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Clinician urges reconsideration of code 0580, says newer FDA-cleared Lyme tests detect more Borrelia species
Summary
A clinician told reviewers that newer FDA-cleared Lyme disease test kits, including ARDA assays, use dozens of recombinant proteins and detect multiple Borrelia species and urged that billing/code 0580 be reconsidered because the lab was not given a chance to present data during its prior review.
A clinician told a review panel that newer FDA-cleared Lyme disease test kits, including ARDA assays, use many recombinant proteins and can detect multiple Borrelia species, and urged reconsideration of billing code 0580 because the laboratory did not have an opportunity to present its data during last year’s review.
The clinician said the ARDA assay contains "7 different recombinant proprietary antigens" and that "the IGM component, the 0615, uses 31 individual recombinant proteins," which together allow the tests "to be able to detect up to 9 different species of Lyme Borrelia." The speaker emphasized that those features provide more clinical information than older tests.
Why it matters: the clinician noted both tests are "FDA cleared" and "accepted as surveillance criteria by the CDC," and said the kits are patented. The presenter argued those factors distinguish the ARDA assays from older tests that were used in the prior crosswalk and that the differences have implications for diagnostics and code assignment.
The clinician said the laboratory was "never aware" the product came up for review last year and therefore "didn't have the opportunity to present the data on it." The speaker criticized how the test was subsequently crosswalked back to an older, lower-generation test from seven years ago and ultimately to a 1990s-era Western blot, calling those tests "completely, completely different" in technology and clinical information.
The clinician contrasted code examples discussed by the panel, saying that 0042 is a single-tier confirmatory test while 0502 is a second-generation FDA-cleared two-tier test kit. The presenter also stated the newer kit contains more antigens—saying it "contains 37 different recombinant proteins"—and reiterated that producing and maintaining an FDA-cleared test involves ongoing expenses such as validation, mailing, and in some cases state taxes.
No formal action or vote on code 0580 was recorded in the transcript provided. The discussion focused on the technical differences between generations of tests and the procedural concern that the laboratory had not been given a chance to present its evidence during the prior review.
