Rule2023-24670
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction; Correction
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 9, 2023
Effective
November 9, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This document corrects technical errors in the final rule that appeared in the August 28, 2023 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction" (referred to hereafter as the "FY 2024 IPPS/LTCH PPS final rule").
Full Text
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<title>Federal Register, Volume 88 Issue 216 (Thursday, November 9, 2023)</title>
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[Federal Register Volume 88, Number 216 (Thursday, November 9, 2023)]
[Rules and Regulations]
[Pages 77211-77214]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24670]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 411, 412, 419, 488, 489, and 495
[CMS-1785-CN2 and CMS-1788-CN2]
RINs 0938-AV08 and 0938-AV17
Medicare Program; Hospital Inpatient Prospective Payment Systems
for Acute Care Hospitals and the Long-Term Care Hospital Prospective
Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality
Programs and Medicare Promoting Interoperability Program Requirements
for Eligible Hospitals and Critical Access Hospitals; Rural Emergency
Hospital and Physician-Owned Hospital Requirements; and Provider and
Supplier Disclosure of Ownership; and Medicare Disproportionate Share
Hospital (DSH) Payments: Counting Certain Days Associated With Section
1115 Demonstrations in the Medicaid Fraction; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule; correction.
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SUMMARY: This document corrects technical errors in the final rule that
appeared in the August 28, 2023 Federal Register titled ``Medicare
Program; Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals and the Long-Term Care Hospital Prospective Payment System
and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and
Medicare Promoting Interoperability Program Requirements for Eligible
Hospitals and Critical Access Hospitals; Rural Emergency Hospital and
Physician-Owned Hospital Requirements; and Provider and Supplier
Disclosure of Ownership; and Medicare Disproportionate Share Hospital
(DSH) Payments: Counting Certain Days Associated with Section 1115
Demonstrations in the Medicaid Fraction'' (referred to hereafter as the
``FY 2024 IPPS/LTCH PPS final rule'').
DATES:
Effective date: This correcting document is effective November 9,
2023.
Applicability date: This correcting document is applicable for
discharges beginning October 1, 2023.
FOR FURTHER INFORMATION CONTACT: Mady Hue, (410) 786-4510, and Andrea
Hazeley, (410) 786-3543, MS-DRG Classifications.
SUPPLEMENTARY INFORMATION:
I. Background
This correcting document identifies and corrects errors in FR Doc.
2023-16252 of August 28, 2023 (88 FR 58640). The corrections in this
correcting document are applicable to discharges occurring on or after
October 1, 2023, as if they had been included in the document that
appeared in the August 28, 2023 Federal Register.
II. Summary of Errors
On pages 58734 and 58735, we are correcting the omission of a
comment and response with respect to the request for MS-DRG
reassignment of cases reporting spinal fusion procedures utilizing an
aprevo<SUP>TM</SUP> customized interbody fusion device.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rulemaking
in the Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Social Security Act (the Act)
requires the Secretary to provide for notice of the proposed rulemaking
in the Federal Register and provide a period of not less than 60 days
for public comment. In addition, section 553(d) of the APA, and section
1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date
after issuance or publication of a rule. Sections 553(b)(B) and
553(d)(3) of the APA provide for exceptions from the notice and comment
and delay in effective date APA requirements; in cases in which these
exceptions apply,
[[Page 77212]]
sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide
exceptions from the notice and 60-day comment period and delay in
effective date requirements of the Act as well. Section 553(b)(B) of
the APA and section 1871(b)(2)(C) of the Act authorize an agency to
dispense with normal rulemaking requirements for good cause if the
agency makes a finding that the notice and comment process are
impracticable, unnecessary, or contrary to the public interest. In
addition, both section 553(d)(3) of the APA and section
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay
in effective date where such delay is contrary to the public interest
and an agency includes a statement of support.
