FDAnews
www.fdanews.com/articles/200316-cvrxs-heart-failure-device-gains-cms-approval-for-incremental-payments

CVRx’s Heart-Failure Device Gains CMS Approval for Incremental Payments

December 7, 2020

The Centers for Medicare and Medicaid Services (CMS) has approved “transitional pass-through payment” status for CVRx’s BAROSTIM neuromodulation device for heart failure to take effect on Jan. 1.

Pass-through payments are amounts paid to Medicaid managed care plans as supplemental payments or “add-ons” to the base payment rate. Medicare makes the additional payments where cost considerations might limit patient access. The new designation for BAROSTIM allows for incremental payment for devices used in hospital outpatient and ambulatory surgery center settings.

BAROSTIM received premarket approval from the FDA in 2019 for reducing symptoms associated with heart failure in patients who suffer from a left ventricular ejection fraction of 35 percent or less.

View today's stories