Resources

Buprenorphine Waiver Management


Apply for a Waiver

SAMHSA handles the application process for practitioners who want to prescribe buprenorphine for opioid addiction treatment and increase their current patient limit.

  • For first time physicians looking to apply for a waiver to prescribe buprenorphine, please visit SAMHSA's webpage on Applying for a Physician Waiver.  Please note that certain practitioners may immediately begin treating up to 100 patients if they hold certain board certifications, or if they provide medications for the treatment of opioid use disorder in a qualified practice setting.
    • Any practitioner applying for a waiver to prescribe buprenorphine must have documentation showing that they have taken the required training. Learn about ASAM's Buprenorphine Courses here!

ASAM, with the help of SAMHSA, has created an in-depth FAQ on How to Navigate the Final Rule to help members and the public understand the nuances of the final rule's requirements and provide examples of processes and systems that can ensure a physician is in compliance with the final rule.

For more information or if you are having trouble applying, contact the SAMHSA Center for Substance Abuse Treatment (CSAT) Buprenorphine Information Center at 866-BUP-CSAT (866-287-2728) or send an email to info@buprenorphine.samhsa.gov.

Apply to Increase Patient Limit

On August 8, 2016, a final rule from the Department of Health and Human Services (HHS) went into effect to increase access to medication-assisted treatment with buprenorphine products in the office setting by allowing eligible practitioners to request approval to treat up to 275 patients. The requirements of the final rule are intended to ensure patients receive high-quality care and diversion of medications is minimized. Please note that the final rule does not change the application process for a 30- or 100-patient waiver.  

For practitioners who don’t qualify for the new year-one patient limits , and who have had a 30-patient waiver for at least one year who wish to apply for a patient increase to 100, please visit SAMHSA's webpage on Applying to Increase Patient Limits

Physicians with a 100-patient waiver for at least one year who are eligible to apply for a patient increase to 275  must complete the online Waiver Notification Form SMA-167. SAMHSA will review applications within 45 days of receipt and will notify the applicant if they have been approved. DO NOT begin prescribing to the higher limit until you are approved.

  • SAMHSA has created the Understanding the Final Rule for a Patient Limit of 275 guidance document to help physicians determine whether they are eligible for the higher patient limit, which 275-patient limit has been codified under the SUPPORT Act. The Director of SAMHSA's Center for Substance Abuse Treatment (CSAT) has written a Dear Colleague Letter to explain the rationale behind the final rule.

ASAM, with the help of SAMHSA, has created the following resources to help members and the public understand the final rule:

275 Patient Limit Reporting Requirements

For those who have been approved for the 275 patient limit, SAMHSA instituted strict annual reporting requirements to maintain the increased patient limit. The requirement is to submit an annual report to SAMHSA about your buprenorphine prescribing activities. The report is normally due before the anniversary of your waiver approval date. For the first round of renewals, SAMHSA has granted a grace period and will notify providers with the 275 limit of the date they need to submit the report.

If your annual report is not received by SAMHSA by the required date, your 275 patient prescribing authority will be automatically rescinded and your patient limit will return to 100 as previously authorized. Additionally, all patients under your care beyond the 100 patient limit will need to be notified of your reduced patient capacity and directed to alternative resources for treatment.

The annual report form will satisfy the annual report requirement only after the form has been fully completed, submitted, and reviewed by SAMHSA. Incomplete forms may require additional time and cause disruptions to your 275 patient limit prescribing authority.

The SAMHSA 275 Annual Report Form (linked below) details all of the requirements necessary to complete and submit the form.   

SAMHSA's 275 Annual Report Form

Physicians who plan to apply for a patient increase to 275 must follow several requirements and standards. Two of these requirements are to practice according to nationally recognized evidence-based guidelines and have a diversion control plan. The below resources will help you abide by these two requirements.

