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A Small But Certain Step Toward Removing the “X” Waiver

Summary:
On January 14, the U.S. Department of Health and Human Services issued new, relaxed guidelines for physicians wishing to prescribe buprenorphine to their patients with opioid use disorder. While the so‐​called “X” waiver required of prescribers remains, the new guidelines permit physicians (not nurse practitioners or physician assistants) to prescribe buprenorphine without the waiver. They may only prescribe to patients located within their own state and they may have no more than 30 opioid use disorder patients on buprenorphine at any time. Buprenorphine is a synthetic opioid that was developed to treat pain. It is only a partial opioid agonist, and therefore is less prone to suppress the respiratory mechanism in high doses. Since the early part of this century, it has been used for

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On January 14, the U.S. Department of Health and Human Services issued new, relaxed guidelines for physicians wishing to prescribe buprenorphine to their patients with opioid use disorder. While the so‐​called “X” waiver required of prescribers remains, the new guidelines permit physicians (not nurse practitioners or physician assistants) to prescribe buprenorphine without the waiver. They may only prescribe to patients located within their own state and they may have no more than 30 opioid use disorder patients on buprenorphine at any time.

Buprenorphine is a synthetic opioid that was developed to treat pain. It is only a partial opioid agonist, and therefore is less prone to suppress the respiratory mechanism in high doses. Since the early part of this century, it has been used for Medication Assisted Treatment (MAT) for opioid use disorder. Practitioners have been allowed to prescribe and dispense buprenorphine to their patients and follow them as outpatients in their office. Unfortunately, onerous federal regulations apply.

Under the Drug Addiction Treatment Act of 2000, practitioners who wish to treat substance use disorder with buprenorphine are required to obtain an “X waiver.” Providers must take an 8‐​hour course in order to have the ”X” added to their Drug Enforcement Administration narcotics prescribing license. There are also strict limits on how many patients a practitioner can treat at any given time, as well as restrictions on nurse practitioners or physician assistants wishing to obtain the X waiver.

These have combined to create an acute lack of buprenorphine MAT providers. According to the Substance Abuse and Mental Health Services Administration, less than 7 percent of practitioners have jumped through the hoops and obtained X waivers. The shortage is particularly severe in rural areas. Nationally, only 1 in 9 patients with opioid use disorder are able to obtain buprenorphine MAT. This has fueled a black market for buprenorphine, where many with opioid dependency or addiction use the drug—which is a poor substitute for the “high” they get from their opioid of choice—to self‐​medicate against withdrawal symptoms.

For this reason, health care practitioners interested in treating opioid use disorder, as well as other harm reduction advocates, have called for ending the requirement of an X waiver to use buprenorphine for MAT. In France roughly one‐​fifth of general practitioners treat people with substance use disorder in their offices without any further licensing or education requirements. It has contributed to a dramatic reduction in France’s overdose death rate.

In January 2020, the National Academy of Science, Engineering, and Medicine (NASEM) joined the chorus calling to end the “X” waiver.

Methadone is another synthetic opioid that has been used for MAT since the late 1960s. Unfortunately, in the U.S., methadone can only be used for MAT in DEA‐​regulated methadone clinics, and the patients must receive and consume the methadone in the presence of clinic staff. In several other developed countries, such as Canada, the U.K., and France, patients are prescribed and dispensed methadone without this requirement. Naltrexone, an opioid blocker sometimes administered in depot injections that last a month, has also been used for MAT.

Recent research found MAT with either methadone or buprenorphine to be the only effective treatments associated with reduced overdoses and overdose deaths out of 6 different treatment pathways studied, including a pathway using naltrexone.

The relaxation of the MAT regulations for buprenorphine is a step in the right direction. But limiting the new rule to physicians and restricting their number of patients to 30 doesn’t go far enough. Interviewed by MedPage Today, Assistant Secretary of HHS Admiral Brett Giroir, MD said:

[W]e anticipate that this is going to be primary care providers who may be in rural areas that may treat 5 or 10 people within their practice with this. If they’re going to get into the business of 40 or 50 or 80 or 100, right now we think they should go through the X waiver process with all the controls on that, but this is a first step that we’ll evaluate.

Dr. Nora Volkow, Director of the National Institute on Drug Abuse, told MedPage Today:

This is a compromise. We’re changing a practice, and by doing it in a conservative way, we can ensure that we’re not producing harm by practices of things that we may not know. Initially the X waiver was also starting with 30, and I assume that that’s because there was experience with that; that made a reasonable, justifiable number.

There was bipartisan support in the last Congress for legislation that would eliminate the X waiver requirement for health care practitioners prescribing buprenorphine for MAT. Hopefully the new Congress and the incoming Biden administration will pick up where their predecessors left off so that people with opioid use disorder can get the help they need.

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