The Drug Addiction Treatment Act of 2000 (DATA 2000), Title XXXV, Section 3502 of the

Children's Health Act The Children's Health Act of 2000 (), signed by President Clinton on October 17, 2000, was brought into law to conduct a study focusing on children from before conception to 21 years of age. The law authorized the formation of federal child health ...

, permits

physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...

s who meet certain qualifications to treat

opioid addiction Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. Op ...

with Schedule III, IV, and V

narcotic The term narcotic (, from ancient Greek ναρκῶ ''narkō'', "to make numb") originally referred medically to any psychoactive compound with numbing or paralyzing properties. In the United States, it has since become associated with opiates ...

medications that have been specifically approved by the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

for that indication. Since there is only one narcotic medication approved by the FDA for the treatment of opioid use disorder within the schedules given, DATA 2000 essentially governs the prescription of

buprenorphine Buprenorphine is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue (sublingual), in the cheek (buccal), by injection (intravenous and subcutaneous), as a skin patch (transdermal), ...

(Schedule III) for the treatment of opioid use disorder.

Methadone Methadone, sold under the brand names Dolophine and Methadose among others, is a synthetic opioid agonist used for chronic pain and also for opioid dependence. It is used to treat chronic pain, and it is also used to treat addiction to heroin ...

and

LAAM Levacetylmethadol (INN), levomethadyl acetate (USAN), OrLAAM (trade name) or levo-α-acetylmethadol (LAAM) is a synthetic opioid similar in structure to methadone. It has a long duration of action due to its active metabolites. Medical uses LAA ...

are Schedule II narcotics approved for the same purpose within the highly regulated methadone clinic setting, usually known as an opioid treatment program (OTP).

DATA 2000 waiver

Under the Act, physicians may apply for a waiver to prescribe buprenorphine for the treatment of opioid addiction or dependence outside of an opioid treatment program (OTP). Requirements include a current state medical license, a valid DEA registration number, specialty or subspecialty certification in addiction from the American Board of Medical Specialties,

American Society of Addiction Medicine The American Society of Addiction Medicine (ASAM), founded in 1954, is a professional medical society representing over 6,000 physicians, clinicians and associated professionals in the field of addiction medicine. ASAM is dedicated to increasing ...

, or

American Osteopathic Association The American Osteopathic Association (AOA) is the representative member organization for the more than 176,000 osteopathic medical doctors (D.O.s) and osteopathic medical students in the United States. The AOA is headquartered in Chicago, Illinoi ...

. Exceptions were also created for physicians who participated in the initial studies of buprenorphine and for state certification of addiction specialists. However, the Act was intended to bring the treatment of addiction back to the primary care provider. Thus most waivers are obtained after taking an 8-hour course from one of the five medical organizations designated in the Act and otherwise approved by the Secretary of the Department of Health and Human Services. When physicians qualify for the waiver, they are given a second DEA number (i.e., in addition to the standard DEA prescribing number). This number begins with 'X', prompting the common nickname 'X-waiver'. Once prescribers obtain the waiver, they may treat up to 30 patients with buprenorphine-- following recent federal changes described below, they can request to increase their patient panel sizes after they have had a waiver for one year.

Recent changes impacting the DATA waiver and buprenorphine prescribing

The Comprehensive Addiction Recovery Act of 2016 allowed for qualifying physician assistants and nurse practitioners to obtain DATA waivers. In July 2016, the Department of Health and Human Services issued a final rule, “Medication Assisted Treatment for Opioid Use Disorders”, in the Federal Register
81 FR 44712
. This rule, effective on October 27, 2016, allowed eligible prescribers who have already held a waiver for one year to apply to treat up to 275 patients, up from the previous ceiling of 100. The SUPPORT Act of 2018 further amended the definition of “qualifying other practitioner” to include clinical nurse specialists (CNS), certified registered nurse anesthetists (CRNA), and certified nurse midwives (CNW) until October 1, 2023. Such "qualifying other providers" are subject to 24 hours of qualifying training while physicians are required to complete 8.

Current prescribing limits

"Qualifying physicians can treat 100 patients in the first year if they meet the criteria outlined in the SUPPORT Act, and 275 after one year of prescribing at the 100-patient limit. If a physician does not meet the criteria to treat 100 patients in the first year, they would have to prescribe at the 30-patient limit for one year before requesting an increase to 100 patients, and then treat at the 100-patient limit for one year before requesting an increase to 275 patients."

Legislative history

The Drug Addiction Treatment Act of 2000 was authored by Senator

Orrin Hatch Orrin Grant Hatch (March 22, 1934 – April 23, 2022) was an American attorney and politician who served as a United States senator from Utah from 1977 to 2019. Hatch's 42-year Senate tenure made him the longest-serving Republican U.S. senator ...

(R-UT), Senator Joe Biden (D-DE), and Senator

Carl Levin Carl Milton Levin (June 28, 1934 – July 29, 2021) was an American attorney and politician who served as a United States senator from Michigan from 1979 to 2015. A member of the Democratic Party, he was the chair of the Senate Armed Services C ...

(D-MI).

References

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External links

Medication-Assisted Treatment (MAT)

Substance Abuse and Mental Health Services Administration The Substance Abuse and Mental Health Services Administration (SAMHSA; pronounced ) is a branch of the U.S. Department of Health and Human Services. It is charged with improving the quality and availability of treatment and rehabilitative services ...

(SAMHSA), U. S. federal buprenorphine program for opioid addiction
SAMHSA Buprenorphine Treatment Practitioner Locator
listing of U.S. doctors who can prescribe buprenorphine for opioid addiction
Non-government physician locator
another listing of U.S. doctors who can prescribe buprenorphine for opioid addiction
Non-government DATA-2000 Clinic and Physician locator
directory of listings of U.S. doctors and clinics who are DATA-2000 Certified to prescribe buprenorphine for opioid addiction
National Alliance for Medication Assisted Recovery, NAMA Recovery
non-profit international organization representing MAT patients in policy, discrimination and treatment issues, large library 25 chapters in US and 20 international affiliates
National Alliance of Advocates for Buprenorphine Treatment, NAABT.org
non-profit educational site
Survey data of Substance Abuse Treatment facilities by state
United States federal health legislation United States federal controlled substances legislation