Thursday, September 9, 2021

Very Brief Blog: Last Two Days to Comment on Novitas Cardiology Genetics LCD

 There are numerous indications to test for genetic causes of cardiac diseases, including arrhythmias and cardiac hypertrophy.   Medicare coverage policies have sometimes been quite limited.

The NOVITAS MAC has had a draft LCD under comment from July 29 to September 11.  I think it has some good features, but it may be pretty quirky in other ways.   For example, it asks the risk of any gene testing to be 40% or more, which seems to high for normal medical practice.  They also seem a little unaware of the overlap of syndromes and thus, the use of panel based gene testing.  

Those with stronger content knowledge in cardiology genetics will want to comment by September 11 (yes, that's technically a Saturday.)  I've put the draft LCD DL39082 and article DA58795 in a zip file in the cloud here.   Comments are directed to, .

I discussed some pro's and con's of this approach to writing LCDs - more vague LCDs - back on August 17 here.


Core rules [partially quoted] include - 

Genetic testing for hereditary cardiovascular disease will be considered medically reasonable and necessary if:

1. 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 


2. 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, 


3. Clinical validity and qualitative descriptors from Moderate, Strong & Definitive with contradictory evidence NOT being reported as disputed or refuted.