83 FR 20164 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 88 (May 7, 2018)
Page Range
20164-20643
FR Document
2018-08705
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[dash]of[dash]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[dash]exempt cancer hospitals, and LTCHs). We also are proposing to establish new 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 Hospital-Acquired 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.
Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Proposed Rules]
[Pages 20164-20643]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-08705]
[[Page 20163]]
Vol. 83
Monday,
No. 88
May 7, 2018
Part II
Book 2 of 2 Books
Pages 20163-20706
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 413, 424, et al.
Medicare Program; Hospital Inpatient Prospective Payment Systems for
Acute Care Hospitals and the Long[dash]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; Proposed Rule
Federal Register / Vol. 83 , No. 88 / Monday, May 7, 2018 / Proposed
Rules
[[Page 20164]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, 424, and 495
[CMS-1694-P]
RIN 0938-AT27
Medicare Program; Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long[dash]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
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: We are proposing to revise the Medicare hospital inpatient
prospective payment systems (IPPS) for operating and capital-related
costs of acute care hospitals to implement changes arising from our
continuing experience with these systems for FY 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[dash]of[dash]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[dash]exempt cancer hospitals, and
LTCHs). We also are proposing to establish new 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
Hospital-Acquired 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 http://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, 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[dash]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[dash]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,
PPS-Exempt Cancer Hospital Quality Reporting Issues.
Mary Pratt, (410) 786-6867, Long-Term Care Hospital Quality Data
Reporting Issues.
[[Page 20165]]
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: http://www.regulations.gov. Follow the search instructions on that website to
view public comments.
Electronic Access
This Federal Register document is available from the Federal
Register online database through Federal Digital System (FDsys), a
service of the U.S. Government Printing Office. This database can be
accessed via the Internet at: http://www.thefederalregister.org/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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Click on the link on the left side of the
screen titled, ``FY 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:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html under the list item for Regulation
Number CMS-1694-P. For further details on the contents of the tables
referenced in this proposed rule, we refer readers to section VI. of
the Addendum to this proposed rule.
Readers who experience any problems accessing any of the tables
that are posted on the CMS 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 (Sec. 412.4)
B. Proposed Changes in the Inpatient Hospital Updates for FY
2019 (Sec. 412.64(d))
C. Rural Referral Centers (RRCs) Proposed Annual Updates to
Case-Mix Index and Discharge Criteria (Sec. 412.96)
D. Proposed Payment Adjustment for Low-Volume Hospitals (Sec.
412.101)
E. Indirect Medical Education (IME) Payment Adjustment Factor
(Sec. 412.105)
F. Proposed Payment Adjustment for Medicare Disproportionate
Share Hospitals (DSHs) for FY 2019 (Sec. 412.106)
G. Sole Community Hospitals (SCHs) and Medicare-Dependent, Small
Rural Hospitals (MDHs) (Sec. Sec. 412.90, 412.92, and 412.108)
H. Hospital Readmissions Reduction Program: Proposed Updates and
Changes (Sec. Sec. 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 (Sec. Sec. 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 Capital-Related 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 (Sec. 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 (Sec. 412.538)
VIII. Quality Data Reporting Requirements for Specific Providers and
Suppliers
A. Hospital Inpatient Quality Reporting (IQR) Program
B. PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program
C. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)
D. Proposed Changes to the Medicare and Medicaid EHR Incentive
Programs (Now Referred to as the Medicare and Medicaid Promoting
Interoperability Programs)
[[Page 20166]]
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[dash]of[dash]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[dash]Related Costs for FY 2019
A. Determination of Federal Hospital Inpatient
Capital[dash]Related Prospective Payment Rate Update for FY 2019
B. Calculation of the Inpatient Capital[dash]Related Prospective
Payments for FY 2019
C. Capital Input Price Index
IV. Proposed Changes to Payment Rates for Excluded Hospitals:
Rate[dash]of[dash]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
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[dash]related costs of acute care hospitals as well as for
certain hospitals and hospital units excluded from the IPPS. In
addition, it would make payment and policy changes for inpatient
hospital services provided by long-term care hospitals (LTCHs) under
the long[dash]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[dash]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[dash]Based
Purchasing (VBP) Program, the Hospital Readmissions Reduction Program,
and the Hospital-Acquired 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,
[[Page 20167]]
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[dash]113)
and section 307(b)(1) of the BIPA (Pub. L. 106[dash]554) (as codified
under section 1886(m)(1) of the Act), which provide for the development
and implementation of a prospective payment system for payment for
inpatient hospital services of LTCHs described in section
1886(d)(1)(B)(iv) of the Act.
Sections 1814(l), 1820, and 1834(g) of the Act, which
specify that payments are made to critical access hospitals (CAHs)
(that is, rural hospitals or facilities that meet certain statutory
requirements) for inpatient and outpatient services and that these
payments are generally based on 101 percent of reasonable cost.
Section 1866(k) of the Act, as added by section 3005 of
the Affordable Care Act, which establishes a quality reporting program
for hospitals described in section 1886(d)(1)(B)(v) of the Act,
referred to as ``PPS-exempt cancer hospitals.''
Section 1886(a)(4) of the Act, which specifies that costs
of approved educational activities are excluded from the operating
costs of inpatient hospital services. Hospitals with approved graduate
medical education (GME) programs are paid for the direct costs of GME
in accordance with section 1886(h) of the Act.
Section 1886(b)(3)(B)(viii) of the Act, which requires the
Secretary to reduce the applicable percentage increase that would
otherwise apply to the standardized amount applicable to a subsection
(d) hospital for discharges occurring in a fiscal year if the hospital
does not submit data on measures in a form and manner, and at a time,
specified by the Secretary.
Section 1886(o) of the Act, which requires the Secretary
to establish a Hospital Value-Based Purchasing (VBP) Program under
which value-based incentive payments are made in a fiscal year to
hospitals meeting performance standards established for a performance
period for such fiscal year.
Section 1886(p) of the Act, as added by section 3008 of
the Affordable Care Act, which establishes a Hospital-Acquired
Condition (HAC) Reduction Program, under which payments to applicable
hospitals are adjusted to provide an incentive to reduce hospital-
acquired conditions.
Section 1886(q) of the Act, as added by section 3025 of
the Affordable Care Act and amended by section 10309 of the Affordable
Care Act and section 15002 of the 21st Century Cures Act, which
establishes the ``Hospital 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.
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
[[Page 20168]]
to advancing our work to improve patient outcomes. The Meaningful
Measures Initiative represents a new approach to quality measures that
will foster operational efficiencies and will reduce costs, including
collection and reporting burden while producing quality measurement
that is more focused on meaningful outcomes.
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\1\ Meaningful Measures webpage: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
\2\ Remarks by Administrator Seema Verma at the Health Care
Payment Learning and Action Network (LAN) Fall Summit, as prepared
for delivery on October 30, 2017. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
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The Meaningful Measures framework has the following objectives:
Address high-impact measure areas that safeguard public
health;
Patient-centered and meaningful to patients;
Outcome-based where possible;
Fulfill each program's statutory requirements;
Minimize the level of burden for health care providers
(for example, through a preference for EHR-based measures where
possible, such as electronic clinical quality measures; \3\
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\3\ Refer to section VIII.A.9.c.of the preamble of this proposed
rule where we are seeking public comment on the potential future
development and adoption of eCQMs.
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Significant opportunity for improvement;
Address measure needs for population based payment through
alternative payment models; and
Align across programs and/or with other payers.
In order to achieve these objectives, we have identified 19
Meaningful Measures areas and mapped them to six overarching quality
priorities as shown in the following table:
------------------------------------------------------------------------
Quality priority Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm Healthcare-Associated
Caused in the Delivery of Care. Infections
Preventable Healthcare Harm
Strengthen Person and Family Engagement Care is Personalized and
as Partners in Their Care. Aligned with Patient's Goals
End of Life Care According to
Preferences
Patient's Experience of Care
Patient Reported Functional
Outcomes
Promote Effective Communication and Medication Management
Coordination of Care. Admissions and Readmissions to
Hospitals
Transfer of Health Information
and Interoperability
Promote Effective Prevention and Preventive Care
Treatment of Chronic Disease. Management of Chronic
Conditions
Prevention, Treatment, and
Management of Mental Health
Prevention and Treatment of
Opioid and Substance Use
Disorders
Risk Adjusted Mortality
Work with Communities to Promote Best Equity of Care
Practices of Healthy Living. Community Engagement
Make Care Affordable................... Appropriate Use of Healthcare
Patient-focused Episode of Care
Risk Adjusted Total Cost of
Care
------------------------------------------------------------------------
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.
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.
a. MS-DRG Documentation and Coding Adjustment
Section 631 of the American Taxpayer Relief Act of 2012 (ATRA, Pub.
L. 112-240) amended section 7(b)(1)(B) of Public Law 110-90 to require
the Secretary to make a recoupment adjustment to the standardized
amount of Medicare payments to acute care hospitals to account for
changes in MS-DRG documentation and coding that do not reflect real
changes in case-mix, totaling $11 billion over a 4-year period of FYs
2014, 2015, 2016, and 2017. The FY 2014 through FY 2017 adjustments
represented the amount of the increase in aggregate payments as a
result of not completing the prospective adjustment authorized under
section 7(b)(1)(A) of Public Law 110-90 until FY 2013. Prior to the
ATRA, this amount could not have been recovered under Public Law 110-
90. Section 414 of the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114-10) replaced the single positive adjustment
we intended to make in FY 2018 with a 0.5 percent positive adjustment
to the standardized amount of Medicare payments to acute care hospitals
for FYs 2018 through 2023. (The FY 2018 adjustment was subsequently
adjusted to 0.4588 percent by section 15005 of the 21st Century Cures
Act.) Therefore, for FY 2019, we are proposing to make an adjustment of
+0.5 percent to the standardized amount.
b. Expansion of the Postacute Care Transfer Policy
Section 53109 of the Bipartisan Budget Act of 2018 amended section
1886(d)(5)(J)(ii) of the Act to also include discharges to hospice care
by a hospice program as a qualified discharge, effective for discharges
occurring on or after October 1, 2018. Accordingly, we are proposing to
make conforming amendments to Sec. 412.4(c) of the regulation,
effective for discharges on or after October 1, 2018, to specify that
if a discharge is assigned to one of the MS-DRGs subject to the
postacute care transfer policy and the individual is transferred to
hospice care by a hospice program, the discharge 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
[[Page 20169]]
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 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 25-percent 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 risk-adjusted readmission rate
during a 3-year period for acute myocardial infarction (AMI), heart
failure (HF), pneumonia, chronic obstructive pulmonary disease (COPD),
total hip arthroplasty/total knee arthroplasty (THA/TKA), and coronary
artery bypass graft (CABG). In this 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 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, Risk-Standardized
Payment Associated With a 30-Day Episode-of-Care for Acute Myocardial
Infarction (NQF #2431) (AMI Payment); (3) Hospital-Level, Risk-
Standardized 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.
[[Page 20170]]
g. Hospital-Acquired Condition (HAC) Reduction Program
Section 1886(p) of the Act, as added under section 3008(a) of the
Affordable Care Act, establishes an incentive to hospitals to reduce
the incidence of hospital-acquired conditions by requiring the
Secretary to make an adjustment to payments to applicable hospitals
effective for discharges beginning on October 1, 2014. This 1-percent
payment reduction applies to a hospital whose ranking in the worst-
performing quartile (25 percent) of all applicable hospitals, relative
to the national average, of conditions acquired during the applicable
period and on all of the hospital's discharges for the specified fiscal
year. As part of our agency-wide Patients over Paperwork and Meaningful
Measures Initiatives, discussed in section I.A.2. of the preamble of
this 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.
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 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[dash]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
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 Sec. 412.4(c) of the regulation to
specify that, effective for discharges on or after October 1, 2018, if
a discharge is assigned to one of the MS-DRGs subject to the postacute
care transfer policy and the individual is transferred to hospice care
by a hospice program, the discharge 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
[[Page 20171]]
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 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[dash]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 risk-adjusted readmission rate during a 3-year period for
acute myocardial infarction (AMI), heart failure (HF), pneumonia,
chronic obstructive pulmonary disease (COPD), total hip arthroplasty/
total knee arthroplasty (THA/TKA), and coronary artery bypass graft
(CABG). Overall, in this proposed rule, we estimate that 2,610
hospitals would have their base operating DRG payments reduced by their
determined proposed proxy FY 2019 hospital-specific 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[dash]based incentive
payments under the program in a given year must be equal to the total
amount of base operating MS-DRG payment amount reductions for that
year, as estimated by the Secretary. The estimated amount of base
operating MS-DRG payment amount reductions for the FY 2019 program year
and, therefore, the estimated amount available for value-based
incentive payments for FY 2019 discharges is approximately $1.9
billion.
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 chart-abstracted 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
[[Page 20172]]
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
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[dash]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[dash]related groups
(DRGs).
The base payment rate is comprised of a standardized amount that is
divided into a labor-related share and a nonlabor-related share. The
labor-related share is adjusted by the wage index applicable to the
area where the hospital is located. If the hospital is located in
Alaska or Hawaii, the nonlabor-related share is adjusted by a cost-of-
living adjustment factor. This base payment rate is multiplied by the
DRG relative weight.
If the hospital treats a high percentage of certain low-income
patients, it receives a percentage add-on payment applied to the DRG-
adjusted base payment rate. This add-on payment, known as the
disproportionate share hospital (DSH) adjustment, provides for a
percentage increase in Medicare payments to hospitals that qualify
under either of two statutory formulas designed to identify hospitals
that serve a disproportionate share of low-income patients. For
qualifying hospitals, the amount of this adjustment varies based on the
outcome of the statutory calculations. The Affordable Care Act revised
the Medicare DSH payment methodology and provides for a new additional
Medicare payment that considers the amount of uncompensated care
beginning on October 1, 2013.
If the hospital is training residents in an approved residency
program(s), it receives a percentage add-on payment for each case paid
under the IPPS, known as the indirect medical education (IME)
adjustment. This percentage varies, depending on the ratio of residents
to beds.
Additional payments may be made for cases that involve new
technologies or medical services that have been approved for special
add-on payments. To qualify, a new technology or medical service must
demonstrate that it is a substantial clinical improvement over
technologies or services otherwise available, and that, absent an
add[dash]on payment, it would be inadequately paid under the regular
DRG payment.
The costs incurred by the hospital for a case are evaluated to
determine whether the hospital is eligible for an additional payment as
an outlier case. This additional payment is designed to protect the
hospital from large financial losses due to unusually expensive cases.
Any eligible outlier payment is added to the DRG-adjusted base payment
rate, plus any DSH, IME, and new technology or medical service add-on
adjustments.
Although payments to most hospitals under the IPPS are made on the
basis of the standardized amounts, some categories of hospitals are
paid in whole or in part based on their hospital-specific rate, which
is determined from their costs in a base year. For example, sole
community hospitals (SCHs) receive the higher of a
hospital[dash]specific rate based on their costs in a base year (the
highest of FY 1982, FY 1987, FY 1996, or FY 2006) or the IPPS Federal
rate based on the standardized amount. SCHs are the sole source of care
in their areas. Specifically, section 1886(d)(5)(D)(iii) of the Act
defines an SCH as a hospital that is located more than 35 road miles
from another hospital or that, by reason of factors such as isolated
location, weather conditions, travel conditions, or absence of other
like hospitals (as determined by the Secretary), is the sole source of
hospital inpatient services reasonably available to Medicare
beneficiaries. In addition, certain rural hospitals previously
designated by the Secretary as essential access community hospitals are
considered SCHs.
Under current law, the Medicare-dependent, small rural hospital
(MDH) program is effective through FY 2022. Through and including FY
2006, an MDH received the higher of the Federal rate or the Federal
rate plus 50 percent of the amount by which the Federal rate was
exceeded by the higher of its FY 1982 or FY 1987 hospital[dash]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.
[[Page 20173]]
2. Hospitals and Hospital Units Excluded From the IPPS
Under section 1886(d)(1)(B) of the Act, as amended, certain
hospitals and hospital units are excluded from the IPPS. These
hospitals and units are: Inpatient rehabilitation facility (IRF)
hospitals and units; long-term care hospitals (LTCHs); psychiatric
hospitals and units; children's hospitals; cancer hospitals; extended
neoplastic disease care hospitals, and hospitals located outside the 50
States, the District of Columbia, and Puerto Rico (that is, hospitals
located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands,
and American Samoa). Religious nonmedical health care institutions
(RNHCIs) are also excluded from the IPPS. Various sections of the
Balanced Budget Act of 1997 (BBA, Pub. L. 105-33), the Medicare,
Medicaid and SCHIP [State Children's Health Insurance Program] Balanced
Budget Refinement Act of 1999 (BBRA, Pub. L. 106-113), and the
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act
of 2000 (BIPA, Pub. L. 106-554) provide for the implementation of PPSs
for IRF hospitals and units, LTCHs, and psychiatric hospitals and units
(referred to as inpatient psychiatric facilities (IPFs)). (We note that
the annual updates to the LTCH PPS are included along with the IPPS
annual update in this document. Updates to the IRF PPS and IPF PPS are
issued as separate documents.) Children's hospitals, cancer hospitals,
hospitals located outside the 50 States, the District of Columbia, and
Puerto Rico (that is, hospitals located in the U.S. Virgin Islands,
Guam, the Northern Mariana Islands, and American Samoa), and RNHCIs
continue to be paid solely under a reasonable cost-based system subject
to a rate[dash]of[dash]increase ceiling on inpatient operating costs.
Similarly, extended neoplastic disease care hospitals are paid on a
reasonable cost basis subject to a rate[dash]of[dash]increase ceiling
on inpatient operating costs.
The existing regulations governing payments to excluded hospitals
and hospital units are located in 42 CFR parts 412 and 413.
3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)
The Medicare prospective payment system (PPS) for LTCHs applies to
hospitals described in section 1886(d)(1)(B)(iv) of the Act effective
for cost reporting periods beginning on or after October 1, 2002. The
LTCH PPS was established under the authority of sections 123 of the
BBRA and section 307(b) of the BIPA (as codified under section
1886(m)(1) of the Act). During the 5-year (optional) transition period,
a LTCH's payment under the PPS was based on an increasing proportion of
the LTCH Federal rate with a corresponding decreasing proportion based
on reasonable cost principles. Effective for cost reporting periods
beginning on or after October 1, 2006 through September 30, 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.
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[dash]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 Long-Term 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,
[[Page 20174]]
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 dual-
eligible patients.
5. The Bipartisan Budget Act of 2018 (Pub. L. 115-123)
The Bipartisan Budget Act of 2018 (Pub. L. 115-123), enacted on
February 9, 2018, contains provisions affecting payments under the IPPS
and the LTCH PPS, which we are 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 low-volume hospital
payment adjustment policy for FYs 2018 through 2022. For FY 2018, this
provision extends the qualifying criteria and payment adjustment
formula that applied for FYs 2011 through 2017. For FYs 2019 through
2022, this provision modifies the discharge criterion and payment
adjustment formula. In FY 2023 and subsequent fiscal years, the
qualifying criteria and payment adjustment revert to the requirements
that were in effect for FYs 2005 through 2010.
Section 50205 extends the MDH program through FY 2022. It
also provides for an eligible hospital that is located in a State with
no rural area to qualify for MDH status under an expanded definition if
the hospital satisfies any of the statutory criteria at section
1886(d)(8)(E)(ii)(I), (II) (as of January 1, 2018), or (III) of the Act
to be reclassified as rural.
Section 51005(a) modified section 1886(m)(6) of the Act by
extending the blended payment rate for site neutral payment rate LTCH
discharges for cost reporting periods beginning in FY 2016 by an
additional 2 years (FYs 2018 and 2019). In addition, section 51005(b)
reduces the LTCH IPPS comparable per diem amount used in the site
neutral payment rate for FYs 2018 through 2026 by 4.6 percent. In this
proposed rule, we 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
capital-related 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[dash]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 wage-related costs in the wage
index.
Calculation of the proposed occupational mix adjustment
for FY 2019 based on the 2016 Occupational Mix Survey.
Analysis and implementation of the proposed FY 2019
occupational mix adjustment to the wage index for acute care hospitals.
Proposed application of the rural floor and the frontier
State floor and the proposed expiration of the imputed floor.
Proposals to codify policies regarding multicampus
hospitals.
Proposed revisions to the wage index for acute care
hospitals based on hospital redesignations and reclassifications under
sections 1886(d)(8)(B), (d)(8)(E), and (d)(10) of the Act.
The proposed adjustment to the wage index for acute care
hospitals for FY 2019 based on commuting patterns of hospital employees
who reside in a county and work in a different area with a higher wage
index.
Determination of the labor-related share for the proposed
FY 2019 wage index.
Public comment solicitation on wage index disparities.
3. Other Decisions and Proposed Changes to the IPPS for Operating Costs
In section IV. of the preamble of 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
[[Page 20175]]
measures and the process for hospital review and correction of those
rates for FY 2019.
Proposed changes to the requirements and provision of
value-based incentive payments under the Hospital Value-Based
Purchasing Program.
Proposed requirements for payment adjustments to hospitals
under the HAC Reduction Program for FY 2019.
Proposed changes to Medicare GME affiliation agreements
for new urban teaching hospitals.
Discussion of and proposals relating to the implementation
of the Rural Community Hospital Demonstration Program in FY 2019.
Proposed revisions of the hospital inpatient admission
orders documentation requirements.
4. Proposed FY 2019 Policy Governing the IPPS for Capital-Related Costs
In section V. of the preamble to this proposed rule, we discuss the
proposed payment policy requirements for capital[dash]related costs and
capital payments to hospitals for FY 2019.
5. Proposed Changes to the Payment Rates for Certain Excluded
Hospitals: Rate[dash]of[dash]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
In section VII. of the preamble of the proposed rule, we set
forth--
Proposed changes to the LTCH PPS Federal payment rates,
factors, and other payment rate policies under the LTCH PPS for FY
2019.
Proposed changes to the blended payment rate for site
neutral payment rate cases.
Proposed elimination of the 25-percent threshold policy.
7. Proposed Changes Relating to Quality Data Reporting for Specific
Providers and Suppliers
In section VIII. of the preamble of the proposed rule, we address--
Proposed requirements for the Hospital Inpatient Quality
Reporting (IQR) Program.
Proposed changes to the requirements for the quality
reporting program for PPS-exempt cancer hospitals (PCHQR Program).
Proposed changes to the requirements under the LTCH
Quality Reporting Program (LTCH QRP).
Proposed changes to requirements pertaining to the
clinical quality measurement for eligible hospitals and CAHs
participating in the Medicare and Medicaid Promoting Interoperability
Programs.
8. Proposed Revision to the Supporting Documentation Requirements for
an Acceptable Medicare Cost Report Submission
In section IX. of the preamble of 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[dash]of[dash]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
rate[dash]of[dash]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[dash]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[dash]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
[[Page 20176]]
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: http://www.medpac.gov.
II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-
DRG) Classifications and Relative Weights
A. Background
Section 1886(d) of the Act specifies that the Secretary shall
establish a classification system (referred to as diagnosis-related
groups (DRGs)) for inpatient discharges and adjust payments under the
IPPS based on appropriate weighting factors assigned to each DRG.
Therefore, under the IPPS, Medicare pays for inpatient hospital
services on a rate per discharge basis that varies according to the DRG
to which a beneficiary's stay is assigned. The formula used to
calculate payment for a specific case multiplies an individual
hospital's payment rate per case by the weight of the DRG to which the
case is assigned. Each DRG weight represents the average resources
required to care for cases in that particular DRG, relative to the
average resources used to treat cases in all DRGs.
Section 1886(d)(4)(C) of the Act requires that the Secretary adjust
the DRG classifications and relative weights at least annually to
account for changes in resource consumption. These adjustments are made
to reflect changes in treatment patterns, technology, and any other
factors that may change the relative use of hospital resources.
B. MS-DRG Reclassifications
For general information about the MS-DRG system, including yearly
reviews and changes to the MS-DRGs, we refer readers to the previous
discussions in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR
43764 through 43766) and the FYs 2011 through 2018 IPPS/LTCH PPS final
rules (75 FR 50053 through 50055; 76 FR 51485 through 51487; 77 FR
53273; 78 FR 50512; 79 FR 49871; 80 FR 49342; 81 FR 56787 through
56872; and 82 FR 38010 through 38085, respectively).
C. Adoption of the MS-DRGs in FY 2008
For information on the adoption of the MS-DRGs in FY 2008, we refer
readers to the FY 2008 IPPS final rule with comment period (72 FR 47140
through 47189).
D. 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 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
[[Page 20177]]
rulemaking, we believe the directive under section 15005 of Public Law
114-255 is clear. Therefore, in the FY 2018 IPPS/LTCH PPS final rule
(82 FR 38009) for FY 2018, we implemented the required +0.4588
percentage point adjustment to the standardized amount. This is a
permanent adjustment to payment rates. While we did not address future
adjustments required under section 414 of the MACRA and section 15005
of Public Law 114-255 at that time, we stated that we expected to
propose positive 0.5 percentage point adjustments to the standardized
amounts for FYs 2019 through 2023.
3. Proposed Adjustment for FY 2019
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[dash]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.
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 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. Click on the link on the left side of the
screen titled ``FY 2019 IPPS Proposed Rule Home Page'' or ``Acute
Inpatient Files for Download.''
F. Proposed Changes to Specific MS-DRG Classifications
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 updates. Given the need
for more time to carefully evaluate requests and propose updates, we
changed the deadline to request updates to the MS-DRGs to November 1 of
each year. This will provide an additional 5 weeks for the data
analysis and review process. Interested parties had to submit any
comments and suggestions for FY 2019 by November 1, 2017, and are
encouraged to submit any comments and suggestions for FY 2020 by
November 1, 2018 via the CMS MS-DRG Classification Change Request
Mailbox located at: [email protected]. The comments
that were submitted in a timely manner for FY 2019 are discussed in
this section of the preamble of this 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
[[Page 20178]]
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 (Other Heart Assist System
Implant) and MS-DRGs 268 and 269 (Aortic and Heart Assist Procedures
Except Pulsation Balloon with and without MCC, respectively) where
procedures involving heart assist devices are currently assigned. We
also encouraged the public to submit any comments on restructuring the
MS-DRGs for heart assist system procedures to the CMS MS-DRG
Classification Change Request Mailbox located at:
[email protected] by November 1, 2017.
The logic for Pre-MDC MS-DRGs 001 and 002 is comprised of two
lists. The first list includes procedure codes identifying a heart
transplant procedure, and the second list includes procedure codes
identifying the implantation of a heart assist system. The list of
procedure codes identifying the implantation of a heart assist system
includes the following three codes.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02HA0QZ................... Insertion of implantable heart assist system
into heart, open approach.
02HA3QZ................... Insertion of implantable heart assist system
into heart, percutaneous approach.
02HA4QZ................... Insertion of implantable heart assist system
into heart, percutaneous endoscopic
approach.
------------------------------------------------------------------------
In addition to these three procedure codes, there are also 33 pairs
of code combinations or procedure code ``clusters'' that, when reported
together, satisfy the logic for assignment to MS-DRGs 001 and 002. The
code combinations are represented by two procedure codes and include
either one code for the insertion of the device with one code for
removal of the device or one code for the revision of the device with
one code for the removal of the device. The 33 pairs of code
combinations are listed below.
----------------------------------------------------------------------------------------------------------------
Code Code description Code Code description
----------------------------------------------------------------------------------------------------------------
02HA0RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, open approach.
02HA0RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, open approach.
02HA0RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, open approach. approach.
02HA0RZ.................. Insertion of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart, open
approach. approach.
02HA0RZ.................. Insertion of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart,
approach. percutaneous approach.
02HA0RZ.................. Insertion of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system into heart, open system from heart,
approach. percutaneous endoscopic
approach.
02HA3RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
approach.
02HA3RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
approach.
02HA3RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
approach.
02HA4RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
endoscopic approach.
[[Page 20179]]
02HA4RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
endoscopic approach.
02HA4RZ.................. Insertion of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart, open
percutaneous endoscopic approach.
approach.
02HA4RZ.................. Insertion of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart,
percutaneous endoscopic percutaneous approach.
approach.
02HA4RZ.................. Insertion of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system into heart, system from heart,
percutaneous endoscopic percutaneous endoscopic
approach. approach.
02WA0QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart, open
approach.
02WA0QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart,
percutaneous approach.
02WA0QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, open approach. system from heart,
percutaneous endoscopic
approach.
02WA0RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart, open
approach. approach.
02WA0RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart,
approach. percutaneous approach.
02WA0RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, open system from heart,
approach. percutaneous endoscopic
approach.
02WA3QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
approach. approach.
02WA3QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous approach.
02WA3QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous endoscopic
approach.
02WA3RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart, open
percutaneous approach. approach.
02WA3RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous approach. percutaneous approach.
02WA3RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous approach. percutaneous endoscopic
approach.
02WA4QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
endoscopic approach. approach.
02WA4QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
endoscopic approach. percutaneous approach.
02WA4QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
endoscopic approach. percutaneous endoscopic
approach.
02WA4RZ.................. Revision of short-term with 02PA0RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart, open
percutaneous endoscopic approach.
approach.
02WA4RZ.................. Revision of short-term with 02PA3RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous endoscopic percutaneous approach.
approach.
02WA4RZ.................. Revision of short-term with 02PA4RZ................. Removal of short-term
external heart assist external heart assist
system in heart, system from heart,
percutaneous endoscopic percutaneous endoscopic
approach. approach.
----------------------------------------------------------------------------------------------------------------
In response to our solicitation for public comments on
restructuring the MS-DRGs for heart assist system procedures,
commenters recommended that CMS maintain the current logic under the
Pre-MDC MS-DRGs 001 and 002. Similar to the discussion in the FY 2018
IPPS/LTCH PPS final rule (82 FR 38011 through 38012) involving MS-DRG
215 (Other Heart Assist System Implant), the commenters provided
examples of common clinical scenarios involving a left ventricular
assist device (LVAD) and included the procedure codes that were
reported under the ICD-9 based MS-DRGs in comparison to the procedure
codes reported under the ICD-10 MS-DRGs, which are reflected in the
following table.
[[Page 20180]]
----------------------------------------------------------------------------------------------------------------
ICD-9-CM procedure
Procedure code ICD-9 MS-DRG ICD-10-PCS codes ICD-10 MS-DRG
----------------------------------------------------------------------------------------------------------------
New LVAD inserted................ 37.66 (Insertion of 001 or 002 02WA0QZ (Insertion of 001 or 002
implantable heart implantable heart
assist system). assist system into
heart, open approach).
02WA3QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
approach).
02WA4QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
endoscopic approach).
LVAD Exchange--existing LVAD is 37.63 (Repair of 215 02PA0QZ (Removal of 001 or 002
removed and replaced with either heart assist implantable heart
new LVAD system or new LVAD pump. system). assist system from
heart, open approach).
02PA3QZ (Removal of
implantable heart
assist system from
heart, percutaneous
approach).
02PA4QZ (Removal of
implantable heart
assist system from
heart, percutaneous
endoscopic approach)
and.
02WA0QZ (Insertion of
implantable heart
assist system into
heart, open approach).
02WA3QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
approach).
02WA4QZ (Insertion of
implantable heart
assist system into
heart, percutaneous
endoscopic approach).
LVAD revision and repair-- 37.63 (Repair of 215 02WA0QZ (Revision of 215
existing LVAD is adjusted or heart assist implantable heart
repaired without removing the system). assist system in heart,
existing LVAD device. open approach).
02WA3QZ (Revision of
implantable heart
assist system in heart,
percutaneous approach).
02WA4QZ (Revision of
implantable heart
assist system in heart,
percutaneous endoscopic
approach).
----------------------------------------------------------------------------------------------------------------
The commenters noted that, for Pre-MDC MS-DRGs 001 and 002, the
procedures involving the insertion of an implantable heart assist
system, such as the insertion of a LVAD, and the procedures involving
exchange of an LVAD (where an existing LVAD is removed and replaced
with either a new LVAD or a new LVAD pump) demonstrate clinical
similarities and utilize similar resources. Although the commenters
recommended that CMS maintain the current logic under the Pre-MDC MS-
DRGs 001 and 002, they also recommended that CMS continue to monitor
the data in these MS-DRGs for future consideration of distinctions (for
example, different approaches and evolving technologies) that may
impact the clinical and resource use of patients undergoing procedures
utilizing heart assist devices. The commenters also requested that
coding guidance be issued for assignment of the correct ICD-10-PCS
procedure codes describing LVAD exchanges to encourage accurate
reporting of these procedures.
We agree with the commenters that we should continue to monitor the
data in Pre-MDC MS-DRGs 001 and 002 for future consideration of
distinctions (for example, different approaches and evolving
technologies) that may impact the clinical and resource use of patients
undergoing procedures utilizing heart assist devices. In response to
the request that coding guidance be issued for assignment of the
correct ICD-10-PCS procedure codes describing LVAD exchanges to
encourage accurate reporting of these procedures, as we noted in the FY
2018 IPPS/LTCH PPS final rule (82 FR 38012), coding advice is issued
independently from payment policy. We also noted that, historically, we
have not provided coding advice in rulemaking with respect to policy
(82 FR 38045). We collaborate with the American Hospital Association
(AHA) through the Coding Clinic for ICD-10-CM and ICD-10-PCS to promote
proper coding. We 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 Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
MS-DRG 002--All cases........................................... 179 18.3 99,635
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 001, there were a total of 1,993
cases with an average length of stay of 35.6 days and average costs of
$185,660. For MS-DRG 002, there were a total of 179 cases with an
average length of stay of 18.3 days and average costs of $99,635.
We then examined claims data in Pre-MDC MS-DRGs 001 and 002 for
cases that reported one of the three procedure codes identifying the
implantation of a heart assist system such as the LVAD. Our findings
are shown in the following table.
[[Page 20181]]
MS-DRGs for Heart Transplant or Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
MS-DRG 001--Cases with procedure code 02HA0QZ (Insertion of 1,260 35.5 206,663
implantable heart assist system into heart, open approach).....
MS-DRG 001--Cases with procedure code 02HA3QZ (Insertion of 1 8 33,889
implantable heart assist system into heart, percutaneous
approach)......................................................
MS-DRG 001--Cases with procedure code 02HA4QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
endoscopic approach)...........................................
MS-DRG 002--All cases........................................... 179 18.3 99,635
MS-DRG 002--Cases with procedure code 02HA0QZ (Insertion of 82 19.9 131,957
implantable heart assist system into heart, open approach).....
MS-DRG 002--Cases with procedure code 02HA3QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
approach)......................................................
MS-DRG 002--Cases with procedure code 02HA4QZ (Insertion of 0 0 0
implantable heart assist system into heart, percutaneous
endoscopic approach)...........................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 001, there were a total of 1,260
cases reporting procedure code 02HA0QZ (Insertion of implantable heart
assist system into heart, open approach) with an average length of stay
of 35.5 days and average costs of $206,663. There was one case that
reported procedure code 02HA3QZ (Insertion of implantable heart assist
system into heart, percutaneous approach) with an average length of
stay of 8 days and average costs of $33,889. There were no cases
reporting procedure code 02HA4QZ (Insertion of implantable heart assist
system into heart, percutaneous endoscopic approach). For MS-DRG 002,
there were a total of 82 cases reporting procedure code 02HA0QZ
(Insertion of implantable heart assist system into heart, open
approach) with an average length of stay of 19.9 days and average costs
of $131,957. There were no cases reporting procedure codes 02HA3QZ
(Insertion of implantable heart assist system into heart, percutaneous
approach) or 02HA4QZ (Insertion of implantable heart assist system into
heart, percutaneous endoscopic approach).
We also examined the cases in MS-DRGs 001 and 002 that reported one
of the possible 33 pairs of code combinations or clusters. Our findings
are shown in the following 8 tables. The first table provides the total
number of cases reporting a procedure code combination (or cluster)
compared to all of the cases in the respective MS-DRG, followed by
additional detailed tables showing the number of cases, average length
of stay, and average costs for each specific code combination that was
reported in the claims data.
Heart Transplant or Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 and 002 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001--All cases........................................... 1,993 35.6 $185,660
MS-DRG 001--Cases with a procedure code combination (cluster)... 149 28.4 179,607
MS-DRG 002--All cases........................................... 179 18.3 99,635
MS-DRG 002--Cases with a procedure code combination (cluster)... 6 3.8 57,343
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RS (Insertion of 3 20.3 $121,919
biventricular short-term external heart assist system into
heart, open approach) with 02PA0RZ (Removal of short-term
external heart assist system from heart, open approach)........
Cases with a procedure code combination of 02HA0RS (Insertion of 2 12 114,688
biventricular short-term external heart assist system into
heart, open approach) with 02PA3RZ (Removal of short-term
external heart assist system from heart, percutaneous approach)
All cases reporting one or more of the above procedure code 5 17 119,027
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
[[Page 20182]]
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RZ (Insertion of 30 55.6 $351,995
short-term external heart assist system into heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02HA0RZ (Insertion of 19 29.8 191,163
short-term external heart assist system into heart, open
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 49 45.6 289,632
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA0RZ (Insertion of 1 4 48,212
short-term external heart assist system into heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02HA0RZ (Insertion of 2 4.5 66,386
short-term external heart assist system into heart, open
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 3 4.3 60,328
combinations in MS-DRG 002.....................................
All cases reporting one or more of the above procedure code 52 43.3 276,403
combinations across both MS-DRGs 001 and 002...................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA3RS (Insertion of 3 43.3 $233,330
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA0RZ (Removal of short-
term external heart assist system from heart, open approach)...
Cases with a procedure code combination of 02HA3RS (Insertion of 24 14.8 113,955
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA3RZ (Removal of short-
term external heart assist system from heart, percutaneous
approach)......................................................
Cases with a procedure code combination of 02HA3RS (Insertion of 1 44 153,284
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA4RZ (Removal of short-
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
All cases reporting one or more of the above procedure code 28 18.9 128,150
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA3RS (Insertion of 2 4 $30,954
biventricular short-term external heart assist system into
heart, percutaneous approach) with 02PA3RZ (Removal of short-
term external heart assist system from heart, percutaneous
approach)......................................................
All cases reporting one of the above procedure code combinations 2 4 30,954
in MS-DRG 002..................................................
All cases reporting one or more of the above procedure code 30 17.9 121,670
combinations across both MS[dash]DRGs 001 and 002..............
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02HA4RZ (Insertion of 4 17.3 $154,885
short-term external heart assist system into heart,
percutaneous endoscopic approach) with 02PA3RZ (Removal of
short-term external heart assist system from heart,
percutaneous approach).........................................
Cases with a procedure code combination of 02HA4RZ (Insertion of 2 15.5 80,852
short-term external heart assist system into heart, open
approach) with 02PA4RZ (Removal of short-term external heart
assist system from heart, percutaneous endoscopic approach)....
All cases reporting one or more of the above procedure code 6 16.7 130,207
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
[[Page 20183]]
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA0QZ (Revision of 1 105 $516,557
implantable heart assist system in heart, open approach) with
02PA0RZ (Removal of short-term external heart assist system
from heart, open approach).....................................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG 001 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA0RZ (Revision of 2 40 $285,818
short-term external heart assist system in heart, open
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02WA0RZ (Revision of 1 43 372,673
short-term external heart assist system in heart, open
approach) with 02PA03Z (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 3 41 314,770
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
Procedure Code Combinations for Implant of Heart Assist System
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA3RZ (Revision of 2 24 $123,084
short-term external heart assist system in heart, percutaneous
approach) with 02PA0RZ (Removal of short-term external heart
assist system from heart, open approach).......................
Cases with a procedure code combination of 02WA3RZ (Revision of 55 14.7 104,963
short-term external heart assist system in heart, percutaneous
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 57 15 105,599
combinations in MS-DRG 001.....................................
----------------------------------------------------------------------------------------------------------------
MS-DRG 002
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA3RZ (Revision of 1 2 101,168
short-term external heart assist system in heart, percutaneous
approach) with 02PA3RZ (Removal of short-term external heart
assist system from heart, percutaneous approach)...............
All cases reporting one or more of the above procedure code 58 14.8 105,522
combinations across both MS-DRGs 001 and 002...................
----------------------------------------------------------------------------------------------------------------
MS-DRG 001
----------------------------------------------------------------------------------------------------------------
Cases with a procedure code combination of 02WA4RZ (Revision of 1 10 112,698
short-term external heart assist system in heart, percutaneous
endoscopic approach) with 02PA0RZ (Removal of short-term
external heart assist system from heart, open approach)........
----------------------------------------------------------------------------------------------------------------
We did not find any cases reporting the following procedure code
combinations (clusters) in the claims data.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
02HA4RS.................. Insertion of with 02PA0RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart, open
assist system into approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA3RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous approach.
heart, percutaneous
endoscopic approach.
02HA4RS.................. Insertion of with 02PA4RZ................. Removal of short-term
biventricular short- external heart assist
term external heart system from heart,
assist system into percutaneous endoscopic
heart, percutaneous approach.
endoscopic approach.
02WA3QZ.................. Revision of implantable with 02PA0RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart, open
approach. approach.
02WA3QZ.................. Revision of implantable with 02PA3RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous approach.
[[Page 20184]]
02WA3QZ.................. Revision of implantable with 02PA4RZ................. Removal of short-term
heart assist system in external heart assist
heart, percutaneous system from heart,
approach. percutaneous endoscopic
approach.
----------------------------------------------------------------------------------------------------------------
The data show that there are differences in the average length of
stay and average costs for cases in Pre-MDC MS-DRGs 001 and 002
according to the type of procedure (insertion, revision, or removal),
the type of device (biventricular short-term external heart assist
system, short-term external heart assist system or implantable heart
assist system), and the approaches that were utilized (open,
percutaneous, or percutaneous endoscopic). We agree with the
commenters' recommendation to maintain the structure of Pre-MDC MS-DRGs
001 and 002 for FY 2019 and will continue to analyze the claims data.
We are inviting public comments on our decision to maintain the current
structure of Pre[dash]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 request
to review claims data for procedures involving extracorporeal membrane
oxygenation (ECMO) in combination with the insertion of a percutaneous
short-term external heart assist device to determine if the current MS-
DRG assignment is appropriate.
The logic for MS-DRG 215 is comprised of the procedure codes shown
in the following table, for which we examined claims data in the
September 2017 update of the FY 2017 MedPAR file in response to the
commenters' requests. Our findings are shown in the following table.
MS-DRG 215
[Other heart assist system implant]
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases....................................................... 3,428 8.7 $68,965
Cases with procedure code 02HA0RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative, open
approach)......................................................
Cases with procedure code 02HA0RS (Insertion of biventricular 9 10 118,361
short-term external heart assist system into heart, open
approach)......................................................
Cases with procedure code 02HA0RZ (Insertion of short-term 66 11.5 99,107
external heart assist system into heart, open approach)........
Cases with procedure code 02HA3RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative,
percutaneous approach).........................................
Cases with procedure code 02HA3RS (Insertion of biventricular 117 7.2 64,302
short-term external heart assist system into heart,
percutaneous approach).........................................
Cases with procedure code 02HA3RZ (Insertion of short-term 3,136 8.4 67,670
external heart assist system into heart, percutaneous approach)
Cases with procedure code 02HA4RJ (Insertion of short-term 0 0 0
external heart assist system into heart, intraoperative,
percutaneous endoscopic approach)..............................
Cases with procedure code 02HA4RS (Insertion of biventricular 1 2 43,988
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
Cases with procedure code 02HA4RZ (Insertion of short-term 31 5.3 57,042
external heart assist system into heart, percutaneous
endoscopic approach)...........................................
Cases with procedure code 02WA0JZ (Revision of synthetic 1 84 366,089
substitute in heart, open approach)............................
Cases with procedure code 02WA0QZ (Revision of implantable heart 56 25.1 123,410
assist system in heart, open approach).........................
Cases with procedure code 02WA0RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, open
approach)......................................................
Cases with procedure code 02WA0RZ (Revision of short-term 8 13.5 99,378
external heart assist system in heart, open approach)..........
Cases with procedure code 02WA3QZ (Revision of implantable heart 0 0 0
assist system in heart, percutaneous approach).................
Cases with procedure code 02WA3RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, percutaneous
approach)......................................................
Cases with procedure code 02WA3RZ (Revision of short-term 80 10 71,077
external heart assist system in heart, percutaneous approach)..
Cases with procedure code 02WA4QZ (Revision of implantable heart 0 0 0
assist system in heart, percutaneous endoscopic approach)......
Cases with procedure code 02WA4RS (Revision of biventricular 0 0 0
short-term external heart assist system in heart, percutaneous
endoscopic approach)...........................................
Cases with procedure code 02WA4RZ (Revision of short-term 0 0 0
external heart assist system in heart, percutaneous endoscopic
approach)......................................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 215, we found a total of 3,428
cases with an average length of stay of 8.7 days and average costs of
$68,965. For procedure codes describing the insertion of a
biventricular short-term external heart
[[Page 20185]]
assist system with open, percutaneous or percutaneous endoscopic
approaches, we found a total of 127 cases with an average length of
stay ranging from 2 to 10 days and average costs ranging from $43,988
to $118,361. For procedure codes describing the insertion of a short-
term external heart assist system with open, percutaneous or
percutaneous endoscopic approaches, we found a total of 3,233 cases
with an average length of stay ranging from 5.3 days to 11.5 days and
average costs ranging from $57,042 to $99,107. For procedure codes
describing the revision of a short-term external heart assist system
with open or percutaneous approaches, we found a total of 88 cases with
an average length of stay ranging from 10 to 13.5 days and average
costs ranging from $71,077 to $99,378. We found 1 case 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 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.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02HA0RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
open approach.
02HA3RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
percutaneous approach.
02HA4RJ................... Insertion of short-term external heart
assist system into heart, intraoperative,
percutaneous endoscopic approach.
------------------------------------------------------------------------
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[dash]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.
ECMO and Percutaneous Short-Term External Heart Assist Device
----------------------------------------------------------------------------------------------------------------
Number of Average length
Pre-MDC MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 003--All cases........................................... 14,383 29.5 $118,218
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 1,786 19 119,340
membrane oxygenation, continuous)..............................
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 94 11.4 110,874
membrane oxygenation, continuous) and 02HA3RZ (Insertion of
short-term external heart assist system into heart,
percutaneous approach).........................................
[[Page 20186]]
MS-DRG 003--Cases with procedure code 5A15223 (Extracorporeal 1 1 64,319
membrane oxygenation, continuous) and 02HA4RZ (Insertion of
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 14,383 cases with an
average length of stay of 29.5 days and average costs of $118,218 in
Pre-MDC MS-DRG 003. We found 1,786 cases reporting procedure code
5A15223 (Extracorporeal membrane oxygenation, continuous) with an
average length of stay of 19 days and average costs of $119,340. We
found 94 cases reporting procedure code 5A15223 and 02HA3RZ (Insertion
of short-term external heart assist system into heart, percutaneous
approach) with an average length of stay of 11.4 days and average costs
of $110,874. Lastly, we found 1 case reporting procedure code 5A15223
and 02HA4RZ (Insertion of short-term external heart assist system into
heart, percutaneous endoscopic approach) with an average length of stay
of 1 day and average costs of $64,319.
We also reviewed the cases in MS-DRG 215 for procedure codes
02HA3RZ and 02HA4RZ. Our findings are shown in the following table.
Percutaneous Short-Term External Heart Assist Device
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 215--All cases........................................... 3,428 8.7 $68,965
MS-DRG 215--Cases with procedure code 02HA3RZ (Insertion of 3,136 8.4 67,670
short-term external heart assist system into heart,
percutaneous approach).........................................
MS-DRG 215--Cases with procedure code 02HA4RZ (Insertion of 31 5.3 57,042
short-term external heart assist system into heart,
percutaneous endoscopic approach)..............................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 3,428 cases with an
average length of stay of 8.7 days and average costs of $68,965. We
found a total of 3,136 cases reporting procedure code 02HA3RZ with an
average length of stay of 8.4 days and average costs of $67,670. We
found a total of 31 cases reporting procedure code 02HA4RZ with an
average length of stay of 5.3 days and average costs of $57,042.
For Pre-MDC MS-DRG 003, while the average length of stay and
average costs for cases where procedure code 5A15223 was reported with
procedure code 02HA3RZ or procedure code 02HA4RZ are lower than the
average length of stay and average costs for cases where procedure code
5A15223 was reported alone, we are unable to determine from the data if
those ECMO procedures were performed percutaneously in the absence of a
unique code. In addition, the one case reporting procedure code 5A15223
with 02HA4RZ only had a 1 day length of stay and it is unclear from the
data what the circumstances of that case may have involved. For
example, the patient may have been transferred or may have expired.
Therefore, 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 268 and 269 (Aortic and Heart Assist Procedures Except
Pulsation Balloon with and without MCC, respectively), but recommended
that CMS continue to monitor the data in these MS-DRGs for future
consideration of distinctions (for example, different approaches and
evolving technologies) that may impact the clinical and resource use of
procedures involving heart assist devices.
The logic for heart assist system devices in MS-DRGs 268 and 269 is
comprised of the procedure codes shown in the following table, for
which we examined claims data in the September 2017 update of the FY
2017 MedPAR file in response to the commenter's request. Our findings
are shown in the following table.
MS-DRGs for Aortic and Heart Assist Procedures Except Pulsation Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 268--All cases........................................... 3,798 9.6 $49,122
MS-DRG 268--Cases with procedure code 02PA0QZ (Removal of 16 23.4 79,850
implantable heart assist system from heart, open approach).....
MS-DRG 268--Cases with procedure code 02PA0RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, open approach)..........................................
MS-DRG 268--Cases with procedure code 02PA0RZ (Removal of short- 0 0 0
term external heart assist system from heart, open approach)...
MS-DRG 268--Cases with procedure code 02PA3QZ (Removal of 28 10.5 31,797
implantable heart assist system from heart, percutaneous
approach)......................................................
[[Page 20187]]
MS-DRG 268--Cases with procedure code 02PA3RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous approach)..................................
MS-DRG 268--Cases with procedure code 02PA3RZ (Removal of short- 96 12.4 51,469
term external heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 268--Cases with procedure code 02PA4QZ (Removal of 5 7.8 37,592
implantable heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 268--Cases with procedure code 02PA4RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous endoscopic approach).......................
MS-DRG 268--Cases with procedure code 02PA4RZ (Removal of short- 0 0 0
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 269--All cases........................................... 16,900 2.4 30,793
MS-DRG 269--Cases with procedure code 02PA0QZ (Removal of 10 8 23,741
implantable heart assist system from heart, open approach).....
MS-DRG 269--Cases with procedure code 02PA0RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, open approach)..........................................
MS-DRG 269--Cases with procedure code 02PA0RZ (Removal of short- 0 0 0
term external heart assist system from heart, open approach)...
MS-DRG 269--Cases with procedure code 02PA3QZ (Removal of 6 5 19,421
implantable heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 269--Cases with procedure code 02PA3RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous approach)..................................
MS-DRG 269--Cases with procedure code 02PA3RZ (Removal of short- 11 4 25,719
term external heart assist system from heart, percutaneous
approach)......................................................
MS-DRG 269--Cases with procedure code 02PA4QZ (Removal of 1 3 14,415
implantable heart assist system from heart, percutaneous
endoscopic approach)...........................................
MS-DRG 269--Cases with procedure code 02PA4RS (Removal of 0 0 0
biventricular short-term external heart assist system from
heart, percutaneous endoscopic approach).......................
MS-DRG 269--Cases with procedure code 02PA4RZ (Removal of short- 0 0 0
term external heart assist system from heart, percutaneous
endoscopic approach)...........................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, for MS-DRG 268, there were a total of 3,798
cases, with an average length of stay of 9.6 days and average costs of
$49,122. There were 16 cases reporting procedure code 02PA0QZ (Removal
of implantable heart assist system from heart, open approach), with an
average length of stay of 23.4 days and average costs of $79,850. There
were no cases that reported procedure codes 02PA0RS (Removal of
biventricular short-term external heart assist system from heart, open
approach), 02PA0RZ (Removal of short-term external heart assist system
from heart, open approach), 02PA3RS (Removal of biventricular short-
term external heart assist system from heart, percutaneous approach),
02PA4RS (Removal of biventricular short-term external heart assist
system from heart, percutaneous endoscopic approach) or 02PA4RZ
(Removal of short-term external heart assist system from heart,
percutaneous endoscopic approach). There were 28 cases reporting
procedure code 02PA3QZ (Removal of implantable heart assist system from
heart, percutaneous approach), with an average length of stay of 10.5
days and average costs of $31,797. There were 96 cases reporting
procedure code 02PA3RZ (Removal of short-term external heart assist
system from heart, percutaneous approach), with an average length of
stay of 12.4 days and average costs of $51,469. There were 5 cases
reporting procedure code 02PA4QZ (Removal of implantable heart assist
system from heart, percutaneous endoscopic approach), with an average
length of stay of 7.8 days and average costs of $37,592. For MS-DRG
269, there were a total of 16,900 cases, with an average length of stay
of 2.4 days and average costs of $30,793. There were 10 cases reporting
procedure code 02PA0QZ (Removal of implantable heart assist system from
heart, open approach), with an average length of stay of 8 days and
average costs of $23,741. There were no cases reporting procedure codes
02PA0RS (Removal of biventricular short-term external heart assist
system from heart, open approach), 02PA0RZ (Removal of short-term
external heart assist system from heart, open approach), 02PA3RS
(Removal of biventricular short-term external heart assist system from
heart, percutaneous approach), 02PA4RS (Removal of biventricular short-
term external heart assist system from heart, percutaneous endoscopic
approach) or 02PA4RZ (Removal of short-term external heart assist
system from heart, percutaneous endoscopic approach). There were 6
cases reporting procedure code 02PA3QZ (Removal of implantable heart
assist system from heart, percutaneous approach), with an average
length of stay of 5 days and average costs of $19,421. There were 11
cases reporting procedure code 02PA3RZ (Removal of short-term external
heart assist system from heart, percutaneous approach), with an average
length of stay of 4 days and average costs of $25,719. There was 1 case
reporting procedure code 02PA4QZ (Removal of implantable heart assist
system from heart, percutaneous endoscopic approach), with an average
length of stay of 3 days and average costs of $14,415.
The data show that there are differences in the average length of
stay and average costs for cases in MS-DRGs 268 and 269 according to
the type of device (short-term external heart assist system or
implantable heart assist system), and the approaches that were utilized
(open, percutaneous, or percutaneous endoscopic). 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
[[Page 20188]]
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[reg] 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[reg] 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[reg] 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-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. 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
----------------------------------------------------------------------------------------------------------------
Number of Average length
ICD-10-PCS procedures cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 129 (Major Head and Neck Procedures with CC/MCC or Major 1 7 $10,357
Device)--Cases with procedure code D710BBZ (Low dose rate (LDR)
brachytherapy of bone marrow using Palladium[dash]103 (Pd-103))
MS-DRG 724 (Malignancy, Male Reproductive System without CC/ 1 7 32,298
MCC)--Cases with procedure code DV10BBZ (Low dose rate (LDR)
brachytherapy of prostate using Palladium[dash]103 (Pd-103))...
MS-DRG 129--Cases with procedure code DW11BBZ (Low dose rate 1 3 42,565
(LDR) brachytherapy of head and neck using Palladium[dash]103
(Pd-103))......................................................
MS-DRG 330 (Major Small and Large Bowel Procedures with CC)-- 1 8 74,190
Cases with procedure code DW16BBZ (Low dose rate (LDR)
brachytherapy of pelvic region using Palladium[dash]103 (Pd-
103))..........................................................
----------------------------------------------------------------------------------------------------------------
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[reg] technology for FY 2019. We are inviting public comments
on our proposal to maintain the current MS[dash]DRG structure for
procedures involving the CivaSheet[reg] technology.
c. Laryngectomy
The logic for case assignment to Pre-MDC MS-DRGs 11, 12, and 13
(Tracheostomy for Face, Mouth and Neck Diagnoses with MCC, with CC, and
without CC/MCC, respectively) as displayed in the ICD-10 MS-DRG Version
35 Definitions Manual, which is available via the Internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending, is
comprised of a list of procedure codes for laryngectomies, a list of
procedure codes for tracheostomies, and a list of diagnosis codes for
conditions involving the face, mouth, and neck. The procedure codes for
laryngectomies are listed separately and are reported differently from
the procedure codes listed for tracheostomies. The procedure codes
listed for tracheostomies must be reported with a diagnosis code
involving the face, mouth, or neck as a principal diagnosis to satisfy
the logic for assignment to Pre-MDC MS-DRG 11, 12, or 13.
Alternatively, any principal diagnosis code reported with a procedure
code from the list of procedure codes for laryngectomies will satisfy
the logic for assignment to Pre[dash]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 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) T-Cell Therapy
Chimeric Antigen Receptor (CAR) T-cell 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[dash]cells,
[[Page 20189]]
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[dash]cells are then administered to the patient by infusion.
Two CAR T[dash]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 B-cell 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[dash]cell therapy drugs are
currently identified with ICD-10-PCS procedure codes XW033C3
(Introduction of engineered autologous chimeric antigen receptor t-cell
immunotherapy into peripheral vein, percutaneous approach, new
technology group 3) and XW043C3 (Introduction of engineered autologous
chimeric antigen receptor t-cell immunotherapy into central vein,
percutaneous approach, new technology group 3), which both became
effective October 1, 2017. Procedures described by these two ICD-10-PCS
procedure codes are designated as non-O.R. procedures that have no
impact on MS-DRG assignment.
We have received many inquiries from the public regarding payment
of CAR T[dash]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[dash]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[dash]cell therapy
procedures would be reported. The CAR T-cell procedures involve a type
of autologous immunotherapy in which the patient's cells are
genetically transformed and then returned to that patient after the
patient undergoes cell depleting chemotherapy. Our clinical advisors
believe that patients receiving treatment utilizing CAR T-cell therapy
procedures would have similar clinical characteristics and
comorbidities to those seen in cases representing patients receiving
treatment for other 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[dash]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 T-cell 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[dash]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
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
[[Page 20190]]
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(copyright) neurostimulator), to retitled MS-DRG 023
(Craniotomy with Major Device Implant or Acute Complex Central Nervous
System (CNS) Principal Diagnosis (PDX) with MCC or Chemotherapy Implant
or Epilepsy with Neurostimulator), even if there is no MCC reported:
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H00MZ (Insertion of
neurostimulator lead into brain, open approach);
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H03MZ (Insertion of
neurostimulator lead into brain, percutaneous approach); and
0NH00NZ (Insertion of neurostimulator generator into
skull, open approach), in combination with 00H04MZ (Insertion of
neurostimulator lead into brain, percutaneous endoscopic approach).
The finalized listing of epilepsy diagnosis codes (82 FR 38018
through 38019) contained codes provided by the requestor (82 FR 38016),
in addition to diagnosis codes organized in subcategories G40.A- and
G40.B- as recommended by a commenter in response to the proposed rule
(82 FR 38018) because the diagnosis codes organized in these
subcategories also are representative of diagnoses of epilepsy.
For FY 2019, we received a request to include two additional
diagnosis codes organized in subcategory G40.1- in the listing of
epilepsy diagnosis codes for cases assigned to MS-DRG 023 because these
diagnosis codes also represent diagnoses of epilepsy. The two
additional codes identified by the requestor are:
G40.109 (Localization-related (focal) (partial)
symptomatic epilepsy and epileptic syndromes with simple partial
seizures, not intractable, without status epilepticus); and
G40.111 (Localization-related (focal) (partial)
symptomatic epilepsy and epileptic syndromes with simple partial
seizures, intractable, with status epilepticus).
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 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
MS-DRG MS-DRG title weight
------------------------------------------------------------------------
MS-DRG 061.................. Ischemic Stroke, 2.7979
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent with
MCC.
MS-DRG 062.................. Ischemic Stroke, l.9321
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent with
CC.
MS-DRG 063.................. Ischemic Stroke, l.6169
Precerebral Occlusion or
Transient Ischemia with
Thrombolytic Agent
without CC/MCC.
MS-DRG 064.................. Intracranial Hemorrhage or l.7685
Cerebral Infarction with
MCC.
MS-DRG 065.................. Intracranial Hemorrhage or 1.0311
Cerebral Infarction with
CC or TPA in 24 hours.
MS-DRG 066.................. Intracranial Hemorrhage or .7466
Cerebral Infarction with
MCC.
------------------------------------------------------------------------
[[Page 20191]]
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 presenting with intracranial hemorrhage or cerebral
infarction with mechanical ventilation and create two new MS-DRGs as
follows:
Suggested new MS-DRG XXX (Intracranial Hemorrhage or
Cerebral Infarction with Mechanical Ventilation >96 Hours); and
Suggested new MS-DRG XXX (Intracranial Hemorrhage or
Cerebral Infarction with Mechanical Ventilation <=96 Hours).
The second request was to consider any principal diagnosis under
the current GROUPER logic for MDC 1 with mechanical ventilation and
create two new MS-DRGs as follows:
Suggested New MS-DRG XXX (Neurological System Diagnosis
with Mechanical Ventilation 96+ Hours); and
Suggested New MS-DRG XXX (Neurological System Diagnosis
with Mechanical Ventilation <=96 Hours).
Both requesters suggested that CMS use the three ICD-10-PCS codes
identifying mechanical ventilation to assign cases to the respective
suggested new MS-DRGs. The three ICD-10-PCS codes are shown in the
following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
5A1935Z............................. Respiratory ventilation, less than
96 consecutive hours.
5A1945Z............................. Respiratory ventilation, 24-96
consecutive hours.
5A1955Z............................. Respiratory ventilation, greater
than 96 consecutive hours.
------------------------------------------------------------------------
Below we discuss the different aspects of each request in more
detail.
The first request involved two aspects: (1) Analyzing patients
diagnosed with cerebral infarction and required mechanical ventilation
who received a thrombolytic (for example, TPA) and did not undergo an
O.R. procedure; and (2) analyzing patients diagnosed with intracranial
hemorrhage or ischemic cerebral infarction and required mechanical
ventilation who did not receive a thrombolytic (for example, TPA)
during the current episode of care and did not undergo an O.R.
procedure.
For the first subset of patients, we analyzed claims data from the
September 2017 update of the FY 2017 MedPAR file for MS-DRGs 061, 062,
and 063 because cases that are assigned to these MS-DRGs specifically
identify patients who were diagnosed with a cerebral infarction and
received a thrombolytic. The 90 ICD-10-CM diagnosis codes that specify
a cerebral infarction and were included in our analysis are listed in
Table 6P.1a associated with this proposed rule (which is available via
the Internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
The ICD-10-PCS procedure codes displayed in the following table
describe use of a thrombolytic agent.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
3E03017............................. Introduction of other thrombolytic
into peripheral vein, open
approach.
3E03317............................. Introduction of other thrombolytic
into peripheral vein,
percutaneous approach.
3E04017............................. Introduction of other thrombolytic
into central vein, open approach.
3E04317............................. Introduction of other thrombolytic
into central vein, percutaneous
approach.
3E05017............................. Introduction of other thrombolytic
into peripheral artery, open
approach.
3E05317............................. Introduction of other thrombolytic
into peripheral artery,
percutaneous approach.
3E06017............................. Introduction of other thrombolytic
into central artery, open
approach.
3E06317............................. Introduction of other thrombolytic
into central artery, percutaneous
approach.
3E08017............................. Introduction of other thrombolytic
into heart, open approach.
3E08317............................. Introduction of other thrombolytic
into heart, percutaneous
approach.
------------------------------------------------------------------------
We examined claims data in MS-DRGs 061, 062, and 063 and identified
cases that reported mechanical ventilation of any duration with a
principal diagnosis of cerebral infarction where a thrombolytic agent
was administered and the patient did not undergo an O.R. procedure. Our
[[Page 20192]]
findings are shown in the following table.
Cerebral Infarction With Thrombolytic and MV
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 061--All cases........................................... 5,192 6.4 $20,097
MS-DRG 061--Cases with principal diagnosis of cerebral 166 12.8 41,691
infarction and mechanical ventilation >96 hours................
MS-DRG 061--Cases with principal diagnosis of cerebral 378 7.5 26,368
infarction and mechanical ventilation =24-96 hours.............
MS-DRG 061--Cases with principal diagnosis of cerebral 214 4.9 19,795
infarction and mechanical ventilation <24 hours................
MS-DRG 062--All cases........................................... 9,730 3.9 13,865
MS-DRG 062--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 062--Cases with principal diagnosis of cerebral 10 5.3 19,817
infarction and mechanical ventilation =24-96 hours.............
MS-DRG 062--Cases with principal diagnosis of cerebral 23 3.8 14,026
infarction and mechanical ventilation <24 hours................
MS-DRG 063--All cases........................................... 1,984 2.7 11,771
MS-DRG 063--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 063--Cases with principal diagnosis of cerebral 3 2.7 14,588
infarction and mechanical ventilation =24-96 hours.............
MS-DRG 063--Cases with principal diagnosis of cerebral 5 2.0 11,195
infarction and mechanical ventilation <24 hours................
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 5,192 cases in MS-DRG
061 with an average length of stay of 6.4 days and average costs of
$20,097. There were a total of 758 cases reporting the use of
mechanical ventilation in MS-DRG 061 with an average length of stay
ranging from 4.9 days to 12.8 days and average costs ranging from
$19,795 to $41,691. For MS-DRG 062, there were a total of 9,730 cases
with an average length of stay of 3.9 days and average costs of
$13,865. There were a total of 33 cases reporting the use of mechanical
ventilation in MS-DRG 062 with an average length of stay ranging from
3.8 days to 5.3 days and average costs ranging from $14,026 to $19,817.
For MS[dash]DRG 063, there were a total of 1,984 cases with an average
length of stay of 2.7 days and average costs of $11,771. There were a
total of 8 cases reporting the use of mechanical ventilation in MS-DRG
063 with an average length of stay ranging from 2.0 days to 2.7 days
and average costs ranging from $11,195 to $14,588.
We then compared the total number of cases in MS-DRGs 061, 062, and
063 specifically reporting mechanical ventilation >96 hours with a
principal diagnosis of cerebral infarction where a thrombolytic agent
was administered and the patient did not undergo an O.R. procedure
against the total number of cases reporting mechanical ventilation <=96
hours with a principal diagnosis of cerebral infarction where a
thrombolytic agent was administered and the patient did not undergo an
O.R. procedure. Our findings are shown in the following table.
Cerebral Infarction With Thrombolytic and MV
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 061--All cases........................................... 5,192 6.4 $20,097
MS-DRG 061--Cases with principal diagnosis of cerebral 166 12.8 41,691
infarction and mechanical ventilation >96 hours................
MS-DRG 061--Cases with principal diagnosis of cerebral 594 6.5 23,780
infarction and mechanical ventilation <=96 hours...............
MS-DRG 062--All cases........................................... 9,730 3.9 13,865
MS-DRG 062--Cases with principal diagnosis of cerebral 0 0.0 0
infarction and mechanical ventilation >96 hours................
MS-DRG 062--Cases with principal diagnosis of cerebral 34 4.2 15,558
infarction and mechanical ventilation <=96 hours...............
MS-DRG 063--All cases........................................... 1,984 2.7 11,771
MS-DRG 063--Cases with principal diagnosis of cerebral 0 0.0 $0
infarction and mechanical ventilation >96 hours................
MS-DRG 063--Cases with principal diagnosis of cerebral 8 2.3 12,467
infarction and mechanical ventilation <=96 hours...............
----------------------------------------------------------------------------------------------------------------
As shown in this table, the total number of cases reported in MS-
DRG 061 was 5,192, with an average length of stay of 6.4 days and
average costs of $20,097. There were 166 cases that reported mechanical
ventilation >96
[[Page 20193]]
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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
We also used the list of 90 ICD-10-CM diagnosis codes that specify
a cerebral infarction listed in Table 6P.1a associated with 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
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 064--All cases........................................... 76,513 6.0 $12,574
MS-DRG 064--Cases with principal diagnosis of cerebral 2,153 13.4 38,262
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 064--Cases with principal diagnosis of cerebral 4,843 6.6 18,119
infarction or intracranial hemorrhage and mechanical
ventilation =24-96 hours.......................................
MS-DRG 064--Cases with principal diagnosis of cerebral 4,001 3.1 8,675
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
MS-DRG 065--All cases........................................... 106,554 3.7 7,236
MS-DRG 065--Cases with principal diagnosis of cerebral 22 10.2 20,759
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 065--Cases with principal diagnosis of cerebral 127 4.2 12,688
infarction or intracranial hemorrhage and mechanical
ventilation =24-96 hours.......................................
MS-DRG 065--Cases with principal diagnosis of cerebral 301 2.1 6,145
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
MS-DRG 066--All cases........................................... 34,689 2.5 5,321
MS-DRG 066--Cases with principal diagnosis of cerebral 1 4.0 3,426
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 066--Cases with principal diagnosis of cerebral 31 3.7 10,364
infarction or intracranial hemorrhage and mechanical
ventilation =24-96 hours.......................................
MS-DRG 066--Cases with principal diagnosis of cerebral 163 1.4 4,148
infarction or intracranial hemorrhage and mechanical
ventilation <24 hours..........................................
----------------------------------------------------------------------------------------------------------------
The total number of cases reported in MS-DRG 064 was 76,513, with
an average length of stay of 6.0 days and average costs of $12,574.
There were a total of 10,997 cases reporting the use of mechanical
ventilation in MS-DRG 064 with an average length of stay ranging from
3.1 days to 13.4 days and average costs ranging from $8,675 to $38,262.
For MS-DRG 065, there were a total of 106,554 cases with an average
length of stay of 3.7 days and average costs of $7,236. There were a
total of 450 cases reporting the use of mechanical ventilation in MS-
DRG 065 with an average length of stay ranging from 2.1 days to 10.2
days and average costs ranging from $6,145 to $20,759. For MS-DRG 066,
there were a total of 34,689 cases with an average length of stay of
2.5 days and average costs of $5,321. There were a total of 195 cases
reporting the use of mechanical ventilation in MS-DRG 066 with an
average length of stay ranging from 1.4 days to 4.0 days and average
costs ranging from $3,426 to $10,364.
We then compared the total number of cases in MS-DRGs 064, 065, and
066 specifically reporting mechanical ventilation >96 hours with a
principal diagnosis of cerebral infarction or intracranial hemorrhage
where a thrombolytic agent was not administered and the patient did not
undergo an O.R. procedure against the total number of cases reporting
mechanical ventilation <=96 hours with a principal diagnosis of
cerebral infarction or intracranial hemorrhage where a thrombolytic
agent was not administered and the patient did not undergo an O.R.
procedure. Our findings are shown in the following table.
[[Page 20194]]
Cerebral Infarction or Intracranial Hemorrhage With MV and Without Thrombolytic
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 064--All cases........................................... 76,513 6.0 $12,574
MS-DRG 064--Cases with principal diagnosis of cerebral 2,153 13.4 38,262
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 064--Cases with principal diagnosis of cerebral 8,794 4.9 13,704
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
MS-DRG 065--All cases........................................... 106,554 3.7 7,236
MS-DRG 065--Cases with principal diagnosis of cerebral 22 10.2 20,759
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 065--Cases with principal diagnosis of cerebral 428 2.7 8,086
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
MS-DRG 066--All cases........................................... 34,689 2.5 5,321
MS-DRG 066--Cases with principal diagnosis of cerebral 1 4.0 3,426
infarction or intracranial hemorrhage and mechanical
ventilation >96 hours..........................................
MS-DRG 066--Cases with principal diagnosis of cerebral 194 1.8 5,141
infarction or intracranial hemorrhage and mechanical
ventilation <=96 hours.........................................
----------------------------------------------------------------------------------------------------------------
The total number of cases reported in MS-DRG 064 was 76,513, with
an average length of stay of 6.0 days and average costs of $12,574.
There were 2,153 cases that reported mechanical ventilation >96 hours,
with an average length of stay of 13.4 days and average costs of
$38,262, and there were 8,794 cases that reported mechanical
ventilation <=96 hours, with an average length of stay of 4.9 days and
average costs of $13,704.
The total number of cases reported in MS-DRG 65 was 106,554, with
an average length of stay of 3.7 days and average costs of $7,236.
There were 22 cases that reported mechanical ventilation >96 hours,
with an average length of stay of 10.2 days and average costs of
$20,759, and there were 428 cases that reported mechanical
ventilation<=96 hours, with an average length of stay of 2.7 days and
average costs of $8,086.
The total number of cases reported in MS-DRG 66 was 34,689, with an
average length of stay of 2.5 days and average costs of $5,321. There
was one case that reported mechanical ventilation >96 hours, with an
average length of stay of 4.0 days and average costs of $3,426, and
there were 194 cases that reported mechanical ventilation <=96 hours,
with an average length of stay of 1.8 days and average costs of $5,141.
We also analyzed claims data for MS-DRGs 207 and 208. As shown in
the following table, there were a total of 19,471cases 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 Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 207--All cases........................................... 19,471 13.8 $38,124
MS-DRG 208--All cases........................................... 55,802 6.7 17,439
----------------------------------------------------------------------------------------------------------------
Our analysis of claims data relating to the first request for MS-
DRGs 061, 062, 063, 064, 065, and 066 and consultation with our
clinical advisors do not support creating new MS-DRGs for cases that
identify patients diagnosed with cerebral infarction or intracranial
hemorrhage who require mechanical ventilation with or without a
thrombolytic and in the absence of an O.R. procedure.
For the first subset of patients (in MS-DRGs 061, 062 and 063), our
data findings for MS-DRG 061 demonstrate the 166 cases that reported
mechanical ventilation >96 hours had a longer average length of stay
(12.8 days versus 6.4 days) and higher average costs ($41,691 versus
$20,097) compared to all the cases in MS-DRG 061. However, there were
no cases that reported mechanical ventilation >96 hours for MS-DRG 062
or MS-DRG 063. For the 594 cases that reported mechanical ventilation
<=96 hours in MS[dash]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[dash]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 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
[[Page 20195]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average length
MDC cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with mechanical ventilation >96 hours................. 127,626 18.4 $61,056
MDC 1 (Diseases and Disorders of the Nervous System)--Cases with 13,668 18.3 61,234
mechanical ventilation >96 hours...............................
MDC 2 (Disease and Disorders of the Eye)--Cases with mechanical 33 22.7 79,080
ventilation >96 hours..........................................
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and 602 20.3 62,625
Throat)--Cases with mechanical ventilation >96 hours...........
MDC 4 (Diseases and Disorders of the Respiratory System)--Cases 27,793 16.6 48,869
with mechanical ventilation >96 hours..........................
MDC 5 (Diseases and Disorders of the Circulatory System)--Cases 16,923 20.7 84,565
with mechanical ventilation >96 hours..........................
MDC 6 (Diseases and Disorders of the Digestive System)--Cases 6,401 22.4 73,759
with mechanical ventilation >96 hours..........................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and 1,803 24.5 80,477
Pancreas)--Cases with mechanical ventilation >96 hours.........
MDC 8 (Diseases and Disorders of the Musculoskeletal System and 2,780 22.3 83,271
Connective Tissue)--Cases with mechanical ventilation >96 hours
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue 390 22.2 68,288
and Breast)--Cases with mechanical ventilation >96 hours.......
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and 1,168 20.9 60,682
Disorders)--Cases with mechanical ventilation >96 hours........
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)-- 2,325 19.6 57,893
Cases with mechanical ventilation >96 hours....................
MDC 12 (Diseases and Disorders of the Male Reproductive System)-- 54 26.8 95,204
Cases with mechanical ventilation >96 hours....................
MDC 13 (Diseases and Disorders of the Female Reproductive 89 24.6 83,319
System)--Cases with mechanical ventilation >96 hours...........
MDC 14 (Pregnancy, Childbirth and the Puerperium)--Cases with 22 17.4 56,981
mechanical ventilation >96 hours...............................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, 468 20.1 68,658
Immunologic Disorders)--Cases with mechanical ventilation >96
hours..........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly 538 29.7 99,968
Differentiated Neoplasms)--Cases with mechanical ventilation
>96 hours......................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or 48,176 17.3 55,022
Unspecified Sites)--Cases with mechanical ventilation >96 hours
MDC 19 (Mental Diseases and Disorders)--Cases with mechanical 54 29.3 52,749
ventilation >96 hours..........................................
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental 312 20.5 47,637
Disorders)--Cases with mechanical ventilation >96 hours........
[[Page 20196]]
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)--Cases 2,436 18.2 57,712
with mechanical ventilation >96 hours..........................
MDC 22 (Burns)--Cases with mechanical ventilation >96 hours..... 242 34.8 188,704
MDC 23 (Factors Influencing Health Status and Other Contacts 64 17.7 50,821
with Health Services)--Cases with mechanical ventilation >96
hours..........................................................
MDC 24 (Multiple Significant Trauma)--Cases with mechanical 922 17.6 72,358
ventilation >96 hours..........................................
MDC 25 (Human Immunodeficiency Virus Infections)--Cases with 363 19.1 56,688
mechanical ventilation >96 hours...............................
----------------------------------------------------------------------------------------------------------------
As shown in the table, the top 5 MDCs with the largest number of
cases reporting mechanical ventilation >96 hours are MDC 18, with
48,176 cases; MDC 4, with 27,793 cases; MDC 5, with 16,923 cases; MDC
1, with 13,668 cases; and MDC 6, with 6,401 cases. We 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 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
mechanical ventilation >96 hours. In summary, the claims data reflect a
wide variance with regard to the frequency and average costs for cases
reporting the use of mechanical ventilation >96 hours.
We also examined claims data across each of the 25 MDCs for the
number of cases reporting the use of mechanical ventilation <=96 hours.
Our findings are shown in the table below.
Mechanical Ventilation <=96 Hours Across All MDCs
----------------------------------------------------------------------------------------------------------------
Number of Average length
MDC cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with mechanical ventilation <=96 hours................ 266,583 8.5 $26,668
MDC 1 (Diseases and Disorders of the Nervous System)--Cases with 29,896 7.4 22,838
mechanical ventilation <=96 hours..............................
MDC 2 (Disease and Disorders of the Eye)--Cases with mechanical 60 8.4 29,708
ventilation <=96 hours.........................................
MDC 3 (Diseases and Disorders of the Ear, Nose, Mouth and 1,397 9.8 29,479
Throat)--Cases with mechanical ventilation <=96 hours..........
MDC 4 (Diseases and Disorders of the Respiratory System)--Cases 64,861 7.8 20,929
with mechanical ventilation <=96 hours.........................
MDC 5 (Diseases and Disorders of the Circulatory System)--Cases 45,147 8.8 35,818
with mechanical ventilation <=96 hours.........................
