CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

Before the CDC suffered a loss of trust over its handling of the COVID-19 pandemic, the agency had fumbled its response to the overdose crisis. Under its leadership, overdose deaths have continued to spiral, as people living with pain have lost access to vital medications.

One of its key missteps was the formulation and implementation of its 2016 prescribing guideline for chronic pain. On November 3 this year, the agency took partial corrective action, revising its approach that contributed to so many harms to people with pain.

In its update, the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain, the CDC emphasizes flexibility in pain pharmacotherapy. It also rejects controversial dose and duration limits that had been widely misinterpreted by policymakers. For this welcome change to have meaning, however, the CDC must work proactively with regulators to rescind harmful policies that resulted from its prior guideline.

What Went Wrong in 2016?

Recommendations in the 2016 CDC opioid guideline included concrete thresholds related to opioid dosing and the number of days opioids should be prescribed for acute pain. Regulators, eager for a ready solution to the overdose crisis, adopted these thresholds as one-size-fits-all laws and mandates.

The uptick was fast and far-reaching. State and federal lawmakers, quality metric agencies, pharmacy benefit plans, state medical boards, and the Drug Enforcement Agency, among others, embraced the thresholds, which had a chilling effect on providers. Patients who’d been placed on opioids were transformed into liabilities. Far too many lost access to care, creating “opioid refugees” with nowhere to turn. Nearly half of primary care providers, according to studies, will refuse to take on such patients.

People with pain were also subjected to dangerous opioid cessation practices — actually increasing their risks of overdose and suicide by three to five times, and needlessly destabilizing their health and lives.

What began as an appropriate call for caution in opioid prescribing turned into a crisis of under-treated pain.

To be fair, the problem can’t be laid entirely at the CDC’s door. The U.S. has undergone a rapid pendulum swing in opioid prescribing, which began to drop in 2012 and is now roughly at levels last seen in the early 1990s.

Further, opioids are not generally considered a first line of treatment for chronic pain. The updated 2022 guideline rightly urges careful balancing of benefits and risks and the expanded use and coverage of other treatments.

But some people do need opioids, one size does not fit all, and the CDC, as the agency in the proverbial driver’s seat issuing guidelines, is in the best position to undo ongoing harm and effect a course correction.

Taking the 2022 Prescribing Guidelines a Step Further

For many patients who have already lost access to care, the 2022 update is too little too late. But the issue still stands to affect millions. While it’s difficult to pinpoint exact numbers, given recent drops in prescribing, an estimated 5 to 8 million Americans, or up to as many as 13 million, use opioids to manage pain.

In light of documented harms and ongoing risks, the CDC must close the gap between rhetoric and action. In 2019, the agency came out publicly against misapplications of its 2016 guideline, but we witnessed no slowing in the number of patients suffering harm.

The language in the 2022 update is stronger; it repeatedly emphasizes clinician discretion and individualized care, and stridently warns regulators not to implement its provisions strictly. It also recognizes that people of color are at heightened risk of having their pain under-treated and spotlights equity.

But the 2022 update could still be misapplied. While dose benchmarks are notably absent from its recommendations, qualified dosage “guideposts” in the text remain. Numbers, history tells us, are temptingly easy for policymakers to adopt as mandates.

Furthermore, the urgency of this problem has not abated. Just recently, patients were abandoned when their provider was raided by the DEA. Desperate, one patient has sought help in a methadone clinic, even though she has no history of a use disorder. Another, who had recently experienced repeated impediments to care, died by suicide alongside his wife.

What Should the CDC Do?

In proactively working with regulators to undo harm, the CDC can begin in its own house at the Department of HHS. It should work with the Centers for Medicare and Medicaid Policy to rescind quality payment metrics based on dose thresholds. Moreover, it should offer technical assistance to the National Committee for Quality Assurance, payers, and pharmacy benefit plans to encourage similar redactions.

Likewise, the CDC should actively engage the DEA and state medical boards so that they cease policing providers based on the dosages they prescribe, and encourage the DEA to arrange transitional care for patients who fall through the cracks.

While the agency can’t tell state or federal lawmakers which laws to rescind or pass, they should conduct active outreach with regulators to educate them about what went wrong with strict thresholds and the genuine risks to patient safety that have resulted. As the nation’s premier public health agency, the CDC has the data and expertise to conduct empirically-based outreach to these decision makers.

The agency has developed implementation tools for providers. It must also disseminate those tools to policymakers, so it can help them understand how key presumptions in opioid regulation — that cutting the medical supply of opioids would reduce overdoses and that cutting people off medication will ensure their safety — have proven wrong with disastrous effects.

How Will the CDC Monitor and Prevent Misapplication?

Fortunately, the CDC already seems poised for vigilance. In a perspective piece in the New England Journal of Medicine, authors of the 2022 update state that the CDC will “monitor” against misapplication. We strongly urge the CDC to remediate past harm, in addition to engaging in forward-looking monitoring.

Monitoring is especially important because the 2022 update represents a significant expansion that now covers the full spectrum of pain from acute, to subacute, to chronic. Typically, it’s good practice to check safety equipment on an aircraft before you expand the fleet. Given the well-acknowledged misapplication of its prior guideline, proper implementation of this expanded guideline is essential.

The health and lives of tens of millions of Americans depend on it.

Leo Beletsky, JD, MPH, is a professor of law and health sciences and the faculty director of the Action Lab at Northeastern University, and an associate professor at the UC San Diego School of Medicine. Kate M. Nicholson, JD, is the founder and executive director of the National Pain Advocacy Center, a nonprofit organization that takes no industry funding and works to advance the health and rights of people living with pain.