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December 22, 2015

ApoE Genotype Coding and Billing Guidelines (cM00093)

The MolDX Team has determined Apolipoprotein (Apo) E genotype testing, developed to assess the risk of cardiovascular disease, has insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, ApoE Genotype tests are statutorily excluded tests.

As reviewed, the developers described the indication to perform an Apolipoprotein (Apo) E genotype test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, Apolipoprotein (Apo) E genotype tests would continue to be statutory excluded tests.

To receive an ApoE service denial, please submit the following claim information:

  • CPT code 81401- APOE, common 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 statutorily excluded service, append with a HCPCS modifier GY
  • Select the appropriate diagnosis for the patient
  • Enter the appropriate Identifier adjacent to each code used to report the service 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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