OPIOID USE 

DISORDERS

HHS Needs Measures 

to Assess the 

Effectiveness of 

Efforts to Expand 

Access to MedicationAssisted Treatment

Report to Majority Leader, U.S. Senate

October 2017

GAO-18-44

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-18-44, a report to the 

Majority Leader, U.S. Senate

October 2017

OPIOID USE DISORDERS

HHS Needs Measures to Assess the Effectiveness of

Efforts to Expand Access to Medication-Assisted 

Treatment

Why GAO Did This Study

The misuse of prescription opioid 

pain relievers and illicit opioids, such 

as heroin, has contributed to 

increases in overdose deaths. 

According to the most recent Centers 

for Disease Control and Prevention

data, in 2015 over 52,000 people 

died of drug overdose deaths, and 

about 63 percent of them involved an 

opioid. For those who are addicted 

to or misuse opioids, MAT has been 

shown to be an effective treatment. 

GAO was asked to review HHS and 

other efforts related to MAT for 

opioid use disorders. This report (1) 

describes HHS’s key efforts to 

expand access to MAT, (2) examines 

HHS’s evaluation, if any, of its efforts 

to expand access to MAT, and (3) 

describes efforts by selected 

stakeholders (states, private health 

insurers, and national associations)

to expand access to MAT. GAO 

gathered information from HHS 

officials as well as a nongeneralizable selection of 15

stakeholders selected based on their 

MAT expansion activities, among 

other factors. GAO also assessed 

HHS’s evaluation plans using 

internal control standards for defining 

objectives and evaluating results.

What GAO Recommends

GAO recommends that HHS take 

two actions: (1) establish 

performance measures with targets 

related to expanding access to MAT, 

and (2) establish timeframes for its 

evaluation of its efforts to expand 

access to MAT. HHS concurred with 

both recommendations.

What GAO Found

In an effort to reduce the prevalence of opioid misuse and the fatalities 

associated with it, the Department of Health and Human Services (HHS) 

established a goal to expand access to medication-assisted treatment (MAT). 

MAT is an approach that combines behavioral therapy and the use of certain 

medications, such as methadone and buprenorphine. HHS has implemented five 

key efforts since 2015 that focus on expanding access to MAT for opioid use 

disorders—four grant programs that focus on expanding access to MAT in 

various settings (including rural primary care practices and health centers) and 

regulatory changes that expand treatment capacity by increasing patient limits for 

buprenorphine prescribers and allowing nurse practitioners and physician 

assistants to prescribe buprenorphine. 

Some of the grant awards were made in 2015, while others were made as 

recently as May 2017. (See figure.) As of August 2017, efforts under all the grant 

programs were ongoing. Grant recipients can use funding to undertake a range 

of activities, such as hiring and training providers and supporting treatments 

involving MAT. In addition, certain providers and grant recipients are required to 

develop plans for preventing MAT medications from being diverted for 

nonmedical purposes.

Figure: Implementation Timeframes of HHS Grants for Expanding Access to 

Medication-Assisted Treatment for Opioid Use Disorders, 2015 through 2019a

a

These grants were awarded between August 2015 and May 2017.

b

There are two sets of these grants. The first cohort of 11 grants is for 2015 through 2018 and the 

second cohort of 11 grants is for 2016 through 2019.

HHS officials told GAO that as of August 2017, the department was in the 

process of finalizing its plans to evaluate its efforts to address the opioid 

epidemic. In September 2016, HHS awarded a contract to conduct the 

evaluation. HHS officials told GAO that they are still working with the contractor 

to finalize the evaluation approach and that it will focus on whether HHS’s efforts 

to address the opioid epidemic have been implemented as intended. HHS 

officials said that in the future, HHS may also evaluate whether, or to what 

extent, its efforts have been effective in expanding access to MAT, in addition to 

evaluating implementation.

View GAO-18-44. For more information, 

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

or curdae@gao.gov.
United States Government Accountability Office

While HHS has some of the information that could be used in a future evaluation 

of the effectiveness of its efforts to expand access to MAT, it has not adopted 

specific performance measures with targets specifying the magnitude of the 

increases HHS hopes to achieve through its efforts to expand access to MAT, 

and by when. For example, HHS has not established a long-term target

specifying the percentage increase in the number of prescriptions for

buprenorphine HHS would like to achieve, which would help to show whether 

efforts by HHS and others are resulting in a sufficient number of prescriptions for 

MAT medications. HHS has also not chosen a specific method of measuring 

treatment capacity or established targets associated with it, which would help 

determine whether a sufficient number of providers are becoming available to 

evaluate and treat patients who may benefit from MAT.

Without specifying these performance measures and associated targets, HHS 

will not have an effective means to determine whether its efforts are helping to

expand access to MAT or whether new approaches are needed. Gauging this 

progress is particularly important given the large gap identified nationwide

between the total number of individuals who could benefit from MAT and the 

limited number who can currently access it based on provider availability.

In addition, GAO also found that as of August 2017, HHS had not finalized its

approach for its planned evaluation activities, including timeframes. Without 

timeframes for the evaluation’s activities, HHS increases the risk that the 

evaluation will not be completed as expeditiously as possible. 

In addition to HHS efforts to expand access to MAT, officials from selected 

states, private health insurers, and national associations reported using several 

efforts to expand patients’ access to MAT for opioid use disorders. For example, 

several stakeholders provided GAO with the following examples of their efforts:

• States. State health officials from all five selected states have implemented 

or are planning approaches that focus on integrating the use of MAT into 

primary care, such as by providing services for centralized intake and initial

management of patients or through telehealth that connects patients in rural 

areas with addiction specialists in a different location. 

• Private health insurers. Three private health insurers reported removing 

prior authorization requirements for MAT medications so patients can avoid a

waiting period before receiving the medications.

• National associations. Officials told GAO that they are conducting outreach 

and training for their members and developing tools and resource guides. For 

example, one association developed a road map with strategies that state 

policymakers can use to address the opioid epidemic, including strategies for 

reducing the stigma associated with MAT through educating the public and 

potential providers.
Page i GAO-18-44 Opioid Use Disorders

Letter 1

Background 5

HHS Uses Grant Programs and Other Efforts to Expand Access to 

MAT for Opioid Use Disorders 8

HHS is Finalizing Its Approach for Evaluating MAT Expansion 

Efforts but Lacks Performance Measures with Targets and 

Implementation Timeframes 13

Selected Stakeholders Reported Using Outreach, Training, and 

Other Efforts to Help Expand Access to Medication-Assisted 

Treatment for Opioid Use Disorders 18

Conclusions 20

Recommendations for Executive Action 21

Agency Comments 22

Appendix I Diversion Plan Requirements for Opioid Treatment 

Programs and Practitioners Who Prescribe Buprenorphine 23

Appendix II Comments from the Department of Health 

and Human Services 26

Appendix III GAO Contact and Staff Acknowledgments 30

Table

Table 1: Factors for Measuring Access to Medication-Assisted 

Treatment (MAT) for Opioid Use Disorders and Related 

Data Sources 16

Figure

Figure 1: Implementation Timeframes of HHS Grants for 

Expanding Access to Medication-Assisted Treatment for 

Opioid Use Disorders, 2015 through 2019a 10

Contents
Page ii GAO-18-44 Opioid Use Disorders

Abbreviations 

AHRQ Agency for Healthcare Research and Quality

APG agency priority goal

ASPE Assistant Secretary for Planning and Evaluation

CARA Comprehensive Addiction and Recovery Act of 2016 

CSA Controlled Substances Act

DATA 2000 Drug Addiction Treatment Act of 2000

FDA Food and Drug Administration

HHS Department of Health and Human Services

HRSA Health Resources and Services Administration

MAT medication-assisted treatment

Opioid STR State Targeted Response to the Opioid Crisis Grants 

OTP opioid treatment program 

PDMP prescription drug monitoring program

RTI Research Triangle Institute International

SAMHSA Substance Abuse and Mental Health Services 

Administration

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Page 1 GAO-18-44 Opioid Use Disorders

