work to supplement its application with
the information once it is available.
However, for purposes of calculating
charges, the applicant used the average
charge as the wholesale acquisition cost
(WAC) price for a treatment duration of
14 days and added this amount to the
average charge per case. Using this
estimate, the applicant calculated the
final inflated case-weighted
standardized charge per case as $91,304,
which exceeds the average
case-weighted threshold amount of
$74,815. Therefore, the applicant
asserted that VABOMERETM meets the
cost criterion.
We are concerned that, as noted
earlier, instead of using actual charges
from the Premier Research Database, the
applicant computed the average
case-weighted unstandardized charge
per case based on the average caseweighted threshold amounts in Table 10
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from the FY 2018 IPPS/LTCH PPS final
rule. Because the applicant did not
demonstrate that the average caseweighted standardized charge per case
for VABOMERETM (using actual charges
from the Premier Research Database)
would exceed the average case-weighted
threshold amounts in Table 10, we are
unable to determine if the applicant
meets the cost criterion. We are inviting
public comments on whether
VABOMERETM meets the cost criterion,
including with respect to the concern
regarding the applicant’s analysis.
With regard to the substantial clinical
improvement criterion, the applicant
believed that the results from the
VABOMERETM clinical trials clearly
establish that VABOMERETM represents
a substantial clinical improvement for
treatment of deadly, antibiotic resistant
infections. Specifically, the applicant
asserted that VABOMERETM offers a
treatment option for a patient
population unresponsive to, or
ineligible for, currently available
treatments, and the use of
VABOMERETM significantly improves
clinical outcomes for a patient
population as compared to currently
available treatments. The applicant
provided the results of the Targeting
Antibiotic Non-sensitive Gram-Negative
Organisms (TANGO) I and II clinical
trials to support its assertion.
TANGO-I 88 was a prospective,
randomized, double-blinded trial of
VABOMERETM versus piperacillintazobactam in patients with cUTIs and
acute pyelonephritis (A/P). TANGO-I is
also a noninferiority (NI) trial powered
to evaluate the efficacy, safety, and
tolerability of VABOMERETM compared
to piperacillin-tazobactam in the
treatment of cUTI, including AP, in
adult patients. There were two primary
endpoints for this study, one for the
FDA, which was cure or improvement
and microbiologic outcome of
eradication at the end-of-treatment
(EOT) (day 5 to 14) in the proportion of
patients in the Microbiologic Evaluable
Modified Intent-to-Treat (m-MITT)
population who achieved overall
success (clinical cure or improvement
and eradication of baseline pathogen to
<104 CFU/mL), and one for the
European Medicines Agency (EMA),
which was the proportion of patients in
the co-primary m-MITT and
Microbiologic Evaluable (ME)
populations who achieve a
microbiologic outcome of eradication
(eradication of baseline pathogen to
88 Vabomere Prescribing Information, Clinical
Studies (August 2017), available at: https://
www.accessdata.fda.gov/drugsatfda_docs/label/
2017/209776lbl.pdf.
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<103 CFU/mL) at the test-of-cure (TOC)
visit (day 15 to 23). The trial enrolled
550 adult patients who were
randomized 1:1 to receive
VABOMERETM as a 3-hour IV infusion
every 8 hours, or piperacillin 4gtazobactam 500mg as a 30 minute IV
infusion every 8 hours, for at least 5
days for the treatment of a cUTI.
Therapy was set at a minimum of 5 days
to fully assess the efficacy and safety of
VABOMERETM. After a minimum of 5
days of IV therapy, patients could be
switched to oral levofloxacin (500 mg
once every 24 hours) to complete a total
of 10-day treatment course (IV + oral),
if they met pre-specified criteria.
Treatment was allowed for up to 14
days, if clinically indicated.
Patient demographic and baseline
characteristics were balanced between
treatment groups in the m-MITT
population.
• Approximately 93 percent of
patients were Caucasian and 66 percent
were females in both treatment groups.
• The mean age was 54 years old with
32 percent and 42 percent of the
patients 65 years old and older in the
VABOMERETM and piperacillin/
tazobactam treatment groups,
respectively.
• Mean body mass index was
approximately 26.5 kg/m2 in both
treatment groups.
• Concomitant bacteremia was
identified in 12 (6 percent) and 15 (8
percent) of the patients at baseline in
the VABOMERETM and piperacillin/
tazobactam treatment groups,
respectively.
• The proportion of patients who
were diagnosed with diabetes mellitus
at baseline was 17 percent and 19
percent in the VABOMERETM and
piperacillin/tazobactam treatment
groups, respectively.
• The majority of the patients
(approximately 90 percent) were
enrolled from Europe, and
approximately 2 percent of the patients
were enrolled from North America.
Overall, in both treatment groups, 59
percent of the patients had
pyelonephritis and 40 percent had a
cUTI, with 21 percent and 19 percent of
the patients having a non-removable
and removable source of infection,
respectively.
Mean duration of IV treatment in both
treatment groups was 8 days and mean
total treatment duration (IV and oral)
was 10 days; patients with baseline
bacteremia could receive up to 14 days
of therapy (IV and oral). Approximately
10 percent of the patients in each
treatment group in the m-MITT
population had a levofloxacin-resistant
pathogen at baseline and received
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levofloxacin as the oral switch therapy.
According to the applicant, this protocol
violation may have impacted the
assessment of the outcomes at the TOC
visit. These patients were not excluded
from the analysis of adverse reactions
(headache, phlebitis, nausea, diarrhea,
and others) occurring in 1 percent or
more of the patients receiving
VABOMERETM, as the decision to
switch to oral levofloxacin was based on
post-randomization factors.
Regarding the FDA primary endpoint,
the applicant stated the following:
• Overall success rate at the end of IV
treatment (day 5 to 14) was 98.4 percent
and 94 percent for the VABOMERETM
and piperacillin/tazobactam treatment
groups, respectively.
• The TOC—7 days post IV therapy
was 76.5 percent (124 of 162 patients)
for the VABOMERETM group and 73.2
percent (112 of 153 patients) for the
piperacillin/tazobactam group.
• Despite being an NI trial, TANGO–
I showed a statistically significant
difference favoring VABOMERETM in
the primary efficacy endpoint over
piperacillin/tazobactam (a commonly
used agent for gram-negative infections
in U.S. hospitals).
• VABOMERETM demonstrated
statistical superiority over piperacillintazobactam with overall success of 98.4
percent of patients treated with
VABOMERETM in the TANGO–I clinical
trial compared to 94.0 percent for
patients treated with piperacillin/
tazobactam, with a treatment difference
of 4.5 percent and 95 percent CI of (0.7
percent, 9.1 percent).
• Because the lower limit of the 95
percent CI is also greater than 0 percent,
VABOMERETM was statistically superior
to piperacillin/tazobactam.
• Because non-inferiority was
demonstrated, then superiority was
tested. Further, the applicant asserted
that a noninferiority design may have a
‘‘superiority’’ hypothesis imbedded
within the study design that is
appropriately tested using a
non-inferiority design and statistical
analysis. As such, according to the
applicant, superiority trials concerning
antibiotics are impractical and even
unethical in many cases because one
cannot randomize patients to receive
inactive therapies. The applicant stated
that it would be unethical to leave a
patient with a severe infection without
any treatment.
• The EMA endpoint of eradication
rates at TOC were higher in the
VABOMERETM group compared to the
piperacillin/tazobactam group in both
the m-MITT (66.7 percent versus 57.7
percent) and ME (66.3 percent and 60.4
percent) populations; however, it was
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not a statistically significant
improvement.
We note that the eradication rates of
the EMA endpoint were not statistically
significant. We are inviting public
comments with respect to our concern
as to whether the FDA endpoints
demonstrating noninferiority are
statistically sufficient data to support
that VABOMERETM is a substantial
clinical improvement in the treatment of
patients with a cUTI.
In TANGO–I the applicant offers data
comparing VABOMERETM to
piperacillin–tazobactam EOT/TOC rates
in the setting of cUTIs/AP, but does not
offer a comparison to other antibiotic
treatments of cUTIs known to be
effective against gram–negative
uropathogens, specifically other
carbapenems.89 We also note that the
study population is largely European
(98 percent), and given the variable
geographic distribution of antibiotic
resistance we are concerned that the use
of piperacillin/tazobactam as the
comparator may have skewed the
eradication rates in favor of
VABOMERETM, or that the favorable
results would not be applicable to
patients in the United States. We are
inviting public comments regarding the
lack of a comparison to other antibiotic
treatments of cUTIs known to be
effective against gram–negative
uropathogens, whether the comparator
the applicant used in its trial studies
may have skewed the eradication rates
in favor of VABOMERETM, and if the
favorable results would be applicable to
patients in the United States to allow for
sufficient information in evaluating
substantial clinical improvement.
The applicant asserted that the
TANGO-II study 90 of monotherapy with
VABOMERETM compared to best
available therapy (BAT) (salvage care of
cocktails of toxic/poorly efficacious last
resort agents) for the treatment of CRE
infections showed important differences
in clinical outcomes, including reduced
mortality, higher clinical cure at EOT
and TOC, benefit in important patient
subgroups of HABP/VABP, bacteremia,
renal impairment, and
immunocompromised and reduced AEs,
particularly lower nephrotoxicity in the
study group. TANGO-II is a
multi-center, randomized, Phase III,
89 Golan, Y., 2015, ‘‘Empiric therapy for hospitalacquired, Gram-negative complicated intraabdominal infection and complicated urinary tract
infections: a systematic literature review of current
and emerging treatment options,’’ BMC Infectious
Diseases, vol. 15, pp. 313. https://doi.org/10.1186/
s12879-015-1054-1.
90 Alexander, et al., ‘‘CRE Infections: Results
From a Retrospective Series and Implications for
the Design of Prospective Clinical Trials,’’ Open
Forum Infectious Diseases.
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Jkt 244001
open-label trial of patients with
infections due to known or suspected
CRE, including cUTI, AP, HABP/VABP,
bacteremia, or complicated intraabdominal infection (cIAI). Eligible
patients were randomized 2:1 to
monotherapy with VABOMERETM or
BAT for 7 to 14 days. There were no
consensus BAT regimes, it could
include (alone or in combination) a
carbapenem, aminoglycoside,
polymyxin B, colistin, tigecycline or
ceftazidime-avibactam.
A total of 72 patients were enrolled in
the TANGO-II trial. Of these, 50 of the
patients (69.4 percent) had a gramnegative baseline organism (m-MITT
population), and 43 of the patients (59.7
percent) had a baseline CRE (mCRE–
MITT population). Within the mCRE–
MITT population, 20 of the patients had
bacteremia, 15 of the patients had a
cUTI/AP, 5 of the patients had HABP/
VABP, and 3 of the patients had a cIAI.
The most common baseline CRE
pathogens were K. pneumoniae (86
percent) and Escherichia coli (7
percent). Cure rates of the mCRE–MITT
population at EOT for VABOMERETM
and BAT groups were 64.3 percent and
40 percent, respectively, TOC, 7 days
after EOT, were 57.1 percent and 26.7
percent, respectively, 28-day mortality
was 17.9 percent (5 of 28 patients) and
33.3 percent (5 of 15 patients),
respectively. The applicant asserted that
with further sensitivity analysis, taking
into account prior antibiotic failures
among the VABOMERETM study arm,
the 28-day all-cause mortality rates were
even lower among VABOMERETM
versus BAT patients (5.3 percent (1 of
19 patients) versus 33.3 percent (5 of 15
patients)). Additionally, in July 2017,
randomization in the trial was stopped
early following a recommendation by
the TANGO-II Data Safety Monitoring
Board (DSMB) based on risk-benefit
considerations that randomization of
additional patients to the BAT
comparator arm should not continue.
According to the applicant, subgroup
analyses of the TANGO-II studies
include an analysis of adverse events in
which VABOMERETM compared to BAT
demonstrated the following:
• VABOMERETM was associated with
less severe treatment emergent adverse
events of 13.3 percent versus 28 percent.
• VABOMERETM was less likely to be
associated with a significant increase in
creatinine 3 percent versus 26 percent.
• Efficacy results of the TANGO-II
trial cUTI/AP subgroup demonstrated
VABOMERETM was associated with an
overall success rate at EOT for the
mCRE–MITT populations of 72 percent
(8 of 11 patients) versus 50 percent (2
of 4 patients) and an overall success rate
PO 00000
Frm 00141
Fmt 4701
Sfmt 4702
20303
at TOC of 27.3 percent (3 of 7 patients)
versus 50 percent (2 of 4 patients).
We note that many of the TANGO-II
trial outcomes showing improvements
in the use of VABOMERETM over BAT
are not statistically significant. We also
note that the TANGO-II study included
a small number of patients; the study
population in the mCRE-MITT only
included 43 patients. Additionally, the
cUTI/AP subgroup analysis only
included a total of 15 patients and did
not show an increased overall success
rate at TOC (27.3 percent versus 50
percent) over the BAT group. We are
inviting public comments with respect
to our concern as to whether the lack of
statistically significant outcomes and
the small number of study participants
allows for enough information to
evaluate substantial clinical
improvement.
We are inviting public comments on
whether the VABOMERETM technology
meets the substantial clinical
improvement criterion, including with
respect to the specific concerns we have
raised.
Below we summarize and respond to
written public comments we received
regarding VABOMERETM during the
open comment period in response to the
New Technology Town Hall meeting
notice published in the Federal
Register.
Comment: The applicant submitted
information regarding the comparison of
VABOMERETM to other antibiotic
treatments for a cUTI known to be
effective against gram-negative
uropathogens. The applicant asserted
that doripenem is a carbapenem
antibiotic and, therefore, is subject to
degradation and inactivation by
carbapenemases, including the
Klebsiella pneumoniae carbapenemase
(KPC). The applicant stated that
doripenem has been shown to have poor
activity in vitro against CRE and
VABOMERETM, in contrast, takes a
novel, first in class beta-lactamase
inhibitor, vaborbactam, and combines it
with the carbapenem drug meropenem
in a manner that—because of the
unique, novel, and new properties of
vaborbactam when combined with
meropenem to create VABOMERETM—
to effectively restore the effectiveness of
meropenem (a carbapenem) in fighting
against carbapenem-resistant bacteria.
The applicant indicated that extensive
in vitro studies have been conducted
and show that carbapenems such as
doripenem have poor activity in vitro
against KPC-producing CRE. Because
the in vitro data show that doripenem
has poor activity against KPC-producing
CRE, the applicant stated that no
comparative clinical efficacy data
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between doripenem and VABOMERETM
exists.
Response: We appreciate the
applicant’s comments. However, we
believe that because the study
population for VABOMERETM is
patients with cUTIs and not UTIs with
KPCs, we are concerned that the
applicant does not offer comparison
data to other antibiotic treatments of
cUTIs known to be effective against
gram-negative uropathogens. As noted,
we are inviting public comments on
whether the VABOMERETM technology
meets the substantial clinical
improvement criterion, including with
respect to the specific concerns we have
raised.
daltland on DSKBBV9HB2PROD with PROPOSALS2
d. DURAGRAFT® Vascular Conduit
Solution
Somahlution, Inc. submitted an
application for new technology add-on
payments for DURAGRAFT® for FY
2019. DURAGRAFT® is designed to
protect the endothelium of the vein graft
following harvesting and prior to
grafting to prevent vascular graft disease
(VGD) and vein graft failure (VGF), and
to reduce the clinical complications
associated with graft failure. These
complications include myocardial
infarction and repeat revascularization.
DURAGRAFT® is formulated into a
solution that is used during standard
graft handling, flushing, and bathing
steps.
VGD is the principal cause of both
early (within 30 days) and intermediate/
late (months to years) VGF. The
principal mediator of VGD following
grafting in bypass surgeries is damage
that occurs during intra-operative
vascular graft harvesting and
handling.91 92 Endothelium can be
destroyed or damaged intraoperatively
through the acute physical stress of
harvesting, storage, and handling, and
through more insidious processes such
as those associated with ischemic
injury, metabolic stress and oxidative
damage. According to the applicant,
more recently, it has been demonstrated
that damage associated with graft
storage solution has the highest
correlation with the development of 12month VGF.93 94 This is likely due not
91 Harskamp, Ralf E., MD, Alexander, John H.,
MD, MHS, Schulte, Phillip J., Phd, et al., ‘‘Vein
Graft Preservation Solutions, Patency, and
Outcomes After Coronary Artery Bypass Graft
Surgery: follow-up from the PREVENT IV
randomized clinical trial’’, Jama Surg, 2014, vol.
149(8), pp. 798–805.
92 Testa, L., Bedogni, F., ‘‘Treatment of
Saphenous Vein Graft Disease: ‘Never Ending Story’
of the Eternal Return,’’ Res Cardiovasc Med, 2014,
vol. 3(3), pp. e21092.
93 Ibid.
94 Ibid.
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20:30 May 04, 2018
Jkt 244001
only to the active tissue damage
associated with commonly used storage
solutions, but also to their inability to
protect against ischemic injury.95 96 97
VGD encompasses the
pathophysiological changes that occur
in damaged vein grafts following their
use in surgical grafting. These changes,
apparent within minutes to hours of
grafting, are manifested as endothelial
dysfunction, death and/or denudation
and include pro-inflammatory, prothrombogenic and proliferative changes
within the graft. These initial responses
to damage cause even more damage in
a domino-like effect, thereby
perpetuating the response-damage cycle
that is the basis of VGD progression.
The applicant further noted that
endothelial dysfunction and
inflammation also result in the
diminished ability of the graft to
respond appropriately to new blood
flow patterns and adaptive positive
remodeling may be thwarted. This is
because proper remodeling is dependent
upon a functional endothelial response
to shear stress that involves the
production of remodeling factors by the
endothelium including nitro
vasodilators, prostaglandins,
lipoxyoxygenases, hyperpolarizing
factors and other growth factors.
Therefore, damaged, missing and/or
dysfunctional endothelial cells prevent,
to varying extents, graft adaption which
makes the graft susceptible to shearmediated endothelial damage. The
collective damage results in intimal
hyperplasia or graft wall thickening that
is the basis for atheroma development
and subsequent lumen narrowing and
graft failure, which is the end state of
VGD. The applicant pointed to several
references to highlight pathologic
changes leading to VGD, occlusion and
loss of vasomotor
function.98 99 100 101 102 103 104 105 The
95 Weiss, D.R., Juchem, G., Kemkes, B.M., et al.,
‘‘Extensive deendothelialization and
thrombogenicity in routinely prepared vein grafts
for coronary bypass operations: facts and remedy,’’
Century Publishing Corporation, International
Journal of Clinical Experimental Medicine, 2009
May 28, vol. 2(2), pp. 95–113.
96 Wilbring, M., Tugtekin, S.M., Zatschler, B., et
al., ‘‘Even short-time storage in physiological saline
solution impairs endothelial vascular function of
saphenous vein grafts,’’ Elsevier Science Inc.,
European Journal of Cardio-Thoracic Surgery, 2011
Oct, vol. 40(4), pp. 811–815.
97 Thatte, H.S., Biswas, K.S., Najjar, S.F., et al.,
‘‘Multi-photon microscopic evaluation of
saphenous vein endothelium and its preservation
with a new solution,’’ GALA, Elsevier Science Inc.,
Ann Thorac Surg, 2003 Apr, vol. 75(4), pp. 1145–
1152.
98 Verrier, E.D., Boyle, E.M., ‘‘Endothelial cell
injury in cardiovascular surgery: an overview,’’ Ann
Thorac Surg, 1997, vol. 64, pp. S2–S8.
99 Harskamp, R.E., Lopes, R.D., Baisden, C.E., et
al., ‘‘Saphenous vein graft failure after coronary
PO 00000
Frm 00142
Fmt 4701
Sfmt 4702
applicant summarized, that when the
damaged luminal surface of a vein graft
is presented to the bloodstream at time
of reperfusion, a domino-effect of
further damage is triggered through
inflammatory, thrombogenic and
aberrant hyper-proliferative processes
that lead to both early and late VGF.
Presenting an intact functional
endothelial layer at the time of grafting
is, therefore, tantamount to protecting
the graft and its associated endothelium
from damage that occurs post-grafting,
in turn conferring protection against
graft failure. Given the low success rate
of failed graft intervention, addressing
graft endothelial protection at the time
of surgery is critical.106
With respect to the newness criterion,
DURAGRAFT® has not received FDA
approval at the time of the development
of this proposed rule. The applicant
indicated that it anticipates FDA
approval of its premarket application by
the second quarter of 2018. The
applicant also indicated that ICD–10–
PCS code XY0VX83 (Extracorporeal
introduction of endothelial damage
inhibitor to vein graft, new technology
group 3) would identify procedures
involving the use of the DURAGRAFT®
technology.
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, according to the
applicant, there are currently no other
treatment options available with the
artery bypass surgery: pathophysiology,
management, and future directions,’’ Ann Thorac
Surg., 2013 May, vol. 257(5), pp. 824–33.
100 Hess, C.N., Lopes, R.D., Gibson, C.M., et al.,
‘‘Saphenous vein graft failure after coronary artery
bypass surgery: insights from PREVENT IV,’’
Circulation 2014 Oct 21, vol. 130(17), pp. 1445–51.
