A Medicare contractor last week said it would not cover the CardioMEMS implantable heart monitor made by St. Jude Medical (NYSE:STJ), citing the need for more clinical data on the device.
Novitas, a Medicare Administrative Contractor that covers patients in Pennsylvania, New Jersey, Maryland, Delaware, Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, Mississippi and and Washington, D.C., said it would not cover the CardioMEMS device, which is designed to monitor patients for signs of heart failure.
“Given the information made available in the public domain, there appears to be limitations with lack of long-term clinical outcomes, specific study limitations, and need for additional studies. At this time, Novitas considers this device investigational and considers this non-covered unless in an approved clinical trial,” the insurer said.
St. Jude acquired CardioMEMS for $435 million after the heart failure monitor won FDA approval in 2014.
Leerink Partners analysts Danielle Antalffy and Puneet Souda said the Novitas decision would be superseded by a national coverage decision by the Centers for Medicare & Medicaid Services, which is expected in September.
“CMS is likely to ultimately provide coverage for CardioMEMs, albeit with restrictive language around patient selection potentially mirroring inclusion/exclusion criteria in the Champion clinical trial,” the analysts wrote in a note to investors yesterday.
In November 2015, St. Jude put another brick in the wall of its defense of the CardioMEMS device, with data from the Champion trial showing lower hospitalization rates for patients treating using data from the CardioMEMS device.
In September 2015, a study from the non-profit Institute for Clinical and Economic Review in Boston found that the CardioMEMS device may not be a cost-effective solution for patients with congestive heart failure, saying it’s priced about $10,000 higher than ICER’s “value-based price benchmark” of $7,622.