441 G St. N.W.

Washington, DC 20548

October 31, 2017

The Honorable Mitch McConnell

Majority Leader

United States Senate

Dear Senator McConnell:

The misuse of and addiction to prescription opioid pain relievers and illicit 

opioids, such as heroin, contributes to significant morbidity and mortality 

in the United States. Substance Abuse and Mental Health Services 

Administration (SAMHSA) data show that in 2014 almost 2.3 million 

people aged 12 years and older misused or were dependent on opioids, 

up from almost 1.7 million in 2005. According to the most recent Centers 

for Disease Control and Prevention data, in 2015 there were over 52,000 

drug overdose deaths in the United States, and about 63 percent of these 

deaths involved an opioid.1

For those who misuse or are addicted to opioids—a condition known as 

opioid use disorder—research shows that medication-assisted treatment 

(MAT) is an effective treatment.2 MAT—which combines behavioral 

therapy and the use of certain medications (methadone, buprenorphine, 

and naltrexone)—has been shown to reduce opioid use and to increase 

treatment retention compared with other treatments.3 Treatment can 

 1

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

Overdose Deaths – United States, 2010-2015.” Morbidity and Mortality Weekly Report, 

vol. 65, no. 50-51 (December 30, 2016): 1445-1452. 

2

The term “MAT” can be used to refer to treatment for a number of different substance 

abuse disorders. For the purposes of this report, we use the term to refer to MAT for 

opioid use disorders, unless specified otherwise. 

3

Methadone and buprenorphine suppress withdrawal symptoms in detoxification therapy 

and control the craving for opioids in maintenance therapy. Both drugs are opioids that 

activate opioid receptors and carry risks of misuse. Both drugs can also be prescribed for 

pain. Naltrexone is used for relapse prevention because it suppresses the euphoric effects 

of opioids, and it carries no known risk of misuse. 

Letter
Page 2 GAO-18-44 Opioid Use Disorders

occur as part of federally regulated opioid treatment programs (OTP) or in 

other settings, such as office-based settings, within certain restrictions.4

While MAT has been shown to be effective, several reports have also 

highlighted that accessing MAT services may be challenging for many. 

For example, in a 2016 report we identified several factors that affect 

access to MAT, including lack of insurance coverage and an insufficient 

number of existing treatment programs or practicing physicians offering 

MAT.5 Similarly, a 2016 Surgeon General’s report on Alcohol, Drugs, and 

Health noted barriers to accessing treatment, such as the cost of care 

and challenges accessing providers who offer treatment services.6 In part 

because of these challenges, it is likely that only a portion of the 

individuals who need MAT are receiving it. The 2016 Surgeon General’s 

report and a 2015 study on MAT treatment capacity have both highlighted 

this “treatment gap.” The 2015 study, for instance, found that the 

availability of MAT has not kept pace with the incidence of opioid use 

disorders in the United States, as more are in need of the treatment than 

can currently access it—a treatment gap estimated to be nearly 1 million 

people in 2012.7

In March 2015, the Department of Health and Human Services (HHS) 

established the HHS Opioid Initiative, which aimed to decrease (1) opioid 

overdoses and overall overdose mortality, and (2) the prevalence of 

opioid use disorders. Led by the Office of the Assistant Secretary for 

Planning and Evaluation (ASPE) in coordination with the Immediate 

Office of the Secretary, the HHS Opioid Initiative had three priorities 

related to opioid use disorders, one of which was to expand access to 

 4

The 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. 

5

For more information, see GAO, Opioid Addiction: Laws, Regulations, and Other Factors 

Can Affect Medication–Assisted Treatment Access, GAO-16-833 (Washington, D.C.: 

September 27, 2016). 

6

Department of Health and Human Services (HHS), Office of the Surgeon General, Facing 

Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health. 

Washington, D.C.: HHS, November 2016.

7

Jones et al., “National and State Treatment Need and Capacity for Opioid Agonist 

Medication-Assisted Treatment” American Journal of Public Health vol. 105, no. 8 (2015).
Page 3 GAO-18-44 Opioid Use Disorders

MAT.8 Although the HHS Opioid Initiative ended in January 2017, HHS 

activities related to improving access to treatment for opioid use disorders 

have continued under the new administration’s five-point Opioid Strategy, 

which was announced in April 2017.9 Several agencies within HHS, such 

as SAMHSA and the Health Resources and Services Administration 

(HRSA), are overseeing various efforts to expand access to MAT, with 

ASPE responsible for leading efforts to collectively evaluate the results of 

these efforts.

You requested that we provide information on HHS and other efforts to 

expand access to MAT for opioid use disorders. In this report, we

1. describe HHS’s key efforts to expand access to MAT;

2. examine HHS’s evaluation, if any, of its key efforts to expand access 

to MAT; and

3. describe efforts by selected stakeholders (states, private health 

insurers, and national associations) to expand access to MAT.

To describe HHS’s key efforts to expand access to MAT, we reviewed 

HHS documents that describe the HHS Opioid Initiative and the activities 

associated with it, such as HHS press releases, the ASPE Issue Brief on 

the Opioid Initiative, and HHS funding announcements for grants to 

expand access to MAT. We also reviewed HHS’s April 2017 

announcement of the Opioid Strategy, as well as relevant federal laws 

and regulations relating to MAT. In addition, we interviewed officials at 

relevant federal agencies, such as ASPE, SAMHSA, HRSA, the Agency 

for Healthcare Research and Quality (AHRQ), and the Food and Drug 

Administration (FDA) with knowledge of MAT expansion efforts within 

HHS.10 We specifically asked the officials to identify their key efforts to 

expand access to MAT and to confirm the key efforts that we identified 

independently through our document reviews. Our review focused on 

 8

The other two priority areas were to (1) provide training and educational resources, 

including updated prescriber guidelines, to assist health professionals in making informed 

prescribing decisions involving opioids, and (2) increase the use of naloxone, which is a 

medication that reduces opioid and heroin overdose deaths.

9

The Opioid Strategy’s five priority areas are: (1) strengthening public health surveillance, 

(2) advancing the practice of pain management, (3) improving access to treatment and 

recovery services, (4) targeting the availability and distribution of overdose-reversing 

drugs, and (5) supporting cutting edge research.

10ASPE coordinates with several agencies across HHS that manage efforts to expand 

access to MAT. 
Page 4 GAO-18-44 Opioid Use Disorders

those efforts implemented from fiscal year 2015 through August 2017. We 

also inquired about the extent to which diversion control plans—

procedures that reduce the possibility that controlled substances will be 

transferred or used illicitly—are included in HHS’s efforts to expand 

access to MAT, and we reviewed relevant documents.

