Opioid Addiction: Laws, Regulations, and Other Factors Can Affect Medication-Assisted Treatment Access
Released: 2016-10-27T00:00:00

Letter

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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