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Official title: To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes.
Introduced September 19, 2025 by Rick W. Allen · Last progress September 19, 2025
The bill improves and speeds patient access to necessary drugs and transparency around step-therapy exceptions, but increases costs and administrative burdens that could raise premiums or prompt plans to shift or tighten coverage elsewhere.
Patients with chronic or complex conditions can get prescribed non-preferred drugs when they meet clinical criteria and receive faster decisions (72 hours, 24 hours for expedited requests), reducing dangerous treatment delays.
Patients and prescribers have clearer, standardized, and accessible exception procedures and forms, making it easier to request and document step-therapy exceptions.
Approved exceptions remain in effect for at least one year, giving patients (including Medicaid and Medicare beneficiaries) more continuity of therapy and predictable cost-sharing.
Health plans and taxpayers may face higher drug spending if more exceptions are approved, which could translate into higher premiums or employer plan costs.
Plans and PBMs may respond to higher costs by tightening formularies, increasing prior authorization, or imposing other coverage limits elsewhere, potentially shifting barriers to care.
New standardized processes, shorter decision timelines, and annual reporting create administrative and compliance burdens for plans, issuers, prescribers, hospitals, and PBMs, raising paperwork and operating costs.
Based on analysis of 2 sections of legislative text.
Requires group health plans and issuers using medication step therapy to implement a clear, prompt exceptions process and cover drugs when statutory clinical criteria are met.
Requires group health plans and health insurers that use medication step therapy (formularies that force patients to try certain drugs first) to adopt a clear, prompt, and transparent exceptions process that patients or prescribers can initiate and that results in coverage when specific clinical criteria are met. The law lists circumstances (ineffectiveness, risk of harm, contraindication, preserving function, clinical stability on current drug, and similar situations) that must trigger approval of an exception so the patient can receive the prescriber’s chosen medication consistent with the plan’s cost‑sharing rules.