ARTICLE SUMMARY:
In this week’s Pathways Picks: CMS steps up national coverage efforts; the EU issues a cybersecurity action plan; MedTech Europe reports industry survey results; the UK MHRA publishes new guidance on its impending postmarket surveillance requirements; FDA recognizes new sterilization standards and updates modular review guidance to include HDEs; and more global medtech policy updates.
Medicare Picks
Active week in CMS coverage group:
CMS has launched national coverage analyses (NCAs) for two device types and finalized a national coverage determination (NCDs) for another technology, all 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. Here’s a look at the three recent actions:
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.
