UPDATE JUNE 1, 2020
At least one of the erroneous documents from CMS has been deleted since my post on May 18.
My original May 18 blog is preserved below.
Summary: CMS has a national coverage determination controlling FDA-authorized cancer tests using Next Gen technology.
They've added some tests to the public, officially-covered test list - some of which I understand, and some of which I don't.
Two years ago, in March 2018, CMS finalized a new National Coverage Determination policy on the topic of NGS testing in patients with cancer, especially advanced cancer. The NCD authorized automatic, nationally-endorsed coverage for patients with "advanced cancer" (such as metastatic or relapsed), if the NGS test was FDA cleared or approved, if it was a "companion diagnostic," and if it had an indication matching the patient's need.
See the text of this NCD, NCD 90.2, here.
By a separate publication to the public and its MAC contractors, CMS quickly authorized (1) the Foundation Medicine test in all solid cancers and (2) the Thermo Fisher Oncomine Dx-Target test in lung cancer.
This made sense since both are approved for at least several genes as "companion diagnostics" (see FDA CDx web page here).
The Thermo test is approved for lung cancer patients; the Foundation Medicine test is approved for several genes/cancers, and cleared, more broadly, to assist physicians by tumor gene profiling in all solid cancers.
In a recent transmittal, document CR11655, February 21, 2020, CMS has added NGS companion diagnostic test Illumina Praxis RAS (0111U). This is easy; it's an FDA approved companion diagnostic test for colon cancer RAS family genes. The coverage is effective on the same date as its PLA code, which was October 1, 2019.
However, CMS has also added two other tests that puzzle me.
In CR11655, also added the much older code 0048U for the MSK IMPACT test. MSK IMPACT is a large FDA cleared gene panel test that is not a companion diagnostic. The coverage isn't related to the recent germline-focused revision of the NCD, since the coverage now in February 2020 is retroactive to July 2018. So I'm stumped. IMPACT does look at both tumor and normal tissue DNA, so it might be covered as a 510(k) test under the recently revised NCD, for germline testing, but that germline-based coverage would seem to start with the germline revision date, January 27, 2020, not July 2018.
IMPACT is payable under the NCD, now, for ICD10 codes in lung cancer or colon cancer (see code 0048U in the CMS NCD coding spreadsheet inside a CMS zip file: here).
In another document, CR11749, released May 1, 2020 and effective October 2020, CMS adds the test, Lab for Personalized Medicine (LPM), MyMRD NGS Panel for AML, myelodysplastic syndrome, 23 genes. It's code 0171U. I don't think I have found that this test is either FDA cleared or approved (I may be missing something). If it's not an FDA approved test, and it's under the national coverage part of the NCD, I'm stumped. Coverage for 0171U is effective April 1, 2020. Note - Invivoscribe does have a PCR-based single gene test, LeukoStrat CDx FLT3 (PMA P160040B). The CMS coverage seemed to be for the NGS 23 Gene Panel 0171U which isn't the same as their FDA PCR single gene test. (Again, I may be missing something.)
If anybody knows the solution, I'm all ears.
As far as I can tell, the Myriad MyChoice CDx test (for BRCA and other genes, NGS based, yielding genomic instability scores) could be added to NCD 90.2, since it's NGS test for advanced cancer, and it is an FDA approved companion diagnostic.
Find CR11655 (February 21, 2020) here.
Find CR11497 (May 1, 2020) here.
Find both in one zip file in the cloud here.
There was an August 2018 news article that MSK IMPACT was going to seek FDA CDx status, but I haven't read that it happened.