Background

		Opioid Use

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.

		Medications for Opioid Addiction and Their Role in MAT

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  with another agent called naloxone, and as a subdermal (under the  skin) implant. 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.

		Controlled Substances and the Controlled Substances Act

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). 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. 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.

	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

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. 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  Schedules II-V to register with DEA. 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. 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  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.

		Additional Requirements Apply to Methadone and Buprenorphine When Used for Opioid Addiction Treatment

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. See table 2 for a comparison of these requirements.
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.
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 peer- review 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. 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— narcotic drugs to a patient to relieve acute withdrawal symptoms while  arranging for the patient’s referral to treatment.

			Buprenorphine

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. 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. 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. Practitioners who  prescribe or dispense buprenorphine under a DATA 2000 waiver are  subject to the CSA’s inventory and recordkeeping requirement.

	Practitioner Capacity, Perceived Value, and Insurance Coverage Can Affect Patients’ Access to MAT for Opioid Addiction

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.  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  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. 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. 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  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  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  treatment has generally increased, although some concerns about access  remain. 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.

	Agency Comments

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.
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.

Appendix I: Literature Review Methodology

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 peer- reviewed and scholarly journals from January 2011 through April 2016.  We searched the following databases for relevant articles in peer- reviewed 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. 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.

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

Appendix III: GAO Contact and Staff Acknowledgments

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

	Staff Acknowledgments

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.

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Summary:
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.

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 medication-assisted 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.