DEPARTMENT OF HEALTH AND HUMAN SERVICES

Center For Drug Evaluation and 

Research

U.S. Food and Drug Administration

Silver Spring, Maryland

May 9, 2023

Substance Abuse and Mental Health 

Services Administration 

Rockville, Maryland

Dear Colleague:

As overdose deaths involving opioids, particularly illicitly manufactured fentanyl, continue to 

remain extremely high across the country1, we are pleased that the opportunity to treat people 

with safe and effective medications for opioid use disorder (OUD), such as buprenorphine, has 

increased with the passage of Section 1262 of the Consolidated Appropriations Act, 2023. This 

section of the Act removes the requirement that a health care practitioner apply for a separate 

waiver to dispense certain controlled medications, including buprenorphine. Medication 

treatment saves lives, and we encourage colleagues in the field to screen for OUD and to initiate 

or refer for treatment as indicated.

An often-cited barrier to prescribing buprenorphine for the treatment of OUD is the perception 

that patients must engage in counseling and other services in order to start or continue receiving 

the medication.2,3,4 This letter serves to clarify the importance of counseling and other services as 

part of a comprehensive treatment plan, but to also reiterate that the provision of medication 

should not be made contingent upon participation in such services.5,6

Providing interventions in a person-centered manner is an important treatment principle. This

means assessing and taking into account a person’s stage of change7as treatment begins and 

progresses, incorporating the patient’s goals and priorities into the treatment plan, and applying a 

shared decision-making approach. It also means that counseling and other services can and 

should be offered as individuals stabilize on buprenorphine and progress in their treatment and 

recovery. This is because many studies have indicated that counseling services provide patients 

1 Centers for Disease Control and Prevention, National Center for Injury Prevention and Control (2022). Opioids - Data Overview. Available at: 

https://www.cdc.gov/opioids/data/index.html

2 Mendoza, S., Rivera-Cabrero, A. S., & Hansen, H. (2016). Shifting blame: Buprenorphine prescribers, addiction treatment, and prescription 

monitoring in middle-class America. Transcult Psychiatry, 53(4), 465-487. doi:10.1177/1363461516660884

3 Netherland, J., Botsko, M., Egan, J. E., Saxon, A. J., Cunningham, C. O., Finkelstein, R., . . . Collaborative, B. (2009). Factors affecting willingness 

to provide buprenorphine treatment. J Subst Abuse Treat, 36(3), 244-251. doi:10.1016/j.jsat.2008.06.006

4 Quest, T. L., Merrill, J. O., Roll, J., Saxon, A. J., & Rosenblatt, R. A. (2012). Buprenorphine therapy for opioid addiction in rural Washington: the 

experience of the early adopters. J Opioid Manag, 8(1), 29-38. doi:10.5055/jom.2012.0093

5 Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder. Treatment Improvement Protocol (TIP) 

Series 63 Publication No. PEP21-02-01-002. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2021.

6 Substance Abuse and Mental Health Services Administration (SAMHSA): Practical Tools for Prescribing and Promoting Buprenorphine in 

Primary Care Settings. SAMHSA Publication No. PEP21-06-01-002. Rockville, MD: National Mental Health and Substance Use Policy Laboratory. 

Substance Abuse and Mental Health Services Administration, 2021.

7 Prochaska, J. O., DiClemente, C. C., & Norcross, J. C. (1992). In search of how people change. Applications to addictive behaviors. Am Psychol, 

47(9), 1102–1114. https://doi.org/10.1037//0003-066x.47.9.1102
Page 2

with the tools to manage their condition, achieve and sustain better health, and improve their 

quality of life.8,9,10 Many individuals with substance use disorders (SUDs) have complex

psychosocial issues that may impact treatment and for which medication alone may be 

insufficient for optimal outcomes. In addition, several studies of patients undergoing treatment

with buprenorphine for OUD have demonstrated greater treatment adherence and lower health 

care utilization when the medication is combined with counseling.11,12,13,14

The decision as to when counseling and other services, such as case-management and peer 

support, are to be provided should be made in collaboration with the individual patient. 

Additionally, the evidence-base does not provide direction on the type of counseling or services 

that might be optimal for different patients and at different stages of treatment and recovery 

progression. This reflects the person-centered nature of treatment interventions, as well as the 

need for practitioners to work with patients and to meet them where they are to support sustained 

recovery. 