To examine any HHS evaluation of its key efforts to expand access to 

MAT, we reviewed relevant documentation that describes HHS’s 

evaluation plans to assess MAT expansion efforts. These documents 

included a 2016 report by Mathematica Policy Research that describes a 

proposed evaluation approach developed under contract with HHS and 

the solicitation for a contractor to conduct the evaluation. We assessed 

these plans using criteria for defining objectives and evaluating results in 

federal internal control standards.11 We also interviewed ASPE officials 

about their evaluation approach and the status of the evaluation.

To describe efforts by selected stakeholders to expand access to MAT, 

we first identified relevant stakeholder organizations that represent states, 

private health insurance plans, and national associations. Through our 

interviews with HHS officials, background interviews with officials from 

organizations, such as the America’s Health Insurance Plans and Blue 

Cross Blue Shield Association, and background research, we identified a 

non-generalizable selection of 15 stakeholders in the following groups—

states, private health insurance plans, and national associations—to 

obtain information about their efforts to expand access to MAT. 

Specifically, we gathered information from officials at (1) state health 

departments and behavioral health services agencies in five states: 

Rhode Island, Maryland, Washington, West Virginia, and Indiana; (2) 

seven private health insurance plans; and (3) three national associations 

that represent providers, government officials, and public health officials: 

the American Society of Addiction Medicine, the National Governors 

Association, and the Association of State and Territorial Health Officials. 

In addition to identifying and selecting stakeholders with efforts to expand 

access to MAT for opioid use disorder based on background interviews 

and research, we considered (1) geographic diversity and Centers for 

Disease Control and Prevention data on states with high opioid death 

rates when selecting the five states; and (2) health insurers with large 

 11Internal control is a process effected by an entity’s oversight body, management, and 

other personnel that provides reasonable assurance that the objectives of an entity will be 

achieved. See GAO, Standards for Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: Sept. 2014).
Page 5 GAO-18-44 Opioid Use Disorders

market share when selecting the seven private health insurers.12 We also 

asked several stakeholders about their views on the diversion of MAT 

medications as part of their efforts to expand access to MAT, and we 

reviewed relevant documents.

We conducted this performance audit from October 2016 to October 2017 

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.

Health care practitioners prescribe opioid medications to treat pain and 

sometimes for other health problems, such as severe coughing. 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. Opioids 

slow down some processes of the body, such as breathing and heartbeat, 

by binding with certain receptors in the body.

Over time, the body becomes tolerant to opioids, which means that larger 

doses of opioid medications are needed to achieve the same effect. 

People may use opioids in a manner other than as prescribed—that is, 

they can be misused. Because opioids are highly addictive substances, 

they can pose serious risks when they are misused, which can lead to 

addiction and death. Symptoms of an opioid use disorder include a strong 

desire for opioids, the inability to control or reduce use, and continued use 

despite interference with major obligations or social functioning. Another 

concern associated with prescribed opioids is the potential for diversion 

for illegal purposes, such as nonmedical use or financial gain.13

 12Centers for Disease Control and Prevention, Drug Overdose Death Data, US 2015, 

accessed February 7, 2017, https://www.cdc.gov/drugoverdose/data/statedeaths.html and 

National Association of Insurance Commissioners “2014 Market Share Reports – For the 

Top 125 Accident and Health Insurance Groups and Companies by State and 

Countrywide.” June 16, 2015.

13Diversion can include selling prescription drugs that were obtained legally, transferring a 

legitimately prescribed opioid to family or friends who may be trying to self-medicate, or 

pretending to be in pain to obtain a prescription opioid because of an addiction.

Background

Opioid Use Disorders and 

MAT
Page 6 GAO-18-44 Opioid Use Disorders

Research has shown that MAT—which combines behavioral therapy and 

the use of certain medications (methadone, buprenorphine, and 

naltrexone)—can be more effective in reducing opioid use and increasing 

retention (i.e., reducing dropouts) compared to abstinence based 

treatment—that is when patients are treated without medication. Three 

medications are currently approved by FDA for use in MAT for opioid use 

disorders—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 cravings. It has a long history of use for the 

treatment of opioid dependence in adults. Methadone suppresses 

withdrawal symptoms during detoxification therapy, which involves 

stabilizing patients who are addicted to opioids by withdrawing them in 

a controlled manner. Methadone also controls the craving for opioids 

during maintenance therapy, which is ongoing therapy meant to 

prevent relapse and increase treatment retention. Methadone can be 

administered to patients as an oral solution or in tablet form.

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

binds to opioid receptors and activates them, but not to the same 

degree as full opioid agonists. It reduces or eliminates opioid 

withdrawal symptoms, including drug cravings. It can be used for 

detoxification treatment and maintenance therapy. It is available for 

MAT for opioid use disorder in tablet form for sublingual (under the 

tongue) administration, in film form for sublingual or buccal (inside the 

cheek) administration, and as a subdermal (under the skin) implant.14

• 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. It also results 

in withdrawal symptoms if recent opioid use has occurred. It can be 

taken daily in an oral tablet form or as a once-monthly injection given 

in a doctor’s office.

 14Some tablets and films also include naloxone. 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. 
Page 7 GAO-18-44 Opioid Use Disorders

Two of the three medications used to treat opioid use disorders—

methadone and buprenorphine—are drugs that carry a potential for 

misuse. Under the Controlled Substances Act (CSA), treatment involving 

these medications can take place in certain authorized settings: as part of 

federally regulated OTPs or in other settings, such as a physician’s office, 

within certain restrictions.15

• OTPs. OTPs provide MAT, including methadone and buprenorphine, 

for people diagnosed with an opioid use disorder. Methadone may 

generally only be administered or dispensed within an OTP, as 

prescriptions for methadone cannot be issued when used for opioid 

use disorder treatment.16 Buprenorphine may be administered or 

dispensed within an OTP, or may also be prescribed by a qualifying 

practitioner who has received a waiver from SAMHSA.17 Naltrexone is 

not a controlled substance and can be used in OTPs and other 

settings.

• Office-Based and Other Settings. Under a Drug Addiction Treatment 

Act of 2000 (DATA 2000) waiver, practitioners may prescribe 

buprenorphine to up to 30 patients in the first year of their waiver, 100 

patients in the second year, and up to 275 patients in the third year.18

 15Enacted 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. 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 (2017) and 42 C.F.R. pt. 8 (2016). The 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. 

16Methadone may be administered outside of an OTP under certain regulatory exceptions. 

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.

17SAMHSA is the agency within HHS that leads public health efforts to advance the 

behavioral health of the nation. SAMHSA’s mission is to reduce the impact of substance 

abuse and mental illness on America’s communities.

18DATA 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. 

Authorized Settings for 

MAT Medications
Page 8 GAO-18-44 Opioid Use Disorders

Practitioners at the 275-patient level must meet additional 

qualifications and requirements. Naltrexone does not have similar 

restrictions.19

HHS has implemented five key efforts from 2015 through August 2017 

that focus on expanding access to MAT for opioid use disorders. Four of 

these are grant programs, including programs focused on health centers 

or primary care practices in rural areas.

• Targeted Capacity Expansion: Medication Assisted Treatment –

Prescription Drug and Opioid Addiction (MAT-PDOA). This grant 

program is administered by SAMHSA and provides funding to states 

to increase their capacity to provide MAT and recovery support 

services to individuals with opioid use disorders.20 Grant recipients 

are expected to identify a minimum of two high-risk communities 

within the state and partner with local government or communitybased organizations to address the MAT-related treatment needs in 

these communities. Among other things, recipients are to use 

outreach and other engagement activities to increase participation in 

and access to MAT for diverse populations at risk for opioid use 

disorders. In August 2015, SAMHSA awarded 3-year grants to 11 

states, under which each of the states will receive up to $1 million in 

each grant year. In September 2016, SAMHSA awarded 11 additional 

3-year grants to other states. Total funding is expected to be up to 

$66 million for all 22 grants. SAMHSA announced the availability of up 

to 5 additional 3-year grants for fiscal year 2017. Applications for 

these grants of up to $2 million per year were due in July 2017 and as 

of August 2017 they had not been awarded.

