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October 27, 2015 - Updated 04.11.17

STAT3 Gene Testing Coding and Billing Guidelines (CM00075, Vol.2)

Effective for dates of service on and after June 26, 2013.

STAT3 gene testing may be performed during the diagnosis of Autosomal Dominant Hyper IgE Syndrome (AD-HIES). Since management is not determined by the presence or absence of a STAT3 mutation in patients with a probably clinical diagnosis, MolDX has determined STAT3 analysis is a statutorily excluded test.

To receive a STAT3 analysis service denial, please submit the following claim information:

  • CPT code 81405 - STAT3, targeted sequence analysis
  • 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 DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:
    • Part A: Loop 2300 NTE 01/SV 202-7 (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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