1
Introduction and Background
The opioid epidemic has been recognized as a national emergency (Gostin et al., 2017; HHS, 2021). In 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) reported that nearly one in five people aged 12 or older (19.4 percent) used an illicit drug in the past year, which is a higher percentage than in 2015 and 2016 (SAMHSA, 2018b).
Deaths due to prescription drugs, synthetic opioids, and heroin increased significantly over the past decade. Particularly notable is an increase in deaths due to illicitly manufactured fentanyl and its analogs. The use of opioids with other drugs, such as benzodiazepines, stimulants, or alcohol, also increased dramatically (CDC, 2018, 2019, 2020b). While the most recent provisional data available from the Centers for Disease Control and Prevention’s (CDC’s) National Center for Health Statistics (NCHS) indicate that approximately 81,230 drug overdose deaths occurred in the United States in the 12 months ending in May 2020, this is primarily driven by synthetic opioids such as fentanyl as well as stimulants such as cocaine and methamphetamine (Ahmad et al., 2020). In addition to the driving factor of illicitly manufactured fentanyl, other contributors to the mortality increases include suicidality, limited availability and use of effective treatment (NASEM, 2019, 2020a; Oquendo and Volkow, 2018), inadequate access to naloxone and other harm reduction strategies (NASEM, 2020a), low treatment retention, and pockets of continued over-prescribing of high-dose opioids (NASEM, 2017). Inadequate support for school- and community-based prevention programs with the goal of long-term reduction in drug use and overdoses and stigma have additionally hampered a full array of public health responses to the pandemic. On December 17, 2020, CDC released a Health Alert Network Advisory to alert the nation that unprecedented rises in fatal drug overdoses across the United States is occurring, and have worsened significantly during the COVID-19 pandemic (CDC, 2020a).
The overdose crisis continues to call for a comprehensive approach to saving and improving lives. While genetics and biological factors increase the risk of developing opioid use disorder (OUD), social determinants of health play a critical role (Dasgupta et al., 2018; Volkow and Blanco, 2020). Social determinants of health contribute to the spectrum of use, from initiation to misuse and continued harmful use in the setting of an OUD. Enhancing overdose prevention and response, improving access to treatment that is evidence-based, and instituting protocols to ensure that individuals are being retained in treatment and recovery are important elements of a comprehensive approach.
To prevent overdose deaths, naloxone should be easily accessible to a diverse range of actors (Bach and Hartung, 2019; Davis et al., 2014; Naumann et al., 2019). In many states, community pharmacists have the ability to dispense naloxone without a prescription. Pharmacy dispensing, however, is likely not sufficient to meet the
overall need (Guy et al., 2019). Standing orders and community-based naloxone distribution programs also serve as important access points (NASEM, 2019). Syringe services programs can provide naloxone as well. This will help to reduce high-risk injection behaviors and consequences (NASEM, 2020a). Given the prevalence of potent illicitly manufactured synthetic opioids, routine distribution and utilization of rapid fentanyl test strips as a part of syringe services programs may lead to behavior changes in injecting and an overall lower overdose risk (Krieger et al., 2018a,b; Peiper et al., 2019). This may be an especially important intervention given recent evidence that naloxone may not be as effective in preventing overdose deaths by fentanyl and its analogs (Torralva and Janowsky, 2019).
Treatment access for substance use disorders (SUDs) and OUD in particular is not uniformly distributed across the country (NASEM, 2017). Buprenorphine has become increasingly available in some medical practices, with an increase in waivered prescribers and policy changes on how many patients can a prescriber can treat at any given time (Andrilla et al., 2019); this is especially important as buprenorphine, in addition to methadone, has been found to be effective for treating OUD associated with fentanyl (Wakeman et al., 2019). However, more than 40 percent of U.S. counties have no practitioners able to prescribe buprenorphine for the treatment of OUD (HHS OIG, 2020). Differences in insurance coverage contribute as well. A recent study found that states that adopted Medicaid expansion under the Patient Protection and Affordable Care Act saw increases in admissions to OUD treatment, especially for medications for OUD (MOUD), more than double in the 4 years after adoption (Saloner and Maclean, 2020). The same study found an increase in admissions to intensive outpatient services for SUD (Saloner and Maclean, 2020), the type of service provided by the State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT) program. Still, the availability of treatment is limited when compared with the overall need. Additionally, patient retention is a challenge in treatment programs (Williams et al., 2019).
Data suggest that increased treatment access and more appropriate opioid prescribing practices are associated with fewer overdose deaths, reduced prevalence of OUD, and related comorbidities (Seth et al., 2018). Use of MOUD1 leads to a reduction in overdoses and an increase in quality-of-life measures. This can be especially beneficial for populations at high risk of overdose, including those who are incarcerated (NASEM, 2020a). Although medically supervised withdrawal may be necessary to start treatment, it can lead to a higher likelihood of overdose if not coupled with initiation of the medication and engagement in care (SAMHSA, 2016). Current practice guidelines reinforce approved MOUD over medically supervised withdrawal alone (NASEM, 2017). Barriers to MOUD include limited availability of waivered providers, insurance coverage limits, and stigma (NASEM, 2020a). Peer-support services may also decrease substance use and provide linkages to medical care (Ashford et al., 2018; Englander et al., 2020).
