Tuesday, July 11, 2023

AMA Release 18 New PLA Codes for July 2023

 AMA accepts applications for PLA codes quarterly (e.g. around April 1) and releases the results on the next quarter (e.g. around July 1).   For July 1, 2023, AMA released 18 new codes, revised 7 codes, and deleted 4 codes.   Find the results here:


AMA's 2023 code book includes released as late as July 1, 2022, effective October 1, 2022. and published in the code book in fall 2022 (code book for January 2023).  Each quarterly update is cumulative, relative to the last annual code book.  Generally speaking, this PDF includes codes that missed the code book for 2023: codes submitted July 1, released October 1, and effective January 1, 2023 but NOT in the code book due to its publication deadline the prior summer.

Another way of saying this, the last code in the January 2023 annual book was 0353U, so this PDF tallies codes from 0354U forward.   Codes have now been created as far as 0419U, that last code being a Tempus code for a 13 gene PGx neuropsychiatry panel.

Deleted Codes

The four deleted codes are:

0066U - Qiagen placental microglobulin $15

0357U - Intervenn DAWN AI enabled" mass spec test, 142 fragments, immunotherapy benefit."  This was on the Annual Lab Meeting agenda June 2023, but had no presenter.   It will appear in the July 2023 experts meeting agenda unless CMS deletes it.

0386U - Capsulomics "Envisage" test, 4-gene methylation analysis, Barrett's.  Same meeting status as 0357U.

0397U - Resolution Bioscience, Agilent ctDx FIRST, cfDNA, lung cancer, 109 genes.  Deleted, but this was a code applied for in January and released in April, quite recently.  Same meeting status as 0357U.

UPDATE  357, 386, 397 were in fact already deleted from the July 2023 meeting agenda here.

Revised Codes

0269U 14 -> 22 genes (thrombocytopenia panel) (this and below, Versiti Labs)

0271U 23 -> 24 genes (neutropenia panel)

0272U 51-> 60 genes (bleeding disorders panel) 

0274U 43-> 62 genes (platelet panel)

0277U 31-> 40 genes (platelet function panel)

0278U 12 ->14 genes (thrombosis panel)

0362U Add FNA source (to existing FFPE source).   Qualisure Dx, Protean BioDx, "Thyroid GuidePx Test", subtypes of thyroid cancer, 92 genes.

New Codes

0402U, Abbott ALINITY, STI pathogens.

0403U, LynxDx MyProstateScore, 18 genes, urine

0404U, Biovica, DiviTum TKa, serum thymidine kinase, for breast cancer

0405U, Breakthrough Genomics (BTG), Early Detection of Pan Can, 59 genes, plasma.  See also 0410U, ClearNote, Avantect, WGS for pancreatic cancer, plasma.

0406U, bioAffinity, CyPath Lung, flow, 5 markers, algorithm for lung cancer

0407U, Renalytix, IntelxDKD, multiplex immunoassay, CKD decline

0408U, COVO SARS COVID test, acoustic wave biosensor 

0409U, Lucence, LiquidHALLMARK, plasma NGS for solid tumors, 80 DNA genes, 36 RNA genes

0410U, ClearNote AVANTECT, WGS in plasma for pancreatic cancer risk

0411U, IDGenetix, now owned by CASTLE, 15 genes, neuropsychiatry PGx. This has the )-( symbol, at least one other PLA code has the same text name (which is template based text).

0412U, C2N Dx, PRECIVITY AD, amyloid blood test (42/40) for Alzheimer [Amyloid brain pathology]

0413U, Dartmouth Health, DT/CGAT, Optical Gene Mapping (OGM), hematolymphoid.

0414U, Imagene, LUNG-OI, digitzed whole slide imaging for 8 genes in FFPE, reported for each biomarker.  (ALK, BRAF, EGFR, etc).   

0415U, SmartHealth, Morningstar Labs, SmartHealth Vascular Dx, CV disease, multiplex immunoassay, 5 year ACS score.

0416U, Genetworx, RCA lab services, UTI with ABR, 20 organisms, urine, DNA

0417U, Variantyx, Comprehensive Mitochondrial, WMS (whole mitochondrial sequencing), plus 335 nuclear genes

0418U, PreciseDx, PreciseDx Breast Biopsy Test, digitalized whole slide imaging (WSI) of 8 features including IHC, recurrence score.

0419U, Tempus NP, 13-gene neuropsychiatry pharmacogenetics.


PLA codes with the term "SLIDE" include:

0414U, 8 genes, WSI, LungOI Imagene

0418U, 8 slides, WSI, includes IHC, PreciseDx Breast

0108U, 9 biomarkers, WSI, Cernostics/Castle

0261U, AI, 4 biomarkers, 2 IHC, Immunoscore HalioDx (acq. Veracyte)

     See blog on pricing swings for 0108U, 0261U, here.

0376U, ArteraAI, does not have the word "slide" in its name but images 128 microscopic features.

PLA codes with "artificial intelligence"

0357U,Intervenn Melanoma, 142 mass spec analytes with AI (deleted)

0261U, AI, 4 biomarkers, 2 IHC, Immunoscore HalioDx (acq. Veracyte)

The ArteraAI test has AI in its name (0376U) but not in the code text; 128 features scored with algorithm.