101 Sellke, F.W., Boyle, E.M., Verrier, E.D., ‘‘The
pathophysiology of vasomotor dysfunction,’’ Ann
Thorac Surg, 1997, vol. 64, pp. S9–S15.
102 Motwani, J.G., Topol, E.J., ‘‘Aortocoronary
saphenous vein graft disease: pathogenesis,
predisposition and prevention,’’ Circulation 1998,
vol. 97(9), pp. 916–31.
103 Mills, N.L., Everson, C.T., ‘‘Vein graft failure,’’
Curr Opin Cardiol, 1995, vol. 10, pp. 562–8.
104 Davies, M.G., Hagen, P.O., ‘‘Pathophysiology
of vein graft failure: a review,’’ Eur J Vasc Endovasc
Surg, 1995, vol. 9, pp. 7–18.
105 Edmunds, L.H., ‘‘Techniques of myocardial
revascularization. In: Edmunds LH, ed. Cardiac
surgery in the adult,’’ New York: McGraw-Hill,
1997, pp. 481–534.
106 Kim, F.Y., Marhefka, G., Ruggiero, N.J., et al.,
‘‘Saphenous vein graft disease: review of
pathophysiology, prevention, and treatment,’’
Cardiol, Rev 2013, vol. 21(2), pp. 101–9.
E:\FR\FM\07MYP2.SGM
07MYP2
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
same mechanism of action as that of
DURAGRAFT®. Moreover, the
applicant conveyed there are currently
no commercial solutions approved for
treating arteries or veins intended for
bypass surgery. The applicant explained
that the DURAGRAFT® treatment has
been formulated into a solution so that
it can be used to treat grafts during
handling, flushing, and bathing steps
without changing surgical practice to
perform the treatment. According to the
applicant, DURAGRAFT® is specifically
designed to inhibit endothelial cell
damage and death, as well as prevent
damage to other cells of the vascular
conduit, which achieves a superior
clinical outcome in coronary artery
bypass grafting (CABG).
The applicant did not directly address
within its application the second and
third criteria; whether a product is
assigned to the same or a different MS–
DRG and whether the new use of the
technology involves the treatment of the
same or similar type of disease and the
same or similar patient population.
However, the applicant stated, as
previously indicated, that there are
currently no other treatment options
available that utilize the same
mechanism of action as that of the
DURAGRAFT®.
Based on the applicant’s statements
presented above, we are concerned that
the mechanism of action of the
DURAGRAFT® may be the same or
similar to other vein graft storage
solutions. We also are concerned with
the lack of information regarding how
the technology meets the substantial
similarity criteria. Specifically, we
understand that there are other vein
graft storage solutions available, such as
various saline, blood, and electrolyte
solutions. We believe that additional
information would be helpful regarding
whether the use of the technology treats
the same or similar patient population
or type of disease, and whether the
ICD–10–PCS
procedure
code
021009W ..............
02100AW .............
021049W ..............
02104AW. ............
021109W ..............
02110AW .............
021149W ..............
02114AW .............
021209W ..............
02120AW .............
021249W ..............
02124AW .............
021309W ..............
02130AW .............
021349W ..............
02134AW .............
20305
product is assigned to the same or
different MS–DRG as compared to the
other storage solutions. We are inviting
public comments on whether
DURAGRAFT® meets the substantial
similarity criteria and the newness
criterion.
With regard to the cost criterion, the
applicant conducted the following
analysis to demonstrate that the
technology meets the cost criterion. In
order to identify the range of MS–DRGs
that cases representing potential
patients who may be eligible for
treatment using DURAGRAFT® may
map to, the applicant identified all MS–
DRGs for patients who underwent
coronary artery bypass grafting (CABG).
Specifically, the applicant searched the
FY 2016 MedPAR file for claims that
included IPPS patients and identified
potential cases by the following ICD–
10–PCS procedure codes:
Code title
Bypass coronary artery, one artery from aorta with autologous venous tissue, open approach.
Bypass coronary artery, one artery from aorta with autologous arterial tissue, open approach.
Drainage of intracranial subdural space, percutaneous approach
Bypass cerebral ventricle to cerebral cisterns, percutaneous approach.
Bypass coronary artery, two arteries from aorta with autologous venous tissue, open approach.
Bypass coronary artery, two arteries from aorta with autologous arterial tissue, open approach.
Bypass coronary artery, two arteries from aorta with autologous venous tissue, percutaneous endoscopic approach.
Bypass coronary artery, two arteries from aorta with autologous arterial tissue, percutaneous endoscopic approach.
Bypass coronary artery, three arteries from aorta with autologous venous tissue, open approach.
Bypass coronary artery, three arteries from aorta with autologous arterial tissue, open approach.
Bypass coronary artery, three arteries from aorta with autologous venous tissue, percutaneous endoscopic approach.
Bypass coronary artery, three arteries from aorta with autologous arterial tissue, percutaneous endoscopic approach.
Bypass coronary artery, four or more arteries from aorta with autologous venous tissue, open approach.
Bypass coronary artery, four or more arteries from aorta with autologous arterial tissue, open approach.
Bypass coronary artery, four or more arteries from aorta with autologous venous tissue, percutaneous endoscopic approach.
Bypass coronary artery, four or more arteries from aorta with autologous arterial tissue, percutaneous endoscopic approach.
This resulted in potential cases
spanning 98 MS–DRGs, with
approximately 93 percent of all
potential cases, 59,139, mapping to the
following 10 MS–DRGs:
MS–DRG title
MS–DRG 3 .......
daltland on DSKBBV9HB2PROD with PROPOSALS2
MS–DRG
Extracorporeal Membrane Oxygenation (ECMO) or Tracheostomy with Mechanical Ventilation 96+ Hours or Principal Diagnosis Except Face, Mouth & Neck with Major Operating Room.
Cardiac Valve and Other Major Cardiothoracic Procedure with Cardiac Catheterization with MCC.
Cardiac Valve and Other Major Cardiothoracic Procedure without Cardiac Catheterization with MCC.
Cardiac Valve and Other Major Cardiothoracic Procedure without Cardiac Catheterization with CC.
Other Cardiothoracic Procedures with MCC.
Other Cardiothoracic Procedures without CC.
Coronary Bypass with Cardiac Catheterization with MCC.
Coronary Bypass with Cardiac Catheterization without MCC.
Coronary Bypass without Cardiac Catheterization with MCC.
Coronary Bypass without Cardiac Catheterization without MCC.
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
MS–DRG
216
219
220
228
229
233
234
235
236
...
...
...
...
...
...
...
...
...
Using the 59,139 identified cases, the
average case-weighted unstandardized
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20:30 May 04, 2018
Jkt 244001
charge per case was $200,886. The
applicant then standardized the charges.
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Frm 00143
Fmt 4701
Sfmt 4702
The applicant did not remove charges
for any current treatment because, as
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daltland on DSKBBV9HB2PROD with PROPOSALS2
discussed above, the applicant indicated
there are no other current treatment
options available. The applicant noted
that it did not provide an inflation factor
to project future charges. The applicant
added charges for the DURAGRAFT®
technology. This charge was created by
applying the national average CCR for
implantable devices of 0.332 from the
FY 2018 IPPS/LTCH PPS final rule (82
FR 38103) to the cost of the device.
According to the applicant, no further
charges or related charges were added.
Based on the FY 2018 IPPS/LTCH PPS
Table 10 thresholds, the average caseweighted threshold amount was
$164,620. The final average caseweighted standardized charge per case
was $185,575. Because the final average
case-weighted standardized charge per
case exceeds the average case-weighted
threshold amount, the applicant
maintained that the technology meets
the cost criterion. We are inviting public
comments on whether DURAGRAFT®
meets the cost criterion.
With respect to the substantial
clinical improvement criterion, the
applicant asserted that the
substitutional use of DURAGRAFT®
significantly reduces clinical
complications associated with VGF
following CABG surgery.
According to the applicant,
DURAGRAFT® provides a benefit by
protecting vascular grafts and their
fragile luminal endothelial layer from
the point of harvest until the point of
grafting; an intra-operative ischemic
interval lasting from about 10 minutes
to 3 hours depending on the complexity
of the surgery. According to the
applicant, there are currently no
products available to protect vascular
grafts during this time interval. The
current standard practice is to place
grafts in heparinized saline or
heparinized autologous blood to keep
them wet; a practice which has been
shown to cause significant damage to
the graft within minutes, and which has
been shown to clinically and
statistically correlate with the
development of 12-month
VGF.107 108 109 110 Therefore, neglecting to
107 Harskamp, Ralf E., MD, Alexander, John H.,
MD, MHS, Schulte, Phillip J., Phd, et al., ‘‘Vein
Graft Preservation Solutions, Patency, and
Outcomes After Coronary Artery Bypass Graft
Surgery: follow-up from the PREVENT IV
randomized clinical trial’’, Jama Surg, 2014, vol.
149(8), pp. 798–805.
108 Weiss, D.R., Juchem, G., Kemkes, B.M., et al.,
‘‘Extensive deendothelialization and
thrombogenicity in routinely prepared vein grafts
for coronary bypass operations: facts and remedy,’’
Century Publishing Corporation, International
Journal of Clinical Experimental Medicine, 2009
May 28, vol. 2(2), pp. 95–113.
109 Wilbring, M., Tugtekin, S.M., Zatschler, B., et
al., ‘‘Even short-time storage in physiological saline
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20:30 May 04, 2018
Jkt 244001
protect the endothelial layer prior to
implantation can have long-term
consequences.
When a damaged luminal surface
(endothelium) of a vascular graft is
presented to the bloodstream at the time
of reperfusion, a domino-effect of
further damage is triggered in vivo
through inflammatory, thrombogenic,
and aberrant adaptive responses
including hyper-proliferative processes
that lead to VGF. These
pathophysiologic responses occur
within minutes of reperfusion of a graft
that has received sub-optimal treatment/
handling initiating a cascade of
exacerbating damage that can continue
for years later. Presenting an intact
functional endothelial layer at the time
of grafting is, therefore, tantamount to
protecting the graft from damage that
occurs post-grafting, in turn conferring
protection against graft failure. Given
the low success rate of failed graft
intervention addressing the graft,
endothelial protection at the time of
surgery is critical.111
The combined PREVENT IV subanalyses of Hess and Harskamp
demonstrate that from dozens of factors
evaluated for impact on the
development of 12-month VGF,
exposure to solutions used for
intra-operative graft wetting and storage
have the largest correlation with the
development of VGF.112, 113 Short-term
exposure of free vascular grafts to these
solutions is routine in CABG operations,
where 10 minutes to 3 hours may elapse
between the vein harvest and
reperfusion.114, 115 According to the
applicant, standard of care solutions are
solution impairs endothelial vascular function of
saphenous vein grafts,’’ Elsevier Science Inc.,
European Journal of Cardio-Thoracic Surgery, 2011
Oct, vol. 40(4), pp. 811–815.
110 Thatte, H.S., Biswas, K.S., Najjar, S.F., et al.,
‘‘Multi-photon microscopic evaluation of
saphenous vein endothelium and its preservation
with a new solution,’’ GALA, Elsevier Science Inc.,
Ann Thorac Surg, 2003 Apr, vol. 75(4), pp. 1145–
1152.
111 Kim, F.Y., Marhefka, G., Ruggiero, N.J., et al.,
‘‘Saphenous vein graft disease: review of
pathophysiology, prevention, and treatment,’’
Cardiol Rev 2013, vol. 21(2), pp. 101–9.
112 Harskamp, Ralf E., MD, Alexander, John H.,
MD, MHS, Schulte, Phillip J., Phd, et al., ‘‘Vein
Graft Preservation Solutions, Patency, and
Outcomes After Coronary Artery Bypass Graft
Surgery: follow-up from the PREVENT IV
randomized clinical trial’’, Jama Surg, 2014, vol.
149(8), pp. 798–805.
113 Testa, L., Bedogni, F., ‘‘Treatment of
Saphenous Vein Graft Disease: ‘Never Ending Story’
of the Eternal Return,’’ Res Cardiovasc Med, 2014,
vol. 3(3), pp. e21092.
114 Motwani, J.G., Topol, E.J., ‘‘Aortocoronary
saphenous vein graft disease: pathogenesis,
predisposition and prevention,’’ Circulation 1998,
vol. 97(9), pp. 916–31.
115 Mills, N.L., Everson, C.T., ‘‘Vein graft failure,’’
Curr Opin Cardiol, 1995, vol. 10, pp. 562–8.
PO 00000
Frm 00144
Fmt 4701
Sfmt 4702
heparinized saline and heparinized
autologous blood, which were never
designed to protect vascular grafts and
have also demonstrated an inability to
protect against ischemic injury, actively
harming the graft endothelium as
well.116 117 118 119 According to the
applicant, given the criticality of
presenting an intact functional
endothelium at the time of reperfusion,
it should not be surprising that the use
of these solutions is so highly associated
with 12-month VGF. Based on these
data, DURAGRAFT® treatment has been
designed to be a fully protective
solution. DURAGRAFT® is formulated
into a flushing, wetting, and storage
solution replacing solutions
traditionally used for this purpose and,
therefore, does not change surgical
practice.
The applicant noted that retrospective
studies designed to assess clinical
effectiveness and safety were conducted
based on the readily available databases
already in existence as a result of the
use of DURAGRAFT® treatment in two
hospitals that had noncommercial
access to the product through hospital
pharmacies. These studies evaluated the
effect of DURAGRAFT® use during
CABG surgery on post-CABG clinical
complications associated with VGF,
including myocardial infarction (MI)
and repeat revascularization. The
applicant conveyed that because of the
time, resources and funding required for
randomized studies evaluating clinical
outcomes following CABG surgery,
conducting such a study was not a
viable approach for a small company
such as Somahlution.
The first retrospective study (Protocol
001), an unpublished, independent
Physician Investigator (PI), singlecenter, multi-surgeon retrospective,
116 Harskamp, Ralf E., MD, Alexander, John H.,
MD, MHS, Schulte, Phillip J., Phd, et al., ‘‘Vein
Graft Preservation Solutions, Patency, and
Outcomes After Coronary Artery Bypass Graft
Surgery: follow-up from the PREVENT IV
randomized clinical trial,’’ Jama Surg, 2014, vol.
149(8), pp. 798–805.
117 Weiss, D.R., Juchem, G., Kemkes, B.M., et al.,
‘‘Extensive deendothelialization and
thrombogenicity in routinely prepared vein grafts
for coronary bypass operations: facts and remedy,’’
Century Publishing Corporation, International
Journal of Clinical Experimental Medicine, 2009
May 28, vol. 2(2), pp. 95–113.
118 Wilbring, M., Tugtekin, S.M., Zatschler, B., et
al., ‘‘Even short-time storage in physiological saline
solution impairs endothelial vascular function of
saphenous vein grafts,’’ Elsevier Science Inc.,
European Journal of Cardio-Thoracic Surgery, 2011
Oct, vol. 40(4), pp. 811–815.
119 Thatte, H.S., Biswas, K.S., Najjar, S.F., et al.,
‘‘Multi-photon microscopic evaluation of
saphenous vein endothelium and its preservation
with a new solution,’’ GALA, Elsevier Science Inc.,
Ann Thorac Surg, 2003 Apr, vol. 75(4), pp. 1145–
1152.
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comparative study (DURAGRAFT® vs.
Saline or Blood Solutions), was a pilot
study conducted at the University of
CHU in Angers France, which followed
patients for 5 years post-CABG surgery.
This pilot study was conducted to
assess the safety and effect of
DURAGRAFT® treatment on both short
and long-term clinical outcomes. This
study also served as the basis for the
design of a larger retrospective study
conducted at the U.S. Department of
Veterans Affairs (VA) Medical Centers,
discussed later. The objective of this
single-center clinical study in CABG
patients was to evaluate the potential
benefits of DURAGRAFT® treatment as
compared to a no-treatment control
group (saline). The investigator who
prepared the analysis remained blinded
to individual patient data. Eligibility
criteria included patients with first-time
CABG surgery in which at least one vein
graft was used. Patients with in-situ
internal mammary artery (IMA) graft(s)
only (no saphenous vein or free arterial
grafts) and concomitant valve surgery
and/or aortic aneurysm repair were
excluded. The institutional review
board of the University Health Alliance
(UHA) approved the protocol, and
patients gave written informed consent
for their follow-up. A total of 630
patients who underwent elective and
isolated CABG surgery with at least one
saphenous vein graft at a single-center
in Europe between January 2002 and
December 2008 were included. The notreatment control group (saline)
included 375 patients who underwent
CABG surgery from January 2002 to May
2005 and the DURAGRAFT® treatment
group included 255 patients who
underwent CABG surgery from June
2005 to December 2008. At long-term
follow-up (greater than 30 days and up
to 5 years), 5 patients were lost to
follow-up (10 died before the 30-day
follow-up). Therefore, a total of 247
patients from the DURAGRAFT®
treatment group (97 percent) and 368
patients from the no-treatment control
group (saline) (98 percent) were
available for the long-term analysis.
Patients undergoing CABG surgery
whose vascular grafts were treated
intraoperatively with DURAGRAFT®
demonstrated no statistically significant
differences in major adverse cardiac
events (MACE) within the first 30 days
following CABG surgery. According to
the applicant, these data suggest that
DURAGRAFT® treatment is at least as
safe as the standard of care used in
CABG surgeries in that long-term
outcomes between the two groups were
not statistically different. However, also
according to the applicant, a consistent
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numerical trend toward improved
clinical effectiveness outcomes for the
DURAGRAFT® treatment group
compared to the no-treatment control
(saline) group was clearly identified.
Although statistically insignificant,
there was a consistent reduction
observed in the rates for multiple
endpoints such as all-cause death, MI,
MACE, and revascularization. This
study found reductions in
DURAGRAFT®-treated grafts relative to
saline for revascularization (57 percent),
MI (70 percent), MACE (37 percent) and
all-cause death (23 percent) compared to
standard of care (heparinized saline/
blood) through 5 years follow-up. Based
on the small sample-size for this
evaluation of only 630 patients, and the
known frequencies of these events
following CABG surgeries, statistical
differences were not expected. A
subsequent post-hoc analysis also was
performed by the researchers at CHUAngers to evaluate whether any longterm clinical variables (such as dual
antiplatelet therapy, beta-blockers,
angiotensin receptor-blockers, statins,
diabetes, lifestyle and other factors) had
any impact on the study endpoints. The
conclusions of the post-hoc analyses
were that the assessed clinical variables
did not impact the clinical study
findings and so any differences between
groups were likely due to ‘‘test article’’
effect. According to the applicant,
importantly, the data collected from this
feasibility study are consistent with data
collected in the statistically-powered
VA study in which statistically
significant reductions of MI, repeat
revascularization, and MACE were
observed in the DURAGRAFT®
treatment group, lending confidence
that the observed trends in this study,
as well as the VA study, represent real
differences associated with
DURAGRAFT® use.
The second study, the U.S. VA
Hospital Study (Protocol 002), was an
unpublished, independent PI initiated,
single-center, multi-surgeon,
retrospective, comparative
(DURAGRAFT® vs. Saline) clinical
trial, which was conducted to assess the
safety and impact of DURAGRAFT®
treatment on both short and long-term
clinical outcomes in patients who
underwent isolated CABG surgery with
saphenous vein grafts (SVGs) at the
Boston (West Roxbury) VA Medical
Center between 1996 and 2004. The
time interval from 1996 through 1999
represents a time period when
DURAGRAFT® treatment was not
available and heparinized saline was
routinely used to wet and store grafts,
while 2001 through 2004 represents a
PO 00000
Frm 00145
Fmt 4701
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20307
time period after the center began
exclusively using DURAGRAFT®,
which was prepared by the hospital’s
pharmacy. The year 2000 was omitted
from this analysis by the PI due to the
transition of the implementation of
DURAGRAFT® treatment into the clinic
and the uncertainty of its use in CABG
patients during the transition period.
Data were extracted from a total of 2,436
patients who underwent a CABG
procedure with at least one SVG from
1996 through 1999 (Control n=1,400
pts.) and 2001 through 2004
(DURAGRAFT® treatment n=1,036
pts.). The median age was 66 years old
for the control treatment group and 67
years old for the DURAGRAFT®
treatment group. Patients were excluded
from the study if they had a prior
history of CABG procedures, had no use
of SVG, or underwent additional
procedures during the CABG surgery.
Mean follow-up in the DURAGRAFT®
treatment group was 8.5±4.2 years and
9.9±5.6 years in the control treatment
group. According to the applicant, this
study supports not only safety, but also
improved long-term clinical outcomes
in DURAGRAFT®-treated CABG
patients. Thirty-day MI also was
significantly reduced in this study. The
VA study found statistically significant
reductions in DURAGRAFT®-treated
grafts relative to saline for
revascularization (35 percent), MI (45
percent), and MACE (19 percent) from
the follow-up period of 1,000 days to 15
years post-surgery.
