Last week, I was privileged to attend the 29th Annual Meeting of the American Society of Pharmacy Law, on Hilton Head Island, South Carolina. Here are some few general ‘takeaways’ for our health-care provider and physician practitioner/practice groups specifically, and business clients generally:
- Compliance isn’t about getting the right answer on any given occasion or, in the words of the United States Sentencing Guidelines Commission’s guidance for business entities, preventing and detecting violations of law in every instance. From “big pharma” all the way to the corner drug store, it’s about having reproducible processes and verifiable systems with integrity in place that conduct due diligence 100% of the time. No system is perfect, no judgment call will always be accurate, and everyone gets it wrong occasionally. The key to defending a civil audit, an administrative enforcement investigation or a federal grand jury inquiry is being able to demonstrate that your business has processes to ensure laws and regulations are in place and employs people dedicated to making sure they are utilized.
- Everyone acknowledges the opioid epidemic is killing our citizens, without discriminating by wealth, race, gender or any other category or classification, and that “something must be done” about it. But there remains a deep, cultural divide between those in health care who believe the solution is treatment, and those in law enforcement who believe the solution is enforcement – and this culture war shows no sign of détente in the near future.
- There are now over 900 lawsuits against manufacturers, distributors, pharmacies and other defendants seeking money damages arising out of the opioid crisis, giving rise to a cottage industry of opioid case lawyers, on both sides of the cases. We’ll all end up paying for them in the long run.
- Investigation of suspected violation(s) of statutes and regulations of wholesale pharmaceutical distributors, retail dispensers (i.e., pharmacies) and providers varies widely from judicial district to judicial district. Having local connections with regulators and enforcement personnel has no substitute for business and business persons when it comes to knowing how regulations are interpreted in specific regions of the country, and between regions that are connected.
- “PBMs,” or pharmacy benefit managers who, as third-party administrators of prescription drug programs for insurers, government health care provider programs and other payor plans, have an inordinate amount of influence over how we get our medicines in this country, who we get them from, and what we pay for them.
Overall, the ASPL meeting was highly informative and worth attending for industry professionals and counsel. As more pharmacies, distributors and retail stores are sued and investigated, attorneys need to be proactive in providing their clients timely advice to avoid the rising costs of legal proceedings.