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Read twice and referred to the Committee on Finance.
Introduced March 6, 2025 by Ronald Lee Wyden · Last progress March 6, 2025
Makes wide-ranging health-care changes: it reforms pharmacy benefit manager (PBM) practices and drug-payment transparency, updates Medicaid hospital DSH payment rules, extends and adjusts Medicare telehealth and new multi-cancer screening payment rules, reauthorizes and funds many public‑health and human‑services programs, creates a federal wastewater surveillance grant program, strengthens FDA pediatric and rare‑disease provisions, and preserves a short HDHP safe harbor for telehealth. Many provisions impose new reporting, pricing, and payment requirements and phase in over months to years.
The bill combines program authorizations and regulatory reforms that affect hospitals, pharmacies, PBMs, health plans, Medicare and Medicaid beneficiaries, public‑health grantees, drug developers, and state health agencies. It includes new funding authorizations for community health centers and other public‑health programs, deadlines for agency guidance, and a mix of near‑term and delayed effective dates (6–30 months or specified through 2026–2029 for some items).
Redesignates the second subsection designated as subsection (l) as subsection (m), and makes textual amendments within the redesignated subsection (m)(1), including inserting references to 'podiatric medicine' and minor wording/punctuation changes in specified subclauses and clauses.
Adds new section 9826 ('Oversight of entities that provide pharmacy benefit management services') to subchapter B of the Internal Revenue Code, establishing contract and reporting requirements for entities providing PBM services to group health plans and defining related terms (reporting frequency, required data elements, limited public disclosure, rulemaking deadlines)
Amends 26 U.S.C. §9831 (general exceptions) to insert an exception for certain group health plans as specified by the new provisions related to PBM reporting and treatment of group health plans in this title
Adds a new subsection (g) to 26 U.S.C. §4980D clarifying that, for purposes of the new §9826 requirements that apply with respect to entities providing PBM services on behalf of group health plans, references to a group health plan (and the employer reference in subsection (e)(1)) shall be treated as including such entities providing PBM services
Amends 29 U.S.C. §1108 (exemptions from prohibited transactions under ERISA) including redesignation of subclauses and insertion of new clauses/subparagraphs that (among other changes) make certain PBM contract arrangements reasonable only if PBM entities meet specified transparency and remittance conditions, require remittance timing and auditability of rebate/fee records, and clarify covered service providers and fiduciary monitoring duties
Amends 21 U.S.C. §505(j)(3) (the abbreviated new drug application provision) by adding a new subparagraph (H) that authorizes the Secretary to inform or determine whether a proposed generic drug is qualitatively and quantitatively the same as a listed drug (including disclosure of ingredients causing differences), and sets related procedural protections and limitations on disclosure; companion guidance timelines are required of the Secretary of Health and Human Services
Amends 35 U.S.C. §271(e) to extend the act of infringement, with respect to certain submissions described in paragraph (2)(C)(ii), to any patent that claims the biological product, a method of using the biological product, or a method or product used to manufacture the biological product
Adds an additional subparagraph (J) providing $4,600,000,000 for fiscal year 2026 to the list of amounts in section 10503(b)(1) of the Affordable Care Act (community health centers)
Adds an additional subparagraph (J) providing $350,000,000 for fiscal year 2026 to the list of amounts in section 10503(b)(2) of the Affordable Care Act (National Health Service Corps)
Adds multiple subparagraphs (F)–(J) specifying funding amounts for teaching health centers for specified periods/fiscal years (Jan 1–Sep 30, 2025 and FY2026–FY2029)
And 39 more affected sections...
To reauthorize and make improvements to Federal programs relating to the prevention, detection, and treatment of traumatic brain injuries, and for other purposes.
Dr. Lorna Breen Health Care Provider Protection Reauthorization Act
Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
Read twice and referred to the Committee on Finance.
Introduced in Senate