A recent massive settlement between 457 hospitals spread across 43 states and the Department of Justice (DOJ) has culminated with the medical providers agreeing to pay $257 million. Cardiac devices implanted into Medicare patients in violation of coverage restrictions constituted the impetus for the qui tam action. The DOJ settlement involved almost seven dozen hospital systems, including some of the nation’s largest health care systems.
The False Claim action was filed pursuant to an extensive investigation regarding excessive implantation of implantable cardioverter defibrillators (ICDs). ICDs are implanted in the chest in the vicinity of the heart. When the patient experiences dangerously rapid fibrillations, the medical device provides an electrical shock designed to restore the heart’s normal rhythm. While Medicare does provide coverage for implantation of the device, the public insurance program specifies detailed risk factors and clinical indications that determine coverage.
The criteria that dictate eligibility are governed by the National Coverage Determination (NCD) system. This protocol was adopted by the Centers for Medicare and Medicaid Services and uses a range of information to verify that treatment under the publicly funded medical program is based on scientifically established medical diagnostic and treatment regimens that are “reasonable and necessary.” The information relied on under the NCD in making this determination regarding ICDs included but was not limited to the following:
- Testimony & recommendations of cardiologists and other medical professionals
- Clinical trials
- Patient advocacy groups
- Manufacturers of cardiac medical devices
- Professional cardiac societies
The False Claims lawsuit was filed based on implantation in patients where use of the device was expressly excluded under the NCD. The restrictions prohibited implantation in patients who have undergone a recent angioplasty or bypass surgery. Implantation also is not authorized for patients who have suffered a recent heart attack. While patients that fit these criteria can receive the heart implants, a waiting period of forty days must be observed after a patient has suffered a heart attack. This waiting period is ninety days for patients who have undergone an angioplasty or bypass surgery. The rationale for this delay is to ensure the heart has time to recover before undergoing the implantation procedure.
The qui tam settlement involved hospitals that performed these heart implant procedures between 2003 and 2010 without observing the mandated waiting period. The qui tam action was filed by a cardiac nurse and health care reimbursement consultant. The whistleblowers were awarded in excess of $38 million out of the settlement amount.
At Barrett Law, we know that whistleblowers often have concerns about retaliation that might dissuade disclosure of improper medical billing and fraud. However, our Mississippi Qui Tam Lawyers work diligently to protect our clients from such acts under applicable state and federal laws. Further, we work closely to ensure that our client’s degree of involvement and cooperation in pursuing a recovery results in an appropriate award. We invite you to contact our firm today at (800) 707-9577 to schedule your free consultation, so we can answer any questions you may have regarding your qui tam lawsuit.