When Prescribing Controlled Medications, What Type of Conduct Leads to Legal Trouble?

LAS VEGAS—Helping providers understand such conduct, and how to use these lessons learned to “enhance current prescribing compliance protocols in a manner that preserves patient access to controlled medication where clinically appropriate” was the focus of a course presented at PAINWeek 2014 by Jennifer Bolen, JD, of The Legal Side of Pain, a division of the J. Bolen Group, LLC, Nashville, Tennessee.

Bolen provided snapshots of court documents and extracted references from published case law and administrative decisions to illustrate today’s clinical standard of care expectations. This included an understanding of the influence of medical expert testimony on pain management prosecutions and the overall direction of pain management regulatory compliance issues.

Included were cases representative of federal prosecutions (federal criminal court, DEA administrative cases) and state prosecutions (state criminal authorities and state licensing boards). She also provided typical, simplified prosecution chronologies for federal and DEA cases. Intentionally omitted were civil (negligence, wrongful death) and financial (payor financial investigations and overpayment audits) cases.

What the federal and DEA cases have in common are that they are expensive and disruptive, involve the use of experts, require documentation, and involve reputation. Common substantive issues are that the cases are document intensive, with the potential for undercover and other surveillance, with a focus on pill quantity, patients per day, and office hours. Patients and staff are interviewed. Common failures among prescribers include:

    • Failure to document
    • Failure to perform according to standard of care
    • Treating everyone the same way
    • Failure to stay involved with the patient
    • Failure to account for dose and combination prescribing
    • Failures in risk evaluation and monitoring.

Under the Controlled Substances Act (CSA), the DEA has the authority to deny, suspend, or revoke a DEA registration upon a finding that the registrant has:

    • Materially falsified any application filed
    • Been convicted of a felony relating to a controlled substance or a List I chemical
    • Had their state license or registration suspended, revoked, or denied
    • Committed an act which would render the DEA registration inconsistent with the public interest
    • Been excluded from participation in a Medicaid or Medicare program.