In November 2023, a South Carolina federal district court in Genesis Health Care, Inc., v. Becerra, et al. addressed the long-standing issue of who qualifies as a “patient” of a covered entity pursuant to the federal 340B program, and paved the... Read More
In June, the United States Supreme Court evaluated the False Claims Act’s (FCA) scienter element to determine whether the existence of an objectively reasonable interpretation that a claim was not false could be presented as a valid defense to the... Read More
Recently, there has been an increase in the emergence of third-party companies specializing in assisting physicians and facilities obtain access to “unclaimed” rebates from manufacturers for prescription drugs. These rebates pertain to drugs... Read More
On December 22, 2022, the Pennsylvania Department of Human Services released a Medical Assistance (“MA”) Program Bulletin (“Bulletin”) applicable to 340B covered entities enrolled in the MA program. The Bulletin, which took effect on January... Read More
In February, the Office of Inspector General (“OIG”) issued an advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide a free 14-day supply of its drug to patients experiencing delays in the insurance approval process.... Read More
On January 30, 2023, the Biden Administration announced that the COVID-19 Public Health Emergency (“PHE”), which has been in effect since January 2020, is set to expire on May 11, 2023. Considering the impending end to the PHE, healthcare... Read More
In its campaign against the corruption of medical decision making and illegal kickbacks, the Department of Justice (“DOJ”) has increasingly come to rely upon two pieces of legislation together with the Federal Anti-Kickback Statute (“AKS”):... Read More