According to the applicant, in
addition to the retrospective studies, a
multi-center, within-patient
randomized, prospective study utilizing
multidetector computed tomography
(MDCT) angiography was conducted to
assess safety and the effect of the use of
DURAGRAFT® on the graft by assessing
early anatomic markers of VGD such as
graft wall thickening and early stenotic
events. The study was based on an ‘‘inpatient control’’ design in which both
the control saline exposed vascular graft
and a DURAGRAFT®-treated graft were
grafted within the same patient to
reduce patient bias and allow a paired
analysis of the grafts. The study was
conducted under two protocols. The
first study protocol evaluated patients
up to 3 months post-CABG and
included 1- and 3-month protocol
driven MDCT scans in 125 patients (250
grafts). The second study, a longer-term
safety and efficacy study of 97 patients,
included a 12-month protocol driven
angiogram. The 3 month (full data set)
and 12 month (interim data set) data
demonstrate that safety and efficacy
appear to be equivalent for
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DURAGRAFT® and standard of care
(SoC) at 3 months, but between 3
months and 9 months a separation
between DURAGRAFT® and SoC begins
to emerge and by 12 months
DURAGRAFT® use is associated with a
numerical trend towards improved
safety relative to SoC. Furthermore by
12 months, the interim analysis
demonstrated that differences in
markers of early graft disease were able
to be discerned between
DURAGRAFT®-treated grafts and SoC.
Reductions in both wall thickness and
degree of stenosis were observed in
DURAGRAFT®-treated grafts relative to
SoC grafts. These reductions were
observed when the entire graft was
assessed and were more profound when
the proximal region of the graft was
specifically evaluated. According to the
applicant, this is of note because the
proximal region of the graft is the region
in which early graft disease has been
shown to more frequently manifest in
many grafting indications, including
CABG, peripheral bypass, aortic
grafting, and AV fistula grafting
indications, and is thought to be due to
hemodynamic perturbations that occur
in this region where arterial flow is just
entering the venous environment. While
there are no notable differences at 3
months in either safety or efficacy, there
are trends towards better safety at 12
months in patients in the
DURAGRAFT® treatment group
compared to the control group.120 The
efficacy results of the prospective study
were presented at the October 2017
meeting of the TCT Congress in Denver.
The retrospective studies
demonstrated an association of reduced
risk of non-fatal myocardial infarction,
repeat revascularization, and MACE
with DURAGRAFT® treatment.
However, we have a number of concerns
relating to these studies. In addition to
the studies being unpublished, we are
concerned that they leave too many
variables unaccounted for that could
affect vein integrity such as method of
vein harvest, vein distention pressure,
and post-operative care (including use
of anti-platelet and anti-lipid
treatments). Also, control groups
underwent CABG procedures many
years earlier than the DURAGRAFT®
treatment groups in both studies. Over
the years, with advances in medical
management and surgical techniques,
long-term survival and risk of cardiac
events are expected to improve. Finally,
120 Perrault, L., ‘‘SOMVC001 (DuraGraft) Vascular
Graft Treatment in Patients Undergoing Coronary
Artery Bypass Grafting,’’ American Heart
Association, Inc, Circulation, 2016, vol. 134, pp.
A23242, originally published November 11, 2016.
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it may be helpful to gain more insight
from data that will be available upon
completion and results of the multicenter, prospective, randomized,
double-blind, comparative,
within-person (DURAGRAFT® vs.
Saline) control trial that is currently
ongoing.
We are inviting public comments on
whether DURAGRAFT® meets the
substantial clinical improvement
criterion.
Below we summarize and respond to
written public comments we received
regarding the DURAGRAFT® during the
open comment period in response to the
New Technology Town Hall meeting
notice published in the Federal
Register.
Comment: One commenter, a
cardiothoracic surgeon, stated that after
practicing cardiac surgery for over 30
years, authoring peer-reviewed
publications in Cardiac Surgery, and
participating in several clinical studies,
it supported the approval of new
technology add-on payments for the
DURAGRAFT® technology. The
commenter indicated that one of the
reasons why vein grafts get occluded
could be because of poor handling
during and after harvest. The
commenter expressed that there are
currently no other solutions used in
treatment options available that protect
vascular conduits once they are
harvested aside from the standard
practice of storing them in saline or
blood-based solutions until they are
ready for implantation. The commenter
stated that saline and blood-based
solutions are very damaging to vein
segments, and the damage that occurs is
linked to poor clinical outcomes
including increased risk of myocardial
infarction (MI) and increased rates of
repeat revascularization. The
commenter indicated that it had many
years of first-hand experience with the
use of DURAGRAFT® because the
commenter served as the Principal
Investigator for a retrospective clinical
study that evaluated the
DURAGRAFT®’s effect on clinical
outcomes compared to standard-of-care
treatment options. The commenter
conveyed that the results of the
retrospective clinical study included
statistically significant reductions in MI
and repeat revascularization rates. The
commenter also pointed out its
awareness of a prospective clinical
study the DURAGRAFT®’s
manufacturer has conducted evaluating
radiologic assessments to analyze graft
disease, which precedes loss of patency.
According to the commenter, the study
demonstrated increased wall thickness
and increased stenosis in grafts stored in
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Sfmt 4702
saline compared to grafts stored using
the DURAGRAFT®. The commenter
stated that this finding from the
prospective clinical study is very
consistent with the clinical results of
the retrospective study. The commenter
concluded by stating that it supported
the commercial availability and use of
the DURAGRAFT®, including use in the
treatment of its own patients.
Response: We appreciate the
commenter’s input. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payment for the
DURAGRAFT® for FY 2019.
Comment: Another commenter, a
cardiovascular and thoracic surgeon
with clinical expertise in coronary
artery bypass grafting surgery (CABG)
who has been involved in endothelial
dysfunction as a primary field of study
and the Principal Investigator for the
multi-center, within-patient,
randomized, prospective study that
Somahlution submitted to the FDA in
support of U.S. product clearance,
supported the approval of new
technology add-on payments for the
DURAGRAFT®. The commenter
indicated that as an author and coauthor of more than 250 articles in peerreviewed publications, a senior author
of more than 75 papers and writer of
several book chapters, and having
delivered over 40 conference
presentations worldwide, the study
results, specifically of the 12-month
multidector computed tomography
(MDCT) imaging showing less lumen
narrowing or stenosis, and less wall
thickening as a resulting outcome of the
DURAGRAFT®-treated veins compared
to heparinized-saline, are critically
important from a clinical perspective.
According to the commenter, the
primary mechanism of the
DURAGRAFT® technology is to protect
the endothelial cells in the vein graft
and this has been repeatedly
demonstrated in pre-clinical studies.
The commenter explained that the
findings of the clinical anatomic
changes in the graft demonstrated in the
prospective study are consistent with
the pre-clinical findings and the
literature that has clearly pointed to
damaged endothelium of the graft as the
starting insult for later development of
poor patient outcomes from graft disease
and failure. Finally, the commenter
noted that surgeons in all countries
currently use a variety of graft storage
and preservation solutions during a
CABG procedure because there has been
no other available solution used in
treatment options, aside from the
DURAGRAFT®, with systematic
evaluation demonstrating a clear safety
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profile and benefit to patient outcomes.
The commenter encouraged CMS to
approve new technology add-on
payments for the DURAGRAFT®
technology to provide additional
support for this new preservation
solution to become available to surgeons
in the United States.
Response: We appreciate the
commenter’s input. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payments for
DURAGRAFT® for FY 2019.
¯
e. remede® System
Respicardia, Inc. submitted an
application for new technology add-on
¯
payments for the remede® System for
FY 2019. According to the applicant, the
¯
remede® System is indicated for use as
a transvenous phrenic nerve stimulator
in the treatment of adult patients who
have been diagnosed with moderate to
severe central sleep apnea. The
¯
remede® System consists of an
implantable pulse generator, and a
stimulation and sensing lead. The pulse
generator is placed under the skin, in
either the right or left side of the chest,
and it functions to monitor the patient’s
respiratory signals. A transvenous lead
for unilateral stimulation of the phrenic
nerve is placed either in the left
pericardiophrenic vein or the right
brachiocephalic vein, and a second lead
to sense respiration is placed in the
azygos vein. Both leads, in combination
with the pulse generator, function to
sense respiration and, when
appropriate, generate an electrical
stimulation to the left or right phrenic
nerve to restore regular breathing
patterns.
The applicant’s application describes
central sleep apnea (CSA) as a chronic
respiratory disorder characterized by
fluctuations in respiratory drive,
resulting in the cessation of respiratory
muscle activity and airflow during
sleep.121 The applicant reported that
CSA, as a primary disease, has a low
prevalence in the United States
population; and it is more likely to
occur in those individuals who have
cardiovascular disease, heart failure,
atrial fibrillation, stroke, or chronic
opioid usage. The apneic episodes
which occur in patients with CSA cause
hypoxia, increased blood pressure,
increased preload and afterload, and
promotes myocardial ischemia and
arrhythmias. In addition, CSA
121 Jagielski, D., Ponikowski, P., Augostini, R.,
Kolodziej, A., Khayat, R., Abraham, W.T., 2016,
‘‘Transvenous Stimulation of the Phrenic Nerve for
the Treatment of Central Sleep Apnoea: 12 months’
experience with the remede®system,’’ European
Journal of Heart Failure, pp. 1–8.
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‘‘enhances oxidative stress, causing
endothelial dysfunction, inflammation,
and activation of neurohormonal
systems, which contribute to
progression of underlying diseases.’’ 122
According to the applicant, prior to
¯
the introduction of the remede®
System, typical treatments for CSA took
the form of positive airway pressure
devices. Positive airway pressure
devices, such as continuous positive
airway pressure (CPAP), have
previously been used to treat patients
diagnosed with obstructive sleep apnea.
Positive airway devices deliver constant
pressurized air via a mask worn over the
mouth and nose, or nose alone. For this
reason, positive airway devices may
only function when the patient wears
the necessary mask. Similar to CPAP,
adaptive servo-ventilation (ASV)
provides noninvasive respiratory
assistance with expiratory positive
airway pressure. However, ASV adds
servo-controlled inspiratory pressure, as
well, in an effort to maintain airway
patency.123
¯
On October 6, 2017, the remede®
System was approved by the FDA as an
implantable phrenic nerve stimulator
indicated for the use in the treatment of
adult patients who have been diagnosed
with moderate to severe CSA. The
device was available commercially upon
FDA approval. Therefore, the newness
¯
period for the remede® System is
considered to begin on October 6, 2017.
The applicant has indicated that the
device also is designed to restore regular
breathing patterns in the treatment of
CSA in patients who also have been
diagnosed with heart failure.
The applicant was approved for two
unique ICD–10–PCS procedure codes
for the placement of the leads:
05H33MZ (Insertion of neurostimulator
lead into right innominate
(brachiocephalic) vein) and 05H03MZ
(Insertion of neurostimulator lead into
azygos vein), effective 10/01/2016. The
applicant indicated that implantation of
the pulse generator is currently reported
using ICD–10–PCS procedure code
0JH60DZ (Insertion of multiple array
stimulator generator into chest
subcutaneous tissue).
As discussed above, if a technology
meets all three of the substantial
similarity criteria, it would be
122 Costanzo, M.R., Ponikowski, P., Javaheri, S.,
Augostini, R., Goldberg, L., Holcomb, R., Abraham,
W.T., ‘‘Transvenous Neurostimulation for Centra
Sleep Apnoea: A randomised controlled trial,’’
Lancet, 2016, vol. 388, pp. 974–982.
123 Cowie, M.R., Woehrle, H., Wegscheider, K.,
Andergmann, C., d’Ortho, M.P., Erdmann, E.,
Teschler, H., ‘‘Adaptive Servo-Ventilation for
Central Sleep Apneain Systolic Heart Failure,’’ N
Eng Jour of Med, 2015, pp. 1–11.
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20309
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for the purposes of
new technology add-on payments.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, according to the
¯
applicant, the remede® System provides
stimulation to nerves to stimulate
breathing. Typical treatments for
hyperventilation CSA include
supplemental oxygen and CPAP.
Mechanical ventilation also has been
used to maintain a patent airway. The
¯
applicant asserted that the remede®
System is a neurostimulation device
resulting in negative airway pressure,
whereas devices such as CPAP and ASV
utilize positive airway pressure.
With respect to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, the
¯
applicant stated that the remede®
System is assigned to MS–DRGs 040
(Peripheral, Cranial Nerve and Other
Nervous System Procedures with MCC),
041 (Peripheral, Cranial Nerve and
Other Nervous System Procedures with
CC or Peripheral Neurostimulator), and
042 (Peripheral, Cranial Nerve and
Other Nervous System Procedures
without CC/MCC). The current
procedures for the treatment options of
CPAP and ASV are not assigned to these
MS–DRGs.
With respect to the third criterion,
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, according to
¯
the applicant, the remede® System is
indicated for the use as a transvenous
unilateral phrenic nerve stimulator in
the treatment of adult patients who have
been diagnosed with moderate to severe
CSA. The applicant stated that the
¯
remede® System reduces the negative
symptoms associated with CSA,
particularly among patients who have
been diagnosed with heart failure. The
applicant asserted that patients who
have been diagnosed with heart failure
are particularly negatively affected by
CSA and currently available CSA
treatment options of CPAP and ASV.
According to the applicant, the
currently available treatment options,
CPAP and ASV, have been found to
have worsened mortality and morbidity
outcomes for patients who have been
diagnosed with both CSA and heart
failure. Specifically, ASV is currently
contraindicated in the treatment of CSA
in patients who have been diagnosed
with heart failure.
The applicant also suggested that the
¯
remede® System is particularly suited
for the treatment of CSA in patients who
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also have been diagnosed with heart
failure. We are concerned that, while
¯
the remede® System may be beneficial
to patients who have been diagnosed
with both CSA and heart failure, the
FDA approved indication is for use in
the treatment of adult patients who have
been diagnosed with moderate to severe
CSA. We note that the applicant’s
clinical analyses and data results related
to patients who specifically were
diagnosed with CSA and heart failure.
We are inviting public comments on
¯
whether the remede® System meets the
newness criterion.
With regard to the cost criterion, the
applicant provided the following
analysis to demonstrate that the
technology meets the cost criterion. The
applicant identified cases representing
potential patients who may be eligible
¯
for treatment involving the remede®
System within MS–DRGs 040, 041, and
042. Using the Standard Analytical File
(SAF) Limited Data Set (MedPAR) for
FY 2015, the applicant included all
claims for the previously stated MS–
DRGs for its cost threshold calculation.
The applicant stated that typically
claims are selected based on specific
ICD–10–PCS parameters, however this
is a new technology for which no ICD–
10–PCS procedure code and ICD–10–
CM diagnosis code combination exists.
Therefore, all claims for the selected
MS–DRGs were included in the cost
threshold analysis. This process
resulted in 4,462 cases representing
potential patients who may be eligible
¯
for treatment involving the remede®
System assigned to MS–DRG 040; 5,309
cases representing potential patients
who may be eligible for treatment
¯
involving the remede® System assigned
to MS–DRG 041; and 2,178 cases
representing potential patients who may
be eligible for treatment involving the
¯
remede® System assigned to MS–DRG
042, for a total of 11,949 cases.
Using the 11,949 identified cases, the
applicant determined that the average
unstandardized case-weighted charge
per case was $85,357. Using the FY
2015 MedPAR dataset to identify the
total mean charges for revenue code
0278, the applicant removed charges
associated with the current treatment
options for each MS–DRG as follows:
$9,153.83 for MS–DRG 040; $12,762.31
for MS–DRG 041; and $21,547.73 for
MS–DRG 042. The applicant anticipated
that no other related charges would be
eliminated or replaced. The applicant
then standardized the charges and
applied a 2-year inflation factor of
1.104055 obtained from the FY 2018
IPPS/LTCH PPS final rule (82 FR
38524). The applicant then added
charges for the new technology to the
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inflated average case-weighted
standardized charges per case. No other
related charges were added to the cases.
The applicant calculated a final inflated
average case-weighted standardized
charge per case of $175,329 and a Table
10 average case-weighted threshold
amount of $78,399. Because the final
inflated average case-weighted
standardized charge per case exceeded
the average case-weighted threshold
amount, the applicant maintained that
the technology meets the cost criterion.
With regard to the analysis above, we
are concerned that all cases in MS–
DRGs 040, 041, and 042 were used in
the analysis. We are unsure if all of
these cases represent patients that may
be truly eligible for treatment involving
¯
the remede® System. We are inviting
public comments on whether the
¯
remede® System meets the cost
criterion.
With respect to the substantial
clinical improvement criterion, the
¯
applicant asserted that the remede®
System meets the substantial clinical
improvement criterion. The applicant
¯
stated that the remede® System offers a
treatment option for a patient
population unresponsive to, or
ineligible for, treatment involving
currently available options. According
to the applicant, patients who have been
diagnosed with CSA have no other
available treatment options than the
¯
remede System. The applicant stated
that published studies on both CPAP
and ASV have proven that primary
endpoints have not been met for treating
patients who have been diagnosed with
CSA. In addition, according to the ASV
study, there was an increase in
cardiovascular mortality.
According to the applicant, the
¯
remede® System will prove to be a
better treatment for the negative effects
associated with CSA in patients who
have been diagnosed with heart failure,
such as cardiovascular insults resulting
from sympathetic nervous system
activation, pulmonary hypertension,
and arrhythmias, which ultimately
contribute to the downward cycle of
heart failure,124 when compared to the
currently available treatment options.
The applicant also indicated that prior
studies have assessed CPAP and ASV as
options for the treatment of diagnoses of
CSA primarily in patients who have
been diagnosed with heart failure.
The applicant shared the results from
two studies concerning the effects of
124 Abraham, W., Jagielski, D., Oldenburg, O.,
Augostini, R., Kreuger, S., Kolodziej, A.,
Ponikowski, P., ‘‘Phrenic Nerve Stimulation for the
Treatment of Central Sleep Apnea,’’ JACC: Heart
Failure, 2015, vol. 3(5), pp. 360–369.
PO 00000
Frm 00148
Fmt 4701
Sfmt 4702
positive airway pressure ventilation
treatment:
• The Canadian Continuous Positive
Airway Pressure for Patients with
Central Sleep Apnea and Heart Failure
trial found that, while CPAP managed
the negative symptoms of CSA, such as
improved nocturnal oxygenation,
increased ejection fraction, lower
norepinephrine levels, and increased
walking distance, it did not affect
overall patient survival; 125 and
• In a randomized trial of 1,325
patients who had been diagnosed with
heart failure who received treatment
with ASV plus standard treatment or
standard treatment alone, ASV was
found to increase all-cause and
cardiovascular mortality as compared to
the control treatment.126
The applicant also stated that
published literature indicates that
currently available treatment options do
not meet primary endpoints with
concern to the treatment of CSA;
patients treated with ASV experienced
an increased likelihood of mortality,127
and patients treated with CPAP
experienced alleviation of symptoms,
but no change in survival.128 The
applicant provided further research,
which suggested that a primary
drawback of CPAP in the treatment of
diagnoses of CSA is a lack of patient
adherence to therapy.129
The applicant also stated that the
¯
remede System represents a substantial
clinical improvement over existing
technologies because of the reduction in
the number of future hospitalizations,
few device-related complications, and
improvement in CSA symptoms and
quality of life. Specifically, the
applicant stated that the clinical data
has shown a statistically significant
reduction in Apnea-hypopnea index
(AHI), improvement in quality of life,
and significantly improved Minnesota
Living with Heart Failure Questionnaire
score. In addition, the applicant
125 Bradley, T.D., Logan, A.G., Kimoff, R.J., Series,
F., Morrison, D., Ferguson, K., Phil, D., 2005,
‘‘Continous Positive Airway Pressure for Central
Sleep Apnea and Heart Failure,’’ N Eng Jour of Med,
vol. 353(19), pp. 2025–2033.
126 Cowie, M.R., Woehrle, H., Wegscheider, K.,
Andergmann, C., d’Ortho, M.-P., Erdmann, E.,
Teschler, H., ‘‘Adaptive Servo-Ventilation for
Central Sleep Apneain Systolic Heart Failure,’’ N
Eng Jour of Med, 2015, pp. 1–11.
127 Ibid.
128 Bradley, T.D., Logan, A.G., Kimoff, R.J., Series,
F., Morrison, D., Ferguson, K., Phil, D., 2005,
‘‘Continous Positive Airway Pressure for Central
Sleep Apnea and Heart Failure,’’ N Engl Jour of
Med, vol. 353(19), pp. 2025–2033.
129 Ponikowski, P., Javaheri, S., Michalkiewicz,
D., Bart, B.A., Czarnecka, D., Jastrzebski, M.,
Abraham, W.T., ‘‘Transvenous Phrenic Nerve
Stimulation for the Treatment of Central Sleep
Apnoea in Heart Failure,’’ European Heart Journal,
2012, vol. 33, pp. 889–894.
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indicated that study results showed the
¯
remede System demonstrated an
acceptable safety profile, and there was
a trend toward fewer heart failure
hospitalizations.
The applicant provided six published
articles as evidence. All six articles were
prospective studies. In three of the six
studies, the majority of patients studied
had been diagnosed with CSA with a
heart failure comorbidity, while the
remaining three studies only studied
patients who had been diagnosed with
CSA with a heart failure comorbidity.
