We were each quoted in a Law360 article examining the status of the Anti-Kickback Statute (AKS) on the 50th anniversary of the law’s passing, and offered our perspective, informed by both our practices advising healthcare providers on AKS issues and our experience as government attorneys dealing with AKS issues, on the legal challenges and disputes among the courts on how to apply the AKS and the current state of the enforcement environment encountered by healthcare providers as it relates specifically to AKS issues. Continue Reading Impact of Anti-Kickback Statute on Its 50th Anniversary
Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA).
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud and abuse issues. Bass, Berry & Sims is pleased to share this HHS-OIG Year In Review (HHS-OIG YIR) that highlights key guidance OIG issued in 2022, as well as other items of import involving the agency.Continue Reading 2022: HHS-OIG Year In Review
I recently provided insight for a Law360 article outlining Pfizer’s request to have the Supreme Court weigh in on the scope of the Anti-Kickback Statute (AKS).
Continue Reading Insight on Request for Supreme Court Review of Anti-Kickback Statute’s Scope
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)
I commented on the recent ruling by the Second Circuit Court of Appeals, which upheld the district court’s rejection of Pfizer’s argument that liability under the Anti-Kickback Statute requires an element of “corrupt” intent.
Continue Reading Court Decision Upholding OIG’s Rejection of Pharmaceutical Company’s Drug Co-Pay Assistance Program
Join us for a webinar 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.Continue Reading Healthcare How-To Instructional Webinar Series: How to Request an Advisory Opinion (and Why)
One of the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) key compliance priorities is modernizing the agency’s program integrity and compliance information.
OIG has explained that its goals for this priority are to continue producing timely and useful resources and to make the resources it provides easier to access and use, to spur innovation and improve compliance programs. On September 22, in furtherance of these goals, OIG posted a request for information (RFI) on its website.
OIG Seeks to Understand Value of Its Resources
Although all of the guidance available on OIG’s website remains “good guidance,” many of the resources have not been updated in decades. In addition, advancements in technology now allow stakeholders to manage and operationalize data and information in previously unavailable ways. Through the RFI, OIG seeks input from the healthcare industry and the public on a wide range of issues, including how stakeholders use OIG’s resources, as well as how to improve the value and timeliness of those resources.Continue Reading OIG Publishes Wide-Ranging Request for Information