TAR Requirements Replaced for PLA Service Targeted Genomic Sequence Analysis

Effective for dates of service on or after June 1, 2021, the Treatment Authorization Request (TAR) requirements for Proprietary Laboratory Analyses (PLA) code 0037U (targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden) are replaced. A TAR requires documentation of any one of the following criteria:

• For ovarian, fallopian tube or primary peritoneal cancer:
  • The patient has been treated with two or more chemotherapies, or o The patient is experiencing complete or partial response to first-line platinum-based chemotherapy.
• For Metastatic Castration-Resistant Prostate Cancer (MCRPC): o The patient has been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. • For breast cancer: o The patient has HER2-negative metastatic breast cancer and has been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
  • The patient has HER2-negative locally advanced or metastatic breast cancer.
• For metastatic pancreatic adenocarcinoma:
  • The patient’s disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.