S. 4189 — INSULIN Act of 2026

This section requires group health plans and issuers of group or individual health insurance coverage to cover selected insulin products (at least one of each dosage form and type) for plan years beginning on or after January 1, 2027, without applying any deductible and with cost-sharing limited to $35 per 30-day supply (or the lesser of $35 or 25 percent of the negotiated price net of concessions beginning in 2028). It prohibits prior authorization or other medical management requirements except for safety or quantity limits, counts such cost-sharing toward deductibles and out-of-pocket maximums, applies parallel requirements to ERISA plans and the Internal Revenue Code, and directs that the deductible exemption not affect actuarial value calculations for qualified health plans or coverage under catastrophic plans.

This section applies the requirements of section 727 to group health plans (and related coverage) with fewer than two current employee participants on the first day of the plan year. It makes parallel changes to the Internal Revenue Code so that the requirements of section 9827 apply to such plans and are subject to the excise tax under section 4980D.

This section authorizes the Secretaries of Health and Human Services, Labor, and the Treasury to implement the provisions of this title for plan years beginning on or after January 1, 2027, and ending not later than January 1, 2030, through subregulatory guidance or program instructions. It exempts those provisions from the Paperwork Reduction Act.

This section requires pharmacy benefit managers, third-party administrators, health insurance issuers, and related entities to remit 100 percent of rebates, fees, alternative discounts, and other remuneration tied to insulin utilization under a group health plan directly to the plan. Remittances must occur no later than 90 days after the end of the calculation period, with full disclosure to the plan sponsor and audit rights available to the sponsor or its designee at least once per plan year.

This section revises the citizen petition process under section 505(q) of the Federal Food, Drug, and Cosmetic Act to deter filings intended primarily to delay generic or biosimilar drug approvals. It requires any petition or supplement to be submitted within 60 days after the petitioner knew or reasonably should have known the relevant information, mandates that petitions precede any related civil action, and directs the Secretary to refer petitions found to have a primary purpose of delay to the Federal Trade Commission. It also lists factors for determining delay intent, including serial filings, timing near approval dates, lack of supporting data, and prior petition history, and eliminates the prior 150-day response deadline.

This section authorizes the Secretary of Health and Human Services to expedite the development and review of biosimilar biological product applications designated as competitive biosimilar therapies when fewer than three licensed biosimilars compete with the reference product. It permits sponsor requests for designation decided within 60 days, pre-submission meetings and senior review involvement, expedited facility reinspections upon applicant attestation of remediation, and requires licensees to report marketing status within one year of licensure.

This section requires the Secretary of Health and Human Services, in collaboration with the Administrator of the Centers for Medicare & Medicaid Services and the Commissioner of Food and Drugs, to complete a study within one year on delays in bringing insulin products to market, causes of those delays, and barriers to biosimilar biological product competition, including formulary placement, U.S. market entry compared to other developed nations, and patient and provider education. It also requires submission of a report to Congress with the study results and recommended policy solutions.

This section establishes a 5-year pilot program under which the Secretary awards grants to 10 States with high rates of uninsured individuals and diabetes diagnoses. States must use funds to provide affordable insulin (no more than $35 per 1-month supply) to uninsured individuals through Federally qualified health centers and retail community pharmacies, enroll individuals in manufacturer assistance programs, establish or expand on-site pharmacies, or conduct other approved activities. The Secretary must set a formula providing a minimum grant amount to each State and accounting for rates of insulin-dependent diabetes and uninsured individuals; States must report annually on expenditures and individuals served. The section authorizes $100 million for FY2027.

This section requires the Comptroller General of the United States to conduct a study, in consultation with patient, clinical, and provider groups and other experts, and issue a report within 2 years of enactment on the characteristics of uninsured individuals who use insulin. The study must examine, to the extent data are available, states or regions with higher prevalence, reasons for uninsured status, demographic characteristics such as race and ethnicity, and income levels.

This section directs the Secretary of Health and Human Services to award a grant to a qualified nonprofit or trade association to establish and maintain a resource center and 24/7 hotline that provides information on manufacturer and other assistance programs for uninsured individuals seeking affordable insulin. The center must operate a standardized website with links to providers and pharmacies by ZIP Code, facilitate program enrollment, deliver culturally and linguistically appropriate information, issue guidance to hospitals, and conduct public education in underserved communities while meeting conflict-of-interest standards that bar insulin manufacturers from involvement.