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X-Waiver for Buprenorphine Prescribers: HHS Eases Restrictions on Treating Opioid Use Disorder

January 28, 2021
Pandemic spike in opioid overdoses has led to changes for those prescribing buprenorphine as an opioid addiction treatment. What the exemptions mean for pain practitioners, behavioral medicine, and addiction specialists.

Important Update: Within days of this announcement, the new White House Administration reversed the guideline, returing buprenorphine waiver policies to their prior settings. See The Washington Post report.

 

In response to the ongoing opioid crisis – with more than 81,000 opioid overdoses reported in the 12 months ending in May 2020, the US Department of Health and Human Services announced on January 12, 2021 updated practice guidelines for treating opioid use disorder (OUD) that will ease restrictions on the ability for clinicians to prescribe buprenorphine to treat opioid addiciton.1,2

The new guidelines state that physicians who already have a DEA registration number need not apply for a second waiver (called an X-waiver), which was previously required to prescribe buprenorphine for OUD under the Controlled Substances Act (CSA).

“While every effort should be made to prevent opioid use in the first instance, the best public-health and medical evidence is clear: access to medication-assisted treatment (MAT), including buprenorphine that can be prescribed in office-based settings, is the gold standard for opioid use disorder,” according to an HHS announcement of the updated guidelines.2

X-waiver for buprenorphine prescribing no longer needed. HHS rule update aims to ease restrictions on physicians treating opioid addiction, OUD.

X-Waiver Exemptions: Which Buprenorphine Prescribers Are Affected?

The exemption from an additional X-waiver applies under specific conditions. First, the exemption only applies to prescribers who treat patients located in the states in which they are authorized to practice. In addition, the number of patients a clinician can treat with buprenorphine without the additional waiver is limited to 30 at a time. However, this cap of 30 patients does not apply to hospital-based physicians such as those working in emergency departments.

The exemption applies only to drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD. Physicians who choose to use the X-waiver exemption are required to mark an "X" on the prescription and clearly identify that it is being written for opioid use disorders. Physicians also must maintain separate charts for patients being treated for OUD.

According to HHS, an interagency working group will monitor the implementation and results of the exemption, as well as the impact of the changes on the use and diversion of medication.

 

Even with Buprenorphine, More Options Needed to Help People with Opioid Addiction Cope with COVID

Expansion of treatment options for OUD is especially important now, according to Jeffrey Fudin, PharmD. founder of Remitigate LLC and Pharmacist Consulting Services PLLC, and co-editor at large for Practical Pain Management.

“The COVID-19 pandemic has ravaged the substance abuse community with a dramatic increase in morbidity and mortality due to social isolation, anxiety, and decreased access to live group support meetings,” he said. “Coupled with that are the essential leniencies afforded to providers and patients alike with regard to controlled substance access and prescription renewals.”

As noted above, "We have seen more overdose deaths in the United States for any 12-month span (in 2020). Additionally, illicit synthetic opioid-related deaths led by the fentalogues increased by 38.4%1 between May 2019 and May 2020 compared to the prior 12-month period," said Dr. Fudin. (More on fentalogues in Persico et al.3)

Dr. Fudin said he was not surprised by the HHS waiver-X update. “There have been necessary discussions for quite some time by HHS about how they could increase access to medications for opioid use disorder (MOUD) by tapping into primary care provider access, but what does surprise me is that physicians only were included in the modification,” he noted.

Barriers to Opioid Addiction Treatment Will Persist in Pandemic

Many barriers remain to effectively treating OUD despite the updated guidelines, Dr. Fudin said.

“Much of the general population, lawmakers and politicians, and healthcare clinicians across the spectrum still perceive persons with opioid use disorder (OUD) to be the cause and the problem, when in fact, they are the victims,” Dr. Fudin emphasized. “Nobody is born with addiction, and nobody wakes up one day and says that they want to be an opioid addict when they grow up,” he said. “To me, this is the most enormous barrier to overcome.”

