AMA: ‘CDC Guideline Has Harmed Many Patients’
/By Pat Anson, PNN Editor
The American Medical Association is urging the Centers for Disease Control and Prevention to make significant changes to its 2016 opioid prescribing guideline to protect pain patients from arbitrary limits and other restrictions on opioid medication.
“It is clear that the CDC Guideline has harmed many patients,” the AMA said in a 17-page letter to the CDC.
The letter was in response to the CDC’s request for public comment as it considers an update and expansion of its controversial guideline. The guideline was only intended for primary care physicians treating chronic pain, but the CDC’s voluntary limits on opioid prescribing have been widely adopted as strict policy by federal agencies, states, insurers, pharmacies and doctors of all specialties.
The guideline has also failed to end the so-called opioid epidemic, which is now largely fueled by illicit fentanyl and other street drugs.
“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial and much more dangerous overdose and drug epidemic driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens,” wrote AMA Executive Vice President and CEO James Madara, MD.
“The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis.”
Over 5,300 public comments were submitted to the CDC, most of them from patients who blame the agency for their untreated and poorly treat pain. Tuesday was the deadline for comments to be submitted.
One-Size-Fits-All Restrictions
The AMA’s letter points out that opioid prescriptions were declining long before the CDC guideline was released, falling 33% from 2013 to 2018.
Many patients cutoff from opioids have had no effective alternatives for pain relief. Some non-opioid therapies recommended by the CDC – such as massage and meditation – are still not fully covered by insurance.
“In many cases, health insurance plans and pharmacy benefit managers have used the 2016 CDC Guidelines to justify inappropriate one-size-fits-all restrictions on opioid analgesics while also maintaining restricted access to other therapies for pain,” Madara wrote.
The CDC plans to update and expand its guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication.
Madara said the agency should start by recognizing that pain patients need individualized care, not “one-size-fits-all algorithms and policies that do not take individual patient’s needs into account.”
“Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies, health insurance plans, pharmacy chains, pharmacy benefit management companies, and other advisory or regulatory bodies,” Madara said.
The AMA said the CDC Guideline could be substantially improved in three ways:
Acknowledge that many patients experience pain that is not well controlled, impairs their quality of life, and could be managed with more compassionate patient care.
Make the guideline part of a coordinated federal strategy to ensure patients receive comprehensive pain care delivered in a patient-centered approach.
Urge states, insurers, pharmacies and other stakeholders to immediately suspend use of the CDC Guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy.
The CDC has been slow to respond to criticism of its 2016 guideline. The agency ignored an early warning from a consulting firm that many patients are “left with little to no pain management options” because “doctors are following these guidelines as strict law rather than recommendation.” The warning came in August 2016, five months after the CDC released its guideline.
It took the agency another three years to publicly admit that many patients were being tapered off opioids inappropriately, putting them at risk of uncontrolled pain, withdrawal and suicide. The agency’s long awaited “clarification” in 2019 had little impact on the problem, because many insurers, pharmacies and doctors still adhere to strict dosing policies.
Even now, the agency appears to be dragging its feet on making revisions to the guideline, which seem more focused on expanding the recommendations rather than fixing them. The CDC does not anticipate the updated guideline to be ready until late 2021.
