What changed between these versions
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.
Overview
The changes between v1 and v2 are extensive, constituting a complete substitute amendment. · Overall, v2 narrows the scope of some provisions and delays the implementation of others, while removing key transparency and competition measures present in v1.
v2 is a complete substitute amendment, fundamentally altering the scope and mechanisms of the bill. Most notably, v2 entirely removes the title focused on Pharmacy Benefit Manager (PBM) transparency and the full pass-through of insulin rebates, a core component of v1. It also delays the effective date for insulin cost-sharing caps by one year and significantly tightens the criteria for expediting biosimilar competition. While retaining programs for uninsured individuals, v2 modifies the definition of "uninsured individual" for these programs and removes a study on insulin competition.
Major additions
This new rule of construction specifies that the cost-sharing requirements shall not permit a group health plan or health insurance issuer to pay any amount in excess of the specified cost-sharing to an entity providing pharmaceutical benefit management services, a provider, or a pharmaceutical manufacturer with respect to the provision of selected insulin products.
This addition aims to prevent plans from circumventing the cost-sharing caps by overpaying other entities, potentially ensuring that the intended cost savings are passed on to patients. It introduces a new financial restriction on plans and their partners.
This new subsection, titled 'Application of Patient Protections,' states that the provisions of this title shall apply to selected insulin product benefits as though such benefits were required to be provided under section 2707(a) of the Public Health Service Act.
This addition clarifies that the patient protections outlined in the broader title of the Public Health Service Act, such as those related to coverage and non-discrimination, will apply to the newly mandated insulin coverage. This ensures comprehensive patient safeguards for the capped insulin products.
Deletions
v1 included a 'Sense of Congress' statement that Congress should enact subsequent legislation to offset any Federal Government costs resulting from the Act.
The deletion removes a non-binding but explicit legislative intent to address the fiscal impact of the bill through future offsets. This changes the stated legislative priorities or concerns regarding the bill's cost implications.
v1 included an entire title dedicated to 'Pharmacy Benefit Manager Transparency and Rebate Reform.' This title mandated that PBMs, third-party administrators, and health insurance issuers remit 100 percent of all rebates, fees, alternative discounts, and other remuneration received from pharmaceutical manufacturers related to insulin utilization, back to the group health plan. It also required timely remittance, full disclosure, and audit availability.
The deletion of this entire title removes a core operative mechanism aimed at increasing transparency in the insulin supply chain and ensuring that financial concessions from manufacturers directly benefit health plans. This significantly alters the bill's approach to reducing insulin costs by removing a direct regulatory control over PBM practices and rebate flows, potentially allowing PBMs to retain more of these concessions.
v1 included specific amendments to ERISA (Section 732(a)) and the Internal Revenue Code (Sections 9831(a) and 4980D(d)(1)) to ensure the application of cost-sharing requirements to retiree and certain small group plans.
The deletion of these specific amendments means that the explicit statutory language ensuring the application of insulin cost-sharing requirements to retiree and small group plans is removed. While v2 includes general conforming amendments, the direct and detailed application to these specific plan types is no longer present, potentially creating ambiguity or altering the scope of coverage for these groups.
v1 required the Secretary to establish procedures for referring to the Federal Trade Commission any citizen petition or supplement determined to have been submitted with the primary purpose of delaying approval of a drug application, including notification to the petitioner.
The deletion removes a mechanism intended to deter the use of citizen petitions for anti-competitive delays in drug approval. This could reduce accountability for petitioners who submit such delay-focused petitions, potentially impacting the timely market entry of generic and biosimilar drugs.
v1 specified a list of actions the Secretary 'may' take to expedite the development and review of competitive biosimilar therapies, including holding meetings with sponsors, providing timely advice, involving senior managers, and assigning a cross-disciplinary project lead.
The deletion removes the explicit enumeration of specific actions the Secretary could take to expedite biosimilar development. While the general authority to expedite remains, the removal of these detailed directives might reduce the clarity or emphasis on these particular facilitative measures, potentially affecting the efficiency of the expedited review process.
v1 mandated expedited reinspection of biosimilar manufacturing facilities if an applicant attested to necessary remediations after an inspection report found approval dependent on such remediation.
