On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services (HHS) in Pfizer’s landmark challenge against the Office of Inspector General’s (OIG) interpretation of the federal Anti-Kickback Statute (AKS).

Continue Reading Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

A favorable advisory opinion from the Office of Inspector General for the United States Department of Health and Human Services (OIG) ensures that the government will not impose sanctions concerning the requesting party’s business arrangement. Requesting an advisory opinion may be a good business decision for stakeholders in the healthcare industry.

Continue Reading Download Now – How to Request an Advisory Opinion (and Why)

Healthcare is one of the most highly regulated industries in the country and providers of all types will eventually be called to action, whether it be responding to an investigation, conducting a compliance review, or proceeding with a self-disclosure. Bass, Berry & Sims has designed the Healthcare How-To Instructional Webinar Series to provide simple step-by-step instructions and best practices for responding accurately and efficiently while avoiding bad tactics, questionable strategies, and unnecessary risk which can create problems and less than ideal outcomes.

The Anti-Kickback Statute’s breadth means that virtually every business arrangement can implicate the statute. Given the highly regulated nature of healthcare and the ever-present risk of enforcement, entities may wish to consider submitting an advisory opinion request to the Office of Inspector General (OIG) to obtain a legal opinion regarding whether their arrangement constitutes grounds for sanctions under OIG’s exclusion authorities.

Join us for a virtual seminar on July 26, 2022 at 12:00 p.m. Central in which Matt Tormey, EVP Compliance and Risk, Chief Compliance Officer, Ensemble Health Partners, moderates a discussion with two former OIG officials in Bass, Berry & Sims’ healthcare practice group focusing on how, when, and why to submit an advisory opinion request. To register, click here.
Continue Reading Healthcare How-To Instructional Webinar Series: How to Request an Advisory Opinion (and Why)

As previous False Claims Act (FCA) Fundamentals posts have discussed, the FCA, 31 U.S.C. § 3729, et seq., can be triggered by submitting claims tied to violations of certain federal statutes. This post will explain the basics of two such statutes: the Anti-Kickback Statute (AKS) and the Stark Law.

Continue Reading False Claims Act Fundamentals: Anti-Kickback Statute and the Stark Law

I am looking forward to speaking on a panel at the ABA’s 2022 Virtual Civil False Claims Act and Qui Tam Enforcement Institute titled “Hot Topics 2022: Focus on AKS/Stark” on June 9, 2022 from 1:00 PM – 2:00 PM EST. I will be joined by Gejaa Gobena, Partner, Hogan Lovells, Jennifer Verkamp, Partner, Morgan Verkamp, and Ro Srinivas, Senior Trial Counsel, Department of Justice, Civil Division, Commercial Litigation Branch (Fraud Section).

Continue Reading [Virtual Event] Civil False Claims Act Conference

The False Claims Act, despite its name, does not define what it means for a claim to be “false” or “fraudulent.” This post examines the primary ways courts have interpreted the False Claims Act’s falsity element and discusses common issues that arise concerning falsity.

Continue Reading False Claims Act Fundamentals: What Is a False Claim?

Bass, Berry & Sims is pleased to announce the release of the 10th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2021. Compiled by the firm’s Healthcare Fraud & Abuse Task Force, the Review provides a comprehensive analysis of enforcement developments affecting the healthcare industry, significant court decisions involving the False Claims Act, and an overview of settlements involving fraud and abuse issues.

Continue Reading Download Now – 10th Annual Healthcare Fraud & Abuse Review

Although this blog focuses mainly on the federal False Claims Act (FCA), other antifraud statutes feature in the qui tam relator and government enforcement toolkit. Key among them: the California Insurance Frauds Prevention Act (IFPA).

Continue Reading The California Insurance Frauds Prevention Act: What to Know About California’s Powerful Commercial Health Insurance Fraud Statute

The 7th Annual Healthcare Fraud Conference was hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Because we are unable to provide an in-person forum due to ongoing concerns resulting from the COVID-19 pandemic, we once again hosted the conference virtually.

This year’s complimentary CLE program, provides the same caliber of practical advice, insight into significant fraud and abuse issues facing healthcare professionals, and thoughtful discussion from industry panelists for which this conference is known.

Topics include:

  • Healthcare Fraud Year in Review
  • Hot Topics in Healthcare Fraud: Today and Tomorrow
  • The Future of the False Claims Act
  • Provider Relief Fund Audits and Investigations
  • Navigating Corporate Integrity Agreements and Administrative Remedies
  • Litigating Healthcare Fraud Enforcement Cases
  • Stark Law and Anti-Kickback Statute Enforcement Developments
  • FCA Self-Disclosure Considerations

This year’s conference was held on Wednesday, December 1 and Thursday, December 2. To watch the conference on-demand, please click here.

Click here to view the agenda and presenters.

Continue Reading [Virtual Event] 7th Annual Healthcare Fraud Conference

Pfizer lost a legal battle focused on the company’s financial assistance program against the Department of Health and Human Services Office of Inspector General (OIG) in the U.S. District Court for the Southern District of New York. The agency denied the pharmaceutical company’s request to vacate an OIG advisory opinion that effectively precludes the manufacturer