“A bill to reduce the price of insulin and provide for patient protections with respect to the cost of insulin.”
No CRS summary available for this bill.
This section cites the Act as the “Improving Needed Safeguards for Users of Lifesaving Insulin Now Act of 2026” or the “INSULIN Act of 2026” and sets forth the table of contents.
This section requires group health plans and health insurance issuers offering group or individual coverage, for plan years beginning on or after January 1, 2027, to cover selected insulin products (i.e., at least one of each dosage form of each type of licensed and marketed insulin) without applying any deductible or cost-sharing exceeding $35 per 30-day supply before January 1, 2028, or the lesser of $35 or 25% of the net negotiated price on or after January 1, 2028; prohibits prior authorization or medical management except as clinically justified for safety or quantity limits; and counts such cost-sharing toward deductibles and out-of-pocket maximums. (Thus, plans need not cover non-selected insulin products and may impose higher cost-sharing for out-of-network selected insulin products.) This section further amends the Affordable Care Act (ACA) as follows: (1) specifies that the insulin deductible exemption does not affect qualified health plan actuarial value calculations beginning in plan year 2028; and (2) requires catastrophic plans to cover selected insulin products under the same terms before enrollees reach the annual out-of-pocket limit beginning January 1, 2027. This section makes parallel changes to the Employee Retirement Income Security Act of 1974 (ERISA).
This section revises the general exception from part 7 requirements for group health plans (and group health insurance coverage) with fewer than two participants who are current employees—typically retiree-only plans—to exclude sections 711 and 727 (from section 711 only). It makes parallel changes to the Internal Revenue Code by (1) providing in §9831(a) that the small plan exception does not apply to §§9811 and 9827 and (2) expanding the §4980D(d)(1) excise tax exception to cover §9827 (in addition to §9811).
This section (1) authorizes the Secretaries of Health and Human Services, Labor, and the Treasury to implement the provisions of, and amendments made by, this title for plan years beginning on or after January 1, 2027, and ending not later than January 1, 2030, via subregulatory guidance, program instruction, or otherwise, notwithstanding any other provision of law; and (2) exempts such provisions and amendments from the Paperwork Reduction Act of 1995.
This section establishes parallel requirements under the Public Health Service Act (PHSA), Employee Retirement Income Security Act (ERISA), and Internal Revenue Code (IRC) that a pharmacy benefits manager, third-party administrator of a group health plan, health insurance issuer offering group health insurance coverage (under PHSA and ERISA), or entity providing pharmacy benefits management services under such plans or coverage remit 100% of rebates, fees, alternative discounts, and all other remuneration related to insulin utilization to the group health plan. Such amounts must be (1) remitted in a timely fashion, and in no case later than 90 days after the end of the calculation period; (2) fully disclosed and enumerated to the group health plan sponsor; and (3) available for audit by the plan sponsor or a designated third party no less than once per plan year.
This section revises citizen petition procedures applicable to abbreviated new drug applications (ANDAs) under subsection (j) and biosimilar biological product applications under section 351(k) of the Public Health Service Act (21 U.S.C. 355(q)) to deter delay tactics and expedite generic and biosimilar approvals. (As background, these procedures limit FDA review of certain citizen petitions during the 30-month patent exclusivity period or other exclusivity periods to prevent abuse that blocks market entry of lower-cost alternatives to brand-name drugs and biologics.) Specifically, the section (1) in paragraph (1) inserts additional FDA regulations (10.31) into the scope of restricted petitions; expands factors for determining if a petition was submitted with the primary purpose of delaying approval (e.g., serial filings, lack of supporting data, timing near approval dates, prior delay findings); requires FDA referral procedures to the Federal Trade Commission (FTC) for such delay petitions with petitioner notification; strikes the final agency action requirement; and redesignates and modifies remaining subparagraphs; and (2) in paragraph (2), requires petitions before related civil actions with full disclosure of issues and timely submission within 60 days after the petitioner knew or reasonably should have known the relevant information; revises FDA final decision timelines; and mandates court dismissal of non-compliant civil actions (without prejudice for missing petitions, with prejudice for untimely ones). (Thus, these changes reduce opportunities for petitioners to serially challenge approvals via petitions or lawsuits, facilitating faster generic and biosimilar access.)
