[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38038-38039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12479]


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DEPARTMENT OF DEFENSE

Office of the Secretary


Expiration of Temporary Changes to TRICARE Regulations During the 
Coronavirus Disease 2019 (COVID-19) Pandemic

AGENCY: Office of the Assistant Secretary of Defense for Health Affairs 
(ASD(HA)), Department of Defense (DoD).

ACTION: Notice of expiration of temporary changes.

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SUMMARY: The ASD(HA) is publishing this notice to announce that 
temporary changes to the TRICARE regulations related to the coronavirus 
disease 2019 (COVID-19) pandemic were terminated on April 10, 2023, for 
those temporary changes that terminate at the end of the President's 
national emergency; on May 11, 2023, for changes that terminate at the 
end of the Health and Human Services (HHS) Public Health Emergency 
(PHE); and will be terminated on September 30, 2023, for the temporary 
regulation change creating a diagnosis related group (DRG) add-on for 
New COVID-19 Treatments Add-on Payments (NCTAPs).

FOR FURTHER INFORMATION CONTACT: Erica Ferron, 303-676-3626, 
[email protected].

SUPPLEMENTARY INFORMATION: The ASD(HA) approved temporary modifications 
to TRICARE regulations in response to the COVID-19 pandemic and the 
President's national emergency for the COVID-19 outbreak (Proclamation 
9994, 85 Federal Register (FR) 15337). Interim final rules (IFRs) 
implementing temporary changes to the TRICARE regulation were published 
on May 12, 2020 (85 FR 27921); September 3, 2020 (85 FR 54914); October 
30, 2020 (85 FR 68753); and January 12, 2023 (88 FR 1992). All 
provisions of the IFR published on May 12, 2020, and all but one 
provision of the IFR published on September 3, 2020, were finalized, 
with changes, in a final rule published June 1, 2022 (87 FR 33001).
    The temporary provisions in the four IFRs, as modified by the final 
rule where applicable, were set to expire automatically, depending on 
the particular temporary provision, at: (1) the termination of the 
President's national emergency; (2) the termination of the associated 
Secretary of HHS's PHE; (3) the termination of the Centers for Medicare 
and Medicaid Services' (CMS's) Hospitals Without Walls initiative; or 
(4) at the end of the fiscal year in which the HHS PHE terminates. On 
January 30, 2023, the Biden Administration announced plans to terminate 
both the President's national emergency and the HHS PHE on May 11, 
2023.\1\ CMS has previously stated that the Hospital Without Walls 
initiative would terminate when the HHS PHE ended.\2\ Public Law 118-3 
was subsequently enacted on April 10, 2023, immediately terminating the 
President's national emergency.\3\ Several provisions in the IFRs are 
permanent changes; these provisions will not expire.
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    \1\ https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf.
    \2\ https://www.cms.gov/files/document/hospitals-and-cahs-ascs-and-cmhcs-cms-flexibilities-fight-covid-19.pdf.
    \3\ https://www.congress.gov/bill/118th-congress/house-joint-resolution/7/text.
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    The Department stated in its IFRs that the ASD(HA) would publish a 
document in the FR announcing the termination dates for the temporary 
provisions; this FR notice satisfies that requirement. This document 
also provides notice that the ASD(HA) is not extending any of the 
provisions overseas beyond their termination in the United States.
    A. The following temporary regulatory changes ended at the end of 
the day on April 10, 2023, in the United States and overseas as stated 
in this notice. DoD will publish final rules removing these temporary 
regulatory changes from the Code of Federal Regulations (CFR) after 
their termination date:
    1. Paragraph 199.4(b)(3)(xiv) of Title 32 of the CFR: Temporary 
waiver of the requirement for a three-day prior hospital stay before 
admission to a skilled nursing facility ended for all new skilled 
nursing facility admissions after April 10, 2023.
    2. Title 32 CFR 199.4(e)(26)(iii)(B): Temporary coverage of 
National Institute of Allergy and Infectious Disease (NIAID)-sponsored 
COVID-19 clinical trials ended on April 10, 2023. Eligible 
beneficiaries who enrolled in a covered trial on or before April 10, 
2023, will continue to have their care covered through the end of the 
trial.
    3. Title 32 CFR 199.4(g)(15)(i)(A): Temporary coverage of the 
treatment use of investigational drugs under U.S. Food and Drug 
Administration (FDA)-approved expanded access programs ended for all 
new episodes of treatment after April 10, 2023.
    4. Title 32 CFR 199.6(c)(2)(i): Temporary waiver of certain 
interstate and international licensing requirements ended for all care 
received after April 10, 2023.
    B. The following temporary regulatory changes ended at the end of 
the day on May 11, 2023, in the United States and overseas as stated in 
this notice. DoD will publish final rules removing these temporary 
regulatory changes from the CFR after their termination date:
    1. Title 32 CFR 199.6(b)(4)(i)(I): Temporary waiver of certain 
acute care facility requirements for facilities registering with 
Medicare as a hospital under CMS's Hospitals Without Walls initiative 
ended on May 11, 2023. Care provided after May 11, 2023, will be 
reimbursed under the methodology appropriate for the facility's current 
status (ambulatory surgery center, etc.), consistent with Medicare's 
guidance to facilities qualified as acute care facilities

