February 2019: Myriad's Comments on CMS Issue re NCD and Germline Testing

Myriad recent investor call

February 6, 2019

https://seekingalpha.com/article/4238451-myriad-genetics-inc-mygn-ceo-mark-capone-q2-2019-results-earnings-call-transcript

Doug Schenkel

Okay. And another recent controversy is CMS seemingly moving to apply the NGS NCD the germline test, such as myRisk. Clearly, there's a lot of debate in the community, meaning the clinical community about the appropriateness of this change, but the final outcome definitely remains unclear as we sit here today.

So for Myriad specifically, recognizing those questions whether the supplies to you given that you use CE sequencing for at least a part of myRisk that remains even more unclear. So can you just provide us with your view, how your treating this development in guidance and comment on whether or not any commercial payers have indicated that they are contemplating following on (inaudible)?

Mark Capone

Yes. So let's start with the commercial payer part first. I think it's -- I appreciate the question because there's been some confusion. I want to be very clear. There is 0 chance, and I mean, absolute ZERO chance, that commercial payers would in any way preclude early-stage breast cancer patients from getting hereditary cancer testing. First of all, remember hereditary cancer is already in the -- BRCA testing is in the USPSTF requirements.

It must be offered to patients that no patient out-of-pocket cost. It has been in NCCN Guidelines regardless of cancer stage for a decade or more. And so there is no chance that commercial payers would in any way try to remove that benefit from patients. That's just not going to happen. Now from a Medicare perspective, as you know, the industry as a whole was quite surprised by these.

Obviously, you're well aware Doug, the NCD as originally approved -- was approved, it was really viewed as a somatic tumor test, whereas the germline tests were all done on an LCD at a local contractor basis. So the fact that you took what was to everybody in the industry a somatic test and merged that into the germline test that's where we end up today with next-generation sequencing only applying for patients that are late stage for breast cancer.

Obviously, that's under significant discussion from the entire industry. To your point, what is true though is that Sanger sequencing can still be used for all stage breast cancer patients that meet Medicare eligibility. That's early-stage, that's late stage. And as you also mentioned, we, of course, have Sanger sequencing capability. BRACAnalysis is the only FDA-approved product from the FDA and it is based on Sanger sequencing and BART technology.

So for us, none of this has changed what we've been doing. We continue to do what we always have been. And there was no change from a Myriad perspective. There will be no change from a commercial perspective, but we, along with the rest of the industry, are very actively engaged in making sure the confusion from the merger of the LCD and the NCD gets resolved.