The bill, titled the "INSULIN Act of 2026," aims to significantly reduce the price of insulin and implement patient protections regarding its cost. For plan years beginning January 1, 2027, group health plans and health insurance issuers would be prohibited from applying deductibles to selected insulin products. Cost-sharing for a 30-day supply would be capped at $35 , or 25% of the negotiated price for plan years starting January 1, 2028, whichever is less. These payments would count towards deductibles and out-of-pocket maximums, and plans would generally be restricted from imposing prior authorization on selected insulin. To enhance transparency and reform rebate practices, the legislation mandates that pharmacy benefit managers (PBMs) , third-party administrators, and health insurance issuers remit 100% of all rebates , fees, and other remuneration related to insulin utilization directly to the group health plan. This remittance must occur in a timely fashion, within 90 days, be fully disclosed to the plan sponsor, and be available for audit. These provisions aim to ensure that cost savings from insulin rebates directly benefit health plans and, by extension, consumers. The bill also addresses biosimilar biological product and generic drug competition to foster affordability. It amends the Federal Food, Drug, and Cosmetic Act to prevent delays in generic and biosimilar approvals by reforming the citizen petition process . The Secretary of Health and Human Services would be empowered to identify petitions submitted with the primary purpose of delaying approval and refer them to the Federal Trade Commission . Additionally, the bill introduces a process to expedite the development and review of "competitive biosimilar therapies" when there are fewer than three licensed biosimilars for a reference product. To support uninsured individuals, the bill establishes a 5-year pilot program awarding grants to 10 States with high rates of uninsured individuals and diabetes. These grants would enable States to provide affordable insulin , defined as not more than $35 per 1-month supply, through Federally qualified health centers and retail pharmacies. Funds could also be used to enroll individuals in manufacturer assistance programs or establish on-site pharmacies. The legislation further mandates a Government Accountability Office (GAO) study on the characteristics of uninsured insulin users to better understand their needs and inform future policy. Finally, the bill establishes an Insulin Resource Center and Hotline for uninsured individuals, funded by a grant to an eligible entity. This center would provide fair and impartial information on assistance programs for affordable insulin, including a standardized website and a 24/7 hotline staffed by navigators or healthcare professionals. This initiative aims to increase awareness and utilization of available resources for those in need.
The bill, titled the "INSULIN Act of 2026," aims to significantly reduce the price of insulin and implement patient protections regarding its cost. For plan years beginning January 1, 2027, group health plans and health insurance issuers would be prohibited from applying deductibles to selected insulin products. Cost-sharing for a 30-day supply would be capped at $35 , or 25% of the negotiated price for plan years starting January 1, 2028, whichever is less. These payments would count towards deductibles and out-of-pocket maximums, and plans would generally be restricted from imposing prior authorization on selected insulin. To enhance transparency and reform rebate practices, the legislation mandates that pharmacy benefit managers (PBMs) , third-party administrators, and health insurance issuers remit 100% of all rebates , fees, and other remuneration related to insulin utilization directly to the group health plan. This remittance must occur in a timely fashion, within 90 days, be fully disclosed to the plan sponsor, and be available for audit. These provisions aim to ensure that cost savings from insulin rebates directly benefit health plans and, by extension, consumers. The bill also addresses biosimilar biological product and generic drug competition to foster affordability. It amends the Federal Food, Drug, and Cosmetic Act to prevent delays in generic and biosimilar approvals by reforming the citizen petition process . The Secretary of Health and Human Services would be empowered to identify petitions submitted with the primary purpose of delaying approval and refer them to the Federal Trade Commission . Additionally, the bill introduces a process to expedite the development and review of "competitive biosimilar therapies" when there are fewer than three licensed biosimilars for a reference product. To support uninsured individuals, the bill establishes a 5-year pilot program awarding grants to 10 States with high rates of uninsured individuals and diabetes. These grants would enable States to provide affordable insulin , defined as not more than $35 per 1-month supply, through Federally qualified health centers and retail pharmacies. Funds could also be used to enroll individuals in manufacturer assistance programs or establish on-site pharmacies. The legislation further mandates a Government Accountability Office (GAO) study on the characteristics of uninsured insulin users to better understand their needs and inform future policy. Finally, the bill establishes an Insulin Resource Center and Hotline for uninsured individuals, funded by a grant to an eligible entity. This center would provide fair and impartial information on assistance programs for affordable insulin, including a standardized website and a 24/7 hotline staffed by navigators or healthcare professionals. This initiative aims to increase awareness and utilization of available resources for those in need.