Friday, April 15, 2022

AMA Releases Current Review for 2Q PLA Code Applications

AMA takes PLA code applications quarterly (most recently April 5) and posts them for a few days of public comment (posted April 14).   The comment request deadline is April 21.  The committee finishes its review and edits by April 26 and the AMA CPT panel vote will be at the May meeting (May 13).  Nearly all codes are accepted, but the publication date will be July 1.

See the listing and comment instructions here:

There is a bumper crop of PLA applications.  This is the last cycle for codes that will enter the June 2022 CMS annual public pricing meetings.

See the full listing above; in brief:

  • EpiSwitch checkpoint inhibitor response
  • AllerGenis Peanut Diagnostic
  • HelioLiver cancer surveillance
  • G360 TissueNext (FFPE, 84 or more genes)
  • irSight prenatal, proband code and comparator code, genome-plus
  • CellSearch multiple myeloma test
  • CellSearch HER2 tumor cell test
  • SelectMDx for prostate cancer
  • SIGNATERA MRD test, bespoke multiplex PCR & NGS. 
    • This Natera test has already been granted ADLT status, but the code to implement that status was pending.
  • DELETE:  0012U, 13U, 14U, 56U, Mayo "Mate Pair" rearrangement tests
  • Luna, Single Cell prenatal diagnostics
  • IMMRAY Pan Can D, 8 pancreatic cancer proteins
  • Versiti 0276U hematology panel, revise
  • MIR Sentinel Prostate cancer test (442 non coding rnAs)
  • OWLiver, IVD for fatty liver disease, 28 lipid biomarkers, NASH score
  • GeneSight Psychotropic (15 genes, depression, anxiety, ADHD)
  • AD-DETECT(tm) Amyloid 42/40 Ratio, LC-MS, plasma
  • Visby Medical sexual health (GU pathogens)
  • RightMed Comprehensive, 25 genes (w/o F2, F5)
  • RightMed PGx 16 test, 16 genes 
  • RightMed gene report, 27 genes  
  • RightMed Comprehensive test, SNP for 27 genes
  • NaviDKD kidney health, glycation end products
  • MeMedBV - likelihood of bacterial infection
  • Xpert Xpress MVP - vaginosis panel
  • Xpert CT/NG - limited panel
  • Pretect HPV - RNA expression for HPV genotypes
  • EUROIMMUN Dermatomycosis, 29 genes, microarray, hair, nail, etc