National Coverage Analysis (NCA) Tracking Sheet

Renal Denervation for Uncontrolled Hypertension

CAG-00470N

Issue

High blood pressure, or hypertension, happens when the force of the blood pushing against the walls of blood vessels is too high. Hypertension can lead to serious problems such as heart attack and stroke. Renal denervation (RDN) is a new technology that uses catheters placed into the renal (kidney) arteries to ablate, or destroy, the renal sympathetic nerves to reduce blood pressure. RDN is intended to complement medications and lifestyle changes in patients with uncontrolled hypertension.

CMS received a complete, formal request to provide coverage for RDN. This is a Transitional Coverage for Emerging Technologies (TCET) pilot that tested the processes and concepts of TCET.

This NCA will focus on the clinical indications for use of RDN among Medicare beneficiaries. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from RDN and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies. Outcomes of interest may include office blood pressure, ambulatory blood pressure, nephroprotection, stroke, heart failure, decreased mortality, decreased emergency room or hospital admissions, and quality of life. The scope of this NCA is limited to radiofrequency- and ultrasound-based renal denervation procedures.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of RDN. We are also interested in health disparities and equity aspects that should be considered in the review.

National Coverage Determinations

Benefit Category

Ambulatory Surgical Center Facility Services
Incident to a physician's professional Service
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Medtronic View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/13/2025
Expected NCA Completion Date
10/11/2025
Public Comment Period
01/13/2025 - 02/12/2025
Proposed Decision Memo Due Date
07/13/2025
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Lori Ashby
Lori.Ashby@cms.hhs.gov
410-786-6322
Lead Medical Officers
Steven Farmer, MD, PhD

Medicare Benefit Category Determination Date

Actions Taken

January 13, 2025

CMS initiates this national coverage analysis for Renal Denervation (RDN) for Uncontrolled Hypertension. The 30-day public comment period begins with this posting date and ends after 30 calendar days. CMS considers all public comments and is particularly interested in clinical studies and other scientific information relevant to the topic under review. We are also interested in health disparities and equity aspects that should be considered in the review.

Instructions on submitting comments can be found at:https://www.cms.gov/medicare/coverage/determination-process/public-comments. To submit a comment, please use the blue "Comment" button at the top of the page. Enter comments directly into the “Submit A Public Comment” webpage.