The Centers for Medicare & Medicaid Services (CMS) will now cover the cost of next-generation sequencing (NGS) tests for patients with cancer.
The agency has finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests using NGS and will reimburse Medicare recipients with advanced cancer.
CMS decided to issue broad coverage on NGS panels after a parallel review performed with the US Food and Drug Administration (FDA).
In December 2017, the FDA approved a cancer diagnostic test, FoundationOne CDx (F1CDx, Foundation Medicine), the first NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies and can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor. At the same time, CMS proposed reimbursement for NGS.
In addition to covering the F1CDx, CMS will also reimburse Medicare recipients for FDA-approved or cleared companion in vitro diagnostics when these diagnostics have an FDA-approved or cleared indication for use in the patient’s specific cancer and the physician uses the results for treatment, with a report template to specify treatment options.
For example, the FDA also recently authorized use of the Memorial Sloan Kettering Cancer Center's IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test, which can identify the presence of mutations in 468 unique genes.
"These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” said Kate Goodrich, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. "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."
CMS has designated that for Medicare recipients to be reimbursed, the test must be ordered by a treating physician and the patient must meet all of following criteria:
The patient has recurrent, relapsed, refractory, metastatic, or advanced (stage III or IV) cancer; and
The patient has not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and
The patient has decided to seek further cancer treatment.
The diagnostic laboratory test using NGS must also meet certain criteria; it must be FDA approved or have clearance as a companion in vitro diagnostic test. It must also be FDA approved for, or have a cleared indication for, use in that patient’s cancer, and the results must be provided to the treating physician for management of the patient using a report template to specify treatment options.
Medicare Administrative Contractors may determine whether coverage will be offered for other NGS diagnostic tests. The patient must meet the same criteria, and the test must be performed in a CLIA-certified laboratory and ordered by a treating physician.
"We applaud CMS for issuing this final National Coverage Determination that significantly expands coverage beyond the preliminary draft policy," said Troy Cox, chief executive officer at Foundation Medicine. "The final NCD will significantly improve access and coverage for Medicare beneficiaries to comprehensive genomic profiling and biomarker-driven treatments. We look forward to commercializing FoundationOne CDx by the end of March, providing the oncology community with the only FDA-approved broad assay for all solid tumors."
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Cite this: Medicare Will Cover Advanced Genetics Testing in Cancer Patients - Medscape - Mar 19, 2018.