Background Opioid Use Disorder Opioids—such as hydrocodone, oxycodone, morphine, and methadone— can be prescribed to treat both acute and chronic pain. Many opioids have a high potential for abuse and may lead to severe psychological or physical dependence. OUD, which is a type of substance use disorder, is generally characterized by a loss of control of opioid use, risky opioid use, impaired social functioning, tolerance, and withdrawal. According to SAMHSA and the National Institute on Drug Abuse, OUD is a chronic, treatable illness. SAMHSA states that treatment for OUD should be individualized and can include a range of treatment options that include medication and behavioral health services. Specifically, services related to the treatment of OUD include the following: Screening can identify individuals who have OUD, are at risk for developing OUD, or have medical problems related to opioid use. Screening, brief intervention, and referral to treatment (SBIRT) is a specific type of screening that involves a health care provider educating individuals with a positive screen for opioid use and referring them to specialized treatment, as needed. Outpatient counseling and therapy includes counseling and treatment services individually or in a group. Inpatient hospital services include those that occur in a hospital, such as services for detoxification. Inpatient residential services include care in a 24-hour residential setting. Inpatient residential providers offer medical care in combination with housing, typically lasting from a week to several weeks or more. Medication-assisted treatment (MAT) combines the use of certain prescription medications (such as methadone, buprenorphine, and naltrexone) and behavioral therapy. Methadone and buprenorphine suppress withdrawal symptoms and control the craving for opioids, while naltrexone suppresses the euphoric effects of opioids. Research has shown that MAT for OUD reduces opioid use and increases the chance that patients will continue OUD treatment compared to abstinence-based treatment (where patients are treated without medication). Case management services include providing coordination and management of care across multiple health care providers. Crisis intervention includes immediate care intended to prevent harm. Peer recovery coaching includes recovery support through a certified peer specialist with experience of recovery from addiction. Medicaid Program Overview States administer their Medicaid programs within broad federal requirements and according to a state plan approved by CMS. The Medicaid program allows states to design and implement their programs within certain federal parameters, resulting in more than 50 distinct programs. A state’s approved Medicaid plan outlines the services provided and the groups of individuals covered. States also have the option of using waivers to expand services under the Medicaid program. As such, the types of services covered by Medicaid can vary across states. Historically, Medicaid eligibility has been limited to certain categories of low-income individuals, such as children, parents, pregnant women, persons with disabilities, and individuals aged 65 and older. The Patient Protection and Affordable Care Act (PPACA), enacted in 2010, allowed states to expand Medicaid coverage to nearly all individuals with incomes up to 138 percent of the FPL, regardless of eligibility category. As of October 2019, 33 states and the District of Columbia expanded Medicaid eligibility, and 17 states had not. Medicaid Services for Pregnant and Postpartum Women Under federal law, state Medicaid programs must provide coverage for health care services for certain pregnant women, including low-income pregnant women with incomes at or below 138 percent FPL. Most states opt to extend coverage to pregnant women with incomes above this threshold. By statute, states are permitted to limit the services covered for certain pregnant women, including low-income pregnant women, to services related to the pregnancy. Such coverage is referred to as “pregnancy-related coverage.” CMS defines pregnancy-related services as those services necessary for the health of the pregnant woman and fetus, or that have become necessary as a result of the woman having been pregnant, which includes prenatal, delivery, postpartum, and family planning services, as well as services for other conditions that may complicate the pregnancy. In contrast, states are required by statute to provide pregnant women who qualify for Medicaid on another basis, such as a disability, full Medicaid benefits. At a minimum, states must provide Medicaid coverage for pregnant enrollees through 60 days postpartum, though states may extend coverage further. Some women may qualify for continued Medicaid coverage after the 60-day postpartum period if they meet the requirements for another eligibility pathway, such as for parents, while others may transition to other programs or become uninsured. Medicaid Services for Children Medicaid’s Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit is the primary mechanism to help ensure the provision of appropriate health care services to children under Medicaid. Under the EPSDT benefit, states are required to cover comprehensive health screenings and preventive health services, such as those related to vision and oral health, and all other Medicaid coverable services that are necessary to correct or ameliorate any conditions discovered through screenings. States are required to follow a schedule of screenings, known as a periodicity schedule, that are recommended for children at specific ages and frequencies. States can develop their own schedule within federal parameters or follow an established schedule, such as from the American Academy of Pediatrics (AAP). States are required to report annually on the provision of certain EPSDT services to CMS. States must report information on the number of children provided health screening services, the total number of health screenings services provided, the number of children referred for corrective treatment, the number of children receiving dental services, and the state’s results in attaining EPSDT participation goals. States may also voluntarily report annually on the quality of health care services provided under EPSDT using a set of quality measures known as the Child Core Set. CMS plans to increasingly use the Child Core Set in the future and state reporting will be mandatory beginning with the state reports for fiscal year 2024. States also have flexibility in determining where EPSDT services can be delivered. As a means of improving access—particularly in underserved communities, such as rural areas—Medicaid programs may cover certain services delivered by health care providers in schools. There were approximately 130,000 schools across the United States as of 2016, according to data from the Department of Education. Some of these schools have health clinics. Additionally, there were approximately 2,600 school-based health centers as of 