CMS Finalizes Coverage of Next Generation Sequencing Tests, Ensuring Enhanced Access for Cancer Patients
The
This decision was made following the parallel review with the
"We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways," said
In addition to covering the
"These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial," said
This NCD recognizes the importance of analytical and clinical validation of the diagnostic laboratory test that is part of
After reviewing all the public comments for this specific determination, we have removed coverage with evidence development in this final NCD. Many commenters reported that they are already developing or have developed the evidence to demonstrate these diagnostic laboratory tests using NGS to improve health outcomes for Medicare beneficiaries with cancer - or are equipped to conduct their own studies to generate evidence that use of the test guides management and treatment, and improves health outcomes for the Medicare population. We strongly encourage continuing and publishing the results of these important studies, especially on the endpoints of overall survival, progression free survival, objective response, and patient reported outcomes relevant to the quality of life for Medicare beneficiaries. This is not only important to ensuring that patients, caregivers and their providers can make informed decisions, but also to continue to develop and publish results to develop new technologies in the healthcare system.
For more information:
CMS: Medicare Coverage Center (https://www.cms.gov/Center/Special-Topic/Medicare-Coverage-Center.html)
CMS: National Coverage Analyses (NCAs) Alphabetical Index (https://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx)
CMS: Public Comments (https://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx)
CMS: Coverage with
The CMS, an agency within the
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