Boston Scientific Settles Defib Suits
Just a month after saying it was prepared to go to trial, Boston Scientific decided to pay out $195 million to settle claims alleging that Guidant Corp. did not properly warn patients about potential harm associated with its defibrillators. Boston Scientific inherited the litigation when it bought Guidant for $27 billion in 2006. The settlement covers claims brought by 4,000 people that were consolidated in the U.S. District Court for the District of Minnesota. It also covers “an undetermined number—but not all—of additional similar claims throughout the country,” according to a statement by Boston Scientific. The settlement is much less than Boston Scientific had been banking on; the company had put aside $730 million to cover the litigation. “We are pleased by this resolution, which is in the best interest of all involved,” said Jim Tobin, Boston Scientific president and CEO, in a statement.
GAO Seeks Ultrasound Credentialing
The U.S. Government Accountability Office is urging the Centers for Medicare and Medicaid Services to consider requiring sonographers who provide Medicare-covered exams to be credentialed or to work in accredited facilities. The goal is to ensure consistent quality at a time when the cost of Medicare-covered imaging services nearly doubled, from $5.7 billion in 1999 to $10.9 billion in 2004. Much of the increase in volume and costs have been for cardiovascular-related exams, according to GAO's June 2007 report (GAO-07–734). The agency's analysis of 2005 Medicare claims found that three-quarters of the 41 million ultrasound exams covered were either echocardiograms (53% of procedures) or noninvasive vascular exams (20% of procedures).
MedPAC Imaging Report Slammed
The medical device industry trade group AdvaMed has issued a report questioning the conclusions of a Medicare Payment Advisory Commission survey on physician use of magnetic resonance imaging and computed tomography sent to Congress in mid-2006. The group said it was concerned that CMS might use the MedPAC report to set policy or pay rates. AdvaMed's report, conducted by United BioSource Corp. (UBC), claimed that MedPAC used flawed methodology. MedPAC surveyed 189 providers in 6 markets, but ultimately only included 80 providers. “The sample is far too limited to yield results that are acceptable for national estimates,” according to the UBC report. After comparing rates reported in the literature and conducting other analyses, UBC concluded that MedPAC's utilization estimates—100% or higher—“may be extraordinarily high, and there is uncertainty about what the true reasonable range is.”
Joint Commission Announces Goals
The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) will require health care institutions to take specific actions to reduce the risks of patient harm associated with the use of anticoagulant therapy as part of its 2008 National Patient Safety Goals. The new requirement applies to hospitals, ambulatory care and office-based surgery settings, and home care and long-term care organizations. The 2008 safety goals also include a new requirement that addresses the recognition of and response to unexpected deterioration in a patient's condition. Under this requirement, hospitals allow caregivers to directly request and obtain assistance from specially trained individuals if and when a patient's condition worsens. Full implementation of both requirements is targeted for January 2009.