Billing and Coding: MolDX: Germline testing for use of PARP inhibitors

The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. Results of tests that assess for deleterious variants in homologous recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in patients who are being considered for treatment with PARP inhibitors in accordance with published guidelines and approved therapeutic product labeling. These genes are often tested as part of routine management of these cancer patients as part of services that interrogate a panel of genes as described in LCD L38966. In rare circumstances limited testing for only a select group of genes may be tested to ensure compliance with FDA indicated drug usage, wherein additional genes outlined in guidelines such as the NCCN are not necessary because the patient does not meet testing criteria for larger panels. According to criteria defined by L38966, billing for these services can occur in the following situation: The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use AND The patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing AND The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing. To report a service, please submit the following claim information: Select appropriate CPT ® code One (1) unit of service Enter DEX Z-Code™ identifier adjacent to the CPT ® code in the comment/narrative field for the following Part B claim field/types: Loop 2400 or SV101-7 for the 5010A1 837P Item 19 for paper claim Enter DEX Z-Code™ identifier adjacent to the CPT ® code in the comment/narrative field for the following Part A claim field/types: Line SV202-7 for 837I electronic claim Block 80 for the UB04 claim form Select at least one ICD-10-CM diagnosis code.

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