State Leaders: Gravity of Opioid Crisis Justifies Rethinking Restrictions on Buprenorphine

Saying that the harms of restricting buprenorphine prescribing are now outweighing the benefits of regulation, leading health officials in 18 states are asking the federal government to consider giving physicians more leeway in prescribing the evidence-based treatment for opioid use disorder (OUD).

In an April 8 letter to Health and Human Services (HHS) Secretary Alex Azar, the state health directors say that absent more dramatic action by Congress, HHS should allow providers who are newly waived to prescribe buprenorphine to prescribe for up to 100 patients immediately, up from the current 30-patient limit in the first year.

The officials also would like to see greater flexibility in the short-term prescribing of buprenorphine to mitigate opioid withdrawal, to serve as a more effective bridge as patients try to secure ongoing treatment for OUD.

“The current requirements to obtain a waiver to prescribe buprenorphine under the Drug Addiction Treatment Act (DATA 2000) place limits on the medical community's capacity to respond to the needs of opioid-dependent individuals,” the letter to Azar states. “The DATA 2000 regulatory framework was implemented prior to the current wave of opioid addiction.”

Health officials in the District of Columbia and the U.S. territories of Puerto Rico, Palau and the Virgin Islands also signed on to the letter. The states that are calling for federal action are Arkansas, California, Connecticut, Delaware, Hawaii, Idaho, Indiana, Louisiana, Maryland, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Virginia and Washington.

In recent months, there has been a growing call in many circles to revisit various regulations that restrict the prescribing of agonist medications for the treatment of OUD. Other leaders have suggested that the gravity of the opioid crisis justifies re-examination of regulations that restrict the dispensing of methadone to highly controlled clinic settings.

In this week's letter to Azar, the state officials argue that knowledge around the effectiveness of buprenorphine has expanded even since amendments to DATA 2000 to expand prescribing were adopted in 2016. “For example, we have learned that buprenorphine, even in the absence of comprehensive services, is highly effective in preventing morbidity and mortality associated with OUD,” the letter states. “Furthermore, the number of buprenorphine-associated deaths is dwarfed by those related to full agonist opioids.”

The officials argue that the ideal approach would be for Congress to eliminate the DATA 2000 waiver requirements and allow all Drug Enforcement Administration (DEA)-registered practitioners to prescribe buprenorphine. Absent this action, however, they are asking HHS to allow newly waived prescribers to be able to treat up to 100 patients right away. They also want a longstanding regulation to be modified to allow for the prescribing of a two-to-four week supply of buprenorphine to mitigate opioid withdrawal while a patient seeks to find ongoing treatment.

“The harms caused by suppressing prescribing are greater than the benefits of the DATA 2000 strictures in regulating buprenorphine,” the letter states.