Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility

In a reversal, CMS is now proposing to cover FDA-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to assess their inherited risk for these cancers. The NGS Testing Coverage Sage Approximately 9% to 24% of women with ovarian cancer carry germline mutations in BRCA1 and BRCA2. Germline NGS testing of BRCA1/2 genes can provide information important for preventative screening and surgical interventions. The current Medicare coverage problem began last year when CMS directed Medicare Administrative Contractors (MACs) to align their genetic testing local coverage determinations (LCDs) with a National Coverage Determination (NCD) for next-generation sequencing for advanced cancer patients. At the time, the policy was thought to be restricted to NGS panels used to detect somatic mutations driving patients’ cancer and to personalize treatment. So, Palmetto GBA revised a local coverage determination for BRCA1 and BRCA2 genetic testing to restrict coverage for NGS panels when performed in individuals with early-stage disease. Labs, patient advocacy organizations and professional societies objected and contended that restricting coverage would be harmful to patients. CMS then reopened the NCD, and heard numerous comments from stakeholders. The New NCD In the new proposals, CMS proposes that the evidence is sufficient to expand coverage of Next Generation Sequencing (NGS) as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the patient has:

• Ovarian or breast cancer;
• Clinical indications for germline (inherited) testing;
• Risk factors for germline (inherited) breast or ovarian cancer; and
• Not been previously tested using NGS.

The diagnostic laboratory test using NGS must also:

• Have FDA approval or clearance;
• Be for an FDA approved or cleared indication for use in that patient’s cancer; and
• Generate results provided to the treating physician for management of the patient using a report template to specify treatment options.

Additionally, other MACS may determine coverage of other NGS as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:

• A cancer diagnosis other than breast or ovarian cancer;
• Clinical indications for germline (inherited) testing,
• Risk factors for germline (inherited) cancer other than inherited breast or ovarian cancer; and
• Not been previously tested using NGS.

What’s Next? Stakeholder comments closed at the end of November and CMS is slated to finalize the NCD on Jan. 27, 2020.