Congress caps insulin copays at $35, funds uninsured access pilot.

What it does

This bill caps insulin cost-sharing at $35 per 30-day supply for insured patients starting in 2028, eliminates deductibles for selected insulin products, and prevents insurers from imposing prior authorization on insulin without clinical justification. It also funds a pilot program to help uninsured individuals access affordable insulin, establishes a resource center and hotline for uninsured patients, accelerates generic and biosimilar insulin approvals by tightening rules on delay-tactic citizen petitions, and directs a study on uninsured insulin users.

Why we flagged it

The bill's core mechanism is a direct price cap on insulin copays for insured patients, combined with new access programs for the uninsured and regulatory streamlining to accelerate generic/biosimilar competition. This is consumer-protection legislation, not a tax or subsidy carve-out.

What the text implies

• The $35 copay cap applies only to 'selected insulin products' chosen by insurers, not all insulins—insurers retain discretion over which products qualify, potentially steering patients toward preferred formulations and limiting choice.
• The bill exempts insulin copay relief from actuarial value calculations under the ACA, preventing it from triggering higher premiums for other benefits; this is a technical fix but may obscure the true cost-shifting to insurers and employers.
• Citizen petition reforms (Section 5) tighten FDA review timelines and impose penalties for 'delay-tactic' petitions, but the criteria for determining 'primary purpose of delay' are subjective and may chill legitimate safety objections from competitors or patient advocates.
• The uninsured pilot program ($100M over 5 years) covers only 10 states and is time-limited; it does not create a permanent entitlement, leaving coverage gaps in non-participating states and after the pilot expires.
• The resource center grant (Section 8) is restricted to non-manufacturer entities, but manufacturer assistance programs remain voluntary and unregulated—the bill does not mandate that manufacturers offer or maintain these programs.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

Insured patients gain direct cost relief (capped copays, no deductibles) and reduced administrative barriers; uninsured patients receive new grant-funded access programs and a dedicated resource center. The bill does not restrict patient rights or remedies—it expands them. Accelerating generic/biosimilar competition lowers long-term prices for all users.

Who stands to gain

• Insured patients (direct copay relief)
• Uninsured individuals in pilot states (grant-funded access)
• Generic and biosimilar insulin manufacturers (accelerated approval pathway)
• Federally-qualified health centers and retail pharmacies (grant funding for dispensing and on-site p

Named in the bill

HHS (Department of Health and Human Services), FDA (Food and Drug Administration), CMS (Centers for Medicare & Medicaid Services), Insulin manufacturers (Eli Lilly, Novo Nordisk, Sanofi, biosimilar makers), Pharmacy Benefit Managers (PBMs), Health insurers and group health plans, Federally-qualified health centers, Retail community pharmacies, GAO (Government Accountability Office)

Where it stands

28 cosponsors: 14 Republicans, 13 Democrats, 1 Independents.

• Mar 25, 2026 — Introduced · Congress.gov: “Introduced in Senate”
• Mar 25, 2026 — Referred to Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions”
• Jul 22, 2026 — Reported out of committee · Congress.gov: “Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature…”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

8 lobbying clients named this bill on 8 disclosure filings across 1 quarter, Jun 2026 to Jun 2026. Those filings disclosed $4,462,567 in lobbying spend. A filing names 14 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 88% of bills with at least one filing.

Jeanne Shaheen, the sponsor, reported $-12,050 in PAC receipts in the 2026 cycle.

• Pharmaceutical Care Management Association — $3,282,990 on 1 filing
• Johns Hopkins University — $350,000 on 1 filing
• Highmark Inc — $230,000 on 1 filing
• League of Conservation Voters — $230,000 on 1 filing
• Breakthrough T1d (formerly Known As Jdrf Intl.) — $220,000 on 1 filing

Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.