S-4189-119
Placed on Senate Legislative Calendar under General Orders. Calendar No. 552.
Sponsored by Jeanne Shaheen (D-NH)
What it does
The INSULIN Act of 2026 would cap out-of-pocket costs for insulin at $35 per 30-day supply for patients covered by private insurance and employer-sponsored health plans, effective January 1, 2027. Starting in 2028, the cap would drop further to the lesser of $35 or 25% of the negotiated net price. The bill would also require pharmacy benefit managers (PBMs) to pass 100% of manufacturer rebates on insulin back to health plans, tighten rules against delay tactics used to block generic and biosimilar insulin competitors, and create a 5-year $100 million pilot grant program to provide affordable insulin to uninsured individuals in up to 10 states.
Who benefits
The approximately 8–9 million Americans who use insulin and have private or employer-sponsored insurance, particularly those currently paying well above $35 per month. Uninsured diabetics in the 10 states selected for the pilot grant program. Federally qualified health centers and retail pharmacies that would receive grant funding. Generic and biosimilar insulin manufacturers who would face fewer regulatory delay tactics from brand-name competitors. Employers and health plan sponsors who would receive full PBM rebate pass-throughs, potentially reducing overall plan costs. Low-income and underserved communities targeted by the resource center and hotline provisions.
Who is hurt
Pharmacy benefit managers, whose business model relies in part on retaining a portion of manufacturer rebates, would be required to pass 100% of insulin rebates to plans. Brand-name insulin manufacturers could face increased competition from biosimilars and generics under the expedited approval and anti-delay provisions. Health insurers and plan sponsors may face higher administrative costs to comply with the new cost-sharing rules. Uninsured individuals in the 40 states not selected for the pilot program would receive no direct benefit. Patients who use insulin products not designated as "selected" by their plan would not be covered by the cap. Workers at PBM companies could face employment effects if business models are restructured.
Supporters argue
Supporters argue that insulin prices in the United States are dramatically higher than in peer nations — often 10 times the cost — and that one in four insulin-dependent patients rations doses due to cost, a practice with documented life-threatening consequences. They contend the bill addresses the full supply chain: capping patient costs immediately, eliminating PBM rebate retention that inflates list prices, and accelerating biosimilar competition to drive down underlying prices over time. The bill's broad bipartisan sponsorship — including members from both parties across ideologically diverse states — reflects that insulin affordability is a concrete, measurable problem with a direct legislative remedy.
Opponents argue
Opponents argue that price caps on cost-sharing treat only the patient-facing symptom while leaving the underlying list price structure intact, and that without addressing manufacturer pricing directly, costs will simply be redistributed to premiums paid by all insured individuals. They contend that requiring 100% rebate pass-through to plans — rather than to patients at the point of sale — may not reduce out-of-pocket costs for the uninsured or underinsured, and that the pilot program's 10-state limit leaves the vast majority of uninsured diabetics without relief. Critics also note that the bill's "Sense of Congress" provision acknowledging unfunded federal costs signals a fiscal gap that could undermine long-term program sustainability.
Constitutional context
Congress regulates private insurance markets and employer health plans under the Commerce Clause (Art. I, §8, cl. 3) and the Taxing and Spending Clause (Art. I, §8, cl. 1). NFIB v. Sebelius (2012) affirmed broad congressional authority to regulate existing commercial activity in health insurance markets. The bill's grant program to states is a straightforward exercise of spending power and does not appear to raise Spending Clause coercion concerns given its voluntary, competitive structure. Post-Loper Bright (2024), any implementing regulations issued by HHS, DOL, or Treasury would face independent judicial review rather than deferential scrutiny.
Checks and balances
Congress sets the cost-sharing caps and rebate pass-through requirements; HHS, DOL, and Treasury jointly implement through subregulatory guidance; courts review agency rules under independent post-Loper Bright scrutiny, and plan sponsors may audit PBM compliance annually.
Historical precedent
The Inflation Reduction Act of 2022 capped insulin copays at $35 per month for Medicare Part D enrollees; early CMS data showed measurable reductions in out-of-pocket costs for affected seniors, providing a partial model for extending similar caps to the private market.