2017, some of which served children in underserved communities, according to the School-Based Health Alliance. Telehealth as a Modality to Provide Services Some state Medicaid programs allow for services to be delivered via telehealth, including in schools. Telehealth can be used to provide clinical care remotely, such as for screening, counseling, and therapy. Health care providers offer care to patients through remote technology, such as a live, two-way video call. Such services could be provided, for example, via a video conference on a desktop computer or laptop that connects a student in school with a provider in another location. States have flexibility to choose whether to cover services delivered via telehealth. Because the federal Medicaid statute does not recognize telehealth as a distinct service, CMS views telehealth as a service delivery mechanism. According to CMS, services delivered via telehealth are subject to the same Medicaid requirements as those services provided in person. Selected States Provide Medicaid and Other Coverage for a Range of Opioid Use Disorder Services for Eligible Pregnant and Postpartum Women Selected States Provide Medicaid Coverage of Most Opioid Use Disorder Services for Eligible Pregnant Women and Women through 60 Days Postpartum The Medicaid programs in our six selected states provided coverage of most OUD services during pregnancy and the first 60 days postpartum, as of January 1, 2019. Specifically, the selected states’ Medicaid manuals indicate these states provide coverage for at least seven of the eight OUD services we identified in our review, such as screenings, inpatient and outpatient services, and MAT. (See fig. 1.) In the six states we reviewed, we did not identify differences between the types of covered OUD services for pregnant women in expansion and non-expansion states. For example, the three expansion states— Arkansas, Colorado, and Massachusetts—and the three non-expansion states—Alabama, South Dakota, and Texas—each covered at least seven of the eight OUD services for pregnant women. Similarly, we did not identify differences in Medicaid coverage for OUD services between the selected states that limited coverage to pregnancy- related services and those that provided full benefits. Arkansas and South Dakota—the two states providing only pregnancy-related coverage— covered seven of the eight OUD services for pregnant women. According to Medicaid officials in these two states, the programs cover these OUD services because they are considered medically necessary. In contrast, neither state generally provides Medicaid coverage for peer recovery coaching for beneficiaries, including pregnant women. Three of the selected states—Alabama, Colorado, and Texas—covered certain OUD services for pregnant women that they do not cover for other beneficiaries under Medicaid. For example, in Alabama, screening services and inpatient residential services were covered only for pregnant women, but not other eligible, low-income women. In Colorado, pregnant women were the only group in the state for whom residential OUD services were covered under Medicaid. In Texas, pregnant women were the only group in the state for whom case management is a covered service under Medicaid. Selected States Provide Medicaid Coverage for Most Opioid Use Disorder Services If Women Are Able to Maintain Medicaid Eligibility beyond 60 Days Postpartum In all six selected states, once Medicaid coverage furnished on the basis of pregnancy ends after 60 days postpartum, women can continue to receive most OUD services under Medicaid if they qualify for Medicaid on another basis. For example, these women could qualify if their income is equal to or lower than the maximum allowable income for parents. However, in the six selected states, the maximum allowable income for eligible parents was generally lower than that for pregnant women, as of January 2019. (See fig. 2.) Women in the six selected states who are eligible to maintain Medicaid coverage after 60 days postpartum can continue most of the same OUD services that were covered during pregnancy. However, officials in two states said that the OUD services covered specifically for pregnant women under Medicaid would generally not be covered after the postpartum period ends. Four of the selected states provided estimates of the number of women who maintain Medicaid eligibility after the postpartum period ends. For example, officials in Massachusetts, an expansion state, estimated that in 2017 and 2018, approximately 99 percent of women with Medicaid coverage while pregnant maintained Medicaid coverage after the postpartum period ended. State officials in Colorado, also an expansion state, estimated that in 2015, 75 percent of women maintained coverage after the postpartum period ended. Additionally, in Arkansas, another expansion state, officials estimated that about 60 percent of women in 2017 and 2018 maintained Medicaid coverage after the postpartum period ended. Officials in Alabama, a non-expansion state, estimated that in 2017, about 43 percent of women maintained Medicaid coverage after the postpartum period ended. States may also obtain approval from CMS, such as under a waiver, to extend Medicaid coverage for women with OUD beyond 60 days postpartum, according to CMS officials. However, CMS officials were not aware of the number of states that have done so. In our review, we found that one of the six selected states, Colorado, used a section 1915(b) waiver to extend Medicaid eligibility for substance use services, including OUD services, for women beyond 60 days postpartum. Under the state’s “Special Connections” program, which was approved under the waiver, women who are eligible for Medicaid during their pregnancy can continue Medicaid coverage for OUD services for up to 12 months postpartum, including inpatient residential services, which would not otherwise be covered under Medicaid. A state official told us that the program began in 1991 to provide substance use disorder services to pregnant women and up to 60 days postpartum. In 2006, the state extended coverage under the program to provide substance use disorder services up to 12 months postpartum. The program aids in early identification and intervention for pregnant women with substance use disorders who are at risk of delivering low birth weight babies with health complications. Officials said the goal of the program is to improve the likelihood that the mother remains free from substance abuse. According to Colorado officials, 227 women participated in the program in 2018. Selected States Use Other Funding Sources to Provide Coverage of Opioid Use Disorder Services for Postpartum Women Not Eligible for Medicaid We also found that the six selected states use other funding sources to provide coverage of OUD services for women with incomes that exceed the state’s Medicaid eligibility thresholds. Officials from the six selected states reported that they received SAMHSA grants so each state could provide OUD services for