Billings Hospital One of 51 Hospitals Nationwide to Pay More Than $23 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices
WASHINGTON – The Department of Justice announced today that it has reached settlements with 51 hospitals in 15 states for more than $23 million related to cardiac devices that were implanted in Medicare patients in violation of Medicare coverage requirements. Saint Vincent Healthcare in Billings is one of the hospitals included in the settlements. St. Vincent is part of the Sisters of Charity of Leavenworth Health System, based in Broomfield, CO, and is one of five Sisters of Charity hospitals that together paid 1.95 million under the settlements.
An implantable cardioverter defibrillator, or ICD, is an electronic device that is implanted near and connected to the heart. It detects and life-threatening heart rhythms, called fibrillations, by delivering a shock to the heart, restoring the heart’s normal rhythm. Only patients with certain clinical characteristics and risk factors qualify for an ICD covered by Medicare.
Medicare coverage for the device, which costs approximately $25,000, is governed by a National Coverage Determination (NCD). The Centers for Medicare and Medicaid Services implemented the NCD based on clinical trials and the guidance and testimony of cardiologists and other health care providers, professional cardiology societies, cardiac device manufacturers and patient advocates. The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. The medical purpose of a waiting period - 40 days for a heart attack and 90 days for bypass/angioplasty - is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary. The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD.
The settlements announced today follow similar agreements announced in October of 2015 in which the Department settled with 457 hospitals for more than $250 million. The settlements announced today represent the final stage of a nationwide investigation into the practices of hundreds of hospitals improperly billing Medicare for these devices. The case underlying the settlements was brought as a qui tam, or whistleblower, lawsuit under the False Claims Act. The investigation was part of the government’s Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which is a collaborative effort between DOJ and the Department of Health and Human Services. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. Since January 2009, the Justice Department has recovered a total of more than $27.4 billion through False Claims Act cases, with more than $17.4 billion of that amount recovered in cases involving fraud against federal health care programs. With these additional agreements, the Justice Department’s investigation has now yielded settlements with more than 500 hospitals totaling more than $280 million.
The settlements were the result of a coordinated effort among the DOJ’s Civil Division Commercial Litigation Branch, the U.S. Attorney’s Office of the Southern District of Florida and HHS-OIG’s Office of Investigations and Office of Counsel to the Inspector General. More information on the settlements announced today can be found at the DOJ’s Office of Public Affairs Website.
The claims resolved by these settlements are allegations only and there has been no determination of liability.
This lawsuit is captioned U.S. ex rel. Ford et al. v. Abbott Northwestern et al. No. 08-cv-20071 (S.D. Fla.)