The first study 130 assessed the
treatment of patients who had been
diagnosed with CSA in addition to heart
failure. According to the applicant, as
referenced in the results of the
published study, Ponikowski, et al.,
assessed the treatment effects of 16 of 31
enrolled patients with evidence of CSA
within 6 months prior to enrollment
who met inclusion criteria (apneahypopnea index of greater than or equal
to 15 and a central apnea index of
greater than or equal to 5) and who did
not meet exclusion criteria (a baseline
oxygen saturation of less than 90
percent, being on supplemental oxygen,
having evidence of phrenic nerve palsy,
having had severe chronic obstructive
pulmonary disease (COPD), having hard
angina or a myocardial infarction in the
past 3 months, being pacemaker
dependent, or having inadequate
capture of the phrenic nerve during
neurostimulation). Of the 16 patients
whose treatment was assessed, all had
various classifications of heart failure
diagnoses: 3 (18.8 percent) were
classified as class I on the New York
Heart Association classification scale
(No limitation of physical activity.
Ordinary physical activity does not
cause undue fatigue, palpitation,
dyspnea (shortness of breath)); 8 (50
percent) were classified as a class II
(Slight limitation of physical activity.
Comfortable at rest. Ordinary physical
activity results in fatigue, palpitation,
dyspnea (shortness of breath)); and 5
(31.3 percent) were classified as class III
(Marked limitation of physical activity.
Comfortable at rest. Less than ordinary
activity causes fatigue, palpitation, or
dyspnea).131 After successful surgical
implantation of a temporary
130 Ponikowski, P., Javaheri, S., Michalkiewicz,
D., Bart, B.A., Czarnecka, D., Jastrzebski, M.,
Abraham, W.T., ‘‘Transvenous Phrenic Nerve
Stimulation for the Treatment of Central Sleep
Apnoea in Heart Failure,’’ European Heart Journal,
2012, vol. 33, pp. 889–894.
131 ‘‘Classes of Heart Failure,’’ 2017, May 8,
Retrieved from American Heart Association:
Available at: https://www.heart.org/HEARTORG/
Conditions/HeartFailure/AboutHeartFailure/
Classes-of-Heart-Failure_UCM_306328_
Article.jsp#.WmE2rlWnGUk.
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transvenous lead for unilateral phrenic
nerve stimulation, patients underwent a
control night without nerve stimulation
and a therapy night with stimulation,
while undergoing polysomnographic
(PSG) testing. Comparison of both nights
was performed.
According to the applicant, some
improvements of CSA symptoms were
identified in statistical analyses. Sleep
time and efficacy were not statistically
significantly different for control night
and therapy night, with median sleep
times of 236 minutes and 245 minutes
and sleep efficacy of 78 percent and 71
percent, respectively. There were no
statistical differences across categorical
time spent in each sleep stage (for
example, N1, N2, N3, and REM)
between control and therapy nights. The
average respiratory rate and hypopnea
index did not differ statistically across
nights. Marginal positive statistical
differences occurred between control
and therapy nights for the baseline
oxygen saturation median values (95
and 96 respectively) and obstructive
apnea index (OAI) (1 and 4,
respectively). Beneficial statistically
significant differences occurred from
control to therapy nights for the average
heart rate (71 to 70, respectively),
arousal index events per hour (32 to 12,
respectively), apnea-hypopnea index
(AHI) (45 to 23, respectively), central
apnea index (CAI) (27 to 1,
respectively), and oxygen desaturation
index of 4 percent (ODI = 4 percent) (31
to 14, respectively). Two adverse events
were noted: (1) Lead tip thrombus noted
when lead was removed; the patient was
anticoagulated without central nervous
system sequelae; and (2) an episode of
ventricular tachycardia upon lead
placement and before stimulation was
initiated. The episode was successfully
treated by defibrillation of the patient’s
implanted ICD. Neither adverse event
was directly related to the phrenic nerve
stimulation therapy.
The second study 132 was a
prospective, multi-center,
nonrandomized study that followed
patients diagnosed with CSA and other
underlying comorbidities. According to
the applicant, as referenced in the
results of the published study,
Abraham, et al., 49 of the 57 enrolled
patients who were followed indicated a
primary endpoint of a reduction of AHI
with secondary endpoints of feasibility
and safety of the therapy. Patients were
included if they had an AHI of 20 or
greater and apneic events that were
132 Abraham,
W., Jagielski, D., Oldenburg, O.,
Augostini, R., Kreuger, S., Kolodziej, A.,
Ponikowski, P., ‘‘Phrenic Nerve Stimulation for the
Treatment of Central Sleep Apnea,’’ JACC: Heart
Failure, 2015, vol. 3(5), pp. 360–369.
PO 00000
Frm 00149
Fmt 4701
Sfmt 4702
20311
related to CSA. Among the study patient
population, 79 percent had diagnoses of
heart failure, 2 percent had diagnoses of
atrial fibrillation, 13 percent had other
cardiac etiology diagnoses, and the
remainder of patients had other cardiac
unrelated etiology diagnoses. Exclusion
criteria were similar to the previous
study (that is, (Ponikowski P., 2012)),
with the addition of a creatinine of
greater than 2.5 mg/dl. After
¯
implantation of the remede® System,
patients were assessed at baseline, 3
months (n=47) and 6 months (n=44) on
relevant measures. At 3 months,
statistically nonsignificant results
occurred for the OAI and hypopnea
index (HI) measures. The remainder of
the measures showed statistically
significant differences from baseline to
3 months: AHI with a ¥27.1 episodes
per hour of sleep difference; CAI with
a ¥23.4 episodes per hour of sleep
difference; MAI with a ¥3 episodes per
hour of sleep difference; ODI = 4
percent with a ¥23.7 difference; arousal
index with ¥12.5 episodes per hour of
sleep difference; sleep efficiency with a
8.4 percent increase; and REM sleep
with a 4.5 percent increase. Similarly,
among those assessed at 6 months,
statistically significant improvements
on all measures were achieved,
including OAI and HI. Regarding safety,
a data safety monitoring board (DSMB)
adjudicated and found the following 3
of 47 patients (6 percent) as having
serious adverse events (SAE) related to
the device, implantation procedure or
therapy. None of the DSMB adjudicated
SAEs was due to lead dislodgement.
Two SAEs of hematoma or headache
were related to the implantation
procedure and occurred as single events
in two patients. A single patient
experienced atypical chest discomfort
during the first night of stimulation, but
on reinitiation of therapy on the second
night no further discomfort occurred.
The third study 133 assessed the safety
and feasibility of phrenic nerve
stimulation for 6 monthly follow-ups of
8 patients diagnosed with heart failure
with CSA. Of the eight patients
assessed, one was lost to follow-up and
one died from pneumonia. According to
the applicant, as referenced in the
results in the published study, Zheng, et
al. (2015), no unanticipated serious
adverse events were found to be related
to the therapy; in one patient, a lead
became dislodged and subsequently
successfully repositioned. Three
133 Zhang, X., Ding, N., Ni, B., Yang, B., Wang, H.,
& Zhang, S.J., 2015, ‘‘Satefy and Feasibility of
Chronic Transvenous Phrenic Nerve Stimulation for
Treatment of Central Sleep Apnea in Heart Failure
Patients,’’ The Clinical Respiratory Journal,
pp. 1–9.
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patients reported improved sleep
quality, and all patients reported
increased energy. A reduction in sleep
apneic events and decreases in AHI and
CAI were related to application of the
treatment. Gradual increases to the 6minute walking time occurred through
the study.
The fourth study 134 extended the
previous Phase I study 135 from 6
months to 12 months, and included
only 41 of the original 49 patients
continuing in the study. Of the 57
patients enrolled at the time of the
Phase I study, 41 were evaluated at the
12-month follow-up. Of the 41 patients
examined at 12 months, 78 percent had
diagnoses of CSA related to heart
failure, 2 percent had diagnoses of atrial
fibrillation with related CSA, 12 percent
had diagnoses of CSA related to other
cardiac etiology diagnoses, and the
remainder of patients had diagnoses of
CSA related to other noncardiac etiology
diagnoses. At 12 months, 6 sleep
parameters remained statistically
different and 3 were no longer
statistically significant. The HI, OAI,
and arousal indexes were no longer
statistically significantly different from
baseline values. A new parameter, time
spent with peripheral capillary oxygen
saturation (SpO2) below 90 percent was
not statistically different at 12 months
(31.4 minutes) compared to baseline
(38.2 minutes). The remaining 6
parameters showed maintenance of
improvements at the 12-month time
point as compared to the baseline: AHI
from 49.9 to 27.5 events per hour; CAI
from 28.2 to 6.0 events per hour; MAI
from 3.0 to 0.5 events per hour; ODI =
4 percent from 46.1 to 26.9 events per
hour; sleep efficiency from 69.3 percent
to 75.6 percent; and REM sleep from
11.4 percent to 17.1 percent. At the 3month, 6-month, and 12-month time
points, patient quality of life was
assessed to be 70.8 percent, 75.6
percent, and 83.0 percent, respectively,
indicating that patients experienced
mild, moderate, or marked
improvement. Seventeen patients were
followed at 18 months with statistical
differences from baseline for AHI and
CAI. Three patients died over the 12month follow-up period: 2 died of endstage heart failure and 1 died from
sudden cardiac death. All three deaths
134 Jagielski, D., Ponikowski, P., Augostini, R.,
Kolodziej, A., Khayat, R., & Abraham, W.T., 2016,
‘‘Transvenous Stimulation of the Phrenic Nerve for
the Treatment of Central Sleep Apnoea: 12 months’
experience with the remede®system,’’ European
Journal of Heart Failure, 2016, pp. 1–8.
135 Abraham, W., Jagielski, D., Oldenburg, O.,
Augostini, R., Kreuger, S., Kolodziej, A.,
Ponikowski, P., 2015, ‘‘Phrenic Nerve Stimulation
for the Treatment of Central Sleep Apnea,’’ JACC:
Heart Failure, 2015, vol. 3(5), pp. 360–369.
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Jkt 244001
were adjudicated by the DSMB and
none were related to the procedure or to
phrenic nerve stimulation therapy. Five
patients were found to have related
serious adverse events over the 12month study time. Three events were
previously described in the results
referenced in the published study,
Abraham, et al., and an additional 2
SAEs occurred during the 12-month
follow-up. One patient experienced
impending pocket perforation resulting
in pocket revision, and another patient
experienced lead failure.
The fifth study 136 was a randomized
control trial with a primary outcome of
achieving a reduction in AHI of 50
percent or greater from baseline to 6
months enrolling 151 patients with the
neurostimulation treatment (n=73) and
no stimulation control (n=78). Of the
total sample, 96 (64 percent) of the
patients had been diagnosed with heart
failure; 48 (66 percent) of the treated
patients had been diagnosed with heart
failure, and 48 (62 percent) of the
control patients had been diagnosed
with heart failure. Sixty-four (42
percent) of all of the patients included
in the study had been diagnosed with
atrial fibrillation and 84 (56 percent)
had been diagnosed with coronary
artery disease. All of the patients had
¯
been treated with the remede® System
device implanted; the system was
activated in the treatment group during
the first month. ‘‘Over about 12 weeks,
stimulation was gradually increased in
the treatment group until diaphragmatic
capture was consistently achieved
without disrupting sleep.’’ 137 While
patients and physicians were
unblinded, the polysomnography core
laboratory remained blinded. The perprotocol population from which
statistical comparisons were made is 58
¯
patients treated with the remede®
System and 73 patients in the control
group. The authors appropriately
controlled for Type I errors (false
positives), which arise from performing
multiple tests. Thirty-five treated
patients and 8 control patients met the
primary end point, the number of
patients with a 50 percent or greater
reduction in AHI from baseline; the
difference of 41 percent is statistically
significant. All seven of the secondary
endpoints were assessed and found to
have statistically significant difference
in change from baseline between groups
at the 6-month follow-up after
controlling for multiple comparisons:
136 Costanzo, M.R., Ponikowski, P., Javaheri, S.,
Augostini, R., Goldberg, L., Holcomb, R., Abraham,
W.T.,’’Transvenous Neurostimulation for Centra
Sleep Apnoea: A randomised controlled trial,’’
Lancet, 2016, vol. 388, pp. 974–982.
137 Ibid.
PO 00000
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Sfmt 4702
CAI of ¥22.8 events per hour lower for
the treatment group; AHI (continuous)
of ¥25.0 events per hour lower for the
treatment group; arousal events per hour
of ¥15.2 lower for the treatment group;
percent of sleep in REM of 2.4 percent
higher for the treatment group; patients
with marked or moderate improvement
in patient global assessment was 55
percent higher in the treatment group;
ODI = 4 percent was ¥22.7 events per
hour lower for the treatment group; and
the Epworth sleepiness scale was ¥3.7
lower for the treatment group. At 12
months, 138 (91 percent) of the patients
were free from device, implant, and
therapy related adverse events.
The final study data was from the
pivotal study with limited information
in the form of an abstract 138 and an
executive summary.139 The executive
summary detailed an exploratory
analysis of the 141 patients enrolled in
the pivotal trial which were patients
diagnosed with CSA. The abstract
indicated that the 141 patients from the
pivotal trial were randomized to either
the treatment arm (68 patients) in which
initiation of treatment began 1 month
¯
after implantation of the remede®
System device with a 6-month
follow-up period, or to the control group
arm (73 patients) in which the initiation
¯
of treatment with the remede® System
device was delayed for 6 months after
implantation. Randomization efficacy
was compared across baseline
polysomnography and associated
respiratory indices in which four of the
five measures showed no statistical
differences between those treated and
controls; treated patients had an average
MAI score of 3.1 as compared to control
patients with an average MAI score of
2.2 (p=0.029). Patients included in the
trial must have been medically stable, at
least 18 years old, have had an
electroencephalogram within 40 days of
scheduled implantation, had an apnoeahypopnoea index (AHI) of 20 events per
hour or greater, a central apnoea index
at least 50 percent of all apneas, and an
obstructive apnea index less than or
equal to 20 percent.140 Primary
exclusion criteria were CSA caused by
pain medication, heart failure of state D
from the American Heart Association, a
138 Goldberg, L., Ponikowski, P., Javaheri, S.,
Augostini, R., McKane, S., Holcomb, R., Costanzo,
M.R., ‘‘In Heart Failure Patients with Central Sleep
Apnea, Transvenous Stimulation of the Phrenic
Nerve Improves Sleep and Quality of Life,’’ Heart
Failure Society of America, 21st annual meeting.
2017.
139 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
140 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
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new implantable cardioverter
defibrillator, pacemaker dependent
subjects without any physiologic escape
rhythm, evidence of phrenic nerve
palsy, documented history of psychosis
or severe bipolar disorder, a
cerebrovascular accident within 12
months of baseline testing, limited
pulmonary function, baseline oxygen
saturation less than 92 percent while
awake and on room air, active infection,
need for renal dialysis, or poor liver
function.141 Patients included in this
trial were primarily male (89 percent),
white (95 percent), with at least one
comorbidity with cardiovascular
conditions being most prevalent (heart
failure at 64 percent), with a
concomitant implantable cardiovascular
stimulation device in 42 percent of
patients at baseline. The applicant
stated that, after randomization, there
were no statistically significant
differences between the treatment and
control groups, with the exception of
the treated group having a statistically
higher rate of events per hour on the
mixed apnea index (MAI) at baseline
than the control group.
The applicant asserted that the results
from the pivotal trial 142 allow for the
comparison of heart failure status in
patients; we note that patients with
American Heart Association objective
assessment Class D (Objective evidence
of severe cardiovascular disease. Severe
limitations. Experiences symptoms even
while at rest) were excluded from this
pivotal trial. The primary endpoint in
the pivotal trial was the proportion of
patients with an AHI reduction greater
than or equal to 50 percent at 6 months.
When controlling for heart failure
status, both treated groups experienced
a statistically greater proportion of
patients with AHI reductions than the
controls at 6 months (58 percent more
of treated patients with diagnoses of
heart failure and 35 percent more of
treated patients without diagnoses of
heart failure as compared to their
respective controls). The secondary
endpoints assessed were the CAI
average events per hour, AHI average
events per hour, arousal index (ArI)
average events per hour, percent of
sleep in REM, and oxygen desaturation
index 4 percent (ODI = 4 percent)
average events per hour. Excluding the
percent of sleep in REM, the treatment
groups for both patients with diagnoses
of heart failure and non-heart failure
conditions experienced statistically
greater improvements at 6 months on all
141 Ibid.
142 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
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secondary endpoints as compared to
their respective controls. Lastly, quality
of life secondary endpoints were
assessed by the Epworth sleepiness
scale (ESS) average scores and the
patient global assessment (PGA). For
both the ESS and PGA assessments,
both treatment groups of patients with
diagnoses of heart failure and non-heart
failure conditions had statistically
beneficial changes between baseline and
6 months as compared to their
respective control groups.
The applicant provided analyses from
the above report focusing on the
primary and secondary
polysomnography endpoints,
specifically, across patients who had
been diagnosed with CSA with heart
failure and non-heart failure. Eighty
patients included in the study from the
executive summary report had comorbid
heart failure, while 51 patients did not.
Of those patients with heart failure, 35
were treated while 45 patients were
controls. Of those patients without heart
failure, 23 were treated and 28 patients
were controls. The applicant did not
provide baseline descriptive statistical
comparisons between treated and
control groups controlling for heart
failure status. Across all primary and
secondary endpoints, the patient group
who were diagnosed with CSA and
comorbid heart failure experienced
statistically significant improvements.
Excepting percent of sleep in REM, the
patient group who were diagnosed with
CSA without comorbid heart failure
experienced statistically significant
improvements in all primary and
secondary endpoints. We are inviting
public comments on whether this
current study design is sufficient to
support substantial clinical
¯
improvement of the remede® System
with respect to all patient populations,
particularly the non-heart failure
population.
As previously noted, the applicant
also contends that the technology offers
a treatment option for a patient
population unresponsive to, or
ineligible for, currently available
treatment options. Specifically, the
¯
applicant stated that the remede®
System is the only treatment option for
patients who have been diagnosed with
moderate to severe CSA; published
studies on positive pressure treatments
like CPAP and ASV have not met
primary endpoints; and there was an
increase in cardiovascular mortality
according to the ASV study. According
to the applicant, approximately 40
percent of patients who have been
diagnosed with CSA have heart failure.
The applicant asserted that the use of
¯
the remede System not only treats and
PO 00000
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Sfmt 4702
20313
improves the symptoms of CSA, but
there is evidence of reverse remodeling
in patients with reduced left ventricular
ejection fraction (LVEF).
¯
We are concerned that the remede®
System is not directly compared to the
CPAP or ASV treatment options, which,
to our understanding, are the current
treatment options available for patients
who have been diagnosed with CSA
without heart failure. We note that the
FDA indication for the implantation of
¯
the remede® System is for use in the
treatment of adult patients who have
been diagnosed with CSA. We also note
that the applicant’s supporting studies
were directed primarily at patients who
¯
had been treated with the remede®
System who also had been diagnosed
with heart failure. The applicant
asserted that it would not be appropriate
to use CPAP and ASV treatment options
when comparing CPAP and ASV to the
¯
remede® System in the patient
population of heart failure diagnoses
because these treatment options have
been found to increase mortality
outcomes in this population. In light of
the limited length of time in which the
¯
remede® System has been studied, we
are concerned that any claims on
mortality as they relate to treatment
¯
involving the use of the remede®
System may be limited. Therefore, we
are concerned as to whether there is
sufficient data to determine that the
technology represents a substantial
clinical improvement with respect to
patients who have been diagnosed with
CSA without heart failure.
The applicant has shown that, among
the subpopulation of patients who have
been diagnosed with CSA and heart
¯
failure, the remede® System decreases
morbidity outcomes as compared to the
CPAP and ASV treatment options. We
understand that not all patients
evaluated in the applicant’s supporting
clinical trials had been diagnosed with
CSA with a comorbidity of heart failure.
However, in all of the supporting
studies for this application, the vast
majority of study patients did have this
specific comorbidity of CSA and heart
failure. Of the three studies which
enrolled both patients diagnosed with
CSA with and without heart
failure,143 144 145 146 only two studies
143 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
144 Costanzo, M.R., Ponikowski, P., Javaheri, S.,
Augostini, R., Goldberg, L., Holcomb, R., Abraham,
W.T., ‘‘Transvenous Neurostimulation for Centra
Sleep Apnoea: A randomised controlled trial,’’
Lancet, 2016, vol. 388, pp. 974–982.
145 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
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performed analyses controlling for heart
failure status.147 148 The data from these
two studies, the Costanzo, et al. (2016)
and the Respicardia, Inc. executive
report, are analyses based on the same
pivotal trial data and, therefore, do not
provide results from two separate
samples. Descriptive comparisons are
made in the executive summary of the
pivotal trial 149 between all treated and
control patients. However, we are
unable to determine the similarities and
differences between patients with heart
failure and non-heart failure treated
versus controlled groups. Because
randomization resulted in one
difference between the overall treated
and control groups (MAI events per
hour), it is possible that further failures
of randomization may have occurred
when controlling for heart failure status
in unmeasured variables. Finally, the
sample size analyzed and the subsample
sizes of the heart failure patients (80)
and non-heart failure patients (51) are
particularly small. It is possible that
these results are not representative of
the larger population of patients who
have been diagnosed with CSA.
