WeVote
Log In

Bill

Bill

HB 4878

Health: pharmaceuticals; reporting certain information and regulating certain conduct related to drugs and the federal 340B program; provide for. Creates new act.

2025-2026 Regular Session Introduced by Curt VanderWall

HB 4878 would increase transparency by restricting 340B access limitations and requiring annual price/340B reporting by manufacturers and hospitals.

bill electronically reproduced 09/11/2025
#health:pharmaceuticals #stateagencies(existing):attorneygeneral #stateagencies(existing):licensingandregulatoryaffairs
0
WeVote Research Nonpartisan
Bill Summary · HB 4878

Summary — HB 4878 (Introduced) — 340B Drug Pricing Transparency and Regulations

Purpose

HB 4878 would create a new Michigan statute to (1) prohibit certain conduct that limits access to drugs discounted under the federal 340B program, (2) require annual manufacturer and hospital reporting about drug prices and 340B transactions, and (3) prescribe enforcement and related duties for state agencies. The intent is to increase transparency around drug price increases and the operation of 340B-related transactions and to ensure 340B savings support patient services or community benefits.

Key definitions (select)

  • 340B program: federal 340B drug pricing program (42 USC 256b).
  • 340B drug: covered outpatient drug (42 USC 1396r‑8).
  • 340B entity: covered entity under 42 USC 256b (e.g., qualifying hospitals/clinics).
  • Department: Michigan Department of Licensing and Regulatory Affairs (LARA).

Prohibited conduct

Manufacturers, wholesalers, and wholesale distributor‑brokers would be barred from denying, restricting, prohibiting, conditioning, discriminating against, or otherwise limiting:
- a 340B entity’s acquisition of a 340B drug; or
- delivery of a 340B drug to a pharmacy authorized/contracted to receive 340B drugs on behalf of a 340B entity.
Delegation of that conduct is also prohibited. An exception applies if state or federal law explicitly authorizes the conduct.

Manufacturer reporting (annual)

  • Effective: annually beginning July 1, 2026 (and each July 1 thereafter).
  • Trigger: any prescription drug that costs more than $40 for one course of treatment and whose wholesale acquisition cost (WAC) rose >15% over the prior 12 months.
  • Reports to: LARA and the House and Senate fiscal agencies.
  • Required data (selected): manufacturer name; drug name/variations; brand/generic; biological/interchangeable; 5‑year WAC history; year introduced and initial WAC; current production cost per course (including compounding needs); patent expiration; all dispensed forms.
  • LARA must post reported data on its public website.

Hospital reporting (340B hospitals)

  • Effective: annually beginning November 15, 2026 (reporting prior calendar year).
  • Reports to: a “qualified hospital organization” (Michigan trade association contracting with LARA) — that organization must aggregate/anonymize and publish an annual report by December 31.
  • Required data (selected): aggregated acquisition costs for 340B drugs; aggregated payments received for 340B drugs and number of pricing units dispensed/administered (reported by payer type including commercial, Medicaid, Medicare); aggregated payments to contract pharmacies and other third parties; other program‑related expenses.
  • For the top 50 most frequently dispensed/administered 340B drugs, data must be reported at the national drug code (NDC) level.
  • Hospitals must also report aggregate community investments (e.g., subsidized health care, financial assistance, community health improvement, Medicaid/Medicare shortfalls), provide their community health needs assessment, and financial assistance policy (if any).

Other substantive provisions

  • Hospitals that participate in 340B must ensure savings are invested in patient services or community benefit programs at the hospital or via affiliated entities funded by the hospital.
  • 340B entities must avoid duplicate discounts/rebates as provided by federal law.
  • If a 340B entity acquires a non‑340B entity, prescriptions written before the acquisition date for patients of the acquired entity cannot be retroactively claimed as 340B.
  • LARA may promulgate implementing rules and must contract with a qualified hospital organization to facilitate hospital reporting.

Enforcement & penalties

  • LARA must notify alleged violators within 30 days, allow 60 days to correct informally, and if not corrected refer the matter to the Attorney General.
  • Civil fine up to $500; each day a violation continues after AG referral counts as a separate violation. The AG may pursue collection.

Fiscal and operational impacts

  • Indeterminate fiscal impact on LARA (expected costs to receive reports, post data, contract with hospital organization, and promulgate rules).
  • Potential additional fine revenue if violations occur; enforcement costs also possible.
  • Compliance costs for hospitals, manufacturers, pharmacies and wholesalers are indeterminate.

Legislative status & timeline (select)

  • Filed: March 13, 2025.
  • Committee actions: referred and considered April–May 2025; reported favorably without amendment May 1, 2025; committee report sent to Calendars May 10, 2025.
  • Electronically reproduced & reintroduced/recorded: September 11, 2025; referred to Committee on Health Policy.

Prepared from the House Fiscal Agency analysis and the introduced bill text (HB 4878).

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

Sign in to ask a question.