pregnant and postpartum women that extend beyond 60 days. According to the SAMHSA officials we interviewed, grants have been used to increase access to MAT, expand recovery support for pregnant women, and provide enhanced services for women to access OUD treatment. Furthermore, SAMHSA officials said that pregnant and postpartum women are specifically identified as target populations for grants, such as the agency’s State Targeted Response to the Opioid Crisis grant and its State Opioid Response grant. For example, officials in Arkansas told us that by using SAMHSA grants, they are able to allow uninsured or underinsured women who are seeking treatment for OUD to continue MAT treatment after 60 days postpartum. In addition, officials in the six selected states told us that women beyond 60 days postpartum generally would not experience gaps in treatment for OUD when transitioning from Medicaid to SAMHSA grant-funded programs, as women can generally continue receiving the same services and seeing the same providers. For example, state officials in Alabama, South Dakota, and Texas told us the state Medicaid agency contracts with providers that agree to participate in both the state’s Medicaid program and SAMHSA’s grant programs to allow for continuity of eligible services. Officials in Texas also told us they used state funds to implement a program to provide OUD services for up to 18 months postpartum. State officials told us that in this program—called the Neonatal Abstinence Syndrome-Opioid Treatment Services program—when a woman’s Medicaid coverage ends, she transitions to state-funded treatment to continue the same OUD services with the same provider. According to state officials, this program, funded since 2015, expands treatment services to postpartum women who would typically lose Medicaid coverage and become unable to pay for MAT services, which officials say help reduce relapse, overdose, and maternal mortality risk. State officials added that there is flexibility to extend services for postpartum women participating in the program for up to 2 years, if needed. State officials told us that since 2016, 296 women have participated in the program. In addition to the efforts in the selected states, the federal government has planned efforts to help states combat the opioid crisis, specifically for pregnant and postpartum women with OUD. For example, CMS plans to offer up to 12 cooperative agreements to states under the Maternal Opioid Misuse model as a way to improve access to services under Medicaid to pregnant and postpartum women with OUD. The model will have a 5-year performance period, 2020 through 2024, to allow states to implement strategies to improve the quality of care for pregnant and postpartum women with OUD. According to CMS officials, the model does not require that states extend coverage beyond 60 days postpartum, but states could choose to do so. CMS published the funding opportunity for the model in February 2019, and plans to select states to participate by the fall of 2019. In July 2019, CMS issued guidance to states regarding Medicaid coverage of services such as counseling for postpartum women while their infant is receiving treatment for Neonatal Abstinence Syndrome. The Centers for Disease Control and Prevention also issued a publication in September 2019 summarizing an initiative on state strategies to address OUD among pregnant and postpartum women and infants prenatally exposed to substances. The initiative identified five focus areas, including access to and coordination of quality services, provider awareness and training, and financing and coverage. In addition, the SUPPORT Act includes a provision for HHS to issue guidance to improve care for postpartum women with substance use disorder by the fall of 2019. Selected States Provide Medicaid Coverage for Annual Screenings and Any Medically Necessary Services for Substance Use, Including Opioids, for Eligible Children The six selected states provide Medicaid coverage for annual screenings of eligible children for substance use, including opioids, as well as any medically necessary treatment for conditions identified through these screenings, as of 2019. This coverage is provided through the Medicaid EPSDT benefit. Based on our review of Medicaid state plans and EPSDT policies and periodicity schedules, we found that the six selected states established the following screening schedules at the time of our review: Arkansas’ Medicaid state plan and Colorado’s and South Dakota’s EPSDT policies specify that these states follow AAP’s screening schedule. AAP recommends annual substance use screening for all children beginning at age 11 until they reach the age of 21. Alabama’s EPSDT policy requires annual screening for all children ages 6 to 13. Massachusetts’ EPSDT policy requires providers to conduct an annual assessment of every child’s risk for substance use as part of a health history assessment during a child’s annual visit. This assessment can be conducted at any age. Texas’ EPSDT periodicity schedule recommends annual screening for all children ages 12 to 18. Additionally, Massachusetts and Texas Medicaid programs require behavioral health screening for all eligible children. The Medicaid programs in these states provide separate payment for behavioral health screening if the screening is conducted using an approved screening tool, some of which also screen for substance use, such as opioids. Texas officials reported that substance use screenings are considered part of the required overall mental health screening component of annual checkups. Similarly, Arkansas officials said that as part of a new EPSDT policy they are drafting, the state Medicaid program will require behavioral health screening for all children, which can include substance use screening if determined medically necessary by the provider. The six selected state Medicaid programs report data on the total number of screenings provided under EPSDT for children’s health care needs. However, officials from five of the selected states said that it is difficult or impossible to separate and thus track the number of the substance use screenings as distinct from other types of EPSDT screenings or visits that are recorded in Medicaid data. States are required to track and report the total number of EPSDT screenings provided, but not the number of substance use disorder screenings. Officials from all six selected states said that they conduct outreach and education to providers and parents to ensure awareness of the EPSDT benefits, as required. We found that the extent of information the states provide on these services varied among the six states. For example, outreach materials from three of the six selected states included information about the availability of substance use screening, and one of these three states, Alabama, also included information about services for opioid use. For all six selected states, officials emphasized that Medicaid’s EPSDT benefit requires states to cover any medically necessary treatment