As suspicion – or acknowledgement – that many cases of opioid use disorder (OUD) were iatrogenic and the opioid crisis grew, both federal and state governmental health agencies sought to develop and issue guidance for physicians. Having been fed misinformation by pharmaceutical companies for years, physicians needed evidence-based guidelines to appropriately treat their non-cancer chronic pain patients. The Centers for Disease Control and Prevention (CDC) responded definitively by issuing guidelines after seeking input from experts and stakeholders and combing through the evidence and responses. In addition, legislatures put strict limitations on prescribing in certain situations. It is clear that compliance with opioid prescribing legislation is mandatory, but what about compliance with guidelines?
Background. The most noted guidance is the CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, which was published in the Morbidity and Mortality Weekly Report on March 18, 2016 (the 2016 Guideline). State guidelines followed, as well as legislative limitations on prescribing opioids. Although the 2016 Guideline was rated highly for evidence-based practice, something was not right: Physicians, perhaps fearing investigation, were applying the 2016 Guideline too strictly, often resulting in patient harm.
After an April 2019 commentary in the New England Journal of Medicine described the misapplication of the 2016 Guideline and its consequences, the CDC issued a media statement regarding issues that could put patients at risk (the CDC Statement). The CDC Statement enumerated misuses of the 2016 Guidance: applying it to populations outside of its scope; implementing hard limits or “cutting off” opioids; abrupt tapering; and applying it to patients receiving medication-assisted treatment for OUD. On Oct. 10, 2019, the U.S. Department of Health and Human Services (HHS) bolstered the CDC Statement with a guide of its own: HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (the 2019 Guide), which advises a more patient-centered, tempered approach that takes into account multiple factors.
For example, the 2019 Guide discusses that the 2016 Guideline recommends avoiding or carefully justifying increasing dosage above 90 MME/day, but it does not recommend abruptly reducing opioids for patients who are already on higher dosages. Alas, the 2019 Guide makes recommendations for tapering that physicians may be unprepared to do, such as assessing for OUD. If the patient meets the criteria for OUD, the 2019 Guide recommends transitioning the patient to buprenorphine for treating the OUD, which requires the prescribing physician to have a DATA 2000 waiver. However, if the patient does not meet the criteria for OUD, a slow taper or a transition to buprenorphine for pain, which does not require a DATA 2000 waiver, is recommended. The 2019 Guide also recommends ensuring that patients receive appropriate psychosocial support: “Ask how you can support the patient.”
Legal perspective. In order to understand the legal effect of guidance, we need to understand how regulations are issued. Under the Administrative Procedures Act, which governs how federal agencies issue and implement regulations, there are two types of rules: “legislative” rules that go through the required notice and comment rulemaking procedures, and “interpretive” rules that may be issued without prior notice or public comment. In notice and comment rulemaking, a proposed rule is published in the Federal Register. The public has the opportunity to review and comment on the proposed rule. After considering the comments, the agency publishes the final rule in the Federal Register. Comments can significantly change the content of a final rule. These legislative rules are legally binding; however, interpretive rules, to the extent that they exceed the parameters of legislative rules or the underlying statute, are generally not. In recognition of this important distinction, the U.S. Department of Justice (DOJ) recently updated its Justice Manual to formalize prior Attorney General memoranda prohibiting the DOJ from relying on agency guidance/interpretive rules in enforcement actions. So technically, the 2016 Guideline and other guidance is just that: guidance. From a practical standpoint, however, well-documented and widely accepted guidance can become the standard of care, and significant deviation can result in malpractice claims in the event of adverse events or governmental investigations.
Conclusion. The CDC Statement and the 2019 Guide were essentially issued to put a stop to physicians “over-correcting” their opioid prescribing practices because of the 2016 Guideline. Although the 2019 Guide asks much of prescribing physicians, its basic premise should be embraced: “Review the risks and benefits of the current therapy with the patient, and decide if tapering is appropriate based on individual circumstances.” (Emphasis added.) But be sure to document those circumstances thoroughly: Your evaluation of the risks and benefits of opioid and alternative treatments as the basis for your medical decision making should be clear to a third party reviewing the medical record.
DISCLAIMER: This article is for informational purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.