S. 4189: INSULIN Act of 2026

The core of S. 4189 is a national limit on what people in the commercial insurance market pay for certain insulin products. For plan years beginning on or after January 1, 2027, patients could not be charged more than $35 for a 30-day supply of selected insulin products, and plans could not apply deductibles to those products. Starting January 1, 2028, the patient cost would be capped at the lesser of $35 or 25% of the negotiated price after all price concessions, which means some people could pay less than $35 if the net price is low enough.

The bill is unusually specific about what plans must cover. “Selected insulin products” means at least one of each dosage form, such as vials, pens, or inhalers, for each different type of insulin, such as rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed, as long as that form is licensed and marketed. It also sharply limits insurer roadblocks: prior authorization and other medical management tools would be barred except when clinically justified for safety or to enforce reasonable quantity limits.

Another major piece targets pharmacy benefit managers and other intermediaries. PBMs, third-party administrators, and health insurance issuers would have to send 100% of all rebates, fees, and alternative discounts tied to insulin use back to the group health plan, and they would have to do it no later than 90 days after the end of the period used to calculate that payment. Plan sponsors or their designees would also gain the right to audit those disclosures at least once per plan year, giving employers and other plan buyers more leverage to see where insulin money is going.

The bill also tries to increase supply-side competition and help uninsured patients directly. It tightens citizen petition rules by requiring petitions that seek to delay generic or biosimilar applications to be filed within 60 days after the petitioner knows the basis for the request, and it requires the Secretary to refer petitions whose primary purpose is delay to the Federal Trade Commission. The Secretary could also label a product a “competitive biosimilar therapy” when there is inadequate competition, defined as fewer than 3 licensed biosimilars for the same reference product, with a designation decision due within 60 calendar days. For uninsured people, the bill authorizes $100,000,000 for fiscal year 2027 for a 5-year pilot in 10 states where “affordable” insulin means no more than $35 per 1-month supply, plus $2,000,000 for each fiscal year 2027 through 2032 for a 24/7 voice-and-text hotline and website run by an entity that cannot be an insulin manufacturer or take consideration from one.