NATIONAL COVERAGE DETERMINATION
CMS Issues National Coverage Determination (NCD) for Paradise® Ultrasound Renal Denervation System for Uncontrolled Hypertension
On October 28, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a NCD for renal denervation (RDN) therapy, including Recor Medical’s Paradise Ultrasound Renal Denervation system.
This is a major milestone for patients and providers, opening the door for broader access to the Paradise System. The NCD is a formal CMS decision establishing coverage for Medicare beneficiaries, with specific requirements for patients, facilities, and physicians. Coverage applies to all Medicare fee-for-service and Medicare Advantage patients.
Patient Coverage Criteria
A. Uncontrolled hypertension SBP ≥140 mmHg & DBP ≥90 mmHg despite active clinical management
B. Diagnosis confirmed via ambulatory BP monitoring or serial home BP readings
C. On stable, maximally tolerated GDMT for ≥6 weeks
D. Secondary hypertension evaluated and treated if appropriate
E. No RDN contraindications consistent with the FDA labeling of the device used
F. Coordination managed by primary clinician ≥6 months with at least 3 visits, of which 2 can be virtual
G. No prior RDN procedure
See the full policy including physician and facility criteria here.
Medicare fee-for-service and Medicare Advantage procedures must meet all the criteria outlined in the NCD to qualify for reimbursement.
Get a copy of the Paradise Ultrasound RDN System Clinical Checklist. The clinical information highlighted in this checklist is derived from CMS’ National Coverage Determination for Renal Denervation for Uncontrolled Hypertension, and help physician gather information in connection with an HTN diagnosis.
See the full policy including physician and facility criteria here.
Questions About the NCD?
For additional information read Recor Medical’s press release “CMS Issues National Coverage Determination for Recor Medical’s Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension.”
Contact the Field Reimbursement Team reimbursement@recormedical.com
