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October 30, 2015 - Updated 05.17.17

GBA Genetic Testing Coding and Billing Guidelines (CM00084, V2)

Effective for dates of service on and after July 30, 2013.

Mutations found in glucosidase, beta, acid (GBA) are associated with Gaucher disease (GD), which encompasses a continuum of clinical findings. Since GBA genetic testing is used to confirm the clinical findings to diagnose GD, MolDX has determined that GBA genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include the GBA gene as a statutorily excluded service.

To receive a GBA test denial, please submit the following claim information:

  • CPT code 81251- GBA, 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
  • For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
    • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
      • Loop 2400 or SV101-7 for the 5010A1 837P
      • Box 19 for paper claim
    • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
      • Line SV202-7 for 837I electronic claim
      • Block 80 for the UB04 claim form

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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