In 2016, the CDC released a clinical practice guideline for primary care physicians prescribing opioids for chronic pain,1 which was adopted by various entities, including Medicaid agencies and insurers.2 However, according to the CDC and others, the guideline has been misinterpreted and misapplied. An example of a misapplication concern involves the management of patients with chronic pain, which are not intended to follow the same guidelines as those patients being initiated on opioids.
In the years since the 2016 Guideline came out, the CDC and others have published reports, commentaries, and guidelines intended to reduce some of the confusion surrounding pain management in patients for whom opioid therapy is appropriate. In November 2022, the CDC also released their new Clinical Practice Guideline for Prescribing Opioids for Pain, which updates and replaces the 2016 Guideline.
A 2019 New Hampshire Board of Medicine case3 details a challenging opioid therapy scenario that has been similarly described by policyholders of various specialties who call the NORCAL Group Risk Management Department for advice. In the calls, policyholders request strategies for tapering or terminating treatment of patients on high-dose opioids.
The following medical board case provides some insight on the importance of understanding and following state rules and regulations and documenting patient noncompliance. Although the physician in the following case is a pain management specialist, the same findings could be applied to a primary care physician in a similar treatment scenario.
Allegation
The physician’s sudden taper of the patient’s pain medications resulted in increased pain, anxiety, and suicidal ideation.
Case File
The patient began treating with a pain management physician in May 2014. The patient reported chronic pain over the course of many years, due to different sources. He was taking 80 mgs of oxycontin twice daily and 30 mgs of oxycodone four times daily, in addition to clonazepam for anxiety. According to the treatment plan, the physician would continue the patient’s oxycontin and oxycodone at the same doses, see the patient monthly, perform urine toxicology and check the prescription drug monitoring database at every other office visit, and conduct yearly random pill counts. He also had the patient sign a therapeutic agreement.
In December 2015, because the patient complained of diminished pain relief, the physician increased the patient’s oxycodone from 30 milligrams four times per day to five times per day. At the next visit, the patient reported the increased dose effectively managed his pain and improved his ability to complete chores around the house. He remained on this dose until April 2018.
In April 2018, the physician informed the patient that the Centers for Medicare & Medicaid Services (CMS) had issued new guidelines that only allowed a total of 90 MME/daily (a misinterpretation). As part of his plan to taper the patient’s pain medications to 90 MME/day, he reduced the patient’s oxycontin dose by 40 milligrams a day (a decrease of 13%).
In the first week following the dose reduction, the patient requested a reinstatement of the higher dose to treat his pain, but the physician refused, citing the 2016 CDC and CMS guidelines, which he believed prohibited opioid prescribing in excess of 90 MME/day. The next time the patient called, the physician offered to refer him to cognitive behavioral therapy, which the patient refused.
At his May 2018 office visit, the patient reported that his pain was 7/10, and that he had gone to the hospital due to emotional distress caused by his pain. The physician reduced the patient’s oxycontin dosage by another 20 mgs in a continuing effort to get the MME/day to ≤90. Shortly thereafter, the patient failed a random pill count and was admitted to the hospital due to threats of suicide unless he was given a higher dose of opioids.
In June 2018, during a phone conversation, the physician notified the patient that, in light of his recent threats of suicide, the physician was no longer comfortable prescribing opioids to him, and he was terminated from treatment. The physician then called the local police department and the patient’s primary care physician to report his concerns about the patient’s well-being. He also sent a prescription to the patient’s pharmacy for opioid withdrawal symptoms.
The patient filed a complaint with the medical board alleging that the sudden taper of his pain medications resulted in increased pain, anxiety, and suicidal ideation.
The medical board, in support of its determination that the physician had violated New Hampshire practice statutes, ethical requirements, and its chronic pain medication laws and regulations, cited the following findings:
- The patient’s medical record lacked evidence of: the method the physician used to assess the patient’s medication misuse risk; re-evaluation of the original treatment plan; and opioid therapy efficacy, other than referring multiple times to the patient’s ability to perform household chores.
