MolDX: Molecular Testing for Identification and Management of Hereditary Transthyretin Amyloidosis

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

This contractor will cover molecular diagnostic tests for use in the evaluation and management of beneficiaries suspected of having Hereditary Transthyretin Amyloidosis (hATTR) when all the following criteria are met: The patient has a clinical diagnosis of ATTR; OR Has cardiac features suggestive of ATTR-cardiomyopathy; AND Is of African ancestry; OR Has a first-degree relative with an hATTR diagnosis; OR Has at least one additional feature suggestive of hATTR according to expert consensus and society guidelines. Has progressive sensorimotor and/or autonomic neuropathy; AND Has a first-degree relative with an hATTR diagnosis; OR Has at least one additional feature suggestive of hATTR according to expert consensus and society guidelines. The patient has been offered counseling regarding the test and potential results. The results of the test will be used to aid in treatment decisions. 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. 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. 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 has successfully completed a technical assessment (TA) that ensures the test is reasonable and necessary as described above.