Sponsors (131)
The bill improves and standardizes step-therapy exception processes to give patients—especially those with chronic conditions—faster, more reliable access to prescribed drugs and better oversight, while imposing compliance, drug-spending, and market-adjustment costs that could raise premiums or cause short-term disruptions.
Patients with chronic conditions (including many Medicare and Medicaid beneficiaries) will get faster, more reliable access to prescribed drugs because plans must offer standardized step-therapy exception processes, meet strict decision timelines (72-hour standard; 24-hour expedited), and keep approved exceptions effective for at least one year.
Health care providers, hospitals, and health systems will face less administrative friction and faster determinations due to required standardized, accessible forms and electronic/paper submission options, which should speed prescribing and reduce staff time spent on ad hoc processes.
Taxpayers and the public benefit from increased transparency and oversight because plans must report exception request/approval data to the Secretary and public reports will track how often exceptions are requested and granted, enabling scrutiny of PBMs and plan practices.
Health plans and issuers will incur increased administrative and compliance costs to implement standardized processes, forms, expedited timelines, and reporting, which could raise premiums or shift costs to consumers and employers.
Requiring plans to apply beneficiary cost-sharing as of the plan-year start when an exception is approved could raise near-term plan drug spending, contributing to higher premiums or other cost-shifting.
Reporting obligations and prohibitions on certain PBM contract restrictions may prompt plans to renegotiate PBM/TPA contracts, causing short-term market adjustments, renegotiation costs, and possible service disruptions for providers and patients.
Based on analysis of 2 sections of legislative text.
Requires group health plans and insurers using step therapy to adopt a clear, prompt exceptions process and cover approved drugs with plan-year cost-sharing applied retroactively.
Requires group health plans and health insurance issuers that use prescription drug step therapy to provide a clear, prompt, and transparent exceptions process so patients or their prescribers can request coverage of a specific drug. If the request meets specified clinical criteria, the plan must cover the requested drug and apply patient cost-sharing as of the start of the plan year. The bill lists several grounds for granting an exception (ineffective prior treatment, risk of severe harm from delay, contraindications or adverse reactions, preservation of functional ability, prior approval/stability on the drug, or other Secretary-determined circumstances) and requires standardized, accessible forms and submission options so prescribers and beneficiaries can present clinical rationale and supporting medical information.
Introduced September 19, 2025 by Rick W. Allen · Last progress September 19, 2025