Buprenorphine has been in the news over the past few months owing to the Trump administration’s proposed loosening of many restrictions regarding its prescription and use. While the Biden administration initially seemed hesitant to carry out this plan, on April 28th, new practice guidelines for the use of buprenorphine came into effect that make prescribing and using the drug a much easier process. In this article, we will detail the exact legislative changes that have been made and what the prescription process will look like going forward.
For context, buprenorphine is a drug frequently prescribed as Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD), an area where it has proven particularly effective. However, as the drug is itself an opioid, legislators had made previously considerable effort to ensure that the drug would only be prescribed in conditions that were as safe and monitored as possible. Safety is still of utmost concern to legislators, but given the breadth of knowledge that now exists about the drug, paired with the ongoing opioid crisis in the United States, new legislation allows for physicians to prescribe the drug with fewer restrictions.
To give an example, all physicians prescribing buprenorphine have to apply for and receive an “X waiver.” Prior to this legislation, receiving the “X waiver” meant meeting certain requirements with regards to training, including completing an eight-hour course about the drug and its applications, and ensuring that they can meet counseling and other ancillary services requirements.
This new legislation changes several key aspects of the law. First, it expands who can administer buprenorphine, allowing for a wider range of health workers, including physician assistants, nurse practitioners, and certified nurse midwives to administer the drug. Furthermore, while the “X waiver” is still a necessity, for physicians treating up to 30 patients at one time, the training requirement has been removed. In practice, that means a physician can prescribe buprenorphine without the previously requisite training so long as they are treating only 30 patients or fewer.
This is a step in a positive direction, but the wording of this new law contains some vagueness that could lead to confusion in the future. For example, if one is a primary care provider, the limit imposed by this legislation is relatively straightforward: as long as the practice does not prescribe more than 30 patients with buprenorphine at any given time, they are not required to meet the previous training requirements demanded by the “X waiver” (though they must still receive it).
However, the application of the law to emergency physicians remains unclear. As emergency physicians rarely treat more than 30 patients at one time, it is still unknown whether referring a patient for treatment or simply stopping the management of their buprenorphine prescription would result in that patient being removed from the 30 patient limit. This should become clearer as this law is put into practice.
For emergency situations, the “Three Day Rule” exception is still in effect. The “Three Day Rule” allows physicians without a waiver to administer, but not prescribe, buprenorphine, allowing for up to three days of un-waivered treatment so long as the treatment is administered one day at a time. While changes were proposed to allow practitioners to dispense three days’ worth of medication at one time, these have been neither ratified nor enacted. Given the DEA’s current timeline, no change will be made until at least June 9th of this year.
Given the United States’ ongoing opioid epidemic, movement in this area is promising, with these changes and the proposed amendments to the “Three Day Rule” showing significant progress. Nevertheless, opioid treatment is a field with many understandable regulatory hurdles, and thus, the legal situation of any drug used in treatment must be monitored and adapted as times and usage change. We will keep you up to date as the situation with regards to buprenorphine progresses.