OPIOID ADDICTION

Laws, Regulations, 

and Other Factors 

Can Affect 

Medication-Assisted 

Treatment Access

Report to the Majority Leader, U.S. 

Senate

September 2016

GAO-16-833

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-16-833, a report to the 

Majority Leader, U. S. Senate

September 2016

OPIOID ADDICTION

Laws, Regulations, and Other Factors Can Affect

Medication-Assisted Treatment Access

What GAO Found

The Department of Health and Human Services (HHS) has stated that 

addressing opioid abuse is a high priority and is promoting access to medicationassisted treatment (MAT)—an approach that combines behavioral therapy and 

the use of medications—to combat the problem. Three medications are currently 

approved for use in MAT for opioid addiction—methadone, buprenorphine, and 

naltrexone. Methadone and buprenorphine are regulated like other controlled 

substances under the Controlled Substances Act (CSA) when used to treat pain 

and have additional requirements that apply when used to treat opioid addiction. 

The third medication—naltrexone—is not a controlled substance and is therefore 

not subject to the CSA. Methadone is a Schedule II controlled substance, which 

indicates a higher risk of abuse. Buprenorphine is a Schedule III controlled 

substance, with lower risk, and so generally has fewer requirements. For 

example, when used to treat pain, methadone generally may not be dispensed 

without a written or electronic prescription. In contrast, buprenorphine may be 

dispensed based on a written, electronic, or oral (phone) prescription. When 

used for opioid addiction treatment, the CSA and implementing regulations

impose additional requirements for methadone and buprenorphine:

• Methadone may generally only be administered or dispensed within an opioid 

treatment program (OTP), as prescriptions for methadone cannot be issued 

when used for opioid addiction treatment. 

• Buprenorphine may be administered or dispensed within an OTP and may 

also be prescribed by a qualifying practitioner who has received a waiver

from the Substance Abuse and Mental Health Services Administration. 

Practitioners who received this waiver are limited in the number of patients 

they may treat for opioid addiction. 

In addition to laws and regulations, several key factors can affect patients’ 

access to MAT for opioid addiction, according to articles from peer-reviewed and 

scholarly journals, documents GAO reviewed, and interviews with agency 

officials and experts. Specifically, through these sources GAO identified the 

following key factors:

• The availability of qualified practitioners and their capacity to meet 

patient demand for MAT. For example, there were approximately 1,400 

OTPs in 2016. However, sources GAO reviewed stated that they are lacking 

in certain locations. Furthermore, some MAT practitioners may be operating 

at full capacity, leading to wait lists that can affect patients’ access to MAT. 

• The perceptions of MAT and its value among patients, practitioners, 

and institutions. Some practitioners do not believe that MAT is more 

effective than abstinence-based treatment—when patients are treated

without medication—despite science-based evidence, and there are 

concerns that the medications will be misused.

• The availability and limits of insurance coverage for MAT. Patients with 

no insurance coverage for MAT may face prohibitive out-of-pocket costs that 

may limit their access to it, and coverage for MAT varies for those individuals 

with insurance. In some cases, state Medicaid programs limit the length of 

time that patients can use MAT medications. 

View GAO-16-833. For more information, 

contact Elizabeth H.Curda at (202) 512-7114 

or curdae@gao.gov.

Why GAO Did This Study

The abuse of prescription opioid pain 

relievers and illicit opioids, such as 

heroin, have contributed to increasing 

numbers of overdose deaths in the 

United States, and Centers for Disease 

Control and Prevention data show 

more than 28,000 opioid overdose 

deaths in 2014. Research has shown 

that MAT can more effectively reduce 

opioid use and increase treatment 

retention compared to treatment 

without medication. 

GAO was asked to review issues 

related to patient and provider use of

MAT for opioid addiction. GAO 

examined (1) how federal laws and 

regulations apply when using

medications to treat opioid addiction 

compared to using the same 

medications for pain management and 

(2) key factors that can affect access to

MAT for opioid addiction. GAO 

reviewed federal laws and regulations

pertaining to MAT medications and 

reviewed key documents from HHS 

and other sources. GAO also identified 

53 articles from peer-reviewed and 

scholarly journals related to MAT for 

opioid addiction for further 

examination. GAO interviewed 

stakeholders from patient and provider

groups; experts on the issue of 

addiction treatment; and officials at 

relevant federal agencies.

GAO provided a draft of this report to 

the Office of National Drug Control 

Policy, HHS, and the Department of 

Justice. The Office of National Drug 

Control Policy agreed with the report’s 

findings. The Office of National Drug 

Control Policy and HHS provided 

technical comments, which GAO

incorporated as appropriate. The 

Department of Justice had no 

comments. 
Page i GAO-16-833 MAT for Opioid Addiction

Letter 1

Background 4

Methadone and Buprenorphine are Regulated Like Other 

Controlled Substances When Used to Treat Pain and Have 

Additional Requirements When Used to Treat Addiction 7

Practitioner Capacity, Perceived Value, and Insurance Coverage 

Can Affect Patients’ Access to MAT for Opioid Addiction 14

Agency Comments 18

Appendix I Literature Review Methodology 20

Appendix II Comments from the Office of National Drug Control Policy 21

Appendix III GAO Contact and Staff Acknowledgments 23

Bibliography 24

Tables

Table 1: Controlled Substances Act (CSA) Schedules, Statutory 

Criteria, and Example Substances 6

Table 2: Comparison of Controlled Substances Act (CSA) 

Requirements for Methadone and Buprenorphine When 

Used for Pain Management and Opioid Addiction 

Treatment 10

Contents
Page ii GAO-16-833 MAT for Opioid Addiction

Abbreviations

CSA Controlled Substances Act

DATA 2000 Drug Addiction Treatment Act of 2000

DEA Drug Enforcement Administration

FDA Food and Drug Administration

HHS Department of Health and Human Services

MAT medication-assisted treatment

OTP opioid treatment program 

SAMHSA Substance Abuse and Mental Health Services 

Administration

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

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necessary if you wish to reproduce this material separately.
Page 1 GAO-16-833 MAT for Opioid Addiction

441 G St. N.W.

Washington, DC 20548

September 27, 2016

The Honorable Mitch McConnell

Majority Leader

United States Senate

Dear Senator McConnell:

The abuse of prescription opioid pain relievers and illicit opioids, such as 

heroin, contributes to significant morbidity and mortality in the United 

States. According to Centers for Disease Control and Prevention data, 

more than 28,000 people died of opioid overdoses in the United States in 

2014—more than any previous year on record.1 The number of overdose 

deaths from opioid pain relievers increased from roughly 4,000 in 1999 to 

almost 19,000 in 2014. The total number of overdose deaths also 

included those attributable to heroin, which increased from just under 

2,000 to over 10,000 deaths in the same timeframe. In addition, 

Substance Abuse and Mental Health Services Administration (SAMHSA) 

data also show that in 2014 almost 2.3 million people aged 12 years and

older abused or were dependent on opioids, up from almost 1.7 million in 

2005.

