Policies and Procedures
Great minds discuss ideas;Average minds discuss events; Small
minds discuss people. ---Oliver Wendell Homes
The DATA 2000 Waiver
DATA 2000 enables qualifying physicians to receive a waiver from the special registration requirements in the Narcotic Addict Treatment Act (NATA) of 1974 (and its enabling regulations, including Title 42, Part 8 of the Code of Federal Regulations, that govern OTPs) for the provision of opioid addiction treatment.
This waiver allows qualifying physicians (see “Physician Waiver Qualifications”) to prescribe or dispense Schedule III, IV, and V “narcotic” medications for the treatment of opioid addiction in the office and other clinical settings if (and only if) those medications have been approved by the Food and Drug Administration (FDA) for use in addiction treatment. As of this writing, Subutex® (buprenorphine) and Suboxone® (buprenorphine/naloxone) sublingual tablets are the only Schedule III, IV, or V pharmaceuticals to have received such FDA approval.
Narcotic Addict Treatment Act of 1974 makes it illegal for narcotics to be used “off label” to treat opioid addiction. This prohibition extends even to other forms of buprenorphine (e.g., Buprenex®) that have not been specifically approved for the treatment of opioid addiction.
Notification of Intent
To receive a DATA 2000 waiver to practice opioid addiction treatment with approved Schedule III, IV, and V opioid medications, a physician must notify the Substance Abuse and Mental Health Services Administration (SAMHSA) of his or her intent to begin dispensing or prescribing this treatment. This Notification of Intent must be submitted to SAMHSA before the initial dispensing or prescribing of opioid treatment. Notification of Intent forms can be obtained on the SAMHSA Buprenorphine Website at http://www.buprenorphine.samhsa.gov
Forms can be submitted to SAMHSA online or printed out and then submitted 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 addiction patients for appropriate counseling and other nonpharmacological therapies, and that the physician will not have more than 100 patients on such addiction treatment at any one time. (Note that the 100-patient limit applies both to physicians in solo practice and to entire group practices, and the limit is not affected by the number of locations of practice of the physicians or groups.)
Physicians who meet the qualifications defined in DATA 2000 are issued a waiver by SAMHSA and a special identification number by the Drug Enforcement Administration (DEA). DEA has issued regulations that require physicians to include this identification number on all records when dispensing and on all prescriptions when prescribing approved opioid medications (currently only Subutex® and Suboxone®) for opioid addiction.
Under DATA 2000, a physician may initiate opioid addiction treatment for “an individual patient” after submitting a Notification of Intent to SAMHSA but before receipt of a waiver and identification number. To provide this “immediate-type” treatment, a physician must not only submit the usual Notification of Intent to SAMHSA but also must include notification of intent to begin immediately treating an individual patient. SAMHSA's Notification of Intent form includes a checkbox for indicating this immediate-type intent.
Physician Waiver Qualifications
To qualify for a waiver under DATA 2000, a licensed physician (M.D. or D.O.) 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 (ASAM).
*The physician holds a subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA).
*The physician has, with respect to the treatment and management of patients who are opioid addicted, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by ASAM, the American Academy of Addiction Psychiatry, the American Medical Association, AOA, the American Psychiatric Association, or any other organization that the Secretary of the U.S. Department of Health and Human Services (DHHS) 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 DHHS 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 patients who are opioid addicted. The physician has such other training or experience as the DHHS Secretary considers as demonstrating the ability of the physician to treat and manage opioid-dependent patients. Any criteria of the DHHS Secretary under this subclause shall be established by regulation.
For More Information
Proper training on the use of buprenorphine will be key to the successful introduction of this new treatment paradigm, regardless of the clinical setting of buprenorphine treatment. Thus, SAMHSA and the consensus panel strongly encourage all physicians who plan to practice opioid addiction treatment with buprenorphine to participate in a DATA 2000-qualifying 8-hour training program on buprenorphine.
SAMHSA maintains a list of upcoming DATA 2000-qualifying buprenorphine training sessions on the SAMHSA Buprenorphine Website at http://www.buprenorphine.samhsa.gov.
These sessions include Web-based courses accessible from the physician's own computer. Detailed information about the DATA 2000 paradigm and the physician waiver process also can be found on the SAMHSA Buprenorphine Web site. Additionally, information can be obtained by contacting the SAMHSA Buprenorphine Information Center by:
at phone at 866-BUP-CSAT (866-287-2728) or by e-mail at firstname.lastname@example.org.
