What does Preamble of INSULIN Act of 2026 do?

This bill aims to reduce the price of insulin. It also intends to provide patient protections regarding the cost of insulin.

What does SENSE OF CONGRESS. of INSULIN Act of 2026 do?

This section expresses the sense of Congress that subsequent legislation should provide an offset for any costs to the Federal Government resulting from the enactment of this Act.

What does REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN INSULIN of INSULIN Act of 2026 do?

This section amends the Public Health Service Act and ERISA to establish requirements regarding cost-sharing for certain insulin products. For plan years beginning on or after January 1, 2027, group health plans and health insurance issuers generally cannot apply deductibles or impose cost-sharing exceeding $35 per 30-day supply. Starting January 1, 2028, the cost-sharing limit may be the lesser of $35 or 25% of the negotiated price of the selected insulin product. ’Selected insulin products’ include at least one of each dosage form and type of insulin that is licensed and marketed. Plans are not required to cover selected insulin products from out-of-network providers. Plans cannot impose prior authorization or other medical management requirements on selected insulin products unless clinically justified. Cost-sharing payments for insulin will count toward deductibles and out-of-pocket maximums.

What does APPLICATION TO RETIREE AND CERTAIN SMALL GROUP PLANS. of INSULIN Act of 2026 do?

This section amends the Employee Retirement Income Security Act of 1974 (ERISA) by modifying references within section 732(a) to include sections 711 and 727. The Internal Revenue Code of 1986 is amended to exclude requirements under sections 9811 and 9827 from paragraph (2) of section 9831(a). Section 4980D(d)(1) of the Internal Revenue Code is amended to allow references to sections 9811 or 9827.

What does ADMINISTRATION. of INSULIN Act of 2026 do?

The Secretaries of Health and Human Services, Labor, and the Treasury are authorized to implement this title through subregulatory guidance or program instructions. Implementation of this title applies to plan years beginning on or after January 1, 2027, and ending not later than January 1, 2030. The Paperwork Reduction Act of 1995 does not apply to the provisions of this title.

What does FULL REBATE ON INSULIN PASS-THROUGH TO PLAN. of INSULIN Act of 2026 do?

This section amends both the Public Health Service Act (PHSA) and the Employee Retirement Income Security Act of 1974 (ERISA). It requires pharmacy benefits managers, third-party administrators, health insurance issuers, or entities providing pharmacy benefits management services to remit 100 percent of rebates related to insulin utilization to the group health plan. Remittance must occur within 90 days after the end of the calculation period. The rebates, fees, alternative discounts, and other remuneration must be fully disclosed and enumerated to the group health plan sponsor. The plan sponsor or a designated third party can audit these remittances at least once per plan year.

What does ENSURING TIMELY ACCESS TO GENERICS. of INSULIN Act of 2026 do?

This section amends Section 505(q) of the Federal Food, Drug, and Cosmetic Act to address the process for citizen petitions related to drug applications. The amendment outlines factors the Secretary may consider when determining if a petition was submitted with the primary purpose of delaying an application, including the timing of submission relative to approval dates and the petitioner's history of submitting petitions. The Secretary is required to establish procedures for referring petitions deemed to have a primary purpose of delay to the Federal Trade Commission. The amendment modifies requirements for submitting citizen petitions before filing a civil action, requiring submission within 60 days of knowing relevant information. It clarifies the circumstances under which a court shall dismiss a civil action related to a drug application for failure to exhaust administrative remedies or failure to timely file a petition.

What does EXPEDITING COMPETITIVE BIOSIMILAR COMPETITION. of INSULIN Act of 2026 do?

This section amends the Public Health Service Act to establish a process for expediting the development and review of biosimilar applications. The Secretary of Health and Human Services may expedite the review of a biosimilar application if it is designated as a 'competitive biosimilar therapy'. Sponsors can request designation as a competitive biosimilar therapy concurrently with or prior to submitting a biosimilar biological product license application. A biological product is eligible for designation if the Secretary determines there is inadequate biosimilar competition, defined as fewer than three licensed biosimilar products for the same reference product. To expedite review, the Secretary may hold meetings with the sponsor, provide timely advice, involve senior staff, assign a project lead, and expedite reinspections of facilities. The holder of a license for a biosimilar biological product with expedited review must report to the Secretary within one year on whether the product has been marketed in interstate commerce.

What does INSULIN COMPETITION REPORT. of INSULIN Act of 2026 do?

This section requires a study to determine delays in getting insulin products to market. The study will examine factors such as biosimilar biological product development and competition. Barriers to biosimilar placement on formularies, market entry compared to other nations, and patient/provider education will be examined. The Secretary of Health and Human Services, in collaboration with the Administrator for the Centers for Medicare & Medicaid Services and the Commissioner of Food and Drugs, will conduct the study. A report detailing the study's results and policy recommendations will be submitted to Congress within one year of the Act's enactment.

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INSULIN Act of 2026

Last updated: 3/25/2026 · Introduced: 3/25/2026

Author: Jeanne Shaheen (D-NH)

TL;DR (AI)

This bill caps out-of-pocket costs for insulin at $35 per 30-day supply for most health plans starting in 2027, with a potential adjustment based on the negotiated price.
It mandates that pharmacy benefit managers pass 100% of insulin rebates and discounts directly to group health plans, increasing transparency and potentially lowering costs.
The bill aims to expedite the approval of biosimilar insulin products by establishing a process for prioritizing their review and addressing potential delays.
It establishes a 5-year pilot program, funded with $100 million, to provide affordable insulin to uninsured individuals in 10 states.
The legislation directs a study to examine factors hindering insulin market competition and requires the creation of an Insulin Resource Center and Hotline to assist uninsured individuals.

119th Congressin committeeS. 3014(In Committee)Official page

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Other Sections

Includes provisions on preamble, sense of congress..

2 sections

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TITLE I

-COMMERCIAL MARKET PATIENT PROTECTIONS

3 sections

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TITLE II

-PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM

4 sections

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TITLE IV

-PROGRAMS FOR PROVIDING AFFORDABLE INSULIN TO UNINSURED

3 sections

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