MDC 6 (Diseases and Disorders of the Digestive System)--Cases 15,629 11.3 33,660
with mechanical ventilation <=96 hours.........................
MDC 7 (Diseases and Disorders of the Hepatobiliary System and 4,678 10.5 31,565
Pancreas)--Cases with mechanical ventilation <=96 hours........
MDC 8 (Diseases and Disorders of the Musculoskeletal System and 7,140 10.4 40,183
Connective Tissue)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue 1,036 10.7 26,809
and Breast)--Cases with mechanical ventilation <=96 hours......
MDC 10 (Endocrine, Nutritional and Metabolic Diseases and 3,591 9.0 23,863
Disorders)--Cases with mechanical ventilation <=96 hours.......
MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract)-- 5,506 10.2 27,951
Cases with mechanical ventilation <=96 hours...................
MDC 12 (Diseases and Disorders of the Male Reproductive System)-- 168 11.5 35,009
Cases with mechanical ventilation <=96 hours...................
MDC 13 (Diseases and Disorders of the Female Reproductive 310 10.8 32,382
System)--Cases with mechanical ventilation <=96 hours..........
MDC 14 (Pregnancy, Childbirth and the Puerperium)--Cases with 55 7.6 21,785
mechanical ventilation <=96 hours..............................
MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, 1,171 8.7 26,138
Immunologic Disorders)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 17 (Myeloproliferative Diseases and Disorders, Poorly 1,178 15.3 46,335
Differentiated Neoplasms)--Cases with mechanical ventilation
<=96 hours.....................................................
MDC 18 (Infectious and Parasitic Diseases, Systemic or 69,826 8.5 25,253
Unspecified Sites)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 19 (Mental Diseases and Disorders)--Cases with mechanical 264 10.4 18,805
ventilation <=96 hours.........................................
MDC 20 (Alcohol/Drug Use and Alcohol/Drug Induced Organic Mental 918 8.3 19,376
Disorders)--Cases with mechanical ventilation <=96 hours.......
MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs)--Cases 10,842 6.5 17,843
with mechanical ventilation <=96 hours.........................
[[Page 20197]]
MDC 22 (Burns)--Cases with mechanical ventilation <=96 hours.... 353 9.7 45,557
MDC 23 (Factors Influencing Health Status and Other Contacts 307 6.6 16,159
with Health Services)--Cases with mechanical ventilation <=96
hours..........................................................
MDC 24 (Multiple Significant Trauma)--Cases with mechanical 1,709 8.8 36,475
ventilation <=96 hours.........................................
MDC 25 (Human Immunodeficiency Virus Infections)--Cases with 541 10.4 29,255
mechanical ventilation <=96 hours..............................
----------------------------------------------------------------------------------------------------------------
As shown in the table, the top 5 MDCs with the largest number of
cases reporting mechanical ventilation <=96 hours are MDC 18, with
69,826 cases; MDC 4, with 64,861 cases; MDC 5, with 45,147 cases; MDC
1, with 29,896 cases; and MDC 6, with 15,629 cases. We 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. 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[dash]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 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[dash]DRGs 258 and 259 (Cardiac Pacemaker Device Replacement with
and without MCC, respectively) because assignment of cases to these MS-
DRGs
[[Page 20198]]
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 non-O.R. procedure codes describing a
pacemaker device insertion without any other procedure code involving a
pacemaker lead would be assigned to MS-DRGs 258 and 259. Therefore, the
listed procedure codes describing a pacemaker device insertion under
MS-DRGs 258 and 259 are designated as non-O.R. affecting the MS-DRG.
Lastly, we discussed our examination of the Version 33 GROUPER
logic for MS-DRGs 260, 261, and 262 (Cardiac Pacemaker Revision Except
Device Replacement with MCC, with CC, and without CC/MCC,
respectively), and noted that cases assigned to these MS-DRGs also
included lists of procedure code combinations describing procedures
involving the removal of pacemaker leads and the insertion of new
leads, in addition to lists of single procedure codes describing
procedures involving the insertion of pacemaker leads, removal of
cardiac devices, and revision of cardiac devices (81 FR 56808). We
finalized our proposal to modify the ICD-10 MS-DRG GROUPER logic for
MS-DRGs 260, 261, and 262 so that cases reporting any one of the listed
ICD-10-PCS procedure codes describing procedures involving pacemakers
and related procedures and associated devices are assigned to MS DRGs
260, 261, and 262 under MDC 5. Therefore, the GROUPER logic that
required a combination of procedure codes be reported for assignment
into MS-DRGs 260, 261 and 262 under Version 33 was no longer required
effective with discharges occurring on or after October 1, 2016 (FY
2017) under Version 34 of the ICD-10 MS-DRGs.
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-Fee-for-Service-Payment/AcuteInpatientPPS/FY2016-IPPS-Final-Rule-Home-Page-Items/FY2016-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
complete documentation of the GROUPER logic that was in effect at that
time for the Version 33 ICD-10 MS-DRGs discussed earlier.
For FY 2019, we received a request to assign all procedures
involving the insertion of pacemaker devices to surgical MS-DRGs,
regardless of the principal diagnosis. The requestor recommended that
procedures involving pacemaker insertion be grouped to surgical MS-DRGs
within the MDC to which the principal diagnosis is assigned, or that
they group to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure
Unrelated to Principal Diagnosis with MCC, with CC and without CC/MCC,
respectively). Currently, in Version 35 of the ICD-10 MS-DRGs,
procedures involving pacemakers are assigned to MS-DRGs 040, 041, and
042 (Peripheral, Cranial Nerve and Other Nervous System Procedures with
MCC, with CC or Peripheral Neurostimulator and without CC/MCC,
respectively) under MDC 1 (Diseases and Disorders of the Nervous
System), to MS-DRGs 242, 243, and 244 (Permanent Cardiac Pacemaker
Implant with MCC, with CC, and without CC/MCC, respectively), MS-DRGs
258 and 259 (Cardiac Pacemaker Device Replacement with MCC and without
MCC, respectively), and MS-DRGs 260, 261 and 262 (Cardiac Pacemaker
Revision Except Device Replacement with MCC, with CC, and without CC/
MCC, respectively) under MDC 5 (Diseases and Disorders of the
Circulatory System), and to MS-DRGs 907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with CC, and without CC/MCC,
respectively), under MDC 21 (Injuries, Poisoning and Toxic Effects of
Drugs), with all other unrelated principal diagnoses resulting in a
medical MS-DRG assignment. According to the requestor, the medical MS-
DRGs do not provide adequate payment for the pacemaker device,
specialized operating suites, time, skills, and other resources
involved for pacemaker insertion procedures. Therefore, the requestor
recommended that procedures involving pacemaker insertions be grouped
to surgical MS-DRGs. We refer readers to the ICD-10 MS-DRG Definitions
Manual Version 35, which is available via the Internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
complete documentation of the GROUPER logic for the MS-DRGs discussed
earlier.
The following procedure codes describe procedures involving the
insertion of a cardiac rhythm related device which are classified as a
type of pacemaker insertion under the ICD-10 MS-DRGs. These four codes
are assigned to MS-DRGs 040, 041, and 042, as well as MS-DRGs 907, 908,
and 909, and are designated as O.R. procedures.
[[Page 20199]]
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0JH60PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
open approach.
0JH63PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
percutaneous approach.
0JH80PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, open approach.
0JH83PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, percutaneous approach.
------------------------------------------------------------------------
We examined cases from the September update of the FY 2017 MedPAR
claims data for cases involving pacemaker insertion procedures
reporting the above ICD-10-PCS codes in MS-DRGs 040, 041 and 042 under
MDC 1. Our findings are shown in the following table.
Cases Involving Pacemaker Insertion Procedures in MDC 1
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 1 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 040--All cases........................................... 4,462 10.4 $26,877
MS-DRG 040--Cases with procedure code 0JH60PZ (Insertion of 13 14.2 55,624
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 040--Cases with procedure code 0JH63PZ (Insertion of 2 3.5 15,826
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 040--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 040--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 041--All cases........................................... 5,648 5.2 16,927
MS-DRG 041--Cases with procedure code 0JH60PZ (Insertion of 12 6.4 22,498
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 041--Cases with procedure code 0JH63PZ (Insertion of 4 5 17,238
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 041--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 041--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 042--All cases........................................... 2,154 3.1 13,730
MS-DRG 042--Cases with procedure code 0JH60PZ (Insertion of 5 8 18,183
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 042--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 042--Cases with procedure code 0JH80PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 042--Cases with procedure code 0JH83PZ (Insertion of 0 0 0
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, percutaneous approach).............................
----------------------------------------------------------------------------------------------------------------
The following table is a summary of the findings shown above from
our review of MS-DRGs 040, 041 and 042 and the total number of cases
reporting a pacemaker insertion procedure.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 1
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 1 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 040, 041, and 042--All cases............................ 12,264 6.7 $19,986
MS-DRGs 040, 041, and 042--Cases with a pacemaker insertion 36 9.1 32,906
procedure......................................................
----------------------------------------------------------------------------------------------------------------
We found a total of 12,264 cases in MS-DRGs 040, 041, and 042 with
an average length of stay of 6.7 days and average costs of $19,986. We
found a total of 36 cases in MS-DRGs 040, 041, and 042 reporting
procedure codes describing the insertion of a pacemaker device with an
average length of stay of 9.1 days and average costs of $32,906.
We then examined cases involving pacemaker insertion procedures
reporting those same four ICD-10-PCS procedure codes 0JH60PZ, 0JH63PZ,
0JH80PZ and 0JH83PZ in MS-DRGs 907, 908, and 909 under MDC 21. Our
findings are shown in the following table.
[[Page 20200]]
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 21
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 21 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 907--All cases........................................... 7,405 10.1 $28,997
MS-DRG 907--Cases with procedure code 0JH60PZ (Insertion of 7 11.1 60,141
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 908--All cases........................................... 8,519 5.2 14,282
MS-DRG 908--Cases with procedure code 0JH60PZ (Insertion of 4 3.8 35,678
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 909--All cases........................................... 3,224 3.1 9,688
MS-DRG 909--Cases with procedure code 0JH60PZ (Insertion of 2 2 42,688
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
----------------------------------------------------------------------------------------------------------------
We note that there were no cases found where procedure codes
0JH63PZ, 0JH80PZ or 0JH83PZ were reported in MS-DRGs 907, 908 and 909
under MDC 21 and, therefore, they are not displayed in the table.
The following table is a summary of the findings shown above from
our review of MS-DRGs 907, 908, and 909 and the total number of cases
reporting a pacemaker insertion procedure.
MS-DRGs for Cases Involving Pacemaker Insertion Procedures in MDC 21
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 21 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 907, 908 and 909--All cases............................. 19,148 6.7 $19,199
MS-DRGs 907, 908 and 909--Cases with a pacemaker insertion 13 7.5 49,929
procedure......................................................
----------------------------------------------------------------------------------------------------------------
We found a total of 19,148 cases in MS-DRGs 907, 908, and 909 with
an average length of stay of 6.7 days and average costs of $19,199. We
found a total of 13 cases in MS-DRGs 907, 908, and 909 reporting
pacemaker insertion procedures with an average length of stay of 7.5
days and average costs of $49,929.
We also examined cases involving pacemaker insertion procedures
reporting the following procedure codes that are assigned to MS-DRGs
242, 243, and 244 under MDC 5.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0JH604Z................... Insertion of pacemaker, single chamber into
chest subcutaneous tissue and fascia, open
approach.
0JH605Z................... Insertion of pacemaker, single chamber rate
responsive into chest subcutaneous tissue
and fascia, open approach.
0JH606Z................... Insertion of pacemaker, dual chamber into
chest subcutaneous tissue and fascia, open
approach.
0JH607Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into chest
subcutaneous tissue and fascia, open
approach.
0JH60PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
open approach.
0JH634Z................... Insertion of pacemaker, single chamber into
chest subcutaneous tissue and fascia,
percutaneous approach.
0JH635Z................... Insertion of pacemaker, single chamber rate
responsive into chest subcutaneous tissue
and fascia, percutaneous approach.
0JH636Z................... Insertion of pacemaker, dual chamber into
chest subcutaneous tissue and fascia,
percutaneous approach.
0JH637Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into chest
subcutaneous tissue and fascia,
percutaneous approach.
0JH63PZ................... Insertion of cardiac rhythm related device
into chest subcutaneous tissue and fascia,
percutaneous approach.
0JH804Z................... Insertion of pacemaker, single chamber into
abdomen subcutaneous tissue and fascia,
open approach.
0JH805Z................... Insertion of pacemaker, single chamber rate
responsive into abdomen subcutaneous tissue
and fascia, open approach.
0JH806Z................... Insertion of pacemaker, dual chamber into
abdomen subcutaneous tissue and fascia,
open approach.
0JH807Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen
subcutaneous tissue and fascia, open
approach.
0JH80PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, open approach.
0JH834Z................... Insertion of pacemaker, single chamber into
abdomen subcutaneous tissue and fascia,
percutaneous approach.
0JH835Z................... Insertion of pacemaker, single chamber rate
responsive into abdomen subcutaneous tissue
and fascia, percutaneous approach.
0JH836Z................... Insertion of pacemaker, dual chamber into
abdomen subcutaneous tissue and fascia,
percutaneous approach.
0JH837Z................... Insertion of cardiac resynchronization
pacemaker pulse generator into abdomen
subcutaneous tissue and fascia,
percutaneous approach.
0JH83PZ................... Insertion of cardiac rhythm related device
into abdomen subcutaneous tissue and
fascia, percutaneous approach.
------------------------------------------------------------------------
Our data findings are shown in the following table. We note that
procedure codes displayed with an asterisk (*) in the table are
designated as non-O.R. procedures affecting the MS-DRG.
[[Page 20201]]
Cases Involving Pacemaker Insertion Procedures in MDC 5
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 242--All cases........................................... 18,205 6.9 $26,414
MS-DRG 242--Cases with procedure code 0JH604Z* (Insertion of 2,518 7.7 25,004
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH605Z* (Insertion of 306 7.7 24,454
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH606Z* (Insertion of 13,323 6.7 25,497
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH607Z (Insertion of 1,528 8.1 37,060
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH60PZ (Insertion of 5 16.6 59,334
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 242--Cases with procedure code 0JH634Z* (Insertion of 65 8.5 26,789
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 242--Cases with procedure code 0JH635Z* (Insertion of 10 7 35,104
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 242--Cases with procedure code 0JH636Z* (Insertion of 313 6.4 23,699
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 242--Cases with procedure code 0JH637Z (Insertion of 82 7.1 35,382
cardiac resynchronization pacemaker pulse generator into chest
Subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 242--Cases with procedure code 0JH63PZ (Insertion of 2 12.5 32,405
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 242--Cases with procedure code 0JH804Z* (Insertion of 25 14.4 43,080
pacemaker, single chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH805Z* (Insertion of 2 4 26,949
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 242--Cases with procedure code 0JH806Z* (Insertion of 50 6.8 25,306
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 242--Cases with procedure code 0JH807Z (Insertion of 5 21.2 67,908
cardiac resynchronization pacemaker pulse generator into
abdomen subcutaneous tissue and fascia, open approach).........
MS-DRG 242--Cases with procedure code 0JH836Z (Insertion of 1 5 36,111
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--All cases........................................... 24,586 4 18,669
MS-DRG 243--Cases with procedure code 0JH604Z* (Insertion of 2,537 4.7 17,118
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH605Z* (Insertion of 271 4.4 17,268
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH606Z* (Insertion of 19,921 3.9 18,306
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH607Z (Insertion of 1,236 4.4 28,658
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH60PZ (Insertion of 6 4.2 20,994
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 243--Cases with procedure code 0JH634Z* (Insertion of 55 5.2 16,784
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--Cases with procedure code 0JH635Z* (Insertion of 15 4.1 17,938
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 243--Cases with procedure code 0JH636Z* (Insertion of 431 3.7 16,164
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 243--Cases with procedure code 0JH637Z (Insertion of 58 5 28,926
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 243--Cases with procedure code 0JH63PZ (Insertion of 3 8.3 23,717
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 243--Cases with procedure code 0JH804Z* (Insertion of 10 8.2 20,871
pacemaker, single chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH805Z* (Insertion of 1 4 15,739
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 243--Cases with procedure code 0JH806Z* (Insertion of 57 4.4 18,787
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 243--Cases with procedure code 0JH807Z (Insertion of 3 4 19,653
cardiac resynchronization pacemaker pulse generator into
abdomen subcutaneous tissue and fascia, open approach).........
MS-DRG 243--Cases with procedure code 0JH80PZ (Insertion of 1 7 16,224
cardiac rhythm related device into abdomen subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 243--Cases with procedure code 0JH836Z* (Insertion of 1 2 14,005
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 244--All cases........................................... 15,974 2.7 15,670
MS-DRG 244--Cases with procedure code 0JH604Z* (Insertion of 1,045 3.2 14,541
pacemaker, single chamber into chest subcutaneous tissue and
fascia, open approach).........................................
[[Page 20202]]
MS-DRG 244--Cases with procedure code 0JH605Z* (Insertion of 127 3 13,208
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH606Z* (Insertion of 14,092 2.7 15,596
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 244--Cases with procedure code 0JH607Z (Insertion of 303 2.8 26,221
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH60PZ (Insertion of 2 4.5 9,248
cardiac rhythm related device into chest subcutaneous tissue
and fascia, open approach).....................................
MS-DRG 244--Cases with procedure code 0JH634Z* (Insertion of 32 2.8 11,525
pacemaker, single chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 244--Cases with procedure code 0JH635Z* (Insertion of 1 2 30,100
pacemaker, single chamber rate responsive into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 244--Cases with procedure code 0JH636Z* (Insertion of 320 2.6 13,670
pacemaker, dual chamber into chest subcutaneous tissue and
fascia, percutaneous approach).................................
MS-DRG 244--Cases with procedure code 0JH637Z (Insertion of 20 2.7 19,218
cardiac resynchronization pacemaker pulse generator into chest
subcutaneous tissue and fascia, percutaneous approach).........
MS-DRG 244--Cases with procedure code 0JH63PZ (Insertion of 1 3 12,120
cardiac rhythm related device into chest subcutaneous tissue
and fascia, percutaneous approach).............................
MS-DRG 244--Cases with procedure code 0JH805Z* (Insertion of 1 1 21,604
pacemaker, single chamber rate responsive into abdomen
subcutaneous tissue and fascia, open approach).................
MS-DRG 244--Cases with procedure code 0JH806Z* (Insertion of 36 3.2 16,492
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, open approach).........................................
MS-DRG 244--Cases with procedure code 0JH836Z* (Insertion of 1 3 12,160
pacemaker, dual chamber into abdomen subcutaneous tissue and
fascia, percutaneous approach).................................
----------------------------------------------------------------------------------------------------------------
The following table is a summary of the findings shown above from
our review of MS-DRGs 242, 243, and 244 and the total number of cases
reporting a pacemaker insertion procedure.
Cases Involving Pacemaker Insertion Procedures in MDC 5
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG in MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 242, 243 and 244--All cases............................. 58,765 4.6 $20,253
MS-DRGs 242, 243, and 244--Cases with a pacemaker insertion * 58,822 4.6 20,270
procedure......................................................
----------------------------------------------------------------------------------------------------------------
* The figure is not adjusted for cases reporting more than one pacemaker insertion procedure code. The figure
represents the frequency in which the number of pacemaker insertion procedures was reported.
We found a total of 58,765 cases in MS-DRGs 242, 243, and 244 with
an average length of stay of 4.6 days and average costs of $20,253. We
found a total of 58,822 cases reporting pacemaker insertion procedures
in MS-DRGs 242, 243, and 244 with an average length of stay of 4.6 days
and average costs of $20,270. We note that the analysis performed is by
procedure code, and because multiple pacemaker insertion procedures may
be reported on a single claim, the total number of these pacemaker
insertion procedure cases exceeds the total number of all cases found
across MS-DRGs 242, 243, and 244 (58,822 procedures versus 58,765
cases).
We then analyzed claims for cases reporting a procedure code
describing (1) the insertion of a pacemaker device only, (2) the
insertion of a pacemaker lead only, and (3) both the insertion of a
pacemaker device and a pacemaker lead across all the MDCs except MDC 5
to determine the number of cases currently grouping to medical MS-DRGs
and the potential impact of these cases moving into the surgical
unrelated MS-DRGs 981, 982 and 983 (Extensive O.R. Procedure Unrelated
to Principal Diagnosis with MCC, with CC and without CC/MCC,
respectively). Our findings are shown in the following table.
Pacemaker Insertion Procedures in Medical MS-DRGs
----------------------------------------------------------------------------------------------------------------
Number of Average length
All MDCs except MDC 5 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for insertion of pacemaker device.................... 2,747 9.5 $29,389
Procedures for insertion of pacemaker lead...................... 2,831 9.4 29,240
Procedures for insertion of pacemaker device with insertion of 2,709 9.4 29,297
pacemaker lead.................................................
----------------------------------------------------------------------------------------------------------------
[[Page 20203]]
We found a total of 2,747 cases reporting the insertion of a
pacemaker device in 177 medical MS-DRGs with an average length of stay
of 9.5 days and average costs of $29,389 across all the MDCs except MDC
5. We found a total of 2,831 cases reporting the insertion of a
pacemaker lead in 175 medical MS-DRGs with an average length of stay of
9.4 days and average costs of $29,240 across all the MDCs except MDC 5.
We found a total of 2,709 cases reporting both the insertion of a
pacemaker device and the insertion of a pacemaker lead in 170 medical
MS-DRGs with an average length of stay of 9.4 days and average costs of
$29,297 across all the MDCs except MDC 5.
We also analyzed claims for cases reporting a procedure code
describing the insertion of a pacemaker device with a procedure code
describing the insertion of a pacemaker lead in all the surgical MS-
DRGs across all the MDCs except MDC 5. Our findings are shown in the
following table.
Pacemaker Insertion Procedures in Medical MS-DRGs
----------------------------------------------------------------------------------------------------------------
Average length
All MDCs except MDC 5 Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for insertion of pacemaker device with insertion 3,667 12.8 $48,856
of pacemaker lead...........................................
----------------------------------------------------------------------------------------------------------------
We found a total of 3,667 cases reporting the insertion of a
pacemaker device and the insertion of a pacemaker lead in 194 surgical
MS-DRGs with an average length of stay of 12.8 days and average costs
of $48,856 across all the MDCs except MDC 5.
For cases where the insertion of a pacemaker device, the insertion
of a pacemaker lead or the insertion of both a pacemaker device and
lead were reported on a claim grouping to a medical MS-DRG, the average
length of stay and average costs were generally higher for these cases
when compared to the average length of stay and average costs for all
the cases in their assigned MS-DRGs. For example, we found 113 cases
reporting both the insertion of a pacemaker device and lead in MS-DRG
378 (G.I. Hemorrhage with CC), with an average length of stay of 7.1
days and average costs of $23,711. The average length of stay for all
cases in MS-DRG 378 was 3.6 days and the average cost for all cases in
MS-DRG 378 was $7,190. The average length of stay for cases reporting
both the insertion of a pacemaker device and lead were twice as long as
the average length of stay for all the cases in MS-DRG 378 (7.1 days
versus 3.6 days). In addition, the average costs for the cases
reporting both the insertion of a pacemaker device and lead were
approximately $16,500 higher than the average costs of all the cases in
MS-DRG 378 ($23,711 versus $7,190). We refer readers to Table 6P.1c
associated with 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 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 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 non-O.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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) for (1) a complete
list of the proposed procedure code combinations or ``pairs''; (2) a
complete list of the procedure codes describing the insertion of a
pacemaker device; and (3) a complete list of the procedure codes
describing the insertion of a pacemaker lead. We 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
[[Page 20204]]
Pacemaker Device Replacement with MCC and without MCC, respectively)
where the listed procedure codes as shown in the ICD-10 MS-DRG
Definitions Manual Version 35, which is available via the internet on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending,
describing a pacemaker device insertion, continue to be designated as
``non-O.R. affecting the MS-DRG'' because they are reported when a
pacemaker device requires replacement and have a corresponding
diagnosis from MDC 5. Also, we 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 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.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02PA0MZ................... Removal of cardiac lead from heart, open
approach.
02PA3MZ................... Removal of cardiac lead from heart,
percutaneous approach.
02PA4MZ................... Removal of cardiac lead from heart,
percutaneous endoscopic approach.
02WA0MZ................... Revision of cardiac lead in heart, open
approach.
02WA3MZ................... Revision of cardiac lead in heart,
percutaneous approach.
02WA4MZ................... Revision of cardiac lead in heart,
percutaneous endoscopic approach.
0JPT0PZ................... Removal of cardiac rhythm related device
from trunk subcutaneous tissue and fascia,
open approach.
0JPT3PZ................... Removal of cardiac rhythm related device
from trunk subcutaneous tissue and fascia,
percutaneous approach.
0JWT0PZ................... Revision of cardiac rhythm related device in
trunk subcutaneous tissue and fascia, open
approach.
0JWT3PZ................... Revision of cardiac rhythm related device in
trunk subcutaneous tissue and fascia,
percutaneous approach.
------------------------------------------------------------------------
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 pacemaker. Specifically, the
following list includes procedure codes that describe an intracardiac
or ``leadless'' pacemaker. These procedure codes are designated as O.R.
procedure codes and are currently assigned to MS-DRGs 228 and 229
(Other Cardiothoracic Procedures with MCC and without MCC,
respectively) under MDC 5.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
02H40NZ................... Insertion of intracardiac pacemaker into
coronary vein, open approach.
02H43NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous approach.
02H44NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous endoscopic
approach.
02H60NZ................... Insertion of intracardiac pacemaker into
right atrium, open approach.
02H63NZ................... Insertion of intracardiac pacemaker into
right atrium, percutaneous approach.
02H64NZ................... Insertion of intracardiac pacemaker into
right atrium, percutaneous endoscopic
approach.
02H70NZ................... Insertion of intracardiac pacemaker into
left atrium, open approach.
02H73NZ................... Insertion of intracardiac pacemaker into
left atrium, percutaneous approach.
02H74NZ................... Insertion of intracardiac pacemaker into
left atrium, percutaneous endoscopic
approach.
02HK0NZ................... Insertion of intracardiac pacemaker into
right ventricle, open approach.
02HK3NZ................... Insertion of intracardiac pacemaker into
right ventricle, percutaneous approach.
02HK4NZ................... Insertion of intracardiac pacemaker into
right ventricle, percutaneous endoscopic
approach.
02HL0NZ................... Insertion of intracardiac pacemaker into
left ventricle, open approach.
02HL3NZ................... Insertion of intracardiac pacemaker into
left ventricle, percutaneous Approach.
02HL4NZ................... Insertion of intracardiac pacemaker into
left ventricle, percutaneous endoscopic
approach.
02WA0NZ................... Revision of intracardiac pacemaker in heart,
open approach.
02WA3NZ................... Revision of intracardiac pacemaker in heart,
percutaneous approach.
02WA4NZ................... Revision of intracardiac pacemaker in heart,
percutaneous endoscopic approach.
02WAXNZ................... Revision of intracardiac pacemaker in heart,
external approach.
02H40NZ................... Insertion of intracardiac pacemaker into
coronary vein, open approach.
02H43NZ................... Insertion of intracardiac pacemaker into
coronary vein, percutaneous approach.
------------------------------------------------------------------------
We examined claims data for procedures involving an intracardiac
pacemaker reporting any of the above codes across all MS-DRGs. Our
findings are shown in the following table.
[[Page 20205]]
Intracardiac Pacemaker Procedures
----------------------------------------------------------------------------------------------------------------
Average length
Across all MS-DRGs Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
Procedures for intracardiac pacemaker........................ 1,190 8.6 $38,576
----------------------------------------------------------------------------------------------------------------
We found 1,190 cases reporting a procedure involving an
intracardiac pacemaker with an average length of stay of 8.6 days and
average costs of $38,576. Of these 1,190 cases, we found 1,037 cases in
MS-DRGs under MDC 5. We also found that the 153 cases that grouped to
MS-DRGs outside of MDC 5 grouped to surgical MS-DRGs; therefore,
another O.R. procedure was also reported on the claim. However, 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[dash]on payments for the LUTONIX[reg]
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................... Dilation of right femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, open approach.
047K0D1................... Dilation of right femoral artery with
intraluminal device using drug-coated
balloon, open approach.
047K0Z1................... Dilation of right femoral artery using drug-
coated balloon, open approach.
047K341................... Dilation of right femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous approach.
047K3D1................... Dilation of right femoral artery with
intraluminal device using drug-coated
balloon, percutaneous approach.
047K3Z1................... Dilation of right femoral artery using drug-
coated balloon, percutaneous approach.
047K441................... Dilation of right femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous endoscopic
approach.
047K4D1................... Dilation of right femoral artery with
intraluminal device using drug-coated
balloon, percutaneous endoscopic approach.
047K4Z1................... Dilation of right femoral artery using drug-
coated balloon, percutaneous endoscopic
approach.
047L041................... Dilation of left femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, open approach.
047L0D1................... Dilation of left femoral artery with
intraluminal device using drug-coated
balloon, open approach.
047L0Z1................... Dilation of left femoral artery using drug-
coated balloon, open approach.
047L341................... Dilation of left femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous approach.
047L3D1................... Dilation of left femoral artery with
intraluminal device using drug-coated
balloon, percutaneous approach.
047L3Z1................... Dilation of left femoral artery using drug-
coated balloon, percutaneous approach.
047L441................... Dilation of left femoral artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous endoscopic
approach.
047L4D1................... Dilation of left femoral artery with
intraluminal device using drug-coated
balloon, percutaneous endoscopic approach.
047L4Z1................... Dilation of left femoral artery using drug-
coated balloon, percutaneous endoscopic
approach.
047M041................... Dilation of right popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, open approach.
047M0D1................... Dilation of right popliteal artery with
intraluminal device using drug-coated
balloon, open approach.
047M0Z1................... Dilation of right popliteal artery using
drug-coated balloon, open approach.
047M341................... Dilation of right popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous approach.
047M3D1................... Dilation of right popliteal artery with
intraluminal device using drug-coated
balloon, percutaneous approach.
047M3Z1................... Dilation of right popliteal artery using
drug-coated balloon, percutaneous approach.
047M441................... Dilation of right popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous endoscopic
approach.
047M4D1................... Dilation of right popliteal artery with
intraluminal device using drug-coated
balloon, percutaneous endoscopic approach.
047M4Z1................... Dilation of right popliteal artery using
drug-coated balloon, percutaneous
endoscopic approach.
047N041................... Dilation of left popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, open approach.
047N0D1................... Dilation of left popliteal artery with
intraluminal device using drug-coated
balloon, open approach.
047N0Z1................... Dilation of left popliteal artery using drug-
coated balloon, open approach.
047N341................... Dilation of left popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous approach.
047N3D1................... Dilation of left popliteal artery with
intraluminal device using drug-coated
balloon, percutaneous approach.
047N3Z1................... Dilation of left popliteal artery using drug-
coated balloon, percutaneous approach.
047N441................... Dilation of left popliteal artery with drug-
eluting intraluminal device using drug-
coated balloon, percutaneous endoscopic
approach.
047N4D1................... Dilation of left popliteal artery with
intraluminal device using drug-coated
balloon, percutaneous endoscopic approach.
047N4Z1................... Dilation of left popliteal artery using drug-
coated balloon, percutaneous endoscopic
approach.
------------------------------------------------------------------------
[[Page 20206]]
The requestor performed its own analysis of claims data and
expressed concern that it found that the average costs of cases using a
drug-coated balloon in the performance of percutaneous endovascular
procedures involving treatment of patients who have been diagnosed with
peripheral arterial disease are significantly higher than the average
costs of all of the cases in the MS-DRGs where these procedures are
currently assigned. The requestor also expressed concern that payments
may no longer be adequate because the new technology add-on payments
have been discontinued and may affect patient access to these
procedures.
We first examined claims data from the September 2017 update of the
FY 2017 MedPAR file for cases reporting any 1 of the 36 ICD-10-PCS
procedure codes listed in the immediately preceding table that describe
the use of a drug-coated balloon in the performance of endovascular
procedures in MS-DRGs 252, 253, and 254. Our findings are shown in the
following table.
MS-DRGs for Other Vascular Procedures With Drug[dash]Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 252--All cases........................................... 33,583 7.6 $23,906
MS-DRG 252--Cases with drug-coated balloon...................... 870 8.8 30,912
MS-DRG 253--All cases........................................... 25,714 5.4 18,986
MS-DRG 253--Cases with drug-coated balloon...................... 1,532 5.4 23,051
MS-DRG 254--All cases........................................... 12,344 2.8 13,287
MS-DRG 254--Cases with drug-coated balloon...................... 488 2.4 17,445
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 33,583 cases in MS-
DRG 252, with an average length of stay of 7.6 days and average costs
of $23,906. There were 870 cases in MS-DRG 252 reporting the use of a
drug-coated balloon in the performance of an endovascular procedure,
with an average length of stay of 8.8 days and average costs of
$30,912. The total number of cases in MS-DRG 253 was 25,714, with an
average length of stay of 5.4 days and average costs of $18,986. There
were 1,532 cases in MS-DRG 253 reporting the use of a DCB in the
performance of an endovascular procedure, with an average length of
stay of 5.4 days and average costs of $23,051. The total number of
cases in MS-DRG 254 was 12,344, with an average length of stay of 2.8
days and average costs of $13,287. There were 488 cases in MS-DRG 254
reporting the use of a DCB in the performance of an endovascular
procedure, with an average length of stay of 2.4 days and average costs
of $17,445.
The results of our data analysis show that there is not a very high
volume of cases reporting the use of a drug-coated balloon in the
performance of endovascular procedures compared to all of the cases in
the assigned MS-DRGs. The data results also show that the average
length of stay for cases reporting the use of a drug[dash]coated
balloon in the performance of endovascular procedures in MS-DRGs 253
and 254 is lower compared to the average length of stay for all of the
cases in the assigned MS-DRGs, while the average length of stay for
cases reporting the use of a drug-coated balloon in the performance of
endovascular procedures in MS-DRG 252 is slightly higher compared to
all of the cases in MS-DRG 252 (8.8 days versus 7.6 days). Lastly, the
data results showed that the average costs for cases reporting the use
of a drug-coated balloon in the performance of percutaneous
endovascular procedures were higher compared to all of the cases in the
assigned MS-DRGs. Specifically, for MS-DRG 252, the average costs for
cases reporting the use of a DCB in the performance of endovascular
procedures were $30,912 versus the average costs of $23,906 for all
cases in MS-DRG 252, a difference of $7,006. For MS-DRG 253, the
average costs for cases reporting the use of a drug-coated balloon in
the performance of endovascular procedures were $23,051 versus the
average costs of $18,986 for all cases in MS-DRG 253, a difference 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[dash]coated balloon in the performance of the
procedure across MS-DRGs 252, 253, and 254.
MS-DRGs for Other Vascular Procedures and Cases With Drug-Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average Length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 252, 253, and 254--All cases............................ 71,641 6.0 $20,310
MS-DRGs 252, 253, and 254--Cases with drug-coated balloon....... 2,890 6.0 24,569
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 71,641 cases across
MS-DRGs 252, 253, and 254, with an average length of stay of 6.0 days
and average costs of $20,310. There were a total of 2,890 cases across
MS-DRGs 252, 253, and 254 reporting the use of a drug-coated balloon in
the performance of the procedure, with an average length of stay of 6.0
days and average costs of $24,569. The data analysis showed that cases
reporting the use of a drug-coated balloon in the performance of the
procedure across MS-DRGs 252, 253 and 254 have similar lengths of stay
(6.0 days) compared to the average length of stay for all of the cases
in MS-DRGs 252, 253, and 254. The data results also showed that the
cases reporting the use of a drug-coated balloon in the performance of
the procedure across
[[Page 20207]]
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[dash]coated balloon alone. We analyzed the
number of cases across MS-DRGs 252, 253, and 254 reporting: (1) The use
of an intraluminal device (stent) with use of a drug-coated balloon in
the performance of the procedure; (2) the use of a drug-eluting
intraluminal device (stent) with the use of a drug-coated balloon in
the performance of the procedure; and (3) the use of a drug-coated
balloon only in the performance of the procedure. Our findings are
shown in the following table.
MS-DRGs for Other Vascular Procedures and Cases With Drug-Coated Balloon
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 252, 253 and 254--All cases............................. 71,641 6.0 $20,310
MS-DRGs 252, 253 and 254--Cases with intraluminal device with 522 6.0 28,418
drug-coated balloon............................................
MS-DRGs 252, 253 and 254--Cases with drug-eluting intraluminal 447 6.0 26,098
device with drug-coated balloon................................
MS-DRGs 252, 253 and 254--Cases with drug-coated balloon only... 2,705 6.1 24,553
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 71,641 cases across
MS-DRGs 252, 253, and 254, with an average length of stay of 6.0 days
and average costs of $20,310. There were 522 cases across MS-DRGs 252,
253, and 254 reporting the use of an intraluminal device with use of a
drug-coated balloon in the performance of the procedure, with an
average length of stay of 6.0 days and average costs of $28,418. There
were 447 cases across MS-DRGs 252, 253, and 254 reporting the use of a
drug[dash]eluting intraluminal device with use of a drug-coated balloon
in the performance of the procedure, with an average length of stay of
6.0 days and average costs of $26,098. Lastly, there were 2,705 cases
across MS-DRGs 252, 253, and 254 reporting the use of a drug-coated
balloon alone in the performance of the procedure, with an average
length of stay of 6.1 days and average costs of $24,553.
The data showed that the 2,705 cases in MS-DRGs 252, 253, and 254
reporting the use of a drug-coated balloon alone in the performance of
the procedure have lower average costs compared to the 969 cases in MS-
DRGs 252, 253, and 254 reporting the use of an intraluminal device (522
cases) or a drug-eluting intraluminal device (447 cases) with a drug-
coated balloon in the performance of the procedure ($24,553 versus
$28,418 and $26,098, respectively). The data also showed that the cases
reporting the use of a drug-coated balloon alone in the performance of
the procedure have a comparable average length of stay compared to the
cases reporting the use of an intraluminal device or a drug-eluting
intraluminal device with a drug-coated balloon in the performance of
the procedure (6.1 days versus 6.0 days).
In summary, we believe that further analysis of endovascular
procedures involving the treatment of superficial femoral arteries for
peripheral arterial disease that utilize a drug-coated balloon in the
performance of the procedure would be advantageous. As additional
claims data become available, we will be able to more fully evaluate
the differences in cases where a procedure utilizes a drug-coated
balloon alone in the performance of the procedure versus cases where a
procedure utilizes an intraluminal device or a drug-eluting
intraluminal device in addition to a drug-coated balloon in the
performance of the procedure.
5. MDC 6 (Diseases and Disorders of the Digestive System)
a. Benign Lipomatous Neoplasm of Kidney
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[dash]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[dash]DRGs to the ICD[dash]10 MS[dash]DRGs, there was not a
specific code available that identified the kidney from which to
[[Page 20208]]
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[dash]DRGs
to the ICD-10 MS[dash]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 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.
b. Bowel Procedures
We received a request to reassign the following 8 ICD-10-PCS
procedure codes that describe repositioning of the colon and takedown
of end colostomy from MS-DRGs 344, 345, and 346 (Minor Small and Large
Bowel Procedures with MCC, with CC, and without CC/MCC, respectively)
to MS-DRGs 329, 330, and 331 (Major Small and Large Bowel Procedures
with MCC, with CC, and without CC/MCC, respectively):
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DSK0ZZ................... Reposition ascending colon, open approach.
0DKL4ZZ................... Reposition ascending colon, percutaneous
endoscopic approach.
0DSL0ZZ................... Reposition transverse colon, open approach.
0DSL4ZZ................... Reposition transverse colon, percutaneous
endoscopic approach.
0DSM0ZZ................... Reposition descending colon, open approach.
0DSM4ZZ................... Reposition descending colon, percutaneous
endoscopic approach.
0DSN0ZZ................... Reposition sigmoid colon, open approach.
0DSN4ZZ................... Reposition sigmoid colon, percutaneous
endoscopic approach.
------------------------------------------------------------------------
The requestor indicated that the resources required for procedures
identifying repositioning of specified segments of the large bowel are
more closely aligned with other procedures that group to MS-DRGs 329,
330, and 331, such as repositioning of the large intestine (unspecified
segment).
We analyzed the claims data from the September 2017 update of the
FY 2017 Med PAR file for MS-DRGs 344, 345 and 346 for all cases
reporting the 8 ICD[dash]10-PCS procedure codes listed in the table
above. Our findings are shown in the following table:
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 344--All cases........................................... 1,452 9.5 $20,609
MS-DRG 344--All cases with a specific large bowel reposition 52 9.6 23,409
procedure......................................................
MS-DRG 345--All cases........................................... 2,674 5.6 11,552
MS-DRG 345--All cases with a specific large bowel reposition.... 246 6 14,915
MS-DRG 346--All cases........................................... 990 3.8 8,977
MS-DRG 346--All cases with a specific large bowel reposition 223 4.5 12,279
procedure......................................................
----------------------------------------------------------------------------------------------------------------
The data showed that the average length of stay and average costs
for cases that reported a specific large bowel reposition procedure
were generally consistent with the average length of stay and average
costs for all of the cases in their assigned MS-DRG.
We then examined the claims data in the September 2017 update of
the FY 2017 MedPAR file for MS-DRGs 329, 330 and 331. Our findings are
shown in the following table.
[[Page 20209]]
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 329, 330, and 331--All cases............................ 112,388 8.4 $21,382
MS-DRG 329--All cases........................................... 33,640 13.3 34,015
MS-DRG 330--All cases........................................... 52,644 7.3 17,896
MS-DRG 331--All cases........................................... 26,104 4.1 12,132
----------------------------------------------------------------------------------------------------------------
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 bowel repositioning procedures in
MS[dash]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.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DQK0ZZ................... Repair ascending colon, open approach.
0DQK4ZZ................... Repair ascending colon, percutaneous
endoscopic approach.
0DQL0ZZ................... Repair transverse colon, open approach.
0DQL4ZZ................... Repair transverse colon, percutaneous
endoscopic approach.
0DQM0ZZ................... Repair descending colon, open approach.
0DQM4ZZ................... Repair descending colon, percutaneous
endoscopic approach.
0DQN0ZZ................... Repair sigmoid colon, open approach.
0DQN4ZZ................... Repair sigmoid colon, percutaneous
endoscopic approach.
0DSB0ZZ................... Reposition ileum, open approach.
0DSB4ZZ................... Reposition ileum, percutaneous endoscopic
approach.
0DSE0ZZ................... Reposition large intestine, open approach.
0DSE4ZZ................... Reposition large intestine, percutaneous
endoscopic approach.
------------------------------------------------------------------------
This approach can be useful in determining whether resource use is
truly associated with a particular procedure or whether the procedure
frequently occurs in cases with other procedures with higher than
average resource use. As shown in the following table, we identified
398 cases reporting a bowel procedure as the only O.R. procedure, with
an average length of stay of 6.3 days and average costs of $13,595
across MS-DRGs 329, 330, and 331, compared to the overall average
length of stay of 8.4 days and average costs of $21,382 for all cases
in MS-DRGs 329, 330, and 331.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 329, 330 and 331--All cases............................. 112,388 8.4 $21,382
MS-DRGs 329, 330 and 331--All cases with a bowel procedure as 398 6.3 13,595
only O.R. procedure............................................
MS-DRG 329--All cases........................................... 33,640 13.3 34,015
MS-DRG 329--Cases with a bowel procedure as only O.R. procedure. 86 8.3 19,309
MS-DRG 330--All cases........................................... 52,644 7.3 17,896
MS-DRG 330--Cases with a bowel procedure as only O.R. procedure. 183 6.9 13,617
MS-DRG 331--All cases........................................... 26,104 4.1 12,132
MS-DRG 331--Cases with a bowel procedure as only O.R. procedure. 129 4.3 9,754
----------------------------------------------------------------------------------------------------------------
The resources required for these cases are more aligned with the
resources required for cases assigned to MS-DRGs 344, 345, and 346 than
with the resources required for cases assigned to MS-DRGs 329, 330, and
331. Our clinical advisors also agreed that these cases are more
clinically aligned with cases in MS-DRGs 344, 345, and 346, as they are
minor procedures relative to the major bowel procedures assigned to MS-
DRGs 329, 330, and 331. Therefore, 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.
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
[[Page 20210]]
received a comment suggesting that CMS publish findings from this
review and discuss possible future actions. The commenter agreed that
it is important to be able to fully evaluate the MS-DRGs to which all
spinal fusion procedures are currently assigned with additional claims
data, particularly considering the 33 clinically invalid codes that
were identified through the rulemaking process (82 FR 38034 through
38035) and the 87 codes identified from the upper and lower joint
fusion tables in the ICD-10-PCS classification and discussed at the
September 12, 2017 ICD-10 Coordination and Maintenance Committee that
were proposed to be deleted effective October 1, 2018 (FY 2019). The
agenda and handouts from that meeting can be obtained from the CMS
website at: https://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/ICD-9-CM-C-and-M-Meeting-Materials.html.
According to the commenter, deleting the 33 procedure codes
describing clinically invalid spinal fusion procedures for FY 2018
partially resolves the issue for data used in setting the FY 2020
payment rates. However, the commenter also noted that the problem will
not be fully resolved until the FY 2019 claims are available for FY
2021 ratesetting (due to the 87 codes identified at the ICD-10
Coordination and Maintenance Committee meeting for deletion effective
October 1, 2018 (FY 2019)).
The commenter noted that it analyzed claims data from the FY 2016
MedPAR data set and was surprised to discover a significant number of
discharges reporting 1 of the 87 clinically invalid codes that were
identified and discussed by the ICD-10 Coordination and Maintenance
Committee among the following spinal fusion MS-DRGs.
------------------------------------------------------------------------
MS-DRG Description
------------------------------------------------------------------------
453....................... Combined Anterior/Posterior Spinal Fusion
with MCC.
454....................... Combined Anterior/Posterior Spinal Fusion
with CC.
455....................... Combined Anterior/Posterior Spinal Fusion
without CC/MCC.
456....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions with MCC.
457....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions with CC.
458....................... Spinal Fusion Except Cervical with Spinal
Curvature or Malignancy or Infection or
Extensive Fusions without CC/MCC.
459....................... Spinal Fusion Except Cervical with MCC.
460....................... Spinal Fusion Except Cervical without MCC.
471....................... Cervical Spinal Fusion with MCC.
472....................... Cervical Spinal Fusion with CC.
473....................... Cervical Spinal Fusion without CC/MCC.
------------------------------------------------------------------------
In addition, the commenter noted that it also identified a number
of discharges for the 33 clinically invalid codes we identified in the
FY 2018 IPPS/LTCH PPS final rule in the same MS-DRGs listed above.
According to the commenter, its findings of these invalid spinal fusion
procedure codes in the FY 2016 claims data comprise approximately 30
percent of all discharges for spinal fusion procedures.
The commenter expressed its appreciation that CMS is making efforts
to address coding inaccuracies within the classification and suggested
that CMS publish findings from its own review of spinal fusion coding
issues in those MS-DRGs where cases reporting spinal fusion procedures
are currently assigned and include a discussion of possible future
actions in the FY 2019 IPPS/LTCH PPS proposed rule. The commenter
believed that such an approach would allow time for stakeholder input
on any possible proposals along with time for the invalid codes to be
worked out of the datasets. The commenter also noted that publishing
CMS' findings will put the agency, as well as the public, in a better
position to address any potential payment issues for these services
beginning in FY 2021.
We thank the commenter for acknowledging the steps we have taken in
our efforts to address coding inaccuracies within the classification as
we continue to refine the ICD-10 MS-DRGs. We 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
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, 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html).
We examined claims data from the September 2017 update of the FY
2017 MedPAR file for cases reporting any of the clinically invalid
spinal fusion procedures with device value ``Z'' No Device in MS-DRGs
028 (Spinal Procedures with MCC), 029 (Spinal Procedures with CC or
Spinal Neurostimulators), and 030 (Spinal Procedures without CC/MCC)
under
[[Page 20211]]
MDC 1 and MS-DRGs 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and
473 under MDC 8 (that are listed and shown earlier in this section).
Our findings are shown in the following tables.
Spinal Fusion Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 028--All cases........................................... 1,927 11.7 $37,524
MS-DRG 028--Cases with invalid spinal fusion procedures......... 132 13 52,034
MS-DRG 029--All cases........................................... 3,426 5.7 22,525
MS-DRG 029--Cases with invalid spinal fusion procedures......... 171 7.4 33,668
MS-DRG 030--All cases........................................... 1,578 3 15,984
MS-DRG 030--Cases with invalid spinal fusion procedures......... 52 2.6 22,471
MS-DRG 453--All cases........................................... 2,891 9.5 70,005
MS-DRG 453--Cases with invalid spinal fusion procedures......... 823 10.1 84,829
MS-DRG 454--All cases........................................... 12,288 4.7 47,334
MS-DRG 454--Cases with invalid spinal fusion procedures......... 2,473 5.4 59,814
MS-DRG 455--All cases........................................... 12,751 3 37,440
MS-DRG 455--Cases with invalid spinal fusion procedures......... 2,332 3.2 45,888
MS-DRG 456--All cases........................................... 1,439 11.5 66,447
MS-DRG 456--Cases with invalid spinal fusion procedures......... 404 12.5 71,385
MS-DRG 457--All cases........................................... 3,644 6 48,595
MS-DRG 457--Cases with invalid spinal fusion procedures......... 960 6.7 53,298
MS-DRG 458--All cases........................................... 1,368 3.6 37,804
MS-DRG 458--Cases with invalid spinal fusion procedures......... 244 4.1 43,182
MS-DRG 459--All cases........................................... 4,904 7.8 43,862
MS-DRG 459--Cases with invalid spinal fusion procedures......... 726 9 49,387
MS-DRG 460--All cases........................................... 59,459 3.4 29,870
MS-DRG 460--Cases with invalid spinal fusion procedures......... 5,311 3.9 31,936
MS-DRG 471--All cases........................................... 3,568 8.4 36,272
MS-DRG 471--Cases with invalid spinal fusion procedures......... 389 9.9 43,014
MS-DRG 472--All cases........................................... 15,414 3.2 21,836
MS-DRG 472--Cases with invalid spinal fusion procedures......... 1,270 4 25,780
MS-DRG 473--All cases........................................... 18,095 1.8 17,694
MS-DRG 473--Cases with invalid spinal fusion procedures......... 1,185 2.3 19,503
----------------------------------------------------------------------------------------------------------------
Summary Table for Spinal Fusion Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 142,752 3.9 $31,788
471, 472, and 473--All cases...................................
MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 16,472 5.1 42,929
471, 472, and 473--Cases with invalid spinal fusion procedures.
----------------------------------------------------------------------------------------------------------------
As shown in this summary table, we found a total of 142,752 cases
in MS-DRGs 028, 029, 030, 453, 454, 455, 456, 457, 458, 459, 460, 471,
472, and 473 with an average length of stay of 3.9 days and average
costs of $31,788. We found a total of 16,472 cases reporting a
procedure code for an invalid spinal fusion procedure with device value
``Z'' No Device across MS-DRGs 028, 029, and 030 under MDC 1 and MS-
DRGs 453, 454, 455, 456, 457, 458, 459, 460, 471, 472, and 473 under
MDC 8, with an average length of stay of 5.1 days and average costs of
$42,929. The results of the data analysis demonstrate that these
invalid spinal fusion procedures represent approximately 12 percent of
all discharges across the spinal fusion MS-DRGs. Because these
procedure codes describe clinically invalid procedures, we would not
expect these codes to be reported on any claims data. 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 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.
[[Page 20212]]
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 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.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 602--All cases........................................... 26,244 5.8 $10,034
MS-DRG 603--All cases........................................... 104,491 3.9 6,128
MS-DRGs 602 and 603--Cases reported with a primary diagnosis of 5,364 5.3 8,245
cellulitis and a secondary diagnosis of B95.62.................
MS-DRGs 602 and 603--Cases reported with a primary diagnosis of 309 5.4 8,832
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
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 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.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 867-All cases............................................ 2,653 7.5 $14,762
MS-DRG 868-All cases............................................ 2,096 4.4 7,532
MS-DRG 869-All cases............................................ 499 3.3 5,624
----------------------------------------------------------------------------------------------------------------
We compared the average length of stay and average costs for MS-
DRGs 867, 868, and 869 to the average length of stay and average costs
for the subsets of cases in MS-DRGs 602 and 603 reported with a 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 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 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
[[Page 20213]]
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[reg] (hemin for injection). ICD-
10-CM diagnosis code E80.21 is currently assigned to MS-DRG 642 (Inborn
and Other Disorders of Metabolism). (We note that this issue has been
discussed previously in the FY 2013 IPPS/LTCH PPS proposed and final
rules (77 FR 27904 through 27905 and 77 FR 53311 through 53313,
respectively) and the FY 2015 IPPS/LTCH PPS proposed and final rules
(79 FR 28016 and 79 FR 49901, respectively).)
We analyzed claims data from the September 2017 update of the FY
2017 MedPAR file for cases assigned to MS-DRG 642. Our findings are
shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 642--All cases........................................... 1,801 4.3 $9,157
MS-DRG 642--Cases reporting diagnosis code E80.21 as principal 183 5.6 19,244
diagnosis......................................................
MS-DRG 642--Cases not reporting diagnosis code E80.21 as 1,618 4.1 8,016
principal diagnosis............................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, cases reporting diagnosis code E80.21 as
the principal diagnosis in MS-DRG 642 had higher average costs and
longer average lengths of stay compared to the average costs and
lengths of stay for all other cases in MS-DRG 642.
To examine the request to reassign cases with ICD-10-CM diagnosis
code E80.21 as the principal diagnosis, we analyzed claims data for all
cases in MS-DRGs for endocrine disorders, including MS-DRG 643
(Endocrine Disorders with MCC), MS[dash]DRG 644 (Endocrine Disorders
with CC), and MS-DRG 645 (Endocrine Disorders without CC/MCC). The
results of our analysis are shown in the following table.
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 643--All cases........................................... 9,337 6.3 $11,268
MS-DRG 644--All cases........................................... 11,306 4.2 7,154
MS-DRG 645--All cases........................................... 4,297 3.2 5,406
----------------------------------------------------------------------------------------------------------------
The data results showed that the average length of stay for the
subset of cases reporting ICD-10-CM diagnosis code E80.21 as the
principal diagnosis in MS-DRG 642 is lower than the average length of
stay for all cases in MS-DRG 643, but higher than the average length of
stay for all cases in MS-DRGs 644 and 645. The average costs for the
subset of cases reporting ICD-10-CM diagnosis code E80.21 as the
principal diagnosis in MS-DRG 642 are much higher than the average
costs for all cases in MS-DRGs 643, 644, and 645. However, after
considering these findings in the context of the current MS-DRG
structure, we 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 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.
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:
------------------------------------------------------------------------
ICD-10-CM code ICD-CM code title
------------------------------------------------------------------------
Z49.01.................... Encounter for fitting and adjustment of
extracorporeal dialysis catheter.
Z49.02.................... Encounter for fitting and adjustment of
peritoneal dialysis catheter.
Z49.31.................... Encounter for adequacy testing for
hemodialysis.
Z49.32.................... Encounter for adequacy testing for
peritoneal dialysis.
------------------------------------------------------------------------
[[Page 20214]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 685--All cases........................................... 78 4 $8,871
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.01..... 78 4 8,871
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.02..... 0 0 0
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.31..... 0 0 0
MS-DRG 685--Cases reporting ICD-10-CM diagnosis code Z49.32..... 0 0 0
----------------------------------------------------------------------------------------------------------------
As shown in the table above, for MS-DRG 685, there were a total of
78 cases reporting ICD-10-CM diagnosis code Z49.01, with an average
length of stay of 4 days and average costs of $8,871. There were no
cases reporting ICD-10-CM diagnosis code Z49.02, Z49.31, or Z49.32.
Our clinical advisors reviewed the clinical issues, as well as the
claims data for MS-DRG 685. Based on their review of the data analysis,
our clinical advisors recommended that MS-DRG 685 be deleted and ICD-
10-CM diagnosis codes Z49.01, Z49.02, Z49.31, and Z49.32 be reassigned.
Historically, patients were admitted as inpatients to receive
hemodialysis services. However, over time, that practice has shifted to
outpatient and ambulatory settings. Because of this change in medical
practice, we 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 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 Complicating Diagnosis). In
addition, we sought public comments on further refinements to the
conditions defined as a complicating diagnosis in MS-DRG 774 and MS-DRG
781 (Other Antepartum Diagnoses with Medical Complications). We
indicated that we would review public comments received in response to
the solicitation as we continued to evaluate these MS-DRGs under MDC 14
and, if warranted, we would propose refinements for FY 2019. Commenters
were instructed to direct comments for consideration to the CMS MS-DRG
Classification Change Request Mailbox located at
[email protected] by November 1, 2017.
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.
[[Page 20215]]
Suggestions for MS-DRG 767
[Vaginal delivery with sterilization and/or D&C]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 767
------------------------------------------------------------------------
O66.41.................. Failed attempted This code indicates
vaginal birth after that the attempt at
previous cesarean vaginal delivery has
delivery. failed.
O71.00.................. Rupture of uterus This code indicates
before onset of that the uterus has
labor, unspecified ruptured before onset
trimester. of labor and
therefore, a vaginal
delivery would not be
possible.
O82..................... Encounter for cesarean This code indicates
delivery without the encounter is for
indication. a cesarean delivery.
O75.82.................. Onset (spontaneous) of This code indicates
labor after 37 weeks this is a cesarean
of gestation but delivery.
before 39 completed
weeks, with delivery
by (planned) C-
section.
------------------------------------------------------------------------
Suggestions for MS-DRG 767
[Vaginal delivery with sterilization and/or D&C]
------------------------------------------------------------------------
Rationale for removing
ICD-10-PCS code Code description code from MS-DRG 767
------------------------------------------------------------------------
10A07Z6................. Abortion of products This code indicates
of conception, the procedure to be
vacuum, via natural an abortion rather
or artificial opening. than a vaginal
delivery.
------------------------------------------------------------------------
For MS-DRG 774, the commenter recommended that the following ICD-
10-CM diagnosis codes be removed from the GROUPER logic and provided
the rationale for why the commenter suggested removing each code.
Suggestions for MS-DRG 774
[Vaginal delivery with Complicating Diagnoses]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 774
------------------------------------------------------------------------
O66.41.................. Failed attempted This code indicates
vaginal birth after that the attempt at
previous cesarean vaginal delivery has
delivery. failed.
O71.00.................. Rupture of uterus This code indicates
before onset of that the uterus has
labor, unspecified ruptured before onset
trimester. of labor and
therefore, a vaginal
delivery would not be
possible.
O75.82.................. Onset (spontaneous) of This code indicates
labor after 37 weeks this is a planned
of gestation but cesarean delivery.
before 39 completed
weeks, with delivery
by (planned) C-
section.
O82..................... Encounter for cesarean This code indicates
delivery without the encounter is for
indication. a cesarean delivery.
O80..................... Encounter for full- According to the
term uncomplicated Official Guidelines
delivery. for Coding and
Reporting, ``Code O80
should be assigned
when a woman is
admitted for a full
term normal delivery
and delivers a
single, healthy
infant without any
complications
antepartum, during
the delivery, or
postpartum during the
delivery episode.''
------------------------------------------------------------------------
For MS-DRG 775, the commenter recommended that the following ICD-
10-CM diagnosis codes and ICD-10-PCS procedure code be removed from the
GROUPER logic and provided the rationale for why the commenter
suggested removing each code.
Suggestions for MS-DRG 775
[Vaginal delivery without complicating diagnoses]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 775
------------------------------------------------------------------------
O66.41.................. Failed attempted This code indicates
vaginal birth after that the attempt at
previous cesarean vaginal delivery has
delivery. failed.
O69.4XX0................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, not vasa previa always
applicable or results in C-section.
unspecified. Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
[[Page 20216]]
O69.4XX2................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, fetus 2. vasa previa always
results in C-section.
Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
O69.4XX3................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, fetus 3. vasa previa always
results in C-section.
Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
O69.4XX4................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, fetus 4. vasa previa always
results in C-section.
Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
O69.4XX5................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, fetus 5. vasa previa always
results in C-section.
Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
O69.4XX9................ Labor and delivery According to the
complicated by vasa physicians consulted,
previa, other fetus. vasa previa always
results in C-section.
Research indicates
that when vasa previa
is diagnosed, C-
section before labor
begins can save the
baby's life.
O71.00.................. Rupture of uterus This code indicates
before onset of that the uterus has
labor, unspecified ruptured before onset
trimester. of labor and
therefore, a vaginal
delivery would not be
possible.
O82..................... Encounter for cesarean This code indicates
delivery without the encounter is for
indication. a cesarean delivery.
------------------------------------------------------------------------
Suggestions for MS-DRG 775
[Vaginal delivery without Complicating Diagnosis]
------------------------------------------------------------------------
Rationale for removing
ICD-10-CM code Code description code from MS-DRG 775
------------------------------------------------------------------------
10A07Z6................. Abortion of Products This code indicates
of Conception, the procedure to be
Vacuum, Via Natural an abortion rather
or Artificial Opening. than a vaginal
delivery.
------------------------------------------------------------------------
Another commenter agreed that the MS-DRG logic for a vaginal
delivery under MDC 14 is technically complex and provided examples to
illustrate these facts. For instance, the commenter noted that the
GROUPER logic code lists appear redundant with several of the same
codes listed for different MS-DRGs and that the GROUPER logic code list
for a vaginal delivery in MS-DRG 774 is comprised of diagnosis codes
while the GROUPER logic code list for a vaginal delivery in MS-DRG 775
is comprised of procedure codes. The commenter also noted that several
of the ICD-10-CM diagnosis codes shown in the table below that became
effective with discharges on and after October 1, 2016 (FY 2017) or
October 1, 2017 (FY 2018) appear to be missing from the GROUPER logic
code lists for MS-DRGs 781 and 774.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
O11.4..................... Pre-existing hypertension with pre-
eclampsia, complicating childbirth.
O11.5..................... Pre-existing hypertension with pre-
eclampsia, complicating the puerperium.
012.04.................... Gestational edema, complicating childbirth.
012.05.................... Gestational edema, complicating the
puerperium.
012.14.................... Gestational proteinuria, complicating
childbirth.
012.15.................... Gestational proteinuria, complicating the
puerperium.
012.24.................... Gestational edema with proteinuria,
complicating childbirth.
012.25.................... Gestational edema with proteinuria,
complicating the puerperium.
O13.4..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating childbirth.
O13.5..................... Gestational [pregnancy-induced] hypertension
without significant proteinuria,
complicating the puerperium.
O14.04.................... Mild to moderate pre-eclampsia, complicating
childbirth.
O14.05.................... Mild to moderate pre-eclampsia, complicating
the puerperium.
O14.14.................... Severe pre-eclampsia, complicating
childbirth.
O14.15.................... Severe pre-eclampsia, complicating the
puerperium.
O14.24.................... HELLP syndrome, complicating childbirth.
O14.25.................... HELLP syndrome, complicating the puerperium.
O14.94.................... Unspecified pre-eclampsia, complicating
childbirth.
O14.95.................... Unspecified pre-eclampsia, complicating the
puerperium.
O15.00.................... Eclampsia complicating pregnancy,
unspecified trimester.
[[Page 20217]]
O15.02.................... Eclampsia complicating pregnancy, second
trimester.
O15.03.................... Eclampsia complicating pregnancy, third
trimester.
O15.1..................... Eclampsia complicating labor.
O15.2..................... Eclampsia complicating puerperium, second
trimester.
O16.4..................... Unspecified maternal hypertension,
complicating childbirth.
O16.5..................... Unspecified maternal hypertension,
complicating the puerperium.
O24.415................... Gestational diabetes mellitus in pregnancy,
controlled by oral hypoglycemic drugs.
O24.425................... Gestational diabetes mellitus in childbirth,
controlled by oral hypoglycemic drugs.
O24.435................... Gestational diabetes mellitus in puerperium,
controlled by oral hypoglycemic drugs.
O44.20.................... Partial placenta previa NOS or without
hemorrhage, unspecified trimester.
O44.21.................... Partial placenta previa NOS or without
hemorrhage, first trimester.
O44.22.................... Partial placenta previa NOS or without
hemorrhage, second trimester.
O44.23.................... Partial placenta previa NOS or without
hemorrhage, third trimester.
O44.30.................... Partial placenta previa with hemorrhage,
unspecified trimester.
O44.31.................... Partial placenta previa with hemorrhage,
first trimester.
O44.32.................... Partial placenta previa with hemorrhage,
second trimester.
O44.33.................... Partial placenta previa with hemorrhage,
third trimester.
O44.40.................... Low lying placenta NOS or without
hemorrhage, unspecified trimester.
O44.41.................... Low lying placenta NOS or without
hemorrhage, first trimester.
O44.42.................... Low lying placenta NOS or without
hemorrhage, second trimester.
O44.43.................... Low lying placenta NOS or without
hemorrhage, third trimester.
O44.50.................... Low lying placenta with hemorrhage,
unspecified trimester.
O44.51.................... Low lying placenta with hemorrhage, first
trimester.
O44.52.................... Low lying placenta with hemorrhage, second
trimester.
O44.53.................... Low lying placenta with hemorrhage, third
trimester.
O70.20.................... Third degree perineal laceration during
delivery, unspecified.
O70.21.................... Third degree perineal laceration during
delivery, IIIa.
O70.22.................... Third degree perineal laceration during
delivery, IIIb.
O70.23.................... Third degree perineal laceration during
delivery, IIIc.
O86.11.................... Cervicitis following delivery.
O86.12.................... Endometritis following delivery.
O86.13.................... Vaginitis following delivery.
O86.19.................... Other infection of genital tract following
delivery.
O86.20.................... Urinary tract infection following delivery,
unspecified.
O86.21.................... Infection of kidney following delivery.
O86.22.................... Infection of bladder following delivery.
O86.29.................... Other urinary tract infection following
delivery.
O86.81.................... Puerperal septic thrombophlebitis.
O86.89.................... Other specified puerperal infections.
------------------------------------------------------------------------
Lastly, the commenter stated that the list of ICD-10-PCS procedure
codes appears comprehensive, but indicated that inpatient coding is not
their expertise. We note that it was not clear which list of procedure
codes the commenter was specifically referencing. The commenter did not
provide a list of any procedure codes for CMS to review or reference a
specific MS-DRG in its comment.
Another commenter expressed concern that ICD-10-PCS procedure codes
10D17Z9 (Manual extraction of products of conception, retained, via
natural or artificial opening) and 10D18Z9 (Manual extraction of
products of conception, retained, via natural or artificial opening
endoscopic) are not assigned to the appropriate MS-DRG. ICD-10-PCS
procedure codes 10D17Z9 and 10D18Z9 describe the manual removal of a
retained placenta and are currently assigned to MS-DRG 767 (Vaginal
Delivery with Sterilization and/or D&C). According to the commenter, a
patient that has a vaginal delivery with manual removal of a retained
placenta is not having a sterilization or D&C procedure. The commenter
noted that, under ICD-9-CM, a vaginal delivery with manual removal of
retained placenta grouped to MS-DRG 774 (Vaginal Delivery with
Complicating Diagnosis) or MS-DRG 775 (Vaginal Delivery without
Complicating Diagnosis). The commenter suggested CMS review these
procedure codes for appropriate MS-DRG assignment under the ICD-10 MS-
DRGs.
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 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-
[[Page 20218]]
for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-
Items/FY2018-IPPS-Final-Rule-Data-
Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending for
documentation of the GROUPER logic associated with the MDC 14 MS-DRGs
to assist in the review of our discussion that follows.
We started our evaluation of the GROUPER logic for the MS-DRGs
under MDC 14 by first reviewing the current concepts that exist. For
example, there are ``groups'' for cesarean section procedures, vaginal
delivery procedures, and abortions. There also are groups where no
delivery occurs, and lastly, there are groups for after the delivery
occurs, or the ``postpartum'' period. These groups are then further
subdivided based on the presence or absence of complicating conditions
or the presence of another procedure. We examined how we could simplify
some of the older, complex GROUPER logic and remain consistent with the
structure of other ICD-10 MS-DRGs. We identified the following MS-DRGs
for closer review, in addition to MS-DRG 767, MS-DRG 768, MS-DRG 774,
MS-DRG 775 and MS-DRG 781.
------------------------------------------------------------------------
MS-DRG Description
------------------------------------------------------------------------
MS-DRG 765................ Cesarean Section with CC/MCC.
MS-DRG 766................ Cesarean Section without CC/MCC.
MS-DRG 769................ Postpartum and Post Abortion Diagnoses with
O.R. Procedure.
MS-DRG 770................ Abortion with D&C, Aspiration Curettage or
Hysterotomy.
MS-DRG 776................ Postpartum and Post Abortion Diagnoses
without O.R. Procedure.
MS-DRG 777................ Ectopic Pregnancy.
MS-DRG 778................ Threatened Abortion.
MS-DRG 779................ Abortion without D&C.
MS-DRG 780................ False Labor.
MS-DRG 782................ Other Antepartum Diagnoses without Medical
Complications.
------------------------------------------------------------------------
The first issue we reviewed was the GROUPER logic for complicating
conditions (MS-DRGs 774 and 781). Because one of the main objectives in
our transition to the MS-DRGs was to better recognize the severity of
illness of a patient, we believed we could structure the vaginal
delivery and other MDC 14 MS-DRGs in a similar way. Therefore, we began
working with the concept of vaginal delivery ``with MCC, with CC and
without CC/MCC'' to replace the older, ``complicating conditions''
logic.
Next, we compared the additional GROUPER logic that exists between
the vaginal delivery and the cesarean section MS-DRGs (MS-DRGs 765,
766, 767, 774, and 775). Currently, the vaginal delivery MS-DRGs take
into account a sterilization procedure; however, the cesarean section
MS-DRGs do not. Because a patient can have a sterilization procedure
performed along with a cesarean section procedure, we adopted a working
concept of ``cesarean section with and without sterilization with MCC,
with CC and without CC/MCC'', as well as ``vaginal delivery with and
without sterilization with MCC, with CC and without CC/MCC''.
We then reviewed the GROUPER logic for the MS-DRGs involving
abortion and where no delivery occurs (MS-DRGs 770, 777, 778, 779, 780,
and 782). We believed that we could consolidate the groups in which no
delivery occurs.
Finally, we considered the GROUPER logic for the MS-DRGs related to
the postpartum period (MS-DRGs 769 and 776) and determined that the
structure of these MS-DRGs did not appear to require modification.
After we established those initial working concepts for the MS-DRGs
discussed above, we examined the list of the ICD-10-PCS procedure codes
that comprise the sterilization procedure GROUPER logic for the vaginal
delivery MS-DRG 767. We identified the two manual extraction of
placenta codes that the commenter had brought to our attention (ICD-10-
PCS codes 10D17Z9 and 10D18Z9). We also identified two additional
procedure codes, ICD-10-PCS codes 10D17ZZ (Extraction of products of
conception, retained, via natural or artificial opening) and 10D18ZZ
(Extraction of products of conception, retained, via natural or
artificial opening endoscopic) in the list that are not sterilization
procedures. Two of the four procedure codes describe manual extraction
(removal) of retained placenta and the other two procedure codes
describe dilation and curettage procedures. We then identified four
more procedure codes in the list that do not describe sterilization
procedures. ICD-10-PCS procedure codes 0UDB7ZX (Extraction of
endometrium, via natural or artificial opening, diagnostic), 0UDB7ZZ
(Extraction of endometrium, via natural or artificial opening), 0UDB8ZX
(Extraction of endometrium, via natural or artificial opening
endoscopic, diagnostic), and 0UDB8ZZ (Extraction of endometrium, via
natural or artificial opening endoscopic) describe dilation and
curettage procedures that can be performed for diagnostic or
therapeutic purposes. We believe that these ICD-10-PCS procedure codes
would be more appropriately assigned to MDC 13 (Diseases and Disorders
of the Female Reproductive System) in MS-DRGs 744 and 745 (D&C,
Conization, 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 C-section'' logic from these MS-DRGs as part of
our working concept and efforts to refine MDC 14. We determined it
would be less complicated to simply allow the existing ICD-10
MS[dash]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
[[Page 20219]]
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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.
Next, we reviewed the ``Delivery Procedure'' and ``Delivery
Outcome'' GROUPER logic code lists for the vaginal delivery MS-DRGs
767, 768, 774, and 775. We identified ICD-10-PCS procedure code 10A0726
(Abortion of products of conception, vacuum, via natural or artificial
opening) and ICD-10-PCS procedure code 10S07ZZ (Reposition products of
conception, via natural or artificial opening) under the ``Delivery
Procedure'' code list as procedure codes that should not be included
because ICD-10-PCS procedure code 10A07Z6 describes an abortion
procedure and ICD-10-PCS procedure code 10S07ZZ describes repositioning
of the fetus and does not indicate a delivery took place. We also note
that, as described earlier in this discussion, a commenter recommended
that ICD-10-PCS procedure code 10A07Z6 be removed from the GROUPER
logic specifically for MS-DRGs 767 and 775. Therefore, we removed these
two procedure codes from the logic code list for ``Delivery Procedure''
in MS-DRGs 767, 768, 774, and 775. We agreed with the commenter that
ICD-10-PCS procedure code 10A07Z6 would be more appropriately assigned
to one of the Abortion MS-DRGs. For the remaining procedures currently
included in the ``Delivery Procedure'' code list we considered which
procedures would be expected to be performed during the course of a
standard, uncomplicated delivery episode versus those that would
reasonably be expected to require additional resources outside of the
delivery room. The list of procedure codes we reviewed is shown in the
following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0DQP7ZZ................... Repair rectum, via natural or artificial
opening.
0DQQ0ZZ................... Repair anus, open approach.
0DQQ3ZZ................... Repair anus, percutaneous approach.
0DQQ4ZZ................... Repair anus, percutaneous endoscopic
approach.
0DQQ7ZZ................... Repair anus, via natural or artificial
opening.
0DQQ8ZZ................... Repair anus, via natural or artificial
opening endoscopic.
0DQR0ZZ................... Repair anal sphincter, open approach.
0DQR3ZZ................... Repair anal sphincter, percutaneous
approach.
0DQR4ZZ................... Repair anal sphincter, percutaneous
endoscopic approach.
------------------------------------------------------------------------
While we 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 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 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),
[[Page 20220]]
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[dash]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).
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 3-way severity level split that includes ``with O.R.
Procedure'' and ``without O.R. Procedure''.
Once we established each of these fundamental concepts from a
clinical perspective, we were able to analyze the data to determine if
our initial suggested modifications were supported.
To analyze our suggested modifications for the cesarean section and
vaginal delivery MS-DRGs, we examined the claims data from the
September 2017 update of the FY 2017 MedPAR file for MS-DRGs 765, 766,
767, 768, 774, and 775.
MS-DRGs for MDC 14 Pregnancy, Childbirth and the Puerperium
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 765 (Cesarean Section with CC/MCC)--All cases............ 3,494 4.6 $8,929
MS-DRG 766 (Cesarean Section without CC/MCC)--All cases......... 1,974 3.1 6,488
MS-DRG 767 (Vaginal Delivery with Sterilization and/or D&C)--All 351 3.2 7,886
cases..........................................................
MS-DRG 768 (Vaginal Delivery with O.R. Procedure Except 17 6.2 26,164
Sterilization and/or D&C)--All cases...........................
MS-DRG 774 (Vaginal Delivery with Complicating Diagnosis)--All 1,650 3.3 6,046
cases..........................................................
MS-DRG 775 (Vaginal Delivery without Complicating Diagnosis)-- 4,676 2.4 4,769
All cases......................................................
----------------------------------------------------------------------------------------------------------------
[[Page 20221]]
As shown in the table, there were a total of 3,494 cases in MS-DRG
765, with an average length of stay of 4.6 days and average costs of
$8,929. For MS-DRG 766, there were a total of 1,974 cases, with an
average length of stay of 3.1 days and average costs of $6,488. For MS-
DRG 767, there were a total of 351 cases, with an average length of
stay of 3.2 days and average costs of $ 7,886. For MS-DRG 768, there
were a total of 17 cases, with an average length of stay of 6.2 days
and average costs of $26,164. For MS-DRG 774, there were a total of
1,650 cases, with an average length of stay of 3.3 days and average
costs of $6,046. Lastly, for MS-DRG 775, there were a total of 4,676
cases, with an average length of stay of 2.4 days and average costs of
$4,769.
To compare and analyze the impact of our suggested modifications,
we ran a simulation using the Version 35 ICD-10 MS-DRG GROUPER. The
following table reflects our findings for the suggested Cesarean
Section MS-DRGs with a 3-way severity level split.
Suggested MS-DRGs for Cesarean Section
----------------------------------------------------------------------------------------------------------------
Number of Average Length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 783 (Cesarean Section with Sterilization with MCC)....... 178 6.4 $12,977
MS-DRG 784 (Cesarean Section with Sterilization with CC)........ 511 4.1 8,042
MS-DRG 785 (Cesarean Section with Sterilization without CC/MCC). 475 3.0 6,259
MS-DRG 786 (Cesarean Section without Sterilization with MCC).... 707 5.9 11,515
MS-DRG 787 (Cesarean Section without Sterilization with CC)..... 1,887 4.2 7,990
MS-DRG 788 (Cesarean Section without Sterilization without CC/ 1,710 3.3 6,663
MCC)...........................................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 178 cases for the
cesarean section with sterilization with MCC group, with an average
length of stay of 6.4 days and average costs of $12,977. There were a
total of 511 cases for the cesarean section with sterilization with CC
group, with an average length of stay of 4.1 days and average costs of
$8,042. There were a total of 475 cases for the cesarean section with
sterilization without CC/MCC group, with an average length of stay of
3.0 days and average costs of $6,259. For the cesarean section without
sterilization with MCC group there were a total of 707 cases, with an
average length of stay of 5.9 days and average costs of $11,515. There
were a total of 1,887 cases for the cesarean section without
sterilization with CC group, with an average length of stay of 4.2 days
and average costs of $7,990. Lastly, there were a total of 1,710 cases
for the cesarean section without sterilization without CC/MCC group,
with an average length of stay of 3.3 days and average costs of $6,663.
The following table reflects our findings for the suggested Vaginal
Delivery MS-DRGs with a 3-way severity level split.