The Department of Health and Human Services (HHS) has stated that 

addressing opioid abuse is a high priority and has identified increasing 

the use of medication-assisted treatment (MAT) as a means of reducing 

opioid addiction and preventing overdoses.2 MAT for opioid addiction 

combines behavioral therapy and the use of medications—methadone, 

 1

Centers for Disease Control and Prevention, “Increases in Drug and Opioid Overdose 

Deaths — United States, 2000–2014.” Morbidity and Mortality Weekly Report, 64 (2016).

A small number of these deaths were attributed to both opioid pain relievers and heroin.

2

For the purposes of our report, we use the term “opioid addiction” to include opioid use 

disorder. Opioid use disorder is defined as a problematic pattern of opioid use leading to 

clinically significant impairment or distress as indicated by at least 2 of 11 criteria 

occurring within a 12-month period. These criteria include opioids that are often taken in 

larger amounts or over a longer period than was intended; persistent desire or 

unsuccessful efforts to cut down or control opioid use; or craving, a strong desire or urge 

to use opioids. In addition to expanding MAT, HHS’s other priority targets are to (1) 

encourage proper opioid prescribing practices and (2) expand the use and distribution of 

naloxone (a non-MAT medication) that reverses an opioid overdose.

Letter
Page 2 GAO-16-833 MAT for Opioid Addiction

buprenorphine, or naltrexone—to treat this addiction. Methadone and 

buprenorphine are opioids that can be used for pain management, and 

also can be abused or subject to diversion for improper use, such as 

being resold illegally.3

Research has shown that MAT can be more effective in reducing opioid 

use and increasing treatment retention (i.e., reducing dropouts) compared 

to abstinence-based treatment, when patients are treated without 

medication. Despite the evidence that MAT can be an effective treatment 

for opioid addiction, other studies indicate that access to MAT has not 

kept pace with the increasing problem of opioid addiction in the United 

States. For example, a 2015 article indicated that the maximum number 

of people who could access MAT was approximately 1.4 million in 2012—

indicating a gap of nearly 1 million people when compared to the 2.3 

million people who abused opioids or were dependent upon them.

You requested that we provide information on issues related to patient 

and provider access to MAT for opioid addiction. In this report, we 

examine

1. how federal laws and regulations apply when using medications to 

treat opioid addiction compared to using the same medications for 

pain management and

2. key factors that can affect access to MAT for opioid addiction.

To identify and describe how federal laws and regulations apply when 

using medications to treat opioid addiction compared to using the same 

medications for pain management, we identified the medications 

approved for treating opioid addiction in the United States, which are 

methadone, buprenorphine, and naltrexone. We then reviewed any 

federal laws and regulations pertaining to the prescribing, administering, 

or dispensing of these medications for opioid addiction treatment and pain 

management. While these medications may also be subject to state laws 

and regulations, the laws and regulations were beyond the scope of this 

report. In addition, we interviewed officials at relevant federal agencies, 

 3

Methadone and buprenorphine suppress withdrawal symptoms and control the craving 

for opioids. Both medications are opioids that carry risks of abuse. Naltrexone is used for 

relapse prevention because it suppresses the effects of opioids, and it carries no known 

risk of abuse. 
Page 3 GAO-16-833 MAT for Opioid Addiction

such as the Drug Enforcement Administration (DEA) in the Department of 

Justice, and the Food and Drug Administration (FDA) and SAMHSA in 

HHS, about the relevant laws and implementing regulations.

To identify key factors that can affect access to MAT for opioid addiction, 

we conducted a literature review; reviewed documentation, such as 

reports; and conducted interviews. For the literature review, we searched 

for relevant articles published in peer-reviewed and scholarly journals 

from January 2011 through April 2016 and reviewed 50 articles.4 We also 

independently identified three additional articles. We examined the 

methodologies for each of these articles and determined that they were 

sufficiently reliable for the purposes of our report. (For more details about 

the methodology of our literature review, see app. I.) We also interviewed 

federal officials from HHS, DEA, and the Office of National Drug Control 

Policy; researchers who authored articles identified in our literature 

review; and officials from relevant stakeholder organizations, including the 

American Society of Addiction Medicine, the National Association of State 

Alcohol and Drug Abuse Directors, Faces and Voices of Recovery, and 

Young People in Recovery. Finally, we obtained information related to 

individuals’ use of opioids and the availability of opioid treatment 

programs (OTP) from the following SAMHSA resources: the National 

Survey on Drug Use and Health and the National Survey on Substance 

Abuse Treatment Services. We assessed the reliability of data from these 

sources based on information from SAMHSA officials about the 

procedures in place to ensure the data’s quality and completeness. We 

determined that they were sufficiently reliable for the purposes of this 

report.

We conducted this performance audit from December 2015 to September 

2016 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

 4

We chose this period because injectable naltrexone—a medication used in MAT for 

opioid addiction—was approved by the FDA in 2010. 
Page 4 GAO-16-833 MAT for Opioid Addiction

Opioids are drugs that slow down the actions of the body, such as 

breathing and heartbeat, by binding with certain receptors in the body. 

Some patients are prescribed opioids to treat pain. Opioid medications 

are available as immediate or extended release and in different forms, 

such as a pill, liquid, or a patch worn on the skin. Over time, the body 

becomes tolerant to them, which means that larger doses are needed to 

achieve the same effect. People may use opioids in a manner other than 

as prescribed—that is, they can be abused or misused. Because opioids 

are highly addictive substances, they can pose serious risks when they 

are abused or misused, which can lead to addiction and cause death. 

