Policy Shift in the Opioid Epidemic: An Update on the X-Waiver

The burdensome 8-hour training course previously required for the X-waiver has been eliminated, though the X-waiver itself is still required regardless of practice. 8 Those providers treating more than 30 patients with buprenorphine, however, must still complete the full 8-hour training.

What does this mean for ER physicians? The jury is still out, but ACEP believes that once you no longer have a patient under your care, that patient would not count toward a 30-patient limit. While ACEP is seeking guidance from HHS lawyers, as it stands, an emergency physician should qualify for the current policy exemption. 9

Moving forward, a few items to keep in mind:

1. New residents starting in July and those who are considering prescribing buprenorphine should consider applying for an X-waiver through SAMHSA, which may take up to 45 days to process.
2. Speak with your program leadership on prescribing buprenorphine. Follow institutional guidelines.
3. Speak up against substance use disorder stigma and the misconceptions surrounding prescribing buprenorphine
4. Keep in mind the unaffected 3-Day-Rule, in which ER physicians may prescribe and dispense buprenorphine for up to 3 days' duration.

On Jan. 14, 2021, the Department of Health and Human Services (DHHS) acted on an 11th-hour Trump administration decision and issued an X-waiver requirement exemption for physicians with Drug Enforcement Administration (DEA) licenses - a decision lauded by multiple states' departments of health, ACEP, and multiple other states and national organizations.

Under this change, physicians were able to prescribe buprenorphine medication-assisted treatment (MAT) without additional certification, opening the door to meet the increasing public health needs of those with opioid use disorder (OUD). However, on Jan. 27, the Biden administration and DHHS reversed the decision, citing the premature release of these new guidelines prior to Congressional approval. Moving forward, the Biden administration has announced plans to increase access to MAT and reduce overdose rates, but the details are unclear.

History of the X-Waiver

Under the Drug Addiction Treatment Act of 2000 (DATA 2000), the DEA began requiring qualifying physicians to apply for and obtain a medication-assisted treatment (MAT) waiver in order to administer, dispense, and prescribe the schedule III FDA-approved medication buprenorphine for the treatment of opioid use disorder. The goal of DATA 2000 was to allow qualifying physicians to expand access to important medications to treat opioid use disorder while reducing physician reliance on other less effective therapies such as methadone. The waiver required physicians to submit a notification of intent to the Substance Abuse and Mental Health Services Administration (SAMSHA), have an active state medical license, a current DEA registration number, and obtain an additional certification in addiction through an 8-hour course approved by DHHS. This waiver, coined the "X-waiver" after the additional DEA number that begins with the letter "X" given to providers who obtain the waiver, allowed physicians to prescribe buprenorphine for up to 30 patients at a time. After their first year, eligible providers were able to apply to treat up to 100 followed by 275 patients thereafter, a 2016 DHHS ruling. In a bid to further increase patient access to MAT, a subsequent ruling also allowed other qualifying practitioners, including certified registered nurse anesthetists, to have access to the X-waiver and prescribe buprenorphine.

End of the X-Waiver?

The goal of the recent bipartisan 2021 Mainstreaming Addiction Treatment Act was to reduce barriers to FDA-approved medications for opioid use disorder and reduce diversion of the medication by increasing legal access. Regardless of the initial intention of DATA 2000 and its subsequent rulings, the X-waiver requirement created a barrier to approving more buprenorphine MAT providers. Until recently, only 7% of eligible providers could prescribe buprenorphine with a 275 patient panel, 1 and almost one-third of people living in rural settings do not have access to an X-waivered provider in their county. 2 In a country crippled with a pervasive opioid epidemic compounded by a racial justice crisis and COVID-19, removing constraints to buprenorphine prescribing helps increase patient access to essential treatment.

Under DATA 2000's "Three Day Rule," providers in the emergency department were able to administer, but not prescribe, a daily dose of buprenorphine for up to 3 days in a row without obtaining an X-waiver. If discharged, patients would have to return to the ED on subsequent days to receive their second and third daily dosing if they were not able to find an X-waivered outpatient provider. While the recent ruling eliminating the X-waiver pertained only to physicians who treat fewer than 30 patients with buprenorphine, this limitation did not include hospital-based physicians, like ED physicians who could have administered and prescribed an outpatient course of buprenorphine. In addition, it has been shown that when ED physicians prescribe buprenorphine from the ED, patients are twice as likely to be enrolled in outpatient MAT treatment for opioid use disorder 3 and less likely to return to the same ED within 30 days for drug-related causes. 4