Suggested MS-DRGs for Vaginal Delivery
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 796 (Vaginal Delivery with Sterilization/D&C with MCC)... 25 6.7 $11,421
MS-DRG 797 (Vaginal Delivery with Sterilization/D&C with CC).... 63 2.4 6,065
MS-DRG 798 (Vaginal Delivery with Sterilization/D&C without CC/ 126 2.3 6,697
MCC)...........................................................
MS-DRG 805 (Vaginal Delivery without Sterilization/D&C with MCC) 406 5.0 9,605
MS-DRG 806 (Vaginal Delivery without Sterilization/D&C with CC). 1,952 2.9 5,506
MS-DRG 807 (Vaginal Delivery without Sterilization/D&C without 4,105 2.3 4,601
CC/MCC)........................................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 25 cases for the
vaginal delivery with sterilization/D&C with MCC group, with an average
length of stay of 6.7 days and average costs of $11,421. There were a
total of 63 cases for the vaginal delivery with sterilization/D&C with
CC group, with an average length of stay of 2.4 days and average costs
of $6,065. There were a total of 126 cases for vaginal delivery with
sterilization/D&C without CC/MCC group, with an average length of stay
of 2.3 days and average costs of $6,697. There were a total of 406
cases for the vaginal delivery without sterilization/D&C with MCC
group, with an average length of stay of 5.0 days and average costs of
$9,605. There were a total of 1,952 cases for the vaginal delivery
without sterilization/D&C with CC group, with an average length of stay
of 2.9 days and average costs of $5,506. There were a total of 4,105
cases for the vaginal delivery without sterilization/D&C without CC/MCC
group, with an average length of stay of 2.3 days and average costs of
$4,601.
We then reviewed the claims data from the September 2017 update of
the FY 2017 MedPAR file for MS-DRGs 777, 778, 780, 781, and 782. Our
findings are shown in the following table.
MS-DRGs for MDC 14 Pregnancy, Childbirth and the Puerperium
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 777 (Ectopic Pregnancy)--All cases....................... 72 1.9 $7,149
MS-DRG 778 (Threatened Abortion)--All cases..................... 205 2.7 4,001
[[Page 20222]]
MS-DRG 780 (False Labor)--All cases............................. 41 2.1 3,045
MS-DRG 781 (Other Antepartum Diagnoses with Medical 2,333 3.7 5,817
Complications)--All cases......................................
MS-DRG 782 (Other Antepartum Diagnoses without Medical 70 2.1 3,381
Complications)--All cases......................................
----------------------------------------------------------------------------------------------------------------
As shown in the table, there were a total of 72 cases in MS-DRG
777, with an average length of stay of 1.9 days and average costs of
$7,149. For MS-DRG 778, there were a total of 205 cases, with an
average length of stay of 2.7 days and average costs of $4,001. For MS-
DRG 780, there were a total of 41 cases, with an average length of stay
of 2.1 days and average costs of $3,045. For MS-DRG 781, there were a
total of 2,333 cases, with an average length of stay of 3.7 days and
average costs of $5,817. Lastly, for MS-DRG 782, there were a total of
70 cases, with an average length of stay of 2.1 days and average costs
of $3,381.
To compare and analyze the impact of deleting those 5 MS-DRGs and
creating 6 new MS-DRGs, we ran a simulation using the Version 35 ICD-10
MS-DRG GROUPER. Our findings below represent what we found and would
expect under the suggested modifications. The following table reflects
the MS-DRGs for the suggested Other Antepartum Diagnoses MS-DRGs with a
3-way severity level split.
Suggested MS-DRGs for Other Antepartum Diagnoses
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 817 (Other Antepartum Diagnoses with O.R. Procedure with 60 5.1 $13,117
MCC)...........................................................
MS-DRG 818 (Other Antepartum Diagnoses with O.R. Procedure with 66 4.2 10,483
CC)............................................................
MS-DRG 819 (Other Antepartum Diagnoses with O.R. Procedure 44 1.7 5,904
without CC/MCC)................................................
MS-DRG 831 (Other Antepartum Diagnoses without O.R. Procedure 786 4.3 7,248
with MCC)......................................................
MS-DRG 832 (Other Antepartum Diagnoses without O.R. Procedure 910 3.5 4,994
with CC).......................................................
MS-DRG 833 (Other Antepartum Diagnoses without O.R. Procedure 855 2.7 3,843
without CC/MCC)................................................
----------------------------------------------------------------------------------------------------------------
Our analysis of claims data from the September 2017 update of the
FY 2017 MedPAR file recognized that when the criteria to create
subgroups were applied for the 3-way severity level splits for the
suggested MS-DRGs, those criteria were not met in all instances. For
example, the criteria that there are at least 500 cases in the MCC or
CC group was not met for the suggested Vaginal Delivery with
Sterilization/D&C 3[dash]way severity level split or the suggested
Other Antepartum Diagnoses with O.R. Procedure 3[dash]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[dash]way severity level
splits would address the complexity of the current MDC 14 GROUPER logic
for a vaginal delivery and takes into account the new and different
clinical concepts that exist under ICD-10 for this subset of patients
while also maintaining the existing MS-DRG structure for identifying
severity of illness, utilization of resources and complexity of
service.
However, as an alternative option, we also performed analysis for a
2-way severity level split for the suggested MS-DRGs. Our findings are
shown in the following tables.
Suggested MS-DRGs for Cesarean Section
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Cesarean Section with Sterilization with CC/MCC).... 689 4.7 $9,317
MS-DRG XXX (Cesarean Section with Sterilization without CC/MCC). 475 3.0 6,259
MS-DRG XXX (Cesarean Section without Sterilization with MCC).... 2,594 4.7 8,951
MS-DRG XXX (Cesarean Section without Sterilization without CC/ 1,710 3.3 6,663
MCC)...........................................................
----------------------------------------------------------------------------------------------------------------
Suggested MS-DRGs for Vaginal Delivery
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C with CC/MCC) 88 3.6 $7,586
MS-DRG XXX (Vaginal Delivery with Sterilization/D&C without CC/ 126 2.3 6,697
MCC)...........................................................
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C with MCC) 2,358 3.2 6,212
[[Page 20223]]
MS-DRG XXX (Vaginal Delivery without Sterilization/D&C without 4,105 2.3 4,601
CC/MCC)........................................................
----------------------------------------------------------------------------------------------------------------
Suggested MS-DRGs for Other Antepartum Diagnoses
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure with 126 4.7 $11,737
MCC)...........................................................
MS-DRG XXX (Other Antepartum Diagnoses with O.R. Procedure 44 1.7 5,904
without CC/MCC)................................................
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure 1,696 3.9 6,039
with MCC)......................................................
MS-DRG XXX (Other Antepartum Diagnoses without O.R. Procedure 855 2.7 3,843
without CC/MCC)................................................
----------------------------------------------------------------------------------------------------------------
Similar to the analysis performed for the 3-way severity level
split, we acknowledge that when the criteria to create subgroups was
applied for the alternative 2[dash]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 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);
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
[[Page 20224]]
785. If no, the logic assigns the case to one of the proposed new MS-
DRGs 786, 787, or 788. If there was not a cesarean section procedure
reported on the claim, the logic asks if there was a vaginal delivery
procedure reported on the claim. If yes, the logic asks if there was
another O.R. procedure other than sterilization, D&C, delivery
procedure or a delivery inclusive O.R. procedure. If yes, the logic
assigns the case to existing MS-DRG 768. If no, the logic asks if there
was a sterilization and/or D&C reported on the claim. If yes, the logic
assigns the case to one of the proposed new MS-DRGs 796, 797, or 798.
If no, the logic assigns the case to one of the proposed new MS-DRGs
805, 806, or 807. If there was not a vaginal delivery procedure
reported on the claim, the GROUPER logic directs you to the other non-
delivery MS-DRGs as shown in Diagram 2.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP07MY18.000
The logic for Diagram 2. begins by asking if there is a principal
diagnosis of abortion reported on the claim. If yes, the logic then
asks if there was a D&C, aspiration curettage or hysterotomy procedure
reported on the claim. If yes, the logic assigns the case to existing
MS-DRG 770. If no, the logic assigns the case to existing MS-DRG 779.
If there was not a principal diagnosis of abortion reported on the
claim, the logic asks if there was a principal diagnosis of an
antepartum condition reported on the claim. If yes, the logic then asks
if there was an O.R. procedure reported on the claim. If yes, the logic
assigns the case to one of the proposed new MS-DRGs 817, 818, or 819.
If no, the logic assigns the case to one of the proposed new MS-DRGs
831, 832, or 833. If there was not a principal diagnosis of an
[[Page 20225]]
antepartum condition reported on the claim, the logic asks if there was
a principal diagnosis of a postpartum condition reported on the claim.
If yes, the logic then asks if there was an O.R. procedure reported on
the claim. If yes, the logic assigns the case to existing MS-DRG 769.
If no, the logic assigns the case to existing MS-DRG 776. If there was
not a principal diagnosis of a postpartum condition reported on the
claim, the logic identifies that there was a principal diagnosis
describing childbirth, delivery or an intrapartum condition reported on
the claim without 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.
[GRAPHIC] [TIFF OMITTED] TP07MY18.001
BILLING CODE 4120-01-C
We refer readers to Tables 6P.1h through 6P.1k for the lists of the
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
[[Page 20226]]
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 non-infectious origin with acute organ dysfunction) are currently
assigned to MS-DRGs 870 (Septicemia or Severe Sepsis with Mechanical
Ventilation >96 Hours), 871 (Septicemia or Severe Sepsis with
Mechanical Ventilation >96 Hours with MCC), and 872 (Septicemia or
Severe Sepsis with Mechanical Ventilation >96 Hours without MCC) under
MDC 18 (Infectious and Parasitic Diseases, Systemic or Unspecified
Sites). Our clinical advisors noted that these diagnosis codes are
specifically describing conditions of a non-infectious origin, and
recommended that they be reassigned to a more clinically appropriate
MS-DRG.
We examined claims data from the September 2017 update of the FY
2017 MedPAR file for cases in MS-DRGs 870, 871, and 872. Our findings
are shown in the following table.
Septicemia or Severe Sepsis With and Without Mechanical Ventilation >96 Hours With and Without MCC
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 870--All cases........................................... 31,658 14.3 $42,981
MS-DRG 871--All cases........................................... 566,531 6.3 13,002
MS-DRG 872--All cases........................................... 150,437 4.3 7,532
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 31,658 cases in MS-DRG
870, with an average length of stay of 14.3 days and average costs of
$42,981. We found a total of 566,531 cases in MS-DRG 871, with an
average length of stay of 6.3 days and average costs of $13,002.
Lastly, we found a total of 150,437 cases in MS-DRG 872, with an
average length of stay of 4.3 days and average costs of $7,532.
We then examined claims data in MS-DRGs 870, 871, or 872 for cases
reporting an ICD-10-CM diagnosis code of R65.10 or R65.11. Our findings
are shown in the following table.
SIRS of Non-Infectious Origin With and Without Acute Organ Dysfunction
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRGs 870, 871 and 872 cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 870, 871, and 872--Cases reporting a principal diagnosis 1,254 3.8 $6,615
code of R65.10.................................................
MS-DRGs 870, 871, and 872--Cases reporting a principal diagnosis 138 4.8 9,655
code of R65.11.................................................
MS-DRGs 870, 871, and 872--Cases reporting a secondary diagnosis 1,232 5.5 10,670
code of R65.10.................................................
MS-DRGs 870, 871, and 872--Cases reporting a secondary diagnosis 117 6.2 12,525
code of R65.11.................................................
----------------------------------------------------------------------------------------------------------------
As shown in this table, we found a total of 1,254 cases reporting a
principal diagnosis code of R65.10 in MS-DRGs 870, 871, and 872, with
an average length of stay of 3.8 days and average costs of $6,615. We
found a total of 138 cases reporting a principal diagnosis code of
R65.11 in MS-DRGs 870, 871, and 872, with an average length of stay of
4.8 days and average costs of $9,655. We found a total of 1,232 cases
reporting a secondary diagnosis code of R65.10 in MS-DRGs 870, 871, and
872, with an average length of stay of 5.5 days and average costs of
$10,670. Lastly, we found a total of 117 cases reporting a secondary
diagnosis code of R65.11 in MS-DRGs 870, 871, and 872, with an average
length of stay of 6.2 days and average costs of $12,525.
The claims data included a total of 1,392 cases in MS-DRGs 870,
871, and 872 that reported a principal diagnosis code of R65.10 or
R65.11. We note that these 1,392 cases appear to have been coded
inaccurately according to the ICD-10-CM Official Guidelines for Coding
and Reporting at Section I.C.18.g., which specifically state: ``The
systemic inflammatory response syndrome (SIRS) can develop as a result
of certain non[dash]infectious disease processes, such as trauma,
malignant neoplasm, or pancreatitis. When SIRS is documented with a
non-infectious condition, and no subsequent infection
[[Page 20227]]
is documented, the code for the underlying condition, such as an
injury, should be assigned, followed by code R65.10, Systemic
inflammatory response syndrome (SIRS) of non-infectious origin without
acute organ dysfunction or code R65.11, Systemic inflammatory response
syndrome (SIRS) of non-infectious origin with acute organ
dysfunction.'' Therefore, according to the Coding Guidelines, ICD-10-CM
diagnosis codes R65.10 and R65.11 should not be reported as the
principal diagnosis on an inpatient claim.
We have acknowledged in past rulemaking the challenges with coding
for SIRS (and sepsis) (71 FR 24037). In addition, we note that there
has been confusion with regard to how these codes are displayed in the
ICD-10 MS-DRG Definitions Manual under MS-DRGs 870, 871, and 872, which
may also impact the reporting of these conditions. For example, in
Version 35 of the ICD-10 MS-DRG Definitions Manual (which is available
via the Internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Data-Files.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=ascending, the
logic for case assignment to MS-DRGs 870, 871, and 872 is comprised of
a list of several diagnosis codes, of which ICD-10-CM diagnosis codes
R65.10 and R65.11 are included. Because these codes are listed under
the heading of ``Principal Diagnosis'', it may appear that these codes
are to be reported as a principal diagnosis for assignment to MS-DRGs
870, 871, or 872. However, the Definitions Manual display of the
GROUPER logic assignment for each diagnosis code is for grouping
purposes only. The GROUPER (and, therefore, documentation in the MS-DRG
Definitions Manual) was not designed to account for coding guidelines
or coverage policies. Since the inception of the IPPS, the data editing
function has been a separate and independent step in the process of
determining a DRG assignment. Except for extreme data integrity issues
that prevent a DRG from being assigned, such as an invalid principal
diagnosis, the DRG assignment GROUPER does not edit for data integrity.
Prior to assigning the MS-DRG to a claim, the MACs apply a series of
data integrity edits using programs such as the Medicare Code Editor
(MCE). The MCE is designed to identify cases that require further
review before classification into an MS-DRG. These data integrity edits
address issues such as data validity, coding rules, and coverage
policies. The separation of the MS-DRG grouping and data editing
functions allows the MS-DRG GROUPER to remain stable during a fiscal
year even though coding rules and coverage policies may change during
the fiscal year. As such, in the FY 2018 IPPS/LTCH PPS final rule (82
FR 38050 through 38051), we finalized our proposal to add ICD-10-CM
diagnosis codes R65.10 and R65.11 to the Unacceptable Principal
Diagnosis edit in the MCE as a result of the Official Guidelines for
Coding and Reporting related to SIRS, in efforts to improve coding
accuracy for these types of cases.
To address the issue of determining a more appropriate MS-DRG
assignment for ICD-10-CM diagnosis codes R65.10 and R65.11, we reviewed
alternative options under MDC 18. Our clinical advisors determined the
most appropriate option is MS-DRG 864 (Fever) because the conditions
that are assigned here describe conditions of a non-infectious origin.
Therefore, 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)
----------------------------------------------------------------------------------------------------------------
Average length
MS-DRG Number of cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 864--All cases........................................ 12,144 3.4 $6,232
----------------------------------------------------------------------------------------------------------------
We are inviting public comments on our proposals.
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
(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[dash]10-CM Coding Guidelines instruct to ``Code first (T51
through T65) to identify chemical and intent.'' Because code first
notes provide sequencing directive, when patients are admitted with
corrosive burns (which can be full thickness and extensive), toxic
effect codes T51 through T65 must be sequenced first followed by codes
for the corrosive burns. This causes full-thickness and extensive burns
to group to MS-DRGs 901 through 905 when excisional debridement and
split thickness skin grafts are performed, and to MS-DRGs 917 and 918
when procedures are not performed. This is in contrast to cases
reporting a primary diagnosis of corrosive burn, which group to
MS[dash]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
[[Page 20228]]
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[dash]DRGs 903, 907, 908, and
909 and, therefore, did not include the results for these MS[dash]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
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All Cases with primary diagnosis of toxic effect and secondary 55 5.5 $18,077
diagnosis of corrosive burn--Across all MS-DRGs................
MS-DRG 901--All cases........................................... 968 13 31,479
MS-DRG 901--Cases with primary diagnosis of toxic effect and 1 8 12,388
secondary diagnosis of corrosive burn..........................
MS-DRG 902--All cases........................................... 1,775 6.6 14,206
MS-DRG 902--Cases with primary diagnosis of toxic effect and 8 10.3 20,940
secondary diagnosis of corrosive burn..........................
MS-DRG 904--All cases........................................... 905 9.8 23,565
MS-DRG 904--Cases with primary diagnosis of toxic effect and 8 6.4 22,624
secondary diagnosis of corrosive burn..........................
MS-DRG 905--All cases........................................... 263 4.9 13,291
MS-DRG 905--Cases with primary diagnosis of toxic effect and 2 2.5 7,682
secondary diagnosis of corrosive burn..........................
MS-DRG 906--All cases........................................... 458 4.8 13,555
MS-DRG 906--Cases with primary diagnosis of toxic effect and 1 5 7,409
secondary diagnosis of corrosive burn..........................
MS-DRG 917--All cases........................................... 31,730 4.8 10,280
MS-DRG 917--Cases with primary diagnosis of toxic effect and 6 4.8 7,336
secondary diagnosis of corrosive burn..........................
MS-DRG 918--All cases........................................... 19,819 3 5,529
MS-DRG 918--Cases with primary diagnosis of toxic effect and 28 3.5 5,643
secondary diagnosis of corrosive burn..........................
----------------------------------------------------------------------------------------------------------------
As shown in this table, there were a total of 55 cases with a
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 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 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 Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
All cases with primary diagnosis of corrosive burn--Across all 60 8.5 $19,456
MS-DRGs........................................................
MS-DRG 927--All cases........................................... 159 28.1 128,960
MS-DRG 927--Cases with primary diagnosis of corrosive burn...... 1 41 75,985
MS-DRG 928--All cases........................................... 1,021 15.1 42,868
MS-DRG 928--Cases with primary diagnosis of corrosive burn...... 13 13.2 31,118
MS-DRG 929--All cases........................................... 295 7.9 21,600
MS-DRG 929--Cases with primary diagnosis of corrosive burn...... 4 12.5 18,527
MS-DRG 933--All cases........................................... 121 4.6 21,291
MS-DRG 933--Cases with primary diagnosis of corrosive burn...... 1 7 91,779
MS-DRG 934--All cases........................................... 503 6.1 13,286
[[Page 20229]]
MS-DRG 934--Cases with primary diagnosis of corrosive burn...... 11 5.8 13,280
MS-DRG 935--All cases........................................... 1,705 5.2 13,065
MS-DRG 935--Cases with primary diagnosis of corrosive burn...... 29 5 9,822
----------------------------------------------------------------------------------------------------------------
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[dash]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-Service-Payment/AcuteInpatientPPS/index.html 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-year-old patient with benign prostatic hypertrophy or a
78-year-old patient coded with a delivery. In these cases, the
diagnosis is clinically and virtually impossible for a patient of the
stated age. Therefore, either the diagnosis or the age is presumed to
be incorrect. Currently, in the MCE, the following four age diagnosis
categories appear under the Age Conflict edit and are listed in the
manual and written in the software program:
Perinatal/Newborn--Age of 0 years only; a subset of
diagnoses which will only occur during the perinatal or newborn period
of age 0 (for example, tetanus neonatorum, health examination for
newborn under 8 days old).
Pediatric--Age is 0-17 years inclusive (for example,
Reye's syndrome, routine child health exam).
Maternity--Age range is 12-55 years inclusive (for
example, diabetes in pregnancy, antepartum pulmonary complication).
Adult--Age range is 15-124 years inclusive (for example,
senile delirium, mature cataract).
(1) Perinatal/Newborn Diagnoses Category
Under the ICD-10 MCE, the Perinatal/Newborn Diagnoses category
under the Age Conflict edit considers the age of 0 years only; a subset
of diagnoses which will only occur during the perinatal or newborn
period of age 0 to be inclusive. This includes conditions that have
their origin in the fetal or perinatal period (before birth through the
first 28 days 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.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Z05.0..................... Observation and evaluation of newborn for
suspected cardiac condition ruled out.
Z05.1..................... Observation and evaluation of newborn for
suspected infectious condition ruled out.
Z05.2..................... Observation and evaluation of newborn for
suspected neurological condition ruled out.
Z05.3..................... Observation and evaluation of newborn for
suspected respiratory condition ruled out.
Z05.41.................... Observation and evaluation of newborn for
suspected genetic condition ruled out.
Z05.42.................... Observation and evaluation of newborn for
suspected metabolic condition ruled out.
Z05.43.................... Observation and evaluation of newborn for
suspected immunologic condition ruled out.
Z05.5..................... Observation and evaluation of newborn for
suspected gastrointestinal condition ruled
out.
Z05.6..................... Observation and evaluation of newborn for
suspected genitourinary condition ruled
out.
Z05.71.................... Observation and evaluation of newborn for
suspected skin and subcutaneous tissue
condition ruled out.
[[Page 20230]]
Z05.72.................... Observation and evaluation of newborn for
suspected musculoskeletal condition ruled
out.
Z05.73.................... Observation and evaluation of newborn for
suspected connective tissue condition ruled
out.
Z05.8..................... Observation and evaluation of newborn for
other specified suspected condition ruled
out.
Z05.9..................... Observation and evaluation of newborn for
unspecified suspected condition ruled out.
------------------------------------------------------------------------
Therefore, we 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 website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/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..................... Postpartum depression.
F53.1..................... Puerperal psychosis.
O30.131................... Triplet pregnancy, trichorionic/triamniotic,
first trimester.
O30.132................... Triplet pregnancy, trichorionic/triamniotic,
second trimester.
O30.133................... Triplet pregnancy, trichorionic/triamniotic,
third trimester.
O30.139................... Triplet pregnancy, trichorionic/triamniotic,
unspecified trimester.
O30.231................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, first trimester.
O30.232................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, second trimester.
O30.233................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, third trimester.
O30.239................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, unspecified trimester.
O30.831................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, first trimester.
O30.832................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, second trimester.
O30.833................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, third trimester.
O30.839................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, unspecified
trimester.
O86.00.................... Infection of obstetric surgical wound,
unspecified.
O86.01.................... Infection of obstetric surgical wound,
superficial incisional site.
O86.02.................... Infection of obstetric surgical wound, deep
incisional site.
O86.03.................... Infection of obstetric surgical wound, organ
and space site.
O86.04.................... Sepsis following an obstetrical procedure.
O86.09.................... Infection of obstetric surgical wound, other
surgical site.
------------------------------------------------------------------------
In addition, as discussed in section II.F.15. of the preamble of
this proposed rule, Table 6C.--Invalid Diagnosis Codes associated with
this proposed rule (which is available via the Internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) 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 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
[[Page 20231]]
code list. We are inviting public comments on our proposals.
b. Sex Conflict Edit
In the MCE, the Sex Conflict edit detects inconsistencies between a
patient's sex and any diagnosis or procedure on the patient's record;
for example, a male patient with cervical cancer (diagnosis) or a
female patient with a prostatectomy (procedure). In both instances, the
indicated diagnosis or the procedure conflicts with the stated sex of
the patient. Therefore, the patient's diagnosis, procedure, or sex is
presumed to be incorrect.
(1) Diagnoses for Females Only Edit
We received a request to consider the addition of the following
ICD-10-CM diagnosis codes to the list for the Diagnoses for Females
Only edit.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Z30.015................... Encounter for initial prescription of
vaginal ring hormonal contraceptive.
Z31.7..................... Encounter for procreative management and
counseling for gestational carrier.
Z98.891................... History of uterine scar from previous
surgery.
------------------------------------------------------------------------
The requestor noted that, currently, ICD-10-CM diagnosis code
Z30.44 (Encounter for surveillance of vaginal ring hormonal
contraceptive device) is on the Diagnoses for Females Only edit code
list and suggested that ICD-10-CM diagnosis code Z30.015, which also
describes an encounter involving a vaginal ring hormonal contraceptive,
be added to the Diagnoses for Females Only edit code list as well. In
addition, the requestor suggested that ICD-10-CM diagnosis codes Z31.7
and Z98.891 be added to the Diagnoses for Females Only edit code list.
We reviewed ICD-10-CM diagnosis codes Z30.015, Z31.7, and Z98.891,
and we 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/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. 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..................... Postpartum depression.
F53.1..................... Puerperal psychosis.
N35.82.................... Other urethral stricture, female.
N35.92.................... Unspecified urethral stricture, female.
O30.131................... Triplet pregnancy, trichorionic/triamniotic,
first trimester.
O30.132................... Triplet pregnancy, trichorionic/triamniotic,
second trimester.
O30.133................... Triplet pregnancy, trichorionic/triamniotic,
third trimester.
O30.139................... Triplet pregnancy, trichorionic/triamniotic,
unspecified trimester.
O30.231................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, first trimester.
O30.232................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, second trimester.
O30.233................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, third trimester.
O30.239................... Quadruplet pregnancy, quadrachorionic/quadra-
amniotic, unspecified trimester.
O30.831................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, first trimester.
O30.832................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, second trimester.
O30.833................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, third trimester.
O30.839................... Other specified multiple gestation, number
of chorions and amnions are both equal to
the number of fetuses, unspecified
trimester.
O86.00.................... Infection of obstetric surgical wound,
unspecified.
O86.01.................... Infection of obstetric surgical wound,
superficial incisional site.
O86.02.................... Infection of obstetric surgical wound, deep
incisional site.
O86.03.................... Infection of obstetric surgical wound, organ
and space site.
O86.04.................... Sepsis following an obstetrical procedure.
O86.09.................... Infection of obstetric surgical wound, other
surgical site.
Q51.20.................... Other doubling of uterus, unspecified.
Q51.21.................... Other complete doubling of uterus.
Q51.22.................... Other partial doubling of uterus.
Q51.28.................... Other doubling of uterus, other specified.
Z13.32.................... Encounter for screening for maternal
depression.
------------------------------------------------------------------------
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 Codes associated with
this proposed rule (which is available via the internet on the CMS
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) lists the diagnosis codes that
are no longer effective as of October 1, 2018. Included
[[Page 20232]]
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 Code description
------------------------------------------------------------------------
F53....................... Puerperal psychosis.
O86.00.................... Infection of obstetric surgical wound.
Q51.20.................... 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/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.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
0UY90Z0................... Transplantation of uterus, allogeneic, open
approach.
0UY90Z1................... Transplantation of uterus, syngeneic, open
approach.
0UY90Z2................... Transplantation of uterus, zooplastic, open
approach.
------------------------------------------------------------------------
We also 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/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. 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.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
N35.016................... Post-traumatic urethral stricture, male,
overlapping sites.
N35.116................... Postinfective urethral stricture, not
elsewhere classified, male, overlapping
sites.
N35.811................... Other urethral stricture, male, meatal.
N35.812................... Other urethral bulbous stricture, male.
N35.813................... Other membranous urethral stricture, male.
N35.814................... Other anterior urethral stricture, male,
anterior.
N35.816................... Other urethral stricture, male, overlapping
sites.
N35.819................... Other urethral stricture, male, unspecified
site.
N35.911................... Unspecified urethral stricture, male,
meatal.
N35.912................... Unspecified bulbous urethral stricture,
male.
N35.913................... Unspecified membranous urethral stricture,
male.
N35.914................... Unspecified anterior urethral stricture,
male.
N35.916................... Unspecified urethral stricture, male,
overlapping sites.
N35.919................... Unspecified urethral stricture, male,
unspecified site.
N99.116................... Postprocedural urethral stricture, male,
overlapping sites.
R93.811................... Abnormal radiologic findings on diagnostic
imaging of right testicle.
R93.812................... Abnormal radiologic findings on diagnostic
imaging of left testicle.
R93.813................... Abnormal radiologic findings on diagnostic
imaging of testicles, bilateral.
R93.819................... Abnormal radiologic findings on diagnostic
imaging of unspecified testicle.
------------------------------------------------------------------------
We also 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.
c. Manifestation Code as Principal Diagnosis Edit
In the ICD-10-CM classification system, manifestation codes
describe the manifestation of an underlying disease, not the disease
itself and, therefore, should not be used as a principal diagnosis.
As discussed in section II.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
[[Page 20233]]
website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/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:
``b. Questionable obstetric admission
ICD-10-PCS procedure codes describing a cesarean section or vaginal
delivery are considered to be a questionable admission except when
reported with a corresponding secondary diagnosis code describing
the outcome of delivery.
Procedure code list for cesarean section
10D00Z0 Extraction of Products of Conception, High, Open Approach
10D00Z1 Extraction of Products of Conception, Low, Open Approach
10D00Z2 Extraction of Products of Conception, Extraperitoneal, Open
Approach
Procedure code list for vaginal delivery
10D07Z3 Extraction of Products of Conception, Low Forceps, Via
Natural or Artificial Opening
10D07Z4 Extraction of Products of Conception, Mid Forceps, Via
Natural or Artificial Opening
10D07Z5 Extraction of Products of Conception, High Forceps, Via
Natural or Artificial Opening
10D07Z6 Extraction of Products of Conception, Vacuum, Via Natural or
Artificial Opening
10D07Z7 Extraction of Products of Conception, Internal Version, Via
Natural or Artificial Opening
10D07Z8 Extraction of Products of Conception, Other, Via Natural or
Artificial Opening
10D17Z9 Manual Extraction of Products of Conception, Retained, Via
Natural or Artificial Opening
10D18Z9 Manual Extraction of Products of Conception, Retained, Via
Natural or Artificial Opening Endoscopic
10E0XZZ Delivery of Products of Conception, External Approach
Secondary diagnosis code list for outcome of delivery
Z37.0 Single live birth
Z37.1 Single stillbirth
Z37.2 Twins, both liveborn
Z37.3 Twins, one liveborn and one stillborn
Z37.4 Twins, both stillborn
Z37.50 Multiple births, unspecified, all liveborn
Z37.51 Triplets, all liveborn
Z37.52 Quadruplets, all liveborn
Z37.53 Quintuplets, all liveborn
Z37.54 Sextuplets, all liveborn
Z37.59 Other multiple births, all liveborn
Z37.60 Multiple births, unspecified, some liveborn
Z37.61 Triplets, some liveborn
Z37.62 Quadruplets, some liveborn
Z37.63 Quintuplets, some liveborn
Z37.64 Sextuplets, some liveborn
Z37.69 Other multiple births, some liveborn
Z37.7 Other multiple births, all stillborn
Z37.9 Outcome of delivery, unspecified''
We 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.
ICD-10-PCS Procedure Codes for Cesarean Section Under the Proposed
Questionable Obstetric Admission Edit Code List in the MCE
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
10D00Z0................... Extraction of products of conception, high,
open approach.
10D00Z1................... Extraction of products of conception, low,
open approach.
10D00Z2................... Extraction of products of conception,
extraperitoneal, open approach.
------------------------------------------------------------------------
We are proposing that the nine ICD-10-PCS procedure codes listed in
the following table would be used to establish the list of codes for
the proposed new Questionable Obstetric Admission edit logic for
vaginal delivery.
[[Page 20234]]
ICD-10-PCS Procedure Codes for Vaginal Delivery Under the Proposed
Questionable Obstetric Admission Edit Code List in the MCE
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
10D07Z3................... Extraction of products of conception, low
forceps, via natural or artificial opening.
10D07Z4................... Extraction of products of conception, mid
forceps, via natural or artificial opening.
10D07Z5................... Extraction of products of conception, high
forceps, via natural or artificial opening.
10D07Z6................... Extraction of products of conception,
vacuum, via natural or artificial opening.
10D07Z7................... Extraction of products of conception,
internal version, via natural or artificial
opening.
10D07Z8................... Extraction of products of conception, other,
via natural or artificial opening.
10D17Z9................... Manual extraction of products of conception,
retained, via natural or artificial
opening.
10D18Z9................... Manual extraction of products of conception,
retained, via natural or artificial
opening.
10E0XZZ................... Delivery of products of conception, external
approach.
------------------------------------------------------------------------
We 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 Code description
------------------------------------------------------------------------
Z37.0..................... Single live birth.
Z37.1..................... Single stillbirth.
Z37.2..................... Twins, both liveborn.
Z37.3..................... Twins, one liveborn and one stillborn.
Z37.4..................... Twins, both stillborn.
Z37.50.................... Multiple births, unspecified, all liveborn.
Z37.51.................... Triplets, all liveborn.
Z37.52.................... Quadruplets, all liveborn.
Z37.53.................... Quintuplets, all liveborn.
Z37.54.................... Sextuplets, all liveborn.
Z37.59.................... Other multiple births, all liveborn.
Z37.60.................... Multiple births, unspecified, some liveborn.
Z37.61.................... Triplets, some liveborn.
Z37.62.................... Quadruplets, some liveborn.
Z37.63.................... Quintuplets, some liveborn.
Z37.64.................... Sextuplets, some liveborn.
Z37.69.................... Other multiple births, some liveborn.
Z37.7..................... Other multiple births, all liveborn.
Z37.9..................... Outcome of delivery, unspecified.
------------------------------------------------------------------------
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.
e. Unacceptable Principal Diagnosis Edit
In the MCE, there are select codes that describe a circumstance
which influences an individual's health status, but does not actually
describe a current illness or injury. There also are codes that are not
specific manifestations, but may be due to an underlying cause. These
codes are considered unacceptable as a principal diagnosis. In limited
situations, there are a few codes on the MCE Unacceptable Principal
Diagnosis edit code list that are considered ``acceptable'' when a
specified secondary diagnosis is also coded and reported on the claim.
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 available via the Internet on the CMS website at: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) lists the 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.
[[Page 20235]]
f. Future Enhancement
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38053 through
38054), we noted the importance of ensuring accuracy of the coded data
from the reporting, collection, processing, coverage, payment, and
analysis aspects. We have engaged a contractor to assist in the review
of the limited coverage and noncovered procedure edits in the MCE that
may also be present in other claims processing systems that are
utilized by our MACs. The MACs must adhere to criteria specified within
the National Coverage Determinations (NCDs) and may implement their own
edits in addition to what are already incorporated into the MCE,
resulting in duplicate edits. The objective of this review is to
identify where duplicate edits may exist and to determine what the
impact might be if these edits were to be removed from the MCE.
We have noted that the purpose of the MCE is to ensure that errors
and inconsistencies in the coded data are recognized during Medicare
claims processing. We are considering whether the inclusion of coverage
edits in the MCE necessarily aligns with that specific goal because the
focus of coverage edits is on whether or not a particular service is
covered for payment purposes and not whether it was coded correctly.
As we continue to evaluate the purpose and function of the MCE with
respect to ICD-10, we encourage public input for future discussion. As
we discussed in the FY 2018 IPPS/LTCH PPS final rule, we recognize a
need to further examine the current list of edits and the definitions
of those edits. We continue to encourage public comments on whether
there are additional concerns with the current edits, including
specific edits or language that should be removed or revised, edits
that should be combined, or new edits that should be added to assist in
detecting errors or inaccuracies in the coded data. Comments should be
directed to the MS-DRG Classification Change Mailbox located at:
[email protected] by November 1, 2018 for FY 2020.
14. Proposed Changes to Surgical Hierarchies
Some inpatient stays entail multiple surgical procedures, each one
of which, occurring by itself, could result in assignment of the case
to a different MS-DRG within the MDC to which the principal diagnosis
is assigned. Therefore, it is necessary to have a decision rule within
the GROUPER by which these cases are assigned to a single MS-DRG. The
surgical hierarchy, an ordering of surgical classes from most
resource[dash]intensive to least resource[dash]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[dash]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[dash]weighted MS-DRG (in the
highest, most resource[dash]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[dash]intensive surgical class, in cases involving
multiple procedures, this result is sometimes unavoidable.
We note that, notwithstanding the foregoing discussion, there are a
few instances when a surgical class with a lower average cost is
ordered above a surgical class with a higher average cost. For example,
the ``other O.R. procedures'' surgical class is uniformly ordered last
in the surgical hierarchy of each MDC in which it occurs, regardless of
the fact that the average costs for the MS-DRG or MS-DRGs in that
surgical class may be higher than those for other surgical classes in
the MDC. The ``other O.R. procedures'' class is a group of procedures
that are only infrequently related to the diagnoses in the MDC, but are
still occasionally performed on patients with cases assigned to the MDC
with these diagnoses. Therefore, assignment to these surgical classes
should only occur if no other surgical class more closely related to
the diagnoses in the MDC is appropriate.
A second example occurs when the difference between the average
costs for two surgical classes is very small. We have found that small
differences generally do not warrant reordering of the hierarchy
because, as a result of reassigning cases on the basis of the hierarchy
change, the average costs are likely to shift such that the
higher[dash]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
[[Page 20236]]
MCC, with CC and without CC/MCC, respectively) below MS-DRG 770 and
above MS-DRG 769 (Postpartum and Post Abortion Diagnoses with O.R.
Procedure). Our proposals for Appendix D MS-DRG Surgical Hierarchy by
MDC and MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 36 are
illustrated in the following table.
Proposed Surgical Hierarchy: MDC 14
[Pregnancy, childbirth and the puerperium]
------------------------------------------------------------------------
------------------------------------------------------------------------
Proposed New MS-DRGs 783-785........... Cesarean Section with
Sterilization.
Proposed New MS-DRGs 786-788........... Cesarean Section without
Sterilization.
MS-DRG 768............................. Vaginal Delivery with O.R.
Procedures.
Proposed New MS-DRGs 796-798........... Vaginal Delivery with
Sterilization/D&C.
MS-DRG 770............................. Abortion with D&C, Aspiration
Curettage or Hysterotomy.
Proposed New MS-DRGs 817-819........... Other Antepartum Diagnoses with
O.R. Procedure.
MS-DRG 769............................. Postpartum and Post Abortion
Diagnoses with O.R. Procedure.
------------------------------------------------------------------------
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[dash]DRG Classification Change Request Mailbox
located at: [email protected] by November 1, 2018
for FY 2020 consideration.
15. Proposed Changes to the MS-DRG Diagnosis Codes for FY 2019
a. Background of the CC List and the CC Exclusions List
Under the IPPS MS-DRG classification system, we have developed a
standard list of diagnoses that are considered CCs. Historically, we
developed this list using physician panels that classified each
diagnosis code based on whether the diagnosis, when present as a
secondary condition, would be considered a substantial complication or
comorbidity. A substantial complication or comorbidity was defined as a
condition that, because of its presence with a specific principal
diagnosis, would cause an increase in the length-of-stay by at least 1
day in at least 75 percent of the patients. However, depending on the
principal diagnosis of the patient, some diagnoses on the basic list of
complications and comorbidities may be excluded if they are closely
related to the principal diagnosis. In FY 2008, we evaluated each
diagnosis code to determine its impact on resource use and to determine
the most appropriate CC subclassification (non-CC, CC, or MCC)
assignment. We refer readers to sections II.D.2. and 3. of the preamble
of the FY 2008 IPPS final rule with comment period for a discussion of
the refinement of CCs in relation to the MS[dash]DRGs we adopted for FY
2008 (72 FR 47152 through 47171).
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-Service-Payment/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/index.html.
c. Principal Diagnosis Is Its Own CC or MCC
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38060), we provided
the public with notice of our plans to conduct a comprehensive review
of the CC and MCC lists for FY 2019. In the FY 2018 IPPS/LTCH PPS final
rule (82 FR 38056 through 38057), we also finalized our proposal to
maintain the existing lists of principal diagnosis codes in Table 6L.--
Principal Diagnosis Is Its Own MCC List and Table 6M.--Principal
Diagnosis Is Its Own CC List for FY 2018, without any changes to the
existing lists, noting our plans to conduct a comprehensive review of
the CC and MCC lists for FY 2019 (82 FR 38060). We stated that having
multiple lists for CC and MCC diagnoses when reported as a principal
and/or secondary diagnosis may not provide an accurate representation
of resource utilization for the MS-DRGs.
We also stated that the purpose of the Principal Diagnosis Is Its
Own CC or MCC Lists was to ensure consistent MS-DRG assignment between
the ICD-9-CM and ICD-10 MS-DRGs. The Principal Diagnosis Is Its Own CC
or MCC Lists were developed for the FY 2016 implementation of the ICD-
10 version of the MS-DRGs to facilitate replication of the ICD-9-CM MS-
DRGs. As part of our efforts to replicate the ICD-9-CM MS-DRGs, we
implemented logic that may have increased the complexity of the MS-DRG
assignment hierarchy and altered the format of the ICD-10 MS-DRG
Definitions Manual. Two examples of workarounds used to facilitate
replication are the proliferation of procedure clusters in the surgical
MS-DRGs and the creation of the Principal Diagnosis Is Its Own CC or
MCC Lists special logic.
The following paragraph was added to the Version 33 ICD-10 MS-DRG
Definitions Manual to explain the use of the Principal Diagnosis Is Its
Own CC or MCC Lists: ``A few ICD-10-CM diagnosis codes express
conditions that are normally coded in ICD-9-CM using two or more ICD-9-
CM diagnosis codes. In the interest of ensuring that the ICD-10 MS-DRGs
Version 33 places a patient in the same DRG regardless whether the
patient record were to be coded in ICD-9-CM or ICD-10-CM/PCS, whenever
one of these ICD-10-CM combination codes is used as principal
diagnosis, the cluster of ICD-9-CM codes that would be coded on an ICD-
9-CM record is considered. If one of the ICD-9-CM codes in the cluster
is a CC
[[Page 20237]]
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[dash]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[dash]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 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 310,184
Principal Diagnosis Is Its Own CC/MCC lists (special
logic).................................................
Number of cases reporting an additional CC/MCC secondary 204,749
diagnosis code at or above the level of the designated
severity level of the principal diagnosis..............
Number of cases not reporting an additional CC/MCC 105,435
secondary diagnosis code...............................
------------------------------------------------------------------------
Step 2. We removed special logic from GROUPER and created a
modified GROUPER.
Step 3. We reprocessed 105,435 claims with modified GROUPER.
Without Special Logic--105,435 Claims Analyzed
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of cases reporting a principal diagnosis from the 310,184
Principal Diagnosis Is Its Own CC/MCC lists............
Number of cases resulting in different MS-DRG assignment 18,596
------------------------------------------------------------------------
To estimate the overall financial impact of removing the special
logic from the GROUPER, we calculated the aggregate change in estimated
payment for the MS-DRGs by comparing average costs for each MS-DRG
affected by the change, before and after removing the special logic.
Before removing the special logic in the Version 35 GROUPER, the cases
impacted by the special logic had an estimated average payment of $58
million above the average costs for all the MS-DRGs to which the claim
was originally assigned. After removing the special logic in the
Version 35 GROUPER, the 18,596 cases impacted by the special logic had
an estimated average payment of $39 million below the average costs for
the newly assigned MS-DRGs.
We performed regression analysis to compare the proportion of
variance in the MS-DRGs with and without the special logic. The results
of the
[[Page 20238]]
regression analysis showed a slight decrease in variance when the logic
was removed. While the decrease itself was not statistically
significant (an R-squared of 36.2603 percent after the special logic
was removed, compared with an R-squared of 36.2501 percent in the
current version 35 GROUPER), we note that the proportion of variance
across the MS-DRGs essentially stayed the same, and certainly did not
increase, when the special logic was removed.
We further examined the 18,596 claims that were impacted by the
special logic in the GROUPER for processing claims containing a code on
the Principal Diagnosis Is Its Own CC or MCC Lists. The 18,596 claims
were analyzed by the principal diagnosis code and the MS-DRG assigned,
resulting in 588 principal diagnosis and MS-DRG combinations or
subsets. Of the 588 subsets of cases that utilized the special logic,
556 of the 588 subsets (95 percent) had fewer than 100 cases, 529 of
the 588 subsets (90 percent) had fewer than 50 cases, and 489 of the
588 subsets (83 percent) had fewer than 25 cases.
We examined the 32 subsets of cases (5 percent of the 588 subsets)
that utilized the special logic and had 100 or more cases. Of the 32
subsets of cases, 18 (56 percent) are similar in terms of average costs
and length of stay to the MS-DRG assignment that results when the
special logic is removed, and 14 of the 32 subsets of cases (44
percent) are similar in terms of average costs and length of stay to
the MS-DRG assignment that results when the special logic is utilized.
The table below contains examples of four subsets of cases that
utilize the special logic, comparing average length of stay and average
costs between two MS-DRGs within a base DRG, corresponding to the MS-
DRG assigned when the special logic is removed and the MS-DRG assigned
when the special logic is utilized. All four subsets of cases involve
the principal diagnosis code E11.52 (Type 2 diabetes mellitus with
diabetic peripheral angiopathy with gangrene). There are four subsets
of cases in this example because the records involving the principal
diagnosis code E11.52 are assigned to four different base DRGs, one
medical MS-DRG and three surgical MS[dash]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 Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRGs 240 and 241--Special logic impacted cases with ICD-10-CM 436 5.5 $11,769
code E11.52 as principal diagnosis.............................
MS-DRG 240--All cases........................................... 7,675 8.3 17,876
MS-DRG 241--All cases........................................... 778 5.0 10,882
[[Page 20239]]
MS-DRGs 253 and 254--Special logic impacted cases with ICD-10-CM 225 5.2 17,901
E11.52 as principal diagnosis..................................
MS-DRG 253--All cases........................................... 25,714 5.4 18,986
MS-DRG 254--All cases........................................... 12,344 2.8 13,287
MS-DRGs 256 and 257--Special logic impacted cases with ICD-10-CM 193 4.2 8,478
E11.52 as principal diagnosis..................................
MS-DRG 256--All cases........................................... 2,251 6.1 11,987
MS-DRG 257--All cases........................................... 115 4.6 7,794
MS-DRGs 300 and 301--Special logic impacted cases with ICD-10-CM 185 3.6 5,981
E11.52 as principal diagnosis..................................
MS-DRG 300--All cases........................................... 29,327 4.1 7,272
MS-DRG 301--All cases........................................... 9,611 2.8 5,263
----------------------------------------------------------------------------------------------------------------
Based on our analysis of the data, we 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.
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
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-Service-Payment/AcuteInpatientPPS/index.html.
To identify new, revised and deleted diagnosis and procedure codes,
for FY 2019, we developed Table 6A.--New Diagnosis Codes, Table 6B.--
New Procedure Codes, Table 6C.--Invalid Diagnosis Codes, Table 6D.--
Invalid Procedure Codes, Table 6E.--Revised Diagnosis Code Titles, and
Table 6F.--Revised Procedure Code Titles for this proposed rule.
These tables are not published in the Addendum to the proposed rule
but are available via the Internet on the CMS
[[Page 20240]]
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html as described in section VI. of the
Addendum to this proposed rule. As discussed in section II.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-Service-Payment/AcuteInpatientPPS/index.html
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;
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.
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[dash]CC was accomplished using an
iterative approach in which each diagnosis was evaluated to determine
the extent to which its presence as a secondary diagnosis resulted in
increased hospital resource use. We refer readers to the FY 2008 IPPS/
LTCH PPS final rule (72 FR 47159) for a complete discussion of our
approach. Since this comprehensive analysis was completed for FY 2008,
we have evaluated diagnosis codes individually when receiving requests
to change the severity level of specific diagnosis codes. However,
given the transition to ICD-10-CM and the significant changes that have
occurred to diagnosis codes since this review, we believe it is
necessary to conduct a comprehensive analysis once again. We have begun
this analysis and will discuss our findings in future rulemaking. We
are currently using the same methodology utilized in FY 2008 and
described below to conduct this analysis.
For each secondary diagnosis, we measured the impact in resource
use for the following three subsets of patients:
(1) Patients with no other secondary diagnosis or with all other
secondary diagnoses that are non-CCs.
(2) Patients with at least one other secondary diagnosis that is a
CC but none that is an MCC.
(3) Patients with at least one other secondary diagnosis that is an
MCC.
Numerical resource impact values were assigned for each diagnosis
as follows:
------------------------------------------------------------------------
Value Meaning
------------------------------------------------------------------------
0................................ Significantly below expected value
for the non-CC subgroup.
1................................ Approximately equal to expected value
for the non-CC subgroup.
2................................ Approximately equal to expected value
for the CC subgroup.
3................................ Approximately equal to expected value
for the MCC subgroup.
4................................ Significantly above the expected
value for the MCC subgroup.
------------------------------------------------------------------------
Each diagnosis for which Medicare data were available was evaluated
to determine its impact on resource use and to determine the most
appropriate CC subclass (non[dash]CC, CC, or MCC) assignment. In order
to make this determination, the average cost for each subset of cases
was compared to the expected cost for cases in that subset. The
following format was used to evaluate each diagnosis:
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Code Diagnosis Cnt1 C1 Cnt2 C2 Cnt3 C3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Count (Cnt) is the number of patients in each subset and C1, C2,
and C3 are a measure of the impact on resource use of patients in each
of the subsets. The C1, C2, and C3 values are a measure of the ratio of
average costs for patients with these conditions to the expected
average cost across all cases. The C1 value reflects a patient with no
other secondary diagnosis or with all other secondary diagnoses that
are non-CCs. The C2 value reflects a patient with at least one other
secondary diagnosis that is a CC but none that is a major CC. The C3
value reflects a patient with at least one other secondary diagnosis
that is a major CC. A value close to 1.0 in the C1 field would suggest
that the code produces the same expected value as a non-CC diagnosis.
That is, average costs for the case are similar to the expected average
costs for that subset and the diagnosis is not expected to increase
resource usage. A higher value in the C1 (or C2 and C3) field suggests
more resource usage is associated with the diagnosis and an increased
likelihood that it is more like a CC or major CC than a non-CC. Thus, a
value close to 2.0 suggests the condition is more like a CC than a non-
CC but not as significant in resource usage as an MCC. A value close to
3.0 suggests the condition is expected to consume resources more
similar to an MCC than a CC or non-CC. For example, a C1 value of 1.8
for a secondary diagnosis means that for the subset of patients who
have the secondary diagnosis and have either no other secondary
diagnosis present, or all the other secondary diagnoses present are
non[dash]CCs, the impact on resource use of the secondary diagnoses is
greater than the expected value for a non[dash]CC by an amount equal to
80
[[Page 20241]]
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[dash]CC).
These mathematical constructs are used as guides in conjunction
with the judgment of our clinical advisors to classify each secondary
diagnosis reviewed as an MCC, CC or non-CC. Our clinical panel reviews
the resource use impact reports and suggests modifications to the
initial CC subclass assignments when clinically appropriate.
b. Requested Changes to Severity Levels
(1) Human Immunodeficiency Virus [HIV] Disease
We received a request that we consider changing the severity level
of ICD-10-CM diagnosis code B20 (Human immunodeficiency virus [HIV]
disease) from an MCC to a CC. We used the approach outlined above to
evaluate this request. The table below contains the data that were
evaluated for this request.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
B20 (Human immunodeficiency virus [HIV] disease)........ 2,918 0.9946 8,938 2.1237 11,479 3.0960 MCC CC
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
J80 (Acute respiratory distress syndrome)............... 1,840 1.7704 6,818 2.5596 18,376 3.3428 CC MCC
--------------------------------------------------------------------------------------------------------------------------------------------------------
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[dash]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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed
ICD-10-CM diagnosis code Cnt1 C1 Cnt2 C2 Cnt3 C3 Current CC CC
subclass subclass
--------------------------------------------------------------------------------------------------------------------------------------------------------
G93.40 (Encephalopathy, unspecified).................... 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[dash]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 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. 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
[[Page 20242]]
(Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC,
with CC, and without CC/MCC, respectively) and MS-DRGs 987, 988, and
989 (Nonextensive O.R. Procedure Unrelated to Principal Diagnosis with
MCC, with CC, and without CC/MCC, respectively) to determine whether it
would be appropriate to change the procedures assigned among these MS-
DRGs. MS-DRGs 981 through 983 and 987 through 989 are reserved for
those cases in which none of the O.R. procedures performed are related
to the principal diagnosis. These MS-DRGs are intended to capture
atypical cases, that is, those cases not occurring with sufficient
frequency to represent a distinct, recognizable clinical group.
a. Moving Procedure Codes From MS-DRGs 981 Through 983 or MS-DRGs 987
Through 989 Into MDCs
We annually conduct a review of procedures producing assignment to
MS-DRGs 981 through 983 (Extensive O.R. Procedure Unrelated to
Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) or MS-DRGs 987 through 989 (Nonextensive O.R. Procedure
Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC,
respectively) on the basis of volume, by procedure, to see if it would
be appropriate to move procedure codes out of these MS-DRGs into one of
the surgical MS-DRGs for the MDC into which the principal diagnosis
falls. The data are arrayed in two ways for comparison purposes. We
look at a frequency count of each major operative procedure code. We
also compare procedures across MDCs by volume of procedure codes within
each MDC.
We identify those procedures occurring in conjunction with certain
principal diagnoses with sufficient frequency to justify adding them to
one of the surgical MS-DRGs for the MDC in which the diagnosis falls.
Based on the results of our review of the claims data from the
September 2017 update of the FY 2017 MedPAR file, 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 congenital
condition and is currently assigned to MDC 4 (Diseases and Disorders of
the Respiratory System). ICD-10-PCS procedure code 0PS044Z (Reposition
sternum with internal fixation device, percutaneous endoscopic
approach) may be reported to identify the Nuss procedure and is
currently assigned to MDC 8 (Diseases and Disorders of the
Musculoskeletal System and Connective Tissue) in MS-DRGs 515, 516, and
517. The requester noted that acquired pectus excavatum (ICD-10-CM
diagnosis code M95.4) groups to MS-DRGs 515, 516, and 517 when reported
with a ICD-10-PCS procedure code describing repositioning of the
sternum and requested that cases involving diagnoses describing
congenital pectus excavatum also group to those MS-DRGs when reported
with a ICD-10-PCS procedure code describing repositioning of the
sternum.
Our analysis of this grouping issue confirmed that, when pectus
excavatum (ICD-10-CM diagnosis code Q67.6) is reported as a principal
diagnosis with a procedure such as the Nuss procedure (ICD-10-PCS
procedure code 0PS044Z), these cases group to MS-DRGs 981, 982, and
983. The reason for this grouping is because whenever there is a
surgical procedure reported on a claim, which is unrelated to the MDC
to which the case was assigned based on the principal diagnosis, it
results in an MS-DRG assignment to a surgical class referred to as
``unrelated operating room procedures.'' In the example provided,
because the ICD-10-CM diagnosis code Q67.6 describing pectus excavatum
is classified to MDC 4 and the ICD-10-PCS procedure code 0PS044Z is
classified to MDC 8, the GROUPER logic assigns this case to the
``unrelated operating room procedures'' set of MS-DRGs.
During our review of ICD-10-CM diagnosis code Q67.6, we also
reviewed additional ICD-10-CM diagnosis codes in the Q65 through Q79
code range to determine if there might be other conditions classified
to MDC 4 that describe congenital malformations and deformities of the
musculoskeletal system. We identified the following six ICD-10-CM
diagnosis codes:
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.7..................... Pectus carinatum.
Q76.6..................... Other congenital malformations of ribs.
Q76.7..................... Congenital malformation of sternum.
Q76.8..................... Other congenital malformations of bony
thorax.
Q76.9..................... Congenital malformation of bony thorax,
unspecified.
Q77.2..................... Short rib syndrome.
------------------------------------------------------------------------
[[Page 20243]]
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 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.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.0..................... Congenital facial asymmetry.
Q67.1..................... Congenital compression facies.
Q67.2..................... Dolichocephaly.
Q67.3..................... Plagiocephaly.
Q67.4..................... Other congenital deformities of skull, face
and jaw.
Q67.5..................... Congenital deformity of spine.
Q67.8..................... Other congenital deformities of chest.
Q76.1..................... Klippel-Feil syndrome.
Q76.2..................... Congenital spondylolisthesis.
Q76.3..................... Congenital scoliosis due to congenital bony
malformation.
Q76.411................... Congenital kyphosis, occipito-atlanto-axial
region.
Q76.412................... Congenital kyphosis, cervical region.
Q76.413................... Congenital kyphosis, cervicothoracic region.
Q76.414................... Congenital kyphosis, thoracic region.
Q76.415................... Congenital kyphosis, thoracolumbar region.
Q76.419................... Congenital kyphosis, unspecified region.
Q76.425................... Congenital lordosis, thoracolumbar region.
Q76.426................... Congenital lordosis, lumbar region.
Q76.427................... Congenital lordosis, lumbosacral region.
Q76.428................... Congenital lordosis, sacral and
sacrococcygeal region.
Q76.429................... Congenital lordosis, unspecified region.
Q76.49.................... Other congenital malformations of spine, not
associated with scoliosis.
Q76.5..................... Cervical rib.
Q77.0..................... Achondrogenesis.
Q77.1..................... Thanatophoric short stature.
Q77.3..................... Chondrodysplasia punctate.
Q77.4..................... Achondroplasia.
Q77.5..................... Diastrophic dysplasia.
Q77.6..................... Chondroectodermal dysplasia.
Q77.7..................... Spondyloepiphyseal dysplasia.
Q77.8..................... Other osteochondrodysplasia with defects of
growth of tubular bones and spine.
Q77.9..................... Osteochondrodysplasia with defects of growth
of tubular bones and spine, unspecified.
------------------------------------------------------------------------
Next, we analyzed the MS-DRG assignments for the related codes
listed above and found that cases with the following conditions are
assigned to MS-DRGs 551 and 552 (Medical Back Problems with and without
MCC, respectively) under MDC 8.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q76.2..................... Congenital spondylolisthesis.
Q76.411................... Congenital kyphosis, occipito-atlanto-axial
region.
Q76.412................... Congenital kyphosis, cervical region.
Q76.413................... Congenital kyphosis, cervicothoracic region.
Q76.414................... Congenital kyphosis, thoracic region.
Q76.415................... Congenital kyphosis, thoracolumbar region.
Q76.419................... Congenital kyphosis, unspecified region.
Q76.49.................... Other congenital malformations of spine, not
associated with scoliosis.
------------------------------------------------------------------------
The remaining conditions shown below are assigned to MS-DRGs 564,
565, and 566 (Other Musculoskeletal System and Connective Tissue
Diagnoses with MCC, with CC, and without CC/MCC, respectively) under
MDC 8.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
Q67.0..................... Congenital facial asymmetry.
Q67.1..................... Congenital compression facies.
Q67.2..................... Dolichocephaly.
Q67.3..................... Plagiocephaly.
[[Page 20244]]
Q67.4..................... Other congenital deformities of skull, face
and jaw.
Q67.5..................... Congenital deformity of spine.
Q67.8..................... Other congenital deformities of chest.
Q76.1..................... Klippel-Feil syndrome.
Q76.3..................... Congenital scoliosis due to congenital bony
malformation.
Q76.425................... Congenital lordosis, thoracolumbar region.
Q76.426................... Congenital lordosis, lumbar region.
Q76.427................... Congenital lordosis, lumbosacral region.
Q76.428................... Congenital lordosis, sacral and
sacrococcygeal region.
Q76.429................... Congenital lordosis, unspecified region.
Q76.5..................... Cervical rib.
Q77.0..................... Achondrogenesis.
Q77.1..................... Thanatophoric short stature.
Q77.3..................... Chondrodysplasia punctate.
Q77.4..................... Achondroplasia.
Q77.5..................... Diastrophic dysplasia.
Q77.6..................... Chondroectodermal dysplasia.
Q77.7..................... Spondyloepiphyseal dysplasia.
Q77.8..................... Other osteochondrodysplasia with defects of
growth of tubular bones and spine.
Q77.9..................... Osteochondrodysplasia with defects of growth
of tubular bones and spine, unspecified.
------------------------------------------------------------------------
As a result of our review, we 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 8. The requester noted that clavicle
fracture repair procedures with an internal fixation device group to
MS-DRGs 515, 516, and 517 when reported with an ICD-10-CM diagnosis
code describing a fractured clavicle. However, sternal fracture repair
procedures with an internal fixation device group to MS-DRGs 981, 982,
and 983 or MS-DRGs 166, 167 and 168 when reported with an ICD-10-CM
diagnosis code describing a fracture of the sternum. According to the
requestor, because the clavicle and sternum are in the same anatomical
region of the body, it would appear that assignment to MS-DRGs 515,
516, and 517 would be more appropriate for sternal fracture repair
procedures.
The requestor provided the following list of ICD-10-PCS procedure
codes in its request for consideration to reassign to MS-DRGs 515, 516
and 517 when reported with an ICD-10-CM diagnosis code for sternal
fracture.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS000Z................... Reposition sternum with rigid plate internal
fixation device, open approach.
0PS004Z................... Reposition sternum with internal fixation
device, open approach.
0PS00ZZ................... Reposition sternum, open approach.
0PS030Z................... Reposition sternum with rigid plate internal
fixation device, percutaneous approach.
0PS034Z................... Reposition sternum with internal fixation
device, percutaneous approach.
------------------------------------------------------------------------
We 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.
As noted in the previous discussion, whenever there is a surgical
procedure reported on a claim, which is unrelated to the MDC to which
the case was assigned based on the principal diagnosis, it results in
an MS-DRG assignment to a surgical class referred to as ``unrelated
operating room procedures.'' In the examples provided by the requestor,
when the ICD-10-CM diagnosis code describing a sternal fracture is
classified under MDC 4 and the ICD-10-PCS procedure code describing a
sternal fracture repair procedure is classified under MDC 8, the
GROUPER logic assigns these cases to the ``unrelated operating room
procedures'' group of MS-DRGs (981,
[[Page 20245]]
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 fracture currently
classified under MDC 4. We identified 10 ICD-10-CM diagnosis codes
describing a sternal fracture with an ``initial encounter'' classified
under MDC 4 that are listed in the following table.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
S22.20XA.................. Unspecified fracture of sternum, initial
encounter for closed fracture.
S22.20XB.................. Unspecified fracture of sternum, initial
encounter for open fracture.
S22.21XA.................. Fracture of manubrium, initial encounter for
closed fracture.
S22.21XB.................. Fracture of manubrium, initial encounter for
open fracture.
S22.22XA.................. Fracture of body of sternum, initial
encounter for closed fracture.
S22.22XB.................. Fracture of body of sternum, initial
encounter for open fracture.
S22.23XA.................. Sternal manubrial dissociation, initial
encounter for closed fracture.
S22.23XB.................. Sternal manubrial dissociation, initial
encounter for open fracture.
S22.24XA.................. Fracture of xiphoid process, initial
encounter for closed fracture.
S22.24XB.................. Fracture of xiphoid process, initial
encounter for open fracture.
------------------------------------------------------------------------
Our analysis of this grouping issue confirmed that when 1 of the 10
ICD-10-CM diagnosis codes describing a sternal fracture listed in the
table above from MDC 4 is reported as a principal diagnosis with an
ICD-10-PCS procedure code for a sternal repair procedure from MDC 8,
these cases group to MS-DRG 981, 982, or 983. We also confirmed that
when 1 of the 10 ICD-10-CM diagnosis codes describing a sternal
fracture listed in the table above from MDC 4 is reported as a
principal diagnosis with an ICD-10-PCS procedure code for a sternal
repair procedure from MDC 4, these cases group to MS-DRG 166, 167 or
168.
Our clinical advisors 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 from MDC 4 to
MDC 8. They advised that this requested reclassification is clinically
appropriate because it is consistent with the other related ICD-10-CM
diagnosis codes that describe fractures of the sternum and which are
classified under MDC 8. The ICD-10-CM diagnosis codes describing a
sternal fracture currently classified under MDC 8 to MS-DRGs 564, 565,
and 566 are listed in the following table.
------------------------------------------------------------------------
ICD-10-CM code Code description
------------------------------------------------------------------------
S22.20XD.................. Unspecified fracture of sternum, subsequent
encounter for fracture with routine
healing.
S22.20XG.................. Unspecified fracture of sternum, subsequent
encounter for fracture with delayed
healing.
S22.20XK.................. Unspecified fracture of sternum, subsequent
encounter for fracture with nonunion.
S22.20XS.................. Unspecified fracture of sternum, sequela.
S22.21XD.................. Fracture of manubrium, subsequent encounter
for fracture with routine healing.
S22.21XG.................. Fracture of manubrium, subsequent encounter
for fracture with delayed healing.
S22.21XK.................. Fracture of manubrium, subsequent encounter
for fracture with nonunion.
S22.21XS.................. Fracture of manubrium, sequela.
S22.22XD.................. Fracture of body of sternum, subsequent
encounter for fracture with routine
healing.
S22.22XG.................. Fracture of body of sternum, subsequent
encounter for fracture with delayed
healing.
S22.22XK.................. Fracture of body of sternum, subsequent
encounter for fracture with nonunion.
S22.22XS.................. Fracture of body of sternum, sequela.
S22.23XD.................. Sternal manubrial dissociation, subsequent
encounter for fracture with routine
healing.
S22.23XG.................. Sternal manubrial dissociation, subsequent
encounter for fracture with delayed
healing.
S22.23XK.................. Sternal manubrial dissociation, subsequent
encounter for fracture with nonunion.
S22.23XS.................. Sternal manubrial dissociation, sequela.
S22.24XD.................. Fracture of xiphoid process, subsequent
encounter for fracture with routine
healing.
S22.24XG.................. Fracture of xiphoid process, subsequent
encounter for fracture with delayed
healing.
S22.24XK.................. Fracture of xiphoid process, subsequent
encounter for fracture with nonunion.
S22.24XS.................. Fracture of xiphoid process, sequela.
------------------------------------------------------------------------
By reclassifying the 10 ICD-10-CM diagnosis codes listed in the
table earlier in this section describing sternal fracture codes with an
``initial encounter'' from MDC 4 to MDC 8, the cases reporting these
ICD-10-CM diagnosis codes in combination with the respective ICD-10-PCS
procedure codes will reflect a more appropriate grouping from a
clinical perspective and will no longer result in an MS-DRG assignment
to the ``unrelated operating room procedures'' surgical class when
reported with a surgical procedure classified under MDC 8.
Therefore, 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 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
[[Page 20246]]
with MCC, with CC, and without CC/MCC, respectively) under MDC 4 to MS-
DRGs 515, 516, and 517 under MDC 8. The requestor noted that clavicle
fracture repair procedures with an internal fixation device group to
MS-DRGs 515, 516, and 517 when reported with an ICD-10-CM diagnosis
code describing a fractured clavicle. However, rib fracture repair
procedures with an internal fixation device group to MS-DRGs 981, 982,
and 983 or to MS-DRGs 166, 167 and 168 when reported with an ICD-10-CM
diagnosis code describing a rib fracture. According to the requestor,
because the clavicle and ribs are in the same anatomical region of the
body, it would appear that assignment to MS-DRGs 515, 516, and 517
would be more appropriate for rib fracture repair procedures.
The requestor provided the following list of 10 ICD-10-PCS
procedure codes in its request for consideration for reassignment to
MS-DRGs 515, 516 and 517 when reported with an ICD-10-CM diagnosis code
for rib fracture.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PH104Z................... Insertion of internal fixation device into 1
to 2 ribs, open approach.
0PH134Z................... Insertion of internal fixation device into 1
to 2 ribs, percutaneous approach.
0PH144Z................... Insertion of internal fixation device into 1
to 2 ribs, percutaneous endoscopic
approach.
0PH204Z................... Insertion of internal fixation device into 3
or more ribs, open approach.
0PH234Z................... Insertion of internal fixation device into 3
or more ribs, percutaneous approach.
0PH244Z................... Insertion of internal fixation device into 3
or more ribs, percutaneous endoscopic
approach.
0PS104Z................... Reposition 1 to 2 ribs with internal
fixation device, open approach.
0PS134Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous approach.
0PS204Z................... Reposition 3 or more ribs with internal
fixation, device, open approach.
0PS234Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous approach.
------------------------------------------------------------------------
We note that the above 10 ICD-10-PCS procedure codes that may be
reported to describe a rib fracture repair are already assigned to MS-
DRGs 515, 516, and 517 under MDC 8. In addition, 6 of the 10 ICD 10-PCS
procedure codes listed above (0PH104Z, 0PH134Z, 0PH144Z, 0PH204Z,
0PH234Z and 0PH244Z) are also assigned to MS-DRGs 166, 167, and 168
under MDC 4.
As noted in the previous discussions above, whenever there is a
surgical procedure reported on a claim, which is unrelated to the MDC
to which the case was assigned based on the principal diagnosis, it
results in an MS-DRG assignment to a surgical class referred to as
``unrelated operating room procedures.'' In the examples provided by
the requestor, when the ICD-10-CM diagnosis code describing a rib
fracture is classified under MDC 4 and the ICD-10-PCS procedure code
describing a rib fracture repair procedure is classified under MDC 8,
the GROUPER logic assigns these cases to the ``unrelated operating room
procedures'' group of MS-DRGs (981, 982, and 983) and when the ICD-10-
CM diagnosis code describing a rib fracture is classified under MDC 4
and the ICD-10-PCS procedure code describing a rib repair procedure is
also classified under MDC 4, the GROUPER logic assigns these cases to
MS-DRG 166, 167, or 168.
For our review of this grouping issue and the request to have
procedures for rib fracture repairs assigned to MDC 8, we analyzed the
ICD-10-CM diagnosis codes describing a rib fracture and found that,
while some rib fracture ICD-10-CM diagnosis codes are classified under
MDC 8 (which would result in those cases grouping appropriately to MS-
DRGs 515, 516, and 517), there are other ICD-10-CM diagnosis codes that
are currently classified under MDC 4. We identified the following ICD-
10-CM diagnosis codes describing a rib fracture with an initial
encounter classified under MDC 4, as listed in the following table.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
S2231XA................... Fracture of one rib, right side, initial
encounter for closed fracture.
S2231XB................... Fracture of one rib, right side, initial
encounter for open fracture.
S2232XA................... Fracture of one rib, left side, initial
encounter for closed fracture.
S2232XB................... Fracture of one rib, left side, initial
encounter for open fracture.
S2239XA................... Fracture of one rib, unspecified side,
initial encounter for closed fracture.
S2239XB................... Fracture of one rib, unspecified side,
initial encounter for open fracture.
S2241XA................... Multiple fractures of ribs, right side,
initial encounter for closed fracture.
S2241XB................... Multiple fractures of ribs, right side,
initial encounter for open fracture.
S2242XA................... Multiple fractures of ribs, left side,
initial encounter for closed fracture.
S2242XB................... Multiple fractures of ribs, left side,
initial encounter for open fracture.
S2243XA................... Multiple fractures of ribs, bilateral,
initial encounter for closed fracture.
S2243XB................... Multiple fractures of ribs, bilateral,
initial encounter for open fracture.
S2249XA................... Multiple fractures of ribs, unspecified
side, initial encounter for closed
fracture.
S2249XB................... Multiple fractures of ribs, unspecified
side, initial encounter for open fracture.
S225XXA................... Flail chest, initial encounter for closed
fracture.
S225XXB................... Flail chest, initial encounter for open
fracture.
------------------------------------------------------------------------
Our analysis of this grouping issue confirmed that, when one of the
following four ICD-10-PCS procedure codes identified by the requestor
(and listed in the table earlier in this section) from MDC 8 (0PS104Z,
0PS134Z, 0PS204Z, or 0PS234Z) is reported to describe a rib fracture
repair procedure with a principal diagnosis code for a rib fracture
with an initial encounter listed in the table above from MDC 4, these
cases group to MS-DRG 981, 982, or 983.
During our review of those four repositioning of the rib procedure
codes, we also identified the following four ICD-10-PCS procedure codes
classified
[[Page 20247]]
to MDC 8 that describe repositioning of the ribs.
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS10ZZ................... Reposition 1 to 2 ribs, open approach.
0PS144Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous endoscopic
approach.
0PS20ZZ................... Reposition 3 or more ribs, open approach.
0PS244Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous endoscopic
approach.
------------------------------------------------------------------------
We confirmed that when one of the above four procedure codes is
reported with a principal diagnosis code for a rib fracture listed in
the table above from MDC 4, these cases also group to MS-DRG 981, 982,
or 983.
Lastly, we confirmed that when one of the six ICD-10-PCS procedure
codes describing a rib fracture repair listed in the previous table
above from MDC 4 is reported with a principal diagnosis code for a rib
fracture with an initial encounter from MDC 4, these cases group to MS-
DRG 166, 167, or 168.
In response to the request to reassign the procedure codes that
describe a rib fracture repair procedure from MS-DRGs 981, 982, and 983
and from MS-DRGs 166, 167, and 168 under MDC 4 to MS-DRGs 515, 516, and
517 under MDC 8, as discussed above, the 10 ICD-10-PCS procedure codes
submitted by the requestor that may be reported to describe a rib
fracture repair are already assigned to MS-DRGs 515, 516, and 517 under
MDC 8 and 6 of those 10 procedure codes (0PH104Z, 0PH134Z, 0PH144Z,
0PH204Z, 0PH234Z, and 0PH244Z) are also assigned to MS-DRGs 166, 167,
and 168 under MDC 4.
We analyzed claims data from the September 2017 update of the FY
2017 MedPAR file for cases reporting a principal diagnosis of a rib
fracture (initial encounter) from the list of diagnosis codes shown in
the table above with one of the six ICD-10-PCS procedure codes
describing the insertion of an internal fixation device into the rib
(0PH104Z, 0PH134Z, 0PH144Z, 0PH204Z, 0PH234Z, and 0PH244Z) in MS-DRGs
166, 167, and 168 under MDC 4. Our findings are shown in the table
below.
MS-DRGs for Other Respiratory System O.R. Procedures
----------------------------------------------------------------------------------------------------------------
Number of Average length
MS-DRG cases of stay Average costs
----------------------------------------------------------------------------------------------------------------
MS-DRG 166--All cases........................................... 22,938 10.2 $24,299
MS-DRG 166--Cases with principal diagnosis of rib fracture(s) 40 11.4 43,094
and insertion of internal fixation device for the rib(s).......
MS-DRG 167--All cases........................................... 10,815 5.7 13,252
MS-DRG 167--Cases with principal diagnosis of rib fracture(s) 10 6.7 30,617
and insertion of internal fixation device for the rib(s).......
MS-DRG 168--All cases........................................... 3,242 3.1 9,708
MS-DRG 168--Cases with principal diagnosis of rib fracture(s) 4 2 21,501
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 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 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.
[[Page 20248]]
------------------------------------------------------------------------
ICD-10-PCS code Code description
------------------------------------------------------------------------
0PS104Z................... Reposition 1 to 2 ribs with internal
fixation device, open approach.
0PS10ZZ................... Reposition 1 to 2 ribs, open approach.
0PS134Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous approach.
0PS144Z................... Reposition 1 to 2 ribs with internal
fixation device, percutaneous endoscopic
approach.
0PS204Z................... Reposition 3 or more ribs with internal
fixation device, open approach.
0PS20ZZ................... Reposition 3 or more ribs, open approach.
0PS234Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous approach.
0PS244Z................... Reposition 3 or more ribs with internal
fixation device, percutaneous endoscopic
approach.
------------------------------------------------------------------------
Our clinical advisors 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.
18. Proposed Changes to the ICD-10-CM and ICD-10-PCS Coding Systems
In September 1985, the ICD[dash]9[dash]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[dash]9[dash]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[dash]Federal educational programs
and other communication techniques with a view toward standardizing
coding applications and upgrading the quality of the classification
system.
The official list of ICD-9-CM diagnosis and procedure codes by
fiscal year can be found on the CMS website at: http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/codes.html. The official
list of ICD-10-CM and ICD-10-PCS codes can be found on the CMS website
at: http://www.cms.gov/Medicare/Coding/ICD10/index.html.
The NCHS has lead responsibility for the ICD-10-CM and ICD-9-CM
diagnosis codes included in the Tabular List and Alphabetic Index for
Diseases, while CMS has lead responsibility for the ICD-10-PCS and ICD-
9-CM procedure codes included in the Tabular List and Alphabetic Index
for Procedures.
The Committee encourages participation in the previously mentioned
process by health-related organizations. In this regard, the Committee
holds public meetings for discussion of educational issues and proposed
coding changes. These meetings provide an opportunity for
representatives of recognized organizations in the coding field, such
as the American Health Information Management Association (AHIMA), the
American Hospital Association (AHA), and various physician specialty
groups, as well as individual physicians, health information management
professionals, and other members of the public, to contribute ideas on
coding matters. After considering the opinions expressed at the public
meetings and in writing, the Committee formulates recommendations,
which then must be approved by the agencies.
The Committee presented proposals for coding changes for
implementation in FY 2019 at a public meeting held on September 12-13,
2017, and finalized the coding changes after consideration of comments
received at the meetings and in writing by November 13, 2017.
The Committee held its 2018 meeting on March 6-7, 2018. The
deadline for submitting comments on these code proposals is scheduled
for April 6, 2018. It was announced at this meeting that any new ICD-
10-CM/PCS codes for which there was consensus of public support and for
which complete tabular and indexing changes would be made by May 2018
would be included in the October 1, 2018 update to ICD-10-CM/ICD-10-
PCS. As discussed in earlier sections of the preamble of 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: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. The code titles are adopted as
part of the ICD-10 (previously ICD-9-CM) Coordination and Maintenance
Committee process. Therefore, although we make the code titles
available for the IPPS proposed rule, they are not subject to comment
in the proposed rule. 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: http://cms.hhs.gov/
Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/
icd9ProviderDiagnosticCodes/
[[Page 20249]]
03_meetings.asp. The minutes of the discussions of diagnosis codes at
the September 12-13, 2017 meeting and March 6-7, 2018 meeting can be
found at: http://www.cdc.gov/nchs/icd/icd10cm_maintenance.html. These
websites also provide detailed information about the Committee,
including information on requesting a new code, attending a Committee
meeting, and timeline requirements and meeting dates.
We encourage commenters to address suggestions on coding issues
involving diagnosis codes to: Donna Pickett, Co[dash]Chairperson, ICD-
10 Coordination and Maintenance Committee, NCHS, Room 2402, 3311 Toledo
Road, Hyattsville, MD 20782. Comments may be sent by E[dash]mail to:
[email protected].
Questions and comments concerning the procedure codes should be
submitted via E[dash]mail to: [email protected].
