Buprenorphine Prescribing Waiver

    The following summarizes our position on the buprenorphine prescribing waiver.

    Partnership to End Addiction supports reducing barriers to effective substance use disorder treatment, including eliminating the DATA 2000 waiver required to prescribe buprenorphine. Nonetheless, we stress that other policy changes are needed to ensure more people receive effective care. The buprenorphine requirement should be eliminated because (1) it has failed to meet its ostensible purpose, which is to prevent unscrupulous prescribing and diversion and (2) it has limited access to an effective opioid addiction medication during an unprecedented opioid epidemic. With preliminary estimates of 191 people dying every day from an opioid overdose in 2020, access to effective treatment is more critical now than ever before. The current waiver requirement is completely incompatible with the goal to increase access to evidence-based treatment for opioid use disorder (OUD).

    Instead of reducing diversion, the waiver requirement has contributed to diversion of buprenorphine for self-treatment because treatment is unavailable.[1] It is also notable that the DEA has not used waiver requirements to reduce diversion of any other medication, including prescription opioids where diversion of such medications has resulted in unquestionable societal risk and harm. The differential treatment of buprenorphine versus other narcotic pain relievers is driven by stigma rather than science and results in discrimination against patients with OUD. There is no clinical justification for imposing a patient limit, training and administrative requirements associated with prescribing buprenorphine. In fact, providers who prescribe oxycodone, a DEA Schedule II drug, or who prescribe methadone or buprenorphine for pain are not subject to these same restrictions. The only difference is that the patients to whom buprenorphine is prescribed are undergoing treatment for addiction. Given the effectiveness of buprenorphine in treating OUD, a life-threatening disorder, and the limited access to care, we find it unconscionable that the government would single out this treatment with patient limitations.

    Efforts to reduce unscrupulous prescribing have, in fact, reduced overall prescribing of buprenorphine. A very small number of providers have obtained the waiver and fewer actually prescribe buprenorphine.[2] The waiver requirement has created the perception among providers that it is difficult or challenging to treat substance use disorders (SUD), perpetuating stigma and discouraging providers from engaging in the practice. Increasing access to evidence-based SUD treatment is essential to address our nation’s addiction crisis and it is evident that the buprenorphine waiver requirement obstructs this goal.

    In April 2021, the Department of Health and Human Services took an important first step to minimize challenges associated with the buprenorphine waiver requirement. HHS released new buprenorphine practice guidelines that allow waivered physicians, physician assistants, and advance practice nurses to prescribe buprenorphine to up to 30 patients without completing additional training requirements or certifying capacity to provide counseling and ancillary services. Nonetheless, providers are still required to obtain a waiver to prescribe buprenorphine and to complete additional training to treat more than 30 patients. While the Biden administration seems to be supportive of a more complete elimination of the buprenorphine waiver, it believes that such a change would legally require Congressional action.

    We believe that a more complete elimination of the waiver requirement is needed to significantly expand treatment access and remove the stigma associated with buprenorphine. However, we understand that eliminating the waiver requirement, alone, is insufficient to increase access to buprenorphine and other effective SUD care. Eliminating the waiver requirement must be accompanied by efforts to increase SUD training for health care providers and provide adequate reimbursement.

    Despite the prevalence of the disease, health care providers receive very little training in SUD and this has left the health care system woefully unprepared to deal with addiction. To rectify this and increase the number of providers offering evidence-based care such as buprenorphine, addiction training must be incorporated into medical school curricula.

    In addition to medical school training, ongoing training should be required for health care providers through continuing medical education and licensing requirements. Providers also need support and guidance from more experienced providers to consult on complex cases as well as support staff, such as nurses, social workers, and peers to meet patients’ needs adequately.[3]

    Prescribers treating more than 30 patients are still required to certify that they have capacity to refer patients to counseling and other ancillary services. This requirement assumes that these services are accessible; yet, there are severe shortages of behavioral health services across the country. A requirement to refer to services that do not exist may reduce prescribing. Providers often cite lack of availability of behavioral health services as a barrier to prescribing buprenorphine.[4] Policy changes other than a referral requirement are needed to ensure patients have access to behavioral counseling and other ancillary services.

