New HHS Guidance for Increasing Number of Buprenorphine Clinicians Who Can Treat OUD

Does your state allow it?

The ongoing opioid epidemic 

The U.S. hit a grim milestone of more than 100,000 drug overdose deaths,¹ most opioid-involved, in the 12 months ending April 2021. This alarming increase underscores the critical need to expand access to effective medications for opioid use disorder (OUD), including in the hospital setting, as noted by Linker and colleagues in The Hospitalist in December, 2021.²

A brief history of buprenorphine regulation and policy

Pharmacotherapy with buprenorphine, a schedule III partial opioid agonist, and methadone, a schedule II full opioid agonist, reduces overdose and all-cause mortality by more than 50% but is drastically underutilized.³ One critical barrier to providing buprenorphine treatment for OUD in the hospital is the requirement for prescribers to have a Drug Enforcement Agency (DEA) waiver (a.k.a. an X-license) to be able to prescribe buprenorphine upon discharge. Until recently, prescribers were required to complete specific training before applying for the waiver. To increase the number of buprenorphine prescribers, the U.S. Department of Health and Human Services (HHS) enacted a federal policy change⁴ allowing prescribers to receive the 30-patient waiver without this additional training. Through illustrative examples, we present that there may be policy and/or regulatory barriers at the state level that may hinder hospitalists’ use of the new federal pathway. 

The Food and Drug Administration (FDA) approved buprenorphine in 2002 for OUD treatment after Congress passed the Drug Addiction Treatment Act in 2000.⁵ The Drug Addiction Treatment Act of 2000 (DATA 2000) allows physicians to prescribe narcotic medications for the treatment of OUD if certain criteria are met:

• Medications prescribed must be schedule III-V and FDA-approved for opioid dependence (as defined in the Diagnostic and Statistical Manual of Mental Disease-IV).
• Clinicians must have an active medical and DEA license.
• Clinicians must fulfill specific educational training criteria. Most physicians fulfilled the training requirement by completing a Substance Abuse and Mental Health Services Administration (SAMHSA)-certified eight-hour course. 

Physicians initially could prescribe buprenorphine to a maximum of 30 patients in their first year with the DEA waiver, and could increase to a limit of 100 patients after one year and up to 275 patients after two years. In 2016, the Comprehensive Addiction Recovery Act (CARA) was implemented, allowing physician assistants (PAs) and advanced practice nurses (clinical nurse specialists, certified registered nurse anesthetists, nurse practitioners (NPs), and certified nurse-midwives) to obtain waivers. Expanding waiver eligibility to non-physicians significantly increased the size of the workforce,⁶ but it remains inadequate, with many choosing not to apply for a waiver, or prescribing far below their patient limit.⁷ And, in 2020, more than half of rural U.S. counties lacked a single waivered practitioner, and many counties have only one.⁸ 

New hope: federal policy change aims to remove barriers

In a further effort to expand the buprenorphine prescribing workforce, HHS issued a new policy guideline⁴ on April 28, 2021. It outlined a process where eligible providers with a valid DEA registration and state clinical license can receive the 30-patient-limit waivers without completing the prerequisite 8- or 24-hour waiver training for physicians and non-physicians, respectively, and attesting to the capacity to refer patients to counseling and other ancillary services. 

This major policy change aims to decrease gaps in buprenorphine treatment availability at several points of care, such as discharge from inpatient hospital settings and emergency departments (ED). Hospital admissions of people with OUD and serious injection-related infections (e.g., endocarditis and osteomyelitis) are rising. 

Treatment of the underlying disease is critical, particularly given the increases in overdose deaths due to the rising potency and prevalence of fentanyl in the country, and in patients being initiated on medications for OUD in both the ED and inpatient settings. Hospitalists and ED clinicians must be waivered to provide a short buprenorphine prescription upon discharge to provide effective care transitions. This change will hopefully help erode the misperception among medical professionals, leaders, and administrators that OUD treatment with buprenorphine is optional and encourage more widespread recognition that providing this mortality-reducing treatment is not more medically or legally complicated or risky than treatment of other chronic diseases. In fact, not providing access to this treatment may violate several laws and put medical professionals, their employers, and health care entities at risk. 

The Legal Action Center has explained that hospitals may be violating the Emergency Medical Treatment and Labor Act, the Americans with Disabilities Act, the Rehabilitation Act of 1973, and Title VI of the Civil Rights Act of 1964, when they choose not to provide evidence-based medical treatments for substance use disorders, such as OUD.⁹

Role of the states: friend or foe to the new federal exemptions?