In the September 7, 2001 final rule implementing the IPPS new
technology add[dash]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[dash]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[dash]related group
classification) until the fiscal year that begins after such date. This
requirement improves the recognition of new technologies under the IPPS
by providing information on these new technologies at an earlier date.
Data will be available 6 months earlier than would be possible with
updates occurring only once a year on October 1.
While section 1886(d)(5)(K)(vii) of the Act states that the
addition of new diagnosis and procedure codes on April 1 of each year
shall not require the Secretary to adjust the payment, or DRG
classification, under section 1886(d) of the Act until the fiscal year
that begins after such date, we have to update the DRG software and
other systems in order to recognize and accept the new codes. We also
publicize the code changes and the need for a mid[dash]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[dash]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[dash]on payment process. We also established the following process
for making these determinations. Topics considered during the Fall ICD-
10 (previously ICD-9-CM) Coordination and Maintenance Committee meeting
are considered for an April 1 update if a strong and convincing case is
made by the requester at the Committee's public meeting. The request
must identify the reason why a new code is needed in April for purposes
of the new technology process. The participants at the meeting and
those reviewing the Committee meeting summary report are provided the
opportunity to comment on this expedited request. All other topics are
considered for the October 1 update. Participants at the Committee
meeting are encouraged to comment on all such requests. There were not
any requests approved for an expedited April 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: http://www.cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/icd9ProviderDiagnosticCodes/01overview.asp#TopofPage. ICD-10-CM and
ICD-10-PCS addendum and code title information is published on the CMS
website at: http://www.cms.gov/Medicare/Coding/ICD10/index.html. CMS
also sends copies of all ICD-10-CM and ICD-10-PCS coding changes to its
Medicare contractors for use in updating their systems and providing
education to providers.
Information on ICD-10-CM diagnosis codes, along with the Official
ICD-10-CM Coding Guidelines, can also be found on the CDC website at:
http://www.cdc.gov/nchs/icd/icd10.htm. Additionally, information on
new, revised, and deleted ICD-10-CM/ICD-10-PCS codes is provided to the
AHA for publication in the Coding Clinic for ICD-10. AHA also
distributes coding update information to publishers and software
vendors.
The following chart shows the number of ICD-10-CM and ICD-10-PCS
codes and code changes since FY 2016 when ICD-10 was implemented.
Total Number of Codes and Changes in Total Number of Codes per Fiscal
Year ICD-10-CM and ICD-10-PCS Codes
------------------------------------------------------------------------
Fiscal year Number Change
------------------------------------------------------------------------
FY 2016:
ICD-10-CM......................................... 69,823 ........
ICD-10-PCS........................................ 71,974 ........
FY 2017:
ICD-10-CM......................................... 71,486 +1,663
ICD-10-PCS........................................ 75,789 +3,815
[[Page 20250]]
FY 2018:
ICD-10-CM......................................... 71,704 +218
ICD-10-PCS........................................ 78,705 +2,916
Proposed FY 2019:
ICD-10-CM......................................... 71,902 +198
ICD-10-PCS........................................ 78,533 -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, 2018
Committee meetings for implementation as part of the October 1, 2018
update. The deadline for commenting on code proposals discussed at the
September 12-13, 2017 Committee meeting was November 13, 2017. The
deadline for commenting on code proposals discussed at the March 6-7,
2018 Committee meeting was April 6, 2018.
19. 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 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.
------------------------------------------------------------------------
MDC MS-DRG MS-DRG title
------------------------------------------------------------------------
Pre-MDC.................... 001 Heart Transplant or Implant
of Heart Assist System
with MCC.
Pre-MDC.................... 002 Heart Transplant or Implant
of Heart Assist System
without MCC.
1.......................... 023 Craniotomy with Major
Device Implant or Acute
Complex CNS Principal
Diagnosis with MCC or
Chemotherapy Implant or
Epilepsy with
Neurostimulator.
1.......................... 024 Craniotomy with Major
Device Implant or Acute
Complex CNS Principal
Diagnosis without MCC.
1.......................... 025 Craniotomy & Endovascular
Intracranial Procedures
with MCC.
1.......................... 026 Craniotomy & Endovascular
Intracranial Procedures
with CC.
1.......................... 027 Craniotomy & Endovascular
Intracranial Procedures
without CC/MCC.
1.......................... 040 Peripheral, Cranial Nerve &
Other Nervous System
Procedures with MCC.
1.......................... 041 Peripheral, Cranial Nerve &
Other Nervous System
Procedures with CC or
Peripheral
Neurostimulator.
1.......................... 042 Peripheral, Cranial Nerve &
Other Nervous System
Procedures without CC/MCC.
3.......................... 129 Major Head & Neck
Procedures with CC/MCC or
Major Device.
3.......................... 130 Major Head & Neck
Procedures without CC/MCC.
5.......................... 215 Other Heart Assist System
Implant.
5.......................... 216 Cardiac Valve & Other Major
Cardiothoracic Procedure
with Cardiac
Catheterization with MCC.
5.......................... 217 Cardiac Valve & Other Major
Cardiothoracic Procedure
with Cardiac
Catheterization with CC.
5.......................... 218 Cardiac Valve & Other Major
Cardiothoracic Procedure
with Cardiac
Catheterization without CC/
MCC.
5.......................... 219 Cardiac Valve & Other Major
Cardiothoracic Procedure
without Cardiac
Catheterization with MCC.
5.......................... 220 Cardiac Valve & Other Major
Cardiothoracic Procedure
without Cardiac
Catheterization with CC.
5.......................... 221 Cardiac Valve & Other Major
Cardiothoracic Procedure
without Cardiac
Catheterization without CC/
MCC.
5.......................... 222 Cardiac Defibrillator
Implant with Cardiac
Catheterization with AMI/
Heart Failure/Shock with
MCC.
5.......................... 223 Cardiac Defibrillator
Implant with Cardiac
Catheterization with AMI/
Heart Failure/Shock
without MCC.
5.......................... 224 Cardiac Defibrillator
Implant with Cardiac
Catheterization without
AMI/Heart Failure/Shock
with MCC.
5.......................... 225 Cardiac Defibrillator
Implant with Cardiac
Catheterization without
AMI/Heart Failure/Shock
without MCC.
5.......................... 226 Cardiac Defibrillator
Implant without Cardiac
Catheterization with MCC.
5.......................... 227 Cardiac Defibrillator
Implant without Cardiac
Catheterization without
MCC.
5.......................... 242 Permanent Cardiac Pacemaker
Implant with MCC.
5.......................... 243 Permanent Cardiac Pacemaker
Implant with CC.
5.......................... 244 Permanent Cardiac Pacemaker
Implant without CC/MCC.
5.......................... 245 AICD Generator Procedures.
5.......................... 258 Cardiac Pacemaker Device
Replacement with MCC.
5.......................... 259 Cardiac Pacemaker Device
Replacement without MCC.
5.......................... 260 Cardiac Pacemaker Revision
Except Device Replacement
with MCC.
5.......................... 261 Cardiac Pacemaker Revision
Except Device Replacement
with CC.
5.......................... 262 Cardiac Pacemaker Revision
Except Device Replacement
without CC/MCC.
5.......................... 265 AICD Lead Procedures.
5.......................... 266 Endovascular Cardiac Valve
Replacement with MCC.
5.......................... 267 Endovascular Cardiac Valve
Replacement without MCC.
5.......................... 268 Aortic and Heart Assist
Procedures Except
Pulsation Balloon with
MCC.
5.......................... 269 Aortic and Heart Assist
Procedures Except
Pulsation Balloon without
MCC.
5.......................... 270 Other Major Cardiovascular
Procedures with MCC.
[[Page 20251]]
5.......................... 271 Other Major Cardiovascular
Procedures with CC.
5.......................... 272 Other Major Cardiovascular
Procedures without CC/MCC.
8.......................... 461 Bilateral or Multiple Major
Joint Procedures of Lower
Extremity with MCC.
8.......................... 462 Bilateral or Multiple Major
Joint Procedures of Lower
Extremity without MCC.
8.......................... 466 Revision of Hip or Knee
Replacement with MCC.
8.......................... 467 Revision of Hip or Knee
Replacement with CC.
8.......................... 468 Revision of Hip or Knee
Replacement without CC/
MCC.
8.......................... 469 Major Hip and Knee Joint
Replacement or
Reattachment of Lower
Extremity with MCC or
Total Ankle Replacement.
8.......................... 470 Major Hip and Knee Joint
Replacement or
Reattachment of Lower
Extremity without MCC.
------------------------------------------------------------------------
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 (Non-Extensive O.R. Procedure Unrelated to Principal
Diagnosis with MCC, with CC, and without CC/MCC, respectively) when
they do not contain a principal diagnosis that corresponds to one of
the MDCs to which that procedure is assigned. These procedures need not
be assigned to MS-DRGs 981 through 989 in order for this to occur.
Therefore, if requestors included some or all of MS-DRGs 981 through
989 in their request or included MS-DRGs that require the presence of
any O.R. procedure, we did not specifically address that aspect in
summarizing their request or our response to the request in the section
below.
a. Percutaneous and Percutaneous Endoscopic Excision of Brain and
Cerebral Ventricle
One requestor identified 22 ICD-10-PCS procedure codes that
describe procedures involving transcranial brain and cerebral ventricle
excision that the requestor stated would generally require the
resources of an operating room. The 22 procedure codes are listed in
the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
00B03ZX................... Excision of brain, percutaneous approach,
diagnostic.
00B13ZX................... Excision of cerebral meninges, percutaneous
approach, diagnostic.
00B23ZX................... Excision of dura mater, percutaneous
approach, diagnostic.
00B63ZX................... Excision of cerebral ventricle, percutaneous
approach, diagnostic.
00B73ZX................... Excision of cerebral hemisphere,
percutaneous approach, diagnostic.
00B83ZX................... Excision of basal ganglia, percutaneous
approach, diagnostic.
00B93ZX................... Excision of thalamus, percutaneous approach,
diagnostic.
00BA3ZX................... Excision of hypothalamus, percutaneous
approach, diagnostic.
00BB3ZX................... Excision of pons, percutaneous approach,
diagnostic.
00BC3ZX................... Excision of cerebellum, percutaneous
approach, diagnostic.
00BD3ZX................... Excision of medulla oblongata, percutaneous
approach, diagnostic.
00B04ZX................... Excision of brain, percutaneous endoscopic
approach, diagnostic.
00B14ZX................... Excision of cerebral meninges, percutaneous
endoscopic approach, diagnostic.
00B24ZX................... Excision of dura mater, percutaneous
endoscopic approach, diagnostic.
00B64ZX................... Excision of cerebral ventricle, percutaneous
endoscopic approach, diagnostic.
00B74ZX................... Excision of cerebral hemisphere,
percutaneous endoscopic approach,
diagnostic.
00B84ZX................... Excision of basal ganglia, percutaneous
endoscopic approach, diagnostic.
00B94ZX................... Excision of thalamus, percutaneous
endoscopic approach, diagnostic.
00BA4ZX................... Excision of hypothalamus, percutaneous
endoscopic approach, diagnostic.
00BB4ZX................... Excision of pons, percutaneous endoscopic
approach, diagnostic.
00BC4ZX................... Excision of cerebellum, percutaneous
endoscopic approach, diagnostic.
00BD4ZX................... Excision of medulla oblongata, percutaneous
endoscopic approach, diagnostic.
------------------------------------------------------------------------
The requestor stated that, although percutaneous burr hole biopsies
are performed through smaller openings in the skull than open burr hole
biopsies, these procedures require drilling or cutting through the
skull using sterile technique with anesthesia for pain control. The
requestor also noted that similar procedures involving percutaneous
drainage of the subdural space are currently classified as O.R.
procedures in Version 35 of the ICD-10
[[Page 20252]]
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.
b. Open Extirpation of Subcutaneous Tissue and Fascia
One requestor identified 22 ICD-10-PCS procedure codes that
describe procedures involving open extirpation of subcutaneous tissue
and fascia that the requestor stated would generally require the
resources of an operating room. The 22 procedure codes are listed in
the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0JC00ZZ................... Extirpation of matter from scalp
subcutaneous tissue and fascia, open
approach.
0JC10ZZ................... Extirpation of matter from face subcutaneous
tissue and fascia, open approach.
0JC40ZZ................... Extirpation of matter from right neck
subcutaneous tissue and fascia, open
approach.
0JC50ZZ................... Extirpation of matter from left neck
subcutaneous tissue and fascia, open
approach.
0JC60ZZ................... Extirpation of matter from chest
subcutaneous tissue and fascia, open
approach.
0JC70ZZ................... Extirpation of matter from back subcutaneous
tissue and fascia, open approach.
0JC80ZZ................... Extirpation of matter from abdomen
subcutaneous tissue and fascia, open
approach.
0JC90ZZ................... Extirpation of matter from buttock
subcutaneous tissue and fascia, open
approach.
0JCB0ZZ................... Extirpation of matter from perineum
subcutaneous tissue and fascia, open
approach.
0JCC0ZZ................... Extirpation of matter from pelvic region
subcutaneous tissue and fascia, open
approach.
0JCD0ZZ................... Extirpation of matter from right upper arm
subcutaneous tissue and fascia, open
approach.
0JCF0ZZ................... Extirpation of matter from left upper arm
subcutaneous tissue and fascia, open
approach.
0JCG0ZZ................... Extirpation of matter from right lower arm
subcutaneous tissue and fascia, open
approach.
0JCH0ZZ................... Extirpation of matter from left lower arm
subcutaneous tissue and fascia, open
approach.
0JCJ0ZZ................... Extirpation of matter from right hand
subcutaneous tissue and fascia, open
approach.
0JCK0ZZ................... Extirpation of matter from left hand
subcutaneous tissue and fascia, open
approach.
0JCL0ZZ................... Extirpation of matter from right upper leg
subcutaneous tissue and fascia, open
approach.
0JCM0ZZ................... Extirpation of matter from left upper leg
subcutaneous tissue and fascia, open
approach.
0JCN0ZZ................... Extirpation of matter from right lower leg
subcutaneous tissue and fascia, open
approach.
0JCP0ZZ................... Extirpation of matter from left lower leg
subcutaneous tissue and fascia, open
approach.
0JCQ0ZZ................... Extirpation of matter from right foot
subcutaneous tissue and fascia, open
approach.
0JCR0ZZ................... Extirpation of matter from left foot
subcutaneous tissue and fascia, open
approach.
------------------------------------------------------------------------
The requestor stated that these procedures involve making an open
incision deeper than the skin under general anesthesia, and that
irrigation and/or excision of devitalized tissue or cavity are often
required and are considered inherent to the procedure. The requestor
also stated that open drainage of subcutaneous tissue and fascia, open
excisional debridement of subcutaneous tissue and fascia, and open
nonexcisional debridement/extraction of subcutaneous tissue and fascia
are designated as O.R. procedures, and that these 22 procedures should
be designated as O.R. procedures for the same reason. In the ICD-10 MS-
DRGs Version 35, these 22 ICD-10-PCS procedure codes are not recognized
as O.R. procedures for purposes of MS-DRG assignment. The requestor
recommended that the 22 ICD-10-PCS procedure codes listed in the table
be assigned to MS-DRGs 579, 580, and 581 (Other Skin, Subcutaneous
Tissue and Breast Procedures with MCC, CC, and without CC/MCC,
respectively).
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
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[dash]excisional debridement/extraction of subcutaneous tissue and
fascia, and open excision of breast are designated as O.R. procedures,
and that these 13 procedures should be designated as O.R. procedures
for the same reason. In the ICD-10 MS-DRGs Version 35, these 13 ICD-10-
PCS procedure codes are not recognized as O.R. procedures for purposes
of MS-DRG assignment.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0V950ZZ................... Drainage of scrotum, open approach.
0VB50ZZ................... Excision of scrotum, open approach.
0VC50ZZ................... Extirpation of matter from scrotum, open
approach.
[[Page 20253]]
0H9U0ZZ................... Drainage of left breast, open approach.
0H9T0ZZ................... Drainage of right breast, open approach.
0H9V0ZZ................... Drainage of bilateral breast, open approach.
0H9W0ZZ................... Drainage of right nipple, open approach.
0H9X0ZZ................... Drainage of left nipple, open approach.
0HCT0ZZ................... Extirpation of matter from right breast,
open approach.
0HCU0ZZ................... Extirpation of matter from left breast, open
approach.
0HCV0ZZ................... Extirpation of matter from bilateral breast,
open approach.
0HCW0ZZ................... Extirpation of matter from right nipple,
open approach.
0HCX0ZZ................... Extirpation of matter from left nipple, open
approach.
------------------------------------------------------------------------
The requestor recommended that the 3 ICD-10-PCS scrotal procedure
codes be assigned to MS-DRGs 717 and 718 (Other Male Reproductive
System O.R. Procedures Except Malignancy with CC/MCC and without CC/
MCC, respectively) and the 10 breast procedure codes be assigned to MS-
DRGs 584 and 585 (Breast Biopsy, Local Excision and Other Breast
Procedures with CC/MCC and without CC/MCC, respectively).
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 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.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0C980ZZ................... Drainage of right parotid gland, open
approach.
0C990ZZ................... Drainage of left parotid gland, open
approach.
0C9G0ZZ................... Drainage of right submaxillary gland, open
approach.
0C9H0ZZ................... Drainage of left submaxillary gland, open
approach.
0CC80ZZ................... Extirpation of matter from right parotid
gland, open approach.
0CC90ZZ................... Extirpation of matter from left parotid
gland, open approach.
0CCG0ZZ................... Extirpation of matter from right
submaxillary gland, open approach.
0CCH0ZZ................... Extirpation of matter from left submaxillary
gland, open approach.
------------------------------------------------------------------------
The requestor stated that these procedures involve making an open
incision through subcutaneous tissue, fascia, and potentially muscle,
to reach and incise the parotid or submaxillary gland under general
anesthesia, and that irrigation and/or excision of devitalized tissue
or cavity may be required and are considered inherent to the procedure.
The requestor also stated that open drainage of subcutaneous tissue and
fascia, open excisional debridement of subcutaneous tissue and fascia,
and open non[dash]excisional debridement/extraction of subcutaneous
tissue and fascia are designated as O.R. procedures, and that these
eight procedures should be designated as O.R. procedures for the same
reason. In the ICD-10 MS-DRGs Version 35, these eight ICD-10-PCS
procedure codes are not recognized as O.R. procedures for purposes of
MS-DRG assignment. The requestor requested that these procedures be
assigned to MS-DRG 139 (Salivary Gland Procedures).
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.
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.
[[Page 20254]]
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0SPC08Z................... Removal of spacer from right knee joint,
open approach.
0SHC08Z................... Insertion of spacer into right knee joint,
open approach.
0SPD08Z................... Removal of spacer from left knee joint, open
approach.
0SHD08Z................... Insertion of spacer into left knee joint,
open approach.
0SP908Z................... Removal of spacer from right hip joint, open
approach.
0SH908Z................... Insertion of spacer into right hip joint,
open approach.
0SPB08Z................... Removal of spacer from left hip joint, open
approach.
0SHB08Z................... Insertion of spacer into left hip joint,
open approach.
------------------------------------------------------------------------
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, 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.
f. Endoscopic Dilation of Ureter(s) With Intraluminal Device
One requestor identified the following three ICD-10-PCS procedure
codes that describe procedures involving endoscopic dilation of
ureter(s) with intraluminal device.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0T778DZ................... Dilation of left ureter with intraluminal
device, via natural or artificial opening
endoscopic.
0T768DZ................... Dilation of right ureter with intraluminal
device, via natural or artificial opening
endoscopic.
0T788DZ................... Dilation of bilateral ureters with
intraluminal device, via natural or
artificial opening endoscopic.
------------------------------------------------------------------------
The requestor stated that these procedures involve the use of
cystoureteroscopy to view the bladder and ureter and dilation under
visualization, which are often followed by placement of a ureteral
stent. The requestor also stated that endoscopic extirpation of matter
from ureter, endoscopic biopsy of bladder, endoscopic dilation of
bladder, endoscopic dilation of renal pelvis, and endoscopic dilation
of the ureter without insertion of intraluminal device are all assigned
to surgical DRGs, and that these three procedures should be designated
as O.R. procedures for the same reason. In the ICD-10 MS-DRGs Version
35, these three ICD-10-PCS procedure codes are not recognized as O.R.
procedures for purposes of MS-DRG assignment. The requestor recommended
that these procedures be assigned to MS-DRGs 656, 657, and 658 (Kidney
and Ureter Procedures for Neoplasm with MCC, with CC, and without CC/
MCC, respectively) and MS-DRGs 659, 660, and 661 (Kidney and Ureter
Procedures for Non-Neoplasm with MCC, with CC, and without CC/MCC,
respectively).
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-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.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0W9D4ZZ................... Drainage of pericardial cavity, percutaneous
endoscopic approach.
0W9D40Z................... Drainage of pericardial cavity with drainage
device, percutaneous endoscopic approach.
0W9D4ZX................... Drainage of pericardial cavity, percutaneous
endoscopic approach, diagnostic.
[[Page 20255]]
0W994ZX................... Drainage of right pleural cavity,
percutaneous endoscopic approach,
diagnostic.
0W9B4ZX................... Drainage of left pleural cavity,
percutaneous endoscopic approach,
diagnostic.
0BCP4ZZ................... Extirpation of matter from left pleura,
percutaneous endoscopic approach.
0BCN4ZZ................... Extirpation of matter from right pleura,
percutaneous endoscopic approach.
------------------------------------------------------------------------
The requestor stated that these procedures involve making an
incision through the chest wall and inserting a thoracoscope for
visualization of thoracic structures during the procedure. The
requestor also stated that some thoracoscopic procedures are assigned
to surgical MS-DRGs, while other procedures are assigned to medical MS-
DRGs. In the ICD-10 MS-DRGs Version 35, these seven ICD-10-PCS
procedure codes are not recognized as O.R. procedures for purposes of
MS-DRG assignment.
We agree with the requestor that these procedures typically require
the resources of an operating room, as well as significant time and
skill. During our review, we noted that the following two related
procedures using the open approach also were not currently recognized
as O.R. procedures:
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0BCP0ZZ................... Extirpation of matter from left pleura, open
approach.
0BCN0ZZ................... Extirpation of matter from right pleura,
open approach.
------------------------------------------------------------------------
Therefore, to be consistent with the MS-DRGs to which other
approaches for procedures involving drainage or extirpation of matter
from the pleura are assigned, we 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 with MCC, with CC, and without
CC/MCC, respectively) in MDC 5 (Diseases and Disorders of the
Circulatory System); MS-DRGs 820, 821, and 822 (Lymphoma and Leukemia
with Major O.R. Procedure with MCC, with CC, and without CC/MCC,
respectively) in MDC 17 (Myeloproliferative Diseases and Disorders,
Poorly Differentiated Neoplasms); MS-DRGs 826, 827, and 828
(Myeloproliferative Disorders or Poorly Differentiated Neoplasms with
Major O.R. Procedure with MCC, with CC, and without CC/MCC,
respectively) in MDC 17; MS-DRGs 907, 908, and 909 (Other O.R.
Procedures for Injuries with MCC, with CC, and without CC/MCC,
respectively) in MDC 21 (Injuries, Poisonings and Toxic Effects of
Drugs); and MS-DRGs 957, 958, and 959 (Other O.R. Procedures for
Multiple Significant Trauma with MCC, with CC, and without CC/MCC,
respectively) in MDC 24 (Multiple Significant Trauma). We 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.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0JH60WZ................... Insertion of totally implantable vascular
access device into chest subcutaneous
tissue and fascia, open approach.
0JH60XZ................... Insertion of tunneled vascular access device
into chest subcutaneous tissue and fascia,
open approach.
0JH80WZ................... Insertion of totally implantable vascular
access device into abdomen subcutaneous
tissue and fascia, open approach.
0JH80XZ................... Insertion of tunneled vascular access device
into abdomen subcutaneous tissue and
fascia, open approach.
0JHD0WZ................... Insertion of totally implantable vascular
access device into right upper arm
subcutaneous tissue and fascia, open
approach.
0JHD0XZ................... Insertion of tunneled vascular access device
into right upper arm subcutaneous tissue
and fascia, open approach.
0JHF0WZ................... Insertion of totally implantable vascular
access device into left upper arm
subcutaneous tissue and fascia, open
approach.
0JHF0XZ................... Insertion of tunneled vascular access device
into left upper arm subcutaneous tissue and
fascia, open approach.
0JHG0WZ................... Insertion of totally implantable vascular
access device into right lower arm
subcutaneous tissue and fascia, open
approach.
0JHG0XZ................... Insertion of tunneled vascular access device
into right lower arm subcutaneous tissue
and fascia, open approach.
0JHH0WZ................... Insertion of totally implantable vascular
access device into left lower arm
subcutaneous tissue and fascia, open
approach.
0JHH0XZ................... Insertion of tunneled vascular access device
into left lower arm subcutaneous tissue and
fascia, open approach.
0JHL0WZ................... Insertion of totally implantable vascular
access device into right upper leg
subcutaneous tissue and fascia, open
approach.
0JHL0XZ................... Insertion of tunneled vascular access device
into right upper leg subcutaneous tissue
and fascia, open approach.
0JHM0WZ................... Insertion of totally implantable vascular
access device into left upper leg
subcutaneous tissue and fascia, open
approach.
0JHM0XZ................... Insertion of tunneled vascular access device
into left upper leg subcutaneous tissue and
fascia, open approach.
0JHN0WZ................... Insertion of totally implantable vascular
access device into right lower leg
subcutaneous tissue and fascia, open
approach.
0JHN0XZ................... Insertion of tunneled vascular access device
into right lower leg subcutaneous tissue
and fascia, open approach.
0JHP0WZ................... Insertion of totally implantable vascular
access device into left lower leg
subcutaneous tissue and fascia, open
approach.
0JHP0XZ................... Insertion of tunneled vascular access device
into left lower leg subcutaneous tissue and
fascia, open approach.
------------------------------------------------------------------------
The requestor stated that open procedures to insert totally
implantable vascular access devices (VAD) involve implantation of a
port by open approach, cutting through subcutaneous tissue/fascia,
placing the device, and
[[Page 20256]]
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 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[dash]DRG.
We are inviting public comments on our proposal.
i. Percutaneous Joint Reposition With Internal Fixation Device
One requestor identified 20 ICD-10-PCS procedure codes that
describe procedures involving percutaneous joint reposition with
internal fixation device, shown in the following table.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0SS034Z................... Reposition lumbar vertebral joint with
internal fixation device, percutaneous
approach.
0SS334Z................... Reposition lumbosacral joint with internal
fixation device, percutaneous approach.
0SS534Z................... Reposition sacrococcygeal joint with
internal fixation device, percutaneous
approach.
0SS634Z................... Reposition coccygeal joint with internal
fixation device, percutaneous approach.
0SS734Z................... Reposition right sacroiliac joint with
internal fixation device, percutaneous
approach.
0SS834Z................... Reposition left sacroiliac joint with
internal fixation device, percutaneous
approach.
0SS934Z................... Reposition right hip joint with internal
fixation device, percutaneous approach.
0SSB34Z................... Reposition left hip joint with internal
fixation device, percutaneous approach.
0SSC34Z................... Reposition right knee joint with internal
fixation device, percutaneous approach.
0SSD34Z................... Reposition left knee joint with internal
fixation device, percutaneous approach.
0SSF34Z................... Reposition right ankle joint with internal
fixation device, percutaneous approach.
0SSG34Z................... Reposition left ankle joint with internal
fixation device, percutaneous approach.
0SSH34Z................... Reposition right tarsal joint with internal
fixation device, percutaneous approach.
0SSJ34Z................... Reposition left tarsal joint with internal
fixation device, percutaneous approach.
0SSK34Z................... Reposition right tarsometatarsal joint with
internal fixation device, percutaneous
approach.
0SSL34Z................... Reposition left tarsometatarsal joint with
internal fixation device, percutaneous
approach.
0SSM34Z................... Reposition right metatarsal-phalangeal joint
with internal fixation device, percutaneous
approach.
0SSN34Z................... Reposition left metatarsal-phalangeal joint
with internal fixation device, percutaneous
approach.
0SSP34Z................... Reposition right toe phalangeal joint with
internal fixation device, percutaneous
approach.
0SSQ34Z................... Reposition left toe phalangeal joint with
internal fixation device, percutaneous
approach.
------------------------------------------------------------------------
The requestor stated that reposition of the sacrum, femur, tibia,
fibula, and other fractures of bone with internal fixation device by
percutaneous approach are assigned to surgical DRGs, and that
reposition of sacroiliac, hip, knee, and other joint locations with
internal fixation should therefore also be assigned to surgical DRGs.
In the ICD-10 MS-DRGs Version 35, these 20 ICD-10-PCS procedure codes
are not recognized as O.R. procedures for purposes of MS-DRG
assignment.
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 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.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0D5A8ZZ................... Destruction of jejunum, via natural or
artificial opening endoscopic.
0D5B8ZZ................... Destruction of ileum, via natural or
artificial opening endoscopic.
0D5C8ZZ................... Destruction of ileocecal valve, via natural
or artificial opening endoscopic.
0D588ZZ................... Destruction of small intestine, via natural
or artificial opening endoscopic.
------------------------------------------------------------------------
[[Page 20257]]
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.
k. Drainage of Lower Lung Via Natural or Artificial Opening Endoscopic,
Diagnostic
One requestor identified the following ICD-10-PCS procedure codes
that describe procedures involving endoscopic drainage of the lung via
natural or artificial opening for diagnostic purposes.
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0B9J8ZX................... Drainage of left lower lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9F8ZX................... Drainage of right lower lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
------------------------------------------------------------------------
The requestor stated that these procedures are rarely performed in
the operating room.
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:
------------------------------------------------------------------------
ICD-10-PCS procedure code Code description
------------------------------------------------------------------------
0B9D8ZX................... Drainage of right middle lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9C8ZX................... Drainage of right upper lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
0B9G8ZX................... Drainage of left upper lung lobe, via
natural or artificial opening endoscopic,
diagnostic.
------------------------------------------------------------------------
In the ICD-10 MS-DRGs Version 35, these ICD-10-PCS procedure codes
are currently recognized as O.R. procedures for purposes of MS-DRG
assignment.
We 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
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[dash]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 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[dash]10[dash]CM diagnoses and ICD-10-PCS procedure
codes from the FY 2017 MedPAR claims data, grouped through the
ICD[dash]10 version of the proposed FY 2019 GROUPER (Version 36).
The second data source used in the cost[dash]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[dash]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[dash]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[dash]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[dash]lung, liver and/or
intestinal, and lung transplants (MS-DRGs 001, 002, 005, 006, and 007,
respectively) were limited to those Medicare[dash]approved transplant
centers that have cases in the FY 2017 MedPAR
[[Page 20258]]
file. (Medicare coverage for heart, heart[dash]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[dash]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 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[dash]DRGs as
appropriate, and the relative weights calculated for each MS-DRG more
closely reflect the true costs of those cases.
In addition, in the FY 2013 IPPS/LTCH PPS final rule, for FY 2013
and subsequent fiscal years, we finalized a policy to treat hospitals
that participate in the Bundled Payments for Care Improvement (BPCI)
initiative the same as prior fiscal years for the IPPS payment modeling
and ratesetting process without regard to hospitals' participation
within these bundled payment models (77 FR 53341 through 53343).
Specifically, because acute care hospitals participating in the BPCI
initiative still receive IPPS payments under section 1886(d) of the
Act, we include all applicable data from these subsection (d) hospitals
in our IPPS payment modeling and ratesetting calculations as if 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[dash]of[dash]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
[[Page 20259]]
adjustment factors, cost[dash]of[dash]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 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 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.
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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[dash]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[dash]specific CCR.
The Medicare[dash]specific CCR was determined by taking the Medicare
charges for each line item from Worksheet D-3 and deriving the
Medicare[dash]specific costs by applying the hospital[dash]specific
departmental CCRs to the Medicare[dash]specific charges for each line
item from Worksheet D-3. Once each hospital's Medicare[dash]specific
costs were established, we summed the total Medicare[dash]specific
costs and divided by the sum of the total Medicare[dash]specific
charges to produce national average, charge[dash]weighted CCRs.
After we multiplied the total charges for each MS-DRG in each of
the proposed 19 cost centers by the 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[dash]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:
------------------------------------------------------------------------
Group CCR
------------------------------------------------------------------------
Routine Days................................................... 0.451
Intensive Days................................................. 0.373
Drugs.......................................................... 0.196
Supplies & Equipment........................................... 0.299
Implantable Devices............................................ 0.321
Therapy Services............................................... 0.312
Laboratory..................................................... 0.116
Operating Room................................................. 0.185
Cardiology..................................................... 0.107
Cardiac Catheterization........................................ 0.115
Radiology...................................................... 0.149
MRIs........................................................... 0.076
CT Scans....................................................... 0.037
Emergency Room................................................. 0.165
Blood and Blood Products....................................... 0.306
Other Services................................................. 0.355
Labor & Delivery............................................... 0.363
Inhalation Therapy............................................. 0.163
Anesthesia..................................................... 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[dash]volume MS-DRGs, we are proposing to compute relative
weights for the proposed low-volume MS-DRGs by adjusting their final FY
2018 relative weights by the percentage change in the average weight of
the cases in other MS-DRGs. The crosswalk table is shown:
------------------------------------------------------------------------
Low-volume MS-DRG MS-DRG title Crosswalk to MS-DRG
------------------------------------------------------------------------
789...................... Neonates, Died or Final FY 2018 relative
Transferred to weight (adjusted by
Another Acute Care percent change in
Facility. average weight of the
cases in other MS-
DRGs).
790...................... Extreme Immaturity Final FY 2018 relative
or Respiratory weight (adjusted by
Distress Syndrome, percent change in
Neonate. average weight of the
cases in other MS-
DRGs).
791...................... Prematurity with Final FY 2018 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
792...................... Prematurity without Final FY 2018 relative
Major Problems. weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
793...................... Full-Term Neonate Final FY 2018 relative
with Major weight (adjusted by
Problems. percent change in
average weight of the
cases in other MS-
DRGs).
794...................... Neonate with Other Final FY 2018 relative
Significant weight (adjusted by
Problems. percent change in
average weight of the
cases in other MS-
DRGs).
795...................... Normal Newborn..... Final FY 2018 relative
weight (adjusted by
percent change in
average weight of the
cases in other MS-
DRGs).
------------------------------------------------------------------------
[[Page 20276]]
We are inviting public comments on our proposals.
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 Sec. 412.87(b)(2), a
specific medical service or technology will be considered ``new'' for
purposes of new medical service or technology add-on payments until
such time as Medicare data are available to fully reflect the cost of
the technology in the MS-DRG weights through recalibration. We note
that we do not consider a service or technology to be new if it is
substantially similar to one or more existing technologies. That is,
even if a technology receives a new FDA approval or clearance, it may
not necessarily be considered ``new'' for purposes of new technology
add-on payments if it is ``substantially similar'' to a technology that
was approved or cleared by FDA and has been on the market for more than
2 to 3 years. In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR
43813 through 43814), we established criteria for evaluating whether a
new technology is substantially similar to an existing technology,
specifically: (1) Whether a product uses the same or a similar
mechanism of action to achieve a therapeutic outcome; (2) whether a
product is assigned to the same or a different MS-DRG; and (3) whether
the new use of the technology involves the treatment of the same or
similar type of disease and the same or similar patient population. If
a technology meets all three of these criteria, it would be considered
substantially similar to an existing technology and would not be
considered ``new'' for purposes of new technology add-on payments. For
a detailed discussion of the criteria for substantial similarity, we
refer readers to the FY 2006 IPPS final rule (70 FR 47351 through
47352), and the FY 2010 IPPS/LTCH PPS final rule (74 FR 43813 through
43814).
Under the second criterion, Sec. 412.87(b)(3) further provides
that, to be eligible for the add-on payment for new medical services or
technologies, the MS-DRG prospective payment rate otherwise applicable
to discharges involving the new medical service or technology must be
assessed for adequacy. Under the cost criterion, consistent with the
formula specified in section 1886(d)(5)(K)(ii)(I) of the Act, to assess
the adequacy of payment for a new technology paid under the applicable
MS-DRG prospective payment rate, we evaluate whether the charges for
cases involving the new technology exceed certain threshold amounts.
Table 10 that was released with the FY 2018 IPPS/LTCH PPS final rule
contains the final thresholds that we used to evaluate applications for
new medical service or technology add-on payments for FY 2019. We refer
readers to the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2018-IPPS-Final-Rule-Home-Page-Items/FY2018-IPPS-Final-Rule-Tables.html to download and view
Table 10.
As previously stated, Table 10 that is released with each proposed
and final rule contains the thresholds that we use to evaluate
applications for new medical service and technology add-on payments for
the fiscal year that follows the fiscal year that is otherwise the
subject of the rulemaking. For example, the thresholds in Table 10
released with the FY 2018 IPPS/LTCH PPS final rule are applicable to FY
2019 new technology applications. 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: http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html, which is
the same URL where the impact data files associated with the rulemaking
for the applicable fiscal year are posted. We 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[dash]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, Sec. 412.87(b)(1) of our existing
regulations provides that a new technology is an appropriate candidate
for an additional payment when it represents an advance that
substantially improves, relative to technologies previously available,
the diagnosis or treatment of Medicare beneficiaries. For example, a
new technology represents a substantial clinical improvement when it
reduces mortality, decreases the number of hospitalizations or
physician visits, or reduces recovery time compared to the technologies
previously available. (We
[[Page 20277]]
refer readers to the September 7, 2001 final rule for a more detailed
discussion of this criterion (66 FR 46902).)
The new medical service or technology add-on payment policy under
the IPPS provides additional payments for cases with relatively high
costs involving eligible new medical services or technologies, while
preserving some of the incentives inherent under an average-based
prospective payment system. The payment mechanism is based on the cost
to hospitals for the new medical service or technology. Under Sec.
412.88, if the costs of the discharge (determined by applying cost-to-
charge ratios (CCRs) as described in Sec. 412.84(h)) exceed the full
DRG payment (including payments for IME and DSH, but excluding outlier
payments), Medicare will make an add-on payment equal to the lesser of:
(1) 50 percent of the estimated costs of the new technology or medical
service (if the estimated costs for the case including the new
technology or medical service exceed Medicare's payment); or (2) 50
percent of the difference between the full DRG payment and the
hospital's estimated cost for the case. Unless the discharge qualifies
for an outlier payment, the additional Medicare payment is limited to
the full MS-DRG payment plus 50 percent of the estimated costs of the
new technology or medical service.
Section 503(d)(2) of Public Law 108-173 provides that there shall
be no reduction or adjustment in aggregate payments under the IPPS due
to add-on payments for new medical services and technologies.
Therefore, in accordance with section 503(d)(2) of Public Law 108-173,
add-on payments for new medical services or technologies for FY 2005
and later years have not been subjected to budget neutrality.
In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we
modified our regulations at Sec. 412.87 to codify our longstanding
practice of how CMS evaluates the eligibility criteria for new medical
service or technology add-on payment applications. That is, we first
determine whether a medical service or technology meets the newness
criterion, and only if so, do we then make a determination as to
whether the technology meets the cost threshold and represents a
substantial clinical improvement over existing medical services or
technologies. We amended Sec. 412.87(c) to specify that all applicants
for new technology add-on payments must have FDA approval or clearance
for their new medical service or technology by July 1 of the year prior
to the beginning of the fiscal year that the application is being
considered.
The Council on Technology and Innovation (CTI) at CMS oversees the
agency's cross-cutting priority on coordinating coverage, coding and
payment processes for Medicare with respect to new technologies and
procedures, including new drug therapies, as well as promoting the
exchange of information on new technologies and medical services
between CMS and other entities. The CTI, composed of senior CMS staff
and clinicians, was established under section 942(a) of Public Law 108-
173. The Council is co-chaired by the Director of the Center for
Clinical Standards and Quality (CCSQ) and the Director of the Center
for Medicare (CM), who is also designated as the CTI's Executive
Coordinator.
The specific processes for coverage, coding, and payment are
implemented by CM, CCSQ, and the local Medicare Administrative
Contractors (MACs) (in the case of local coverage and payment
decisions). The CTI supplements, rather than replaces, these processes
by working to assure that all of these activities reflect the agency-
wide priority to promote high-quality, innovative care. At the same
time, the CTI also works to streamline, accelerate, and improve
coordination of these processes to ensure that they remain up to date
as new issues arise. To achieve its goals, the CTI works to streamline
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[dash]covered services through
the promotion of better evidence development, which is critical for
improving the quality of care for Medicare beneficiaries.
To improve the understanding of CMS' processes for coverage,
coding, and payment and how to access them, the CTI has developed an
``Innovator's Guide'' to these processes. The intent is to consolidate
this information, much of which is already available in a variety of
CMS documents and in various places on the CMS website, in a user
friendly format. This guide was published in 2010 and is available on
the CMS website at: https://www.cms.gov/Medicare/Coverage/CouncilonTechInnov/Downloads/Innovators-Guide-Master-7-23-15.pdf.
As we indicated in the FY 2009 IPPS final rule (73 FR 48554), we
invite any product developers or manufacturers of new medical services
or technologies to contact the agency early in the process of product
development if they have questions or concerns about the evidence that
would be needed later in the development process for the agency's
coverage decisions for Medicare.
The CTI aims to provide useful information on its activities and
initiatives to stakeholders, including Medicare beneficiaries,
advocates, medical product manufacturers, providers, and health policy
experts. Stakeholders with further questions about Medicare's coverage,
coding, and payment processes, or who want further guidance about how
they can navigate these processes, can contact the CTI at
[email protected].
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-Service-Payment/AcuteInpatientPPS/newtech.html. To allow interested parties to identify the new medical
services or technologies under review before the publication of the
proposed rule for FY 2020, the CMS website also will post the tracking
forms completed by each applicant. We note that the burden associated
with this information collection requirement is the time and effort
required to collect and submit the data in the formal request for add-
on payments for new medical services and technologies to CMS. The
aforementioned burden is subject to the PRA; it is currently approved
under OMB control number 0938-1347, which expires on December 31, 2020.
2. Public Input Before Publication of a Notice of Proposed Rulemaking
on Add-On Payments
Section 1886(d)(5)(K)(viii) of the Act, as amended by section
503(b)(2) of Public Law 108-173, provides for a mechanism for public
input before publication of a notice of proposed rulemaking regarding
whether a medical service or technology represents a substantial
clinical improvement or advancement. The process for evaluating new
medical service and technology applications requires the Secretary to--
[[Page 20278]]
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[dash]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[dash]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[dash]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
Technology Town Hall meeting, we received written comments regarding
the applications for FY 2019 new technology add[dash]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 patient-
centered 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:
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.
[[Page 20279]]
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[dash]created FDA approval rules related to
expedited approval programs. The commenter explained that the FDA
defines congressionally-created ``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 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. 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 radio pharma ceuticals 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
[[Page 20280]]
``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.
3. ICD-10-PCS Section ``X'' Codes for Certain New Medical Services and
Technologies
As discussed in the FY 2016 IPPS/LTCH final rule (80 FR 49434), the
ICD-10-PCS includes a new section containing the new Section ``X''
codes, which began being used with discharges occurring on or after
October 1, 2015. Decisions regarding changes to ICD-10-PCS Section
``X'' codes will be handled in the same manner as the decisions for all
of the other ICD-10-PCS code changes. That is, proposals to create,
delete, or revise Section ``X'' codes under the ICD-10-PCS structure
will be referred to the ICD-10 Coordination and Maintenance Committee.
In addition, several of the new medical services and technologies that
have been, or may be, approved for new technology add-on payments may
now, and in the future, be assigned a Section ``X'' code within the
structure of the ICD-10-PCS. We posted ICD-10-PCS Guidelines on the CMS
website at: http://www.cms.gov/Medicare/Coding/ICD10/2016-ICD-10-PCS-and-GEMs.html, including guidelines for ICD-10-PCS Section ``X'' codes.
We encourage providers to view the material provided on ICD-10-PCS
Section ``X'' codes.
4. Proposed FY 2019 Status of Technologies Approved for FY 2018 Add-On
Payments
a. Defitelio[reg] (Defibrotide)
Jazz Pharmaceuticals submitted an application for new technology
add-on payments for FY 2017 for defibrotide (Defitelio[reg]), a
treatment for patients diagnosed with hepatic veno-occlusive disease
(VOD) with evidence of multiorgan dysfunction. VOD, also known as
sinusoidal obstruction syndrome (SOS), is a potentially life-
threatening complication of hematopoietic stem cell transplantation
(HSCT), with an incidence rate of 8 percent to 15 percent. Diagnoses of
VOD range in severity from what has been classically defined as a
disease limited to the liver (mild) and reversible, to a severe
syndrome associated with multi-organ dysfunction or failure and death.
Patients treated with HSCT who develop VOD with multi-organ failure
face an immediate risk of death, with a mortality rate of more than 80
percent when only supportive care is used. The applicant asserted that
Defitelio[reg] improves the survival rate of patients diagnosed with
VOD with multi-organ failure by 23 percent.
Defitelio[reg] 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[reg] received FDA approval on March 30, 2016. The
applicant confirmed that Defitelio[reg] 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[reg] was finalized with FDA approval, and that
commercial shipments of Defitelio[reg] to hospitals and treatment
centers began on April 4, 2016. Therefore, we agreed that, based on
this information, the newness period for Defitelio[reg] 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[reg], with an effective date of
October 1, 2016. The approved ICD-10PCS procedure codes are: XW03392
(Introduction of defibrotide sodium anticoagulant into peripheral vein,
percutaneous approach); and XW04392 (Introduction of defibrotide sodium
anticoagulant into central vein, percutaneous approach).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
Defitelio[reg] and consideration of the public comments we received in
response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved
Defitelio[reg] for new technology add-on payments for FY 2017 (81 FR
56906). With the new technology add-on payment application, the
applicant estimated that the average Medicare beneficiary would require
a dosage of 25 mg/kg/day for a minimum of 21 days of treatment. The
recommended dose is 6.25 mg/kg given as a 2-hour intravenous infusion
every 6 hours. Dosing should be based on a patient's baseline body
weight, which is assumed to be 70 kg for an average adult patient. All
vials contain 200 mg at a cost of $825 per vial. Therefore, we
determined that cases involving the use of the Defitelio[reg]
technology would incur an average cost per case of $151,800 (70 kg
adult x 25 mg/kg/day x 21 days = 36,750 mg per patient/200 mg vial =
184 vials per patient x $825 per vial = $151,800). Under Sec.
412.88(a)(2), we limit new technology add-on payments to the lesser of
50 percent of the average cost of the technology or 50 percent of the
costs in excess of the MS-DRG payment for the case. As a result, the
maximum new technology add-on payment amount for a case involving the
use of Defitelio[reg] 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[reg], we
considered the beginning of the newness period to commence on the first
day Defitelio[reg] was commercially available (April 4, 2016). Because
the 3-year anniversary date of the entry of the Defitelio[reg] 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
[[Page 20281]]
proposing that the maximum payment for a case involving Defitelio[reg]
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[reg] 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 accordance with our policy, we stated
in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38120) that we believe
it is appropriate to use the earliest market availability date
submitted as the beginning of the newness period. Accordingly, for both
devices, we stated that the beginning of the newness period is February
29, 2016, when the Perceval valve became commercially available. The
ICD-10-PCS code approved to identify procedures involving the use of
both devices when surgically implanted is ICD-10-PCS code X2RF032
(Replacement of aortic valve using zooplastic tissue, rapid deployment
technique, open approach, new technology group 2).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for the INTUITY
and Perceval valves and consideration of the public comments we
received in response to the FY 2018 IPPS/LTCH PPS proposed rule, we
approved the INTUITY and Perceval valves for new technology add-on
payments for FY 2018 (82 FR 38125). We stated that we believed that the
use of a weighted-average of the cost of the standard valves based on
the projected number of cases involving each technology to determine
the maximum new technology add-on payment was most appropriate. To
compute the weighted-cost average, we summed the total number of
projected cases for each of the applicants, which equaled 2,429 cases
(1,750 plus 679). We then divided the number of projected cases for
each of the applicants by the total number of cases, which resulted in
the following case-weighted percentages: 72 percent for the INTUITY and
28 percent for the Perceval valve. We then multiplied the cost per case
for the manufacturer specific valve by the case-weighted percentage
(0.72 * $12,500 = $9,005.76 for INTUITY and 0.28 * $11,500 = $3,214.70
for the Perceval valve). This resulted in a case-weighted average cost
of $12,220.46 for the valves. Under Sec. 412.88(a)(2), we limit new
technology add-on payments to the lesser of 50 percent of the average
cost of the device or 50 percent of the costs in excess of the MS-DRG
payment for the case. As a result, the maximum new technology add-on
payment for a case involving the INTUITY or Perceval valves is
$6,110.23 for FY 2018.
With regard to the newness criterion for the INTUITY and Perceval
valves, we considered the newness period for the INTUITY and Perceval
valves to begin February 29, 2016. As discussed previously in this
section, in general, we extend new technology add-on payments for an
additional year only if the 3-year anniversary date of the product's
entry onto the U.S. market 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[reg] EXCLUDER[reg] Iliac Branch Endoprosthesis (Gore IBE
Device)
W. L. Gore and Associates, Inc. submitted an application for new
technology add-on payments for the GORE[reg] EXCLUDER[reg] 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[reg] EXCLUDER[reg] 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
[[Page 20282]]
intraluminal device, one or two arteries, percutaneous endoscopic
approach).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for the GORE
IBE device and consideration of the public comments we received in
response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved the
GORE IBE device for new technology add-on payments for FY 2017 (81 FR
56909). With the new technology add-on payment application, the
applicant indicated that the total operating cost of the GORE IBE
device is $10,500. Under Sec. 412.88(a)(2), we limit new technology
add-on payments to the lesser of 50 percent of the average cost of the
device or 50 percent of the costs in excess of the MS-DRG payment for
the case. As a result, the maximum new technology add-on payment for a
case involving the GORE IBE device is $5,250.
With regard to the newness criterion for the GORE IBE device, we
considered the beginning of the newness period to commence when the
GORE IBE device received FDA approval on February 29, 2016. As
discussed previously in this section, in general, we extend new
technology add-on payments for an additional year only if the 3-year
anniversary date of the product's entry onto the U.S. market occurs in
the latter half of the upcoming fiscal year. Because the 3-year
anniversary date of the entry of the GORE IBE device onto the U.S.
market (February 28, 2019) will occur in the first half of FY 2019, 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 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 life-threatening or uncontrolled bleeding.
The applicant was granted approval to use unique ICD-10-PCS
procedure codes that became effective October 1, 2016, to describe the
use of this technology. The approved ICD-10-PCS procedure codes are:
XW03331 (Introduction of Idarucizumab, Dabigatran reversal agent into
peripheral vein, percutaneous approach, new technology group 1); and
XW04331 (Introduction of Idarucizumab, Dabigatran reversal agent into
central vein, percutaneous approach, new technology group 1).
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
Idarucizumab and consideration of the public comments we received in
response to the FY 2017 IPPS/LTCH PPS proposed rule, we approved
Idarucizumab for new technology add-on payments for FY 2017 (81 FR
56897). With the new technology add-on payment application, the
applicant indicated that the total operating cost of Idarucizumab is
$3,500. Under Sec. 412.88(a)(2), we limit new technology add-on
payments to the lesser of 50 percent of the average cost of the
technology or 50 percent of the costs in excess of the MS-DRG payment
for the case. As a result, the maximum new technology add-on payment
for a case involving Idarucizumab is $1,750.
With regard to the newness criterion for Idarucizumab, we
considered the beginning of the newness period to commence when
Idarucizumab was approved by the FDA on October 16, 2015. As discussed
previously in this section, in general, we extend new technology add-on
payments for an additional year only if the 3-year anniversary date of
the product's entry onto the U.S. market occurs in the latter half of
the upcoming fiscal year. Because the 3-year anniversary date of the
entry of 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[reg])
Janssen Biotech submitted an application for new technology add-on
payments for the Stelara[reg] induction therapy for FY 2018.
Stelara[reg] 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[reg] and route of administration
for this monoclonal antibody. IV infusion of Stelara[reg] 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[reg] for IV infusion has only one purpose, induction therapy.
Stelara[reg] must be administered intravenously by a health care
professional in either an inpatient hospital setting or an outpatient
hospital setting.
Stelara[reg] 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[reg] (2 vials); patients
weighing more than (>)55 kg, but less than (<)85 kg are administered
390 mg of Stelara[reg] (3 vials); and patients weighing more than (>)85
kg are administered 520 mg of Stelara[reg] (4 vials). An average dose
of Stelara[reg] administered through IV infusion is 390 mg (3 vials).
Maintenance doses of Stelara[reg] 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
[[Page 20283]]
including the mouth, esophagus, stomach, small intestine, and large
intestine. Conventional pharmacologic treatments of CD include
antibiotics, mesalamines, corticosteroids, immunomodulators, tumor
necrosis alpha (TNF[alpha]) inhibitors, and anti-integrin agents.
Surgery may be necessary for some patients diagnosed with CD in which
conventional therapies have failed.
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
Stelara[reg] and consideration of the public comments we received in
response to the FY 2018 IPPS/LTCH PPS proposed rule, we approved
Stelara[reg] for new technology add-on payments for FY 2018 (82 FR
38129). Cases involving Stelara[reg] that are eligible for new
technology add-on payments are identified by ICD-10-PCS procedure code
XW033F3 (Introduction of other New Technology therapeutic substance
into peripheral vein, percutaneous approach, new technology group 3).
With the new technology add-on payment application, the applicant
estimated that the average Medicare beneficiary would require a dosage
of 390 mg (3 vials) at a hospital acquisition cost of $1,600 per vial
(for a total of $4,800). Under Sec. 412.88(a)(2), we limit new
technology add-on payments to the lesser of 50 percent of the average
cost of the technology or 50 percent of the costs in excess of the MS-
DRG payment for the case. As a result, the maximum new technology add-
on payment amount for a case involving the use of Stelara[reg] is
$2,400.
With regard to the newness criterion for Stelara[reg], we
considered the beginning of the newness period to commence when
Stelara[reg] 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[reg] 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[reg] 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[reg] for FY 2019.
f. Vistogard\TM\ (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.
Chemotherapeutic agent 5-fluorouracil (5-FU) is used to treat
specific solid tumors. It acts upon deoxyribonucleic acid (DNA) and
ribonucleic acid (RNA) in the body, as uracil is a naturally occurring
building block for genetic material. Fluorouracil is a fluorinated
pyrimidine. As a chemotherapy agent, Fluorouracil is absorbed by cells
and causes the cell to metabolize into byproducts that are toxic and
used to destroy cancerous cells. According to the applicant, the
byproducts fluorodoxyuridine monophosphate (F-dUMP) and floxuridine
triphosphate (FUTP) are believed to do the following: (1) Reduce DNA
synthesis; (2) lead to DNA fragmentation; and (3) disrupt RNA
synthesis. Fluorouracil is used to treat a variety of solid tumors such
as colorectal, head and neck, breast, and ovarian cancer. With
different tumor treatments, different dosages, and different dosing
schedules, there is a risk for toxicity in these patients. Patients may
suffer from fluorouracil toxicity/death if 5-FU is delivered in slight
excess or at faster infusion rates than prescribed. The cause of
overdose can happen for a variety of reasons including: Pump
malfunction, incorrect pump programming or miscalculated doses, and
accidental or intentional ingestion.
VistogardTM is an antidote to Fluorouracil toxicity and
is a prodrug of uridine. Once the drug is metabolized into uridine, it
competes with the toxic byproduct FUTP in binding to RNA, thereby
reducing the impact FUTP has on cell death.
With regard to the newness criterion, VistogardTM
received FDA approval on December 11, 2015. However, as discussed in
the FY 2017 IPPS/LTCH PPS final rule (81 FR 56910), due to the delay in
VistogardTM's commercial availability, we considered the
newness period to begin March 2, 2016, instead of December 11, 2015.
The applicant noted that the VistogardTM is the first
FDA[dash]approved antidote used to reverse fluorouracil toxicity. The
applicant submitted a request for a unique ICD-10-PCS procedure code
and was granted approval for the following procedure code: XW0DX82
(Introduction of Uridine Triacetate into Mouth and Pharynx, External
Approach, new technology group 2). The new code became effective on
October 1, 2016.
After evaluation of the newness, costs, and substantial clinical
improvement criteria for new technology add-on payments for
VistogardTM and consideration of the public comments we
received in response to the FY 2017 IPPS/LTCH PPS proposed rule, we
approved VistogardTM for new technology add-on payments for
FY 2017 (81 FR 56912). With the new technology add-on payment
application, the applicant stated that the total operating cost of
VistogardTM is $75,000. Under Sec. 412.88(a)(2), we limit
new technology add-on payments to the lesser of 50 percent of the
average cost of the technology or 50 percent of the costs in excess of
the MS-DRG payment for the case. As a result, the maximum new
technology add-on payment for a case involving VistogardTM
is $37,500.
With regard to the newness criterion for the
VistogardTM, we considered the beginning of the newness
period to commence upon the entry of VistogardTM onto the
U.S. market on March 2, 2016. As discussed previously in this section,
in general, we extend new technology add-on payments for an additional
year only if the 3-year anniversary date of the product's entry onto
the U.S. market occurs in the latter half of the upcoming fiscal year.
Because the 3-year anniversary date of the entry of the
VistogardTM onto the U.S. market (March 2, 2019) will occur
in the first half of FY 2019, 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 (ZINPLAVA\TM\)
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
[[Page 20284]]
bacteria,'' which play a role in protecting the body from infection.
Antibiotics can kill these good bacteria and allow the C-diff bacteria
to multiply and release toxins that damage the cells lining the
intestinal wall, resulting in a CDI. CDI is a leading cause of
hospital-associated gastrointestinal illnesses. Persons at increased
risk for CDI include people who are treated with current or recent
antibiotic use, people who have encountered current or recent
hospitalization, people who are older than 65 years, immunocompromised
patients, and people who have recently had a diagnosis of CDI. CDI
symptoms include, but are not limited to, diarrhea, abdominal pain, and
fever. CDI symptoms range in severity from mild (abdominal discomfort,
loose stools) to severe (profuse, watery diarrhea, severe pain, and
high fevers). Severe CDI can be life[dash]threatening and, in rare
cases, can cause bowel rupture, sepsis and organ failure. CDI is
responsible for 14,000 deaths per year in the United States.
C-diff produces two virulent, pro-inflammatory toxins, Toxin A and
Toxin B, which target host colonocytes (that is, large intestine
endothelial cells) by binding to endothelial cell surface receptors via
combined repetitive oligopeptide (CROP) domains. These toxins cause the
release of inflammatory cytokines leading to intestinal fluid secretion
and intestinal inflammation. The applicant asserted that
ZINPLAVATM targets Toxin B sites within the CROP domain
rather than the 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 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 Sec.
412.88(a)(2), we limit new technology add-on payments to the lesser of
50 percent of the average cost of the technology or 50 percent of the
costs in excess of the MS-DRG payment for the case. As a result, the
maximum new technology add-on payment amount for a case involving the
use of ZINPLAVATM is $1,900.
With regard to the newness criterion for ZINPLAVATM, we
considered the beginning of the newness period to commence on February
10, 2017. Because the 3-year anniversary date of the entry of
ZINPLAVATM onto the U.S. market (February 10, 2020) will
occur after FY 2019, 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 Sec. 412.87(c),
applicants for new technology add[dash]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. KYMRIAH\TM\ (Tisagenlecleucel) and YESCARTA\TM\ (Axicabtagene
Ciloleucel)
Two manufacturers, Novartis Pharmaceuticals Corporation and Kite
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-19-directed T[dash]cell immunotherapies used
for the purposes of treating patients with aggressive variants of
non[dash]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[dash]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[dash]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.)
[[Page 20285]]
Comparison of Indication and FDA Approval for KYMRIAHTM and YESCARTATM
----------------------------------------------------------------------------------------------------------------
Description of indication for which new
FY 2019 applicant technology name technology add-on payments are being FDA approval status
requested
----------------------------------------------------------------------------------------------------------------
KYMRIAHTM (Novartis Pharmaceuticals KYMRIAHTM: Autologous T-cell immune Breakthrough Therapy
Corporation). therapy indicated for use in the designation granted by
treatment of patients with relapsed/ FDA; FDA approval
refractory (R/R) Diffuse Large B Cell pending.
Lymphoma (DLBCL) not eligible for
autologous stem cell transplant (ASCT).
YESCARTATM (Kite Pharma, Inc.).......... YESCARTATM: Autologous T-cell immune FDA approval received 10/
therapy indicated for use in the 18/2017.
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.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Technology approved for other FDA approval of other
indications Description of other indication indication
----------------------------------------------------------------------------------------------------------------
KYMRIAHTM (Novartis Pharmaceuticals KYMRIAHTM: CD-19[dash]directed T-cell FDA approval received 8/30/
Corporation). immunotherapy indicated for the use in 2017.
the treatment of patients up to 25 years
of age with B-cell precursor ALL that is
refractory or in second or later relapse.
YESCARTATM (Kite Pharma, Inc.).......... None...................................... N/A.
----------------------------------------------------------------------------------------------------------------
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 t-cell immunotherapy into
peripheral vein, percutaneous approach, new technology group 3); and
XW043C3 (Introduction of engineered autologous chimeric antigen
receptor t-cell immunotherapy into central vein, percutaneous approach,
new technology group 3). We further note that, in section II.F.2.d. of
the preamble of this 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[dash]cell lymphoma
(PMBCL); and transformed follicular lymphoma (TFL). Within diagnoses of
NHL, DLBCL is the most common subtype of NHL, accounting for
approximately 30 percent of patients who have been diagnosed with NHL,
and survival without treatment is measured in months.\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 Second-line chemotherapy regimens studied to
date include rituximab, ifosfamide, carboplatin and etoposide (R-ICE),
and rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP),
followed by consolidative high-dose therapy (HDT)/ASCT. Both regimens
offer similar overall response rates (ORR) of 51 percent with 1 in 4
patients achieving long-term complete response (CR) at the expense of
increased toxicity.\13\ Second-line treatment with dexamethasone, high-
dose cytarabine, and cisplatin (DHAP) is considered a standard
chemotherapy regimen, but is associated with substantial treatment-
related toxicity.\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,
[[Page 20286]]
given the modest response to second[dash]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 first-line 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[dash]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\
---------------------------------------------------------------------------
\4\ Chaganti, S., et al., ``Guidelines for the management of
diffuse large B-cell lymphoma,'' BJH Guideline, 2016. Available at:
www.bit.do/bsh-guidelines.
\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 non-Hodgkin'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.
\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 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.
---------------------------------------------------------------------------
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[dash]19[dash]directed genetically modified
autologous T[dash]cell immunotherapy which utilizes peripheral blood
T[dash]cells, which have been reprogrammed with a transgene encoding, a
chimeric antigen receptor (CAR), to identify and eliminate CD-19-
expressing malignant and normal cells. Upon binding to CD-19-expressing
cells, the CAR transmits a signal to promote T-cell expansion,
activation, target cell elimination, and persistence of
KYMRIAHTM cells. The transduced T[dash]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 employs gene
modified autologous cells to target and eliminate malignant cells.
---------------------------------------------------------------------------
\18\ KYMRIAHTM [prescribing information], East
Hanover, NJ: Novartis Pharmaceuticals Corp, 2017.
\19\ Kalos, M., Levine, B.L., Porter, D.L., et al.,
``T[dash]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.
---------------------------------------------------------------------------
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[dash]cell immunotherapy
that binds to CD-19-expressing cancer cells and normal B[dash]cells.
These normal B[dash]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[dash]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 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
[[Page 20287]]
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 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-19-expressing malignant and
non-malignant 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[dash]19-expressing malignant
and nonmalignant cells. As explained by the applicant, upon binding to
CD-19-expressing cells, the CAR transmits a signal to promote T-cell
expansion, activation, target cell elimination, and persistence of
KYMRIAHTM cells.26 27 28 According to the
applicant, transduced T[dash]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
---------------------------------------------------------------------------
\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[dash]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.
\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[dash]cells for sustained remissions in
leukemia,'' N Engl J Med, 2014, vol. 371(16), pp. 1507-1517.
---------------------------------------------------------------------------
The applicant for YESCARTATM stated that
YESCARTATM is the first engineered autologous cellular
immunotherapy comprised of CAR T[dash]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 B-
cell 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
[[Page 20288]]
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 Non-
Acute Leukemia with other O.R. Procedures with MCC). These 3 MS-DRGs
accounted for 628 (76 percent) of the 827 cases. While the applicants
for 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 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[dash]cell immunotherapy derived from a
patient's own T[dash]cells. Instead, it is a bi-specific T[dash]cell
engager that recognizes CD-19 and CD-3 cancer cells. Unlike engineered
T[dash]cell therapy, BiTE does not have the ability to enhance the
proliferative and cytolytic capacity of T-cells through ex-vivo
engineering. Further, BiTE is approved for the treatment of patients
who have been diagnosed with Philadelphia chromosome[dash]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[dash]approved CD-19-directed genetically modified autologous
T[dash]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[dash]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[dash]stimulatory
domain and KYMRIAHTM has 4-1BB co-stimulatory domain.
Further, the applicant stated the manufacturing processes of the two
immunotherapies are also different, which may result in cell
composition differences leading to possible efficacy and safety
differences.
---------------------------------------------------------------------------
\32\ Food and Drug Administration. Available at:
www.accessdata.fda.gov/scripts/opdlisting/oopd/.
---------------------------------------------------------------------------
While the applicant for YESCARTATM stated how its
technology is different from KYMRIAHTM, because both
technologies are CD-19-directed T[dash]cell immunotherapies used for
the purpose 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[dash]on payment, because procedures utilizing either
YESCARTATM or KYMRIAHTM CAR T-cell therapy drugs
are reported using the same ICD-10-PCS procedure codes, in order to
accurately pay the new technology add[dash]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[dash]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
[[Page 20289]]
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[dash]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[dash]weighted standardized charge per case for potential
DLBCL cases, potential DLBCL cases with chemotherapy, and potential
DLBCL cases without chemotherapy was $63,271, $39,723, and $72,781,
respectively. The average case-weighted threshold amount for potential
DLBCL cases, potential DLBCL cases with chemotherapy, and potential
DLBCL cases without chemotherapy was $58,278, $48,190, and $62,355
respectively. While the inflated average case-weighted standardized
charge per case ($39,723) is lower than the average case-weighted
threshold amount ($48,190) for potential DLBCL cases with chemotherapy,
the applicant 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[dash]weighted standardized charge
per case from all three cohorts above to the average case-weighted
threshold amount for MS-DRG 016. The average case-weighted threshold
amount for MS-DRG 016 from Table 10 in the FY 2018 IPPS/LTCH PPS final
rule is $161,058. Although the inflated average case-weighted
standardized charge per case for all three cohorts ($63,271, $39,723,
and $72,781) is lower than the average case-weighted threshold amount
for MS-DRG 016, 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.
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[dash]Acute Leukemia with Other O.R. Procedure with
MCC, with CC, respectively), 825 (Lymphoma and Non Acute Leukemia with
Other O.R Procedure without CC/MCC), and 840, 841 and 842 (Lymphoma and
Non-Acute Leukemia with MCC, with CC and without CC/MCC, respectively)
consisted of 10 or more cases, the applicant limited its analysis to
these 8 MS-DRGs. The applicant identified 827 potential cases across
these MS-DRGs. The average case-weighted unstandardized charge per case
was $126,978. The applicant standardized charges using FY 2016
standardization factors and applied an inflation factor of 1.09357 from
the FY 2018 IPPS/LTCH PPS final rule (82 FR 38527). The applicant for
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 case-weighted
standardized charge per case of $118,575. Using the FY 2018 IPPS Table
10 thresholds, the average case-weighted threshold amount was $72,858.
Even without considering the cost of its technology, the applicant
maintained that because the inflated average case-weighted standardized
charge per case 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
[[Page 20290]]
drugs and cases representing patients receiving treatment involving CAR
T-cell therapy procedures to Pre-MDC MS-DRG 016 for FY 2019. Therefore,
in addition to the analysis above, we compared the inflated average
case-weighted standardized charge per case ($118,575) to the average
case-weighted threshold amount for MS-DRG 016. The average case-
weighted threshold amount for MS-DRG 016 from Table 10 in the FY 2018
IPPS/LTCH PPS final rule is $161,058. Although the inflated average
case-weighted standardized charge per case is lower than the average
case-weighted threshold amount for MS-DRG 016, 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 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\
---------------------------------------------------------------------------
\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-2017-03-769620.
---------------------------------------------------------------------------
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[dash]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\
---------------------------------------------------------------------------
\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-2017-03-769620.
\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.
---------------------------------------------------------------------------
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[dash]tor inhibitors such as Everolimus and Temserolimus
have been studied as single agents, or in combination with Rituximab,
as have newer monoclonal antibodies Dacetuzumab, Ofatumomab and
Obinutuzumab. However, none induced a CR rate higher than 20 percent or
showed a median duration of response longer than 1 year.\39\
---------------------------------------------------------------------------
\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.
\39\ Ibid.
---------------------------------------------------------------------------
According to the applicant, although controversial, allogeneic stem
cell transplantation (allo-SCT) has been proposed for patients who have
been diagnosed with R/R disease. It is hypothesized that the malignant
cell will be less able to escape the immune targeting of allogenic T-
cells--known as the graft-vs-lymphoma effect.\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.
---------------------------------------------------------------------------
\40\ Ibid.
\41\ Maude, S.L., Teachey, D.T., Porter, D.L., Grupp, S.A.,
``CD19-targeted chimeric antigen receptor T-cell therapy for acute
lymphoblastic leukemia,'' Blood, 2015, vol. 125(26), pp. 4017-4023.
\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.
---------------------------------------------------------------------------
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[dash]arm, open[dash]label, multi[dash]site, global
Phase II study to determine the safety and efficacy of tisagenlecleucel
in patients
[[Page 20291]]
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[dash]up phase began 2 to 14 days after
lymphodepleting chemotherapy, when the patient received a single
infusion of tisagenlecleucel with a target dose of 5x10\8\ 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[dash]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 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[dash]cell, 52.4 percent response in patients
with Germinal Center B[dash]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.
---------------------------------------------------------------------------
\43\ Data on file, Oncology clinical trial protocol
CCTL019C2201: ``A Phase II, single[dash]arm, multi[dash]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.
---------------------------------------------------------------------------
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 x 108
transduced cells. The study enrolled 38 patients; of these, 21 were
diagnosed with DLBCL and 13 received treatment involving
KYMRIAHTM. 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[dash]up of 11.7 months. Safety and efficacy
results are similar to those of the multi-center study.
---------------------------------------------------------------------------
\47\ ClinicalTrials.gov, ``Phase IIa study of redirected
autologous T[dash]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.
---------------------------------------------------------------------------
The applicant for KYMRIAHTM reported that Study 3 was a
supportive, patient[dash]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[dash]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[dash]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
[[Page 20292]]
months with a 2 year OS rate of 11 percent.
---------------------------------------------------------------------------
\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-2017-03-769620.
---------------------------------------------------------------------------
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[dash]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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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[dash]related issues). Finally, the rate of patients who
experienced a diagnosis of CRS was high, 58 percent.\54\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 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[dash]center,
open[dash]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[dash]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\
[[Page 20293]]
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).
---------------------------------------------------------------------------
\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 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 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.
Overall Response Rates Across All YESCARTA\TM\ Studies vs. SCHOLAR-1
----------------------------------------------------------------------------------------------------------------
Study 1, Phase Scholar-1
% I n=7 Study 1, Phase II n=101 n=529
----------------------------------------------------------------------------------------------------------------
Overall Response Rate (%)............. 71 83...................................... 26
Month 6 (%)........................... 43 41...................................... ..............
Ongoing with >15 Months of follow-up 43 42...................................... ..............
(%).
Ongoing with >18 Months of follow-up 43 Follow-up ongoing....................... ..............
(%).
----------------------------------------------------------------------------------------------------------------
Results for YESCARTA\TM\ Study 1, Phase II: Complete Response
------------------------------------------------------------------------
Study 1, Phase II n=101
------------------------------------------------------------------------
Complete Response (%) (95 Percent 54 (44,64).
Confidence Interval).
Duration of Response, median (range in not reached.
months).
Ongoing Responses, CR (%); Median 8.7 39.
months follow-up; median overall survival
has not been reached.
Ongoing Responses, CR (%); Median 15.3 40.
months follow-up; median overall survival
has not been reached.
------------------------------------------------------------------------
According to the applicant, the 6-month and 12-month survival rates
(95 percent CI) for patients enrolled in the SCHOLAR-1 study were 53
percent (49 percent, 57 percent) and 28 percent (25 percent, 32
percent).\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
YESCARTATM-related 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
YESCARTATM-related adverse events (hemophagocytic
lymphohistiocytosis and cardiac arrest in the hospital setting as a
result of CRS diagnoses). According to the applicant, there were no
clinically important differences in adverse event rates across age
groups (younger than 65 years old; 65 years old or older), including
CRS diagnoses and neurotoxicity.\72\ \73\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
[[Page 20294]]
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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 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[dash]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[dash]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 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[dash]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[dash]cell therapy drugs, including through the use of new
technology add[dash]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 add-on 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[dash]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
[[Page 20295]]
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 add-on payments for the VYXEOSTM technology for
FY 2019. (We note that Celator Pharmaceuticals, Inc. submitted an
application for new technology add[dash]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[dash]AML) or AML with myelodysplasia-related
changes (AML-MRC).
AML is a type of cancer in which the bone marrow makes abnormal
myeloblasts (immature bone marrow white blood cells), red blood cells,
and platelets. If left untreated, AML progresses rapidly. Normally, the
bone marrow makes blood stem cells that develop into mature blood cells
over time. Stem cells have the potential to develop into many different
cell types in the body. Stem cells can act as an internal repair
system, dividing, essentially without limit, to replenish other cells.
When a stem cell divides, each new cell has the potential to either
remain a stem cell or become a specialized cell, such as a muscle cell,
a red blood cell, or a brain cell, among others. A blood stem cell may
become a myeloid stem cell or a lymphoid stem cell. Lymphoid stem cells
become white blood cells. A myeloid stem cell becomes one of three
types of mature blood cells: (1) Red blood cells that carry oxygen and
other substances to body tissues; (2) white blood cells that fight
infection; or (3) platelets that form blood clots and help to control
bleeding. In patients diagnosed with AML, the myeloid stem cells
usually become a type of myeloblast. The myeloblasts in patients
diagnosed with AML are abnormal and do not become healthy white blood
cells. Sometimes in patients diagnosed with AML, too many stem cells
become abnormal red blood cells or platelets. These abnormal cells are
called leukemia cells or blasts.
AML is defined by the World Health Organization (WHO) as greater
than 20 percent blasts in the bone marrow or blood. AML can also be
diagnosed if the blasts are found to have a chromosome change that
occurs only in a specific type of AML diagnosis, even if the blast
percentage does not reach 20 percent. Leukemia cells can build up in
the bone marrow and blood, resulting in less room for healthy white
blood cells, red blood cells, and platelets. When this occurs,
infection, anemia, or increased risk for bleeding may result. Leukemia
cells can spread outside the blood to other parts of the body,
including the central nervous system (CNS), skin, and gums.
Treatment of AML diagnoses usually consists of two phases;
remission induction and post-remission therapy. Phase one, remission
induction, is aimed at eliminating as many myeloblasts as possible. The
most common used remission induction regimens for AML diagnoses are the
``7+3'' regimens using an antineoplastic and an anthracycline.
Cytarabine and daunorubicin are two commonly used drugs for ``7+3''
remission induction therapy. Cytarabine is continuously administered
intravenously over the course of 7 days, while daunorubicin is
intermittently administered intravenously for the first 3 days. The
``7+3'' regimen typically achieves a 70 to 80 percent complete
remission (CR) rate in most patients under 60 years of age.
High rates of CR are not generally seen in older patients for a
number of reasons, such as different leukemia biology, much higher
incidence of adverse cytogenetic abnormalities, higher rate of
multidrug resistant leukemic cells, and comparatively lower patient
performance status (the standard criteria for measuring how the disease
impacts a patient's daily living abilities). Intensive induction
therapy has worse outcomes in this patient population.\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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[dash]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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 20296]]
drugs being combined in vitro, and fixing this ratio in a nano-scale
drug delivery complex to maintain the optimized combination after
administration and ensuring exposure of this ratio to the tumor.
Cytarabine and daunorubicin are co-encapsulated inside the
VYXEOSTM liposome at a fixed ratiometrically, optimized 5:1
cytarabine:daunorubicin molar ratio. According to the applicant,
encapsulation maintains the synergistic ratios, reduces degradation,
and minimizes the impact of drug transporters and the effect of known
resistant mechanisms. The applicant stated that the 5:1 molar ratio has
been shown, in vitro, to maximize synergistic antitumor activity across
multiple leukemic and solid tumor cell lines, including AML, and in
animal model studies to be optimally efficacious compared to other
cytarabine:daunorubicin ratios. In addition, the applicant stated that
in clinical studies, the use of VYXEOSTM has demonstrated
consistently more efficacious results than the conventional ``7+3''
free drug dosing. VYXEOSTM is intended for intravenous
administration after reconstitution with 19 mL sterile water for
injection. VYXEOSTM is administered as a 90[dash]minute
intravenous infusion on days 1, 3, and 5 (induction therapy), as
compared to the ``7+3'' free drug dosing, which consists of two
individual drugs administered on different days, including 7 days of
continuous infusion.
With regard to the newness criterion, as discussed earlier, if a
technology meets all three of the substantial similarity criteria, it
would be considered substantially similar to an existing technology and
would not be considered ``new'' for purposes of new technology add-on
payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant asserted that VYXEOSTM does not use the same or
similar mechanism of action to achieve a therapeutic outcome as any
other drug assigned to the same or a different MS-DRG. The applicant
stated that no other AML treatment is designed, nor is able, to deliver
a fixed, ratiometrically optimized and synergistic drug:drug ratio of
5:1 cytarabine to daunorubicin, and selectively target and accumulate
at the site of malignancy, while minimizing unwanted exposure, which
the applicant based on the data results of preclinical and clinical
studies of the use of VYXEOSTM. The applicant indicated that
VYXEOSTM is a nano-scale liposomal formulation of a fixed
combination of cytarabine and daunorubicin. Further, the applicant
stated that the rationale for the development of VYXEOSTM is
based on prolonged delivery of synergistic drug ratios utilizing the
applicant's proprietary, ratiometric CombiPlex technology. According to
the applicant, conventional ``7+3'' free drug dosing has no delivery
complex, and these individual drugs are administered without regard to
their ratio dependent interaction. According to the applicant,
enzymatic inactivation and imbalanced drug efflux and transporter
expression reduce drug levels in the cell. Further, decreased
cytotoxicity leads to cell survival, emergence of drug resistant cells,
and decreased overall survival.
