|
|
The Drug Addiction Treatment Act of 2000 (DATA 2000)
This act enables qualifying physicians to receive a waiver from the
special registration requirements in the Controlled Substances Act for the
provision of medication-assisted opioid therapy. This waiver allows qualifying
physicians to practice medication-assisted opioid addiction therapy with
Schedule III, IV, or V narcotic medications specifically approved by the Food and Drug Administration (FDA). On
October 8, 2002 Subutex® (buprenorphine hydrochloride) and Suboxone®
tablets (buprenorphine hydrochloride and naloxone hydrochloride)
received FDA approval for the treatment of opioid addiction.
To receive a waiver to practice opioid addiction therapy with approved Schedule III, IV, or V narcotics a physician must notify the Center for Substance Abuse Treatment
(CSAT, a component of the Substance Abuse and Mental Health Services
Administration) of his or her intent to begin dispensing or prescribing this
treatment. This Notification of Intent must be submitted to CSAT before the
initial dispensing or prescribing of opioid therapy. The “waiver notification” section on this Site provides
information on how to obtain and submit a Notification of Intent form. The Notification of Intent can be submitted on-line from this Web site, or via
ground mail or fax.
The Notification of Intent must contain information on the physician’s qualifying credentials (as defined below) and additional certifications including that the physician has the capacity to refer such addiction therapy patients for appropriate counseling and other non-pharmacologic therapies, and that the physician will not have more than 30 patients on such addiction therapy at any one time for the first year.
(Note: The 30-patient limit is not affected by the number of a physician’s practice locations. One year after the date on which the physician submitted the initial notification, the physician will be able to submit a second notification stating the need and intent to treat up to 100 patients.)
The Drug Enforcement Administration (DEA)
The Drug Enforcement Administration (DEA) assigns
the physician a special identification number. DEA regulations
require this ID number to be included on all buprenorphine
prescriptions for opioid addiction therapy, along with the physician’s regular DEA registration number.
To qualify for a waiver under DATA 2000 a
licensed physician (MD or DO) must meet any one or more of the following
criteria:
- The physician holds a subspecialty board certification in
addiction psychiatry from the American Board of Medical Specialties.
- The physician holds an addiction certification from the American Society of Addiction Medicine.
- The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association.
- The physician has, with respect to the treatment and management of opioid-addicted patients, completed not less than eight hours of
training (through classroom situations, seminars at professional society
meetings, electronic communications, or otherwise) that is provided by the
American Society of Addiction Medicine, the American Academy of Addiction
Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization
that the Secretary determines is appropriate for purposes of this subclause.
- The physician has participated as an investigator in one or
more clinical trials leading to the approval of a narcotic drug in schedule
III, IV, or V for maintenance or detoxification treatment, as demonstrated by a
statement submitted to the Secretary by the sponsor of such approved drug.
- The physician has such other training or experience as the
State medical licensing board (of the State in which the physician will provide
maintenance or detoxification treatment) considers to demonstrate the ability
of the physician to treat and manage opioid-addicted patients.
- The physician has such other training or experience as the
Secretary considers to demonstrate the ability of the physician to treat and
manage opioid-addicted patients. Any criteria of the Secretary under this
subclause shall be established by regulation. Any such criteria are effective
only for 3 years after the date on which the criteria are promulgated, but may
be extended for such additional discrete 3-year periods as the Secretary
considers appropriate for purposes of this subclause. Such an extension of
criteria may only be effectuated through a statement published in the Federal
Register by the Secretary during the 30-day period preceding the end of the
3-year period involved.
|
What is Buprenorphine?
