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Reimbursements False Claims Act (FCA) Food and Drug Administration (FDA)

Health Care Compliance Association (HCCA)

UPICs May Audit Skin Substitutes Twice; Are Lawsuits Against Manufacturers Coming?

As the audits and investigations of wound care procedures with skin substitutes march on, providers who were audited once by a CMS unified program integrity contractor (UPIC) should prepare for a second round. And if the UPIC...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Cozen O'Connor

Advanced Bionics Must Pay $12.6 Million to Settle Medicaid Fraud Allegations

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Advanced Bionics Corporation—a manufacturer and distributor of cochlear implants—entered settlements with six AGs to resolve allegations that the company violated federal and state False Claims Acts by submitting fraudulent...more

Cozen O'Connor

FTC Under New Management | First Assertion Of The BOTS Act | Ash Cleanup Costs Redistributed

Cozen O'Connor on

Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more

Perkins Coie

Belated Government Dismissal of False Claims Act Cases: DOJ Maneuvering in Post-Escobar and Granston Memo Era

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The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more

Bass, Berry & Sims PLC

DOJ Informs Supreme Court that It Will Dismiss FCA Case if Remanded to District Court

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On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...more

Robinson+Cole Health Law Diagnosis

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

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