Summary of the Draft Updated Guideline

March 1, 2022

SCOPE AND AUDIENCE:

• Expands scope from chronic pain (2016) to acute, subacute, and chronic pain.
• Expands intended audience to all clinicians treating outpatients except pain management (2016 was aimed only at primary care clinicians).

POSITIVES:

• Recognizes pain as a major public health issue and the importance of treating it.
• Acknowledges the harm that has resulted from the 2016 Guideline.
• Abandons strict day and dose limits from mainline recommendations.
• Cautions against rapid tapers and abrupt discontinuation of medications.
• Emphasizes individualized, person-centered pain treatment.
• Emphasizes collaboration with patients.
• Focuses on disparities in pain care.
• Makes clear that the guideline is not intended to be used as the basis as policy or applied as inflexible standards across patients or systems.

CONCERNS and POSSIBLE RESPONSES:

Exceptions: The Guideline makes exceptions for pain in sickle cell disease, cancer treatment, palliative care, and end-of-life care. The CDC does this because different guidelines already exist for those categories.  But by doing so, it still creates the perception of a “hierarchy” of apparent pain severity and of who deserves access to adequate pain management. Further, exceptions do not work; the 2016 Guideline had similar exceptions, but because the Guideline was broadly misapplied, excepted people with cancer and sickle cell disease still faced barriers to medication and care.

• Response: Note that pain severity varies with many conditions, the dangers of exceptionalism, and the fact that exceptions do not work.  

Treating pain as a monolith: Treating all non-acute pain as if it were a single condition for which one category of treatment is always preferred (or not preferred) is at odds with the Guideline’s emphasis on individualized care. This can lead to payer denials of “non-preferred” treatments. (This is a response to Recommendation 2, which reads: Nonopioid therapies are preferred for subacute [+ 1 month] and chronic pain [+3 months].)

• Response: Encourage a slight change in the framing (e.g., “opioids are not often preferred,” “nonopioid treatments are often effective for,” or “opioids are not considered first-line treatment for”, etc.), which would improve the recommendation and make it less likely to be misinterpreted/misapplied.

Dose limits: Dose limits have been removed from the primary recommendations, which is important because many providers and policymakers primarily focus on the recommendations rather than the whole document. Still, references to 50 MME appear in bold in the accompanying text as a point of caution. Our fear is that this could still be lifted by policymakers. (Recommendation 4)

• Response: To avoid specific MME thresholds being used by policymakers, instead encourage advising clinicians to use the lowest effective dose, and to assess risk and benefits at every dose increase. Emphasize emerging evidence at a recent Food and Drug Administration workshop challenging MMEs as a valid metric for patient care. See more in NCIL’s comments to the Food and Drug Administration (FDA) on the science underlying MMEs (Word).

Tapering: While clinicians are cautioned against rapid and involuntary tapering and discontinuation, there remains an emphasis on tapering and a strong caution against reversing tapers. Further, only a few of the studies on the dangers of tapering and related harms are mentioned. (Recommendation 5.)

• Response: Encourage inclusion of all the recent studies (12) on tapering. Oppose the language suggesting that tapering, once begun, should not be reversed and encourage language that considers reversing tapers when harm or poor patient outcomes occur.   

Poor-quality evidence: Overall, the recommendations are based on low-quality evidence (evidence type 3 and 4, which are the two lowest-rated evidence according to the framework the CDC used). Specific concerns include: 1) a lack of transparency about the limits of the evidence used, such as that most studies involve people with mild to moderate pain, and do not consider those with severe or multiple pain conditions, 2) omission of all studies on long-term opioid use that do not last more than 1 year, which eliminates what evidence of efficacy does exist, and 3) equating limited evidence with evidence of limited effectiveness.

• Response: raise these concerns; encourage inclusion of arbitrarily excluded evidence and greater transparency regarding evidence limitations.

Multimodal pain management: Most of the document refers to trying treatments “before” opioids and switching from opioids to other things – when a combination of treatments is often most effective.

• Response: emphasize that the Guideline’s approach is out of sync with how pain is best treated, and that most people use treatments, including medication, in combination.

Implementation: While the Guideline proposes five important guiding principles to inform implementation at the end of the document, more must be done not only to prevent future harm, but also to undo the harm that resulted from the 2016 Guideline.

• Response: Getting a draft guideline finalized is only one hurdle. What the CDC chooses to emphasize in its communication and training modules will be essential to undoing previous harms and avoiding future problems.  Encourage the CDC to focus on flexibility and individualized care in its messaging, to disseminate materials broadly, and to work with policymakers and others (including payers, quality metric providers, and law enforcement) to rescind the supply and dosage thresholds from their policies).