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Adds subparagraph (K) requiring covered entities to submit annually to the identification system specified information describing the scope of the Federal grant, contract, or project (or the grant-authorizing statute) forming the basis for eligibility for the program, including copies of agreements with subgrantees; requires making that information available to manufacturers upon request.
Adds a new subparagraph (J) to 42 U.S.C. 256b(a)(5) establishing claims modifier requirements (including 340B and non-340B modifiers), covered entity submission of claim-level data to a clearinghouse in a machine-readable electronic format, standards for data submission, privacy/security rules, penalties for noncompliance, and enforcement by the Office of Inspector General of HHS.
Adds paragraph (vii) to 42 U.S.C. 256b(d)(2)(B) authorizing the Secretary to impose civil monetary penalties, in amounts determined appropriate by the Secretary, when a covered entity is not in compliance with subsection (a)(5)(L).
Adds new definitions to section 340B(b) of the Public Health Service Act, including detailed definitions of 'patient' (with conditions related to on-site dispensing, provider relationships, telehealth limits, care coordination, and recordkeeping) and 'specified nonhospital covered entity' (including an annual revenue threshold and hospital affiliation rule).
Adds a new section 2730 to Subpart II of part A of title XXVII of the Public Health Service Act establishing requirements relating to the 340B drug discount program (non-discrimination provisions, prohibited actions, enforcement by civil monetary penalty, and definitions).
Adds a new paragraph (10) to section 1860D–12(b) (42 U.S.C. 1395w–112(b)) to require contracts with PDP sponsors to include application of the requirements of new section 2730 of the Public Health Service Act to such sponsors and their PBMs.
Adds subparagraph (G) to section 1857(f)(3) (42 U.S.C. 1395w–27(f)(3)) referencing section 1860D–12(b)(10) (relating to the 340B drug discount program).
Adds subsection (g) to 42 U.S.C. 256b providing that the provisions of that section supersede any State or local law that establishes, implements, or continues a standard or requirement that differs from or relates to the section or the drug discount program (including distribution of covered outpatient drugs), and that no State or local law shall grant additional rights or impose additional obligations related to the 340B program, except for State regulations issued to carry out subsection (a)(5)(A)(iii).
Adds a new subparagraph (C) to 340B(d)(2) establishing a 340B claims data clearinghouse, specifying criteria for the clearinghouse, its duties (including data review, notices of duplicate discounts/rebates, data sharing with manufacturers and CMS), and processes for resolving violations and refunds.
Inserts a new paragraph (88) into §1902(a) requiring State agencies and Medicaid managed care organizations to furnish claims‑level drug data (including rebate file data and specified data elements) to the 340B clearinghouse in machine‑readable format within 5 days after claim payment, and to remove from rebate requests any claims subject to clearinghouse notices.
And 4 more affected sections...
This proposal updates the federal 340B drug discount program. It lowers pharmacy costs for many low‑income and uninsured patients and sets clearer rules for hospitals, clinics, and partner pharmacies, while stopping health plans and pharmacy benefit managers from treating 340B drugs unfairly.
Key points
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced September 10, 2025 by Buddy Carter · Last progress September 10, 2025