Noridian proposes a draft LCD for Opko 4KScore, seemingly only for the purpose of deleting the LCD. Last month, Palmetto MolDx reviewed and reissued the same LCD with typos corrected. Note that MolDx has generally been removing the word "MolDx" from the title of LCDs that are proteomic rather than DNA/RNA, to indicate the LCD is now excluded from the MolDx scope of work and the LCD may or may not be deleted in the future.
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Since 2016, Palmetto MolDx has had a non-coverage policy for the Opko 4KScore test (L36763, here.) This has always been an unusual policy, since the 4KScore test is a sole-source test billed to the Novitas MAC from New Jersey, and the Novitas MAC covers 4KScore. See L37792. In 2020, 4KScore code 81539 had 12,734 uses paying $9.7M in Medicare Part B.
Palmetto: Revise. Noridian: Nix.
Here's a little oddity. Currently, in the Medicare Coverage Database, the Palmetto LCD L36763 for the 4KScore test is listed as newly revised, with Revision 8 described as a revised title, bibliography format changes, and typos corrected. OK. Here. I don't recall seeing it listed as "draft under revision," so maybe typos can be corrected without public comment.
But there is a version of the same LCD proposed as "DL37120," a draft LCD, on the Noridian website. Here, the LCD is presented with the comment, "This LCD is being retired because this lab or test is no longer available and Noridian does not anticipate any claims for this service." This isn't exactly correct, the test is very available, but not in Noridian's territory, so it's true, Noridian won't see any claims. [*] The CMS database website lists this LCD version as "draft in comment" April 28 to June 11, but the D-LCD itself doesn't list any comment period nor does it list a public comment meeting.
Before procedural revisions in 2019, attributed to "21st Century Cures Act," LCDs could be expanded at any time (without notice) and deleted at any time (without notice). This Noridian maneuver suggests that an LCD deletion gets a comment period for 45 days.
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81539, 4KScore, is $760. This is a common price for specialty tests, the price for 81539 plus (0005U, 0011M, 0012M, 0013M, 0021U, 0089U, 0113U, 0203U).
I think that 81539, 4KScore, was the originally priced test at $760, so all the others are "crosswalked" to it, but I haven't confirmed that.
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Nerd note: 30% Rule
There is an exceptional case where Noridian might see an 81539 claim: if a lab gets an order for the test in a Noridian state, and sends it out as a reference test to Opko, in which case either lab can bill the test (as long as only one does), or, the Opko lab actually has to bill the test if the referring lab (that got the specimen) sends out more than 30% of its tests annually. This is the Medicare rule about the 30% line and lab-to-lab billing. It's a statutory rule to avoid the creation of shell labs that only bill tests that are actually performed in other wet labs, the latter of which would be evading the visibility of direct Medicare billing. But, if a lab gets an order for 10 tests, and sends out just 1, it can still bill for all 10 tests.
MolDx-ology
Generally, the 4 MolDx MACs have had uniform LCDs. The fact that a service wasn't offered in some states (e.g. not offered in CGS MAC or WPS MAC) hasn't been a factor in whether the LCD would be issued across all MolDx MACs. Here, Noridian proposes to delete an LCD because it doesn't expect claims, but if that were the general rule and applied uniformly at MolDx, a number of MolDx LCDs could be deleted in places like Iowa (the WPS MAC).
Guidelines for Prostate Genomics
Although not directly tied to 4KScore (which is used for "biopsy decision management," not active cancer management), the AUA recently updated its guideline for genomic (RNA expression) tests in prostate cancer management - here.
Opko History
Opko acquired BioReference Laboratories in 2015 for around $1.5B. The genetic division, GeneDx, was sold to SEMA4 in early 2022 for around $650M. At $9.7M revenue (Part B) in 2020, 4KScore (Part B) was 0.7% of OPKO's $1.4B in revenue.
OPKO stock peaked at $17 in 2015, currently $2.85.
SEMA4 stock peaked at $20 in December 2020, currently $1.66.
