Opioid Treatment Programs and Related Federal Regulations

Opioid Treatment Programs and Related Federal Regulations

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Updated June 12, 2019
Opioid Treatment Programs and Related Federal Regulations
The use of opioid medications to treat opioid addiction is
individual on naltrexone who uses opioids will not
subject to federal regulations beyond those that apply to the
experience the effects of that opioid.
same medications used for other purposes (e.g., treating
pain). The medications methadone and buprenorphine are
Regulatory Framework
both opioids; their use to treat opioid addiction is often
called opioid substitution therapy, opioid replacement
Two overlapping systems of federal law apply to MAT for
therapy, or opioid agonist treatment. Federally certified
opioid addiction: one regulating pharmaceuticals and the
opioid treatment programs (OTPs)—often called
other regulating controlled substances.
methadone clinics—offer these opioid medications in
addition to counseling and other services for individuals
Federal Food, Drug, and Cosmetic Act (FFDCA)
addicted to heroin or other opioids. With few exceptions,
Under the Federal Food, Drug, and Cosmetic Act (FFDCA,
the use of methadone to treat opioid addiction is limited to
21 U.S.C. §§301 et seq.), the Food and Drug
OTPs; however, physicians who wish to treat opioid
Administration (FDA) in the Department of Health and
addiction using buprenorphine may obtain a waiver to do so
Human Services (HHS) has primary responsibility for
outside an OTP. A non-opioid medication used in the
ensuring the safety and effectiveness of pharmaceuticals,
treatment of opioid addiction, naltrexone, may be used by
regardless of whether they are controlled substances. See
OTPs, physicians with waivers, or anyone with the
CRS Report R41983, How FDA Approves Drugs and
authority to write prescriptions.
Regulates Their Safety and Effectiveness. Methadone,
buprenorphine, and naltrexone are subject to the FFDCA.
To understand how OTPs are regulated, it is helpful to have
some background information about the medications used
Controlled Substances Act (CSA)
to treat opioid addiction and how each is regulated.
Under the Controlled Substances Act (CSA, 21 U.S.C.
§§801 et seq.), the Drug Enforcement Administration
Medication-Assisted Treatment (MAT)
(DEA) in the Department of Justice (DOJ) has primary
responsibility for regulating the use of controlled
Medication-assisted treatment (MAT) is the combined use
substances for legitimate medical, scientific, research, and
of medication and other services to treat addiction. Three
industrial purposes, and for preventing these substances
medications are currently used in MAT for opioid
from being diverted for illegal purposes. See CRS Report
addiction: methadone, buprenorphine, and naltrexone
R45164, Legal Authorities Under the Controlled
(naloxone, a medication used to reverse opioid overdose, is
Substances Act to Combat the Opioid Crisis. Methadone
not used to treat opioid use disorders).
and buprenorphine are controlled under to the CSA.
Naltrexone, which carries no known risk of abuse, is not
Methadone
controlled under the CSA.
Methadone is a full opioid agonist, meaning it binds to and
activates opioid receptors in the brain. Methadone carries
As shown in Table 1, methadone, buprenorphine, and
risk of abuse but is less addictive than some other full
naltrexone are classified differently under the CSA, which
opioid agonists (e.g., heroin). Methadone suppresses
assigns various plants, drugs, and chemicals to one of five
withdrawal symptoms in detoxification therapy and controls
schedules based on accepted medical use, potential for
the craving for opioids in maintenance therapy.
abuse, and severity of potential psychological or physical
dependence. Schedule I contains substances that have no
Buprenorphine
currently accepted medical use and are not available by
Buprenorphine is a partial opioid agonist, meaning it binds
prescription (such as heroin). Schedules II, III, IV, and V
to opioid receptors in the brain and activates them, but not
include substances that have recognized medical uses and
as much as full opioid agonists. Buprenorphine carries risk
are progressively less dangerous and addictive.
of abuse but is less addictive than methadone. Like
methadone, buprenorphine is used for detoxification and
Table 1. FDA-Approved Medications for Opioid MAT
maintenance therapy.
Medication
Class
CSA Schedule
Naltrexone
Methadone
Ful Opioid Agonist
II
Naltrexone is an opioid antagonist, meaning it binds to
opioid receptors but does not activate them; it prevents
Buprenorphine
Partial Opioid Agonist
III
opioid agonists from binding to and activating opioid
Naltrexone
Opioid Antagonist
none
receptors. Naltrexone carries no known risk of abuse.
Naltrexone is used for relapse prevention because an
Source: Prepared by the Congressional Research Service based on
information publicly available from FDA and DEA.

