Comment to CMS Requesting a MEDCAC meeting for the EVOQUE Tricuspid Valve Replacement System
In a written comment to the Centers for Medicare & Medicaid Services, Dr. Robert Steinbrook, Health Research Director at Public Citizen, urged that CMS convene a meeting of MEDCAC as part of the National Coverage Analysis for the EVOQUE Tricuspid Valve Replacement System.
Date: 07/18/2024
As the Health Research Group Director at Public Citizen and a former member (2010-2012) of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), I write to urge the Centers for Medicare & Medicaid Services (CMS) to convene MEDCAC as part of the National Coverage Analysis for the EVOQUE Triscuspid Valve Replacement System. Public Citizen’s Health Research Group shares the significant concerns that have been raised about the evidence that is available for transcatheter tricuspid valve replacement. These concerns include the design of the TRICSEND II trial, which was unblinded and thus susceptible to bias and the placebo effect. The outcomes of the trial were evaluated at only 30 days and 6 months, with substantial missing data at 12 months. There was a high 30-day rate of major adverse events (27.4%) in the treatment group. Moreover, 12 out of 96 patients in the device group died by 12 months, as compared to 4 out of 54 patients in the control group.
MEDCAC is uniquely qualified to advise CMS about the available evidence to support the request for Medicare coverage of the EVOQUE System. We urge CMS to convene a MEDCAC meeting so that the evidence can be publicly presented and fully discussed before a coverage decision is made.