The applicant provided the results of clinical studies to
demonstrate that the CombiPlex technology and the ratiometric dosing of
VYXEOSTM represent a shift in anticancer agent delivery,
whereby the fixed, optimized dosing provides less drug to achieve
improved efficacy, while maintaining a favorable risk-benefit profile.
The results of this ratiometric dosing approach are in contrast to the
typical combination chemotherapy 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.
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[dash]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
[[Page 20297]]
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[dash]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 case-weighted standardized
charge was $170,458, which exceeds the average case[dash]weighted Table
10 MS-DRG threshold amount of $82,561 by $87,897.
The applicant provided additional analyses with the inclusion of
VYXEOSTM charges under 3-vial, 4-vial, 6-vial, and 10-vial
treatment scenarios. According to the applicant, the cost criterion was
satisfied in each of these scenarios, with charges in excess of the
average case-weighted threshold amount.
Finally, the applicant also provided the following sensitivity
analyses (that did not include charges for VYXEOSTM) using
the methodology above:
Sensitivity Analysis 1--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[dash]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[dash]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[dash]risk subset of patients as defined by the
European Prognostic Index. In both groups of patients, the applicant
stated that there was significant improvement in survival for the
high[dash]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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Based on data from the Phase III Study 301,\81\ the applicant cited
the
[[Page 20298]]
following results: The rate of 60-day mortality was less in the
VYXEOSTM treatment arm (13.7 percent) versus the ``7+3''
free drug dosing treatment arm (21.2 percent); the reduction in early
mortality was due to fewer deaths from refractory AML (3.3 percent
versus 11.3 percent), with very similar rates of 60-day mortality due
to adverse events (10.4 percent versus 9.9 percent); there were fewer
deaths in the VYXEOSTM treatment arm versus the ``7+3'' free
drug dosing treatment arm during the treatment phase (7.8 percent
versus 11.3 percent); and there were fewer deaths in the
VYXEOSTM treatment arm during the follow-up phase than in
the ``7+3'' free drug dosing treatment arm (59.5 percent versus 71.5
percent).
---------------------------------------------------------------------------
\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 (secondary) AML''. Abstract and oral
presentation at American Society of Clinical Oncology (ASCO), June
2016.
---------------------------------------------------------------------------
The applicant asserted that high-risk, older patients (60
years old and older) previously untreated for a diagnosis of AML
exhibited statistically significant improvements in response rates
after treatment with VYXEOSTM versus treatment with the
conventional ``7+3'' free drug chemotherapy dosing, suggesting that the
use of VYXEOSTM is a superior pre-transplant induction
treatment versus ``7+3'' free drug dosing. Restoration of normal
hematopoiesis is the ultimate goal of any therapy for AML diagnoses.
The first phase of treatment consists of induction chemotherapy, in
which the goal is to ``empty'' the bone marrow of all hematopoietic
elements (both benign and malignant), and to allow repopulation of the
marrow with normal cells, thereby yielding remission. According to the
applicant, post-induction response rates were 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[dash]risk, older patients (60 years old and older) to
bridge to allogeneic transplant, and VYXEOSTM treated
responding patients will have markedly better outcomes following
transplant. The applicant stated that diagnoses of secondary AML are
considered incurable with standard chemotherapy approaches and, as with
other high[dash]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[dash]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\
---------------------------------------------------------------------------
\82\ Stone Hematology 2004; Gordon AACR 2016; NCI. Available at:
www.cancer.gov.
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According to the applicant, patient outcome following transplant
strongly favored patients in the VYXEOSTM treatment arm. The
Kaplan-Meier analysis of the 91 transplanted patients landmarked at the
time of HCT showed that patients in the VYXEOSTM treatment
arm had markedly better overall survival (hazard ratio 0.46; p=0.0046).
The time-dependent Adjustment Model (Cox proportional hazard ratio) was
used to evaluate the contribution of VYXEOSTM treatment to
overall survival rate after adjustment for transplant and showed that
VYXEOSTM treatment remained a significant contributor, even
after adjusting for transplant. The time-dependent Cox hazard ratio for
overall survival rates in the VYXEOSTM treatment arm versus
the ``7+3'' free drug dosing treatment arm was 0.51 (95 percent CI,
0.35-0.75; p=.0007).
The applicant asserted that VYXEOSTM treatment
of previously untreated older patients (60 years old and older)
diagnosed with high-risk AML increases the response rate and improves
survival compared to conventional ``7+3'' free drug dosing treatment in
patients diagnosed with FLT3 mutation. The applicant noted the
following: Approximately 20 to 30 percent of AML patients harbor some
form of FLT3 mutation, AML patients with a FLT3 mutation have a higher
relapse rate and poorer prognosis than the overall population diagnosed
with AML, and the most common type of mutation is internal tandem
duplication (ITD) mutation localized to a membrane region of the
receptor.
The applicant cited Gordon, et al., 2016,\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 anti-
[[Page 20299]]
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).
---------------------------------------------------------------------------
\83\ Gordon, M., Tardi, P., Lawrence, M.D., et al., ``CPX-351
cytotoxicity against fresh AML blasts increased for FLT3-ITD+ cells
and correlates with drug uptake and clinical outcomes,'' Abstract
287 and poster presented at AACR (American Association for Cancer
Research), April 2016.
---------------------------------------------------------------------------
The applicant asserted that younger patients (18 to 65
years old) with poor risk first relapse AML have shown higher response
rates with VYXEOSTM treatment versus conventional
``salvage'' chemotherapy. Overall, the applicant stated that the use of
VYXEOSTM had an acceptable safety profile in this patient
population based on 60-day mortality data. Study 205 \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[dash]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[dash]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:
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Mitoxantrone, etoposide, and cytarabine induced response
in 23 percent of patients, with median overall survival of only 2
months.
Modulation of deoxycitidine kinase by fludarabine led to
the combination of fludarabine and cytarabine, resulting in a 36
percent CR rate with median remission duration of 39 weeks.
First salvage gemtuzumab ozogamicin induced CR+CRp (or
CR+CRi) response in 30 percent of patients with CD33+ AML and, for
patients with short first CR durations, appeared to be superior to
cytarabine-based therapy.
The applicant noted that Study 205 results showed the use of
VYXEOSTM retained greater anti-leukemic efficacy in patients
who have been diagnosed with poor[dash]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 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[dash]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[reg]). The intent of the guidelines is to
assist in the decision-making process of individuals involved in cancer
treatment and care. According to the NCCN Guidelines[reg], Category 1
clinical practices are based upon high[dash]level evidence, and there
is uniform NCCN consensus that the intervention is appropriate. The
February 7, 2018 NCCN Guidelines[reg] 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
[[Page 20300]]
(AML-RMC) to be included as a Category 1 clinical practice.\86\
---------------------------------------------------------------------------
\86\ NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines[reg]), Acute Myeloid Leukemia, Version I--2018, February
7, 2018, https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf.
---------------------------------------------------------------------------
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 (Meropenem-Vaborbactam)
Melinta Therapeutics, Inc., submitted an application for new
technology add-on payments for VABOMERETM for FY 2019.
VABOMERETM is indicated for use in the treatment of adult
patients who have been diagnosed with complicated urinary tract
infections (cUTIs), including pyelonephritis, caused by 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[deg]C);
elevated white blood cell count (greater than 10,000/mm\3\), or left
shift (greater than 15 percent immature PMNs); nausea or vomiting;
dysuria, increased urinary frequency, or urinary urgency; lower
abdominal pain or pelvic pain. Acute pyelonephritis is defined as
chills, rigors, or fever (temperature of greater than or equal to
38.0[deg]C); elevated white blood cell count (greater than 10,000/
mm\3\), or left shift (greater than 15 percent immature PMNs); nausea
or vomiting; dysuria, increased urinary frequency, or urinary urgency;
flank pain; costo[dash]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
multidrug-resistant gram-negative bacteria, such as carbapenem-
resistant Enterobacteriacea (CRE), has resulted in a critical need for
new antimicrobials.
---------------------------------------------------------------------------
\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-infection-including-pyelonephritis-in-adults.
---------------------------------------------------------------------------
The applicant reported that it has developed a beta-lactamase
combination antibiotic, VABOMERETM, to treat cUTIs,
including those caused by certain carbapenem[dash]resistant organisms.
By combining the carbapenem class antibiotic meropenem with
vaborbactam, VABOMERETM protects meropenem from degradation
by certain CRE strains.
The applicant stated that meropenem, a carbapenem, is a broad
spectrum beta[dash]lactam antibiotic that works by inhibiting cell wall
synthesis of both gram-positive and gram-negative bacteria through
binding of penicillin-binding proteins (PBP). Carbapenemase producing
strains of bacteria have become more resistant to beta-lactam
antibiotics, such as meropenem. However, meropenem in combination with
vaborbactam, inhibits the carbapenemase activity, thereby allowing the
meropenem to bind PBP and kill the bacteria.
According to the applicant, vaborbactam, a boronic acid inhibitor,
is a first-in class beta-lactamase inhibitor. Vaborbactam blocks the
breakdown of carbapenems, such as meropenem, by bacteria containing
carbapenemases. Although vaborbactam has no antibacterial properties,
it allows for the treatment of resistant infections by increasing
bacterial sensitivity to meropenem. New carbapenemase producing strains
of bacteria have become more resistant to beta-lactam antibiotics.
However, meropenem in combination with vaborbactam, can inhibit the
carbapenemase enzyme, thereby allowing the meropenem to bind PBP and
kill the bacteria. The applicant stated that the vaborbactem component
of VABOMERETM helps to protect the meropenem from
degradation by certain beta-lactamases, such as Klebsiella pneumonia
carbapenemase (KPC). According to the applicant, VABOMERETM
is the first of a novel class of beta[dash]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 m\2\. The recommended
dosage of VABOMERETM for patients with varying degrees of
renal function is included in the prescribing information. The duration
of treatment is for up to 14 days.
As discussed earlier, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, VABOMERETM is designed primarily
for the treatment of gram-negative bacteria that are resistant to other
current antibiotic therapies. The applicant stated that
VABOMERETM does not use the same or similar mechanism of
action to achieve a therapeutic outcome. The applicant asserted that
the vaborbactam component of VABOMERETM is a new class of
beta-lactamase inhibitor that protects meropenem from degradation by
certain enzymes such as carbapenamases. The applicant indicated that
the structure of 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[dash]line as well as ``last defense'' antimicrobials used in
hospitals. According to the applicant, in order for carbapenems to be
effective these enzymes must be inhibited. The applicant stated that
the addition of vaborbactam as a potent inhibitor against Class A and C
serine beta-lactamases, particularly KPC, represents a new mechanism of
action. According to the applicant, VABOMERETM's use of
vaborbactam to restore the efficacy of meropenem is a novel approach
and that the FDA's approval of VABOMERETM for the treatment
of cUTIs represents a significant label expansion because mereopenem
alone (without the addition of vaborbactam) is not indicated for the
treatment of patients with cUTI infections. Therefore, the applicant
maintained that this technology and resistance-fighting mechanism
involved in the therapeutic effect achieved by VABOMERETM is
distinct from any other existing product. The applicant noted that
VABOMERETM was designated as a qualified infectious disease
product (QIDP) in January 2014. This designation is given to
antibacterial products that treat serious or life[dash]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
[[Page 20301]]
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 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[dash]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[dash]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 without MCC),
and MS-DRG 690 (Kidney and Urinary Tract Infections without MCC), to
which 627 cases representing potential patients who may be eligible for
treatment involving VABOMERETM, or approximately 30.2
percent of the total cases identified, mapped.
The applicant reported that the resulting 627 cases from the
identified top 5 MS-DRGs have an average case-weighted unstandardized
charge per case of $74,815. 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[dash]weighted
unstandardized charge per case) rather than the actual average
case[dash]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[dash]weighted standardized charge per case as
$91,304, which exceeds the average case[dash]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[dash]weighted unstandardized charge per case based on the
average case-weighted threshold amounts in Table 10
[[Page 20302]]
from the FY 2018 IPPS/LTCH PPS final rule. Because the applicant did
not demonstrate that the average case-weighted standardized charge per
case for VABOMERETM (using actual charges from the Premier
Research Database) would exceed the average case-weighted threshold
amounts in Table 10, we 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[dash]I \88\ was
a prospective, randomized, double-blinded trial of
VABOMERETM versus piperacillin-tazobactam in patients with
cUTIs and acute pyelonephritis (A/P). TANGO[dash]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[dash]of[dash]treatment (EOT) (day 5 to 14) in the proportion of
patients in the Microbiologic Evaluable Modified Intent-to-Treat (m-
MITT) population who achieved overall success (clinical cure or
improvement and eradication of baseline pathogen to <104 CFU/mL), and
one for the European Medicines Agency (EMA), which was the proportion
of patients in the co-primary m-MITT and Microbiologic Evaluable (ME)
populations who achieve a microbiologic outcome of eradication
(eradication of baseline pathogen to <103 CFU/mL) at the
test[dash]of[dash]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 4g-tazobactam 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.
---------------------------------------------------------------------------
\88\ Vabomere Prescribing Information, Clinical Studies (August
2017), available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf.
---------------------------------------------------------------------------
Patient demographic and baseline characteristics were balanced
between treatment groups in the m-MITT population.
Approximately 93 percent of patients were Caucasian and 66
percent were females in both treatment groups.
The mean age was 54 years old with 32 percent and 42
percent of the patients 65 years old and older in the
VABOMERETM and piperacillin/tazobactam treatment groups,
respectively.
Mean body mass index was approximately 26.5 kg/m\2\ 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[dash]removable and removable source of infection, respectively.
Mean duration of IV treatment in both treatment groups was 8 days
and mean total treatment duration (IV and oral) was 10 days; patients
with baseline bacteremia could receive up to 14 days of therapy (IV and
oral). Approximately 10 percent of the patients in each treatment group
in the m-MITT population had a levofloxacin-resistant pathogen at
baseline and received levofloxacin as the oral switch therapy.
According to the applicant, this protocol violation may have impacted
the assessment of the outcomes at the TOC visit. These patients were
not excluded from the analysis of adverse reactions (headache,
phlebitis, nausea, diarrhea, and others) occurring in 1 percent or more
of the patients receiving VABOMERETM, as the decision to
switch to oral levofloxacin was based on post-randomization factors.
Regarding the FDA primary endpoint, the applicant stated the
following:
Overall success rate at the end of IV treatment (day 5 to
14) was 98.4 percent and 94 percent for the VABOMERETM and
piperacillin/tazobactam treatment groups, respectively.
The TOC--7 days post IV therapy was 76.5 percent (124 of
162 patients) for the VABOMERETM group and 73.2 percent (112
of 153 patients) for the piperacillin/tazobactam group.
Despite being an NI trial, TANGO-I showed a statistically
significant difference favoring VABOMERETM in the primary
efficacy endpoint over piperacillin/tazobactam (a commonly used agent
for gram-negative infections in U.S. hospitals).
VABOMERETM demonstrated statistical superiority
over piperacillin-tazobactam with overall success of 98.4 percent of
patients treated with VABOMERETM in the TANGO-I clinical
trial compared to 94.0 percent for patients treated with piperacillin/
tazobactam, with a treatment difference of 4.5 percent and 95 percent
CI of (0.7 percent, 9.1 percent).
Because the lower limit of the 95 percent CI is also
greater than 0 percent, VABOMERETM was statistically
superior to piperacillin/tazobactam.
Because non-inferiority was demonstrated, then superiority
was tested. Further, the applicant asserted that a noninferiority
design may have a ``superiority'' hypothesis imbedded within the study
design that is appropriately tested using a non[dash]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
[[Page 20303]]
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.
---------------------------------------------------------------------------
\89\ Golan, Y., 2015, ``Empiric therapy for hospital-acquired,
Gram-negative complicated intra-abdominal infection and complicated
urinary tract infections: a systematic literature review of current
and emerging treatment options,'' BMC Infectious Diseases, vol. 15,
pp. 313. http://doi.org/10.1186/s12879-015-1054-1.
---------------------------------------------------------------------------
The applicant asserted that the TANGO[dash]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[dash]II is a multi[dash]center, randomized,
Phase III, open-label trial of patients with infections due to known or
suspected CRE, including cUTI, AP, HABP/VABP, bacteremia, or
complicated intra-abdominal infection (cIAI). Eligible patients were
randomized 2:1 to monotherapy with VABOMERETM or BAT for 7
to 14 days. There were no consensus BAT regimes, it could include
(alone or in combination) a carbapenem, aminoglycoside, polymyxin B,
colistin, tigecycline or ceftazidime-avibactam.
---------------------------------------------------------------------------
\90\ Alexander, et al., ``CRE Infections: Results From a
Retrospective Series and Implications for the Design of Prospective
Clinical Trials,'' Open Forum Infectious Diseases.
---------------------------------------------------------------------------
A total of 72 patients were enrolled in the TANGO[dash]II trial. Of
these, 50 of the patients (69.4 percent) had a gram-negative baseline
organism (m-MITT population), and 43 of the patients (59.7 percent) had
a baseline CRE (mCRE-MITT population). Within the mCRE-MITT population,
20 of the patients had bacteremia, 15 of the patients had a cUTI/AP, 5
of the patients had HABP/VABP, and 3 of the patients had a cIAI. The
most common baseline CRE pathogens were K. pneumoniae (86 percent) and
Escherichia coli (7 percent). Cure rates of the mCRE-MITT population at
EOT for VABOMERETM and BAT groups were 64.3 percent and 40
percent, respectively, TOC, 7 days after EOT, were 57.1 percent and
26.7 percent, respectively, 28-day mortality was 17.9 percent (5 of 28
patients) and 33.3 percent (5 of 15 patients), respectively. The
applicant asserted that with further sensitivity analysis, taking into
account prior antibiotic failures among the VABOMERETM study
arm, the 28[dash]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[dash]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[dash]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[dash]II trial cUTI/AP
subgroup demonstrated VABOMERETM was associated with an
overall success rate at EOT for the mCRE-MITT populations of 72 percent
(8 of 11 patients) versus 50 percent (2 of 4 patients) and an overall
success rate at TOC of 27.3 percent (3 of 7 patients) versus 50 percent
(2 of 4 patients).
We note that many of the TANGO[dash]II trial outcomes showing
improvements in the use of VABOMERETM over BAT are not
statistically significant. We also note that the TANGO[dash]II study
included a small number of patients; the study population in the
mCRE[dash]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[dash]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
[[Page 20304]]
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[dash]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.
d. DURAGRAFT[reg] Vascular Conduit Solution
Somahlution, Inc. submitted an application for new technology add-
on payments for DURAGRAFT[reg] for FY 2019. DURAGRAFT[reg] 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[reg] 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
12-month VGF.93 94 This is likely due not 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, pro-thrombogenic 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.
---------------------------------------------------------------------------
\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.
\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.
---------------------------------------------------------------------------
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 shear-
mediated 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
applicant summarized, that when the damaged luminal surface of a vein
graft is presented to the bloodstream at time of reperfusion, a
domino[dash]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\
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
With respect to the newness criterion, DURAGRAFT[reg] 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[reg]
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
[[Page 20305]]
same mechanism of action as that of DURAGRAFT[reg]. 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[reg] 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[reg] 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[reg].
Based on the applicant's statements presented above, we are
concerned that the mechanism of action of the DURAGRAFT[reg] 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 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[reg] 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[reg] 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:
------------------------------------------------------------------------
ICD-10-PCS procedure code Code title
------------------------------------------------------------------------
021009W................... Bypass coronary artery, one artery from
aorta with autologous venous tissue, open
approach.
02100AW................... Bypass coronary artery, one artery from
aorta with autologous arterial tissue, open
approach.
021049W................... Drainage of intracranial subdural space,
percutaneous approach
02104AW................... Bypass cerebral ventricle to cerebral
cisterns, percutaneous approach.
021109W................... Bypass coronary artery, two arteries from
aorta with autologous venous tissue, open
approach.
02110AW................... Bypass coronary artery, two arteries from
aorta with autologous arterial tissue, open
approach.
021149W................... Bypass coronary artery, two arteries from
aorta with autologous venous tissue,
percutaneous endoscopic approach.
02114AW................... Bypass coronary artery, two arteries from
aorta with autologous arterial tissue,
percutaneous endoscopic approach.
021209W................... Bypass coronary artery, three arteries from
aorta with autologous venous tissue, open
approach.
02120AW................... Bypass coronary artery, three arteries from
aorta with autologous arterial tissue, open
approach.
021249W................... Bypass coronary artery, three arteries from
aorta with autologous venous tissue,
percutaneous endoscopic approach.
02124AW................... Bypass coronary artery, three arteries from
aorta with autologous arterial tissue,
percutaneous endoscopic approach.
021309W................... Bypass coronary artery, four or more
arteries from aorta with autologous venous
tissue, open approach.
02130AW................... Bypass coronary artery, four or more
arteries from aorta with autologous
arterial tissue, open approach.
021349W................... Bypass coronary artery, four or more
arteries from aorta with autologous venous
tissue, percutaneous endoscopic approach.
02134AW................... 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 MS-DRG title
------------------------------------------------------------------------
MS-DRG 3................. Extracorporeal Membrane Oxygenation (ECMO) or
Tracheostomy with Mechanical Ventilation 96+
Hours or Principal Diagnosis Except Face,
Mouth & Neck with Major Operating Room.
MS-DRG 216............... Cardiac Valve and Other Major Cardiothoracic
Procedure with Cardiac Catheterization with
MCC.
MS-DRG 219............... Cardiac Valve and Other Major Cardiothoracic
Procedure without Cardiac Catheterization
with MCC.
MS-DRG 220............... Cardiac Valve and Other Major Cardiothoracic
Procedure without Cardiac Catheterization
with CC.
MS-DRG 228............... Other Cardiothoracic Procedures with MCC.
MS-DRG 229............... Other Cardiothoracic Procedures without CC.
MS-DRG 233............... Coronary Bypass with Cardiac Catheterization
with MCC.
MS-DRG 234............... Coronary Bypass with Cardiac Catheterization
without MCC.
MS-DRG 235............... Coronary Bypass without Cardiac
Catheterization with MCC.
MS-DRG 236............... Coronary Bypass without Cardiac
Catheterization without MCC.
------------------------------------------------------------------------
Using the 59,139 identified cases, the average case-weighted
unstandardized charge per case was $200,886. The applicant then
standardized the charges. The applicant did not remove charges for any
current treatment because, as
[[Page 20306]]
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[reg] 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 case-weighted threshold amount was $164,620.
The final average case-weighted 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[reg] meets the cost
criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the substitutional use of DURAGRAFT[reg]
significantly reduces clinical complications associated with VGF
following CABG surgery.
According to the applicant, DURAGRAFT[reg] 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[dash]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 protect the endothelial layer prior to implantation can
have long-term consequences.
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
When a damaged luminal surface (endothelium) of a vascular graft is
presented to the bloodstream at the time of reperfusion, a
domino[dash]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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The combined PREVENT IV sub-analyses 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[dash]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 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[reg] treatment has been designed to be a fully
protective solution. DURAGRAFT[reg] is formulated into a flushing,
wetting, and storage solution replacing solutions traditionally used
for this purpose and, therefore, does not change surgical practice.
---------------------------------------------------------------------------
\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.
\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.
---------------------------------------------------------------------------
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[reg] treatment in two hospitals that had noncommercial access
to the product through hospital pharmacies. These studies evaluated the
effect of DURAGRAFT[reg] 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), single-center, multi-surgeon
retrospective,
[[Page 20307]]
comparative study (DURAGRAFT[reg] 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[reg] 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[dash]center clinical
study in CABG patients was to evaluate the potential benefits of
DURAGRAFT[reg] treatment as compared to a no[dash]treatment control
group (saline). The investigator who prepared the analysis remained
blinded to individual patient data. Eligibility criteria included
patients with first[dash]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[dash]center in Europe between January 2002 and December 2008
were included. The no-treatment control group (saline) included 375
patients who underwent CABG surgery from January 2002 to May 2005 and
the DURAGRAFT[reg] 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[dash]up). Therefore, a
total of 247 patients from the DURAGRAFT[reg] 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[reg] 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[reg] 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 numerical trend toward
improved clinical effectiveness outcomes for the DURAGRAFT[reg]
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[reg]-treated grafts relative to saline for
revascularization (57 percent), MI (70 percent), MACE (37 percent) and
all[dash]cause death (23 percent) compared to standard of care
(heparinized saline/blood) through 5 years follow[dash]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 CHU-Angers to evaluate whether any
long-term 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[dash]powered VA study in which statistically significant
reductions of MI, repeat revascularization, and MACE were observed in
the DURAGRAFT[reg] treatment group, lending confidence that the
observed trends in this study, as well as the VA study, represent real
differences associated with DURAGRAFT[reg] 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[reg] vs. Saline) clinical trial,
which was conducted to assess the safety and impact of DURAGRAFT[reg]
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[reg] treatment was not available and heparinized saline was
routinely used to wet and store grafts, while 2001 through 2004
represents a time period after the center began exclusively using
DURAGRAFT[reg], 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[reg] 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[reg] treatment n=1,036 pts.).
The median age was 66 years old for the control treatment group and 67
years old for the DURAGRAFT[reg] 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[reg] treatment group was
8.54.2 years and 9.95.6 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[reg][dash]treated CABG patients. Thirty-day MI also was
significantly reduced in this study. The VA study found statistically
significant reductions in DURAGRAFT[reg]-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[dash]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[reg] 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 ``in-patient control'' design in which both the control
saline exposed vascular graft and a DURAGRAFT[reg][dash]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[dash] 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
[[Page 20308]]
DURAGRAFT[reg] and standard of care (SoC) at 3 months, but between 3
months and 9 months a separation between DURAGRAFT[reg] and SoC begins
to emerge and by 12 months DURAGRAFT[reg] 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[reg][dash]treated grafts and SoC. Reductions in both wall
thickness and degree of stenosis were observed in
DURAGRAFT[reg][dash]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[reg] 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The retrospective studies demonstrated an association of reduced
risk of non-fatal myocardial infarction, repeat revascularization, and
MACE with DURAGRAFT[reg] 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[reg]
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, it may be helpful
to gain more insight from data that will be available upon completion
and results of the multi-center, prospective, randomized, double-blind,
comparative, within[dash]person (DURAGRAFT[reg] vs. Saline) control
trial that is currently ongoing.
We are inviting public comments on whether DURAGRAFT[reg] meets the
substantial clinical improvement criterion.
Below we summarize and respond to written public comments we
received regarding the DURAGRAFT[reg] 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[dash]reviewed publications in Cardiac Surgery, and participating
in several clinical studies, it supported the approval of new
technology add-on payments for the DURAGRAFT[reg] 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[reg] because the commenter served as the Principal
Investigator for a retrospective clinical study that evaluated the
DURAGRAFT[reg]'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[reg]'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 saline compared to
grafts stored using the DURAGRAFT[reg]. 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[reg], 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[reg] 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[dash]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[reg]. The commenter indicated that as an author and co-author
of more than 250 articles in peer-reviewed 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[reg][dash]treated
veins compared to heparinized-saline, are critically important from a
clinical perspective. According to the commenter, the primary mechanism
of the DURAGRAFT[reg] 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[reg], with systematic evaluation demonstrating a clear safety
[[Page 20309]]
profile and benefit to patient outcomes. The commenter encouraged CMS
to approve new technology add-on payments for the DURAGRAFT[reg]
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[reg] for FY 2019.
e. remed[emacr][reg] System
Respicardia, Inc. submitted an application for new technology add-
on payments for the remed[emacr][reg] System for FY 2019. According to
the applicant, the remed[emacr][reg] System is indicated for use as a
transvenous phrenic nerve stimulator in the treatment of adult patients
who have been diagnosed with moderate to severe central sleep apnea.
The remed[emacr][reg] 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 ``enhances oxidative stress, causing
endothelial dysfunction, inflammation, and activation of neurohormonal
systems, which contribute to progression of underlying diseases.''
\122\
---------------------------------------------------------------------------
\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[reg]system,'' European Journal of
Heart Failure, pp. 1-8.
\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.
---------------------------------------------------------------------------
According to the applicant, prior to the introduction of the
remed[emacr][reg] 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
On October 6, 2017, the remed[emacr][reg] System was approved by
the FDA as an implantable phrenic nerve stimulator indicated for the
use in the treatment of adult patients who have been diagnosed with
moderate to severe CSA. The device was available commercially upon FDA
approval. Therefore, the newness period for the remed[emacr][reg]
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 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 remed[emacr][reg] System provides
stimulation to nerves to stimulate breathing. Typical treatments for
hyperventilation CSA include supplemental oxygen and CPAP. Mechanical
ventilation also has been used to maintain a patent airway. The
applicant asserted that the remed[emacr][reg] System is a
neurostimulation device resulting in negative airway pressure, whereas
devices such as CPAP and ASV utilize positive airway pressure.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that the
remed[emacr][reg] System is assigned to MS-DRGs 040 (Peripheral,
Cranial Nerve and Other Nervous System Procedures with MCC), 041
(Peripheral, Cranial Nerve and Other Nervous System Procedures with CC
or Peripheral Neurostimulator), and 042 (Peripheral, Cranial Nerve and
Other Nervous System Procedures without CC/MCC). The current procedures
for the treatment options of CPAP and ASV are not assigned to these MS-
DRGs.
With respect to the third criterion, whether the new use of the
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, according to the
applicant, the remed[emacr][reg] System is indicated for the use as a
transvenous unilateral phrenic nerve stimulator in the treatment of
adult patients who have been diagnosed with moderate to severe CSA. The
applicant stated that the remed[emacr][reg] System reduces the negative
symptoms associated with CSA, particularly among patients who have been
diagnosed with heart failure. The applicant asserted that patients who
have been diagnosed with heart failure are particularly negatively
affected by CSA and currently available CSA treatment options of CPAP
and ASV. According to the applicant, the currently available treatment
options, CPAP and ASV, have been found to have worsened mortality and
morbidity outcomes for patients who have been diagnosed with both CSA
and heart failure. Specifically, ASV is currently contraindicated in
the treatment of CSA in patients who have been diagnosed with heart
failure.
The applicant also suggested that the remed[emacr][reg] System is
particularly suited for the treatment of CSA in patients who
[[Page 20310]]
also have been diagnosed with heart failure. We are concerned that,
while the remed[emacr][reg] 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 remed[emacr][reg] 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
remed[emacr][reg] System within MS-DRGs 040, 041, and 042. Using the
Standard Analytical File (SAF) Limited Data Set (MedPAR) for FY 2015,
the applicant included all claims for the previously stated MS-DRGs for
its cost threshold calculation. The applicant stated that typically
claims are selected based on specific ICD-10-PCS parameters, however
this is a new technology for which no ICD-10-PCS procedure code and
ICD-10-CM diagnosis code combination exists. Therefore, all claims for
the selected MS-DRGs were included in the cost threshold analysis. This
process resulted in 4,462 cases representing potential patients who may
be eligible for treatment involving the remed[emacr][reg] System
assigned to MS-DRG 040; 5,309 cases representing potential patients who
may be eligible for treatment involving the remed[emacr][reg] System
assigned to MS-DRG 041; and 2,178 cases representing potential patients
who may be eligible for treatment involving the remed[emacr][reg]
System assigned to MS-DRG 042, for a total of 11,949 cases.
Using the 11,949 identified cases, the applicant determined that
the average unstandardized case-weighted charge per case was $85,357.
Using the FY 2015 MedPAR dataset to identify the total mean charges for
revenue code 0278, the applicant removed charges associated with the
current treatment options for each MS-DRG as follows: $9,153.83 for MS-
DRG 040; $12,762.31 for MS-DRG 041; and $21,547.73 for MS-DRG 042. The
applicant anticipated that no other related charges would be eliminated
or replaced. The applicant then standardized the charges and applied a
2-year inflation factor of 1.104055 obtained from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38524). The applicant then added charges for the
new technology to the inflated average case-weighted standardized
charges per case. No other related charges were added to the cases. The
applicant calculated a final inflated average case-weighted
standardized charge per case of $175,329 and a Table 10 average case-
weighted threshold amount of $78,399. Because the final inflated
average case-weighted standardized charge per case exceeded the average
case-weighted threshold amount, the applicant maintained that the
technology 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
remed[emacr][reg] System. We are inviting public comments on whether
the remed[emacr][reg] System meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the remed[emacr][reg] System meets the
substantial clinical improvement criterion. The applicant stated that
the remed[emacr][reg] System offers a treatment option for a patient
population unresponsive to, or ineligible for, treatment involving
currently available options. According to the applicant, patients who
have been diagnosed with CSA have no other available treatment options
than the remed[emacr] System. The applicant stated that published
studies on both CPAP and ASV have proven that primary endpoints have
not been met for treating patients who have been diagnosed with CSA. In
addition, according to the ASV study, there was an increase in
cardiovascular mortality.
According to the applicant, the remed[emacr][reg] 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The applicant shared the results from two studies concerning the
effects of positive airway pressure ventilation treatment:
The Canadian Continuous Positive Airway Pressure for
Patients with Central Sleep Apnea and Heart Failure trial found that,
while CPAP managed the negative symptoms of CSA, such as improved
nocturnal oxygenation, increased ejection fraction, lower
norepinephrine levels, and increased walking distance, it did not
affect overall patient survival; \125\ and
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
The applicant also stated that the remed[emacr] System represents a
substantial clinical improvement over existing technologies because of
the reduction in the number of future hospitalizations, few
device[dash]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
[[Page 20311]]
indicated that study results showed the remed[emacr] 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 (apnea-hypopnea index of greater than or equal
to 15 and a central apnea index of greater than or equal to 5) and who
did not meet exclusion criteria (a baseline oxygen saturation of less
than 90 percent, being on supplemental oxygen, having evidence of
phrenic nerve palsy, having had severe chronic obstructive pulmonary
disease (COPD), having hard angina or a myocardial infarction in the
past 3 months, being pacemaker dependent, or having inadequate capture
of the phrenic nerve during neurostimulation). Of the 16 patients whose
treatment was assessed, all had various classifications of heart
failure diagnoses: 3 (18.8 percent) were classified as class I on the
New York Heart Association classification scale (No limitation of
physical activity. Ordinary physical activity does not cause undue
fatigue, palpitation, dyspnea (shortness of breath)); 8 (50 percent)
were classified as a class II (Slight limitation of physical activity.
Comfortable at rest. Ordinary physical activity results in fatigue,
palpitation, dyspnea (shortness of breath)); and 5 (31.3 percent) were
classified as class III (Marked limitation of physical activity.
Comfortable at rest. Less than ordinary activity causes fatigue,
palpitation, or dyspnea).\131\ After successful surgical implantation
of a temporary transvenous lead for unilateral phrenic nerve
stimulation, patients underwent a control night without nerve
stimulation and a therapy night with stimulation, while undergoing
polysomnographic (PSG) testing. Comparison of both nights was
performed.
---------------------------------------------------------------------------
\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: http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#.WmE2rlWnGUk.
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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 related to CSA. Among the study patient
population, 79 percent had diagnoses of heart failure, 2 percent had
diagnoses of atrial fibrillation, 13 percent had other cardiac etiology
diagnoses, and the remainder of patients had other cardiac unrelated
etiology diagnoses. Exclusion criteria were similar to the previous
study (that is, (Ponikowski P., 2012)), with the addition of a
creatinine of greater than 2.5 mg/dl. After implantation of the
remed[emacr][reg] 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.
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\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.
---------------------------------------------------------------------------
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
[[Page 20312]]
patients reported improved sleep quality, and all patients reported
increased energy. A reduction in sleep apneic events and decreases in
AHI and CAI were related to application of the treatment. Gradual
increases to the 6-minute walking time occurred through the study.
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\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.
---------------------------------------------------------------------------
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 3-month, 6-month, and
12-month time points, patient quality of life was assessed to be 70.8
percent, 75.6 percent, and 83.0 percent, respectively, indicating that
patients experienced mild, moderate, or marked improvement. Seventeen
patients were followed at 18 months with statistical differences from
baseline for AHI and CAI. Three patients died over the 12-month follow-
up period: 2 died of end-stage heart failure and 1 died from sudden
cardiac death. All three deaths were adjudicated by the DSMB and none
were related to the procedure or to phrenic nerve stimulation therapy.
Five patients were found to have related serious adverse events over
the 12-month study time. Three events were previously described in the
results referenced in the published study, Abraham, et al., and an
additional 2 SAEs occurred during the 12-month follow-up. One patient
experienced impending pocket perforation resulting in pocket revision,
and another patient experienced lead failure.
---------------------------------------------------------------------------
\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[reg]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.
---------------------------------------------------------------------------
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
remed[emacr][reg] 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 per-protocol
population from which statistical comparisons were made is 58 patients
treated with the remed[emacr][reg] System and 73 patients in the
control group. The authors appropriately controlled for Type I errors
(false positives), which arise from performing multiple tests. Thirty-
five treated patients and 8 control patients met the primary end point,
the number of patients with a 50 percent or greater reduction in AHI
from baseline; the difference of 41 percent is statistically
significant. All seven of the secondary endpoints were assessed and
found to have statistically significant difference in change from
baseline between groups at the 6-month follow-up after controlling for
multiple comparisons: CAI of -22.8 events per hour lower for the
treatment group; AHI (continuous) of -25.0 events per hour lower for
the treatment group; arousal events per hour of -15.2 lower for the
treatment group; percent of sleep in REM of 2.4 percent higher for the
treatment group; patients with marked or moderate improvement in
patient global assessment was 55 percent higher in the treatment group;
ODI = 4 percent was -22.7 events per hour lower for the treatment
group; and the Epworth sleepiness scale was -3.7 lower for the
treatment group. At 12 months, 138 (91 percent) of the patients were
free from device, implant, and therapy related adverse events.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 remed[emacr][reg] System device with a 6[dash]month
follow[dash]up period, or to the control group arm (73 patients) in
which the initiation of treatment with the remed[emacr][reg] System
device was delayed for 6 months after implantation. Randomization
efficacy was compared across baseline polysomnography and associated
respiratory indices in which four of the five measures showed no
statistical differences between those treated and controls; treated
patients had an average MAI score of 3.1 as compared to control
patients with an average MAI score of 2.2 (p=0.029). Patients included
in the trial must have been medically stable, at least 18 years old,
have had an electroencephalogram within 40 days of scheduled
implantation, had an apnoea-hypopnoea index (AHI) of 20 events per hour
or greater, a central apnoea index at least 50 percent of all apneas,
and an obstructive apnea index less than or equal to 20 percent.\140\
Primary exclusion criteria were CSA caused by pain medication, heart
failure of state D from the American Heart Association, a
[[Page 20313]]
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.
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\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.
\141\ Ibid.
---------------------------------------------------------------------------
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 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.
---------------------------------------------------------------------------
\142\ Respicardia, Inc. (n.d.). Remede System Pivotal Trial.
https://clinicaltrials.gov/ct2/show/NCT01816776.
---------------------------------------------------------------------------
The applicant provided analyses from the above report focusing on
the primary and secondary polysomnography endpoints, specifically,
across patients who had been diagnosed with CSA with heart failure and
non-heart failure. Eighty patients included in the study from the
executive summary report had comorbid heart failure, while 51 patients
did not. Of those patients with heart failure, 35 were treated while 45
patients were controls. Of those patients without heart failure, 23
were treated and 28 patients were controls. The applicant did not
provide baseline descriptive statistical comparisons between treated
and control groups controlling for heart failure status. Across all
primary and secondary endpoints, the patient group who were diagnosed
with CSA and comorbid heart failure experienced statistically
significant improvements. Excepting percent of sleep in REM, the
patient group who were diagnosed with CSA without comorbid heart
failure experienced statistically significant improvements in all
primary and secondary endpoints. We are inviting public comments on
whether this current study design is sufficient to support substantial
clinical improvement of the remed[emacr][reg] 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 remed[emacr][reg]
System is the only treatment option for patients who have been
diagnosed with moderate to severe CSA; published studies on positive
pressure treatments like CPAP and ASV have not met primary endpoints;
and there was an increase in cardiovascular mortality according to the
ASV study. According to the applicant, approximately 40 percent of
patients who have been diagnosed with CSA have heart failure. The
applicant asserted that the use of the remed[emacr] System not only
treats and improves the symptoms of CSA, but there is evidence of
reverse remodeling in patients with reduced left ventricular ejection
fraction (LVEF).
We are concerned that the remed[emacr][reg] 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 remed[emacr][reg] 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
remed[emacr][reg] System who also had been diagnosed with heart
failure. The applicant asserted that it would not be appropriate to use
CPAP and ASV treatment options when comparing CPAP and ASV to the
remed[emacr][reg] System in the patient population of heart failure
diagnoses because these treatment options have been found to increase
mortality outcomes in this population. In light of the limited length
of time in which the remed[emacr][reg] System has been studied, we are
concerned that any claims on mortality as they relate to treatment
involving the use of the remed[emacr][reg] 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
remed[emacr][reg] 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
[[Page 20314]]
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.
---------------------------------------------------------------------------
\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.
\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[reg]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.
---------------------------------------------------------------------------
Therefore, we are concerned that differences in morbidity and
mortality outcomes between CPAP, ASV, and the remed[emacr][reg] 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 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\
---------------------------------------------------------------------------
\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-apnea-risk-factors-clinical-presentation-and-diagnosis?csi=d3a535e6-1cca-4cd5-ab5e-50e9847bda6c&source=contentShare.
\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.
---------------------------------------------------------------------------
We also note that the clinical study had a small patient population
(n=151), with follow[dash]up for 6 months. We are interested in longer
follow[dash]up data that would further validate the points made by the
applicant regarding the beneficial outcomes seen in patients who have
been diagnosed with CSA who have been treated using the
remed[emacr][reg] 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 remed[emacr][reg] 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 remed[emacr][reg] System or at the New
Technology Town Hall Meeting.
f. Titan Spine nanoLOCK[reg] (Titan Spine nanoLOCK[reg] Interbody
Device)
Titan Spine submitted an application for new technology add-on
payments for the Titan Spine nanoLOCK[reg] Interbody Device (the Titan
Spine nanoLOCK[reg]) 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[reg] is a
nanotechnology-based interbody medical device with a dual acid-etched
titanium interbody system used to treat patients diagnosed with
degenerative disc disease (DDD). One of the key distinguishing features
of the device is the surface manufacturing technique and materials,
which produce macro, micro, and nano[dash]surface textures. According
to the applicant, the combination of surface topographies enables
initial implant fixation, mimics an osteoclastic pit for bone growth,
and produces the nano-scale features that interface with the integrins
on the outside of the cellular membrane. Further, the applicant noted
that these features generate better osteogenic and angiogenic responses
that enhance bone growth, fusion, and stability. The applicant asserted
that the Titan Spine nanoLOCK[reg]'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[reg] received FDA
clearance for the use of five lumbar interbody devices and one cervical
interbody device: The nanoLOCK[reg] TA--Sterile Packaged Lumbar ALIF
Interbody Fusion Device with nanoLOCK[reg] surface, available in
multiple sizes to accommodate anatomy; the nanoLOCK[reg] TAS--Sterile
Packaged Lumbar ALIF Stand Alone Interbody Fusion Device with
nanoLOCK[reg] surface, available in multiple sizes to accommodate
anatomy; the nanoLOCK[reg] TL--Sterile Packaged Lumbar Lateral Approach
Interbody Fusion Device with nanoLOCK[reg] surface, available in
multiple sizes to accommodate anatomy; the nanoLOCK[reg] TO--Sterile
Packaged Lumbar Oblique/PLIF Approach Interbody Fusion Device with
nanoLOCK[reg] surface, available in multiple sizes to accommodate
anatomy; the nanoLOCK[reg] TT--Sterile Packaged Lumbar TLIF Interbody
Fusion Device with nanoLOCK[reg] surface, available in multiple sizes
to accommodate anatomy; and the nanoLOCK[reg] TC--Sterile Packaged
Cervical Interbody Fusion Device with nanoLOCK[reg] surface, available
in multiple sizes to accommodate anatomy.
The applicant received FDA clearance on December 14, 2015, for the
nanoLOCK[reg] TCS-- Sterile Package Cervical Stand Alone Interbody
Fusion Device with nanoLOCK[reg] 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[reg]
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[reg] would begin on October 1, 2016. Procedures involving the
Titan Spine nanoLOCK[reg] technology can be identified by the following
ICD-10-PCS Section ``X'' New Technology codes:
XRG0092 (Fusion of occipital-cervical joint using
nanotextured
[[Page 20315]]
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[reg] 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 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[reg] 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[reg]'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[reg] 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 nano-scale textured features
interface with the integrins on the outside of the cellular membrane,
which generates the osteogenic and angiogenic (mRNA) responses
necessary to promote healthy bone growth and fusion. The applicant
stated that when correctly manufactured, an interbody fusion device
includes a hierarchy of complex surface features, visible at different
levels of magnification, that work collectively to impact cellular
response through mechanical, cellular, and biochemical properties. The
applicant stated that Titan Spine's proprietary and unique surface
technology, the Titan Spine nanoLOCK[reg] interbody devices, contain
optimized nano[dash]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[reg]'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[reg]'s surface is created by using a reductive process of the
titanium itself. The applicant asserted that use of the Titan Spine
nanoLOCK[reg] 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[dash]texture, and whether it differs from the effects generated
by PEEK-based substrates. This in vitro study compared angiogenic
factor production and integrin gene expression of human osteoblast-like
MG63 cells cultured on PEEK or titanium-aluminum vanadium (titanium
alloy). Based on these study results, the applicant asserted that the
use of micro[dash]textured surfaces has demonstrated greater promotion
of osteoblast differentiation when compared to use of PEEK-based
surfaces.
---------------------------------------------------------------------------
\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 Peri-implant Inflammatory
Factors,'' SPINE, 2015, vol. 40(6), pp. 339-404.
---------------------------------------------------------------------------
The applicant maintains that the nanoLOCK[reg] 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
[[Page 20316]]
device, and (3) proof that those nano-scale features provide a
scientific benefit, not found on devices where the surface features are
not present. The applicant further stated that many of the commercially
available interbody fusion devices are created using additive
manufacturing processes to mold or build surface from the ground up.
Conversely, Titan Spine applied a subtractive surface manufacturing to
remove pieces of a surface. The surface features that remain after this
subtractive process generate features visible at magnifications that
additive manufacturing has not been able to produce. According to the
applicant, this subtractive process has been validated by the White
House Office of Science and Technology, the National Nanotechnology
Initiative, and the FDA that provide clearances to products that
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[reg]
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[reg] 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[reg] 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[reg] technology is
substantially similar to existing technologies.
We are concerned that the Titan Spine nanoLOCK[reg] interbody
devices may be substantially similar to currently available titanium
interbody devices because other roughened[dash]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 concerned
that the Titan Spine nanoLOCK[reg] interbody devices use the same or
similar mechanism of action as other devices.
We are inviting public comments on whether the Titan Spine
nanoLOCK[reg] 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[reg]
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[dash]On Payment Final Rule (66 FR 46915), two separate reviews and
evaluations of the technologies are necessary in this instance because
cases representing patients receiving treatment for diagnoses
associated with lumbar procedures that may be eligible for use of the
technology under the first indication would not be expected to be
assigned to the same MS-DRGs as cases representing patients receiving
treatment for diagnoses associated with cervical procedures that may be
eligible for use of the technology under the second indication.
Specifically, cases representing patients who have been diagnosed with
lumbar DDD and who have received treatment that involved implanting a
lumbar interbody device would map to MS-DRG 028 (Spinal Procedures with
MCC), MS-DRG 029 (Spinal Procedures with CC or Spinal
Neurostimulators), MS-DRG 030 (Spinal Procedures without CC/MCC), MS-
DRG 453 (Combined Anterior/Posterior Spinal Fusion with MCC), MS-DRG
454 (Combined Anterior/Posterior Spinal Fusion with CC), MS-DRG 455
(Combined Anterior/Posterior Spinal Fusion without CC/MCC), MS-DRG 456
(Spinal Fusion Except Cervical with Spinal Curvature or Malignancy or
Infection or Extensive Fusions with MCC), MS-DRG 457 (Spinal Fusion
Except Cervical with Spinal Curvature or Malignancy or Infection or
Extensive Fusion without MCC), MS-DRG 458 (Spinal Fusion Except
Cervical with Spinal Curvature or Malignancy or Infection or Extensive
Fusions without CC/MCC), MS-DRG 459 (Spinal Fusion Except Cervical with
MCC), and MS-DRG 460 (Spinal Fusion Except Cervical without MCC). Cases
representing patients who have been diagnosed with cervical DDD and who
have received treatment that involved implanting a cervical interbody
device would map to MS-DRG 471 (Cervical Spinal Fusion with MCC), MS-
DRG 472 (Cervical Spinal Fusion with CC), and MS-DRG 473 (Cervical
Spinal Fusion without CC/MCC). Procedures involving the implantation of
lumbar and cervical interbody devices are assigned to separate MS-DRGs.
Therefore, the devices categorized as lumbar interbody devices and the
devices categorized as cervical interbody devices must distinctively
(each category) meet the cost criterion and the substantial clinical
improvement criterion in order to be eligible for new technology
add[dash]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[reg] 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[dash]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
[[Page 20317]]
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[reg] meets the cost criterion.
With regard to the substantial clinical improvement criterion for
the Titan Spine nanoLOCK[reg] 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[reg] 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[reg] device, with both
retrospective and prospective data collection. These data appeared to
be clinically related and included: (1) Pain medication usage; (2)
extremity and back pain (assessed using the Numeric Pain Rating Scale
(NPRS)); and (3) function (assessed using the Oswestry Disability Index
(ODI)). Clinical data collection began with time points defined as
``Baseline (pre-operation), Month 1 (0-4 weeks), Month 2 (5-8 weeks),
Month 3 (9-12 weeks), Month 4 (13-16 weeks), Month 5 (17-20 weeks) and
Month 6+ (>20 weeks)''. The n, mean, and standard deviation were
presented for continuous variables (NPRS extremity pain, back pain, and
ODI scores), and the n and percentage were presented for categorical
variables (subjects taking pain medications). All analyses compared the
time point (for example, Month 1) to the baseline.
Pain scores for extremities (leg and arm) were assessed using the
NPRS, an 11[dash]category ordinal scale where 0 is the lowest value and
10 is the highest value and, therefore, higher scores indicate more
severe pain. Of the 73 patients in the lumbar group, the applicant
presented data on 18 cases for leg or arm pain at baseline that had a
mean score of 6.4, standard deviation (SD) 2.3. Between Month 1 and
Month 6+ the number of lumbar patients for which data was submitted for
leg or arm pain ranged from 3 patients (Month 5, mean score 3.7, SD
3.5) to 15 patients (Month 6+, mean score 2.5, SD 2.4), with varying
numbers of patients for each of the other defined time points of Month
1 through Month 4. None of the defined time points of Month 1 through
Month 4 had more than 14 patients or less than 3 patients that were
assessed.
Of the 73 patients in the cervical group, 7 were assessed for leg
or arm pain at baseline and had a mean score of 5.1, SD 3.5. Between
Month 1 and Month 6+ the number of cervical patients assessed for leg
or arm pain ranged from 0 patients (Month 5, no scores) to 5 patients
(Month 1, mean score 4.2, SD 2.6), with varying numbers of patients for
each of the other defined time points of Month 1 through Month 4. None
of the defined time points of Month 1 through Month 4 had more than 5
patients or less than 2 patients that were assessed.
Back pain scores were also assessed using the NPRS, where 0 is the
lowest value and 10 is the highest value and, therefore, higher scores
indicate more severe pain. Of the 73 patients in the lumbar group, 66
were assessed for back pain at baseline and had a mean score of 7.9, SD
1.8. Between Month 1 and Month 6+ the number of lumbar patients
assessed for back pain ranged from 4 patients (Month 5, mean score 4.0,
SD 2.7) to 43 patients (Month 1, mean score 4.5, SD 2.7), with varying
numbers of patients for each defined time point.
Of the 73 patients in the cervical group, 71 were assessed for back
pain at baseline and had a mean score of 7.5, SD 2.3. Between Month 1
and Month 6+ the number of cervical patients assessed for back pain
ranged from 2 patients (Month 5, mean score 7.0, SD 2.8) to 47 patients
(Month 1, mean score 4.4, SD 2.9), with varying numbers of patients for
each defined time point.
Function was assessed using the ODI, which ranges from 0 to 100,
with higher scores indicating increased disability/impairment. Of the
73 patients in the lumbar group, 59 were assessed for ODI scores at
baseline and had a mean score of 52.5, SD 18.7. Between Month 1 and
Month 6+ the number of lumbar patients assessed for ODI scores ranged
from 3 patients (Month 5, mean score 33.3, SD 19.8) to 38 patients
(Month 1, mean score 48.1, SD 19.7), with varying numbers of patients
for each defined time point. Of the 73 patients in the cervical group,
56 were assessed for ODI scores at baseline and had a mean score of
53.6, SD 18.2. Between Month 1 and Month 6+ the number of cervical
patients assessed for ODI score ranged from 1 patient (Month 5, mean
score 80, no SD noted) to 41 patients (Month 1, mean score 48.6, SD
20.5), with varying numbers of patients for each defined time point.
The percentages of patients not taking pain medicines per day for
the lumbar and cervical groups over time were assessed. Of the 73
patients in the lumbar group, 69 were assessed at baseline and 27.5
percent of the 69 patients were not taking pain medication. Between
Month 1 and Month 6+ the number of lumbar patients assessed for not
taking pain medicines ranged from 5 patients (Month 5, 80 percent were
not taking pain medicines) to 46 patients (Month 1, 54.3 percent were
not taking pain medicines), with varying numbers of patients for each
defined time point. Of the 73 patients in the cervical group, 72 were
assessed and 22.2 percent of the 72 patients were not taking pain
medicines at baseline. Between Month 1 and Month 6+ the number of
cervical patients assessed for not taking pain medicines ranged from 2
patients (Month 5, 100 percent were not taking pain medicines) to 50
patients (Month 1, 70 percent were not taking pain medicines), with
varying numbers of patients for each defined time point.
According to the applicant, both the lumbar and cervical groups
showed a trend of improvement in all four clinical outcomes over time
for which they collected data in their case series. However, the
applicant also indicated that the trend was difficult to assess due to
the relatively limited number of subjects with available assessments
more than 4 months post-implant. The applicant shared that it had
missing values for over 80 percent of the subjects in the study after
the 4th post-operative month. According to the applicant and its
results of the clinical evaluation, which was based on data from less
than 20 percent of subjects, there was a statistically significant
reduction in back pain for nanoLOCK[reg] patients from ``Baseline,''
based on improvement at earlier than standard time points.
[[Page 20318]]
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[reg] 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[reg]
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[reg]'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[dash]level health care claims,
electronic medical records (EMR), and other data sources to identify 70
cases and 350 controls for a total sample size of 420 patients. The
applicant also identified OM1TM data source and noted that
the OM1TM data source reflects data from all U.S. States and
territories and is representative of the U.S. national population. The
applicant used OM1TM data between January 2016 and June
2017, and specifically indicated that these data contain medical and
pharmacy claims information, laboratory data, vital signs, problem
lists, and other clinical details. The applicant indicated that cases
were selected using the ICD-10-PCS Section ``X'' New Technology codes
listed above and controls were chosen from fusion spine procedures
(Fusion Spine Anterior Cervical, Fusion Spine Anterior Cervical and
Discectomy, Fusion Spine Anterior Posterior Cervical, Fusion Spine
Transforaminal Interbody Lumbar, Fusion Spine Cervical Thoracic, Fusion
Spine Transforaminal Interbody Lumbar with Navigation, and Fusion Spine
Transforaminal Interbody Lumber Robot-Assisted). Further, the applicant
stated that cases and controls were matched by age (within 5 years),
year of surgery, Charlson Comorbidity Index, and gender. According to
the applicant, regarding clinical outcomes studied, unlike the case
series, the case-control study captured Charlson Comorbidity Index, the
average length of stay (ALOS), and 30-day unplanned readmissions; like
the case series, this case-control study captured the use of pain
medications by assessing the cumulative post-surgical opioid use.
The mean age for all patients in the study was 55 years old, and 47
percent were male. For the clinical length of stay outcome, the
applicant noted that the mean length of stay was slightly longer among
control patients, 3.9 days (SD = 5.4) versus 3.2 days (SD = 2.9) for
cases, and a larger proportion of patients in the control group had
lengths of stay equal to or longer than 5 days (21 percent versus 17
percent). Three control patients (0.8 percent) were readmitted within
30 days compared to zero readmissions among case patients. A slightly
lower proportion of case patients were on opioids 3 months post-surgery
compared to control patients (15 percent versus 16 percent).
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[reg] devices versus 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[reg] 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[reg] devices
versus patients receiving treatment involving other interbody fusion
devices. We are inviting public comments on whether the Titan Spine
nanoLOCK[reg] meets the substantial clinical improvement criterion.
Below we summarize and respond to written public comments received
regarding the nanoLOCK[reg] 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[reg] 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[reg]
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
[[Page 20319]]
applicant did not demonstrate that the Titan Spine nanoLOCK[reg]
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[reg] 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[reg] technology, their surfaces also are made of titanium.
Therefore, CMS believed that the Titan Spine nanoLOCK[reg] 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[reg] 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 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[reg]. 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 peer-
reviewed literature, the commenter believed that, at this time, there
is not enough scientifically[dash]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[reg] 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[reg] for FY
2019.
Comment: One commenter supported the approval of new technology
add-on payments for the Titan Spine nanoLock[reg] 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, nano-textured 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[reg] 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[dash]world evidence gathered from multiple, independent data
sources (including actual electronic medical records (EMR) and
healthcare claims) on nanoLOCK[reg] 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[reg] 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
comments into consideration when deciding whether to approve new
technology add-on payments for the Titan Spine nanoLock[reg] 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) gram-negative 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[dash]threatening infections caused by MDR bacteria have increased
over the past decade, and the patient population diagnosed with
infections caused by CRE is projected to double within the next 5
years, according to the Centers for Disease Control and Prevention
(CDC). Infections caused by CRE are often associated with poor patient
outcomes due to limited treatment options. Patients who have been
diagnosed with BSIs due to CRE face mortality rates of up to 50
percent. Patients most at risk for CRE infections are those with CRE
colonization, recent hospitalization or stay in a long-term care or
skilled-nursing facility, an extensive history of antibacterial use,
and whose care requires invasive devices like urinary catheters,
intravenous (IV) catheters, or ventilators. The applicant estimated,
using data from the Center for Disease Dynamics, Economics & Policy
(CDDEP), that the Medicare population that has been diagnosed with
antibiotic-resistant cUTI numbers approximately 207,000 and
approximately 7,000 for BSIs/sepsis due to CRE.
[[Page 20320]]
The applicant noted that due to the public health concern of
increasing antibiotic resistance and the need for new antibiotics to
effectively treat MDR infections, Plazomicin has received the following
FDA designations: Breakthrough Therapy; Qualified Infectious Disease
product, Priority Review; and Fast Track. The applicant noted that
Breakthrough Therapy designation was granted on May 17, 2017, for the
treatment of bloodstream infections (BSIs) caused by certain
Enterobacteriaceae in patients who have been diagnosed with these types
of infections who have limited or no alternative treatment options. The
applicant noted that Plazomicin is the first antibacterial agent to
receive this designation. The applicant noted that on December 18,
2014, the FDA designated Plazomicin as a Qualified Infectious Disease
Product (QIDP) for the indications of hospital-acquired bacterial
pneumonia (HAPB), ventilator-associated bacterial pneumonia (VABP), and
complicated urinary tract infection (cUTI), including pyelonephritis
and catheter-related blood stream infections (CRBSI). The applicant
noted that Fast Track designation was granted by the FDA on August 12,
2012, for the Plazomicin development program for the treatment of
serious and life-threatening infections due to CRE. 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 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[dash]acetyltransferase (AAC) 2'-Ia,
-Ib, and -Ic, which is only found in Providencia species. According to
the applicant, as an aminoglycoside, Plazomicin also is not hydrolyzed
by B-lactamase enzymes like ESBLs and carbapenamases. Therefore, the
applicant asserted that Plazomicin is a potent therapeutic agent for
treating MDR Enterobacteriaceae, including aminoglycoside-resistant
isolates, CRE strains, and ESBL-producers.
The applicant asserted that the mechanism of action is new due to
the unique chemical structure. With regard to the general mechanism of
action against bacteria, 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 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
[[Page 20321]]
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[dash]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.
Based on the FY 2018 IPPS/LTCH PPS Table 10 thresholds, the average
case-weighted threshold amount was $56,996 in the first scenario
utilizing 100 percent of all cases, and $55,363 in the second scenario
utilizing 75 percent of all cases. The inflated average case-weighted
standardized charge per case was $62,511 in the first scenario and
$57,054 in the second analysis. Because the inflated average case-
weighted standardized charge per case 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 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 case-weighted standardized charge per case
exceeded the average case[dash]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
[[Page 20322]]
final inflated case-weighted standardized charge per case did not
exceed the average case[dash]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 case-weighted threshold
amount for potential cases representing patients who have been
diagnosed with BSI and who may be eligible for treatment involving
Plazomicin assigned to the MS-DRGs identified in the 75 percent cases
sensitivity analysis.
For potential cases representing patients who have been diagnosed
with cUTI and who may be eligible for treatment involving Plazomicin,
the applicant calculated the average unstandardized case-weighted
charge per case using 100 percent of all cases and 75 percent of all
cases of $59,908 and $48,907, respectively. The applicant applied the
same methodology as the combined analysis above. Based on the FY 2018
IPPS/LTCH PPS final rule Table 10 thresholds, the average case-weighted
threshold amount for potential cases representing patients who have
been diagnosed with cUTI and who may be eligible for treatment
involving Plazomicin assigned to the MS-DRGs identified in the first
scenario utilizing 100 percent of all cases was $51,308, and $46,252 in
the second scenario utilizing 75 percent of all cases. The inflated
average case-weighted standardized charge per case was $53,868 in the
first scenario and $45,185 in the second scenario. In the 100 percent
of cUTI cases sensitivity analysis, the final inflated
case[dash]weighted standardized charge per case exceeded the average
case-weighted threshold amount for potential cases representing
patients who have been diagnosed with cUTI and who may be eligible for
treatment involving Plazomicin assigned to the MS-DRGs identified in
the 100 percent of all cases sensitivity analysis by $2,560 before
including costs of Plazomicin. In the 75 percent of all cases scenario,
the final inflated case-weighted standardized charge per case did not
exceed the average case-weighted threshold amount for potential cases
representing patients who have been diagnosed with cUTI and who may be
eligible for treatment involving Plazomicin assigned to the MS-DRGs
identified in the 75 percent sensitivity analysis, at $1,067 less than
the average case-weighted threshold amount. Because the applicant has
not yet determined pricing for Plazomicin, however, it is possible that
Plazomicin may also exceed the average case[dash]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[dash]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[dash]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
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[dash]center Phase III study comparing the efficacy of Plazomicin
against colistin in the treatment of patients who have been diagnosed
with BSIs or hospital[dash]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[dash]up was done at test[dash]of[dash]cure (TOC; 7
days after last dose of IV study drug), end of study (EOS; day 28), and
long-term follow[dash]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,
[[Page 20323]]
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[dash]day survival benefit in the patients who
had been diagnosed with BSI subset, with survival approximately 70
percent in the Plazomicin group compared to 40 percent in the colistin
group. Additionally, according to the applicant, faster median time to
clearance of CRE bacteremia of 1.5 versus 6 days for Plazomicin versus
colistin and higher rate of documented clearance by day 5 (86 percent
versus 46 percent) supported the reduced mortality benefit due to
faster and more sustained clearance of bacteremia and also demonstrated
clinical improvement in terms of more rapid beneficial resolution of
the disease.
The applicant maintained that Plazomicin also represents a
substantial clinical improvement in improved safety outcomes. Patients
treated with Plazomicin had a lower incidence of renal events (10
percent versus 41.7 percent when compared to colistin), fewer Treatment
Emergent Adverse Events (TEAEs), specifically blood creatinine
increases and acute kidney injury, and approximately 30 percent fewer
serious adverse events were in the Plazomicin group. According to the
applicant, other substantial clinical improvements demonstrated by the
CARE study for use of Plazomicin in patients who had been diagnosed
with BSI included lower rate of superinfections or new infections,
occurring in half as many patients treated with Plazomicin versus
colistin (28.6 percent versus 66.7 percent).
According to the applicant, the CARE study demonstrates decreased
all-cause mortality and significantly reduced disease complications at
day 28 (EOS) and day 60 for patients who had been diagnosed with BSI,
in addition to a superior safety profile to colistin. However, the
applicant stated that, with the achieved enrollment, this study was not
powered to support formal hypothesis testing and p-values and 90
percent confidence intervals are provided for descriptive purposes. The
total number of patients who had been diagnosed with BSI was 29, with
14 receiving Plazomicin and 15 receiving colistin. While we understand
the difficulty enrolling a large number of patients who have been
diagnosed with BSI caused by CRE due to severity of the illness and the
need for administering treatment promptly, we 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[dash]center,
multi[dash]national, double[dash]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[dash]of[dash]cure (TOC) was done 15 to 19 days and late
follow[dash]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[dash]qualifying
uropathogen, which were pathogens susceptible to both Plazomicin and
meropenem. In the mMITT population, both groups were comparable in
terms of gender, age, percentage of patients who had been diagnosed
with cUTI/acute pyelonephritis (AP)/urosepsis/bacteremia/moderate renal
impairment at baseline.
According to the applicant, Plazomicin successfully achieved the
primary efficacy endpoint of composite cure (combined microbiological
eradication and clinical cure). At the TOC visit, 81.7 percent of
Plazomicin patients versus 70.1 percent of meropenem patients achieved
composite cure; this was statistically significant with a 95 percent
confidence interval. Plazomicin also demonstrated higher eradication
rates for key resistant pathogens than meropenem at both TOC (89.4
percent versus 75.5 percent) and LFU (77 percent versus 60.4 percent),
suggesting that the Plazomicin treatment benefit observed at TOC was
sustained. Specifically, Plazomicin demonstrated higher eradication
rates, defined as baseline uropathogen reduced to less than 104,
against the most common gram-negative uropathogens, including ESBL
producing (82.4 percent Plazomicin versus 75.0 percent meropenem) and
aminoglycoside resistant (78.8 percent Plazomicin versus 68.6 percent
meropenem) pathogens. This was statistically significant, although of
note, as total numbers of Enterobacteriaceae exceeded population of
mMITT (191 Plazomicin, 197 meropenem) this presumably included patients
who were otherwise excluded from the mMITT population.
According to the applicant, importantly, higher microbiological
eradication rates at the TOC and LFU visits were associated with a
lower rate of clinical relapse at LFU for Plazomicin treated patients
(3 versus 14, or 1.8 percent Plazomicin versus 7.9 percent meropenem),
with majority of the meropenem failures having had asymptomatic
bacteriuria; that is, positive urine cultures without clinical
symptoms, at TOC (21.1 percent), suggesting that the higher
microbiological eradication rate at the TOC visit in Plazomicin-treated
patients decreased the risk of subsequent clinical relapse. Plazomicin
decreased recurrent infection by four-fold compared to meropenem,
suggesting improved patient outcomes, such as reduced need for
additional therapy and re-hospitalization for patients who have been
diagnosed with cUTI. The safety profile of Plazomicin compared to
meropenem was similar. The applicant noted that higher bacteria
eradication results for Plazomicin were not due to meropenem
resistance, as only patients with isolates susceptible to both drugs
were included in the study. According to the applicant, the EPIC
clinical trial results demonstrate clear differentiation of Plazomicin
from meropenem, an agent considered by some as a gold-standard for
treatment of patients who have been diagnosed with cUTI in cases due to
resistant pathogens.
While the EPIC clinical trial was a non-inferiority study, the
applicant contended that statistically significant improved outcomes
and lower clinical relapse rates for patients treated with Plazomicin
demonstrate that Plazomicin meets the substantial clinical
[[Page 20324]]
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-of-cure visit, including higher eradication rates for
ESBL-producing pathogens, and lower rate of subsequent clinical
relapses constitute a substantial clinical improvement for patients who
have been diagnosed with cUTI.
We did not receive any public comments in response to the published
notice in the Federal Register regarding the substantial clinical
improvement 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[dash]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
request for approval for a unique ICD[dash]10[dash]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 renin-angiotensin-aldosterone system
(RAAS), which serves as one of the body's central regulators of blood
pressure. Angiotensin II increases blood pressure through
vasoconstriction, increased aldosterone release, and renal control of
fluid and electrolyte balance. Current therapies for the treatment of
patients who have been diagnosed with shock do not leverage the RAAS.
The applicant asserted that GIAPREZATM is a novel treatment
with a unique mechanism of action relative to SOC treatments for
patients who have been diagnosed with shock, which is adequate fluid
resuscitation and vasopressors. Specifically, the two classes of SOC
vasopressors are catecholamines like Norepinephrine, epinephrine,
dopamine, and phenylephrine IV solutions, and vasopressins like
Vasostrict[reg] and vasopressin-sodium chloride IV solutions.
Catecholamines leverage the sympathetic nervous system and vasopressin
leverages the arginine-vasopressin system to regulate blood pressure.
However, the third system that works to regulate blood pressure, the
RAAS, is not currently leveraged by any available therapies to raise
mean arterial pressure in the treatment of patients who have been
diagnosed with shock. The applicant maintained that
GIAPREZATM is the first synthetic human angiotensin II
approved by the FDA and the only FDA-approved vasopressor that
leverages the RAAS and, therefore, GIAPREZATM utilizes a
different mechanism of action than currently available treatment
options.
The applicant explained that GIAPREZATM leverages the
RAAS, which is a body system not used by existing vasopressors to raise
blood pressure through inducing
[[Page 20325]]
vasoconstriction. We are concerned that GIAPREZATM's general
mechanism of action, increasing blood pressure by inducing
vasoconstriction through binding to certain G[dash]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 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[dash]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
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
[[Page 20326]]
38524). The final inflated average case[dash]weighted standardized
charge per case was calculated for each scenario and compared with the
average case-weighted threshold amount for each group of MS-DRGs based
on the thresholds in Table 10.
Results of the analyses for each of the two code selection
scenarios, each with three sensitivity analyses for a total of six
analyses, are summarized in the tables below:
----------------------------------------------------------------------------------------------------------------
Final average
Number of MS- Case- weighted inflated Amount
DRGs assessed Number of new technology standardized exceeded
Medicare cases add-on payment charge per threshold
threshold case
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 1
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (28 Codes):
100 Percent................. 439 120,966 $77,427 $77,427 $34,095
80 Percent.................. 10 96,102 77,641 100,167 22,526
25 Percent.................. 1 66,980 53,499 71,951 18,452
----------------------------------------------------------------------------------------------------------------
Cost Analysis Based on ICD-9-CM Diagnosis Code Scenario 2
----------------------------------------------------------------------------------------------------------------
ICD-9-CM Diagnosis Code
Selection (88 Codes):
100 Percent................. 466 164,892 78,675 112,174 33,499
80 Percent.................. 52 131,690 79,732 108,396 28,664
25 Percent.................. 1 67,016 53,499 71,688 18,189
----------------------------------------------------------------------------------------------------------------
The applicant maintained that, based on the Table 10 thresholds,
the inflated average case-weighted standardized charge per case in the
analyses exceeded the average case-weighted threshold amount. The
applicant noted that the inflated average case[dash]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
powered for mortality, the ATHOS-3 trial demonstrated a strong trend to
reduce the risk of death in adults from septic or distributive shock
who remain hypotensive despite fluid therapy and vasopressor therapy, a
severe, life-threatening condition, for which there are no other
therapies; (4) provides a catecholamine-sparing effect; and (5) is
generally safe and well-tolerated, with no significant differences in
the percentages of patients with any grade adverse events or serious
adverse events when compared to placebo.
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[dash]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[dash]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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
[[Page 20327]]
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 the placebo group versus
40.5 percent of the GIAPREZATM group. We note that, while
GIAPREZATM may potentially reduce certain adverse effects
associated with SOC treatments, the FDA labeling cautions that the use
of GIAPREZATM can cause dangerous blood clots with serious
consequences (clots in arteries and veins, including deep venous
thrombosis); according to the FDA label, prophylactic treatment for
blood clots should be used.
The applicant stated that while the study was not powered to detect
mortality effects, there was a nonsignificant trend toward longer
survival in the GIAPREZATM group. Overall mortality rates at
7 days and 8 days in the modified intent to treat (MITT) population
were 22 percent less in the GIAPREZATM group than in the
placebo group. At 28 days, the mortality rate in the placebo group was
54 percent versus 46 percent in the GIAPREZATM group.
However, the p-values for the decrease in mortality with
GIAPREZATM at 7 days, 8 days, and 28 days did not
demonstrate statistical significance.
The applicant concluded that GIAPREZATM is the first
commercial product to increase blood pressure in adults who have been
diagnosed with septic or other distributive shock that leverages the
renin-angiotensin-aldosterone system. The applicant stated that the
results of the ATHOS-3 study provide support for a well-tolerated new
therapeutic agent that demonstrates significant improvements in mean
arterial pressure. Additionally, the applicant noted that hypotension
in adults who have been diagnosed with septic or other distributive
shock is a prevalent life-threatening condition where therapeutic
options are limited and a high unmet medical need exists. The applicant
stated that the use of GIAPREZATM will represent a safe and
effective new therapy that not only leverages a system that current
therapies are not utilizing, but also offers a viable alternative where
one does not exist.
We understand that, in this heterogeneous and difficult to treat
patient population, studies assessing mortality as a primary endpoint
are difficult, and as such, surrogate endpoints (that is, achieving
baseline MAP) have been explored to assess the efficacy of treatments.
While the outcomes presented by the applicant, such as achieving target
MAP, lower SOFA scores, and reduced catecholamine usage, could be
surrogates for clinical outcomes in these patients, there is not a
strong pool of evidence connecting these single data points directly
with morbidity and mortality. Therefore, we are unsure whether
achieving target MAP, lower SOFA scores, and reduced catecholamine
usage represents a substantial clinical improvement or instead short-
term, temporary improvements without a change in overall patient
prognosis.
In response to this concern about MAP constituting a meaningful
measure for substantial clinical improvement, the applicant supplied
additional information from the current Surviving Sepsis guidelines,
which recommend an initial target MAP of 65 mmHg. The applicant
explained that as MAP falls below a critical threshold, inadequate
tissue perfusion occurs, potentially resulting in multiple organ
dysfunction and death. Therefore, early and adequate hemodynamic
support and treatment of hypotension is critical to restore adequate
organ perfusion and prevent worsening organ dysfunction and failure. In
diagnoses of septic or distributive shock, the goal of treatment is to
increase and maintain a threshold MAP in order to improve tissue
perfusion. According to the applicant, tissue perfusion becomes
linearly dependent on arterial pressure below a threshold MAP. In
patients who have been diagnosed with septic shock requiring
vasopressors, the current Surviving Sepsis guidelines are based on
available evidence that demonstrates that adequate MAP is important to
clinical outcomes and that prolonged decreases in MAP below 65 mmHg is
associated with poor outcome. According to information supplied by the
applicant, even short durations like less than 5 minutes of low MAP
have been associated with severe outcomes, such as myocardial
infarction, stroke, and acute kidney injury. The applicant stated that
a retrospective study \155\ found that MAP was independently related to
ICU and hospital mortality in patients with severe sepsis or septic
shock.
---------------------------------------------------------------------------
\155\ Walsh, M., Devereaux, P.J., Garg, A.X., et al.,
``Relationship between Intraoperative Mean Arterial Pressure and
Clinical Outcomes after Noncardiac Surgery Toward an Empirical
Definition of Hypotension,'' Anesthesiology, 2013, vol. 119(3), pp.
507-515.
---------------------------------------------------------------------------
Finally, we are concerned that the study results may demonstrate
substantial clinical improvement only for patients who are unresponsive
to the administration of fluids and vasopressors because patients were
only included in the ATHOS-3 study if they failed fluids and
vasopressors, rather than for the broader patient population of adult
patients who have been diagnosed with septic or other distributive
shock for which GIAPREZATM was approved by the FDA for use
as an available treatment option. The applicant continues to maintain
that the use of GIAPREZATM has significant efficacy in
improving blood pressure for patients who have been diagnosed with
distributive shock, while decreasing adrenergic vasopressor usage,
thereby, providing another avenue for therapy in this difficult to
treat patient population. However, we are still concerned that the
results from the clinical trial may be too narrow to accurately
represent the entire patient population that has been diagnosed with
septic or other distributive shock and, therefore, we are concerned
that the clinical trial's results may not adequately demonstrate that
GIAPREZATM is a substantial clinical improvement over
existing therapies for all the patients for whom the treatment option
is indicated. We are inviting public comments on whether
GIAPREZATM meets the substantial clinical improvement
criterion.
We did not receive any public comments in response to the published
notice in the Federal Register regarding the substantial clinical
improvement criterion for GIAPREZATM or at the New
Technology Town Hall meeting.
i. GammaTileTM
Isoray Medical, Inc. and GT Medical Technologies, Inc. submitted an
application for new technology add-on payments for FY 2019 for the
GammaTileTM. (We note that Isoray
[[Page 20328]]
Medical, Inc. and GammaTile, LLC previously submitted an application
for new technology add[dash]on payments for GammaTileTM for
FY 2018, which was withdrawn prior to the issuance of the FY 2018 IPPS/
LTCH PPS final rule.) The GammaTileTM is a brachytherapy
technology for use in the treatment of patients who have been diagnosed
with brain tumors, which uses cesium-131 radioactive sources embedded
in a collagen matrix. GammaTileTM is designed to provide
adjuvant radiation therapy to eliminate remaining tumor cells in
patients who required surgical resection of brain tumors. According to
the applicant, the GammaTileTM technology is a new vehicle
of delivery for and inclusive of cesium-131 brachytherapy sources
embedded within the product. The applicant stated that the technology
has been manufactured for use in the setting of a craniotomy resection
site where there is a high chance of local recurrence of a CNS or dual-
based tumor. The applicant asserted that the use of the
GammaTileTM technology provides a new, unique modality for
treating patients who require radiation therapy to augment surgical
resection of malignancies of the brain. By offsetting the radiation
sources with a 3 mm gap of a collagen matrix, the applicant asserted
that the use of the GammaTileTM technology resolves issues
with ``hot'' and ``cold'' spots associated with brachytherapy, improves
safety, and potentially offers a treatment option for patients with
limited, or no other, available options. The GammaTileTM is
biocompatible and bioabsorbable, and is left in the body permanently
without need for future surgical removal. The applicant asserted that
the commercial manufacturing of the product will significantly improve
on the process of constructing customized implants with greater speed,
efficiency, and accuracy than is currently available, and requires less
surgical expertise in placement of the radioactive sources, allowing a
greater number of surgeons to utilize brachytherapy techniques in a
wider variety of hospital settings.