Symptoms of opioid addiction include a strong desire for opioids, inability 

to control or reduce use, and continued use despite interference with 

major obligations or social functioning, among others.

Three medications are currently approved by the FDA for use in MAT for 

opioid addiction—methadone, buprenorphine, and naltrexone.

• Methadone: Methadone is a full opioid agonist, meaning it binds to 

and activates opioid receptors to help prevent withdrawal symptoms 

and reduce drug craving. It has a long history of use in treatment of 

opioid dependence in adults. It suppresses withdrawal symptoms in 

detoxification therapy, which involves stabilizing patients who are 

addicted by withdrawing them in a controlled manner. Methadone also 

controls the craving for opioids in maintenance therapy, which is 

ongoing therapy meant to prevent relapse and increase treatment 

retention. It can be administered to patients as an oral solution or in 

tablet form. Methadone also carries risk of abuse.

• Buprenorphine: Buprenorphine is a partial opioid agonist, meaning it 

binds to opioid receptors and activates them, but not as much as full 

opioid agonists. It reduces or eliminates opioid withdrawal symptoms, 

including drug cravings, and it may do so without producing the 

euphoria or dangerous side effects of heroin and other opioids. It can 

be used for detoxification treatment and maintenance therapy. It is 

available in tablet form or film for sublingual (under the tongue) 

administration both in a stand-alone formulation and in combination 

Background

Opioid Use

Medications for Opioid 

Addiction and Their Role 

in MAT
Page 5 GAO-16-833 MAT for Opioid Addiction

with another agent called naloxone, and as a subdermal (under the 

skin) implant.5 Buprenorphine also carries risk of abuse.

• Naltrexone: Naltrexone is an opioid antagonist, meaning it binds to 

opioid receptors but does not activate them. It is used for relapse 

prevention following complete detoxification from opioids. Naltrexone 

prevents opioid drugs from binding to and activating opioid receptors, 

thus blocking the euphoria the user would normally feel and causing 

severe withdrawal symptoms if recent opioid use has occurred. It can 

be taken orally in tablets or as a once-monthly injection given in a 

doctor’s office. Naltrexone carries no known risk of abuse.

Two of the three medications used to treat opioid addiction—methadone 

and buprenorphine—are controlled substances and are governed at the 

federal level by the Controlled Substances Act (CSA).6 Enacted in 1970, 

the CSA and its implementing regulations establish a framework through 

which the federal government regulates the use of these substances for 

legitimate medical, scientific, research, and industrial purposes, while 

preventing them from being diverted for illegal purposes. The CSA 

assigns controlled substances—including narcotics, stimulants, 

depressants, hallucinogens, and anabolic steroids—to one of five 

schedules based on the substance’s medical use, potential for abuse, 

and risk of dependence.7 Schedule I contains substances that have no 

currently accepted medical use and may not be manufactured, 

distributed, or dispensed under federal law. In contrast, Schedules II, III, 

IV, and V include substances that have recognized medical uses and may 

be manufactured, distributed, and dispensed in accordance with the CSA. 

The order of the schedules reflects substances that are progressively less 

dangerous and addictive, as shown in table 1 below.

 5

The naloxone, in the combined formulation, is included to deter diversion or abuse of the 

medication by causing a withdrawal reaction if it is intravenously injected by individuals 

physically dependent on opioids. 

6

See Pub. L. No. 91-513, tit. II, 84 Stat. 1236, 1242-84 (1970) (codified, as amended, at 

21 U.S.C. § 801 et seq.). In this report, references to the CSA include any applicable 

requirements set forth in implementing regulations. See 21 C.F.R. ch. 2 (2016) and 42 

C.F.R. pt. 8 (2015). 

7

DEA exercises scheduling authority under the CSA. For a current list of scheduled 

substances, see 21 C.F.R. pt. 1308.

Controlled Substances 

and the Controlled 

Substances Act
Page 6 GAO-16-833 MAT for Opioid Addiction

Table 1: Controlled Substances Act (CSA) Schedules, Statutory Criteria, and Example Substances 

Schedule Statutory criteria for each schedule

Examples of substance under each 

schedule

Schedule I A substance is placed on Schedule I if the drug or other substance (1) has 

a high potential for abuse; (2) has no currently accepted medical use in 

treatment in the United States; and (3) there is a lack of accepted safety 

for use of the drug or other substance under medical supervision.

Heroin, lysergic acid diethylamide 

(LSD),

methylenedioxymethamphetamine

(Ecstacy), methaqualone (Quaalude)

Schedule II A substance is placed on Schedule II if the drug or other substance (1) has 

a high potential for abuse; (2) has a currently accepted medical use in 

treatment in the United States or a currently accepted medical use with 

severe restrictions; and (3) abuse of the drug or other substance may lead 

to severe psychological or physical dependence.

Methadone, methamphetamine, 

methylphenidate (Ritalin), morphine, 

oxycodone (OxyContin), phencyclidine 

(PCP)

Schedule III A substance is placed on Schedule III if the drug or other substance (1) 

has a potential for abuse less than the drugs or other substances in 

Schedules I and II; (2) has a currently accepted medical use in treatment in 

the United States; and (3) abuse of the drug may lead to moderate or low

physical dependence or high psychological dependence.

Anabolic steroids and buprenorphine

Schedule IV A substance is placed on Schedule IV if the drug or other substance (1) 

has a low potential for abuse relative to the drugs or other substances in 

Schedule III; (2) has a currently accepted medical use in treatment in the 

United States; and (3) abuse of the drug or other substance may lead to 

limited physical dependence or psychological dependence relative to the 

drugs or other substances in Schedule III.

Xanax, Valium, Equanil, Talwin 

Schedule V A substance is placed on Schedule V if the drug or other substance (1) has 

a low potential for abuse relative to the drugs or other substances in 

Schedule IV; (2) has a currently accepted medical use in treatment in the 

United States; and (3) abuse of the drug or other substance may lead to 

limited physical dependence or psychological dependence relative to the 

drugs or other substances in Schedule IV.