or service to address health conditions for a child, including opioid use. Officials from the six selected states also described a variety of initiatives to increase access to substance use disorder, including OUD, services for children. For example: Officials from Alabama said they recently began a program that offers more substance use disorder services in schools in a face-to-face capacity to help increase convenience and reduce stigma around these services for both the children and the parents. They explained that the Alabama Department of Mental Health added modifiers to ensure that their systems can capture data appropriately and analyze trends in providing school-based services, which are currently offered in over 40 individual schools. Officials added that Medicaid pays for covered services that are provided to Medicaid-eligible children in schools under this program. Officials from two states—Arkansas and Massachusetts—said they recently expanded the types of substance use disorder services covered for all Medicaid beneficiaries. Officials from Arkansas added that they are working to expand the number of providers who can offer substance use disorder treatment under Medicaid. Officials from two states—Massachusetts and Texas—said they had recently developed programs specifically aimed at serving children with substance use disorder, including OUD, using federal authority. Massachusetts received approval from CMS to conduct a Medicaid demonstration to establish OUD programs for children. Texas is using SAMHSA grant funding to support eight youth recovery centers that are intended to improve services and recovery supports for youth with substance use disorder, including OUD. Over 30 States Reported Medicaid Coverage of Opioid Use Disorder Services Delivered through Telehealth in Schools, but No Evidence Services are Being Used We conducted outreach to Medicaid officials from all 50 states and the District of Columbia between February and July 2019 to inquire about whether the state provided Medicaid coverage of OUD services delivered via telehealth in schools as a means of increasing access to these services for children. Officials from 31 states and the District of Columbia reported that they provide Medicaid coverage of OUD services delivered in schools via telehealth. Medicaid officials from some states reported that their Medicaid policies explicitly allow for coverage of OUD services provided in schools via telehealth, while others reported that they allow for Medicaid coverage of these services, but their policies do not explicitly address the issue. (See app. I for the state responses regarding Medicaid coverage of OUD services provided in schools via telehealth.) Officials from the remaining 18 states reported that their Medicaid policies do not allow for payment for OUD services delivered in schools via telehealth. Some of these state officials reported that they did not allow schools to serve as a location for patient services during a telehealth visit for Medicaid payment purposes. Other state officials reported that they allowed Medicaid payment for certain services provided in schools via telehealth, but OUD services were not among them. For example, officials from Texas said the state established a school-based telehealth program for behavioral health services. However, this program does not include services for the treatment of substance use disorder, including OUD. Officials added that the state has a requirement that substance use disorder services can only be delivered in certain approved facilities. While Medicaid officials from 31 states and the District of Columbia reported that they provide Medicaid coverage of OUD services in schools via telehealth, they also said they were not aware of any instances of these services being utilized. Medicaid officials from the 31 states and the District of Columbia reported that either these services were not being provided based on data or other information they had, or they were unaware if the services were being provided. Officials from seven states responded that they either reviewed Medicaid utilization data or asked school-based staff and determined that there was no utilization of these services. For example, officials from one state—Ohio—conducted a data query and found that in 2018 there had been two instances of substance use disorder services billed to Medicaid that were delivered via telehealth in a school. However, officials noted that these instances involved treatment for substances other than opioids. While not for OUD, these two instances were the only instances of Medicaid payment for substance use disorder services delivered via telehealth in schools that we identified in our review. As part of our outreach to states and background research, we did find that some states or localities have taken steps to facilitate the use of telehealth for delivery of substance use disorder services, including OUD, in schools. For example: Officials from one county in Maryland said they recently began using a telehealth smart device application to screen students in schools for substance use disorder, including OUD, and refer them to treatment. However, county officials said that the program was locally funded, and they had not considered seeking Medicaid payment. A South Dakota tribal reservation recently implemented a new school- based telehealth program for behavioral health. According to officials, this program could include OUD services delivered via telehealth in schools, and these services could be billed to Medicaid if the provider was already licensed to bill Medicaid; however, officials said that none of these services had been provided to date. Massachusetts recently expanded its Medicaid telehealth policy to allow for the payment of mental health and substance use disorder services provided in many locations, including schools. However, officials said the state was still building the telehealth infrastructure, and services had not yet been provided at the time of our review. Officials were unsure whether OUD services would be delivered via telehealth in schools under the new policy once implementation began. State officials and subject matter experts that we spoke with also reported a range of potential benefits and challenges associated with providing substance use disorder services, including OUD services, in schools via telehealth. (See table 1.) There have also been federal efforts to emphasize the use of telehealth to improve access to OUD services for children. For example, these efforts include the following: In June 2018, CMS issued guidance emphasizing the use of telehealth as a means of improving access to OUD services and noted that states need not necessarily submit a change to their state plan to begin delivering covered Medicaid services through telehealth. Similar to what we heard from experts, this guidance suggests that leveraging technology to provide such services might help with addressing provider shortages, particularly in rural areas. In July 