INSULIN Act of 2026

This bill aims to reduce insulin prices and provide patient protections regarding insulin costs. It sets cost-sharing limits for insulin products in health plans, mandates transparency for pharmacy benefit managers, promotes generic and biosimilar competition, and establishes programs to help uninsured individuals access affordable insulin.

Sec. 2, Requirements with respect to cost-sharing for certain insulin products: For plan years starting on or after January 1, 2028, group health plans and insurers must cover selected insulin products without applying any deductible, and cannot impose cost-sharing exceeding $35 per 30-day supply, or 25% of the net negotiated price if lower. Plans must cover at least one of each dosage form and delivery device for each insulin type. Out-of-network providers are not required to be covered, and plans may impose higher cost-sharing for out-of-network insulin if allowed by law. Plans cannot impose prior authorization or medical management on selected insulin products unless clinically justified for safety.

Sec. 3, Administration: The Secretaries of Health and Human Services, Labor, and Treasury may implement the cost-sharing provisions for plan years beginning on or after January 1, 2028, and ending by January 1, 2030, through subregulatory guidance. The Paperwork Reduction Act does not apply to these provisions.

Sec. 4, GAO study on uninsured individuals who use insulin: The Comptroller General must conduct a study and issue a report within two years on the characteristics of uninsured individuals who use insulin, including geographic prevalence, reasons for being uninsured, demographics, and income levels.

Sec. 5, Ensuring timely access to generics: This section amends the Federal Food, Drug, and Cosmetic Act to strengthen rules against citizen petitions filed with the primary purpose of delaying generic drug applications. It adds factors the Secretary may consider in determining such intent, requires petitions to be submitted before civil actions, and sets a 180-day deadline for submission after the petitioner knows the relevant information.

Sec. 6, Expediting biosimilar competition: The Secretary may expedite development and review of biosimilar applications if the product is designated as a competitive biosimilar biological product. Such designation requires that there are fewer than three licensed biosimilars using the same reference product and that at least three years have passed since all exclusivity periods expired.

Sec. 7, Pilot program for providing affordable insulin to uninsured individuals: The Secretary must conduct a 5-year pilot program awarding grants to 10 states with high rates of uninsured individuals and diabetes. States may use funds to purchase or dispense insulin through health centers and pharmacies, assist with manufacturer assistance programs, support on-site pharmacies, or other activities. Insulin must be affordable, meaning out-of-pocket cost is not more than $35 per 1-month supply. $100 million is authorized for fiscal year 2027.

Sec. 8, Insulin resource center and hotline for uninsured individuals: The Secretary must award a grant to an eligible entity to establish a resource center and hotline providing fair information on assistance programs for uninsured individuals seeking affordable insulin. The entity must be independent of insulin manufacturers and provide culturally and linguistically appropriate information. The Secretary must ensure the center meets standards and may withdraw the grant if standards are not met.