A plain-language briefing on any bill in Congress.

Establishes the bill’s official name: the Affordable Insulin Now Act. No substantive policy effect.

New Section 2799A-11 of the PHSA

What it does: Inserts a new section into Part D of Title XXVII of the PHSA, which governs private health insurance requirements. This is the provision that directly reaches fully insured individual and group health insurance plans sold to individuals and businesses.

Core rule (subsection (a)): For plan years beginning on or after January 1, 2026, every group health plan and health insurance issuer offering group or individual coverage must:

• Cover “selected insulin products” with zero deductible — patients get insulin coverage from day one of their plan year, regardless of whether they’ve met their annual deductible.
• Cap cost-sharing (copays, coinsurance, or any other patient charge) at the lesser of:
  • $35 per 30-day supply, or
  • 25% of the negotiated price (the price the insurer actually contracted to pay for the insulin) net of all price concessions — meaning after rebates, discounts, or payments flowing back to the plan from the manufacturer or from third-party intermediaries like pharmacy benefit managers (PBMs).

Who is affected: Insurers offering fully insured health plans in the individual and small/large group markets; ultimately, the insured patients who use insulin.

Selected insulin products defined (subsection (b)): The plan or insurer must cover at least one product of each dosage form (vial, pump, inhaler) and each type (rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed), when available. The plan or insurer gets to select which specific product in each category to cover at the capped price — not every insulin on the market is automatically subject to the $35 cap, only the ones the plan designates.

⚠️ Notable fine print: This “selection” mechanism gives insurers flexibility. A plan could select a generic or biosimilar insulin in each category, and only that selected product would be capped. A patient whose doctor prescribes a brand-name insulin not selected by the plan could still face higher costs for that specific product. This is a significant narrowing of the bill’s reach.

Insulin defined (subsection (b)(2)): “Insulin” means biologics licensed under Section 351(a) or 351(k) of the PHSA — meaning FDA-approved insulin products, including biosimilar insulins deemed to be licensed under the Biologics Price Competition and Innovation Act of 2009. This covers virtually all commercially available insulin in the U.S.

Out-of-network exception (subsection (c)): If a patient goes to an out-of-network pharmacy, the plan is not required to apply the $35 cap, and may charge higher cost-sharing. Plans with provider networks may treat out-of-network insulin differently.

Rule of construction (subsection (d)):The bill explicitly does not require a plan to cover insulin products that are not selected insulin products, and does not prevent a plan from charging more than $35 for non-selected insulins. This reinforces the “selection” narrowing noted above.

Application toward deductibles and out-of-pocket maximums (subsection (e)): Any cost-sharing a patient pays for insulin under the cap — even though insulin is now deductible-exempt — still counts toward the patient’s annual deductible and annual out-of-pocket maximum. This prevents a scenario where patients are financially penalized in other parts of their coverage because their insulin payments don’t accumulate toward their yearly limits.

New Section 9826 of the IRC

What it does: Adds a parallel provision to Chapter 100, Subchapter B of the IRC. This portion of the tax code governs the health plan requirements applicable to self-insured employer plans — plans where a large employer pays medical claims directly rather than buying insurance from an insurer.

Why this is necessary: Self-insured employer plans (used by roughly 60% of covered workers, typically at large companies) are not regulated by state insurance law or the PHSA in the same way as fully insured plans. They are primarily governed by ERISA and, for certain purposes, the IRC. Without this IRC amendment, self-insured employer plans might escape the cap.

Substantive content:Identical in all material respects to the PHSA provision — the same $35 or 25%-of-net-price cap, the same deductible exemption, the same “selected insulin products” framework, the same out-of-network carve-out, and the same rule that insulin cost-sharing still counts toward annual deductibles and OOP maximums.

Effective date: Plan years beginning on or after January 1, 2026.

A clerical amendment updates the IRC’s table of sections to list the new Section 9826.

New Section 726 of ERISA

What it does:Adds a parallel provision to Subpart B, Part 7 of ERISA’s Title I, which directly governs employer-sponsored group health plans and their benefit requirements.

