The 2016 guideline

Published as an MMWR Recommendations and Reports and simultaneously in JAMA, the 2016 CDC guideline was written for primary care clinicians treating patients aged 18 and over with chronic pain outside active cancer treatment, palliative care and end-of-life care.

Its most consequential passage was recommendation 5:

When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine milligram equivalents (MME) or more per day, and should avoid increasing dosage to 90 MME or more per day or carefully justify a decision to titrate dosage to 90 MME or more per day.

Dowell, Haegerich & Chou, 2016 — recommendation 5

Recommendation 10 advised use of urine drug testing before starting opioid therapy and consideration of testing at least annually.

What happened to it

A study of federal and state opioid policy activity between 2016 and 2018 identified 527 opioid-related policies — statutes, rules and guidelines — approved in that window. 170 specifically imposed limits on opioid prescribing, and 35 specifically referred to or incorporated the CDC guideline in support of those changes. Forty-six states and the District of Columbia mandated pain or opioid prescribing continuing education, potentially affecting as many as 1.7 million prescribers.

Guidance addressed to primary care clinicians treating one class of patient became a numeric limit applied by insurers, pharmacies and state boards to specialists, to long-established patients and, in some cases, to people receiving palliative and end-of-life care.

The 2022 guideline, in its own words

CDC replaced the guideline in 2022. The revision is unusually direct about what went wrong, and the passages below are quoted rather than characterized because the characterization is where these things usually get softened.

On misapplication

Such misapplication includes extension to patient populations not covered in the 2016 CDC Opioid Prescribing Guideline (e.g., cancer and palliative care patients), rapid opioid tapers and abrupt discontinuation without collaboration with patients, rigid application of opioid dosage thresholds, application of the guideline’s recommendations for opioid use for pain to medications for opioid use disorder treatment…, duration limits by insurers and pharmacies, and patient dismissal and abandonment.

Dowell et al., 2022

On the guideline not being a standard

This clinical practice guideline should not be applied as inflexible standards of care across patient populations by health care professionals; health systems; pharmacies; third-party payers; or state, local, or federal organizations or entities.

Dowell et al., 2022

And, on dosage specifically: the recommendations “are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision-making.”

On what payers and systems should not do

Payers, health systems, and state medical boards should not use this clinical practice guideline to set rigid standards or performance incentives related to dose or duration of opioid therapy; should ensure that policies based on cautionary dosage thresholds do not result in rapid tapers or abrupt discontinuation of opioids; and should ensure that policies do not penalize clinicians for accepting new patients who are using prescribed opioids for chronic pain, including those receiving high dosages of opioids, or for refraining from rapidly tapering patients prescribed long-term opioid medications.

Dowell et al., 2022

On abrupt discontinuation

Unless there are indications of a life-threatening issue such as warning signs of impending overdose (e.g., confusion, sedation, or slurred speech), opioid therapy should not be discontinued abruptly, and clinicians should not rapidly reduce opioid dosages from higher dosages.

Dowell et al., 2022 — recommendation 5

On dismissal

Two statements that this site relies on repeatedly. On monitoring data: “Clinicians should not dismiss patients from their practice on the basis of PDMP information.” On testing: “Clinicians should not dismiss patients from care on the basis of a toxicology test result,” and clinicians should explain to patients that toxicology testing will not be used punitively and is intended to improve their safety.

What this does not mean

It does not mean the 2016 guideline was wrong to exist, or that its authors were careless. It was a response to a real crisis, its scope was stated, and the misapplication was done by other parties. The lesson this site draws is narrower and more useful: a number issued as guidance will be implemented as a rule by every system downstream of it that needs something machine-readable. Anyone issuing a number should assume that and design for it.

Questions this raises

Did the CDC withdraw the 90 MME threshold?

The 2022 guideline replaced the 2016 numeric instruction with a formulation containing no number, and states this was deliberate — to discourage misapplication of dosage thresholds as inflexible standards. It also says payers, health systems and boards should not use the guideline to set rigid dose-related standards. See what a prescribing limit actually does.

Does the CDC guideline say patients can be dismissed for a positive drug test?

It says the opposite. The 2022 guideline states clinicians should not dismiss patients from care on the basis of a toxicology test result, or from their practice on the basis of prescription monitoring information, and that patients should be told testing will not be used punitively. See the urine drug testing evidence.