Health Law & Policy Matters Health Care Attorneys | Mintz Levin Law Firm

Category Archives: State & Federal Audits, Investigations & Litigation

Subscribe to State & Federal Audits, Investigations & Litigation RSS Feed

Health Care Enforcement Defense Practice Publishes Most Recent Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Our Health Care Enforcement Defense Practice has published its most recent Qui Tam Update analyzing 68 recently unsealed health care related whistleblower cases. In this issue, the team analyzes overall trends in the 68 cases, and looks more closely at three notable cases. First we review a settlement that resulted in Arizona’s largest-ever False Claims Act recovery – the… Continue Reading

Hospital Executive Pleads Guilty to False Meaningful Use Attestation for EHR Incentive Payments

Posted in State & Federal Audits, Investigations & Litigation

Written by: Sarah Beth Smith and Laurence J. Freedman The former CFO of Shelby Regional Medical Center, Joe White, pleaded guilty to knowingly making a false statement related to the hospital’s meaningful use of electronic health records (“EHR”).  Shelby Regional had received $785,655 in meaningful use incentive payments from Medicare for fiscal year 2012. White faces sentencing of… Continue Reading

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

Written by: Laurence J. Freedman and Samantha P. Kingsbury Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud… Continue Reading

Hospital Alliance Deemed a Single Entity, Incapable of Conspiring

Posted in Antitrust, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

On October 21, 2014, the U.S. District Court for the Southern District of Ohio granted Defendants’ motion for summary judgment, holding that Premier Health Partners and its affiliate hospitals, Atrium Health Systems, Catholic Health Initiatives, MedAmerica Health Systems, Samaritan Health Partners, and Upper Valley Medical Center, operating under a joint operating agreement, constituted a single… Continue Reading

Managing Antitrust Risks in Pre-Transaction Planning

Posted in Health Care Reform, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Payors & PBMs, Pharma & Medical Devices, Physicians, State & Federal Audits, Investigations & Litigation

Dynamic changes in the nation’s health care delivery systems have been prompted, in part, by the implementation of the Patient Protection and Affordable Care Act (“ACA”).  In the wake of the ACA, hospitals and other health care industry participants have been undergoing significant consolidation.  Health care antitrust enforcers continue to closely scrutinize health care transactions… Continue Reading

Fraud and Abuse Waivers for MSSP ACOs Extended Another Year

Posted in Accountable Care Organizations, Fraud & Abuse, Physicians, State & Federal Audits, Investigations & Litigation

Written by:  Stephanie D. Willis Fridays are for fraud and abuse news-related releases, yet again.  Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule regarding applicable fraud and abuse law waivers for ACOs participating in the Medicare Shared… Continue Reading

Mintz Levin’s Health Care Qui Tam Update

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Kimberly J. Gold Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 65 recently unsealed health care–related qui tam cases, with an in-depth look at six cases. The six featured cases are: United States ex rel. Fox Rx, Inc. v. Managed Health Care… Continue Reading

Supreme Court Examines Boundaries of Antitrust Immunity

Posted in Antitrust, State & Federal Audits, Investigations & Litigation

On October 14, 2014, the US Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services. The question under consideration… Continue Reading

Front End Changes and, Again, More DIR Columns

Posted in Payors & PBMs, Pharma & Medical Devices, Pharmacies, Reimbursement, State & Federal Audits, Investigations & Litigation

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members.  The tool CMS has turned to most often is the direct and indirect remuneration (“DIR”) report.  The stated purpose of DIR reporting… Continue Reading

Life Care Centers Seeks Sixth Circuit Review of Decision Allowing Statistical Sampling/Extrapolation in FCA Case

Posted in Fraud & Abuse, Long-term Care/Skilled Nursing Facilities, State & Federal Audits, Investigations & Litigation

Written by Larry Freedman, Samantha Kingsbury, and Ellyn Sternfield  Last week, we posted about U.S. District Court Judge Harry Mattice’s September 29th ruling that government attorneys could extrapolate from a small sample of patient admissions to over 50,000 patient admissions (and over 150,000 claims) by Life Care Centers of America, Inc. (a nursing home operator) to try to… Continue Reading

The Supreme Court Continues to Punt on False Claims Cases

Posted in Clinical Trials & Research/FDA, Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA).  I first wrote about the case of U.S. ex rel. Ge v. Takeda in August 2013, when the U.S. had appealed a… Continue Reading

Federal Judge Rules to Allow Extrapolation on More Than 50,000 Patient Admissions in FCA Case

Posted in Fraud & Abuse, Long-term Care/Skilled Nursing Facilities, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by:  Ellyn L. Sternfield and Samantha P. Kingsbury Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the… Continue Reading

Antitrust Article Examines FTC’s Recent Scrutiny of Quality of Care Efficiency Defenses in M&A Activity

Posted in Antitrust, Health Care Reform, Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, State & Federal Audits, Investigations & Litigation, Uncategorized

