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SB 921

Health Insurance - Step Therapy or Fail-First Protocols - Drugs to Treat Associated Conditions of Advanced Metastatic Cancer

2025 Regular Session Introduced by Dawn Gile

Extends protection against step therapy to FDA‑approved drugs for treating symptoms or side effects of stage four cancer, when prescribed by a physician.

Approved by the Governor - Chapter 707
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Bill Summary · SB 921

Summary — SB 921 (Chapter 707, 2025)

Title: Health Insurance — Step Therapy or Fail–First Protocols — Drugs to Treat Associated Conditions of Advanced Metastatic Cancer
Status: Approved by the Governor (Chapter 707), May 20, 2025
Effective date: January 1, 2026
Statute amended: Article — Insurance, §15‑142(e)

Purpose

The bill narrows the ability of insurers, nonprofit health service plans, and health maintenance organizations (collectively, “carriers”) to require step therapy or “fail‑first” protocols for certain prescription drugs used by people with stage four (advanced metastatic) cancer. It extends existing protections for drugs used to treat the cancer itself to also cover FDA‑approved drugs prescribed to treat symptoms or side effects of stage four disease or its treatment.

Key provisions

  • Prohibition: A carrier may not impose a step therapy or fail‑first protocol for a prescription drug that:
    • Is approved by the U.S. Food and Drug Administration (FDA); and
    • Is prescribed by the treating physician to treat a symptom of, or a side effect from treatment of, the insured’s or enrollee’s stage four advanced metastatic cancer that the treating provider determines will negatively impact the insured’s/enrollee’s health if left untreated; and
    • Is used in a manner that is consistent with best practices for treatment of stage four advanced metastatic cancer (or an associated condition/side effect) and is supported by peer‑reviewed medical literature; and
    • Is covered under the terms of the insured’s or enrollee’s policy or contract.
  • Scope: Applies to insurers, nonprofit health service plans, and HMOs that issue, deliver, or renew policies, contracts, or health benefit plans in Maryland on or after January 1, 2026. Carriers that provide drug coverage through pharmacy benefits managers (PBMs) are subject to the same requirements.
  • Existing limits retained: The statute does not require coverage for drugs that are not otherwise covered by the policy or required by law.

Who is affected

  • Patients with stage four (advanced metastatic) cancer who are prescribed FDA‑approved drugs to manage symptoms or treatment side effects.
  • Carriers (insurers, nonprofit plans, HMOs) offering hospital/medical/surgical benefits and their PBMs operating in Maryland.
  • Employers/local governments with fully insured plans to the extent their carriers change step‑therapy practices (fiscal impact expected minimal).

Fiscal and administrative impact

  • Maryland Insurance Administration: minimal special fund revenue increase (one‑time $125 rate/form filing fee in FY2026); review can be handled with existing resources.
  • No anticipated material impact on the State Employee and Retiree Health and Welfare Benefits Program.
  • Local government and small business fiscal effects are expected to be minimal or none.

Legislative history and sponsors

  • Introduced: January 24, 2025; passed the General Assembly and approved by the Governor May 20, 2025 (Chapter 707).
  • Sponsors (as listed): KANUHA (primary); John F. Curran (primary).
  • Related/companion bills: HB 1087 and HB 2865.

Notes

  • The bill expands an existing protection (which already prevented step therapy for drugs used to treat stage four cancer when use was FDA‑ or NCCN‑supported and peer‑reviewed) to cover symptom/side‑effect treatments when prescribed by the treating physician and supported by best practices and peer‑reviewed literature.

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

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