2019, CMS and SAMHSA jointly issued guidance on addressing mental health and substance issues in schools. The guidance states that telehealth for mental health services in schools has been found to be effective. This guidance also emphasizes that telehealth can be helpful for ensuring that Medicaid services are provided to Medicaid beneficiaries who are in rural areas or in areas where qualified practitioners are scarce. HRSA officials we spoke with also described several different HRSA programs from which funds could be used to facilitate or deliver substance use disorder services via telehealth, including in some school-based health centers; however, the officials were not able to determine whether telehealth is being utilized to deliver OUD services in school-based health centers, specifically. The SUPPORT Act also includes a provision for HHS to issue guidance to states on Medicaid coverage of substance use disorder services delivered via telehealth, including in school-based health centers, by fall of 2019. Agency Comments We provided a draft of this report to HHS for review. HHS provided technical comments, which we incorporated as appropriate. We are sending copies of this report to the Secretary of Health and Human Services, the Administrator of the Centers for Medicare & Medicaid Services, the Health Research and Services Administration, the Substance Abuse and Mental Health Services Administration, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact Jessica Farb at (202) 512-7114 or farbj@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 II. Appendix I: State Reported Medicaid Coverage of Opioid Use Disorder Services Delivered through Telehealth in Schools Appendix II: GAO Contact and Staff Acknowledgements GAO Contact Staff Acknowledgments In addition to the contact named above, Rashmi Agarwal (Assistant Director), Kaitlin McConnell (Analyst-in-Charge), Arushi Kumar, Kimberly Lloyd Perrault, Jennifer Rudisill, and Emily J. Weisenberger made key contributions to this report. Also contributing were Drew Long and Ethiene Salgado-Rodriguez. Related GAO Products Medicaid: Additional CMS Data and Oversight Needed to Help Ensure Children Receive Recommended Screenings. GAO-19-481. Washington, D.C.: August 16, 2019. Opioid Crisis: Status of Public Health Emergency Authorities. GAO-18- 685R. Washington, D.C.: September 28, 2018. Adolescent and Young Adult Substance Use: Federal Grants for Prevention, Treatment, and Recovery Services and for Research. GAO- 18-606. Washington, D.C.: September 4, 2018. Newborn Health: Federal Action Needed to Address Neonatal Abstinence Syndrome. GAO-18-32. Washington, D.C.: October 4, 2017. Drug Control Policy: Information on Status of Federal Efforts and Key Issues for Preventing Illicit Drug Use. GAO-17-766T. Washington, D.C.: July 26, 2017. Medicaid Expansion: Behavioral Health Treatment Use in Selected States in 2014. GAO-17-529. Washington, D.C.: June 22, 2017. Health Care: Telehealth and Remote Patient Monitoring Use in Medicare and Selected Federal Programs. GAO-17-365. Washington, D.C.: April 14, 2017. School Based Health Centers: Available Information on Federal Funding. GAO-11-18R. Washington, D.C.: October 8, 2010.


Background Opioids, such as hydrocodone and oxycodone, can be prescribed to treat both acute and chronic pain. Opioids can pose serious risks when they are misused. These risks include addiction, overdose, and death. As a result, opioids are classified as controlled substances, which means that their use and disposal are subject to additional oversight by DEA. Some studies suggest that the majority of patients who received prescriptions for opioids often do not use a large portion of the drugs dispensed. A study that surveyed U.S. adults who had received opioids found that approximately 60 percent of patients who were no longer using the medication had unused opioids. Two studies reported that over one- half of patients did not use all of the opioids prescribed to them after surgery; these studies found that patients reported leaving 15 to 20 pills unused, representing 54 percent to 72 percent of the opioids they were prescribed. Another study on patient opioid use after a cesarean section and thoracic surgery found that most patients, 83 percent and 71 percent respectively, used less than half of the total opioids they were prescribed. Federal Authorities There is no federal law or regulation imposing requirements for how patients are to dispose of unused opioids. However, DEA, FDA, and EPA all have authorities and initiatives related to patient disposal of opioids. DEA regulations specify three take-back options that patients can opt to use to dispose of their unused controlled substances: take-back events, permanent collection sites, and mail-back programs. DEA hosts semi- annual events called National Prescription Drug Take-Back Days, where temporary collection sites are set up in locations such as police stations. Advertisements encourage community participation in the events and educate the community on safe disposal of unused medications, including opioids. DEA also registers collectors and provides information to the public about the location of permanent collection sites for take-back, such as at local retail pharmacies or hospital pharmacies, and sets requirements for the provision of postage-paid envelopes that patients can use to mail unused drugs to a collector for destruction. DEA regulations establish a standard for the destruction of controlled substances that applies to DEA registrants, which can destroy opioids on patients’ behalf. DEA registrants include pharmaceutical companies that manufacture controlled substances, health care providers who prescribe them, and pharmacies that dispense them. The standard for destruction requires that controlled substances maintained or collected by DEA registrants be rendered non-retrievable. This means that the physical and chemical conditions of the controlled substance must be permanently altered, thereby rendering the controlled substance unavailable and unusable for all practical purposes. According to DEA, as of May 2019, the only method currently used to meet this standard is incineration, and DEA rulemaking states that DEA will not evaluate, review, or approve methods used to render a controlled substance non-retrievable. FDA has broad authority under the Federal Food, Drug, and Cosmetic Act to evaluate whether a drug is safe and effective and ensure the benefits of drugs outweigh the risks. FDA may require manufacturers to develop a risk evaluation and mitigation strategy (REMS) for drugs with serious safety risks, including the risk of abuse, to ensure that the benefits outweigh the risks. Under one REMS, for example, manufacturers of opioids intended for outpatient use must make training available to health care providers involved in the treatment and monitoring of patients who receive opioids. The training must contain certain elements, including how providers should counsel patients and caregivers about the safe use and