[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 [www.gpo.gov]
[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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[GRAPHIC] [TIFF OMITTED] TR09NO23.001

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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

[[Page 77214]]

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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