INSULIN Act of 2026

Summary of S.4189 — INSULIN Act of 2026 (119th Congress)

Purpose
- The INSULIN Act of 2026 aims to reduce the out-of-pocket cost of insulin for patients and strengthen protections and transparency around insulin pricing, access, and competition. It establishes price-sharing limits, expands coverage rules, and creates programs to assist uninsured individuals.

Key Provisions and Changes

Title I — Commercial Market Patient Protections
- Cost-sharing requirements for insulin products:
- For plan years starting in 2027, group health plans or health insurance issuers must cover selected insulin products without deductibles and with restricted cost-sharing.
- 30-day supply cost-sharing cap:
- Plan year beginning before Jan 1, 2028: $35.
- Plan year beginning on/after Jan 1, 2028: the lesser of $35 or 25% of the negotiated price net of price concessions (including rebates and other discounts from PBMs, TPAs, etc.).
- Selected insulin products: at least one dosage form of each major insulin type (rapid-acting, short-acting, intermediate-acting, long-acting, pre-mixed) across dosage forms, as chosen by the plan.
- Definitions: “insulin” refers to insulin licensed under the Public Health Service Act and marketed under that licensure; “selected insulin products” are those designated by the plan for coverage.
- Out-of-network protections: The act does not require coverage for out-of-network insulin under the same cost-sharing limits; plans may apply higher cost-sharing for out-of-network insulin.
- No retroactive reduction in other cost-sharing for insulin vs. other drugs; ensures that these insulin-specific limits do not constrain coverage for non-selected insulin products.
- Application toward deductibles/out-of-pocket maximums: insulin cost-sharing counts toward deductibles and out-of-pocket maximums.
- Administrative safeguards: No unnecessary prior authorizations or other medical management requirements for selected insulin products beyond safety/clinical justification, and only to ensure reasonable quantity limits.

• ACA and ERISA alignment:
  • The bill amends cost-sharing rules under the Public Health Service Act, ERISA, and Internal Revenue Code to implement these insulin-specific protections, while preserving other existing cost-sharing rules for non-selected insulin products.
  • Retiree and small-group plans: Applies similar requirements to ERISA-covered retiree and certain small-group plans.

Title II — Pharmacy Benefit Manager (PBM) Transparency and Rebate Reform
- Full pass-through of insulin rebates to plans:
- Requires PBMs, third-party administrators, and issuers to remit 100% of rebates, fees, alternative discounts, and other remuneration related to insulin utilization to the group health plan.
- Timely remittance: Rebates must be remitted promptly after the period ends, no later than 90 days; full disclosure to the plan sponsor; and audit availability at least annually.
- Administrative alignment: Applies to all relevant entities under Part D amendments to ensure transparency of insulin-related remuneration.

Title III — Biosimilar Competition and Affordability
- Faster approval and competition for insulin-related biosimilars:
- Expedited processes for certain biosimilar applications designated as competitive biosimilar therapies.
- Criteria and designation timeline to accelerate review and potential market entry.
- Provisions for enhanced communication between sponsors and FDA reviewers; emphasis on reducing delays and improving competition.
- Insulin competition report:
- A report within one year of enactment detailing delays in insulin product entry, biosimilar competition dynamics, formulary placement, and barriers to entry; policy recommendations to improve competition and access.

Title IV — Programs for Providing Affordable Insulin to Uninsured Individuals
- Pilot program (Sec. 401):
- A five-year pilot program awarding grants to 10 States to provide affordable insulin to uninsured individuals.
- Eligible uses: purchase/dispense insulin via Federally Qualified Health Centers (FQHCs) and community pharmacies; enroll individuals in manufacturer and other assistance programs; establish on-site or partner pharmacies; public education and outreach.
- Definition of affordability: out-of-pocket cost not more than $35 per 1-month supply.
- Authorization of appropriations: $100 million for fiscal years 2027–2032.
- GAO study (Sec. 402):
- Study on uninsured individuals who use insulin, including regional/state disparities, demographics, and income.
- Insulin Resource Center and Hotline (Sec. 403):
- Secretary-led grant to establish a resource center and hotline to assist uninsured individuals in accessing insulin assistance programs, with a public website and multilingual support; annual reporting to Congress.

Implementation and Administration
- Implementation timing: Provisions apply to plan years beginning on or after January 1, 2027, with some specific sections incorporating earlier or transitional timing (e.g., certain cost-sharing limits effective 2027–2028).
- Regulatory posture: The Secretary of HHS, Labor, and the Treasury would implement the Title I provisions;Paperwork Reduction Act relief provided; subregulatory guidance permitted for 2027–2030 implementation.
- Offsets: Sense of Congress section recognizes the need for an offset to cover any costs resulting from enactment.

Who Is Affected
- Individuals with group health plans or individual market coverage that include insulin benefits, particularly those enrolled in plans offering selected insulin products.
- Employers, plan sponsors, and health plan administrators (including PBMs and TPAs) involved in insulin pricing and rebates.
- Uninsured individuals seeking affordable insulin and their healthcare providers.
- State health departments and Federally Qualified Health Centers participating in the uninsured insulin pilot program.
- Biosimilar manufacturers and sponsors seeking expedited review and enhanced competition.

Timeline Highlights
- 2027: Start of cost-sharing protections for selected insulin products; 30-day supply caps begin.
- 2028: Price-sharing caps tied to negotiated prices or fixed cap; continued implementation and related requirements.
- 2027–2032: Funding for uninsured insulin pilot program ($100 million total).
- Within 1 year of enactment: Insulin competition report to Congress.
- Within 2 years of enactment: GAO study on uninsured insulin users.

Overall Impact
- Aims to substantially reduce patient cost-sharing for insulin, increase transparency around rebates to plans, accelerate biosimilar competition to spur price reductions, and create targeted programs to expand access for uninsured individuals. The bill blends price controls, transparency, and programmatic outreach to address insulin affordability and access across insured and uninsured populations.