disposal of these opioids, among other things. In October 2018, the SUPPORT Act authorized FDA to, at its discretion, require specific packaging or disposal systems as a part of certain drugs’ REMS. For drugs with a serious risk of overdose or abuse, FDA may require the drug to be made available for dispensing to certain patients with “safe disposal packaging” or a “safe disposal system” for purposes of rendering the drug non-retrievable in accordance with DEA regulations. Before imposing these requirements, FDA must consider the potential burden on patient access to the drug and the health care delivery system. As of May 2019, FDA had not imposed any REMS requirements using the new SUPPORT Act authority. Under the Resource Conservation and Recovery Act (RCRA), EPA has authority to regulate the generation, transportation, treatment, storage, and disposal of hazardous waste, including certain discarded opioids. However, hazardous waste pharmaceuticals generated by households are not regulated as hazardous waste even if the waste would otherwise be considered hazardous. Opioids and other household waste pharmaceuticals collected through a take-back option are also exempt from most hazardous waste regulations, provided certain conditions are met. Some states and localities have imposed additional requirements for pharmaceutical disposal, such as requirements for drug manufacturers to manage or fund the disposal of collected household pharmaceuticals. Federal Agencies Recommend Take- Back Options as the Preferred Disposal Method Federal Agencies Recommend Take-Back Options Whenever Feasible, Followed by Disposal Using the Toilet or Trash According to DEA, FDA, and EPA, patients should use take-back options to dispose of unused opioids, whenever feasible. Only if take-back options are not feasible, FDA recommends flushing opioids on FDA’s flush list down the toilet to remove them from the home as soon as possible. For opioids not on the flush list, the agencies recommend placing the drugs in the household trash mixed with an unpalatable substance. (See fig. 1). Officials from FDA said that the primary goal of these recommendations is to remove dangerous substances from the home as soon as possible to reduce accidental poisoning, which also may address issues related to intentional misuse. FDA officials explained that the agency has not measured the effects of its recommendations for disposing of opioids on opioid misuse, as of May 2019, because it is difficult to establish a causal link between the recommendations and any reductions in misuse. DEA, FDA, and EPA recommend using a take-back option as the preferred method for patients to dispose of unused prescription opioids. Under this method, patients can bring unused opioids to DEA’s semi- annual take-back events or to DEA-registered permanent collection sites, or use mail-back to deliver opioids to a DEA-registered collector for destruction. When patients use these take-back options, the drugs they dispose of are ultimately incinerated, which is the only method that DEA officials said is known to render the drugs non-retrievable, that is, permanently and irreversibly destroyed. Our analysis of DEA and U.S. Census Bureau data shows that as of April 2019, 71 percent of the country’s population lived less than 5 miles from a permanent collection site, and in 42 states, at least half of the population lived within 5 miles of a site. (See fig. 2). This number has increased since our April 2017 report, when we found that about half of the country’s population lived less than 5 miles away from a site. Our analysis also shows that 90 percent of the population lived within 15 miles of a site, though in rural areas only 57 percent lived within 15 miles. In addition, two studies found that patients were willing to bring unused opioids to a take-back location as long as it was located within 5 to 8 miles of their home address. If take-back options are not feasible, FDA recommends flushing the opioids on its flush list down the toilet, because a single dose can be fatal to a child or a pet. Flushing is a permanent way to remove opioids from the home. FDA confirmed that as of June 2019, 11 of 14 drugs on the flush list are opioids, which represents about three-quarters of the approved opioid active ingredients intended for outpatient use (see sidebar). Some portion of drugs that are flushed down the toilet ultimately enter surface and wastewater streams. However, a 2017 FDA study on the environmental impact of drugs listed on the flush list concluded that flushing these opioids has negligible effects on the environment and human health, particularly relative to the amount of opioids that are excreted after taking them as prescribed, because not all of the drug is metabolized. (See text box for a summary of the effects of disposal options on the environment.) Environmental Effects of Disposal Options The environmental impact of opioid disposal depends on the method used—take-back options, flushing, or trash. According to Environmental Protection Agency (EPA) and Drug Enforcement Agency (DEA) officials, disposal of drugs through take-back options results in disposal by permitted incineration, which fully destroys the active form of the drugs. EPA officials told us that flushing or placing opioids in the trash can introduce active opioids into wastewater streams, groundwater, and surface waters. Incineration of Drugs from Take-Back Options. Opioids disposed of using take-back options are destroyed by incineration, which, according to DEA officials, is the only method currently used to meet its non-retrievable standard for destruction. EPA officials told us that based on data from DEA, the amount of household pharmaceutical waste gathered and incinerated during DEA’s semi-annual take-back events is small compared to the total amount of waste one incinerator burns on an average day. EPA officials recommended take-back options as the preferred method of opioid disposal. Flushing. Opioids enter the water supply when excreted by patients who take opioids as prescribed and when patients intentionally flush unused opioids down the toilet. EPA officials told us that most wastewater treatment facilities are not designed to eliminate opioids from wastewater streams. Further, measureable concentrations of opioids have been reported in surface and ground water sources around the world. Trash. Disposal of unused opioids in the trash often introduces opioids into landfills. Studies in scientific literature show that pharmaceutical ingredients have been observed in the water that passes through landfills, called leachate. Similar to opioids that are flushed, opioids in landfill leachate can end up in wastewater streams and other water sources, according to EPA officials. Household Trash If an opioid is not on the FDA flush list and a take-back option is not feasible, the agencies direct patients to take a series of steps to dispose of their opioids in household trash by: (1) mixing the drugs in an unpalatable substance such as