• Substance Abuse Service Expansion Supplement to Health 

Centers. This grant program is administered by HRSA and provides 

funds for existing health centers to improve and expand their delivery 

of substance abuse services, including services with a specific focus 

on MAT for opioid use disorders in underserved populations.21 Health 

 19See GAO-16-833 for additional CSA requirements for methadone and buprenorphine 

when they are used for pain management and opioid treatment.

20Recovery support services are nonclinical services that assist individuals and families 

working toward recovery from substance use conditions. The services include social 

supports and services such as child care, employment services, housing, peer coaching, 

and drug-free social activities. 

21HRSA is the primary federal agency for improving health care to people who are 

geographically isolated, or economically or medically vulnerable.

HHS Uses Grant 

Programs and Other 

Efforts to Expand 

Access to MAT for 

Opioid Use Disorders
Page 9 GAO-18-44 Opioid Use Disorders

centers that receive these grants are required to increase the number 

of patients with health center-funded access to MAT for opioid use or 

for other substance abuse disorders treatment by adding at least one 

full-time substance abuse provider and supporting new or enhanced 

existing substance abuse services. HRSA awarded 2-year grants in 

March 2016 to 271 health centers. According to HRSA documents, 

total funding could be up to $200 million for all grants over 2 years. 

HRSA announced the availability of another set of grants to health 

centers for fiscal year 2017. Applications for these grants were due in 

July 2017, and as of August 2017 they had not been awarded.22

• Increasing Access to Medication-Assisted Treatment in Rural 

Primary Care Practices. This grant program is administered by 

AHRQ and funds demonstration research projects that aim to expand 

access to MAT for opioid use disorders in primary care practices in 

rural areas of the United States.23 Grant recipients are expected to 

recruit and engage primary care providers and their practices, provide 

training, and support physicians and their practices in initiating 

treatment. The program also identifies and tests strategies for 

overcoming the challenges associated with implementing MAT in 

primary care settings and creates training and other resources for 

implementing MAT. AHRQ awarded these 3-year grants of up to $1 

million per year to four recipients—the recipients are teams of state 

health departments, academic health centers, local community 

organizations, physicians, and others—with project start dates of 

September 30, 2016. According to AHRQ documents, total funding is 

expected to be up to $12 million for the four grants over 3 years.

• State Targeted Response to the Opioid Crisis Grants (Opioid 

STR). This grant program is administered by SAMHSA and provides 

funding to states and others to increase access to treatment services 

 22According to HRSA officials, in September 2017, HRSA plans to award approximately 

$195 million to existing health centers to expand access to mental health and substance 

abuse services focusing on the treatment, prevention, and awareness of opioid abuse 

through the Access Increases in Mental Health and Substance Abuse Services 

supplemental funding opportunity. $100 million of this funding will provide ongoing support 

for mental health and substance abuse services; the remaining $95 million will be 

available as one-time funding for health information technology and/or training 

investments that support the expansion of these services and their integration into primary 

care. 

23AHRQ is the lead federal agency charged with improving the safety and quality of 

America’s health care system. AHRQ develops the knowledge, tools, and data needed to 

improve the health care system and help Americans, health care professionals, and 

policymakers make informed health decisions.
Page 10 GAO-18-44 Opioid Use Disorders

for opioid use disorders, including MAT; reduce unmet treatment 

needs; and reduce opioid overdose deaths. Grant recipients are 

expected to implement or expand access to evidence-based 

practices, particularly the use of MAT, and to report on the number of 

people who receive opioid use disorder treatment, the number of 

providers implementing MAT, and the number of providers trained to 

use MAT. SAMHSA awarded 2-year grants starting in May 2017 to 50 

states, the District of Columbia, four U.S. territories and the free 

associated states of Micronesia and Palau. According to SAMHSA 

documents, total funding could be up to $970 million for all grants over 

2 years.

Figure 1 displays the implementation timeframes, the number of grants, 

and funding levels for the four HHS grant programs related to MAT. As 

the figure shows, some of these awards were made in fiscal year 2015, 

while others were made as recently as May 2017. As of August 2017, 

these efforts were ongoing.

Figure 1: Implementation Timeframes of HHS Grants for Expanding Access to Medication-Assisted Treatment for Opioid Use 

Disorders, 2015 through 2019a

a

These grants were awarded between August 2015 and May 2017.

b

There are two sets of these grants. The first cohort of 11 grants is for 2015 through 2018 and the 

second cohort of 11 grants is for 2016 through 2019.

In addition to these four grant programs, HHS’s fifth key effort increases 

treatment capacity by expanding the waivers that practitioners may 

receive to prescribe buprenorphine. Specifically, SAMHSA issued a 

regulation that became effective August 8, 2016 increasing the number of 
Page 11 GAO-18-44 Opioid Use Disorders

patients that eligible practitioners can treat with buprenorphine outside of 

an OTP (e.g., in an office-based setting).24 Previously, qualified 

practitioners could request approval to treat up to 30 patients at a time, 

and after 1 year the limit could increase to 100 patients at a time upon 

SAMHSA approval. The new regulation expanded access to MAT by 

allowing eligible practitioners who have had waivers to prescribe 

buprenorphine to 100 patients for at least 1 year to request approval to 

treat up to 275 patients thereafter. Similarly, SAMHSA has implemented 

provisions of the Comprehensive Addiction and Recovery Act of 2016 

(CARA) that expanded the types of practitioners who can receive a 

waiver to prescribe buprenorphine in an office-based setting to include 

qualifying nurse practitioners and physician assistants.25 CARA generally 

requires that these nurse practitioners and physician assistants complete 

24 hours of training to be eligible for a waiver.26 According to HHS 

documents, as of early 2017, nurse practitioners and physician assistants 

who have completed this training could request a waiver from SAMHSA 

to treat up to 30 patients at a time.

In addition to its five key efforts focused specifically on expanding access 

to MAT for opioid use disorders, HHS has other efforts with broader 

focuses, such as treating multiple types of substance abuse. While these 

efforts are not specifically focused on expanding access to MAT for opioid 

use disorders, they may result in expanded access to MAT. For example, 

CMS has approved section 1115 Medicaid demonstration projects to 

allow states to undertake comprehensive reforms of their delivery of 

substance abuse services, including provisions to enhance the use of 

 24Medication Assisted Treatment for Opioid Use Disorders, 81 Fed. Reg. 44,712 (July 8, 

2016) (to be codified at 42 C.F.R. pt. 8). The final rule modified the requirements for 

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). The waiver authority and related patients limits do not apply to 

methadone. 

25Specifically, CARA amends the CSA to expand the definition of “qualifying practitioner,” 

for the purposes of waiver eligibility, to include qualifying nurse practitioners and physician 

assistants from the date of CARA’s enactment until October 1, 2021. See Pub. L. No. 114-

198, § 303(a)(1)(C)(v), 130 Stat. 695, 721 (July 22, 2016).

