X'ing the X-Waiver
On January 14th, 2021, Health and Human Services announced that the DATA 2000 (X-waiver) required for practitioners (physicians, nurse practitioners (NPs), and physician assistants (PAs)) to prescribe buprenorphine for opioid use disorder (OUD) would be removed for physicians. While this announcement was received with eager anticipation (and simultaneous disappointment because NPs and PAs were not included in the requirement change), the celebration was short-lived. Shortly afterwards, the announcement was removed from the website, and several weeks later SAMSHA released an official statement saying that the new guidelines were announced prematurely and that such changes could not be issued at the time. Two anonymous officials said the original plan from Trump’s administration “was plagued by legal and operational problems, including a failure to get necessary clearance from the White House budget office.”
Since then, multiple groups such as People’s Action, VOCAL-NY, the Drug Policy Alliance, and the National Harm Reduction Coalition have advocated for the bipartisan Mainstreaming Addiction Treatment (MAT) Act. The act would 1) eliminate the X-waiver for all practitioners (practitioners would still be subject to state licensure requirements) and 2) require the Secretary of Health and Human Services to launch an educational campaign about substance use disorder treatment for practitioners and encourage them to integrate treatment into their practice. Passing the Act would “remove redundant and outdated barriers for healthcare providers to prescribe life-saving medicines,” wrote the organizations in a collective statement to Rep. Paul Tonko, D—N.Y. while he reintroduced the MAT Act to the House.
President Biden has called for universal access to medication for opioid use disorder by 2025 but the United States cannot afford to wait. In the 12 months prior to June 2020, there were 81,000 deaths from overdoses–the highest number of overdose deaths ever recorded in 12-months. Between June 2019 and May 2020, almost half of the U.S. jurisdictions with available synthetic overdose data and 10 western states reported a 50% and 98% increase, respectively, in overdose deaths involving synthetic opioids. This large increase in opioid overdoses mandates urgent action.
These deaths are preventable with access to harm reduction services and treatment, such as buprenorphine. Within 5 years of permitting all medical doctors to prescribe buprenorphine without any additional education or licensing, the number of opioid overdose deaths in France decreased by 79%. Another study found that treatment with buprenorphine decreases all-cause mortality by nearly 50% for the first 4-weeks after initiation compared to patients on methadone. Furthermore, because buprenorphine is a partial opioid agonist, meaning it only partially activates the opioid receptor, it is safer than full opioid agonists such as methadone or extended-release oxycodone. As a partial agonist, buprenorphine has a “ceiling effect” when taken on its own. This means some of the effects of opioids (such as respiratory depression) only increase until a certain point–the “ceiling”. After the ceiling is reached, the effects of the opioids will not worsen, even if the buprenorphine dose increases.
The ceiling effect makes overdoses due to buprenorphine alone rare. Deaths involving buprenorphine usually involve other substances, such as alcohol or benzodiazepines (however, a recent study by Xu et al. showed that buprenorphine reduced the risk of overdose for patients with an OUD on benzodiazepines compared to patients on benzodiazepines alone). Finally, several studies found that diverted buprenorphine is most often used for self-medication or management of withdrawal symptoms by people who already use opioids, rather than to get high or for recreational use. In a qualitative study of people who used non-prescribed buprenorphine in New York City, participants reported that they used illicit buprenorphine because they wanted treatment but were unable to find a prescribing physician.
The X-waiver is one of the many barriers that prevents nearly 80% of people diagnosed with OUD from receiving medication in the United States. It also perpetuates stigma associated with treating substance use disorders. “As long as additional training is required, the treatment itself will remain stigmatized and separate from mainstream health care practice,” writes Frank et al. in the editorial “No end to the crisis without an end to the waiver”.
We know buprenorphine is safe and effective for treating opioid use disorder–the evidence is overwhelming; yet, the X-waiver requirement continues to be a barrier to treatment for people with opioid use disorder.