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HR 2636119th CongressIn Committee

Making Insulin Affordable for All Children Act

Introduced: Apr 3, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs

H.R. 2636, the Making Insulin Affordable for All Children Act, would require private health plans and health insurance issuers to greatly reduce or eliminate cost-sharing for insulin products for individuals age 26 and under. For plan years beginning in 2026 or later, “selected insulin products” would be covered with no deductible and with cost-sharing capped at the lesser of $35 per 30-day supply or 25% of the negotiated price after price concessions. The bill applies across private coverage, including group plans (ERISA), marketplace plans, and related tax treatment. It also introduces related changes to ACA (Patient Protection and Affordable Care Act) and ERISA provisions to reflect this targeted insulin cost-sharing policy, defines what counts as insulin and “selected insulin products,” and directs federal agencies to implement the provisions (potentially via guidance). The goal is to reduce out-of-pocket costs for insulin for younger people while preserving plan flexibility for non-selected insulin products. Key elements include: (1) a requirement that plans cover insulin for those 26 and younger with no deductible and capped cost-sharing; (2) definitions to determine which insulin products are subject to the limits; (3) alignment with existing ACA/ERISA/tax code structures, including catastrophic coverage rules and actuarial value calculations; (4) counting any required insulin cost-sharing toward deductibles and out-of-pocket maximums; (5) a mandate for implementation guidance from federal agencies.

Key Points

  • 1Targeted demographic and scope: Applies to individuals 26 years old or younger enrolled in private health plans, including group plans and coverage under ERISA and related private insurance frameworks.
  • 2Cost-sharing caps: For plan years starting on or after January 1, 2026, selected insulin products must be covered without a deductible and with cost-sharing limited to the lesser of $35 per 30-day supply or 25% of the negotiated price after all price concessions.
  • 3Selected insulin products: The bill defines “selected insulin products” as at least one of each dosage form (e.g., vial, pump, inhaler) of each insulin type (rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, premixed) that is available and selected by the plan.
  • 4Insulin definition: Insulin is any licensed product under the relevant Public Health Service Act provisions and maintained under licensure, including biosimilars licensed under those provisions.
  • 5Interaction with ACA/ERISA/tax code: The bill amends multiple areas (Public Health Service Act, ERISA, and Internal Revenue Code) to implement the cost-sharing requirements and to address related actuarial value and catastrophic coverage considerations.
  • 6Actuarial value and deductions: The bill includes a rule stating that the deductible-exemption for insulin coverage shall not be counted when determining a plan’s actuarial value, affecting how plans are viewed under ACA standards.
  • 7Catastrophic coverage mechanism: In catastrophic-coverage plans, plans must cover selected insulin products before the individual’s cost-sharing reaches the annual limit, ensuring early access to insulin before hitting out-of-pocket caps.
  • 8Implementation authority: The Secretary of Health and Human Services, the Secretary of Labor, and the Secretary of the Treasury may implement these provisions through sub-regulatory guidance or other instructions.
  • 9Effective date and process: The requirements apply to plan years beginning after January 1, 2026, and the bill provides for cross-agency implementation rather than immediate policy shifts.

Impact Areas

Primary group/area affected:- Individuals 26 years of age or younger enrolled in private health plans (including employer-sponsored plans, marketplace plans, and other private coverage).Secondary group/area affected:- Employers and plan sponsors administering group health plans (ERISA plans) and health insurers offering group or individual coverage, who must adjust coverage rules and formulary selections to conform with the “selected insulin products” framework and cost-sharing caps.Additional impacts:- Insurer costs and plan design: Potential changes to formulary design, the selection of insulin products, and administrative processes to ensure compliance with the “selected insulin products” concept and the cost-sharing caps.- Market effects: Possible shifts in negotiated prices and rebates because the cost-sharing exposure for insulin is capped and deductible-free, potentially influencing pricing negotiations with manufacturers and PBMs.- Consumer affordability: Expected reduction in out-of-pocket costs for insulin for eligible individuals, which could improve adherence and reduce financial barriers for pediatric and young adult patients.- Administrative burden and guidance needs: Implementation will require new guidelines, training, and possible changes to claims processing to properly apply caps, track price concessions, and count cost-sharing toward deductibles and out-of-pocket maximums.
Generated by gpt-5-nano on Nov 18, 2025