The MEF in query was created by Palmetto and incorporates the Medicare fee charges to labs (identifiable by NPI) for 22,000 lab exams (identifiable by CPT codes). Funding agency Nephron obtained the MEF from CMS, beneath FOIA, with the precise objective of pinpointing what the federal government was paying one lab, Myriad Genetics, for GeneSight, a multi-gene, combinatorial pharmacogenetic check that helps docs perceive how sufferers’ genetic variations can influence their capability to answer sure melancholy medication. Throughout an August earnings name, Myriad executives stated that GeneSight was being reimbursed by Medicare at a brand new fee however declined to reveal the value.
In a September observe, titled “FOIA Says: New GeneSight Worth is $1,569,” Nephron analyst Jack Meehan alerted buyers of the brand new Medicare worth. Though the brand new fee is a 28% lower to GeneSight’s prior Medicare worth of $2,184, it’s nonetheless greater than thrice what one other lab, AutoGenomics, receives from CMS (round $450), for a check which identifies sufferers in danger for opioid dependency.
The MEF confirmed that Myriad was utilizing a nonspecific molecular pathology code that labs use for exams that do not have a proprietary code or aren’t described by current CPT codes, to invoice for GeneSight. This bit of data was already identified from publicly obtainable CMS knowledge, which confirmed that Assurex, the corporate that developed GeneSight and which Myriad acquired in 2016, used the code to invoice for GeneSight. The truth is, Meehan identified that primarily based on CMS knowledge from 2017, GeneSight obtained the largest share of funds billed beneath that code ($31.5 million).
Meehan advised buyers that it’s uncommon for a check with GeneSight’s degree of utilization to not have a proprietary or distinctive claims code, which might permit Medicare to raised observe spending.
“Our FOIA response helps to shine higher mild on GeneSight pricing, which beforehand has been a thriller to the funding group,” Meehan wrote.
Finally, there have been two items of recent data associated to GeneSight that Meehan was in a position to glean from the MEF. One was the brand new GeneSight Medicare worth, and the opposite was that the check now had a brand new Z-code, that are distinctive identifiers for molecular exams initially developed by McKesson to enhance payors’ capability to trace utilization. Palmetto now owns Z-codes.
In a press release, Chip Parkinson, Myriad’s government vp of payer markets and reimbursement, stated that it’s the firm’s understanding that sure points of CMS and contractors’ check pricing and coding determinations, equivalent to Z-codes, are proprietary data. As such, trade stakeholders could need to pay a subscription charge to entry this data, Parkinson stated, and there could also be guidelines or procedures related to the disclosure of this data.
Quinn, who’s a guide to a number of of Myriad’s opponents within the PGx and hereditary most cancers threat testing markets, mentioned the brand new GeneSight pricing and Z-code in a publish on his weblog, and uploaded for reference the MEF doc, which he obtained from Nephron. Shortly thereafter, Quinn obtained a cease-and-desist letter from Palmetto’s legislation agency asserting that the whole MEF is the mental property of Palmetto, and that Quinn should delete the file from his weblog and all copies in his possession. The legislation agency additional demanded that Quinn present the names and phone data of those that could have downloaded the MEF from his weblog and anybody he distributed the file to.
Quinn has deleted the MEF file and redacted the GeneSight Z-code from his weblog publish, although the pricing evaluation stays. Nonetheless, he doubts Palmetto’s declare that the whole MEF is proprietary, particularly since a lot of the knowledge within the file is already accessible on its Diagnostics Alternate (DEX) portal inside MolDx, a claims processing and utilization monitoring program Palmetto operates for molecular diagnostics.
Whereas Palmetto could assert its proper to regulate the use and dissemination of Z-codes, past that “it is not clear the place [Palmetto’s] mental property begins and ends,” Quinn stated.
Paul Levy, an legal professional with Public Citizen Litigation Group, defined that if an organization holds the copyright to particular content material, for instance, the New York Occasions holds a copyright to one in all its revealed articles, then even when that article is launched by the federal government as a part of a FOIA request, that article cannot be republished. That stated, he additionally questioned what particularly Palmetto is claiming as its mental property. The cease-and-desist letter mentions that Palmetto “owns” Z-codes, and that these codes “usually are not for public distribution or publication,” however it additionally seems to say all of the contents of the MEF is Palmetto’s mental property. “So, what’s the claimed mental property?” questioned Levy.
He discovered significantly problematic the half in Palmetto’s letter asking Quinn for the names of those that could have downloaded the MEF. “If I had been Quinn, I’d inform them to go soar in a lake about disclosing his customers,” Levy stated. “In the event that they wish to pursue the identities of the downloaders, they’ll sue the downloaders as Doe defendants and serve a subpoena searching for the knowledge. Then, a choose will determine if the declare has any benefit.”
In response to emailed questions for this text, a CMS spokesperson confirmed that the company is trying into the matter, but in addition famous that “on a case-by-case foundation Medicare Administrative Contractors can declare data as proprietary.”
A spokesperson for BlueCross BlueShield of South Carolina, which Palmetto operates beneath, declined to supply feedback for this text.