CMS has proposed expanding Medicare coverage of advanced genetic screening tests to certain types of cancer, according to Bloomberg Law, which cites a proposed decision memo.
The proposal released Oct. 29 would nationally cover next-generation sequencing as a diagnostic laboratory test for Medicare patients with certain types of ovarian or breast cancer, CMS Administrator Seema Verma said in a series of tweets.
"Laboratory diagnostic tests using NGS can provide a genetic profile of a patient's cancer cells and may help clinicians identify the most effective course of treatment — which is why we've been actively monitoring the rapid innovation of these tests," she wrote.
For CMS to pay for an advanced genetic screening test, the test must be ordered by a treating physician, and the patient must have risk factors for germline (inherited) breast or ovarian cancer, as well as meet other requirements. The advanced genetic screening tests must also be cleared or approved by the FDA.
The decision by CMS to require FDA clearance or approval for coverage of the tests could result in more laboratories seeking FDA clearance or approval, according to Bloomberg Law.
CMS has opened a 30-day public comment period on the agency's proposed decison and will respond to public comments in a final decision.
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