Why this is necessary: ERISA is the primary federal statute regulating employer benefit plans. A requirement in ERISA is directly enforceable against plan sponsors (employers) by the Department of Labor.

Substantive content: Again, materially identical to the PHSA and IRC provisions — same cap formula, same deductible exemption, same selected-product framework, same out-of-network exception, same cost-sharing credit rule.

Effective date: Plan years beginning on or after January 1, 2026.

A clerical amendment updates ERISA’s table of contents to add Section 726.

Technical note on the three-statute approach: The bill amends all three statutes because that is the standard architectural approach for private insurance mandates since the ACA. The “three-legged stool” of PHSA + IRC + ERISA is necessary to achieve comprehensive coverage of the private insurance market. Any federal insurance mandate that omits one of these three statutes leaves a regulatory gap.

Amendment to Section 1302(d)(2) of the ACA

What it does:Adds a “special rule” to the ACA’s actuarial value (AV) calculation framework. Under the ACA, plans sold on the exchanges must meet minimum actuarial values — “metal tiers” like Bronze (60% AV), Silver (70%), Gold (80%), and Platinum (90%). When a plan is required to cover something without a deductible, that coverage technically increases the actuarial value of the plan, which could push it into a higher metal tier and create compliance complications.

Plain language:The bill says: when calculating how generous a plan is under ACA metal-tier rules, the insulin deductible waiver should be ignored. It shouldn’t count as extra plan generosity for actuarial value purposes.

Who is affected: ACA marketplace plans and the insurers that sell them; by extension, consumers whose premiums are affected by actuarial value calculations.

Why it matters:Without this fix, requiring plans to cover insulin before the deductible could inadvertently push a Bronze plan’s actuarial value above 60%, forcing it to reclassify as Silver, change its premium structure, and potentially disrupt premium subsidy calculations for consumers. This is a technical but important backstop provision.

Amendment to Section 1302(e) of the ACA

What it does:Catastrophic health plans under the ACA are a special category of low-premium, high-deductible plans available to people under 30 or those who qualify for hardship exemptions. Under current law, catastrophic plans are only required to cover three primary care visits per year and preventive services before the deductible is met; virtually everything else, including insulin, is subject to the very high catastrophic deductible (equivalent to the ACA’s annual out-of-pocket maximum — $9,450 for an individual in 2024).

New rule: The bill adds a new paragraph (4) to Section 1302(e) of the ACA requiring that catastrophic plans also cover selected insulin products — subject to the same $35/25%-of-net-price cap — before the deductible is met, as an exception to the general catastrophic plan structure.

Who is affected: People under 30 or with hardship exemptions who have chosen catastrophic plans, typically younger or lower-income individuals who chose the lowest-premium option and may also have diabetes.

Why it matters: Without this provision, a young person with Type 1 diabetes on a catastrophic plan — perhaps the cheapest option available to them — would still have no pre-deductible insulin coverage under the bill. This carve-in closes that specific gap.

Medicare: The Inflation Reduction Act (IRA), signed August 2022 and effective January 1, 2023, capped insulin out-of-pocket costs at $35 per month per covered insulin for Medicare Part D enrollees. A parallel cap on insulin administered through durable medical equipment under Medicare Part B took effect July 1, 2023. This covers approximately 3.3 million Medicare beneficiaries who use insulin. HHS data from ASPE (2023) found these beneficiaries saved an average of $500 annually.

Private insurance — federal level:There is currently no federal cap on out-of-pocket costs for insulin under private insurance. Federal law does not limit how much a private insurer or employer plan can charge insulin-dependent patients. Cost-sharing for insulin is subject to whatever the plan’s deductible, copay, or coinsurance structure requires.

State level:As of the research date, approximately 33 states have enacted some form of insulin cost-sharing cap for state-regulated plans. However, state caps do not apply to self-insured employer plans because ERISA preempts state insurance regulation of those plans. Because approximately 60% of covered workers are in self-insured plans, state laws miss a large share of the privately insured market. For example, California’s $35 cap applies only to state-regulated health plans; large employers that self-insure are exempt. This is the precise gap H.R. 6255 would fill at the federal level.