[[Page 38039]]

under the Hospital Without Walls initiative.\4\
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    \4\ https://www.cms.gov/files/document/hospitals-and-cahs-ascs-and-cmhcs-cms-flexibilities-fight-covid-19.pdf.
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    2. Title 32 CFR 199.14(a)(1)(iii)(E)(2): Temporary adjustments to 
the DRG-based reimbursement amounts for patients diagnosed with COVID-
19 ended for all new admissions after May 11, 2023.
    3. Title 32 CFR 199.14(a)(9)(i): Temporary reimbursement of all 
long-term care hospitals (LTCHs) at the LTCH prospective payment system 
standard Federal rate ended for all new admissions after May 11, 2023.
    C. The temporary regulation change creating a DRG add-on for NCTAPs 
(32 CFR 199.14(a)(1)(iv)(C)) will end for all new admissions after 
September 30, 2023. The NCTAP is designed to mitigate potential 
financial disincentives for hospitals to provide new COVID-19 
treatments for eligible inpatient cases that use certain new products 
with current FDA approval or emergency use authorization to treat 
COVID-19. DoD will publish a final rule removing this temporary 
regulatory change from the CFR after its termination date.
    D. The following provisions permanently adopted in the IFRs, as 
modified by the final rule, where applicable, remain in effect:
    1. Title 32 CFR 199.6(b)(4)(xxi) and paragraph 199.14(c): Addition 
of freestanding End Stage Renal Disease (ESRD) facilities as authorized 
institutional providers and adoption of a reimbursement system for 
freestanding ESRD facilities.
    2. Title 32 CFR 199.14(a)(1)(iv)(A): Adoption of Medicare's New 
Technology Add On Payments; permanent, special payments that are 
offered because new medical services and new technologies are not yet 
included in the calculation of standardized DRG rates.
    3. Title 32 CFR 199.14(a)(1)(iv)(B): Adoption of Medicare's 
Hospital Value Based Purchasing Program.
    E. The Department is evaluating certain temporary provisions 
adopted in the IFRs not yet finalized in a final rule (specifically, 
temporary coverage of the treatment use of investigational drugs 
approved under FDA expanded access program, NIAID-sponsored clinical 
trials, and NCTAPs). If the ASD(HA) determines permanent changes to the 
regulation are required, such changes would be announced in future 
final rules. The effective date of such coverage would be announced in 
the final rule. Until such rules publish, these provisions expire as 
stated in the original IFRs and announced in this notice.

    Dated: June 7, 2023.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2023-12479 Filed 6-9-23; 8:45 am]
BILLING CODE 5001-06-P