Written by: Stephanie D. Willis Dionne Lomax and Helen Kim, our colleagues in the Antitrust Practice, have authored an article in Competition Policy International’s September 2014 edition of the Antitrust Chronicle observing that, even in the wake of the Affordable Care Act, which is intended to encourage efficiencies in health care delivery to improve health care quality overall, the… Continue Reading

A Cautionary Tale for Companies With Potential False Claims Act Exposure

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by: Heidi Lawson and Danny Harary A False Claims Act suit can be a company’s worst nightmare, as it may potentially result in large settlements and awards on account of the statute’s trebled damages provision.  However, the nightmare for AmerisourceBergen was compounded by the fact that the company’s insurer, ACE, denied coverage for the claim… Continue Reading

Department of Justice Criminal Division Will Increase its Review of False Claims Act Cases for Criminal Prosecution

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Written by Laurence J. Freedman and Samantha P. Kingsbury On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced that her office will be stepping up its review of False Claims Act (FCA) qui… Continue Reading

Upcoming Webinar on September 23, 2014: What Your Company Needs to Know to Protect Itself from FCPA Liability

Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & Litigation

Please join us on September 23rd, 2014 at 1:00 p.m. for a webinar where we’ll discuss the recent statements from the Department of Justice and the U.S. Securities and Exchange Commission describing the susceptibility of pharmaceutical and medical device companies in regards to FCPA enforcement. Key questions that will be addressed include: Why does the… Continue Reading

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

Posted in Fraud & Abuse, Payors & PBMs, Pharma & Medical Devices, Pharmacies, State & Federal Audits, Investigations & Litigation

Written by:  Tara E. Swenson Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations.  While manufacturers are likely not out from underneath the microscope, it seems as though the lens may have shifted… Continue Reading

Acute Care Hospitals Settle FCA Lawsuits for $98 Million

Posted in Fraud & Abuse, Hospitals & Health Systems, State & Federal Audits, Investigations & Litigation

Written by Brian Dunphy and Larry Freedman Community Health Systems, Inc. (CHS) and Community Health Systems Professional Services Corporation, together a national owner and operator of acute care hospitals, and 119 of their hospitals, agreed to pay $98 million to settle seven False Claims Act (FCA) lawsuits filed by qui tam relators around the country.  The… Continue Reading

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

Posted in Clinical Laboratories, Fraud & Abuse, Hospitals & Health Systems, Long-term Care/Skilled Nursing Facilities, Physicians, State & Federal Audits, Investigations & Litigation

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former employee, Kevin P. McDonough.  McDonough accused Mobilex of underpricing imaging services supplied to Medicare Part A beneficiaries so that… Continue Reading

New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

Posted in Clinical Laboratories, Fraud & Abuse, State & Federal Audits, Investigations & Litigation

The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals.  This legislation (the “Bill”) originally proposed by the Attorney General’s office was intended to combat self-referral arrangements between clinical laboratories and sober houses under common ownership, but it extends beyond such… Continue Reading

Corporate Practice of Medicine: An Old Doctrine Breathing New Life

Posted in Hospitals & Health Systems, Payors & PBMs, Physicians, State & Federal Audits, Investigations & Litigation

Written by: Bridgette A. Wiley Many states prohibit or limit the corporate practice of medicine (CPOM), either through statute or common law.  These states generally bar a business corporation from practicing medicine or employing a physician to provide professional medical services.  As a matter of public policy, the CPOM doctrine intends to ensure that medical… Continue Reading

D.C. Circuit Affirms That Internal Investigation May Be Protected By the Attorney-Client Privilege

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

A recent decision from the D.C. Circuit Court of Appeals reaffirmed that a company’s internal investigations—if structured properly—are protected from disclosure in litigation by the attorney-client privilege. As discussed in Mintz Levin’s Employment Matters blog, the court’s decision In re: Kellogg, Brown, and Root, Inc. has significant practical application, especially for health care companies, which… Continue Reading

OCR Confirms that Medical Records Should Not be Left in the Driveway

Posted in Hospitals & Health Systems, Mergers, Acquisitions & Other Transactions, Physicians, Privacy & Security/HIPAA/HITECH, State & Federal Audits, Investigations & Litigation

Written by:  Dianne J. Bourque The most recent Office for Civil Rights (“OCR”) HIPAA enforcement action serves as an important reminder to health care providers of the security risks associated with a mishandled medical records custody transfer and the risks of leaving paper records in the driveway.  The enforcement action and ensuing settlement – an… Continue Reading

Can a Relator Be Held Liable for Using Confidential Company Documents to Support a Qui Tam Case?

Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation

Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a decision in Walsh et al. v. Amerisource Bergen Corp. et al denying the Relator’s motion to dismiss a counterclaim that alleged the Relator breached a confidentiality agreement by filing the underlying qui tam case.  Although courts have differed on whether enforcing confidentiality agreements runs counter to… Continue Reading