    To ensure prescribers can hire appropriate support staff and to increase availability of ancillary services, reimbursement rates must be increased. One possible reason for the shortage of quality behavioral health services is low insurance participation and reimbursement. Lack of insurance coverage is also cited as a barrier to prescribing buprenorphine.[5] A number of states have increased access to and quality of buprenorphine treatment by changing reimbursement policies in Medicaid.[6] These strategies should be replicated on the national level and applied in other insurance products, to ensure adequate access to effective addiction treatment.

    In summary, removing the buprenorphine wavier requirement is an important policy change but it must be accompanied by other innovative policies to significantly increase access to effective OUD treatment. Partnership to End Addiction supports eliminating the DATA 2000 waiver requirement, together with funding and requirements for provider training and increased reimbursement rates for SUD treatment, to increase access to life-saving care.

    Published

    April 2017

    [1] Schuman-Olivier, Z., Albanese, M., Nelson, S.E., Roland, L., Puopolo, F., Klinker, L., & Shaffer, H.J. (2010). Self-treatment: illicit buprenorphine use by opioid-dependent treatment seekers. Journal of Substance Abuse Treatment, 39(1), 41–50.

    Carroll, J.J., Rich, J.D., & Greene, T.C. (2018). The More Things Change: Buprenorphine/naloxone Diversion Continues While Treatment Remains Inaccessible. Journal of Addiction Medicine, 12(6), 459–465.

    [2] Kissin, W., McLeod, C., Sonnefeld, J., & Stanton, A. (2006). Experiences of a National Sample of Qualified Addiction Specialists Who Have and Have Not Prescribed Buprenorphine for Opioid Dependence. Journal of Addictive Diseases, 25(4), 91-103.

    [3] Walley, A.Y., Alperen, J.K., Cheng, D.M., Botticelli, M., Castro-Dolan, C., Samet, J.H., & Alford, D.P. (2008). Office-Based Management of Opioid Dependence with Buprenorphine: Clinical Practices and Barriers. Journal of General Internal Medicine, 23(9), 1393–1398.

    Huhn, A.S., & Dunn, K.E. (2017). Why Aren’t Physicians Prescribing More Buprenorphine? Journal of Substance Abuse Treatment, 78, 1–7.

    [4] Kissin, W., McLeod, C., Sonnefeld, J., & Stanton, A. (2006). Experiences of a National Sample of Qualified Addiction Specialists Who Have and Have Not Prescribed Buprenorphine for Opioid Dependence. Journal of Addictive Diseases, 25(4), 91-103.

    [5] Kissin, W., McLeod, C., Sonnefeld, J., & Stanton, A. (2006). Experiences of a National Sample of Qualified Addiction Specialists Who Have and Have Not Prescribed Buprenorphine for Opioid Dependence. Journal of Addictive Diseases, 25(4), 91-103.

    Walley, A.Y., Alperen, J.K., Cheng, D.M., Botticelli, M., Castro-Dolan, C., Samet, J.H., & Alford, D.P. (2008). Office-Based Management of Opioid Dependence with Buprenorphine: Clinical Practices and Barriers. Journal of General Internal Medicine, 23(9), 1393–1398.

    Huhn, A.S., & Dunn, K.E. (2017). Why Aren’t Physicians Prescribing More Buprenorphine? Journal of Substance Abuse Treatment, 78, 1–7.

    [6] O’Brien, J., Sadwith, T., Croze, C., & Parker, S. (2019). Review of State Strategies to Expand Medication Assisted Treatment: A Report to the Laura and John Arnold Foundation. Technical Assistance Collaborative. Retrieved from https://www.tacinc.org/resource/state-strategies-to-expand-medication-assisted-treatment/.