Lung Cancer Medicare Access to Precise Testing Act
- Bill Number
- H.R. 6321
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-11-28: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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
- 2025-12-16T09:05:46Z
AI-Generated Summary
Purpose
The legislation, titled the "Lung Cancer Medicare Access to Precise Testing Act" (H.R. 6321), aims to expand Medicare coverage to include biomarker testing for lung cancer patients. This testing helps identify specific biological markers (such as genes or proteins) that can guide personalized treatment options, improving early detection and targeted therapies.
Key Provisions
- Coverage Requirement: Amends Section 1861 of the Social Security Act to add lung cancer biomarker testing as a covered service under Medicare Part B (outpatient services). The testing applies to individuals diagnosed with lung cancer and involves analyzing tissue, blood, or other bodily fluids to detect biomarkers.
- Effective Date: Coverage begins for tests furnished on or after January 1, 2027.
- Payment Structure: Amends Section 1833 of the Social Security Act to require Medicare to pay 100% of the reasonable charges for these tests, meaning no deductibles or coinsurance (out-of-pocket costs) for beneficiaries.
- Definition: Explicitly defines "lung cancer biomarker testing" as any test identifying one or more specific biomarkers in lung cancer patients.
Significant Changes to Existing Law
- Previously, Medicare covered some diagnostic tests for cancer, but lung cancer biomarker testing was not explicitly mandated or defined as a covered benefit. This bill adds it as a new subparagraph (KK) under covered services and introduces a dedicated definition in a new subsection (nnn).
- It eliminates cost-sharing for these tests, which may not have been fully covered before, ensuring full reimbursement at 100% of reasonable costs under a new payment clause (II).
Potential Impacts
- On Citizens: Improves access to advanced diagnostic tools for Medicare beneficiaries (primarily those 65 and older or with disabilities) diagnosed with lung cancer, potentially leading to earlier, more effective treatments and better health outcomes without financial barriers.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to implement new coverage rules, process claims, and update payment systems, which could increase administrative workload and federal healthcare spending.
- On International Relations: No direct impact, as this is a domestic Medicare policy focused on U.S. healthcare.
Main Stakeholders Affected
- Medicare Beneficiaries with Lung Cancer: Gain no-cost access to biomarker testing, benefiting an estimated hundreds of thousands of older adults annually diagnosed with the disease.
- Healthcare Providers and Laboratories: Can bill Medicare directly for these tests, encouraging wider adoption of precision medicine techniques.
- Government and Taxpayers: CMS and the federal government face higher expenditures (biomarker tests can cost hundreds to thousands of dollars each), potentially straining the Medicare trust fund.
- Pharmaceutical and Biotech Companies: May see increased demand for targeted therapies based on test results.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens Medicare's role in covering evidence-based, innovative diagnostics under Title XVIII of the Social Security Act, aligning with broader trends in precision medicine without altering core eligibility rules.
- Constitutional: No apparent challenges; it falls within Congress's authority to regulate interstate commerce and social welfare programs like Medicare.
- Political: Could appeal to bipartisan support for cancer research and senior healthcare (introduced by representatives from both parties), but may spark debates over expanding entitlements amid concerns about rising Medicare costs and budget deficits. It sets a precedent for mandating coverage of emerging tests, potentially influencing future health policy expansions.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Gottheimer, Josh [D-NJ-5]
Cosponsors (2)
Rep. Kiggans, Jennifer A. [R-VA-2], Rep. Swalwell, Eric [D-CA-14]
Recent Actions
- 2025-11-28: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
- 2025-11-28: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
- 2025-11-28: Introduced in House
- 2025-11-28: Introduced in House
Bill Versions
- Lung Cancer Medicare Access to Precise Testing Act — issued 2025-11-28 — PDF (3 pages)