S-864-119
Committee on Health, Education, Labor, and Pensions. Hearings held.
Sponsored by Roger Marshall (R-KS)
What it does
This bill would amend the Public Health Service Act and the Affordable Care Act to require that financial assistance paid on behalf of a patient — including copay cards and coupons from prescription drug manufacturers and payments from non-profit organizations — count toward a patient's deductible, copayment, coinsurance, and out-of-pocket maximum. It would also create a safe harbor so that high-deductible health plans (HDHPs) paired with Health Savings Accounts (HSAs) do not lose their qualified status when such third-party payments are counted toward the deductible. The bill would take effect for plan years beginning on or after January 1, 2026.
Who benefits
Patients with chronic or serious conditions who rely on expensive specialty drugs and currently use manufacturer copay assistance programs — particularly those with cancer, multiple sclerosis, rheumatoid arthritis, and other conditions requiring high-cost biologics. Patients enrolled in high-deductible health plans who use HSAs and currently cannot benefit from manufacturer assistance without risking their HSA eligibility. Non-profit patient assistance organizations whose payments would now count toward cost-sharing. Specialty drug manufacturers, whose copay assistance programs would become more valuable to patients and could support brand loyalty. Patients subject to utilization management tools (e.g., prior authorization, step therapy) who use specialty drugs.
Who is hurt
Health insurers and self-insured employers, who may face higher costs as patients reach their out-of-pocket maximums sooner, potentially increasing total claims paid. Pharmacy benefit managers (PBMs), whose accumulator adjustment programs — which currently strip manufacturer assistance from counting toward cost-sharing — would be prohibited. Generic and biosimilar drug manufacturers, whose products may become less competitive if brand-name copay assistance effectively lowers the patient's out-of-pocket cost for branded drugs. Taxpayers broadly, if higher insurer costs are passed through as premium increases. Patients who do not use specialty drugs and may see modest premium increases to offset insurer cost shifts.
Supporters argue
Supporters argue that PBM "accumulator adjustment" programs create a hidden trap: patients use manufacturer copay assistance believing it counts toward their deductible, only to face a sudden, unexpected cost cliff mid-year when the assistance runs out and their deductible resets to zero. They contend this practice forces patients with serious illnesses to abandon medically necessary treatments, citing patient advocacy data showing medication abandonment rates spike when accumulator programs are in effect. Supporters further argue the HSA safe harbor provision removes a structural barrier that currently forces patients to choose between tax-advantaged savings and accessing available drug assistance.
Opponents argue
Opponents argue that manufacturer copay assistance programs are primarily a marketing tool that shields patients from the true cost of expensive brand-name drugs, undermining incentives to choose lower-cost generics or biosimilars and ultimately driving up overall drug spending. They contend that when patients are insulated from list prices, insurers and employers bear higher costs that are passed on through premium increases affecting all enrollees — not just those using specialty drugs. Opponents further argue the bill could slow biosimilar adoption at a critical moment when competition is beginning to lower prices for some of the most expensive drug classes, potentially costing the health system more than it saves individual patients.
Constitutional context
Congress regulates health insurance markets and prescription drug coverage under the Commerce Clause (Art. I, §8, cl. 3) and the Taxing and Spending Clause (Art. I, §8, cl. 1). This bill amends existing ACA statutory provisions, which were upheld in NFIB v. Sebelius (2012). The IRC safe harbor provision is a straightforward exercise of Congress's taxing power. Post-Loper Bright (2024), any agency rulemaking required to implement the bill's standards would face independent judicial review rather than deference.
Checks and balances
Congress gains authority by mandating how insurers define and apply cost-sharing terms; HHS and the IRS implement the standards through rulemaking, subject to independent judicial review under Loper Bright (2024).
Historical precedent
Several states (including Virginia, Georgia, and Illinois) have enacted laws prohibiting accumulator adjustment programs, providing partial precedent, though no prior federal statute has directly mandated that third-party manufacturer payments count toward ACA cost-sharing requirements.