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 also carries risk of abuse. Schedule I contains substances that have no  currently accepted medical use and may not be manufactured,  distributed, or dispensed under federal law. 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. Buprenorphine is a Schedule III controlled substance, which has  currently accepted medical uses and a lower potential for abuse. 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). 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. 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. 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. 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. 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. 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. Several documents and the literature we reviewed examined the reasons  why MAT is not used more frequently within the criminal justice system. For example, patients with no insurance coverage  for MAT may face prohibitive out-of-pocket costs that may limit their  access to it. 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. 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. 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. “Challenges and Opportunities for the Use of Medications to Treat Opioid  Addiction in the United States and Other Nations of the World.” Journal of  Addictive Diseases, vol. “Where is  Buprenorphine Dispensed to Treat Opioid Use Disorders?
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.