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October 12, 2015 - Updated 10.13.17

Myriad's BRACAnalysis CDx Coding and Billing Guidelines (CM00028, V3)

Effective December 19, 2014, the FDA approved Lynparzaâ„¢ (olaparib), a new drug treatment for women with advanced ovarian cancer, and the companion diagnostic BRACAnalysis CDx™, the laboratory test to detect mutated BRCA genes.

Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, blocks enzymes involved in repairing damaged DNA and is intended for women with heavily pretreated ovarian cancer associated with defective BRCA genes. BRACAnalysis CDx™ detects the presence of BRCA1 and BRCA2 gene mutations. Therefore, in order to be eligible for Lynparza treatment and the companion diagnostic, the medical record must document previous treatment for ovarian cancer. BRACAnalysis CDx™ is only covered for women diagnosed with advanced ovarian cancer and who have not been previously tested for BRCA mutations.

To report a BRACAnalysis CDx™ service, please submit the following claim information:

  • CPT code 81479
  • One (1) unit of service

Assigned MolDX identifier in the comment/narrative field for the following claim field/types:

  • Loop 2300 NTE01 for Part A or Loop 2400 or MolDX identifier (MID) field for Part B
  • Submit the assigned MolDX identifier on an attachment to the claim form for paper claim (Form locator for Part A or Box 19 for Part B)

Select at least one ICD-9-CM diagnosis code from the following tables for dates of service prior to 10/01/2015:

  • 183.0 - Malignant neoplasm of ovary
  • 198.6 - Secondary malignant neoplasm of ovary

Select appropriate ICD-10-CM code:

  • C56.1 - Malignant neoplasm of right ovary
  • C56.2 - Malignant neoplasm of left ovary
  • C56.9 - Malignant neoplasm of unspecified ovary
  • C79.60 - Secondary malignant neoplasm of unspecified ovary
  • C79.61 - Secondary malignant neoplasm of right ovary
  • C79.62 - Secondary malignant neoplasm of left ovary
  • C79.9 - Secondary malignant neoplasm of unspecified site

Note: MolDX considers only one BRCA testing per beneficiary lifetime to be reasonable and necessary.

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