Certain cough medicines with codeine, 

and certain opium preparations

Source: GAO analysis of drug schedule definitions in the Controlled Substances Act, 8 U.S.C. § 812, the list of scheduled substances in 21 C.F.R. pt. 1308 (2016), and other public documents. | 

GAO-16-833
Page 7 GAO-16-833 MAT for Opioid Addiction

When used for pain management, methadone and buprenorphine are 

regulated under federal laws and regulations that apply to controlled 

substances generally and do not impose requirements unique to 

methadone or buprenorphine.8 However, certain requirements—such as 

restrictions on prescriptions—vary based on the schedule in which a 

controlled substance is classified. Methadone, like oxycodone (i.e., 

OxyContin), is a Schedule II controlled substance, which has the highest 

potential for abuse among scheduled drugs with an accepted medical 

use. Buprenorphine is a Schedule III controlled substance, which has 

currently accepted medical uses and a lower potential for abuse.

The CSA requires practitioners who dispense, administer, or prescribe 

methadone or buprenorphine and all other controlled substances in 

 8

Under the CSA, DEA has authority to regulate the use of methadone and buprenorphine 

for pain management as part of its oversight of controlled substances, and it has issued a 

policy statement that the legal standard for prescribing controlled substances to treat pain 

is the same as that for prescribing controlled substances generally. See Dispensing 

Controlled Substances for the Treatment of Pain, 71 Fed. Reg. 52,716 (Sept. 6, 2006). 

For purposes of this report, when we refer to DEA’s regulation of the use of methadone or 

buprenorphine, we mean DEA’s regulation of practitioners (such as physicians, 

pharmacies, or hospitals) who are authorized to prescribe, dispense, or administer these 

substances in the course of their professional practice. 

Methadone and 

Buprenorphine are 

Regulated Like Other 

Controlled 

Substances When 

Used to Treat Pain 

and Have Additional 

Requirements When 

Used to Treat 

Addiction

Methadone and 

Buprenorphine are 

Regulated Like Other 

Controlled Substances 

When Used to Treat Pain
Page 8 GAO-16-833 MAT for Opioid Addiction

Schedules II-V to register with DEA.9 In order to be registered, an 

applicant must meet certain criteria, including being licensed or otherwise 

authorized to dispense, administer, or prescribe controlled substances 

under the laws of the state in which they practice. Practitioners must 

reapply for this registration every three years.

The CSA also imposes certain requirements regarding the issuance of 

prescriptions for methadone and buprenorphine; these requirements vary 

depending on the controlled substance’s schedule. For example, when 

used for pain management, methadone and other Schedule II controlled 

substances may typically only be dispensed by pharmacists based on a 

written or electronic prescription.10 In contrast, buprenorphine and other 

Schedule III controlled substances may be dispensed based on a written, 

electronic, or oral prescription (i.e., a practitioner calls a pharmacist with 

the prescription). In addition, when used for pain management, 

prescriptions for Schedule II controlled substances may not be refilled, 

whereas prescriptions for Schedule III controlled substances may be 

refilled up to five times within six months after the date of the original 

prescription. All prescriptions for controlled substances—regardless of 

their schedule—must be issued for a legitimate medical purpose by a 

registered practitioner acting in the usual course of professional practice.

However, certain CSA requirements do not apply when Schedule II-IV 

controlled substances such as methadone and buprenorphine are used 

for pain management. For example, the CSA’s inventory and 

recordkeeping requirement—which requires certain practitioners to 

 9

Practitioners may not prescribe, dispense, or administer Schedule I controlled 

substances to their patients under the CSA. Under the CSA, “administer” means for a 

practitioner to directly apply a controlled substance to the patient or for the practitioner’s 

agent or the patient to do so in the practitioner’s presence and at the practitioner’s 

direction. “Dispense” means to deliver a controlled substance to a patient pursuant to the 

lawful order of a practitioner, including the prescribing and administering of a controlled 

substance. 21 U.S.C. § 802(2),(10).

10In emergency situations, pharmacists may dispense Schedule II controlled substances 

based on an oral prescription provided that the quantity prescribed and dispensed is 

limited to the amount needed during the emergency period. The pharmacist immediately 

writes down the prescription, including all required information, and the prescribing 

practitioner provides a written prescription to the pharmacist within seven days of 

authorizing the oral prescription. See 21 C.F.R. § 1306.11(d). When electronic 

prescriptions are issued for Schedule II-V controlled substances—including methadone 

and buprenorphine—certain conditions must be met. See 21 C.F.R. pt. 1311.
Page 9 GAO-16-833 MAT for Opioid Addiction

maintain inventories of controlled substances and to make those 

inventories available for inspection for at least two years—generally does 

not apply when a practitioner prescribes or administers Schedule II-V 

controlled substances in the lawful course of professional practice for pain 

management purposes.11

When used for opioid addiction treatment, the CSA and implementing 

regulations issued by DEA and SAMHSA impose requirements in addition 

to those that generally apply when methadone and buprenorphine are 

used to treat pain.12 See table 2 for a comparison of these requirements.

 11The CSA inventory and recordkeeping requirement does apply to (1) practitioners who 

dispense Schedule II-V controlled substances; (2) practitioners who administer Schedule 

II-V controlled substances if the practitioner regularly dispenses or administers controlled 

substances and charges patients for those controlled substances; and (3) practitioners 

who administer or prescribe Schedule II-V controlled substances for maintenance or 

detoxification treatment.

12Certain CSA requirements apply specifically to the use of medications for addiction 

treatment purposes. See 21 U.S.C. § 823(g). Within HHS, SAMSHA has responsibility for 

implementing some of these CSA requirements, and DEA is responsible for implementing 

others. SAMHSA’s implementing regulations appear at 42 C.F.R. pt. 8, and DEA’s appear 

in various provisions within title 21, chapter 2, of the C.F.R., including 21 C.F.R. §§ 

1301.28, 1304.24, 1306.04(c), 1306.05(b), and 1306.07. The third medication that has 

been approved to treat opioid addiction—naltrexone—is not a controlled substance and is 

therefore not subject to the CSA. Naltrexone may be used to treat opioid use disorder by 

any practitioner with the authority to write prescriptions.

