Genetic Testing for Cardiovascular Disease

Jurisdiction: J9 MAC Part B. States: Florida, Puerto Rico, US Virgin Islands. Type: Active LCD

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. History/Background and/or General Information With advancement in science and technology comes the ability to incorporate genetic testing for hereditary cardiovascular disease into clinical care, with the goal of improved patient outcomes. The scope of this LCD is genetic testing in the practice of cardiovascular medicine in the Medicare population. The genetic basis of cardiovascular disease is an area of rapidly expanding knowledge. To date, identification of genetic variants associated with cardiovascular disease includes hypertrophic and dilated cardiomyopathy (associated with mutations in sarcomere and structural genes), arrhythmogenic cardiomyopathy (associated with mutations in desmosome genes), inherited arrhythmias (associated with mutations in transmembrane ion channels genes), and Marfan and related syndromes (associated with mutations in genes encoding connective tissue elements). Association does not necessarily translate to improvement in patient care. In certain circumstances, genetic testing for inherited cardiovascular disease in patients with the corresponding appropriate phenotypic medical condition could have the potential to assist patient management in the Medicare population. However, given the complexity and rapidly expanding knowledge in this topic area, there is also a potential for testing that does not help the patient or leads to confusion. Specialized clinical expertise in cardiovascular medicine in addition to advanced knowledge in both genetic variation and effect on gene function is required to facilitate optimal outcomes for patients. Covered Indications Genetic testing for hereditary cardiovascular disease will be considered medically reasonable and necessary if: The patient has rigorous disease-appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patient’s condition, prior to ordering the test AND The evidence for the gene-disease association is evaluated by the evidence-based, transparent, peer-reviewed process of the National Institutes of Health (NIH) sponsored Clinical Genome Resource (ClinGen) and is determined to demonstrate actionability in clinical decision making, meeting all bulleted metrics: Disease severity of sudden death, possible death or major morbidity, modest morbidity Substantial or moderate evidence of a >40% likelihood of disease Substantial or moderate evidence of a highly effective or moderately effective intervention The nature of intervention is either low risk/medically acceptable/low intensity intervention or moderately acceptable/risk/intensive interventions, AND Clinical validity and qualitative descriptors from Moderate, Strong & Definitive with contradictory evidence NOT being reported as disputed or refuted. Limitations The following are considered not medically reasonable and necessary: A genetic test where either analytical validity, clinical validity, or clinical utility has not been established. Genetic testing in patients who do not demonstrate the disease-appropriate phenotype of the gene-disease association. Genetic testing of asymptomatic patients. Genetic testing solely for purposes of proband identification. Genetic testing with family history as the only indication. Gene tests for cardiovascular disease are considered germline testing, and therefore only permitted once per beneficiary’s lifecycle. Provider Qualifications The ordering provider of a genetic test for a patient with a cardiovascular disease-appropriate phenotype: Must be the treating clinician who is responsible for the cardiovascular disease management of the patient’s condition; and, Understands how the test result will impact the patient’s condition; and, Has presented this information to the patient eliciting patient understanding. Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.