Opioid discontinuation as an institutional mandate: Questions and answers on why we wrote to the Centers for Disease Control and Prevention

On March 6, 2019, a self-designated committee (Health Professionals for Patients in Pain, HP3, a group that is not incorporated and accepts no contributions) sent a public letter to the Centers for Disease Control and Prevention (CDC), urging the agency to address the widespread misapplication of its 2016 guideline on prescribing opioids.¹ Three hundred and eighteen health care professionals and three former directors of the White House Office of National Drug Control Policy (“Drug Czars”) signed the letter, as did² the parent organization for Substance Abuse, the Association for Multidisciplinary Education and Research on Substance use and Addiction.

The core request of writers and signatories was that the CDC’s director issue a bold, public clarification that its guideline did not call for nonconsensual opioid tapers or patient abandonment—two harmful activities that have drawn the attention of the media,^3,4 professionals,^5,6 and Human Rights Watch.⁷ The letter also asked the CDC to evaluate adverse outcomes experienced by so-called “legacy” opioid recipients, a commitment made by the CDC itself within the text of its own guideline.

On April 10, 2019, the CDC’s director, Dr. Robert R. Redfield, offered that clarification in writing, and he encouraged HP3 to disseminate his response.⁸ The director declared that the guideline’s widely cited thresholds of 50 and 90 morphine milligram equivalents (MME) were not appropriate to impose on patients who were already stable on doses that exceeded those thresholds. His announcement came on the heels of a drug safety announcement, one day earlier, from the United States Food and Drug Administration (FDA), cautioning against rapid opioid taper as risking harm to patients. These two government announcements, issued within one day of each other, now exist in tension with a wide range of harmful activities by insurers, pharmacy chains, regulators, and quality metric agencies, nearly all of which have invoked the authority of the CDC as justification. Their moves have included incentivizing or mandating nonconsensual dose reductions, or using the number of patients above specific dose thresholds as the basis for deeming care inferior or dangerous.^9,10

The point of this essay is to explain why we penned the March 6 open letter to the CDC in the first place. Journalists and colleagues have asked us to expand upon our motivation for writing the letter and inquired about the possible impact the CDC’s clarification—were it forthcoming (and, on April 10, it was)—could have. This questions and answers (Q&A) offers an abbreviated account of how we came to take the action we did, and what we see as plausible next steps.

Why did you issue a letter about a guideline? Are you saying it’s bad?

The HP3 letter itself endorsed the CDC’s guideline. We found its recommendations to be reasonable interpretations of the evidence, even if some particulars remain open to honest debate. For example, the guideline’s emphasis on opioid dose thresholds as delimiting safer and less safe forms of prescribing could be defended as a relevant parameter when clinicians face the prospect of raising doses in select patients.^11,12 However, the focus on dose thresholds could be critiqued as inviting excessive institutional attention to one parameter while tacitly discouraging attention to other clinically actionable characteristics.^13–15

The problem, as we saw it, lay not so much in the debatable ambiguities, as in institutional failures to protect patients in chronic pain who receive or require opioids on a long-term basis. As clinicians who see and hear from patients, we are devastated by the many stories of patients who are denied medications, who suffer functional decline and resurgence of pain, or who contemplate and even complete suicide. These tragedies have our concern, even if we would concur that not all those opioid prescriptions or dosages were appropriate at the time they were started. Our understanding, similar to that of the director, was that the CDC’s guideline never mandated forced dose reductions (the evidence being unsettled¹⁶), yet many institutional actors forced the matter in several ways. These have included the establishment of prohibitive bureaucratic barriers, the derivation of crude quality metrics that brook no exception, the issuance for chiding letters to physicians, letters of legal warning, and state regulations.

Results of physician polling¹⁷ and our own observation reveal dose reduction by less-than-expert physicians acting out of concern for professional liability or in deference to institutional mandates. Reducing total milligrams among contracted physicians might bring bragging rights for insurers,¹⁸ but the expense included patient harms.¹⁹

If the CDC’s guideline caused a problem, why not withdraw the guideline itself?

