HR-10227-119
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sponsored by Diana DeGette (D-CO)
What it does
This bill would require group and individual health plans to cover a selection of insulin products without a deductible and cap patient cost-sharing at $35 per 30-day supply (or less, based on a percentage-of-price formula starting in 2028). It would also bar most prior authorization requirements on covered insulin, fund a grant-based resource center and 24/7 hotline for uninsured individuals seeking insulin assistance, require a GAO study on uninsured insulin users, and create an expedited FDA review pathway for biosimilar insulins in markets with inadequate competition.
Who benefits
Insured patients who use insulin, especially those with high-deductible plans, would see lower and more predictable out-of-pocket costs; an estimated several million insured diabetics could benefit. Uninsured individuals seeking insulin would gain access to a centralized resource center, hotline, and public education campaign. Biosimilar insulin manufacturers could benefit from expedited FDA review in markets with fewer than three competing products, potentially increasing competition.
Who is hurt
Insurers and pharmacy benefit managers would bear the cost of capped cost-sharing and lost prior-authorization leverage, potentially passing costs through premiums across the broader insured pool. Employers sponsoring group health plans may face modestly higher administrative and coverage costs. Insulin manufacturers with dominant market share could face new competitive pressure once biosimilar rivals receive expedited review, and the reference-product manufacturer may see downward pricing pressure over time.
Supporters argue
Supporters argue that insulin list prices have risen dramatically over the past two decades and that many insured patients still ration doses because of high deductibles and cost-sharing, citing patient surveys showing cost-related rationing. They contend the bill combines proven copay-cap mechanics from the Inflation Reduction Act's Medicare provisions with new tools—like restricting prior authorization and expediting biosimilar competition—to address both immediate affordability and long-term market competition.
Opponents argue
Opponents argue that copay caps and coverage mandates shift costs onto insurers and, ultimately, all premium-payers rather than addressing the underlying list prices set by manufacturers, potentially raising premiums modestly for the broader insured population. They contend that restricting prior authorization and medical management tools could limit plans' ability to control utilization and costs, and that the biosimilar expedited-review pathway may not meaningfully increase competition if manufacturers lack incentive to enter markets with thin margins.
Constitutional context
Congress is regulating the terms of private and employer-sponsored health insurance under its Commerce Clause and Spending Clause authority, an area of regulation the Supreme Court upheld in NFIB v. Sebelius (2012) as within Congress's power to regulate existing commercial insurance markets, even though it may not compel individuals to purchase coverage in the first instance.
Checks and balances
Congress sets the statutory cost-sharing caps and coverage requirements; HHS, Labor, and Treasury implement them through subregulatory guidance (with Paperwork Reduction Act review waived), and courts retain authority to review agency interpretations post-Loper Bright.
Historical precedent
The Inflation Reduction Act of 2022 capped insulin copays at $35 for Medicare Part D enrollees, and this bill extends a similar cap to private group and individual insurance markets.