This section establishes an expedited development and review process, at the sponsor's request, for biosimilar biological product license applications under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) if designated by FDA as a competitive biosimilar therapy. Such designation is available for a biosimilar to a reference product with inadequate biosimilar competition (i.e., fewer than three non-discontinued licensed biosimilars for that reference product listed under 42 U.S.C. 262(k)(9)(A)) and must be determined by FDA within 60 calendar days of the sponsor's request. (Thus, FDA may provide frequent meetings and advice, involve senior staff and a cross-disciplinary project lead, and expedite facility reinspections based on sponsor attestations.) License holders for expedited biosimilars must report to FDA within one year of licensure on whether the product has been marketed in interstate commerce.
This section directs the Secretary of Health and Human Services, in collaboration with the Centers for Medicare & Medicaid Services Administrator and Food and Drug Administration Commissioner, to complete within one year of enactment a study on (1) the extent of and causes for delays in bringing insulin products to market and (2) market dynamics and the extent to which biosimilar biological product (i.e., products highly similar to FDA-approved insulin biologics) development and competition could increase—or is increasing—the number of approved and available biological products for patients, including barriers to biosimilar placement on insurance formularies, U.S. market entry compared to other highly developed nations, and patient-provider education. The section further requires submission to Congress of a report describing the study results and recommended policy solutions.
This section establishes a five-year pilot program under which the Secretary of Health and Human Services awards grants to 10 states with high rates of uninsured individuals and diabetes (including newly diagnosed cases) to provide affordable insulin—defined as not more than $35 out-of-pocket per one-month supply—to uninsured individuals, who are U.S. citizens or qualified aliens lacking coverage under federal health care programs, FEHB, group health plans, or premium tax credits. Grant funds may be used (1) to assist insulin purchases or dispensing through federally qualified health centers (FQHCs) and retail community pharmacies; (2) to enroll individuals in drug manufacturer financial or medication assistance programs; (3) to establish, maintain, or expand FQHC on-site pharmacies or enable retail pharmacies to provide low-cost insulin; or (4) for other Secretary-approved activities to help uninsured individuals obtain insulin. The Secretary must establish a grant allocation formula providing a minimum amount to each state plus additional amounts based on rates of insulin-dependent type 1 or type 2 diabetes and uninsured individuals; grantees must report annually on expenditures, activities, and individuals served; and $100 million is authorized for FY2027, to remain available until expended.
This section directs the Comptroller General of the United States to conduct a study, in consultation with patient, clinical, and provider groups and other experts, on the characteristics of uninsured individuals who use insulin (as defined in section 399V–8 of the Public Health Service Act) and to issue a report not later than two years after enactment. The study must consider, to the extent data are available, (1) states or regions with higher prevalence of such individuals, (2) potential reasons for their uninsured status, (3) demographic characteristics such as race and ethnicity, and (4) income levels.
This section directs the Secretary of Health and Human Services to award a grant to an eligible entity (i.e., a trade association, community- or consumer-focused nonprofit, or similar organization with required relationships and capabilities) to establish and maintain a resource center on manufacturer and other assistance programs for uninsured individuals seeking affordable insulin and to conduct related public education activities. The grantee must (1) distribute fair and impartial information on assistance programs and facilitate enrollment; (2) operate a public website clearinghouse with links to federally qualified health centers, retail community pharmacies (by ZIP code), and health insurance enrollment; (3) provide culturally and linguistically appropriate information; (4) maintain a 24/7 real-time hotline with voice and text support staffed by navigators or licensed health care professionals; (5) guide hospitals on sharing the website and hotline; and (6) conduct public education in collaboration with HHS, partnering with community health centers, hospitals, pharmacies, community organizations, and state/local health departments to target underserved communities. The Secretary must publicize the resource center on HHS and other federal websites, establish standards prohibiting grantee receipt of consideration from insulin manufacturers and requiring fair, accurate, impartial information, ensure compliance (with authority to withdraw the grant), collect data on outcomes such as reduced out-of-pocket costs and increased program utilization, and submit annual reports to specified congressional committees on activities, assistance program changes, and resource center usage.