Thursday, February 18, 2016

51 Hospitals Pay US More Than $23 Million to Resolute False Claims Act Allegations Regarded to Implantation of Cardiac Tools

The Department of Justice has gained settlements with 51 hospitals in fifteen states for more than $23 million regarded to cardiac devices that were implanted in Medicare sufferers in violation of Medicare coverage needs, the Department of Justice declared today.  These settlements reflect the final stage of a nationwide investigation into the practices of various hospitals improperly billing Medicare for these tools.  With these extra agreements, the Justice Department's investigation has now acquired settlements with more than 500 hospitals totaling more than $280 million.


"These settlements indicate the Department's sustained vigilance in attracting hospitals and health systems that breach Medicare's national coverage rules," stated Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division.  "We will hold accountable those who don’t abide by the rules of government in order to secure the federal fisc and, more significantly, sufferer health."


An implantable cardioverter defibrillator, or ICD, is an electronic tool that is implanted near and linked to the heart.  It tracks and treats chaotic, immensely fast, life-threatening heart rhythms, called fibrillations, by giving a shock to the heart, restoring the normal rhythm of heart.  It is same in function to an external defibrillator except that it is little enough to be implanted in a sufferer's chest.  Merely sufferers with few clinical characteristics and threat factors qualify for an ICD covered by Medicare.


Medicare coverage for the tool, which costs nearly $25,000, is governed by a National Coverage Determination (NCD).  The CMS (Centers for Medicare and Medicaid Services) implemented the NCD deployed on clinical trials and the instruction and testimony of cardiologists and other health care contributors, professional cardiology societies, cardiac device manufacturers and sufferer advocates.  The NCD offers that ICDs normally should not be implanted in sufferers who have now suffered a heart attack or recently had heart bypass surgery or angioplasty.  The medical intention of a waiting time - 40 days for a heart attack and 90 days for bypass/angioplasty - is to offer the heart a chance to make better function on its own to the point that an ICD may not be essential.  The NCD mostly prohibits implantation of ICDs during these waiting times, with few exceptions.  The Department of Justice alleged that from the time period of 2003 to 2010, each of the settling hospitals implanted ICDs during the times prohibited by the NCD.


"The settlements declared last October and today indicate the Department of Justice's devotion to secure Medicare dollars and federal health advantages," claimed U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida.  "Directed by a panel of leading cardiologists and the review of thousands of sufferers' charts, the extreme investigation behind the settlements was strongly impacted by evidence-based medicine.  In view of the number of defendants, this is one of the greatest whistleblower lawsuits in the US and represents 1 of this office's most important recoveries to date.   Our office will sustain to vigilantly secure the Medicare program from possible false billing claims."


"We won’t stand idly by while Medicare coverage rules are neglected," claimed Inspector General Daniel R. Levinson of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG).  "OIG worked closely with the Department of Justice to make certain such violators made substantial payments to fix these false billing claims."


The department initially settled with 457 hospitals for more than $250 million.


The settlements declared today include 51 hospitals, which are mentioned on the attached chart.  Many of the settling defendants were named in a qui tam, or whistleblower, lawsuit brought under the False Claims Act, which allows private people to bring lawsuits on behalf of the US and gain a section of the proceeds of any settlement or judgment granted against a defendant.  The lawsuit was submitted in federal district court in the Southern District of Florida by Leatrice Ford Richards, a cardiac nurse and Thomas Schuhmann, a health care reimbursement consultant.  The whistleblowers have acquired more than $3.5 million from the settlements declared today.


The settlements were the outcome of a coordinated attempt among the Civil Division's 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.


This settlement explains the government's emphasis on combating health care deception and marks another success for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was declared in the month of May 2009 by the Attorney General and the Secretary of Health and Human Services.  The partnership between the 2 departments has focused attempts to mitigate and stop Medicare and Medicaid financial fraud through modified cooperation.  One of the strongest tools in this attempt is the False Claims Act.  Since the month of 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 rate recovered in cases including deception against federal health care programs.


The claims solved by these settlements are allegations merely and there has been no indication of liability.


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