Additional Requirements 

Apply to Methadone and 

Buprenorphine When

Used for Opioid Addiction 

Treatment
Page 10 GAO-16-833 MAT for Opioid Addiction

Table 2: Comparison of Controlled Substances Act (CSA) Requirements for Methadone and Buprenorphine When Used for 

Pain Management and Opioid Addiction Treatment

Pain management Opioid addiction treatment

Methadone Buprenorphine Methadone Buprenorphinea

Allowable practitioner 

actions 

Administer, dispense, 

and prescribeb Administer, dispense, and prescribe

Administer and 

dispense

Dispense and prescribe

Limitations on location None None Opioid treatment 

programs (OTPs) 

onlyc, d

Outpatient settings, 

such as a doctor’s office 

or community health 

center

Restrictions on 

prescriptions

Written or electronic 

prescriptions only;e

prescriptions may not be 

refilled.

Written, electronic, or 

oral (phone) 

prescriptions 

permitted; 

prescriptions may be 

refilled, subject to 

certain limitations.f

Prescriptions may not 

be issued

Prescriptions permitted 

with same limitations 

that apply when used 

for pain management

Registration requirements Practitioners must 

register with the Drug 

Enforcement 

Administration (DEA)

Practitioners must 

register with DEA

OTPs are subject to an 

additional DEA 

registration 

requirement specific to 

OTPs, must be 

accredited, and must 

receive certification by 

the Substance Abuse 

and Mental Health 

Services 

Administration 

(SAMHSA) 

Practitioners are 

exempt from the 

separate OTP 

registration requirement 

if they receive a waiver 

from SAMHSAg

Applicability of CSA 

inventory and 

recordkeeping 

requirementsh

CSA inventory and 

recordkeeping 

requirements apply when 

dispensed but generally 

do not apply when 

administered or 

prescribed

CSA inventory and 

recordkeeping 

requirements apply 

when dispensed but 

generally do not apply 

when administered or 

prescribed

CSA inventory and 

recordkeeping 

requirements apply

CSA inventory and 

recordkeeping 

requirements apply

Who may prescribe, 

administer, or dispense (as 

permitted)

A DEA-registered 

practitioner

A DEA-registered 

practitioner

A practitioner or 

program that obtains a 

separate OTP 

registration or their 

agenti

Physicians with a 

waiver and, as of July 

22, 2016, qualifying 

nurse practitioners and 

physicians’ assistants 

with a waiverj 

Limitations on number of 

patients

None None None 30 patients in a 

physician’s first year 

with a waiver; 100 or 

275 patients thereafterk

Source: GAO analysis of the Controlled Substances Act and implementing regulations. | GAO-16-833

a

The requirements for buprenorphine refer to buprenorphine when dispensed or prescribed under a 

waiver authorized by amendments to the CSA enacted through the Drug Addiction Treatment Act of 

2000 (DATA 2000). See 21 U.S.C. § 823(g)(2). In the absence of such a waiver, buprenorphine
Page 11 GAO-16-833 MAT for Opioid Addiction

would be subject to the same limitations and requirements as methadone when used for opioid 

addiction treatment. See 21 C.F.R. § 1306.07.

b

”Administer” means for a practitioner to directly apply a controlled substance to patient, or for the 

practitioner’s agent or the patient to do in the practitioner’s presence and at the practitioner’s 

direction. “Dispense” means to deliver a controlled substance to a patient pursuant to the lawful order 

of a practitioner.

c

The term “OTP” refers both to a program or a practitioner engaged in opioid treatment of individuals. 

See 42 C.F.R. § 8.2.

d

Methadone may be administered outside of an OTP under an exception known as the “3-day rule,”

which permits a practitioner who is not separately registered as an OTP to administer—but not 

prescribe—narcotic drugs to a patient to relieve acute withdrawal symptoms while arranging for the 

patient’s referral to treatment. In addition, take-home doses of methadone may be given to patients 

for a day that an OTP is closed and, for certain patients, for longer periods of time subject to federal 

regulations and the discretion of the OTP’s medical director.

e

Subject to certain limitations, pharmacists may dispense Schedule II controlled substances, including 

methadone, upon an oral prescription in emergency situations.

f

Prescriptions may be refilled up to five times within 6 months after the date of the original 

prescription.

g

SAMHSA is authorized to grant such waivers to qualifying physicians to treat opioid addiction with 

Schedule III-V medications approved by the Food and Drug Administration (FDA) for that purpose. 

Currently, the only Schedule III-V medication FDA has approved to treat opioid addiction is 

buprenorphine.

h

The CSA requires certain practitioners to maintain inventories and records of controlled substances 

and to make those inventories and records available for inspection for at least two years. See 21 USC 

§ 827; 21 C.F.R. pt. 1304.

i

The agent must be supervised by and under the order of the licensed practitioner and is required to 

be a pharmacist, registered nurse, licensed practical nurse, or any other healthcare professional 

authorized by federal and state law to administer or dispense opioid drugs.

j

To obtain a waiver, a physician must have a current state medical license; DEA registration number; 

expertise evidenced by certain certification, training, or experience; and the capacity to refer patients 

to appropriate counseling and other services. On July 22, 2016, the Comprehensive Addiction and 

Recovery Act of 2016 amended the CSA to also permit qualifying nurse practitioners and physicians 

assistants to receive a DATA 2000 waiver from the date of the act’s enactment until October 1, 2021. 

Pub. L. No. 114-198, § 303(a)(1).

k

In July 2016, SAMHSA issued a final rule that increased the highest patient limit from 100 to 275 for 

certain physicians. 81 Fed. Reg. 44,711 (July 8, 2016). The effective date of this rule is August 8, 

2016.

Prescriptions cannot be issued for methadone when used for opioid 

addiction treatment. Therefore, when used for that purpose, methadone 

may generally only be administered or dispensed within an OTP.13

 13The term OTP refers both to a program or a practitioner engaged in opioid treatment of 

individuals. See 42 C.F.R. § 8.2. OTPs are also called narcotic treatment programs or, 

often, methadone clinics. They may offer opioid medications, counseling, and other 

services for individuals addicted to heroin or other opioids.

