Access to Innovative Treatments Act of 2026
- Bill Number
- H.R. 9418
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-06-24: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-07-09T10:53:45Z
AI-Generated Summary
Purpose This legislation amends the Social Security Act to create a structured review process for certain Medicare national coverage decisions on drugs and biological products. Its goal is to ensure that coverage determinations align with FDA approvals rather than automatically applying older restrictions.
Key Provisions
- Establishes a mandatory review timeline for specified national coverage determinations (NCDs) that deny or limit coverage for FDA-approved drugs or biologicals in ways inconsistent with that approval.
- Requires the Secretary of Health and Human Services to begin a review within 90 days of a request, followed by a 30-day public comment period.
- Mandates a final decision within 120 days after the comment period, including summaries of comments, responses, and public release of supporting evidence when the decision differs from advisory committee recommendations.
- Prohibits applying pre-existing NCDs to newly approved drugs if doing so would conflict with the FDA approval.
- Limits requests for successive reviews of the same NCD to once every two years, while preserving the Secretary’s general authority to reconsider determinations.
- Updates Medicare Part D rules so that prescription drug plans cannot base coverage denials on these specified NCDs.
Significant Changes to Existing Law The bill adds new paragraphs to Section 1862(l) of the Social Security Act, creating an expedited review mechanism that did not previously exist for adverse drug-related NCDs. It also modifies Section 1860D-2(e)(3) to prevent Part D plans from relying on these NCDs when determining coverage.
Potential Impacts
- On government agencies: The Centers for Medicare & Medicaid Services would face new administrative requirements for timely reviews and public comment processes.
- On citizens: Medicare beneficiaries could gain faster access to newly approved treatments if coverage restrictions are reversed or modified.
- On international relations: No direct effects are outlined in the legislation.
Main Stakeholders Affected
- Medicare beneficiaries seeking coverage for new drugs.
- Pharmaceutical and biotechnology manufacturers.
- Medicare Advantage and prescription drug plans.
- The Centers for Medicare & Medicaid Services and its advisory committees.
Notable Legal, Constitutional, or Political Implications The bill introduces a formal, time-bound review pathway that balances executive discretion in Medicare coverage with structured public input and transparency requirements. It does not alter constitutional authority over Medicare but shifts how certain coverage decisions are made and revisited.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Barragán, Nanette Diaz [D-CA-44]
Cosponsors (1)
Recent Actions
- 2026-06-24: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-06-24: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-06-24: Introduced in House
- 2026-06-24: Introduced in House
Bill Versions
- Access to Innovative Treatments Act of 2026 — issued 2026-06-24 — PDF (5 pages)