dirt, cat litter, or used coffee grounds, (2) placing the mixture in a sealed container or plastic bag, and (3) throwing the container in the trash. An EPA official said that mixing the drugs with an unpalatable substance is meant to deter misusers from searching through the trash to retrieve the drugs. Disposal of opioids in the trash—either with an unpalatable substance or in-home disposal product—removes them from the home, but this option may not be permanent and the drugs still may be available for misuse. Drugs that are disposed in the trash ultimately are introduced to landfills, where they can escape landfill containment and enter wastewater streams or ground water sources. FDA Has Not Evaluated Commercial Disposal Methods FDA’s website notes the availability of commercial products for disposing of unused opioids and other drugs in the home. FDA officials stated that, as of May 2019, the agency had not evaluated the effectiveness of these products or made any recommendations related to their use, but they are aware that patients may opt to use these products. These products, known as in-home disposal products, are proprietary substances that patients can mix with their unused drugs, including opioids, before disposing of them in the trash. In-home disposal product vendors told us they sell or donate their products to pharmacies, local law enforcement, and community groups, which then distribute them to patients. A representative from a group that distributes these products, the AmerisourceBergen Foundation, noted that in-home disposal products may be a convenient option for patients for whom take-back options are not feasible, and marketing materials from a product vendor instruct patients to use their product if a take-back option is not available. Vendors indicate that their products can prevent misuse of opioids by rendering drugs non-retrievable at home and by motivating patients to dispose of unused opioids. According to DEA officials, rendering opioids non-retrievable by using an in-home disposal product is challenging, because the drugs have a variety of chemical and physical properties and potencies. Furthermore, according to DEA officials, a lethal dose of fentanyl can be as low as 250 micrograms in adults—and lower in children—underscoring the importance of effective disposal. Some vendors have presented evaluations of their commercial products. A recent comprehensive review of eight in-home disposal products raised concerns about the credibility of vendors’ evaluations and concluded that additional independent laboratory analysis is needed to fully examine product performance and assess how well these products achieve stated goals. Our review of evaluations from three vendors found that the studies contained some inconsistencies and gaps in the evaluation methods used, raising questions about the studies’ conclusions that the products are effective for disposing of opioids. In some cases, studies included detailed, but inconsistent, methods. For example, in four studies about one product, the researchers concluded that the product deactivated most of an opioid dissolved in water. However, one of the earlier studies reported that whole pills did not dissolve in water, which could impact the results, but later studies did not include similar data. In other cases, companies’ evaluations were summaries of results that did not provide enough information to independently verify or assess whether the products deactivate opioids and prevent misuse. For example, one company’s research documents presented images of a mixture as evidence that the drugs had degraded, rather than results of a test measuring if drugs were still detectable. In addition, the studies included little information about the products’ effectiveness at treating mixtures of multiple drugs at the same time, a scenario that stakeholders have referred to as “real world” use testing. Few Patients Use Federally Recommended Opioid Disposal Methods; FDA and Others Have Taken Steps to Educate the Public Few Patients Use Federally Recommended Methods to Dispose of Unused Opioids Disposal methods—when patients use them promptly—remove unused opioids from the home and therefore can be effective at reducing opioid misuse. FDA officials said that the federally recommended methods for disposing unused opioids are intended to remove these substances from the home as soon as possible, and stated that as long as individuals dispose of opioids promptly rather than storing them, then FDA has achieved its goal. However, the studies we reviewed suggest that most patients do not dispose of unused opioids using a federally recommended method. Specifically, three studies examined how patients disposed of unused opioids and found that between 12 percent and 41 percent of patients disposed of them using a federally recommended method. For example, one of the studies found that of 570 survey respondents who had unused opioids, 12 percent of respondents reported using a take-back option, 14 percent reported that they flushed them down the toilet, and 6 percent reported that they threw them in the trash after mixing with an unpalatable substance. Other studies we reviewed show that take-back options are often used to dispose of drugs other than opioids. Two studies found that less than 10 percent of the catalogued drugs brought to DEA take-back days were controlled substances, which included opioids, while another study weighed drugs brought to take-back events and permanent collection sites and reported less than 3 percent were controlled substances, including opioids. The same study found that annually, controlled substances disposed of at take-back events and permanent collection sites accounted for about 0.3 percent of those dispensed in the area, and concluded that take-back events may have a minimal impact on reducing the availability of unused opioids for misuse. Studies indicate that patients who receive an in-home disposal product may be more likely to dispose of unused opioids, but they may also be less likely to use federally recommended options like take-back or flushing. Two studies in our review found that patients who receive an in- home disposal product have reported that they are more likely to dispose of unused opioids than those who did not receive the product. Use of in- home disposal products—which may not be effective at permanently destroying drugs—may deter patients from using federally recommended options, like take-back, that have been proven effective. For example, one of these studies found that only one of the 70 patients who received an in-home disposal product used a take-back option for disposal, despite the study taking place in a state where we estimated that 77 percent of the population lived less than 5 miles from a permanent collection site. Studies indicate that patients are often unaware of federally recommended disposal options. Three of the 25 studies we reviewed suggest that many patients were not aware of federally recommended methods for disposing of opioids. For