For months, the position of the American Society of Addiction Medicine (ASAM) on the move to deregulate the prescribing of buprenorphine for opioid use disorder (OUD) has been unclear. However, in a quiet move—a statement by Margaret A.E. Jarvis, MD, ASAM board member, in her testimony before the Congressional Bipartisan Opioid Task Force on July 23—the organization took sides—get rid of the “x-waiver.”
The x-waiver denotes a special permission from the Drug Enforcement Administration (DEA). The x-waiver is required under the Drug Addiction Treatment Act of 2000 (DATA 2000), which made it possible for buprenorphine to be used to treat OUD—only the second opioid ever allowed for this (the first and only other one is methadone). Having an x-waiver also means that prescribers are subject to DEA audits, in particular, looking at whether they are heeding limits on the number of patients per prescriber.
An opioid drug cannot be used for treatment of OUD except under special conditions. For methadone, those conditions are opioid treatment programs (OTPs) (which can also dispense buprenorphine). DATA 2000 and the x-waiver require prescribers to have training and to have a special registration with the DEA.
Because ASAM was crucial to the development of buprenorphine treatment—it provided the workforce of prescribers and the training involved—it had a vested interest in keeping the prescribing limited. But that has all changed.
Mainstreaming Addiction Treatment Act (Tonko Bill)
There is a bill under consideration in Congress: the Mainstreaming Addiction Treatment Act, introduced by Rep. Paul Tonko (D-New York), which would eliminate the separate DEA waiver for prescribing buprenorphine for treatment of OUD. But the ASAM endorsement of the Tonko bill comes with two conditions:
- Eliminate DEA regulations on medications in Schedules III–V that are based on the prescribing intent to treat addiction, including ending related routine DEA audits
- Require all prescribers of DEA-controlled substances to complete medical education on addiction
ASAM would like to see the training requirement for the x-waiver transferred to the DEA-controlled substance license. Everyone who prescribes controlled substances for anything—pain, anxiety, and so on—has this license.
OTPs have been concerned about the lack of comprehensive care in office-based opioid treatment, and particularly concerned about calls to have primary care—not addiction specialists—prescribe buprenorphine and even methadone for OUD.
Meanwhile, OTP patients who take methadone have been attracted to the more lenient take-home provisions for buprenorphine. So far, there is no federal proposal to change this disparity. Methadone is viewed as less safe than buprenorphine; in addition, methadone is Schedule II, while buprenorphine is Schedule III.
For Dr. Jarvis’ written testimony, go to https://www.asam.org/docs/default-source/advocacy/final-oral-margaret-jarvis-testimony-bipartisan-heroin-task-force-(7).pdf?sfvrsn=799e4dc2_2.
For the Mainstreaming Addiction Treatment Act, go to https://www.govtrack.us/congress/bills/116/hr2482