by Lisa Schlager
The Centers for Medicare and Medicaid Services (CMS) recently finalized a National Coverage Determination (NCD) to provide Medicare beneficiaries living with advanced cancer (defined as “recurrent, relapsed, refractory, metastatic, and advanced stage III or IV cancer”) with coverage of FDA-approved or -cleared Next Generation Sequencing (NGS) diagnostic panels. These tests, also known as companion diagnostics, examine a person’s tumor or blood to see which targeted medications may be most effective in treating their cancer.
These tests help physicians identify:
- which patients may benefit from certain targeted treatment options including certain PARP inhibitors and immunotherapies, and
- eligibility for certain clinical trials
Currently, four FDA-approved companion diagnostic tumor tests for advanced cancer patients fall under this NCD:
- FoundationOne CDx,
- FoundationFocus CDxBRCA,
- Illumina's Praxis Extended RAS Panel, and
- Thermo Fisher Scientific's Oncomine Dx Target Test
These, and any future diagnostic tests meeting the criteria outlined by CMS, are covered under the NCD. This policy relates to NGS tissue-based cancer panels as well as liquid biopsy tests that have FDA-approved or -cleared companion diagnostic indications.
Myriad’s BRACAnalysis CDx—a companion diagnostic blood test used to determine if women with advanced, recurrent ovarian cancer would benefit from Lynparza—is covered under a prior NCD. While tumor tests such as Oncotpye DX, Mammaprint, and Prolaris can help guide treatment options, they currently do not have companion diagnostic indications and fall under different Medicare NCDs.
Labs with tests that are not FDA-approved or -cleared can still seek coverage with a Local Coverage Determination (LCD) via regional Medicare Area Contractors (MACs).
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