The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose inherent fraud and abuse risks. OIG is “skeptical about the educational value of such programs” and cautioned that remuneration to referring practitioners

Mind Medicine, Inc. (MindMed) and NYU Langone Medical Center (NYU) recently announced a joint project to launch a clinical training program focused on psychedelic-assisted therapies and psychedelic-inspired medicines. MindMed, a psychedelic drug startup, is studying the use of hallucinogenic drugs in the treatment of mental health conditions. This venture is the first step in establishing a

On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug Letairis. In addition to the False Claims Act

Teva Pharmaceuticals USA Inc. is in the crosshairs of the U.S. Department of Justice (DOJ) on two separate matters. On August 18, the DOJ announced that it filed a lawsuit against Teva and an affiliate, Teva Neuroscience Inc., under the False Claims Act for violations of the federal Anti-Kickback Statute. The suit alleges that the

The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion, of which about $2.5 billion was returned to the Medicare trust fund. The recoveries included judgments and settlements from fraud

Eric Fader, Jeff Kaiser, Chris Kutner, Ada Kozicz and Ben Malerba are authors of the newly released book, “The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide.”

Published by the American Bar Association, the book covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute (AKS) and other

On June 16, the U.S. Court of Appeals for the District of Columbia Circuit upheld a ruling from a year ago that struck down a federal regulation requiring pharmaceutical companies to disclose wholesale prices of prescription drugs in television advertisements. The appeals court agreed with the lower court’s opinion that the rule exceeded the legal

On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by Dr. Staley

On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response. This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA agency