While DATA 2000 increased the role of individual physicians in treating OUD with FDA-approved schedule III-V medications, the Federation of State Medical Boards (FSMB), in collaboration with SAMHSA, developed model guidelines for state medical boards to use in regulating office-based OUD treatment with buprenorphine. This resulted in the Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office,⁵ revised in 2013. Although it was designed to encourage state medical boards to adopt consistent standards, some states have codified additional requirements through state legislatures or medical and nursing boards.¹⁰ We’ve identified two scenarios where the adoption of the new federal guidelines may be delayed at a state level. 

First, state laws and regulations may contain language derived from DATA 2000 or the FSMB model policy, to reflect federal requirements in state law or regulation, predating the new HHS guideline, without further restriction. For example, in Maine, a joint rule of the Board of Licensure in Medicine, the State Board of Nursing, and the Board of Osteopathic Licensure required buprenorphine treatment providers to “obtain a DATA 2000 waiver and complete buprenorphine training.”¹¹ Maine is now amending the joint rule to state that the practitioner must “obtain a DATA 2000 waiver and complete buprenorphine training in accordance with applicable state and federal laws, rules, and regulations.” Thus, Maine will likely have only a short delay in implementing the new HHS guideline.¹¹

Alternatively, state laws and regulations may impose more restrictive rules than DATA 2000 due to perceived diversion and/or safety issues with buprenorphine prescribing and may not align with the new HHS guideline. In Kentucky, for example, the Board of Medical Licensure has additional requirements for buprenorphine prescribers and is not adopting the new HHS guideline. Physicians in Kentucky alerted the medical board of the HHS policy change and the corresponding supportive recommendation from the American Society of Addiction Medicine, while the state’s buprenorphine regulations were open for revision. Unfortunately, the revised (July 2021) Kentucky Administrative Regulation on professional standards for prescribing, dispensing, or administering buprenorphine still stipulates that the DEA-licensed prescriber shall have obtained “…buprenorphine certification through a completion of a SAMHSA-certified course.” This effectively blocks the implementation of the new federal policy in Kentucky.¹²

Takeaway 

The federal government has decreased provider-level policy barriers to obtaining a DEA waiver, but how this change is realized in the states, and whether practitioners waivered under the new pathway will be able to practice without violating regulations from their nursing, medical, or osteopathic boards, is not yet known. It’s not uncommon for state laws and regulations to be more restrictive than federal ones. However, given the ongoing and worsening opioid epidemic, more than two decades of U.S. data demonstrating the overall safety, cost-effectiveness, and mortality reduction associated with buprenorphine treatment, and several medical societies¹³ calling for the removal of the waiver requirement entirely, the state example of Kentucky is worrisome. 

Patients with OUD frequently visit EDs, hospitals, primary care, general psychiatry practices, and long-term care and skilled nursing facilities (e.g., after sequelae of non-fatal overdose or serious injection-related infections). Access to evidence-based medication treatment for OUD is often absent or inconsistent^14,15 at these locations and is direly needed along the entire care continuum for this chronic illness.¹⁶

Overall, the potential for inconsistencies between federal and state regulations (that vary between states) is important for hospitalists, ED clinicians, and others to be aware of if they obtain the waiver without doing the training. Further, we hope that raising awareness of these state-level barriers to expanding access to life-saving buprenorphine treatment will spark more conversation on the need for hospitalists practicing in every state to utilize the new federal pathway to obtain the X-waiver. 

Acknowledgment 

The National Institutes of Health Helping to End Addiction Long-term Initiative, a large-scale community intervention trial in four states (Kentucky, Massachusetts, New York, and Ohio) aims to reduce opioid overdose deaths by expanding access to evidence-based practices, including buprenorphine treatment in the hospital and other clinical care venues.¹⁷ Examination of policies surrounding buprenorphine treatment is one part of the initiative. This work is supported by the initiative with the following awards: UM1DA049406 (KY) and UM1DA049412 (MA). The content is solely the responsibility of the authors and does not necessarily represent the official views of the Initiative.