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link to page 2 Opioid Treatment Programs and Related Federal Regulations
Opioid Treatment Programs (OTPs)
DATA-Waived Providers (DWPs)
Under the CSA, responsibility for regulating OTPs falls to
Under the Drug Addiction Treatment Act of 2000 (DATA
both DEA in DOJ and the Substance Abuse and Mental
2000, P.L. 106-310), a physician may obtain a waiver to
Health Services Administration (SAMHSA) in HHS. OTPs
treat opioid addiction with buprenorphine (but not
must obtain
methadone) outside an OTP. DATA 2000 waives the
requirement for separate DEA registration as an OTP if
 accreditation from a SAMHSA-approved accreditor,
both the practitioner and the medication meet specified
conditions. As of June 1, 2019, the number of DATA-
 certification from SAMHSA, and
waived providers exceeded 67,000; the number is updated
daily on SAMHSA’s website.
 registration from DEA.
Practitioner Requirements
Programs meeting all requirements may “administer or
To qualify for a waiver, a practitioner must notify the HHS
dispense directly (but not prescribe)” any drug approved by
Secretary of the intent to use opioid replacement therapy
FDA for treatment of opioid addiction. They may also
and certify that he or she is a qualifying practitioner
administer a drug being studied for treatment of opioid
(licensed under state law with expertise as evidenced by
addiction, as authorized by FDA under an investigational
certification, training, or experience); have the capacity to
new drug application.
refer patients for counseling and other services; and comply
with a limit on the number of patients. The patient limit is
With few exceptions, the use of methadone to treat opioid
30 during the first year, may increase to 100 after one year
addiction is limited to OTPs, which may also offer other
or immediately if the practitioner holds additional
forms of MAT, including buprenorphine for detoxification
credentialing (42 C.F.R. §8.2) or operates in a qualified
or maintenance and naltrexone for relapse prevention.
practice setting (42 C.F.R. §8.615), and may increase to 275
under conditions specified in regulation (42 C.F.R. §§8.610
OTPs generally administer methadone on a daily basis with
et seq. per the SUPPORT Act).
staff observing as a patient takes an oral dose of liquid
methadone; however, a stable patient may receive a few
The SUPPORT Act (P.L. 115-271) made permanent an
take-home doses (e.g., for a weekend).
authority for qualifying nurse practitioners and physician
assistants to obtain DATA waivers and expanded the
According to SAMHSA’s National Survey of Substance
definition of “qualifying other practitioners” to include
Abuse Treatment Services, most U.S. substance abuse
clinical nurse specialists, certified registered nurse
treatment facilities (90%) do not have OTPs. As of the
anesthetists, and certified nurse midwives.
beginning of 2018, 1,317 of the 13,585 U.S. facilities had
OTPs, with 382,867 clients in treatment with methadone at
Medication Requirements
these centers.
DATA-waived providers (DWPs) may administer,
dispense, or prescribe opioid replacement therapy using a
OTP Accreditation
medication that is a narcotic drug in schedule III–V, that is
Accreditation is based on a peer review process in which
FDA-approved for use in detoxification or maintenance
SAMHSA-approved accrediting organizations evaluate
treatment, and that has not been the subject of an adverse
OTPs by making site visits and reviewing policies,
determination (as defined in statute). Buprenorphine is
procedures, and practices. Examples of accrediting
currently the only medication to meet the conditions for a
organizations include the Joint Commission and the
DATA waiver.
Commission on Accreditation of Rehabilitation Facilities.
Table 2 summarizes who can administer, dispense, or (in
OTP Certification
some cases) prescribe different types of MAT.
Certification is based on SAMHSA’s determination that an
accredited program is qualified to carry out treatment
Table 2. MAT Used by OTPs, DWPs, and Others
conforming to standards in federal regulation. SAMHSA
uses the results of the accreditation process as well as other
Used to Treat Opioid Addiction by
information to determine whether a program is qualified.
SAMHSA promulgates guidelines to help accrediting
Other
organizations and OTPs conform to treatment standards.
Medication
OTPs
DWPs
Prescribers
OTP Registration
Methadone
Yes
No
No
Registration with DEA as an OTP is separate from—and in
Buprenorphine
Yes
Yes
No
addition to—the DEA registration required of any “person”
(including a hospital, pharmacy, or doctor, among others)
Naltrexone
Yes
Yes
Yes
who handles controlled substances. OTPs must also comply
Source: CRS analysis of 21 U.S.C. §§801 et seq. and SAMHSA data.
with relevant DEA regulations addressing records
maintenance, security controls, and other matters.
Johnathan H. Duff, Analyst in Health Policy
IF10219

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Opioid Treatment Programs and Related Federal Regulations

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