Renal Denervation (RDN) for Uncontrolled Hypertension

CMS covers radiofrequency and ultrasound renal denervation only when performed per an FDA market-authorized indication and only within a CMS‑approved Coverage with Evidence Development (CED) study that meets specified patient, physician, facility, and study-design criteria. Patients must have documented uncontrolled hypertension (SBP >=140 and DBP >90) by ambulatory or home readings despite ≥6 weeks of stable, guideline-directed medical therapy and lifestyle measures, must have been coordinated in care for ≥6 months with ≥3 encounters, have no prior RDN, and have secondary causes evaluated; operators and facilities must meet training and program requirements and CED studies must satisfy registration, outcomes, comparator, subgroup, data‑sharing, and reporting requirements. RDN is explicitly not covered for patients outside a CMS‑approved CED study and for patients with device‑label contraindications.

"RDN (rfRDN or uRDN) is covered only when furnished according to an FDA market-authorized indication and all other coverage criteria in this policy are met."