- The physician identified the patient’s anxiety as interfering with pain management, but failed to address it. (The patient’s primary care physician prescribed clonazepam throughout the pain management treatment.)
- The physician failed to recommend behavioral health modalities for pain management; for example, he did not refer the patient for psychiatric treatment, addiction treatment, or cognitive behavioral therapy. (CBT was offered after the taper started.)
- The physician failed to recommend non-opioid medications for the patient’s pain, such as anti-inflammatories, antidepressants, or anti-seizure medications.
The physician was reprimanded, fined, and ordered to complete continuing medical education (CME) in pain management and pain management recordkeeping.
Discussion
This case illustrates the importance of physician familiarity with state opioid prescribing laws. Prescribing policies and procedures, therapeutic agreements, risk assessments, informed consents, documentation, and communication should comply with state regulations. New Hampshire is one of 47 states (according to a recent study) with opioid prescribing laws in place.4 The Federation of State Medical Boards publishes Pain Management Policies, Board by Board Overview, a state-by-state chart that provides citations (with links) to state statutes, regulations, guidelines, and policies.
The case also indicates that mere statements in the medical record that risk assessments or risk/benefit analysis have been completed may not sufficiently show compliance with laws and treatment guidelines.
Risk Reduction Strategies
Although the risks of long-term high-dose opioid therapy are well documented in medical literature,5 inappropriate tapering for legacy patients can present a high risk for patient injury and dissatisfaction. Tapering can drive patients to illicit opioid use (either because of poorly controlled pain or self-treatment), withdrawal symptoms, and suicide.6,7,8 It can also prompt patients to self-terminate care, which increases the risk that other diseases will progress.7 Dealing with the competing risks of continuing opioid therapy at present doses versus tapering to safer levels can become so frustrating or time consuming for physicians that the only realistic solution may seem to be termination of treatment, which itself increases patient injury and liability risk. The following strategies increase the chance that patients can be transitioned to safer, potentially more effective pain management:9,10,11
- Do not abruptly discontinue opioids in patients who are physically dependent on them.
- Collaborate with the patient to create an individualized tapering plan.
- Determine a range of reasonable, health-affirming choices that align with the patient’s own personal goals and values (i.e., shared decision-making).
- Do not rush the tapering schedule.
- Educate the patient not only about first steps, but also about the long-range plan and milestones.
- Explain the ways in which the clinical team will support the patient throughout the tapering process.
- Follow up and re-evaluate the tapering schedule frequently.
- Acknowledge patient success.
- Monitor for suicide risk.
- Treat the symptoms of opioid withdrawal.
- Maximize non-pharmacologic and non-opioid pharmacologic treatments for pain as appropriate.
- Consult with pain management specialists.
- Identify and treat anxiety, depression, and OUD, which may manifest during tapering.
- Consult with behavioral health or addiction specialists as appropriate.
- Use an empathetic approach for patients with OUD.
- Educate patients about addiction as a medical issue, not a moral failing.
- Offer or arrange for medication-assisted treatment (MAT).
- Inform patients that tolerance to former dosage levels of opioids is lost quickly (as briefly as a week), which puts them at high risk of overdose if former doses of opioids are taken during tapering.9
It’s important to note that proposing risk reduction strategies for pain management comes with the acknowledgement that some primary care practices may face limited referral options, insurance coverage for various pain management modalities, and clinician time to manage cases. It is important to realize, however, that lack of resources, insurance, options, etc. are not valid defenses to medical negligence. Primary care physicians cannot abdicate responsibility to address a patient’s complaints of pain – keeping in mind that addressing pain does not mean curing pain. Expectation management is important for all pain management patients, but crucial for legacy patients (patients who have been on long-term opioid therapy) in practices with limited resources. If a particular patient’s pain management is outside a physician’s scope, or resources cannot be accessed, the physician has to communicate that clearly and compassionately. A physician can state the needed care is “past my area of expertise and I need help managing your condition in the safest way possible.”
