DOJ Opioids Task Force Creates Risks for Prescribers

Originally Published on Medical Mutual MedNotes Blog.

The federal response to the opioid crisis is in full swing, as the U.S. government plans to spend a record $4.6 billion fighting the epidemic in 2018. Moreover, the U.S. Department of Justice (DOJ) has established a Prescription Interdiction Litigation Task Force to address the illegal distribution and consumption of opioid pharmaceuticals. As part of this task force, 12 appointed federal prosecutors across the U.S. have focused their efforts solely on uncovering illegal and detrimental opioid administration, prescription, and dispensing practices.

It is important for doctors to understand that this response extends beyond corrupt prescribers operating with knowing intent to dispense opioids outside of typical professional practice limits. Rather, criminal charges can now be brought against physicians who are found to be negligent in their opioid prescription practices.

This focus may have a significant impact on physicians and their practices, and now more than ever it’s important that doctors stay informed and consistently scrutinize their decisions to prescribe opiates to patients experiencing chronic pain. Should they fail to do this, many may face criminal consequences that can amount to 20 or more years in federal prison.

Breaking it Down

Federal statutes provide that it is unlawful to manufacture, distribute, dispense opioids or to possess opioids with intent to distribute or dispense them. Broadening the reach of these statutes, according to the ruling determined by the United States v. Moore in 1975, the Supreme Court ruled that physicians can be prosecuted under these federal laws when their activities “fall outside the usual course of professional practice.”

This interpretation is of particular concern to physicians, as it means they can be prosecuted under the very same statutes as drug dealers, regardless of intent. The phrase, “outside the usual course of professional practice” is extremely vague and undefined, leaving individual cases to proceed in a similar fashion to civil action lawsuits that rely upon the personal opinions of experts. Physicians whose patients have suffered from substantial bodily injury or death due to opioid abuse may be facing 20 or more years in prison.

Putting it in Perspective

DOJ’s new focus on the opioid crisis will certainly have a positive impact on the medical community, as it punishes corrupt physicians who abuse their power to achieve financial gain. However, due to the vague nature of the statutes, we can also expect to see doctors who prescribe opioids with the best of intentions be targeted by the U.S. government.

In cases of negligent or harmful opioid prescription practices, civil and criminal lawsuits are not mutually exclusive, and both can be brought against a physician at any time. As DOJ continues to seek out opioid prescribers operating outside of the law, prosecutors will sometimes review existing civil cases in an attempt to uncover potential criminal activity. Upon learning the details of a civil suit, DOJ can launch its own simultaneous investigation and decide to bring criminal charges against the physician. Should he or she be convicted, the physician will face the prospect of spending the majority of their remaining life in prison.

How Physicians Can Protect Themselves

In my experience defending clients against opioid-related charges, there are eight key steps that can help protect physicians from liability:

  1. Thoroughly evaluate the cause of chronic pain with the help of imaging to document an accurate diagnosis
  2. Assess whether other treatment modalities and/or medications can be successfully utilized. If so, offer this treatment method first. If the patient has already exhausted other treatment modalities and they have failed or the patient refuses, then document those facts.
  3. If the patient presents after being treated by another physician, obtain previous medical records and request to speak with that physician
  4. Require that patients complete a written opioid contract to establish informed consent. Medical Mutual members can access this form here.
  5. Maintain detailed billing records, especially when accepting payment from uninsured patients
  6. Keep thorough documentation of all interactions, including the full exam, reasons for prescription, and evaluation of alternative treatments
  7. Establish a protocol for routine drug screening and outline procedure for how to handle positive results
  8. Check the prescription monitoring database (PDMP) to ensure the patient does not have a history of abuse and document the results.

 

It’s imperative that all physicians who prescribe opioids to patients understand that their prescription practices may come under extreme scrutiny, and that they should always proceed with caution. To better understand ways they can protect themselves, I encourage doctors to review the CDC Guideline for Prescribing Opioids for Chronic Pain, which addresses initiation, selection, and risk assessment for treatment with opioids.

In addition to this guideline, the CDC has also provided a number of useful clinician resources related to opioid treatment of pain, covering topics such as non-opioid treatment options, assessment of benefits and harm, dosage calculation, and tapering techniques. Finally, physicians should familiarize themselves with state medical board guidelines regarding opioid prescription practices by contacting their medical malpractice insurer for additional information.

DOJ’s attempt to punish doctors who abuse opioid prescriptions risks also catching well-meaning physicians who unintentionally cause harm while trying to provide care with prescription opioids. By keeping up-to-date on best practices and keeping their prescription methods responsible and well-documented, physicians can reduce their risk of liability in the event of an adverse outcome.

Disclaimer: This post is written in general terms and is not a substitute for legal advice or intended to create an attorney-client relationship.

Norman Klick is a civil litigator who represents medical professionals, insurance companies, businesses, and individuals in matters involving professional liability and commercial disputes. Norman may be reached at 336.478.1162 or nfk@crlaw.com

For media inquiries, please contact: Erin Molinaro | ekm@crlaw.com