Avoid negative impacts to your claims: Review policies on genetic testing for cardiovascular disease

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.

The decision to perform genetic testing should be reserved for patients with a confirmed or suspected diagnosis of an inherited cardiovascular disease or for individuals at high risk from a previously identified pathogenic variant in their family. However, Medicare does not cover genetic screening for cardiovascular disease, in which case family history alone would be insufficient for coverage. A crucial element is rigorous, disease-appropriate phenotyping. Genetic testing does not provide a definite diagnostic result in most circumstances.

The LCD provides instruction regarding when the services would be considered reasonable and necessary; however, the companion article directs the following: 

• No genes currently meet criteria for coverage as outlined in the LCD.

The LCD and billing and coding article must be used in combination to ensure the instruction is clear. 

The procedure codes identified in the billing and coding article are currently non-covered for cardiovascular genetic testing until such time that the tests meet criteria #2 in the indications:

• 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

Read the LCD L39084  and billing and coding article A58797 in its entirety to make sure you are following guidelines.