Thursday, December 16, 2021

Novitas Finalizes Cardio Genetics LCD I Warned About; No Genes Covered

 In mid-August, I published an alarmed blog about a newly proposed cardiovascular LCD from Novitas (and First Coast) MACs.   My concern was that the LCD simply proposed generalistic comments about what cardio genes might or might not be covered (with no specifics).   In addition, the LCD provided rules for medical review that could be applied arbitrarily in such a way that virtually no medical record would support any testing.  See my blog here.

The final LCD has been released, with essentially zero changes despite extensive comments.  (L39084).  Moreover, the LCD remains generalistic - you could word search and replace "cardiovascular" with any other disease area and the rules could be applied.   

But when you get to the billing and coding article, A58797 (here), there's the real surprise.  It consists of nothing but a list of cardiovascular related genes (and the list of all Tier 2 genes) and a summary statement that nothing is covered.  The ICD-10 section is concise: "Due to non coverage, there are no ICD 10 codes that support medical necessity."

In case it's not clear, my issue was and is, that the LCD body is that it contains generalistic coverage rules, and one medical director might write an article that covers 20 or 30 genes per those rules, and the next medical director might cover "zero" of them per exactly the same generalistic rules.   You can't tell until you open the billing and coding article, which isn't subject to public comment and can be revised at any moment at the whim of the current medical director.  (See similarly high level and generalistic rules for covering germline testing in MolDx DL38966, blog here).

I've put the whole set of draft and final versions, public comments, and billing article in a cloud zip file here.

The Novitas and First Coast MACs were ground zero for massive genetics Medicare fraud in recent years, according to allegations from Department of Justice.  Much of those hundreds of millions of dollars flowed out freely under uncontrolled (and unwatched?) use of Tier 2 codes.  As I've pointed out, payments for 81408 - very rare full sequence genes - went from almost 0 in 2017 to the highest paid Medicare code in 2019 and almost the highest in 2020 (crazy !!!!!).   They put out a highly atypically written genetics billing and coding article this fall related to that effort, here.  

Frankly Bizarre Reasoning and Misuse of Citations

Below, click to enlarge and see one example of Q&A along the path to the noncoverage LCD. I am stunned and unable to draw any line at all between the actual 2020 Musunuru AHA guidance article cited (here) and the Novitas flat noncoverage billing article that was created.   To me this is a gross example of mis-citation without any associated mental reasoning.   It's like citing an article that the moon rotates around the earth to justify a conclusion that the moon doesn't exist.

click to enlarge