The deletion removes a specific requirement for expedited reinspection of facilities. This could lead to longer delays in the approval process for biosimilar products if facilities require re-inspection, potentially slowing market entry.
v1 required the holder of a biosimilar license, for which development and review were expedited, to report to the Secretary within one year of licensure on whether the product had been marketed in interstate commerce.
The deletion removes a reporting requirement designed to track whether expedited biosimilar products actually reach the market. This reduces oversight on the effectiveness of expedited review in promoting market availability and competition.
v1 mandated the Secretary of Health and Human Services, in collaboration with CMS and FDA, to complete a study and submit a report to Congress within one year on delays in getting insulin products to market, market dynamics, and barriers to biosimilar competition and patient/provider education.
The deletion removes a requirement for a comprehensive federal study and report on insulin market competition and barriers. This eliminates a planned effort to gather data and recommend policy solutions to increase insulin affordability and competition, potentially leaving policymakers without a dedicated analysis on these issues.
Modifications
Individuals covered by group health plans or individual health insurance will wait an additional year (until January 1, 2028) for the $35 insulin cost-sharing cap to take effect, meaning they may continue to face higher out-of-pocket costs for insulin during 2027.
Before
v1 required group health plans and health insurance issuers to provide coverage of selected insulin products with specified cost-sharing limits for plan years beginning on or after January 1, 2027.
After
v2 requires group health plans and health insurance issuers to provide coverage of selected insulin products with specified cost-sharing limits for plan years beginning on or after January 1, 2028.
This clarification ensures that certain insulin products that transitioned from drug to biologic status under the Biologics Price Competition and Innovation Act of 2009 are unequivocally covered by the cost-sharing requirements, potentially broadening the range of products subject to the capped price for patients.
Before
v1 defined 'insulin' as insulin licensed under subsection (a) or (k) of section 351 and continuing to be marketed pursuant to such licensure.
After
v2 defines 'insulin' as insulin licensed under subsection (a) or (k) of section 351, including insulin deemed to be licensed under section 351 pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, and continuing to be marketed pursuant to such licensure.
This modification ensures that health plans must cover a broader range of insulin delivery mechanisms, not just dosage forms, at the capped cost. This could increase patient choice and access to their preferred or medically necessary insulin delivery methods, such as specific types of pens or inhalers.
Before
v1 defined 'selected insulin products' to include at least one of each dosage form (such as vial, pen, or inhaler dosage forms) of each different type of insulin.
After
v2 defines 'selected insulin products' to include at least one of each dosage form and delivery device (such as vial, pen, inhaler dosage forms, or such other delivery devices approved by the Secretary) of each different type of insulin.
This shift from specific statutory language to a general reference may alter the precise legal application or interpretation of the insulin cost-sharing requirements for various plan types, including retiree and small group plans, compared to the explicit provisions in v1. The specific application to retiree and small group plans from v1 Sec 102 is no longer explicitly detailed.
Before
v1 included specific, detailed amendments to ERISA (Section 727) and the Internal Revenue Code (Section 9827) to replicate the cost-sharing requirements for group health plans, and further amendments in Section 102 to apply these to retiree and certain small group plans.
After
v2 replaces these specific amendments with general conforming amendments to ERISA (Section 715(a)(1)) and the Internal Revenue Code (Section 9815(a)(1)), inserting 'and the INSULIN Act of 2026' after 'Affordable Care Act'.
This delays the ability of federal agencies (HHS, Labor, Treasury) to issue guidance for the new cost-sharing requirements, aligning with the delayed effective date of the core policy. This means stakeholders will have to wait longer for official interpretive guidance.
Before
v1 allowed for implementation of its provisions by subregulatory guidance for plan years beginning on or after January 1, 2027, and ending not later than January 1, 2030.
After
v2 allows for implementation of its provisions by subregulatory guidance for plan years that begin on or after January 1, 2028, and end not later than January 1, 2030.
This change provides petitioners with a significantly longer timeframe to submit challenges to drug applications and removes a standard that could have compelled earlier submission. This could potentially allow more time for strategic delays in the approval of generic and biosimilar drugs, impacting their timely market entry.
Before
v1 required citizen petitions and supplements to be submitted 'within 60 days after the person knew, or reasonably should have known, the information that forms the basis of the request'.
After
v2 requires citizen petitions and supplements to be submitted 'within 180 days after the person knew the information that forms the basis of the request'.
