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.
The physician’s sudden taper of the patient’s pain medications resulted in increased pain, anxiety, and suicidal ideation.
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 physician was reprimanded, fined, and ordered to complete continuing medical education (CME) in pain management and pain management recordkeeping.
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.
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
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.
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.
Demystifying Opioids Package. Minnesota Health Collaborative. March 2019.
How to Taper Patients off of Chronic Opioid Therapy. Stanford Center for Continuing Medical Education. August 2018.
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.
More Information About Opioid Prescribing for Chronic Pain
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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.