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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 405, 410, 414, 424, 425, 427, 428, 495, and 512</CFR> <DEPDOC>[CMS-1832-CN2]</DEPDOC> <RIN>RIN 0938-AV50</RIN> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule; correction. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document corrects technical errors in the final rule that appeared in the November 5, 2025 <E T="04">Federal Register</E> (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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> This correcting document is effective November 28, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Emily Yoder (410) 786-104 or <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for issues related to skin substitutes. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> 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. <HD SOURCE="HD1">II. Summary of Errors</HD> 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. <HD SOURCE="HD1">III. Waiver of Proposed Rulemaking and Delay in Effective Date</HD> Section 1871(b)(1) of the Social Security Act (the Act) requires the Secretary to provide for notice of a proposed rule in the <E T="04">Federal Register</E> 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 <E T="04">Federal Register</E> 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. <HD SOURCE="HD1">IV. Correction of Errors</HD> 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 <SU>2</SU> ”. 5. On page 49506, third column, first full paragraph, line 8, the phrase “$125.38 rate” is corrected to read “$125.38/cm <SU>2</SU> rate”. 6. On page 49507, second column, a. First partial paragraph, line 9, the phrase “$127.28/cm <SU>2</SU> .” is corrected to read “$127.14/cm <SU>2</SU> ”. b. Second full paragraph, lines 8 through 17 the phrase “the exception of updates to several code classifications 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 <SU>2</SU> . 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 <SU>2</SU> ” is corrected to read “$127.14/cm <SU>2</SU> ”. b. Lines 11 and 12, the phrase “This rate reflects updates to several code classifications and uses” is corrected to read “This rate uses”. <SIG> <NAME>Wilma M. Robinson,</NAME> Deputy Executive Secretary to the Department, Department of Health and Human Services. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-21458 Filed 11-26-25; 8:45 am]</FRDOC> </RULE>