Health Law Scan

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing physician practice customers in exchange for referring other physician practices to the vendor would not implicate the federal Anti-Kickback Statute (AKS).

The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer (the requestor) that would provide a free hearing aid to certain qualified patients who received a cochlear implant.

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.

We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring Katie McDermott and Howard Young analyzing this protracted suit filed under the qui tam provisions of the False Claims Act (FCA) against the owners of two specialty clinical laboratories and a contracted sales and marketing company.

We invite Health Law Scan readers to join us on Thursday, July 22 at 3:00 pm ET for our next installment of the Fast Break webinar series. For this month’s edition of Fast Break, we will be joined by healthcare litigation partners Katie McDermott and Howard Young to analyze the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory, a protracted suit filed under the qui tam provisions of the False Claims Act against the owner of a specialty clinical laboratory and the individuals who led its sales operation.

We hope you were able to join us for last month's Fast Break on the Regulatory Sprint to Coordinated Care, which has been a longstanding initiative of the Centers for Medicare and Medicaid Services, US Department of Health and Human Services (HHS), and Office of the Inspector General to navigate a path to value-based payment models, culminating in the December 2020 final rules. If not, you missed a conversational session featuring Katie McDermott, Al Shay, and Jake Harper diving a bit deeper into this topic.

Members of our healthcare industry team have published two LawFlashes that may be of particular interest to hospice clients and friends of Health Law Scan, referring to recent Anti-Kickback Safe Harbor Revisions and the Consolidated Appropriations Act, 2021.

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.

We invite you to join us on Wednesday, November 20, for our second installment of the Fast Break: Regulatory Sprint series.

In Part 2 of a two-part Morgan Lewis series for Bloomberg Law on the proposed Stark Law and anti-kickback statute (AKS) rules, Kathleen McDermott, Matt Hogan, and Jacob Harper examine the safe harbors and exceptions aimed at empowering patients to manage their healthcare.