NATIONAL COVERAGE DETERMINATION
CMS Releases National Coverage Determination (NCD) Proposed Decision Memo for Renal Denervation for Uncontrolled Hypertension
On July 10, 2025, the Centers for Medicare and Medicare Services (CMS) posted the proposed decision memo for Renal Denervation (RDN) for Uncontrolled Hypertension (HTN) and is soliciting public comments on this life-changing therapy. CMS is proposing coverage with evidence development (CED) for FDA-approved indications of the Paradise® Ultrasound Renal Denervation System.
30-day public comment periond
As part of the National Coverage Determination (NCD) process, CMS has opened a 30-day public comment period. This is an opportunity for all stakeholders (physicians, hospital administrators, patients, professional societies, industry, etc.) to provide feedback to CMS on the proposed coverage and how it will impact access for hypertensive patients.
Join Recor Medical for a live webinar and make your voices heard.
Recor Medical is hosting a live Webinar to discuss the proposed coverage criteria how you can make your voice heard by CMS regarding the draft memo. Thursday, July 24th at 10am PT/1pm
Patient criteria
- Hypertension >140/90 mmHg despite active clinical management
- Diagnosis confirmed via ambulatory or home BP monitoring
- On stable, maximally tolerated GDMT (plus lifestyle changes) for ≥3 months
- Secondary hypertension evaluated and treated if appropriate
- No RDN contraindications (e.g. eGFR <40, pregnancy, renal artery issues, etc.)
- Managed by primary clinician ≥6 months with ≥3 visits (max 1 virtual)
- No prior RDN procedure
Referring clinician
- Referring clinicians must have ongoing responsibility for managing the patient’s HTN
Operator criteria
- RDN-performing physicians must have interventional/endovascular skills
Facility criteria
- Facility must have a multidisciplinary hypertension program, including a managing clinician, navigator, and specialists
- Must offer preprocedural imaging (e.g., ultrasound, CTA, MRA)
- Must have a suitable interventional cardiology or radiology suite
For more extensive descriptions about specific criteria, check out the proposed decision memo.
Comment Considerations
CMS will be accepting public comments until August 9, 2025, 11:59pm ET. Comments may be submitted through the CMS website. Below are some key points to consider including when submitting comments:
- Your name, profession and affiliation
- Description of your clinical practice and/or your institution’s relevant RDN experience including the Paradise System as appropriate
- Description of the clinical impact of RDN within your practice and/or at your institution
- Any access challenges faced by your center and the importance of improving access for patients to renal denervation with the Paradise System
- Any specific criteria you believe place an unnecessary burden on patient access
- Any specific criteria you support and believe should remain in the final NCD
Questions About the NCD?
Contact the Field Reimbursement Team reimbursement@recormedical.com
