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IMPORTANT INFORMATION:
On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid-dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

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There may be doctors in your area participating in a study to measure opioid dependence treatment outcomes. Patients who meet the eligibility requirements to participate in this study can receive up to $225 in compensation to complete surveys about their treatment.

NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.

Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.

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Certification FAQs
1. What steps are involved before I can begin prescribing SUBOXONE?
2. Who is qualified to prescribe SUBOXONE?
3. What is the 100-patient limit?
4. After becoming qualified, what is the next step?
5. What happens after my notification is sent to SAMHSA?
6. What if I submit my notification but do not receive an acknowledgment from SAMHSA?
7. How will I know when I can begin prescribing SUBOXONE?
8. Are there any special considerations to keep in mind when I prescribe SUBOXONE?
9. Where can I get more information about opioid dependence and DATA 2000?
1. What steps are involved before I can begin prescribing SUBOXONE?
A: Under DATA 2000, qualified physicians may obtain a waiver allowing them to prescribe and/or dispense approved Schedule III-V medications (eg, SUBOXONE) for the office-based treatment of opioid dependence.

To become certified to prescribe SUBOXONE for office-based treatment of opioid dependence (ie, to receive a DATA 2000 waiver), physicians must complete 2 steps:

1. Prove that they are qualified.
2. Notify SAMHSA of their intent to treat patients with SUBOXONE.

2. Who is qualified to prescribe SUBOXONE?
A: According to DATA 2000, licensed physicians are considered qualified to prescribe SUBOXONE if they have met at least 1 of the following criteria:
  • Addiction psychiatry subspecialty board certified from the American Board of Medical Specialties
  • Addiction medicine certified from the American Society of Addiction Medicine (ASAM)
  • Addiction medicine subspecialty board certified from the American Osteopathic Association (AOA)
  • Completed not less than 8 hours of authorized training on the treatment or management of opioid-dependent patients
  • Organizations currently authorized to provide training: American Academy of Addiction Psychiatry (AAAP), American Medical Association, AOA (through the American Osteopathic Academy of Addiction Medicine [AOAAM]), American Psychiatric Association (APA), and ASAM
  • Participated as an investigator in one or more clinical trials leading to the approval of buprenorphine
  • Training or other such experience as determined by the physician's state medical licensing board
  • Training or other such experience as determined by the United States Secretary of Health and Human Services
In addition, physicians must satisfy BOTH of the following criteria:
  • Have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy
  • Agree to treat no more than 100 patients at any one time after one year of treating opioid-dependent patients
3. What is the 100-patient limit?
A:
  • Physicians who submitted their first notification of intent less than 1 year ago can treat up to 30 patients after re-notifying SAMSHA of their need and intent to treat up to 100 patients
  • Physicians who renotified SAMHSA of their need and intent more than 1 year ago can treat up to 100 patients
Information about additional training courses may be found on the websites of the organizations listed below, or by contacting the organization directly:

American Academy of Addiction Psychiatry (AAAP)
Phone: (401) 524-3076
Contact: www.aaap.org/contact.htm
Website: www.aaap.org

American Osteopathic Academy of Addiction Medicine (AOAAM)
Phone: (800) 621-1773
Website: www.aoaam.org

American Psychiatric Association (APA)
Phone: (703) 907-7300
E-mail: apa@psych.org
Website: www.psych.org

American Society of Addiction Medicine (ASAM)
Phone: (301) 656-3920
E-mail: email@asam.org
Website: www.asam.org

Some of the above organizations also offer CD-ROM and web-based buprenorphine training (see their websites for details).
4. After becoming qualified, what is the next step?
A: DATA 2000 requires all qualified physicians to notify SAMHSA of their intent to treat opioid-dependent patients with SUBOXONE prior to initiating treatment. This is generally done by submitting an NOI form to SAMHSA.
  • Online: To complete and submit the NOI online, visit the SAMHSA buprenorphine website at www.buprenorphine.samhsa.gov
  • Mail/Fax: To download a printable version of the NOI, click here. Completed forms may be faxed to SAMHSA (240-276-1630) or mailed to the following address:

SAMHSA
Division of Pharmacologic Therapies
Attention: Opioid Treatment Waiver Program
1 Choke Cherry Road, Rm 2-1063
Rockville, MD 20857
Phone: (240) 276-2716
5. What happens after my notification is sent to SAMHSA?
A:

Shortly after your NOI is submitted, SAMHSA will send you a letter (or e-mail) acknowledging receipt of your form. This letter means your notification is under active review.
6. What if I submit my notification but do not receive an acknowledgment from SAMHSA?
A: If, after submitting your NOI, you do not receive an acknowledgment from SAMHSA, please contact SAMHSA directly at (866) BUP-CSAT (866-287-2728) or info@buprenorphine.samhsa.gov.

To check on the status of your waiver, SAMHSA will need the date you submitted your NOI, and may ask for other identifying information, as well.

The same steps apply if you want to check on the status of your waiver after receiving SAMHSA's acknowledgment of receipt.

SAMHSA strives to process all waiver requests within 45 days of their receipt. However, if it has been more than 60 days since you submitted your form, SAMHSA asks that you please contact them so they can track your application.
7. How will I know when I can begin prescribing SUBOXONE?
A: When SAMHSA's review of your NOI is complete, you will receive a letter confirming your waiver and providing you with a DATA 2000 prescribing identification number.
  • This new number will be identical to your current Drug Enforcement Agency (DEA) Schedule III, IV, or V number, except that an "X" will replace the first character (eg, AW3456789 becomes XW3456789)
  • The new number is to be used on all SUBOXONE prescriptions (see FAQ #8)
  • Subsequently, you will be sent a revised DEA registration certificate showing both your DEA numbers
  • As of October 2004, all DEA Controlled Substance Registration Certificates are issued in the "standard" size together with a wallet-size duplicate certificate
8. Are there any special considerations to keep in mind when I prescribe SUBOXONE?
A:

As of July 2005, all prescriptions for SUBOXONE tablets must include your DATA 2000 "X" prescribing number. Records must be kept of these and all other prescriptions written for controlled substances.
9. Where can I get more information about opioid dependence and DATA 2000?
A: Additional information about opioid dependence is available at TurnToHelp.com.

The full text of DATA 2000, including all language describing physician qualifications, training criteria, and the physician-waiver process can be found at buprenorphine.samhsa.gov or by contacting SAMHSA directly:

SAMHSA Buprenorphine Information Center
Phone: (866) 287-2728 (866-BUP-CSAT)
E-mail: info@buprenorphine.samhsa.gov

Patient education brochures and other treatment resources can be downloaded from the Product Resource section of this website.
Reference
SAMHSA buprenorphine website. Available at: http://www.buprenorphine.samhsa.gov/index.html. Accessed December 3, 2009.