CMS proposes Medicare coverage for renal denervation
The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed providing Medicare coverage on a national level for the use of renal denervation (RDN) to treat uncontrolled hypertension. The proposal covers both ultrasound RDN and radiofrequency RDN.
Hypertension is common throughout the United States, affecting nearly one-half of the country’s population, but medications often fall short when managing these patients. RDN is a minimally invasive procedure that involves using ultrasound or radiofrequency pulses to target certain points in a patient’s renal arteries. One recent analysis suggested approximately 35 million U.S. patients may be eligible for RDN.
This proposal, if finalized, would dramatically increase patient access to RDN. Decisions on whether or not to cover RDN are currently made on a case-by-case basis, but this would mean it is consistently covered on a national level.
The use of RDN for uncontrolled hypertension has gained significant momentum in recent years. Recor Medical's Paradise Ultrasound RDN system was the first to receive U.S. Food and Drug Administration (FDA) approval in November 2023, and then Medtronic’s Symplicity Spyral RDN system followed suit just a few weeks later.
Medtronic officially requested a national coverage determination (NCD) for RDN in 2024, and CMS confirmed it was considering the possibility in early 2025.
Paradise Ultrasound image courtesy of Recor Medical.
Recor Medical, Medtronic celebrate CMS proposal
Both Recor Medical and Medtronic have shared their support of the CMS proposal.
“We are encouraged by CMS’s proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need,” Lara Barghout, CEO of Recor Medical, said in a statement. “This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.”
“The proposed NCD from CMS—as it stands today—will provide many U.S. Medicare patients in need with access to RDN,” Jason Weidman, senior vice president and president of Medtronic’s coronary and renal denervation business, noted in a separate statement. “We recognize and thank CMS for their ongoing efforts in creating new pathways to expedite access to breakthrough technologies.”
Click here for the full proposal. CMS is accepting public comments until Aug. 9. A final decision is expected by October.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.