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, 77211-77214 [2023-24670]
Download as PDF
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
3. In §52.1683:
a. Remove the headings from
paragraphs (f), (n), and (v); and
■ b. Add paragraph (w).
The addition reads as follows:
■
■
§ 52.1683
Control strategy: Ozone.
ddrumheller on DSK120RN23PROD with RULES1
*
*
*
*
*
(w)(1) The January 29, 2021, New
York Reasonably Available Control
Technology (RACT) analysis plan,
submitted pursuant to the 2008 8-hour
ozone national ambient air quality
standard (NAAQS) Serious
classification, which applies to the New
York portion of the New York-Northern
New Jersey-Long Island (NY-NJ-CT)
nonattainment area is approved as it
continues to meet the RACT
requirements for the two precursors for
ground-level ozone, i.e., oxides of
nitrogen (NOX) and volatile organic
compounds (VOCs), set forth by the
Clean Air Act (CAA or Act) with respect
to the 2008 8-hour ozone standard.
(2) The January 29, 2021, New York
Reasonably Available Control
Technology (RACT) analysis plan,
submitted pursuant to the 2015 8-hour
ozone national ambient air quality
standard (NAAQS) Serious
classification, which applies to the
entire State, including the New York
portion of the New York-Northern New
Jersey-Long Island (NY-NJ-CT)
nonattainment area is approved as it
applies to the Clean Air Act control
technique guidelines (CTG)
requirements for major sources of
volatile organic compounds (VOC).
(3) The reminder of New York’s
January 29, 2021, RACT analysis plan,
pursuant to the 2015 8-hour ozone
NAAQS as applied to the entire State,
including the New York portion of the
NY-NJ-CT moderate nonattainment area,
and as it applies to non-CTG major
sources of VOCs and to major sources of
oxides of nitrogen (NOX), is approved.
(4) The November 29, 2021, New York
plan submittal providing a certification
that the State has satisfied the
requirements for an ozone
nonattainment new source review
program as sufficient for purposes of the
State-wide 2008 8-hour ozone NAAQS
Serious classification, including the
New York portion of the NY-NJ-CT
nonattainment area, is approved.
(5) The Reasonable Further Progress
Plans for milestone years 2017 and 2020
pursuant to the 2008 8-hour Ozone
NAAQS, included in New York’s
November 13, 2017, and November 29,
2021, State Implementation Plan
submittals for the New York portion of
the New York-Northern New JerseyLong Island nonattainment area are
approved.
VerDate Sep<11>2014
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Jkt 262001
(6) The 2017 and 2020 motor vehicle
emission budgets used for
transportation conformity purposes for
the New York portion of the New YorkNorthern New Jersey-Long Island
nonattainment area contained in New
York’s November 13, 2017, and
November 29, 2021, SIP submittals are
approved.
(7) New York’s certification that the
State has satisfied the requirements for
Clean Fuel for Fleets under the Clean
Air Act for the 2008 8-hour Ozone
NAAQS, included in the State’s
November 29, 2021, SIP submittal for
the New York portion of the New YorkNorthern New Jersey-Long Island
nonattainment area is approved.
[FR Doc. 2023–24616 Filed 11–8–23; 8:45 am]
BILLING CODE 6560–50–P
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 LongTerm 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
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Final rule; correction.
AGENCY:
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
SUMMARY:
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77211
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 aprevoTM 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,
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09NOR1
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Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
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 30day 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
VerDate Sep<11>2014
16:21 Nov 08, 2023
Jkt 262001
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 aprevoTM
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
customized interbody spinal fusion
devices) reiterated its request to reassign
cases reporting the performance of a
spinal fusion procedure utilizing an
aprevoTM 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 aprevoTM 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
aprevoTM 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 aprevoTM 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
aprevoTM 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.
