The Safe Step Act requires health insurance plans and insurers to create a streamlined process allowing patients and their doctors to request exceptions to "step therapy" protocols—insurance rules that force patients to try cheaper drugs before covering more expensive ones. Plans must respond to exception requests within 72 hours (or 24 hours for urgent medical situations) and approve coverage if patients meet specific criteria, such as previous drugs being ineffective, causing harmful side effects, or creating dangerous delays in treatment. If an exception is approved, the patient's coverage for the requested medication must last at least one year. The law applies to employer-sponsored health plans and group insurance coverage and takes effect six months after enactment, with the Department of Labor required to issue detailed regulations within six months. Starting three years after enactment and annually thereafter, insurers must report data to Congress about exception requests, approvals, and denials, allowing lawmakers to monitor how step therapy policies are being applied.
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