Catastrophic plans: Currently, insulin is fully subject to the catastrophic plan deductible before any coverage applies.

H.R. 6255 does not appropriate any federal funds. It is a mandate — it imposes requirements on private insurance plans and employers without direct federal spending. There is no budget line, no trust fund draw, and no new federal program created.

The bill’s costs are borne privately: insurers and employers must absorb any gap between what patients currently pay and the new $35 cap. Insurers could spread these costs across premiums (i.e., modest premium increases for all enrollees), negotiate harder with manufacturers, or adjust their formularies (drug lists) to favor lower-cost insulins.

As of the research date, the Congressional Budget Office has not published a cost estimate for H.R. 6255. The bill was referred to committee but has not been marked up.

When a substantially similar version passed the House in March 2022, the CBO estimated the bill would:

• Cost the federal government approximately $13.6 billion over 10 years — primarily because the bill reduced cost-sharing for insulin in ACA marketplace plans, which increases the actuarial value of those plans and thus increases premium tax credit costs to the federal government (since subsidies are tied to plan premiums and plan generosity).
• The CBO estimated that lowering insulin cost-sharing would cause some plans’ premiums to rise slightly as insurers adjust for the mandate, and federal subsidies would rise proportionally.

Important caveat: The 2022 CBO estimate was for a different Congress, different baseline, and a slightly different legislative context. The cost estimate for H.R. 6255 could differ. No direct comparison should be made without a new score. However, the structural mechanism is the same, and the federal cost channel (premium subsidy effect) is the same.

Because the bill amends the IRC (Chapter 100, Section 9826), the Ways and Means Committee has jurisdiction over its tax provisions. There is no explicit tax increase or new tax; the IRC amendment mirrors the ERISA requirement for self-insured plans. However, changes in employer health plan costs can have downstream effects on taxable compensation and payroll taxes.

(Flagged throughout Section 3 above; consolidated here)

The bill’s most important limitation is that the $35 cap only applies to “selected insulin products” — at least one of each dosage form and type that the plan or issuer itself chooses. This means:

• An insurer could select a lower-cost biosimilar insulin in each category and cap only that product.
• A patient whose endocrinologist prescribes a specific brand-name insulin not selected by the plan — perhaps because of clinically meaningful differences in how the patient responds to it — would not benefit from the cap for that specific product.
• Plans could use the selection mechanism to steer patients toward certain insulins through formulary design.

Proponents argue the framework is modeled on the Medicare Part D approach, which has worked effectively without requiring every insulin on the market to be capped. Critics of the framework (particularly patient advocates like T1 International) have noted that not all insulins are therapeutically interchangeable for all patients, and a forced switch to a plan’s “selected” product could cause clinical harm.

The alternative $35 cap formula — “25 percent of the negotiated price net of all price concessions received by or on behalf of the plan or coverage, including price concessions received by or on behalf of third-party entities providing services to the plan or coverage, such as pharmacy benefit management services” — contains an implicit transparency requirement.

To calculate whether the 25%-of-net-price standard is lower than $35, the plan must have full visibility into all rebates and concessions PBMs have received on its behalf. PBMs — large intermediaries like Express Scripts, CVS Caremark, and OptumRx — have historically kept rebate amounts confidential. Requiring this calculation in effect requires disclosure of PBM concessions to the plan, which is a structural shift in the PBM transparency landscape even though the bill does not explicitly mandate PBM disclosure.

The bill applies to plan years beginning on or after January 1, 2026. For calendar-year plans (the most common), this means coverage beginning January 1, 2026. For non-calendar-year plans (some employer plans), the effective date could be later in 2026. There is no phase-in; the requirement is immediate for covered plan years. No sunset clause or expiration date is included — the bill’s provisions would be permanent.

The bill explicitly allows plans with provider networks to charge patients more than $35 for insulin obtained from out-of-network pharmacies. This is a standard carve-out in insurance mandate legislation, but it means patients in areas with limited in-network pharmacy access — rural areas, in particular — may not fully benefit. The bill does not define a minimum network adequacy standard for insulin access in this context.