example, a study of cancer patients who received opioid prescriptions reported that more than three- quarters of these patients were unaware of proper opioid disposal methods. Another 2016 study of 1,032 patients found that nearly half of the respondents did not recall receiving information on proper disposal from pharmacists, medication packaging, or media outlets. Studies also indicate that patients choose not to dispose of unused opioids, and that they knowingly participate in the majority of opioid misuse. Five of the studies we reviewed found that between one-quarter and three-quarters of patients stored unused opioids for future use or had misplaced their unused opioids. For example, one of these studies found that 49 percent of survey respondents kept or planned to keep unused opioids for future use, and 14 percent were likely to let a family member use their opioid medications in the future. Federal data about the sources of misused opioids indicate that patients are complicit with most misuse. SAMHSA estimates that 5 percent of people nationwide who misused opioids in 2017 took these drugs from someone else without asking. In contrast, SAMHSA estimates that 85 percent of opioid misuse occurs with the patient’s knowledge or active participation, either through the patient misusing his or her own prescription by taking the drug for pain other than for which it was prescribed or by giving or selling the prescribed opioids to another person. (See fig. 3). FDA and Others Have Taken Steps to Educate Patients and Providers about Appropriate Opioid Disposal To motivate patients to use federally recommended methods to dispose of unused opioids, FDA and some physician organizations have created educational materials on safe disposal methods. For example, FDA launched a public awareness campaign called “Remove the Risk” on April 25, 2019—complete with educational materials such as public service announcements, social media posts, fact sheets, and other web-based content. AMA representatives reported that the AMA has provided physicians with educational material on drug disposal and prescribing. Specifically, AMA representatives told us that the association has compiled a two-page document for physicians containing information about drug disposal, links to DEA information on nearby permanent collection sites and take-back events, and FDA guidance on safe disposal of medications. This document included recommendations for physicians to talk to patients about safe use of prescription opioids, remind patients to store their medications in a safe place out of reach from children, and have a conversation with patients about the most appropriate ways to dispose of expired, unwanted, or unused opioids. The AmerisourceBergen Foundation has also partnered with communities to promote safe opioid disposal by providing education about take-back options and commercial in-home disposal products to patients. A representative from the Foundation explained that its Safe Disposal Support Program provides non-profit organizations or municipalities with commercial in-home disposal products, which then can be distributed free of charge to other organizations, individuals, or households. It also recommends that patients use take-back options when available. The representative said that organizations are to demonstrate to patients how these products work either through a brief in-person demonstration at an event or through a video. According to the representative, these products and demonstrations help people reflect on what is in their home and needs to be disposed of, either using a product or a take-back option. Despite such efforts, little is known about the extent to which stakeholders’ efforts to educate the public are effective in increasing use of federally recommended disposal methods. FDA officials said that they are not aware of the extent to which providers are familiar with all disposal methods or the extent to which providers discuss the importance of proper disposal with patients. As part of FDA’s REMS requirements for outpatient opioids, manufacturers must make training available to health care providers involved in the treatment and monitoring of patients who receive opioids, which includes information about the need to communicate with patients about disposal of unused drugs. FDA officials said that opioid manufacturers must assess the effectiveness of their REMS, including an assessment of prescribers’, other health care providers including pharmacists’, and patients’ understanding of the key risk messages conveyed through the educational materials. FDA expects to receive the next REMS assessment with the results of these analyses in 2020. The AMA has not been able to measure the effects of its recommendations, but provided anecdotal feedback from its members that many physicians do not consistently speak to their patients about disposal. FDA officials and AMA representatives indicated that in addition to educating patients on opioid disposal methods, focusing efforts on reducing the amount of unused opioids would be an effective approach for reducing misuse and abuse. For example, FDA officials said that adding packaging configurations that contain smaller quantities of certain opioids could help prescribers to more carefully consider the amount of opioid pain medication they prescribe. This in turn may reduce the number of unused opioids available in the home that could be inappropriately accessed by family members or visitors, and could potentially reduce the risk for misuse and abuse. Representatives from the AMA explained that it and other organizations are working to provide opioid prescribing resources and guidance to help physicians effectively manage patients’ pain, which representatives said will reduce the number of unused opioids available for misuse. FDA officials and a researcher also noted that dispensing opioids in packaging that makes it easy to count the number of unused pills may help patients identify intentional misuse. Agency Comments The FDA and EPA provided technical comments on a draft of this report, which we incorporated as appropriate; the DEA did not have comments. We are sending copies of this report to the appropriate congressional committees, the Secretary of Health and Human Services, the Administrator of the DEA, the Administrator of the EPA, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff members have any questions about this report, please contact me at (202) 512-7114 or cosgrovej@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix I. Appendix I: GAO Contact and Staff Acknowledgments GAO Contact James Cosgrove, (202) 512-7114 or cosgrovej@gao.gov. Staff Acknowledgments In addition to the contact named above, individuals making key contributions to this report include Leslie V. Gordon (Assistant Director), A. Elizabeth Dobrenz (Analyst-in-Charge), Sam Amrhein, Jieun Chang, Diana Chung, Kaitlin Farquharson, and Dennis Mayo. Also contributing were Giselle Hicks, Cynthia Khan, and Ethiene Salgado-Rodriguez.