A Legal Interpretation of the CDC Opioid Prescribing Guidelines

https://www.practicalpainmanagement.com/resource-centers/opioid-monitoring-2nd-ed/legal-interpretation-cdc-opioid-prescribing-guidelines

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

Q When discussing MMEs, the CDC guidelines include the following note: “Tapentadol is a μ-receptor agonist and norepinephrine reuptake inhibitor. Morphine milligram equivalents are based on degree of μ-receptor agonist activity, but it is unknown if this drug is associated with overdose in the same dose-dependent manner as observed with medications that are solely μ-receptor agonists.” This may be confusing to PCPs, some of whom may stay away from tapentadol because the MME isn’t clear. Would prescribing tapentadol increase or decrease liability for the prescriber?

Ms. Bolen: This statement is confusing. I think the CDC is indicating that it is unknown whether tapentadol fits into the 50/90 MME schematic regarding overdose risk, because it is unclear how to calculate the MME for this agent. Physicians need to proceed with knowledge from the label of tapentadol and clinical research, just as they do with any other opioid. If tapentadol is appropriate for the patient, then a trial may be justified. Physicians should carefully document their rationale for prescribing any drug to a patient.

This language has not been clarified in court, to my knowledge. It is unfair to call out one drug without explaining that this statement is not intended to discourage or encourage prescribing of the drug.

Q One issue that is often overlooked in the opioid prescribing debate concerns the art of medicine. Can you discuss the legal merits of clinical experience versus evidence-based medicine? Although many arguments against long-term opioid use are based on a lack of clinical evidence, for example, many physicians have cited anecdotal evidence that opioids work well for specific patients.

Ms. Bolen: The art of medicine has been lost, and it is seemingly giving way to government-controlled practice of medicine. A lot of emphasis is placed on evidence-based medicine; however, evidence is lacking on many important topics. For example, while we have some guidance on MME values, there is no universal calculator, and MME calculations are all over the map. Thus, when information on evidence-based medicine and MME values are presented in the same sentence or paragraph in guidelines, it just compounds the confusion for the clinician who is trying to use some of these tollbooths as guides, but who also realizes that no guideline is perfect and there is always risk built into opioid prescribing. This sets up a legal train wreck in court: attorneys get confused, expert witnesses present subjective rather than objective testimony, and judges make bad evidentiary decisions based more on emotion and the tide of skewed statistics than on the current and true measure of proper opioid prescribing.

When a physician has anecdotal evidence that opioids are working well for specific patients, the physician needs to do a better job of documenting the rationale behind the continued treatment plan, such as reevaluating the need for opioids and the appropriate dose, confirming lack of aberrant drug tests or PDMPs, and prescribing naloxone. This information needs to be documented periodically—twice a year at a minimum. For higher-risk patients, the check should be done at least quarterly. Following a template in an electronic medical record (EMR) is not what is needed in this situation to preserve discretion and the art of medicine.

Q Do EMRs provide a sufficient record of physician discussions about the risks and realistic benefits of opioid therapy?

Ms. Bolen: No. Most EMRs are set up to get the physician paid for services and are not set up to comply with controlled substance rules, regulations, and guidelines. Doctors need to tailor their EMR system with templates for adding language, get outside that checkbox mentality, and carefully guard against the use of boilerplate forms.

This is particularly relevant to informed consent, which some EMRs have built in to the system. Informed consent isn’t just a piece of paper in a medical record. It is a process and an ongoing dialogue between the physician and the patient. Real proof of informed consent is individualized interaction with the patient on the risks and benefits of opioid therapy and counseling regarding naloxone that is supplemented with educational materials.

Q The CDC guidelines favor short-acting opioids over long-acting ones for new prescriptions. When a physician wants to switch a patient from a short-acting prescription to a long-acting formula, what’s your legal recommendation?

Ms. Bolen: When a physician wants to switch a patient from short-acting to long-acting formulas, the recommendation is to document the clinical ration-
ale for the switch in the medical record, do a trial, prescribe naloxone, and document the patient’s response to the trial. Make sure you are going through the tollbooth and document that you have practiced in the manner of a reasonably prudent practitioner before you do the switch.

The FDA, SAMHSA, and State of Ohio consider patients taking long-acting opioids to be at increased risk for a respiratory depression event and recommend prescribing naloxone.^5-8 For patients who require a switch, there needs to be a negotiated settlement between the physician and the patient regarding the naloxone prescription. For example, a physician could give a 7-day supply of extended-release opioid and require the patient to fill the naloxone prescription before giving the remainder of the opioid prescription.

From a legal perspective, you minimize risk by doing prudent things when making transitions from short- to long-acting opioids that could cause a higher-
risk potential for overdose. In the case of opioids at increased risk of being misused and abused, such as fentanyl, it is prudent to do a drug test and PDMP check before and during treatment.

Q Many states are beginning to limit the length of first-time opioid prescriptions, and the CDC now recommends 3 days or less. Such restrictions could help reduce overprescribing by dentists, surgeons, ER doctors, and others, but is there a case to be made that some patients should receive longer prescriptions?

Ms. Bolen: For acute or new opioid prescriptions, a 3-day limited supply certainly could reduce the medicine cabinet storage of opioids that are not finished after a root canal or other procedure. I do think there is some prudence to restricting the amount if it is clearly limited to the first time a patient is prescribed an opioid from a given practitioner for a specific issue.

However, this recommendation also is confusing because people are translating it to apply to every patient across the board every time. I’m not sure that is the recommendation’s intent, and 3 days may be overly restrictive for many reasons.

Rules and laws in this particular area are going to evolve, and I believe that guidelines need to be clear as to what this 3-day limit means, why it is there, who it applies to, and whether there are any potential exceptions to it. For example, would that first-time prescription recommendation apply to somebody in hospice?

Yes, it is a good thing to try to control the problems that we have with opioids, but guidelines might be so overly restrictive that they create suffering. Thus, the language needs to be very carefully reviewed to avoid creating inconsistencies.

Q The research community is in broad agreement that pain is best managed by a multimodal approach, with pain medications representing only one part of the equation—and opioids as the last resort. Are you seeing more willingness among insurance carriers to increase access to such multimodal treatments? Should carriers be legally required to provide them?

Ms. Bolen: If opioids are to be used less, insurance companies have to cover other options for pain management that meet the standard of care. I am starting to see little signals that insurance carriers are lightening up on covering some interventions and alternative therapies that were previously restricted. The reason for these changes is unclear. It may be that the companies performed financial analyses and realized they are better off covering alternative therapies than paying for ER visits and opioids, or that companies realized they are potentially liable for some of these opioid-related overdose deaths, because their formularies dictate which medication is preferred over another. For example, if a formulary prefers one controlled medication over another and doesn’t simultaneously increase access to nondrug treatments, the insurance company perpetuates the problem and may open the door for legal liability, depending on other aspects of a case.

If states pass rules that recommend multimodal treatment as a basis for the standard of care, providers will be better able to argue for coverage of multimodal strategies. This issue needs to keep evolving over time because right now, the insurance carriers have a huge stranglehold over the medical industry.

We need a stronger emphasis on behavioral health and a greater value assigned to the evaluation and management of patients on chronic opioid therapies to allow physicians to spend more time with these patients and be fairly compensated. We also need to allow patients access to medical services, such as physical therapy, that aren’t necessarily covered or easy to access without prior authorization.

This interview was conducted by Kristin Della Volpe and has been edited and condensed for clarity.

Filed under: General Problems