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SB 646

AN ACT RELATING TO HEALTH AND SAFETY -- PESTICIDE CONTROL

2025 Regular Session Introduced by Bob Britto and 3 co-sponsors

Maryland bans step therapy for insulin and insulin-like drugs by insurers, HMOs, and PBMs; applies to new or renewed policies from Jan 1, 2026, speeding access for diabetics.

03/19/2025 Committee recommended measure be held for further study
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Bill Summary · SB 646

SB 646 — Health Insurance: Prohibition on Step Therapy / Fail‑First for Insulin (Chapter 689, 2025)

Status: Approved by the Governor (Chapter 689). Approved May 20, 2025. Effective January 1, 2026. Companion bill: HB 970.

Purpose

To prohibit insurers, nonprofit health service plans, and health maintenance organizations from imposing step therapy or “fail‑first” protocols for insulin and insulin‑like prescription drugs used to treat Type 1, Type 2, or gestational diabetes, so patients can access prescriber‑ordered insulin without required prior trials of other drugs.

Key provisions

  • Amends Article — Insurance §15‑142(e) to add an explicit prohibition on applying step therapy / fail‑first protocols to:
    • Insulin; and
    • Insulin analogs or other prescription drugs that perform a similar function to insulin, irrespective of activation period, whether solutions are mixed before/after dispensing, or the route of administration (injection, inhalation, etc.).
  • Retains the existing statutory exemption that already prevented step therapy on certain FDA‑approved drugs used to treat stage four advanced metastatic cancer (supported by peer‑reviewed literature and consistent with FDA/NCCN indications).
  • Scope: applies to insurers, nonprofit health service plans, and HMOs that provide hospital/medical/surgical benefits and to entities that provide prescription drug coverage through pharmacy benefits managers (PBMs).
  • Applicability: the prohibition applies to all policies, contracts, and health benefit plans issued, delivered, or renewed in Maryland on or after January 1, 2026.

Definitions

  • “Step therapy or fail‑first protocol” — a plan policy requiring an insured/enrollee to try one or more prescribed drugs in sequence before covering the drug ordered by the prescriber.

Who is affected

  • Primary: people with diabetes (Type 1, Type 2, gestational) insured under Maryland health plans subject to State law.
  • Insurers, nonprofit health service plans, HMOs, and PBMs operating in Maryland must revise formularies and utilization management practices to comply.
  • Prescribers benefit from reduced administrative barriers to their chosen insulin therapy.

Timing and enforcement

  • Effective date: January 1, 2026 — applies to new or renewed policies on or after that date.
  • Enforcement is through the insurance regulatory framework (Maryland Insurance Administration oversight). The bill text establishes the statutory prohibition; standard regulatory tools would apply for compliance.

Potential impacts

  • Patient access: expected to speed access to prescribed insulin therapies and reduce risks from delayed effective treatment (e.g., diabetic ketoacidosis).
  • Plan operations: requires payers/PBMs to stop using step‑therapy requirements for covered insulins; could change utilization management workflows and prior authorization practices.
  • Fiscal: legislative fiscal note identified minimal state fiscal effects — a one‑time fee/revenue for the Maryland Insurance Administration (small amount) and no expected effect on the State Employee & Retiree Health and Welfare Benefits Program.

For source and enactment information: SB 646 (Sen. Muse) — Chapter 689, Laws of Maryland 2025 (approved May 20, 2025).

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

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