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LD 178

An Act Regarding Coverage For Step Therapy For Advanced Metastatic Cancer

132nd Legislature (2025-2026) Introduced by Sally Cluchey and 2 co-sponsors

Prohibits step therapy for FDA‑approved metastatic cancer drugs on a formulary, ensuring coverage without fail‑first requirements starting for plans issued or renewed after Jan 1,

Signed by Governor
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Bill Summary · LD 178

Summary — LD 178: An Act Regarding Coverage for Step Therapy for (Advanced) Metastatic Cancer

Status: Signed by the Governor (July 1, 2025)
Introduced: January 14, 2025
Primary sponsor: Rep. Kristi Mathieson; cosponsors Rep. Denise Tepler and Rep. Sally Cluchey
Subjects: Health insurance; metastatic cancer; utilization review / step therapy

Purpose

LD 178 prohibits health insurers and utilization review organizations from requiring "step therapy" (also called "fail‑first" protocols) before providing coverage for certain prescription drugs used to treat metastatic cancer. The goal is to ensure timely access to FDA‑approved therapies listed on an insurer’s formulary for treatment of metastatic cancer and related conditions.

Key provisions

  • Prohibits health insurance carriers and utilization review organizations from imposing step therapy protocols as a precondition to coverage of:
    • Prescription drugs that are FDA‑approved, and
    • Are on the carrier’s formulary for treatment of metastatic cancer and associated conditions.
  • Scope: Applies to health plans issued or renewed on or after January 1, 2026.
  • The statutory language focuses on FDA‑approved drugs that are already on a carrier’s formulary; it does not require coverage of drugs not on a formulary or not FDA‑approved.

Who is affected

  • Insurers and third‑party utilization review organizations that administer prescription coverage in Maine.
  • Enrollees with metastatic cancer or related conditions who would otherwise face step‑therapy requirements.
  • The State Employee Health Plan (explicitly identified in the fiscal note as an impacted plan year starting FY 2026‑27).

Fiscal impact

  • No fiscal impact in FY 2025‑26.
  • Starting FY 2026‑27, the State Employee Health Plan is estimated to incur an additional $15,600 annually.
    • Cost split: General Fund $7,176; Highway Fund $2,496; Other funds $5,928.
  • Fiscal notes (approved 05/21/25 and 05/28/25) project the same recurring costs for FY 2027‑28 and FY 2028‑29.

Effective date and procedural timeline

  • Applies to plans issued or renewed on or after January 1, 2026.
  • Legislative actions: referred Jan 14, 2025; reported out with Committee Amendment “A” (H‑272); passed both chambers (May–June 2025); signed by Governor July 1, 2025.

Notes / Limitations

  • The prohibition applies only to FDA‑approved drugs that are on a carrier’s formulary for metastatic cancer and related conditions; it does not mandate coverage of non‑formulary or non‑FDA‑approved uses.
  • The fiscal notes address the State Employee Health Plan; statewide insurer cost impacts beyond that plan are not quantified in the provided documents.

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

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