COMPREHENSIVE ADDICTION AND RECOVERY ACT
To help address the challenges of overdose deaths and lack of access to evidence-based treatment, the Comprehensive Addiction and Recovery Act (CARA; P.L. 114-198) was signed into law on July 22, 2016.2 CARA is extensive legislation intended to address many aspects of the opioid epidemic, including prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. It authorizes more than $181 million each year in new federal funding to address the opioid epidemic. It mandates the implementation of programs and services to address opioid use across the United States to address addiction and recovery.3 While OUD is a significant cause of harm and a significant cause of increases in mortality in the United States, it is critical to note that many individuals with OUD have an additional SUD. This is because various types of SUDs tend to co-occur (NIDA, 2020; Seth et al., 2018). The CARA program grants described in this report, while focused primarily on opioids, may also occasionally include treatment and recovery services for co-occurring SUDs.
___________________
1 The committee prefers the term MOUD rather than medication-assisted treatment (MAT), because the latter gives the false impression that medications alone are not helpful in treating OUD (NASEM, 2019, 2020a); the term MAT will be used only when presenting direct quotes from grantees or SAMHSA.
2 See https://www.congress.gov/bill/114th-congress/senate-bill/524/text (accessed March 13, 2020).
3 See https://www.cadca.org/comprehensive-addiction-and-recovery-act-cara (accessed March 13, 2020).
Following the passage of CARA, the Consolidated Appropriations Act, 2018, included appropriations requesting a study of the SAMHSA programs in CARA, to be conducted by the National Academies of Sciences, Engineering, and Medicine (the National Academies).4 Specifically, the legislation states that
within the total for administration, technical assistance, and evaluation, provided to SAMHSA for the State Opioid Response Grants, the agreement includes … a [National Academies] review [to] identify outcomes that are to be achieved by activities authorized in the Comprehensive Addiction and Recovery Act (P.L. 114-198) and the metrics by which the achievement of such outcomes shall be determined, as required by section 701 of such Act. The [National Academies] study should report on the effectiveness of the programs in achieving their respective goals for preventing, treating, and supporting recovery from SUD. The [National Academies] study will result in the public availability of program-level data and recommendations to Congress concerning the appropriate allocation of resources to such programs to ensure cost-effectiveness in the Federal government’s response to the opioid addiction epidemic. It is expected that an interim report will be completed within three years after enactment of this Act, and a final report will be completed within five years after enactment of this Act.
There are four sections in CARA specific to SAMHSA.
Title I, Prevention and Education, Section 107: Improving Access to Overdose Treatment Program (OD Treatment Access). This provision allows the Department of Health and Human Services (HHS) to award grants to eligible entities to expand access to opioid overdose reversal drugs or devices.
Title II, Law Enforcement and Treatment, Section 202: First Responder (FR) Training. This provision authorizes HHS to make grants to state, local, and tribal law enforcement agencies for training in the emergency use of naloxone (or other Food and Drug Administration [FDA]-approved devices) and naloxone purchases.
Title V, Addiction and Treatment Services for Women, Families, and Veterans, Section 501. This provision reauthorizes a grant program targeting Pregnant and Postpartum Women (PPW-PLT). This is a grant program for nonresidential OUD and SUD treatment of pregnant and postpartum women (PPW) and their children. It also creates a pilot program for state substance abuse agencies to address identified gaps in the continuum of care.
Title III, Treatment and Recovery, Section 302: Building Communities of Recovery (BCOR). This provision authorizes HHS to award grants for supporting the development and expansion of recovery services.
STATEMENT OF TASK AND REPORT METHODOLOGY
The committee’s Statement of Task is in Box 1-1; the committee will produce three reports in 5 years. The first report recommended changes or additions to the reporting metrics used in the SAMHSA grant programs, and a summary of its recommendations can be found in Appendix C of this report. The subsequent report, presented here, provides an update on progress toward achieving program goals based on a review of a variety of data collected by grantees and reported to SAMHSA. The final report will assess each program’s effectiveness in accomplishing its goals. The final report, to be published in 2023, will also recommend to Congress the appropriate distribution of resources for these and similar grant programs to ensure the implementation of a cost-effective federal response to the opioid epidemic.
To address its charge for the second report, the committee gathered data from SAMHSA about each of the grant programs. For the first report, SAMHSA provided the funding opportunity announcements (FOAs) and mandatory reporting tools required for the four programs. For this present report, SAMHSA has additionally provided data summaries for the PPW-PLT and BCOR programs in the form of data outputs from the Center for Substance Abuse Treatment (CSAT) Government Performance and Results Act (GPRA) tool, as well as redacted grantee annual progress reports. For the OD-Treatment Access and FR-CARA programs, SAMHSA provided summaries generated from text-based answers to the questions in the Center for Substance Abuse Prevention (CSAP) Division of State Programs-Management Reporting Tool (DSP-MRT), and from an additional program-specific reporting tool for OD Treatment Access.