Therefore, we are concerned that
differences in morbidity and mortality
outcomes between CPAP, ASV, and the
¯
remede® System in the general CSA
patient population have not adequately
been tested or compared. Specifically,
the two patient populations, those who
have been diagnosed with heart failure
and CSA versus those who have been
diagnosed with CSA alone, may
experience different symptoms and
outcomes associated with their disease
processes. Patients who have been
diagnosed with CSA alone present with
excessive sleepiness, poor sleep quality,
insomnia, poor concentration, and
inattention.150 Conversely, patients who
have been diagnosed with the comorbid
conditions of CSA as a result of heart
146 Jagielski, D., Ponikowski, P., Augostini, R.,
Kolodziej, A., Khayat, R., & Abraham, W.T.,
‘‘Transvenous Stimulation of the Phrenic Nerve for
the Treatment of Central Sleep Apnoea: 12 months’
experience with the remede®system,’’ European
Journal of Heart Failure, 2016, pp. 1–8.
147 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
148 Costanzo, M.R., Ponikowski, P., Javaheri, S.,
Augostini, R., Goldberg, L., Holcomb, R., Abraham,
W.T., ‘‘Transvenous Neurostimulation for Centra
Sleep Apnoea: A randomised controlled trial,’’
Lacet, 2016, vol. 388, pp. 974–982.
149 Respicardia, Inc. (n.d.). Remede System
Pivotal Trial. https://clinicaltrials.gov/ct2/show/
NCT01816776.
150 Badr, M.S., 2017, Dec 11, ‘‘Central sleep
apnea: Risk factors, clinical presentation, and
diagnosis,’’ Available at: https://
www.uptodate.com/contents/central-sleep-apnearisk-factors-clinical-presentation-anddiagnosis?csi=d3a535e6–1cca-4cd5-ab5e50e9847bda6c&source=contentShare.
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failure experience significant
cardiovascular insults resulting from
sympathetic nervous system activation,
pulmonary hypertension, and
arrhythmias, which ultimately
contribute to the downward cycle of
heart failure.151
We also note that the clinical study
had a small patient population (n=151),
with follow-up for 6 months. We are
interested in longer follow-up data that
would further validate the points made
by the applicant regarding the beneficial
outcomes seen in patients who have
been diagnosed with CSA who have
¯
been treated using the remede® System.
We also are interested in additional
information regarding the possibility of
electrical stimulation of unintended
targets and devices combined with the
possibility of interference from outside
devices. Furthermore, we are unsure
with regard to the longevity of the
implanted device, batteries, and leads
because it appears that the technology is
meant to remain in use for the
remainder of a patient’s life. We are
inviting public comments on whether
¯
the remede® System represents a
substantial clinical improvement over
existing technologies.
We did not receive any public
comments in response to the published
notice in the Federal Register regarding
the substantial clinical improvement
¯
criterion for the remede® System or at
the New Technology Town Hall
Meeting.
f. Titan Spine nanoLOCK® (Titan Spine
nanoLOCK® Interbody Device)
Titan Spine submitted an application
for new technology add-on payments for
the Titan Spine nanoLOCK® Interbody
Device (the Titan Spine nanoLOCK®)
for FY 2019. (We note that the applicant
previously submitted an application for
new technology add-on payments for
this device for FY 2017.) The Titan
Spine nanoLOCK® is a nanotechnologybased interbody medical device with a
dual acid-etched titanium interbody
system used to treat patients diagnosed
with degenerative disc disease (DDD).
One of the key distinguishing features of
the device is the surface manufacturing
technique and materials, which produce
macro, micro, and nano-surface
textures. According to the applicant, the
combination of surface topographies
enables initial implant fixation, mimics
an osteoclastic pit for bone growth, and
produces the nano-scale features that
interface with the integrins on the
151 Abraham, W., Jagielski, D., Oldenburg, O.,
Augostini, R., Kreuger, S., Kolodziej, A.,
Ponikowski, P., ‘‘Phrenic Nerve Stimulation for the
Treatment of Central Sleep Apnea,’’ JACC: Heart
Failure, 2015, vol. 3(5), pp. 360–369.
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outside of the cellular membrane.
Further, the applicant noted that these
features generate better osteogenic and
angiogenic responses that enhance bone
growth, fusion, and stability. The
applicant asserted that the Titan Spine
nanoLOCK®’s clinical features also
reduce pain, improve recovery time, and
produce lower rates of device
complications such as debris and
inflammation.
On October 27, 2014, the Titan Spine
nanoLOCK® received FDA clearance for
the use of five lumbar interbody devices
and one cervical interbody device: The
nanoLOCK® TA—Sterile Packaged
Lumbar ALIF Interbody Fusion Device
with nanoLOCK® surface, available in
multiple sizes to accommodate
anatomy; the nanoLOCK® TAS—Sterile
Packaged Lumbar ALIF Stand Alone
Interbody Fusion Device with
nanoLOCK® surface, available in
multiple sizes to accommodate
anatomy; the nanoLOCK® TL—Sterile
Packaged Lumbar Lateral Approach
Interbody Fusion Device with
nanoLOCK® surface, available in
multiple sizes to accommodate
anatomy; the nanoLOCK® TO—Sterile
Packaged Lumbar Oblique/PLIF
Approach Interbody Fusion Device with
nanoLOCK® surface, available in
multiple sizes to accommodate
anatomy; the nanoLOCK® TT—Sterile
Packaged Lumbar TLIF Interbody
Fusion Device with nanoLOCK®
surface, available in multiple sizes to
accommodate anatomy; and the
nanoLOCK® TC—Sterile Packaged
Cervical Interbody Fusion Device with
nanoLOCK® surface, available in
multiple sizes to accommodate
anatomy.
The applicant received FDA clearance
on December 14, 2015, for the
nanoLOCK® TCS— Sterile Package
Cervical Stand Alone Interbody Fusion
Device with nanoLOCK® surface,
available in multiple sizes to
accommodate anatomy. According to
the applicant, July 8, 2016 was the first
date that the nanotechnology
production facility completed
validations and clearances needed to
manufacture the nanoLOCK® interbody
fusion devices. Once validations and
clearances were completed, the
technology was available on the U.S.
market on October 1, 2016. Therefore,
the applicant believes that the newness
period for nanoLOCK® would begin on
October 1, 2016. Procedures involving
the Titan Spine nanoLOCK® technology
can be identified by the following ICD–
10–PCS Section ‘‘X’’ New Technology
codes:
• XRG0092 (Fusion of occipitalcervical joint using nanotextured
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surface interbody fusion device, open
approach);
• XRG1092 (Fusion of cervical
vertebral joint using nanotextured
surface interbody fusion device, open
approach);
• XRG2092 (Fusion of 2 or more
cervical vertebral joints using
nanotextured surface interbody fusion
device, open approach);
• XRG4092 (Fusion of cervicothoracic
vertebral joint using nanotextured
surface interbody fusion device, open
approach);
• XRG6092 (Fusion of thoracic
vertebral joint using nanotextured
surface interbody fusion device, open
approach);
• XRG7092 (Fusion of 2 to 7 thoracic
vertebral joints using nanotextured
surface interbody fusion device, open
approach);
• XRG8092 (Fusion of 8 or more
thoracic vertebral joints using
nanotextured surface interbody fusion
device, open approach);
• XRGA092 (Fusion of thoracolumbar
vertebral joint using nanotextured
surface interbody fusion device, open
approach);
• XRGB092 (Fusion of lumbar
vertebral joint using nanotextured
surface interbody fusion device, open
approach);
• XRGC092 (Fusion of 2 or more
lumbar vertebral joints using
nanotextured surface interbody fusion
device, open approach); and
• XRGD092 (Fusion of lumbosacral
joint using nanotextured surface
interbody fusion device, open
approach).
We note that the applicant expressed
concern that interbody fusion devices
that have failed to gain or apply for FDA
clearance with nanoscale features could
confuse health care providers with
marketing and advertising using terms
related to nanotechnology and
ultimately adversely affect patient
outcomes. Therefore, the applicant
believed that there is a need for
additional clarity to the current ICD–10–
PCS Section ‘‘X’’ codes previously
identified for health care providers
regarding interbody fusion nanotextured
surface devices. The applicant
submitted a request for code revisions at
the March 2018 ICD–10 Coordination
and Maintenance Meeting regarding the
ICD–10–PCS Section ‘‘X’’ New
Technology codes used to identify
procedures involving the Titan Spine
nanoLOCK® technology.
As discussed previously, if a
technology meets all three of the
substantial similarity criteria, it would
be considered substantially similar to an
existing technology and would not be
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considered ‘‘new’’ for the purposes of
new technology add-on payments. We
note that the substantial similarity
discussion is applicable to both the
lumbar and the cervical interbody
devices because all of the devices use
the Titan Spine nanoLOCK®
technology.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, the applicant
stated that, for both interbody devices
(the lumbar and the cervical interbody
device), the Titan Spine nanoLOCK®’s
surface stimulates osteogenic cellular
response to assist in bone formation
during fusion. According to the
applicant, the mechanism of action
exhibited by the Titan Spine’s
nanoLOCK® surface technology
involves the ability to create surface
features that are meaningful to cellular
regeneration at the nano-scale level.
During the manufacturing process, the
surface produces macro, micro, and
nano-surface textures. The applicant
believes that this unique combination
and use of these surface topographies
represents a new approach to
stimulating osteogenic cellular
response. The applicant further asserted
that the macro-scale textured features
are important for initial implant
fixation; the micro-scale textured
features mimic an osteoclastic pit for
supporting bone growth; and the nanoscale textured features interface with the
integrins on the outside of the cellular
membrane, which generates the
osteogenic and angiogenic (mRNA)
responses necessary to promote healthy
bone growth and fusion. The applicant
stated that when correctly
manufactured, an interbody fusion
device includes a hierarchy of complex
surface features, visible at different
levels of magnification, that work
collectively to impact cellular response
through mechanical, cellular, and
biochemical properties. The applicant
stated that Titan Spine’s proprietary and
unique surface technology, the Titan
Spine nanoLOCK® interbody devices,
contain optimized nano-surface
characteristics, which generate the
distinct cellular responses necessary for
improved bone growth, fusion, and
stability. The applicant further stated
that the Titan Spine nanoLOCK®’s
surface engages with the strongest
portion of the vertebral endplate, which
enables better resistance to subsidence
because a unique dual acid-etched
titanium surface promotes earlier bone
in-growth. According to the applicant,
the Titan Spine nanoLOCK®’s surface is
created by using a reductive process of
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the titanium itself. The applicant
asserted that use of the Titan Spine
nanoLOCK® significantly reduces the
potential for debris generated during
impaction when compared to treatments
using Polyetheretherketone (PEEK)based implants coated with titanium.
According to the results of an in vitro
study 152 (provided by the applicant),
which examined factors produced by
human mesenchymal stem cells on
spine implant materials that compared
angiogenic factor production using
PEEK-based versus titanium alloy
surfaces, osteogenic production levels
were greater with the use of rough
titanium alloy surfaces than the levels
produced using smooth titanium alloy
surfaces. Human mesenchymal stem
cells were cultured on tissue culture
polystyrene, PEEK, smooth TiAlV, or
macro-/micro-/nanotextured rough
TiAlV (mmnTiAlV) disks. Osteoblastic
differentiation and secreted
inflammatory interleukins were
assessed after 7 days. The results of an
additional study 153 provided by the
applicant examined whether
inflammatory microenvironment
generated by cells as a result of use of
titanium aluminum-vanadium (Ti-alloy,
TiAlV) surfaces is effected by surface
micro-texture, and whether it differs
from the effects generated by PEEKbased substrates. This in vitro study
compared angiogenic factor production
and integrin gene expression of human
osteoblast-like MG63 cells cultured on
PEEK or titanium-aluminum vanadium
(titanium alloy). Based on these study
results, the applicant asserted that the
use of micro-textured surfaces has
demonstrated greater promotion of
osteoblast differentiation when
compared to use of PEEK-based
surfaces.
The applicant maintains that the
nanoLOCK® was the first, and remains
the only, device in spinal fusion, to
apply for and successfully obtain a
clearance for nanotechnology from the
FDA. According to the applicant, in
order for a medical device to receive a
nanotechnology FDA clearance, the
burden of proof includes each of the
following to be present on the medical
device in question: (1) Proof of specific
nano scale features, (2) proof of
capability to manufacture nano-scale
features with repeatability and
documented frequency across an entire
152 Olivares-Navarrete, R., Hyzy, S., Gittens, R.,
‘‘Rough Titanium Alloys Regulate Osteoblast
Production of Angiogenic Factors,’’ The Spine
Journal, 2013, vol. 13(11), pp. 1563–1570.
153 Olivares-Navarrete, R., Hyzy, S., Slosar, P., et
al., ‘‘Implant Materials Generate Different Periimplant Inflammatory Factors,’’ SPINE, 2015, vol.
40(6), pp. 339–404.
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device, and (3) proof that those nanoscale features provide a scientific
benefit, not found on devices where the
surface features are not present. The
applicant further stated that many of the
commercially available interbody fusion
devices are created using additive
manufacturing processes to mold or
build surface from the ground up.
Conversely, Titan Spine applied a
subtractive surface manufacturing to
remove pieces of a surface. The surface
features that remain after this
subtractive process generate features
visible at magnifications that additive
manufacturing has not been able to
produce. According to the applicant,
this subtractive process has been
validated by the White House Office of
Science and Technology, the National
Nanotechnology Initiative, and the FDA
that provide clearances to products that
exhibit unique and repeatable features
at predictive frequency due to a
manufacturing technique.
With regard to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, cases
representing patients that may be
eligible for treatment involving the
Titan Spine nanoLOCK® technology
would map to the same MS–DRGs as
other (lumbar and cervical) interbody
devices currently available to Medicare
beneficiaries and also are used for the
treatment of patients who have been
diagnosed with DDD (lumbar or
cervical).
With regard to the third criterion,
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, the applicant
stated that the Titan Spine nanoLOCK®
can be used in the treatment of patients
who have been diagnosed with similar
types of diseases, such as DDD, and for
a similar patient population receiving
treatment involving both lumbar and
cervical interbody devices.
In summary, the applicant maintained
that the Titan Spine nanoLOCK®
technology has a different mechanism of
action when compared to other spinal
fusion devices. Therefore, the applicant
did not believe that the Titan Spine
nanoLOCK® technology is substantially
similar to existing technologies.
We are concerned that the Titan Spine
nanoLOCK® interbody devices may be
substantially similar to currently
available titanium interbody devices
because other roughened-surface
interbody devices also stimulate bone
growth. While there is a uniqueness to
the nanotechnology used by the
applicant, other devices also stimulate
bone growth such as PEEK-based
surfaces and, therefore, we remain
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concerned that the Titan Spine
nanoLOCK® interbody devices use the
same or similar mechanism of action as
other devices.
We are inviting public comments on
whether the Titan Spine nanoLOCK®
interbody devices are substantially
similar to existing technologies and
whether these devices meet the newness
criterion.
The applicant provided three analyses
of claims data from the FY 2016
MedPAR file to demonstrate that the
Titan Spine nanoLOCK® interbody
devices meet the cost criterion. We note
that cases reporting procedures
involving lumbar and cervical interbody
devices would map to different MS–
DRGs. As discussed in the Inpatient
New Technology Add-On Payment
Final Rule (66 FR 46915), two separate
reviews and evaluations of the
technologies are necessary in this
instance because cases representing
patients receiving treatment for
diagnoses associated with lumbar
procedures that may be eligible for use
of the technology under the first
indication would not be expected to be
assigned to the same MS–DRGs as cases
representing patients receiving
treatment for diagnoses associated with
cervical procedures that may be eligible
for use of the technology under the
second indication. Specifically, cases
representing patients who have been
diagnosed with lumbar DDD and who
have received treatment that involved
implanting a lumbar interbody device
would map to MS–DRG 028 (Spinal
Procedures with MCC), MS–DRG 029
(Spinal Procedures with CC or Spinal
Neurostimulators), MS–DRG 030 (Spinal
Procedures without CC/MCC), MS–DRG
453 (Combined Anterior/Posterior
Spinal Fusion with MCC), MS–DRG 454
(Combined Anterior/Posterior Spinal
Fusion with CC), MS–DRG 455
(Combined Anterior/Posterior Spinal
Fusion without CC/MCC), MS–DRG 456
(Spinal Fusion Except Cervical with
Spinal Curvature or Malignancy or
Infection or Extensive Fusions with
MCC), MS–DRG 457 (Spinal Fusion
Except Cervical with Spinal Curvature
or Malignancy or Infection or Extensive
Fusion without MCC), MS–DRG 458
(Spinal Fusion Except Cervical with
Spinal Curvature or Malignancy or
Infection or Extensive Fusions without
CC/MCC), MS–DRG 459 (Spinal Fusion
Except Cervical with MCC), and MS–
DRG 460 (Spinal Fusion Except Cervical
without MCC). Cases representing
patients who have been diagnosed with
cervical DDD and who have received
treatment that involved implanting a
cervical interbody device would map to
MS–DRG 471 (Cervical Spinal Fusion
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with MCC), MS–DRG 472 (Cervical
Spinal Fusion with CC), and MS–DRG
473 (Cervical Spinal Fusion without CC/
MCC). Procedures involving the
implantation of lumbar and cervical
interbody devices are assigned to
separate MS–DRGs. Therefore, the
devices categorized as lumbar interbody
devices and the devices categorized as
cervical interbody devices must
distinctively (each category) meet the
cost criterion and the substantial
clinical improvement criterion in order
to be eligible for new technology add-on
payments beginning in FY 2019.
The first analysis searched for any of
the ICD–10–PCS procedure codes
within the code series Lumbar—0SG
[body parts 0 1 3] [open approach only
0] [device A only] [anterior column only
0, J], which typically are assigned to
MS–DRGs 028, 029, 030, and 453
through 460. The average case-weighted
unstandardized charge per case was
$153,005. The applicant then removed
charges related to the predicate
technology and then standardized the
charges. The applicant then applied an
inflation factor of 1.09357, the value
used in the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38527) to update the
charges from FY 2016 to FY 2018. The
applicant added charges related to the
Titan Spine nanoLOCK® lumbar
interbody devices. This resulted in a
final inflated average case-weighted
standardized charge per case of
$174,688, which exceeds the average
case-weighted Table 10 MS–DRG
threshold amount of $83,543.
The second analysis searched for any
of the ICD–10–PCS procedure codes
within the code series Cervical—0RG
[body parts 0—A] [open approach only
0] [device A only] [anterior column only
0, J], which typically are assigned to
MS–DRGs 028, 029, 030, 453 through
455, and 471 through 473. The average
case-weighted unstandardized charge
per case was $88,034. The methodology
used in the first analysis was used for
the second analysis, which resulted in
a final inflated average case-weighted
standardized charge per case of
$101,953, which exceeds the average
case-weighted Table 10 MS–DRG
threshold amount of $83,543.
The third analysis was a combination
of the first and second analyses
described earlier that searched for any
of the ICD–10–PCS procedure codes
within the Lumbar and Cervical code
series listed above that are assigned to
the MS–DRGs in the analyses above.
The average case-weighted
unstandardized charge per case was
$127,736. The methodology used for the
first and second analysis was used for
the third analysis, which resulted in a
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final inflated average case-weighted
standardized charge per case of
$149,915, which exceeds the average
case-weighted Table 10 MS–DRG
threshold amount of $104,094.
Because the final inflated average
case-weighted standardized charge per
case exceeds the average case-weighted
threshold amount in all of the
applicant’s analyses, the applicant
maintained that the technology meets
the cost criterion.
We are inviting public comments on
whether the Titan Spine nanoLOCK®
meets the cost criterion.
With regard to the substantial clinical
improvement criterion for the Titan
Spine nanoLOCK® Interbody Lumbar
and Cervical Devices, the applicant
submitted the results of two clinical
evaluations. The first clinical evaluation
was a case series and the second was a
case control study. Regarding the case
series, 4 physicians submitted clinical
information on 146 patients. The 146
patients resulted from 2 surgery groups:
a cervical group of 73 patients and a
lumbar group of 73 patients. The
division into cervical and lumbar
groups was due to differences in
surgical procedure and expected
recovery time. Subsequently, the
collection and analyses of data were
presented for lumbar and cervical
nanoLOCK® device implants. Data was
collected using medical record review.
Patient baseline characteristics, the
reason for cervical and lumbar surgical
intervention, inclusion and exclusion
criteria, details on the types of pain
medications and the pattern of usage
preoperatively and postoperatively were
not provided. We note that the applicant
did not provide an explanation of why
the outcomes studied in the case series
were chosen for review. However, the
applicant noted that the case series data
were restricted to patients treated with
the Titan Spine nanoLOCK® device,
with both retrospective and prospective
data collection. These data appeared to
be clinically related and included: (1)
Pain medication usage; (2) extremity
and back pain (assessed using the
Numeric Pain Rating Scale (NPRS)); and
(3) function (assessed using the
Oswestry Disability Index (ODI)).