The bill does not explicitly delegate rulemaking authority to any agency. However, because it amends the PHSA, the IRC, and ERISA, enforcement would fall to the three agencies that jointly administer the ACA’s private insurance provisions:

• Department of Health and Human Services (HHS) for PHSA provisions
• Department of the Treasury (IRS) for IRC provisions
• Department of Labor (DOL) for ERISA provisions

These agencies would almost certainly need to issue implementing regulations or sub-regulatory guidance to clarify details such as: what documentation a plan must maintain to demonstrate compliance; how to calculate “negotiated price net of all price concessions”; and how the “selection” process must be documented for patients.

ERISA already preempts state insurance regulation of self-insured employer plans. By adding the insulin cap requirement to ERISA, the bill creates a federal floor — self-insured plans must meet the federal requirement. States may impose requirements on fully insured plans that are more generous (lower than $35), but states cannot impose less than the federal floor. The bill does not explicitly address preemption of state-level insulin caps for fully insured plans, but the general rule is that more protective state laws survive ACA-era federal minimums.

The bill does not amend or alter the Medicare insulin cap established by the IRA. The Medicare $35 cap for Part D and Part B insulin remains unchanged.

The bill applies only to people covered by private health insurance. Americans who are uninsured — a population that includes some insulin-dependent diabetics — receive no benefit from this bill.

What the bill says it does: Cap out-of-pocket insulin costs for privately insured Americans at $35 per month.

What some analysts argue it actually does: The bill allows plans to satisfy the requirement by designating a single low-cost insulin in each category, which may not be the product a given patient uses or needs. Patients on non-selected products would not benefit from the cap. Patient advocacy organizations — including T1 International — have argued in prior Congresses that not all insulins work the same for all patients, that physicians and patients make specific choices based on glycemic control, and that a formulary-based cap could create clinical and economic pressure to switch products that might harm specific patients even if the average patient is unaffected.

The counterargument:Supporters, including the American Diabetes Association (ADA), note that the “at least one of each type and form” standard is similar to how Medicare Part D works, and that requiring every insulin to be capped regardless of price would remove all incentive for price competition or use of biosimilars — which are already dramatically cheaper than brand-name insulins.

What the bill says: Caps patient cost-sharing for insulin, saving patients money at the pharmacy counter.

What analysts project: When cost-sharing is lowered for a specific service, the insurance risk pool absorbs the difference, and insurers typically recoup it through modest premium increases spread across all enrollees. For the ACA marketplace specifically, this can increase actuarial values and cause federal premium subsidies to rise (a dynamic reflected in the prior CBO score). Employers with self-insured plans would simply see a higher per-employee health cost for diabetic employees. In other words: the bill transfers some costs from insulin-using patients to all premium-paying enrollees and (in ACA plans) to federal taxpayers. Supporters argue this is the appropriate purpose of insurance — spreading health risks across a broad pool — while critics argue it is a cross-subsidy that raises costs for healthy enrollees.

What the bill says: Caps patient out-of-pocket costs.

What it does not do:The bill does not regulate what manufacturers charge for insulin — only what patients pay out-of-pocket. If manufacturers raise list prices knowing insurers will absorb the gap, the overall cost to the health system could rise even as individual patient costs fall. The Senate companion bill (INSULIN Act, S. 4189) takes a somewhat different approach that also addresses the net price formula more explicitly. Advocates like T1 International and the organization Yes! Magazine have noted that the IRA’s Medicare cap similarly does not control list prices, and that real reform requires addressing insulin pricing at the manufacturer level — something H.R. 6255 does not do.

The bill does not specify penalties for non-compliance, enforcement mechanisms, or the process for patients to seek relief if a plan violates the cap. Under current law, PHSA violations by insurers can result in HHS enforcement actions and civil money penalties, ERISA violations can result in DOL enforcement and participant suits, and IRC violations can result in IRS excise taxes. Whether these existing mechanisms are adequate to deter non-compliance — particularly for large self-insured plans with sophisticated legal teams — is an open question not resolved by the bill.

