A complete substitute amendment, v2 significantly restructures the original bill. It removes the entire title on Pharmacy Benefit Manager transparency and rebate reform, delays the effective date for insulin cost-sharing caps, and narrows the criteria for expediting biosimilar competition. The definition of "uninsured individual" for grant programs is also modified.
INSULIN Act of 2026
- Sponsor
- Sen. Shaheen, Jeanne [D-NH]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Aug 7, 2026
Bottom line
The bill aims to make insulin more affordable and accessible for both insured and uninsured individuals by capping out-of-pocket costs and promoting market competition, while reflecting significant compromises from its introduced form.
What it actually does
This bill establishes a $35 monthly cap on out-of-pocket insulin costs for most insured individuals, effective January 1, 2028, and mandates coverage without deductibles. It also includes provisions to expedite generic and biosimilar drug competition, and creates a pilot program and resource center to help uninsured individuals access affordable insulin. Notably, the reported version removes earlier provisions that would have required pharmacy benefit managers to pass through 100% of insulin rebates to health plans.
Proponents argue
Supporters argue that this legislation is a crucial step towards making life-saving insulin affordable for millions of Americans, preventing patients from rationing their medication due to high costs. They contend that capping out-of-pocket expenses and fostering greater competition among drug manufacturers will alleviate financial burdens and improve health outcomes for individuals with diabetes, particularly those who are uninsured or underinsured.
Opponents contend
Critics of certain aspects of the bill, or those who sought more comprehensive reform, might argue that while the cost-sharing cap is beneficial, the removal of the PBM rebate pass-through provision represents a missed opportunity to address underlying market distortions. Some may also contend that the competition provisions, particularly for biosimilars, are not strong enough to drive significant price reductions, or that mandating cost caps on private plans could lead to increased premiums for all enrollees.
The bill is moderately complex due to its legislative drafting style and multiple policy areas, requiring a dedicated reading for full comprehension. The time given for public review of the reported text is limited.
Section 2, PHSA Section 2729A
Insulin Cost-Sharing Cap and Deductible Exemption
This provision mandates that for plan years beginning on or after January 1, 2028, most group health plans and health insurance issuers must cover 'selected insulin products' without applying any deductible. Furthermore, it caps the out-of-pocket cost-sharing for a 30-day supply of these selected insulin products at the lesser of $35 or 25% of the negotiated price (net of all price concessions). It also explicitly prohibits plans from paying amounts in excess of this cap to PBMs, providers, or manufacturers.
Supporters argue
Supporters argue this cap directly addresses the affordability crisis of insulin, ensuring that patients can access their life-saving medication without facing prohibitive costs or deductibles. They contend it will prevent rationing and improve health outcomes.
Critics contend
Some critics, particularly from the insurance industry, might argue that such mandates increase overall healthcare costs, which could be passed on to all enrollees through higher premiums. They may also raise concerns about potential market distortions if plans are limited in how they manage drug formularies.
Tradeoffs
The provision balances immediate patient affordability with potential shifts in cost burden to other enrollees or health plans. It aims to reduce patient out-of-pocket costs but may not directly lower the list price of insulin, instead shifting who pays for it.
Section 4
GAO Study on Uninsured Insulin Users
This section directs the Comptroller General of the United States to conduct a comprehensive study on the characteristics of uninsured individuals who use insulin. The study, to be reported within two years of enactment, will examine prevalence in different regions, reasons for uninsured status, demographic characteristics (including race and ethnicity), and income levels of these individuals.
Section 5, FDCA Section 505(q)
Ensuring Timely Access to Generics
This provision amends the Federal Food, Drug, and Cosmetic Act to strengthen the Food and Drug Administration's (FDA) ability to address citizen petitions filed with the primary purpose of delaying generic drug approvals. It expands the factors the FDA can consider when determining if a petition is intended to delay, such as the timing of submission relative to when information was known, serial petitions, and requests for more onerous standards. It also requires petitions to be submitted before civil actions and sets a 180-day deadline for submission after relevant information is known, with consequences for non-compliance.
Section 6, PHSA Section 351(k)(10)
Expediting Biosimilar Competition
This provision allows the Secretary of Health and Human Services to expedite the development and review of biosimilar biological products designated as 'competitive biosimilar biological products.' A product qualifies for this designation if there is 'inadequate biosimilar competition,' defined as fewer than three licensed biosimilars for a reference product AND at least three years have passed since the expiration of all exclusivity periods for that reference product or its biosimilars. This aims to accelerate the entry of biosimilars into the market, including biosimilar insulin.
