Policy Archive Successful Effort

Medicare Finalizes Genetic Testing Policy

January 27, 2020 - Today, the Centers for Medicare and Medicaid Services released its final National Coverage Determination (NCD) on next-generation sequencing (NGS) for Medicare beneficiaries. The policy paves the way for national coverage of tumor/biomarker testing and multigene panel testing for hereditary cancer under specific circumstances. It also allows for local Medicare regions to establish policies for NGS-based testing for hereditary cancer mutations.

The NCD is the result of a two-year effort. In late November, numerous organizations joined us in submitting comments urging substantive changes to the policy. We met with staff from the Medicare Coverage and Analysis Group to discuss our concerns on January 16. The final policy shows that the majority of our concerns were heard.

Nationally covered services include:

Somatic/Tumor Testing - when the patient has:

• recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
• not been previously tested with the same test using NGS for the same cancer genetic content, and
• decided to seek further cancer treatment (e.g., chemotherapy).

  The diagnostic laboratory test using NGS must have:

• FDA approval or clearance as a companion in vitro diagnostic; and,
• an FDA-approved or -cleared indication for use in that patient's cancer; and,
• results provided to the treating physician for management of the patient using a report template to specify treatment options.

Multigene Testing for Hereditary Cancer - when the patient has:

• ovarian or breast cancer; and,
• a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
• a risk factor for germline (inherited) breast or ovarian cancer; and
• not been previously tested with the same germline test using NGS for the same germline genetic content.

  The diagnostic laboratory test using NGS must have all of the following:

• FDA-approval or clearance; and,
• results provided to the treating physician for management of the patient using a report template to specify treatment options.

The policy also allows the MACs to develop Local Coverage Determinations (LCDs) for NGS-based hereditary cancer testing for patients with any type of cancer who meet specified criteria. This is important because currently, there are no FDA-approved or -cleared tests for hereditary cancer (germline) gene mutations. As such, coverage will fall to the MACs.

See the "Related Resources" below for further background on this policy.

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FORCE supports genetic testing for all Medicare beneficiaries who have a known mutation in their family or meet established guidelines for hereditary cancer risk assessment. Beneficiaries without a personal history of cancer have never qualified for coverage of genetic testing under Medicare because the program is very specific about the preventive services it provides. We would like to change this.

We are spearheading federal legislation aimed at revising the Medicare statutes to allow for genetic counseling, testing, and related evidence-based preventive and risk-reducing services for individuals who meet national medical guidelines–survivors and previvors. The Reducing Hereditary Cancer Act was introduced in the House of Representatives in June 2021 and introduction in the Senate is pending. Learn more about this effort...