The applicant for the GammaTileTM technology anticipates
FDA clearance by the spring of 2018. In its application, the applicant
indicated that it anticipated that the product would be cleared by the
FDA for use in both the primary and salvage treatment of radiosensitive
malignances of the brain. However, in discussions with the applicant,
the applicant indicated that it is only anticipating FDA clearance for
use in the salvage treatment of recurrent radiosensitive malignances of
the brain. The applicant submitted a request for approval for a unique
ICD-10-PCS code for the use of the GammaTileTM technology,
which was approved effective October 1, 2017 (FY 2018). The ICD-10-PCS
code used to identify procedures involving the use of the
GammaTileTM technology is 00H004Z (Insertion of radioactive
element, cesium-131 collagen implant into brain, open approach).
As discussed earlier, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant stated that when compared to treatment using external beam
radiation therapy, GammaTileTM uses a new and unique
mechanism of action to achieve a therapeutic outcome. The applicant
explained that the GammaTileTM technology is fundamentally
different in structure, function, and safety from all external beam
radiation therapies, and delivers treatment through a different
mechanism of action. In contrast to external beam radiation modalities,
the applicant further explained that the GammaTileTM is a
form of internal radiation termed brachytherapy. Brachytherapy
treatments are performed using radiation sources positioned very close
to the area requiring radiation treatment and only deliver radiation to
the tissues that are immediately adjacent to the margin of the surgical
resection. For this reason, brachytherapy is a current standard of care
treatment for many non-central nervous system tumors, including breast,
cervical, and prostate cancers.
Due to the custom positioning of the radiological sources and the
use of the cesium-131 isotope, the applicant noted that the
GammaTileTM technology focuses therapeutic levels of
radiation on an extremely small area of the brain. Unlike all external
beam techniques, the applicant stated that this radiation does not pass
externally inward through the skull and healthy areas of the brain to
reach the targeted tissue and, therefore, may limit neurocognitive
deficits seen with the use of external beam techniques. Because of the
rapid reduction in radiation intensity that is characteristic of
cesium-131, the applicant asserted that the GammaTileTM
technology can target the margin of the excision with greater precision
than any alternative treatment option, while sparing healthy brain
tissue from unnecessary and potentially damaging radiation exposure.
The applicant also stated that, when compared to other types of
brain brachytherapy, GammaTileTM uses a new and unique
mechanism of action to achieve a therapeutic outcome. The applicant
explained that cancerous cells at the margins of a tumor resection
cavity can also be irradiated with the placement of brachytherapy
sources in the tumor cavity. However, the applicant asserted that the
GammaTileTM technology is a pioneering form of brachytherapy
for the treatment of brain tumors that uses the isotope cesium-131
embedded in a collagen implant that is customized to the geometry of
the brain cavity. According to the applicant, use of cesium-131 and the
custom distribution of seeds in a three-dimensional collagen device
result in a unique and highly effective delivery of radiation therapy
to brain tissue.
With regard to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the GammaTileTM
technology is a treatment option for patients who have been diagnosed
with brain tumors that progress locally after initial treatment with
external beam radiation therapy, and potential cases representing
patients that may be eligible for treatment involving this technology
are assigned to the same MS-DRG (MS-DRG 23 (Craniotomy with Major
Device Implant/Acute Complex CNS PDX with MCC or Chemotherapy Implant))
as other current treatment forms of brachytherapy and external beam
radiation therapy.
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 GammaTileTM technology offers a treatment
option for a patient population with limited, or no other, available
treatment options. The applicant explained that treatment options for
patients who have been diagnosed with brain tumors that progress
locally after initial treatment with external beam radiation therapy
are limited, and there is no current standard of care in this setting.
According to the applicant, surgery alone for recurrent tumors may
provide symptom relief, but does not remove all of the cancer cells.
The applicant further stated that repeating external beam radiation
therapy for adjuvant treatment is hampered by an increasing risk of
brain injury because additional external beam radiation therapy will
increase the
[[Page 20329]]
total dose of radiation to brain tissue, as well as increase the total
volume of irradiated brain tissue. Secondary treatment with external
beam radiation therapy is often performed with a reduced and,
therefore, less effective dose. The applicant stated that the technique
of implanting cesium-131 seeds in a collagen matrix is currently only
available to patients in one location, and requires a high degree of
expertise to implant. The manufacturing process of the
GammaTileTM will greatly expand the availability of
treatment beyond research programs at highly specialized cancer
treatment centers.
Based on the above, the applicant concluded that the
GammaTileTM technology is not substantially similar to other
existing technologies and meets the newness criterion.
However, we are concerned that the mechanism of action of the
GammaTileTM may be the same or similar to current forms or
radiation or brachytherapy. Specifically, while the placement of the
cesium-131 source (or any radioactive source) in a collagen matrix
offset may constitute a new delivery vehicle, we are concerned that
this sort of improvement in brachytherapy for the use in the salvage
treatment of radiosensitive malignancies of the brain may not represent
a new mechanism of action.
We are inviting public comments on whether GammaTileTM
meets the substantial similarity criteria and the newness criterion.
With regard to the cost criterion, the applicant conducted the
following analysis. The applicant worked with the Barrow Neurological
Institute at St. Joseph's Hospital and Medical Center (St. Joseph's) to
obtain actual claims from mid-2015 through mid-2016 for craniotomies
that did not involve placement of the GammaTileTM
technology. The cases were assigned to MS-DRGs 25 through 27
(Craniotomy and Endovascular Intracranial Procedures with MCC, with CC,
and without CC/MCC, respectively). For the 460 claims, the average
case-weighted unstandardized charge per case was $143,831. The
applicant standardized the charges for each case and inflated each
case's charges by applying the FY 2017 IPPS/LTCH PPS final rule outlier
charge inflation factor of 1.05074 by the age of each case (that is,
the factor was applied to 2015 claims 3 times and 2016 claims 2 times).
The applicant then calculated an estimate for ancillary charges
associated with placement of the GammaTileTM device, as well
as standardized charges for the GammaTileTM device itself.
The applicant determined it meets the cost criterion because the final
inflated average case[dash]weighted standardized charge per case
(including the charges associated with the GammaTileTM
device) of $246,310 exceeds the average case-weighted threshold amount
of $141,249 for MS-DRG 23, the MS-DRG that would be assigned for cases
involving placement of the GammaTileTM device.
The applicant also noted that its analysis does not include a
reduction in costs due to reduced operating room times. The applicant
stated that there is significant time and workload associated with
assembling the device, and codes billed for this work are paid at a
flat rate. We are inviting public comments on whether the
GammaTileTM technology meets the cost criterion.
With regard to substantial clinical improvement, the applicant
stated that the GammaTileTM technology offers a treatment
option for a patient population unresponsive to, or ineligible for,
currently available treatments for recurrent CNS malignancies and
significantly improves clinical outcomes when compared to currently
available treatment options. The applicant explained that therapeutic
options for patients who have been diagnosed with large or recurrent
brain metastases are limited. However, according to the applicant, the
GammaTileTM technology provides a treatment option for
patients who have been diagnosed with radiosensitive recurrent brain
tumors that are not eligible for treatment with any other currently
available treatment option. Specifically, the applicant stated that the
GammaTileTM device may provide the only radiation treatment
option for patients who have been diagnosed with tumors located close
to sensitive vital brain sites (for example, brain stem) and patients
who have been diagnosed with recurrent brain tumors who may not be
eligible for additional treatment involving the use of external beam
radiation therapy. There is a lifetime limit for the amount of
radiation therapy a specific area of the body can receive. Patients
whose previous treatment includes external beam radiation therapy may
be precluded from receiving high doses of radiation associated with
subsequent external beam radiation therapy, and the
GammaTileTM technology can also be used to treat tumors that
are too large for treatment with external beam radiation therapy.
Patients who have been diagnosed with these large tumors are not
eligible for treatment with external beam radiation therapy because the
radiation dose to healthy brain tissue would be too high.
The applicant described how the GammaTileTM technology
improves clinical outcomes compared to existing treatment options,
including external beam radiation therapy and other forms of brain
brachytherapy. To demonstrate that the GammaTileTM
technology represents a substantial clinical improvement over existing
technologies, the applicant submitted data from three abstracts
(described below), with one associated paper demonstrating feasibility
or superior progression-free survival compared to the patient's own
historical control rate.
In a presentation at the Society for Neuro-Oncology in November
2014 (Dardis, Christopher; Surgery and permanent intraoperative
brachytherapy improves time to progression of recurrent intracranial
neoplasms), the outcomes of 20 patients who were diagnosed with 27
tumors covering a variety of histological types treated with the
GammaTileTM prototype were presented. The applicant noted
the following with regard to the patients: (1) All tumors were
intracranial, supratentorial masses and included low and
high[dash]grade meningiomas, metastases from various primary cancers,
high[dash]grade gliomas, and others; (2) all treated masses were
recurrent following treatment with surgery and/or radiation and the
group averaged two prior craniotomies and two prior courses of external
beam radiation treatment; and (3) following surgical excision, the
prototype GammaTileTM were placed in the resection cavity to
deliver a dose of 60 Gray to a depth of 5 mm of tissue; and all
patients had previously experienced re-growth of their tumors at the
site of treatment and the local control rate of patients entering the
study was 0 percent.
With regard to outcomes, the applicant stated that, after their
initial treatment, patients had a median progression-free survival time
of 5.8 months; post treatment with the prototype
GammaTileTM, at the time of this analysis, only 1 patient
had progressed at the treatment site, for a local control rate of 96
percent; and median progression-free survival time, a measure of how
long a patient lives without recurrence of the treated tumor, has not
been reached (as this value can only be calculated when more than 50
percent of treated patients have failed the prescribed treatment).
A second set of outcomes on the prototype GammaTileTM
was presented at the Society for Neuro-Oncology Conference on
Meningioma in June 2016 (Brachman, David; Surgery and
[[Page 20330]]
permanent intraoperative brachytherapy improves time to progress of
recurrent intracranial neoplasms). This study enrolled 16 patients with
20 recurrent grade 2 or 3 meningiomas, who had undergone prior surgical
excision external beam radiation therapy. These patients underwent
surgical excision of the tumor, followed by adjuvant radiation therapy
with the prototype GammaTileTM. The applicant noted the
following outcomes: (1) Of the 20 treated tumors, 19 showed no evidence
of radiographic progression at last follow-up, yielding a local control
rate of 95 percent; 2 of the 20 patients exhibited radiation necrosis
(1 symptomatic, 1 asymptomatic); and (2) the median time to failure
from the prior treatment with external beam radiation therapy was 10.3
months and after treatment with the prototype GammaTileTM
only 1 patient failed at 18.2 months. Therefore, the median treatment
site progression-free survival time after the prototype
GammaTileTM treatment has not yet been reached (average
follow[dash]up of 16.7 months, range 1 to 37 months).
A third prospective study was accepted for presentation at the
November 2016 Society for Neuro-Oncology annual meeting (Youssef, Emad;
Cs131 implants for salvage therapy of recurrent high grade gliomas). In
this study, 13 patients who were diagnosed with recurrent
high[dash]grade gliomas (9 with glioblastoma and 4 with grade 3
astrocytoma) were treated in an identical manner to the cases described
above. Previously, all patients had failed the international standard
treatment for high[dash]grade glioma, a combination of surgery,
radiation therapy, and chemotherapy referred to as the ``Stupp
regimen.'' For the prior therapy, the median time to failure was 9.2
months (range 1 to 40 months). After therapy with a prototype
GammaTileTM, the applicant noted the following: (1) The
median time to same site local failure has not been reached and 1
failure was seen at 18 months (local control 92 percent); and (2) with
a median follow[dash]up time of 8.1 months (range 1 to 23 months) 1
symptomatic patient (8 percent) and 2 asymptomatic patients (15
percent) had radiation-related MRI changes. However, no patients
required re-operation for radiation necrosis or wound breakdown. Dr.
Youssef was accepted to present at the 2017 Society for Neuro-Oncology
annual meeting, where he provided an update of 58 tumors treated with
the GammaTileTM technology. At a median whole group
follow[dash]up of 10.8 months, 12 patients (20 percent) had a local
recurrence at an average of 11.33 months after implant. Six and 18
month recurrence free survival was 90 percent and 65 percent,
respectively. Five patients had complications, at a rate that was equal
to or lower than rates previously published for patients without access
to the GammaTileTM technology.
The applicant also included discussion of a presentation by D.S.
Pinnaduwage, Ph.D., at the August 2017 annual meeting of the American
Association of Physicists in Medicine. Dr. Pinnaduwage compared the
brain radiation dose of the GammaTileTM technology with
other radioactive seed sources. Iodine-125 and palladium-103 were
substituted in place of the cesium-131 seeds. The study reported
findings that other radioactive sources reported higher rates of
radiation necrosis and that ``hot spots'' increased with larger tumor
size, further limiting the use of these isotopes. The study concluded
that the larger high-dose volume with palladium-103 and iodine-125
potentially increases the risk for radiation necrosis, and the
inhomogeneity becomes more pronounced with increasing target volume.
The applicant asserted that, when considered in total, the data
reported in these three studies support the conclusion that a
significant therapeutic effect results from the addition of
GammaTileTM radiation therapy to the site of surgical
removal. According to the applicant, the fact that these patients had
failed prior best available treatments (aggressive surgical and
adjuvant radiation management) presents the unusual scenario of a
salvage therapy outperforming the current standard-of-care. The
applicant noted that follow-up data continues to accrue on these
patients.
The applicant stated that the use of the GammaTileTM
technology reduces rates of mortality compared to alternative treatment
options. The applicant explained that studies on the
GammaTileTM technology have shown improved local control of
tumor recurrence. According to the applicant, the results of these
studies showed local control rates of 92 percent to 96 percent for
tumor sites that had local control rates of 0 percent from previous
treatment. The applicant noted that these studies also have not reached
median progression-free survival time with follow-up times ranging from
1 to 37 months. Previous treatment at these same sites resulted in
median progression-free survival times of 5.8 to 10.3 months.
The applicant further stated that the use of the
GammaTileTM technology reduces rates of radiation necrosis
compared to alternative treatment options. The applicant explained that
the rate of symptomatic radiation necrosis in the
GammaTileTM clinical studies of 5 to 8 percent is
substantially lower than the 26 percent to 57 percent rate of
symptomatic radiation necrosis requiring re-operation historically
associated with brain brachytherapy, and lower than the rates reported
for initial treatment of similar tumors with modern external beam and
stereotactic radiation techniques. The applicant indicated that this is
consistent with the customized and ideal distribution of radiation
therapy provided by the GammaTileTM technology.
The applicant also asserted that the use of GammaTileTM
technology reduces the need for re-operation compared to alternative
treatment options. The applicant explained that patients receiving a
craniotomy, followed by external beam radiation therapy or
brachytherapy, could require re-operation in the following three
scenarios:
Tumor recurrence at the excision site could require
additional surgical removal;
Symptomatic radiation necrosis could require excision of
the affected tissue; and
Certain forms of brain brachytherapy require the removal
of brachytherapy sources after a given period of time.
However, according to the applicant, because of the high local
control rates, low rates of symptomatic radiation necrosis, and short
half-life of cesium-131, the GammaTileTM technology will
reduce the need for re-operation compared to external beam radiation
therapy and other forms of brain brachytherapy.
Additionally, the applicant stated that the use of
GammaTileTM technology reduces the need for additional
hospital visits and procedures compared to alternative treatment
options. The applicant noted that the GammaTileTM technology
is placed during surgery, and does not require any additional visits or
procedures. The applicant contrasted this improvement with external
beam radiation therapy, which is often delivered in multiple fractions
that must be administered over multiple days. The applicant provided an
example where whole brain radiotherapy (WBRT) is delivered over 2 to 3
weeks, while the placement of the GammaTileTM technology
occurs during the craniotomy and does not add any time to a patient's
recovery.
[[Page 20331]]
The applicant further summarized how the GammaTileTM
technology is a substantial clinical improvement over existing
treatment options as: (1) Providing a treatment option for patients
with no other available treatment options; (2) reducing rate of
mortality compared to alternative treatment options; (3) reducing rate
of radiation necrosis; (4) reducing the need for re-operation; (5)
reducing the need for additional hospital visits and procedures; and
(6) providing more rapid beneficial resolution of the disease process
treatment.
Based on consideration of all of the data presented above, the
applicant believed that the use of the GammaTileTM
technology represents a substantial clinical improvement over existing
technologies. The studies were limited to patients who have been
diagnosed with recurrent tumors after previous surgical resection. As
previously discussed, the applicant explained that it is anticipating
FDA clearance for the use of the GammaTileTM only in the
treatment of recurrent malignancies.
We are concerned with the limited nature of the clinical efficacy
and safety data provided by the applicant. The findings presented
appear to be derived from relatively small case-studies. While the
applicant described increases in median time to disease recurrence in
support of improvement, we are concerned with regard to the lack of
analysis, meta-analysis, or statistical tests that indicated that
seeded brachytherapy procedures represented a statistically significant
improvement over alternative treatments, as limited as they may be. We
also are concerned with the lack of studies involving the actual
manufactured device. In addition, we are concerned that the applicant
referenced various findings in its application, but did not include
relevant reference materials to substantiate those findings. For
instance, the applicant made statements regarding the low complication
rates with the use of GammaTileTM prototypes, without any
discussion of average rates with comparison to other alternative
treatments.
We are inviting public comments on whether GammaTileTM
meets the substantial clinical improvement criterion.
We did not receive any public comments on the
GammaTileTM technology in response to the published notice
in the Federal Register or at the New Technology Town Hall Meeting.
j. Supersaturated Oxygen (SSO2) Therapy (DownStream[reg]
System)
TherOx, Inc. submitted an application for new technology add-on
payments for the Supersaturated Oxygen (SSO2) Therapy (the
DownStream[reg] System) for FY 2019. The DownStream[reg] System is an
adjunctive therapy designed to ameliorate progressive myocardial
necrosis by minimizing microvascular damage in patients who have
received treatment for a diagnosis of acute myocardial infarction (AMI)
following percutaneous intervention (PCI) with coronary artery stent
placement. The applicant stated that, while contemporary therapies for
patients who have received treatment for a diagnosis of AMI have
focused on relieving blockages and improving blood flow to the diseased
myocardium, little has been done to provide localized hyperbaric oxygen
to ischemic tissue. According to the applicant, patients who have
received treatment for a diagnosis of AMI are at high risk for reduced
quality of life, heart failure, and higher mortality as a result of the
extent of necrosis or infarct size experienced in the myocardium during
the infarction. The applicant asserted that the net effect of the
SSO2 Therapy is to reduce the infarct size and, therefore,
preserve heart muscle.
The SSO2 Therapy consists of three main components: the
DownStream[reg] System; the DownStream cartridge; and the
SSO2 delivery catheter. The DownStream[reg] System and
cartridge function together to create an oxygen-enriched saline
solution called SSO2 solution from hospital[dash]supplied
oxygen and physiologic saline. A small amount of the patient's blood is
then mixed with the SSO2 solution, producing oxygen-enriched
hyperoxemic blood, which is then delivered to the left main coronary
artery (LMCA) via the delivery catheter at a flow rate of 100 ml/min.
The duration of the SSO2 Therapy is 60 minutes and the
infusion is performed in the catheterization laboratory. The oxygen
partial pressure (pO2) of the infusion is elevated to ~1,000 mmHg,
therefore providing oxygen locally to the myocardium at a hyperbaric
level for 1 hour. After the 60-minute SSO2 infusion is
complete, the cartridge is unhooked from the patient and discarded per
standard practice. Coronary angiography is performed as a final step
before removing the delivery catheter and transferring the patient to
the intensive care unit (ICU).
According to the applicant, the SSO2 Therapy has been
designated as a Class III medical device (high risk) by the FDA. The
applicant indicated that it expects to receive pre-market approval from
the FDA in the first quarter of 2018. The applicant asserted that use
of the SSO2 Therapy can be identified by the ICD-10-PCS
procedure codes 5A0512C (Extracorporeal supersaturated oxygenation,
intermittent) and 5A0522C (Extracorporeal supersaturated oxygenation,
continuous).
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. According to the
applicant, the SSO2 Therapy is administered adjunctively
immediately following completion of successful PCI. The applicant
maintained that currently available treatment options for patients who
have been diagnosed and begun initial treatment for AMI involve the
revascularization of the blocked coronary artery by means of either
thrombolytic therapy or PCI with stent placement accompanied by the
administration of adjunctive pharmacologic agents such as glycoprotein
IIb/IIIa inhibitors, or via coronary artery bypass graft (CABG)
surgery. The applicant asserted that because there are no other
approved therapies for patients who have been diagnosed with AMI post-
PCI, the SSO2 Therapy meets the newness criterion. Below we
evaluate the applicant's assertions with respect to whether the
SSO2 Therapy meets each of the three substantial similarity
criteria.
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 SSO2 Therapy employs two
mechanisms of action: (1) First, the increased oxygen levels re-open
the microcirculatory system within the infarct zone, which has
experienced ischemia during the occlusion period; and (2) second, once
reopened, the blood flow contains additional oxygen to restart the
metabolic processes within the stunned myocardium. The applicant
asserted that these mechanisms have been studied in preclinical
investigations sponsored by the applicant, where controlled studies
were performed in both porcine and canine AMI models to determine the
safety, effectiveness, and mechanism of action of the SSO2
Therapy. According to the applicant, the findings of these studies
demonstrated improved left ventricular function, infarct size
reduction, a microvascular mechanism of action, and that the
SSO2 Therapy is nontoxic. Based on the information provided
by the applicant, current
[[Page 20332]]
treatment options for patients who have been diagnosed and receive
treatment for AMI function to restore coronary artery blood flow, which
addresses macrovascular disease but not the underlying cellular changes
resulting from hypoxia. The applicant maintains that currently
available treatment options for patients who have been diagnosed and
receive treatment for AMI do not treat hypoxemic damage at the
microvascular or microcirculatory level, and that SSO2
Therapy does not use the same or a similar mechanism of action as any
existing treatment available for patients who have been diagnosed and
receive treatment for a diagnosis of AMI.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, we believe that potential cases
involving the SSO2 Therapy may be assigned to the same MS-
DRG(s) as other cases involving PCI with stent placement also used to
treat patients who have been diagnosed with AMI.
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, in spite of many advances and refinements in PCI for
reopening the blocked coronary artery, patients who have been diagnosed
and receiving treatment for AMI are at high risk for reduced quality of
life, heart failure, and higher mortality, as a result of the extent of
necrosis experienced in the myocardium during the infarction. According
to the applicant, patients who have been diagnosed with and receiving
treatment for AMI continue to experience elevated early and late Major
Adverse Cardiac Events (MACE), as well as a higher risk for congestive
heart failure (CHF) development. The applicant made the following
assertions: The net effect of the SSO2 Therapy is to reduce
the infarct size, or extent of necrosis, in the myocardium post-AMI
and, therefore, improve left ventricular function, leading to improved
patient outcomes; there are no other approved therapies for patients
who have been diagnosed with and receive treatment for AMI post-PCI and
submitted data evaluating the SSO2 Therapy directly as
compared to the currently available standard of care, PCI with stenting
alone; and SSO2 Therapy's emphasis is on treating patients
who have been diagnosed with AMI at the microvascular level instead of
reopening the blocked coronary artery at the macrovascular level as
with other treatments and that it, therefore, treats a different type
of disease than currently available treatment options for patients who
have been diagnosed with and receive treatment for AMI.
We are inviting public comments on whether the SSO2
Therapy is substantially similar to 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 to which potential
cases representing potential patients who may be eligible for treatment
involving the SSO2 Therapy may map, the applicant identified
all MS-DRGs for cases of patients who have been diagnosed with anterior
STEMI as a principal diagnosis. Specifically, the applicant searched
the FY 2016 MedPAR file for claims reporting diagnoses of anterior
STEMI by ICD-10-CM diagnosis codes I21.0 (ST elevation myocardial
infarction of anterior wall), I21.01 (ST elevation (STEMI) myocardial
infarction involving left main coronary artery), I21.02 (ST elevation
(STEMI) myocardial infarction involving left anterior descending
coronary artery), or I21.09 (ST elevation (STEMI) myocardial infarction
involving other coronary artery of anterior wall) as a primary
diagnosis. The applicant identified 11,030 potential cases across 4 MS-
DRGs, with approximately 86 percent of all potential cases mapping to
the following 2 MS-DRGs: MS-DRG 246 (Percutaneous Cardiovascular
Procedures with Drug-Eluting Stent with MCC or 4+ Vessels/Stents) and
MS-DRG 247 (Percutaneous Cardiovascular Procedures with Drug-Eluting
Stent without MCC). The remaining 14 percent of potential cases mapped
to MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug
Eluting Stent with MCC or 4+ Vessels/Stents) and MS-DRG 249
(Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent
without MCC).
Using the 11,030 identified cases, the applicant determined that
the average unstandardized case-weighted charge per case was $94,290.
The applicant then standardized the charges. The applicant did not
remove charges for the current treatment because, as discussed above,
the SSO2 Therapy will be used as an adjunctive treatment
option following successful PCI with stent placement. The applicant
then applied the inflation factor of 1.05074 from the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38524) 3 times to inflate the charges from FY
2016 to FY 2019. The applicant added charges related to the new
technology, which accounts for the use of 1 cartridge per patient, as
well as the 60 minutes of procedure time, to the average charges per
case. Based on the FY 2018 IPPS/LTCH PPS final rule Table 10 threshold
amounts, the average case[dash]weighted threshold amount was $91,064.
The inflated average case-weighted standardized charge per case was
$146,974. Because the inflated average case-weighted standardized
charge per case exceeds the average case-weighted threshold amount, the
applicant maintained that the technology meets the cost criterion. We
are inviting comments on whether or not the SSO2 Therapy
meets the cost criterion.
With regard to the substantial clinical improvement criterion,
according to the applicant, the preferred standard of care for the
treatment of patients who have been diagnosed with AMI involves the
revascularization of the blocked coronary artery by means of PCI with
stent placement, accompanied by the administration of adjunctive
pharmacologic agents such as antiplatelet drugs, including glycoprotein
IIb/IIIa inhibitors. The applicant stated that the clinical unmet need
for these patients, particularly patients who have been diagnosed with
anterior wall STEMI with the greatest potential impact to their
ventricle, is to provide incremental therapeutic benefit beyond PCI
with stenting to reduce the damage to their myocardium. The applicant
believed that SSO2 Therapy fulfills this unmet clinical need
in the treatment of patients who have been diagnosed with ST-elevation
AMI by reducing infarct size as compared to the standard of care, PCI
with stenting alone.
The applicant asserted that, as an adjunctive treatment, the
SSO2 Therapy has demonstrated superiority over PCI with
stenting alone in reducing the infarct size for high-risk patients
diagnosed with anterior AMI treated within 6 hours of symptom onset.
The applicant also noted that the SSO2 Therapy has been
shown to preserve left ventricular integrity as compared to patients
who receive treatment involving PCI with stenting alone, utilizing
direct measurements of left ventricular volume over the 30-day post-
procedure period. The applicant noted that the quantification of the
extent of necrosis or infarction in the muscle is the best physical
measure of the consequences of AMI for patients in post-intervention,
as the infarct size is the quantification of the extent of scarring of
the left ventricle post-AMI and, therefore, provides a direct measure
of the health of the
[[Page 20333]]
myocardium and indirectly on the heart's structure and function. A
large infarct means the muscle cannot contract normally, leading to
left ventricular enlargement, reduced ejection fraction, clinical heart
failure, and death. The applicant highlighted the importance of the
SSO2 Therapy's mechanism of action, which treats hypoxemic
damage at the microvascular or microcirculatory level, by noting that
the degree to which microvascular impairment in the myocardium is
irreversible and unaffected by therapeutic intervention leads to a
greater extent of infarction. Furthermore, the applicant noted that
compromised microvascular flow remains a serious problem in STEMI care
and leads to microvascular obstruction (MVO), which a recent study has
shown to be an important independent predictor of mortality and heart
failure (HF) hospitalization at 1 year. The applicant asserted that MVO
is closely tied to the resultant damage or infarct size in patients
diagnosed with acute STEMI and is of critical importance to address
mechanistically in any treatment administered in conjunction to PCI, to
effect an improved outcome in primary care.
The applicant performed controlled studies in both porcine and
canine AMI models to determine the safety, effectiveness, and mechanism
of action of the SSO2 Therapy. The key summary points from
these animal studies are:
The SSO2 Therapy administration post-AMI
acutely improves heart function as measured by left ventricular
ejection fraction (LVEF) and regional wall motion as compared with non-
treated control subjects.
The SSO2 Therapy administration post-AMI
results in tissue salvage, as determined by post-sacrifice histological
measurements of the infarct size. Control animals exhibit larger
infarcts than the SSO2-treated animals.
The SSO2 Therapy has been shown to be non-toxic
to the coronary arteries, myocardium, and end organs in randomized,
controlled swine studies with or without induced acute myocardial
infarction.
The SSO2 Therapy administration post-AMI has
exhibited regional myocardial blood flow improvement in treated animals
as compared to controls.
A significant reduction in myeloperoxidase (MPO) levels
was observed in the SSO2-treated animals versus controls,
which indicate improvement in underlying myocardial hypoxia.
Transmission electron microscopy (TEM) photographs have
shown amelioration of endothelial cell edema and restoration of
capillary patency in ischemic zone cross-sectional histological
examination of the SSO2-treated animals, while nontreated
controls exhibit significant edema and vessel constriction at the
microvascular level.
The applicant also submitted results from five clinical studies
that it asserted demonstrate the substantial clinical benefit
associated with the SSO2 Therapy. These studies include the
Phase I/IA feasibility trial, the European OYSTER-AMI study, the AMIHOT
I and AMIHOT II randomized trials, and the IC-HOT clinical study.
The Phase I/IA and OYSTER-AMI studies demonstrated that the
SSO2 Therapy held promise in improving left ventricular
function, especially in the infarct zone, for patients who have been
diagnosed with and receiving treatment for AMI. Specifically, an IDE-
sanctioned Phase I pilot study was conducted in the United States and
Italy involving 29 patients who had been diagnosed with and receiving
treatment involving the SSO2 Therapy for anterior AMI and
found significant LV functional improvement over time as noted in the
2-D echocardiography analysis of the combined Phase I/IA data. Baseline
measurements of ejection fraction (EF) and wall motion score index
(WMSI) were taken immediately post-PCI prior to SSO2 Therapy
administration. An improving trend in EF and significant improvement in
WMSI were observed at 24-hours after SSO2 Therapy
administration, and further improvement in ventricular function was
demonstrated at 1 and 3 months compared to baseline. The analysis
demonstrated that these improvements in global LV functional measures
were due to recovery of ventricular function in the infarct zone;
regional WMSI assessments showed no change in the noninfarct zone.
Similar results were found in the European OYSTER-AMI trial, which
assessed supersaturated oxygen in reperfused ST-elevation AMI,
directing attention to 41 patients receiving treatment involving the
SSO2 Therapy versus untreated controls. The study showed
that the supersaturated oxygen treatment group had a significantly
faster cardiac enzyme and ST segment elevation reduction, therefore
suggesting an improvement in microvascular reperfusion. The
SSO2 Therapy treatment group also showed a significantly
better improvement in left ventricular wall motion and ejection
fraction,\156\ which a number of studies have shown to be directly
related to mortality.\157\ The OYSTER-AMI study further suggested that
the SSO2 Therapy reduces the infarct size, as demonstrated
in reduced cardiac enzyme CK and CK-MB release.
---------------------------------------------------------------------------
\156\ Bartorelli, A.L., ``Hyperoxemic Perfusion for Treatment of
Reperfusion Microvascular Ischemia in Patients with Myocardial
Infarction,'' Am J Cardivasc Drugs, 2003, vol. 3(4), pp. 253-6.
\157\ Stone, G.W., et al., ``Relationship between infarct size
and outcomes following primary PCI: Patient-level analysis from 10
randomized trials,'' J Am Coll Cardio, vol. 67.14, 2016, pp. 1674-
1683.
---------------------------------------------------------------------------
The AMIHOT I clinical trial was designed as a prospective,
randomized evaluation of patients who had been diagnosed with and
receiving treatment for AMI presenting within 24 hours of symptom
onset, including both anterior and inferior patients diagnosed with
AMI. The AMIHOT I trial was conducted with IDE approval from FDA. The
study included 269 randomized patients, with 3 independent biomarkers
(infarction size reduction, regional wall motion score improvement at 3
months, and reduction in ST segment elevation) designated as co-primary
endpoints to evaluate the effectiveness of the SSO2 Therapy.
The study was designed to demonstrate superiority of the
SSO2 Therapy group as compared to controls for each of these
endpoints, and to demonstrate non-inferiority of the SSO2
Therapy group as compared to control with respect to 30-day MACE. The
study population was comprised of qualifying patients who had been
diagnosed with AMI and receiving treatment with either PCI alone or
with the SSO2 Therapy as an adjunct to successful PCI within
24 hours of symptom onset. According to the applicant, results for the
control/SSO2 Therapy group comparisons for the three co-
primary effectiveness endpoints demonstrated a nominal improvement in
the test group, although this nominal improvement did not achieve
clinical and statistical significance in the entire population. A pre-
specified analysis of the SSO2 Therapy patients who were
revascularized within 6 hours of AMI symptom onset and who had anterior
wall infarction showed a marked improvement in all three co-primary
endpoints as compared to the control group. Key safety data revealed no
statistically significant differences in the composite primary endpoint
of 1-month (30 days) Major Adverse Cardiac Event (MACE) rates between
the SSO2 Therapy and control groups. MACE includes the
combined incidence of death, reinfarction, target vessel
revascularization, and stroke. In total, 9/134 (6.7 percent) patients
in the SSO2 Therapy group and 7/135 (5.2 percent) patients
in the control group experienced 30-day MACE (p=0.62).
[[Page 20334]]
Another pivotal trial in the evaluation of the SSO2
Therapy, the AMIHOT II trial, randomized 301 patients who had been
diagnosed with and receiving treatment for anterior AMI with either PCI
plus the SSO2 therapy or PCI alone. The AMIHOT II trial had
a Bayesian statistical design that allows for the informed borrowing of
data from the previously completed AMIHOT I trial. The primary efficacy
endpoint of the study required proving superiority of the infarct size
reduction with the SSO2 Therapy as compared to patients who
were receiving treatment involving PCI with stenting alone. The primary
safety endpoint for the AMIHOT II trial required a determination of
noninferiority in the 30-day MACE rate, comparing the SSO2
Therapy group with the control group, within a safety delta of 6.0
percent. Endpoint evaluation was performed using a Bayesian
hierarchical model that evaluated the AMIHOT II result conditionally in
consideration of the AMIHOT I 30-day MACE data. According to the
applicant, the results of the AMIHOT II trial showed that the
SSO2 therapy, together with PCI and stenting, demonstrated a
relative reduction of 26 percent in the left ventricular infarct size
and absolute reduction of 6.5 percent compared to PCI and stenting
alone. We are interested in information regarding at what timeframe in
the study was the reduction of infarct size measured. In addition, the
applicant stated that the finding of device effectiveness was supported
by additional analyses that showed a 53 percent increased likelihood of
having a small infarct among the SSO2 therapy patients.\158\
In assessing 30-day Major Adverse Cardiac Events (MACE), while higher
in the SSO2 Therapy group, the rates were statistically
noninferior (5.4 percent versus 3.8 percent). However, given the higher
30[dash]day MACE outcome among the SSO2 Therapy patients in
both the AMIHOT I and AMIHOT II trials, we are concerned about the lack
of long-term data on improvement in patient clinical outcomes, despite
the lack of statistical significance.
---------------------------------------------------------------------------
\158\ Stone, G.W., Martin, J.L., Boer, M.J., et al., ``Effect of
Supersaturated Oxygen Deliver on Infarct Size After Percutaneous
Coromary Intervention in Acute Myocardial Infarction,'' Cir
Cardiovasc Interv, 2009, vol. 2, pp. 366-75.
---------------------------------------------------------------------------
The applicant also submitted the IC-HOT clinical trial, which was
designed to confirm the safety and efficacy of the use of the
SSO2 Therapy in those individuals presenting with a
diagnosis of anterior AMI who have undergone successful PCI with
stenting of the proximal and/or mid left anterior descending artery
within 6 hours of experiencing AMI symptoms. It is an IDE,
nonrandomized, single arm study. The study was primarily focused on
safety, utilizing a composite endpoint of 30-day Net Adverse Clinical
Events (NACE). A maximum observed event rate of 10.7 percent was
established based on a contemporary PCI trial of comparable patients
who had been diagnosed with anterior wall STEMI. The IC-HOT trial
exhibited a 7.1 percent observed NACE rate, meeting the study endpoint.
Notably, no 30-day mortalities were observed, and the type and
frequency of 30-day adverse events occurred at similar or lower rates
than in contemporary STEMI studies of PCI-treated patients who had been
diagnosed with anterior AMI. Furthermore, according to the applicant,
the IC-HOT study supported the conclusions of effectiveness established
in AMIHOT II with a measured 30-day median infarct size = 19.4 percent
(as compared to the AMIHOT II SSO2 Therapy group infarct
size = 20.0 percent). Notable measures include 4[dash]day microvascular
obstruction (MVO), which has been shown to be an independent predictor
of outcomes, 4[dash]day and 30[dash]day left ventricular end diastolic
and end systolic volumes, and 30[dash]day infarct size. The IC-HOT
study results exhibited a favorable MVO as compared to contemporary
trial data, and decreasing left ventricular volumes at 30 days,
compared to contemporary PCI populations that exhibit increasing left
ventricular size. The applicant asserted that the IC-HOT clinical trial
data continue to demonstrate substantial clinical benefit of the
SSO2 Therapy as compared to the standard of care, PCI with
stenting alone.
We are inviting public comments on whether the SSO2
Therapy meets the substantial clinical improvement criterion.
Below we summarize and respond to written public comments we
received regarding the DownStream[reg] System during the open comment
period in response to the New Technology Town Hall meeting notice
published in the Federal Register.
Comment: A number of commenters supported the approval of new
technology add-on payments for the DownStream[reg] System
(SSO2 Therapy) for the treatment of patients diagnosed with
AMI. The commenters asserted that SSO2 Therapy is effective
at significantly reducing infarct size in patients diagnosed with
anterior wall myocardial infarction who have been treated with primary
percutaneous intervention. The commenters reiterated the results of the
AMIHOT II randomized trial which demonstrated that treatment with
SSO2 Therapy following successful PCI in patients diagnosed
with an anterior wall myocardial infarction resulted in a 6.5 percent
absolute reduction and a 26 percent relative reduction in infarct size,
compared to treatment with PCI alone (the percentages above are based
on a 26.5 percent median infarct size in the control PCI group versus
20 percent infarct size in the SSO2 Therapy group). One
commenter stated that the infarct size reduction of 6.5 percent
documented in the AMIHOT II trial results is substantial when it comes
to patient care. In addition, other commenters believed that
SSO2 Therapy is a safe treatment option because there was no
significant difference in Major Adverse Cardiac Events (MACE) between
the treatment and control groups.
The commenters also referenced the results from the IC-HOT
confirmatory study. The commenters believed that the results of this
study demonstrated stabilization of the left ventricular size with no
dilatation at 30 days, which confirmed the efficacy and safety of
SSO2 Therapy. The commenters stated that, in a sample
patient population of 98 patients diagnosed with anterior wall
myocardial infarction, to achieve a result in infarct size of 19.4
percent of the left ventricular following use of SSO2
Therapy is similar to the results achieved in the patients enrolled in
the treatment group of the AMIHOT II trial and is also substantial to
patient care. The commenters emphasized that patients diagnosed with
anterior wall myocardial infarction are high[dash]risk patients with a
high mortality rate, and patients who survive experiences with large
infarct size and left ventricular dysfunction eventually suffer
congestive heart failure, ultimately requiring a defibrillator and have
poor quality of life. The commenters also noted that the MRI results
documented from the IC-HOT trial have shown a reduction in left
ventricular volumes, suggesting the left ventricular cavity did not
dilate and the ventricle remained stable, which is consistent with the
experience of many of the commenters that treated patients using
SSO2 Therapy as part of the trial. Another commenter noted
that 25 percent of the patients in the IC[dash]HOT trial had a normal
ejection fraction at follow[dash]up MRI scan. The commenters believed
that SSO2 Therapy should be a standard[dash]of[dash]care,
given the low number of adverse events and the low instances of new
heart failure admissions in their
[[Page 20335]]
experience with the use of SSO2 Therapy.
Another commenter provided additional clinical studies in response
to a question presented at the New Technology Town Hall meeting
regarding the relationship between myocardial infarct size and clinical
outcomes. The commenter stated that these clinical studies would
provide further context to the research regarding the relationship
between myocardial infarct size and clinical outcomes and emphasized
that this relationship is not dependent on the type of treatment
administered. The commenter opined that as long as infarct size is
reduced, long-term clinical benefit follows. The commenter maintained
that the strong correlation between the scarring of the left ventricle
as a consequence of diagnoses of AMI and important long-term clinical
outcomes has been well documented in large-scale thrombolytic therapy
trials, one of which showed that a 5 percent reduction in medium
infarct size was associated with improved clinical outcomes and
established the superiority of primary PCI over thrombolysis as the
standard[dash]of[dash]care for the treatment of AMI.\159\ The commenter
indicated that, based on the results of the additional clinical
studies, recognizing the significance of the relationship between
infarct size and clinical outcomes, additional trials were performed to
evaluate the effect of continued infarct size reduction, such as a
pooled patient[dash]level analysis to evaluate myocardial infarct size
measured within 30 days of STEMI and its relationship to mortality as
well as hospitalization for heart failure during and up to 1-year
follow up. The commenter stated that one trial demonstrated a highly
significant relationship for mortality and hospitalization for heart
failure, where every 5 percent increase in infarct size was associated
with a 19 percent increase in mortality at 1 year.\160\ The commenter
further stated that the results of this trial indicated that this
relationship was independent of other high-risk clinical and
angiographic features in patients with a large infarction, including
age, sex, diabetes, hypertension, hyperlipidemia, current smoking, and
symptom-to-first device time.\161\ The commenter believed that, given
this established relationship, the 6.5 percent absolute reduction in
median infarct size demonstrated with the use of SSO2
Therapy in the AMIHOT II trial is clinically meaningful. The commenter
concluded that SSO2 Therapy is the only therapy to date that
has demonstrated a significant and clinically meaningful reduction in
infarct size beyond that achieved with PCI alone.
---------------------------------------------------------------------------
\159\ Sch[ouml]mig, A., Kastrati, A., Dirschinger, J., et al.,
``Coronary stenting plus platelet glycoprotein IIb/IIIa blockade
compared with tissue plasminogen activator in acute myocardial
infarction. Stent versus Thrombolysis for Occluded Coronary Arteries
in Patients with Acute Myocardial Infarction Study Investigators,''
New England Journal of Medicine, 2000, vol. 343(6), pp. 385-91.
\160\ Stone, G.W., Selker, H.P., Thiele, H., et al.,
``Relationship between infarct size and outcomes following primary
PCI,'' JACC, 2016, vol. 67(14), pp. 1674-83.
\161\ Ibid.
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Response: We appreciate all of the commenters' input. However, we
are concerned whether the additional clinical studies presented
regarding the relationship between myocardial infarct size and clinical
outcomes can be applied to SSO2 Therapy and whether the
applicant has provided enough information to demonstrate that the
reduction of infarct size with use of SSO2 Therapy is a
substantial clinical improvement. We are inviting public comments
regarding these concerns.
k. Cerebral Protection System (Sentinel[reg] Cerebral Protection
System)
Claret Medical, Inc. submitted an application for new technology
add-on payments for the Cerebral Protection System (Sentinel[reg]
Cerebral Protection System) for FY 2019. According to the applicant,
the Sentinel Cerebral Protection System is indicated for the use as an
embolic protection (EP) device to capture and remove thrombus and
debris while performing transcatheter aortic valve replacement (TAVR)
procedures. The device is percutaneously delivered via the right radial
artery and is removed upon completion of the TAVR procedure. The De
Novo request for the Sentinel[reg] Cerebral Protection System was
granted on June 1, 2017 (DEN160043).
Aortic stenosis (AS) is a narrowing of the aortic valve opening. AS
restricts blood flow from the left ventricle to the aorta and may also
affect the pressure in the left atrium. The most common presenting
symptoms of AS include dyspnea on exertion or decreased exercise
tolerance, exertional dizziness (presyncope) or syncope and exertional
angina. Symptoms experienced by patients who have been diagnosed with
AS and normal left ventricular systolic function rarely occur until
stenosis is severe (defined as valve area is less than 1.0 cm2, the jet
velocity is over 4.0 m/sec, and/or the mean transvalvular gradient is
greater than or equal to 40 mmHg).\162\ AS is a common valvular
disorder in elderly patients. The prevalence of AS increases with age,
and some degree of valvular calcification is present in 75 percent of
patients who are 85 to 86 years old.\163\ TAVR procedures are the
standard of care treatment for patients who have been diagnosed with
severe AS. Patients undergoing TAVR procedures are often older, frail,
and may be affected by multiple comorbidities, implying a significant
risk for thromboembolic cerebrovascular events.\164\ Embolic ischemic
strokes can occur in patients undergoing surgical and interventional
cardiovascular procedures, such as stenting (carotid, coronary,
peripheral), catheter ablation for atrial fibrillation, endovascular
stent grafting, left atrial appendage closure (LAAO), patent formal
ovale (PFO) closure, balloon aortic valvuloplasty, surgical valve
replacement (SAVR), and TAVR. Clinically overt stroke, or silent
ischemic cerebral infarctions, associated with the TAVR procedure, may
result from a variety of causes, including mechanical manipulation of
instruments or other interventional devices used during the procedure.
These mechanical manipulations are caused by, but not limited to, the
placement of a relatively large bore delivery catheter in the aortic
arch, balloon valvuloplasty, valve positioning, valve re-positioning,
valve expansion, and corrective catheter manipulation, as well as use
of guidewires and guiding or diagnostic catheters required for proper
positioning of the TAVR device. The magnitude and timing of embolic
activity resulting from these manipulations was studied by Szeto, et
al.,\165\ using a transcranial Doppler, and it was found that embolic
material is liberated throughout the TAVR procedure with some of the
emboli reaching the central nervous system leading to cerebral ischemic
infarctions. Some of the cerebral ischemic infarctions lead to
neurologic injury and clinically apparent stroke. Szeto, et al., also
noted that the rate of
[[Page 20336]]
silent ischemic cerebral infarctions following TAVR procedures is
estimated to be between 68 and 91 percent.166 167
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\162\ Otto, C., Gaasch, W., ``Clinical manifestations and
diagnosis of aortic stenosis in adults,'' In S. Yeon (Ed.), 2016,
Available at: https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-aortic-stenosis-in-adults.
\163\ Lindroos, M., et al., ``Prevalence of aortic valve
abnormalities in the elderly: An echocardiographic study of a random
population sample,'' J Am Coll Cardio, 1993, vol. 21(5), pp. 1220-
1225.
\164\ Giustino, G., et al., ``Neurological Outcomes With Embolic
Protection Devices in Patients Undergoing Transcatheter Aortic Valve
Replacement,'' J Am Coll Cardio, CARDIOVASCULAR INTERVENTIONS, 2016,
vol. 9(20).
\165\ Szeto, W.Y., et al., ``Cerebral Embolic Exposure During
Transfemoral and Transapical Transcatheter Aortic Valve
Replacement,'' J Card Surg, 2011, vol. 26, pp. 348-354.
\166\ Gupta, A., Giambrone, A.E., Gialdini, G., et al., ``Silent
brain infarction and risk of future stroke: A systematic review and
meta-analysis,'' Stroke, 2016, vol. 47, pp. 719-25.
\167\ Mokin, M., Zivadinov, R., Dwyer, M.G., Lazar, R.M.,
Hopkins, L.N., Siddiqui, A.H., ``Transcatheter aortic valve
replacement: perioperative stroke and beyond,'' Expert Rev
Neurother, 2017, vol. 17, pp. 327-34.
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The TAVR procedure is a minimally invasive procedure that does not
involve open heart surgery. During a TAVR procedure the prosthetic
aortic valve is placed within the diseased native valve. The prosthetic
valve then becomes the functioning aortic valve. As previously
outlined, stroke is one of the risks associated with TAVR procedures.
According to the applicant, the risk of stroke is highest in the early
post[dash]procedure period and, as previously outlined, is likely due
to mechanical factors occurring during the TAVR procedure.\168\ Emboli
can be generated as wire-guided devices are manipulated within
atherosclerotic vessels, or when calcified valve leaflets are traversed
and then crushed during valvuloplasty and subsequent valve
deployment.\169\ Stroke rates in patients evaluated 30 days after TAVR
procedures range from 1.0 percent to 9.6 percent,\170\ and have been
associated with increased mortality. Additionally, new ``silent
infarcts,'' assessed via diffusion-weighted magnetic resonance imaging
(DW-MRI), have been found in a majority of patients after TAVR
procedures.\171\
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\168\ Nombela-Franco, L., et al., ``Timing, predictive factors,
and prognostic value of cerebrovascular events in a large cohort of
patients undergoing transcatheter aortic valve implantation,''
Circulation, 2012, vol. 126(25), pp. 3041-53.
\169\ Freeman, M., et al., ``Cerebral events and protection
during transcatheter aortic valve replacement,'' Catheterization and
Cardiovascular Interventions, 2014, vol. 84(6), pp. 885-896.
\170\ Haussig, S., Linke, A., ``Transcatheter aortic valve
replacement indications should be expanded to lower-risk and younger
patients,'' Circulation, 2014. vol. 130(25), pp. 2321-31.
\171\ Kahlert, P., et al., ``Silent and apparent cerebral
ischemia after percutaneous transfemoral aortic valve implantation:
a diffusion-weighted magnetic resonance imaging study,''
Circulation, 2010, vol. 121(7), pp. 870-8.
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As stated earlier, the De Novo request for the Sentinel[reg]
Cerebral Protection System was granted on June 1, 2017. The FDA
concluded that this device should be classified into Class II (moderate
risk). Effective October 1, 2016, ICD-10-PCS Section ``X'' code X2A5312
(Cerebral embolic filtration, dual filter in innominate artery and left
common carotid artery, percutaneous approach) was approved to identify
cases involving TAVR procedures using the Sentinel[reg] Cerebral
Protection System.
As discussed earlier, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome,
according to the applicant, the Sentinel[reg] Cerebral Protection
System device is inserted at the beginning of the TAVR procedure, via a
small tube inserted through a puncture in the right wrist. Next, using
a minimally invasive catheter, two small filters are placed in the
brachiocephalic and left common carotid arteries. The filters collect
debris, preventing it from becoming emboli, which can travel to the
brain. These emboli, if left uncaptured, can cause cerebral ischemic
lesions, often referred to as silent ischemic cerebral infarctions,
potentially leading to cognitive decline or clinically overt stroke. At
the completion of the TAVR procedure, the filters, along with the
collected debris, are removed. The applicant stated that there are no
other similar products for commercial sale available in the United
States for cerebral protection during TAVR procedures. Two
neuroprotection devices, the TriguardTM Cerebral Protection
Device (Keystone Heart, Herzliya Pituach, Israel) and the Embrella
Embolic DeflectorTM System (Edwards Lifesciences, Irvine,
CA) are used in Europe. These devices work by deflecting embolic debris
distally, rather than capturing and removing debris with filters.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, as stated earlier, the Sentinel[reg]
Cerebral Protection System is an EP device used to capture and remove
thrombus and debris while performing TAVR procedures. Therefore,
potential cases representing patients who may be eligible for treatment
involving this device would map to the same MS-DRGs as cases involving
TAVR procedures.
With respect to the third criterion, whether the new use of the
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, according to the
applicant, this technology will be used to treat patients who have been
diagnosed with severe aortic valve stenosis who are eligible for a TAVR
procedure. The applicant asserted that there are currently no approved
alternative treatment options for cerebral protection during TAVR
procedures, and the Sentinel[reg] Cerebral Protection System is the
first and only embolic protection device for use during TAVR procedures
and, therefore, meets the newness criterion. The applicant also
asserted that the device meets the newness criterion, as evidenced by
the FDA's granting of the De Novo request and there was no predicate
device.
Based on the above, it appears that the Sentinel[reg] Cerebral
Protection System is not substantially similar to other existing
technologies. We are inviting public comments on whether the
Sentinel[reg] Cerebral Protection System is substantially similar to
any existing technology and whether it meets the newness criterion.
The applicant conducted the following analysis to demonstrate that
the technology meets the cost criterion. The applicant searched the FY
2016 MedPAR file for cases with the following ICD-10-CM procedure codes
to identify cases involving TAVR procedures, which are potential cases
representing patients who may be eligible for treatment involving use
of the Sentinel[reg] Cerebral Protection System: 02RF37Z (Replacement
of aortic valve with autologous tissue substitute, percutaneous
approach); 02RF38Z (Replacement of aortic valve with zooplastic tissue,
percutaneous approach); 02RF3JZ (Replacement of aortic valve with
synthetic substitute, percutaneous approach); 02RF3KZ (Replacement of
aortic valve with nonautologous tissue substitute, percutaneous
approach); 02RF37H (Replacement of aortic valve with autologous tissue
substitute, transapical, percutaneous approach ); 02RF38H (Replacement
of aortic valve with zooplastic tissue, transapical, percutaneous
approach); 02RF3JH (Replacement of aortic valve with synthetic
substitute, transapical, percutaneous approach); and 02RF3KH
(Replacement of aortic valve with nonautologous tissue substitute,
transapical, percutaneous approach). This process resulted in 26,012
potential cases. The applicant limited its search to MS-DRG 266
(Endovascular Cardiac Valve Replacement with MCC) and MS-DRG 267
(Endovascular Cardiac Valve Replacement without MCC) because these two
MS-DRGs accounted for 97.4 percent of the total cases identified.
Using the 26,012 identified cases, the applicant determined that
the average unstandardized case-weighted charge per case was $211,261.
No charges were removed for the prior technology because the device is
used to capture
[[Page 20337]]
and remove thrombus and debris while performing TAVR procedures. The
applicant then standardized the charges, but did not inflate the
charges. The applicant then added charges for the new technology to the
average case-weighted standardized charges per case by taking the cost
of the device and dividing the amount by the CCR of 0.332 for
implantable devices from the FY 2018 IPPS/LTCH PPS final rule (82 FR
38103). The applicant calculated a final inflated average
case[dash]weighted standardized charge per case of $187,707 and a Table
10 average case[dash]weighted threshold amount of $170,503. Because the
final inflated average case-weighted standardized charge per case
exceeded the average case-weighted threshold amount, the applicant
maintained that the technology meets the cost criterion. We are
inviting public comments on whether the Sentinel[reg] Cerebral
Protection System meets the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that the Sentinel[reg] Cerebral Protection System
represents a substantial clinical improvement over existing
technologies because it is the first and only cerebral embolic
protection device commercially available in the United States for use
during TAVR procedures. The applicant stated that the data below shows
that the Sentinel[reg] Cerebral Protection System effectively captures
brain bound embolic debris and significantly improves clinical outcomes
(that is, stroke) beyond the current standard of care, that is, TAVR
procedures with no embolic protection.
The applicant provided the results of four key studies: (1) The
SENTINEL[reg] study \172\ conducted by Claret Medical, Inc.; (2) the
CLEAN[dash]TAVI trial; \173\ (3) the Ulm real-world registry; \174\ and
(4) the MISTRAL-C study.\175\
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\172\ Kapadia, S., Kodali, S., Makkar, R., et al., ``Protection
against cerebral embolism during transcatheter aortic valve
replacement,'' JACC, 2017, vol. 69(4), pp. 367-377.
\173\ Haussig, S., Mangner, N., Dwyer, M.G., et al., ``Effect of
a Cerebral Protection Device on Brain Lesions Following
Transcatheter Aortic Valve Implantation in Patients With Severe
Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial,'' JAMA,
2016, vol. 316, pp. 592-601.
\174\ Seeger, J., et al., ``Cerebral Embolic Protection During
Transfemoral Aortic Valve Replacement Significantly Reduces Death
and Stroke Compared With Unprotected Procedures,'' JACC Cardiovasc
Interv, 2017, in press.
\175\ Mieghem, Van, et al., ``Filter-based cerebral embolic
protection with transcatheter aortic valve implantation: the
randomized MISTRAL-C trial,'' Eurointervention, 2016, vol. 12(4),
pp. 499-507.
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The applicant reported that the SENTINEL[reg] study was a
prospective, single blind, multi-center, randomized study using the
Sentinel[reg] Cerebral Protection System which enrolled patients who
had been diagnosed with severe symptomatic calcified native aortic
valve stenosis indicated for a TAVR procedure. A total of 363 patients
at 19 centers in the United States and Germany were randomized across 3
arms (Safety, Test, and Control) in a 1:1:1 fashion. According to the
applicant, evaluations performed for patients in each arm were as
follows:
Safety Arm patients who underwent a TAVR procedure
involving the Sentinel[reg] Cerebral Protection System--Patients
enrolled in this arm of the study received safety follow-up at
discharge, at 30 days and 90 days post-procedure; and neurological
evaluation at baseline, discharge, 30 days and 90 days (only in the
case of a stroke experienced less than or equal to 30 days) post-
procedure. The Safety Arm patients did not undergo MRI or
neurocognitive assessments.
Test Arm patients who underwent a TAVR procedure involving
the Sentinel[reg] Cerebral Protection System--Patients enrolled in this
arm of the study underwent safety follow-up at discharge, at 30 days
and 90 days post-procedure; MRI assessment for efficacy at baseline, 2
to 7 days and 30 days post-procedure; neurological evaluation at
baseline, discharge, 30 days and 90 days (only in the case of a stroke
experienced less than or equal to 30 days) post-procedure;
neurocognitive evaluation at baseline, 2 to 7 days (optional), 30 days
and 90 days post-procedure; Quality of Life assessment at baseline, 30
days and 90 days; and histopathological evaluation of debris captured
in the Sentinel[reg] Cerebral Protection System's device filters.
Control Arm patients who underwent a TAVR procedure only--
Patients enrolled in this arm of the study underwent safety follow-up
at discharge, at 30 days and 90 days post-procedure; MRI assessment for
efficacy at baseline, 2 to 7 days and 30 days post-procedure;
neurological evaluation at baseline, discharge, 30 days and 90 days
(only in the case of a stroke experienced less than or equal to 30
days) post-procedure; neurocognitive evaluation at baseline, 2 to 7
days (optional), 30 days and 90 days post[dash]procedure; and Quality
of Life assessment at baseline, 30 days and 90 days.
The primary safety endpoint was occurrence of major adverse cardiac
and cerebrovascular events (MACCE) at 30 days compared with a
historical performance goal. MACCE was defined as follows: All causes
of death; all strokes (disabling and nondisabling, Valve Academic
Research Consortium-2 (VARC-2)); and acute kidney injury (stage 3,
VARC-2). The point estimate for the historical performance goal for the
primary safety endpoint at 30 days post-TAVR procedure was derived from
a review of published reports of 30-day TAVR procedure outcomes. The
VARC-2 established an independent collaboration between academic
research organizations and specialty societies (cardiology and cardiac
surgery) in the United States and Europe to create consistent endpoint
definitions and consensus recommendations for implementation in TAVR
procedure clinical research.\176\
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\176\ Leon, M.B., Piazza, N., Nikolsky, E., et al.,
``Standardized endpoint definitions for transcatheter aortic valve
implantation clinical trials: a consensus report from the Valve
Academic Research Consortium,'' European Heart Journal, 2011, vol.
32(2), pp. 205-217, doi:10.1093/eurheartj/ehq406.
---------------------------------------------------------------------------
The applicant reported that results of the SENTINEL[reg] study
demonstrated the following:
The rate of MACCE was numerically lower than the control
arm, 7.3 percent versus 9.9 percent, but was not statistically
significant from that of the control group (p = 0.41).
New lesion volume was 178.0 mm\3\ in control patients and
102.8 mm\3\ in the Sentinel[reg] Cerebral Protection System device arm
(p = 0.33). A post[dash]hoc multi[dash]variable analysis identified
preexisting lesion volume and valve type as predictors of new lesion
volume.
Strokes experienced at 30 days were 9.1 percent in control
patients and 5.6 percent in patients treated with the Sentinel[reg]
Cerebral Protection System devices (p = 0.25). Neurocognitive function
was similar in control patients and patients treated with the
Sentinel[reg] Cerebral Protection System devices, but there was a
correlation between lesion volume and neurocognitive decline (p =
0.0022).
Debris was found within filters in 99 percent of patients
and included thrombus, calcification, valve tissue, artery wall, and
foreign material.
The applicant also noted that the post-hoc analysis of
this data demonstrated that there was a 63 percent reduction in 72-hour
stroke rate (compared to control), p = 0.05.
According to the applicant, the CLEAN-TAVI (Claret Embolic
Protection and TAVI) trial, was a small, randomized, double-blind,
controlled trial. The trial consisted of 100 patients assigned to
either EP (n = 50) with the Claret Medical, Inc. device (the
Sentinel[reg] Cerebral Protection System) or to no EP (n = 50).
Patients were all
[[Page 20338]]
treated with femoral access and self-expandable (SE) devices. The study
endpoint was the number of brain lesions at 2 days post[dash]procedure
versus baseline. Patients were evaluated with DW[dash]MRI at 2 and 7
days post[dash]TAVR procedure. The mean age of patients was 80 years
old; 43 percent were male. The study results showed that patients
treated with the Sentinel[reg] Cerebral Protection System had a lower
number of new lesions (4.00) than patients in the control group (10.0);
(p<0.001).
According to the applicant, the single-center Ulm study, a large
propensity matched trial, with 802 consecutive patients, occurred at
the University of Ulm between 2014 and 2016. The first 522 patients
(65.1 percent of patients) underwent a TAVR procedure without EPs, and
the subsequent 280 patients (34.9 percent of patients) underwent a TAVR
procedure with EP involving the Sentinel[reg] Cerebral Protection
System. For both arms of the study, a TAVR procedure was performed in
identical settings except without cerebral EP, and neurological follow-
up was performed within 7 days post-procedure. The primary endpoint was
a composite of all-cause mortality or all-stroke according to the VARC-
2 criteria within 7 days. The authors who documented the study noted
the following:
Patient baseline characteristics and aortic valve
parameters were similar between groups, that both filters of the device
were successfully positioned in 280 patients, all neurological follow-
up was completed by the 7th post-procedure date, and that propensity
score matching was performed to account for possible confounders.
Results indicated a decreased rate of disabling and
nondisabling stroke at 7 days post[dash]procedure was seen in those
patients who were treated with the Sentinel[reg] Cerebral Protection
System device versus control patients (1.6 percent versus 4.6 percent,
p = 0.03).
At 48 hours, stroke rates were lower with patients treated
with the Sentinel[reg] Cerebral Protection System device versus control
patients (1.1 percent versus 3.6 percent, p = 0.03).
In multi[dash]variate analysis, TAVR procedures performed
without the use of a EP device was found to be an independent predictor
of stroke within 7 days (p = 0.04).
The aim of the MISTRAL-C study was to determine if the
Sentinel[reg] Cerebral Protection System affects new brain lesions and
neurocognitive performance after TAVR procedures. The study was
designed as a multi-center, double-blind, randomized trial enrolling
patients who were diagnosed with symptomatic severe aortic stenosis and
1:1 randomization to TAVI patients treated with or without the
Sentinel[reg] Cerebral Protection System. From January 2013 to August
2015, 65 patients were enrolled in the study. Patients ranged in age
from 77 years old to 86 years old, 15 (47 percent) were female and 17
(53 percent) were male patients randomized to the Sentinel[reg]
Cerebral Protection System group and 16 (49 percent) were female and 17
(51 percent) were male patients randomized to the control group. There
were 3 mortalities between 5 days and 6 months post[dash]procedure for
the Sentinel[reg] Cerebral Protection System group. There were no
strokes reported for the Sentinel[reg] Cerebral Protection System
group. There were 7 mortalities between 5 days and 6 months
post[dash]procedure for the control group. There were 2 strokes
reported for the control group. Patients underwent DW-MRI and
neurological examination, including neurocognitive testing 1 day before
and 5 to 7 days after TAVI. Follow-up DW-MRI and neurocognitive testing
was completed in 57 percent of TAVI patients treated with the
Sentinel[reg] Cerebral Protection System and 80 percent for the group
of TAVI patients treated without the Sentinel[reg] Cerebral Protection
System. New brain lesions were found in 78 percent of the patients with
follow-up MRI. According to the applicant, patients treated with the
Sentinel[reg] Cerebral Protection System had numerically fewer new
lesions and a smaller total lesion volume (95 mm3 versus 197 mm3).
Overall, 27 percent of the patients treated with the Sentinel[reg]
Cerebral Protection System and 13 percent of the patients treated in
the control group had no new lesions. Ten or more new brain lesions
were found only in the patients treated in the control group (20
percent in the control group versus 0 percent in the Sentinel[reg]
Cerebral Protection System group, p = 0.03). Neurocognitive
deterioration was present in 4 percent of the patients treated with the
Sentinel[reg] Cerebral Protection System versus 27 percent of the
patients treated without (p=0.017). The filters captured debris in all
of the patients treated with Sentinel[reg] Cerebral Protection System
device.
In the Ulm study, the primary outcome was a composite of all-cause
mortality or stroke at 7 days, and occurred in 2.1 percent of the
Sentinel[reg] Cerebral Protection System group versus 6.8 percent of
the control group (p = 0.01, number needed to treat (NNT) = 21). Use of
the Sentinel[reg] Cerebral Protection System device was associated with
a 2.2 percent absolute risk reduction in mortality with NNT 45.
Composite endpoint of major adverse cardiac and cerebrovascular events
(MACCE) was found in 2.1 percent of those patients undergoing a TAVR
procedure with the use of the Sentinel[reg] Cerebral Protection System
device versus 7.9 percent in the control group (p = 0.01). Similar but
statistically nonsignificant trends were found in the SENTINEL[reg]
study, with rate of MACCE of 7.3 percent in the Sentinel[reg] Cerebral
Protection System group versus 9.9 percent in the control group (p =
0.41).
The applicant reported that the four studies discussed above that
evaluated the Sentinel[reg] Cerebral Protection System device have
limitations because they are either small, nonrandomized and/or had
significant loss to follow[dash]up. A meta-analysis of EP device
studies, the majority of which included use of the Sentinel[reg]
Cerebral Protection System device, found that use of cerebral EP
devices was associated with a nonsignificant reduction in stroke and
death.\177\
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\177\ Giustino, G., et al., ``Neurological Outcomes With Embolic
Protection Devices in Patients Undergoing Transcatheter Aortic Valve
Replacement,'' Journal of the American College of Cardiology:
Cardiovascular Interventions, 2016, vol. 9(20), pp. 2124-2133.
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We are concerned that the use of cerebral protection devices may
not be associated with a significant reduction in stroke and death. We
note that the SENTINEL[reg] study, although a randomized study, did not
meet its primary endpoint, as illustrated by nonstatistically
significant reduction in new lesion volume on MRI or nondisabling
strokes within 30 days (5.6 percent stroke rate in the Sentinel[reg]
Cerebral Protection System device group versus a 9.1 percent stroke
rate in the control group at 30 days; p = 0.25). We also note that only
with a post[dash]hoc analysis of the SENTINEL[reg] study data were
promising trends noted, where the device use was associated with a 63
percent reduction in stroke events at 72 hours (p = 0.05).
Additionally, although there was a statistically significant difference
between the patients treated with and without cerebral embolic
protection in the composite of all-cause mortality or stroke at 7 days,
the Ulm study was a nonrandomized study and propensity matching was
performed during analyses. We are concerned that studies involving the
Sentinel[reg] Cerebral Protection System may be inconclusive regarding
whether the device represents a substantial clinical improvement for
patients undergoing TAVR procedures. We also are concerned that the
SENTINEL[reg] studies did not show a substantial decrease in
neurological
[[Page 20339]]
complications for patients undergoing TAVR procedures. We are inviting
public comments on whether the Sentinel[reg] Cerebral Protection System
meets the substantial clinical improvement criterion.
Below we summarize and respond to a written public comment we
received regarding the Sentinel[reg] Cerebral Protection System during
the open comment period in response to the New Technology Town Hall
meeting notice published in the Federal Register.
Comment: One commenter noted that the TriGUARD device, a similar
device to the Sentinel[reg] Cerebral Protection System device, has been
commercially available throughout Europe and its member countries,
including the United Kingdom since June 29, 2013. The commenter
indicated that the TriGUARD device received its Israel Medical Device
Registration and Approval (AMAR) on November 5, 2015. The commenter
asserted that because the Sentinel[reg] Cerebral Protection System is
the first and only cerebral EP device commercially available in the
United States for use during TAVR procedures it represents a
substantial clinical improvement over currently available and existing
technologies.
Response: We appreciate the information provided by the commenter.
We will take this information into consideration when deciding whether
to approve new technology add-on payments for the Sentinel[reg]
Cerebral Protection System for FY 2019.
l. AZEDRA[reg] (Ultratrace[reg] Iobenguane Iodine-131) Solution
Progenics Pharmaceuticals, Inc. submitted an application for new
technology add-on payments for AZEDRA[reg] (Ultratrace[reg] iobenguane
Iodine-131) for FY 2019. AZEDRA[reg] is a drug solution formulated for
intravenous (IV) use in the treatment of patients who have been
diagnosed with obenguane avid malignant and/or recurrent and/or
unresectable pheochromocytoma and paraganglioma. AZEDRA[reg] contains a
small molecule ligand consisting of meta-iodobenzylguanidine (MIBG) and
\131\Iodine (\131\I) (hereafter referred to as ``\131\I-MIBG''). The
applicant noted that iobenguane Iodine-131 is also known as \131\I-
MIBG).
The applicant reported in its application that pheochromocytomas
and paragangliomas are rare tumors with an incidence of approximately 2
to 8 people per million per year.178 179 Both tumors are
catecholamine[dash]secreting neuroendocrine tumors, with
pheochromocytomas being the more common of the two and comprising 80 to
85 percent of cases. While 10 percent of pheochromocytomas are
malignant, whereby ``malignant'' is defined by the World Health
Organization (WHO) as ``the presence of distant metastases,''
paragangliomas have a malignancy frequency of 25
percent.180 181 Approximately one-half of malignant tumors
are pronounced at diagnosis, while other malignant tumors develop
slowly within 5 years.\182\ Pheochromocytomas and paragangliomas tend
to be indistinguishable at the cellular level and frequently at the
clinical level. For example catecholamine-secreting paragangliomas
often present clinically like pheochromocytomas with hypertension,
episodic headache, sweating, tremor, and forceful palpitations.\183\
Although pheochromocytomas and paragangliomas can share overlapping
histopathology, epidemiology, and molecular pathobiology
characteristics, there are differences between these two neuroendocrine
tumors in clinical behavior, aggressiveness and metastatic potential,
biochemical findings and association with inherited genetic syndrome
differences, highlighting the importance of distinguishing between the
presence of malignant pheochromocytoma and the presence of malignant
paraganglioma. At this time, there is no curative treatment for
malignant pheochromocytomas and paragangliomas. Successful management
of these malignancies requires a multidisciplinary approach of
decreasing tumor burden, controlling endocrine activity, and treating
debilitating symptoms. According to the applicant, decreasing
metastatic tumor burden would address the leading cause of mortality in
this patient population, where the 5-year survival rate is 50 percent
for patients with untreated malignant pheochromocytomas and
paragangliomas.\184\ The applicant stated that controlling
catecholamine hypersecretion (for example, severe paroxysmal or
sustained hypertension, palpitations and arrhythmias) would also mean
decreasing morbidity associated with hypertension (for example, risk of
stroke, myocardial infarction and renal failure), and begin to address
the 30-percent cardiovascular mortality rate associated with malignant
pheochromocytomas and paragangliomas.
---------------------------------------------------------------------------
\178\ Beard, C.M., Sheps, S.G., Kurland, L.T., Carney, J.A.,
Lie, J.T., ``Occurrence of pheochromocytoma in Rochester,
Minnesota'', pp. 1950-1979.
\179\ Stenstr[ouml]m, G., Sv[auml]rdsudd, K., ``Pheochromocytoma
in Sweden 1958-1981. An analysis of the National Cancer Registry
Data,'' Acta Medica Scandinavica, 1986, vol. 220(3), pp. 225-232.
\180\ Fishbein, Lauren, ``Pheochromocytoma and Paraganglioma,''
Hematology/Oncology Clinics 30, no. 1, 2016, pp. 135-150.
\181\ Lloyd, R.V., Osamura, R.Y., Kl[ouml]ppel, G., & Rosai, J.
(2017). World Health Organization (WHO) Classification of Tumours of
Endocrine Organs. Lyon, France: International Agency for Research on
Center (IARC).
\182\ Kantorovich, Vitaly, and Karel Pacak. ``Pheochromocytoma
and paraganglioma.'' Progress in Brain Research., 2010, vol. 182,
pp. 343-373.
\183\ Carty, S.E., Young, W.F., Elfky, A., ``Paraganglioma and
pheochromocytoma: Management of malignant disease,'' UpToDate.
Available at: https://www.uptodate.com/contents/paraganglioma-and-pheochromocytoma-management-of-malignant-disease.
\184\ Kantorovich, Vitaly, and Karel Pacak. ``Pheochromocytoma
and paraganglioma.'' Progress in Brain Research., 2010, vol. 182,
pp. 343-373.
---------------------------------------------------------------------------
The applicant reported that, at this time, controlling
catecholamine activity in pheochromocytomas and paragangliomas is
medically achieved with administration of combined alpha and beta-
adrenergic blockade, and surgically with tumor tissue reduction.
Because there is no curative treatment for malignant pheochromocytomas
and paragangliomas, resecting both primary and metastatic lesions
whenever possible to decrease tumor burden \185\ provides a methodology
for controlling catecholamine activity and lowering cardiovascular
mortality risk. Besides surgical removal of tumor tissue for lowering
tumor burden, there are other treatment options that depend upon tumor
type (that is, pheochromocytoma tumors versus paraganglioma tumors),
anatomic location, and the number and size of the metastatic tumors.
Currently, these treatment options include: (1) Radiation therapy; (2)
nonsurgical local ablative therapy with radiofrequency ablation,
cryoablation, and percutaneous ethanol injection; (3) transarterial
chemoembolization for liver metastases; and (4) radionuclide therapy
using metaiodobenzylguanidine (MIBG) or somatostatin. Regardless of the
method to reduce local tumor burden, periprocedural medical care is
needed to prevent massive catecholamine secretion and hypertensive
crisis.\186\
---------------------------------------------------------------------------
\185\ Noda, T., Nagano, H., Miyamoto, A., et al., ``Successful
outcome after resection of liver metastasis arising from an
extraadrenal retroperitoneal paraganglioma that appeared 9 years
after surgical excision of the primary lesion,'' Int J Clin Oncol,
2009, vol. 14, pp. 473.
\186\ Carty, S.E., Young, W.F., Elfky, A., ``Paraganglioma and
pheochromocytoma: Management of malignant disease,'' UpToDate.
Available at: https://www.uptodate.com/contents/paraganglioma-and-pheochromocytoma-management-of-malignant-disease.
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[[Page 20340]]
The applicant stated that AZEDRA[reg] specifically targets
neuroendocrine tumors arising from chromaffin cells of the adrenal
medulla (in the case of pheochromocytomas) and from neuroendocrine
cells of the extra-adrenal autonomic paraganglia (in the case of
paraganglioms).\187\ According to the applicant, AZEDRA[reg] is a more
consistent form of \131\I-MIBG compared to compounded formulations of
\131\I-MIBG that are not currently approved by the FDA. If approved by
the FDA, the applicant asserted that AZEDRA[reg] would be the only drug
indicated for use in the treatment of patients, who if left untreated,
experience debilitating clinical symptoms and high mortality rates from
iobenguane avid malignant and/or recurrent and/or unresectable
pheochromocytoma and paraganglioma tumors.
---------------------------------------------------------------------------
\187\ Ibid.
---------------------------------------------------------------------------
Among local tumor tissue reduction options, use of external beam
radiation therapy (ERBT) at doses greater than 40 Gy can provide local
pheochromocytoma and paraganglioma tumor control and relief of symptoms
for tumors at a variety of sites, including the soft tissues of the
skull base and neck, abdomen, and thorax, as well as painful bone
metastases.\188\ However, the applicant stated that ERBT irradiated
tissues are unresponsive to subsequent treatment with \131\I-MIBG
radionuclide.\189\ MIBG was initially used for the imaging of
paragangliomas and pheochromocytomas because of its similarity to
noradrenaline, which is taken up by chromaffin cells. Conventional MIBG
used in imaging expanded to off-label compassionate use in patients who
had been diagnosed with malignant pheochromocytomas and paragangliomas.
Because \131\I-MIBG is sequestered within pheochromocytoma and
paraganglioma tumors, subsequent malignant cell death occurs from
radioactivity. Approximately 50 percent of tumors are eligible for
\131\I-MIBG therapy based on having MIBG uptake with diagnostic
imaging. According to the applicant, despite uptake by tumors, studies
have also found that \131\I-MIBG therapy has been limited by total
radiation dose, hematologic side effects, and hypertension. While the
pathophysiology of total radiation dose and hematologic side effects
are more readily understandable, hypertension is believed to be
precipitated by large quantities of non[dash]iodinated MIBG or ``cold''
MIBG being introduced along with radioactive \131\I-MIBG therapy.\190\
The ``cold'' MIBG blocks synaptic reuptake of norepinephrine, which can
lead to tachycardia and paroxysmal hypertension within the first 24
hours, the majority of which occur within 30 minutes of administration
and can be dose-limiting.\191\
---------------------------------------------------------------------------
\188\ Ibid.
\189\ Fitzgerald, P.A., Goldsby, R.E., Huberty, J.P., et al.,
``Malignant pheochromocytomas and paragangliomas: a phase II study
of therapy with high-dose 131I-metaiodobenzylguanidine (131I-
MIBG),'' Ann N Y Acad Sci, 2006, vol. 1073, pp. 465.
