An update to tumor testing coverage for Medicare patients

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination that covers diagnostic lab tests that use next-generation sequencing (NGS) technology in patients with advanced cancer (molecular profiling).

What counts as “advanced cancer”, you might ask?

Initially, this testing was limited to stage IV cancer or recurrent cancer. Following public comments, this has been updated, and the advanced cancer definition now includes relapsed, metastatic, or initial stage III diagnoses in addition to those above.

This is a huge step in the right direction to help Medicare patients gain access to personalized cancer treatment that could greatly improve quality and duration of life.

One of the greatest benefits to doing molecular profiling is that it can help identify FDA-approved targeted therapies that are beneficial if specific genetic variants are present in cancer. In the event that an FDA-approved therapy isn’t available, genetic testing for cancer can also help to place patients in clinical trials. Either way, these are great options for patients with cancer particularly if other treatments have failed to work, or have stopped working when they once did.

This coverage report makes it possible for Medicare patients to receive Foundation Medicine’s FDA approved companion diagnostic tumor profiling test, FoundationOne CDx (F1CDx). This approval was initiated last November. Now, CMS is also covering other FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer. Non-FDA-approved tests may also be covered, but those decisions are made by local Medicare Administrative Contractors, not CMS.

Overall, this finalized coverage has both widened the types of cancer patients that can benefit from tumor testing AND allowed for a more broad range of tests for those patients, provided local administrators approve other tests. Making genetic testing for cancer treatment more accessible in the Medicare population moves us further along in making precision medicine an option for everyone, so at MyOncoPath, we’re delighted to see these types of updates!

Suggested links for more detail


  • NEW! Want to know more about MyOncoPath and how we can help? Schedule a FREE 15-minute call with one of our genetic counselors.
  • To learn more about personalized medicine for oncology or for any other general genetics-related questions, schedule a 30-minute appointment with a genetic counselor at MyOncoPath
  • If you’ve been diagnosed with cancer and want to discuss your specific diagnosis and whether cancer genetic testing is right for you, schedule a full consult with us.
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