Section 7, PHSA Section 399V-8
Pilot Program for Providing Affordable Insulin to Uninsured Individuals
This section establishes a five-year pilot program, authorizing $100 million for fiscal year 2027, to award grants to 10 states. These states, selected based on high rates of uninsured individuals and diabetes, will use the funds to help uninsured individuals access affordable insulin. Uses include assisting with purchases through Federally Qualified Health Centers (FQHCs) and retail pharmacies, enrolling individuals in manufacturer assistance programs, and supporting on-site pharmacies. 'Affordable' is defined as no more than $35 per 1-month supply. The definition of 'uninsured individual' is broadened to include those eligible for ACA subsidies but not enrolled.
Section 8
Insulin Resource Center and Hotline for Uninsured Individuals
This section authorizes $2 million annually for fiscal years 2027-2032 for a grant to an eligible entity to establish and maintain a national resource center and 24/7 hotline. This center will provide fair and impartial information about manufacturer and other assistance programs for affordable insulin, facilitate enrollment, offer a website clearinghouse of providers and health insurance information, and conduct public education campaigns. The entity operating the center must be independent of insulin manufacturers and provide unbiased information. The definition of 'uninsured individual' is broadened to include those eligible for ACA subsidies but not enrolled.
This rule of construction explicitly states that the insulin cost-sharing cap provisions shall not be construed to permit a group health plan or health insurance issuer to pay any amount in excess of the specified cost-sharing amount to an entity providing pharmaceutical benefit management services, a provider, or a pharmaceutical manufacturer with respect to the provision of selected insulin products.
Section 2(d)(2) of the reported bill, amending PHSA Section 2729A(d)(2)
Why it matters:This is a technically phrased provision that directly impacts the financial relationships between health plans, PBMs, and manufacturers regarding insulin. Its placement in a 'Rules of Construction' section is standard legislative practice for clarifying intent, but it also means its significant financial implications might not be immediately apparent to a casual reader.
Case for: Supporters would argue this provision is crucial to ensure that the cost-sharing cap truly benefits patients by preventing plans or PBMs from recouping lost revenue by shifting costs elsewhere in the supply chain or through inflated payments to intermediaries, thereby preserving the intent of the affordability measure.
Case against: Some PBMs or manufacturers might argue that this provision could interfere with existing contractual arrangements or limit their ability to negotiate effectively, potentially leading to unintended consequences in the drug supply chain or impacting their business models.
Estimated impact: Potentially significant financial impact on PBMs and manufacturers by limiting their ability to charge plans for insulin beyond the net negotiated price, thereby reinforcing the cost-sharing cap's effect on the entire supply chain.
This provision defines 'inadequate biosimilar competition' for the purpose of expediting biosimilar development and review. It requires not only fewer than three licensed biosimilars for a reference product but also that 'not less than 3 years have passed since the expiration of all exclusivity periods' applicable to the reference product or its biosimilars.
Section 6(a), amending PHSA Section 351(k)(10)(C)
Why it matters:Definitions often contain critical details that shape the practical application of a policy. The specific wording here determines which biosimilars qualify for expedited review, making it a key gatekeeping mechanism. Its technical nature means it's less likely to be highlighted in summary documents.
Case for: Proponents of this specific wording might argue that it provides a reasonable balance, allowing reference product manufacturers a period to recoup R&D investments while still promoting biosimilar competition once that period is clearly over. It aims to prevent premature expedited review that could undermine innovation incentives.
Case against: Critics might argue that adding a three-year waiting period after exclusivity expiration unnecessarily delays biosimilar entry, even when competition is already 'inadequate.' They contend that this could prolong high drug prices and reduce patient access to more affordable options.
Estimated impact: This provision will likely reduce the number of biosimilar products that qualify for expedited review, potentially delaying the market entry of some biosimilars and thus slowing down price reductions for certain biological products.
These sections define 'uninsured individual' for the purposes of the pilot program and the resource center. The reported bill removes the exclusion for individuals 'entitled to a premium assistance tax credit under section 36B of the Internal Revenue Code of 1986' that was present in the introduced version.
Section 7(f)(5) and Section 8(h)(5)
Why it matters:Changes to definitions can have broad implications for program eligibility. Removing this exclusion expands the pool of individuals considered 'uninsured' for these programs, which is a significant policy shift. Its placement in a definition is standard but can obscure the impact.
Case for: Proponents of this change would argue that it expands the reach of the pilot program and resource center to a crucial population: individuals who are eligible for ACA subsidies but have not enrolled, often due to affordability concerns or lack of awareness. This ensures more vulnerable individuals can access assistance.
Case against: No direct opposition is typically raised against expanding eligibility for assistance programs, though some might argue that the primary solution for this group should be enrollment in subsidized health insurance, rather than relying on separate assistance programs.
Estimated impact: This change significantly expands the number of individuals eligible for the state pilot program and the national resource center, potentially reaching millions more Americans who currently lack health insurance despite being eligible for federal subsidies.