CMS to Cover NGS Companion Diagnostics

The Centers for Medicare & Medicaid Services (CMS) announced in March that it will pay for next-generation sequencing (NGS)–based companion diagnostics for its beneficiaries with advanced cancer.

“Before this decision, coverage policies varied greatly among local Medicare contractors,” says Marc Ladanyi, MD, chief of the Molecular Diagnostics Service at Memorial Sloan Kettering Cancer Center in New York, NY. “For example, our local contractor only covered NGS testing in non–small cell lung cancer, some contractors did not cover NGS testing at all, and others offered more robust coverage.”

The decision was issued after a parallel review with the FDA of the NGS-based FoundationOne CDx (F1CDx) test, which serves as a companion diagnostic to identify patients eligible for 15 targeted therapies and can detect genetic mutations in 324 genes. In November 2017, the FDA approved the F1CDx test on the same day that CMS issued its proposed NGS coverage decision for public comment. The final CMS decision covers any NGS-based test for advanced cancer nationally, as long as it is approved or cleared by the FDA as a companion diagnostic. Coverage of all other NGS-based tests is left to the discretion of local contractors.

“These tests will help patients and their physicians make more informed decisions regarding cancer treatment,” says a CMS spokesperson. “We also believe this testing could better identify patients who may seek to participate in cancer clinical trials.”

Although this decision will increase patients' access to NGS diagnostics, Ladanyi believes it is too restrictive. He cites the example of the NGS-based MSK-IMPACT test, developed at his institution. Because it has FDA clearance as a tumor-profiling test, its use will not be covered by the CMS decision, even though “it provides the same tumor genomic information as a companion diagnostic test.” He is also concerned that the CMS decision “may have the unintended consequence of encouraging the use of dated, single-gene, non–NGS-based assays already covered at a national level by CMS, even though they provide less information and, when performed in aggregate, can cost more than a single multigene NGS-based panel assay.”

In addition, Eliezer Van Allen, MD, of Dana-Farber Cancer Institute in Boston, MA, says the decision would have greater impact if CMS required data to be collected on NGS testing to improve care for future patients. That way, “when a test is ordered, the entity that offers it would deposit the genomic data and clinical outcomes—like whether an action was taken based on the test, and what the result was for the patient—in a registry accessible to qualified individuals, such as researchers, clinicians, or hospital systems,” he explains. Absent such data sharing, “taxpayer money is funding the creation of a new series of data silos that will not benefit the entire cancer community.”

It remains unclear whether private insurers will follow CMS's lead in covering NGS-based testing. “These payers could still argue that there is no prospective study on the blanket testing approach, although CMS instituting coverage certainly could shift the conversation,” says Van Allen. –Kristin Harper

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