CMS Initiates NCA on Renal Denervation for Uncontrolled Hypertension

January 13, 2025—Medtronic and Recor Medical, Inc. separately announced that the Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA; CAG-00470N) on renal denervation (RDN) for uncontrolled hypertension. CMS’s expected completion date for the NCA is October 11, 2025.

Both companies noted that the NCA process will allow the agency to review and develop a national Medicare coverage policy in a National Coverage Determination (NCD) for RDN procedures to treat patients with hypertension.

Medtronic’s Symplicity Spyral RDN system, which uses radiofrequency energy, received FDA approval on November 17, 2023. Medtronic stated that the device has been evaluated in the SPYRAL-HTN clinical program, which includes a large real-world registry.

FDA approval of Recor’s Paradise ultrasound renal denervation (uRDN) was announced by Recor and its parent company, Otsuka Medical Devices Co., Ltd., on November 7, 2023. Recor noted it has initiated the United States Global Paradise System postapproval study to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension.

According to the CMS tracking sheet, the agency received a complete, formal request from Medtronic to provide coverage for RDN. CMS stated that the scope of the NCA is limited to radiofrequency- and ultrasound-based RDN procedures.

This is a Transitional Coverage for Emerging Technologies (TCET) pilot that tested the processes and concepts of TCET, noted CMS.

CMS advised that the NCA is focusing on the clinical indications for use of RDN among Medicare beneficiaries. It 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.

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

The 30-day public comment period begins with the posting date (January 13, 2025) and ends after 30 calendar days. Instructions on submitting comments can be found here.

On November 1, 2024, Medtronic and Recor independently announced that CMS granted transitional pass-through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System for the companies’ respective RDN devices to treat hypertension. The TPT payment will be effective for up to 3 years beginning January 1, 2025.