How It Used to Be
Until Summer 2020, MolDx had a stable way of paying for pharmacogenetics. There was a PGx LCD, which had very limited coverage (just a few genes and a few drugs) and there was the Myriad Genesight LCD, which paid circa $2000 for Genesight when ordered by psychiatrists for patients with treatment resistant depression.
The New PGx Rules
Completely changed in Summer 2020. The old PGx LCD was deleted and there's no more Myriad Genesight LCD, either. Instead, MolDx has a new PGx approach that pays for those genes and drugs listed on FDA and CPIC tables (totaling about 30 genes and about 150 drugs, though some pairs are really uncommon drugs).
In the new LCD, MolDx tells the public fairly bluntly it does not see proof of convincing value of "combinatorial" or algorithmic PGx such as Genesight (FN1), but offers to cover Genesight (i.e., genes on the Genesight panel) when they fit to the new PGx LCD (i.e. when they fit CPIC gene-drug pairings).
Restrictions based on a patient history of "treatment resistant depression" and restrictions based on psychiatrist-only orders have vanished, since those restrictions are not mentioned in the CPIC guidance that is now the de facto Medicare coverage.
Myriad Call Discusses Impact on Genesight
Myriad's August 13, 2020 earnings call transcript is available from Seeking Alpha and other sources (e.g. here) or streams on the Myriad website.
Myriad emphasizes that Genesight is now freed from patient history qualifications and freed from restrictions on MD specialty.
However, Myriad also states that MolDx has issued a new price for Genesight, which Myriad does not reveal. (Actually, they state, "We recently agreed on new pricing for Genesight with MolDx.") Myriad proposes that the net expansion of coverage vs the per test price reduction will leave it about even.
Myriad is expanding its Genesight sales force, and will make at-home test collection possible.
Myriad GeneSight Pricing Should Be Available via FOIA
Myriad tells investors, "we not providing [average collection $ per patient] that level of detail...we're not getting into detail around pricing and coding for the test."
But let's see what we can unpack from available sources.
First, Medicare's new price for GeneSight should be readily available via FOIA (Freedom of Information Act request). For example Noridian specifically states in its FOIA instructions that one type of available document is "contractor-established prices not published on the Noridian website," and since this is a general concept, it should be true for other MACs as well (here). (FN2)
At a California Clinical Lab Association meeting this month, MolDx stated that test pricing for PGx panels would be set by its public gapfill spreadsheet and associated internal (not public) methods used by MolDx.
MolDx also stated that in regard to the PGx LCD and other LCDs, there may be cap rates set by the largest test on the fee schedule. For a specific example, the Foundation Medicine F1 test coded 0037U at $3500 may set a cap for similar comprehensive tumor tests (per MolDx remarks) and per MolDx review, you may equal the test and equal its payment, or you may prove to have a smaller test and discounted payment.
Differences re Genesight Pricing and Coding for Medicare
Toward the end of the call, there's a question, "Are you planning to stack multiple codes for each test, for each of the genes that are required?" to which Myriad answers, "Yeah."
However, the Palmetto website article on multiple genes states that 2 or more genes should be coded 81479 (not stack coded) and will be at paid a price set by MolDx, something MolDx reiterated explicitly at the August CCLA meeting.
So there's still some puzzlement there, since Myriad seems to be stating it has finished an agreement with MolDx, and, it will involve coding by gene CPT code, and, MolDx has stated elsewhere that 2 genes or more can't be stack coded. Read the MolDx article on billing 2 or more genes at once, A57503.
Myriad remarks, "we are not aligned with some of the language in the LCD about combinatorial testing."
A FOIA request should yield the carrier price for GeneSight. In addition, the MolDx system has available via FOIA the "Master Edit File," (MEF) a list of 15,000 Z codes, about half of which crosswalk to 81479. Many of those have listed MolDx local prices in the MEF.
An investor remarks that Genesight has been paid $2200 from CMS, and Myriad answers that's not quite right. In CY2017, the last year for which lab specific data is available from CMS, Assurex (NPI 1235363052) was paid for 14,733 Part B fee for service tests of 81479 (unlisted code) totaling average allowed rate = $2180, against submitted charges of $5,482, adding to $32,117,940. Here.