  • Nationally Recognized Evidence-Based Guidelines
    • The final rule defines a nationally recognized evidence-based guideline as a document produced by a national or international medical professional association, public health agency, or governmental body with the aim of assuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions. They provide examples of current nationally recognized evidence-based guidelines, which are below:
      • ASAM's National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. You can find information on ASAM's guideline here!
      • SAMHSA's Treatment Improvement Protocol 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, available here.
      • The World Health Organization Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence, available here.
      • The Department of Veterans Affairs /Department of Defense/ Clinical Practice Guideline on Management of Substance Use Disorder, available here.
      • The Federation of State Medical Boards’ Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office, available here.
  • Diversion Control Plan
    • The final rule defines a diversion control plan as a set of documented procedures that reduce the possibility that controlled substances will be transferred or used illicitly. ASAM has created several sample documents to help members and other physicians understand best practices to prevent diversion. Below are those resources and others to assist in this.
  • Confidentiality
    • The final rule requires physicians who apply to provide appropriate releases of information, in accordance with federal and state laws and regulations, including 42 CFR Part 2, to permit the coordination of care with behavioral health, medical and other service practitioners. ASAM has created a sample form in order to assist physicians with this requirement.

Qualifications

For NPs and PAs to be eligible to apply for a buprenorphine waiver, they must complete 24 hours of training that covers the following topics: opioid maintenance and detoxification; clinical use of all FDA-approved drugs for medication-assisted treatment; patient assessment; treatment planning; psychosocial services; staff roles; and diversion control.

To qualify, NPs and PAs must:

  • Be licensed under state law to prescribe Schedule III, IV, or V medications for pain
  • Complete not less than 24 hours of appropriate education through a qualified provider
  • Through other training or experience, demonstrate the ability to treat and manage Opioid Use Disorder
  • If required by state law, be supervised or work in collaboration with a qualifying physicians to prescribe medications for the treatment of OUD

Please ensure that your state regulations allow you to prescribe buprenorphine and other medications to treat OUD before you apply for the waiver.  Some states may have overriding state legislation that will prevent NPs from prescribing these medications even if Federal law allows it. Nurse practice laws and regulations are specific to each state. AANP has created an interactive map to provide licensure and regulatory requirements, as well as practice environment details, for all 50 states and the U.S. Territories. AANP also has a list of state practice laws and regulations categorized by type.

NPs and PAs can begin the training immediately by taking the 8-hour buprenorphine courses offered by ASAM or that other stakeholders offer. The remaining 16 hours will have to be completed with one training provider. ASAM is in the process of developing multiple 16-hour training course options and formats, including collaborations with:

Other providers that can provide the 16 hours of additional training are the American Academy of Addiction Psychiatry, American Medical Association, American Osteopathic Association, American Nurses Credentialing Center, American Psychiatric Association, American Association of Nurse Practitioners, and American Academy of Physician Assistants. 

Apply for a Waiver

NPs and PAs who have completed the 24 hours of required training may seek to obtain a DATA 2000 waiver for up to 30 patients by completing the Waiver Notification Form.

NPs and PAs may send copies of their training certificates to infobuprenorphine@samhsa.hhs.gov or fax them to 301.576.5237. These waiver applications are forwarded to the Drug Enforcement Administration (DEA), which will assign the NP or PA a special identification number. DEA regulations require this number to be included on all buprenorphine prescriptions for opioid dependency treatment, along with the NP’s or PA’s regular DEA registration number.

SAMHSA shall review waiver applications within 45 days of receipt. If approved, NPs and PAs will receive a letter via email that confirms their waiver and includes their prescribing identification number.

Applications can also be made via SAMHSA's mobile app MATx. Click here to learn more about MATx.

To be redirected to SAMHSA's website, click here.


Expanded Buprenorphine Prescribing Authority under the SUPPORT Act (H.R.6)

On October 24, 2018, the President signed HR 6, The SUPPORT for Patients and Communities Act. This law grants expands the addiction treatment workforce by authorizing additional practitioners to prescribe buprenorphine for the treatment of opioid use disorder. As a result, qualifying clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwifes are able to prescribe buprenorphine until October 1, 2023.

The ASAM Treatment of Opioid Use Disorder Course is available for qualifying clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. Please select a credit type below to begin the training:

  • For AANP CE Credit: Click Here
  • For AAPA Category 1 CME Credit or AMA PRA Category 1 CME Credit: Click Here