___________________
4 See https://www.govinfo.gov/content/pkg/CPRT-115HPRT29457/pdf/CPRT-115HPRT29457.pdf (accessed January 5, 2021).
Grantee progress reports received from SAMHSA were heavily redacted, resulting in much contextual information not being available to the committee. SAMHSA explained that their agreements with grantees prohibited SAMHSA from sending the committee unredacted program progress reports. To fill in some of these gaps, the committee reached out to individual grantees to request additional information; a limited number of unredacted progress reports were received. After an initial review of all of the materials received, the committee contacted SAMHSA with clarifying questions about the data, and the agency’s responses were used in the creation of this report. The committee’s specific methodological approach and the limitations of the data provided are outlined separately in Chapters 2 and 3.
The committee’s approach to assessing progress toward achieving program objectives was broadly informed by several conceptual and methodological approaches, applied within the constraints of the available data. Specifically, the committee, while tasked to conduct an independent evaluation of the programs, did not have the charge or opportunity to design an a priori evaluation of the programs or to directly inform or oversee either program or SAMHSA efforts to collect data. The first report in this series did recommend changes in data collection (NASEM, 2020b; see Appendix C), but the committee did not have the authority to ensure that those changes were implemented. The committee is unaware of SAMHSA’s plans to respond to the recommendations made in that report. Furthermore, program evaluation plans when prepared were not fully available to the committee, and SAMHSA did not conduct an overall program evaluation. As a result, the evaluation conducted by the committee was limited to reviewing the data provided either by individual programs or by SAMHSA, largely in redacted and aggregate form.
There are known limitations to using aggregate data for purposes of evaluations that are more appropriately conducted with pre- and post-intervention data, as well as with appropriate comparison groups (Jacob et al., 2014; Lago, 2013; Ryan and Thompson, 2002). The CARA programs under review were under way prior to the committee receiving data and pre-period data were not available; moreover, while data from similar programs in the grantees’ geographic area could have been used for comparative analyses, the committee did not have access to those data. In addition, redaction often made it difficult to compare grantees, particularly absent information on specific geographic and/or policy contexts.
The committee began by considering conceptual frameworks from implementation sciences for the evaluation, including frameworks that SAMHSA has used such as the Strategic Prevention Framework, which considers
(1) Assessment, (2) Capacity, (3) Planning, (4) Implementation, and (5) Evaluation, along with two cross-cutting components (cultural competence and sustainability; SAMHSA, 2019a); RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance; Glasgow et al., 2001); the Exploration, Preparation, Implementation, Sustainment (EPIS) framework (Becan et al., 2018); and other models. The committee considered a blend of features, similar to the EPIS and RE-AIM framework, focusing on engagement of agencies/stakeholders, preparation and implementation, and reach and effectiveness. The challenge in using a particular framework, or even a blend, is that the programs had distinct features, focused on specific required activities, and data were not available across programs on relevant evaluation and implementation constructs from a given framework, nor were measures used that are validated indicators for those constructs—and the committee was not in a position to require specific measures. Although the committee did not adopt a specific framework, general principles from implementation science and evaluation frameworks were used as part of the evaluation.
Given these considerations, as well as the distinct nature of the four programs, the committee assessed progress by reviewing and matching information received to each of the required and allowable activities specified in the FOAs. The committee considered whether there was evidence regarding progress in terms of planning and implementation steps (e.g., hiring, training staff, relationship building) and outcomes (e.g., client-based substance use outcomes; naloxone distribution and use; public education; trainings conducted). The committee describes the information it used in detail in Chapters 2 and 3. Importantly, the committee notes that the grantees of all four CARA programs have continued implementing the programs since the point in time at which they submitted these required reporting materials to SAMHSA. As such, this report does not reflect grantees’ most recent progress.
As with the first report, the committee focused only on the four grant programs previously described, not on SAMHSA’s approach to OUD or SUD in general. Still, it is the committee’s hope that this report can be useful for other efforts to address SUD or reform reporting and evaluation requirements in grant programming. SUDs, including OUD, are relapsing disorders with a complex biopsychosocial etiology; it is not the committee’s expectation that any of these grant programs could fully address the challenges of OUD and SUD in communities where they exist. However, by reporting on the programs’ progress to date, it may be possible to further improve their services and glean lessons applicable to SAMHSA’s future grant making and other program planning efforts related to OUD and SUD.
ORGANIZATION OF THE REPORT
The report contains three other chapters. Chapter 2 addresses the two programs administered by SAMHSA’s CSAT—BCOR and PPW-PLT. Chapter 3 addresses the two programs administered by SAMHSA’s CSAP—FR-CARA and the OD Treatment Access programs. Both chapters briefly describe the programs (a more in-depth description can be found in the first report of this series), the data provided by SAMHSA, limitations of the data, the committee’s understanding of how the provided material relates to the specific required and allowable activities, and the committee’s findings about progress to date. Chapter 4 contains the committee’s conclusions about the four programs overall, and a discussion on challenges it sees in preparing the final report.
This page intentionally left blank.