Methadone
Page 12 GAO-16-833 MAT for Opioid Addiction

Under the CSA, OTPs must be certified by SAMSHA and registered by 

DEA. To be eligible for full certification, an OTP must first be accredited 

by a SAMHSA-approved accrediting organization. Accreditation is a peerreview process in which an accrediting organization evaluates an OTP by 

making site visits and reviewing policies, procedures, and practices. Once 

accredited, SAMHSA may certify an OTP if it determines that the OTP 

conforms with federal regulations governing opioid treatment standards. 

Among other things, federal opioid treatment standards set forth patient 

admission criteria, recordkeeping guidelines, and required services, such 

as counseling.

Once certified by SAMHSA, the OTP must apply for a separate 

registration from DEA—that is, a registration distinct from and in addition 

to the previously described DEA registration generally required of all 

practitioners who administer, dispense, or prescribe controlled 

substances. In order to register an OTP, DEA must determine that the 

OTP will comply with any applicable DEA requirements regarding the 

security of the stocks of controlled substances being used for treatment, 

as well as inventory and recordkeeping requirements. OTP registration 

from DEA must be renewed annually.

With limited exceptions, OTPs must administer methadone while patients 

are at the OTP facility. Federal opioid treatment standards permit patients 

to receive a single take-home dose for a day when an OTP is closed, 

including weekends and federal holidays. The medical director of an OTP 

may also allow certain patients to take home a specific number of doses 

based on the duration of the treatment the patient has completed.14 OTPs 

are required to maintain current procedures adequate to identify the theft 

or diversion of take-home medications. Methadone could also be used 

outside of an OTP, such as in an emergency room, under an exception 

known as the “3-day rule,” which permits a practitioner who is not 

separately registered as an OTP to administer—but not prescribe—

 14In evaluating whether to permit a patient’s take-home use, medical directors are to 

consider recent abuse of drugs, including alcohol; regularity of clinic attendance; recent 

criminal activity; stability of the patient’s home environment and social relationships; length 

of time in treatment; assurance that take-home medication can be safely stored in the 

patient’s home; and whether the rehabilitative benefit the patient may derive from 

decreasing the frequency of clinic attendance outweighs the potential risks of diversion. 42 

C.F.R. § 8.12(h)(4)(i)(2).
Page 13 GAO-16-833 MAT for Opioid Addiction

narcotic drugs to a patient to relieve acute withdrawal symptoms while 

arranging for the patient’s referral to treatment.15

Like methadone, buprenorphine can be administered or dispensed in an 

OTP when used for addiction treatment. In addition, qualifying 

practitioners who receive a Drug Addiction Treatment Act of 2000 (DATA 

2000) waiver may dispense or prescribe buprenorphine for opioid 

addiction treatment to a limited number of patients in an outpatient 

setting, such as a doctor’s office.16 Until recently, only physicians were 

eligible to receive a DATA 2000 waiver. On July 22, 2016, the 

Comprehensive Addiction and Recovery Act of 2016 amended the CSA 

to also permit qualifying nurse practitioners and physicians’ assistants to 

receive a DATA 2000 waiver from the date of the act’s enactment until 

October 1, 2021.17 To qualify for a waiver, practitioners must be 

appropriately licensed under state law and have expertise as evidenced 

by certain certification, training, or experience. In addition, practitioners

must have the capacity to refer patients for appropriate counseling and 

other services. Practitioners who receive a DATA 2000 waiver from 

SAMHSA may treat 30 patients in their first year under the waiver and 

may increase to 100 patients after one year upon submission of a notice 

to the Secretary of HHS. As of August 8, 2016, certain practitioners may 

be approved to treat up to 275 patients after one year.18 Practitioners who 

 15Under this exception, no more than 1 day’s medication may be administered at one 

time, the treatment may not last for more than 72 hours, and the 72 hour period may not 

be renewed or extended. 21 C.F.R. § 1306.07(b).

16Specifically, DATA 2000 amended the CSA to authorize SAMHSA to grant qualifying 

practitioners a waiver of the separate registration requirement applicable to OTPs, for the 

purpose of treating opioid addiction with FDA-approved Schedule III-V opioid medications. 

Such medications may be prescribed or dispensed. 21 U.S.C. § 823(g)(2). Currently, the 

only Schedule III-V medication approved by FDA to treat opioid addiction is 

buprenorphine. 

Although DATA 2000 authorized qualifying practitioners to receive a waiver of the 

separate OTP registration requirement, they must still have a valid DEA registration, as 

applicable to anyone who administers, dispenses, or prescribes controlled substances.

17Pub. L. No. 114-198, § 303(a)(1)(2016).

18SAMHSA has authority to change the statutory limits on the number of patients by 

regulation. 8 U.S.C. § 823(g)(2)(B)(iii). In July 2016, SAMHSA issued a final rule that 

increased the statutory limit of 100 patients to 275 patients for certain practitioners. 81 

Fed. Reg. 44,711 (July 8, 2016). 

Buprenorphine
Page 14 GAO-16-833 MAT for Opioid Addiction

prescribe or dispense buprenorphine under a DATA 2000 waiver are 

subject to the CSA’s inventory and recordkeeping requirement.

In addition to laws and regulations, several key factors can affect patients’ 

access to MAT for opioid addiction, according to articles and documents 

we reviewed and our interviews with stakeholders and agency officials. 

These factors include (1) the availability of qualified practitioners and their 

capacity to meet patient demand for MAT; (2) perceptions of MAT and its 

value among patients, practitioners, and in institutions; and (3) financing 

issues related to the availability and limits of insurance coverage for MAT.

