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October 22, 2015

BRCA1 and BRACA2 Gene Tests (CM00058)

Based on the vignettes published in the 2012 CPT Changes: An Insider’s View, CPT codes 81215 and 81217 describe tests to determine if the patient carries the familial mutation. Carrier testing to identify risk for disease without signs and symptoms of disease is not a Medicare benefit. Therefore, BRCA1 and BRCA2 genetic testing for a familial mutation is not a Medicare benefit and are statutorily excluded services. In addition to single gene testing, MolDX will also deny panels of tests that include the interrogation of BRCA1 and/or BRCA2 familial testing as statutorily excluded services.

To receive a BRCA1 or BRCA 2 known familial variant gene test service denial, please submit the following claim information:

  • Select the appropriate CPT code:
    • CPT code 81215-BRCA1, known familial variant
    • CPT code 81217-BRCA2, known familial variant
  • An Advance Beneficiary Notice of Non-Coverage (ABN)External Website is not required for statutorily excluded services.
    • For a voluntary issued ABN, append with HCPCS modifier GX
    • To indicate a valid ABN is on file for a known statutorily excluded service, append with HCPCS modifier GY
  • Select the appropriate diagnosis for the patient
  • Enter the appropriate identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:
    • Part A: Loop 2300 NTE 01 (electronic claim); Form Locator 80 (paper claim)
    • Part B: Loop 2400 or SV101-7 (electronic claim); Item 19 (paper claim)

Reference: Sec. 1862 (1)(A) Statutory Exclusion covers diagnostic testing “except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,…”
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