Dr. Emily Uebbing and I teamed up to cover the new HHS guidelines for the X-Waiver requirement when prescribing buprenorphine for opioid use disorder. Here’s what Dr. Uebbing uncovered…
It has been just over a year since the COVID-19 pandemic reached the United States (U.S.), however, the U.S. has been facing a deadly epidemic far longer than that. The opioid epidemic has been plaguing the U.S. since the 1990s and has significantly worsened in the last 12-months as the COVID-19 pandemic led to stress, isolation, and, ultimately, drug use for some people. The past year has accounted for the most drug overdose deaths ever recorded in a 12-month period. Overdose deaths from synthetic opioids, such as fentalogues, account for the majority of the deaths and increased by 38.4% in the 12-month period from May 2019-May 2020 compared to the prior 12-month period.1
The CDC endeavors to combat the opioid pandemic with the release of a multiyear Overdose Data to Action plan that began in September 2019. A large part of this plan includes increasing access to treatment for opioid use disorder. A barrier to which has long been the stringent X-waiver registration required by primary care providers.2
The Drug Addiction Treatment Act of 2000 (DATA 2000) established the X-waiver as an additional registration, separate from Drug Enforcement Administration (DEA) registration. It was required by any provider in order to prescribe schedule III-V medications for outpatient OUD treatment not in sync with a treatment program. The intended purpose of the X-waiver was to allow primary care providers to have a role in opioid use disorder treatment, as prior to this, medications for opioid use disorder treatment could only be prescribed through treatment programs.3 In order to obtain an X-waiver, a practitioner previously had to either be a physician who holds a board certification in addiction medicine or addiction psychiatry, or be a physician extender holding a DEA license (i.e. NP or PA) who provides medication-assisted treatment in a “qualified practice setting. This was in addition to paperwork, fees, and an 8-hour training for physicians or a 24-hour training for other practitioners.4 (https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner) X-waiver application, audits, and trainings deterred many providers from obtaining an X-waiver and ultimately limited patient access to treatment.3
The X-waiver has faced scrutiny since its conception, especially in relation to use of buprenorphine. Buprenorphine has been used for chronic pain longer than it has been used for OUD; the difference is that the X-waiver is not required for use of buprenorphine in chronic pain but it is for treatment of OUD. And unfortunately, some prescribers and even dispensing pharmacists didn’t know the difference. In regards to chronic pain, buprenorphine is hailed as a safer option compared to traditional opioids for patients as it uniquely reaches a plateau on carbon dioxide accumulation and related respiratory depression.5 One article simply inquired why the X-waiver applies for buprenorphine when it is used to treat OUD but not for chronic pain and other opioid medications that are responsible for causing the opioid epidemic itself.3
The Department of Health and Human Services (HHS) announced on January 12, 2021, the elimination of the requirement of an X-waiver for buprenorphine through releasing Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. The guidelines exempt physicians ONLY that are already registered with the DEA. Other providers such as nurse practitioners, physician assistance, and clinical nurse specialists, can still apply for an X-waiver and prescribe buprenorphine for OUD with an active X-waiver registration. Additionally, the guidelines released by the HHS limits physicians to treating no more than 30 patients at one time for OUD with buprenorphine.6, 7
The recent news from the HHS regarding the removal of the X-waiver requirement for physicians to prescribed buprenorphine is applauded as a valiant effort to removing barriers to treatment of opioid use disorder (OUD) at a time when access to OUD treatment is needed most. The question remains, why such a small step? Allowing physicians but no other providers may create more stress and stigma for physicians. Are other practitioners less capable or qualified?
An interesting sidebar is how recent politics has played into the desire for pharmacists to distribute and administer COVID-19 vaccines nationwide in an effort to combat a deadly pandemic; but community pharmacists are overlooked as key healthcare clinicians when it comes to the opioid epidemic and increasing access for medication assisted treatments by the most accessible community-based clinicians within both largely populated areas as well as rural communities.
In conclusion, this may be the first small step towards fostering increased access to medications for opioid use disorder to mitigate the opioid morbidity and mortality. In a perfect world, to meet the real intent of X-waiver elimination, pharmacists too would be included among those healthcare clinicians that can provide buprenorphine maintenance for OUD. The hope is that this small step will be followed by other measures to benefit patients with diagnosed opioid use disorder. In conclusion, this change should foster buprenorphine prescribers and supporting staff to engage in this important role an an effort to the increase buprenorphine access.
As always, comments are welcomed with enthusiasm!
About the Author: Dr. Emily Uebbing graduated with her PharmD from University of Rhode Island College of Pharmacy in 2020. She currently is a PGY1 Pharmacy Resident Stratton VA Medical Center Albany, New York and has accepted a position commencing June/July 2021 at Stratton VA as the incoming PGY2 Pharmacy Pain and Palliative Care Resident.
- Centers for Disease Control and Prevention. Overdose Deaths Accelerating During COVID-19, (December 2020). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html
- Centers for Disease Control and Prevention. Understanding the epidemic, (March 2020). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/drugoverdose/epidemic/index.html
- Fiscella K, Wakeman SE, Beletsky L. Buprenorphine Deregulation and Mainstreaming Treatment for Opioid Use Disorder: X the X Waiver. JAMA Psychiatry. 2019;76(3):229–230. doi:10.1001/jamapsychiatry.2018.3685
- Substance Abuse and Mental Health Services Administration. Become a buprenorphine waivered practitioner. January 21, 2021. Accessed January 25, 2021. Available at: https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
- Fudin J, Opioid Agonists, Partial Agonists, Antagonists: Oh My!. Pharmacy & Healthcare Communications, LLC; 2018. Available at: https://www.pharmacytimes.com/contributor/jeffrey-fudin/2018/01/opioid-agonists-partial-agonists-antagonists-oh-my
- Department of Health and Human Services. Announcement of practice guidelines for the administration of buprenorphine for treating opioid use disorder. January 12, 2021. Accessed January 18, 2021. Available at: https://www.hhs.gov/sites/default/files/mat-physician-practice-guidelines.pdf
- Kuntz L. Dropping the X-waiver for buprenorphine. Psychiatric Times. 2021;38:1. Available at: https://www.psychiatrictimes.com/view/improving-care-teens-with-opioid-use-disorder