Thursday, August 18, 2022

MolDx Coverage of Psychiatric Pharmacogenetics: What's Up?

In 2020, MolDx brought out a groundbreaking new LCD for Pharmacogenetics, which tied coverage to CPIC and FDA recommendations, updating coverage in sync with the updates to those coverage resources.   (This summer, 2022, Novitas has offered a draft LCD that would tie or sync its cancer genomic coverage to external resources like NCCN.)

Find the current version of the LCD L38335 here, and the current billing article A57384 here.

While the body of the LCD focuses on gene:drug pairs endorsed by CPIC and FDA.  However, the billing article also has a section called "Multi Drug Panels."  These list 5 tests that are covered EITHER for (a) depression, (b) other psych disorders, or (c) both.   

The current table of coverage for psych gene panels reads like this:

What about pricing?   Go to the DEX online database (email registration required) and you can look up each test and the price MolDx assigns it.  Genesight pegs in at $1568 currently. 

But Wait, There's More

Oddity #1
If you track Genesight, you'll find two entries in the DEX database.  The first entry for Genesight is entitled Genesight Psychotropic, and it describes the Genesight test in detail, but has a flag, "Not Covered" under DEX.    The next entry after that is Genesight Psychotropic Multi Gene, which is stated as "covered" for $1568.   I believe that MolDx current management philosophy viewed the "single test" for Genesight as not covered (hence the term: Not Covered), but if the test is defined differently as a multi-gene test, with reporting criteria that match those required by the LCD, then it IS covered.

GeneSight Coding is Changing

Last year, AMA CPT introduced a new coding for 6 or more PGx genes, a code which CMS is pricing this summer and which will be effective 1/1/2022.   Right now, the expert panel recommendation is to gapfill the test, although crosswalk alternatives are available.  Most priced PLA codes for PGX gene panels have been a lot more than 6 genes.   

Myriad now has a PLA code for its Genesight test, and as of now, recommendations are to crosswalk it to an existing PGX gene panel of about the same size, priced around $1300.  It's code 0345U, effective October 1 (CMS price to be effective January 1).  The crosswalk proposal is to 0175U, Genomind PGX Express, which is also 15 genes, like Genesight.  0175U is $1336.