MolDX: Genetic Testing for Heritable Thoracic Aortic Disease

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

Genetic testing for Heritable Thoracic Aortic Disease (HTAD) is covered when ALL the following are met: The patient presents with an aortic root/ascending aortic dilation, aneurysm or dissection (as defined by national consensus guidelines) AND at least one of the following are true: Presentation before age 60 years, OR Presence of syndromic features of Marfan syndrome, Loeys-Dietz syndrome, or vascular Ehlers-Danlos syndrome, OR Family history of thoracic aortic disease or peripheral/intracranial aneurysm in a first- or second-degree relative, OR Family history of unexplained sudden death at a relatively young age in a first- or second-degree relative. Demonstration that the patient has been offered counseling regarding the test and potential results. The test performed includes at least the minimum genetic content (genes or genetic variants) with definitive or well-established guidelines-based evidence (as determined by ClinGen and the American College of Cardiology (ACC) and American Heart Association (AHA) Guideline for the Diagnosis and Management of Aortic Disease) required for clinical decision making for its intended use that can be reasonably detected by the test. A single variant may be tested if it is the only variant considered to be reasonable and necessary for a patient given that it is a known familial variant. The test does not include additional genetic content that is not properly validated, or of unclear clinical validity or utility such that it could reasonably or possibly be mis-utilized by the patient or treating physician and result in impaired patient outcomes. Testing does not conflict with other applicable policy, specifically provisions of repeat germline testing defined in L38429. The test has satisfactorily completed a Technical Assessment (TA) by Molecular Diagnostic Services Program (MolDX ® ).