Opioid Prescribing and Monitoring - (Second Edition)
Primary Care Models for Pain Management

A Legal Interpretation of the CDC Opioid Prescribing Guidelines

A Q&A with Jennifer Bolen, JD
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The 2016 Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain has left many providers confused over the potential legal ramifications.1 Among the many gray areas, medical providers have expressed uncertainty over whether the issued guideline is legally binding. Likewise, ambiguity has clouded the potential implications of the recommendation to avoid dosages over 90 morphine milligram equivalents (MME) per day and to limit first-time opioid prescriptions to 3 days.1

Practical Pain Management spoke with Jennifer Bolen, JD, to clarify these and other issues and help physicians better protect their patients and themselves. Ms. Bolen, formerly an assistant US attorney with the Department of Justice for nearly 14 years, owns and operates a Knoxville, Tennessee-based medical-legal consulting firm called The Legal Side of Pain. Her firm specializes in developing and implementing risk management programs for facilities and practices engaged in the use of controlled substances for the treatment of pain and the office-based treatment of opioid addiction, and compliance programs for clinical laboratories.

Q The 2016 CDC Guideline for Prescribing Opioids for Chronic Pain was released as a set of recommendations.1 However, many primary care providers (PCPs) and insurance companies are treating the document as the law. Can you clarify: Are these guidelines legally binding?

Ms. Bolen: In the document, the CDC notes, “The recommendations in the guideline are voluntary, rather than prescriptive standards.”1 While the guidelines are not legally binding, they set up the criteria for an evolving standard related to the use of opioids. From a legal context, any medical expert witness, medical licensing board, judge, or court of law can interpret the guidelines as the standard for what a reasonably prudent practitioner might do in the same or similar circumstances. To ignore these recommendations would be a serious mistake.

Q Can a prescriber be held legally liable for practicing outside the CDC guidelines? For example, if a PCP is brought up on charges by a state bureau of narcotics or the Drug Enforcement Agency (DEA) for prescribing outside the recommended < 90 morphine milligram equivalents (MME) limit for opioids, how much legal weight would the guidelines carry?

Ms. Bolen: A state licensing board or federal court could easily use references to the CDC guideline through the testimony of medical experts, and apply it to the facts in the case. Thus, if a provider prescribed more than 90 MME per day and did not comply with a state guideline or rule based on the following CDC recommendations regarding use of this dosage, the provider could be held legally accountable:

  • Document justification of the decision based on individualized assessment of risks and benefits:
    • diagnosis
    • incremental benefits for pain and function relative to harms as dosage increases to 90 MME per day
    • other treatment effectiveness
    • recommendations based on pain specialist consultation
  • Prescribe naloxone
  • Justify the need for concomitant benzodiazepine use (if relevant)
  • Conduct regular urine drug testing
  • Check the prescription drug monitoring program (PDMP) database periodically
  • Discuss safety concerns with patients, including increased risk for respiratory depression and overdose

The CDC guidelines do not say that physicians cannot prescribe over 90 MME. Several states have adopted guidelines and/or rules addressing MME. Some states require consultation while others suggest it. One state, Maine, imposed a 100 MME per day limit on opioid prescriptions (except for terminal cancer and palliative care).2,3 In most cases, state laws do not impose a daily MME limit on opioids for chronic pain. Thus, from a risk management perspective, providers should look at the CDC’s 90 MME per day dosage as a tollbooth or a marker of what to do when they reach or cross the threshold. If their state licensing board uses a lower MME, they should adopt that as their tollbooth.

It is imperative for physicians to know where their licensing board stands on this issue. Physicians should ask themselves, “Am I doing what a reasonably prudent practitioner would do in the same or similar circumstances when I reach my state’s or the CDC’s MME marker, and have I thoughtfully considered my rationale for doing or not doing something that was recommended?”

Federal and state laws regarding controlled substance prescribing must be followed first. The closest thing to a federal guideline on opioid prescribing in pain management is the DEA’s 2006 Policy Statement on Dispensing Controlled Substances for the Treatment of Pain.4 Federal and state courts may allow expert witnesses to use the DEA’s policy statement and the CDC’s 2016 guideline as supporting evidence for “the usual course of professional practice” element in federal cases, or “reasonably prudent practitioner-like” standards in state cases, including licensing board proceedings. In federal court, prosecutors can also look to expert witnesses to testify about rules and guidance from the US Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA).

Q The CDC guidelines specify that clinicians should consider dual prescribing of naloxone. What does this mean for a prescribing clinician? Do all patients need a prescription, or is that up to the clinician to decide?

Ms. Bolen: A reasonably prudent physician would prescribe naloxone along with an opioid dose ≥ 50 MME per day, as well as to a patient at increased risk of overdose (eg, one with a history of overdose or substance use disorder or concurrent benzodiazepine use). The challenge is making sure that the patient fills the naloxone prescription. Depending on the patient’s background, at some point you will have to draw a line and say that you are not willing to increase the dose unless the patient fills the naloxone prescription and brings it in to show you. It is completely imprudent if you do not confirm the naloxone prescription.

In fact, more and more state licensing boards are setting up similar boundaries and making naloxone prescription for at-risk patients legally binding. For example, the State Medical Board of Ohio released a regulatory statement on using naloxone and discussed factors for respiratory depression events, including smoking, chronic obstructive pulmonary disease (COPD), emphysema, asthma, sleep apnea, and other respiratory disease.3

Last updated on: September 13, 2017
Continue Reading:
What Do the CDC Guidelines Mean for Patients on Long-Term, High-Dose Opioids?
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