Saturday, July 15, 2023

AMA Releases July PLA Submissions; and September AMA CPT Submissions

AMA CPT - September in New Orleans

For the September 2023 meeting in New Orleans, AMA has released the full agenda, for both lab and general codes.  Unfortunately, the deadline for requesting lab proposals to review and comment, closed on July 14.  The agenda for other types of codes, to request for comment, runs all the way to August 31.  Find the  September CPT agenda here.  Find September meeting registration here.

Of note, there is an agenda item (79) to review the process for converting PLA codes to Category I codes.   When this occurs, it could occur in one of two ways. If the test is a proprietary MAAA test that meets Cat I criteria (wide acceptance, 5 publications), it could become a MAAA code in the 81500 series.  Any other code can't be a proprietary CPT code, but could become a general code for the service.   For example, there are multiple optical genomic mapping PLA codes, and AMA could create a "general" CPT code for OGM.

There are a number of codes that involve artificial intelligence.  (eg 76, AI generated prostate cancer mapping.).  I may be missing something, but I didn't see any Cat I lab code proposals.



AMA accepted quarterly PLA applications in early July, and released the applications for review on July 14.  There is a process (at the link) for requesting codes to review and comment.  The comment cycle is very fast (only a few days) and PLA committee will meet around July 27.   Codes will be published October 1 and active January 1.  Codes in this batch will be priced by CMS at next summer's CLFS meetings (July 2024).

For full descriptions see the PDF at AMA.  Two codes use ddPCR (1, 16.) (*)

  1. CxBladder Detect+
    1. urine, ddPCR, 5 genes, bladder cancer risk
  2. Colosense
    1. CRC screening, 8 RNA markers, fecal
  3. Guardant360 Response
    1. Pan cancer, cfDNA, response to cancer therapy
  4. Genomind Neuropsych
    1. 26 genes, psychiatric treatments
  5. MiR Prostate Cancer
    1. 53 sncRNAs for risk of prostate cancer (urine exosomes)
  6. QLear Wound Pathogen
    1. 28 pathogens, 18 antibiotic resistance genes
  7. CardioRisk+
    1. Buccal, cardio risk score with 560,000 SNPs
  8. RCIGM rapid whole genome comparator
  9. RCIGM ULTRA rapid whole genome
  10. Early Sepsis Indicator
    1. Monocyte distribution
  11. Epic ctDNA Breast Cancer Panel
    1. ctDNA for 56 or more genes (LBx)
  12. Omnipathology Oropharyngeal HPV
    1. PCR for 14 high risk HPV
  13. Malabsorption evaluation panel
    1. 4 fecal biomarkers
  14. Glycine receptor Alpha1 IgG
    1. In CSF via live cell binding assay
  15. Kelch-like Protein 11 Ab
    1. serum or CSF
  16. NavDx REVISE
    1. Revising 0356U ddPCR HPV DNA, blood, w fragmentation patterns
  17. EpiSwitch prostate screening test
    1. 5 epigenetic markers in combo with PSA
  18. BluePrint 80 gene breast cancer profiling
    1. Basal, luminal, etc
  19. RightMed exclude F2 F5 report
    1. 25 genes including drug-gene interactions
  20. ChemoID
    1. Cancer cell in vitro sensitivity, 10 or more drugs
  21. PROphet NSCLC
    1. 388 proteins, aptamer proteomics, lung cancer response to immunotherapy
  22. MindX Blood Test Anxiety
    1. RNA sequencing, blood, anxiety risk
    1. Revising 0351U Infectious disease assays revised for serum "or whole blood"
  24. EffectiveRX Comprehensive Panel
    1. 33 genes, PGx, drug interactions, etc
(*)  MDR tests that use NGS sometimes bump against rules for "one test per patient" in NCD 90.1, the CMS NCD about NGS in cancer patients (advanced vs early patients).  ddPCR is "not NGS" so it doesn't even fall under the scope of 90.2, dodging some of the quirky problems.