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Government Investigations Team Insights - July 2024

AGG’s Government Investigations Team Insights provides periodic updates covering legal and regulatory topics. Our team, which includes former federal prosecutors, SEC enforcement attorneys, and federal agency attorneys, has...more

The Risks and Benefits to Healthcare Providers Using ChatGPT to Support Billing Claims

On November 30, 2022, OpenAI launched ChatGPT and immediately set off a firestorm. An AI chatbot that can write stories, plays, poems, and essays; pass licensing and other exams; produce code; engage in conversations; and...more

The Future of Telemedicine in an Era of Enforcement

On the same day that the U.S. Department of Justice (“DOJ”) announced the filing of criminal charges against 36 defendants for alleged schemes involving more than $1.2 billion in fraudulent telemedicine claims, the U.S....more

The Eleventh Circuit’s Long-Awaited AseraCare Decision Changes the Landscape for FCA Cases Based On Medical Necessity

On September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit issued its much anticipated decision in United States v. AseraCare Inc., et al., Case No. 16-13004 (11th Cir. Sept. 9, 2019), agreeing with the lower...more

The Supreme Court Is Presented With Another Split Decision And A Widening Circuit Split On Materiality Post-Escobar

On November 20, 2018, Brookdale Senior Living Communities, Inc. filed a petition for writ of certiorari, asking the Supreme Court to resolve circuit splits that have arisen post-Escobar regarding both the materiality and the...more

INSYS Therapeutics Reaches Settlement in Connection with Marketing of Opioid Painkiller

On August 8, 2018, INSYS Therapeutics, Inc. announced that it had reached an agreement in principle with the U.S. Department of Justice (DOJ) to settle DOJ’s investigation of INSYS’s marketing of the drug Subsys. Subsys is a...more

A Second Judge Gives United Health A Partial FCA Victory Based On Materiality

On February 12, 2018, a second judge in the Central District of California, Judge Michael W. Fitzgerald, dismissed, with leave to amend by February 26, 2018, counts in a False Claims Act (FCA) case alleging that UnitedHealth...more

Third Circuit: Proof of Kickback Scheme Alone Not Enough to Find Liability under the False Claims Act

On January 19, 2018, in United States ex rel. Greenfield v. Medco Health Solutions, Inc., the Third Circuit Court of Appeals held that the plaintiff in a False Claims Act (FCA) suit premised on violations of the Anti-Kickback...more

Recent Developments on the Opioid Front

The “Opioid Crisis” continues to drive measures that will significantly affect the pharmaceutical industry in general, the relationship between prescribers and their patients, and the role of regulators – and law enforcement...more

Early Victory: Judge Dismisses Qui Tam Suit Against UnitedHealthcare

On October 5, 2017, in United States of America ex rel. Swoben v. Scan Health Plan, et al. (“Swoben”), Judge John F. Walter of the United States District Court for the Central District of California granted United Health...more

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

State Official Charged With Taking Bribes In Connection With $1 Billion Healthcare Fraud Scheme

On July 22, 2016, the Department of Justice announced the indictment of the owner of more than 30 Miami-area skilled nursing and assisted living facilities, a hospital administrator, and a physician’s assistant in connection...more

AGG Food & Drug Newsletter - May 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

California Regents File State False Claims Act Case Against Healthcare Providers And Pharmacies For Allegedly Defrauding UC...

The Regents of the University of California (UC) have filed a lawsuit against Studio Pharmacy, Excel Care Pharmacy, Pharma Pro Solutions, California Clinical Trials, and 17 individual defendants, including four physicians and...more

OIG Implements New Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Regulations

On December 7, 2016, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a final rule to implement revisions to certain Anti-Kickback Statute (AKS) safe harbors, as well as revisions to...more

Department Of Justice Announces The Indictment Of 21 Individuals Affiliated With Forest Park Medical Center

On December 1, 2016, the United States Attorney’s Office for the Northern District of Texas announced the indictment of 21 executives, physicians, surgeons, and others affiliated with Forest Park Medical Center (FPMC) in...more

The First Circuit Rules On Materiality And Rule 9(b) In Two FCA Opinions

On November 22, 2016, the United States Court of Appeals for the First Circuit issued two False Claims Act (FCA) opinions in the continuing debate over the parameters of the FCA. In United States ex. rel. Escobar et al. v....more

Tenet Healthcare Will Pay $513 Million To Resolve Criminal Charges And Civil Claims

Tenet Healthcare Corporation, an investor-owned healthcare services company based in Texas, and two of its Atlanta-based subsidiaries have entered into an agreement with the government to resolve criminal charges and civil...more

OIG Continues its Focus on GIP Abuse: What Hospice Providers Need to Know

On March 31, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report on hospice billing for general inpatient care (GIP). According to the OIG, hospices billed Medicare for...more

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