Safe Step Act
The Safe Step Act would require group health plans and health insurance coverage that use medication step therapy protocols to create a formal, clear exceptions process. A participant, beneficiary, or their prescriber could request an exception when the standard step therapy would be inappropriate or harmful. If an exception is granted, the requested drug must be covered under the plan with the participant’s cost-sharing terms in effect for the plan year. The bill also sets specific criteria for when an exception can be approved, requires a transparent process (including standard forms, timelines, and the ability for a designated advocate to act on behalf of the patient), and establishes expedited review for urgent cases. In addition, plans would report annually on exceptions and related data to the Secretary (and Congress), and there are protections to ensure information necessary for reporting can be accessed. The measure would apply to plan years beginning at least six months after enactment, with implementing regulations due within six months. Key terms: - A step therapy protocol is a policy that requires trying a preferred drug before approving coverage for a non-preferred drug. - An exceptions process is a formal route to obtain an override to that protocol when clinically appropriate.
Key Points
- 1Required exceptions process for step therapy: For plans that cover prescription drugs under a step therapy protocol, the bill mandates a clear, prompt, and transparent process for patients, beneficiaries, or prescribers to request an exception.
- 2Criteria for exception approval: Exceptions can be granted if other treatments have been ineffective, delaying treatment would cause serious harm, treatments are contraindicated or cause harm, the current drug maintains functional abilities, the patient is already stable on the prescribed drug, or other circumstances as determined by the Secretary.
- 3Process design and accessibility: Plans must provide a standard form (paper and electronic), allow submission of information electronically or by paper, permit sharing of necessary medical information, and allow a patient representative or advocate to act on their behalf. Information about the process must be in plan materials and on plan websites.
- 4Expedited and timely determinations: Generally, plans must respond within 72 hours of an initial request or within 24 hours in urgent cases, with provisions to request and receive additional information quickly if needed.
- 5Duration and enforcement: If an exception is granted, coverage for the drug remains in effect for at least one year, and the plan must ensure cost-sharing terms are applied as they were at the beginning of the plan year.
- 6Reporting and transparency: Plans must annually report to the Secretary data on exception requests, approvals/denials, reasons for denials, appeals, and other related metrics; the Secretary must publish a national summary analysis to Congress. The bill also prohibits certain third-party contracts that would block required reporting.