Medicare Proposes Paying for Advanced Cancer Screening Tests

The Medicare agency would pay for advanced genetic screening tests that are critical to personalized treatments known as precision medicine, under a proposal released Oct. 29.

The proposed decision memo would extend Medicare coverage of next-generation sequencing tests to certain types of ovarian and breast cancer that may be caused by hereditary factors, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said in a series of tweets.

Next-generation sequencing can screen millions of DNA changes in a single test, unlike traditional diagnostics that link one test to one disease. These powerful genomic tests are the linchpin to advancing precision medicine, an emerging approach for disease prevention and treatment that targets care based on an individual’s genes, environment, and lifestyle.

“Today’s proposal is just one of the many actions taken as part of @CMSGov’s commitment to fostering innovation and ensuring our #Medicare beneficiaries have access to the latest technologies,” Verma said in a tweet.

To be eligible for coverage, the patient must meet a set of criteria, including that the patient has ovarian or breast cancer with genetic risk risk factors.

The test must be approved or cleared by the Food and Drug administration for use in that patient’s cancer and results. The results of the diagnostic test must be provided to the treating physician for management of the patient using a report template to specify treatment options.

The move to require FDA approval as a condition of CMS coverage could drive more laboratories testing companies to ask the FDA to approve them, something the agency has sought for years.

The FDA historically has exercised enforcement discretion over diagnostic tests developed in a single laboratory but not ones made commercially by companies such as Novo Nordisk Inc. or Janssen Diagnostics, LLC.

But the agency proposed exercising new oversight in draft guidance released in 2014. The move, which the FDA withdrew in favor of legislative solution, caused a regulatory tug-of-war between the device makers who want more oversight and clinical lab groups that eschew it.

A draft bill by Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) would move diagnostics out of the medical device regulations and create a new medical product category that would cover both laboratory-developed tests and conventional diagnostics tests.