Free to Breathe

Comment Period for Medicare Approval of NGS Testing Extended to 1/17/18

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.

cms.gov/medicare-coverage-d...

7 Replies
oldestnewest

Wonderful information, Anita! It needs to be covered any time (and as often as needed) during treatment as far as I am concerned. Thank you for the link!

1 like
Reply

This is very important people and I’d like to thank Anita for the reminder.

Knowing that Cancer mutates each time it gets around your latest treatment you should have the genetics tested whenever there’s progression. We’re learning which treatments will or will not work with specific chemos and knowing this can save patients from having treatments that won’t work. Saving money and unnecessary side effects.

At Anita’s request I’ve commented. Please join us.

2 likes
Reply

I am diagnosed with stage 4 NSC adenoma carcinoma lung cancer. I live with the possibility of this cancer spreading further in my body. If it does, Medicare covered comprehensive genetic testing should be available to help provide the best treatment possible. I believe the testing done in 2013 was not comprehensive enough to provide information that I may need in the future and thus retesting would be greatly needed. Cancer treatments by themselves are a financial burden. Don’t take away any life-saving options just because we cannot afford it.

1 like
Reply

This proposal would result in an expansion of access to comprehensive testing because once approved by Medicare, private insurance will follow and will also pay for this testing.

3 likes
Reply

Anita, thank you for bringing this to our attention. The more information we have about our individual cancers, the better are the chances of effective treatment. So much has been discovered since my diagnosis in 2015. Knowing that these sneaky cancer cells mutate, this testing should be covered at all stages, not just once since each mutation responds to a different treatment.

I hope you are responding well to your current treatment.

Jean

2 likes
Reply

Jean, I've been feeling better and am reengaging with my advocacy work. It's a whole week before my next chemo, too. Maybe chemo is pushing it all back - I find out in a few weeks.

I'm also knittIng a super complicated cabled cowl, and loving it. Good sign?

Anita

2 likes
Reply

So happy to hear you are knitting something challenging. You sound good. The eyedrop tyranny following cataract surgery is almost over. See the doc next week. Fortunately I caught the flu after the surgeries. Even though I missed the holidays with the family, the surgeries were done on time. Also was able to use the down time to complete some knitting projects for the church group. Long distance vision much improved, but need reading glasses for close work.

My primary doc put me on something called low dose Naltrexone last month. It might help slow my lung tumor. It is working for him, so here's hoping. Will know more next month when I have the next scan. Scanxiety here I come. I'm sure my oncologist, who is very traditional in his approach is shaking his head.

Hope you continue to feel better and improve on this treatment.

Jean

1 like
Reply

You may also like...