The Department of Health and Human Services (HHS) released new buprenorphine practice guidelines in April that will allow most healthcare providers to treat patients for opioid use disorder without the burdensome training previously required.
Effective April 27, 2021, eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives are exempted from training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine.
Limits to the Exemption
The exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine. It does not include prescribing, dispensing, or using Schedule II medications, such as methadone, for the treatment of opioid use disorders.
Despite the exemption of certain requirements, the waiver itself, known as the X-waiver, is still in place. Before treating patients, all providers must submit a Notice of Intent to the Substance Abuse and Mental Health Services Administration (SAMHSA) to receive it. Providers who treat more than 30 patients at one time will still be required to complete the training, counseling, and other ancillary services. As well, non physician providers such as physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives must be supervised by, or work in collaboration with, a DEA registered physician if required by state law.
Interpreting the 30-Patient Rule in the ED
How or if the 30-patient limit applies in the emergency department is unclear.
Dr. Patrice Harris, head of the American Medical Association’s opioid task force, told NPR that the “restriction could pose a problem for emergency department doctors who are seeing large numbers of patients with opioid use disorder.”
However, the American College of Emergency Physicians (ACEP) is interpreting the exemption differently.
“Working in the emergency department, you rarely, if ever, are treating more than 30 patients at one time,” writes Jeffrey Davis, Director of Regulatory Affairs at ACEP. “Thus, ACEP believes that once you refer a patient for treatment or stop managing a patient’s buprenorphine prescription, the patient is no longer under your care and would not count towards the 30-patient limit.”
ACEP is seeking legal confirmation on that opinion from the Department of Health and Human Services (HHS). If HHS confirms ACEP’s interpretation, emergency physicians would also benefit from the exemption.
Three-Day Rule Still in Effect … but Changing
The Three-Day Rule also remains in place. The Three-Day Rule currently 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.”
Changes to the Three-Day Rule were included in a short-term funding bill signed into law on December 11, 2020. The Easy MAT Act, sponsored by emergency physician and U.S Representative Raul Ruiz (D-CA), requires the Attorney General (acting on behalf of the DEA) to revise the Three-Day Rule to allow “practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, 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).”
According to Davis, the key 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.”
While the changes to the Three-Day Rule have not yet been enacted, the law requires the DEA to make them within six months from the date the bill was enacted, or by June 9, 2021. Until that time, the current Three-Day Rule is still in place, which allows emergency physicians to provide MAT (Medication-Assisted Treatment) one day at a time for up to three days, with the patient presenting to the ED in person each of the three days.
The Future of Opioid Use Disorder and MAT
More than 90,000 drug overdose deaths are predicted to have occurred in the United States in the 12 months ending in September 2020, the highest number of overdose deaths ever recorded in a 12-month period, according to provisional data from the Centers for Disease Control and Prevention, and overdose deaths have continued to accelerate during the COVID-19 pandemic.
“Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” said Assistant Secretary for Health, Rachel Levine, MD. “These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities.”
There is a separate effort to fully repeal the X-waiver pending before Congress, according to Stat News writer Lev Facher. The bill, H.R. 2482: Mainstreaming Addiction Treatment (MAT) Act, was originally authored by Rep. Paul Tonko (D-N.Y.) and introduced back in 2019. In February 2021, it was reintroduced by U.S. Senators Maggie Hassan (D-NH) and Lisa Murkowski (R-AK) and Representatives Tonko and Michael Turner (R-OH). It currently has 117 bipartisan cosponsors.
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