Ensuring Access to Lower-Cost Medicines for Seniors Act
- Sponsor
- Sen. Lankford, James [R-OK]
- Committees
- Finance Committee (primary)
- Last action
- Apr 16, 2026
Bottom line
The bill aims to reduce out-of-pocket prescription drug costs for Medicare beneficiaries by mandating formulary inclusion and favorable cost-sharing for generic and biosimilar medications.
What it actually does
This bill mandates that Medicare Part D prescription drug plans and Medicare Advantage plans offering drug coverage (MA-PD plans) must include lower-cost generic drugs and biosimilar biological products on their formularies if a higher-cost reference drug or biological product is already included. It also requires these plans to establish specific cost-sharing tiers for these lower-cost alternatives, ensuring significantly reduced copayments or coinsurance compared to branded drugs, and prohibits more restrictive access limits on generics and biosimilars.
Proponents argue
Proponents argue this bill will significantly lower prescription drug costs for seniors, increase competition in the pharmaceutical market, and improve access to affordable medications by removing barriers like restrictive utilization management and high cost-sharing for generics and biosimilars. They emphasize the importance of leveraging lower-cost alternatives to make healthcare more affordable and accessible for Medicare beneficiaries.
Opponents contend
Opponents might argue that mandating formulary inclusion and specific tiering could limit plan flexibility, potentially disrupt existing negotiated discounts with manufacturers, and lead to unintended consequences for plan design or overall program costs if plans are forced to include less cost-effective options or lose negotiating leverage. Some might also raise concerns about the administrative burden on PDP sponsors and the potential for higher premiums.
The bill is concise and its core provisions are clearly stated, making it accessible for a quick but informed review.
Section 2(a), new 1860D-4(b)(3)(J)(i)
Mandatory Formulary Inclusion for Lower-Cost Generics and Biosimilars
Starting January 1, 2028, if a Medicare Part D plan's formulary includes a brand-name reference drug, it must also include all available generic versions of that drug if their wholesale acquisition cost (WAC) is lower. Similarly, if a formulary includes a reference biological product, it must include at least one biosimilar biological product with a lower WAC, if one or more such products are available.
Supporters argue
Supporters argue this ensures beneficiaries have access to more affordable alternatives, driving down out-of-pocket costs and encouraging competition in the pharmaceutical market.
Critics contend
Critics might argue this could interfere with plans' ability to negotiate the best prices or manage their formularies efficiently, potentially leading to higher overall costs if plans are forced to include less preferred options.
Tradeoffs
This provision balances beneficiary access and potential cost savings against plan flexibility in formulary management and potential impacts on existing rebate structures.
Section 2(a), new 1860D-4(b)(3)(J)(iii)
Prohibition on Restrictive Access Limits for Generics and Biosimilars
Part D plans cannot impose more restrictive access limits, such as prior authorization, utilization management, or step therapy, on generic drugs or biosimilar biological products required to be on the formulary than they impose on their higher-cost reference drugs or biological products. This also prohibits giving preferred status to the reference drug or biological product.
Section 2(a), new 1860D-4(b)(3)(K)(i)
Dedicated Lower-Cost Tier for Generics and Biosimilars
Beginning January 1, 2028, if a Part D plan uses tiered cost-sharing, it must create at least one tier exclusively for generic drugs and biosimilar biological products. For this tier, the copayment must either be zero or at least $20 lower than the copayment for the plan's lowest branded drug tier (or actuarially expected average cost-sharing if coinsurance is used).
Section 2(a), new 1860D-4(b)(3)(K)(ii)
Specialty Tier for High-Cost Generics and Biosimilars
If a Part D plan has a 'specialty tier' for high-cost drugs, it must also create a second specialty tier specifically for high-cost generic drugs and biosimilar biological products. The coinsurance for this new specialty tier must be at least 5 percentage points lower than the coinsurance percentage applicable to any other specialty tier. This applies if the reference drug or biological product is on a higher cost-sharing tier or excluded from the formulary.
Section 2(a), new 1860D-4(b)(3)(K)(iv)(II)
No Higher Deductibles for Generics/Biosimilars
The Secretary shall not approve any Part D plan design that applies a deductible to generic drugs or biosimilar biological products unless that same deductible (or a greater one) also applies to all other covered Part D drugs on the formulary. Exceptions are allowed for lesser or zero deductibles for specific drug types if also applied to generics/biosimilars of that given type.
This subparagraph defines key terms such as 'part D biosimilar biological product,' 'part D generic drug,' 'part D reference biological product,' 'part D reference drug,' and 'wholesale acquisition cost' by referencing existing sections of the Social Security Act, Federal Food, Drug, and Cosmetic Act, and Public Health Service Act.
Section 2(a), new 1860D-4(b)(3)(J)(iv)
Why it matters:This is standard legislative practice to consolidate definitions, making the main text cleaner but requiring readers to actively seek out the precise meaning of terms by consulting external statutes.
Case for: Supporters would argue that using established definitions from existing law ensures consistency and avoids creating new regulatory interpretations, streamlining the legislative process.
Case against: Critics might point out that relying on external definitions can make the bill less self-contained and harder for a layperson to fully comprehend without consulting multiple statutes, potentially obscuring the full impact.
Estimated impact: These definitions clarify the exact scope of drugs and biological products that are affected by the new formulary inclusion and cost-sharing mandates, which is fundamental to the bill's operation.
This subparagraph directs the Secretary (of HHS) to establish uniform requirements for PDP sponsors to determine which generic drugs and biosimilar biological products meet the inclusion criteria (specifically, having a lower wholesale acquisition cost). It also outlines how formulary changes are to be implemented (quarterly determinations, prompt implementation) and specifies circumstances under which a lower wholesale acquisition cost shall be 'deemed' to exist (e.g., no published WAC for the reference drug or if the reference drug is unavailable for purchase).
Section 2(a), new 1860D-4(b)(3)(J)(ii)
Why it matters:This is standard practice to give regulatory agencies the necessary flexibility in developing the operational details of a policy, especially for complex and dynamic markets like pharmaceuticals. The 'deemed' provision addresses practical market realities that could otherwise create loopholes.
Case for: Proponents would argue that delegating these details to the Secretary allows for adaptive and practical implementation, especially given the dynamic nature of drug pricing and availability. The 'deemed' provision prevents plans from circumventing the intent of the law due to market anomalies.
Case against: Critics might express concern about the broad discretion given to the Secretary, potentially leading to regulations that could be burdensome, overly prescriptive, or deviate from congressional intent without direct legislative oversight.
Estimated impact: This provision is crucial for the practical enforcement and effectiveness of the formulary inclusion mandate, as it dictates the specific rules and timelines for compliance.