Exclusive: How CDC Will Evaluate the Impact of Its Opioid Guidelines
/By Pat Anson
We’ve learned more about a research study the CDC plans to conduct on the impact of its opioid prescribing guideline, which took opioids off the table as a treatment option for millions of Americans suffering from chronic or acute pain. The study was briefly outlined in a public notice published in the Federal Register in October.
It’s been over 8 years since the CDC released its controversial guideline and two years since the agency revised it, after receiving many reports of patient harm, including rapid opioid tapering, withdrawal, poorly treated pain, and suicide.
The agency has released few details on the “mixed-method quasi-experimental design” of the study, the first attempt by the agency to get direct feedback from patients, caregivers and doctors about the guideline’s impact on pain management.
Further details of the study are not coming from the CDC, but from the Office of Management and Budget (OMB), which is evaluating whether the study meets the requirements of the Paperwork Reduction Act, a law that gives OMB broad authority over the collection of data by federal agencies. The CDC’s briefings for the OMB can be found here, here and here.
“The goal of this research study is to conduct a rigorous, comprehensive evaluation to assess the 2022 CDC Clinical Practice Guideline implementation, uptake, and outcomes. The government will use this information collection to inform CDC efforts and interventions to ensure that Americans have access to safer, effective ways of managing their pain,” the CDC explained.
“We propose conducting an analysis of changes in public and private payers’ policies—e.g., those governing Medicaid, Medicare, private health plans—since late 2022 when the CDC released the Clinical Practice Guideline.”
The study will be conducted over a four-year period and cost nearly $4 million, with much of the work subcontracted to Abt Global, a private research and consulting firm. Abt Global will perform a series of interviews, surveys and focus groups involving patients, caregivers and doctors; as well as dentists, insurers, health system leaders, professional medical associations, and state medical boards.
The DEA and other law enforcement agencies that investigated and prosecuted doctors for “unlawful” opioid prescribing are not included in the study.
The CDC’s previous attempts at evaluating the 2016 and 2022 guidelines relied on data about opioid prescribing rates, not on patient welfare or even whether the guidelines met their primary goal of reducing opioid addiction and overdoses. In that respect, the guidelines have failed. While opioid prescribing has fallen to levels not seen in decades, opioid-related overdoses have nearly doubled since the 2016 guideline’s release.
‘What Has Been Most Effective in Managing Your Pain?’
The CDC is planning an online survey of about 600 doctors (with invitations sent to 3,000) and virtual interviews with 30 of them, asking about their pain management and opioid prescribing practices, as well as any “unintended consequences“ of the agency’s guidelines. Similar questions will be asked of the dentists, insurers, health systems, medical boards, and professional societies.
No interviews or surveys are planned with patients or caregivers. Instead, a series of one-hour focus groups will be conducted involving a total of 135 patients and 90 caregivers, who will receive a $75 gift card as an incentive to participate. The CDC says it will “partner with patient advocacy organizations” to identify participants from their membership lists.
Due to the nature of focus groups, the opinions gathered from patients and caregivers are likely to be viewed as anecdotal or qualitative “perceptions,” not quantitative research.
“We will conduct focus groups with patients to provide an in-depth understanding of a single or small number of cases set in their real-world contexts. Examining the experiences of patients can provide a deeper understanding of real-world behavior within a specific healthcare context to elucidate perceptions of whether and/or how changes occurred in overall treatment and/or pain management, including opioid prescribing,” the CDC said.
The focus groups will be led by Abt Global moderators, who will ask a series of open-ended questions to promote discussion. Notably, there are more questions in the “Patient Focus Group Guide” about non-opioid pain treatments than there are about opioids.
There are also no questions about the CDC’s 2016 guideline. The focus is only on pain management after November 2022, when the revised guideline was released in an attempt to give more flexibility to doctors in using opioids to manage pain.
Focus Group Questions for Patients
What treatments and medications for pain have you tried? What has been most effective in managing your pain?
There are a lot of strategies to help with pain. Tell us about your experience with physical therapy or exercise therapy to help with your pain.
Counseling or behavioral therapy is often used to help with pain. What has your experience been receiving counseling for pain management?
Have you had experience with any other non-medication therapies for pain (e.g., acupuncture)? Can you share your experience with those?
Medications other than opioids, such as ibuprofen and acetaminophen, which can be both prescribed or over-the-counter, are also often used for pain management. Tell us your experience with these non-opioid medications to manage your pain.
Tell us about your first experience being prescribed opioids for pain. How was your pain after you began taking opioids? What side effects did you experience?
When were you initially prescribed opioids for pain? How long were you initially prescribed opioids for? Had you received additional refills for opioids after that first prescription?
Have you noticed any changes to how clinicians manage your pain since November 2022? If so, what have you noticed?
Give me an example of how the management of your pain has improved since November 2022?
Give me an example of how the management of your pain remained the same since November 2022?
How has your pain management gotten worse since November 2022?
Since November 2022, what other factors may have affected how your pain has been managed, such as a change in primary care clinician or changes in your insurance coverage or changing from a primary care clinician to a pain management specialist?
This kind of detail about the questions, participants and research methods has not been made public before. Only a brief overview of the study was provided in the October 2024 notice in the Federal Register, which the CDC made no effort to publicize to get broad public feedback.
As a result, the notice received only two public comments, one of them a letter from the American Society of Anesthesiologists (ASA). The ASA called the 2022 guideline a “significant improvement” over the 2016 guideline, but added that 40% of its members felt the updated guideline was “ineffective.” There were also criticisms that the guidelines “might lead to reduced access to necessary pain medications.”
The CDC was dismissive of both public comments and said no changes would be made to its study design or methodology.
“The public comments received did not have specific suggestions that impact any evaluation instruments; therefore, no changes were made to the instruments,” CDC said.