We believe that this final rule correction does not constitute a
rule that would be subject to the notice and comment or delayed
effective date requirements. This document corrects technical errors in
the preamble of the FY 2024 IPPS/LTCH PPS final rule, but does not make
substantive changes to the policies or payment methodologies that were
adopted in the final rule. As a result, this final rule correction is
intended to ensure that the information in the FY 2024 IPPS/LTCH PPS
final rule accurately reflects the policies adopted in that document.
In addition, even if this were a rule to which the notice and
comment procedures and delayed effective date requirements applied, we
find that there is good cause to waive such requirements. Undertaking
further notice and comment procedures to incorporate the corrections in
this document into the final rule or delaying the effective date would
be contrary to the public interest because it is in the public's
interest for providers to receive information regarding the relevant
Medicare payment policy in as timely a manner as possible, and to
ensure that the FY 2024 IPPS/LTCH PPS final rule accurately reflects
our policies. Furthermore, such procedures would be unnecessary, as we
are not altering our payment methodologies or policies, but rather, we
are simply implementing correctly the methodologies and policies that
we previously proposed, requested comment on, and subsequently
finalized. This final rule correction is intended solely to ensure that
the FY 2024 IPPS/LTCH PPS final rule accurately reflects these payment
methodologies and policies. Therefore, we believe we have good cause to
waive the notice and comment and effective date requirements. Moreover,
even if these corrections were considered to be retroactive rulemaking,
they would be authorized under section 1871(e)(1)(A)(ii) of the Act,
which permits the Secretary to issue a rule for the Medicare program
with retroactive effect if the failure to do so would be contrary to
the public interest. As we have explained previously, we believe it
would be contrary to the public interest not to implement the
corrections in this final rule correction for discharges occurring on
or after October 1, 2023, because it is in the public's interest for
providers to receive information regarding the relevant Medicare
payment policy in as timely a manner as possible, and to ensure that
the FY 2024 IPPS/LTCH PPS final rule accurately reflects our policies.
IV. Correction of Errors
In FR Doc. 2023-16252, appearing on page 58640 in the Federal
Register of Monday, August 28, 2023, the following corrections are
made:
1. On page 58734, third column, after the fourth full paragraph,
the language is corrected by adding the following:
``Another commenter (the manufacturer of the aprevo<SUP>TM</SUP>
customized interbody spinal fusion devices) reiterated its request to
reassign cases reporting the performance of a spinal fusion procedure
utilizing an aprevo<SUP>TM</SUP> customized interbody spinal fusion
device from the lower severity (without CC/MCC) MS-DRGs to the higher
severity (with MCC) MS-DRGs. According to the commenter, CMS's analysis
as discussed in the proposed rule confirmed that cases reporting the
use of aprevo<SUP>TM</SUP> contained average costs that exceeded the
average costs of every spinal fusion MS-DRG.
The commenter expressed strong disagreement with CMS'
characterization of the reliability of the Medicare claims data and
stated that it can verify the utilization of the aprevo<SUP>TM</SUP>
technology with absolute certainty at both the provider and patient
level, which the commenter referred to as legitimate claims data.
Moreover, the commenter stated that it is their access to precise
procedure data for the aprevo<SUP>TM</SUP> spinal fusion device that
enabled the commenter to notify CMS of discrepancies identified by the
manufacturer with the Medicare claims data. Specifically, the commenter
stated that it has continued to collect claims data from its customers
and that there is now data on 77 claims based on legitimate customer
utilization of the aprevo<SUP>TM</SUP> device. The commenter stated
that approximately half of these 77 claims are documented in CMS's
Standard Analytical File (SAF) FY 2022 Q1-Q4 report, and half of the 77
claims are customer claims which were provided directly by hospitals to
the commenter, representing procedures occurring in Q1 FY 2023 and not
yet reflected in CMS's Limited Data Set (LDS) files. The commenter
provided the following table.
