The Safe Step Act requires health insurance plans and health insurers to establish a clear, fast process allowing patients or their doctors to request exceptions to "step therapy" protocols—insurance rules that require trying cheaper drugs first before covering more expensive ones. Plans must approve exceptions when patients meet certain criteria, such as prior drugs being ineffective, causing dangerous side effects, or when delaying treatment poses serious health risks. Plans must respond to standard exception requests within 72 hours (or 24 hours for urgent cases) and must cover approved drugs for at least one year under the patient's regular cost-sharing terms. The bill affects employers offering group health plans and health insurers, with implementation required six months after enactment. Plans must report annually to the Department of Labor on exception requests, approvals, and denials, which the Secretary will summarize in yearly reports to Congress.
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