H.R. 5509 — Safe Step Act

This section establishes requirements for group health plans and health insurance issuers offering group coverage that use medication step therapy protocols (i.e., requirements to try and fail on specified lower-cost or preferred prescription drugs before accessing others) to implement a clear, prompt, and transparent exceptions process. The process must allow a participant, beneficiary, or prescriber to request an exception, with approval required—and coverage of the requested drug at the plan year's initial cost-sharing rates—if any of the following apply: (1) prior treatments (including same class or mechanism) were ineffective per clinical evidence or prescriber judgment; (2) delay risks severe or irreversible harm or disease progression; (3) prior treatments are contraindicated or likely to cause harm; (4) prior treatments impair occupational or daily living functions; (5) the patient is stable on the requested drug with prior approval under another plan; or (6) other circumstances set by the Secretary. The process must include a standard form (paper/electronic), minimal documentation, expedited review options, prescriber input opportunities, and public availability of details in plan materials (e.g., summary of benefits); representatives, including third-party advocates, may assist.