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HD 4461

A communication from the Executive Office of Health and Human Services (see Section 13L of Chapter 118E the General Laws) submitting the 340B/High-Cost Drugs Impact report

194th Legislature (2025-2026)

MassHealth would limit 340B payments for 20 high-cost drugs (via 340B) to support value-based contracts, starting no earlier than Aug 18, 2025.

Placed on file
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WeVote Research Nonpartisan
Bill Summary · HD 4461

Summary of HD 4461: 340B/High-Cost Drugs Impact Report and MassHealth 340B Policy

Overview

HD 4461 is a proposed bill, introduced on March 6, 2025, and currently placed on file. It consists of a communication from the Executive Office of Health and Human Services (EOHHS) submitting the 340B/High-Cost Drugs Impact report as required by law (see Section 13L of Chapter 118E of the General Laws). The bill centers on the process for evaluating potential restrictions on 340B drug purchases and outlines MassHealth’s proposed 340B-related policy changes for high-cost drugs.

Purpose and Intent

  • Establish a reporting requirement to evaluate any proposed restriction or limitation on an eligible hospital’s access to the discounted 340B drug purchases, prior to implementation.
  • Outline a MassHealth policy to limit payment for certain high-cost drugs when purchased through the 340B program, enabling benefits from value-based contracts (VBP) with manufacturers.
  • Ensure transparency about anticipated fiscal impact, potential savings, and mitigation measures associated with such restrictions.

Key Provisions

A. 340B/High-Cost Drugs Impact Report Requirement

  • Trigger: At least 180 days before any restriction or limitation on 340B-access for an eligible hospital.
  • Submittal: The Secretary of Health and Human Services must provide to:
    • Joint Committee on Health Care Financing
    • Senate and House Committees on Ways and Means
  • Report contents (A–D):
    • (A) The proposed restriction or limitation
    • (B) Anticipated aggregate savings to the Commonwealth
    • (C) Estimated fiscal impact on each affected hospital
    • (D) How the Secretary plans to mitigate fiscal impact, including maintaining savings from existing 42 U.S.C. § 256b programs

B. MassHealth 340B-Related Coverage Limitation

  • Policy: MassHealth intends to limit payment for twenty drugs for MassHealth members if purchased through 340B, to leverage value-based contracts.
  • Drug list: Nine newly designated high-cost drugs (described below) plus eleven drugs already excluded from 340B coverage (total of 20 drugs).
  • Coverage nuance: MassHealth will continue to pay for these drugs when purchased outside 340B; no impact on MassHealth member access or on hospitals’ ability to be paid for 340B drugs provided to non-MassHealth patients.
  • Implementation timeline: No sooner than August 18, 2025.

C. New 340B Exclusions (Nine Drugs)

MassHealth designates these nine drugs as non-payable when purchased through 340B for MassHealth members:
- Amtagvi (lifileucel)
- Beqvez (fidanacogene elaparvovec)
- Casgevy (exagamglogene autotemcel)
- Elevidys (delandistrogene moxeparvovec-rokl)
- Lenmeldy (atidarsagene autotemcel)
- Lyfgenia (lovotibeglogene autotemcel)
- Omisirge (omidubicel-onlv)
- Roctavian (valoctocogene roxaparvovec-rvox)
- Tecelra (afamitresgene autoleucel)

  • Note: These drugs are high-cost (gross cost >= $100,000 per utilizor per year) under 130 CMR 406.404(D).
  • Impact scope: Applies only to MassHealth purchases; does not affect use of 340B drugs for other patients or general MassHealth coverage for medically necessary drugs.

D. Mitigation and Fiscal Considerations

  • The Secretary does not anticipate a net fiscal impact requiring mitigation.
  • MassHealth will notify affected providers via provider bulletins and may adjust the policy if a fiscal impact is found.
  • Rationale for potential savings: Value-based contracts may deliver savings if drug performance outcomes meet expectations; current savings are not estimable and depend on the number and success of VBPs.

Affected Parties

  • MassHealth members who are MassHealth beneficiaries for the specified drugs (when purchased through 340B).
  • Hospitals and providers that procure these drugs and are reimbursed based on actual acquisition cost.
  • Drug manufacturers, particularly those participating in value-based contracts with MassHealth.

Procedural and Timeline Details

  • Reporting prerequisite: 180 days before any proposed restriction on 340B purchasing.
  • Implementation readiness: The new 340B exclusions are to take effect no sooner than August 18, 2025.
  • Current status: Placed on file (as of March 6, 2025).

Bottom Line

HD 4461 seeks to (1) require a formal, advance impact report before restricting 340B access and (2) authorize MassHealth to limit payments for 20 high-cost drugs purchased via 340B to support value-based contracting, with a phased implementation starting no sooner than mid-2025. The policy emphasizes preserving patient access, maintaining appropriate reimbursement dynamics for hospitals, and leveraging VBPs to achieve potential Commonwealth savings.

Compiled from official sources — confirm details with the bill’s official record.

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