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April 7, 2022

Important Update on the “Three-Day” Rule for Administering Medications to Treat Opioid Use Disorder

As described in previous Regs and Eggs, there are many regulatory barriers to providing medication assisted treatment (MAT) to patients with opioid use disorder (OUD). Currently, physicians and other health care practitioners must receive an “X-waiver,” as required by the Drug Addiction Treatment Act of 2000 (DATA 2000), in order to prescribe buprenorphine to patients with OUD in settings other than opioid treatment programs (such as the emergency department). Furthermore, only opioid treatment programs (OTPs) can dispense methadone to patients.

However, the federal government has been slowly chipping away at these barriers. With respect to the X-waiver, the Biden Administration released guidance back in April 2021 that effectively eliminated the training and mandatory certification requirements that go along with the waiver. The exception does come with a 30-patient limit, and if practitioners want to treat more than 30 patients “at one time,” they still must complete the training and meet all the other requirements that are in place around counseling and other ancillary services. But meeting this 30-patient limit hasn’t been an issue for emergency physicians. It is important to remember that practitioners who wish to prescribe buprenorphine still need to obtain an X-waiver. ACEP continues to believe that the X-waiver is a significant barrier to treatment and supports the Mainstreaming Addiction Treatment (MAT) Act, which would eliminate the requirement.

There is also an exception (found at 21 CFR § 1306.07(b)) to the requirements around prescribing buprenorphine and dispensing methadone that allows physicians without an X-waiver and those outside of OTPs to administer, but not prescribe, “narcotic drugs” (including buprenorphine and methadone) to a person “for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.” This is called the “Three-Day” Rule.

ACEP had long supported legislation sponsored by emergency physician and U.S Representative Raul Ruiz (D-CA/36th) to refine the Three-Day Rule called the Easy MAT Act. To our great delight, the Easy MAT Act was incorporated into a short-term funding bill that was signed into law on December 11, 2020. The law requires the Attorney General (who will delegate this to the Drug Enforcement Administration or DEA) to revise the Three-day Rule within six months so that “practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person’s use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both).”

The key here is that under this law, practitioners (not just physicians) will be allowed to dispense three-days’ worth of medication at one time. Therefore, patients can presumably receive one day’s-worth of medication while at the emergency department (ED) and then take the two remaining days-worth home, saving them from having to make subsequent trips to the ED.

As mentioned above, the DEA had six months from the date the bill was enacted (meaning six months from December 11, 2020 or June 9, 2021) to issue a regulation that would implement this change. However, the DEA still has not issued the required regulation.

In the meantime, as the DEA continues to work on the regulation, the agency announced a couple weeks ago on March 23 that it will allow a waiver of the current three-day rule requirement that practitioners must administer one day’s worth of medication to patients at one time. In line with the objective the Easy MAT Act, practitioners who wish to dispense the full three days-worth of medication to patients at one time can make a request to DEA to receive permission to do so.

Since the DEA has not issued a regulation, practitioners have to actually email the DEA to obtain the approval. Requests for exception must be emailed to: ODLP@dea.gov under the subject line: “Request for Exception to Limitations on Dispensing for OUD.”

Members of ACEP’s Pain Management and Addiction Medicine section have been the “guinea pigs” here and some have gone ahead and emailed the DEA already. Through those email exchanges, members of the section have learned that facilities are allowed to make one request on behalf of all their practitioners who operate under their DEA licenses. In fact, the exception covers any DEA-registered practitioner working in a hospital, clinic, or emergency department, or any DEA-registered hospital/clinic that allows practitioners to operate under their registration number.

This is critical, since only DEA-registered practitioners can apply for an X-waiver— but this exception can cover all practitioners that operate under their facility’s DEA license. Practically speaking, residents (who typically don’t have their own DEA license and therefore can’t receive an X-waiver) could be covered under the exception.

It is important to note that you must continue to follow state and local laws regarding the dispensing of narcotic drugs. If state or local laws and/or regulations are more restrictive, you must follow those more restrictive laws and/or regulations. Neither DEA regulations, nor this exception, preempt state or local laws in such situations.

To help all those interested in applying for the exception, I along with the Pain Management and Addiction Medicine section worked on the following email template that you or your facility could send to the DEA.

Sample Email

To: ODLP@dea.gov.

Subject Line: Request for Exception to Limitations on Dispensing for OUD

Body of Email: I would like to request an exception to the one-day supply limitation currently imposed pursuant to 21 CFR 1306.07(b) for [your name if you are seeking the exception as an individual], or the below listed practitioners who work clinically in [Name Hospital Emergency Department if your facility is applying]. This permission would allow practitioners to dispense up to a three-day supply of buprenorphine or methadone under the circumstances described in subsection 1306.07(b). Pursuant to the regulation, the purpose of this emergency treatment is to relieve acute withdrawal symptoms for my patient while arrangements are being made for referral for treatment. 

The list of practitioners and DEA registration number and registered location for each is listed below; the practice location name and address for each is the same: [Name of Hospital Emergency Department; Easy St, City, State; Zip].

Name

DEA registration number

Registered Location

Practice Location Name

Practice Location Address

 

 

 

 

 

While this recent announcement is a good step towards reducing the barrier that the original Three-Day Rule had in place (requiring patients to come back to the ED each day within the three-day period to receive treatment), I do remain extremely disappointed that the DEA has not yet issued a regulation implementing the Easy MAT Act. A regulation would do a number of things that a simple exception cannot.

  • First, it would eliminate the need for you or your facility to email the DEA to obtain permission to dispense up to three-days’ worth of medication at one time. If a regulation were issued, that important policy would officially be in place, and you wouldn’t need to get approval in order to do it.
  • Second, it may provide some clinical guidance around the dispensing of buprenorphine or methadone, including listing some best practices.
  • And third, it would hopefully help address any questions you may have about how dispensing narcotic drugs, including methadone, in the ED interacts with existing federal, state, or local laws and regulations—which is a specific stipulation included in the Easy MAT Act.

In all, a regulation officially implementing the Easy MAT Act is still very much needed, and ACEP will continue to push the DEA to issue it as soon as possible. In the meantime, please let me know if you have questions about the exception.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs!

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