Update on Medicare consideration of approving next generation sequencing testing, such as the Foundation One test, as a reimbursable medical test: the comment period has been extended to 1/17/18. If you haven’t commented yet, you still have time!
Here is more information about this particular proposal, shared with me by David Marshak, the Patient Advocacy Manager for Foundation One:
“The proposal is for Medicare to cover any tests that contain FDA-approved companion diagnostics, or that are “FDA-cleared” if the patient participates in a prospective registry.”
“According to the proposal as it’s written now, a patient would be covered the first time they have the test, but if they have the test a second time (e.g. there’s a recurrence and potentially new genomic mutations associated with treatment options), the second test would not be covered. The test can be helpful both at initial diagnosis and at later points as well. So some people have been commenting that it should be covered at any point in a patient’s treatment where the test would be needed to identify actionable treatment options.”
“The way the FoundationOne CDx test works, there are companion diagnostics across 7 genes (3 genes for NSCLC) associated with 17 targeted therapies (9 therapies for NSCLC). But in addition to those companion diagnostics, the test profiles 324 genes total (including those already mentioned) as well as biomarkers like MSI and tumor mutation burden to identify additional treatment options. So for a NSCLC patient for example, having companion diagnostics associated with NSCLC means that Medicare would cover the test, but they would be getting many more genes profiled (and a chance of finding out about more treatment options) in addition to the companion diagnostics.”
Many of us had very narrow testing on diagnosis with companion tests that only identify one mutation. For example, I was only tested for EGFR, ALK, and T790M. The proposal is to pay for a much more comprehensive test to be used when a doctor is looking to see if a patient has an oncogene driven cancer for which there is an FDA approved treatment. Not only do you get test results that may lead to an effective treatment, you also get a lot of other information as a bonus. It would be a major step forward if many more people diagnosed with NSCLC had this information at the beginning of treatment.