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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

October 12, 2015 - Updated 07.11.18

Myriad's BRACAnalysis CDx Coding and Billing Guidelines (CM00028, V4)

The FDA approved Lynparza™ (olaparib), as a treatment for women with advanced ovarian cancer or metastatic breast 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  or HER2-negative metastatic breast cancer associated with defective BRCA genes. BRACAnalysis CDx™ detects the presence of BRCA1 and BRCA2 gene mutations. According to the FDA, “results of the test are used as an aid in identifying breast and ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment,  with Lynparza® (olaparib). BRACAnalysis CDx™ is only covered for women diagnosed with ovarian cancer or breast 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

Enter the appropriate DEX Z-code™ identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:

  • Line SV202-7 for 837I Part A or Loop 2400 or SV101-7 for 5010A1 837P Part B
  • Block 80 for UB04 for Part A or Box 19 for Part B

Select appropriate ICD-10-CM code:

  • C48.0 Malignant neoplasm of retroperitoneum
  • C48.1 Malignant neoplasm of specified parts of peritoneum
  • C48.2 Malignant neoplasm of peritoneum, unspecified
  • C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
  • C50.011 Malignant neoplasm of nipple and areola, right female breast
  • C50.012 Malignant neoplasm of nipple and areola, left female breast
  • C50.021 Malignant neoplasm of nipple and areola, right male breast
  • C50.022 Malignant neoplasm of nipple and areola, left male breast
  • C50.111 Malignant neoplasm of central portion of right female breast
  • C50.112 Malignant neoplasm of central portion of left female breast
  • C50.121 Malignant neoplasm of central portion of right male breast
  • C50.122 Malignant neoplasm of central portion of left male breast
  • C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
  • C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
  • C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
  • C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
  • C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
  • C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
  • C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
  • C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
  • C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
  • C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
  • C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
  • C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
  • C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
  • C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
  • C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
  • C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
  • C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast
  • C50.611 Malignant neoplasm of axillary tail of right female breast
  • C50.612 Malignant neoplasm of axillary tail of left female breast
  • C50.621 Malignant neoplasm of axillary tail of right male breast
  • C50.622 Malignant neoplasm of axillary tail of left male breast
  • C50.811 Malignant neoplasm of overlapping sites of right female breast
  • C50.812 Malignant neoplasm of overlapping sites of left female breast
  • C50.821 Malignant neoplasm of overlapping sites of right male breast
  • C50.822 Malignant neoplasm of overlapping sites of left male breast
  • C50.911 Malignant neoplasm of unspecified site of right female breast
  • C50.912 Malignant neoplasm of unspecified site of left female breast
  • C50.921 Malignant neoplasm of unspecified site of right male breast
  • C50.922 Malignant neoplasm of unspecified site of left male breast
  • C56.1 - Malignant neoplasm of right ovary
  • C56.2 - Malignant neoplasm of left ovary
  • C56.9 - 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
  • Z85.3 Personal history of malignant neoplasm of breast
  • Z85.43 Personal history of malignant neoplasm of ovary
  • Z85.44 Personal history of malignant neoplasm of other female genital organs

Note: Only one BRCA testing per beneficiary lifetime will be considered reasonable and necessary. If a patient received BRCA testing prior to Lynparza treatment consideration, regardless of the performing lab, additional testing would not be considered a reasonable and necessary service.

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