This bill, called the Safe Step Act, adds a new section to the Employee Retirement Income Security Act (ERISA). It requires any group health plan or the insurer offering group coverage that uses a medication step therapy protocol to have a clear exceptions process. A medication step therapy protocol is one that makes a patient try a preferred drug first before the plan will cover a non-preferred drug.
The bill lists specific reasons a plan must approve an exception if the prescriber or patient asks: prior drugs were ineffective, delays would cause serious harm, required drugs are contraindicated or likely to cause harm, required drugs would prevent safe functioning at work or daily life, the patient is stable on the requested drug with prior approval, or other circumstances the Secretary of Labor identifies. Plans must let prescribers or patients submit clinical information, use a standard form (paper and electronic), allow representatives to act for patients, and explain required information and criteria. Normal exception decisions must be made within 72 hours; expedited reviews for serious cases must be done within 24 hours. If an exception is granted, coverage for the requested drug must continue for at least one year. Plans must report data about exception requests to the Secretary and the Secretary must report summaries to Congress. The rule applies to plan years that begin at least six months after the law is enacted, and the Secretary of Labor must issue final regulations within six months.
No publicly available information on estimated costs to group health plans, plan sponsors, plan participants, health insurance issuers, or the federal government is included in the bill text or metadata provided.
No publicly available information.
No publicly available information.