The Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) of renal denervation, with a view to reviewing and developing a national Medicare coverage policy for the therapy for patients with hypertension.
The expected completion date for the national coverage analysis is 11 October 2025. Until a national coverage determination is put into effect, renal denervation procedures will continue to be evaluated for coverage based on medical necessity for individual Medicare patients.
This latest news follows the announcement in late 2024 that CMS had granted transitional pass-through (TPT) payment for Medtronic’s Symplicity Spyral renal denervation (RDN) catheter and Recor Medical’s Paradise ultrasound RDN (uRDN) system.
TPT payment, which is effective for up to three years beginning 1 January 2025, aims to support patient access to new and innovative technology.
Both the Medtronic and Recor Medical renal denervation systems gained US Food and Drug Administration approval in November 2023. Medtronic‘s Symplicity Spyral system is a minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure, whilst the Paradise system is an ultrasound-based technology.
In a press release, Medtronic says that the national coverage analysis was initiated by CMS in response to its request to support Medicare beneficiary access to the Symplicity Spyral system.
“Hypertension is a global health epidemic that impacts a wide variety of patients,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “As the leader in developing a minimally invasive treatment option for hypertension, Medtronic has been closely engaged with CMS to establish a national coverage pathway for Symplicity Spyral. We appreciate CMS’ efforts in creating new pathways to expedite access to breakthrough technologies like Symplicity Spyral and look forward to our continued partnership in developing a national coverage policy.”
Recor Medical has similarly welcomed the commencement of the analysis, describing it as the first step in the National Coverage Determination (NCD) process towards the potential expansion of coverage of the Paradise system among Medicare beneficiaries.
In a press release, Recor states that it appreciates CMS’ consideration of potential national coverage of renal denervation as a hypertension treatment option for Medicare beneficiaries and will continue to work closely with CMS throughout the NCD process.
