The Drug Addiction Treatment Act of 2000 (DATA) should be updated to keep pace with the current state of the opioid crisis, according to a commentary published in National Academy of Medicine Perspectives. The authors suggest that removing X-waiver requirements would allow healthcare providers to better assist patients with opioid use disorder.
DATA successfully expanded access to opioid use disorder medications outside of treatment programs in support of a wider range of effective treatment options and allowed for the creation of innovative care models. However, DATA ultimately limited treatment expansion and placed regulatory burdens on medical providers who may have otherwise been able to help individuals recover from opioid use disorder because of the “X-waiver,” which refers to the permit physicians obtain through formal training, approval, and certification to prescribe Schedule 3 to 5 medications to treat patients with opioid use disorder in an outpatient setting. Buprenorphine is currently the only medication prescribed via this certification mechanism.
Considering the many obstacles to recovery created by the stigma associated with substance use disorder and substance use disorder treatment, the very existence of the X-waiver requirement adds to the perception of risk related to the treatment of this population of patients. Furthermore, X-waivers are tied with a 30-patient cap on the number of buprenorphine prescriptions that physicians are allowed to deliver unless they go through additional steps to increase that number or prescribe for a longer period of time. This limitation is an impediment to the current need for opioid use disorder treatment medications and adds obstacles for physicians wishing to prescribe buprenorphine.
Many areas are devoid of providers with an X-waiver, limiting the access to buprenorphine for patients with opioid use disorder. The lack of prescribers can be attributed in part to the burden of the process, which involves 8 hours of training on addiction recovery, buprenorphine prescribing, and controlled substance regulations. Even after an X-waiver is obtained, regular audits by the Drug Enforcement Agency, surveillance by law enforcement, and “random checks” can cause anxiety and disruption in health care providers. Ultimately, the regulations and limitations lead many physicians to decide against buprenorphine prescribing.
The commentary authors acknowledge that eliminating the X-waiver could have downsides, as it has the benefit of providing education about addiction. However, they feel that this education gap would be better addressed in a more comprehensive manner, such as absorbing X-waiver training into the curricula of health professionals’ schools, which are already starting to include addiction medicine training. The priority should be expanding access to this life-saving medication, note the authors.
They believe that every clinician (including physician assistants and nurse practitioners) willing to prescribe buprenorphine should be allowed and encouraged to do so.
“The elimination of the X-waiver is an investment in treating the opioid crisis. Evidence-based treatment for [opioid use disorder] increases individuals’ chances of gainful employment, reduces criminal activity, and reduces the risk [for] exposure to HIV and Hepatitis C. Repealing the X-waiver will start a domino eﬀect of positive change. It sends a strong message that treating [opioid use disorder] is a part of common medical practice. With a death toll of 49,000 Americans a year from opioid overdose, there is no time to lose.”
Disclosure: Several authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Woodruﬀ AE, Tomanovich M, Beletsky L, Salisbury-Afshar E, Wakeman S, and Ostrovsky A. 2019. Dismantling buprenorphine policy can provide more comprehensive addiction treatment [published online September 9, 2019]. NAM Perspectives. doi: 10.31478/201909a