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The commenter provided findings from its own analysis of claims in
CMS's SAF data and stated an analysis of the customer claims in CMS's
SAF
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data that were verified by the commenter demonstrated a significant
increase in charges for revenue center 0278 (Implantable Devices) over
the average implantable device charges for the highest CC level MS-DRG
(MS-DRG 454). The commenter stated that this implantable device charge
data proved beyond doubt that the increased total charges of legitimate
customer claims in CMS's own data is attributable to the higher cost of
the aprevo<SUP>TM</SUP> custom-made anatomically designed devices.
The commenter also stated that CMS has a long-standing policy of
using external data to inform MS-DRG reclassification as a way of
addressing concerns about the timeliness of data from the MedPAR file.
According to the commenter, CMS accepts the submission of external data
that is intended to demonstrate that inpatient stays involving a new
technology are costlier on average than the other inpatient stays in
the same MS-DRG.
With respect to the revised code proposal, the commenter stated
that while it agreed that the revised procedure code descriptions will
improve the reporting of procedures that utilize the
aprevo<SUP>TM</SUP> spinal fusion device by eliminating a
misinterpretation of the current description that it stated has caused
illegitimate uses of the codes, it continues to have concerns as it
relates to the requested MS-DRG assignment and rate-setting for cases
reporting use of the aprevo<SUP>TM</SUP> spinal fusion device for FY
2024. The commenter stated that Medicare claims data reflecting
improved coding as it relates to aprevo<SUP>TM</SUP> utilization will
not be available when the FY 2025 rulemaking process is underway. The
commenter stated that if CMS chooses to wait another year to act it
will compromise beneficiary access to an important technology that
provides significant health benefits.
Additionally, the commenter stated that while the new technology
add-on payment for the transforaminal interbody fusion (TLIF)
indication will continue for FY 2024, the new technology add-on payment
for the anterior lumbar interbody fusion (ALIF) and lateral lumbar
interbody fusion (LLIF) procedures, which represent 70 percent of
aprevo<SUP>TM</SUP> utilization, expires on September 30, 2023.
According to the commenter, if CMS does not assign all procedures
reporting the use of an aprevo<SUP>TM</SUP> spinal fusion device to MS-
DRGs 453 and 456 for FY 2024, it will risk beneficiary access to this
important technology.''
2. On page 58735, top half of the page, third column, after the
first partial paragraph, and before the first full paragraph, the
language is corrected by adding the following paragraphs:
``As discussed in the FY 2024 IPPS/LTCH PPS proposed rule and prior
rulemaking, we generally utilize MedPAR data when considering changes
to the MS-DRG classifications, which includes an analysis of the volume
of cases, the average length of stay, and average costs, with
consideration of other factors. For the FY 2024 IPPS/LTCH PPS proposed
rule, our initial analysis of potential changes to the MS-DRG
classifications was based on ICD-10 claims data from the September 2022
update of the FY 2022 MedPAR file, with certain additional analysis
based on ICD-10 claims data from the December 2022 update of the FY
2022 MedPAR file.
In the July 30, 1999 IPPS final rule (64 FR 41499 through 41500),
we stated that in order for us to consider using non-MedPAR data, the
non-MedPAR data must be independently validated, meaning when an entity
submits non-MedPAR data, we must be able to independently review the
medical records and verify that a particular procedure was performed
for each of the cases that purportedly involved the procedure. In this
particular circumstance, where external data for cases reporting the
use of an aprevo<SUP>TM</SUP> spinal fusion device was provided, CMS
did not have access to the medical records to conduct an independent
review; therefore, we were not able to validate or confirm the non-
MedPAR data submitted by the commenter for consideration in this final
rule. However, our work in this area is ongoing, and we will continue
to examine the data and consider these issues as we develop potential
future rulemaking proposals.''
Elizabeth J. Gramling,
Executive Secretary, Department of Health and Human Services.
[FR Doc. 2023-24670 Filed 11-8-23; 8:45 am]
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