AMA takes PLA code applications every quarter (e.g. circa July 1, circa October 1) and briefly posts them for public inspection a couple weeks later. This also gives you a chance to register for the public meeting for those PLA codes, which is essentially a 15 minute version of a regular CPT editorial meeting. (Between the applications and the CPT meeting, there is an internal meeting of a review group called PLA-TAG to which applicants may be invited for questions if needed.)
AMA has posted the applications for new or revised PLA codes, received October 7 earlier this month.
The BioFire is Out!
It's pretty interesting. Biofire is deleting its FilmArray respiratory panel codes, possibly because they have been replaced by panels containing added COVID (that's only a guess, and they are deleting their RESP codes, not their GI codes.) These are PLA codes 0098U, 0099U, 0100U.
It's especially interesting because in CY2019 data, only four PLA codes out of well over 100 - the FMI tumor test, the Oncotype Prostate test, and two Biofire codes 0097U GI, 0099U Resp - had any significant usage (with a rapid dropoff, being in sequence paid: $78M, $20M, $3M, $2M). Nearly all other PLA codes were essentially unused by CMS in CY2020, paying 0-$10,000.
New PLA Codes
There are only a handful of new code applicants this fall; in the past there have been as many as 20-30 in a single quarter.
The six new applications (see PDF linked at top) are Guardant G360CDx, PIGF pre eclampsia screen, a MAAA immunoassay, Onctype MAP, 257 genes, ThyGeNext Thyroid Oncogene Panel, Precision Blood (51 antigens by DNA), and PreTRM, an LC-MS preterm birth risk predictor MAAA.
Both Guardant and Foundation Medicine have recently approved (FDA PMA) CDx liquid biopsy tests, and both were Breakthrough Devices. Foundation Medicine applied for a liquid biopsy oncogene test PLA code in a prior quarter.
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The descriptors posted by AMA for these new PLA codes are subject to edits by the PLA committee.
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The next regular CPT deadline is November 6, here.
