Hospitals, DOJ Settle Over Cardiac Device Dispute
By Jonathan Springston, Associate Managing Editor, AHC Media
The Department of Justice (DOJ) announced Wednesday that is has reached settlements with 51 hospitals in 15 states for more than $23 million related to cardiac devices implanted in Medicare patients in violation of Medicare coverage requirements. The DOJ says these settlements conclude a nationwide investigation into hundreds of improper billings for these devices. In October, the DOJ settled with 457 hospitals in 43 states for more than $250 million.
An implantable cardioverter defibrillator (ICD) is an electronic device implanted near and connected to the heart, detecting and treating life-threatening heart rhythms, and only certain patients meeting particular characteristics qualify.
A National Coverage Determination (NCD) governs Medicare coverage for the device, which costs about $25,000. The NCD says surgeons should not implant an ICD in a patient who recently suffered a heart attack or who recently underwent bypass surgery or angioplasty so that the heart may improve on its own, thus eliminating the need for an ICD.
The DOJ alleged that from 2003-2010, each settling hospital implanted ICDs within 40 days after a heart attack or within 90 days after a bypass or angioplasty, a violation of NCD rules.
“The settlements announced last October and [Wednesday] demonstrate the DOJ’s commitment to protect Medicare dollars and federal health benefits,” U.S. Attorney Wilfredo A. Ferrer of the Southern District of Florida, said. “Guided by a panel of leading cardiologists and the review of thousands of patients’ charts, the extensive investigation behind the settlements was heavily influenced by evidence-based medicine. In terms of the number of defendants, this is one of the largest whistleblower lawsuits in the United States and represents one of this office’s most significant recoveries to date.”
In the March issue of Clinical Cardiology Alert, Cara Pellegrini, MD, examines a propensity-matched study that found that women who received a primary prevention ICD had a significant survival advantage, which was similar to that observed among men.