26Alternatively, CARA allows the Secretary of HHS to determine that other training or 

experience demonstrates the ability of a nurse practitioner or physician assistant to treat 

and manage opiate-dependent patients. To be eligible for a waiver to prescribe 

buprenorphine in office-based settings, physicians must complete 8 hours of training.
Page 12 GAO-18-44 Opioid Use Disorders

MAT for opioid use disorders.27 In July 2015, CMS issued a state 

Medicaid Director letter informing states that they may seek approval of 

section 1115 demonstrations to undertake comprehensive substance use 

service reforms. According to CMS, all participating states are using the 

demonstration authority to develop a full continuum of care for individuals 

with substance abuse disorders, including coverage of short-term 

residential treatment services not otherwise covered by Medicaid.

In addition, FDA has programs to help expedite development and to 

provide for faster review of marketing applications for certain drugs.

28

According to FDA, it has conducted expedited reviews of Suboxone 

(buprenorphine and naloxone sublingual film), Vivitrol (extended release 

naltrexone injection) and Probuphine (buprenorphine subdermal 

implant).29

According to some federal officials and other stakeholders that we 

interviewed, as part of efforts to expand access to MAT for opioid use 

disorder, steps are being taken to prevent the possibility that the MAT 

medications could, in some cases, be diverted for illicit use, misuse, or for 

purposes not intended by a prescriber. For example, OTPs and 

practitioners who request and receive a waiver to prescribe 

buprenorphine to treat up to 275 patients outside of an OTP setting are 

required under federal regulations to maintain a diversion control plan.30

In addition, the MAT-PDOA grant program explicitly requires grant 

 27Section 1115 of the Social Security Act allows the Secretary of HHS authority to waive 

certain traditional federal Medicaid requirements and allow costs that would not otherwise 

be eligible for federal payments for demonstrations that, in the Secretary’s view, are likely 

to promote Medicaid objectives. 

28FDA has four programs intended to facilitate and expedite development and review of 

certain new drug applications: fast track designation, breakthrough therapy designation, 

accelerated approval, and priority review designation. For additional information, see 

FDA’s May 2014 Guidance for Industry Expedited Programs for Serious Conditions –

Drugs and Biologics.

29In December 2015, we found that FDA review time was an average of 8.6 months for 

marketing applications for drugs when the agency used at least one expedited program 

compared with 12.1 months of review time for marketing applications for drugs when FDA 

did not use an expedited program. See GAO, Drug Safety: FDA Expedites Many 

Applications, But Data for Postapproval Oversight Need Improvement, GAO-16-192 

(Washington, D.C.: Dec. 15, 2015).

3042 C.F.R. §§ 8.12(c)(2), 8.620(b)(5) (2016). Physicians who prescribe or dispense 

buprenorphine outside of an OTP at the 30- and 100-patient limit are not required to have 

a diversion control plan. 
Page 13 GAO-18-44 Opioid Use Disorders

recipients to implement a diversion control plan, though the other grant 

programs do not have similar additional requirements. (See appendix I for 

an overview of the diversion control plan requirements for OTPs and the 

practitioners who prescribe buprenorphine outside of an OTP.) The 2016 

Surgeon General’s report on Alcohol, Drugs, and Health noted that 

decades of research have shown that the benefits of MAT greatly 

outweigh the risks associated with diversion, and that withholding these 

medications greatly increases the risk of relapse to illicit opioid use and 

overdose death.

HHS officials told us that as of August 2017, the department is in the 

process of finalizing its approach for evaluating the implementation of its 

agencies’ collective efforts to address the opioid epidemic that were 

undertaken as part of the HHS Opioid Initiative and will continue under 

the new administration’s Opioid Strategy. HHS officials provided a draft of 

the evaluation’s schedule. According to the officials, the evaluation will 

include, but not be limited to, efforts to expand access to MAT. In 

September 2016, HHS awarded a 2-year contract to Research Triangle 

Institute International (RTI) to evaluate HHS agencies’ collective efforts. 

HHS officials told us that they are still working with RTI to finalize the 

evaluation approach given new leadership priorities. Specifically, in April 

2017, the new Secretary of HHS announced a revised strategy for 

addressing the opioid epidemic that will continue to address access to 

MAT for opioid use disorders but also include additional priority areas.31

According to HHS officials, to be responsive to the new priorities, the 

evaluation will focus initially on whether HHS’s efforts have been 

implemented as intended, and officials expect the evaluation to also 

provide information on any challenges HHS has faced in implementing 

these efforts.

According to HHS officials, while the evaluation of MAT expansion efforts 

will use information from several sources, they have not yet determined 

 31The HHS Secretary outlined a new five-pronged strategy in April 2017 that HHS will 

implement to fight the opioid epidemic. The five priority areas are: (1) strengthening public 

health surveillance, (2) advancing the practice of pain management, (3) improving access 

to treatment and recovery services, (4) targeting the availability and distribution of 

overdose-reversing drugs, and (5) supporting cutting edge research. 

HHS is Finalizing Its 

Approach for 

Evaluating MAT 

Expansion Efforts but 

Lacks Performance 

Measures with 

Targets and 

Implementation 

Timeframes
Page 14 GAO-18-44 Opioid Use Disorders

exactly which information will be used or how it will be used.32 This 

information may include, for example, results from a separate, planned 

evaluation of one of the grant programs, Opioid STR, as well as other

information HHS agencies collect as part of their ongoing monitoring 

efforts for each of their individual MAT grant programs.33 While the 

reporting requirements vary across the four MAT grant programs, the 

grantees provide HHS with information related to expanding access to 

MAT. Specifically,

• Targeted Capacity Expansion: Medication Assisted Treatment –

Prescription Drug and Opioid Addiction (MAT-PDOA): Every 6 

months, grant recipients are expected to submit progress reports to 

SAMHSA on the planned and actual number of patients treated, as 

well as information on other performance measures.34

• Increasing Access to Medication-Assisted Treatment in Rural 

Primary Care Practices: Grant recipients are expected to submit 

quarterly progress reports to AHRQ with various information, such as 

information on the number of physicians who have been certified to 

prescribe buprenorphine and the number of primary care practices 

successfully initiating the delivery of MAT services as a result of the 

grant project.

• Substance Abuse Service Expansion Supplement to Health 

Centers: Health centers that received these grants were expected to 

submit quarterly progress reports to HRSA through the second 

quarter of 2017 on the number of physicians who have obtained a 

DATA 2000 waiver and the number of patients who received MAT 

from these physicians. Health centers must now report these data 

elements in their annual performance reporting along with information 

 32In June 2016, Mathematica Policy Research, under contract with HHS, developed a 

proposed methodological approach for evaluating the implementation and impact of HHS 

agencies’ efforts under the Opioid Initiative, including identification of program evaluations 

at the agency level that could be incorporated. This proposal also identified various HHS 

activities to be included in the evaluation, such as HHS’s grant programs.

33According to SAMHSA officials, the agency is planning to award a contract to evaluate 

the impact of the Opioid STR grant program. 

34In addition to the information in the biannual progress reports, according to SAMHSA, it 

requires grant recipients to submit additional information on a real-time basis, within 7 

days of its collection, as part of SAMHSA’s obligations under the Government 

Performance and Results Modernization Act of 2010.This includes information on 

abstinence from drug use, retention in services, housing status, and other information.
Page 15 GAO-18-44 Opioid Use Disorders

on the number of certified nurse practitioners and physician assistants 

who have received a DATA 2000 waiver.

