On March 16, 2018, Centers for Medicare & Medicaid Services (CMS) took action to advance innovative personalized medicine for Medicare patients with cancer. CMS announced their final National Coverage Determination of Next Generation Sequencing tests, ensuring enhanced access for cancer patients.
CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer). CMS believes when these tests are used as a companion diagnostic to identify patients with certain genetic mutations that may benefit from U.S. Food and Drug Administration (FDA)-approved treatments, these tests can assist patients and their oncologists in making more informed treatment decisions. Additionally, when a known cancer mutation cannot be matched to a treatment then results from the diagnostic lab test using NGS can help determine a patient’s candidacy for cancer clinical trials.
This decision was made following the parallel review with the FDA, which granted its approval of the FoundationOne CDx (F1CDx™) test on Nov. 30, 2017. At the same time, CMS issued a proposed NCD for NGS cancer diagnostics. F1CDx™ is the first breakthrough-designated, NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies as well as can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.
In addition to covering the FDA-approved F1CDx™, CMS is covering FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options.
“These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” said Kate Goodrich, M.D., CMS chief medical officer and director of the Center for Clinical Standards and Quality (CCSQ). “The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”
This NCD recognizes the importance of analytical and clinical validation of the diagnostic laboratory test that is part of FDA approval or clearance and provides national coverage after demonstration that use of the diagnostic laboratory test guides the management and treatment of the patient improves health outcomes. Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met. Coverage determinations for other diagnostic laboratory tests using NGS for Medicare patients with advanced cancer will be made by local Medicare Administrative Contractors. In addition, after considering all public comments, this final decision expanded coverage to patients with relapsed, refractory or stage III cancers. The final decision also extends coverage to repeat testing when the patient has a new primary diagnosis of cancer.
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