This summer, MolDx retired special coverage of the Myriad Genesight test (a psychiatric drug gene panel with algorithm), and announced the test would fall under a general PGx policy that now covers PGx genes based on whether the patient's gene-drug combination is endorsed by the FDA or by CPIC, the pharmacogenetics consortium. The policy specifically states that no extra credit/coverage is given for "algorithmic" PGx test.
At its August investor call, Myriad declined to discuss the new price assigned by MolDx. Note that some comparable firms release MolDx pricing publicly on the basis of its being investor-worthy information under SEC principles (e.g. CareDx here).
A new report by the NEPHRON consultancy releases the price as being $1568.64, under Z-code Z0003J. (According to Nephron, the previous price was $2183.50 under Z-code ZBZV6.)
This is still a higher price that for most 10-20 gene panels on the Clinical Lab Fee Schedule. For example, 81432 +81433 (BRCA-related genes, 10 or more, including dup del analysis and including BRCA1-2) pay about $1100 together.
A CLFS pharmacogenetic 16-gene panel, 0078U, is only $450.
Other MolDx payments to Myriad include the gene set (81292, 81294, 813317, 81319, 81298, 81300, 81295, 91297), which are related to Lynch syndrome, for about $3495 (e.g. these genes paid in 2017 CMS payment by lab data and CMS 2018, 2019 Utah data). Labs that perform a larger gene set will trigger, by definition, the standard Lynch syndrome AMA CPT codes 81435, 81436, including 81292 etc, for which MolDx pays only $1170 altogether.*
One other oddity of the Master Edit File is that the Z code for Genesight would seemingly fall under the MolDx LCD for PGx testing, L38294. Dozens of PGX codes are assigned to this LCD, so MolDx clearly knows how to do that and has had time to do so. But the Z code for Genesight PGx test isn't assigned to any LCD edits in the most recent Master Edit File from MOLDX.
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Other Master File Oddities
Some large tumor gene panels, which would seemingly fall under MolDx's solid tumor LCD, are also assigned to "no LCD" for edits (e.g. see the OmniSEQ ZBnn7).
In other cases, MolDx appears to ignore PAMA's downward price changes - depending on who the lab is.
For example, the CARIS BRCA test ZBnnC is priced not at the fee schedule price for 81162 ($1824) but as code 81479 for $2396. Same for the Sonic BRCA panel ZBnn9, which is described as a BRCA panel (normally 81432+81433 = $1118) but the Sonic BRCA panel assigned code 81479 for $2396.
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* There are also separate Noridian and Palmetto articles that "genes billed together" should "never be stack coded" but should be coded as 81479 for non-stack pricing, eg here.
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Noridian's instructions for obtaining information from FOIA is here. Cloud copy here. Noridian specifically notes that FOIA info includes: "Contractor priced fees (C-Status) not published on Noridian's website" and "Medicare coverage criteria not addressed in policies or provider bulletins."
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Copy of release letter for FOIA for Master Edit File here.
Copy of law firm letter "cease and desist" against describing errors in payment rules here.
Between Fall 2019 and Fall 2020 the Master Edit File expanded from around 12,000 lines to around 20,000 lines, which probably has contributed to the accumulation of errors and a general unmanageability relative to the early vision of the Z code system when there were only a couple hundred codes. For example, they issue Z-codes for tests paying as little as $5 (Z code ZB6nn), and for some topics like FilmArray 0097U, there are 180 separate NPI's tied to its Z code. What this accomplishes is unclear (perhaps staff could have been deployed building a house of cards or doing crosswords). Some 1200 codes have special MolDx prices, but in some cases, as noted earlier, this just seems to shield some tests at some lucky labs from PAMA pricing, by switching them from CPT codes priced under PAMA to then 81479 code and then intentionally assigning that lab a higher than PAMA price.