• State Targeted Response to the Opioid Crisis Grants (Opioid 

STR): Every 6 months, grant recipients are expected to submit 

progress reports to SAMHSA on the number of individuals who 

receive opioid use disorder treatment, the number who receive opioid 

use disorder recovery services, and the number of providers 

implementing MAT, among other measures.

While HHS’s evaluation will focus on whether HHS’s efforts have been 

implemented as intended, officials told us that in the future an evaluation 

may also focus on the effectiveness of these efforts, including the 

effectiveness of efforts to expand access to MAT. Doing so would be 

consistent with federal standards for internal control, which call for 

agencies to evaluate results.35 HHS has some of the information that 

could be used in a future evaluation of the effectiveness of its efforts to 

expand access to MAT. In particular, an HHS document describing the 

department’s fiscal year 2016 – 2017 goals identifies expanding MAT 

access as an important strategy for the success of HHS’s longer-term 

goal of reducing opioid use disorders and opioid overdoses. In addition, 

HHS has identified three potential ways to measure access to MAT:

• the number of prescriptions for MAT medications,36

• the treatment capacity of practitioners who are authorized to prescribe 

buprenorphine for opioid use disorders through a DATA 2000 waiver, 

and

• the treatment capacity of OTPs certified to administer methadone and 

other medications.

 35GAO-14-704G.

36Previously, HHS used a (now retired) performance measure with a target to increase by 

10 percent the number of unique patients receiving prescriptions for buprenorphine and 

naltrexone during fiscal years 2016 and 2017.This performance measure was established 

as part of the Agency Priority Goal (APG) process, which is led by the Office of 

Management and Budget. HHS established an APG to reduce opioid-related morbidity 

and mortality, and one of its corresponding performance measures was to increase the 

number of unique patients receiving prescriptions for buprenorphine and naltrexone by 

September 30, 2017. According to HHS officials, the APGs and related measures have 

been retired and will be replaced after HHS receives guidance from the Office and 

Management and Budget. However, it is uncertain whether or to what extent the new 

APGs will include any measures related to MAT.
Page 16 GAO-18-44 Opioid Use Disorders

In addition, HHS has data that could be useful for tracking progress in 

these areas (see table 1).

Table 1: Factors for Measuring Access to Medication-Assisted Treatment (MAT) for Opioid Use Disorders and Related Data 

Sources 

Factor Data source

The number of prescriptions for MAT medications The Assistant Secretary of Planning and Evaluation obtains 

quarterly data from QuintilesIMS on the number of prescriptions 

for MAT medications.a

The treatment capacity of practitioners who are authorized to 

prescribe buprenorphine for opioid use disorders through a Drug 

Addiction Treatment Act of 2000 (DATA 2000) waiver

The Substance Abuse and Mental Health Services 

Administration tracks data on practitioners who can prescribe 

buprenorphine through a DATA 2000 waiver.

The treatment capacity of opioid treatment programs (OTPs) 

certified to administer methadone and other medications

The Substance Abuse and Mental Health Services 

Administration tracks data on OTPs through its National Survey 

of Substance Abuse Treatment Services.

b

Source: GAO analysis of HHS data. | GAO-18-44

a

These data include buprenorphine and naltrexone, but do not include data on methadone, which 

cannot be prescribed. QuintilesIMS, a merger of IMS Health and Quintiles, is a company that 

provides health plan claims and prescription data.

b

The National Survey of Substance Abuse Treatment Services is an annual census of facilities 

providing substance abuse treatment, including treatment for opioid use disorder. Data are collected 

throughout the 50 states, the District of Columbia, and other U.S. jurisdictions. The survey collects 

data on the number of clients in treatment, but does not measure the potential capacity of facilities.

However, HHS has not adopted specific performance measures with 

targets specifying the magnitude of the increases HHS hopes to achieve 

through its efforts to expand access to MAT, and by when. For example, 

HHS has not established a long-term target specifying the percentage 

increase in the number of prescriptions for buprenorphine HHS would like 

to achieve, which would help to show whether efforts by HHS and others 

are resulting in sufficient progress in increasing prescriptions for this MAT 

medication. HHS has also not chosen a specific method of measuring 

treatment capacity or established targets associated with it, which would 

help to show whether a sufficient number of providers are becoming 

available to evaluate and treat patients who may benefit from MAT.

Without specifying these performance measures and associated targets, 

HHS will not have an effective means to determine whether its efforts are 

helping to expand access to MAT. The lack of such performance 

measures with associated targets is inconsistent with federal internal 

control standards that specify that management should define objectives 
Page 17 GAO-18-44 Opioid Use Disorders

and evaluate results.37 According to these standards, using performance 

information such as performance measures can help agencies monitor 

results and determine progress in meeting program goals. In the context 

of HHS’s efforts to expand access to MAT, establishing appropriate 

performance measures with associated targets would allow HHS to 

determine whether its efforts are making sufficient progress or whether 

they need to be improved. Gauging this progress is particularly important, 

given the large nationwide MAT treatment gap identified in 2015 between 

the total number of individuals who could benefit from MAT and the 

limited number who can access it based on provider availability. This gap 

was estimated at nearly 1 million people as of 2012, and according to 

HHS officials and other stakeholders, lack of providers continues to be a 

challenge.38 Until HHS establishes performance measures with 

associated targets for the factors related to access to MAT, the 

department will be unable to evaluate its progress expanding access to 

MAT for opioid use disorders.

In addition, as of August 2017, HHS has not finalized its approach for the 

planned evaluation activities, including timeframes. ASPE officials said 

that timeframes for a finalized evaluation approach had not been 

established because they were still working with RTI to finalize the 

evaluation approach given the new leadership priorities. When we spoke 

with the officials, they provided us with a draft evaluation schedule that 

covered the contract period ending September 2018. As of October 2017, 

HHS had not provided a finalized evaluation approach or schedule.

Federal internal controls call for management to establish and operate 

monitoring activities and evaluate results.39 Without an implementation 

timeframe for the evaluation’s activities, HHS increases the risk that its 

evaluation of its agencies’ efforts will not be completed as expeditiously 

as possible, including an evaluation of HHS’s efforts to expand access to 

MAT.

 37GAO-14-704G. 

38The maximum number of people who could access MAT was approximately 1.4 million 

in 2012, compared to the 2.3 million people who abused opioids or were dependent upon 

them. See C. M. Jones et al., “National and State Treatment Need and Capacity for Opioid 

Agonist Medication-Assisted Treatment” American Journal of Public Health, vol. 105, no. 8 

(2015).

39GAO-14-704G.
Page 18 GAO-18-44 Opioid Use Disorders

Officials from selected state health departments and behavioral health 

agencies, private health insurers, and national associations reported 

using several different efforts to help expand patients’ access to MAT for 

opioid use disorders. All of the stakeholders we interviewed reported 

conducting outreach efforts to communicate information about the 

importance of MAT and how to access it, or providing training to educate 

providers on prescribing MAT medications.

Efforts by states. State health officials we spoke to described several 

planned or ongoing efforts to expand access to MAT, some of which are 

supported by federal funding, including federal grant programs. Officials 

from all five selected states told us that they are offering outreach to and 

training for providers to help expand access to MAT. For example, 

several state officials told us that they are promoting training to (1) 

encourage physicians to obtain authorization (DATA 2000 waivers) to 

prescribe buprenorphine and (2) encourage physicians with waivers to 

treat patients up to their patient limit or to request a higher patient limit.

