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.

Typical investigation tactics include inspection warrants, search warrants, and medical record review. Others may involve undercover work or “follow the money.” Bolen provided one example of what she called a “bad idea”: “two diversion investigators go out to talk to a physician. Physician opens the door and denies his identity.”

“Expert witnesses” is another investigation tactic, with different types of medical experts having specific roles—and an impact in the courtroom (Table 1).

Table 1. Medical Experts

 Their Job
 Courtroom Impact
  • Medical
  • Pharmacy
  • Toxicology
  • Medical Examiner
  • DEA Agent
  • Financial
  • Review records
  • Give opinions
  • Assist with case development (consulting expert vs. testifying expert issue)
  • May have history of prior testimony
  • May or may not understand legal standards applicable to cases. May not understand objective/subjective aspects of prescribing standard
  • May or may not be good at describing prescribing in the usual course of professional practice and legitimate medical purpose

Also outlined were topics medical experts frequently address in the courtroom (Table 2). 

Table 2. Frequently the Topic of Courtroom Testimony by Medical Experts

 Dose and chronicity of prescribing; combination prescribing; morphine equivalent daily dose (MEDD)
 Lack of individualized patient care
 Paper over process

 Drug testing

    • Failure to do it
    • Failure to confirm RX drugs and unexpected results
    • Financially motivated
    • Kickbacks, Rebates
    • Failure to test for marijuana and failure to address + THC results
    • Failure to address "out of range, above range, below range, quantitative results"
 Medication counts (lack of, failure to discuss with patients)
 LAO + SAO - same amounts every visit both drugs
 Lack of physical examination
 Lack of specialty referrals
 Failure to address behavioral issues; failure to evaluate abuse/addiction risks and history
 Failure to follow the treatment agreement
 Failure to engage in informed consent process
 Failure to consider non-drug therapies
 Failure to consider non-opioid medication
Copyright 2014, The J. Bolen Group, LLC. All rights reserved.

Early factors of inappropriate prescribing were described in the 1978 case, US v. Rosen:

    1. Inordinately large quantity of controlled substances was prescribed.
    2. Large numbers of prescriptions were issued.
    3. No physical examination was given.
    4. Prescriber warned the patient to fill the prescriptions at different drug stores.
    5. Prescriber gave prescriptions to patient despite knowing (or having reason to know) that patient was diverting the medication.
    6. Medication prescribed at intervals inconsistent with legitimate medical treatment.
    7. Prescriber uses street slang to refer to commonly prescribed controlled medications.
    8. No logical relationship between the drugs prescribed and the condition treated.
    9. Prescriber wrote more than one prescription in order to spread them out.

In the case of Iyer, a 2009 DEA Administrative Case, the three points of which physicians should be aware were 1) responsibility to issue prescriptions for a legitimate medical purpose while acting in the usual course of professional practice; 2) responsibility to monitor patients (as a part of routine clinical practice) for warning signs that they are personally abusing or diverting their medications; and 3) failure to fulfill these responsibilities constitutes acts inconsistent with the public health and safety.

Attendees were encouraged to use the cases Bolen presented to evaluate their own practices and create checklists of areas for improvement. “Harm reduction strategies” that providers can embrace to head off potential lawsuits include patient and staff education; addressing CNS issues and related medical conditions (sleep apnea, multiple CNS depressants in medication therapy, sleep hygiene); weight loss and smoking cessation; alcohol education and compliance measures; safe use, storage, and disposal education, and coordination of care issues.