American Diabetes Association (ADA)

The ADA, which represents 37 million Americans with diabetes and 7.7 million who rely on insulin, has endorsed the bill through its Vice President for Federal Advocacy, Catherine Ferguson, who stated: “By capping what privately insured Americans pay out-of-pocket for insulin, the Affordable Insulin Now Act will ensure that the 7.7 million Americans relying on insulin have access to this life-saving medication.” The ADA has been active in state-level advocacy as well, supporting the 33 state insulin cap laws already enacted.

Protect Our Care

The liberal health care advocacy group Protect Our Care endorsed the bill, stating that: “diabetics not on Medicare still face exorbitant bills for their insulin, leading many to risk their lives by rationing the vital medication. The Affordable Insulin Now Act will cap out-of-pocket costs for privately insured Americans at $35 or 25% of the selected insulin product’s negotiated price.”

Rep. Lucy McBath (D-GA-06)

Rep. McBath, who co-sponsored the original IRA insulin cap for Medicare, framed the 119th Congress bill as completing unfinished work: extending a proven and popular policy from Medicare to the broader privately insured population.

Core supporting argument:Insulin rationing — patients taking less than their prescribed dose because they can’t afford the full amount — is a documented, life-threatening phenomenon in the United States. Unlike in virtually every other high-income country, U.S. insulin prices are not regulated, and out-of-pocket costs can reach several hundred dollars per month per product. The $35 Medicare cap has been popular, uncontroversial in practice, and has generated no documented negative effects on insulin availability. Extending it to private insurance is a logical and incremental step that protects the same patients across different insurance categories.

Bipartisan Senate support context: The existence of the INSULIN Act of 2026 (S. 4189) — co-sponsored by both Democrats (Warnock, Shaheen) and Republicans (Kennedy, Collins) — demonstrates that insulin cost-capping has some bipartisan appeal, even though H.R. 6255 in the House has only Democratic sponsors.

Pharmaceutical Manufacturers

Insulin manufacturers — principally Eli Lilly, Novo Nordisk, and Sanofi, which together control approximately 90% of the U.S. insulin market — have not publicly endorsed this legislation. All three companies have voluntarily reduced insulin list prices in recent years (Eli Lilly to $35/vial in 2023; Novo Nordisk and Sanofi also announced caps) under pressure from Congress, state legislatures, and public opinion. Industry opposition has historically centered on arguments that:

• Mandatory government price controls undermine R&D investment in next-generation insulins and other biologics.
• List prices are often not what patients pay — PBM and insurer rebate systems complicate the relationship between list price and patient cost.
• Voluntary manufacturer programs already provide affordable insulin to most low-income uninsured patients who ask for it.

Industry lobbying context: The three major insulin manufacturers and PhRMA (the pharmaceutical industry trade association) have spent hundreds of millions of dollars lobbying Congress over the past decade. Pharmaceutical lobbying expenditures have consistently ranked among the highest of any industry.

Free-Market Policy Critics

Organizations like the Heritage Foundation and Cato Institute have opposed insulin price caps on the grounds that:

• Price caps distort pharmaceutical markets and could reduce future investment in diabetes therapies.
• The federal government mandating private contract terms (what an insurer can charge a patient) is an overreach into private economic arrangements.
• The better solution is removing regulatory barriers to insulin market entry (e.g., streamlining biosimilar approvals) to increase competition and drive prices down naturally.

Insurance Industry

America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association have generally preferred voluntary approaches and have raised concerns that cost-sharing mandates for specific drugs set a precedent for unlimited federal mandates on private plans. They argue the costs will be passed to consumers through higher premiums.

Fiscal Conservatives

The prior CBO estimate of approximately $13.6 billion in federal costs over 10 years (for the 117th Congress version) provides a basis for fiscal conservative opposition to the bill, particularly because the costs flow through increased premium subsidies for ACA marketplace plans — an increase in federal entitlement spending.