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As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement discretion would be provided for certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG established this process to provide regulatory flexibility to ensure necessary care responding to COVID-19, particularly with respect to the federal anti-kickback statute (AKS) and civil monetary penalty (CMP) beneficiary inducement prohibition provisions. OIG responses are publicly available through a frequently asked questions (FAQ) posting on the OIG COVID-19 portal. OIG has continued to update this FAQ since its initial publication, including the most recent inquiry discussed in our March 22 post, and also providing guidance on the following question:
In
U.S. ex rel. Manieri v. Avanir Pharmaceuticals, Inc., 2021 WL 857102 (N.D. Oh. Mar. 8, 2021), the Northern District of Ohio dismissed a relator’s claim that he had been improperly retaliated because he had raised concerns about alleged fraudulent conduct involving speaker fees under the False Claims Act (FCA) and the Federal Anti-Kickback Statute (AKS).
Manieri serves as a helpful reminder of the high standard for pleading a retaliation claim under the FCA.
The case was brought by a former employee of Avanir, Kevin Manieri, who alleged that Avanir violated the FCA and the AKS by paying speaker fees to physicians in exchange for the promise that such speaker-physicians will prescribe a drug manufactured by Avanir. Before the most recent opinion, Avanir settled with the U.S. government in Sept. 2019, paying more than $108 million in criminal penalties and forfeiture and civil damages stemming from Manieri’s suit and two other lawsuits from former employees. Avanir also
As many of us are starting to see the small light at the end of the tunnel, many hospitals are still reeling from the stress of the last year. Following the recent release of.
As many of us are starting to see the small light at the end of the tunnel, many hospitals are still reeling from the stress of the last year. Following the recent release of “Hospital.
Friday, April 9, 2021
As many of us are starting to see the small light at the end of the tunnel, many hospitals are still reeling from the stress of the last year. Following the recent release of “Hospital Experiences Responding to the COVID-19 Pandemic: Results of a National Pulse Survey March 23–27, 2020” (the “Report”), a report issued by the Department of Health and Human Services Office of Inspector General (“OIG”) that examines the impact of the public health emergency on United States hospitals, we review federal and state efforts to keep hospitals afloat during this time, and expectations as we continue to recover.