When the federal government issues a much-anticipated proposal that would revise regulations on buprenorphine prescribing under the Drug Addiction Treatment Act (DATA) of 2000, it remains likely that the major national organizations representing addiction specialist MDs will not issue a unified response. However, the president of the American Academy of Addiction Psychiatry (AAAP) tells Addiction Professional that the academy probably will approach the American Society of Addiction Medicine (ASAM) to determine if consensus that was unattainable a couple of years ago could now be achieved.
AAAP, along with the American Psychiatric Association (APA) and the American Osteopathic Academy of Addiction Medicine, in 2014 issued recommendations that the groups believe would encourage more physicians to prescribe buprenorphine while ensuring that patients still have access to high-quality treatment beyond a script alone. ASAM in its own recommendations has generally supported a more liberal loosening of DATA 2000 regulations that generally limit individual physicians to prescribing buprenorphine to no more than 100 patients at a time.
“The two possible approaches are, do you want [existing] docs to treat more, or do you want more prescribers?” says AAAP president John Renner, MD. The academy clearly has embraced the idea of finding an approach that engages new prescribers.
Renner says AAAP hopes proposed regulations from the Substance Abuse and Mental Health Services Administration (SAMHSA) prove to be reasonably compatible to what his organization has suggested as ways to improve access to buprenorphine treatment for opioid dependence. But a couple of the components of the AAAP's preferred three-tiered system for prescribing look to be a difficult sell.
The first tier addresses hesitation by some physician practices to become subject to Drug Enforcement Administration (DEA) inspections by virtue of prescribing buprenorphine. It suggests that for small primary care or psychiatry practices, they could prescribe for up to 30 patients at a time but would be DEA-inspected only for suspected violations of accepted clinical practice.
But, Renner says, “We continually have been told that DEA is not going to budge” on maintaining the broader scope of its current oversight authority.
Tier 2 under the AAAP proposal would allow solo practitioners to increase their patient limit from 30 in the first year to 150 (up from the present 100). In multidisciplinary practices, the physician could increase the patient load to 340 patients at a time with the addition of up to three physician extenders (nurse practitioners and physician assistants). Yet obstacles exist here as well.
“We did not get the sense that SAMHSA is ready to move” on prescribing authority for nurse practitioners and physician assistants, Renner says, even though this would occur under a physician's supervision.
Tier 3 would establish medical practices that would accommodate more than 340 patients at a time but would essentially be regulated along the lines of a federally regulated opioid treatment program (OTP).
Renner says AAAP believes the proposal it drafted with the other two professional organizations back in 2014 would protect patients from being exposed to practices that do not offer supportive services in addition to medication. “We don't want to see a return to something like the methadone mills of 30 years ago,” says Renner, who runs an outpatient addiction treatment program at the VA Boston Health Care System.
Changing physician circumstances
Renner says that the discussion around buprenorphine prescribing probably focuses too much on the authority of the individual prescriber today.
“We have begun to realize that when DATA 2000 was developed, the majority of physicians were in private or small practices,” he says. “Now, most work in large organizations.” This sometimes means one will encounter a physician who will say, 'I would like to prescribe, but my boss doesn't want to have that kind of patient here,'” he says. This adds another layer of complexity to the challenge of expanding access to buprenorphine treatment.