Given the elevated risk of fatal overdose without medication therapy, any difficulty in

connecting patients with counseling and/or other behavioral health resources should not prevent 

practitioners from prescribing buprenorphine for the treatment of OUD.

15 Evidence reveals that 

when counseling or other resources are not immediately available, patients can still benefit from 

buprenorphine treatment.16,17 While counseling should always be offered to patients, this reflects 

the understanding that engaging people with OUD in treatment is complex and can begin with 

stabilization on medication. As with any chronic condition, treatment planning should meet 

people where they are, be supportive, person-centered, and shared.

The Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food 

and Drug Administration (FDA) are committed to addressing the overdose epidemic through the 

provision of person-centered care and reducing barriers to accessing evidence-based treatments

for SUDs.

8 Murphy, S. M., & Polsky, D. (2016). Economic Evaluations of Opioid Use Disorder Interventions. Pharmacoeconomics, 34(9), 863-887. 

doi:10.1007/s40273-016-0400-5

9 Ray, L. A., Meredith, L. R., Kiluk, B. D., Walthers, J., Carroll, K. M., & Magill, M. (2020). Combined Pharmacotherapy and Cognitive Behavioral 

Therapy for Adults with Alcohol or Substance Use Disorders: A Systematic Review and Meta-analysis. JAMA Netw Open, 3(6), e208279. 

doi:10.1001/jamanetworkopen.2020.8279

10 Lynch, F. L., McCarty, D., Mertens, J., Perrin, N. A., Green, C. A., Parthasarathy, S., . . . Pating, D. (2014). Costs of care for persons with opioid 

dependence in commercial integrated health systems. Addict Sci Clin Pract, 9(1), 16. doi:10.1186/1940-0640-9-16

11 Hsu, Y. J., Marsteller, J. A., Kachur, S. G., & Fingerhood, M. I. (2019). Integration of Buprenorphine Treatment with Primary Care: Comparative 

Effectiveness on Retention, Utilization, and Cost. Popul Health Manag, 22(4), 292-299. doi:10.1089/pop.2018.0163

12 Ronquest, N. A., Willson, T. M., Montejano, L. B., Nadipelli, V. R., & Wollschlaeger, B. A. (2018). Relationship between buprenorphine 

adherence and relapse, health care utilization and costs in privately and publicly insured patients with opioid use disorder. Subst Abuse Rehabil, 

9, 59-78. doi:10.2147/SAR.S150253

13 Eren, K., Schuster, J., Herschell, A., Loveland, D., Neimark, G., Mihalyo, M., . . . Ryan, N. (2022). Association of Counseling and Psychotherapy 

on Retention in Medication for Addiction Treatment Within a Large Medicaid Population. J Addict Med, 16(3), 346-353. 

doi:10.1097/ADM.0000000000000914

14 Mutter, R., Spencer, D., & McPheeters, J. (2022). Factors Associated With Initial Treatment Choice, Engagement, and Discontinuation for 

Patients With Opioid Use Disorder. Psychiatr Serv, 73(6), 604-612. doi:10.1176/appi.ps.202100239

15 Practitioners should be aware of applicable state laws or regulations that may still be in effect regarding the prescribing and dispensing of 

buprenorphine for the treatment of OUD, and will need to seek further guidance from their state officials considering the impact of Section 

1262 of the Consolidated Appropriations Act, 2023, in their state.

16 Oleskowicz, T. N., Ochalek, T. A., Peck, K. R., Badger, G. J., & Sigmon, S. C. (2021). Within-subject evaluation of interim buprenorphine 

treatment during waitlist delays. Drug Alcohol Depend, 220, 108532. doi:10.1016/j.drugalcdep.2021.108532

17 Samso Jofra, L., Puig, T., Sola, I., & Trujols, J. (2022). Interim opioid agonist treatment for opioid addiction: a systematic review. Harm Reduct 

J, 19(1), 7. doi:10.1186/s12954-022-00592-x
Page 3

Please visit the SAMHSA store and FDA website for further resources to assist in treating opioid 

use disorders. We thank you for your efforts in helping to save and improve lives.

Sincerely,

Miriam E. Delphin-Rittmon, Ph.D.

Assistant Secretary for Mental Health 

and Substance Use

Patrizia Cavazzoni, MD

Director

Center for Drug Evaluation and Research

/Miriam E. Delphin-Rittmon/

/Patrizia Cavazzoni/