Last week, the U.S. Department of Justice announced the largest ever healthcare fraud enforcement action by the Medicare Fraud Strike Force. Fraud charges were filed against 115 licensed professionals and payment suspension actions were initiated against 259 providers. DOJ’s announcement.
A particular focus is on medical professionals involved in the excessive prescribing and distribution of opioids; mostly tramadol, hydrocodone, and oxycodone. The primary reason behind these extensive investigations is the extreme use of opioids and questionable prescribing practices. HHS OIG Data Brief on Opioid Use.
The Office of Inspector General (OIG) announced that it will continue targeting medical providers who prescribe or dispense large numbers of opioids. Keep in mind that during an investigation of one provider, federal agencies have access to all business records of that provider and often investigate other providers whose names come up during the investigation. (For example, our firm is currently involved in a federal investigation of a pharmacy that served patients of a prescriber accused of illegal opioid prescribing. The investigation of the prescriber commenced two years ago and only recently the agencies started their investigation of the pharmacy).
If you prescribe, administer, or dispense controlled substances, you must keep a few things in mind:
Strictly comply with your state and federal laws on controlled substances. Sometimes you encounter situations outside of the topics covered by state or federal law. In such situation, you must consult your counsel and document your analysis and decisions.
If you are a subject of an investigation, engage your counsel as soon as possible. If the U.S. Department of Justice contacts you, retain a criminal attorney, in addition to your healthcare counsel.
Train your staff on the DEA manuals, your licensing board’s precedential decisions, and any issued guidance on the topic.
Make sure to verify and report to CURES (PDMP).
If you work with a controlled substance inventory, always make sure you have an accurate perpetual inventory and strictly comply with recordkeeping and storage requirements. Keep an eye on the numbers. (Is your stock too large for the industry? Are you ordering a disproportionate amount of control substances? Any notifications of the wholesalers that you are approaching your threshold?)
I encourage you to read the attached article describing some additional business practices that can help you in your compliance with controlled substances laws.
Article on Minimizing the Risk in Prescribing, Dispensing, and Administering Controlled Substance prepared for the ABA Health Law Section conference.