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CMS Lays out Detailed Coverage Criteria for BRCA Testing in Draft LCD

NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Service has issued a draft local coverage determination (LCD) for tests analyzing BRCA genes, even when they're part of multi-gene panels for assessing risk for hereditary cancer syndromes.

The first requirement, according to the draft document, is that CMS will only cover BRCA tests that have had their technical performance assessed by Medicare contractor Palmetto GBA's MolDx program and have received a favorable decision. Then, CMS describes a long list of criteria involving a patient's age of cancer diagnosis, type of cancer, and their family history of breast, ovarian, or other cancers, to lay out the circumstances under which specific test claims will be covered.

Importantly, the coverage criteria has a section dedicated to multigene panels, which are increasingly entering the market following the 2013 Supreme Court decision in Association for Molecular Pathology et al. v. Myriad Genetics. In that case, the court invalidated a number of claims underlying Myriad's BRACAnalysis test for gauging breast and ovarian cancer risk and opened up competition in the hereditary cancer diagnostics market.

Subsequently, with sequencing costs dropping, labs such as Invitae have launched a number of next-generation sequencing panels that assess BRCA genes, as well as a number of other markers associated with hereditary cancer risk. According to the draft document, CMS will cover such panels when independent pre- and post-test counseling is provided; the genes on the panel are relevant to the personal and family history of the person being tested; BRCA testing criteria outlined by CMS are met; and the person meets professional guidelines for being tested for at least one other hereditary cancer syndrome, such as Lynch syndrome.

"Large panels with genes that are not relevant to the individual's personal and family history are not reasonable and necessary," CMS states in the document.

CMS acknowledges that targeted multi-gene panels may provide a cost-effective diagnostic strategy, but only when patients' personal and family histories necessitate testing. The agency also points out in the draft LCD that the Affordable Care Act requires private insurers to provide coverage for genetic counseling and genetic testing (when medically necessary) as a preventative service with no out-of-pocket cost.

Moreover, BRCA testing to gauge hereditary cancer risk is covered only once per lifetime, but CMS also notes that testing will be covered for ovarian cancer patients considering treatment with a PARP inhibitor. The US Food and Drug Administration last year approved AstraZeneca's Lynparza (olaparib) as an option for patients who have been heavily pretreated with chemotherapy and have germline BRCA1 or BRCA2 mutations. The agency approved Myriad's BRACAnalysis CDx alongside Lynparza as a companion test to identify women with BRCA mutations who are most likely to benefit from treatment.

"Repeat testing prior to Lynparza therapy is not reasonable and necessary and will not be covered by Medicare," CMS notes. BRCA testing is also not covered for population screening purposes or for women younger than 18 years old. 

Stakeholders can comment on the draft LCD from June 17 to Aug. 3.

This article has been updated to clarify the langauge in the draft LCD regarding BRCA retesting.