Practitioner availability and capacity. According to literature we 

reviewed and some stakeholders we interviewed, the number of qualified 

practitioners—specifically OTPs and physicians with waivers who can 

prescribe buprenorphine—available to offer MAT services for opioid 

addiction may affect patients’ access to this treatment. Further, some of 

these practitioners may be operating at full capacity, leading to wait lists 

that can affect patients’ access to MAT. For example, in March 2016, 

SAMHSA reported that there were approximately 1,400 OTPs.19

However, a 2014 SAMHSA brief and several stakeholders and articles 

stated that opioid-dependent individuals may not be able to access MAT 

due to lack of nearby OTPs, which are mostly concentrated in urban 

areas. As a result, some stakeholders told us that patients in rural areas 

have to travel several hours on a daily basis to seek treatment because 

they generally need to be at the OTP every day to take methadone. When 

OTPs are accessible, one article estimated that the majority of them are 

operating at 80 percent or more capacity, suggesting that they would not 

be able to handle a significant number of new patients, and another 

article noted that OTPs can have extensive waitlists. Some articles stated 

that OTP capacity is limited by factors such as funding limitations and a 

variety of state and local requirements.

In addition, several articles and a 2014 SAMHSA brief highlighted that the 

availability of buprenorphine, after FDA approval in 2002, helped to 

expand access to MAT for opioid addiction but also noted that patients’ 

access is impeded by the availability of physicians and the limits on the 

 19See 81 Fed. Reg. 17,639, 17,644 (March 30, 2016). 

Practitioner Capacity, 

Perceived Value, and 

Insurance Coverage 

Can Affect Patients’ 

Access to MAT for 

Opioid Addiction
Page 15 GAO-16-833 MAT for Opioid Addiction

number of patients that each physician can treat. In March 2016, 

SAMHSA reported that there were approximately 32,000 physicians with 

DATA 2000 waivers to prescribe buprenorphine.20 According to one 

article, use of buprenorphine in OTPs has been limited, and another 

article noted that, in 2011, 43 percent of counties in the United States had 

no physicians with waivers who could prescribe buprenorphine as part of 

MAT. In March 2016, SAMHSA also reported that there is substantial 

geographic variation in the capacity to prescribe buprenorphine, including 

shortages of physicians, primarily in rural areas. Several articles and 

stakeholders noted that these patient limits can affect provider capacity 

and restrict access to MAT, even after the CSA was amended in 2006 to 

increase the maximum number of patients per physician from 30 patients 

to 100 patients after the first year.21 For example, several stakeholders 

told us that patients experience waiting lists for treatment when 

physicians are treating their maximum number of patients. One article 

noted that because there are many areas of the country that have an 

insufficient number of physicians, the result is that many people needing 

treatment may remain on waitlists for weeks or months. It added that 

prolonged waitlists are associated with reduced likelihood of treatment 

entry.

Perceptions of MAT and its value. Several stakeholders, articles, and 

documents reported that perceptions of MAT, such as perceived stigma 

among patients and questions about its value among practitioners and 

institutions, can affect patients’ access to MAT. Eight articles we reviewed 

noted that a perceived stigma about the use of MAT—especially 

methadone—among patients can make them reluctant to seek treatment, 

subsequently leading to social isolation and undermining the chances of 

long-term recovery. Another article noted that OTPs experience 

discrimination, such as community opposition, because they offer onsite 

medical care to people who are dependent on opioids. Another article 

stated that because of this perceived stigma, there is a desire among 

some patients to avoid OTPs to limit interactions with others who may be 

 20See 81 Fed. Reg. 17,639, 17,644 (March 30, 2016). 

21Office of National Drug Control Policy Reauthorization Act of 2006, Pub. L. No. 109-469, 

§ 1102, 120 Stat. 3502, 3540 (2006). In July 2016, SAMHSA issued a final rule that 

increased the highest patient limit from 100 to 275 patients for certain physicians, effective 

August 8, 2016. 81 Fed. Reg. 44,711 (July 8, 2016).
Page 16 GAO-16-833 MAT for Opioid Addiction

drug users and to avoid daily attendance requirements. This perception 

often makes buprenorphine—a MAT medication that can be prescribed in 

an office-based setting—a more attractive treatment option to many 

patients.

In addition, some practitioners may be reluctant to provide MAT based on 

beliefs about the value of using medications for treating addiction. For 

example, some articles and a 2014 SAMHSA report found that despite 

science-based evidence regarding the effective use of MAT, some 

practitioners do not believe there is a role for medications in the treatment 

of addiction disorders. Similarly, according to several articles we reviewed 

and stakeholders we interviewed, many practitioners believe in the 

efficacy of abstinence-based treatment—when patients are treated 

without medication—to treat addiction, even though research indicates 

that abstinence fails a large proportion of the time and is generally less 

effective than MAT.

Several documents and the literature we reviewed examined the reasons 

why MAT is not used more frequently within the criminal justice system. 

For example, a 2011 Legal Action Center report, a 2014 SAMHSA brief, 

and two articles cited various reasons why drug courts and other 

sentencing officials deny access to MAT. These included a lack of 

understanding about the nature of addiction and MAT, such as the belief 

that MAT is substituting one addiction for another. In addition, some 

judges may view opioid addiction as a social problem that is best 

addressed through abstinence. The 2014 SAMHSA brief and some 

reports and articles we reviewed show that institutions within the criminal 

justice system have policies that limit MAT, and these policies may be 

influenced by both negative perceptions of MAT and other factors, such 

as concerns over the risk of diversion. For example, some of these 

documents noted that some drug courts have policies that prohibit 

participants from using any controlled substances, which would include 

MAT.

Some stakeholders, documents, and an article we reviewed highlighted 

education as a key mechanism that can help reduce the perceived stigma 

of MAT and its value, including among those within the criminal justice 

system. For example, some stakeholders told us that they organize town 

hall meetings and workshops to educate their communities about the 

importance of MAT. The stakeholders explained that these efforts are 

opportunities to help educate patients and practitioners about MAT. Also, 

some documents and an article we reviewed on MAT and the criminal 
Page 17 GAO-16-833 MAT for Opioid Addiction

justice system noted that peoples’ views about MAT can be addressed 

through education.

