In the continuing tussle over whether providers should have to obtain an X-waiver to prescribe buprenorphine, the Biden administration has staked out some middle ground, at least for now.
The Department of Health and Human Services (HHS) has issued updated buprenorphine practice guidelines that significantly loosen some of the requirements needed to obtain the X-waiver, although waiver requirement remains.1
What does this all mean for emergency providers, many of whom encounter patients with opioid use disorders (OUD) regularly? Lewis Nelson, MD, FACEP, says under the new guidelines, many providers will no longer be required to complete the eight-hour training course that was part of obtaining the X-waiver. But there are some stipulations.
For example, clinicians can choose to bypass the customary training and certification process; perhaps more importantly, these clinicians who choose that route would not be allowed to treat more than 30 patients with buprenorphine at the same time. Those wishing to exceed the 30-patient threshold would take the traditional training and certification route.2 Also, Nelson notes all buprenorphine prescriptions (and prescribing providers) still will be tracked by the DEA.
Theoretically, an emergency provider could prescribe buprenorphine to more than 30 people in a week. Nelson believes that is unlikely to happen.
“If you are an emergency physician like I am, you would not typically give someone more than a week or two of the medication,” says Nelson, professor and chair of the department of emergency medicine and director of the division of medical toxicology at Rutgers New Jersey Medical School and University Hospital in Newark, NJ.
Nelson explains the typical goal in the ED is to start patients on buprenorphine, and then transition them to a long-term medication-assisted treatment (MAT) provider. However, the goals might be entirely different for some primary care providers.
“If you have a cadre of more than 30 people that you want to prescribe buprenorphine for on a regular basis, then you need to get the waiver training,” Nelson says.
While Nelson sees the revised guidelines as a positive, he is skeptical that merely dropping the training requirement to prescribe buprenorphine will result in any significant increase in the number of emergency provider-issued prescriptions.
“I think there will be a marginal benefit. I don’t think it will be the silver bullet that some people want to believe it is,” he explains.
Nelson acknowledges the eight-hour training requirement was a barrier to treatment, but he observes the training was available at no or low cost.
“I think the real problem is [buprenorphine] is a medication that has been explained or touted as being very difficult to use,” he offers. “The medicine has always been given a certain mystical quality because it is a little different than all of the other opioids. It is a partial agonist, not a full agonist ... like morphine or oxycodone.”
Further, there remains a certain stigma associated with patients who require OUD treatment, and some clinicians prefer not to be involved. “[OUD] is often viewed as a weakness or a vice, not a medical disease. Many clinicians are hesitant to treat this patient population, particularly with a drug that isn’t something that is very clearly easy to use,” Nelson explains.
In fact, Nelson stresses that because of its pharmacological properties, buprenorphine is a relatively safe drug that is not often diverted or abused. However, while medical students receive considerable instruction on how to use traditional opioids, they generally do not learn how to use buprenorphine. “That is why there has always been this extra training requirement [for buprenorphine],” Nelson says.
Nelson sees a need to replace the eight-hour training that was required for the X-waiver so clinicians can develop a comfort level with prescribing the drug.
“One of the things I am working on ... is making sure that we develop a training program that is an hour long to replace the waiver training. I am still concerned that many clinicians will not know how to use this drug,” he says.
When not used properly, buprenorphine can result in short-term consequences, such as precipitated withdrawal.
“While not life-threatening, this is pretty uncomfortable [for the patient],” notes Nelson, adding this is the primary reason why some clinicians are reluctant to use buprenorphine. “I spend a lot of time trying to explain to physicians how to do this. Even among those of us who practice in toxicology and addiction, there is not a unified answer. There are multiple different dosing regimens and multiple different time schemes that people use.”
Nonetheless, Nelson says emergency clinicians could receive appropriate guidance on buprenorphine in multiple ways, including via real-time approaches. For instance, he notes providers can call the New Jersey Poison Control Center, and staff will walk them through how to initiate a patient on buprenorphine.
In addition to making such training easily accessible, Nelson believes incentives are needed to encourage emergency providers to initiate appropriate patients on MAT.
“Right now, we are disincentivizing the treatment of this population,” he says. “Many of these patients are uninsured or underinsured, they take a lot of time in the ED, and there are often complicated issues [involved].”
Some states, such as Pennsylvania, have provided financial incentivizes to hospitals that initiate patients on MAT in their EDs.3 Nelson believes the providers should be incentivized. “If you want to make a wholesale change, you are going to need to incentivize people to do it,” he says. “This is just a complicated drug and a very marginalized patient population. It is a double-whammy.”
Push for More
In a statement, the American College of Emergency Physicians (ACEP) welcomed the guideline changes, but argued the updates do not address other remaining barriers.
“During the pandemic, the opioid epidemic has accelerated across the country and the number of overdose deaths has increased,” ACEP President Mark Rosenberg, DO, MBA, FACEP, said. “Expanding patient access to [MAT] in the emergency department is one of the most effective methods for addressing [OUD] or overdose.”4
Acknowledging the Biden administration may not have the legal authority to outright eliminate the X-waiver requirement, ACEP urged Congress to pass the Mainstreaming Addiction Treatment (MAT) Act or similar legislation that would fully repeal the X-waiver.5 That would make it easier for patients to access the life-saving treatment, according to Rosenberg.
ACEP believes the HHS guidelines are a step forward, but the organization said the existence of the X-waiver leads to misperceptions about MAT and nurtures the stigma that makes some clinicians reluctant to treat OUD patients.4
- Department of Health and Human Services. Practice guidelines for the administration of buprenorphine for treating opioid use disorder. Fed Regist April 28, 2021.
- Substance Abuse and Mental Health Services Administration. Become a buprenorphine waivered practitioner. Last updated May 14, 2021.
- Brooks D. Use state-level policy to drive rapid changes in opioid use disorder treatment. ED Management. June 1, 2021.
- American College of Emergency Physicians. Emergency physicians welcome updated buprenorphine guidelines but barriers to treatment persist. April 27, 2021.
- Congress.gov. HR 1384. Mainstreaming Addiction Treatment Act of 2021.