The Safe Step Act would add a new section to the Employee Retirement Income Security Act (ERISA). It requires group health plans and issuers that use medication step therapy protocols to have a clear exceptions process. The bill lists six reasons a plan must grant an exception, such as past treatment failure, contraindications, risk of severe harm from delay, or stability on a current drug. Plans must provide a standard form (paper and electronic), allow a prescriber or a representative to request exceptions, and explain the criteria used. Normal requests must be decided within 72 hours; urgent requests that risk serious harm must be decided within 24 hours. If an exception is granted, coverage for the drug must last at least one year. Plans must report detailed data about exception requests to the Secretary and the Secretary must report to Congress. The law would apply to plan years starting at least six months after enactment, and the Labor Secretary must issue final regulations within six months.
No publicly available information on estimated federal or private costs. The bill requires plans and issuers to create or update exception processes, keep records, and submit annual reports to the Secretary, and it requires the Secretary of Labor to issue regulations, which may create administrative work for plans, issuers, and the agency.
The sponsors introduced this bill to require a prompt, transparent exceptions process so patients can get prescribed drugs without harmful delays from step therapy. The bill emphasizes timely decisions, clear forms, protection for patients who are stable on a medicine, and public reporting on exception requests.
No publicly available information.