CMS Approves Transitional Pass-Through Payments for Renal Denervation Systems from Medtronic and Recor Medical

CMS Approval:
The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payments for renal denervation (RDN) systems from Medtronic and Recor Medical, effective January 1, 2025, for up to three years.

Device Details:

Recor Medical’s Paradise Ultrasound RDN System:
Uses ultrasound energy to denervate the sympathetic nerves surrounding the renal arteries, reducing overactivity that can lead to hypertension. It was the first RDN system for hypertension to gain FDA approval in November 2023.

Medtronic’s Symplicity Spyral RDN System:
Uses radiofrequency energy to calm excessive nerve activity associated with the kidneys. It was approved by the FDA in November 2023, shortly after Recor Medical’s system.

New Device Category and Code: CMS created a new device category and code (C1736:
Catheter Renal Denervation, Ultrasound) specifically for Recor Medical’s Paradise Ultrasound RDN System, recognizing its differentiated technology.

Impact:
The TPT payments aim to support patient access to new and innovative technologies by reducing cost barriers for healthcare systems. Both companies see this as a significant step forward in expanding patient access to these breakthrough treatments for uncontrolled high blood pressure.

Previous Reimbursement:
Both systems had previously received New Technology Add-On Payments (NTAP) for inpatient procedures, effective October 1, 2024, providing additional reimbursement on top of the regular Medicare Severity Diagnosis Related Group payment.