Artera Prostate has a PLA code, 0376U, several years old. At least to 2024, there were no paid claims (December 2024). I do not know if there are paid claims in 2025, but for this essay I assumed not. I do understand the Artera Prostate test (validated on many many thousands of slides) has NCCN endorsement.
Below is direct Chat GPT research.
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ESSAY
ArteraAI presents an interesting distinction between coding/pricing success and actual Medicare payment success. The company is appropriately described as Los Altos, California–based: FDA’s De Novo database lists Artera, Inc., 108 1st St., Los Altos, CA, as the requester for ArteraAI Prostate. FDA granted De Novo authorization for ArteraAI Prostate on July 31, 2025, classifying it as a pathology software algorithm device analyzing digital images for cancer prognosis. (FDA Access Data)
But the performing CLIA laboratory for the ArteraAI Prostate Test appears to be in Jacksonville, Florida, not California. Artera’s own test materials identify the clinical lab address as 6800 Southpoint Pkwy, Suite 950, Jacksonville, FL 32216. That places the performing lab under First Coast Service Options, the A/B MAC for Jurisdiction N, covering Florida, Puerto Rico, and the U.S. Virgin Islands. (ArteraAI) And yes — FCSO is First Coast Service Options.
The test has a PLA-type CPT code, 0376U, and CMS established a Medicare CLFS payment rate effective January 1, 2024. Artera publicly described this as a CMS payment-rate decision for the ArteraAI Prostate Test, a clinical diagnostic laboratory test. (ArteraAI) That is meaningful, but it is not the same thing as coverage. A CPT/PLA code plus a CLFS dollar amount means the test can be billed and priced; it does not necessarily mean that a MAC is paying claims.
That is the concerning point: according to the claims-data observation you are making, there appear to be no paid Medicare claims for 0376U in Florida or elsewhere, despite the existence of the code, the CLFS price, the ability to enroll/bill through an NPI, and the absence of a clear published LCD either covering or non-covering the test. In that sense, ArteraAI is not “unsuccessful” at coding or pricing; it is unsuccessful at converting those assets into actual Medicare payment.
This is especially striking because the test is not a speculative early-stage assay. It has FDA De Novo authorization, and Artera has stated that the ArteraAI Prostate Test was included in the 2024 NCCN Guidelines for Prostate Cancer as a predictive test for therapy personalization, with Level IB evidence under the Simon criteria. (ArteraAI) Artera’s clinician-facing materials also describe use across NCCN risk groups, with reported 10-year risks of distant metastasis and prostate cancer–specific mortality. (ArteraAI)
The likely rationale for the Florida lab location is therefore not mysterious. A California performing lab would fall under Noridian/MolDX jurisdiction, with the familiar Z-code/technical assessment pathway. By contrast, a Florida performing lab submits through First Coast Service Options / Jurisdiction N, outside the MolDX MAC structure. That may have looked like a cleaner path for a PLA-priced AI pathology test: obtain the code, obtain the CLFS price, bill through a non-MolDX MAC, and avoid a California MolDX technology-assessment bottleneck. (BQ - At least historically, FCSO paid codes 81401-81408 Tier 2, and PLA, fairly easily.).
But if the claims data show zero paid claims, the strategy may have produced only a formal pathway, not a payment pathway. The result is a reimbursement limbo that is highly relevant for innovators: FDA clearance, NCCN recognition, a PLA code, and a CLFS price still may not produce Medicare dollars when no MAC has articulated a coverage position and claims simply do not pay.