Clinical data collection began with time
points defined as ‘‘Baseline (preoperation), Month 1 (0–4 weeks), Month
2 (5–8 weeks), Month 3 (9–12 weeks),
Month 4 (13–16 weeks), Month 5 (17–
20 weeks) and Month 6+ (>20 weeks)’’.
The n, mean, and standard deviation
were presented for continuous variables
(NPRS extremity pain, back pain, and
ODI scores), and the n and percentage
were presented for categorical variables
(subjects taking pain medications). All
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analyses compared the time point (for
example, Month 1) to the baseline.
Pain scores for extremities (leg and
arm) were assessed using the NPRS, an
11-category ordinal scale where 0 is the
lowest value and 10 is the highest value
and, therefore, higher scores indicate
more severe pain. Of the 73 patients in
the lumbar group, the applicant
presented data on 18 cases for leg or arm
pain at baseline that had a mean score
of 6.4, standard deviation (SD) 2.3.
Between Month 1 and Month 6+ the
number of lumbar patients for which
data was submitted for leg or arm pain
ranged from 3 patients (Month 5, mean
score 3.7, SD 3.5) to 15 patients (Month
6+, mean score 2.5, SD 2.4), with
varying numbers of patients for each of
the other defined time points of Month
1 through Month 4. None of the defined
time points of Month 1 through Month
4 had more than 14 patients or less than
3 patients that were assessed.
Of the 73 patients in the cervical
group, 7 were assessed for leg or arm
pain at baseline and had a mean score
of 5.1, SD 3.5. Between Month 1 and
Month 6+ the number of cervical
patients assessed for leg or arm pain
ranged from 0 patients (Month 5, no
scores) to 5 patients (Month 1, mean
score 4.2, SD 2.6), with varying numbers
of patients for each of the other defined
time points of Month 1 through Month
4. None of the defined time points of
Month 1 through Month 4 had more
than 5 patients or less than 2 patients
that were assessed.
Back pain scores were also assessed
using the NPRS, where 0 is the lowest
value and 10 is the highest value and,
therefore, higher scores indicate more
severe pain. Of the 73 patients in the
lumbar group, 66 were assessed for back
pain at baseline and had a mean score
of 7.9, SD 1.8. Between Month 1 and
Month 6+ the number of lumbar
patients assessed for back pain ranged
from 4 patients (Month 5, mean score
4.0, SD 2.7) to 43 patients (Month 1,
mean score 4.5, SD 2.7), with varying
numbers of patients for each defined
time point.
Of the 73 patients in the cervical
group, 71 were assessed for back pain at
baseline and had a mean score of 7.5,
SD 2.3. Between Month 1 and Month 6+
the number of cervical patients assessed
for back pain ranged from 2 patients
(Month 5, mean score 7.0, SD 2.8) to 47
patients (Month 1, mean score 4.4, SD
2.9), with varying numbers of patients
for each defined time point.
Function was assessed using the ODI,
which ranges from 0 to 100, with higher
scores indicating increased disability/
impairment. Of the 73 patients in the
lumbar group, 59 were assessed for ODI
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scores at baseline and had a mean score
of 52.5, SD 18.7. Between Month 1 and
Month 6+ the number of lumbar
patients assessed for ODI scores ranged
from 3 patients (Month 5, mean score
33.3, SD 19.8) to 38 patients (Month 1,
mean score 48.1, SD 19.7), with varying
numbers of patients for each defined
time point. Of the 73 patients in the
cervical group, 56 were assessed for ODI
scores at baseline and had a mean score
of 53.6, SD 18.2. Between Month 1 and
Month 6+ the number of cervical
patients assessed for ODI score ranged
from 1 patient (Month 5, mean score 80,
no SD noted) to 41 patients (Month 1,
mean score 48.6, SD 20.5), with varying
numbers of patients for each defined
time point.
The percentages of patients not taking
pain medicines per day for the lumbar
and cervical groups over time were
assessed. Of the 73 patients in the
lumbar group, 69 were assessed at
baseline and 27.5 percent of the 69
patients were not taking pain
medication. Between Month 1 and
Month 6+ the number of lumbar
patients assessed for not taking pain
medicines ranged from 5 patients
(Month 5, 80 percent were not taking
pain medicines) to 46 patients (Month 1,
54.3 percent were not taking pain
medicines), with varying numbers of
patients for each defined time point. Of
the 73 patients in the cervical group, 72
were assessed and 22.2 percent of the 72
patients were not taking pain medicines
at baseline. Between Month 1 and
Month 6+ the number of cervical
patients assessed for not taking pain
medicines ranged from 2 patients
(Month 5, 100 percent were not taking
pain medicines) to 50 patients (Month 1,
70 percent were not taking pain
medicines), with varying numbers of
patients for each defined time point.
According to the applicant, both the
lumbar and cervical groups showed a
trend of improvement in all four clinical
outcomes over time for which they
collected data in their case series.
However, the applicant also indicated
that the trend was difficult to assess due
to the relatively limited number of
subjects with available assessments
more than 4 months post-implant. The
applicant shared that it had missing
values for over 80 percent of the
subjects in the study after the 4th postoperative month. According to the
applicant and its results of the clinical
evaluation, which was based on data
from less than 20 percent of subjects,
there was a statistically significant
reduction in back pain for nanoLOCK®
patients from ‘‘Baseline,’’ based on
improvement at earlier than standard
time points.
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We are concerned that the small
sample size of patients assessed at each
timed follow-up point for each of the
clinical outcomes evaluated in the case
series limits our ability to draw
meaningful conclusions from these
results. The applicant provided t-test
results for the lumbar and cervical
groups assessed for pain (back, leg, and
arm). We are concerned that the t-test
resulting from small sample sizes (for
example, 2 of 73 patients in Month 5,
and 5 of 73 patients in Month 6+) does
not indicate a statistically meaningful
improvement in pain scores.
Based on the results of the case series
provided by the applicant, we are
unable to determine whether the
findings regarding extremity and back
pain, ODI scores, and percentage of
subjects not taking pain medication for
patients who received treatment
involving the Titan Spine nanoLOCK®
devices represent a substantial clinical
improvement due to the inconsistent
sample size over time across both
treatment arms in all evaluated outcome
measures. The quantity of missing data
in this case series, along with the lack
of explanation for the missing data,
raises concerns for the interpretation of
these results. We also are unable to
determine based on this case series
whether there were improvements in
extremity pain and back pain, ODI
scores, and percentage of subjects not
taking pain medicines for patients who
received treatment involving the Titan
Spine nanoLOCK® devices versus
conventional and other intervertebral
body fusion devices, as there were no
comparisons to current therapies. As
noted above, the applicant did not
provide an explanation of why the
outcomes studied in the case series were
chosen for review. Therefore, we believe
that we may have insufficient
information to determine if the
outcomes studied in the case series are
validated proxies for evidence that the
nanoLOCK®’s surface promotes greater
osteoblast differentiation when
compared to use of PEEK-based
surfaces. We are inviting public
comments regarding our concerns,
including with respect to why the
outcomes studied in the case series were
chosen for review.
The applicant’s second clinical
evaluation was a case-control study
with a 1:5 case control ratio. The
applicant used deterministically linked,
de-identified, individual-level health
care claims, electronic medical records
(EMR), and other data sources to
identify 70 cases and 350 controls for a
total sample size of 420 patients. The
applicant also identified OM1TM data
source and noted that the OM1TM data
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source reflects data from all U.S. States
and territories and is representative of
the U.S. national population. The
applicant used OM1TM data between
January 2016 and June 2017, and
specifically indicated that these data
contain medical and pharmacy claims
information, laboratory data, vital signs,
problem lists, and other clinical details.
The applicant indicated that cases were
selected using the ICD–10–PCS Section
‘‘X’’ New Technology codes listed above
and controls were chosen from fusion
spine procedures (Fusion Spine
Anterior Cervical, Fusion Spine
Anterior Cervical and Discectomy,
Fusion Spine Anterior Posterior
Cervical, Fusion Spine Transforaminal
Interbody Lumbar, Fusion Spine
Cervical Thoracic, Fusion Spine
Transforaminal Interbody Lumbar with
Navigation, and Fusion Spine
Transforaminal Interbody Lumber
Robot-Assisted). Further, the applicant
stated that cases and controls were
matched by age (within 5 years), year of
surgery, Charlson Comorbidity Index,
and gender. According to the applicant,
regarding clinical outcomes studied,
unlike the case series, the case-control
study captured Charlson Comorbidity
Index, the average length of stay
(ALOS), and 30-day unplanned
readmissions; like the case series, this
case-control study captured the use of
pain medications by assessing the
cumulative post-surgical opioid use.
The mean age for all patients in the
study was 55 years old, and 47 percent
were male. For the clinical length of
stay outcome, the applicant noted that
the mean length of stay was slightly
longer among control patients, 3.9 days
(SD = 5.4) versus 3.2 days (SD = 2.9) for
cases, and a larger proportion of patients
in the control group had lengths of stay
equal to or longer than 5 days (21
percent versus 17 percent). Three
control patients (0.8 percent) were
readmitted within 30 days compared to
zero readmissions among case patients.
A slightly lower proportion of case
patients were on opioids 3 months postsurgery compared to control patients (15
percent versus 16 percent).
We are concerned that there may be
significant outliers not identified in the
case and control arms because for the
mean length of stay outcome, the
standard deviation for control patients
(5.4 days) is larger than the point
estimate (3.9 days). Based on the results
of this clinical evaluation provided by
the applicant, we are unable to
determine whether the findings
regarding lengths of stay and cumulative
post-surgical opioid use for patients
who received treatment involving the
nanoLOCK® devices versus
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conventional intervertebral body fusion
devices represent a substantial clinical
improvement. Without further
information on selection of controls and
whether there were adjustments in the
statistical analyses controlling for
confounding factors (for example, cause
of back pain, level of experience of the
surgeon, BMI and length of pain), we are
concerned that the interpretation of the
results may be limited. Finally, we are
concerned that the current data does not
adequately support a strong association
between the outcome measures of length
of stay, readmission rates, and use of
opioids and the use of nano-surface
textures in the manufacturing of the
Titan Spine nanoLOCK® device. For
these reasons, we are concerned that the
current data do not support a substantial
clinical improvement over the currently
available devices used for lumbar and
cervical DDD treatment.
We note that the applicant indicated
its intent to submit the results of
additional ongoing studies to support
the evidence of substantial clinical
improvement over existing technologies
for patients who receive treatment
involving the nanoLOCK® devices
versus patients receiving treatment
involving other interbody fusion
devices. We are inviting public
comments on whether the Titan Spine
nanoLOCK® meets the substantial
clinical improvement criterion.
Below we summarize and respond to
written public comments received
regarding the nanoLOCK® during the
open comment period in response to the
New Technology Town Hall meeting
notice published in the Federal
Register.
Comment: One commenter focused on
two items related to the substantial
clinical improvement and the lack of
real-world evidence and published
studies regarding the nanoLOCK®
technologies. The first item referenced
by the commenter related to CMS’
concern presented in the FY 2017 IPPS/
LTCH PPS final rule that the results of
the in vitro studies that the applicant for
the nanoLOCK® technology relied upon
in its application may not have
necessarily correlated with the clinical
results specified by the applicant.
Specifically, because at that time the
applicant had only conducted in vitro
studies, without obtaining any clinical
data from live patients during a specific
clinical trial, CMS stated that it was
unable to substantiate the clinical
results that the applicant believed the
technology achieved from a clinical
standpoint based on the results of the
studies provided. As a result, CMS
stated that it was concerned that the
results of the studies provided by the
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applicant did not demonstrate that the
Titan Spine nanoLOCK® technologies
met the substantial clinical
improvement criterion. The commenter
also indicated that it believed the
applicant has yet to publish data that
would satisfy the concerns CMS noted
in the FY 2017 IPPS/LTCH PPS final
rule. In addition, the commenter noted
that the applicant suggested that the
health care community has started to
move away from randomized controlled
trials toward real-world evidence, and
then presented claims analyses that
attempted to link any assumed
substantial clinical improvement in
patient outcomes from fusion surgery to
the nanoLOCK® technology. In
response to this assertion, the
commenter stated that without a
randomized controlled study of this
technology as compared to the standard
of care or, as CMS noted in FY 2017,
clinical data from live patients during a
specific clinical trial, these links cannot
be scientifically substantiated. The
commenter also noted that none of the
studies presented during the February
13, 2018 New Technology Town Hall
meeting appear to be published at this
time, which would subject them to a
rigorous peer-reviewed process. The
commenter continued to support CMS’
concern previously expressed in the FY
2017 IPPS/LTCH PPS final rule
regarding whether substantial clinical
improvement has been demonstrated.
The second item of focus referenced
by the commenter was also presented by
CMS in the FY 2017 IPPS/LTCH PPS
final rule. The commenter noted that
there are other titanium surfaced
devices currently available on the U.S.
market. In the FY 2017 IPPS/LTCH PPS
final rule, CMS stated that, while these
devices do not use the Titan Spine
nanoLOCK® technology, their surfaces
also are made of titanium. Therefore,
CMS believed that the Titan Spine
nanoLOCK® interbody devices may be
substantially similar to currently
available titanium interbody devices.
The commenter stated that it agreed
with the statements CMS made in the
FY 2017 IPPS/LTCH PPS final rule and
also believed that the Titan Spine
nanoLOCK® technology is not only
substantially similar to other currently
available titanium interbody devices,
but also is similar to other technologies
with microscopic, roughened surfaces
with nano-scale features. The
commenter indicated that the
verification of these surfaces and
visualization of nano-scale features in
other orthopedic and spinal implants
have been confirmed in consensus
standards, as well as in electron
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microscopy techniques, including
atomic force microscopy. In addition,
the commenter stated that the success of
these devices at an in vitro level has
been reported in the peer-reviewed
literature, similar to that published on
the nanoLOCK®. Despite verification of
the applicant’s claims regarding these
surfaces, visualization of nano-scale
features, and success of these devices at
an in vitro level being reported in peerreviewed literature, the commenter
believed that, at this time, there is not
enough scientifically-validated evidence
of improvement in patient outcomes to
substantiate approval of new technology
add-on payments for any device
manufactured with nano-scale features,
including the Titan Spine nanoLOCK®
technology.
Response: We appreciate the
commenter’s input. We will take these
comments into consideration when
deciding whether to approve new
technology add-on payments for the
Titan Spine nanoLock® for FY 2019.
Comment: One commenter supported
the approval of new technology add-on
payments for the Titan Spine
nanoLock® technology. The commenter
stated that Titan Spine is the only
company that has received FDA
approval for the use of
‘‘nanotechnology’’ in its indication for
treatment use and has published
substantial research on the cellular
impact of its unique topographic, nanotextured surface. (We note, as described
above, this technology is currently FDA
cleared (not FDA approved) and the
technology was available on the U.S.
market once validations and clearances
were completed.) The commenter
asserted that, for these reasons, the
nanoLOCK® represents an emerging
technology that should not be
considered substantially similar to other
spinal technologies on the market. The
commenter further asserted that the
real-world evidence gathered from
multiple, independent data sources
(including actual electronic medical
records (EMR) and healthcare claims) on
nanoLOCK® usage in the treatment of
patients consistently shows patient
improvement in terms of clinically and
economically relevant outcomes—faster
recovery times, reduced length of
hospital stays, and reductions in
downstream medical costs such as
opiate utilization, among others. The
commenter stated that impressive
patient outcomes by use of the
nanoLOCK® are unmatched by other
competing devices, improving patient
outcomes of Medicare beneficiaries with
serious spinal pathologies.
Response: We appreciate the
commenters’ input. We will take these
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comments into consideration when
deciding whether to approve new
technology add-on payments for the
Titan Spine nanoLock® for FY 2019.
g. Plazomicin
Achaogen, Inc. submitted an
application for new technology add-on
payments for Plazomicin for FY 2019.
According to the applicant, Plazomicin
is a next-generation aminoglycoside
antibiotic, which has been found in
vitro to have enhanced activity against
many multi-drug resistant (MDR) gramnegative bacteria. The proposed
indication for the use of Plazomicin,
which had not received FDA approval
as of the time of the development of this
proposed rule, is for the treatment of
adult patients who have been diagnosed
with the following infections caused by
designated susceptible microorganisms:
(1) Complicated urinary tract infection
(cUTI), including pyelonephritis; and
(2) bloodstream infections (BSIs). The
applicant stated that it expects that
Plazomicin would be reserved for use in
the treatment of patients who have been
diagnosed with these types of infections
who have limited or no alternative
treatment options, and would be used
only to treat infections that are proven
or strongly suspected to be caused by
susceptible microorganisms.
The applicant stated that there is a
strong need for antibiotics that can treat
infections caused by MDR
Enterobacteriaceae, specifically
carbapenem resistant Enterobacteriaceae
(CRE). Life-threatening infections
caused by MDR bacteria have increased
over the past decade, and the patient
population diagnosed with infections
caused by CRE is projected to double
within the next 5 years, according to the
Centers for Disease Control and
Prevention (CDC). Infections caused by
CRE are often associated with poor
patient outcomes due to limited
treatment options. Patients who have
been diagnosed with BSIs due to CRE
face mortality rates of up to 50 percent.
Patients most at risk for CRE infections
are those with CRE colonization, recent
hospitalization or stay in a long-term
care or skilled-nursing facility, an
extensive history of antibacterial use,
and whose care requires invasive
devices like urinary catheters,
intravenous (IV) catheters, or
ventilators. The applicant estimated,
using data from the Center for Disease
Dynamics, Economics & Policy
(CDDEP), that the Medicare population
that has been diagnosed with antibioticresistant cUTI numbers approximately
207,000 and approximately 7,000 for
BSIs/sepsis due to CRE.
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The applicant noted that due to the
public health concern of increasing
antibiotic resistance and the need for
new antibiotics to effectively treat MDR
infections, Plazomicin has received the
following FDA designations:
Breakthrough Therapy; Qualified
Infectious Disease product, Priority
Review; and Fast Track. The applicant
noted that Breakthrough Therapy
designation was granted on May 17,
2017, for the treatment of bloodstream
infections (BSIs) caused by certain
Enterobacteriaceae in patients who have
been diagnosed with these types of
infections who have limited or no
alternative treatment options. The
applicant noted that Plazomicin is the
first antibacterial agent to receive this
designation. The applicant noted that on
December 18, 2014, the FDA designated
Plazomicin as a Qualified Infectious
Disease Product (QIDP) for the
indications of hospital-acquired
bacterial pneumonia (HAPB), ventilatorassociated bacterial pneumonia (VABP),
and complicated urinary tract infection
(cUTI), including pyelonephritis and
catheter-related blood stream infections
(CRBSI). The applicant noted that Fast
Track designation was granted by the
FDA on August 12, 2012, for the
Plazomicin development program for
the treatment of serious and lifethreatening infections due to CRE.
Plazomicin had not received approval
from the FDA as of the time of the
development of this proposed rule.
However, the applicant indicated that it
anticipates receiving approval from the
FDA by July 1, 2018. The applicant has
submitted a request for approval for a
unique ICD–10–PCS procedure code for
the use of Plazomicin, beginning with
FY 2019.
As discussed earlier, if a technology
meets all three of the substantial
similarity criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, the applicant
asserted that Plazomicin does not use
the same or similar mechanism of action
to achieve a therapeutic outcome as any
other drug assigned to the same or a
different MS–DRG. The applicant stated
that Plazomicin has a unique chemical
structure designed to improve activity
against aminoglycoside-resistant
bacteria, which also are often resistant
to other key classes of antibiotics,
including beta-lactams and
carbapenems. Bacterial resistance to
aminoglycosides usually occurs through
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enzymatic modification by
aminoglycoside modifying enzymes
(AMEs) to compromise binding the
target bacterial site. According to the
applicant, AMEs were found in 98.6
percent of aminoglycoside
nonsusceptible E. coli, Klebsiella spp,
Enterobacter spp, and Proteus spp
collected in 2016 U.S. surveillance
studies. Genes encoding AMEs are
typically located on elements that also
carry other causes of antibiotic
resistance like B-lactamase and/or
carbapenemase genes. Therefore,
extended spectrum beta-lactamases
(ESBL) producing Enterobacteriaceae
and CRE are commonly resistant to
currently available aminoglycosides.
According to the applicant, Plazomicin
contains unique structural
modifications at key positions in the
molecule to overcome antibiotic
resistance, specifically at the 6 and N1
positions. These side chain substituents
shield Plazomicin from inactivation by
AMEs, such that Plazomicin is not
inactivated by any known AMEs, with
the exception of N-acetyltransferase
(AAC) 2’-Ia, -Ib, and -Ic, which is only
found in Providencia species. According
to the applicant, as an aminoglycoside,
Plazomicin also is not hydrolyzed by Blactamase enzymes like ESBLs and
carbapenamases. Therefore, the
applicant asserted that Plazomicin is a
potent therapeutic agent for treating
MDR Enterobacteriaceae, including
aminoglycoside-resistant isolates, CRE
strains, and ESBL-producers.
