MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer

Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD

This policy describes and clarifies coverage for Lab-Developed Tests (LDTs), Federal Drug Administration (FDA)-cleared, and FDA-approved clinical laboratory tests in hereditary cancer tests including Next-Generation Sequencing (NGS) tests as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage. This policy’s scope is specific for hereditary germline testing, and is exclusive of polygenic risk scores, solid tumor, hematologic malignancies, circulating tumor deoxyribonucleic acid (DNA) testing (ctDNA), and other acquired cancer-related tests. Criteria for Coverage All the following must be present for coverage eligibility: The patient must have: Any cancer diagnosis AND a clinical indication for germline (inherited) testing for hereditary cancer AND a risk factor for germline (inherited) cancer AND has not been previously tested for the same germline genetic content. The test has satisfactorily completed a Technical Assessment (TA) by Molecular Diagnostic Services Program (MolDX®) for the stated indications of the test. The test performed includes at least the minimum genetic content (genes or genetic variants) with definitive or well-established guidelines-based evidence required for clinical decision making for its intended use that can be reasonably detected by the test. Because these genes and variants will change as the literature and drug indications evolve, they are listed separately in associated documents, such as the MolDX® TA forms. A single gene or variant may be tested if it is the only gene or variant considered to be reasonable and necessary for a cancer type. If a previous test was performed with a similar/duplicative intended use, a subsequent test is only reasonable and necessary if the non-duplicative genetic content of the second test is reasonable and necessary. If the test is an NGS test, it must abide by all conditions listed in the NCD 90.2. Situations in which a test should not be used or coverage is denied: The test in question will be non-covered if: It is an NGS test and does not fulfill all the criteria set forth in the NCD 90.2 A previous test was performed for the same genetic content It is a panel or single gene test used to identify a known familial variant(s) that could be identified with a test targeted to that specific variant(s) It is a panel or single gene test used to confirm a variant(s) detected by somatic tumor testing that can be confirmed by a test targeted to that specific variant(s) A satisfactory TA is not completed For tests that are currently covered but a TA submission has not been made, providers must submit complete TA materials by the original effective date of the policy or coverage will be denied.