References

1. Ahmad FB, et al. County-level provisional drug overdose death counts. National Center for Health Statistics. 2021. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.  Accessed April 28, 2022.
2. Linker A, et al. Treatment of opioid use disorder in hospitalized patients. The Hospitalist. 2021 Dec;25(12):3-5.
3. Larochelle MR, et al. Medication for opioid use disorder after nonfatal opioid overdose and association with mortality: a cohort study. Ann Intern Med. 2018;169(3):137-145. doi: 10.7326/M17-3107. 
4. Department of Health and Human Services Federal Notice: 86 FR 22439. Practice guidelines for the administration of buprenorphine for treating opioid use disorder. https://www.federalregister.gov/d/2021-08961. Published April 28, 2021. Accessed April 28, 2022.
5. Federation of State Medical Boards. Model policy on DATA 2000 and treatment of opioid addiction in the medical office. https://www.fsmb.org/siteassets/advocacy/policies/model-policy-on-data-2000-and-treatment-of-opioid-addiction-in-the-medical-office.pdf. Published April, 2013. Accessed April 28, 2022.
6. Barnett ML, et al. In rural areas, buprenorphine waiver adoption since 2017 driven by nurse practitioners and physician assistants. Health Aff. 2019;38(12):2048-2056. doi.org/10.1377/hlthaff.2019.00859.
7. Duncan A, et al. Monthly patient volumes of buprenorphine-waivered clinicians in the US. JAMA Netw Open. 2020;3(8):e2014045. doi.org/10.1001/jamanetworkopen.2020.14045.
8. Andrilla CHA, Patterson DG. Tracking the geographic distribution and growth of clinicians with a DEA waiver to prescribe buprenorphine to treat opioid use disorder. J Rural Health. 2022;38:87-92. doi.org/10.1111/jrh.12569.
9. Yeboah-Sampong S, et al. Emergency: Hospitals are violating federal law by denying required care for substance use disorders in emergency departments. Legal Action Center. 2021. Available for download at: https://www.lac.org/resource/emergency-hospitals-can-violate-federal-law-by-denying-necessary-care-for-substance-use-disorders-in-emergency-departments. Accessed April 28, 2022.
10. Andraka-Christou B, et al. Toward a typology of office-based buprenorphine treatment laws. J Addict Med. 2022;16:192-207. doi.org/10.1097/adm.0000000000000863.
11. Joint rule regarding office based treatment of opioid use disorder: Department of professional and financial regulation. Board of Nursing, Maine. Available at https://www.maine.gov/boardofnursing/laws-rules/Ch.%2012%20-%20Joint%20Rule%20Regarding%20Office%20Based%20Treatment%20of%20Opioid%20Use%20Disorder%20(PDF).pdf. Accessed April 28, 2022.
12. Professional standards for prescribing, dispensing, or administering buprenorphine-mono-product or buprenorphine-combined-with-naloxone. 201 Kentucky Administrative Regulation 9:270. 2022 Jan 1; (48)(7).
13. Marino R, et al. ACMT position statement: Remove the waiver requirement for prescribing buprenorphine for opioid use disorder. J Med Toxicol. 2019;15:307-309. doi.org/10.1007/s13181-019-00728-9.
14. Substance use and mental health services administration: Use of medication-assisted treatment in emergency departments. HHS Publication No. PEP21-PL-Guide-5 Rockville, MD: National Mental Health and Substance Use Policy Laboratory. Substance Abuse and Mental Health Services Administration, 2021. Available for download at https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep21-pl-guide-5.pdf. Accessed April 28, 2022.
15. Jicha, et al. Substance use disorder assessment, diagnosis, and management for patients hospitalized with severe infections due to injection drug use. J Addict Med. 2019;13(1):69-74. doi:10.1097/ADM.0000000000000454.
16. Williams AR, et al. Development of a cascade of care for responding to the opioid epidemic. Am J Drug Alcohol Abuse. 2019; 45:1:1-10. doi.org/10.1080/00952990.2018.1546862.
17. Walsh SL, et al. The HEALing (Helping to End Addiction Long-term SM) Communities Study: Protocol for a cluster randomized trial at the community level to reduce opioid overdose deaths through implementation of an integrated set of evidence-based practices. Drug Alcohol Depend. 2020;217. Published online October 17, 2021. Accessed April 28, 2022. doi.org/10.1016/j.drugalcdep.2020.108335.

Silwal

Ms. Silwal is a PhD student at the college of communication and information, University of Kentucky, Lexington, Ky., and a health policy research assistant, policy workgroup, HEALing Communities study, Kentucky.  

Bohler

Mr. Bohler is a PhD student in behavioral health policy, Brandeis University, Waltham, Mass., and a research associate at the Institute of Behavioral Health, Heller School for Social Policy and Management, Brandeis University, Waltham, Mass.  

Dr. Thomas

Dr. Thomas is a professor and associate dean for research at the Heller School for Social Policy and Management, Brandeis University, Waltham, Mass.  

Dr. South

Dr. South is an assistant professor and hospitalist in the department of hospital medicine, an assistant thread leader for the health equity and advocacy thread, and an attending physician on the addiction consult and education service at the college of medicine, University of Kentucky, Lexington, Ky.  

Dr. Talbert

Dr. Talbert is a professor and division chief of biomedical informatics, department of internal medicine, University of Kentucky, Lexington, Ky.  

Dr. Fanucchi

Dr. Fanucchi is an associate professor, division of infectious diseases and center on drug and alcohol research, college of medicine, University of Kentucky, and the director of the addiction consult and education service, University of Kentucky, Lexington, Ky.  

Dr. Lofwall

Dr. Lofwall is a professor of behavioral science and psychiatry, Bell alcohol and addictions chair, college of medicine, University of Kentucky, and the medical director, First Bridge and Straus Clinics, center on drug and alcohol research, University of Kentucky, Lexington, Ky.