The applicant asserted that the
mechanism of action is new due to the
unique chemical structure. With regard
to the general mechanism of action
against bacteria, we are concerned that
the mechanism of action of Plazomicin
appears to be similar to other
aminoglycoside antibiotics. As with
other aminoglycosides, Plazomicin is
bactericidal through inhibition of
bacterial protein synthesis. The
applicant maintained that the structural
changes to the antibiotic constitute a
new mechanism of action because it
allows the antibiotic to remain active
despite AMEs. Additionally, the
applicant stated that Plazomicin would
be the first, new aminoglycoside
brought to market in over 40 years.
We are inviting public comments on
whether Plazomicin’s mechanism of
action is new, including comments in
response to our concern that its
mechanism of action to eradicate
bacteria (inhibition of bacterial protein
synthesis) may be similar to that of
other aminoglycosides, even if
improvements to its structure may allow
Plazomicin to be active even in the
presence of common AMEs that
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inactivate currently marketed
aminoglycosides.
With respect to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, we believe
that potential cases representing
patients who may be eligible for
treatment involving Plazomicin would
be assigned to the same MS–DRGs as
cases representing patients who receive
treatment for UTI or bacteremia.
With respect to the third criterion,
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, the applicant
asserted that Plazomicin is intended for
use in the treatment of patients who
have been diagnosed with cUTI,
including pyelonephritis, and
bloodstream infections, who have
limited or no alternative treatment
options. Because the applicant
anticipates that Plazomicin will be
reserved for use in the treatment of
patients who have limited or no
alternative treatment options, the
applicant believed that Plazomicin may
be indicated to treat a new patient
population for which no other
technologies are available. However, it
is possible that existing antimicrobials
could also be used to treat those same
bacteria Plazomicin is intended to treat.
Specifically, the applicant is seeking
FDA approval for use in the treatment
of patients who have been diagnosed
with cUTI, including pyelonephritis,
caused by the following susceptible
microorganisms: Escherichia coli
(including cases with concurrent
bacteremia), Klebsiella pneumoniae,
Proteus spp (including P. mirabilis and
P. vulgaris), and Enterobactercloacae,
and for use in the treatment of patients
who have been diagnosed with BSIs
caused by the following susceptible
microorganisms: Klebsiella pneumonia
and Escherichia coli. Because the
susceptible organisms for which
Plazomicin is proposed to be indicated
include nonresistant strains that
existing antibiotics may effectively treat,
we are concerned that Plazomicin may
not treat a new patient population.
Therefore, we are inviting public
comments on whether Plazomicin treats
a new type of disease or a new patient
population. We also are inviting public
comments on whether Plazomicin is
substantially similar to any existing
technologies and whether it meets the
newness criterion.
With regard to the cost criterion, the
applicant conducted the following
analysis to demonstrate that the
technology meets the cost criterion. In
order to identify the range of MS–DRGs
that potential cases representing
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patients who have been diagnosed with
the specific types of infections for
which the technology has been
proposed to be indicated for use in the
treatment of and who may be potentially
eligible for treatment involving
Plazomicin may map to, the applicant
identified all MS–DRGs in claims that
included cases representing patients
who have been diagnosed with UTI or
Septicemia. The applicant searched the
FY 2016 MedPAR data for claims
reporting 16 ICD–10–CM diagnosis
codes for UTI and 45 ICD–10–CM
diagnosis codes for Septicemia and
identified a total of 2,046,275 cases
assigned to 702 MS–DRGs. The
applicant also performed a similar
analysis based on 75 percent of
identified claims, which spanned 43
MS–DRGs. MS–DRG 871 (Septicemia or
Severe Sepsis without Mechanical
Ventilation 96+ hours with MCC)
accounted for roughly 25 percent of all
cases in the first analysis of the 702 MS–
DRGs identified, and almost 35 percent
of the cases in the second analysis of the
43 MS–DRGs identified. Other MS–
DRGs with a high volume of cases based
on mapping the ICD–10–CM diagnosis
codes, in order of number of discharges,
were: MS–DRG 872 (Septicemia or
Severe Sepsis without Mechanical
Ventilation 96+ hours without MCC);
MS–DRG 690 (Kidney and Urinary Tract
Infections without MCC); MS–DRG 689
(Kidney and Urinary Tract Infections
with MCC); MS–DRG 853 (Infectious
and Parasitic Diseases with O.R.
Procedure with MCC); and MS–DRG 683
(Renal Failure with CC).
The applicant calculated an average
unstandardized case-weighted charge
per case using 2,046,275 identified cases
(100 percent of all cases) and using
1,533,449 identified cases (75 percent of
all cases) of $69,414 and $63,126,
respectively. The applicant removed 50
percent of the charges associated with
other drugs (associated with revenue
codes 025x, 026x, and 063x) from the
MedPAR data because the applicant
anticipates that the use of Plazomicin
would reduce the charges associated
with the use of some of the other drugs,
noting that this was a conservative
estimate because other drugs would still
be required for these patients during
their hospital stay. The applicant then
standardized the charges and applied
the 2-year inflation factor of 9.357
percent from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38527) to inflate
the charges from FY 2016 to FY 2018.
No charges for Plazomicin were added
in the analysis because the applicant
explained that the anticipated price for
Plazomicin has yet to be determined.
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Based on the FY 2018 IPPS/LTCH PPS
Table 10 thresholds, the average caseweighted threshold amount was $56,996
in the first scenario utilizing 100
percent of all cases, and $55,363 in the
second scenario utilizing 75 percent of
all cases. The inflated average caseweighted standardized charge per case
was $62,511 in the first scenario and
$57,054 in the second analysis. Because
the inflated average case-weighted
standardized charge per case exceeds
the average case-weighted threshold
amount in both scenarios, the applicant
maintained that the technology meets
the cost criterion. The applicant noted
that the case-weighted threshold
amount is met before including the
average per patient cost of the
technology in both analyses. As such,
the applicant anticipated that the
inclusion of the cost of Plazomicin, at
any price point, would further increase
charges above the average case-weighted
threshold amount.
The applicant also supplied
additional cost analyses, directing
attention at each of the two proposed
indications individually; the cost
analyses considered potential cases
representing patients who have been
diagnosed with cUTI who may be
eligible for treatment involving
Plazomicin separately from potential
cases representing patients who have
been diagnosed with BSI/Bacteremia
who may be eligible for treatment
involving Plazomicin, with the cost
analysis for each considering 100
percent and 75 percent of identified
cases using the FY 2016 MedPAR data
and the FY 2018 GROUPER Version 36.
The applicant reported that, for
potential cases representing patients
who have been diagnosed with
Bacteremia and who may be eligible for
treatment involving Plazomicin, 100
percent of identified cases spanned 539
MS–DRGs, with 75 percent of the cases
mapping to the following 4 MS–DRGs:
871 (Septicemia or Severe Sepsis
without Mechanical Ventilation 96+
hours with MCC), 872 (Septicemia or
Severe Sepsis without Mechanical
Ventilation 96+ hours without MCC),
853 (Infectious and Parasitic Diseases
with O.R. Procedure with MCC), and
870 (Septicemia or Severe Sepsis with
Mechanical Ventilation 96+ hours).
According to the applicant, for
potential cases representing patients
who have been diagnosed with cUTI
and who may be eligible for treatment
involving Plazomicin, 100 percent of
identified cases mapped to 702 MS–
DRGs, with 75 percent of the cases
mapping to 56 MS–DRGs. Potential
cases representing patients who have
been diagnosed with cUTIs and who
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20321
may be eligible for treatment involving
Plazomicin assigned to MS–DRG 871
(Septicemia or Severe Sepsis without
Mechanical Ventilation 96+ hours with
MCC) accounted for approximately 18
percent of all of the cases assigned to
any of the identified 56 MS–DRGs (75
percent of cases sensitivity analysis),
followed by MS–DRG 690 (Kidney and
Urinary Tract Infections without MCC),
which comprised almost 13 percent of
all of the cases assigned to any of the
identified 56 MS–DRGs. Two other
common MS–DRGs containing potential
cases representing potential patients
who may be eligible for treatment
involving Plazomicin who have been
diagnosed with the specific type of
indicated infections for which the
technology is intended to be used, using
the applicant’s analysis approach for
UTI based on mapping the ICD–10–CM
diagnosis codes were: MS–DRG 872
(Septicemia or Severe Sepsis without
Mechanical Ventilation 96+ hours
without MCC) and MS–DRG 689
(Kidney and Urinary Tract Infections
with MCC).
For potential cases representing
patients who have been diagnosed with
BSI and who may be eligible for
treatment involving Plazomicin, the
applicant calculated the average
unstandardized case-weighted charge
per case using 1,013,597 identified cases
(100 percent of all cases) and using
760,332 identified cases (75 percent of
all cases) of $87,144 and $67,648,
respectively. The applicant applied the
same methodology as the combined
analysis above. Based on the FY 2018
IPPS/LTCH PPS final rule Table 10
thresholds, the average case-weighted
threshold amount for potential cases
representing patients who have been
diagnosed with BSI assigned to the MS–
DRGs identified in the sensitivity
analysis was $66,568 in the first
scenario utilizing 100 percent of all
cases, and $61,087 in the second
scenario utilizing 75 percent of all cases.
The inflated average case-weighted
standardized charge per case was
$77,004 in the first scenario and $60,758
in the second scenario; in the 100
percent of Bacteremia cases sensitivity
analysis, the final inflated caseweighted standardized charge per case
exceeded the average case-weighted
threshold amount for potential cases
representing patients who have been
diagnosed with BSI and who may be
eligible for treatment involving
Plazomicin assigned to the MS–DRGs
identified in the sensitivity analysis by
$10,436 before including costs of
Plazomicin. In the 75 percent of all
cases sensitivity analysis scenario, the
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final inflated case-weighted
standardized charge per case did not
exceed the average case-weighted
threshold amount for potential cases
representing patients who have been
diagnosed with BSI assigned to the MS–
DRGs identified in the sensitivity
analysis, at $329 less than the average
case-weighted threshold amount.
Because the applicant has not yet
determined pricing for Plazomicin,
however, it is possible that Plazomicin
may also exceed the average caseweighted threshold amount for potential
cases representing patients who have
been diagnosed with BSI and who may
be eligible for treatment involving
Plazomicin assigned to the MS–DRGs
identified in the 75 percent cases
sensitivity analysis.
For potential cases representing
patients who have been diagnosed with
cUTI and who may be eligible for
treatment involving Plazomicin, the
applicant calculated the average
unstandardized case-weighted charge
per case using 100 percent of all cases
and 75 percent of all cases of $59,908
and $48,907, respectively. The applicant
applied the same methodology as the
combined analysis above. Based on the
FY 2018 IPPS/LTCH PPS final rule
Table 10 thresholds, the average caseweighted threshold amount for potential
cases representing patients who have
been diagnosed with cUTI and who may
be eligible for treatment involving
Plazomicin assigned to the MS–DRGs
identified in the first scenario utilizing
100 percent of all cases was $51,308,
and $46,252 in the second scenario
utilizing 75 percent of all cases. The
inflated average case-weighted
standardized charge per case was
$53,868 in the first scenario and $45,185
in the second scenario. In the 100
percent of cUTI cases sensitivity
analysis, the final inflated
case-weighted standardized charge per
case exceeded the average caseweighted threshold amount for potential
cases representing patients who have
been diagnosed with cUTI and who may
be eligible for treatment involving
Plazomicin assigned to the MS–DRGs
identified in the 100 percent of all cases
sensitivity analysis by $2,560 before
including costs of Plazomicin. In the 75
percent of all cases scenario, the final
inflated case-weighted standardized
charge per case did not exceed the
average case-weighted threshold amount
for potential cases representing patients
who have been diagnosed with cUTI
and who may be eligible for treatment
involving Plazomicin assigned to the
MS–DRGs identified in the 75 percent
sensitivity analysis, at $1,067 less than
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the average case-weighted threshold
amount. Because the applicant has not
yet determined pricing for Plazomicin,
however, it is possible that Plazomicin
may also exceed the average
case-weighted threshold amount for
potential cases representing patients
who have been diagnosed with cUTI
and who may be eligible for treatment
involving Plazomicin assigned to the
MS–DRGs identified in the 75 percent of
all cases sensitivity analysis if charges
for Plazomicin are more than $1,067.
We are inviting public comments on
whether Plazomicin meets the cost
criterion.
With respect to the substantial
clinical improvement criterion, the
applicant asserted that Plazomicin is a
next generation aminoglycoside that
offers a treatment option for a patient
population who have limited or no
alternative treatment options. Patients
who have been diagnosed with BSI or
cUTI caused by MDR Enterobacteria,
particularly CRE, are difficult to treat
because carbapenem resistance is often
accompanied by resistance to additional
antibiotic classes. For example, CRE
may be extensively drug resistant (XDR)
or even pandrug resistant (PDR). CRE
are resistant to most antibiotics, and
sometimes the only treatment option
available to health care providers is a
last-line antibiotic (such as colistin and
tigecycline) with higher toxicity.
According to the applicant, Plazomicin
would give the clinician an alternative
treatment option for patients who have
been diagnosed with MDR bacteria like
CRE because it has demonstrated
activity against clinical isolates that
possess a broad range of resistance
mechanisms, including ESBLs,
carbapenemases, and aminoglycoside
modifying enzymes that limit the utility
of different classes of antibiotics.
Plazomicin also can be used to treat
patients who have been diagnosed with
BSI caused by resistant pathogens, such
as ESBL-producing Enterobacteriaceae,
CRE, and aminoglycoside-resistant
Enterobacteriaceae. The applicant
maintained that Plazomicin is a
substantial clinical improvement
because it offers a treatment option for
patients who have been diagnosed with
serious bacterial infections that are
resistant to current antibiotics. We note
that Plazomicin is not indicated
exclusively for resistant bacteria, but
rather for certain susceptible organisms
of gram-negative bacteria, including
resistant and nonresistant strains for
which existing antibiotics may be
effective. We are concerned that the
applicant focused solely on
Plazomicin’s activity for resistant
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bacteria and did not supply information
demonstrating substantial clinical
improvement in treating nonresistant
strains in the bacteria families for which
Plazomicin is indicated.
The applicant stated that Plazomicin
also meets the substantial clinical
improvement criterion because it
significantly improves clinical outcomes
for a patient population compared to
currently available treatment options.
Specifically, the applicant asserted that
Plazomicin has: (1) A mortality benefit
and improved safety profile in treating
patients who have been diagnosed with
BSI due to CRE; and (2) statistically
better outcomes at test-of-cure in
patients who have been diagnosed with
cUTI, including higher eradication rates
for ESBL-producing pathogens, and
lower rate of subsequent clinical
relapses. The applicant conducted two
Phase III studies, CARE and EPIC. The
CARE trial compared Plazomicin to
colistin, a last-line antibiotic that is a
standard of care agent for patients who
have been diagnosed with BSI when
caused by CRE. The EPIC trial compared
Plazomicin to meropenem for the
treatment of patients who have been
diagnosed with cUTI/acute
polynephritis.
The CARE clinical trial was a
randomized, open label, multi-center
Phase III study comparing the efficacy of
Plazomicin against colistin in the
treatment of patients who have been
diagnosed with BSIs or
hospital-acquired bacterial pneumonia
(HABP)/ventilator-acquired bacterial
pneumonia (VABP) due to CRE. Due to
the small number of enrolled patients
with HAPB/VABP, however, results
were only analyzed for patients who
had been diagnosed with BSI due to
CRE. The primary endpoint was day 28
all-cause mortality or significant disease
complications. Patients were
randomized to receive 7 to 14 days of
IV Plazomicin or colistin, along with an
adjunctive therapy of meropenem or
tigecycline. All-cause mortality and
significant disease complications were
consistent regardless of adjunctive
antibiotics received, suggesting that the
difference in outcomes was driven by
Plazomicin and colistin, with little
impact from meropenem and
tigecycline. Follow-up was done at
test-of-cure (TOC; 7 days after last dose
of IV study drug), end of study (EOS;
day 28), and long-term follow-up (LFU;
day 60). Safety analysis included all
patients; microbiological modified
intent-to-treat (mMITT) analysis
included 17/18 Plazomicin and 20/21
colisitin patients. Baseline
characteristics like age, gender,
APACHE II score, infection type,
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baseline pathogens, creatinine
clearance, and adjunctive therapy with
either meropenem or tigecycline were
comparable in the Plazomicin and
colistin groups.
According to the applicant, the
following results demonstrate a reduced
mortality benefit in the patients who
had been diagnosed with BSI subset.
All-cause mortality at day 28 in the
Plazomicin group was more than 5
times less than in the colistin group and
all-cause mortality or significant
complications at day 28 was reduced by
39 percent in the Plazomicin group
compared to the colistin group. There
was a large sustained 60-day survival
benefit in the patients who had been
diagnosed with BSI subset, with
survival approximately 70 percent in
the Plazomicin group compared to 40
percent in the colistin group.
Additionally, according to the
applicant, faster median time to
clearance of CRE bacteremia of 1.5
versus 6 days for Plazomicin versus
colistin and higher rate of documented
clearance by day 5 (86 percent versus 46
percent) supported the reduced
mortality benefit due to faster and more
sustained clearance of bacteremia and
also demonstrated clinical improvement
in terms of more rapid beneficial
resolution of the disease.
The applicant maintained that
Plazomicin also represents a substantial
clinical improvement in improved
safety outcomes. Patients treated with
Plazomicin had a lower incidence of
renal events (10 percent versus 41.7
percent when compared to colistin),
fewer Treatment Emergent Adverse
Events (TEAEs), specifically blood
creatinine increases and acute kidney
injury, and approximately 30 percent
fewer serious adverse events were in the
Plazomicin group. According to the
applicant, other substantial clinical
improvements demonstrated by the
CARE study for use of Plazomicin in
patients who had been diagnosed with
BSI included lower rate of
superinfections or new infections,
occurring in half as many patients
treated with Plazomicin versus colistin
(28.6 percent versus 66.7 percent).
According to the applicant, the CARE
study demonstrates decreased all-cause
mortality and significantly reduced
disease complications at day 28 (EOS)
and day 60 for patients who had been
diagnosed with BSI, in addition to a
superior safety profile to colistin.
However, the applicant stated that, with
the achieved enrollment, this study was
not powered to support formal
hypothesis testing and p-values and 90
percent confidence intervals are
provided for descriptive purposes. The
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total number of patients who had been
diagnosed with BSI was 29, with 14
receiving Plazomicin and 15 receiving
colistin. While we understand the
difficulty enrolling a large number of
patients who have been diagnosed with
BSI caused by CRE due to severity of the
illness and the need for administering
treatment promptly, we are concerned
that results indicating reduced mortality
and treatment advantages over existing
standard of care for patients who have
been diagnosed with BSI due to CRE are
not statistically significant due to the
small sample size. Therefore, we are
concerned that the results from the
CARE study cannot be used to support
substantial clinical improvement.
The EPIC clinical trial was a
randomized, multi-center,
multi-national, double-blind study
evaluating the efficacy and safety of
Plazomicin compared with meropenem
in the treatment of patients who have
been diagnosed with cUTI based on
composite cure endpoint (achieving
both microbiological eradication and
clinical cure) in the microbiological
modified intent-to-treat (mMITT)
population. Patients received between 4
to 7 days of IV therapy, followed by
optional oral therapy like levofloxacin
(or any other approved oral therapy) as
step down therapy for a total of 7 to 10
days of therapy. Test-of-cure (TOC) was
done 15 to 19 days and late follow-up
(LFU) 24 to 32 days after the first dose
of IV therapy. Six hundred nine patients
fulfilled inclusion criteria, and were
randomized to receive either Plazomicin
or meropenem, with 306 patients
receiving Plazomicin and 303 patients
receiving meropenem. Safety analysis
included 303 (99 percent) Plazomicin
patients and 301 (99.3 percent)
meropenem patients. mMITT analysis
included 191 (62.4 percent) Plazomicin
patients and 197 (65 percent)
meropenem patients; exclusion from
mMITT analysis was due to lack of
study-qualifying uropathogen, which
were pathogens susceptible to both
Plazomicin and meropenem. In the
mMITT population, both groups were
comparable in terms of gender, age,
percentage of patients who had been
diagnosed with cUTI/acute
pyelonephritis (AP)/urosepsis/
bacteremia/moderate renal impairment
at baseline.
According to the applicant,
Plazomicin successfully achieved the
primary efficacy endpoint of composite
cure (combined microbiological
eradication and clinical cure). At the
TOC visit, 81.7 percent of Plazomicin
patients versus 70.1 percent of
meropenem patients achieved
composite cure; this was statistically
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significant with a 95 percent confidence
interval. Plazomicin also demonstrated
higher eradication rates for key resistant
pathogens than meropenem at both TOC
(89.4 percent versus 75.5 percent) and
LFU (77 percent versus 60.4 percent),
suggesting that the Plazomicin treatment
benefit observed at TOC was sustained.
