Novitas made some updates October 29, 2021, including "Clarifying 81479 text" - see most recent version here. The minimal update is shown as "Footnote".
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It's been two years since the Department of Justice announced what it alleged to be $2B in fraudulent genetic charges, almost entirely in Southern states, in September 2019. (Here). This represented the largest scheme in 50 years of Medicare (ibid), and resulted in hundreds of millions of dollars of anomalous payments, substantially shifting Medicare MoPath payments - which had been around $500M - to over $1.5B in a couple years.
I covered this topic in a five-part article series in December 2020 (entry point here). The anomalies most prominently involved explosive growth in the highest Tier 2 codes (which pay up to $2000 a pop) which were unedited and uncontrolled, especially in the Novitas, Cahaba, and FCSO MACs. That is, they were "ATM machine" codes. (When the Palmetto MAC took over the Cahaba states, and applied Palmetto edits, genetic spending there fell precipitously downward).
You could also see the anomalous pattern in CYP pharmacogenetic codes (separate blog here.) In 2018, half of national Medicare CYP payments (81225, 81226) went to Georgia alone (!!). These payments under Cahaba CYP edits (or lack of edits) fell 90% or more when these states switched over to Palmetto (or MolDx) edits. (ibid).
I've analyzed this situation across 2017, 2018, and 2019. I've been anxiously waiting for CMS to release state-level data for CY2020 payments, which should occur any week now (late October).
Meanwhile, I just learned of a new genetics coding article from the Novitas MAC that's intended to ward off the types of payments cited by DOJ when it undertook Operation Double Helix.
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Novitas' Remarkable New Article A58917: Molecular Pathology Coding and Billing
You've got to read this one. Find it here:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58917&ver=9&bc=0
It's effective November 8, 2021. The article provides history of genetics coding, under "stack codes" for gene amplfication up to 2013, and under gene-specific codes since then. However, the article asserts, in the last two years "stack coding" has exploded.
The article puts tight controls on Tier 2 genes (see my series of 5 blogs, cited at the top of this article). They write that "diseases that manifest severe signs or symptoms in newborns" or "childhood, or that result in early death" are subject to AUTOMATIC DENIALS in the Medicare population. I've been making exactly that point for over a year now, as loudly as I could. Tier 2 codes for such rare genes, like those coded under 81408, grew from being almost unknown in Medicare in 2017, to the HIGHEST PAID CODES in Medicare in CY2019. Astounding. How could genes that are officially listed as too rare to merit Category I CPT codes, be the very highest paying, most utilized of all codes in all of Medicare?
The new Novitas article also has anti-fraud phrases like stating that past payment for certain codes (because they were unaudited and unedited) in no way implies active endorsement or medical necessity of billing that code.
Why it's taken 24 months from the original DOJ announcement of Operation Double Helix, to product this article, is beyond me. It should have taken a week back in 9/2019 (maybe two weeks, for a two-fingered typist).
Novitas Also Has PGX LCD and Article in Draft Form
The Novitas MAC also has a new PGx LCD (DL39063) and article (DA58801) in draft form from last spring, which could be finalized anytime now. I haven't studied these with a magnifying glass, but they seem similar to the PGx LCDs used in MOLDX states.
Cloud Zip File
As a convenience to readers, I've put a copy of the Novitas MoPath coding article, and the PGx LCD & Article, in a public access Zip file in the cloud - here.
"Footnote"
Update of 81479 text on October 29.
