Bill
S 819
prohibits discrimination against 340B participants by payers, manufacturers, and distributors to protect access to 340B drugs and patient choice.
Status: Enacted — SIGNED (Chapter 98). Filed Jan 15, 2025; enacted Feb 28, 2025.
Sponsor/Authors:
- Filed in the Massachusetts Senate by Senator Pavel M. Payano (petition signatures from multiple state senators listed). (Note: the bill text is a Massachusetts bill; some metadata provided elsewhere lists federal cosponsors which appear to be unrelated to this state measure.)
Purpose
- To prohibit discrimination against participants in the federal 340B Drug Pricing Program — specifically 340B-covered entities and pharmacies that contract with them — by payers (insurers/PBMs) and by manufacturers or distributors. The bill aims to protect the ability of safety‑net providers to acquire and dispense 340B-priced outpatient drugs and to preserve patient choice.
What the bill does — key provisions
- Adds a new Section 34 to Chapter 32A and a new Section 47VV to Chapter 175 of the Massachusetts General Laws.
Definitions
- Defines “340B-covered entity” using the federal definition (42 U.S.C. §256b(a)(4)), “contract pharmacy,” “340B drug,” “340B grantee,” distributors, manufacturers, pharmacies, and “package.”
Prohibitions on payers (insurers, issuers, managers)
- Prohibits any drug coverage plan that reimburses a 340B-covered entity or its contract pharmacy from:
- Paying less for a 340B drug (or otherwise reimbursing less per quantity) on the basis that the recipient is a 340B-covered entity or contract pharmacy.
- Imposing requirements, exclusions, reimbursement terms, fees, chargebacks, clawbacks, adjustments, or other assessments that differ from terms applied to non-340B entities or pharmacies because they are 340B participants.
- Imposing different professional dispensing fees, network participation restrictions, audit frequency/scope, or inventory-accounting requirements on 340B participants than those imposed on similarly situated non-340B providers.
- Requiring a claim to be labeled or modified to identify it as a 340B drug (except where the claim is for Medicaid payment as defined by state law).
- Protects patient choice: payers may not steer, prevent, or otherwise interfere with a patient’s choice to receive 340B drugs from a 340B-covered entity or its contract pharmacy.
Prohibitions on manufacturers and distributors
- Manufacturers or distributors (and their agents/affiliates) may not directly or indirectly:
- Deny, restrict, prohibit, discriminate against, or otherwise interfere with the acquisition or delivery of a 340B drug to a contract pharmacy or pharmacy authorized to receive 340B drugs — except where prohibited by HHS.
- Interfere with contracts between pharmacies and 340B grantees.
- (The provided excerpt is truncated after Section 2(c); additional manufacturer/distributor restrictions likely continue in the full text.)
Who is affected
- Beneficiaries: 340B-covered entities (safety‑net hospitals, federally qualified health centers, Ryan White clinics, others qualifying under federal law), and pharmacies contracting with them.
- Regulated parties: health insurers, pharmacy benefit managers (PBMs), Medicaid plans, manufacturers, distributors, and pharmacies.
- Patients who receive outpatient drugs from 340B entities or contract pharmacies — who are protected from steering or interference.
Procedural and timing notes
- Legislative path (per provided actions): filed Jan 15, 2025; passed both chambers; delivered to the Governor and signed as Chapter 98 on Feb 28, 2025. (A hearing was scheduled in the Senate Finance Committee for 6/10/2025 per docket entries, but the bill is shown as enacted.)
- The text excerpt does not include specific enforcement mechanisms, penalties, or private right of action language. The full statute should be consulted to determine enforcement authority (e.g., state regulators, civil remedies).
Implications
- Seeks to maintain contracting and reimbursement parity for 340B participants and to curb common industry practices (differential reimbursement, network exclusion, claim-identifiers tied to reduced pay) that stakeholders say erode 340B savings and program integrity.
- Affects commercial payers’ contracting practices, PBM and pharmacy network design, manufacturer/distributor distribution policies, and the operations of contract pharmacies serving 340B entities.
Caveat
- The publicly provided bill excerpt is partially truncated (Section 2(c) and later text). For complete legal language, implementation details, and enforcement provisions, consult the full enacted Chapter 98 text as published by the Massachusetts General Court.
Compiled from official sources — confirm details with the bill’s official record.
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