\190\ Loh, K.C., Fitzgerald, P.A., Matthay, K.K., Yeo, P.P.,
Price, D.C., ``The treatment of malignant pheochromocytoma with
iodine-131 metaiodobenzylguanidine (\131\I-MIBG): a comprehensive
review of 116 reported patients,'' J Endocrinol Invest, 1997, vol.
20(11), pp. 648-658.
\191\ Gonias, S, et al., ``Phase II Study of High-Dose
[\131\I]Metaiodobenzylguanidine Therapy for Patients With Metastatic
Pheochromocytoma and Paraganglioma,'' J of Clin Onc, July 27, 2009.
---------------------------------------------------------------------------
The applicant asserted that its new proprietary manufacturing
process called Ultratrace[reg] allows AZEDRA[reg] to be manufactured
without the inclusion of unlabeled or ``cold'' MIBG in the final
formulation. The applicant also noted that targeted radionuclide MIBG
therapy to reduce tumor burden is one of two treatments that have been
studied the most. The other treatment is cytotoxic chemotherapy and,
specifically, Carboplatin, Vincristine, and Dacarbazine (CVD). The
applicant stated that cytotoxic chemotherapy is an option for patients
who experience symptoms with rapidly progressive, non-resectable, high
tumor burden, or that cytoxic chemotherapy is another option for a
large number of metatstatic bone lesions.\192\ According to the
applicant, CVD was believed to have an effect on malignant
pheochromocytomas and paragangliomas due to the embryonic origin being
similar to neuroblastomas. The response rates to CVD have been variable
between 25 percent and 50 percent.193 194 These patients
experience side effects consistent with chemotherapeutic treatment with
CVD, with the added concern of the precipitation of hormonal
complications such as hypertensive crisis, thereby requiring close
monitoring during cytotoxic chemotherapy.\195\ According to the
applicant, use of CVD relative to other tumor burden reduction options
is not an ideal treatment because of nearly 100 percent recurrence
rates, and the need for chemotherapy cycles to be continually
readministered at the risk of increased systemic toxicities and
eventual development of resistance. Finally, there is a subgroup of
patients that are asymptomatic and have slower progressing tumors where
frequent follow-up is an option for care.\196\ Therefore, the applicant
believed that AZEDRA[reg] offers cytotoxic radioactive therapy for the
anticipated indicated population that avoids harmful side effects that
typically result from use of low-specific activity products.
---------------------------------------------------------------------------
\192\ Carty, S.E., Young, W.F., Elfky, A., ``Paraganglioma and
pheochromocytoma: Management of malignant disease,'' UpToDate.
Available at: https://www.uptodate.com/contents/paraganglioma-and-pheochromocytoma-management-of-malignant-disease.
\193\ Niemeijer, N.D., Alblas, G., Hulsteijn, L.T., Dekkers,
O.M. and Corssmit, E.P.M., ``Chemotherapy with cyclophosphamide,
vincristine and dacarbazine for malignant paraganglioma and
pheochromocytoma: systematic review and meta[hyphen]analysis,''
Clinical endocrinology, 2014, vol 81(5), pp. 642-651.
\194\ Ayala-Ramirez, Montserrat, et al., ``Clinical Benefits of
Systemic Chemotherapy for Patients with Metastatic Pheochromocytomas
or Sympathetic Extra-Adrenal Paragangliomas: Insights from the
Largest Single Institutional Experience,'' Cancer, 2012, vol.
118(11), pp. 2804-2812.
\195\ Wu, L.T., Dicpinigaitis, P., Bruckner, H., et al.,
``Hypertensive crises induced by treatment of malignant
pheochromocytoma with a combination of cyclophosphamide,
vincristine, and dacarbazine,'' Med Pediatr Oncol, 1994, vol. 22(6),
pp. 389-392.
\196\ Carty, S.E., Young, W.F., Elfky, A., ``Paraganglioma and
pheochromocytoma: Management of malignant disease,'' UpToDate.
Available at: https://www.uptodate.com/contents/paraganglioma-and-pheochromocytoma-management-of-malignant-disease.
---------------------------------------------------------------------------
The applicant reported that the anticipated and recommended
AZEDRA[reg] dosage and frequency for patients receiving treatment
involving \131\I-MIBG therapy for a diagnosis of avid malignant and/or
recurrent and/or unresectable pheochromocytoma and paraganglioma tumors
is:
Dosimetric Dosing--5 to 6 micro curies (mCi) (185 to 222
MBq) for a patient weighing more than or equal to 50 kg, and 0.1 mCi/kg
(3.7 MBq/kg) for patients weighing less than 50 kg. Each recommended
dosimetric dose is administered as an IV injection.
Therapeutic Dosing--500 mCi (18.5 GBq) for patients
weighing more than 62.5 kg, and 8 mCi/kg (296 MBq/kg) for patients
weighing less than or equal to 62.5 kg. Therapeutic doses are
administered by IV infusion, in ~50 mL over a period of ~30 minutes
(100 mL/hour), administered approximately 90 days apart.
With respect to the newness criterion, the applicant indicated that
FDA granted Orphan Drug designation for AZEDRA[reg] on January 18,
2006, followed by Fast Track designation on March 8, 2006, and
Breakthrough Therapy designation on July 26, 2015. The applicant's New
Drug Application (NDA) proceeded on a rolling basis, and was completed
on November 2, 2017.
[[Page 20341]]
However, at the time of the development of this proposed rule, the
applicant indicated that it had not yet received FDA approval for the
indicated use of AZEDRA[reg]. The applicant stated that it anticipates
FDA approval by June 30, 2018. Currently, there are no approved ICD-10-
PCS procedure codes to uniquely identify procedures involving the
administration of AZEDRA[reg].
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, the applicant stated that while
AZEDRA[reg] and low[dash]specific activity conventional I-131 MIBG both
target the same transporter sites on the tumor cell surface, the
therapies' safety and efficacy outcomes are different. These
differences in outcomes are because AZEDRA[reg] is manufactured using
the proprietary Ultratrace[reg] technology, which maximizes the
molecules that carry the tumoricidal component (I-131 MIBG, the
warhead) and minimizes the extraneous unlabeled component (MIBG, free
ligands), which could cause cardiovascular side effects. Therefore,
according to the applicant, AZEDRA[reg] is designed to increase
efficacy and decrease safety risks, whereas conventional I-131 MIBG
uses existing technologies and results in a product that overwhelms the
normal reuptake system with excess free ligands, which leads to safety
issues as well as decreasing the probability of the warhead binding to
the tumor cells.
With regard to the second criterion, whether a product is assigned
to the same or a different DRG, the applicant noted that there are no
specific MS-DRGs for the assignment of cases involving the treatment of
patients who have been diagnosed with pheochromocytoma and
paraganglioma. We believe that potential cases representing patients
who may be eligible for treatment involving the administration of
AZEDRA[reg] would be assigned to the same MS-DRGs as cases representing
patients who receive treatment for obenguane avid malignant and/or
recurrent and/or unresectable pheochromocytoma and paraganglioma. We
also refer readers to the cost criterion discussion below, which
includes the applicant's list of the MS-DRGs that potential cases
involving treatment with the administration of AZEDRA[reg] most likely
would map.
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, if approved,
AZEDRA[reg] would be the only FDA-approved drug indicated for use in
the treatment of patients who have been diagnosed with malignant
pheochromocytoma and paraganglioma tumors that avidly take up \131\I-
MIBG and are recurrent and/or unresectable. The applicant stated that
these patients face serious mortality and morbidity risks if left
untreated, as well as potentially suffer from side effects if treated
by available off-label therapies.
The applicant also contended that AZEDRA[reg] can be distinguished
from other currently available treatments because it potentially
provides the following advantages:
AZEDRA[reg] will have a very limited impact on normal
norepinephrine reuptake due to the negligible amount of unlabeled MIBG
present in the dose. Therefore, AZEDRA[reg] is expected to pose a much
lower risk of acute drug-induced hypertension.
There is minimal unlabeled MIBG to compete for the
norepinephrine transporter binding sites in the tumor, resulting in
more effective delivery of radioactivity.
Current off-label therapeutic use of \131\I is compounded
by individual pharmacies with varied quality and conformance standards.
Because of its higher specific activity (the activity of a
given radioisotope per unit mass), AZEDRA[reg] infusion times are
significantly shorter than conventional \131\I administrations.
Therefore, with these potential advantages, the applicant
maintained that AZEDRA[reg] represents an effective option for the
treatment of patients who have been diagnosed with malignant and/or
recurrent and/or unresectable pheochromocytoma and paraganglioma
tumors, where there is a clear, unmet medical need.
For the reasons cited earlier, the applicant believed that
AZEDRA[reg] is not substantially similar to other currently available
therapies and/or technologies and meets the ``newness'' criterion. We
are inviting public comments on whether AZEDRA[reg] is substantially
similar to other currently available therapies and/or technologies and
meets the ``newness'' criterion.
The applicant reported that it conducted an analysis using FY 2015
MedPAR data to demonstrate that AZEDRA[reg] meets the cost criterion.
The applicant searched for potential cases representing patients who
may be eligible for treatment involving AZEDRA[reg] that had one of the
following ICD-9-CM diagnosis codes (which the applicant believed is
indicative of diagnosis appropriate for treatment involving
AZEDRA[reg]): 194.0 (Malignant neoplasm of adrenal gland), 194.6
(Malignant neoplasm of aortic body and other paraganglia), 209.29
(Malignant carcinoid tumor of other sites), 209.30 (Malignant poorly
differentiated neuroendocrine carcinoma, any site), 227.0 (Benign
neoplasm of adrenal gland), 237.3 (Neoplasm of uncertain behavior of
paraganglia)--in combination with one of the following ICD-9-CM
procedure codes describing the administration of a radiopharmaceutical:
00.15 (High-dose infusion interleukin-2); 92.20 (Infusion of liquid
brachytherapy radioisotope); 92.23 (Radioisotopic teleradiotherapy);
92.27 (Implantation or insertion of radioactive elements); 92.28
(Injection or instillation of radioisotopes). The applicant stated that
the combination of these diagnosis and procedure codes in this process
was intended to identify potential cases representing patients who had
been diagnosed with a correlating condition relating to AZEDRA[reg]'s
intended treatment use and who had received subsequent treatment with a
predecessor radiopharmaceutical therapy (such as, for example, a
potential off-label use of conventional I-131 MIBG therapy) for
malignant and/or recurrent pheochromocytoma and paraganglioma tumors.
The applicant reported that the potential cases used for the cost
analysis mapped to MS-DRGs 054 and 055 (Nervous System Neoplasms with
and without MCC, respectively), MS-DRG 271 (Other Major Cardiovascular
Procedures with CC), MS-DRG 436 (Malignancy of Hepatobiliary System or
Pancreas with CC), MS-DRG 827 (Myeloproliferated Disorder or Poorly
Differentiated Neoplasm with Major O.R. Procedure with CC), and MS-DRG
843 (Other Myeloproliferated Disorder or Poorly Differentiated Neoplasm
Diagnosis with MCC). Due to patient privacy concerns, the applicant
stated that the MedPAR data did not identify the exact number of cases
assigned to the six identified MS-DRGs. For purposes of its analysis,
the applicant assumed an equal distribution between these six MS-DRGs.
The applicant noted in its application that potential cases that may be
eligible for treatment involving the administration of AZEDRA[reg]
would typically map to other MS-DRGs such as MS-DRGs 643, 644, and 645
(Endocrine Disorders with MCC, with CC, and without CC/MCC,
respectively), and MS-DRG 849 (Radiotherapy).
[[Page 20342]]
However, because data were not available for these MS-DRGs they were
not included in the analysis. Using the identified cases, the applicant
determined that the average unstandardized case[dash]weighted charge
per case was $95,472. The applicant used a 3-year inflation factor of
1.14359 (a yearly inflation factor of 1.04574 applied over 3 years),
based on the FY 2018 IPPS/LTCH PPS final rule (82 FR 38527), to inflate
the charges from FY 2015 to FY 2018. The applicant determined an
inflated average case-weighted standardized charge per case of
$103,833. Because the price of AZEDRA[reg] has yet to be determined,
the applicant did not include the price of the drug in its analysis,
nor did the applicant remove any charges associated with any
predecessor radiopharmaceutical therapy use of MIBG agents. Based on
the FY 2018 IPPS/LTCH PPS Table 10 thresholds, the average case-
weighted threshold amount was $58,352. The applicant contended that
AZEDRA[reg] meets the cost criterion because the inflated average
case[dash]weighted standardized charge per case exceeds the average
case-weighted threshold amount before including the average per patient
cost for the product.
We are concerned with the limited number of cases the applicant
analyzed, and the applicant's inability to determine the exact number
of cases representing patients that potentially may be eligible for
treatment involving AZEDRA[reg] for each MS-DRG. We also are concerned
that the MS-DRGs identified by the applicant's search of the FY 2015
MedPAR data do not match the MS-DRGs that the applicant noted that
potential cases that may be eligible for treatment involving the
administration of AZEDRA[reg] would typically map (MS-DRGs 643, 644,
and 645, and MS-DRG 849). However, we acknowledge the difficulty in
obtaining cost data for such a rare condition. We also note that, for
the six identified MS-DRGs, the applicant's inflated average
case[dash]weighted standardized charge per case of $103,833 exceeded
all individual Table 10 average case[dash]weighted threshold amounts
($97,188 for MS-DRG 271 being the greatest). We are inviting public
comments on whether the AZEDRA[reg] technology meets the cost
criterion.
With regard to substantial clinical improvement, the applicant
maintained that the use of AZEDRA[reg] has been shown to reduce the use
of antihypertensive medications, reduce tumor size, improve blood
pressure control, reduce secretion of tumor biomarkers, and demonstrate
strong evidence of overall survival rates. In addition, the applicant
asserted that AZEDRA[reg] provides a treatment option for those
outlined in its anticipated indication patient population. The
applicant asserted that AZEDRA[reg] meets the substantial clinical
improvement criterion based on the results from two clinical studies:
(1) MIP-IB12 (IB12): A Phase I Study of Iobenguane (MIBG) I-131 in
Patients With Malignant Pheochromocytoma/Paraganglioma; \197\ and (2)
MIP-IB12B (IB12B): A Study Evaluating Ultratrace[reg] Iobenguane I-131
in Patients With Malignant Relapsed/Refractory Pheochromocytoma/
Paraganglioma. The applicant explained that the IB12B study is similar
to the IB12 study in that both studies evaluated two open[dash]label,
single[dash]arm studies. The applicant reported that both studies
included patients who had been diagnosed with malignant and/or
recurrent and/or unresectable pheochromocytoma and Paraganglioma
tumors, and both studies assessed objective tumor response, biochemical
tumor response, overall survival rates, occurrence of hypertensive
crisis, and the long[dash]term benefit of AZEDRA[reg] treatment
relative to the need for antihypertensives. According to the applicant,
the study designs, however, differed in dose regimens (1 dose
administered to patients in the IB12 study, and 2 doses administered to
patients in the IB12B study) and primary study endpoints. Differences
in the designs of the studies prevented direct comparison of study
endpoints and pooling of the data. However, the applicant stated that
results from safety data from the IB12 study and the IB12B study were
pooled and used to support substantial clinical improvement assertions.
We note that the results from neither the IB12 study nor the IB12B
study compared the effects of AZEDRA[reg] to any of the other treatment
options to decrease tumor burden (for example, cytotoxic chemotherapy,
radiation therapy, and surgical debulking).
---------------------------------------------------------------------------
\197\ Noto, Richard B., et al., ``Phase 1 Study of High-
Specific-Activity I-131 MIBG for Metastatic and/or Recurrent
Pheochromocytoma or Paraganglioma (IB12 Phase 1 Study),'' J Clin
Endocrinol Metab, vol. 103(1), pp. 213-220.
---------------------------------------------------------------------------
Regarding the data results from the IB12 study, the applicant
asserted that, based on the reported safety and tolerability, and
primary endpoint of radiological response at 12 months, high-specific-
activity I-131 MIBG may be an effective alternative therapeutic option
for patients who have been diagnosed with iobenguane-avid, metastatic
and/or recurrent pheochromocytoma and paraganglioma tumors for whom
there are no approved therapies and for those patients who have failed
available treatment options. In addition, the applicant used the
exploratory finding of decreased or discontinuation of antihypertensive
medications relative to baseline medications as evidence that
AZEDRA[reg] has clinical benefit and positive impact on the
long[dash]term effects of hypertension induced norepinephrine producing
malignant pheochromocytoma and paraganlioma tumors. We understand that
the applicant used antihypertensive medications as a proxy to assess
the long-term effects of hypertension such as renal, myocardial, and
cerebral end organ damage. The applicant reported that it studied 15 of
the original IB12 study's 21-patient cohort, and found 33 percent (n=5)
had decreased or discontinuation of antihypertensive medications during
the 12 months of follow-up. The applicant did not provide additional
data on the incidence of renal insufficiency/failure, myocardial
ischemic/infarction events, or transient ischemic attacks or strokes.
It was unclear to us if these five patients also had decreased urine
metanephrines, changed their diet, lost significant weight, or if other
underlying comorbidities that influence hypertension were resolved,
making it difficult to understand the significance of this exploratory
finding.
Regarding the applicant's assertion that the use of AZEDRA[reg] is
safer and more effective than alternative therapies, we note that the
IB12 study was a dose-escalating study and did not compare current
therapies with AZEDRA[reg]. We also note the following: (1) The average
age of the 21 enrolled patients in the IB12 study was 50.4 years old (a
range of 30 to 72 years old); (2) the gender distribution was 61.9
percent (n=13) male and 38.1 percent (n=8) female; and (3) 76.2 percent
(n=16) were white, 14.3 percent (n=3) were black or African American,
and 9.5 percent (n=2) were Asian. We agree with the study's conductor
\198\ that the size of the study is a limitation, and with a younger,
predominately white, male patient population, generalization of study
results to a more diverse population may be difficult. The applicant
reported that one other aspect of the patient population indicated that
all 21 patients received prior anti-cancer therapy for treatment of
malignant
[[Page 20343]]
pheochromocytoma and paraganglioma tumors, which included the
following: 57.1 Percent (n=12) received radiation therapy including
external beam radiation and conventional MIBG; 28.6 percent (n=6)
received cytotoxic chemotherapy (for example, CVD and other
chemotherapeutic agents); and 14.3 percent (n=3) received
Octreotide.\199\ Although this population illustrates a population that
has failed some of the currently available therapy options, which may
potentially support a finding of substantial clinical improvement for
those with no other treatment options, we are unclear which patients
benefited from treatment involving AZEDRA[reg], especially in view of
the finding of a Fitzgerald et al. study cited earlier \200\ that
tissues previously irradiated by ERBT were found to be unresponsive to
subsequent treatment with \131\I-MIBG radionuclide. It was not clear in
the application how previously ERBT-treated patients who failed ERBT
fared with the RECIST scores, biotumor marker results, and reduction in
antihypertensive medications. We also lacked information to draw the
same correlation between previously CVD[dash]treated patients and their
RECIST scores, biotumor marker results, and reduction in
antihypertensive medications.
---------------------------------------------------------------------------
\198\ Noto, Richard B., et. al., ``Phase 1 Study of High-
Specific-Activity I-131 MIBG for Metastatic and/or Recurrent
Pheochromocytoma or Paraganglioma (IB12 Phase 1 Study),'' J Clin
Endocrinol Metab, vol. 103(1), pp. 213-220.
\199\ Ibid.
\200\ Fitzgerald, P.A., Goldsby, R.E., Huberty, J.P., et al.,
``Malignant pheochromocytomas and paragangliomas: a phase II study
of therapy with high-dose 131I-metaiodobenzylguanidine (131I-
MIBG).'' Ann N Y Acad Sci, 2006, vol. 1073, pp. 465.
---------------------------------------------------------------------------
The applicant asserted that the use of AZEDRA[reg] reduces tumor
size and reduces the secretion of tumor biomarkers, thereby providing
important clinical benefits to patients. The IB12 study assessed the
overall best tumor response based on Response Evaluation Criteria in
Solid Tumors (RECIST).\201\ Tumor biomarker response was assessed as
complete or partial response for serum chromogranin A and total
metanephrines in 80 percent and 64 percent of patients, respectively,
and the applicant noted that both the overall best tumor response based
on RECIST and tumor biomarker response favorable results are at doses
higher than 500 mCi. We noticed that tumor burden improvement, as
measured by RECIST criteria, showed that none of the 21 patients
achieved a complete response. In addition, although 4 patients showed
partial response, these 4 patients also experienced dose[dash]limiting
toxicity with hematological events, and that all 4 patients received
administered doses greater than 18.5 GBq (500 mCi). We also note that,
regardless of total administered activity (for example, greater than or
less than 18.5 GBq (500 mCi)), 61.9 percent (n=13) of the 21 patients
enrolled in the study had stable disease and 14.3 percent (n=2) of the
14 patients who received greater than administered doses of 18.5 GBq
(500 mCi) had progressive disease. Finally, we also noticed that, for
most tumor markers, there were no dose relationship trends. While we
recognize that there is no FDA-approved therapy for patients who have
been diagnosed with \131\I-MIBG avid malignant and/or recurrent and/or
unresectable pheochromocytoma and paraganglioma tumors, we have
questions as to whether the overall tumor best response and overall
best tumor marker data results from the IB12 study support a finding
that the AZEDRA[reg] technology represents a substantial clinical
improvement.
---------------------------------------------------------------------------
\201\ Therasse, P., Arbuck, S.G., Eisenhauer, J.W., Kaplan,
R.S., Rubinsten, L., Verweij, J., Van Blabbeke, M., Van Oosterom,
A.T., Christian, M.D., and Gwyther, S.G., ``New guidelines to
evaluate the response to treatment in solid tumors,'' J Natl Cancer
Inst, 2000, vol. 92(3), pp. 205-16. Available at: http://www.eortc.be/Services/Doc/RECIST.pdf.
---------------------------------------------------------------------------
Finally, regarding the applicant's assertion that, based on the
IB12 study data, AZEDRA[reg] provides a safe alternative therapy for
those patients who have failed other currently available treatment
therapies, we note that none of the patients experienced hypertensive
crisis, and that 76 percent (n=16) of the 21 patients enrolled in the
study experienced Grade III or IV adverse events. Although the
applicant indicated the adverse events were related to the study drug,
the applicant also noted that there was no statistically significant
difference between the greater than or less than 18.5 GBq administered
doses; both groups had adverse events rates greater than 75 percent.
Specifically, 5 of 7 patients (76 percent) who received less than or
equal to 18.5 GBq administered doses, and 11 of 14 patients (79
percent) who received greater than 18.5 GBq administered doses
experienced Grade III or IV adverse advents. The most common (greater
than or equal to 10 percent) Grade III and IV adverse events were
neutropenia, leukopenia, thrombocytopenia, nausea, and vomiting. We
also note that: (1) There were 5 deaths during the study that occurred
from approximately 2.5 months up to 22 months after treatment and there
was no detailed data regarding the 5 deaths, especially related to the
total activity received during the study; (2) there was no information
about which patients received prior radiation therapy with EBRT and/or
conventional MIBG relative to those who experienced Grade III or IV
adverse events; and (3) the total lifetime radiation dose was not
provided by the applicant. We are inviting public comments on whether
the safety data profile from the IB12 study supports a finding that
AZEDRA[reg] represents a substantial clinical improvement for patients
who received treatment with \131\I-MIBG for a diagnosis of avid
malignant and/or recurrent and/or unresectable pheochromocytoma and
paraganglioma tumors, given the risks for Grade III or IV adverse
events.
The applicant provided study data results from the IB12B study
(MIP-IB12B), an open[dash]label, prospective 5[dash]year follow-up,
single[dash]arm, multi[dash]center, Phase II pivotal study to evaluate
the safety and efficacy of the use of AZEDRA[reg] for the treatment of
patients who have been diagnosed with malignant and/or recurrent
pheochromocytoma and paraganglioma tumors to support substantial
clinical improvement. The applicant reported that IB12B's primary
endpoint is the proportion of patients with a reduction (including
discontinuation) of all antihypertensive medication by at least 50
percent for at least 6 months. Seventy-four patients who received at
least 1 dosimetric dose of AZEDRA[reg] were evaluated for safety and 68
patients who received at least 1 therapeutic dose of AZEDRA[reg], each
at 500 mCi (or 8 mCi/kg for patients weighing less than or equal to
62.5 kg), were assessed for specific clinical outcomes. The applicant
asserted that results from this prospective study met the primary
endpoint (reduction or discontinuation of anti-hypertensive
medications), as well as demonstrated strong supportive evidence from
key secondary endpoints (overall tumor response, tumor biomarker
response, and overall survival rates) that confers important clinical
relevance to patients who have been diagnosed with malignant
pheochromocytoma and paraganlioma tumors. The applicant also indicated
that the use of AZEDRA[reg] was shown to be generally well tolerated at
doses administered at 8 mCi/kg. We note that the data results from the
IB12B study did not have a comparator arm, making it difficult to
interpret the clinical outcome data relative to other currently
available therapies.
As discussed for the IB12 study, the applicant reported that
antihypertension treatment was a proxy for effectiveness of AZEDRA[reg]
on norepinephrine induced hypertension producing tumors. In the IB12B
study, 25 percent (17/68) of patients met the primary
[[Page 20344]]
endpoint of having a greater than 50 percent reduction in
antihypertensive agents for at least 6 months. The applicant further
indicated that an additional 16 patients showed a greater than 50
percent reduction in antihypertensive agents for less than 6 months,
and pooling data results from these 33 patients, the applicant
concluded that 49 percent (33/68) achieved a greater than 50 percent
reduction at any time during the study 12-month follow-up period. The
applicant further compared its data results from the IB12B study
regarding antihypertension medication and the frequency of
post[dash]infusion hypertension with published studies on MIBG and CVD
therapy. The applicant noted a retrospective analysis of CVD therapy of
52 patients who had been diagnosed with metastatic pheochromocytoma and
paraganliom tumors that found only 15 percent of CVD[dash]treated
patients achieved a 50-percent reduction in antihypertensive agents.
The applicant also compared its results for post-infusion hypertension
with literature reporting on MIBG and found 14 and 19 percent
(depending on the study) of patients receiving MIBG experience
hypertension within 24 hours of infusion. Comparatively, the applicant
stated that the use of AZEDRA[reg] had no acute events of hypertension
following infusion. We are inviting public comments on whether these
data results regarding hypertension support a finding that the
AZEDRA[reg] technology represents a substantial clinical improvement,
and if antihypertensive medication reduction is an adequate proxy for
improvement in renal, cerebral, and myocardial end organ damage.
Regarding reduction in tumor burden (as defined by RECIST scores),
the applicant indicated that at the conclusion of the IB12B
12[dash]month follow-up period, 23.4 percent (n=15) of the 68 patients
showed a partial response (PR), 68.8 percent (n=44) of the 68 patients
achieved stable disease (SD), and 4.7 percent (n=3) of the 68 patients
showed progressive disease. None of the patients showed completed
response (CR). The applicant maintained that achieving SD is important
for patients who have been treated for malignant pheochromocytoma and
paraganglioma tumors because this is a progressive disease without a
cure at this time. The applicant also indicated that literature shows
that SD is maintained in approximately 47 percent of treatment
na[iuml]ve patients who have been diagnosed with metastatic
pheochromocytoma and paraganglioma tumors at 1 year due to the indolent
nature of the disease.\202\ In the IB12B study, the data results
equated to 23 percent of patients achieving partial response and 69
percent of patients achieving stable disease. According to the
applicant, this compares favorably to treatment with both conventional
radiolabeled MIBG and CVD chemotherapy.
---------------------------------------------------------------------------
\202\ Hescot, S., Leboulleux, S., Amar, L., Vezzosi, D., Borget,
I., Bournaud-Salinas, C., de la Fouchardiere, C., Lib[eacute], R.,
Do Cao, C., Niccoli, P., Tabarin, A., ``One-year progression-free
survival of therapy-naive patients with malignant pheochromocytoma
and paraganglioma,'' The J Clin Endocrinol Metab, 2013, vol. 98(10),
pp. 4006-4012.
---------------------------------------------------------------------------
The applicant stated that the data results demonstrated effective
tumor response rates. The applicant reported that the IB12 and IB12B
study data showed overall tumor response rates of 80 percent and 92
percent, respectively. In addition, the applicant contended that the
study data across both trials show that patients demonstrated improved
blood pressure control, reductions in tumor biomarker secretion, and
strong evidence in overall survival rates. The overall median time to
death from the first dose was 36.7 months in all treated patients.
Patients who received 2 therapeutic doses had an overall median
survival rate of 48.7 months, compared to 17.5 months for patients who
only received a single dose.
The applicant indicated that comparison of IB12B study data
regarding overall survival rate with historical data is difficult due
to the differences in the retrospective and heterogeneous nature of the
published clinical studies and patient characteristics, especially when
overall survival is calculated from the time of initial diagnosis. We
agree with the applicant regarding the difficulties in comparing the
results of the published clinical studies, and also believe that the
differences in these studies may make it more difficult to evaluate
whether the use of the AZEDRA[reg] technology improves overall survival
rates relative to other therapies.
We acknowledge the challenges with constructing robust clinical
studies due to the extremely rare occurrence of patients who have been
diagnosed with pheochromocytoma and paraganglioma tumors. However, we
are concerned that because the data for both of these studies is mainly
based upon retrospective studies and small, heterogeneous patient
cohorts, it is difficult to draw strong conclusions regarding efficacy.
Only very limited nonpublished data from two, single[dash]arm,
noncomparative studies are available to evaluate the safety and
effectiveness of Ultratrace[reg] I-131 MIBG, leading to a comparison of
outcomes with historical controls. We are inviting public comments on
whether the use of the AZEDRA[reg] technology meets the substantial
clinical improvement criterion, including with respect to the specific
concerns we have raised.
Below we summarize and respond to two written public comments we
received during the open comment period in response to the published
notice in the Federal Register announcing the New Technology Town Hall
Meeting regarding the substantial clinical improvement criterion aspect
of AZEDRA[reg]'s application for new technology add-on payments for FY
2019 below.
Comment: One commenter supported the approval of the application of
AZEDRA[reg] for new technology add-on payments for FY 2019 and its
substantial clinical improvement in the treatment options available for
Medicare beneficiaries. The commenter believed that AZEDRA[reg]
demonstrates a substantial clinical improvement over other available
therapies (as described previously) and meets a current unmet need for
the treatment of patients who have been diagnosed with pheochromocytoma
and paraganglioma. The commenter stated that AZEDRA[reg]'s structure is
unlike the structure of any existing treatment option, given the use of
the Ultratrace[reg] technology which has demonstrated resulting
occurrences of reduced serious cardiovascular side effects and
increased efficacy due to its unique ``carrier-free'' structure.
Another commenter also supported the approval of new technology
add-on payments for AZEDRA[reg] and its substantial clinical
improvement in the treatment options available for Medicare
beneficiaries. This commenter stated that AZEDRA[reg] is much simpler
to administer than low[dash]specific activity I-131 MIBG, offers
quicker and simpler infusions, and provides a rational, personalized,
and effective therapy with promising and highly significant clinical
benefits for patients who have been diagnosed with advanced
pheochromocytoma and paraganglioma.
Response: We appreciate the commenters' input. We will take these
comments into consideration when deciding whether to approve new
technology add-on payments for AZEDRA[reg] for FY 2019.
m. The AquaBeam System (Aquablation)
PROCEPT BioRobotics Corporation submitted an application for new
technology add-on payments for the
[[Page 20345]]
AquaBeam System (Aquablation) for FY 2019. According to the applicant,
the AquaBeam System is indicated for the use in the treatment of
patients experiencing lower urinary tract symptoms caused by a
diagnosis of benign prostatic hyperplasia (BPH). The AquaBeam System
consists of three main components: A console with two high-pressure
pumps, a conformal surgical planning unit with trans-rectal ultrasound
imaging, and a single-use robotic hand-piece.
The applicant reported that The AquaBeam System provides the
operating surgeon a multi-dimensional view, using both ultrasound image
guidance and endoscopic visualization, to clearly identify the
prostatic adenoma and plan the surgical resection area. Based on the
planning inputs from the surgeon, the system's robot delivers
Aquablation, an autonomous waterjet ablation therapy that enables
targeted, controlled, heat-free and immediate removal of prostate
tissue used for the purpose of treating lower urinary tract symptoms
caused by a diagnosis of BPH. The combination of surgical mapping and
robotically-controlled resection of the prostate is designed to offer
predictable and reproducible outcomes, independent of prostate size,
prostate shape or surgeon experience.
In its application, the applicant indicated that benign prostatic
hyperplasia (BPH) is one of the most commonly diagnosed conditions of
the male genitourinary tract \203\ and is defined as the ``. . .
enlargement of the prostate due to benign growth of glandular tissue .
. .'' in older men.\204\ BPH is estimated to affect 30 percent of males
that are older than 50 years old.205 206 BPH may compress
the urethral canal possibly obstructing the urethra, which may cause
symptoms that effect the lower urinary tract, such as difficulty
urinating (dysuria), hesitancy, and frequent
urination.207 208 209
---------------------------------------------------------------------------
\203\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\204\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
\205\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\206\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\207\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\208\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\209\ Roehrborn, C., Gilling, P., Cher, D., andTemplin, B.,
``The WATER Study (Waterjet Ablation Therapy for Ednoscopic
Resection of prostate tissue),'' Redwood City: PROCEPT BioRobotics
Corporation, 2017.
---------------------------------------------------------------------------
The initial treatment for a patient who has been diagnosed with BPH
is watchful waiting and medications.\210\ Symptom severity, as measured
by one test, the International Prostate Symptom Score (IPSS), is the
primary measure by which surgery necessity is decided.\211\ Many
techniques exist for the surgical treatment of patients who have been
diagnosed with BPH, and these surgical treatments differ primarily by
the method of resection: Electrocautery in the case of Transurethral
Resection of the Prostate (TURP), laser enucleation, plasma
vaporization, photoselective vaporization, radiofrequency ablation,
microwave thermotherapy, and transurethral incision \212\ are among the
primary methods. TURP is the primary reference treatment for patients
who have been diagnosed with BPH.\213\ \214\ \215\ \216\ \217\
---------------------------------------------------------------------------
\210\ Ibid.
\211\ Cunningham, G. R., Kadmon, D., 2017, ``Clinical
manifestations and diagnostic evaluation of benign prostatic
hyperplasia,'' 2017. Available at: https://www.uptodate.com/
contents/clinical-manifestations-and-diagnostic-evaluation-of-
benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\212\ Ibid.
\213\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\214\ Cunningham, G. R., Kadmon, D., ``Clinical manifestations
and diagnostic evaluation of benign prostatic hyperplasia,'' 2017.
Available at: https://www.uptodate.com/contents/clinical-
manifestations-and-diagnostic-evaluation-of-benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\215\ Mamoulakis, C., Efthimiou, I., Kazoulis, S.,
Christoulakis, I., and Sofras, F., ``The Modified Clavien
Classification System: A standardized platform for reporting
complications in transurethral resection of the prostate,'' World
Journal of Urology, 2011, vol. 29, pp. 205-210.
\216\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\217\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
---------------------------------------------------------------------------
According to the applicant, while the TURP procedure achieves
alleviation of the symptoms that affect the lower urinary tract
associated with a diagnosis of BPH, morbidity rates caused by adverse
events are high following the procedure. The TURP procedure has a well-
documented history of associated adverse effects, such as hematuria,
clot retention, bladder wall injury, hyponatremia, bladder neck
contracture, urinary incontinence, and retrograde ejaculation.\218\
\219\ \220\ \221\ \222\ The likelihood of both adverse events and
long[dash]term morbidity related to the TURP procedure increase with
the size of the prostate.\223\
---------------------------------------------------------------------------
\218\ Roehrborn, C., Gilling, P., Cher, D., and Templin, B.,
``The WATER Study (Waterjet Ablation Therapy for Ednoscopic
Resection of prostate tissue),'' Redwood City: PROCEPT BioRobotics
Corporation, 2017.
\219\ Cunningham, G. R., & Kadmon, D., 2017, ``Clinical
manifestations and diagnostic evaluation of benign prostatic
hyperplasia,'' 2017. Available at: https://www.uptodate.com/
contents/clinical-manifestations-and-diagnostic-evaluation-of-
benign-prostatic-
hyperplasia?search=cunningham%20kadmon%202017%20benign%20prostatic&so
urce=search_result&selectedTitle=2~150&usage_type=default&display_ran
k=2.
\220\ Mamoulakis, C., Efthimiou, I., Kazoulis, S.,
Christoulakis, I., Sofras, F., ``The Modified Clavien Classification
System: A standardized platform for reporting complications in
transurethral resection of the prostate,'' World Journal of Urology,
2011, vol. 29, pp. 205-210.
\221\ Roehrborn, C., Gange, S., Shore, N., Giddens, J., Bolton,
D., Cowan, B., Rukstalist, D., ``The Prostatic Urethral Lift for the
Treatmentof Lower Urinary Tract Symptoms Associated with Prostate
Enlargement Due to Benign Prostatic Hyperplasia: The LIFT study,''
The Journal of Urology, 2013, vol. 190, pp. 2161-2167.
\222\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
\223\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
---------------------------------------------------------------------------
The applicant asserted that the AquaBeam System provides superior
safety outcomes as compared to the
[[Page 20346]]
TURP procedure, while providing non-inferior efficacy in treating the
symptoms that affect the lower urinary tract associated with a
diagnosis of BPH. The applicant further stated that the AquaBeam System
yields consistent and predictable procedure and resection times
regardless of the size and shape of the prostate and the surgeon's
experience. Lastly, according to the applicant, the AquaBeam System
provides increased efficacy and safety for larger prostates as compared
to the TURP procedure.
With respect to the newness criterion, FDA granted the applicant's
De Novo request on December 21, 2017, for use in the resection and
removal of prostate tissue in males suffering from lower urinary tract
symptoms (LUTS) due to benign prostatic hyperplasia. The applicant
stated that the AquaBeam System was made available on the U.S. market
immediately after the FDA granted the De Novo request. Therefore, if
approved for new technology add-on payments, the newness period is
considered to begin on December 21, 2017. There are currently no
existing ICD-10-PCS procedure codes to specifically identify procedures
involving the Aquablation method or technique for the treatment of
symptoms that affect the lower urinary tract in patients who have been
diagnosed with BPH. The applicant stated that it applied for approval
for a distinct ICD[dash]10-PCS procedure code to uniquely identify
procedures involving the AquaBeam System at the ICD-10 Maintenance and
Coordination Committee March 2018 meeting.
As discussed earlier, if a technology meets all three of the
substantial similarity criteria, it would be considered substantially
similar to an existing technology and would not be considered ``new''
for the purposes of new technology add-on payments.
With regard to the first criterion, whether a product uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
applicant stated that the AquaBeam System is the first technology to
deliver treatment to patients who have been diagnosed with BPH for the
symptoms that effect the lower urinary tract caused by BPH via
Aquablation therapy. The AquaBeam System utilizes intra[dash]operative
image guidance for surgical planning and then Aquablation therapy to
robotically resect tissue utilizing a high-velocity waterjet. According
to the applicant, all other BPH treatment procedures only utilize
cystoscopic visualization, whereas the AquaBeam System utilizes
Aquablation therapy, a combination of cystoscopic visualization and
intra[dash]operative image guidance. According to the applicant, the
AquaBeam System's use of Aquablation therapy qualifies it as the only
technology to utilize a high-velocity room temperature waterjet for
tissue resection, while most other BPH surgical procedures utilize
thermal energy to resect prostatic tissue, or require the implantation
of clips to pull back prostatic tissue blocking the urethra. Lastly,
according to the applicant, all other surgical modalities are executed
by the operating surgeon, while the AquaBeam System allows planning by
the surgeon and utilization of Aquablation therapy ensures accurate and
efficient tissue resection is autonomously executed by the robot.
With respect to the second criterion, whether a product is assigned
to the same or a different MS-DRG, the applicant stated that potential
cases representing potential patients who may be eligible for treatment
involving the AquaBeam System's Aquablation therapy technique will
ultimately map to the same MS-DRGs as cases for existing BPH treatment
options.
With respect to the third criterion, whether the new use of the
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, the applicant
stated that the AquaBeam System's Aquablation therapy will ultimately
treat the same patient population as other available BPH treatment
options. The applicant asserted that the AquaBeam System's Aquablation
therapy has been shown to be more effective and safer than the TURP
procedure for patients with larger prostate sizes. The applicant stated
that prostates 80 ml or greater in size are not appropriate for the
TURP procedure and, therefore, more intensive procedures such as
surgery are required. Furthermore, the applicant claimed that the
AquaBeam System's Aquablation therapy is particularly appropriate for
smaller prostate sizes, ~30 ml, due to increased accuracy provided by
both the computer assistance and ultrasound visualization.
We have the following concerns regarding whether the AquaBeam
System meets the newness criterion. Currently, there are many treatment
options that utilize varying forms of ablation, such as mono and
bipolar TURP procedures, laser, microwave, and radiofrequency, to treat
the symptoms associated with a diagnosis of BPH. We are concerned that,
while this device utilizes water to perform any tissue removal, its
mechanism of action may not be different from that of other forms of
treatment for patients who have been diagnosed with BPH. Further, the
use of water to perform tissue removal in the treatment of associated
symptoms in patients who have been diagnosed with BPH has existed in
other areas of surgical treatment prior to the introduction of this
product (for example, endometrial ablation and wound debridement). In
addition, the standard operative treatment, such as with the TURP
procedure, for patients who have been diagnosed with BPH is to widen
the urethra compressed by an enlarged prostate in an effort to
alleviate the negative effects of an enlarged prostate. Like other
existing methods, the AquaBeam System's Aquablation therapy also
ablates tissue to enlarge compression of the urethra. Additionally,
while the robotic arm and computer programing may result in different
outcomes for patients, we are uncertain that the use of the robotic
hand and computer programming result in a new mechanism of action. We
are inviting public comments on this issue.
We also are inviting public comments on whether the AquaBeam
System's Aquablation therapy is substantially similar to 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. Given that the AquaBeam System's Aquablation therapy
procedure does not currently have a unique ICD-10-PCS procedure code,
the applicant searched the FY 2016 MedPAR data file for cases with the
following current ICD-10-PCS codes describing other BPH minimally
invasive procedures to identify potential cases representing potential
patients who may be eligible for treatment involving the AquaBeam
System's Aquablation therapy: 0V507ZZ (Destruction of prostate, via
natural or artificial opening), 0V508ZZ (Destruction of prostate, via
natural or artificial opening endoscopic), 0VT07ZZ (Resection of
prostate, via natural or artificial opening), and 0VT08ZZ (Resection of
prostate, via natural or artificial opening endoscopic). The applicant
identified a total of 133 MS-DRGs using these ICD-10-PCS codes.
In order to calculate the standardized charges per case, the
applicant conducted two analyses, based on 100 percent and 75 percent
of identified claims in the FY 2016 MedPAR data file. The applicant
based its analysis on 100 percent of claims mapping to 133 MS-DRGs, and
75 percent of claims mapping to 6 MS-DRGs. The cases identified in the
75 percent analysis mapped to MS-DRGs 665 (Prostatectomy with MCC), 666
[[Page 20347]]
(Prostatectomy with CC), 667 (Prostatectomy without CC/MCC), 713
(Transurethral Prostatectomy with CC/MCC), 714 (Transurethral
Prostatectomy without CC/MCC), and 988 (Non-Extensive O.R. Procedures
Unrelated to Principal Diagnosis with CC). In situations in which there
were fewer than 11 cases for individual MS-DRGs in the MedPAR data
file, a value of 11 was imputed to ensure confidentiality for patients.
When evaluating 100 percent of the cases identified, the applicant
included low-volume MS-DRGs that had equal to or less than 11 total
cases to represent potential patients who may be eligible for treatment
involving the AquaBeam System's Aquablation therapy in order to
calculate the average case-weighted unstandardized and standardized
charge amounts. The 75 percent analysis removed those MS-DRGs with 11
cases or less representing potential patients who may be eligible for
treatment involving the AquaBeam System's Aquablation therapy,
resulting in only 6 of the 133 MS-DRGs remaining for analysis. A total
of 8,449 cases were included in the 100 percent analysis and 6,285
cases were included in the 75 percent analysis.
Using the 100 percent and 75 percent samples, the applicant
determined that the average case-weighted unstandardized charge per
case was $69,662 and $47,475, respectively. The applicant removed 100
percent of total charges associated with the service category
``Medical/Surgical Supply Charge Amount'' (which includes revenue
centers 027x and 062x) because the applicant believed that it was the
most conservative choice, as this amount varies by MS-DRG. The
applicant stated that the financial impact of utilizing the AquaBeam
System's Aquablation therapy on hospital resources other than on
``Medical Supplies'' is unknown at this time. Therefore, a value of $0
was used for charges related to the prior technology.
The applicant standardized the charges, and inflated the charges
using an inflation factor of 1.09357, from the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38524). The applicant then added the charges for the
new technology. The applicant computed a final inflated average
case[dash]weighted standardized charge per case of $69,588 for the 100
percent sample, and $51,022 for the 75 percent sample. The average
case-weighted threshold amount was $59,242 for the 100 percent sample,
and $48,893 for the 75 percent sample. Because the final inflated
average case-weighted standardized charge per case exceeds the average
case-weighted threshold amount for both analyses, the applicant
maintained that the technology meets the cost criterion.
We are inviting public comment regarding whether the technology
meets the cost criterion.
With respect to the substantial clinical improvement criterion, the
applicant asserted that the Aquablation therapy provided by the
AquaBeam System represents a substantial clinical improvement over
existing treatment options for symptoms associated with the lower
urinary tract for patients who have been diagnosed with BPH.
Specifically, the applicant stated that the AquaBeam System's
Aquablation therapy provides superior safety outcomes compared to the
TURP procedure, while providing noninferior efficacy in treating the
symptoms that effect the lower urinary tract associated with a
diagnosis of BPH; the AquaBeam System's delivery of Aquablation therapy
yields consistent and predictable procedure and resection times
regardless of the size and shape of the prostate or the surgeon's
experience; and the AquaBeam System's Aquablation therapy demonstrated
superior efficacy and safety for larger prostates (that is, prostates
sized 50 to 80 mL) as compared to the TURP procedure.
The applicant provided the results of one Phase I and one Phase II
trial published articles, the WATER Study Clinical Study Report, and a
meta-analysis of current treatments with its application as evidence
for the substantial clinical improvement criterion.
According to the applicant, the first study \224\ enrolled 15
nonrandomized patients with a prostate volume between 25 to 80 ml in a
Phase I trial testing the safety and feasibility of the AquaBeam
System's Aquablation therapy; all patients received the AquaBeam
System's Aquablation therapy. This study, a prospective, nonrandomized
study, enrolled men who were 50 to 80 years old who were affected by
moderate to severe lower urinary tract symptoms, who did not respond to
standard medical therapy.\225\ Follow-up assessments were conducted at
1, 3, and 6 months and included information on adverse events, serum
PSA level, uroflowmetry, PVR, quality of life, and the International
Prostate Symptom Score (IPSS) and International Index of Erectile
Function (IIEF) scores. The primary outcome was the assessment of
safety as measured by adverse event reporting; secondary endpoints
focused on alleviation of BPH symptoms.\226\
---------------------------------------------------------------------------
\224\ Gilling P., Reuther, R., Kahokehr, A., Fraundorfer, M.,
``Aquablation--Image-guided Robot-assisted Waterjet Ablation of the
Prostate: Initial clinical experience,'' British Journal of Urology
International, 2016, vol. 117, pp. 923-929.
\225\ Ibid.
\226\ Ibid.
---------------------------------------------------------------------------
The applicant indicated that 8 of the 15 patients who were enrolled
in the trial had at least 1 procedure[dash]related adverse event (for
example, catheterization, hematuria, dysuria, pelvic pain, bladder
spasms), which the authors reported to be consistent with outcomes from
minimally[dash]invasive transurethral procedures.\227\ There were no
occurrences of incontinence, retrograde ejaculation, or erectile
dysfunction at 30 days.\228\ Statistically significant improvement on
all outcomes occurred over the 6[dash]month period. Average IPSS scores
showed a negative slope with scores of 23.1, 11.8, 9.1, and 8.6 for
baseline, 1 month, 3 months, and 6 months (p<0.01 in all cases).
Average quality of life scores, which range from 1 to 5, where 1 is
better and 5 is worse, decreased from 5.0 at baseline to 2.6 at 1
month, 2.2 at 3 months, and 2.5 at 6 months. Average maximum urinary
flow rate increased steadily across time points from 8.6 ml/s at
baseline to 18.6 ml/s at 6 months. Lastly, average post[dash]void
residual urine volume decreased from 91 ml at baseline to 38 ml at 1
month, 60 ml at 3 months, and 30 ml at 6 months.\229\
---------------------------------------------------------------------------
\227\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
\228\ Ibid.
\229\ Ibid.
---------------------------------------------------------------------------
The second study \230\ presents results from a Phase II trial
involving 21 men with a prostate volume between 30 to 102 ml who
received treatment involving the AquaBeam System's Aquablation therapy
with follow-up at 1 year. This prospective study enrolled men between
the ages of 50 and 80 years old who were effected by moderate to severe
symptomatic BPH.\231\ The primary end point was the rate of adverse
events; the secondary end points measured alleviation of symptoms
associated with a diagnosis of BPH. Data was collected at baseline and
at 1 month, 3 months, 6 months, and 12 months; 1 patient withdrew at 3
months. The authors asserted that the occurrence of post[dash]operative
adverse events (urinary retention, dysuria, hematuria, urinary tract
infection, bladder spasm, meatal stenosis) were consistent with other
minimally[dash]invasive transurethral
[[Page 20348]]
procedures; \232\ 6 patients had at least 1 adverse event, including
temporary urinary symptoms and medically[dash]treated urinary tract
infections.\233\ The mean IPSS scores decreased from the baseline of
22.8 with 11.5 at 1 month, 7 at 3 months, 7.1 at 6 months, and 6.8 at
12 months and were statistically significantly different. Similarly,
quality of life decreased from a mean score of 5 at baseline to 1.7 at
12 months, all time points were statistically significantly different
from the baseline.
---------------------------------------------------------------------------
\230\ Ibid.
\231\ Ibid.
\232\ Gilling, P., Anderson, P., and Tan, A., ``Aquablation of
the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year
results,'' The Journal of Urology, 2017, vol. 197, pp. 156-1572.
\233\ Ibid.
---------------------------------------------------------------------------
The third document provided by the applicant is the Clinical Study
Report: WATER Study,\234\ a prospective multi[dash]center, randomized,
blinded study. The WATER Study compared the AquaBeam System's
Aquablation therapy to the TURP procedure for the treatment of lower
urinary tract symptoms associated with a diagnosis of BPH. One hundred
eighty one (181) patients with prostate volumes between 30 and 80 ml
were randomized, 65 patients to the TURP procedure group and the other
116 to the AquaBeam System's Aquablation therapy group, with 176 (97
percent of patients) continuing at 3 and 6 month follow[dash]up, where
2 missing patients received treatment involving the AquaBeam System's
Aquablation therapy and 3 received treatment involving the TURP
procedure; randomization efficacy was assessed and confirmed with
findings of no statistical differences between cases and controls among
all characteristics measures, specifically prostate volume. Two primary
endpoints were identified: (1) The safety endpoint was the proportion
of patients with adverse events rates as ``probably or definitely
related to the study procedure'' also classified as the Clavien-Dindo
(CD) Grade 2 or higher or any Grade 1 resulting in persistent
disability; and (2) the primary efficacy endpoint was a change in the
IPSS score from baseline to 6 months. Three secondary endpoints were
based on perioperative data and were: Length of hospital stay, length
of operative time, and length of resection time. The occurrences of
three secondary endpoints during the 6[dash]month follow[dash]up were:
(1) Reoperation or reintervention within 6 months; (2) evaluation of
proportion of sexually active patients; and (3) evaluation of
proportion of patients with major adverse urologic events.
---------------------------------------------------------------------------
\234\ Roehrborn, C., Gilling, P., Cher, D., Templin, B., ``The
WATER Study (Waterjet Ablation Therapy for Ednoscopic Resection of
prostate tissue),'' Redwood City: PROCEPT BioRobotics Corporation,
2017.
---------------------------------------------------------------------------
At 3 months, 25 percent of the patients in the AquaBeam System's
Aquablation therapy group and 40 percent of the patients in the TURP
group had an adverse event. The difference of -15 percent has a 95
percent confidence interval of -29.2 and -1.0 percent. At 6 months,
25.9 percent of the patients in the AquaBeam System's Aquablation
therapy group and 43.1 percent of the patients in the TURP group had an
adverse event. The difference of -17 percent has a 95 percent
confidence interval of -31.5 to -3.0 percent. An analysis of safety
events classified with the CD system as possibly, probably or
definitely related to the procedure resulted in a CD Grade 1 persistent
event difference between -17.7 percent (favoring the AquaBeam System's
Aquablation therapy) with 95 percent confidence interval of -30.1 to -
7.2 percent and a CD Grade 2 or higher event difference of -3.3 percent
with 95 percent confidence interval of -16.5 to 8.7 percent.
The applicant indicated that the primary efficacy endpoint was
assessed by a change in IPSS score over time. While change in score and
change in percentages are generally higher for the AquaBeam System's
Aquablation therapy, no statistically significant differences occurred
between the AquaBeam System's Aquablation therapy and the TURP
procedure over time. For example, the AquaBeam System's Aquablation
therapy group experienced changes in IPSS mean score by visit of 0, -
3.8, -12.5, -16.0, and -16.9 at baseline, 1 week, 1 month, 3 months,
and 6 months, respectively, while the TURP group had mean scores of 0,
-3.6, -11.1, -14.6, and -15.1 at baseline, 1 week, 1 month, 3 months,
and 6 months, respectively.
Lastly, the applicant indicated that secondary endpoints were
assessed. A mean length of stay for both the AquaBeam System's
Aquablation therapy and the TURP procedure groups of 1.4 was achieved.
While the mean operative times were similar, the hand piece in and out
time was statistically significantly shorter for the AquaBeam System's
Aquablation therapy group at 23.3 minutes as compared to 34.2 in the
TURP procedure group. The mean resection time was 23 minutes shorter
for the AquaBeam System's Aquablation therapy group at 3.9 minutes. No
statistically significant difference was seen between the AquaBeam
System's Aquablation therapy and the TURP procedure groups on the
outcomes of re-intervention and worsening sexual function; 32.9 percent
of the AquaBeam System's Aquablation therapy group had worsening sexual
function as compared to 52.8 percent of the TURP procedure group. While
statistically significant differences occurred across groups for change
in ejaculatory function, the difference no longer remained at 6 months.
While a greater proportion of the TURP procedure group patients
experienced a negative change in erectile function as compared to the
AquaBeam System's Aquablation therapy group patients (10 percent versus
6.2 percent at 6 months), no statistically significant differences
occurred. No statistically significant differences between groups
occurred for major adverse urologic events.
The applicant provided a meta-analysis of landmark studies
regarding typical treatments for patients who have been diagnosed with
BPH in order to provide supporting evidence for the assertion of
superior outcomes achieved with the use of the AquaBeam System's
Aquablation therapy. The applicant cited four ``landmark clinical
trials,'' which report on the AquaBeam System's Aquablation
therapy,\235\ the TURP procedure, Green light laser versus the TURP
procedure,\236\ and Urolift.\237\ Comparisons are made between
performance outcomes on three separate treatments for patients who have
been diagnosed with BPH: The AquaBeam System's Aquablation therapy, the
TURP procedure, and Urolift. The applicant stated that all three
clinical trials included men with average IPSS baseline scores of 21 to
23 points. The applicant stated that, while total procedure times are
similar across all three treatment options, the AquaBeam System's
Aquablation therapy has dramatically less time and variability
associated with the tissue treatment. The applicant further stated that
the differences between treatment options were not assessed for
statistical significance. The applicant indicated
[[Page 20349]]
that the AquaBeam System's Aquablation therapy, with an approximate
score of 17, had the largest improvement in IPSS scores at 6 months as
compared to 16 for the TURP procedure and 11 for Urolift. Compared to
46 percent in the TURP group, the applicant found that the AquaBeam
System's Aquablation therapy and Urolift had much lower percentages, 4
percent and 0 percent, respectively, of an ejaculation[dash]related
consequence in patients. Lastly, the applicant stated that safety
events, as measured by the percentage of CD Grade 2 or higher events,
were lower in the AquaBeam System's Aquablation therapy (19 percent)
and Urolift (14 percent) than in TURP (29 percent).
---------------------------------------------------------------------------
\235\ Roehrborn, C., Gilling, P., Cher, D., Templin, B., ``The
WATER Study (Waterjet Ablation Therapy for Ednoscopic Resection of
prostate tissue),'' Redwood City: PROCEPT BioRobotics Corporation,
2017.
\236\ Bachmann, A., Tubaro, A., Barber, N., d'Ancona, F., Muir,
G., Witzsch, U., Thomas, J., ``180-W XPS GreenLight Laser
Vaporisation Versus Transurethral Resection of the Prostate for the
Treatment of Benign Prostatic Obstruction: 6-month safety and
efficacy results of a european multicentre randomised trial--the
GOLIATH study,'' European Association of Urology, 2014, vol. 65, pp.
931-942.
\237\ Sonksen, J., Barber, N., Speakman, M., Berges, R.,
Wetterauer, U., Greene, D., Gratzke, C., ``Prospective, Randomized,
Multinational Study of Prostatic Urethral Lift Versus Transurethral
Resection of the Prostate: 12-month results from the BPH6 study,''
European Association of Urology, 2015, vol. 68, pp. 643-652.
---------------------------------------------------------------------------
We have several concerns related to the substantial clinical
improvement criterion. The applicant performed a meta-analysis
comparing results from three separate studies, which tested the effects
of three separate treatment options. According to the applicant, the
results provided consistently show the AquaBeam System's Aquablation
therapy and Urolift as being superior to the standard treatment of the
TURP procedure. We have concerns with the interpretation of these
results that the applicant provided. The comparison of multiple
clinical studies is a difficult issue. It is not clear if the applicant
took into account the varying study designs, sample techniques, and
other study specific issues, such as physician skill and patient health
status. For instance, the applicant stated that a comparison of Urolift
and the AquaBeam System's Aquablation therapy may not be appropriate
due to the differing indications of the procedures; the applicant
indicated that Urolift is primarily used for the treatment of patients
who have been diagnosed with BPH who have smaller prostate volumes,
whereas the AquaBeam System's Aquablation therapy procedure may be used
in all prostate sizes. Similarly, the applicant stated that the TURP
procedure is generally not utilized in patients with prostates larger
than 80ml, whereas such patients may be eligible for treatment
involving the AquaBeam System's Aquablation therapy.
We note that the applicant submitted a meta-analysis in an effort
to compare currently available therapies to the AquaBeam System's
Aquablation therapy. The possibility of the heterogeneity of samples
and methods across studies leads to the possible introduction of bias,
which results in the difficulty or inability to distinguish between
bias and actual outcomes. We are inviting public comments on the
applicability of this meta-analysis.
Additionally, the differences between the AquaBeam System's
Aquablation therapy and standard treatment options may not be as
impactful and confined to safety aspects. It appears that the data on
efficacy supported the equivalence of the AquaBeam System's Aquablation
therapy and the TURP procedure based upon noninferiority analysis. We
agree that the safety data were reported as showing superiority of the
AquaBeam System's Aquablation therapy over the TURP procedure, although
the data were difficult to track because adverse consequences were
combined into categories; the AquaBeam System's Aquablation therapy was
reportedly better in terms of ejaculatory function. It was noted in the
application that, while the AquaBeam System's Aquablation therapy was
statistically superior to the TURP procedure in the CD Grade 1 +
adverse events, it was not statistically different in the CD Grade 2 or
greater category. The applicant stated that regardless of the method,
the urethra is typically used as the means for performing the BPH
treatment procedure, which necessarily increases the likelihood of CD
Grade 2 adverse events in all transurethral procedures.
In addition, the applicant noted that the treatment option may
depend on the size of the prostate. The applicant stated that the
AquaBeam System's Aquablation therapy is appropriate for small and
large prostate sizes as a BPH treatment procedure. The AquaBeam
System's Aquablation therapy has been shown to have limited positive
outcomes as compared to the TURP procedure for prostates sized greater
than 50 grams to 80 grams in each of the studies provided by the
applicant. However, the applicant noted that the TURP procedure would
not be used for prostates larger than 80 grams in size. Therefore, we
believe that another proper comparator for the AquaBeam System's
Aquablation therapy may be laser or radical/open surgical procedures
given their respective indication for small and large prostate sizes.
Lastly, the applicant compared AquaBeam System's Aquablation
therapy and the standard of care TURP procedure to support a finding of
improved safety. There are other treatment modalities available that
may have a similar safety profile as the AquaBeam System's Aquablation
therapy and we are interested in information that compares the AquaBeam
System's Aquablation therapy to other treatment modalities.
We are inviting public comments on whether the AquaBeam System's
Aquablation therapy meets the substantial clinical improvement
criterion.
We did not receive any public comments in response to the published
notice in the Federal Register regarding the AquaBeam System's
Aquablation therapy or at the New Technology Town Hall Meeting.
n. AndexXaTM (Andexanet alfa)
Portola Pharmaceuticals, Inc. (Portola) submitted an application
for new technology add-on payments for FY 2019 for the use of
AndexXaTM (Andexanet alfa). (We note that the applicant
previously submitted applications for new technology add-on payments
for FY 2017 and FY 2018 for Andexanet alfa, which were withdrawn.)
AndexXaTM is an antidote used to treat patients who are
receiving treatment with an oral Factor Xa inhibitor who suffer a major
bleeding episode and require urgent reversal of direct and indirect
Factor Xa anticoagulation. Patients at high risk for thrombosis,
including those who have been diagnosed with atrial fibrillation (AF)
and venous thrombosis (VTE), typically receive treatment using long-
term oral anticoagulation agents. Factor Xa inhibitors are included in
a new class of anticoagulants. Factor Xa inhibitors are oral
anticoagulants used to prevent stroke and systemic embolism in patients
who have been diagnosed with AF. These oral anticoagulants are also
used to treat patients who have been diagnosed with deep-vein
thrombosis (DVT) and its complications, pulmonary embolism (PE), and
patients who have undergone knee, hip, or abdominal surgery.
Rivarobaxan (Xarelto[reg]), apixaban (Eliqis[reg]), betrixaban
(Bevyxxa[reg]), and edoxaban (Savaysa[reg]) also are included in the
new class of Factor Xa inhibitors, and are often referred to as ``novel
oral anticoagulants'' (NOACs) or ``non-vitamin K antagonist oral
anticoagulants.'' Although these anticoagulants have been commercially
available since 2011, there is no FDA-approved therapy used for the
urgent reversal of any Factor Xa inhibitor as a result of serious
bleeding episodes.
AndexXaTM has not received FDA approval as of the time
of the development of this proposed rule. The applicant indicated that
it anticipates receipt of FDA approval for the use of the technology
during the first quarter of 2018. The applicant received approval for
two unique ICD-10-PCS procedure codes that became effective October 1,
[[Page 20350]]
2016 (FY 2017). The approved ICD-10-PCS procedure codes are: XW03372
(Introduction of Andexanet alfa, Factor Xa inhibitor reversal agent
into peripheral vein, percutaneous approach, new technology group 2);
and XW04372 (Introduction of Andexanet alfa, Factor Xa inhibitor
reversal agent into central vein, percutaneous approach, new technology
group 2).
With regard to the ``newness'' criterion, as discussed earlier, if
a technology meets all three of the substantial similarity criteria, it
would be considered substantially similar to an existing technology and
would not be considered ``new'' for purposes of new technology add-on
payments. The applicant asserted that, if approved,
AndexXaTM would be the first and the only antidote available
used to treat patients who are receiving treatment with an oral Factor
Xa inhibitor who suffer a major bleeding episode and require urgent
reversal of direct and indirect Factor Xa anticoagulation. Therefore,
the applicant asserted that the technology is not substantially similar
to any other currently approved and available treatment options for
Medicare beneficiaries. Below we discuss the applicant's assertion in
the context of the three substantial similarity criteria.
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, AndexXaTM, if approved, would be
the first anticoagulant reversal agent that binds to direct Factor Xa
inhibitors with high affinity, thereby sequestering the inhibitors and
consequently rapidly reducing free plasma concentration of Factor Xa
inhibitors, and neutralizing the inhibitors' anticoagulant effect,
which allows for the restoration of normal hemostasis.
AndexXaTM also binds to and sequesters antithrombin III
molecules that are complexed with indirect inhibitor molecules, which
disrupts the capacity of the antithrombin complex to bind to native
Factor Xa inhibitors. According to the applicant, AndexXaTM
represents a significant therapeutic advance because it provides rapid
reversal of anticoagulation therapy in the event of a serious bleeding
episode. Other anticoagulant reversal agents, such as
KcentraTM and Idarucizumab, do not reverse the effects of
Factor Xa inhibitors.
With regard to the second criterion, whether a product is assigned
to the same or a different MS-DRG, AndexXaTM would be the
first FDA[dash]approved anticoagulant reversal agent for Factor Xa
inhibitors. Therefore, the MS-DRGs do not contain cases that represent
patients who have been treated with any anticoagulant reversal agents
for Factor Xa inhibitors.
With regard to the third criterion, whether the new use of the
technology involves the treatment of the same or similar type of
disease and the same or similar patient population, the applicant
stated that AndexXaTM, if approved, would be the only
anticoagulant reversal agent available for treating patients who are
receiving direct or indirect Factor Xa therapy who experience serious,
uncontrolled bleeding events or who require emergency surgery.
Therefore, the applicant believed that AndexXaTM would be
the first type of treatment option available to this patient
population. As a result, we believe that it appears that
AndexXaTM is not substantially similar to any existing
technologies. We are inviting public comments on whether
AndexXaTM meets the substantial similarity criteria, and
whether AndexXaTM meets the newness criterion.
With regard to the cost criterion, the applicant researched the FY
2015 MedPAR claims data file for potential cases representing patients
who may be eligible for treatment using AndexXaTM. The
applicant used three sets of ICD-9-CM codes to identify these cases:
(1) Codes identifying potential cases representing patients who were
treated with an anticoagulant and, therefore, who are at risk of
bleeding; (2) codes identifying potential cases representing patients
with a history of conditions that were treated with Factor Xa
inhibitors; and (3) codes identifying potential cases representing
patients who experienced bleeding episodes as the reason for the
current admission. The applicant included with its application the
following table displaying a complete list of ICD-9-CM codes that met
its selection criteria.
------------------------------------------------------------------------
ICD-9-CM codes applicable Applicable ICD-9-CM code description
------------------------------------------------------------------------
V12.50.................... Personal history of unspecified circulatory
disease.
V12.51.................... Personal history of venous thrombosis and
embolism.
V12.52.................... Personal history of thrombophlebitis.
V12.54.................... Personal history of transient ischemic
attack (TIA), and cerebral infarction
without residual deficits.
V12.55.................... Personal history of pulmonary embolism.
V12.59.................... Personal history of other diseases of
circulatory system.
V43.64.................... Hip joint replacement.
V43.65.................... Knee joint replacement.
V58.43.................... Aftercare following surgery for injury and
trauma.
V58.49.................... Other specified aftercare following surgery.
V58.73.................... Aftercare following surgery of the
circulatory system, NEC.
V58.75.................... Aftercare following surgery of the teeth,
oral cavity and digestive system, NEC.
V58.61.................... Long-term (current) use of anticoagulants.
E934.2.................... Anticoagulants causing adverse effects in
therapeutic use.
99.00..................... Perioperative autologous transfusion of
whole blood or blood components.
99.01..................... Exchange transfusion.
99.02..................... Transfusion of previously collected
autologous blood.
99.03..................... Other transfusion of whole blood.
99.04..................... Transfusion of packed cells.
99.05..................... Transfusion of platelets.
99.06..................... Transfusion of coagulation factors.
99.07..................... Transfusion of other serum.
------------------------------------------------------------------------
The applicant identified a total of 51,605 potential cases that
mapped to 683 MS-DRGs, resulting in an average case-weighted charge per
case of $72,291. The applicant also provided an analysis that was
limited to cases
[[Page 20351]]
representing 80 percent of all potential cases identified (41,255
cases) that mapped to the top 151 MS-DRGs. Under this analysis, the
average case-weighted charge per case was $69,020. The applicant
provided a third analysis that was limited to cases representing 25
percent of all potential cases identified (12,873 cases) that mapped to
the top 9 MS-DRGs. This third analysis resulted in an average case-
weighted charge per case of $46,974.
Under each of these analyses, the applicant also provided
sensitivity analyses based on variables representing two areas of
uncertainty: (1) Whether to remove 40 percent or 60 percent of blood
and blood administration charges; and (2) whether to remove pharmacy
charges based on the ceiling price of factor eight inhibitor bypass
activity (FEIBA), a branded anti-inhibitor coagulant complex, or on the
pharmacy indicator 5 (PI5) in the MedPAR data file, which correlates to
potential cases utilizing generic coagulation factors. Overall, the
applicant conducted twelve sensitivity analyses, and provided the
following rationales:
The applicant chose to remove 40 percent and 60 percent of
blood and blood administration charges because potential patients who
may be eligible for treatment using AndexXaTM for Factor Xa
reversal may still require blood and blood products to treat other
conditions. Therefore, the applicant believed that it would be
inappropriate to remove all of the charges associated with blood and
blood administration because all of the charges cannot be attributed to
Factor Xa reversal. The applicant maintained that the amounts of blood
and blood products required for treatment vary according to the
severity of the bleeding. Therefore, the applicant stated that the use
of AndexXaTM may replace 60 percent of blood and blood
product administration charges for potential cases with less severity
of bleeding, but only 40 percent of charges for potential cases with
more severe bleeding.
The applicant maintained that FEIBA is the highest priced
clotting factor used for Factor Xa inhibitor reversal, and it is
unlikely that pharmacy charges for Factor Xa reversal would exceed the
FEIBA ceiling price of $2,642. Therefore, the applicant capped the
charges to be removed at $2,642 to exclude charges unrelated to the
reversal of Factor Xa anticoagulation. The applicant also considered an
alternative scenario in which charges associated with pharmacy
indicator 5 (PI5) were removed from the costs of potential cases that
included this indicator in the MedPAR data. On average, charges removed
from the costs of potential cases utilizing generic coagulation factors
were much lower than the total pharmacy charges.
The applicant noted that, in all 12 scenarios, the average case-
weighted standardized charge per case for potential cases representing
patients who may be eligible for treatment using AndexXaTM
would exceed the average case-weighted threshold amounts in Table 10 of
the FY 2018 IPPS/LTCH PPS final rule by more than $855.
The applicant's order of operations used for each analysis is as
follows: (1) Removing 60 percent or 40 percent of blood and blood
product administration charges and up to 100 percent of pharmacy
charges for PI5 or FEIBA from the average case-weighted unstandardized
charge per case; and (2) standardizing the charges per cases using the
Impact File published with the FY 2015 IPPS/LTCH PPS final rule. After
removing the charges for the prior technology and standardizing
charges, the applicant applied an inflation factor of 1.154181, which
is a combination of 9.8446 percent, the value used in the FY 2017 IPPS
final rule as the 2-year outlier threshold inflation factor, and 5.074
percent, the value used in the FY 2018 IPPS final rule as the 1-year
outlier threshold inflation factor, to update the charges from FY 2015
to FY 2018. The applicant did not add charges for AndexXaTM
as the price had not been set at the time of conducting this analysis.
Under each scenario, the applicant stated that the inflated average
case-weighted standardized charge per case exceeded the average case-
weighted threshold amount (based on the FY 2018 IPPS Table 10
thresholds). Below we provide a table for all 12 scenarios that the
applicant indicated demonstrate that the technology meets the cost
criterion.
------------------------------------------------------------------------
Inflated
average Average case-
standardized weighted
Scenario case- weighted threshold
charge per amount
case
------------------------------------------------------------------------
100 Percent of Cases, FEIBA, 60 Percent $71,305 $60,209
Removal of Blood and Blood Product
Administration Costs...................
100 Percent of Cases, PI5, 60 Percent 73,108 60,209
Removal of Blood and Blood Product
Administration Costs...................
100 Percent of Cases, FEIBA, 40 Percent 72,172 60,209
Removal of Blood and Blood Product
Administration Costs...................
100 Percent of Cases, PI5, 40 Percent 73,740 60,209
Removal of Blood and Blood Product
Administration Costs...................
80 Percent of Cases, FEIBA, 60 Percent 68,400 58,817
Removal of Blood and Blood Product
Administration Costs...................
80 Percent of Cases, PI5, 60 Percent 70,184 58,817
Removal of Blood and Blood Product
Administration Costs...................
80 Percent of Cases, FEIBA, 40 Percent 69,279 58,817
Removal of Blood and Blood Product
Administration Costs...................
80 Percent of Cases, PI5, 40 Percent 70,826 58,817
Removal of Blood and Blood Product
Administration Costs...................
25 Percent of Cases, FEIBA, 60 Percent 46,127 45,272
Removal of Blood and Blood Product
Administration Costs...................
25 Percent of Cases, PI5, 60 Percent 47,730 45,272
Removal of Blood and Blood Product
Administration Costs...................
25 Percent of Cases, FEIBA, 40 Percent 47,089 45,272
Removal of Blood and Blood Product
Administration Costs...................
25 Percent of Cases, PI5, 40 Percent 48,403 45,272
Removal of Blood and Blood Product
Administration Costs...................
------------------------------------------------------------------------
We are inviting public comments on whether AndexXaTM
meets the cost criterion.
With regard to the substantial clinical improvement criterion, the
applicant asserted that AndexXaTM represents a substantial
clinical improvement for the treatment of patients who are receiving
direct or indirect Factor Xa therapy who experience serious,
uncontrolled bleeding events or who require emergency surgery because
the technology addresses an unmet medical need for a universal antidote
to direct and indirect Factor Xa inhibitors; if approved, would be the
only agent shown in prospective clinical trials to rapidly (within 2 to
5 minutes) and sustainably reverse the anticoagulation activity of
Factor Xa inhibitors; is potentially nonthrombogenic, as no serious
adverse effects of thrombosis were observed in clinical trials; and
could supplant currently available
[[Page 20352]]
treatments for bleeding from anti-Factor Xa therapy, which have not
been shown to be effective in the treatment of all patients.
With regard to addressing an unmet need for a universal antidote to
direct and indirect Factor Xa inhibitors, the applicant asserted that
the use of any anticoagulant is associated with an increased risk of
bleeding, and bleeding complications can be life-threatening. Bleeding
is especially concerning for patients treated with Factor Xa inhibitors
because there are currently no antidotes to Factor Xa inhibitors
available. As a result, when a patient anticoagulated with an oral
direct Factor Xa inhibitor presents with life-threatening bleeding,
clinicians often resort to using preparations of vitamin K dependent
clotting factors, such as 4-factor prothrombin complex concentrates
(PCCs). Despite the lack of any large, prospective, randomized study
examining the efficacy and safety of these agents in this patient
population, administration of 4-factor PCCs as a means to ``reverse''
the anticoagulant effect of Factor Xa inhibitors is commonplace in many
hospitals due to the lack of any alternative in the setting of a
serious or life[dash]threatening bleed.
The applicant stated that AndexXaTM has a unique
mechanism of action and represents a new biological approach to the
treatment of patients who have been diagnosed with acute severe
bleeding who require immediate reversal of the Factor Xa inhibitor
therapy. The applicant explained that although AndexXaTM is
structurally very similar to native Factor Xa inhibitors, the
technology has undergone several modifications that restrict its
biological activity to reversing the effects of Factor Xa inhibitors by
binding with and sequestering direct or indirect Factor Xa inhibitors,
which allows native Factor Xa inhibitors to dictate the normal
coagulation and hemostasis process. As a result, the applicant
maintained that AndexXaTM represents a safe and effective
therapy for the management of severe bleeding in a fragile patient
population and a substantial clinical improvement over existing
technologies and reversal strategies.
The applicant noted the following: (1) On average, patients with a
bleeding complication were hospitalized for 6.3 to 8.5 days, and (2)
the most common therapies currently used to manage severe bleeding
events in patients undergoing anticoagulant treatment are blood and
blood product transfusions, most frequently with packed red blood cells
(RBC) or fresh frozen plasma (FFP).\238\ According to the applicant,
the blood products that are currently being employed as reversal agents
carry significant risks. For instance, no clinical studies have
evaluated the safety and efficacy of FFP transfusions to treat bleeding
associated with Factor Xa inhibitors.239 240 Furthermore,
transfusions with packed RBCs carry a risk (1 to 4 per 50,000
transfusions) of acute hemolytic reactions, in which the recipient's
antibodies attack the transfused red blood cells, which is associated
with clinically significant anemia, kidney failure, and death.\241\ The
applicant asserted that a RBC transfusion in trauma patients with major
bleeding is associated with an increased risk of nonfatal vascular
events and death.\242\ The applicant noted that, although patients who
are treated with AndexXaTM would receive RBC transfusions if
their hemoglobin is low enough to warrant it, AndexXaTM
reduces the need for RBC transfusion.
---------------------------------------------------------------------------
\238\ Truven, ``2016 Truven Medicare Projected Bleeding
Events'', MARKETSCAN[reg] Medicare Supplemental Database, January 1,
2016 to December 31, 2016 Data pull, Data on File, Supplemental
file.
\239\ Siegal, D.M., ``Managing target-specific oral
anticoagulant associated bleeding including an update on
pharmacological reversal agents,'' J Thromb Thrombolysis, 2015 Apr,
vol. 39(3), pp. 395-402.
\240\ Kalus, J.S., ``Pharmacologic interventions for reversing
the effects of oral anticoagulants,'' Am J Health Syst Pharm, 2013,
vol. 70(10 Suppl 1), pp. S12-21.
\241\ Sharma, S., Sharma, P., Tyler, L.N., ``Transfusion of
Blood and Blood Products: Indications and Complications,'' Am Fam
Physician, 2011, vol. 83(6), pp. 719-24.
\242\ Perel, P., Clayton, T., Altman, D.G., et al., ``Red blood
cell transfusion and mortality in trauma patients: risk-stratified
analysis of an observational study,'' PLoS Med, 2014, vol. 11(6),
pp. e1001664.