Social Stigma around Opioid Addiction

Additional barriers include “clinics with a large clientele of patients that have OUD, and also the disdain within neighborhoods to have such clinics in their neighborhood,” added Dr. Fudin. Other problems he cited include the lack of education or understanding specific to buprenorphine.

MAT and Provider Education

“Many prescribers and pharmacists still do not know that the buprenorphine products that are FDA-approved as analgesics (eg, Butrans, Belbuca) do not require an X-waiver, or that those FDA-approved for OUD only (buprenorphine sublingual single entity or combined with naloxone) can be legally prescribed off-label for pain without an X-waiver or special certification,” he explained.

“Additionally, buprenorphine has a very complex pharmacology, which is often misunderstood by prescribers and pharmacists alike,” said Dr. Fudin. “Many clinicians inaccurately believe that buprenorphine is ‘substitution therapy’ whereby you are substituting one opioid for another, but that could not be further than the truth. More accurately, it is in fact a medication to treat a real disorder, in this case, opioid use disorder,” he said.

“To put it in perspective, disulfiram (Antabuse) has been used for alcohol use disorder (AUD) for decades. It blocks an enzyme that is responsible for metabolizing ethyl alcohol. When a patient takes this as a medication for alcohol use disorder, it causes significant nausea to as a deterrent to alcohol use or desirability,” he explained. “However, most clinicians would not consider that as substituting one drug for another – it is a prophylactic treatment for alcoholism, which is a disease,” he said.  “Naltrexone is an excellent option too,” he added.

Overall, “the best way to overcome these barriers is education and proactive outreach to all healthcare providers and the general public in an effort to help persons with OUD instead of adding to their isolation and social rejection,” Dr. Fudin emphasized.

 

X-Waiver Will Impact Pain Practice, CME, and Buprenorphine Prescribing

The new guidelines will make a difference in clinical practice, said Dr. Fudin. “I believe that with encouragement for providers and appropriate education, adjusting the requirement among physicians for an X-waiver will have some positive impact,” he said. However, “There needs to be extensive education. For example, we wouldn’t want physicians to treat patients requiring MOUD [Medication for Opioid Use Disorder] without appropriate background information, as this could backfire if abuse of buprenorphine expanded,” he cautioned. “I bring this up with trepidation because buprenorphine as a single agent is exceedingly less dangerous when abused in comparison to traditional opioids, but when combined with one or more sedative hypnotics it could cause death,” he emphasized.

“Moreover, MOUDs alone are not a substitute for counseling and group therapy, so clinicians that are given an opportunity to prescribe buprenorphine or naltrexone for OUD do need to be trained more globally, not treating with medication in the absence of behavior health intervention and cognitive therapy.”

Dr. Fudin noted that pharmacists could play a key role in patient engagement and further research. “Although it may seem self-serving, I believe that expansion of MOUD to well-trained pharmacists could provide a very important expansion and outreach to patients, especially in rural areas where other clinicians are not readily available,” he said. “We’ve seen a huge positive impact by pharmacist clinicians with immunizations and birth control prescribing. At the very least, a collaborative arrangement between the physician or physician extender together with a pharmacist for medication renewal and interim assessments could be key to expanding MOUD access."

Finally, Dr. Fudin noted, "It would be valuable to assess the impact of initiation and continued utilization of MOUD using videohealth – with urine screens done at an outpatient laboratory or in community pharmacies that have an appropriate private counseling area and bathroom designated for urine specimen collection,” he said.  

 

Disclosures: Dr. Fudin reports being a speaker for Abbott Laboratories, Acutis Diagnostics, Inc., and serving on the advisory board, speakers bureau, and/or consulting for AcelRx Pharmaceuticals, BioDelivery Sciences International, Daiichi Sankyo, Firstox Laboratories, GlaxoSmithKline (GSK), Human Half-Cell, Inc., Quest Diagnostics, Scilex Pharmaceuticals, and Salix Pharmaceuticals. 

 

Last updated on: February 2, 2021
Continue Reading:
Is the Coronavirus Pandemic Worsening the Opioid Epidemic? Largely, Yes.
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