As usual, the landscape of healthcare regulations has seen considerable activity in August 2023. McDermott’s Healthcare Regulatory Check-Up for this month brings to light several significant instances of regulatory action
One key area of focus this month has been enforcement actions related to violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS). The FCA is a federal law that imposes liability on individuals and companies (typically federal contractors) who defraud governmental programs. The AKS prohibits offering, paying, soliciting, or receiving remuneration to induce or reward referrals of items or services reimbursable by federal healthcare programs.
These infractions go to the heart of the integrity of the healthcare system, bearing repercussions not only for the offending parties but also potentially undermining patient trust and driving up insurance premiums. As such, the incidence of these violations and their subsequent legal handling is of great interest to professionals in healthcare law and policy.
Alongside the updates on enforcement activities, major reimbursement regulatory updates were also highlighted in the Check-Up. With regulatory changes influencing how providers are compensated for their services, keeping abreast of these updates is crucial for legal professionals advising healthcare providers and pharmaceutical companies.
Lastly, a recent advisory opinion issued by the Office of the Inspector General (OIG) drew attention. The opinion expressed concerns about a perceived “contractual joint venture”, a business agreement that, in certain circumstances, could potentially violate anti-fraud and abuse regulations. The specifics of this opinion and its implications for designing and implementing such joint ventures could be pivotal for corporate lawyers in the healthcare sector.
Certainly, it seems that there is never a dull moment in healthcare regulation. Far from it; the field remains dynamic, complex, and challenging. It is precisely these qualities that make the realm of healthcare law so critical for those who practice it and those who rely on its practitioners.