---------------------------------------------------------------------------
The applicant asserted that laboratory studies have failed to
provide consistent evidence of ``reversal'' of the anticoagulant effect
of Factor Xa inhibitors across a range of different PCC products and
concentrations. Results of thrombin generation assays have varied
depending on the format of the assay. Despite years of experience with
low molecular weight heparins and pentasaccharide anticoagulants,
neither PCCs nor factor eight inhibitor bypassing activity are
recognized as safe and effective reversal agents for these Factor Xa
inhibitors.\243\ Unlike patients taking vitamin K antagonists, patients
receiving treatment with oral Factor Xa inhibitor drugs have normal
levels of clotting factors. Therefore, a strategy based on
``repleting'' factor levels is of uncertain foundation and could result
in supra-normal levels of coagulation factors after rapid metabolism
and clearance of the oral anticoagulant.\244\
---------------------------------------------------------------------------
\243\ Sarich, T.C., Seltzer, J.H., Berkowitz, S.D., et al.,
``Novel oral anticoagulants and reversal agents: Considerations for
clinical development,'' Am Heart J, 2015, vol. 169(6), pp. 751-7.
\244\ Siegal, D.M., ``Managing target-specific oral
anticoagulant associated bleeding including an update on
pharmacological reversal agents,'' J Thromb Thrombolysis, 2015 Apr,
vol. 39(3), pp. 395-402.
---------------------------------------------------------------------------
The applicant provided results from two randomized, double-blind,
placebo-controlled Phase III studies,245 246 the ANNEXA-A
(reversal of apixaban) and ANNEXA[dash]R (reversal of rivaroxaban)
trials. The primary endpoint in both these studies was the percent
change in anti-Factor Xa activity. Secondary endpoints included
proportion of participants with an 80 percent or greater reduction in
anti-Factor Xa activity, change in unbound Factor Xa inhibitor
concentration, and change in endogenous thrombin potential (ETP). A
total of 145 participants were enrolled in the study, with 101
participants randomized to AndexXaTM and 44 participants
randomized to placebo. The mean age of participants was 58 years old,
and 39 percent were women. There was a mean of greater than 90 percent
reduction in anti-Factor Xa activity in both parts of both studies in
subjects receiving AndexXaTM. The studies also demonstrated
the following: (1) Rapid and sustainable reversal of anticoagulation;
(2) reduced Factor Xa inhibitor free plasma levels by at least 80
percent below a calculated no-effect level; and (3) reduced anti-Factor
Xa activity to the lowest level of detection within 2 to 5 minutes of
infusion. The applicant noted that decreased Factor Xa inhibitor levels
have been shown to correspond to decreased bleeding complications,
reconstitution of activity of coagulation factors, and correction of
coagulation.247 248 249
---------------------------------------------------------------------------
\245\ Conners, J.M., ``Antidote for Factor Xa Anticoagulants,''
N Engl J Med, 2015 Nov 13.
\246\ Siegal, D.M., Curnutte, J.T., Connolly, S.J., et al.,
``Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity,''
N Engl J Med, 2015 Nov 11.
\247\ Lu, G., DeGuzman, F., Hollenbach, S., et al., ``Reversal
of low molecular weight heparin and fondaparinux by a recombinant
antidote,'' (r-Antidote, PRT064445), Circulation, 2010, vol. 122,
pp. A12420.
\248\ Rose, M., Beasley, B., ``Apixaban clinical review
addendum,'' Silver Spring, MD: Center for Drug Evaluation and
Research, 2012. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202155Orig1s000MedR.pdf.
\249\ Beasley, N., Dunnmon, P., Rose, M., ``Rivaroxaban clinical
review: FDA draft briefing document for the Cardiovascular and Renal
Drugs Advisory Committee,'' 2011. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm270796.pdf.
---------------------------------------------------------------------------
The applicant stated that the results from the two Phase III
studies and previous proof-of-concept Phase II dose-finding studies
showed that use of
[[Page 20353]]
AndexXaTM can rapidly reverse anticoagulation activity of
Factor Xa inhibitors and sustain that reversal. Therefore, the
applicant asserted that the use of AndexXaTM has the
potential to successfully treat patients who only need short-duration
reversal of the Factor Xa inhibitor anticoagulant, as well as patients
who require longer duration reversal, such as patients experiencing a
severe intracranial hemorrhage or requiring emergency surgery.
Furthermore, the applicant noted that its technology's duration of
action allows for a gradual return of Factor Xa inhibitor
concentrations to placebo control levels within 2 hours following the
end of infusion.
With regard to AndexXaTM's nonthrombogenic nature, the
applicant provided clinical trial data which revealed participants in
Phase II and Phase III trials had no thrombotic events and there were
no serious or severe adverse events reported. Results also showed that
use of AndexXaTM has a much lower risk of thrombosis than
typical procoagulants because the technology lacks the region
responsible for inducing coagulation. Furthermore, the applicant
asserted that the use of AndexXaTM is not associated with
the known complications seen with RBC transfusions. The applicant
asserted that, while the Phase II and Phase III trials and studies
measured physiological hallmarks of reversal of NOACs, it is expected
that the availability of a safe and reliable Factor Xa reversal will
result in an overall better prognosis for patients--potentially leading
to a reduction in length of hospital stay, fewer complications, and
decreased mortality associated with unexpected bleeding episodes.
The applicant also stated that use of AndexXaTM can
supplant currently available treatments used for reversing severe
bleeding from anti-Factor Xa therapy, which have not been shown to be
effective in the treatment of all patients. With regard to PCCs and
FFPs, the applicant stated that there is a lack of clinical evidence
available for patients taking Factor Xa inhibitors that experience
severe bleeding events. The applicant noted that the case reports
provide a snapshot of emergent treatment of these often medically
complex anti-Factor Xa-treated patients with major bleeds. However, the
applicant stated that these analyses reveal the inconsistent approach
in assessing the degree of anticoagulation in the patient and the
variability in treatment strategy. The applicant explained that little
or no assessment of efficacy in restoring coagulation in the patients
was performed, and the major outcomes measures were bleeding cessation
or mortality. The applicant concluded that overall, there is very
little evidence for the efficacy suggested in some guidelines, and the
evidence is insufficient to draw any conclusions.
The applicant submitted interim data purporting to show substantial
clinical improvement within its target patient population as part of an
ongoing Phase IIIb/IV open[dash]label ANNEXA-4 study. The ANNEXA-4
study is a multi[dash]center, prospective, open-label, single group
study that evaluated 67 patients who had acute, major bleeding within
18 hours of receipt of a Factor Xa inhibitor (32 patients receiving
rivarobaxan, 31 receiving apixaban, and 4 receiving enoxaparin). The
population in the study was reflective of a real-world population, with
mean age of 77 years old, most patients with cardiovascular disease,
and the majority of bleeds being intracranial or gastrointestinal.
According to the applicant, the results of the ANNEXA-4 study
demonstrate safe, reliable, and rapid reversal of Factor Xa levels in
patients experiencing acute bleeding and are consistent with the
results seen in the Phase II and Phase III trials, based on interim
data. However, we are concerned that this interim data also indicate 18
percent of patients experienced a thrombotic event and 15 percent of
patients died following reversal during the 30-day follow-up period in
the ANNEXA-4 study. For this reason, we are concerned that there is
insufficient data to determine substantial clinical improvement over
existing technologies.
We are inviting public comments on whether AndexXaTM
meets the substantial clinical improvement criterion.
We did not receive any public comments on the AndexXaTM
technology in response to the published notice in the Federal Register
or at the New Technology Town Hall Meeting.
III. Proposed Changes to the Hospital Wage Index for Acute Care
Hospitals
A. Background
1. Legislative Authority
Section 1886(d)(3)(E) of the Act requires that, as part of the
methodology for determining prospective payments to hospitals, the
Secretary adjust the standardized amounts for area differences in
hospital wage levels by a factor (established by the Secretary)
reflecting the relative hospital wage level in the geographic area of
the hospital compared to the national average hospital wage level. We
currently define hospital labor market areas based on the delineations
of statistical areas established by the Office of Management and Budget
(OMB). A discussion of the proposed FY 2019 hospital wage index based
on the statistical areas appears under section III.A.2. of the preamble
of this proposed rule.
Section 1886(d)(3)(E) of the Act requires the Secretary to update
the wage index annually and to base the update on a survey of wages and
wage-related costs of short[dash]term, acute care hospitals. (CMS
collects these data on the Medicare cost report, CMS Form 2552-10,
Worksheet S-3, Parts II, III, and IV. The OMB control number for
approved collection of this information is 0938-0050.) This provision
also requires that any updates or adjustments to the wage index be made
in a manner that ensures that aggregate payments to hospitals are not
affected by the change in the wage index. The proposed adjustment for
FY 2019 is discussed in section II.B. of the Addendum to this proposed
rule.
As discussed in section III.I. of the preamble of this proposed
rule, we also take into account the geographic reclassification of
hospitals in accordance with sections 1886(d)(8)(B) and 1886(d)(10) of
the Act when calculating IPPS payment amounts. Under section
1886(d)(8)(D) of the Act, the Secretary is required to adjust the
standardized amounts so as to ensure that aggregate payments under the
IPPS after implementation of the provisions of sections 1886(d)(8)(B),
1886(d)(8)(C), and 1886(d)(10) of the Act are equal to the aggregate
prospective payments that would have been made absent these provisions.
The proposed budget neutrality adjustment for FY 2019 is discussed in
section II.A.4.b. of the Addendum to this proposed rule.
Section 1886(d)(3)(E) of the Act also provides for the collection
of data every 3 years on the occupational mix of employees for short-
term, acute care hospitals participating in the Medicare program, in
order to construct an occupational mix adjustment to the wage index. A
discussion of the occupational mix adjustment that we are proposing to
apply to the FY 2019 wage index appears under sections III.E.3. and F.
of the preamble of this proposed rule.
2. Core-Based Statistical Areas (CBSAs) for the Proposed FY 2019
Hospital Wage Index
The wage index is calculated and assigned to hospitals on the basis
of the labor market area in which the hospital is located. Under
section 1886(d)(3)(E)
[[Page 20354]]
of the Act, beginning with FY 2005, we delineate hospital labor market
areas based on OMB[dash]established Core[dash]Based Statistical Areas
(CBSAs). The current statistical areas (which were implemented
beginning with FY 2015) are based on revised OMB delineations issued on
February 28, 2013, in OMB Bulletin No. 13-01. OMB Bulletin No. 13-01
established revised delineations for Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas in the
United States and Puerto Rico based on the 2010 Census, and provided
guidance on the use of the delineations of these statistical areas
using standards published on June 28, 2010 in the Federal Register (75
FR 37246 through 37252). We refer readers to the FY 2015 IPPS/LTCH PPS
final rule (79 FR 49951 through 49963) for a full discussion of our
implementation of the OMB labor market area delineations beginning with
the FY 2015 wage index.
Generally, OMB issues major revisions to statistical areas every 10
years, based on the results of the decennial census. However, OMB
occasionally issues minor updates and revisions to statistical areas in
the years between the decennial censuses through OMB Bulletins. On July
15, 2015, OMB issued OMB Bulletin No. 15-01, which provided updates to
and superseded OMB Bulletin No. 13-01 that was issued on February 28,
2013. The attachment to OMB Bulletin No. 15-01 provided detailed
information on the update to statistical areas since February 28, 2013.
The updates provided in OMB Bulletin No. 15-01 were based on the
application of the 2010 Standards for Delineating Metropolitan and
Micropolitan Statistical Areas to Census Bureau population estimates
for July 1, 2012 and July 1, 2013. In the FY 2017 IPPS/LTCH PPS final
rule (81 FR 56913), we adopted the updates set forth in OMB Bulletin
No. 15-01 effective October 1, 2016, beginning with the FY 2017 wage
index. For a complete discussion of the adoption of the updates set
forth in OMB Bulletin No. 15-01, we refer readers to the FY 2017 IPPS/
LTCH PPS final rule. In the FY 2018 IPPS/LTCH PPS final rule (82 FR
38130), we continued to use the OMB delineations that were adopted
beginning with FY 2015 to calculate the area wage indexes, with updates
as reflected in OMB Bulletin No. 15-01 specified in the FY 2017 IPPS/
LTCH PPS final rule.
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. The attachments to OMB Bulletin No. 17-01
provide detailed information on the update to statistical areas since
July 15, 2015, and are based on the application of the 2010 Standards
for Delineating Metropolitan and Micropolitan Statistical Areas to
Census Bureau population estimates for July 1, 2014 and July 1, 2015.
In OMB Bulletin No. 17-01, OMB announced that one Micropolitan
Statistical Area now qualifies as a Metropolitan Statistical Area. The
new urban CBSA is as follows:
Twin Falls, Idaho (CBSA 46300). This CBSA is comprised of
the principal city of Twin Falls, Idaho in Jerome County, Idaho and
Twin Falls County, Idaho.
The OMB bulletin is available on the OMB Web site at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf. We note that we did not have sufficient time to include this
change in the computation of the proposed FY 2019 wage index,
ratesetting, and Tables 2 and 3 associated with this proposed rule.
This new CBSA may affect the budget neutrality factors and wage
indexes, depending on whether the area is eligible for the rural floor
and the impact of the overall payments of the hospital located in this
new CBSA. We are providing below an estimate of this new area's wage
index based on the average hourly wages for new CBSA 46300 and the
national average hourly wages from the wage data for the proposed FY
2019 wage index (described below in section III.B. of the preamble of
this proposed rule). Currently, provider 130002 is the only hospital
located in Twin Falls County, Idaho, and there are no hospitals located
in Jerome County, Idaho. Thus, the proposed wage index for CBSA 46300
is calculated using the average hourly wage data for one provider
(provider 130002).
Below in sections III.D. and E.2. of the preamble of this proposed
rule, we provide the proposed FY 2019 unadjusted and occupational mix
adjusted national average hourly wages. Taking the estimated average
hourly wage of new CBSA 46300 and dividing by the proposed national
average hourly wage results in the estimated wage indexes shown in the
table below.
------------------------------------------------------------------------
Estimated
Estimated occupational
unadjusted mix adjusted
wage index for wage index for
new CBSA 46300 new CBSA 46300
------------------------------------------------------------------------
Proposed National Average Hourly Wage... 42.990625267 42.948428861
Estimated CBSA Average Hourly Wage...... 35.833564813 38.127590025
Estimated Wage Index.................... 0.8335 0.8878
------------------------------------------------------------------------
For FY 2019, we are using the OMB delineations that were adopted
beginning with FY 2015 to calculate the area wage indexes, with updates
as reflected in OMB Bulletin Nos. 13-01, 15-01, and 17-01. In the final
rule, we will incorporate this change into the final FY 2019 wage
index, ratesetting, and tables.
3. Codes for Constituent Counties in CBSAs
CBSAs are made up of one or more constituent counties. Each CBSA
and constituent county has its own unique identifying codes. There are
two different lists of codes associated with counties: Social Security
Administration (SSA) codes and Federal Information Processing Standard
(FIPS) codes. Historically, CMS has listed and used SSA and FIPS county
codes to identify and crosswalk counties to CBSA codes for purposes of
the hospital wage index. As we discussed in the FY 2018 IPPS/LTCH PPS
final rule (82 FR 38129 through 38130), we have learned that SSA county
codes are no longer being maintained and updated. However, the FIPS
codes continue to be maintained by the U.S. Census Bureau. We believe
that using the latest FIPS codes will allow us to maintain a more
accurate and up-to-date payment system
[[Page 20355]]
that reflects the reality of population shifts and labor market
conditions.
The Census Bureau's most current statistical area information is
derived from ongoing census data received since 2010; the most recent
data are from 2015. The Census Bureau maintains a complete list of
changes to counties or county equivalent entities on the website at:
https://www.census.gov/geo/reference/county-changes.html. We believe
that it is important to use the latest counties or county equivalent
entities in order to properly crosswalk hospitals from a county to a
CBSA for purposes of the hospital wage index used under the IPPS.
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38129 through 38130)
we adopted a policy to discontinue the use of the SSA county codes and
began using only the FIPS county codes for purposes of crosswalking
counties to CBSAs. In addition, in the same rule, we implemented the
latest FIPS code updates which were effective October 1, 2017,
beginning with the FY 2018 wage indexes. The updated changes were used
to calculate the wage indexes in a manner generally consistent with the
CBSA-based methodologies finalized in the FY 2005 IPPS final rule and
the FY 2015 IPPS/LTCH PPS final rule.
For FY 2019, we are continuing to use only the FIPS county codes
for purposes of crosswalking counties to CBSAs. For FY 2019, Tables 2
and 3 associated with this proposed rule and the County to CBSA
Crosswalk File and Urban CBSAs and Constituent Counties for Acute Care
Hospitals File posted on the CMS website reflect these county changes.
B. Worksheet S-3 Wage Data for the Proposed FY 2019 Wage Index
The proposed FY 2019 wage index values are based on the data
collected from the Medicare cost reports submitted by hospitals for
cost reporting periods beginning in FY 2015 (the FY 2018 wage indexes
were based on data from cost reporting periods beginning during FY
2014).
1. Included Categories of Costs
The proposed FY 2019 wage index includes all of the following
categories of data associated with costs paid under the IPPS (as well
as outpatient costs):
Salaries and hours from short-term, acute care hospitals
(including paid lunch hours and hours associated with military leave
and jury duty);
Home office costs and hours;
Certain contract labor costs and hours, which include
direct patient care, certain top management, pharmacy, laboratory, and
nonteaching physician Part A services, and certain contract indirect
patient care services (as discussed in the FY 2008 final rule with
comment period (72 FR 47315 through 47317)); and
Wage-related costs, including pension costs (based on
policies adopted in the FY 2012 IPPS/LTCH PPS final rule (76 FR 51586
through 51590)) and other deferred compensation costs.
2. Excluded Categories of Costs
Consistent with the wage index methodology for FY 2018, the
proposed wage index for FY 2019 also excludes the direct and overhead
salaries and hours for services not subject to IPPS payment, such as
skilled nursing facility (SNF) services, home health services, costs
related to GME (teaching physicians and residents) and certified
registered nurse anesthetists (CRNAs), and other subprovider components
that are not paid under the IPPS. The proposed FY 2019 wage index also
excludes the salaries, hours, and wage[dash]related costs of
hospital[dash]based rural health clinics (RHCs), and Federally
qualified health centers (FQHCs) because Medicare pays for these costs
outside of the IPPS (68 FR 45395). In addition, salaries, hours, and
wage-related costs of CAHs are excluded from the wage index for the
reasons explained in the FY 2004 IPPS final rule (68 FR 45397 through
45398).
3. Use of Wage Index Data by Suppliers and Providers Other Than Acute
Care Hospitals Under the IPPS
Data collected for the IPPS wage index also are currently used to
calculate wage indexes applicable to suppliers and other providers,
such as SNFs, home health agencies (HHAs), ambulatory surgical centers
(ASCs), and hospices. In addition, they are used for prospective
payments to IRFs, IPFs, and LTCHs, and for hospital outpatient
services. We note that, in the IPPS rules, we do not address comments
pertaining to the wage indexes of any supplier or provider except IPPS
providers and LTCHs. Such comments should be made in response to
separate proposed rules for those suppliers and providers.
C. Verification of Worksheet S-3 Wage Data
The wage data for the proposed FY 2019 wage index were obtained
from Worksheet S-3, Parts II and III of the Medicare cost report (Form
CMS-2552-10, OMB Control Number 0938-0050) for cost reporting periods
beginning on or after October 1, 2014, and before October 1, 2015. For
wage index purposes, we refer to cost reports during this period as the
``FY 2015 cost report,'' the ``FY 2015 wage data,'' or the ``FY 2015
data.'' Instructions for completing the wage index sections of
Worksheet S[dash]3 are included in the Provider Reimbursement Manual
(PRM), Part 2 (Pub. No. 15-2), Chapter 40, Sections 4005.2 through
4005.4. The data file used to construct the proposed FY 2019 wage index
includes FY 2015 data submitted to us as of February 6, 2018. As in
past years, we performed an extensive review of the wage data, mostly
through the use of edits designed to identify aberrant data.
We asked our MACs to revise or verify data elements that result in
specific edit failures. For the proposed FY 2019 wage index, we
identified and excluded 80 providers with aberrant data that should not
be included in the wage index, although if data elements for some of
these providers are corrected, we intend to include data from those
providers in the final FY 2019 wage index. We also adjusted certain
aberrant data and included these data in the proposed wage index. For
example, in situations where a hospital did not have documentable
salaries, wages, and hours for housekeeping and dietary services, we
imputed estimates, in accordance with policies established in the FY
2015 IPPS/LTCH PPS final rule (79 FR 49965 through 49967). We
instructed MACs to complete their data verification of questionable
data elements and to transmit any changes to the wage data no later
than March 23, 2018. In addition, as a result of the April and May
appeals processes, and posting of the April 27, 2018 PUF, we may make
additional revisions to the FY 2019 wage data, as described further
below. The revised data would be reflected in the FY 2019 IPPS/LTCH PPS
final rule.
In constructing the proposed FY 2019 wage index, we included the
wage data for facilities that were IPPS hospitals in FY 2015, inclusive
of those facilities that have since terminated their participation in
the program as hospitals, as long as those data did not fail any of our
edits for reasonableness. We believed that including the wage data for
these hospitals is, in general, appropriate to reflect the economic
conditions in the various labor market areas during the relevant past
period and to ensure that the current wage index represents the labor
market area's current wages as compared to the national average of
wages. However, we excluded the wage data for CAHs as discussed in the
FY 2004 IPPS final rule (68 FR 45397 through 45398; that is, any
hospital that is designated as a CAH by 7 days prior to the publication
of the preliminary wage index public use file (PUF) is excluded from
the calculation of the wage index). For this proposed
[[Page 20356]]
rule, we removed 8 hospitals that converted to CAH status on or after
January 23, 2017, the cut-off date for CAH exclusion from the FY 2018
wage index, and through and including January 26, 2018, the cut-off
date for CAH exclusion from the FY 2019 wage index. After excluding
CAHs and hospitals with aberrant data, we calculated the proposed wage
index using the Worksheet S-3, Parts II and III wage data of 3,260
hospitals.
For the proposed FY 2019 wage index, we allotted the wages and
hours data for a multicampus hospital among the different labor market
areas where its campuses are located in the same manner that we
allotted such hospitals' data in the FY 2018 wage index (82 FR 38131
through 38132); that is, using campus full-time equivalent (FTE)
percentages as originally finalized in the FY 2012 IPPS/LTCH PPS final
rule (76 FR 51591). Table 2, which contains the proposed FY 2019 wage
index associated with this proposed rule (available via the internet on
the CMS website), includes separate wage data for the campuses of 16
multicampus hospitals. The following chart lists the multicampus
hospitals by CSA certification number (CCN) and the FTE percentages on
which the wages and hours of each campus were allotted to their
respective labor market areas:
------------------------------------------------------------------------
Full-time
CSA certification number (CCN) of multicampus hospital equivalent (FTE)
percentages
------------------------------------------------------------------------
050121................................................ 0.81
05B121................................................ 0.19
070022................................................ 0.99
07B022................................................ 0.01
070033................................................ 0.92
07B033................................................ 0.08
100029................................................ 0.54
10B029................................................ 0.46
100167................................................ 0.37
10B167................................................ 0.63
140010................................................ 0.82
14B010................................................ 0.18
220074................................................ 0.89
22B074................................................ 0.11
330234................................................ 0.72
33B234................................................ 0.28
360019................................................ 0.95
36B019................................................ 0.05
360020................................................ 0.99
36B020................................................ 0.01
390006................................................ 0.95
39B006................................................ 0.05
390115................................................ 0.86
39B115................................................ 0.14
390142................................................ 0.83
39B142................................................ 0.17
460051................................................ 0.97
46B051................................................ 0.03
510022................................................ 0.95
51B022................................................ 0.05
670062................................................ 0.55
67B062................................................ 0.45
------------------------------------------------------------------------
We note that, in past years, in Table 2, we have placed a ``B'' to
designate the subordinate campus in the fourth position of the hospital
CCN. However, for this proposed rule and future rulemaking, we have
moved the ``B'' to the third position of the CCN. Because all IPPS
hospitals have a ``0'' in the third position of the CCN, we believe
that placement of the ``B'' in this third position, instead of the
``0'' for the subordinate campus, is the most efficient method of
identification and interferes the least with the other, variable,
digits in the CCN.
D. Method for Computing the Proposed FY 2019 Unadjusted Wage Index
1. Proposed Methodology for FY 2019
The method used to compute the proposed FY 2019 wage index without
an occupational mix adjustment follows the same methodology that we
used to compute the proposed wage indexes without an occupational mix
adjustment since FY 2012 (76 FR 51591 through 51593).
As discussed in the FY 2012 IPPS/LTCH PPS final rule, in ``Step
5,'' for each hospital, we adjust the total salaries plus wage-related
costs to a common period to determine total adjusted salaries plus
wage-related costs. To make the wage adjustment, we estimate the
percentage change in the employment cost index (ECI) for compensation
for each 30-day increment from October 14, 2014, through April 15,
2016, for private industry hospital workers from the BLS' Compensation
and Working Conditions. We have consistently used the ECI as the data
source for our wages and salaries and other price proxies in the IPPS
market basket, and we are not proposing any changes to the usage of the
ECI for FY 2019. The factors used to adjust the hospital's data were
based on the midpoint of the cost reporting period, as indicated in the
following table.
Midpoint of Cost Reporting Period
------------------------------------------------------------------------
After Before Adjustment factor
------------------------------------------------------------------------
10/14/2014 11/15/2014 1.02567
11/14/2014 12/15/2014 1.02413
12/14/2014 01/15/2015 1.02257
01/14/2015 02/15/2015 1.02100
02/14/2015 03/15/2015 1.01941
03/14/2015 04/15/2015 1.01784
04/14/2015 05/15/2015 1.01627
05/14/2015 06/15/2015 1.01471
06/14/2015 07/15/2015 1.01316
07/14/2015 08/15/2015 1.01161
08/14/2015 09/15/2015 1.01007
09/14/2015 10/15/2015 1.00849
10/14/2015 11/15/2015 1.00685
11/14/2015 12/15/2015 1.00516
12/14/2015 01/15/2016 1.00343
01/14/2016 02/15/2016 1.00171
02/14/2016 03/15/2016 1.00000
03/14/2016 04/15/2016 0.99824
------------------------------------------------------------------------
For example, the midpoint of a cost reporting period beginning
January 1, 2015, and ending December 31, 2015, is June 30, 2015. An
adjustment factor of 1.01316 would be applied to the wages of a
hospital with such a cost reporting period.
Using the data as previously described, the proposed FY 2019
national average hourly wage (unadjusted for occupational mix) is
$42.990625267.
Previously, we also would provide a Puerto Rico overall average
hourly wage. As discussed in the FY 2017 IPPS/LTCH PPS final rule (81
FR 56915), prior to January 1, 2016, Puerto Rico hospitals were paid
based on 75 percent of the national standardized amount and 25 percent
of the Puerto Rico-specific standardized amount. As a result, we
calculated a Puerto Rico-specific wage index that was applied to the
labor share of the Puerto Rico[dash]specific standardized amount.
Section 601 of the Consolidated Appropriations Act, 2016 (Pub. L.
114[dash]113) amended section 1886(d)(9)(E) of the Act to specify that
the payment calculation with respect to operating costs of inpatient
hospital services of a subsection (d) Puerto Rico hospital for
inpatient hospital discharges on or after January 1, 2016, shall use
100 percent of the national standardized amount. As we stated in the FY
2017 IPPS/LTCH PPS final rule (81 FR 56915 through 56916), because
Puerto Rico hospitals are no longer paid with a Puerto Rico-specific
standardized amount as of January 1, 2016, under section 1886(d)(9)(E)
of the Act, as amended by section 601 of the Consolidated
Appropriations Act, 2016, there is no longer a need to calculate a
Puerto Rico-specific average hourly wage and wage index. Hospitals in
Puerto Rico are now paid 100 percent of the national standardized
amount and, therefore, are subject to the national average hourly wage
(unadjusted for occupational mix) (which is $42.990625267 for this FY
2019 proposed rule) and the national wage index, which is applied to
the national labor share of the national standardized amount. For FY
2019, we
[[Page 20357]]
are not proposing a Puerto Rico-specific overall average hourly wage or
wage index.
2. Proposed Update of Policies Related to Other Wage-Related Costs,
Clarification of the Calculation of Other Wage-Related Costs, and
Proposals for FY 2020 and Subsequent Years
Section 1886(d)(3)(E) of the Act requires the Secretary to update
the wage index based on a survey of hospitals' costs that are
attributable to wages and wage-related costs. In the September 1, 1994
IPPS final rule (59 FR 45356), we developed a list of ``core'' wage-
related costs that hospitals may report on Worksheet S-3, Part II of
the Medicare hospital cost report in order to include those costs in
the wage index. Core wage-related costs include categories of
retirement cost, plan administrative costs, health and insurance costs,
taxes, and other specified costs such as tuition reimbursement.
In addition to these categories of core wage-related costs, we
allow hospitals to report wage-related costs other than those on the
core list if the other wage-related costs meet certain criteria. The
criteria for including other wage-related costs in the wage index are
discussed in the September 1, 1994 IPPS final rule (59 FR 45357) and
clarified in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38132 through
38136). In addition, the criteria for including other wage[dash]related
costs in the wage index are listed in the Provider Reimbursement Manual
(PRM), Part II, Chapter 40, Sections 4005.2 through 4005.4, Line 18 on
W/S S-3 Part II and Line 25 and its subscripts on W/S S-3 Part IV of
the Medicare cost report (Form CMS-2552-10, OMB control number 0938-
0050).
In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38132 through
38136), we clarified that a hospital may be able to report a wage-
related cost (defined as the value of the benefit) that does not appear
on the core list if it meets all of the following criteria:
The wage-related cost is provided at a significant
financial cost to the employer. To meet this test, the individual wage-
related cost must be greater than 1 percent of total salaries after the
direct excluded salaries are removed (the sum of Worksheet S-3, Part
II, Lines 11, 12, 13, 14, Column 4, and Worksheet S-3, Part III, Line
3, Column 4).
The wage-related cost is a fringe benefit as described by
the IRS and is reported to the IRS on an employee's or contractor's W-2
or 1099 form as taxable income.
The wage-related cost is not furnished for the convenience
of the provider or otherwise excludable from income as a fringe benefit
(such as a working condition fringe).
We noted that those wage-related costs reported as salaries on Line
1 (for example, loan forgiveness and sick pay accruals) should not be
included as other wage[dash]related costs on Line 18.
The above instructions for calculating the 1-percent test
inadvertently omitted Line 15 for Home Office Part A Administrator on
Worksheet S-3, Part II from the denominator. Line 15 should be included
in the denominator because Home Office Part A Administrator is added to
Line 1 in the wage index calculation. Therefore, in this proposed rule,
we are correcting the inadvertent omission of Line 15 from the
denominator, and we are clarifying that, for calculating the 1-percent
test, each individual category of the other wage-related cost (that is,
the numerator) should be divided by the sum of Worksheet S-3, Part III,
Lines 3 and 4, Column 4 (that is, the denominator). Line 4 sums the
following lines from Worksheet S-3, Part II: Lines 11, 12, 13, 14,
14.01, 14.02, and 15. We also direct readers to instructions for
calculating the 1-percent test in the Provider Reimbursement Manual
(PRM), Part II, Chapter 40, Section 4005.4, Line 25 and its subscripts
on Worksheet S-3, Part IV of the Medicare cost report (Form CMS-2552-
10, OMB control number 0938-0050), which state: ``Calculate the 1-
percent test by dividing each individual category of the other wage-
related cost (that is, the numerator) by the sum of Worksheet S-3, Part
III, Lines 3 and 4, Column 4, (that is, the denominator).''
In addition to our discussion about calculating the 1-percent test
and other criteria for including other-wage related costs in the wage
index, we stated in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38133
through 38166) that we would consider proposing to remove other wage-
related costs from the wage index entirely.
In the FY 2018 IPPS/LTCH PPS proposed and final rules (82 FR 19901
and 82 FR 38133, respectively), we stated that we originally allowed
for the inclusion of wage-related costs other than those on the core
list because we were concerned that individual hospitals might incur
unusually large wage-related costs that are not reflected on the core
list but that may represent a significant wage-related cost. However,
we stated in the FY 2018 IPPS/LTCH PPS proposed and final rules (82 FR
19901 and 82 FR 38133, respectively) that we were reconsidering
allowing other wage-related costs to be included in the wage index
because internal reviews of the FY 2018 wage data showed that only a
small minority of hospitals were reporting other wage-related costs
that meet the 1-percent test described earlier.
This year, as part of the wage index desk review process for FY
2019, internal reviews showed that only 8 hospitals out of the more
than 3,000 IPPS hospitals in the wage index had other wage-related
costs that were correctly reported for inclusion in the wage index.
Given the extremely limited number of hospitals nationally using
Worksheet S-3, Part IV, Line 25 and subscripts, and Worksheet S-3, Part
II, Line 18, to correctly report other wage-related costs in accordance
with the criteria to be included in the wage index, we continue to
believe that other wage-related costs do not constitute an appropriate
and significant portion of wage costs in a particular labor market
area. In other words, while other wage-related costs may represent
costs that may have an impact on an individual hospital's average
hourly wage, we do not believe that costs reported by only a very small
minority of hospitals (less than 0.003 percent) accurately reflect the
economic conditions of the labor market area as a whole in which such
an individual hospital is located. The fact that only 8 hospitals out
of more than 3,000 IPPS hospitals included in the FY 2019 IPPS proposed
wage index reported other wage-related costs correctly in accordance
with the 1-percent test and related criteria indicates that, in fact,
other wage-related costs are not a relative measure of the labor costs
to be included in the IPPS wage index. Therefore, we believe that
inclusion of other wage-related costs in the wage index in such a
limited manner may distort the average hourly wage of a particular
labor market area so that its wage index does not accurately represent
that labor market area's current wages relative to national wages.
Furthermore, the open-ended nature of the types of other wage-
related costs that may be included on Line 25 and its subscripts of
Worksheet S-3 Part IV and Line 18 of Worksheet S-3 Part II, in contrast
to the concrete list of core wage-related costs, may hinder consistent
and proper reporting of fringe benefits. Our internal reviews indicate
widely divergent types of costs that hospitals are reporting as other
wage-related costs on these lines. We are concerned that inconsistent
reporting of other wage-related costs further compromises the accuracy
of the wage index as a representation of the relative average hourly
wage for each labor
[[Page 20358]]
market area. Our intent in creating a core list of wage-related costs
in the September 1, 1994 IPPS final rule was to promote consistent
reporting of fringe benefits, and we are increasingly concerned that
inconsistent reporting of wage-related costs undermines this effort.
Specifically, we expressed in the September 1, 1994 IPPS final rule
that, since we began including fringe benefits in the wage index, we
have been concerned with the inconsistent reporting of fringe benefits,
whether because of a lack of provider proficiency in identifying fringe
benefit costs or varying interpretations across fiscal intermediaries
of the definition for fringe benefits in PRM-I, Section 2144.1 (59 FR
45356). We believe that the limited and inconsistent use of Line 25 and
its subscripts of Worksheet S-3 Part IV and Line 18 of Worksheet S-3
Part II for reporting wage[dash]related costs other than the core list
indicate that including other wage[dash]related costs in the wage index
compromises the accuracy of the wage index as a relative measure of
wages in a given labor market area.
Therefore, for the reasons discussed earlier, for the FY 2020 wage
index and subsequent years, we are proposing to only include the wage-
related costs on the core list in the calculation of the wage index and
not to include any other wage-related costs in the calculation of the
wage index. Under our proposal, we would no longer consider any other
wage-related costs beginning with the FY 2020 wage index. Considering
the extremely limited number of hospitals reporting other wage-related
costs and the inconsistency in types of other wage-related costs being
reported, we believe this proposal will help ensure a more consistent
and more accurate wage index representative of the relative average
hourly wage for each labor market area. In addition, we believe that
this proposal to no longer include other wage-related costs in the wage
index calculation benefits the vast majority of hospitals because most
hospitals do not report other wage-related costs. Because the wage
index is budget neutral, hospitals in an area without other wage-
related costs included in the wage index have their wage indexes
reduced when other areas' wage indexes are raised by including other
wage[dash]related costs in their wage index calculation. We also note
that this proposal to exclude other wage[dash]related costs from the
wage index, starting with the FY 2020 wage index, contributes to agency
efforts to simplify hospital paperwork burden because it would
eliminate the need for Line 18 on Worksheet S-3, Part II and Line 25
and its subscripts on Worksheet S-3, Part IV of the Medicare cost
report (Form CMS-2552-10, OMB control number 0938-0050). We note that
we would include in the FY 2019 wage index the other wage-related costs
of the eight hospitals that accurately reported those costs in
accordance with the current criteria.
In summary, we are clarifying that our current policy for
calculating the 1-percent test includes Line 15 for Home Office Part A
Administrator on Worksheet S-3, Part II in the denominator. In
addition, we are proposing to eliminate other wage-related costs from
the calculation of the wage index for the FY 2020 wage index and
subsequent years, as discussed earlier. We are inviting public comments
on this proposal.
3. Proposals To Codify Policies Regarding Multicampus Hospitals
We have received an increasing number of inquiries regarding the
treatment of multicampus hospitals as the number of multicampus
hospitals has grown in recent years. While the regulations at Sec.
412.230(d)(2)(iii) and (v) for geographic reclassification under the
MGCRB include criteria for how multicampus hospitals may be
reclassified, the regulations at Sec. 412.92 for sole community
hospitals (SCHs), Sec. 412.96 for rural referral centers (RRC), Sec.
412.103 for rural reclassification, and Sec. 412.108 for
Medicare[dash]dependent, small rural hospitals (MDHs) do not directly
address multicampus hospitals. Thus, in this proposed rule, we are
proposing to codify in these regulations the policies for multicampus
hospitals that we have developed in response to recent questions
regarding CMS' treatment of multicampus hospitals for purposes other
than geographic reclassification under the MGCRB.
The proposals below apply to hospitals with a main campus and one
or more remote locations under a single provider agreement where
services are provided and billed under the IPPS and that meet the
provider-based criteria at Sec. 413.65 as a main campus and a remote
location of a hospital, also referred to as multicampus hospitals or
hospitals with remote locations. We are proposing that a main campus of
a hospital cannot obtain an SCH, RRC, or MDH status or rural
reclassification independently or separately from its remote
location(s), and vice versa. Rather, if the criteria are met in the
regulations at Sec. 412.92 for SCHs, Sec. 412.96 for RRCs, Sec.
412.103 for rural reclassification, or Sec. 412.108 for MDHs (as
discussed later in this section), the hospital (that is, the main
campus and its remote location(s)) would be granted the special
treatment or rural reclassification afforded by the aforementioned
regulations.
We believe this is an appropriate policy for two reasons. First,
each remote location of a hospital is included on the main campus's
cost report and shares the same provider number. That is, the main
campus and remote location(s) would share the same status or rural
reclassification because the hospital is a single entity with one
provider agreement. Second, it would not be administratively feasible
for CMS and the MACs to track every hospital with remote locations
within the same CBSA and to assign different statuses or rural
reclassifications exclusively to the main campus or to its remote
location. We note that, for wage index purposes only, CMS tracks
multicampus remote locations located in different CBSAs in order to
comply with the statutory requirement to adjust for geographic
differences in hospital wage levels (section 1886(d)(3)(E) of the Act).
However, for purposes of rural reclassification under Sec. 412.103, we
do not believe it would be appropriate for a main campus and remote
location(s) (whether located in the same or separate CBSAs) to be
reclassified independently or separately from each other because,
unlike MGCRB reclassifications which are used only for wage index
purposes, Sec. 412.103 rural reclassifications have payment effects
other than wage index (for example, payments to disproportionate share
hospitals (DSHs), and non-Medicare payment provisions, such as the 340B
Drug Pricing Program administered by HRSA).
To qualify for rural reclassification or SCH, RRC, or MDH status,
we are proposing that a hospital with remote locations must demonstrate
that both the main campus and its remote location(s) satisfy the
relevant qualifying criteria. A hospital with remote locations submits
a joint cost report that includes data from its main campus and remote
location(s), and its MedPAR data also combine data from the main campus
and remote location(s). We believe that it would not be feasible to
separate data by location, nor would it be appropriate, because we
consider a main campus and remote location(s) to be one hospital.
Therefore, where the regulations at Sec. 412.92, Sec. 412.96, Sec.
412.103, and Sec. 412.108 require data, such as bed count, number of
discharges, or case-mix index, for example, to demonstrate that the
hospital meets the qualifying criteria, we are proposing to codify in
our regulations that the combined data from the main campus and its
remote location(s) are to be used.
[[Page 20359]]
For example, if a hospital with a main campus with 200 beds and a
remote location with 75 beds applies for RRC status, the combined count
of 275 beds would be considered the hospital's bed count, and the main
campus and its remote location would be granted RRC status if the
hospital applies during the last quarter of its cost reporting period
and both the main campus and the remote location are located in a rural
area as defined in 42 CFR part 412, subpart D. This is consistent with
the regulation at Sec. 412.96(b)(1), which states, in part, that the
number of beds is determined under the provisions of Sec. 412.105(b).
For Sec. 412.105(b), beds are counted from the main campus and remote
location(s) of a hospital. We believe this is also consistent with
Sec. 412.96(b)(1)(ii), which sets forth the criteria that the hospital
is located in a rural area and the hospital has a bed count of 275 or
more beds during its most recently completed cost reporting period,
unless the hospital submits written documentation with its application
that its bed count has changed since the close of its most recently
completed cost reporting period for one or more of several reasons,
including the merger of two or more hospitals.
Similarly, combined data would be used for demonstrating the
hospital meets criteria at Sec. 412.92 for SCH status. For example,
the patient origin data, which are typically MedPAR data used to
document the boundaries of the hospital's service area as required in
Sec. 412.92(b)(1)(ii) and (iii), would be used from both locations. We
reiterate that we believe this is the appropriate policy because the
main campus and remote location are considered one hospital and that it
is the only administratively feasible policy because there is currently
no way to split the MedPAR data for each location.
For Sec. 412.103 rural reclassification, a hospital with remote
location(s) seeking to qualify under Sec. 412.103(a)(3), which
requires that the hospital would qualify as an RRC or SCH if the
hospital were located in a rural area, would similarly demonstrate that
it meets the criteria at Sec. 412.92 or at Sec. 412.96, such as bed
count, by using combined data from the main campus and its remote
location(s) (with the exception of certain criteria discussed below
related to location, mileage, travel time, and distance requirements).
We refer readers to the portions of our discussion that explain how
hospitals with remote locations would meet criteria for RRC or SCH
status.
A hospital seeking MDH status would also use combined data for bed
count and discharges to demonstrate that it meets the criteria at Sec.
412.108(a)(1). For example, if the main campus of a hospital has 75
beds and its remote location has 30 beds, the bed count exceeds 100
beds and the hospital would not satisfy the criteria at Sec.
412.108(a)(1)(i) (which is proposed to be redesignated as
412.108(a)(1)(ii)).
We are reminding readers that, under Sec. 412.108(b)(4) and Sec.
412.92(b)(3)(i), an approved MDH or SCH status determination remains in
effect unless there is a change in the circumstances under which the
status was approved. While we believe that this proposal is consistent
with the policies for multicampus hospitals that we have developed in
response to recent questions, current MDHs and SCHs should make sure
that this proposal does not create a change in circumstance (such as an
increase in the number of beds to more than 100 for MDHs or to more
than 50 for SCHs), which an MDH or SCH is required to report to the MAC
within 30 days of the event, in accordance with Sec. 412.108(b)(4)(ii)
and (iii) and Sec. 412.92(b)(3)(ii) and (iii).
With regard to other qualifying criteria set forth in the
regulations at Sec. Sec. 412.92, 412.96, 412.103, and 412.108 that do
not involve data that can be combined, specifically qualifying criteria
related to location, mileage, travel time, and distance requirements, a
hospital would need to demonstrate that the main campus and its remote
location(s) each independently satisfy those requirements in order for
the entire hospital, including its remote location(s), to be
reclassified or obtain a special status.
To qualify for SCH status, for example, it would be insufficient
for only the main campus, and not the remote location, to meet distance
criteria. Rather, the main campus and its remote location(s) would each
need to meet at least one of the criteria at Sec. 412.92(a).
Specifically, the main campus and its remote location must each be
located more than 35 miles from other like hospitals, or if in a rural
area (as defined in Sec. 412.64), be located between 25 and 35 miles
from other like hospitals if meeting one of the criteria at Sec.
412.92(a)(1) (and each meet the criterion at Sec. 412.92(a)(1)(iii) if
applicable), or between 15 and 25 miles from other like hospitals if
the other like hospitals are inaccessible for at least 30 days in each
2 out of 3 years (Sec. 412.92(a)(2)), or travel time to the nearest
like hospital is at least 45 minutes (Sec. 412.92(a)(3)). We believe
that this is necessary to show that the hospital is indeed the sole
source of inpatient hospital services reasonably available to
individuals in a geographic area who are entitled to benefits under
Medicare Part A, as required by section 1886(d)(5)(D)(iii)(II) of the
Act. For hospitals with remote locations that apply for SCH
classification under Sec. 412.92(a)(1)(i) and (ii), combined data are
used to document the boundaries of the hospital's service area using
data from across both locations, as discussed earlier, and all like
hospitals within a 35-mile radius of each location are included in the
analysis. To be located in a rural area to use the criteria in Sec.
412.92(a)(1), (2), and (3), the main campus and its remote location(s)
must each be either geographically located in a rural area, as defined
in Sec. 412.64, or reclassified as rural under Sec. 412.103.
Similarly, for RRC classification under Sec. 412.96 and MDH
classification under Sec. 412.108, the main campus and its remote
location(s) must each be either geographically located in a rural area,
as defined in 42 CFR part 412, subpart D, or reclassified as rural
under Sec. 412.103 to meet the rural requirement portion of the
criteria at Sec. 412.96(b)(1), Sec. 412.96(c), or Sec. 412.108(a)(1)
(or for MDH, be located in a State with no rural area and satisfy any
of the criteria under Sec. 412.103(a)(1) or (a)(3) or under Sec.
412.103(a)(2) as of January 1, 2018). For hospitals with remote
locations that apply for RRC classification under Sec.
412.96(b)(2)(ii) or Sec. 412.96(c)(4), 25 miles is calculated from
each location (the main campus and its remote location(s)), and
combined data from both the main campus and its remote location(s) are
used to calculate the percentage of Medicare patients, services
furnished to Medicare beneficiaries, and discharges.
For hospitals seeking to reclassify as rural by meeting the
criteria at Sec. 412.103(a)(1), (a)(2), or (a)(6), we also are
proposing to codify in our regulations that it would not be sufficient
for only the main campus, and not its remote location(s), to
demonstrate that its location meets the aforementioned criteria.
Rather, under Sec. 412.103(a)(1) and (2) (which also are incorporated
in Sec. 412.103(a)(6)), we are proposing that the main campus and its
remote location(s) must each either be located (1) in a rural census
tract of an MSA as determined under the most recent version of the
Goldsmith Modification, the Rural-Urban Commuting Area codes (Sec.
412.103(a)(1)), or (2) in an area designated by any law or regulation
of the State in which it is located as a rural area, or be designated
as a rural hospital by State law or regulation (Sec. 412.103(a)(2)).
For hospitals seeking to reclassify as rural
[[Page 20360]]
by meeting the criteria in Sec. 412.103(a)(3), which require that the
hospital would qualify as an RRC or a SCH if the hospital were located
in a rural area, we refer readers to our discussion presented earlier
that explains how hospitals with remote locations would meet criteria
for RRC or SCH status.
We note that we have also received questions about how a hospital
with remote locations that trains residents in approved medical
residency training programs would be treated for IME adjustment
purposes if it reclassifies as rural under Sec. 412.103. As we noted
in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50114), the rural
reclassification provision of Sec. 412.103 only applies to IPPS
hospitals under section 1886(d) of the Act. Therefore, it applies for
IME payment purposes, given that the IME adjustment under section
1886(d)(5)(B) of the Act is an additional payment under IPPS. In
contrast, sections 1886(a)(4) and (d)(1)(A) of the Act exclude direct
GME costs from operating costs and these costs are not included in the
calculation of the IPPS payment rates for inpatient hospital services.
Payment for direct GME is separately authorized under section 1886(h)
of the Act and, therefore, not subject to Sec. 412.103. Therefore, if
a geographically urban teaching hospital reclassifies as rural under
Sec. 412.103, such a reclassification would only affect the teaching
hospital's IME adjustment, and not its direct GME payment. Accordingly,
we are clarifying that in order for the IME cap adjustment regulations
at Sec. 412.105(f)(1)(iv)(A), Sec. 412.105(f)(1)(vii), and Sec.
412.105(f)(1)(xv) to be applicable to a teaching hospital with a main
campus and a remote location(s), the main campus and its remote
location(s), respectively, must each be either geographically located
in a rural area as defined in 42 CFR part 412, subpart D, or
reclassified as rural under Sec. 412.103. For direct GME purposes at
Sec. 413.79, both the main campus and its remote location(s) are
required to be geographically rural because a hospital's status for any
direct GME payments or adjustments is unaffected by a Sec. 412.103
rural reclassification.
We are proposing to codify these policies regarding the application
of the qualifying criteria for hospitals with remote locations in the
regulations at Sec. 412.92 for SCHs, Sec. 412.96 for RRCs, Sec.
412.103 for rural reclassification, or Sec. 412.108 for MDHs.
Specifically, we are proposing to revise these regulations as follows:
We are proposing to add paragraph (a)(4) to Sec. 412.92 to specify
that, for a hospital with a main campus and one or more remote
locations under a single provider agreement where services are provided
and billed under the IPPS and that meets the provider-based criteria at
Sec. 413.65 as a main campus and a remote location of a hospital,
combined data from the main campus and its remote location(s) are
required to demonstrate that the criteria at Sec. 412.92(a)(1)(i) and
(ii) are met. For the mileage and rural location criteria at Sec.
412.92(a) and the mileage, accessibility, and travel time criteria
specified at Sec. 412.92(a)(1) through (a)(3), the hospital must
demonstrate that the main campus and its remote location(s) each
independently satisfy those requirements.
In Sec. 412.96, we are proposing to redesignate paragraph (d) as
paragraph (e) and add a new paragraph (d) to specify that, for a
hospital with a main campus and one or more remote locations under a
single provider agreement where services are provided and billed under
the IPPS and that meets the provider-based criteria at Sec. 413.65 as
a main campus and a remote location of a hospital, combined data from
the main campus and its remote location(s) are required to demonstrate
that the criteria at Sec. 412.96(b)(1) and (2) and (c)(1) through
(c)(5) are met. For purposes of meeting the rural location criteria in
Sec. 412.96(b)(1) and (c) and the mileage criteria in Sec.
412.96(b)(2)(ii) and (c)(4), the hospital must demonstrate that the
main campus and its remote location(s) each independently satisfy those
requirements.
We are proposing to add paragraph (a)(7) to Sec. 412.103 to
specify that, for a hospital with a main campus and one or more remote
locations under a single provider agreement where services are provided
and billed under the IPPS and that meets the provider-based criteria at
Sec. 413.65 as a main campus and a remote location of a hospital, the
hospital must demonstrate that the main campus and its remote
location(s) each independently satisfy the location criteria specified
in Sec. 412.103(a)(1) and (2) (which criteria also are incorporated in
Sec. 412.103(a)(6)).
We are proposing to add paragraph (a)(3) to Sec. 412.108 to
specify that, for a hospital with a main campus and one or more remote
locations under a single provider agreement where services are provided
and billed under the IPPS and that meets the provider-based criteria at
Sec. 413.65 as a main campus and a remote location of a hospital,
combined data from the main campus and its remote location(s) are
required to demonstrate that the criteria in Sec. 412.108(a)(1) and
(2) are met. For the location requirement specified at proposed amended
paragraph (a)(1)(i) of this section, the hospital must demonstrate that
the main campus and its remote location(s) each independently satisfy
this requirement.
We are inviting public comments on our proposals described above.
E. Proposed Occupational Mix Adjustment to the FY 2019 Wage Index
As stated earlier, section 1886(d)(3)(E) of the Act provides for
the collection of data every 3 years on the occupational mix of
employees for each short-term, acute care hospital participating in the
Medicare program, in order to construct an occupational mix adjustment
to the wage index, for application beginning October 1, 2004 (the FY
2005 wage index). The purpose of the occupational mix adjustment is to
control for the effect of hospitals' employment choices on the wage
index. For example, hospitals may choose to employ different
combinations of registered nurses, licensed practical nurses, nursing
aides, and medical assistants for the purpose of providing nursing care
to their patients. The varying labor costs associated with these
choices reflect hospital management decisions rather than geographic
differences in the costs of labor.
1. Use of 2016 Medicare Wage Index Occupational Mix Survey for the
Proposed FY 2019 Wage Index
Section 304(c) of the Consolidated Appropriations Act, 2001 (Pub.
L. 106-554) amended section 1886(d)(3)(E) of the Act to require CMS to
collect data every 3 years on the occupational mix of employees for
each short-term, acute care hospital participating in the Medicare
program. We collected data in 2013 to compute the occupational mix
adjustment for the FY 2016, FY 2017, and FY 2018 wage indexes. As
discussed in the FY 2018 IPPS/LTCH PPS proposed rule (82 FR 19903) and
final rule (82 FR 38137), a new measurement of occupational mix is
required for FY 2019.
The FY 2019 occupational mix adjustment is based on a new calendar
year (CY) 2016 survey. Hospitals were required to submit their
completed 2016 surveys (Form CMS-10079, OMB number 0938-0907) to their
MACs by July 3, 2017. The preliminary, unaudited CY 2016 survey data
were posted on the CMS website on July 12, 2017. As with the Worksheet
S-3, Parts II and III cost report wage data, as part of the FY 2019
desk review process, the MACs revised or verified data elements in
hospitals' occupational mix surveys that result in certain edit
failures.
[[Page 20361]]
2. Calculation of the Proposed Occupational Mix Adjustment for FY 2019
For FY 2019, we are proposing to calculate the occupational mix
adjustment factor using the same methodology that we have used since
the FY 2012 wage index (76 FR 51582 through 51586) and to apply the
occupational mix adjustment to 100 percent of the FY 2019 wage index.
Similar to the method we use for the calculation of the wage index
without occupational mix, salaries and hours for a multicampus hospital
are allotted among the different labor market areas where its campuses
are located. Table 2 associated with this proposed rule (which is
available via the Internet on the CMS website), which contains the
proposed FY 2019 occupational mix adjusted wage index, includes
separate wage data for the campuses of 16 multicampus hospitals. We
refer readers to section III.C. of the preamble of this proposed rule
for a chart listing the multicampus hospitals and the FTE percentages
used to allot their occupational mix data.
Because the statute requires that the Secretary measure the
earnings and paid hours of employment by occupational category not less
than once every 3 years, all hospitals that are subject to payments
under the IPPS, or any hospital that would be subject to the IPPS if
not granted a waiver, must complete the occupational mix survey, unless
the hospital has no associated cost report wage data that are included
in the FY 2019 wage index. For the proposed FY 2019 wage index, we are
using the Worksheet S-3, Parts II and III wage data of 3,260 hospitals,
and we are using the occupational mix surveys of 3,078 hospitals for
which we also have Worksheet S-3 wage data, which represented a
``response'' rate of 94 percent (3,078/3,260). For the proposed FY 2019
wage index, we are applying proxy data for noncompliant hospitals, new
hospitals, or hospitals that submitted erroneous or aberrant data in
the same manner that we applied proxy data for such hospitals in the FY
2012 wage index occupational mix adjustment (76 FR 51586). As a result
of applying this methodology, the proposed FY 2019 occupational mix
adjusted national average hourly wage is $42.948428861.
In summary, the proposed FY 2019 unadjusted national average hourly
wage and the proposed FY 2019 occupational mix adjusted national
average hourly wage is:
------------------------------------------------------------------------
Proposed unadjusted national Proposed occupational mix adjusted
average hourly wage national average hourly wage
------------------------------------------------------------------------
$42.990625267 $42.948428861
------------------------------------------------------------------------
F. Analysis and Implementation of the Proposed Occupational Mix
Adjustment and the Proposed FY 2019 Occupational Mix Adjusted Wage
Index
As discussed in section III.E. of the preamble of this proposed
rule, for FY 2019, we are proposing to apply the occupational mix
adjustment to 100 percent of the FY 2019 wage index. We calculated the
proposed occupational mix adjustment using data from the 2016
occupational mix survey data, using the methodology described in the FY
2012 IPPS/LTCH PPS final rule (76 FR 51582 through 51586). Using the
occupational mix survey data and applying the occupational mix
adjustment to 100 percent of the FY 2019 wage index results in a
proposed national average hourly wage of $42.948428861.
The proposed FY 2019 national average hourly wages for each
occupational mix nursing subcategory as calculated in Step 2 of the
occupational mix calculation are as follows:
------------------------------------------------------------------------
Average hourly
Occupational mix nursing subcategory wage
------------------------------------------------------------------------
National RN............................................. $41.67064907
National LPN and Surgical Technician.................... 24.68950438
National Nurse Aide, Orderly, and Attendant............. 16.96671421
National Medical Assistant.............................. 18.1339666
National Nurse Category................................. 35.05256013
------------------------------------------------------------------------
The proposed national average hourly wage for the entire nurse
category as computed in Step 5 of the occupational mix calculation is
$35.05256013. Hospitals with a nurse category average hourly wage (as
calculated in Step 4) of greater than the national nurse category
average hourly wage receive an occupational mix adjustment factor (as
calculated in Step 6) of less than 1.0. Hospitals with a nurse category
average hourly wage (as calculated in Step 4) of less than the national
nurse category average hourly wage receive an occupational mix
adjustment factor (as calculated in Step 6) of greater than 1.0.
Based on the 2016 occupational mix survey data, we determined (in
Step 7 of the occupational mix calculation) that the national
percentage of hospital employees in the nurse category is 42.3 percent,
and the national percentage of hospital employees in the all other
occupations category is 57.7 percent. At the CBSA level, the percentage
of hospital employees in the nurse category ranged from a low of 26.6
percent in one CBSA to a high of 82.0 percent in another CBSA.
We compared the FY 2019 proposed occupational mix adjusted wage
indexes for each CBSA to the proposed unadjusted wage indexes for each
CBSA. As a result of applying the proposed occupational mix adjustment
to the wage data, the proposed wage index values for 232 (56.9 percent)
urban areas and 23 (48.9 percent) rural areas would increase. The
proposed wage index values for 113 (27.7 percent) urban areas would
increase by greater than or equal to 1 percent but less than 5 percent,
and the proposed wage index values for 7 (1.7 percent) urban areas
would increase by 5 percent or more. The proposed wage index values for
9 (19.1 percent) rural areas would increase by greater than or equal to
1 percent but less than 5 percent, and 1 rural area's proposed wage
index value would increase by 5 percent or more. However, the proposed
wage index values for 175 (42.9 percent) urban areas and 24 (51.1
percent) rural areas would decrease. The proposed wage index values for
81 (19.9 percent) urban areas would decrease by greater than or equal
to 1 percent but less than 5 percent, and 1 urban area's proposed wage
index value would decrease by 5 percent or more. The proposed wage
index values of 6 (12.8 percent) rural areas would decrease by greater
than or equal to 1 percent and less than 5 percent, and no rural areas'
proposed wage index values would decrease by 5 percent or more. The
largest proposed positive impacts would be 6.42 percent for an urban
area and 5.25 percent for a rural area. The largest proposed negative
impacts would be 5.84 percent for an urban area and 1.6 percent for a
rural area. One urban area's proposed wage indexes, but no rural area
proposed wage indexes, would remain unchanged by application of the
occupational mix adjustment. These results indicate that a larger
percentage of urban areas (56.9 percent) would benefit from the
occupational mix adjustment than would rural areas (48.9 percent).
We also compared the FY 2019 wage data adjusted for occupational
mix from the 2016 survey to the FY 2019 wage data adjusted for
occupational mix from the 2013 survey. This analysis illustrates the
effect on area wage indexes of using the 2016 survey data compared to
the 2013 survey data; that is, it shows whether hospitals' wage indexes
would increase or decrease under the 2016 survey data as compared to
the prior 2013 survey data. Of the 407
[[Page 20362]]
urban CBSAs and 47 rural CBSAs, our analysis shows that the FY 2019
wage index values for 179 (43.9 percent) urban areas and 20 (42.6
percent) rural areas would increase using the 2016 survey data. Ninety-
eight (24.0 percent) urban areas would increase by greater than or
equal to 1 percent but less than 5 percent, and 27 (6.6 percent) urban
areas would increase by 5 percent or more. Nine (19.1 percent) rural
areas would increase by greater than or equal to 1 percent but less
than 5 percent, and 4 (8.5 percent) rural areas would increase by 5
percent or more. However, the wage index values for 229 (56.1 percent)
urban areas and 27 (57.4 percent) rural areas would decrease using the
2016 survey data. One hundred thirty three (32.6 percent) urban areas
would decrease by greater than or equal to 1 percent but less than 5
percent, and 24 (5.9 percent) urban areas would decrease by 5 percent
or more. Eleven (23.4 percent) rural areas would decrease by greater
than or equal to 1 percent but less than 5 percent, and 2 (4.3 percent)
rural areas would decrease by 5 percent or more. The largest positive
impacts using the 2016 survey data compared to the 2013 survey data are
17.2 percent for an urban area and 13.8 percent for a rural area. The
largest negative impacts are 13.0 percent for an urban area and 14.0
percent for rural areas. No urban areas and no rural areas are
unaffected. These results indicate that the wage indexes of more CBSAs
overall (56.3 percent) would decrease due to application of the 2016
occupational mix survey data as compared to the 2013 occupational mix
survey data to the wage index. Further, a slightly larger percentage of
urban areas (43.9 percent) would benefit from the use of the 2016
occupational mix survey data as compared to the 2013 occupational mix
survey data than would rural areas (42.6 percent).
G. Proposed Application of the Rural, Imputed, and Frontier Floors
1. Proposed Rural Floor
Section 4410(a) of Public Law 105-33 provides that, for discharges
on or after October 1, 1997, the area wage index applicable to any
hospital that is located in an urban area of a State may not be less
than the area wage index applicable to hospitals located in rural areas
in that State. This provision is referred to as the ``rural floor.''
Section 3141 of Public Law 111-148 also requires that a national budget
neutrality adjustment be applied in implementing the rural floor. Based
on the proposed FY 2019 wage index associated with this proposed rule
(which is available via the Internet on the CMS website), we estimated
that 255 hospitals would receive an increase in their FY 2019 proposed
wage index due to the application of the rural floor.
2. Proposed Expiration of Imputed Floor Policy
In the FY 2005 IPPS final rule (69 FR 49109 through 49111), we
adopted the ``imputed floor'' policy as a temporary 3-year regulatory
measure to address concerns from hospitals in all[dash]urban States
that have argued that they are disadvantaged by the absence of rural
hospitals to set a wage index floor for those States. Since its initial
implementation, we have extended the imputed floor policy eight times,
the last of which was adopted in the FY 2018 IPPS/LTCH PPS final rule
and is set to expire on September 30, 2018. (We refer readers to
further discussions of the imputed floor in the IPPS/LTCH PPS final
rules from FY 2014 through FY 2018 (78 FR 50589 through 50590, 79 FR
49969 through 49970, 80 FR 49497 through 49498, 81 FR 56921 through
56922, and 82 FR 38138 through 38142, respectively) and to the
regulations at 42 CFR 412.64(h)(4).) Currently, there are three all-
urban States--Delaware, New Jersey, and Rhode Island--with a range of
wage indexes assigned to hospitals in these States, including through
reclassification or redesignation. (We refer readers to discussions of
geographic reclassifications and redesignations in section III.I. of
the preamble of this proposed rule.)
In computing the imputed floor for an all-urban State under the
original methodology, which was established beginning in FY 2005, we
calculated the ratio of the lowest-to-highest CBSA wage index for each
all-urban State as well as the average of the ratios of lowest-to-
highest CBSA wage indexes of those all-urban States. We then compared
the State's own ratio to the average ratio for all-urban States and
whichever is higher is multiplied by the highest CBSA wage index value
in the State--the product of which established the imputed floor for
the State. As of FY 2012, there were only two all-urban States--New
Jersey and Rhode Island--and only New Jersey benefitted under this
methodology. Under the previous OMB labor market area delineations,
Rhode Island had only one CBSA (Providence-New Bedford-Fall River, RI-
MA) and New Jersey had 10 CBSAs. Therefore, under the original
methodology, Rhode Island's own ratio equaled 1.0, and its imputed
floor was equal to its original CBSA wage index value. However, because
the average ratio of New Jersey and Rhode Island was higher than New
Jersey's own ratio, this methodology provided a benefit for New Jersey,
but not for Rhode Island.
In the FY 2013 IPPS/LTCH PPS final rule (77 FR 53368 through
53369), we retained the imputed floor calculated under the original
methodology as discussed above, and established an alternative
methodology for computing the imputed floor wage index to address the
concern that the original imputed floor methodology guaranteed a
benefit for one all-urban State with multiple wage indexes (New Jersey)
but could not benefit the other all-urban State (Rhode Island). The
alternative methodology for calculating the imputed floor was
established using data from the application of the rural floor policy
for FY 2013. Under the alternative methodology, we first determined the
average percentage difference between the post[dash]reclassified, pre-
floor area wage index and the post[dash]reclassified, rural floor wage
index (without rural floor budget neutrality applied) for all CBSAs
receiving the rural floor. (Table 4D associated with the FY 2013 IPPS/
LTCH PPS final rule (which is available via the Internet on the CMS
website) included the CBSAs receiving a State's rural floor wage
index.) The lowest post-reclassified wage index assigned to a hospital
in an all-urban State having a range of such values then is increased
by this factor, the result of which establishes the State's alternative
imputed floor. We amended Sec. 412.64(h)(4) of the regulations to add
paragraphs to incorporate the finalized alternative methodology, and to
make reference and date changes. In summary, for the FY 2013 wage
index, we did not make any changes to the original imputed floor
methodology at Sec. 412.64(h)(4) and, therefore, made no changes to
the New Jersey imputed floor computation for FY 2013. Instead, for FY
2013, we adopted a second, alternative methodology for use in cases
where an all-urban State has a range of wage indexes assigned to its
hospitals, but the State cannot benefit under the original methodology.
In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50589 through
50590), we extended the imputed floor policy (both the original
methodology and the alternative methodology) for 1 additional year,
through September 30, 2014, while we continued to explore potential
wage index reforms.
In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49969 through
49970), for FY 2015, we adopted a policy to extend the imputed floor
policy (both the original methodology and alternative methodology) for
another year, through September 30, 2015, as we continued to
[[Page 20363]]
explore potential wage index reforms. In that final rule, we revised
the regulations at Sec. 412.64(h)(4) and (h)(4)(vi) to reflect the 1-
year extension of the imputed floor. As discussed in section III.B. of
the preamble of that FY 2015 final rule, we adopted the new OMB labor
market area delineations beginning in FY 2015. Under the new OMB
delineations, Delaware became an all-urban State, along with New Jersey
and Rhode Island. Under the new OMB delineations, Delaware has three
CBSAs, New Jersey has seven CBSAs, and Rhode Island continues to have
only one CBSA (Providence-Warwick, RI-MA). We refer readers to a
detailed discussion of our adoption of the new OMB labor market area
delineations in section III.B. of the preamble of the FY 2015 IPPS/LTCH
PPS final rule. Therefore, under the adopted new OMB delineations
discussed in section III.B. of the preamble of the FY 2015 IPPS/LTCH
PPS final rule, Delaware became an all-urban State and was subject to
an imputed floor as well for FY 2015.
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49497 through
49498), for FY 2016, we extended the imputed floor policy (under both
the original methodology and the alternative methodology) for 1
additional year, through September 30, 2016. In the FY 2017 IPPS/LTCH
PPS final rule (81 FR 56921 through 56922), for FY 2017, we extended
the imputed floor policy (under both the original methodology and the
alternative methodology) for 1 additional year, through September 30,
2017. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38138 through
38142), for FY 2018, we extended the imputed floor policy (under both
the original methodology and the alternative methodology) for 1
additional year, through September 30, 2018. In these three final
rules, we revised the regulations at Sec. 412.64(h)(4) and (h)(4)(vi)
to reflect the additional 1-year extensions.
The imputed floor is set to expire effective October 1, 2018, and
in this FY 2019 proposed rule, we are not proposing to extend the
imputed floor policy. In the FY 2005 IPPS final rule (69 FR 49110), we
adopted the imputed floor policy for all-urban States under the
authority of section 1886(d)(3)(E) of the Act, which gives the
Secretary broad authority to adjust the proportion (as estimated by the
Secretary from time to time) of hospitals' costs which are attributable
to wages and wage-related costs of the DRG prospective payment rates
for area differences in hospital wage levels by a factor (established
by the Secretary). However, we have expressed reservations about the
establishment of an imputed floor, considering that the imputed rural
floor methodology creates a disadvantage in the application of the wage
index to hospitals in States with rural hospitals but no urban
hospitals receiving the rural floor (72 FR 24786 and 72 FR 47322). As
we discussed in the FY 2008 IPPS final rule (72 FR 47322), the
application of the rural and imputed floors requires transfer of
payments from hospitals in States with rural hospitals but where the
rural floor is not applied to hospitals in States where the rural or
imputed floor is applied. For this reason, in this proposed rule, we
are proposing not to apply an imputed floor to wage index calculations
and payments for hospitals in all-urban States for FY 2019 and
subsequent years. That is, hospitals in New Jersey, Delaware, and Rhode
Island (and in any other all-urban State) would receive a wage index
that is calculated without applying an imputed floor for FY 2019 and
subsequent years. Therefore, only States containing both rural areas
and hospitals located in such areas (including any hospital
reclassified as rural under the provisions of Sec. 412.103 of the
regulations) would benefit from the rural floor, in accordance with
section 4410 of Public Law 105-33. In addition, we would no longer
include the imputed floor as a factor in the national budget neutrality
adjustment. Therefore, the proposed wage index and impact tables
associated with this FY 2019 IPPS/LTCH PPS proposed rule (which are
available via the Internet on the CMS website) do not reflect the
imputed floor policy, and there is no proposed national budget
neutrality adjustment for the imputed floor for FY 2019.
We are inviting public comments on our proposal not to extend the
imputed floor for FY 2019 and subsequent years.
3. Proposed State Frontier Floor for FY 2019
Section 10324 of Public Law 111-148 requires that hospitals in
frontier States cannot be assigned a wage index of less than 1.0000.
(We refer readers to the regulations at 42 CFR 412.64(m) and to a
discussion of the implementation of this provision in the FY 2011 IPPS/
LTCH PPS final rule (75 FR 50160 through 50161).) In this FY 2019 IPPS/
LTCH PPS proposed rule, we are not proposing any changes to the
frontier floor policy for FY 2019. In this proposed rule, 50 hospitals
would receive the frontier floor value of 1.0000 for their FY 2019 wage
index. These hospitals are located in Montana, Nevada, North Dakota,
South Dakota, and Wyoming.
The areas affected by the proposed rural and frontier floor
policies for the proposed FY 2019 wage index are identified in Table 2
associated with this proposed rule, which is available via the Internet
on the CMS website.
H. Proposed FY 2019 Wage Index Tables
In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49498 and 49807
through 49808), we finalized a proposal to streamline and consolidate
the wage index tables associated with the IPPS proposed and final rules
for FY 2016 and subsequent fiscal years. Prior to FY 2016, the wage
index tables had consisted of 12 tables (Tables 2, 3A, 3B, 4A, 4B, 4C,
4D, 4E, 4F, 4J, 9A, and 9C) that were made available via the Internet
on the CMS website. Effective beginning FY 2016, with the exception of
Table 4E, we streamlined and consolidated 11 tables (Tables 2, 3A, 3B,
4A, 4B, 4C, 4D, 4F, 4J, 9A, and 9C) into 2 tables (Tables 2 and 3). In
addition, as discussed in section III.J. of the preamble of this
proposed rule, we are adding a Table 4 associated with this proposed
rule entitled ``List of Counties Eligible for the Out-Migration
Adjustment under Section 1886(d)(13) of the Act--FY 2019'' (which is
available via Internet on the CMS Website) We refer readers to section
VI. of the Addendum to this proposed rule for a discussion of the
proposed wage index tables for FY 2019.
I. Revisions to the Wage Index Based on Hospital Redesignations and
Reclassifications
1. General Policies and Effects of Reclassification and Redesignation
Under section 1886(d)(10) of the Act, the Medicare Geographic
Classification Review Board (MGCRB) considers applications by hospitals
for geographic reclassification for purposes of payment under the IPPS.
Hospitals must apply to the MGCRB to reclassify not later than 13
months prior to the start of the fiscal year for which reclassification
is sought (usually by September 1). Generally, hospitals must be
proximate to the labor market area to which they are seeking
reclassification and must demonstrate characteristics similar to
hospitals located in that area. The MGCRB issues its decisions by the
end of February for reclassifications that become effective for the
following fiscal year (beginning October 1). The regulations applicable
to reclassifications by the MGCRB are located in 42 CFR 412.230 through
412.280. (We refer readers to a discussion in the FY 2002 IPPS final
rule (66 FR 39874 and 39875) regarding how the MGCRB defines mileage
for
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purposes of the proximity requirements.) The general policies for
reclassifications and redesignations and the policies for the effects
of hospitals' reclassifications and redesignations on the wage index
are discussed in the FY 2012 IPPS/LTCH PPS final rule for the FY 2012
final wage index (76 FR 51595 and 51596). In addition, in the FY 2012
IPPS/LTCH PPS final rule, we discussed the effects on the wage index of
urban hospitals reclassifying to rural areas under 42 CFR 412.103.
Hospitals that are geographically located in States without any rural
areas are ineligible to apply for rural reclassification in accordance
with the provisions of 42 CFR 412.103.
On April 21, 2016, we published an interim final rule with comment
period (IFC) in the Federal Register (81 FR 23428 through 23438) that
included provisions amending our regulations to allow hospitals
nationwide to have simultaneous Sec. 412.103 and MGCRB
reclassifications. For reclassifications effective beginning FY 2018, a
hospital may acquire rural status under Sec. 412.103 and subsequently
apply for a reclassification under the MGCRB using distance and average
hourly wage criteria designated for rural hospitals. In addition, we
provided that a hospital that has an active MGCRB reclassification and
is then approved for redesignation under Sec. 412.103 will not lose
its MGCRB reclassification; such a hospital receives a reclassified
urban wage index during the years of its active MGCRB reclassification
and is still considered rural under section 1886(d) of the Act and for
other purposes.
We discussed that when there is both a Sec. 412.103 redesignation
and an MGCRB reclassification, the MGCRB reclassification controls for
wage index calculation and payment purposes. We exclude hospitals with
Sec. 412.103 redesignations from the calculation of the reclassified
rural wage index if they also have an active MGCRB reclassification to
another area. That is, if an application for urban reclassification
through the MGCRB is approved, and is not withdrawn or terminated by
the hospital within the established timelines, we consider the
hospital's geographic CBSA and the urban CBSA to which the hospital is
reclassified under the MGCRB for the wage index calculation. We refer
readers to the April 21, 2016 IFC (81 FR 23428 through 23438) and the
FY 2017 IPPS/LTCH PPS final rule (81 FR 56922 through 56930) for a full
discussion of the effect of simultaneous reclassifications under both
the Sec. 412.103 and the MGCRB processes on wage index calculations.
2. MGCRB Reclassification and Redesignation Issues for FY 2019
a. FY 2019 Reclassification Requirements and Approvals
As previously stated, under section 1886(d)(10) of the Act, the
MGCRB considers applications by hospitals for geographic
reclassification for purposes of payment under the IPPS. The specific
procedures and rules that apply to the geographic reclassification
process are outlined in regulations under 42 CFR 412.230 through
412.280.
At the time this proposed rule was constructed, the MGCRB had
completed its review of FY 2019 reclassification requests. Based on
such reviews, there are 337 hospitals approved for wage index
reclassifications by the MGCRB starting in FY 2019. Because MGCRB wage
index reclassifications are effective for 3 years, for FY 2019,
hospitals reclassified beginning in FY 2017 or FY 2018 are eligible to
continue to be reclassified to a particular labor market area based on
such prior reclassifications for the remainder of their 3-year period.
There were 259 hospitals approved for wage index reclassifications in
FY 2017 that will continue for FY 2019, and 345 hospitals approved for
wage index reclassifications in FY 2018 that will continue for FY 2019.
Of all the hospitals approved for reclassification for FY 2017, FY
2018, and FY 2019, based upon the review at the time of this proposed
rule, 941 hospitals are in a MGCRB reclassification status for FY 2019
(with 22 of these hospitals reclassified back to their geographic
location).
Under the regulations at 42 CFR 412.273, hospitals that have been
reclassified by the MGCRB are permitted to withdraw their applications
if the request for withdrawal is received by the MGCRB any time before
the MGCRB issues a decision on the application, or after the MGCRB
issues a decision, provided the request for withdrawal is received by
the MGCRB within 45 days of the date that CMS' annual notice of
proposed rulemaking is issued in the Federal Register concerning
changes to the inpatient hospital prospective payment system and
proposed payment rates for the fiscal year for which the application
has been filed. For information about withdrawing, terminating, or
canceling a previous withdrawal or termination of a 3[dash]year
reclassification for wage index purposes, we refer readers to Sec.
412.273, as well as the FY 2002 IPPS final rule (66 FR 39887 through
39888) and the FY 2003 IPPS final rule (67 FR 50065 through 50066).
Additional discussion on withdrawals and terminations, and
clarifications regarding reinstating reclassifications and ``fallback''
reclassifications were included in the FY 2008 IPPS final rule (72 FR
47333) and the FY 2018 IPPS/LTCH PPS final rule (82 FR 38148 through
38150).
Changes to the wage index that result from withdrawals of requests
for reclassification, terminations, wage index corrections, appeals,
and the Administrator's review process for FY 2019 will be incorporated
into the wage index values published in the FY 2019 IPPS/LTCH PPS final
rule. These changes affect not only the wage index value for specific
geographic areas, but also the wage index value that redesignated/
reclassified hospitals receive; that is, whether they receive the wage
index that includes the data for both the hospitals already in the area
and the redesignated/reclassified hospitals. Further, the wage index
value for the area from which the hospitals are redesignated/
reclassified may be affected.
Applications for FY 2020 reclassifications (OMB control number
0938-0573) are due to the MGCRB by September 4, 2018 (the first working
day of September 2018). We note that this is also the deadline for
canceling a previous wage index reclassification, withdrawal, or
termination under 42 CFR 412.273(d). Applications and other information
about MGCRB reclassifications may be obtained, beginning in mid-July
2018, via the Internet on the CMS website at: