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Introduction

The opioid epidemic has been recognized as a national emergency (Gostin et al., 2017; HHS, 2021, 2023). In 2021 the Substance Abuse and Mental Health Services Administration (SAMHSA) reported that nearly 22 percent of people aged 12 or older used an illicit drug in the past year, which is a higher percentage than in prior years (SAMHSA, 2018b, 2021). Deaths due to prescription drugs, synthetic opioids, and heroin have increased substantially over the past decade (NIDA, 2022). Particularly notable has been the more recent increase in deaths due to illicitly manufactured fentanyl and its analogs (CDC, 2018a; NIDA, 2022). The use of opioids with other drugs, such as benzodiazepines, stimulants, or alcohol, has also increased dramatically (CDC, 2018a, 2019, 2020b). The COVID-19 pandemic has compounded this substance use disorder (SUD) epidemic; on December 17, 2020, the Centers for Disease Control and Prevention (CDC) released a Health Alert Network Advisory to alert the nation that an unprecedented rise in fatal drug overdoses across the United States was occurring, which has worsened significantly during the COVID-19 pandemic (CDC, 2020a); this trend has continued (SAMHSA, 2021).¹

COMPREHENSIVE ADDICTION AND RECOVERY ACT

To help address the challenges of overdose deaths and opioid use disorder and to expand access to evidence-based treatment, the Comprehensive

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¹ The text in this paragraph is reprinted from the second report in this series, updated with more recent data where available (NASEM, 2021).

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 opioid use disorder (OUD) is a significant cause of harm and a significant cause of increase 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 grant programs described in this report, while focused primarily on opioids, may also occasionally include treatment and recovery services for co-occurring SUDs. CARA also mandated a role for the National Academy of Sciences in Section 701, Grant accountability and evaluations. See Box 1-1 for the verbatim text. A report on outcomes and metrics was to be completed by 6 months after passage and an evaluation to be completed 5 years after passage of CARA. No funds were specifically appropriated for this work, and the National Academies received no request to perform the evaluation around the time of passage of CARA.

Following the passage of CARA, the Consolidated Appropriations Act, 2018, included appropriations requesting a study of the SAMHSA programs⁴ specified in the CARA legislation, to be conducted by the National Academies of Sciences, Engineering, and Medicine (the National Academies).⁵ Specifically, the legislation states that

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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).

⁴ Throughout this report, “program” is used to refer to the four grant programs administered by SAMHSA, and the entities to which the funds were distributed are referred to as “grantees.”

⁵ See https://www.govinfo.gov/content/pkg/CPRT-115HPRT29457/pdf/CPRT-115HPRT29457.pdf (accessed January 5, 2021).

There are four sections in CARA specific to SAMHSA. Brief descriptions are provided below:⁶

Title I, Prevention and Education, Section 107: Improving Access to Overdose Treatment Program (OD Treatment Access). This provision allows the U.S. 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 Training (FR-CARA). 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 U.S. 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.⁷

THE FOUR PROGRAMS

Two of the Comprehensive Addiction and Recovery Act (CARA) grant programs—Building Communities of Recovery (BCOR) and the State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT)—are administered by the Center for Substance Abuse Treatment (CSAT).

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⁶ For a complete description of what the legislation text specified about each program, see the complete CARA legislation at https://www.govinfo.gov/content/pkg/CPRT-115HPRT29457/pdf/CPRT-115HPRT29457.pdf (accessed March 9, 2023).

⁷ All text in this section, “Comprehensive Addiction and Recovery Act,” is reprinted from the second report in this series (NASEM, 2021).

The other two grant programs—Improving Access to Overdose Treatment (OD Treatment Access) and First Responder Training (FR-CARA)—are focused on preventing overdose and are administered by the Center for Substance Abuse Prevention (CSAP).

Building Communities of Recovery (BCOR)

As with the PPW-PLT, SAMHSA began accepting applications for the BCOR program in fiscal year (FY) 2017. BCOR is intended to organize community resources and bolster support systems for SUDs. Specifically, the grant’s aim is to support “the development, enhancement, expansion, and delivery of recovery support services (RSS) as well as promotion of and education about recovery.” The BCOR funding opportunity specifies one required activity and three allowable activities around which grantees should focus their efforts; these are laid out in Table 1-1, along with additional information about the program (SAMHSA, 2017a).

BCOR grantees are registered 501(c)(3)s and—to ensure appropriate representation—must be led and governed by individuals within the local communities of recovery (SAMHSA, 2017a). SAMHSA funded 8 grantees in FY2017, and an additional 18 grantees in FY2018 (SAMHSA, 2017g, 2018f).⁸ Some of these most recent grantees have also received other SAMHSA peer-to-peer grants and therefore have relevant existing infrastructure; other grantees are new to SAMHSA. Grantees may receive funding for a maximum of 3 years (SAMHSA, 2017a).

State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT)

The purpose of the PPW-PLT program is to

As a result of this program, “SAMHSA seeks to: 1) reduce the abuse of alcohol and other drugs; 2) increase engagement in treatment services; 3) increase retention in the appropriate level and duration of services; and 4)

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⁸ See Box A-1 in Appendix A for a complete list of BCOR grantees.

increase access to the use of medications approved by the Food and Drug Administration in combination with counseling for the treatment of drug addiction” (SAMHSA, 2017b). Additional information about the program can be found in Table 1-1.

To be eligible for PPW-PLT funding, a potential awardee must be a State Agency for Substance Abuse (SSA; SAMHSA, 2017b). Massachusetts, New York, and Virginia were funded in FY2017 (SAMHSA, 2017h), and Georgia, North Carolina, and Tennessee were funded in FY2018 (SAMHSA, 2018g).⁹ These SSAs are required to partner with at least one direct service provider organization (e.g., a SUD treatment organization) that meets the following criteria:

Improving Access to Overdose Treatment (OD Treatment Access)

The CSAP began accepting applications for the OD Treatment Access program in FY2017. The program aims to expand access to FDA-approved drugs or devices for the emergency treatment of opioid overdose. For a description of additional program information, refer to Table 1-2.

The OD Treatment Access awardees include federally qualified health centers (FQHCs), opioid treatment programs, and qualified practitioners with a waiver to prescribe buprenorphine. One grant was awarded in FY2017, and an additional five were awarded in FY2018 (SAMHSA, 2017f, 2018e).¹⁰ Grantees may receive funding for up to 5 years (SAMHSA, 2017d). Supplementary program information is presented in Table 1-2.

First Responder Training (FR-CARA)

As with the OD Treatment Access program, SAMHSA’s CSAP began accepting applications for the FR-CARA program in FY2017. FR-CARA aims to encourage first responders and other key members of the community (see Box 1-2 for definitions of these entities) to administer drugs and devices for treating opioid overdose when necessary and to promote treatment for OUD. Supplementary program information is presented in Table 1-2.

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⁹ See Box A-2 in Appendix A for a complete list of PPW-PLT grantees.

¹⁰Box A-3 in Appendix A lists the grantees of the OD Treatment Access program.

SAMHSA funded the first cohort of 21 grantees in FY2017 (SAMHSA, 2017e); an additional 27 grantees were funded in FY2018 (SAMHSA, 2018d). The 48 total projects comprise a mix of recipient organizations: Native American tribes; emergency medical response service organizations; state, county, and local health departments; medical centers; health and wellness centers; municipalities; SUD treatment facilities; and a university.¹¹ Grantees may receive funding for up to 4 years (SAMHSA, 2017c).¹²

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¹¹ For the full list of FR-CARA grantees, see Box A-4 in Appendix A.

¹² All text in this section, “The Four Programs,” including the two tables on the following pages, is reprinted from the second report in this series (NASEM, 2021).

TABLE 1-1 Summary of BCOR and PPW-PLT Programs

^a The committee prefers the use of the terms substance use disorder (SUD) and opioid use disorder (OUD); “addiction” will be used when directly quoting grantees or SAMHSA.

SOURCES: The information in this table is pulled directly from the initial Funding Opportunity Announcements for PPW-PLT (SAMHSA, 2017b) and BCOR (SAMHSA, 2017a). The information in the Awards and Projects column comes from the Individual Grant Awards page for PPW-PLT (SAMHSA, 2017h, 2018g) and BCOR (SAMHSA, 2017g, 2018f).

TABLE 1-2 Summary of OD Treatment Access and FR-CARA Programs

^a See the toolkit at https://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit/SMA18-4742 (accessed March 13, 2020).

^b The committee prefers the term “survivors,” however, “victims” will be used when directly quoting SAMHSA.

^c SAMHSA initially awarded funding to 28 grantees in this year. One of the original grantees rescinded (see section “FR-CARA Program Description”).

SOURCES: The information in this table is pulled directly from the Funding Opportunity Announcements for OD Treatment Access (SAMHSA, 2017d) and FR-CARA (SAMHSA, 2017c). The information in the Awards and Projects column comes from the Individual Grant Awards pages for OD Treatment Access (SAMHSA, 2017f, 2018e) and FR-CARA (SAMHSA, 2017e, 2018d).

REPORT SERIES STATEMENT OF TASK

SAMHSA entered into a contract with the National Academies in July 2018. The first CARA grants were awarded in 2017, and the second cohorts were awarded in 2018. The committee’s Statement of Task is in Box 1-3; the committee will produce three reports in 5 years. NASEM convened a committee with experience comprising SUDs recovery and treatment, overdose prevention, psychiatry, nursing, pharmacy, emergency medicine, community-based health programming, program evaluation, cost-effectiveness, implementation science, and health policy and economics.

In the first report, the committee reviewed the reporting metrics selected by SAMHSA for the four CARA grant programs, and recommended changes or additions (NASEM, 2020). For the second report, intended to provide an update on grantee progress, the committee reviewed data collected through the reporting materials that grantees submitted to SAMHSA, described in more detail in Chapter 2. The conclusions of that report centered largely around the limitations of the reporting materials provided by SAMHSA (NASEM, 2021). The conclusions noted:

The final report, presented here, has two foci: (1) to review the effectiveness of the four programs and (2) to recommend to Congress the appropriate distribution of resources for these and similar grant programs in the federal response to the opioid epidemic.

INTERPRETATION OF THE STATEMENT OF TASK

As presented in Chapter 1 of this report, the committee’s charges for the third and final report, according to the Statement of Task, were twofold:

1. Review the specified programs for their effectiveness in achieving their respective goals, as measured by the metrics identified; and
2. Provide 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 epidemic.

In the second report in this series, the committee identified that the limitations in the data SAMHSA provided would limit its ability to address both of these tasks for the third and final report.¹³ In light of that fact, the final chapter of that report laid out proposals for how the committee might attempt to respond to these charges in a way that would be doable and useful to SAMHSA and Congress (NASEM, 2021). This section will

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¹³ For a full discussion of those limitations, see NASEM, 2021.

provide a summary of the challenges, and how the committee has chosen to interpret the two charges.

Assessing Effectiveness

As discussed in detail in the second report, the materials provided by SAMHSA limit the committee’s ability to draw conclusions about the effectiveness of the programs. The committee clarifies that, within evaluation research and practice, effectiveness evaluations are a formal process that rely on specific sets of information and analyses.

In the second report, the committee laid out a set of information that would “allow it to design and perform a more rigorous evaluation of program effectiveness” for the final report (NASEM, 2021). These information needs included, for example, pre-post data, comparison groups, disaggregated data linked to community context, and data collection tools that were generally better linked to the goals of the CARA programs. The committee was aware when publishing the second report that, given that the CARA programs were already well under way, it would not have been possible for SAMHSA to restructure the reporting systems, which often requires a lengthy governmental process (e.g., Office of Management and Budget (OMB) approval process).

For the present report, SAMHSA provided similar information to what was provided for the second report for the CSAT programs (BCOR and PPW-PLT). The agency supplied the committee with additional detail and free text responses from the CSAP program grantees (OD Treatment Access and FR-CARA). The information provided was also more comprehensive of grantee experiences, given that when the second report was under way, most grantees had just begun many of their activities. Many grantees had completed or were near completion of their grant by the time SAMHSA forwarded their reporting for this third report. However, given that it was the same type of information, the materials the committee received from SAMHSA had many of the same limitations as in the second report.

Due to these limitations, the committee again reiterates that it cannot conduct a true effectiveness evaluation of the four CARA programs, relative to other similar programs. However, the materials provided by SAMHSA were sufficient for the committee to describe, to some extent, the general experience and processes of the four grant programs. The committee sought to understand broadly what actions were taken by the grantees and their partners; what impacts to clients, patients, the community, and public were observed; and what structural or environmental changes might have resulted from the grant funding. Its specific approach to answering these questions is described in the next section of this chapter.

The committee feels that, though these findings and conclusions do not amount to an effectiveness evaluation, they may still provide useful insight into the experience of the grantees of the four programs. The extent to which the committee could or could not comment on effectiveness will be discussed in greater detail throughout the chapters on findings.

Ensuring Cost-Effectiveness

The committee was concerned with its ability to make recommendations to Congress concerning the appropriate allocation of resources to “ensure cost-effectiveness” in the federal government’s response to the opioid epidemic. This was due in part to the challenges in evaluating effectiveness, as laid out above, and in part due to the lack of cost data on any of the four programs. In light of these obstacles, the committee laid out three possible interpretations of this charge for the final report: (1) consider whether these four specific programs should be funded again or whether similar programs should be funded in the future; (2) assess whether these programs were cost-effective; or (3) recommend strategies for how Congress could legislate and oversee such programs in the future (NASEM, 2021).

The committee concluded that without major changes to the data SAMHSA provided,¹⁴ it would not be able to draw conclusions about the programs’ effectiveness or cost-effectiveness. The committee suggested that a strategy to answering the third interpretation of the charge would consist of an analysis of “how, in the future, Congress can specify required evaluation methods and processes to assess program effectiveness and cost-benefit analysis, and how SAMHSA can improve program evaluation capacity and efforts in similar programs,” which “would result in more robust evaluation assessment and information for decision makers responsible for guarding the public’s health and related expenditure decisions” (NASEM, 2021).

While response to the first part of the charge to the committee focuses on the experiences of the grantees in the four CARA grant programs, the second charge of the report has a focus that is more forward-looking to future programming and evaluation efforts.

ORGANIZATION OF THE REPORT

The report consists of eight chapters. Chapter 2 lays out the committee’s approach and methods and includes a detailed discussion of the limitations of the data sources. Chapters 3 through 6 cover the committee’s

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¹⁴ For specific data needs laid out by the committee, see the second report in this series (NASEM, 2021).

findings around each of the four CARA programs, with respect to the assessment of grantee activities and outcomes. Due to the differences in the nature of the information the committee received on the CSAT programs versus the CSAP programs, the structure of the findings chapters differ slightly. Chapter 7 presents the conclusions of those findings. In Chapter 8, the committee responds to the second part of its task, outlining key attributes of evaluations and providing recommendations to Congress to guide future programming around the opioid use epidemic. Chapter 9 concludes with observations from the committee about its work.

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 or recurring¹⁵ disorders with a complex biopsychosocial etiology and are impacted by a range of social determinants, root causes, and policy factors; 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, reporting on the experience of the grant programs and their grantees could provide lessons applicable to SAMHSA’s future grant making and other program planning efforts related to OUD and SUD.¹⁶

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¹⁵ “Relapsing” is often the term used in clinical settings. In this report, the committee uses the phrase “relapse or return to use” or “relapsing or recurring.” This choice was informed by two factors: first, recognition that “relapse” can be perceived as stigmatizing, and second, recognition that use of “relapse” alone can imply an all-or-nothing view that any departure from abstinence constitutes a “failed” recovery (for a lengthier discussion, see Miller, 2015); a harm reduction lens applied to SUDs recognizes that this is not the case.

¹⁶ Text in this paragraph is reprinted from the second report in this series (NASEM, 2021).