Galaxy Diagnostics asks CMS to crosswalk three‑pathogen tick PCR as three single‑target assays at $788.16

Hannah Mamushka, presenting for Galaxy Diagnostics, described PLA X287U as a single‑specimen, three‑lane multiplex digital PCR assay that independently detects Bartonella, Borrelia and Babesia genus‑level DNA from whole blood. She told the CMS meeting the assay design includes three independently validated primer/probe chemistries, three sets of controls and separate per‑target acceptance criteria and calls; Galaxy also developed in‑house quality controls and proficiency test specimens because none exist commercially for combined assays of these pathogens.

Galaxy said the work scales roughly linearly per target and proposed a crosswalk to PLA 0301U multiplied by three, which would yield a suggested price of $788.16 (3 × the single‑target anchor). Mamushka pointed to recent CMS precedent for per‑target multipliers and argued the methodology and specimen type closely match the anchor PLA code. "Our recommendation is to crosswalk to 0301U times 3 at 788.16," she said.

Galaxy asked the advisory panel and CMS to consider the operational and validation burden — three independent validations, three QC programs and per‑target sign‑offs — when assessing crosswalk or gap‑fill pricing. CMS did not issue a pricing decision during the meeting; Galaxy offered to provide further documentation on per‑target validation and QC upon request.

Next steps: Galaxy will provide detailed validation and quality‑control materials to CMS and the advisory panel as part of the CLFS review.