Resources

DATA 2000 Patient Limit

Table of Contents

1. Background

2. Applying

3. Reporting Requirements

4. Resources

Background

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. On behalf of our membership, ASAM submitted these written comments on the proposed rule to raise the buprenorphine patient limit

Physicians can now apply to increase their patient limit to 275 if they meet the requirements of the final rule. To be considered for the higher patient limit you must complete the online Waiver Notification Form SMA-167. The Substance Abuse and Mental Health Services Administration (SAMHSA) will review applications within 45 days of receipt. You cannot start prescribing to the higher limit until you receive a notice of approval from SAMHSA. 

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

HHS opened a supplementary comment period on the proposed reporting requirements for physicians with a 275 patient limit, which closed on August 8. On behalf of our membership, ASAM submitted these written comments on the reporting requirements.

SAMHSA opened a comment period on the 24 hours of training required for Nurse Practitioners and Physician Assistants to be able to apply for a buprenorphine waiver. On behalf of our membership, ASAM submitted these written comments on implementing this training requirement

Applying

SAMHSA handles the application process for physicians 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 for 30 patients their first year, please visit SAMHSA's webpage on Applying for a Physician Waiver. Please note that the final rule does not change the application process for a 30-patient waiver.
    • Any physician applying for a waiver to prescribe buprenorphine must have documentation showing that they have taken the 8 hours of required training. Learn about ASAM's Buprenorphine Courses here
  • For physicians with 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. Please note that the final rule does not change the application process for a 100-patient waiver.
  • Physicians with a 100-patient waiver for at least one year who are eligible to apply for a patient increase to 275 under the new rule 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. 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 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. 
  • Information on nurse practitioners (NPs) or physician assistants (PAs) prescribing buprenorphone is available here
  • 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.

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

Resources

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.