As high-profile lawsuits linked to the exploding U.S. opioid epidemic continue to play out in courtrooms nationwide, healthcare providers are working to implement ways to thread the needle between appropriate patient care and avoiding exposure to legal or regulatory action. A big part of that conversation revolves around medication access— in some cases physicians, often seen as gatekeepers, have found themselves under fire for what have been considered routine prescription practices up to now.
These new developments have led to a decreased willingness by some to even discuss opioid use with their patients, a move that some say is scaling back too far in the other direction. This begs the question: Is there a middle ground? If so, how can providers find it and offer optimum care for patients without exposing themselves to liability now or in the future?
It’s a complicated question, and one that got Anna M. Grizzle, an attorney with Nashville’s Bass, Berry & Sims, and some of her colleagues thinking. How could they talk about opioid-addiction to doctors and other clinicians in such a way to promote forward-looking awareness and action vs. a defensive posture? First, they knew they’d need to pull back far enough to look at not just the current legal and regulatory landscape, but also the larger issue of opioid addiction and its current rise.
“There is enormous media coverage devoted to the opioid crisis and its impact on citizens, particularly in rural areas. This coverage has touched on higher debt, more addiction, and the need for treatment. Looking at that coverage, we also started to see an increased focus by enforcement agencies,” says Grizzle, who has more than 20 years’ experience working with healthcare clients on enforcement, compliance, and regulatory issues.
These actions, in and out of the courtroom, are taking place across all healthcare treatment areas, from providers to pharmacies and drug manufacturers. Here are a few recent examples:
University of Michigan Health System: a $4.3 million settlement for failing to obtain DEA registrations, maintain complete and accurate records, and notify the DEA of theft or loss of controlled substances in a timely manner.
Effingham Health System: a $4.1 million settlement for failing to provide effective controls and procedures and failure to notify the DEA of suspected diversion in a timely manner.
Nantucket Cottage Hospital: a $450,000 settlement for failing to properly maintain controlled substances records and failure to maintain effective controls against diversion.
U.S. v. Oakley Pharmacy Inc.: a “first of its kind” lawsuit to stop two Tennessee pharmacies for illegally dispensing opioids (based on unusually high doses and dangerous combinations of prescriptions, as well as patients traveling long distances to fill prescriptions and paying high cash prices).
Multiple lawsuits by state attorney generals, as well as criminal prosecutions and lawsuits by family members and patients themselves.
These and many more actions stood out to Grizzle because they show efforts are being undertaken by
multiple entities that might inadvertently conflict with each other. For instance, at the federal level there is a growing focus on the opioid crisis through the lens of negative impacts on patient care, while state and local officials are looking at the extraordinary cost in terms of treatment and recovery programs to address the issue.
This Blog Post Is an Excerpt From the Healthstream Article, “Navigating the Unknowns of Opioid Regulation and Education: Regulatory and Enforcement Actions Around Opioid Addiction Heighten the Need for Awareness.”
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