Since October 2002 when the Food and Drug Administration (FDA) approved buprenorphine for clinical use in treating opioid dependency, SAMHSA has worked with physicians to help them obtain waivers to meet the requirements of the Drug Addiction Treatment Act of 2000 (DATA 2000). DATA 2000 sets eligibility and certification requirements as well as an interagency notification review process for physicians who apply.
In conjunction with these efforts, SAMHSA tracks the number of physician waivers held throughout the country and monitors the progress of the program as a whole to evaluate its effectiveness.
SAMHSA uses the Online Request for Patient Limit Increase to implement the provisions of DATA 2000 that permit physicians to prescribe or dispense buprenorphine. The form is used to collect all of the necessary information from physicians to determine if they meet specific qualifications. This information is also used to track the number of DATA-certified physicians by state who are eligible to treat up to 30 or up to 100 patients at a time.
Results from a 2005 congressionally mandated evaluation study show how DATA 2000 has expanded opioid-assisted treatment. The study presents physician and patient survey results on treatment outcomes, patient characteristics, prescribing trends, barriers to treatment, and other information.
Overall, the study found that:
- The waiver program appears to have increased the availability of medication-assisted treatment (MAT) for opioid dependency
- Treatment provided under the wavier program has been safe and effective
- Diversion, adverse clinical events, and public health consequences under the program have been minimal
- The 30-patient limit on individual physician practices, as well as continuing cost and reimbursement issues, have dampened the full potential of buprenorphine to improve access
Evaluation Findings and Presentations
- Evaluation of the Buprenorphine Waiver Program: Study Overview (PDF | 91 KB). This short report covers the evaluation’s purpose, evaluation components, and data sources.
- Supplement to the Final Summary Report from the SAMHSA Evaluation of the Buprenorphine Waiver Program: An Updated Literature Review – 2007 (PDF | 261 KB). This document includes a review that was completed after the study was concluded.
- The Determinations Report: A Report on the Physician Waiver Program Established by the Drug Addiction Treatment Act of 2000 (“DATA”) – 2006 (PDF | 48 KB). This report from SAMHSA’s administrator to the Secretary of Health and Human Services and Congress summarizes and comments on key findings from the study.
- The SAMHSA Evaluation of the Impact of the DATA Waiver Program: Summary Report – 2006 (PDF | 380 KB). This document includes a summary of study findings, focused on those related to the determinations outlined in DATA 2000.
Learn more about SAMHSA’s buprenorphine waiver management program.