Thursday, June 11, 2020

MolDx Bombshell: New LCD for Pharmacogenetics Excludes "Combinatorial" Tests L38294

In August 2019, MolDx released a packet of new LCDs, two of which involved pharmacogenetics.  One was for gene-by-single-gene pharmacogenetics, and a second one was for "combinatorial" pharmacogenetics, e.g. panels like Genesight.  See my article here.

On May 11, 2020, Noridian deleted from consideration its version of the combinatorial draft LCD (here).  And puzzlingly, another MolDx MAC, the CGS MAC for Ohio/Kentucky, had published the proposed single gene pharmacogenetics LCD but never published the draft combinatorial one.

The Final Single LCD - Where to Find It

On June 11, 2020, Palmetto MolDx has released its final version of the two LCDs, which is to say, ONE LCD under number L38294.

Find the LCD online here.  I've also placed a cloud copy here.   The "response to comments" document A58157 is here.  For me, the PDF of the response to comments prints to 22 pages.    

The final LCD L38294 is effective July 26, 2020.  As of now, it doesn't have an attached coding article (code list) although it appears intended to govern all PGx genes through their CPT codes.

Final Coverage - Ka-Boom!

Gene-by-single-gene testing is covered consistent with nationally recognized guidelines such as "CPIC," the pharmacogenetics consortium.  This is the position for single gene or several single-gene testing proposed last August.

Regarding proprietary (combinatorial) panels like Genesight, the new LCD states:
Combinatorial PGx testing

Because these tests leverage many of the same biomarkers already discussed above and because these tests are defined by the proprietary algorithms required to associate pharmacokinetic and pharmacodynamic events, this contractor has determined that the evidentiary review of clinical validity and utility of these tests should be demonstrated beyond the capability of single gene and multi-gene panel information already evaluated and established. The algorithms themselves (or more than the sum of the FDA and CPIC Level A and B biomarker information) must establish validity and utility to have independent value to establish coverage. Based on our review of the evidence and on expert feedback submitted both during the CAC meeting and during the comment period for this policy, it’s been determined that there are insufficient data to support coverage for any combinatorial test. This conclusion was also reached by the CAC committee members and professional societies whom all agreed that the combinatorial component of panel tests have not to date demonstrated independent value
As of today, the Genesight proprietary LCD is still up and active in CGS J15, the MAC in Ohio that Myriad bills for Genesight.  L35443.  The simple expectation is that CGS MAC will publish the PGx new LCD and delete the Genesight one in coming months.   Palmetto has already marked its version of the Genesight LCD, L35443, for retirement in July 2020.*  For Medicare nerds, the combinatorial proposed LCD of August 2019 was never released for comment in Ohio, where Genesight is billed,  so Myriad may complain it's not kosher to release a "consolidated" PGx LCD in Ohio either.  

Myriad Stock Falls 20% on June 11

In morning trading, Myriad stock fell from about $15.70 to $12.50, pushing the company's market cap lower than $1B for the first time in many years.  Its five-year high was $50 in August 2018.

Myriad issued a press release on the LCD here.  Separately, Genomeweb ran a subscription article on a qui tam case at Myriad, here.  


In the Carolinas, Palmetto has already bookmarked its version of the Genesight LCD for retirement on 7/25/2020.  Link.  Pic:

Note, the relevant LCD deletion for Myriad/Assurex would be in Ohio MAC, not the Palmetto MAC.


In Ohio, under CGS MAC, where Genesight is billed, the corresponding pharmacogenomics policy DL38394 is marked "released to final May 6" on the proposed version, but CGS MAC hasn't actually released a final version (yes, very confusing).  I've seen this before, where a MAC will add the text "released to final" to an unchanged draft LCD weeks before the actual final decision on the LCD is published.   Myriad bills in Ohio under GeneSight LCD L35443, which hasn't been marked for retirement - yet.