PierianDX Reports that CMS Expands Coverage of Next Generation Sequencing as a Diagnostic Tool for Patients with Breast and Ovarian Cancer


Today the Centers for Medicare & Medicaid Services (CMS) took action to cover FDA approved or cleared laboratory diagnostic tests using Next Generation Sequencing (NGS) for patients with germline (inherited) ovarian or breast cancer.

Over the last several years, CMS has been actively monitoring the rapid innovation of NGS tests and the evolution of cancer diagnostic tools. NGS tests provide the most comprehensive genetic analysis of a patient’s cancer because they enable simultaneous detection of multiple types of genetic alterations. Medicare first began covering laboratory diagnostic tests using NGS in March 2018 for Medicare patients with advanced cancer that met specific criteria. As a result of today’s decision, more Medicare patients will have access to NGS in managing other types of inherited cancers to reduce mortality and improve health outcomes.

“Innovative technologies are transforming medicine, and at every turn, President Trump has shown a dogged determination to give Americans access to them,” said CMS Administrator Seema Verma “We recognize that cancer patients shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan.”

Medicare patients with inherited cancers have few treatment options available, and today’s decision expands access to NGS testing for these patients and gives them more opportunities to personalize their cancer care. Using genetic tests gives patients a more complete profile of their cancer cells and may help identify proven, targeted treatments. Patients who use NGS tests may also find they are good candidates for cancer clinical trials.

CMS recognizes that innovation is happening quickly and evidence is moving fast, and the agency wanted to ensure that patients have ready access to this diagnostic test when appropriate. Therefore, CMS is now providing Medicare’s Administrative Contractors with discretion over whether to cover certain other indications.

To read the decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=296

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