October 28, 2015
Mitochondrial Nuclear Gene Tests Coding and Billing Guidelines (CM00053)
Effective for dates of service on and after January 29, 2013.
Mitochondrial disorders are a group of conditions caused by dysfunction in the mitochondrial respiratory chain. Current genetic testing methods are unable to detect mutations in all individuals with suspected mitochondrial disease, and there is no proven effective treatment for persons with a known mitochondrial disease. Therefore, MolDX has determined mitochondrial nuclear gene tests do not support the required clinical utility for the established Medicare benefit category and are statutorily excluded tests.
To receive a mitochondrial nuclear panel service denial, please submit the following claim information:
- CPT code 81440 - Nuclear encoded mitochondrial genes
- 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 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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