BILLING CODE 4120–01–P
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09NOR1
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Frm 00019
Fmt 4700
Sfmt 4700
09NOR1
3
TOTAL CASES USING APREVO CUSTOM-MADE INTERBODY DEVICE
Aprevo SAF FY22 Ql-Q4
36 I
5.83
$242)08
Aprevo Carlsmed Data FY23
41 I
4.49
$198,433
All Aprevo Cases
77 I
5.12
$218,946
Notes:
** Based on revenue center 278 "Other Implants". https://resdac.org/cms-data/variables/revenue-center-code-fls
$457,465
$374.J.42
$413,151
% Increase Over
MS-DRG4S3
Implant
Charges
$124,141
95%
60%
76%
$ Increase Over
MS-DRG4S3
Implant
Chames ($1241141
$118)6
$74)9
$94,!1_0
77213
CMS’s SAF data and stated an analysis
of the customer claims in CMS’s SAF
E:\FR\FM\09NOR1.SGM
The commenter provided findings
from its own analysis of claims in
PO 00000
ER09NO23.001
MS-DRG 460 le2itimate cases nsin2 aprevo cnstom-made interbody device
aprevo Case 0278
aprevo Case 0278
Charges
Charges
STANDARDIZED % Increase Over Cases $ Increase Over Cases
in Same MS-DRG
in Same MS-DRG
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
16:21 Nov 08, 2023
BILLING CODE 4120–01–C
VerDate Sep<11>2014
STANDARDIZED
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77214
Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations
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 aprevoTM custommade 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 aprevoTM 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 aprevoTM spinal fusion device for
FY 2024. The commenter stated that
Medicare claims data reflecting
improved coding as it relates to
aprevoTM 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 aprevoTM utilization, expires
on September 30, 2023. According to
the commenter, if CMS does not assign
all procedures reporting the use of an
aprevoTM 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
VerDate Sep<11>2014
16:21 Nov 08, 2023
Jkt 262001
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 nonMedPAR data, the non-MedPAR data
must be independently validated,
meaning when an entity submits nonMedPAR 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 aprevoTM
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]
BILLING CODE 4120–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 0 and 80
[WT Docket No. 23–357; FCC 23–90; FR ID
183686]
Radiotelephone Requirements for
Vessels on the Great Lakes
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
In this document, the Federal
Communications Commission (FCC or
Commission) amends its rules to retain
the radiotelephone requirements for
vessels subject to the current Great
Lakes Agreement (GLA or Agreement).
The GLA is a treaty between the United
States and Canada. In relevant part, the
GLA established requirements regarding
the usage and maintenance of
radiocommunications equipment for
safety purposes aboard certain vessels
navigating on the Great Lakes. Pursuant
to Canada’s notice of termination on
November 2, 2022, the GLA will cease
to be effective on November 2, 2023. As
a result, the FCC takes expedited action
in this order to amend subpart T and
certain other parts of the Commission’s
rules to remove the references to the
GLA and maintain the applicability of
rules in the Great Lakes.
DATES: Effective November 9, 2023.
FOR FURTHER INFORMATION CONTACT: For
additional information on this
proceeding, contact Erin McGrath of the
Wireless Telecommunications Bureau,
Mobility Division, at (202) 418–2042 or
erin.mcgrath@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of Commission’s Order, in WT
Docket No. 23–357; FCC 23–90, adopted
on October 30, 2023 and released on
October 31, 2023. The full text of this
document is available for public
inspection online at https://
docs.fcc.gov/public/attachments/FCC23-90A1.pdf. The Commission will send
a copy of this Order in a report to be
sent to Congress and the Government
Accountability Office pursuant to the
Congressional Review Act, see 5 U.S.C.
801(a)(1)(A).
SUMMARY:
Synopsis
1. In this Order, the Commission takes
action to ensure the continued safety of
vessels navigating the Great Lakes by
amending part 0 and part 80 of the
Commission’s rules to retain the
radiotelephone requirements for vessels
subject to the current Great Lakes
Agreement (GLA or Agreement). The
GLA is a treaty between the United
States and Canada that, among other
things, established requirements
regarding the ‘‘usage and maintenance
of radiocommunications equipment for
safety purposes aboard’’ certain vessels
navigating on the Great Lakes.
Agreement Between Canada and the
United States for the Promotion of
Safety on the Great Lakes by Means of
Radio, art. II, U.S.-Canada, April 26,
1973, 25 UST 935, T.I.A.S. 7837,
amended 30 UST 2523, T.I.A.S. 9352
(GLA). These requirements are codified
primarily in subpart T of part 80 of the
E:\FR\FM\09NOR1.SGM
09NOR1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
aprevoTM 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 aprevoTM
customized interbody spinal fusion devices) reiterated its request to
reassign cases reporting the performance of a spinal fusion procedure
utilizing an aprevoTM 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 aprevoTM 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 aprevoTM
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 aprevoTM 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 aprevoTM 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 aprevoTM 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
aprevoTM 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 aprevoTM spinal fusion device for FY
2024. The commenter stated that Medicare claims data reflecting
improved coding as it relates to aprevoTM 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
aprevoTM utilization, expires on September 30, 2023.
According to the commenter, if CMS does not assign all procedures
reporting the use of an aprevoTM 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 aprevoTM 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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