Washington roundup.

Washington roundup

CMS withholds names of docs in study of ICD complications

A Medical Device Daily Staff Report

The Centers for Medicare & Medicaid Services (CMS; Baltimore) yesterday was expected to place on its web site data concerning tens of thousands of implantable cardioverter defibrillators (ICDs), in a move forced by a freedom of information (FOI) request by The New York Times.

At press time, however, the information was not on the web site, and Don McLeod, a spokesperson for CMS, told Medical Device Daily that he had been unable to obtain the information to disseminate to other publications, though he noted that the Times had obtained it via the FOI request. "It's complicated," he said, as explanation for the delay.

In its report on the data yesterday, the Times emphasized in its story that CMS was withholding identification of the doctors who had done the implant procedures, referencing Mark McClellan, head of CMS, who cited "legal and policy" concerns including the possibility that this would violate the privacy of patients.

According to the Times analysis of the implant data, about 4% of 45,000 patients experienced problems following implantation. These complications ranged from displacements of leads connecting the devices to …