October 19, 2015 - Revised 01.19.16
HBB Full Gene Sequencing Coding and Billing Guidelines (CM00039, V2)
Effective for dates of service on and after May 3, 2013
HBB gene testing may be performed during the diagnosis of Sickle cell disease (SCD). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX team has determined HBB full gene sequencing is a statutorily excluded test. MolDX will also deny panels of tests that include the HBB gene.
To receive a HBB gene sequencing service denial, please submit the following claim information:
- Select the appropriate CPT code based on gene test:
- CPT code 81401 – HBB, common variants
- CPT code 81403 - HBB, duplication/deletion
- CPT code 81404 – HBB, full gene sequence
- An Advance Beneficiary Notice of Non-Coverage (ABN)
is not required for statutorily excluded services
- For a voluntary issued ABN, append HCPCS modifier GX
- To indicate a statutorily excluded service, append HCPCS modifier GY
- Select the appropriate diagnosis for the patient
- Enter the assigned Z-Code Identifier adjacent to the appropriate 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, NTE02, 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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