Specifically, Plazomicin demonstrated
higher eradication rates, defined as
baseline uropathogen reduced to less
than 104, against the most common
gram-negative uropathogens, including
ESBL producing (82.4 percent
Plazomicin versus 75.0 percent
meropenem) and aminoglycoside
resistant (78.8 percent Plazomicin
versus 68.6 percent meropenem)
pathogens. This was statistically
significant, although of note, as total
numbers of Enterobacteriaceae exceeded
population of mMITT (191 Plazomicin,
197 meropenem) this presumably
included patients who were otherwise
excluded from the mMITT population.
According to the applicant,
importantly, higher microbiological
eradication rates at the TOC and LFU
visits were associated with a lower rate
of clinical relapse at LFU for Plazomicin
treated patients (3 versus 14, or 1.8
percent Plazomicin versus 7.9 percent
meropenem), with majority of the
meropenem failures having had
asymptomatic bacteriuria; that is,
positive urine cultures without clinical
symptoms, at TOC (21.1 percent),
suggesting that the higher
microbiological eradication rate at the
TOC visit in Plazomicin-treated patients
decreased the risk of subsequent clinical
relapse. Plazomicin decreased recurrent
infection by four-fold compared to
meropenem, suggesting improved
patient outcomes, such as reduced need
for additional therapy and rehospitalization for patients who have
been diagnosed with cUTI. The safety
profile of Plazomicin compared to
meropenem was similar. The applicant
noted that higher bacteria eradication
results for Plazomicin were not due to
meropenem resistance, as only patients
with isolates susceptible to both drugs
were included in the study. According
to the applicant, the EPIC clinical trial
results demonstrate clear differentiation
of Plazomicin from meropenem, an
agent considered by some as a goldstandard for treatment of patients who
have been diagnosed with cUTI in cases
due to resistant pathogens.
While the EPIC clinical trial was a
non-inferiority study, the applicant
contended that statistically significant
improved outcomes and lower clinical
relapse rates for patients treated with
Plazomicin demonstrate that Plazomicin
meets the substantial clinical
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improvement criterion for the cUTI
indication. Specifically, according to the
applicant, the efficacy results for
Plazomicin combined with a generally
favorable safety profile provide a
compelling benefit-risk profile for
patients who have been diagnosed with
cUTI, and particularly those with
infections due to resistant pathogens.
Most patients enrolled in the EPIC
clinical trial were from Eastern Europe.
It is unclear how generalizable these
results would be to patients in the
United States as the susceptibilities of
bacteria vary greatly by location. The
applicant maintains that this is
consistent with prior studies and is
unlikely to have affected the results of
the study because the pharmacokinetics
of Plazomicin and meropenem are not
expected to be affected by race or
ethnicity. However, bacterial resistance
can vary regionally and we are
interested in how this data can be
extrapolated to a majority of the U.S.
population. It is also unknown how
quickly resistance to Plazomicin might
develop. Additionally, the
microbiological breakdown of the
bacteria is unknown without the full
published results, and patients outside
of the mMITT population were included
when the applicant reported the
statistically superior microbiological
eradication rates of Enterobacteriaceae
at TOC. We are concerned whether there
is still statistical superiority of
Plazomicin in the intended bacterial
targets in the mMITT. Finally, because
both Plazomicin and meropenem were
also utilized in conjunction with
levofloxacin, it is unclear to us whether
combined antibiotic therapy will
continue to be required in clinical
practice, and how levofloxacin activity
or resistance might affect the clinical
outcome in both patient groups.
We are inviting public comments on
whether Plazomicin meets the
substantial clinical improvement
criterion for patients who have been
diagnosed with BSI and cUTI, including
with respect to whether Plazomicin
constitutes a substantial clinical
improvement for the treatment of
patients who have been diagnosed with
BSI who have limited or no alternative
treatment options, and whether
statistically better outcomes at test-ofcure visit, including higher eradication
rates for ESBL-producing pathogens,
and lower rate of subsequent clinical
relapses constitute a substantial clinical
improvement for patients who have
been diagnosed with cUTI.
We did not receive any public
comments in response to the published
notice in the Federal Register regarding
the substantial clinical improvement
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criterion for Plazomicin or at the New
Technology Town Hall meeting.
h. GIAPREZATM
The La Jolla Pharmaceutical Company
submitted an application for new
technology add-on payments for
GIAPREZATM for FY 2019.
GIAPREZATM, a synthetic human
angiotensin II, is administered through
intravenous infusion to raise blood
pressure in adult patients who have
been diagnosed with septic or other
distributive shock.
The applicant stated that shock is a
life-threatening critical condition
characterized by the inability to
maintain blood flow to vital tissues due
to dangerously low blood pressure
(hypotension). Shock can result in organ
failure and imminent death, such that
mortality is measured in hours and days
rather than months or years. Standard
therapy for shock currently uses fluid
and vasopressors to raise the mean
arterial pressure (MAP). The two classes
of standard of care (SOC) vasopressors
are catecholamines and vasopressins.
Patients do not always respond to
existing standard of care therapies.
Therefore, a diagnosis of shock can be
a difficult and costly condition to treat.
According to the applicant, 35 percent
of patients who are diagnosed with
shock fail to respond to standard of care
treatment options using catecholamines
and go on to second-line treatment,
which is typically vasopressin. Eighty
percent of patients on vasopressin fail to
respond and have no other alternative
treatment options. The applicant
estimated that CMS covered charges to
treat patients who are diagnosed with
vasodilatory shock who fail to respond
to standard of care therapy are
approximately 2 to 3 times greater than
the costs of other conditions, such as
acute myocardial infarction, heart
failure, and pneumonia. According to
the applicant, one-third of patients in
the intensive care unit are affected by
vasodilatory shock, with 745,000
patients who have been diagnosed with
shock being treated annually, of whom
approximately 80 percent are septic.
With respect to the newness criterion,
according to the applicant, the
expanded access program (EAP), or FDA
authorization for the ‘‘compassionate
use’’ of an investigational drug outside
of a clinical trial, was initiated August
8, 2017. GIAPREZATM was granted
Priority Review status and received FDA
approval on December 21, 2017, for the
use in the treatment of adults who have
been diagnosed with septic or other
distributive shock as an intravenous
infusion to increase blood pressure. We
note that the applicant has submitted a
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request for approval for a unique
ICD-10-PCS code for the administration
of GIAPREZATM beginning in FY 2019.
Currently, there are no ICD–10–PCS
procedure codes to uniquely identify
procedures involving GIAPREZATM.
As discussed above, if a technology
meets all three of the substantial
similarity criteria, it would be
considered substantially similar to an
existing technology and would not be
considered ‘‘new’’ for purposes of new
technology add-on payments.
With regard to the first criterion,
whether a product uses the same or a
similar mechanism of action to achieve
a therapeutic outcome, according to the
applicant, GIAPREZATM is the first
synthetic formulation of human
angiotensin II, a naturally occurring
peptide hormone in the human body.
Angiotensin II is one of the major
bioactive components of the reninangiotensin-aldosterone system (RAAS),
which serves as one of the body’s
central regulators of blood pressure.
Angiotensin II increases blood pressure
through vasoconstriction, increased
aldosterone release, and renal control of
fluid and electrolyte balance. Current
therapies for the treatment of patients
who have been diagnosed with shock do
not leverage the RAAS. The applicant
asserted that GIAPREZATM is a novel
treatment with a unique mechanism of
action relative to SOC treatments for
patients who have been diagnosed with
shock, which is adequate fluid
resuscitation and vasopressors.
Specifically, the two classes of SOC
vasopressors are catecholamines like
Norepinephrine, epinephrine,
dopamine, and phenylephrine IV
solutions, and vasopressins like
Vasostrict® and vasopressin-sodium
chloride IV solutions. Catecholamines
leverage the sympathetic nervous
system and vasopressin leverages the
arginine-vasopressin system to regulate
blood pressure. However, the third
system that works to regulate blood
pressure, the RAAS, is not currently
leveraged by any available therapies to
raise mean arterial pressure in the
treatment of patients who have been
diagnosed with shock. The applicant
maintained that GIAPREZATM is the
first synthetic human angiotensin II
approved by the FDA and the only FDAapproved vasopressor that leverages the
RAAS and, therefore, GIAPREZATM
utilizes a different mechanism of action
than currently available treatment
options.
The applicant explained that
GIAPREZATM leverages the RAAS,
which is a body system not used by
existing vasopressors to raise blood
pressure through inducing
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vasoconstriction. We are concerned that
GIAPREZATM’s general mechanism of
action, increasing blood pressure by
inducing vasoconstriction through
binding to certain G-protein receptors to
stimulate smooth muscle contraction,
may be similar to that of
norepinephrine, albeit leveraging a
different body system. We are inviting
public comments on whether
GIAPREZATM uses a different
mechanism of action to achieve a
therapeutic outcome with respect to
currently available treatment options,
including comments or additional
information regarding whether the
mechanism of action used by
GIAPREZATM is different from that of
other treatment methods of stimulating
vasoconstriction.
With respect to the second criterion,
whether a product is assigned to the
same or a different MS–DRG, we believe
that potential cases representing
patients who may be eligible for
treatment involving GIAPREZATM
would be assigned to the same MS–
DRGs as cases representing patients who
receive SOC treatment for a diagnosis of
shock. As explained below in the
discussion of the cost criterion, the
applicant believed that potential cases
representing patients who may be
eligible for treatment involving
GIAPREZATM would be assigned to MS–
DRGs that contain cases representing
patients who have failed to respond to
administration of fluid and vasopressor
therapies.
With respect to the third criterion,
whether the new use of the technology
involves the treatment of the same or
similar type of disease and the same or
similar patient population, according to
the applicant, once patients have failed
treatment using catecholamines,
treatment options for patients who have
been diagnosed with severe septic or
other distributive shock are limited.
Agents that were previously available
are each associated with their own
adverse events (AEs). The applicant
noted that primary options that have
been investigated include vasopressin,
corticosteroids, methylene blue, and
blood purification techniques. Of these
options, the applicant stated that only
vasopressin has a recommendation as
add on vasopressor therapy in current
treatment guidelines, but the
recommendations are listed as weak
with moderate quality of evidence.
According to the applicant, there is
uncertainty regarding vasopressin’s
effect on mortality due to mixed clinical
trial results, and higher doses of
vasopressin have been associated with
cardiac, digital, and splanchnic
ischemia. Therefore, the applicant
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asserted that there is a significant unmet
medical need for treatments for patients
who have been diagnosed with septic or
distributive shock who remain
hypotensive, despite adequate fluid and
vasopressor therapy and for medications
that can provide catecholamine-sparing
effects.
The applicant also noted that there is
currently no standard of care for
addressing the clinical state of septic or
other distributive shock experienced by
patients who fail to respond to fluid and
available vasopressor therapy.
Additionally, no clinical evidence or
consensus for treatments is available.
Based on the applicant’s statements as
summarized above, it appears that the
applicant is asserting that GIAPREZATM
provides a new therapeutic treatment
option for critically-ill patients who
have been diagnosed with shock who
have limited options and worsening
prognosis. However, we are concerned
that GIAPREZATM may not offer a
treatment option to a new patient
population, specifically because the
FDA approval for GIAPREZATM does
not reserve the use of GIAPREZATM
only as a last-line drug or adjunctive
therapy for a subset of the patient
population who have been diagnosed
with shock who have failed to respond
to standard of care treatment options.
According to the FDA labeling,
GIAPREZATM is a vasoconstrictor to
increase blood pressure in adult patients
who have been diagnosed with septic or
other distributive shock. Patients who
have been diagnosed with septic or
other distributive shock are not a new
patient population. Therefore, it appears
that GIAPREZATM is used to treat the
same or similar type of disease (a
diagnosis of shock) and a similar patient
population receiving SOC therapy for
the treatment of shock. We are inviting
public comments on whether
GIAPREZATM meets the substantial
similarity criteria and the newness
criterion.
With regard to the cost criterion, the
applicant conducted an analysis for a
narrower indication, patients who have
been diagnosed with refractory shock
who have failed to respond to standard
of care vasopressors, and an analysis for
a broader indication of all patients who
have been diagnosed with septic or
other distributive shock. We believe that
only this broader analysis, which
reflects the patient population for which
the applicant’s technology is approved
by the FDA, is relevant to demonstrate
that the technology meets the cost
criterion and, therefore, we are only
summarizing this broader analysis
below. In order to identify the range of
MS–DRGs that potential cases
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representing potential patients who may
be eligible for treatment using
GIAPREZATM may map to, the applicant
used two separate analyses to identify
the MS–DRGs for patients who have
been diagnosed with shock or related
diagnoses. The applicant also performed
three sensitivity analyses on the MS–
DRGs for each of the two selections: 100
Percent of the MS–DRGs, 80 percent of
the MS–DRGs, and 25 percent of the
MS–DRGs. Therefore, a total of six
scenarios were included in the cost
analysis.
The first analysis (Scenario 1) selected
the MS–DRGs most representative of the
potential patient cases where treatment
involving GIAPREZATM would have the
greatest clinical impact and outcomes of
improvement over present treatment
options. The applicant searched for 28
different ICD–9–CM codes under this
scenario. The second analysis (Scenario
2) used the 80 most relevant ICD–9–CM
diagnosis codes based on the inclusion
criteria of the GIAPREZATM Phase III
clinical trial, ATHOS–3, and an
additional 8 ICD–9–CM diagnosis codes
for clinical presentation associated with
vasodilatory or distributive shock
patients failing fluid and standard of
care therapy to capture any additional
potential cases that may be applicable
based on clinical presentations
associated with this patient population.
Among only the top quartile of
potential patient cases, the single MS–
DRG representative of most potential
patient cases was MS–DRG 871
(Septicemia or Severe Sepsis without
Mechanical Ventilation >96 Hours with
MCC) for both ICD–9–CM diagnosis
code selection scenarios, and in both
selections, it accounted for a potential
patient case percentage surpassing 25
percent. Because GIAPREZATM is not
reserved exclusively as a last-line drug
based on the FDA indication, the
applicant removed 50 percent of drug
charges for prior technologies or other
charges associated with prior
technologies from the unstandardized
charges before standardization in order
to account for other drugs that may be
replaced by the use of GIAPREZATM.
The applicant has not yet supplied CMS
with pricing for GIAPREZATM and did
not include charges for the new
technology when conducting this
analysis. For all analyses’ scenarios, the
applicant standardized charges using
the FY 2015 impact file and then
inflated the charges to FY 2019 using an
inflation factor of 15.4181 percent (or
1.154181) by multiplying the inflation
factor of 1.098446 in the FY 2017 IPPS/
LTCH PPS final rule (81 FR 57286) by
the inflation factor of 1.05074 in the FY
2018 IPPS/LTCH PPS final rule (82 FR
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38524). The final inflated average
case-weighted standardized charge per
case was calculated for each scenario
and compared with the average caseweighted threshold amount for each
group of MS–DRGs based on the
thresholds in Table 10.
Results of the analyses for each of the
two code selection scenarios, each with
three sensitivity analyses for a total of
Number of
MS–DRGs
assessed
Number of
Medicare
cases
Cost Analysis Based on ICD–9–CM
ICD–9–CM Diagnosis Code Selection (28 Codes):
100 Percent ..................................................................
80 Percent ....................................................................
25 Percent ....................................................................
daltland on DSKBBV9HB2PROD with PROPOSALS2
ICD–9–CM Diagnosis Code Selection (88 Codes):
100 Percent ..................................................................
80 Percent ....................................................................
25 Percent ....................................................................
The applicant maintained that, based
on the Table 10 thresholds, the inflated
average case-weighted standardized
charge per case in the analyses exceeded
the average case-weighted threshold
amount. The applicant noted that the
inflated average case-weighted
standardized charge per case exceeds
the average case-weighted threshold
amount by at least $18,189, without the
average per patient cost of the
technology. As such, the applicant
anticipated that the inclusion of the cost
of GIAPREZATM, at any price point,
would further increase charges above
the average case-weighted threshold
amount. Therefore, the applicant stated
that the technology meets the cost
criterion. We note that we are unsure
whether the selection in both scenarios
fully captures the broader indication for
which the FDA approved the use of
GIAPREZATM. We are inviting public
comments on whether GIAPREZATM
meets the cost criterion, including with
respect to the concern we have raised.
With respect to the substantial
clinical improvement criterion, the
applicant summarized that it believes
that GIAPREZATM represents a
substantial clinical improvement
because it: (1) Addresses an unmet
medical need for patients who have
been diagnosed with septic or
distributive shock that, despite standard
of care vasopressors, are unable to
maintain adequate mean arterial
pressure; (2) is the only agent shown in
randomized clinical trial to rapidly and
sustainably achieve or maintain target
blood pressure in patients who do not
respond adequately to fluid and
vasopressor therapy; (3) although not
VerDate Sep<11>2014
20:30 May 04, 2018
Jkt 244001
120,966
96,102
66,980
466
52
1
164,892
131,690
67,016
154 Khanna, A., English, S.W., Wang, X.S., et al.,
‘‘Angiotensin II for the treatment of vasodilatory
shock,’’ [supplementary appendix] [published
online ahead of print May 21, 2017], N Engl J Med.,
2017, doi: 10.1056/NEJMoa1704154.
Frm 00164
Fmt 4701
Final
average
inflated
standardized
charge per
case
Amount
exceeded
threshold
$77,427
77,641
53,499
$77,427
100,167
71,951
$34,095
22,526
18,452
112,174
108,396
71,688
33,499
28,664
18,189
Diagnosis Code Scenario 2
powered for mortality, the ATHOS–3
trial demonstrated a strong trend to
reduce the risk of death in adults from
septic or distributive shock who remain
hypotensive despite fluid therapy and
vasopressor therapy, a severe, lifethreatening condition, for which there
are no other therapies; (4) provides a
catecholamine-sparing effect; and (5) is
generally safe and well-tolerated, with
no significant differences in the
percentages of patients with any grade
adverse events or serious adverse events
when compared to placebo.
With regard to expanding on the
statements above, the applicant believes
that the use of GIAPREZATM offers
clinicians a significant new tool to
manage and treat severe hypotension in
all adult patients who have been
diagnosed with septic or other
distributive shock who are unresponsive
to existing vasopressor therapies. The
applicant also stated that the use of
GIAPREZATM provides a new
therapeutic option for critically-ill adult
patients who have been diagnosed with
septic or other distributive shock who
have limited options and worsening
prognoses.
The applicant maintained that
GIAPREZATM was shown to be an
effective treatment option for
critically-ill patients who have been
diagnosed with refractory shock. The
applicant reported that a randomized,
double-blind placebo controlled trial
called ATHOS–3 154 examined the
PO 00000
Caseweighted new
technology
add-on
payment
threshold
Diagnosis Code Scenario 1
439
10
1
Cost Analysis Based on ICD–9–CM
six analyses, are summarized in the
tables below:
Sfmt 4702
78,675
79,732
53,499
ability of GIAPREZATM to increase
mean arterial pressure (MAP), with the
primary endpoint being achievement of
a MAP of greater than or equal to 75
mmHg (the research-backed guideline
set by the Surviving Sepsis Campaign)
or a 10 mmHg increase in baseline MAP.
Significantly more patients in the
treatment arm met the primary endpoint
(69.9 percent versus 23.4 percent,
P<0.001). The applicant asserted that
this MAP improvement constitutes a
significant substantial clinical
improvement because patients treated
with GIAPREZATM were three times
more likely to achieve acceptable blood
pressure than patients receiving the
placebo. The MAP significantly and
rapidly increased in patients treated
with GIAPREZATM and was sustained
over 48 hours consistent across
subgroups and the treatment effect of
GIAPREZATM was confirmed using
multivariate analysis. The group treated
with GIAPREZATM also experienced a
greater mean increase in MAP; the MAP
increased by a mean of 12.5 mmHg for
the GIAPREZATM group compared to a
mean of 2.9 mmHg for the placebo
group.
Second, the applicant maintained that
GIAPREZATM demonstrated potential
improvement in organ function by
lowering the cardiovascular sequential
organ failure assessment (SOFA) scores
of patients at 48 hours (¥1.75
GIAPREZATM group versus ¥1.28
placebo group). However, we are
concerned that lower cardiovascular
SOFA scores may not demonstrate
substantial clinical improvement
because there was no difference in the
improvement of other components of
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the SOFA score or the overall SOFA
score.
Third, the applicant asserted that
GIAPREZATM represents a substantial
clinical improvement because the use of
GIAPREZATM reduced the need to
increase overall doses of catecholamine
vasopressors. The applicant stated that
patients receiving higher doses of
catecholamine vasopressors suffer from
cardiac toxicity, organ dysfunction, and
other metabolic complications that are
associated with higher mortality. By
decreasing the overall dosage of
catecholamine vasopressors,
GIAPREZATM potentially reduces the
adverse effects of vasopressors. The
mean change in catecholamine
vasopressors in patients receiving
GIAPREZATM versus patients receiving
the placebo at 3 hours was ¥0.03 versus
0.03 (P<0.001), showing that
GIAPREZATM allowed for
catecholamines to be titrated down,
while patients not receiving
GIAPREZATM required additional
catecholamine doses. The vasopressor
mean doses were consistently lower in
the GIAPREZATM group, and at 48
hours, vasopressors had been
discontinued in 28.5 percent of patients
in