450 Hospitals Pay $250 Million in One of Nation's Largest False Claims Act Cases for Number of Defendants

Wednesday, November 11, 2015
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In an investigation that has spanned several years and is still ongoing, the Department of Justice (DOJ) has reached False Claims Act (FCA) settlements with more than 450 hospitals totaling $250 million over alleged improper billing of Medicare for unnecessary cardiac implants.  Many of the hospitals comprising the settlements are among the nation's leading health care chains, including Ascension Health and 32 of its affiliated hospitals, Community Health Systems, Inc. and 31 affiliated hospitals and HCA Holdings, Inc. and 42 of its affiliated hospitals.  In all, 43 states and 457 hospitals currently make up what has been termed one of the largest FCA cases in the nation's history regarding the number of defendants involved.  

To see a full listing of the settled hospitals, including Florida Hospital Orlando, click here.   

The FCA case which dates back to 2008, originated in Florida federal court and was initially filed by two whistleblowers (a cardiac nurse and a health care reimbursement consultant) who will now receive a $38 million share of the FCA recovery monies.  However, the case is not yet resolved, with many additional hospitals still undergoing investigation by the DOJ as to the alleged untimely and potentially unnecessary use of implantable cardioverter defibrillators (ICDs).

The Alleged Violation of Medicare Prescribed Waiting Periods.

ICDs are electronic devices implanted near the heart designed to offer internal shocks to thwart detected fibrillations (or life-threatening tachyarrhythmias) and restore the heart's normal rhythm.  Medicare prescribes a waiting period for the implantation of ICDs by way of the National Coverage Determination (NCD).  The NCD was implemented 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.  

Currently the waiting period is set at 40 days post heart attack and 90 days for a bypass/angioplasty.  The purpose of the waiting period is to allow the heart sufficient time to heal on its own thereby rendering the ICD unnecessary.  Hospitals and health care professionals are prohibited by the NCD from implanting ICDs during these time restraints, with certain exceptions which must be apparent in the patient's medical history profile.

For more information on the NCD for ICDs from the Centers for Medicare & Medicaid Services, click here

Each of the settling hospitals in this FCA case, are alleged by the DOJ as implanting ICDs in cardiac patients within the waiting periods expressly prohibited by the NCD.  Coverage for ICDs costs Medicare approximately $25,000 per device. 

Necessary or Not?

Section 3729, 31 United Stated Code (False claims) provides protection against any individual or corporation knowingly submitting or causing to be submitted or conspiring to submit false or fraudulent claims for reimbursement from federal health care programs.  Click here to read the law in its entirety.  In this case, it is alleged that the hospitals were knowingly providing medically unnecessary procedures in an effort to increase their billing to Medicare by not withstanding the waiting periods prescribed for the implantation of ICDs.  It is alleged that many of the ICDs may have proven unnecessary had the hospitals abstained from the procedures allowing the 40 or 90-day time periods to toll, providing for the patients' hearts to potentially heal on their own.  

Some of the hospitals involved in the settlements assert that the earlier timing of the implantations was necessary.  Further, some assert that the NCD is outdated denoting its issuance over a decade ago, and needs to be revised taking into account modern trends and technology in health care.  

Still, the head of the DOJ's Civil Division, Benjamin C. Mizer, maintains the department's position in a statement issued on Friday, October 30, 2015, in which he said, "While recognizing and respecting physician judgment, the department will hold accountable hospitals and health systems for procedures performed by physicians at their facilities that fail to comply with Medicare billing rules.  We are confident that the settlements announced [today] will lead to increased compliance and result in significant savings to the Medicare program while protecting patient health."  

To read the full press release issued by the DOJ, click here


What are your thoughts on National Coverage Determinations by CMS?  Have you ever faced allegations of improper billing for medically unnecessary treatments?

Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent health care providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S.  They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.


Department of Justice, Office of Public Affairs.  "Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices."  Press release.  Justice News: 30 Oct. 2015.  Web.  5 Nov. 2015.

Overley, Jeff.  "450 Hospitals Pay $250M in Sweeping FCA Probe."  Law360.  Portfolio Media, Inc.: 30 Oct. 2015.  Web.  2 Nov. 2015. 

About the Author:
George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida area.  www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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