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Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD). With this provision, and effective immediately, SAMHSA will no longer be accepting NOIs (waiver applications).
All practitioners who have a current DEA registration that includes Schedule III authority, may now prescribe buprenorphine for opioid use disorder in their practice if permitted by applicable state law. SAMHSA encourages practitioners to treat patients within their practices who require treatment for a substance use disorder.
SAMHSA offers tools, training, and technical assistance to practitioners in the fields of mental and substance use disorders. Find information on SAMHSA training and resources.
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Provider Support Contacts
For general information, providers can contact SAMHSA's Center for Substance Abuse Treatment (CSAT) at 1-866-287-2728 or email providersupport@samhsa.hhs.gov.
Frequently Asked Questions
Section 1262 of the ‘Consolidated Appropriations Act of 2023 (PDF | 3.8 MB)’ removes the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of opioid use disorder. It also removes other federal requirements associated with the waiver such as discipline restrictions, patient limits, and certification related to provision of counseling. Separately, section 1263 of the ‘Consolidated Appropriations Act of 2023 (PDF | 3.8 MB)’ requires new or renewing Drug Enforcement Administration (DEA) registrants, starting June 27, 2023, upon submission of their application, to have at least one of the following:
- A total of eight hours of training from certain organizations on opioid or other substance use disorders for practitioners renewing or newly applying for a registration from the DEA to prescribe any Schedule II-V controlled medications;
- Board certification in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, American Board of Addiction Medicine, or the American Osteopathic Association; or
- Graduation within five years and status in good standing from medical, advanced practice nursing, or physician assistant school in the United States that included successful completion of an opioid or other substance use disorder curriculum of at least eight hours.
This means that the special waiver (e.g., a DATA-Waiver) is no longer required to treat patients with opioid use disorder (OUD). Additionally, the DATA-Waiver registration number is no longer required on opioid use disorder prescriptions. Opioid use disorder prescriptions, like all prescriptions, now only require a standard DEA registration number.
- Those prescribers currently registered with the DEA as a DATA-Waived prescriber should have received, or will be receiving, an updated DEA registration certificate to reflect the elimination of the DATA-Waiver registration number. No action is necessary on the registrant’s part.
- It should be noted that state laws applicable to this issue may still be in effect. Registrants should take note of their state’s requirements because they may differ from federal law.
Immediately. Practitioners seeking to prescribe buprenorphine for the treatment of opioid use disorder no longer need to apply for, or possess, a DATA-Waiver prior to prescribing the medication. They should be aware of their state’s requirements because they may differ from federal law. Additionally, from June 27, 2023, practitioners will need to ensure that they are in compliance with the educational requirements as described above, since practitioners will need to have completed this training by the time they either newly apply for or are renewing their DEA registration.
Section 1262 of the ‘Consolidated Appropriations Act of 2023’ removes the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of opioid use disorder. It also removes other federal requirements associated with the waiver such as discipline restrictions, patient limits, and certification related to provision of counseling.
No, practitioners seeking to prescribe buprenorphine for the treatment of opioid use disorder no longer need to apply for or possess a waiver from the federal government before prescribing the medication. They should be aware of their state’s requirements because they may differ from federal law. In addition, providers should make certain they are in compliance with training requirements as of June 27, 2023, as outlined in this document.
Section 1263 of the ‘Consolidated Appropriations Act of 2023’ requires new or renewing Drug Enforcement Administration (DEA) registrants, starting June 27, 2023, upon submission of their application, to have at least one of the following:
- A total of eight hours of training from certain organizations on opioid or other substance use disorders for practitioners renewing or newly applying for a registration from the DEA to prescribe any Schedule II-V controlled medications;
- Board certification in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, American Board of Addiction Medicine, or the American Osteopathic Association; or
- Graduation within five years and status in good standing from medical, advanced practice nursing, or physician assistant school in the United States that included successful completion of an opioid or other substance use disorder curriculum of at least eight hours.
