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October 27, 2015 - Updated 02.01.17

UGT1A1 Gene Analysis Coding and Billing Guidelines (CM00074, V2)

The MolDX team has determined UGT1A1 gene analysis has insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, UGT1A1 gene analysis services are statutorily excluded tests.

To receive an UGT1A1 gene analysis service denial, please submit the following claim information:

  • CPT code 81350-UGT1A1, common variants
  • 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-codeidentifier™ adjacent to the CPT code in the comment/narrative field for the following claim field/types:
    • Part A: Loop 2300 NTE 01 or 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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