CMS Finalizes Medicare Coverage for Renal Denervation Treating Uncontrolled Hypertension

The Centers for Medicare & Medicaid Services (CMS) has finalized a National Coverage Determination (NCD) to provide Medicare coverage for renal denervation (RDN) procedures using both radiofrequency and ultrasound technologies to treat uncontrolled hypertension. This coverage applies to FDA-approved devices, specifically Medtronic's Symplicity Spyral radiofrequency system and Recor Medical's Paradise ultrasound system, both approved in November 2023. Eligible patients must have uncontrolled hypertension despite lifestyle modifications and maximally tolerated guideline-directed medical therapy, with detailed clinical criteria and patient management requirements outlined for physicians and facilities. The policy requires treatment to be conducted within CMS-approved studies to continue gathering evidence on efficacy and safety. Medtronic and Recor Medical praised the decision, highlighting that it expands patient access to these minimally invasive, blood pressure-lowering procedures, which have demonstrated sustained blood pressure reductions and potential cardiovascular benefits. Additionally, the American College of Cardiology and American Heart Association have updated hypertension guidelines to include RDN as a treatment option for certain patients, reinforcing the therapy's growing acceptance.