Fewer biosimilar products will qualify for expedited development and review because they must now meet an additional criterion: a 3-year waiting period after all exclusivity periods have expired. This could slow the entry of new biosimilar competition into the market, potentially delaying access to lower-cost alternatives for patients.
Before
v1 defined 'inadequate biosimilar competition' as fewer than 3 licensed biosimilar biological products on the list published under paragraph (9)(A).
After
v2 defines 'inadequate biosimilar competition' as fewer than 3 licensed biosimilar biological products on the list published under paragraph (9)(A) AND not less than 3 years have passed since the expiration of all exclusivity periods applicable to the reference product or a biosimilar biological product.
Individuals who are eligible for premium assistance tax credits but are not enrolled in health insurance coverage could now qualify as 'uninsured' for the affordable insulin pilot program. This potentially expands the reach of the program to more low-income individuals who may struggle to afford insulin despite being eligible for tax credits.
Before
v1 defined 'uninsured individual' for the pilot program as someone who does not qualify for certain federal/employer coverage AND is not entitled to a premium assistance tax credit under section 36B of the Internal Revenue Code of 1986.
After
v2 defines 'uninsured individual' for the pilot program as someone who does not qualify for certain federal/employer coverage, removing the exclusion for those entitled to a premium assistance tax credit.
Similar to the pilot program, this change means more individuals could be considered 'uninsured' and thus eligible for assistance and information from the resource center. This could increase access to affordable insulin for those who are eligible for tax credits but remain uninsured.
Before
v1 defined 'uninsured individual' for the insulin resource center as someone who does not qualify for certain federal/employer coverage AND is not entitled to a premium assistance tax credit under section 36B of the Internal Revenue Code of 1986.
After
v2 defines 'uninsured individual' for the insulin resource center as someone who is not enrolled in certain federal/employer coverage, removing the exclusion for those entitled to a premium assistance tax credit.
Scope
Complete substitute — Changes are scattered throughout the bill, affecting provisions related to commercial market cost-sharing, generic and biosimilar competition, and programs for uninsured individuals. — v2 represents a meaningful change in policy direction, particularly by removing the PBM transparency and rebate pass-through requirements, delaying cost-sharing caps, and narrowing the criteria for expedited biosimilar competition. — The changes to definitions (e.g., 'uninsured individual') and the general conforming amendments interact with and modify the application of other provisions within the bill and potentially existing federal health care laws.
Impact analysis
Individuals with diabetes covered by commercial health insurance
Negative, as access to capped insulin prices is postponed.
The effective date for the $35 insulin cost-sharing cap is delayed by one year.
Group health plans and health insurance issuers
Mixed; delayed implementation is beneficial, but broader product scope and payment restriction could increase administrative complexity or reduce flexibility.
Required to implement cost-sharing caps a year later, and the definition of 'selected insulin products' now explicitly includes delivery devices. A new rule of construction prevents excess payments to PBMs/providers/manufacturers.
Pharmacy Benefit Managers (PBMs) and other third-party entities involved in insulin pricing
Positive, as a major transparency and rebate pass-through obligation is eliminated, potentially allowing PBMs to retain more of these concessions.
The requirement to remit 100% of insulin rebates, fees, and discounts to group health plans is removed.
Generic drug manufacturers and applicants for generic drug approval
Negative, as the extended petition window and removal of FTC referral could facilitate longer delays in generic drug approvals.
The timeline for citizen petition submission is extended from 60 days (with 'reasonably should have known') to 180 days (after 'knew'). The referral to FTC for delaying petitions is removed.
Biosimilar biological product manufacturers and applicants
Negative, as fewer biosimilar products will qualify for expedited review, potentially slowing market entry and competition.
Criteria for 'inadequate biosimilar competition' (for expedited review) are narrowed by requiring a 3-year wait after exclusivity periods. Specific expedited review actions, expedited reinspection, and reporting requirements are removed.
Uninsured individuals who use insulin and are eligible for premium assistance tax credits
Positive, as they become eligible for assistance programs from which they were previously excluded.
These individuals are now included in the definition of 'uninsured individual' for the affordable insulin pilot program and resource center.
Federal Government agencies (HHS, CMS, FDA)
Procedural change, removing a reporting obligation.
No longer required to conduct a study and report on insulin competition.