[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Rules and Regulations]
[Pages 54589-54590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-21458]
[[Page 54589]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 414, 424, 425, 427, 428, 495, and 512
[CMS-1832-CN2]
RIN 0938-AV50
Medicare and Medicaid Programs; CY 2026 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements; and
Medicare Prescription Drug Inflation Rebate Program; 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 November 5, 2025 Federal Register (90 FR 49266) titled
``Medicare and Medicaid Programs; CY 2026 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment and Coverage
Policies; Medicare Shared Savings Program Requirements; and Medicare
Prescription Drug Inflation Rebate Program'' (hereinafter referred to
as the CY 2026 PFS final rule), specifying finalized changes to the
Medicare physician fee schedule (PFS) that is applicable for calendar
year (CY) 2026, and other changes to Medicare Part B payment policies,
as well as proposals regarding other Medicare payment policies.
DATES: Effective date: This correcting document is effective November
28, 2025.
FOR FURTHER INFORMATION CONTACT: Emily Yoder (410) 786-104 or
[email protected], for issues related to skin
substitutes.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2025-19787 of November 5, 2025, the CY 2026 PFS final
rule (90 FR 49266), there were technical errors that are identified in
this correcting document.
II. Summary of Errors
On pages 49493, 49496, 49501, 49504, and 49506 through 49509, we
inadvertently made typographical and technical errors in our discussion
of the payment for skin substitutes.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Section 1871(b)(1) of the Social Security Act (the Act) requires
the Secretary to provide for notice of a proposed rule in the Federal
Register and provide a period of not less than 60 days for public
comment. In addition, section 1871(e)(1)(B)(i) of the Act mandates a
30-day delay in effective date after issuance or publication of a rule.
Section 1871(b)(2)(C) of the Act provides an exception from the notice
and 60-day comment period and delay in effective date requirements of
the Act, under the good cause standard set forth in 5 U.S.C. 553(b)(B).
Section 1871(e)(1)(B)(ii) of the Act provides an exception from the
delay in effective date requirements of the Act as well. Section
553(b)(B) authorizes an agency to dispense with normal notice and
comment rulemaking procedures for good cause if the agency makes a
finding that the notice and comment process is impracticable,
unnecessary, or contrary to the public interest, and includes a
statement of the finding and the reasons for it in the rule. In
addition, section 1871(e)(1)(B)(ii) of the Act allows the agency to
avoid the 30-day delay in effective date where the waiver is necessary
to comply with statutory requirements or such delay is contrary to the
public interest and the agency includes in the rule a statement of the
finding and the reasons for it.
In our view, this correcting document does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects technical and typographical errors in the payment for
skin substitutes provisions of the CY 2026 PFS final rule. The
corrections contained in this document are consistent with, and do not
make substantive changes to, the policies and payment methodologies
that were proposed, subject to notice and comment procedures, and
adopted in the CY 2026 PFS final rule. As a result, the corrections
made through this document are intended to resolve inadvertent errors
in the discussion of the skin substitutes policies so that the CY 2026
PFS final rule accurately reflects the policies adopted therein.
In addition, even if this were a rulemaking to which the notice and
comment 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 CY 2026 PFS final rule or delaying the effective date
of the corrections are unnecessary because we are not making any
substantive revisions to the CY 2026 PFS final rule, but rather, we are
simply correcting the Federal Register documents to reflect the skin
substitutes policies that we previously proposed, received public
comment on, and subsequently finalized in the CY 2026 PFS final rule.
Further comment is not needed to inform our decision to rectify the
ministerial errors noted in this final rule and correction. For these
reasons, we believe there is good cause to waive notice and comment and
delay in effective date, even if they were required.
IV. Correction of Errors
In FR Doc. 2025-19787 of November 5, 2025 (90 FR 49266), make the
following corrections:
1. On page 49493,
a. Second column, second full paragraph, line 33 and 34, the phrase
``as a drug or as a biological product'' is corrected to read ``as a
biological product''; and
b. Third column, first partial paragraph, line 10, the phrase ``as
a drug or as a biological product'' is corrected to read ``as a
biological product''.
2. On page 49496, first column, fourth full paragraph, line 5, ``as
a drug or as a biological product'' is corrected to read ``as a
biological product''.
3. On page 49501, second column, first partial paragraph, lines 21
through 25, the phrase ``the file titled `Skin Substitute Products by
FDA Regulatory Category' on the CMS website under downloads for the CY
2026 PFS final rule at'' is corrected to read ``Addendum B of the PFS
proposed rule' on the CMS website under downloads for the CY 2026 PFS
proposed rule at''.
4. On page 49504,
a. First column,
(1) First full paragraph, line 2, the phrase ``an initial payment
rate'' is corrected to read ``an initial proposed payment rate''.
(2) Second full paragraph, line 6, the phrase ``quarter of data.''
is corrected to read ``quarter of data at the time of the proposed
rule.''.
b. Second column, second full paragraph, line 3, the phrase ``$125
per square centimeter'' is corrected to read ``$125/cm\2\''.
5. On page 49506, third column, first full paragraph, line 8, the
phrase ``$125.38 rate'' is corrected to read ``$125.38/cm\2\ rate''.
6. On page 49507, second column,
a. First partial paragraph, line 9, the phrase ``$127.28/cm\2\.''
is corrected to read ``$127.14/cm\2\''.
b. Second full paragraph, lines 8 through 17 the phrase ``the
exception of updates to several code classifications
[[Page 54590]]
and updated with the most recent data available as of the time of
drafting this final rule, which resulted in a final payment rate for CY
2026 of $127.19/cm2. Specifically, we used 2026 MUC data (based on 2024
claims data) for the fourth quarter 2024 ASP data, weight by hospital
outpatient claims volume.'' is corrected to read ``the exception of
updating the calculation with more recent utilization data available as
of the time of drafting this final rule, which resulted in a final
payment rate for CY 2026 of $127.14/cm\2\. Specifically, we also used
fourth quarter 2024 ASP data and 2026 MUC data (based on 2024 claims
data), when ASP data was not available, weighted by more up to date
hospital outpatient claims volume.''.
7. On page 49508, second column, first partial paragraph, lines 4
and 5, the phrase ``a skin substitute is approved as a drug or as a
biological product'' is corrected to read ``a skin substitute is
approved as a biological product''.
8. On page 49509, third column, first partial paragraph,
a. Line 8, the figure ``$127.28/cm\2\'' is corrected to read
``$127.14/cm\2\''.
b. Lines 11 and 12, the phrase ``This rate reflects updates to
several code classifications and uses'' is corrected to read ``This
rate uses''.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2025-21458 Filed 11-26-25; 8:45 am]
BILLING CODE 4120-01-P