The U.S. Justice Department is concerned that many implantable defibrillator surgeries performed on Medicare patients in hospitals across the nation may have used medical devices that were against the rules. Hundreds of ongoing investigations were sparked by these concerns, leading the federal agency to send urgent emails to numerous hospitals recently mandating that the suspect heart devices be subject to inspections.
The defibrillators are expensive, costing as much as $40,000 each, but are also vital to preserving a patient’s life. They are used to regulate heart rhythms in patients in whom their heart beats have become irregular. The Justice Department has questioned whether some of the hospitals have disregarded applicable rules concerning when such devices should be implanted in a patient. Some hospitals may have been motivated by the possibility of billing Medicare for the cost of the devices and the surgery to implant them.
Hospitals are being told to perform a self-audit of their performance of the surgeries and to estimate the penalties that they should be required to pay if they implanted the devices without either justification under the standard applicable rules or other good medical reasons to implant them outside the scope of what is ordinarily allowed under the rules.
Harsher penalties are possible if harm came to a patient as a result of non-standard procedures being followed, or if a statistical pattern at a particular hospital is demonstrated of routinely disregarding applicable rules on when to implant such devices. Additionally, hospitals could face medical malpractice lawsuits for wrongful performing the implant surgeries and causing harm to patients.
Source: ModernHealthCare.com, “Feds notify hospitals of liability for wrongly implanted heart devices,” Joe Carlson, Aug. 30, 2012