October 28, 2015 - Updated 02.01.17
MolDX: TP53 Gene Test Coding and Billing Guidelines (CM00090, V2)
Effective for dates of service on and after June 24, 2013.
TP53 gene testing may be performed during the diagnosis of Li-Fraumeni syndrome (LFS), a cancer predisposition syndrome associated with the development of specific tumors. Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, MolDX has determined TP53 gene tests are a statutorily excluded service. MolDX will also deny panels of tests that include the TP53 gene.
To receive a TP53 gene sequencing service denial, please submit the following claim information:
- Appropriate CPT code according to exons tested
- CPT code 81404 – TP53, targeted sequence analysis of 2-5exons
- CPT code 81405 – TP53, full gene sequence or targeted analysis of greater than 5 exons
- An Advance Beneficiary Notice of Non-Coverage (ABN)
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-code™ identifier 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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