Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect:

  • The government intervened in 14% of those unsealed cases (a figure that is consistent with the longer-term trends we have seen over the prior twelve months).
  • Of the 60 unsealed cases, only 28 were being litigated (at least initially). The remaining 32 cases were docketed as closed or dismissed.
  • The 60 unsealed cases were filed in 38 different courts. Jurisdictions with the most unsealed cases included:
    • The Central District of California (which includes Los Angeles) with six cases;
    • The Middle District of Florida (which includes Jacksonville, Orlando, and Tampa) with 4 cases; and
    • The District of Connecticut and Eastern District of Louisiana (New Orleans), each with 3 cases.
  • The most frequently targeted types of defendants included:
    • Pharmaceutical companies, hospitals, and healthcare systems, with each accounting for 9 of the 60 unsealed cases.
    • Physicians and physician group practices, which were targeted in 7 cases.
    • Home health and hospice providers, which were the subject of 6 cases.
    • Outpatient clinics, which were defendants in 5 cases.
  • Former employees were again the most frequent relator type, accounting for 23 of the 60 unsealed cases. Expert witnesses brought 7 cases and current employees brought 2 cases.
  • Only one of the cases was unsealed within the 60-day period specified by statute. That case was under seal for 55 days.
  • The longest time a case was under seal was almost eight-and-a-half years. Average time under seal for this cohort was 700 days, though half of these cases were unsealed in 16 months or less, and 23 of these 60 cases were unsealed in less than a year.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

Mintz Levin’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.  Highlights from this Update include:

  • a relatively high rate of intervention;
  • cases filed in 30 different courts;
  • cases brought against a variety of different health care providers;
  • almost half of the cases filed by current or former employees; and
  • faster times for unsealing cases.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Releases New Qui Tam Update

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners.  Among the factors that may have resulted in the uptick in cases against individuals are the Yates Memo issued in late 2015, improved and increased reliance on sophisticated data analytics, and the aggressive focus on opioid addiction and its causes. Continue Reading Health Care Enforcement Review and 2018 Outlook: Criminal and Civil Enforcement Trends

The volume of health care–related qui tam litigation under the False Claims Act (FCA) remained robust in 2017.  Based on our review of the data in Mintz Levin’s Health Care Qui Tam Database, we identified over 150 qui tam lawsuits that were unsealed in the twelve months ended November 30, 2017.  This post, which is the first in our Health Care Enforcement Review and 2018 Outlook series, discusses a number of interesting trends. Continue Reading Health Care Enforcement Year in Review and 2018 Outlook: Trends In Health Care False Claims Act Cases

Earlier this week, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update. This Update covers 34 health care-related qui tam cases that were unsealed in July 2017.

Here are some of the highlights:

– Of the 34 cases unsealed in July 2017, the government intervened (in whole or in part) in six cases and declined to intervene in 28.

– These 34 unsealed cases were filed in 21 different courts, including:

  • Five in the Southern District of Ohio;
  • Three in the District of Arizona; and
  • Three in the Western District of Virginia.

Continue Reading Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year.  Join our upcoming webinar – “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET. Colleagues in our Health Care Enforcement Defense Practice Group will help companies better understand how to deal with FCA cases, which result in billions of dollars of recovery for the government each year.  Hope Foster, Larry Freedman, Karen Lovitch and Ellyn Sternfield will share insights to the relator process, help companies understand how to react if it is named in a whistleblower suit, and provide tips for how to prevent them.

Register now!

Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update on August 4, 2016. This Update covers 31 health care-related False Claims Act cases that have been unsealed since the last Health Care Qui Tam Update.

The Update takes an in-depth look at three noteworthy cases and analyzes the trends observed in recently unsealed cases:

  • A substantial majority of the unsealed cases had been under seal for periods well in excess of the required statutory period. Of the 31 complaints, 28 were filed before 2015, with three unsealed complaints dating back to 2010. Of the remaining complaints, four were filed in 2012, eight in 2013, 12 in 2014 and three in 2015. As these cases illustrate, lengthy extensions of the seal on qui tam actions continue to be routine.
  • The cases identified were filed in federal district courts in 18 states, including multiple cases in California (3), New York (4), Florida (4), Kentucky (2), Massachusetts (2), Ohio (2), and Pennsylvania (3).
  • The federal government declined to intervene, or elected not to intervene at this time, in 23 of the 31 cases. The federal government intervened, in whole or in part, in eight cases.
  • Nature of the Claims
    • 15 of the recently unsealed cases involved both state and federal claims.
    • Nine involved allegations of unlawful kickbacks. Of these nine, five also alleged violations of the Stark Law.
    • Claims for relief under state or federal anti-whistleblower retaliation provisions appeared in six of the 31 recently unsealed cases.
  • In nearly two-thirds of the unsealed cases (20 of 31), relators were current or former employees of the defendant. In two cases, the relator’s relationship to the defendant was not revealed by the unsealed filings.

