MEDICARE COLLABORATES WITH DOCTORS ON ICD SAFETY
Medicare is planning to work with the American College of Cardiology to collect data nationwide to help learn more about the use of implantable cardioverter defibrillators (ICDs) for primary prevention of sudden cardiac death among Medicare beneficiaries, the Centers for Medicare & Medicaid Services announced recently.
CMS is contracting with the American College of Cardiology to implement a National Cardiovascular Data Registry, which will collect information on ICDs from 1,300 hospitals nationwide. The database will be active starting April 1, 2006.
CMS expanded Medicare coverage in January to increase the number of beneficiaries eligible for ICDs by one-third to nearly 500,000. The agency is requiring hospitals to submit data to the registry as a criterion of coverage.
"These efforts are a part of CMS' Coverage with Evidence Development initiative, which helps ensure that patients receive access to important treatments while facilitating the collection of evidence so that doctors and patients are able to get the most benefits with the least side effects," CMS Administrator Mark McClellan said.
This effort comes as the Department of Justice has subpoenaed the three largest manufacturers of ICDs regarding device safety concerns and questions about their sales practices. Medtronic, Guidant and St. Jude Medical recently reported the U.S. Attorney's Office in Boston had issued subpoenas requesting documents on cardiac devices, components, and monitoring equipment and services.
Medtronic also noted the subpoena sought documents related to "a provision of benefit, if any, to persons in a position to recommend purchases of such devices; and the company's training and compliance materials relating to the fraud and abuse and anti-kickback statutes."