According to the stakeholders, all five selected states have implemented 

or are planning to implement a health care delivery model or approach 

that will expand access to MAT.40 Specifically, these models or 

approaches focus on integrating the use of MAT into primary care 

settings. For example, health officials from three states described use of a 

hub-and-spoke model. This model generally involves centralized intake 

and initial management of patients at a “hub” (e.g., an OTP) and then 

connecting these patients to community providers at “spokes” (e.g., 

primary care clinics) for ongoing care, with ongoing support provided by 

the hub as needed. Additionally, officials from two states described 

offering remote MAT-related consultations through telehealth that 

connects patients in rural areas with addiction specialists.41 According to 

a 2017 Healthcare Fraud Prevention and Partnership whitepaper, 

telehealth expands the reach of the addiction professional workforce and 

the existing pool of MAT providers, and it supports remote forms of 

 40For more information that highlights examples of these models and approaches, see D. 

Korthuis et al., “Primary Care-Based Models for the Treatment of Opioid Use Disorder,” 

Annals of Internal Medicine, vol.166, no.4 (2017). 

41Telehealth services may use two-way video or other telecommunication technologies to 

enable health consultations between a patient and a physician in different locations. Such 

services can be particularly useful to address a lack of access in rural areas. 

Selected 

Stakeholders 

Reported Using 

Outreach, Training, 

and Other Efforts to 

Help Expand Access 

to MedicationAssisted Treatment 

for Opioid Use 

Disorders
Page 19 GAO-18-44 Opioid Use Disorders

behavioral therapy to make trained professionals more accessible to 

those in underserved or isolated communities.42

Officials from three states described focusing their MAT expansion efforts 

in various settings, such as in the criminal justice setting and emergency 

room departments. State health officials from four of the five states told us 

that programs in their states are using peer specialists (individuals who 

have successfully recovered from substance abuse disorders) in 

emergency rooms and other settings to engage with addicted patients 

and refer them to addiction specialists or behavioral health counselors.43

Officials from the selected states said that some of these and other efforts 

are funded through federal sources, such as MAT expansion grants 

awarded by SAMHSA, or with state funds to the extent they are available.

Efforts by private health insurers. Officials from private health insurers 

reported that they are expanding access to MAT through outreach or 

training for providers and through the following three efforts:

• Eliminating the need for prior authorization to prescribe MAT 

medications. Officials from three insurers reported removing prior 

authorization requirements for MAT medications, thereby making it 

easier for patients to access needed MAT medications more readily, 

rather than undergoing a waiting period for approval to receive the 

medications. Other private health insurers told us that they continue to 

require prior authorization, intended for safety reasons and to reduce 

drug misuse, and officials from one insurer told us that they will allow 

a patient to access a limited amount of MAT medications for a period 

of 24 to 72 hours while making a determination about the appropriate 

treatment services for the patient.44

 42Healthcare Fraud Prevention Partnership, Healthcare Payer Strategies to Reduce the 

Harms of Opioids, January 2017. 

4321st Century Cures Act included a provision for GAO, within 2 years of the law’s 

enactment, to review peer-support specialists programs in up to 10 states that receive 

funding from SAMHSA. The review is to include a review of best practices related to 

training and credential requirements for peer-support specialist programs. Pub. L. No. 

114-255, § 9026(b), 130 Stat. 1033, 1256 (2016).

44According to an official from the private health insurer, reasons for denial of MAT can 

include a lack of commitment from the physician to treat the patient, the patient is still on 

opioids that he or she should not be taking, or the patient has not been diagnosed with an 

opioid use disorder. 
Page 20 GAO-18-44 Opioid Use Disorders

• Modifying health benefit coverage. Officials from one private health 

insurance plan told us that the company is redesigning the benefit 

coverage for methadone and has removed member copays. This 

effort is intended to make MAT medications more affordable and allow 

members who are not able to use buprenorphine to have an 

alternative, such as methadone, that is not cost-prohibitive.

• Incentivizing providers and health insurance plan members to use 

MAT. Officials from four private health insurance plans described 

plans to offer incentives to providers or patients to use MAT. For 

example, officials from three health plans stated that they are offering 

alternative payment models or paying higher rates to providers that 

offer MAT, and another private health insurer is offering incentives to 

its members who are enrolled in behavioral health programs that 

provide access to MAT.

Efforts by national associations. Officials we interviewed from the 

national associations—including the American Society of Addiction 

Medicine, the National Governors Association, and the Association of 

State and Territorial Health Officials—told us that they are helping to 

expand access to MAT through outreach and training for their members 

and by developing tools and resource guides for their members. An 

official from one association told us that it shares federal grant 

announcements, including those that are focused on expanding access to 

MAT, with its members. Officials from another association said it provides 

training to providers on how to appropriately prescribe MAT medications. 

In addition, officials from one association told us that they developed an 

opioid-related road map that identifies examples of strategies—including 

MAT—that state policymakers can use in their ongoing efforts to address 

the opioid epidemic. Examples of strategies include reducing the stigma 

associated with MAT through educating the public and potential 

providers. Another strategy in the road map is changing payment policies 

to expand access to MAT services, such as ensuring that Medicaid and 

other state health programs adequately cover all MAT medications and 

behavioral interventions and encouraging or requiring commercial health 

plans to adopt similar policies.

HHS funds grant programs and has taken other steps to expand access 

to MAT, which has been shown to be effective in reducing the prevalence 

of opioid use disorders and with them, the likelihood of drug overdoses. 

HHS’s Opioid Initiative began in 2015, and the grants that support it are 

ongoing, so it is likely too early to determine how effective HHS’s efforts 

have been in expanding access to MAT and in meeting HHS’s other 

Conclusions
Page 21 GAO-18-44 Opioid Use Disorders

priorities related to addressing the opioid epidemic. According to HHS, 

access to MAT can be measured in terms of the number of prescriptions 

for MAT and by the treatment capacities of OTPs and practitioners who 

are authorized to prescribe buprenorphine.

Our review suggests, however, that HHS may not be ready to perform 

this evaluation. While HHS told us that it may evaluate the effectiveness 

of its efforts in the future, the department has not established 

performance measures with targets that would specify the results that 

HHS hopes to achieve through its efforts, and by when. Furthermore, 

HHS has not established timeframes for the activities that will make up its 

planned evaluation of whether HHS’s efforts have been implemented as 

intended. Without performance measures with targets and evaluation 

timeframes, HHS increases the risk that the evaluation will not be 

completed in a timely manner or that HHS will not know whether its MATrelated efforts are successful or whether new approaches are needed. 

The evaluation is particularly important, given the hundreds of millions of 

dollars HHS has invested in its MAT-related grant programs.

We are making the following two recommendations to HHS.

The Assistant Secretary for Planning and Evaluation should establish 

performance measures with targets related to expanding access to MAT 

for opioid use disorders. (Recommendation 1)

The Assistant Secretary for Planning and Evaluation should establish 

timeframes in its evaluation approach that specify when its evaluation of 

efforts to expand access to MAT will be implemented and completed. 

(Recommendation 2)

Recommendations for 

Executive Action
Page 22 GAO-18-44 Opioid Use Disorders

We provided a draft of this report to HHS for review, and HHS provided 

written comments, which are reprinted in appendix II. HHS also provided 

technical comments, which we incorporated as appropriate. In its written 

comments, HHS concurred with both of our recommendations. 

