The Opioid Crisis and Compliance – A Primer for Prescribers

An increasing number of health care providers across the country continue to lose their jobs and face enforcement action after over-prescribing painkillers and other narcotics that can lead to addiction. Doctors are not the only professionals being investigated and penalized for these types of prescription violations.  In fact, physician’s assistants, chiropractors, pharmacists, pharmacy technicians, social workers and other types of health care professionals are also being targeted for alleged improper prescription, distribution, or diversion of narcotics by state and federal law enforcement.

This crackdown on opioid and other addiction-linked drug prescribers is part of efforts by law enforcement and regulators across the country to combat the ongoing heroin and opioid addiction crisis. This crisis, which was declared a “Public Health Emergency” by the President on October 26, 2017, has reached a critical level unseen in modern history. According to the National Center for Health Statistics, over 64,000 Americans died from drug overdoses in 2016 and over 150 Americans die from a drug overdose every day. These grim statistics, combined with increased public outcry, have fostered a growing sense of urgency and resolve among law enforcement, regulators and public officials. This means practitioners and healthcare organizations alike should expect greater scrutiny than ever before from these groups over their prescriptive practices and policies.

Given this climate of increased enforcement, it is essential that all prescribers, and their associated practices and facilities, take necessary steps to insulate their businesses from the cost and additional risk (such as exclusion or license revocation) associated with improper prescriptive practices. Every healthcare organization should have systems and policies in place which assure each of its prescribing health care professionals maintains the requisite skills, education, and training necessary. It is also paramount that the organization ensures all of its practitioners are up-to-date on the appropriate use, frequency, and duration of each prescribed drug.  

In addition to ensuring the above, an active and robust opioid compliance plan will go a long way toward assisting a healthcare facility or organization in avoiding fines, criminal prosecution, and the potential for exclusion from federal healthcare programs. An effective compliance plan can include (but is not limited to) the following:

  • Written policies and procedures related to drug-dispersion, drug disposal and high-risk patients;
  • The inclusion of a Compliance Officer on staff.
  • A system for proactive self-reporting of potentially violative conduct;
  • A system for recordkeeping, patient prescription tracking and an appropriate mechanism for enforcement and disciplinary action;
  • Training regarding relevant state prescription drug monitoring programs and/or laws restricting prescriptive authority or imposing additional reporting requirements;
  • Procedures regarding the thorough investigation of all instances of noncompliance;
  • Audits and/or other monitoring methods to track and identify potential problem areas, including employee interviews etc.;
  • Protected lines of communication between the compliance officer and all employees.
  • Periodic Compliance Reviews facilitated between the Compliance Officer and upper management.
  • The use of an Opioid Compliance Checklist (or OCC)

In addition to the benefits already discussed, Compliance programs can also reduce the likelihood of employee “whistle-blowing” whereby a current employee reports the facility or brings a civil action. This has become extremely important of late, given the increasing prevalence of Qui Tam “whistle-blower” actions across the healthcare industry.

Frier Levitt routinely advises prescribers across the country on their legal obligations and potential exposure to liability in light of federal and state laws and regulations relating to pain management and prescribing opioids and other addictive drugs. We also have experience with the development and implementation of comprehensive opioid compliance plans. If your organization, practice, or facility prescribes opioids and/or other addictive drugs, you may be at risk. An effective compliance plan coupled with policies and procedures designed to mitigate such risk can reduce expenses related to defending such actions or paying the resulting fines. For more information about developing an opioid compliance plan, contact Frier Levitt today.