CMS To Release Data on Defibrillators
CMS on Monday plans to post data on its Web site on the outcomes of patients who have received implantable cardiac defibrillators but not on the performance of specific physicians and hospitals, the New York Times reports. CMS in early 2005 began requiring doctors who performed defibrillator implants to return forms with detailed patient data.
Doctors are expected to note if any of 16 specific complications occurred in patients receiving ICDs. The agency's records, obtained on Friday by the Times through a Freedom of Information Act request, indicate that about 4% of 45,000 patients had at least one complication during a 16-month period that ended in April.
The most frequent complications were blood clots and the displacement of a cable that connects the device to the heart. There were 131 reported cases of death, or about 0.3% of all procedures. CMS Administrator Mark McClellan said the agency decided not to release information on specific physicians or hospitals for legal and policy reasons, including concerns about disclosing the identity of patients.
McClellan said, "We are working on methods now to provide information at the physician and physician group level consistent with our statutory restrictions and our primary objective of protecting patient information."
CMS' decision to withhold physician data "could reignite a long-running debate over patient access to data that shows how complication rates for widely used procedures like heart device implants differ among doctors and hospitals," the Times reports.
The Times reports that "[s]ome heart device specialists said ... Medicare officials should make the doctor and hospital data available to patients. But they added that such raw data, to be useful, would have to be adjusted to reflect factors like whether a doctor treated significantly sicker patients who would be prone to complications."
Brian Olshansky, a heart device specialist at the University of Iowa, said, "It's like any other product. You want to know about the doctors that kill people and about the doctors that hurt people."
Matthew Reynolds, a researcher at Beth Israel Deaconess Medical Center, said, "I think that a lot of people in the clinical community are starting to embrace the idea" of public disclosure. "But there is also a lot of fear because a lot of hospitals that have different outcomes treat sicker patients," he added.
Reynolds also said that the 45,000 implants reported by CMS over 16 months was a low number, meaning that many doctors might just be beginning to report data to the agency (Meier, New York Times, 7/10).