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October 27, 2015

SLCO1B1 Genotype Coding and Billing Guidelines (CM00064)

The MolDX team has reviewed the SLCO1B1 genotype test, developed to assess the effectiveness of statin therapy. To date, there is insufficient evidence to support the required clinical utility for the established Medicare benefit category. Therefore, the SLCO1B1 genotype test is a statutorily excluded service.

To receive a SLCO1B1 service denial, please submit the following claim information:

  • CPT code 81400 – SLCO1B1 family member
  • 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 identifier adjacent to the CPT code 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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