CMS Greenlights Reimbursement for Renal Denervation Systems

The US Centers for Medicare & Medicaid Services (CMS) has issued a final national coverage determination (NCD) on radiofrequency- and ultrasound-based renal denervation (RDN) for the treatment of uncontrolled hypertension.

As expected, the procedure will be reimbursable under the coverage with evidence development (CED) process, which requires treatment within the context of a CMS-approved study designed to continue building real-world clinical evidence for the therapy.

The Food and Drug Administration-approved devices covered under the NCD are the radiofrequency-based Symplicity Spyral system (Medtronic) and the ultrasound-based Paradise system (Recor Medical), both approved in 2023.

Eligible patients must have a diagnosis of uncontrolled hypertension (> 140 mm Hg/90 mm Hg) despite active management by a clinician with primary responsibility for BP management.

Prior to referral for RDN, patients should attempt lifestyle modifications and been on stable doses of maximally tolerated guideline-directed medical therapy (GDMT), with assessment of adherence, for at least 6 weeks. This differs from the proposed coverage decision issued in July 2025, which had indicated that patients should be on GDMT for at least 3 months before referral.

Further patient assessment steps prereferral should include testing and treatment of secondary causes of hypertension. At a minimum, the NCD says patients should be screened for primary aldosteronism, obstructive sleep apnea, and drug- or alcohol-induced hypertension. Additionally, “primary clinicians must coordinate management of the patient for a minimum of 6 months before referral for RDN, during which the patient had at least three encounters, with no more than two of the three encounters being virtual,” the NCD notes.

The document also spells out the necessary physician criteria, which includes assuming longitudinal responsibility for hypertension management for referring physicians, and at least 10 supervised cases of diagnostic/therapeutic renovascular procedures, half as primary operator, for RDN practitioners. Anyone performing RDN also must complete at least five proctored cases with each approved device used in their practice.

The NCD also lays out criteria for facilities that perform RDN procedures, which includes a mandate that they have a hypertension program and “a hypertension clinician with longitudinal patient management responsibility, a hypertension navigator, and access to relevant medical specialties (eg, internal medicine, endocrinology, sleep medicine, cardiology, and nephrology) as appropriate.”