In 2020, more than 93,000 people died from a drug overdose — a nearly 30% jump from 2019, according to data released in July by the CDC. Roughly 57,000 of these deaths were from synthetic opioids (predominantly fentanyl), while 13,000 were from heroin overdoses. In the pandemic, it seems, America’s opioid crisis has only gotten worse. A new federal regulation may change that.
In April 2021, the Biden administration loosened existing guidelines around the prescription of buprenorphine, an FDA-approved medication for opioid use disorder (OUD) that’s been repeatedly proven effective. Buprenorphine is a partial opioid agonist that diminishes the physical effects of addiction like withdrawal symptoms and cravings. Previously, in order to receive a DEA waiver to prescribe it, clinicians were required to undergo multiple hours of training. Under the new rules, the training requirement — eight hours for physicians, 24 hours for APPs — was removed. However, restrictions remain: Clinicians are still required to apply for the waiver — known as the x-waiver for the “X” in front of the DEA number — and those utilizing this training exemption may treat no more than 30 patients with buprenorphine at a time. Clinicians are wondering: Will these relaxed guidelines make a difference in treatment access?
"I hope so,” said Mat Kladney, MD, a primary care provider in New York City who works with patients with OUD. “Big picture: This will increase the availability of buprenorphine, which is a life-saving treatment for patients with OUD. Anything we can do to get it in the hands of patients who need it is a good thing.”
And yet, Dr. Kladney and other clinicians believe that the updated guidelines do not go far enough. Historically, the x-waiver was implemented as part of the 2000 Drug Addiction Treatment Act, which allowed clinicians to prescribe certain medications (including buprenorphine) to treat OUD in an outpatient setting. But Dr. Genie Bailey, an addiction psychiatrist in Fall River, Mass, noted that it’s been decades since that implementation. “We now have 20-plus years of experience in the U.S. and I do not think we need the same limitation of number of patients or trainings that were perceived as necessary in 2000,” she said. “Can you imagine if physicians treating hypertension or chronic lung disease had case limits?”
Dr. Matis Shulman, an addiction psychiatrist also in New York, echoed these sentiments, stating, “I am against the waiver requirement entirely. ... The regulations should make sense with regard to risk, and right now they don’t. I don't think that this particular regulatory requirement is protecting society, it's just hurting patients and creating stigma and an excuse for primary care providers to say, ‘I don't treat those patients.’”
In Dr. Shulman’s opinion, the fact that opioid medications can be prescribed for pain with no hurdles only adds insult to injury. “I don’t think someone saying, ‘I have a substance use disorder, prescribe me for that’ is any different than someone saying, ‘I have back pain, prescribe me for that.’ When we have this extra waiver requirement, it creates a mystique around buprenorphine that makes it seem very dangerous,” he said.
Dr. Kladney agreed: “All the opioids that exist now are just considered normal medication … and because buprenorphine is used as a treatment for OUD, it’s considered something different or special.”
This extra layer of regulation around buprenorphine can make it seem intimidating, and can lead to the perception among primary care clinicians that, as Dr. Shulman put it, “This patient population is scary and requires extra work.”
The prevailing notion of patients with OUD as difficult to treat only enhances the existing stigma around people who use drugs. As Dr. Kladney explained, “People with OUD are very maligned — they’ve been seen as weak-willed, or being bad people. The medical system isn’t immune to these wider cultural beliefs.”
Negative attitudes toward drug users, and to the treatments they require, are oft-cited barriers to prescription, with 3% of waivered clinicians endorsing a lack of belief in agonist treatment, and comments from a 2015 qualitative study evincing a high level of mistrust of both patients with OUD and buprenorphine itself. Given these existing attitudes, adding an additional legal requirement creates, per Dr. Shulman, “a very easy out for most [clinicians].”
Because of their concerns, Drs. Bailey, Shulman, and Kladney think “x-ing the x-waiver” (via the Mainstreaming Addiction Treatment Act, or MAT) would be step one to increasing treatment access. “For someone with OUD, a little barrier is basically a game-ender for a lot of people,” said Dr. Kladney. “So my big issue is to remove as many barriers as possible for these patients for whom little barriers become big barriers. ... Right now, the existence of the x-waiver is still a barrier.”
Another solution, according to Dr. Bailey, would be to treat addiction “like the deadly medical disease it is, much like cancer or MIs, with well-paid, well-trained MDs/NPs and nice facilities.” Dr. Kladney agreed: Integrating addiction medicine into the rest of the health care system by “increasing Medicaid payments for medication visits and including treatment for OUD as part of all primary care training curricula ... would reduce a lot of barriers that lead to people not being able to access care.”
In addition, Dr. Shulman hopes for a “comprehensive” change at the federal level, and believes that would go a long way toward decreasing opioid-related harm and deaths. Currently, there are multiple bills up for approval that could shift the government’s response to substance use in addition to the MAT, such as the Reducing Barriers to Substance Use Treatment Act, which prohibits state Medicaid programs from requiring prior authorization for medications for OUD (MOUD), and the Comprehensive Addiction Resources Emergency Act, which invests in the opioid crisis through grants for treatment, recovery, and harm reduction services.
Ultimately, resolving the opioid crisis will likely require more than any single regulatory change, like relaxing MOUD prescribing guidelines. “Shifting the paradigm is a slow and heavy lift,” said Dr. Bailey. “You can’t fix it with any one thing. You have to tackle the lack of access at all different levels.”
What do you think are the most important issues to tackle when it comes to the opioid crisis? Share your thoughts in the comments below.
Disclosures: Dr. Kladney receives 25% salary support from CTN-0100 (via National Institute on Drug Abuse), a research study for which he is a site principal investigator that compares treatment modalities for OUD. Medications for the study include buprenorphine and naltrexone and are provided by the manufacturers (Suboxone: Indivior; CAM-2038: Braeburn; Vivitrol: Alkermes). Dr. Bailey is also a site principal investigator, and Dr. Shulman is a co-investigator.
Illustration by April Brust