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The Supreme Court’s SuperValu Decision on the “Knowingly” Element in the False Claims Act: Protecting Against Liability When There...

In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a...more

SBA Issues Additional Guidance Regarding “Necessity” Certification Required under the CARES Act

Today the Small Business Administration (SBA) issued additional guidance with respect to the “necessity” certification required under the CARES Act in connection with the Paycheck Protection Program (PPP). The relevant...more

Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more

Part Five of the COVID-19 Roadmap Series: Ensuring a Safe Workplace - COVID-19 Screening and Testing

In Part Five of our Roadmap Series, we take a closer look at COVID-19 screening and testing, including best practices and legal implications, as potential tools to maintain a safe workplace. Can We Screen Our Employees...more

COVID-19 and Lab Testing: What’s the Story Behind the Story?

Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more

Practical Tips and Guidance for Understanding and Using HHS's Stark Law Blanket Waivers and the OIG’s Policy Statement About Them

As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under...more

Law Enforcement Stays Active During the COVID-19 Pandemic

Last Tuesday, we blogged about the arrest of the owner of a Georgia-based marketing company who was charged with health care fraud and conspiracy to violate the Anti-Kickback Statute. The government has alleged that...more

Mintz Levin Health Care Qui Tam Update - February 2019

Overview of Qui Tam Activity - We identified 49 health care-related qui tam cases that were unsealed in September and October 2018. The government intervened in whole or in part in 10 of those 49 unsealed cases, which...more

Health Care Qui Tam Update

In this issue, we provide an overview of 62 recently unsealed qui tam cases and take an in-depth look at four of those cases. Two of the featured cases concern alleged schemes to provide unnecessary therapy to residents of...more

New Jersey Regulates Out-Of-Network Billing

News alert for all New Jersey health care providers! A new law went into effect yesterday (August 30, 2018) that changes billing requirements for out-of-network services in New Jersey. Known as the “Out-of-Network Consumer...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2018

Overview of Qui Tam Activity - ..We identified 46 health care related qui tam cases that were unsealed in February and March 2018. ..The government intervened in whole or in part in 14% of those unsealed cases, which was...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: June 2018

Overview of Qui Tam Activity - ..We identified 60 health care related qui tam cases that were unsealed in December 2017 and January 2018. ..The government intervened in 14% of those unsealed cases, which is consistent...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2018

Overview of Qui Tam Activity - ..We identified 56 health care related qui tam cases that were unsealed in October and November 2017. ..The intervention rate for those unsealed cases was 20%, which is consistent with...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: January 2018

Overview of Qui Tam Activity: ..We identified 47 health care-related qui tam cases that were unsealed in August and September 2017. ..Over those two months, the rate of intervention was relatively high — at least 34%. For...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: September 2017

In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2017

In this issue we report on recent qui tam activity and look at three unsealed cases. One case involves allegations of “up coding” by a hospital that allegedly billed routine transport as emergency transport, reimbursed at...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

Mintz Levin Health Care Qui Tam Update: Recently Unsealed Whistleblower Cases

Featured Unsealed Cases United States ex rel. Thomas v. Best Choice Home Health Care Agency, Inc., No. 2:13-cv-02209 (D. Kan.) - Complaint Filed: May 6, 2013 - Complaint Unsealed: October 24, 2016...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: January 2017

We have identified 30 health care–related qui tam cases that have been unsealed in whole or in part. Trends & Analysis - A substantial majority of the unsealed cases had been under seal for periods well in excess of...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: August 2016

Since our last issue, we have identified 31 recently unsealed health care-related whistleblower cases. In this Qui Tam Update, we analyze the trends and take an in-depth look at a few noteworthy cases....more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: April 2016

Trends & Analysis - ..We have identified 42 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. Included in that count is one proceeding (the...more

Acquittals in Vascular Solutions Case Deal Setback to DOJ

On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: December 2015

Trends & Analysis - We have identified 24 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of the 24 cases, five were filed within the past year, seven were filed in 2014, three...more

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

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