Lots going at at Novitas (and First Coast) MACs, re oncology genomics. They released a draft LCD on this topic in June 2022, and a massively enlarged final version on June 2, 2023. That version was withdrawn in early July, likely because of protests that the final version was so radically different that the public had never seen or commented on it. [*]
On July 27, Novitas (and First Coast) reissued the large final LCD "as if new" - for public comment as a draft. Here.
Per the tracking sheet, comment is open til September 9, and there will be a public comment meeting on August 10 and 11 (one for Novitas, one for First Coast).[**]
The Novitas new proposal is numbered DL39365, the First Coast is DL39367. Therefore, perhaps confusingly, the numbering 39365 is the same as the proposed/finaled/suspended LCD.
What's New?
In CMS download-PDF version, the new proposal 39365 is 66 pages. Clipped into a Word document, it is 89 pages and 38481 words.
The June 2 "aborted" version, cut into my Word program, was 68 pages and 30,250 words. However, I did not include the bibliography in that version. The newest proposed bibliography is 230 citations.
Redline
I used the MS Word "document compare" function to redline the June "final" and July "re proposed" versions, and in overview, I did not notice any differences.
The LCD, from my June review, is sensible in parts but bizarrely written and atypical in other parts. It was also horrifying complex, with a billing article that was a behometh with 80 confusing sections. The LCD only briefly touches on important topics like liquid biopsy and minimal residual disease testing, while giving exhaustive review of about 13 specific branded tests, a few of which seem pretty obscure.
Rather than review that June version, they have simply reissued it for public comment again.
Novitas: Billion Dollar Fraud Payments Gushing Out as Genomics Claims
During all this, on June 23, OIG released a damning report on the billion dollars plus of OBVIOUSLY bogus claims paid out by Novitas and First Coast in the past couple years. (I've also pointed out the OBVIOUS insanity in this blog using CMS public records). Here.
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[*] While there are no rules on how much a "final" LCD can be revised and still be a valid successor to its proposed form, there is some language about this regarding CMS regulations, which must either enumerate the final proposal (among alternatives) or the final proposal must be a "logical outgrowth" of the proposal the public saw. See SSA 1871. In current OPPS rulemaking for FY2024, CMS proposes 5 possible ways to revised radiopharmeutical payment, and CMS could settle on no change, one of the 5 methods, or a 6th method that was a natural and similar variant of what was proposed. Here.
[**] Both the Novitas MAC and First Coast [Florida] MAC are under a complex multi level ownership relationship with Florida BCBS.
