Come one, come all! On January 20th at 1:00 pm EST (right after the inauguration), I will be hosting a webinar along with Dr. Eric Ketcham (chair of ACEP’s Pain Management and Addiction Medicine Section) to discuss recent legislation that modifies the “Three-day Rule” for administering buprenorphine and other specific medications for the treatment of patients with opioid use disorder (OUD). You can register for the webinar here.
Getting this change enacted by Congress was one of ACEP’s top legislative priorities with respect to addressing the opioid epidemic. Another one is removing the X-waiver requirement for prescribing buprenorphine—which remains on top of our to-do list for this new Congress.
So what is the Three-day Rule and how was it modified? Well, I don’t want to spoil all the fun that you will have attending the webinar, but here’s a brief overview.
What is this the Three-day Rule?
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). To complete this mandated process, physicians and other health care practitioners must take an eight-hour training course, apply for the waiver from the federal Substance Abuse and Mental Health Administration, and eventually receive the waiver from the U.S. Drug Enforcement Administration (DEA). Although ACEP does provide an emergency department (ED)-specific waiver training course, we have long argued that this requirement creates a significant barrier to treatment and have advocated for its removal.
There is an exception to this requirement that allows non-waivered physicians to administer, but not prescribe, buprenorphine or other “narcotic drugs” 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 Three-day Rule exception is well intended—the overall purpose is to allow physicians without an X-waiver to treat patients in emergency situations—unfortunately, there is a major flaw in it, which the recent legislation helps address. As you can see, it requires physicians to administer one-day’s worth of the medication to a patient at one time over a three-day period. Logistically, this is extremely difficult in an ED setting as it forces patients receiving treatment to come back to the ED each day over the three-day period to receive treatment, which for a variety of reasons (lack of transportation, inability to miss work, etc.) drastically limits its effectiveness.
How was the Three-Day Rule Modified?
ACEP had long supported legislation sponsored by emergency physician and U.S Representative Raul Ruiz (D-CA/36th) 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 new law requires the Attorney General (who will delegate this to the 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 new 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 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 has 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. This means that the current Three-day Rule remains in place until at least June. It also means, that I, as ACEP’s Director of Regulatory Affairs, will be carefully evaluating the DEA’s reg once it’s released to ensure that it implements the law in a way that maximizes your ability as emergency physicians to take advantage of the new policy.
ACEP has received numerous questions from you all since the legislation passed about how EDs should start thinking about implementing this change, including making sure that hospital administrators, hospital pharmacies, and health care practitioners are up to speed and that you as emergency physicians will be able to start dispensing three-days’ worth of medication to your patients once the DEA issues the reg and gives the green light. Now, while some of the technical details may have to be sorted out in the DEA’s reg, our webinar next week will set a foundation for what you need to know and what major issues we will be looking out for in the DEA reg.
Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.