Specifically, for our first recommendation to establish performance 

measures with targets related to expanding access to MAT for opioid use 

disorders, HHS stated that developing such measures is appropriate and 

that the department will continue to work to develop robust performance 

measures, including measures related to MAT, as part of its overall 

Opioid Strategy, which includes the department’s most recent efforts to 

address the opioid epidemic. For our second recommendation to 

establish timeframes in its evaluation approach that specify when its 

evaluation of efforts to expand access to MAT will be implemented and 

completed, HHS agreed that timeframes are important to any evaluation. 

HHS noted that its evaluation is being conducted under a 2-year contract 

that is scheduled to end in September 2018. HHS has also provided us 

with a draft evaluation schedule. We clarified in our report, however, that 

HHS has not yet provided a finalized approach for the planned evaluation

or a finalized schedule establishing timeframes for the activities that will 

make up the evaluation. Until it finalizes its evaluation approach and 

establishes related timeframes, HHS increases the risk that it will not 

complete its planned evaluation by September 2018.

We are sending copies of this report to the HHS, and appropriate 

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

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

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

Director, Health Care

Agency Comments
Appendix I: Diversion Plan Requirements for 

Opioid Treatment Programs and Practitioners 

Who Prescribe Buprenorphine

Page 23 GAO-18-44 Opioid Use Disorders

According to the Department of Health and Human Services, a diversion 

control plan is a set of documented procedures intended to reduce the 

possibility that controlled substances will be transferred or used illicitly. 

Opioid treatment programs (OTPs) and practitioners who prescribe 

buprenorphine at the highest patient level through a Drug Addiction 

Treatment Act of 2000 (DATA 2000) waiver are required to have these 

plans. OTPs are programs that may administer or dispense medicationassisted treatment (MAT) for people diagnosed with an opioid use 

disorder, including the use of methadone and buprenorphine. In addition, 

under a DATA 2000 waiver, practitioners may prescribe buprenorphine 

for patients, up to a 30-, 100-, or 275 patient limit.

An OTP must maintain a current diversion control plan that contains 

specific measures to reduce the possibility of diversion of controlled 

substances from legitimate treatment use.1 Per federal guidelines, the 

goal of the diversion control plan is to reduce the scope and significance 

of diversion and its impact on communities.2 The guidelines state that 

each OTP’s diversion control plan should make every effort to balance 

diversion control against the therapeutic needs of the individual patient. 

They also state that diversion control plans should address at least four 

general areas of concern: program environment, dosing and take-home 

medication, prevention of multiple program enrollment, and prescription 

medication misuse. The guidelines include details about each of these 

areas:

• Program environment: Diversion in the program environment can be 

deterred and detected by regular surveillance and the monitoring of 

areas in and around the program, where opportunities for diversion 

may exist. A visible human presence at a program’s location gives 

community members the opportunity to approach staff with concerns 

and communicates the program’s commitment to assuring a safe 

environment and a positive impact on the surrounding community.

• Dosing and take-home medication: In the area of dosing and takehome medication, diversion control encompasses careful control of 

 1

This diversion control plan must also assign specific responsibility to the medical and

administrative staff of the OTP for carrying out the diversion control measures and 

functions described in the diversion control plan. 42 C.F.R. § 8.12(c)(2) (2016).

2

Substance Abuse and Mental Health Services Administration. Federal Guidelines for 

Opioid Treatment Programs. HHS Publication No. (SMA) PEP15-FEDGUIDEOTP. 

Rockville, MD: Substance Abuse and Mental Health Services Administration, 2015.

Appendix I: Diversion Plan Requirements for 

Opioid Treatment Programs and 

Practitioners Who Prescribe Buprenorphine

Diversion Control Plan 

Requirement for OTPs
Appendix I: Diversion Plan Requirements for 

Opioid Treatment Programs and Practitioners 

Who Prescribe Buprenorphine

Page 24 GAO-18-44 Opioid Use Disorders

inventory, attentive patient dosing, and close supervision of takehome medication. Observing a patient take his or her dose and having 

each of them drink and speak after dosing are fundamental 

components of diversion control. Take-home dosing should be 

provided with careful attention to regulatory compliance and the 

therapeutic benefit and safety these regulations are meant to 

promote.

• Prevention of multiple program enrollment: Reasonable measures 

should be taken to prevent patients from enrolling in treatment 

provided by more than one clinic or individual practitioner. An OTP, 

after obtaining patient consent, may contact other OTPs within a 

reasonable geographic distance (100 miles) to verify that a patient is 

not enrolled in another OTP.

• Misuse of prescription medication: The misuse of prescription 

medication has become an area of great concern nationally and 

impacts diversion control planning at OTPs. All OTP physicians and 

other healthcare providers, as permitted, should register to use their 

respective state’s prescription drug monitoring program (PDMP) and 

query it for each newly admitted patient prior to initiating dosing. The 

PDMP should be checked periodically (for example, quarterly) through 

the course of each individual’s treatment and, in particular, before 

ordering take-home doses as well as at other important clinical 

decision points.

SAMHSA’s best-practice guidelines for using buprenorphine for treating 

opioid use disorders include multiple references to diversion, including 

monitoring for diversion, storage of this medication to minimize diversion, 

and use of formulations that may be less likely to be diverted. Specifically, 

the best practices state that, when possible, practitioners should use the 

combination buprenorphine/naloxone product, which increases safety and 

decreases the likelihood of diversion and misuse.3 Further, physicians 

who request and receive a waiver to prescribe buprenorphine to treat up 

to 275 patients outside of an OTP are required to have a diversion control 

plan. According to an HHS official, as of July 13, 2017, roughly 3,330 of 

the over 39,000 practitioners with a waiver had a 275-patient limit waiver. 

 3

Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine 

in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. 

DHHS Publication No. (SMA) 04‐3939. Rockville, MD: Substance Abuse and Mental 

Health Services Administration, 2004.

Diversion Control and 

Plans for Practitioners 

Prescribing Buprenorphine 

Outside of an OTP
Appendix I: Diversion Plan Requirements for 

Opioid Treatment Programs and Practitioners 

Who Prescribe Buprenorphine

Page 25 GAO-18-44 Opioid Use Disorders

The majority of these practitioners, just over 27,000, have a 30-patient 

limit.

According to SAMHSA guidance, the diversion plan should contain 

specific measures to reduce the possibility of diversion of buprenorphine 

from legitimate treatment use and should assign specific responsibilities 

of the medical and administrative staff of the practice setting for carrying 

out these measures. Further, the guidance states that the plan should 

address how:

• the environment at the practice setting can prevent onsite diversion;

• to prevent diversion with regard to dosing and take-home medication; 

and

• to prevent patients from receiving a prescription from more than one 

practitioner and later diverting some of the prescribed medication.
Appendix II: Comments from the Department 

of Health and Human Services

Page 26 GAO-18-44 Opioid Use Disorders

Appendix II: Comments from the Department 

of Health and Human Services
Appendix II: Comments from the Department 

of Health and Human Services

Page 27 GAO-18-44 Opioid Use Disorders
Appendix II: Comments from the Department 

of Health and Human Services

Page 28 GAO-18-44 Opioid Use Disorders
Appendix II: Comments from the Department 

of Health and Human Services

Page 29 GAO-18-44 Opioid Use Disorders
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 30 GAO-18-44 Opioid Use Disorders

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

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

Natalie Herzog, Analyst-in-Charge; La Sherri Bush; and Emily Wilson 

made key contributions to this report. Also contributing were Muriel 

Brown, Krister Friday, Sandra George, and Christina Ritchie.

Appendix III: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(101177)
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