PIK3CA Gene Tests Coding and Billing Guidelines (CM00056)
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October 22, 2015 - Revised: 08.09.17

PIK3CA Gene Tests Coding and Billing Guidelines (CM00056)

Effective for dates of service on and after June 28, 2013.

PIK3CA gene has been found to be oncogenic and studies that target the PI3K/AKT pathway as a potential therapeutic option have shown promising results. While these studies are encouraging, there is insufficient evidence to establish a clear association between PIK3CA mutations and treatment response. Therefore, MolDX has determined PIK3CA gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the PIK3CA gene.

To receive a PIK3CA targeted gene sequencing service denial, please submit the following claim information:

  • CPT code 81404 - PIK3CA
  • 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 DEX Z-codeidentifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:
    • Part A: Loop 2300 NTE 01/SV202-7 (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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