Regardless of the decision to eliminate the X-waiver, there are upcoming changes to the Three Day Rule. Under an incorporated and ACEP-supported legislation "East MAT Act" sponsored by Rep. Raul Ruiz, MD (D-CA and emergency physician) passed on Dec. 11, 2020, practitioners will be allowed to prescribe and dispense a 3-day supply of buprenorphine without patients making subsequent trips to the ED for a daily dose. 5 Attorneys General in each state now have 6 months to revise the Three Day Rule, meaning emergency physicians and other providers may begin prescribing three days of buprenorphine starting June 2021.

Next Steps

The X-waiver requirement did have some benefits: it encouraged and expanded educational opportunities and awareness of opioid use disorder as well as best practices for use of addiction treatment modalities such as buprenorphine.

BUPRENORPHINE CHEAT SHEET

• Buprenorphine is a partial mu-opioid agonist and has a stronger receptor binding affinity than full agonists such as morphine without fully activating the mu receptors. Because of this higher affinity, buprenorphine should only be given to patients with active withdrawal.
• Buprenorphine is more effective than placebo and equally as effective as moderate doses of methadone in preventing relapse to heroin. 6
• If a patient is to be initiated on MAT and prescribed buprenorphine in the ED setting, initial treatment may be 8mg sublingual, though dosing varies on opioid use history and institution. Sublingual buprenorphine peaks at approximately 60 minutes, though if a patient who is initiated on buprenorphine in the ED setting is not improving after 30 minutes, a repeat dose may be considered.
• Special precautions in the use of buprenorphine should be taken in patients who are pregnant, patients who have moderate to severe liver disease, and patients with polysubstance use disorders or dependence.
• Side effects include precipitation of opioid withdrawal, constipation, headache, diaphoresis, vasodilation, sedation, and severe nausea and vomiting.

For more information on buprenorphine use, side effects, and prescribing in the ED, please follow ACEP's Buprenorphine Use in the Emergency Department Tool ( https://www.acep.org/patient-care/bupe/ ), your institution's existing policies and procedures, and consider seeking out additional educational opportunities regarding addiction and opioid use disorder:

CONTINUING EDUCATION

• Become involved and connect patients with your local harm reduction organizations
• Be a leader in social justice in opioid use disorder by becoming a Resident Champion through Get Waivered
• Register for a free 8 hour MAT Waiver Training for Medical Students and Residents through Providers Clinical Support System here
• Encourage your residency program or medical school to make addiction treatment a core competency in their curricula.

As the Three-Day Rule is changing in June 2021, it is important that ED providers begin thinking about how to implement the new ruling. Encourage discussions with your hospital’s pharmacy, providers, and leadership so that EDs will be prepared to provide patients with compassionate and evidence-based opioid use disorder care. Echoing the statements made by ACEP 7 and other health care organizations, we urge deregulation in order to provide evidence-based care to those in need. While deregulation of buprenorphine is only part of the solution to the opioid use disorder crisis, it is a step towards care that recognizes and respects the intricacies of this ever-changing epidemic.

References

1. SAMSHA. Medication-Assisted Treatment: Buprenorphine Practitioner Resources and Information . Accessed January 23, 2021.
2. Andrilla CHA, Moore TE, Patterson DG, Larson EH. Geographic Distribution of Providers With a DEA Waiver to Prescribe Buprenorphine for the Treatment of Opioid Use Disorder: A 5‐Year Update . J Rural Health . 2019;35(1):108-112.
3. Berg ML, Idrees U, Ding R, Nesbit SA, Liang HK, McCarthy ML. Evaluation of the use of buprenorphine for opioid withdrawal in an emergency department . Drug Alcohol Depend . 2007;86(2-3):239-244.
4. D'Onofrio G, O'Connor PG, Pantalon MV, et al. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial . JAMA . 2015;313(16):1636-1644.
5. American College of Emergency Physicians. ACEP Helps Get 3-Day Bupe Rule Changed to Improve Patient Care . December 12, 2020.
6. Mattick RP, Breen C, KimberJ, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence . Cochrane Database Syst Rev . 2014(2): CD002207.
7. American College of Emergency Physicians. Sign-on Letter to Acting Secretary Cochran on Practice Guidelines for Prescribing Buprenorphine . January 27, 2021.