INSULIN Act of 2026
- Bill Number
- S. 4189
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-03-25: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-06-19T11:03:25Z
AI-Generated Summary
Purpose
The INSULIN Act of 2026 (S. 4189) aims to lower insulin costs for patients by capping out-of-pocket expenses in commercial health plans, requiring full pass-through of rebates to plans, promoting generic and biosimilar competition, and creating programs to help uninsured individuals access affordable insulin (defined as no more than $35 per 1-month supply).
Key Provisions
- Title I: Commercial Market Patient Protections (effective plan years starting January 1, 2027):
- Health plans and insurers must cover "selected insulin products" (at least one of each type like rapid-acting or long-acting, and each dosage form like vial or pen, chosen by the plan).
- No deductibles applied; cost-sharing capped at $35 per 30-day supply until 2027, then the lesser of $35 or 25% of the net negotiated price (after discounts).
- Cost-sharing counts toward deductibles/out-of-pocket maximums.
- No prior authorization or medical management unless clinically justified for safety or quantity limits.
- Applies to group/individual plans, catastrophic plans, retiree plans, and small group plans via amendments to Public Health Service Act (PHSA), ERISA, and Internal Revenue Code (IRC).
- Out-of-network providers may face higher costs.
- Title II: Pharmacy Benefit Manager (PBM) Transparency and Rebate Reform:
- PBMs, third-party administrators, and insurers must pass 100% of insulin-related rebates, fees, discounts, and remuneration from manufacturers/distributors directly to the health plan.
- Must be remitted timely (within 90 days), fully disclosed, and available for annual audits.
- Title III: Biosimilar Biological Product and Generic Drug Competition:
- Reforms FDA citizen petition process (under Federal Food, Drug, and Cosmetic Act) to curb abuse delaying generics/biosimilars: requires timely submission (within 60 days of knowing info), lists factors for "delay" determination (e.g., serial petitions, lack of data), allows FTC referrals, mandates dismissal of non-compliant lawsuits.
- Creates expedited FDA review/development for "competitive biosimilars" (where <3 biosimilars exist for a reference product), including meetings, advice, senior staff, and fast reinspections.
- Requires HHS report to Congress within 1 year on insulin market delays, biosimilar barriers, and policy solutions.
- Title IV: Programs for Uninsured Individuals:
- 5-year pilot: $100M in grants to 10 high-need states (high uninsured/diabetes rates) for affordable insulin via health centers, pharmacies, manufacturer assistance enrollment, or on-site pharmacies.
- GAO study (within 2 years) on uninsured insulin users' characteristics (e.g., regions, demographics, income).
- Grant (~$2M/year, 2027-2032) for a nonprofit to run an insulin resource center/hotline: website clearinghouse, 24/7 support, enrollment help, education targeting underserved areas; must be impartial, no manufacturer ties.
- Other: Sense of Congress urges future offsets for federal costs; administrative flexibilities (subregulatory guidance through 2030, no Paperwork Reduction Act).
Significant Changes to Existing Law
- New insulin-specific caps: First federal limits on commercial plan cost-sharing/no deductibles (beyond prior Medicare caps); adjusts ACA actuarial value calculations.
- PBM rebates: Mandates full insulin rebate pass-through (previously, PBMs could retain portions).
- FDA processes: Strengthens/tightens citizen petition rules (adds timelines, delay factors, court dismissals); new biosimilar fast-track designation.
- Expands to uninsured: New state grants, resource center, studies (no prior federal equivalents).
- Applies uniformly across PHSA/ERISA/IRC for consistency.
Potential Impacts
- Citizens/Patients: Reduced out-of-pocket costs (~$35/month max for selected insulins in commercial plans); better access for ~8M insulin users, especially diabetics/uninsured; increased generic/biosimilar options may lower list prices long-term.
- Government Agencies: HHS/FDA/CMS gain enforcement/reporting duties, expedited reviews, pilot oversight; Treasury/Labor coordinate implementation; ~$102M authorized (mostly grants).
- Health Plans/PBMs: Higher transparency/costs shifted to plans (via rebates), but potential savings from competition; admin burden eased by guidance.
- No direct international relations impact.
Main Stakeholders Affected
- Patients: Insured/uninsured insulin users (esp. type 1/2 diabetics).
- Health Plans/Insurers/PBMs/TPAs: Compliance with caps, rebates.
- Insulin Manufacturers: Rebate mandates, competition pressure.
- Generic/Biosimilar Developers: Easier/faster market entry.
- Providers/Pharmacies: FQHCs/retail pharmacies aided via grants; fewer barriers.
- States/Government: High-need states benefit from pilots; HHS/FDA/GAO/CMS handle new roles.
Notable Legal, Constitutional, or Political Implications
- Legal: Harmonizes rules across federal health laws (PHSA/ERISA/IRC); empowers FDA/FTC on delays, courts on petition dismissals; audit/disclosure rights for plans.
- Constitutional: Standard commerce clause regulation of insurance/drugs; no apparent free speech/property challenges (e.g., petition reforms target abuse).
- Political: Bipartisan (12 senators); targets commercial/uninsured markets without Medicare expansion; calls for cost offsets signal fiscal caution.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (27)
Sen. Collins, Susan M. [R-ME], Sen. Warnock, Raphael G. [D-GA], Sen. Kennedy, John [R-LA], Sen. Rosen, Jacky [D-NV], Sen. Tuberville, Tommy [R-AL], Sen. King, Angus S., Jr. [I-ME], Sen. Murkowski, Lisa [R-AK], Sen. Kelly, Mark [D-AZ], Sen. Grassley, Chuck [R-IA], Sen. Baldwin, Tammy [D-WI], Sen. Britt, Katie Boyd [R-AL], Sen. Coons, Christopher A. [D-DE], Sen. Wicker, Roger F. [R-MS], Sen. Kaine, Tim [D-VA], Sen. Capito, Shelley Moore [R-WV], Sen. Blunt Rochester, Lisa [D-DE], Sen. Justice, James C. [R-WV], Sen. Ernst, Joni [R-IA], Sen. Hickenlooper, John W. [D-CO], Sen. Cramer, Kevin [R-ND], Sen. Alsobrooks, Angela D. [D-MD], Sen. Hyde-Smith, Cindy [R-MS], Sen. Cortez Masto, Catherine [D-NV], Sen. Banks, Jim [R-IN], Sen. Booker, Cory A. [D-NJ], Sen. McCormick, David [R-PA], Sen. Slotkin, Elissa [D-MI]
Recent Actions
- 2026-03-25: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-03-25: Introduced in Senate
Bill Versions
- Improving Needed Safeguards for Users of Lifesaving Insulin Now Act of 2026 — issued 2026-03-25 — PDF (44 pages)