The original NCD, released in March 2018, was criticized for being liable to ambiguity but potentially adverse to NGS testing in Stage 1/Stage 2 cancer patients or those who require repeat testing. This criticism accelerated after some restrictive additional interpretative statements released by CMS in November 2018. CMS held a comment period in May 2019, and received uniformly negative comments (here).
- The tracking sheet for the NCD revision is here.
- The revised NCD, for new cycle of public comment, is here.
- I've put a PDF version in the cloud, here.
Comments are during on Thanksgiving, Thursday, November 28, so many stakeholders may want to view Friday November 22 as an effective corporate pseudo-deadline. The final NCD is due about 60 days from November 28, e.g. January 28.
Coverage at Genomeweb here.
What Happened in Brief
Warning - these are my first-pass interpretations; it could be that other readers will find textual ambiguities or problems I haven't noticed.
NCD Coverage. Previously, CMS nationally guaranteed coverage for NGS testing for NGS tests approved as CDx, if the patient had advanced cancer (metastatic, stage 3/4, etc). For example, the FMI F1 CDx test was covered per its FDA labeling in such patients.
>>> Now, CMS also proposes to nationally guarantee coverage for FDA approved or cleared tests (NOT necessarily CDx) in patients with ovarian or breast cancer, indications for germline testing, risk factors for inherited cancer. Such patients have no stage restrictions like Stage 3/4.
In short, the areas of the NCD which nationally guarantee coverage pivot on being an FDA CDx test, and now it adds coverage for FDA tests that are not CDx for any indicated genes (per FDA) in breast and ovarian cancer.
LCD Flexibility. Previously, CMS gave MACs discretion to cover non-FDA-approved (LDT) NGS tests, or FDA tests off-label, as long as it was ONLY for one test and ONLY in advanced cancer patients.
>>> Now, CMS will let MACs allow coverage for NGS testing with LDT tests in patients with diagnoses other than breast and ovarian cancer (e.g. colon cancer), as long as they have inherited cancer risk factors and not prior tested with NGS. There are no stage restrictions.
# # #
- HBOC patients get only FDA tests that don't exist. Breast and ovarian cancer patients can only get germline (inherited) testing for FDA cleared or approved tesst. The only ones are for BRCA, and in fact, the Myriad germline BRCA test is not NGS (it's Sanger) and the Foundation BRCA test and Myriad MyChoice BRCA test are NGS but are somatic tumor tests. Oops.
- The standard of care is almost certainly more than BRCA gene testing alone, it's panel testing, while only BRCA has FDA approvals (albeit defective ones relative to the NCD, as just stated).
- Myriad CEO Marc Capone also remarked that the NCD text here was very important and that the NCD points to FDA tests that don't exist, in a November 4 investor call (here).
- Still a one test per patient rule. Only one test per patient, so not obviously helpful yet to recurrent disease detection.
- Glitch re types and classes of testing. The new passages about germline testing preclude any prior NGS method testing, but, for example, you might have to use one somatic FDA test for genes like EGFR and KRAS, and a different germline FDA test for BRCA. The NCD doesn't seem to contemplate this problem. For sure, there isn't any one FDA test today that covers both somatic CDx mutations and germline management mutations. The NCD would cover both, as long as you don't do more than one. Oops.
- The new parts of the NCD allow germline testing as long as "patient has not had a prior NGS test." Really? Any prior NGS test? FDA has approved an NGS HIV test - if you've had that, it's a prior NGS test, so you can't have BRCA testing? Here.
CMS distinguishes breast and ovarian cancer patients because they found the best germline literature in these groups. Throughout the NCD, they are cautious to refer only to published NGS literature for outcomes, which is a little daffy, since a particular mutation sequenced by Sanger or by NGS gives the same outcomes.
There's also still a barrier to technology modernization that I dislike. Many women with breast cancer get the Oncotype Dx or similar tests, which aren't NGS so they aren't under this NCD. But if they were migrated to NGS platforms (and Mammaprint had been able to do this), they would be under the NCD but in very limiting or counterproductive ways.
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The prior NCD covered certain tests, if that test hadn't been used in that patient before. The new language covers certain germline testing, if the patient hasn't recent [any] NGS test before. This is confusing. Although it's now rare, someday, a patient might have e.g. NGS microbiology testing, which would be "a prior NGS test." Who would track that? Obviously an unintended issue. Or a patient might have an NGS epilepsy panel as a child, but need NGS testing for cancer as an adult. The NCD doesn't seem to contemplate that, since it blocks testing if the patient had "a prior NGS test." This will hopefully be fixed in the final revision.