On February 2, 2022, the NGS MAC released a proposed update of its broad molecular services LCD, L35000. Here.
First, the updates are narrow and involve a few codes for cytogenetics. However, I noticed a few other aspects of the LCD.
Odd "Issue Description"
First, LCDs online at CMS are now required to post an ISSUE DESCRIPTION for each new LCD or revision. However, for L35000, NGS MAC has simply filled this box in by using some old cut and paste boilerplate tht "LCDs address circumstances under which an item may be reasonable and necessary." Surely CMS intended this mandatory box "Issue Description" to orient the reader to the new LCD, not merely to fill with unchanging boilerplate that LCDs define covered services.
Request Letter Posted
Second, the request came from Mayo Clinic in October 2022, so the lag to the draft update was just 3 1/2 months. (I've seen other requests lag a year or more).
Third, the request letter is posted online, it's brief at two pages, but readers can reference it for style and content.
Process
In the "Proposed Process Information / Synopsis of Changes" NGS MAC notes that IGH and TP53 genes will be covered, and that this matches to NCCN guidance.
In a "Document Note," NGS MAC notes that only IGH and TP53 gene coverage in CLL is open for comment.
LCD Structure is Unusual
The LCD has a lengthy section with typically one-sentence coverage statements, and an even longer section of non covered genes, the latter showing the gene name only and no remarks.
Although the LCD deals with a very large numbers of genes, the required "Summary of Evidence" and "Analysis of Evidence" sections are very brief and only deal tersely with a couple topics.
LCD Has Major Errors
The LCD has a section that even 5-50 gene panels are not covered in cancer (except 5-50 genes in lung cancer.) The LCD then refers to LCD L36376.
However, L36376 was deleted four years ago (2019). In fact, they have coverage for 5-50 gene and also 51+ gene panels in their LCD L37810.
I submitted a comment that this section of LCD L3500 was out of date, out of sync, and confusing.
Pharmacogenetics
Readers may note that the coverage here for PGx cods (CYP2C6 etc) is exceedingly narrow, far narrower than PGx LCDs at MolDx and Novitas/FCSO MACs.