The federal reporting requirements, previously required of those with a DATA-Waiver (i.e., those under 42 C.F.R. 8.635), no longer apply. However, as with any patient encounter, detailed records must be kept in compliance with the Health Insurance Portability and Accountability Act (HIPAA) (PDF | 721 KB) and 42 CFR part 2, where applicable. SAMHSA again reminds providers that this pertains to federal requirements, and providers should ensure they are aware of and in compliance with any applicable state law.
No. There are no longer any patient caps. A practitioner may treat as many patients as they can support with buprenorphine.
No, the requirement to have a DATA-Waiver and associated patient caps no longer applies.
Yes, the provider must have a valid DEA registration and must be authorized to prescribe buprenorphine in the state in which they deliver care.
Buprenorphine, which is a Schedule III medication, can be prescribed by means of telehealth, so long as the prescription adheres to all relevant federal, state, and local laws; regulations; and other related requirements. Under the COVID-19 public health emergency (PHE), telehealth prescribing was expanded. The Department of Health and Human Services will continue to provide practice updates, particularly as the COVID-19 PHE starts to wind down in anticipation of ending on May 11, 2023.
The answer to this question depends on state law. Along with staying up-to-date with current state laws regarding buprenorphine treatment, practitioners and pharmacies should contact their state health departments with questions about state laws governing OUD practice and prescriptions.
42 CFR Part 2 privacy protections apply to federally assisted programs, which are substance use disorder practitioners who hold themselves out as providing, and who do provide, SUD treatment services, as well as substance use disorder treatment facilities. Practitioners who prescribe buprenorphine only need to follow Part 2 (e.g., written consent to share records and security of records, etc.) if they meet the definition of a “federally assisted program” as defined in 42 CFR 2.11 and 42 CFR 2.12(b), namely:
- If they receive any type of federal assistance in the provision of services; and
- If they work in a standalone SUD treatment program that holds itself out as providing, and provides, SUD services; or
- If they work in an identified SUD unit of a general medical facility that holds itself out as providing, and provides, SUD services; or
- Their primary function consists of providing SUD services and is identified as such.
Many practitioners in general medical facilities do not meet these criteria. Therefore, Part 2 generally does not apply to their patient records and they do not need to follow Part 2 – even if they prescribe buprenorphine. HIPAA protections still apply.
No, the provisions found in the ‘Consolidated Appropriations Act of 2023’ do not impact OUD treatment with methadone.
No. This change expands access to buprenorphine by eliminating the need for practitioners to apply for the DATA-Waiver to prescribe buprenorphine, and eliminates the patient caps that were previously applicable to practitioners who prescribed buprenorphine for OUD treatment. It also allows patients who screen positive for OUD to rapidly receive a prescription for the medication. Practitioners are encouraged to read SAMHSA’s Quick Start Guide (PDF | 1.4 MB) and FDA prescribing guidelines for more information. Practitioners should be aware of their state’s requirements because they may differ from federal law. As of June 27 of 2023, providers will need to make sure they comply with one of the three options outlined above to satisfy the new training requirement related to DEA-registration.
The Act does not override state laws, and medical providers should review the state and local laws in their jurisdictions for further information. State departments of health should be contacted if further information is required about specific state regulations.
Because many patients will have other behavioral health conditions, like anxiety and depression, capacity to treat or refer to counseling is strongly recommended as an evidenced-based practice, but is not required. Although people often focus on the role of medications in treating OUD, counseling and behavioral therapies that address psychological and social needs may also be extremely helpful to patients as part of a holistic treatment plan. However, an inability to provide these services, or patient refusal of such interventions, should not prevent practitioners from prescribing buprenorphine. The decision as to when counseling and other services, such as case management and peer support, should be made in conjunction with the individual patient.
Opioid Treatment Programs provide counseling, case management and peer support for people with OUD and may be good resources. Local counseling services can be found through SAMHSA’s Treatment Locator.
