H.R. 10227 — INSULIN Act of 2026

This section requires group health plans and health insurance issuers to cover selected insulin products for plan years beginning on or after January 1, 2028, without applying a deductible and with cost-sharing limited to the lesser of $35 or 25 percent of the negotiated price per 30-day supply. It prohibits prior authorization or medical management requirements except for safety or quantity limits, extends the same coverage rules to catastrophic plans before the annual out-of-pocket limit is met, and directs that the no-deductible coverage not increase a plan’s actuarial value. The section applies these requirements to ERISA plans and group health plans under the Internal Revenue Code.

This section authorizes the Secretaries of Health and Human Services, Labor, and Treasury to implement the provisions of this title, including amendments, for plan years beginning on or after January 1, 2028, and ending not later than January 1, 2030, through subregulatory guidance or program instructions. It also exempts those provisions from the Paperwork Reduction Act.

This section directs 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 consider, to the extent data is 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 operate a resource center and 24/7 hotline that provides impartial information on manufacturer and other assistance programs for affordable insulin, facilitates enrollment for uninsured individuals, maintains a ZIP Code-based clearinghouse of providers and pharmacies, and conducts targeted public education in underserved communities. The section bars insulin manufacturers from operating the center, requires culturally appropriate services and annual reports to Congress on utilization and program changes, and authorizes data collection to evaluate effects on out-of-pocket costs.

This section authorizes the Secretary of Health and Human Services to expedite the development and review of a biosimilar biological product application upon designation as a competitive biosimilar biological product. Designation is available when fewer than three biosimilars are licensed for the reference product and at least three years have passed since expiration of all applicable exclusivity periods.