To amend title XVIII of the Social Security Act to require coverage of lung cancer biomarker testing under the Medicare program.

HR 6321 — Summary

Overview

HR 6321 is a bill introduced in the U.S. House of Representatives on November 28, 2025. Its central aim is to expand Medicare coverage by requiring coverage of lung cancer biomarker testing under the Medicare program (Title XVIII of the Social Security Act). The bill has been introduced and referred to the House committees with jurisdiction over Medicare policy.

What the bill would do

• Require Medicare to cover biomarker testing used to guide treatment decisions for lung cancer.
• Amend Title XVIII of the Social Security Act to implement this coverage requirement within the Medicare program.

Key provisions (highlights)

• Legislative change: Adds a mandatory coverage requirement for lung cancer biomarker testing under Medicare.
• Coverage scope: Applies to biomarker testing relevant to determining appropriate lung cancer treatment, ensuring access for Medicare beneficiaries undergoing diagnostic and treatment planning.
• Administration: The bill specifies referral to committees with jurisdiction (Energy and Commerce; Ways and Means) for consideration of provisions within their remit. The duration of committee action is described as “a period to be subsequently determined by the Speaker.”

Note: The text of the bill is not provided here, so specific definitions (e.g., what constitutes “lung cancer biomarker testing”), implementation timelines, cost considerations, and any waivers or exclusions are not detailed in the available information.

Who would be affected

• Medicare beneficiaries diagnosed with lung cancer, who would gain coverage for biomarker testing used to guide their treatment.
• Healthcare providers, laboratories, and facilities that perform lung cancer biomarker tests, as Medicare would require coverage for these tests.
• Medicare program administrators and payers, who would implement and monitor coverage compliance.

Legislative status and timeline

• Introduced: November 28, 2025.
• Status: Introduced in the House.
• Legislative actions: Referred on November 28, 2025 to the Committee on Energy and Commerce and to the Committee on Ways and Means, for consideration of provisions within their jurisdiction. The referral includes a note that the period for consideration is “for a period to be subsequently determined by the Speaker.”

Potential impact and considerations

• Access and equity: Could reduce out-of-pocket costs and financial barriers to biomarker testing for lung cancer patients enrolled in Medicare.
• Clinical implications: May facilitate more personalized treatment decisions by ensuring coverage for testing that informs therapy choices.
• Fiscal impact: No dollar amounts are specified; the broader fiscal implications would depend on the coverage scope, testing utilization, and negotiated rates under Medicare.
• Implementation: Would require CMS rulemaking and coordination with clinicians and laboratories to define covered tests, billing, and documentation standards.

Next steps

• If advanced and enacted, the bill would need passage by both chambers of Congress and signature by the President to become law.
• Ongoing updates would likely include committee markup, potential amendments, and detailed coverage criteria.

If you’d like, I can tailor this summary to emphasize particular aspects (clinical impact, budget implications, or implementation steps) or compare it to existing Medicare policies on diagnostic testing.