Standard screening involves clinical interviewing, urine and or oral fluid toxicology testing, and the Clinical Opioid Withdrawal Scale. For further information, please see Treatment Improvement Protocol (TIP) 63 for a comprehensive list of screening tools; Screening, Brief Intervention, and Referral to Treatment (SBIRT); and Technical Assistance Publication 33 (TAP 33) – Systems-Level Implementation of Screening, Brief Intervention, and Referral to Treatment.
SAMHSA’s Quick Start Guide (PDF | 1.4 MB) and Buprenorphine Quick Start Pocket Guide (PDF | 211 KB) provide advice on initiating treatment with buprenorphine among those individuals who screen positive for opioid use disorder. For more comprehensive information, please refer to TIP 63: Medication for Opioid Use Disorder and Practical Tools for Prescribing and Promoting Buprenorphine in Primary Care Settings (PDF | 25.2 MB).
An often-cited barrier to prescribing buprenorphine is the perception that patients must engage in counseling and other services in order to start or continue receiving the medication. While counseling and other services form part of a comprehensive treatment plan, the provision of medication should not be made contingent upon participation in such services.
An important treatment principle is to provide interventions in a person-centered manner. This means assessing and taking into account a person’s stage of change1 as 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. Many studies have indicated that counseling services provide patients with the tools to manage their condition, achieve and sustain better health, and improve their quality of life.2, 3, 4 Indeed, many individuals with SUDs have complex 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 have demonstrated greater treatment adherence and lower health care utilization when the medication is combined with counseling.5, 6, 7
As stated above, the decision as to when counseling and other services, such as case management and peer support, should be made in conjunction with the individual patient. Additionally, the evidence base does not provide direction on the type of counseling or services that might be optimal for patients 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 in order to support sustained recovery.
Given the elevated risk of fatal overdose without medication therapy, any difficulty in connecting patients with counseling and behavioral health resources should not prevent practitioners from prescribing buprenorphine. This is not to say that patients shouldn’t be offered counseling and other services. It instead reflects the understanding that engaging people with OUD and other SUDs 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 collaborative.
1Prochaska, J. O., DiClemente, C. C., & Norcross, J. C. (1992). In search of how people change. Applications to addictive behaviors. The American psychologist, 47(9), 1102–1114.
2 Murphy SM, Polsky D. Economic Evaluations of Opioid Use Disorder Interventions. Pharmacoeconomics. 2016 Sep;34(9):863-87. doi: 10.1007/s40273-016-0400-5. PMID: 27002518; PMCID: PMC5572804
3 Baser O, Chalk M, Fiellin DA, Gastfriend DR. Cost and utilization outcomes of opioid-dependence treatments. Am J Manag Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950
4 Lynch FL, McCarty D, Mertens J, Perrin NA, Green CA, Parthasarathy S, Dickerson JF, Anderson BM, Pating D. Costs of care for persons with opioid dependence in commercial integrated health systems. Addict Sci Clin Pract. 2014 Aug 14;9(1):16. doi: 10.1186/1940-0640-9-16. PMID: 25123823; PMCID: PMC4142137
5 Hsu YJ, Marsteller JA, Kachur SG, Fingerhood MI. Integration of Buprenorphine Treatment with Primary Care: Comparative Effectiveness on Retention, Utilization, and Cost. Popul Health Manag. 2019 Aug;22(4):292-299. doi: 10.1089/pop.2018.0163. Epub 2018 Dec 13. PMID: 30543495
6 Ronquest NA, Willson TM, Montejano LB, Nadipelli VR, Wollschlaeger BA. Relationship between buprenorphine adherence and relapse, health care utilization and costs in privately and publicly insured patients with opioid use disorder. Subst Abuse Rehabil. 2018 Sep 21;9:59-78. doi: 10.2147/SAR.S150253. PMID: 30310349; PMCID: PMC6165853
7 Ruetsch C, Tkacz J, Nadipelli VR, Brady BL, Ronquest N, Un H, Volpicelli J. Heterogeneity of nonadherent buprenorphine patients: subgroup characteristics and outcomes. Am J Manag Care. 2017 Jun 1;23(6):e172-e179. PMID: 28817294