MolDx and PGx
Novitas Follows MolDx
In June 2021, the Novitas and FCSO MACs (which operate in tandem) proposed PGx coverage on generally similar terms to MolDx.
Novitas LCD Finalized
On October 28, 2021, the Novitas/FCSO PGx LCDs were finalized with minimal changes, along with final "billing & coding" articles and responses to public comments. The new policies are effective December 12.
The policies should be seen in light of the 2019 "Operation Double Helix," which found hundreds of millions of dollars of allegedly improper genetics payments, primarily in the Novitas and FCSO MACs.
In addition, the policies should be seen in light of a Novitas general genomics coverage and non coverage article released earlier in October - which I covered in a blog here. It's A58917. The Q&A document with this final LCD specifically notes that A58917 is the governing coding article.
Redline of Draft and Final LCD
I did a redline comparison of the draft and final LCDs, which showed few if any really significant changes. The basic template remains coverage under CPIC and FDA criteria on a rolling basis. New text requires the ordering physician use the tests in management and be experienced in the use of the genetics tests ordered, a requirement also found in the October general anti-fraud article I just cited (here).
The LCD authors (in the comment Q&A) make clear they prefer any LCD comments to be submitted with full-text articles, not just citation or PMID numbers. Many groups, from Mayo to CAP/AMP, submitted comments.
The billing article (39pp) includes many pages of tables copied from CPIC/FDA guidelines.
It's really, really, really fast for any MAC on any topic to propose an LCD in June and finalize by October. LCD finalization usually takes closer to a year, even longer.
I include Cloud Files in a zip file of the draft and final PGx LCD, a redline comparison document, the Q&A PDF and the final Coding and Billing PDF. Find the Zip file open access here. (For the Q&A comments, use file "Landscape.")
I've also posted current versions of all the links here.
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