The guideline has caused a problem because it has been misinterpreted. Given the absence of definitive new data to guide prescribing for chronic pain patients, the current guideline remains a reasonable document. The remedy is technically simple: The CDC and the United States Department of Health and Human Services should simply affirm that there is no justification whatsoever for mandated taper or withdrawal of opioids for patients with long-term pain using medication as directed and who are experiencing functional benefit as assessed by their prescriber. The director’s letter advances that goal.

Can’t this be resolved by providing additional CDC guidelines on tapering?

Not yet. Definitive evidence to justify a formal, national guideline on “how to taper” is lacking, although some physicians will appreciate efforts to organize the wisdom of experts. At this moment, the FDA announcement on tapering, dated April 9, entitled “Additional Information for Health Care Professionals,” provides a reasonable guide. It states, among other things, “If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.”²⁰

The current situation is eerily parallel to the decade-long run-up of opioid prescribing in which institutional pressures aligned to incentivize liberal opioid prescribing, in part through the aggressive use of a pain-centered quality metric.²¹ People who called attention to the impact of the institutional incentives were dismissed with the suggestion that any problems were best understood as the result of a few uneducated or criminal doctors. A little more training and a bit more enforcement, it was argued, would fix the bad actors.

In our view, institutional imperatives should not have been discounted in the run-up to today’s crisis. Neither should they be discounted today.

Now that the CDC has spoken, what should happen?

The CDC’s crystal-clear clarification, coupled with the FDA’s explicit announcement, contrasts with the standard of care invoked by sundry institutional efforts to push nonconsensual dose reductions, carried out by inexpert clinicians, on previously stable patients. Prior to the clarifications, few seemed to care or notice when agencies such as the Government Accountability Office,⁹ quality metric agencies,¹⁰ private and public payers (including Medicaid agencies), health care employers, and pharmacy chains improperly attributed their metrics, incentives, and payment policies to the CDC.

What should happen now is this: patients, physicians, and professional organizations should download, print, and share the FDA and CDC clarifications with the very agencies that have promulgated quality metrics, payment decisions, threatening letters, and legal threats. This is key because right now a proposed change to an opioid quality metric from the National Committee for Quality Assurance (NCQA) threatens new harm. Namely, it intends to count “the proportion of members 18 years and older who received prescription opioids at a high dosage (average milligram morphine dose [MME] ≥90 mg)” and designate inferior performance based on this number alone.²² There are consequences to this misbegotten plan. If adopted, the NCQA will strengthen its existing incentive (based on > 120 MME.) for physicians to abandon “legacy” opioid-receiving patients or to forcibly taper, contrary to the CDC’s clarification.⁸

What we and others should be saying to the NCQA and others is: “Your initiatives require doctors to ignore the standard of care, and to put patients at risk. Why does your agency wish to oppose both the CDC and the FDA on this matter?” The quicker health care providers and patients confront perpetrators of bad policies that violate the CDC guideline and FDA’s intent, the quicker we will restore sanity to opioid treatment of legacy patients in chronic pain.

Disclosure and disclaimer

Dr. Stefan G. Kertesz reports that prior to 2018, he owned stock in two pharmaceutical companies, Merck and Abbott Pharmaceuticals, not amounting to greater than 5% of his assets, and that these were sold in December of 2017. Dr. Alford is course director for a safer opioid prescribing continuing medical education program funded by unrestricted educational grant awarded to Boston University School of Medicine by the REMS Program Companies as part of the Food and Drug Administration (FDA) Opioid REMS program. Dr. Alford does not receive any direct compensation from industry for this activity. Dr. Dart is executive director of the RADARS System. Most manufacturers of prescription opioids or stimulants subscribe to the RADARS System, which is the property of Denver Health and Hospital Authority, a political subdivision of the State of Colorado.

Views expressed are those of the authors alone, and do not represent formal positions or views of any employing institution, including the United States Department of Veterans Affairs.