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October 13, 2017

ATP7B Gene Tests Coding and Billing Guidelines (CM00089, V3)

Effective for dates of service on and after July 24, 2013

ATP7B gene mutations have been primarily associated with Wilson Disease, a disorder of copper metabolism. However, serology remains the gold standard for testing and treating the signs and symptoms of this condition. At present the literature does not support that ATP7B gene testing changes physician treatment or improves patient outcomes. Therefore, MolDX has determined ATP7B gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the ATP7B gene.

To receive an ATP7B gene test denial, please submit the following claim information:

  • Select the appropriate CPT code for the performed service
    • CPT code 81406 - ATP7B, fgs
    • CPT code 81479-unlisted molecular pathology procedure
  • An Advance Beneficiary Notice of Non-Coverage (ABN) 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: Line 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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