1. Do I still need to apply for the X waiver?
Yes, these guidelines exempt eligible practitioners from certification requirements related to training and the provision of psychosocial services, which were previously necessary when dispensing or prescribing buprenorphine for the treatment of opioid use disorder (OUD) to 30 or fewer patients. Submission and approval of a Notice of Intent (NOI) remains legally necessary in order to use buprenorphine in the treatment of patients with OUD.
To indicate the qualified training exemptions when applying on the NOI website, applicants must select a training source or the system will bump them out. To apply, mid-level practitioners (APRNs and PAs) should check SAMHSA’s Providers Clinical Support System (PCSS) in "CERTIFICATION OF QUALIFYING CRITERIA," then enter "practice guidelines" in the text box for the date.
Physicians should select "Other" in "CERTIFICATION OF QUALIFYING CRITERIA," then enter "practice guidelines" in the text box for the city of the training. The training date should be the application date.
Further information regarding how to submit a NOI and obtain a waiver, can be found here: https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner.
2. Why not just eliminate the X waiver?
Removal of the requirement to apply for a waiver to treat those with OUD with buprenorphine, as set forth in the Controlled Substances Act (CSA), requires legislative action.
3. Why is the limit set at 30?
The 30-patient limit is the first tier set by the CSA. The rationale for the new guidelines being set at 30 is grounded in the idea that this is a first step in decreasing barriers. The effects of this policy will need to be examined before expanding the exemption to cover practitioners treating more than 30 patients. Those who wish to treat more than 30 patients are still required to satisfy all existing statutory certification requirements relative to training and psychosocial services.
4. Do these new Practice Guidelines rescind or rollback the requirement to obtain a CSA waiver or submit a Notice of Intent to use buprenorphine in the treatment of patients with OUD? Can I start prescribing buprenorphine straight away without any training?
No, these guidelines do not eliminate the CSA waiver or NOI requirements. Providers are still required to submit a Notice of Intent before using buprenorphine to treat patients with OUD and obtain a waiver number from the DEA. The Notice of Intent requires a simple, on-line application, submission of documentation of a valid DEA registration and state license, followed by approval. Information about this process, can be found at: https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
5. Does this limit increase each year? What if I want to treat more than 30 patients?
No, practitioners practicing under the exemption are limited to treating 30 patients or less. Practitioners who wish to prescribe above the 30-patient limit are required to submit a new Notice of Intent that satisfies all existing statutory certification requirements related to training and psychosocial services. If a prescriber wishes to treat more than 30 individual patients in a given time, the prescriber must submit the required training documentation. For more information about the eligibility and training, please visit: https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner
6. How can I access the educational resources necessary for me to treat more than 30 patients?
For information about the educational resources please visit https://www.samhsa.gov/medication-assisted-treatment/find-buprenorphine-waiver-training. The training requirement varies by provider type – physicians are required to undertake eight hours of structured training, whereas Nurse Practitioners, Physician Assistants and other qualified practitioners must complete 24 hours of training. The training must be completed before a practitioner submits an NOI to SAMHSA, but can be completed within any timeframe.
7. Are there client privacy protection issues to consider when prescribing buprenorphine?
42 CFR Part 2 privacy protections apply to federally assisted programs, which are substance use disorder providers who hold themselves out as providing, and provide, SUD services and substance use disorder treatment facilities. Practitioners with a waiver who prescribe buprenorphine only need to follow Part 2 if they meet the definition of a “federally assisted program” as defined in 42 CFR 2.11 and 42 CFR 2.12(b). The waiver meets the regulatory definition for “federal assistance,” (see 42 CFR 2.12(b)), so the issue is whether the care is provided in a setting that meets the definition of a program (42 CFR 2.11):
- if they work in a standalone substance use disorder (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 have received a DATA-2000 waiver and prescribe buprenorphine. HIPAA protections still apply. Please refer to: https://www.samhsa.gov/medication-assisted-treatment/practitioner-resources/record-keeping-requirements.
8. Do providers still need a DEA registration to prescribe buprenorphine?
Yes, the provider must have a valid DEA registration and a valid state medical license for the state in which they deliver care. These two items must be submitted when applying for the Notice of Intent.
9. Do the guidelines impact my existing regular practice?
No. Only practitioners who affirmatively apply for the exemption by submitting an applicable NOI, and are approved, will be authorized to practice under the Guidelines exemption without satisfying the normal CSA training and psychosocial services requirements. However, even when authorized to practice under the exemption, practitioners are encouraged to read SAMHSA’s Quick Start Guide (PDF | 1.5 MB) and FDA prescribing guidelines for more information.
10. If covering another provider’s panel that includes buprenorphine patients, do I need a CSA waiver to continue buprenorphine prescriptions for treating OUD?
Yes, a CSA waiver is needed to prescribe buprenorphine for OUD. Accordingly, practitioners who may wish to provide coverage for another practitioner’s OUD patients, will need to submit an approved NOI before treating such patients.
11. When practicing under the Guidelines exemption, do I need to provide, or refer to, counseling services? How do I find counseling services in my area?
Because many patients will have other behavioral health conditions, like anxiety and depression, capacity to treat or refer to counseling is recommended, but not required, for practitioners who are approved to practice under the Guidelines exemption. Although people often focus on the role of medications in treating OUD, counseling and behavioral therapies that address psychological and social needs are strongly recommended as part of a holistic treatment plan. To find treatment, please consult https://findtreatment.gov/.
12. How can I find Waivered providers in my area?
Practitioners who have allowed their practice location to be disclosed can be found on our treatment locator. (https://www.samhsa.gov/medication-assisted-treatment/practitioner-program-data/treatment-practitioner-locator)
13. Do the new Practice Guidelines impact administering buprenorphine in emergency department settings?
No, the Guidelines do not change the rules regarding administering (not prescribing) buprenorphine in emergency department settings and emergency department providers are, consistent with applicable DEA regulations, still permitted to administer buprenorphine within their facility for up to three consecutive days without a waiver. Prescribing buprenorphine still requires a valid X waiver.
14. What screening tools are available to assess for opioid misuse?
Standard screening involves clinical interviewing, urine and or oral fluid toxicology testing, and the Clinical Opioid Withdrawal Scale for Opioid Withdrawal. Please see Treatment Improvement Protocol (TIP) 63 for a comprehensive list. https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder-Full-Document/PEP20-02-01-006
15. In order to claim the exemption under the practice guidelines, practitioners will still need to submit a Notice of Intent to SAMHSA and wait for SAMHSA’s approval. Do practitioners also still need to obtain and utilize the X-number from the DEA in order to prescribe buprenorphine?
Yes an "X number" is issued by the DEA when the application is processed. This X number must be written on the buprenorphine prescription itself. It is with this number that the pharmacy will verify the validity of the prescription.