Availability and limits of insurance coverage. According to several 

stakeholders and articles we reviewed, financing of treatment is a key 

factor that can affect patients’ access to MAT. Specifically, these sources 

show that the availability and limits of insurance coverage for MAT can 

create access challenges for patients who lack insurance, as well as for 

those with insurance. For example, patients with no insurance coverage 

for MAT may face prohibitive out-of-pocket costs that may limit their 

access to it. According to one article, a month’s supply of a daily dose of 

sublingual buprenorphine may cost such patients between $200 and $450 

per month. According to another article, access to injectable naltrexone 

among the uninsured is also limited due to costs that can range from 

$750 to $1,200 a month. A third article that reviewed available literature 

on MAT found that the monthly cost of injectable naltrexone is 

significantly higher than that of the other MAT medications—

buprenorphine and methadone. Because of this, the article noted that 

cost is often a factor that practitioners consider when determining whether 

to prescribe naltrexone to a patient.

For individuals with insurance, the benefit coverage for MAT-related 

services can vary by insurance plan and by state. According to one 

article, some private health insurance plans do not cover buprenorphine 

treatment, or they impose limits on the length of treatment with 

buprenorphine. Some sources reported that lifetime coverage limits for 

buprenorphine can range from 12 months to 36 months, even though 

some patients may need access to the medications for the rest of their 

lives to prevent relapse. Similarly, a 2014 SAMHSA report found that 

although state Medicaid programs reimburse for at least one of the three 

MAT medications, most states did not reimburse for all three. In some 

cases, state Medicaid programs also limit the length of time that the 

medications can be used. Although Medicaid expansion allowed under 

the Patient Protection and Affordable Care Act could increase the number 

of individuals with coverage for substance abuse treatment, including 

MAT, the specific coverage can vary by state. We have previously 

examined access to behavioral health treatment—which can include 

MAT—in 10 states, and found that officials in 2 of the states that 

expanded Medicaid reported that the availability of behavioral health 
Page 18 GAO-16-833 MAT for Opioid Addiction

treatment has generally increased, although some concerns about access 

remain.22 Specifically, officials in these states reported difficulties 

providing Medicaid enrollees with access to certain MAT medications due 

to lack of physicians willing to prescribe these drugs for Medicaid 

enrollees.

We provided a draft of this report to the Office of National Drug Control 

Policy, HHS, and the Department of Justice. The Office of National Drug 

Control Policy agreed with the report’s findings, and the office’s

comments are reprinted in appendix II. The Office of National Drug 

Control Policy and HHS provided technical comments, which we 

incorporated as appropriate. The Department of Justice had no 

comments. 

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Department of Justice, 

HHS, the Office of National Drug Control Policy, and appropriate 

congressional committees. In addition, the report will be available at no 

charge on the GAO website at http://www.gao.gov.

 22GAO, Behavioral Health: Options for Low-Income Adults to Receive Treatment in 

Selected States, GAO-15-449 (Washington, D.C.: June 19, 2015). Specifically, officials in 

these two states reported shortages of qualifying physicians with DATA 2000 waivers to 

prescribe buprenorphine to Medicaid-covered patients with opioid addiction. In addition, 

we have ongoing work related to the use of services and drugs to treat Medicaid 

beneficiaries with behavioral health conditions.

Agency Comments
Page 19 GAO-16-833 MAT for Opioid Addiction

If you or your staff have questions about this report, please contact me at 

(202) 512-7114 or curdae@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this report. Major contributors to this report are listed in appendix III.

Sincerely yours,

Elizabeth H. Curda

Acting Director, Health Care
Appendix I: Literature Review Methodology

Page 20 GAO-16-833 MAT for Opioid Addiction

To identify and describe published research on key factors that affect 

access to medication-assisted treatment (MAT) for opioid addiction, we 

conducted a literature search for relevant articles published in peerreviewed and scholarly journals from January 2011 through April 2016.1

We searched the following databases for relevant articles in peerreviewed and scholarly journals: ABI/Inform, PubMed, Biosis Databases, 

ProQuestDialog, PsychInfo, LexisNexis, and Law Reviews Combined. 

Key search terms included various combinations of “opioid addiction,” 

“opioid use,” “opioid dependence,” “medication assisted treatment,” 

“methadone,” “buprenorphine,” and “naltrexone.” From all database 

sources, 188 articles were identified. We first reviewed the abstracts for 

each of these articles for relevancy in determining key factors that affect 

access to MAT for opioid addiction.2 For those abstracts we found 

relevant, we obtained and reviewed the full article and excluded those 

where the article was (1) published prior to 2011; (2) a duplicate of 

another article; (3) an editorial or commentary; (4) a dissertation; (5) not 

focused on the use of MAT within the United States; or (6) not focused on 

factors affecting patients’ use of MAT. After excluding these articles, 50 

articles remained. We also independently identified three additional 

articles as we reviewed related documentation. For a complete list of the 

articles, see the bibliography at the end of this report. As part of our work, 

we examined the methodologies of all identified studies and determined 

that they were sufficiently reliable for the purposes of our report.

 1

We chose this period because injectable naltrexone—the third medication used in MAT 

for opioid addiction—was approved by the FDA in 2010 for the prevention of relapse to 

opioid dependence following opioid detoxification. 

2

We reviewed the abstracts and did not obtain full articles if the article did not appear to 

address factors that affect patients’ use of MAT for opioid addiction; the article’s focus was 

on the use of MAT for opioid addiction outside of the United States; the article was an 

editorial or commentary or was a book; or if the article’s focus was about veterans who 

receive MAT within the Veterans Administration.

Appendix I: Literature Review Methodology 
Appendix II: Comments from the Office of 

National Drug Control Policy

Page 21 GAO-16-833 MAT for Opioid Addiction

Appendix II: Comments from the Office of 

National Drug Control Policy
Appendix II: Comments from the Office of 

National Drug Control Policy

Page 22 GAO-16-833 MAT for Opioid Addiction
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 23 GAO-16-833 MAT for Opioid Addiction

Elizabeth H. Curda, Acting Director, (202) 512-7114 or curdae@gao.gov.

In addition to the contact name above, Linda Kohn, Director; Will Simerl, 

Assistant Director; Natalie Herzog, Analyst-in-Charge; La Sherri Bush; 

and Emily Wilson made key contributions to this report. Also contributing 

were Joanna Berry, Christine Davis, Krister Friday, Cherie’ Starck, and 

Eric Wedum.

Appendix III: GAO Contact and Staff 

Acknowledgments

GAO contact

Staff 

Acknowledgments
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Page 24 GAO-16-833 MAT for Opioid Addiction

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