Appropriate documentation of efforts to accomplish pain management in a manner consistent with the standard of care is a crucial aspect of liability risk management in difficult circumstances. At a minimum, medical record documentation should include efforts to coordinate care and refer to specialists, the results of those efforts, and patient response to those efforts, as well as conversations with patients about waiting periods for specialty care referral and what can and cannot be done in the meantime.
Additional Resources
Tapering Resources
The following resources provide guidance for creating tapering plans for long-term opioid users:
Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. U.S. Department of Health and Human Services. 2019.
- A guide that provides advice to clinicians who are contemplating or initiating a reduction in opioid dosage or discontinuation of long-term opioid therapy for chronic pain
Demystifying Opioids Package. Minnesota Health Collaborative. March 2019.
- A collection of materials that includes opioid tapering frequently asked questions and algorithms for screening, diagnosis, and treatment of OUD
How to Taper Patients off of Chronic Opioid Therapy. Stanford Center for Continuing Medical Education. August 2018.
- A free CME activity designed to enable physicians to recognize when risks of chronic opioid therapy outweigh benefits, and safely and compassionately taper patients off chronic opioid therapy (including the use of buprenorphine to make this transition)
NORCAL Group Resources
Policyholders may find the following resources helpful when utilizing opioid therapy during pain management. They are available in the policyholder portal or by request at 855.882.3412.
- Sample Form: Pain Medication Agreement
- Clinical and Administrative Resources: Medication Management: Prescribing Controlled Substances Establishing and Terminating the Relationship
- Claims Rx: Termination of the Physician-Patient Relationship: Breaking Up is Hard to Do. April 2020.
References
1. Deborah Dowell, Tamara Haegerich, et al. “No Shortcuts to Safer Opioid Prescribing.” The New England Journal of Medicine. 2019;380:2285-2287. DOI: 10.1056/NEJMp1904190.
2. Amy S.B. Bohnert, Gery P. Guy Jr., et al. “Opioid Prescribing in the United States Before and After the Centers for Disease Control and Prevention’s 2016 Opioid Guideline.” Annals of Internal Medicine. 2018;169:367-375. DOI: 10.7326/M18-1243.
3. In the Matter of Joshua Greenspan, M.D. License No. 13011. State of New Hampshire Board of Medicine. Settlement Agreement. June 18, 2019.
4. Elizabeth M. Stone, Lainie Rutkow, et al. “Implementation and Enforcement of State Opioid Prescribing Laws.” Drug and Alcohol Dependence. 2020 Jun 11;213:108107. DOI: 10.1016/j.drugalcdep.2020.108107.
5. Andrew Joseph. “With a New Guide to Tapering Opioids, Federal Health Officials Seek a Balanced Approach to Prescribing.” STAT. October 10, 2019.
6. National Quality Forum. Opioids and Opioid Use Disorder: An Environmental Scan of Quality Measures Final Report. September 12, 2019.
7. Perez HR, Buonora M, Cunningham CO, et al. “Opioid Taper Is Associated with Subsequent Termination of Care: A Retrospective Cohort Study.” Journal of General Internal Medicine. 2020;35:36-42. DOI: 10.1007/s11606-019-05227-9.
8. Nabarun Dasgupta, Leo Beletsky, et al. “Opioid Crisis: No Easy Fix to Its Social and Economic Determinants.” American Journal of Public Health. 2018;108(2):182-186. DOI: 10.2105/AJPH.2017.304187.
9. Joseph V. Pergolizzi, Giustino Varrassi, et al. “Stopping or Decreasing Opioid Therapy in Patients on Chronic Opioid Therapy.” Pain and Therapy. 2019;8(2):163-176. DOI: 10.1007/s40122-019-00135-6.
10. Working Group on Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics. “HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics.” U.S. Department of Health and Human Services. October 2019.
11. U.S. Food and Drug Administration. “FDA Identifies Harm Reported from Sudden Discontinuation of Opioid Pain Medicines and Requires Label Changes to Guide Prescribers on Gradual, Individualized Tapering.” Safety Announcement. April 9, 2019.
