ARTICLE SUMMARY:
The agency has opened a coverage analysis for the CardioMEMS sensor. Excerpted from Pathways’ Pick May 1 LDT Rule, AdComm Feedback, CardioMEMS Coverage, and Global Picks.
CMS opened a national coverage analysis for implanted pulmonary artery pressure sensors for heart failure management, in particular Abbott Laboratories’ CardioMEMSremote hemodynamic monitoring device. There is currently no national coverage policy for the technology, which was first approved by FDA in 2014. Abbott gained authorization for an expanded indication to manage earlier stage heart failure patients in February 2022. That approval was based on results from the GUIDE HF study, which the company says was designed with input from both FDA and CMS. CMS’ coverage analysis was initiated April 30 following a November 2022 request from Abbott. While CardioMEMS is currently the only approved device, a Medicare policy will likely impact future devices, including Endotronix’s Cordella PAsensor, which is currently under FDA review. Comments to CMS are due May 30 and a proposed decision is expected by the end of October.