S4189-119

What This Bill Does

The reported INSULIN Act of 2026 requires group health plans and individual-market insurers, beginning with plan years on or after January 1, 2028, to cover selected insulin products without a deductible. For each 30-day supply, cost sharing may not exceed the lesser of $35 or 25 percent of the negotiated price net of all concessions. A plan must select at least one marketed product in each dosage form, delivery device, and insulin type. The requirement generally does not govern nonselected insulin or out-of-network dispensing, and plans may retain clinically justified safety controls, reasonable quantity limits, and controls specified by the Secretary. The Affordable Care Act, ERISA, and tax-code amendments carry these rules across regulated plans and preserve high-deductible-plan treatment. HHS, Labor, and Treasury may implement the insurance provisions through subregulatory guidance for plan years ending no later than January 1, 2030, without Paperwork Reduction Act procedures. The bill also reforms FDA citizen petitions that can delay generic or biosimilar approvals: a petitioner must first use the administrative process, include all supporting arguments, file within 180 days after learning the basis, and satisfy exhaustion and timeliness rules before seeking judicial relief. FDA may consider listed delay indicators. A new competitive-biosimilar designation permits expedited development and review when fewer than three biosimilars are licensed and at least three years have passed since applicable exclusivities expired. HHS must operate a five-year, ten-State grant pilot for uninsured insulin users, with $100 million authorized for fiscal year 2027 and a $35-per-month affordability standard. Grants may support federally qualified health centers, retail community pharmacies, manufacturer-assistance navigation, and related access activities, with a formula and annual State reporting. GAO must report within two years on uninsured insulin users. HHS must also fund an independent resource center, website, public education, and continuously available voice-and-text hotline; the grantee cannot be an insulin manufacturer or receive enrollment consideration from one, and HHS must report annually. The resource center receives $2 million annually for fiscal years 2027 through 2032. Compared with the introduced bill, the reported substitute shifts insurance applicability from 2027 to 2028, removes the proposed requirement that pharmacy benefit managers and other intermediaries pass 100 percent of insulin rebates to plans, removes a separate insulin-competition report, narrows the detailed expedited-biosimilar process, and adds temporary subregulatory implementation authority.

Who Benefits and How

Insulin-using people enrolled in regulated health coverage receive no-deductible access and a defined monthly cost-sharing ceiling for a representative selection of insulin products. Uninsured people in ten participating States may receive subsidized insulin through health centers and community pharmacies, and uninsured people nationwide may use impartial assistance-program information, enrollment help, a website, and a 24/7 hotline. Generic and qualifying biosimilar applicants gain procedural protections against late or serial delay petitions and a potential expedited FDA review path. Federally qualified health centers, retail pharmacies, a qualified independent resource-center grantee, health navigators, State health agencies, Congress, and federal policymakers gain grants, service roles, data, or oversight information.

Who Bears the Burden and How

Health plans, insurers, pharmacy benefit managers, and administrators must configure formularies and claims, cover selected insulin without deductibles, apply the net-price cap, count payments correctly, and limit utilization controls. HHS, Labor, Treasury, FDA, GAO, participating States, and the resource-center grantee assume rulemaking, review, grant, data, hotline, evaluation, and reporting work. Federal taxpayers bear the authorized pilot and resource-center costs. Drug sponsors using citizen petitions face a 180-day filing rule, mandatory administrative exhaustion, and dismissal consequences. Reference biologic manufacturers may face earlier competition. The reported bill does not retain the introduced 100-percent insulin-rebate pass-through, so plan sponsors and participants do not receive that proposed transfer, while pharmacy benefit managers and other intermediaries avoid its remittance, disclosure, and annual-audit duties.

Key Provisions

• Limits selected-insulin cost sharing to the lesser of $35 or 25 percent of net negotiated price beginning in 2028.
• Requires no-deductible coverage across regulated group and individual health plans with limited clinical and network exceptions.
• Tightens citizen-petition timing, exhaustion, and judicial-dismissal rules for challenges affecting generic and biosimilar approvals.
• Authorizes expedited FDA review for designated biosimilars in markets with fewer than three competitors after exclusivity periods expire.
• Establishes a five-year, ten-State uninsured-insulin pilot backed by a $100 million fiscal year 2027 authorization.
• Requires a two-year GAO study of uninsured insulin users and annual oversight of the assistance resource center.
• Funds an impartial insulin-assistance website, public education program, and 24/7 voice-and-text hotline through fiscal year 2032.
• Removes the introduced full rebate pass-through and separate insulin-competition-report provisions from the reported bill.