The Regulator

UPDATE: The organ procurement rule is in the Federal Register with a January 4, 2027 start date and a first-year cost of $16.5 million. The Centers for Medicare & Medicaid Services (CMS) published its final rule, CMS-3409-F, today. It covers the 54 organ procurement organizations (OPOs) that serve 55 donation service areas, and the Federal Register text answers the timing question CMS’s release left open. CMS estimates costs of about $16.5 million in the first year and $7.9 million a year after that, against benefits of about $598,000 a year from less compliance confusion. The tier structure and the two outcome measures are unchanged, and the current 2022 to 2026 recertification cycle is ending without the new policies applied to it. The revised “organ” definition applies starting with the 2027 assessment period. CMS did not finalize its proposed “medically complex donor” and “medically complex organ” definitions, citing a lack of consensus, and says it may revisit them. Who it hits: every OPO, plus the transplant centers that depend on them. So what: the stakes are the service areas, since an OPO with only bottom-tier areas is decertified, but the rule sets no assessment date for the next cycle. CMS received 129 timely comments. Confidence: High on the dates and cost figures, which come from the rule text; Med on what the next cycle looks like, because the text we read does not give its timeline. Sources: Federal Register final rule, 91 FR 69390.

HHS finalizes a rule excluding gender dysphoria not caused by a physical impairment from its disability definition, effective January 4, 2027. The Department of Health and Human Services (HHS) final rule amends paragraph (g) of 45 CFR 84.4, its Section 504 regulation. Section 504 of the Rehabilitation Act of 1973 bars disability discrimination by anyone receiving HHS funds. The statute excludes “gender identity disorders not resulting from physical impairments,” and HHS now reads that to cover “gender dysphoria not resulting from a physical impairment.” HHS says this resolves ambiguity in the preamble to its 2024 rule, which it calls not legally enforceable, and it received more than 380 comments. Who it hits: hospitals, state Medicaid agencies and other recipients of HHS funding, and the patients they serve. So what: HHS says people with gender dysphoria remain covered by other laws, including Title VI and Title IX, and the text we read gives no cost estimate. The rule cites state attorney general litigation, Texas v. Kennedy in the Northern District of Texas, over the 2024 preamble. Confidence: High on the text and date. Source: Federal Register final rule, 91 FR 69207.

UPDATE: The Labor Department’s pharmacy benefit manager fee disclosure rule was published November 2 and applies to plan years starting July 1, 2027. The Department of Labor’s Employee Benefits Security Administration (EBSA) rule requires pharmacy benefit managers (PBMs) and affiliated brokers and consultants to disclose their compensation to fiduciaries of large self-insured group health plans governed by the Employee Retirement Income Security Act (ERISA). The rule is effective January 4, 2027, and the Federal Register text sets the applicability date we had not reported: plan years beginning on or after July 1, 2027. Who it hits: PBMs and the employers that hire them. So what: a calendar-year plan will first see the disclosures for plan year 2028, since its 2027 plan year began January 1. Confidence: High; the calendar-year inference is ours from the applicability date. Source: Federal Register final rule, Department of Labor.

FDA finalizes guidance on how cell and gene therapy makers must prove potency, from clinical trials through lot release. The Food and Drug Administration (FDA) notice, published today, finalizes a draft issued December 28, 2023. The guidance takes a risk-based approach: for investigational products it describes a phased potency strategy during development, including for products moving through rapid clinical development, and for licensed products it covers potency requirements, including lot release testing. Who it hits: makers of cellular and gene therapies. So what: guidance is a recommendation, not a binding rule, and the notice gives no compliance date or cost estimate. Confidence: High on what the notice says; Low on business impact. Source: Federal Register notice, 91 FR 69259.

FDA finalizes one hepatitis B testing guidance for blood donations that replaces seven older documents dating to 1987. The notice, published today, covers testing whole blood and blood components, including Source Plasma, for hepatitis B virus (HBV). It finalizes a July 2025 draft and supersedes memos and guidances from 1987, 1991, 2007, 2010, 2011 and 2012, plus the HBV parts of a 1996 memorandum. Who it hits: blood establishments and plasma collectors. So what: the notice states no effective date or implementation timeline, so the operational deadline is not yet clear. Confidence: High on what it replaces; Low on timing. Source: Federal Register notice, 91 FR 69258.