Which clinical condition is essential for CMS to provide coverage for Watchman FLX?

The essential clinical condition for CMS (Centers for Medicare & Medicaid Services) to provide coverage for the Watchman FLX is based on established risk stratification scores that evaluate a patient's risk of stroke associated with atrial fibrillation (AF). The CHADS2 score assesses the risk of stroke by looking at specific clinical factors, while the CHA2DS2-VASc score offers a more comprehensive evaluation by providing additional points for certain risk factors, such as age, sex, and other clinical conditions.

For coverage, the requirement of a CHADS2 score of 2 or a CHA2DS2-VASc score of 3 signifies that the patient has a moderate to high risk of thromboembolism, making them appropriate candidates for percutaneous left atrial appendage closure (LAAC) procedures like the Watchman FLX. This ensures that those who would most benefit from the intervention—due to their stroke risk—are prioritized for such treatment options.

In contrast, a CHADS2 score of 5 or low cholesterol levels do not reflect the necessary assessment of stroke risk or relate to the criteria for receiving Watchman FLX coverage. The CHA2DS2-VASc score alone, without the accompanying CHADS2 assessment, also lacks