The full Update is available here.

Recently, South Carolina U.S. District Judge Joseph Anderson, Jr. issued an opinion in which he struggled with how to handle a non-intervened qui tam brought under the Federal False Claims Act (FCA).  In his opinion, Judge Anderson requested that the United States Court of Appeals take an interlocutory appeal to determine two issues:

  1. The extent of the government’s right to object to a reasonable settlement in a non-intervened FCA case; and
  2. The plaintiff’s right to use statistical sampling to provide liability and damages in an FCA case.

While the second issue has been the subject of much debate recently, the first issue is relatively new.  However, with more and more state and federal FCA cases proceeding without government intervention, it is likely an issue that many more state and federal judges will be facing.     Continue Reading Government’s Objections to Non-Intervened FCA Settlement Are Unreasonable – Now What?

Mintz Levin’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, highlighting two qui tam cases unsealed in November and December of 2014 and giving an overview of the other 17 cases unsealed during the same time period. Mintz Levin’s analysis of the 19 total unsealed cases revealed that almost half included both state and federal claims and that nearly 70% of the relators in the cases were current or former employees of the defendants. The two featured cases are:

  • United States ex rel. Fox Rx, Inc. v. Managed Health Care Associates, Inc., No. 2:14-cv-00073-JLR (W.D. Wash.), regarding allegations that Managed Health Care Associates, Inc. (“MHA”), a pharmacy services provider, submitted claims for Schedule II controlled substances that were dispensed without a proper prescription. The relator, Fox Rx, Inc., a Medicare Part D plan sponsor, had brought two previous cases against MHA, which were highlighted in Mintz Levin’s October 2104 Health Care Qui Tam Update. Notably, the government has declined to intervene in all three cases.
  • United States ex rel. Rew v. Mission Health of Georgia, LLC, 8:14-cv-00648-JSM-MAP (M.D. Fla.), regarding allegations that Mission Health’s nursing homes and assisted living facilities failed to obtain physician certification of patients’ need for skilled nursing care. The realtor in this case was formerly the Vice President of Clinical Reimbursement for one of Mission Health of Georgia.

Further information about both cases and the trends we’ve observed in recently unsealed cases are available in the full Qui Tam Update. In our Qui Tam Update series, we monitor recently unsealed FCA cases, identify trends in health care enforcement, and discuss noteworthy cases and developments. To receive the Qui Tam Update by email, subscribe here.

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations that Fox Hollow violated the False Claims Act (FCA) by causing certain hospital clients to submit false claims to the Medicare program.

Fox Hollow manufactures the Silver Hawk Plaque Excision System, which is a device used in atherectomy procedures.  Atherectomy is a minimally invasive surgical procedure that utilizes a small cutting device to remove atherosclerosis (or hardening of the arteries) from large blood vessels.  The goal of atherectomy procedures is to open up narrowed coronary arteries and increase blood flow and circulation.

A former Fox Hollow sales representative, Amanda Cashi, filed an FCA qui tam action in December 2009 alleging that in 2006 and 2007, Fox Hollow caused 12 hospitals located in nine states to submit claims to Medicare for medically unnecessary inpatient stays for beneficiaries receiving elective atherectomy procedures.  More specifically, DOJ alleged that Fox Hollow, in an effort to increase hospital purchases of the Silver Hawk device, advised hospitals to bill atherectomy procedures as more expensive inpatient procedures even though many of those patients should have received less costly outpatient procedures.  As a result, those hospitals allegedly received higher reimbursement than they were entitled to for treating certain beneficiaries receiving Silver Hawk atherectomy procedures.  Ms. Cashi will receive $250,000 as her share of the government’s settlement with ev3. Continue Reading Device Manufacturer Settles False Claims Act Allegations with DOJ for $1.25 Million