Over 60 groups sign letter to CMS administrator Seema Verma, asking to halt an "interpretation" of the 2018 CMS NCD that would now act to block germline testing in cancer patients (with stage 1,2 cancers). This is likely over half of BRCA testing, as breast cancers are usually detected before stage 3 and 4. However, I think for multiple reasons the NCD is itself clearly ambiguous or, taken as a whole, self-contradictory, and that will eventually surface. The very fact that it took nine months for this issue to arise suggests the position is hardly clear.
See the ACLA press release here.
See the Collective Sign-On Letter online at AMP, here.
For additional background:
- March 2018
- I discussed application to germline testing as a possible, but likely ill-conceived, interpretation of NCD - here.
- January 2, 2019
- I noted that MolDx LCDs on germline testing were now, after nine months, being revised to refer readers to the NCD for limits of coverage - here.
- January 22, 2019
- Genomeweb publishes an article about growing unrest in the oncology community, here. I discussed further in blog here.
- January 31, 2019
- Washington Analysis Group publishes investor article with headline, "Myriad Genetics (MYGN) & Invitae (NVTA): Medicare Germline BRCA Coverage Halted?"
- February 1, 2019
ACLA press release clipped below the break.
The crux of the matter is that, while the NCD could be squinted-at and considered ambiguous (for many reasons, read as a whole, and interpreted to avoid absurdity, I don't think it is ambiguous)...in November CMS issued a transmittal on the NCD that contains the wholly new sentence, "A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer under either national or local coverage criteria." And CMS gave this new sentence an effective date retroactive to March 2018, which raises problematic issues under the statutory voluntary repayment law (here).