Access to Innovative Treatments Act of 2026
- Sponsor
- Rep. Barragán, Nanette Diaz [D-CA-44]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jun 24, 2026
Bottom line
This bill aims to increase patient access to newly approved drugs and biologicals under Medicare by creating a transparent and timely review process for coverage denials or limitations and preventing the use of outdated coverage policies.
What it actually does
This bill amends the Social Security Act to establish a formal and time-bound review process for adverse national coverage determinations (NCDs) regarding drug and biological coverage under Medicare. It mandates a public comment period and a final decision by the Secretary of Health and Human Services within specific timelines, and prohibits the application of pre-existing NCDs to newly approved drugs if such application would be inconsistent with their FDA approval or licensure. It also extends this non-reliance principle to Medicare Part D plans.
Proponents argue
Proponents argue that the current Medicare coverage determination process can be slow and opaque, hindering patient access to innovative treatments, especially for new drugs that have already undergone rigorous FDA approval. This bill would ensure timely reconsideration of adverse coverage decisions, align Medicare coverage more closely with FDA approvals, and provide greater transparency and public input, ultimately benefiting patients who need access to cutting-edge therapies.
Opponents contend
Opponents might argue that accelerating the review process and limiting the application of existing NCDs could potentially lead to coverage of drugs without sufficient real-world evidence of effectiveness or cost-effectiveness for the Medicare population. This could increase Medicare spending without clear patient benefit and place an undue administrative burden on the Secretary to conduct rapid, comprehensive reviews within strict timelines.
The bill is concise and relatively easy to read, allowing for a quick understanding of its core provisions within a short timeframe.
Section 2(a), amending Section 1862(l) of the Social Security Act by inserting new paragraph (5).
Mandated Review Process for Adverse National Coverage Determinations
This provision requires the Secretary of Health and Human Services to initiate a review of an adverse national coverage determination (NCD) for a drug or biological within 90 days of receiving a request. An adverse NCD is defined as one that denies or limits coverage of an FDA-approved or licensed drug in a way inconsistent with its approval. The review includes a 30-day public comment period, followed by a final decision within 120 days of the comment period's conclusion.
Supporters argue
Supporters argue this ensures that Medicare coverage decisions are responsive to scientific advancements and patient needs, preventing unnecessary delays in access to treatments that have already been deemed safe and effective by the FDA.
Critics contend
Critics might express concern that the mandated timelines could pressure the Secretary to make decisions without adequate time for thorough review of clinical evidence, potentially leading to premature coverage of costly drugs without sufficient value assessment.
Tradeoffs
This provision balances the desire for rapid patient access to new treatments with the need for thorough, evidence-based coverage determinations and fiscal responsibility within the Medicare program.
Section 2(a), amending Section 1862(l)(5)(B) and (C).
Enhanced Transparency and Public Input in NCD Reviews
This provision mandates a 30-day public comment period during the review of an adverse NCD. The Secretary's final decision must include summaries of public comments received and responses to such comments. Furthermore, if the final decision differs from the recommendations of the Medicare Coverage Advisory Committee, the clinical evidence and other data used in making the decision must be made publicly available.
Section 2(a), amending Section 1862(l)(5)(D).
Two-Year Moratorium on Repeated Reviews
This provision prevents a new review of a specified national coverage determination if the Secretary has already made a final decision on a previous review of that same determination within the preceding two-year period. However, it explicitly states that this limitation does not restrict the Secretary's existing authority to review or reconsider an NCD if deemed appropriate.
Section 2(a), amending Section 1862(l) by inserting new paragraph (6).
Prohibition on Applying Old NCDs to Newly Approved Drugs
This provision prohibits the Secretary from applying a national coverage determination that was made *prior* to the approval or licensure of a new drug or biological if that application would result in denying or limiting coverage under Medicare in a manner inconsistent with the drug's FDA approval or licensure. This ensures new drugs are evaluated based on their specific, current approvals.
Section 2(b), amending Section 1860D-2(e)(3) of the Social Security Act.
Clarification for Part D Plans Regarding Specified NCDs
This provision clarifies that prescription drug plans (Part D) and MA-PD plans cannot use a 'specified national coverage determination' (as defined in the bill, meaning an adverse NCD for an FDA-approved drug) as a basis to deny or limit coverage for a covered Part D drug. This ensures consistency with the new review process and prohibitions established for Medicare Parts A and B.