Preparing for Office-Based Opioid Treatment
Prior to embarking on the provision of office-based addiction treatment services, medical practices that will be new to this type of care should undertake certain preparations to ensure the highest quality experience for patients, providers, and staff. Providers and practice staff should have an appropriate level of training, experience, and comfort with this new form of treatment. Linkages with other medical and mental health professionals should be established to ensure the availability of comprehensive community-based treatment services.
Physician Training, Experience, and Comfort Level
Physicians who intend to treat opioid addiction should seek to establish a level of comfort and expertise with this form of care. A physician's comfort level in providing treatment for addiction will vary according to the physician and his or her practice situation. For example, a physician might choose to refer a patient with addiction and depression, depending on the severity of depression, whether a psychologist or psychiatrist is available in the area, and whether the patient can afford specialized mental health care, among other factors.
Expertise in treating opioid addiction includes knowledge of applicable practice standards or guidelines, familiarity with the evidence supporting the recommended treatments, protocols for primary treatment or referral of patients with certain complicating conditions (e.g., severe depression), and knowledge of any applicable regulations or laws. Physicians must become knowledgeable about the most up-to-date treatments for opioid addiction, including pharmacotherapy, psychosocial interventions, self-help and mutual-help groups, and other appropriate treatments.
Physicians who treat opioid-addicted patients with buprenorphine should participate in addiction medicine training and professional activities and should learn from other professionals in addiction treatment. Basic and ongoing training in addiction treatment will greatly enhance a physician's effectiveness in treating opioid addiction.
Each patient presents with different and usually complex needs. Physicians who treat patients with opioid addiction in the office-based setting must consider and plan for the full range of their patients' needs before initiating treatment. Candidates for buprenorphine treatment of opioid addiction should be assessed for a broad array of biopsychosocial needs in addition to opioid use and addiction, and should be treated and/or referred for help in meeting those needs.
Establishing Office Procedures
Before undertaking the provision of office-based buprenorphine treatment, physicians should make arrangements to provide comprehensive care and contingency plans for patients who may not be appropriate candidates for this treatment. In addition, physicians should arrange for other physicians with DATA 2000 waivers to be available to provide care to the treating physician's opioid addiction patients in the treating physician's absence (e.g., while on vacation).
Office policies and procedures for opioid addiction treatment should be established, written, and clearly communicated to staff members and patients. Staff members should be trained and educated about opioid addiction, addiction treatment, patient confidentiality (see “Confidentiality and Privacy” section below), medication treatments, nonpharmacological treatments, behavioral characteristics of addiction, and the medical approach to addiction treatment.
Common behaviors and defense mechanisms of addicted patients should be anticipated. Medication must be stored in a secure location, and the possibility of diversion must be minimized. Office items (e.g., prescription pads, syringes, needles) and staff possessions should be secured to minimize theft.
Establishing Treatment Linkages
Establishing linkages with other medical professionals is essential. Because patients addicted to opioids commonly have coexisting medical and psychiatric conditions, most physicians will need to establish linkages with other medical and mental health specialists, particularly those specializing in the evaluation and treatment of common comorbid conditions (e.g., hepatitis B and C, HIV, tuberculosis, mood disorders, anxiety disorders, personality disorders, risk of suicide and homicide).
Physical examinations and laboratory evaluations will need to be completed either onsite or offsite from the office of the physician who provides office-based buprenorphine treatment.
An up-to-date listing of community referral resources (e.g., therapy groups, support groups, residential therapeutic communities, sober-living options) should be given to patients. Referral resource lists are available from the substance abuse agencies of some local and State governments. To maximize follow through with referrals, it is most helpful if the physician has first hand knowledge of these groups and programs.
When referrals are made, compliance will increase if staff call to make appointments in the presence of patients. When making referrals to support groups, it is helpful to have an individual in the group who is willing to accompany the patient to his or her first meeting. Referrals to social workers and case managers are often beneficial in helping patients address legal, employment, and family issues.
References: (1) Clinical Guidelines For The use of Buprenorphine In The Treatment of Opioid Addiction (TIP 40) Chapter 6 Policies And Procedures
Editor: Deborah Shrira Date: September 2008