For example, Beletsky points to how the definition of high-dosage opioid use — described as 90 or more morphine milligram equivalents (PDF) daily in the 2016 recommendations — was used to establish legal limits. "The [2016] guideline itself was clear that this was not a bright line rule," he says, "But it became a de facto label, separating appropriate and inappropriate prescribing," he says. And this led law enforcement in some states to use the limit "as a sword to go after prescribers."
These doses and limits — set without much scientific evidence to back them up — have had a chilling effect on doctors, says Cindy Steinberg, a patient advocate with U.S. Pain Foundation.
"Most people that I know — and I know a lot of people living with chronic pain — have already been taken off their medication. Doctors are incredibly fearful of prescribing at all." From Steinberg's perspective, the new CDC guidelines remain overly restrictive and won't make much difference to the patients who have already been harmed.
Specific dose and duration limits are out
The most consequential changes in the new guidance come in the form of 12 bullet points that lay out general principles related to prescribing.
Unlike the 2016 version, those takeaways no longer include specific limits on the dose and duration of an opioid prescription that a patient can take, although deeper in the document it does warn against prescribing above a certain threshold. The new recommendations also explicitly caution physicians against rapidly tapering or discontinuing the prescriptions of patients who are already taking opioids — unless there are indications of a life-threatening issue.
"I think they are very comprehensive and compassionate," says Dr. Antje Barreveld, medical director of the Pain Management Services at Newton Wellesley Hospital. "Those arbitrary marks of what's acceptable and not acceptable is what got us into trouble with the 2016 guidelines, because it made this blanket cutoff for our patients and that's not what pain management is about."
The direction on reducing opioids when possible still raises some concerns for clinicians like Stefan Kertesz, a professor of medicine at the University of Alabama at Birmingham.
"I would emphasize that when you take a stable patient and reduce [their prescription], you're engaged in an experiment," says Kertesz. "Dose reduction is simply an uncertain intervention that sometimes helps and sometimes causes the patient to die. So I would rather they have said, 'Look, this is an uncertain intervention.'"
However, he adds that the strength of the new guidance is its repeated emphasis that a specific dose should not be used by agencies, law enforcement and payers to enforce a one-size fits all approach.
Unravelling rigid opioid prescribing policies
It's uncertain if the new guidance will translate into substantive changes for patients who are struggling to have their pain treated.
Many patients currently can't find treatment, in the aftermath of the 2016 guidelines, says Barreveld, because doctors are wary of prescribing at all.
She remembers one recent instance when an elderly patient of hers was suffering from severe arthritis in her neck and knees. "I recommended to the primary care doctor to start low-dose opioids and the primary care doctor said 'no,'" Barreveld says. "What happened? The patient was admitted to the hospital, thousands of dollars a day for eight days, and what was she discharged on? Two to three pills of an opioid a day."
The previous guidelines led to restrictions on prescribing being codified as policy or law. It's not clear those rules will be re-written in light of the new guidelines even though they state they're "not intended to be implemented as absolute limits for policy or practice."
"That is a good idea, and it will have absolutely no effect unless three major agencies take action immediately," says Kertesz. "The DEA, the National Committee for Quality Assurance, and the Centers for Medicare and Medicaid Services, all three agencies use the dose thresholds from the 2016 guideline as the basis for payment quality metrics and legal investigation."
The ability to coordinate and fix the harms that came from the 2016 guidance relies on leadership from the CDC — an agency whose credibility and authority has taken a hit during the COVID-19 pandemic, Beletsky says. Still, the agency has learned from the criticisms and harms from the last round of guidance. "So my hope is that CDC is now better equipped and prepared to take the guideline and translate it to the ground level," he says.
The quality of life for many patients living with chronic pain will depend on it.