MolDX: Repeat Germline Testing

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

This Medicare contractor herein identifies general limitations to coverage of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)-based testing of germline genetic material of the Medicare beneficiary. This contractor does not consider any laboratory test that investigates the same germline genetic content, for the same genetic information, that has already been tested in the same Medicare beneficiary to be reasonable and necessary as it is duplicative. Germline testing, including using gene panels that contain some genetic content that has already been tested in the same Medicare beneficiary may be considered reasonable and necessary provided that there is established clinical utility present in the remaining, non-duplicative genetic components of the test. Unit of Service (UOS) for any one specific germline DNA or RNA-based test is limited to one per lifetime. Examples of germline tests include (but are not limited to) single gene and gene panel tests for: hereditary cancer syndromes or cancer predisposition, inherited disorders, and pharmacogenomics/cytochrome P450 testing. Providers should take reasonable measures to be aware of what if any germline testing a beneficiary has had prior to billing for germline testing so as to avoid billing Medicare for services that are not reasonable and necessary. Clinicians who order germline testing may wish to be aware of whether the test that they are ordering is covered under Medicare and may wish to verify that they are not ordering repeat germline testing.