ARTICLE SUMMARY:
CMS launched national coverage analyses for two device types. Excerpted from Pathways’ Picks January 15: Medicare Activity, EU Cybersecurity, UK Postmarket Guide, and More.
CMS has launched national coverage analyses (NCAs) for two device types within the past week. That’s unusually active for the Medicare Coverage and Analysis Group, which opened a total of four NCAs and completed just two NCDs in all of 2024. The two opened analyses are labeled as pilots testing the new Transitional Coverage for Emerging Technologies (TCET) program, which is designed to streamline the national coverage process.
Renal denervation. The long arc toward an established renal denervation market for hypertension continues with CMS’ decision to open an NCA for the procedure January 13. The move came in response to a December 12 request from Medtronic, which makes the radiofrequency-based Symplicity Spyral RDN System, approved by FDA in November and subject to claim-by-claim coverage. Medtronic has been working with CMS to pilot the TCET framework as a mechanism for establishing coverage of the device for uncontrolled hypertension, the company and agency confirmed. CMS’ coverage decision is also expected to impact Recor Medical’s Paradise ultrasound renal denervation system. “The scope of this NCA is limited to radiofrequency- and ultrasound-based renal denervation procedures,” CMS specifies. The agency is expected to issue a proposed decision by July 13.
Novel heart failure therapy. CMS also opened an NCA January 10 for a technology called cardiac contractility modulation (CCM) to treat heart failure. The action came in response to a request from Impulse Dynamics, which makes the Optimizer Smart Mini CCM device, FDA-approved as a heart failure therapy in 2019. Notably, while the agency turned around Medtronic’s renal denervation request within about one month, Impulse Dynamics sent its request to CMS more than two years ago, in May 2022. CCM delivers electrical stimulation to the heart muscle to increase the strength of the heart's contractions. A proposed NCD is due July 10.