Buprenorphine Information for Physicians

Federal Law

Basic Information About DATA

On October 17, 2000 Title XXXV of the Children's Health Act of 2000 was enacted that permits the prescribing of schedule III, IV or V opioid treatment drugs that are approved by the FDA for maintenance or detoxification treatment.

Read the full text:

Public Law 106-310, Sec. 3502. Controlled Substances Act (Title XXXV)

Summary of Title XXXV

Their are special confidentiality regulations that apply to patients in drug and alcohol treatment. It is recommended that you review these regulations and download a copy.

42 CRF Part 2 Confidentiality of Alcohol and Drug Abuse Patient Records

For the first time in nearly a century physicians may now treat opiate addiction with Schedule III, IV, or V narcotic medicatons. Only one medication has been approved - buprenorphrine with expectations of other medications receiving approval.

In order to prescribe buprenorphrine a physician must meet certain requirements and submit a waiver to the Center for Substance Abuse Treatment (CSAT) a division of the Substance Abuse and Mental Health Services Administration (SAMHSA).

Physician Waiver Requirements

The physician (or group practice) may not have more than 30 patients on addiction therapy at any one time.
The physician has the capacity to refer addiction therapy patients for appropriate counseling and other non-pharmacologic therapies
The physician must meet the qualifying credentials.

The physician must submit to CSAT a Notification of Intent to begin dispensing or prescribing this treatment before starting treatment.

To qualify for a waiver under DATA 2000 a licensed physician (MD or DO) must meet at least one of the following qualifying credentials:

Have a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties.
Have an addiction certification from the American Society of Addiction Medicine.
Have a subspecialty board certification in addiction medicine from the American Osteopathic Association.
Completed the eight hours of approved training.
Participated as an investigator in one or more clinical trials leading to the approval of a schedule III, IV, or V narcotic drug for maintenance or detoxification treatment.
Other training or experience that the State medical licensing board considers demonstrates the ability of the physician to treat and manage opiate-dependent patients.

Additional options or other experience or licensing to qualify may be considered. Contact CSAT for these other options.

How to Submit the Waiver

There are several ways to submit a waiver:

Submitting a Waiver On Line

What information you should have ready.

Purpose of Notification: either New or Immediate.
Definations:

New is an initial Notification Waiver submitted for the purpose of obtaining an ideentification number form the DEA.

Immediate is a notification submitted to notify the Secretary and Attorney General of the intent to begin the treatment of an individual.

A New and Immediate Notification may be submitted simutaneously.
State License Number.
DEA Registration Number.
Address, Phone and Fax on your current DEA Registration.
Group Practice Employer Number (EIN), Name and Address (if applicable).
If part of a Group Practice the Names and DEA Numbers of the practicioners.
Must meet one of the following criteria:

Subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties.
Certification from the American Society of Addiction Medicine.
Subspecialty board certification in addiction medicine from the American Osteopathic Association.
Completion of the 8 hour training course.
Participation as investigator in one or more clinical trials to approve a schedule III, IV, or V narcotic drug for maintenance or detoxification treatment.
State medical licensing board-approved experience or training in the treatment and management of opiate-dependent patients.
OTHER (contact CSAT for other options).

Certification that you are able to refer patients for appropriate counseling and other appropriate ancillary services.
Certification of maximum patient load which is 30 patients per physician or group practice.
If you wish to be listed in the Physician Locator then you must give consent.

Most of the requirements are within the form that you fill out. You will not need separate documents with the exception of

Upon submitting your waiver you should receive an acknowledgement. If you do not then contact SAMHSA at: info@buprenorphine.samhsa.gov.

It can take up to 45 days to receive the FDA waiver. If it has been over 45 days contact SAMHSA at the email above.

Guidelines

Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction , McNicholas, L. (chair), Treatment Improvement Protocol, Number 40, 2004. DHHS Publication N0. (SMA) 04-3939.

Order Guidelines from NCADI.

Physician Forum

Physician Clinical Discussion Forum A forum for physicians holding waivers under the authority of DATA 2000 to discuss the clinical use of buprenorphine in the treatment of opioid addiction and related issues.