Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 77211 

■ 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. 

* * * * * 

(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. 

(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 

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, 


ddrumheller on DSK120RN23PROD with RULES1
77212 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

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. 

BILLING CODE 4120–01–P 


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BILLING CODE 4120–01–C The commenter provided findings 

from its own analysis of claims in of the customer claims in CMS’s SAF 

CMS’s SAF data and stated an analysis 


ER09NO23.001</GPH>ddrumheller on DSK120RN23PROD with RULES1

STANDARDIZED 

MS-DRG 460 le2itimate cases nsin2 aprevo cnstom-made interbody device 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 

STANDARDIZED 

$457,465 

$374.J.42 

$413,151 

aprevo Ca

Char

% Increase 

in Same 

% Increa

MS-DR

Imp

Cha

$124
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 

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 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: 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). 

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 


ddrumheller on DSK120RN23PROD with RULES1