Saturday, July 2, 2022

AMA Releases New PLA Codes

On July 1, 2022, AMA released new PLA codes.   In this quarterly process, AMA released codes applied-for three months early (around April 1).  The PLA codes will be effective October 1, and will be nationally priced by CMS next summer (summer 2023).  

Find the PLA home page here updated PLA code list here:

One code was revised (0267U, Versiti test, from 23 to 42 genes), four codes deleted (including 0012U-14U, 56U, "MatePair" genomic structure codes from Mayo), and 23 new codes added.

New codes include 

  • 0332U, Oxford BioDynamics EpiSwitch, an 8-gene PCR test for immune checkpoint inhibitor response,  
  • 0334U, an FFPE tumor gene panel from Guardant, 
  • 0335U a fetal sample whole genome sequence analysis from Variantyx, 
  • 0337U-338U, "CellSearch" tests by Menarini (brand acquired from Janssen),
  • 0340U, Pan-cancer MRD test from Natera (I think this is an ADLT test already priced by CMS in July 2021, on the ADLT website, but not previously showing any code),
  • 0345U, GeneSight test from Assurex/Myriad,
  • 0347U-49U, OneOme RightMed PGX 16 gene and larger tests (Mayo spinout),
  • 0346U, QUEST "AD Detect" two-protein plasma LCMS test for Alzheimer's,
  • 0351U, MeMed BV, a 3-gene rapid test for infection host response, FDA cleared,
  • 0352U, Cepheid bacterial vaginosis test.
If some of these look familiar, they were all included in the June 23 CMS public comment meeting on new test codes for 2023.  

Note that regarding 0335U, fetal sample for whole genome sequence analysis, actions like abortion following genetic anomalies have been controversial, including a national Senate bill (S.75) with 26 sponsors, allows civil actions against an abortion provider to be brought by grandparents of the unborn child.  The bill also includes criminal penalties under a separate clause.    The Senate bill also makes it unlawful to transport a woman across a state line for this purpose.  This bill is specific to anomalies linked to chromosome 21.  There is a clause (g) that any nurse, counselor, or health professional "shall report" violations to law enforcement, lack of doing so carrying 1 year imprisonment.  

AMA will release for public comment applications from the new July PLA cycle applications around July 10.