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Supreme Court's Decision in Diaz Could Be a Boon for Criminal Healthcare Fraud Defendants

A defendant's mens rea, or intent, is almost always a contested element in a criminal prosecution, particularly in criminal healthcare fraud cases that frequently arise out of complex legal and regulatory regimes....more

Supreme Court Narrows Scope of Aggravated Identity Theft Law in Healthcare Fraud Case

The healthcare industry is one of the most heavily regulated industries in the United States. Healthcare companies and practitioners devote significant resources to complying with the complex and often changing legal and...more

Supreme Court Ruling Finds "Strong" Mens Rea Requirement for Prosecution Under the CSA

In Ruan v. United States, the U.S. Supreme Court on June 27, 2022, dealt a blow to the U.S. Department of Justice by vacating convictions of two physicians convicted of violating 21 U.S.C. §841(a) of the Controlled Substances...more

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

Pharmacies Not Immune From Enforcement Action for Role in Patient Assistance Programs

A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to...more

Federal Court Finds Massachusetts AG's COVID-19 Debt Collection Regulation Unconstitutional

U.S. District Court Judge Richard Stearns issued an order on May 6, 2020, finding that the two primary features of the Massachusetts Attorney General's COVID-19 debt collection regulation — a ban on debt collector initiated...more

Free Relief Money or a Potential False Claim?

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) provides for billions of dollars in relief funds to healthcare providers responding to the coronavirus (COVID-19) pandemic. In April 2020, the U.S. Department...more

Massachusetts Attorney General's COVID-19 Debt Collection Regulation Faces Legal Challenge

ACA International (ACA), the Association of Credit and Collection Professionals, filed a complaint on April 20, 2020, in the U.S. District Court for the District of Massachusetts challenging the validity of the recently...more

Enforcement Alert: Regulatory Agencies Investigating COVID-19 Testing, Treatment, Ancillary Services

While the COVID-19 pandemic has not yet peaked in the United States, federal and state prosecuting and regulatory agencies are already devoting resources to investigating and prosecuting fraud, waste and abuse associated with...more

Legitimate Academic Pursuits or Illegal Espionage?

A prominent professor at Harvard University, Charles Lieber, chair of the Harvard Chemistry Department, was arrested on Jan. 28, 2020, and charged with the federal crime of making a false statement to the government arising...more

National Science Foundation Sexual Harassment Notice

On Feb. 8, 2018, the National Science Foundation (NSF) announced in its “Important Notice to Presidents of Universities and Colleges and Heads of Other National Science Foundation Grantee Organization” that it was taking...more

HHS-OIG Corporate Integrity Agreements Are Now Aiming at Corporate Directors and Executives

Corporate integrity agreements (CIAs) are a familiar feature of many civil False Claim Act and joint civil/criminal resolutions in healthcare fraud cases. These agreements are entered into between the defendant company and...more

Update Your Compliance Programs to Address Increased Federal Scrutiny of Academic Research and Grant Funding

The federal government has stepped-up its enforcement efforts in the areas of academic research and grant funding. Just this week, Northwestern University agreed to pay $2.93 million to settle a federal whistleblower suit...more

Two Years Later: What We Know About Dodd-Frank's Whistleblower Provisions

In the wake of a number of highly publicized corporate scandals, many of which involved both SEC enforcement and criminal prosecution (WorldCom, Adelphia, Tyco and Enron, among others), Congress enacted the Dodd-Frank Wall...more

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