CMS Approves Coverage for Renal Denervation in Uncontrolled Hypertension Under CED

On October 28, 2025, CMS issued a National Coverage Determination (NCD) for FDA-approved renal denervation (RDN) to treat uncontrolled hypertension.

This coverage is provided under Coverage with Evidence Development (CED), ensuring the therapy is furnished according to specific criteria outlined in the NCD. The decision supports the inclusion of renal denervation as a treatment option within Medicare when used in accordance with these requirements.

CMS identified studies meeting CED requirements, including the SPYRAL CARE study sponsored by Medtronic, which evaluates real-world outcomes of patients treated with Symplicity Renal Denervation plus standard care compared to standard care alone. These studies facilitate data collection to assess the efficacy and safety of RDN in the Medicare population.

This update reflects ongoing CMS efforts to integrate innovative, evidence-based treatments into Medicare coverage while balancing safety and clinical effectiveness. Insurance professionals should monitor CMS updates to understand evolving coverage standards and implications for provider reimbursement and patient access within hypertension management.