This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of Columbia Circuit’s (DC Circuit) favorable decision for drug manufacturers in the ongoing Section 340B dispute and the resolution of several enforcement actions, including some that alleged violations under the False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). We also review several US Department of Health and Human Services (HHS) agency actions, such as a final rule that provides robust civil rights protections for individuals with disabilities, and a new process for submitting independent dispute resolution (IDR) requests under the No Surprises Act that are improperly batched or bundled. We also preview the telehealth extension and remote monitoring legislation that is currently working its way through the House of Representatives. Additionally, we discuss a recently issued Office of Inspector General (OIG) report pertaining to continued fraud and abuse risks with off-the-shelf orthotic braces.
