Under pressure from healthcare experts, the Centers for Disease Control and Prevention (CDC) has clarified the controversial federal guideline for prescribing opioids, which it issued three years ago in the face of the opioid epidemic sweeping the country.
In a letter (PDF) released publicly Tuesday, the CDC said the guidelines were not intended to deny chronic pain patients relief from opioids and encouraged physicians to use their “clinical judgment” in prescribing the medications, which can be addictive. The letter also spoke specifically to the use of opioids in the treatment of cancer and sickle cell patients, making it clear the guideline was not meant to limit access to pain management for patients with these conditions.
The Feb. 28 letter was written by Deborah Dowell, M.D., chief medical officer at the CDC’s National Center for Injury Prevention and Control. Addressed to leaders at three medical organizations, the letter was embargoed for release until Tuesday morning.
It was written to the National Comprehensive Cancer Network, the American Society of Clinical Oncology and the American Society of Hematology and came, the organizations said, as a result of a collaborative effort to have the government agency clarify the guideline to ensure safe and appropriate access for cancer patients, cancer survivors and individuals with sickle cell disease.
The CDC issued its guideline in March 2016 in an attempt to curb widespread opioid abuse that claimed 20,000 U.S. lives in the previous year alone. The guideline was intended for primary care clinicians and advised them to prescribe treatments other than opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life care.
However, critics said the guideline was often misinterpreted and had denied too many patients relief from chronic pain. Just last month, more than 300 healthcare professionals wrote to the CDC urging it to clarify its opioid guideline, arguing it is being misapplied by doctors and insurers to the detriment of pain patients—even driving some chronic pain patients to suicide. The letter was signed by many prominent medical experts, including three former White House "drug czars" who served in the Obama, Clinton and Nixon administrations.
“The guideline is not intended to deny any patients who suffer from chronic pain from opioid therapy as an option for pain management,” Dowell wrote.
“CDC encourages physicians to continue to use their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment,” she said.
The clarification was welcomed by the leaders of the three medical groups. “This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” said Clifford Hudis, M.D., CEO of the American Society of Clinical Oncology, in an announcement from the three groups.
The CDC clarification points physicians to clinical practice guidelines that address pain control for survivors of cancer and for patients with sickle cell disease.
“Pragmatic approaches for pain management exist at the intersection of multiple health concerns,” said Robert Carlson, M.D., CEO of the National Comprehensive Cancer Network. “Our guidelines help clinicians to assess the risk of inappropriate substance use, while still ensuring people with cancer don’t suffer unnecessary, severe pain. CDC’s acknowledgment that clinical decision-making should be based on the relationship between physicians and their patients is important and in the best interest of people with cancer and sickle cell disease.”
Roy Silverstein, M.D., president of the American Society of Hematology, pointed to people with sickle cell disease who suffer from severe, chronic pain "which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied.”
"We appreciate CDC’s acknowledgment that the challenges of managing severe and chronic pain in conditions such as sickle cell disease require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered," he said.
People with #sicklecell disease, #cancer should not be denied clinically appropriate opioid therapy. Thanks @CDCgov for this important clarification https://t.co/cvx7JfiwYu @ASCO @NCCNnews pic.twitter.com/Y7MI6sfHZC— ASH (@ASH_hematology) April 9, 2019
While opioid prescriptions have fallen since the CDC released the guideline, it has had some detrimental consequences for patients, according to physicians and health experts.
Although the guidelines are voluntary, many doctors have cut back or stopped prescribing opioids, worried about legal consequences as federal and state prosecutors have zeroed in on inappropriate and sometimes fraudulent painkiller prescriptions.
Leslie Hayes, M.D., a New Mexico family physician, recently featured in the PBS documentary The Providers, said she’s distressed by some of what she has seen as physicians and insurance companies have responded to the opioid epidemic. Both have been doing “crazy things to get patients off of pain pills,” Hayes said in a recent interview with FierceHealthcare.
A doctor who treats patients with opioid use disorder in her primary care practice, she recently had a patient who was stable on pain medications for 10 years when her insurance company said it would no longer cover one of the drugs. Fortunately, the patient could pay for the medication out-of-pocket. “This is not the way to do things,” she said, about patients being abruptly cut off from medications.
And in some cases, patients who have been prescribed pain medications do get addicted. Rather than getting them into treatment for their opioid use disorder, some doctors just stop treating the patient, she said.
“Opioid use disorder is a treatable condition with high morbidity and mortality. It is just wrong to kick someone out of your practice because they’ve developed a known complication from medication you were prescribing,” she said.
The CDC guideline was intended to guide physicians in prescribing opioids to patients who are new to those drugs, she said. It was not intended to be applied to chronic pain patients who are stable on those medications and doctors need to differentiate between the two.