Federal legal and regulatory aspects of contingency management incentives.

OBJECTIVE: Incentives are an integral part of Contingency Management (CM) Programs for substance use disorder treatment, primarily for the treatment stimulant use disorders, but because stimulant use often co-occurs with opioid use, the Substance Abuse and Mental Health Services Administration (SAMHSA) permits the use of CM incentives as a part of its State Opioid Response grant program. However, incentives implicate federal laws and could result in either financial penalties or criminal sanctions against programs that use them. METHODS: The U.S. Department of Health and Human Services Office of Inspector General (OIG) is tasked with enforcing key federal laws that address the issues of kick-backs, inducements, and false claims. By looking at these laws and regulations, this paper seeks to create a clearer understanding of the the barriers providers face when utilizing CM, as well as the guardrails that can be put in place to alleviate those barriers. RESULTS: This paper distills key concerns raised by the OIG and suggests critical guardrails that militate against fraud, waste and abuse. CONCLUSION: Following the recommended guardrails should allow providers to employ CM strategies to help their patients by making clear that the intent is to help patients without engaging in kickbacks, illegal inducements or false claims.

The fourth wave of the overdose crisis: Examining the prominent role of psychomotor stimulants with and without fentanyl.

The current overdose and broader public health crisis involving illicit drug use is often referred to as the "opioid" or "fentanyl" crisis. Clearly there is extensive data on the profound damage done by opioids over the past 20 years and specifically by fentanyl in the past 5 years. However, there is an extensive array of data that suggests there is more to the current crisis than opioids/fentanyl. Much recent evidence indicates that methamphetamine and cocaine are playing a substantial and increasing role in the illicit drug crisis in the US-the 4th wave. This paper reviews data that illustrate the role of psychomotor stimulants in fatal overdoses, nonfatal overdoses, and emergency department visits. Despite the major detrimental role that stimulants are having on the public health in the US in 2023, there is virtually no evidence-based treatment available in practice for people with stimulant use disorder (StimUD). Although there are no medications with FDA-approval for the treatment of StimUD, there is a behavioral treatment, contingency management (CM), with over 3 decades of robust research supporting its efficacy for individuals with StimUD. Despite the overwhelming evidence supporting CM, it is not being widely used in routine treatment outside the VA healthcare system. This paper reviews some of the (a) evidence for CM, (b) CM protocol design elements that require consideration, (c) current obstacles to the widespread implementation of CM, and (d) strategies for addressing these obstacles. Overcoming these obstacles is a priority to allow routine use of CM as a treatment for StimUD.

Recovery incentives program: California's contingency management benefit.

OBJECTIVE: The role of methamphetamine and cocaine use in California's drug poisoning (overdose) crisis has dramatically increased in the past five (5) years and has disproportionately affected American Indian, Alaska Native, and Black Californians. No FDA-approved medications currently exist for the treatment of individuals with stimulant use disorder (StimUD). Outside the Veteran's Administration, the Recovery Incentives Program: California's Contingency Management Benefit is the first large scale implementation of contingency management (CM). CM is the behavioral treatment with the most evidence and largest effect sizes for StimUD. METHODS: The Program uses a CM protocol where participants can receive a maximum of $599 over a six-month period, contingent upon 36 stimulant-negative urine test results. Urine tests are conducted using a set of approved, CLIA-waived, point-of-care urine drug tests (UDTs). To ensure fidelity to the CM protocol and to prevent fraud, waste, and abuse, all aspects of incentive accounting and distribution are managed electronically via a custom-developed software system. Incentive distribution utilizes electronic gift cards. A significant innovation of the project is the conceptualization of the CM Coordinator, a designated and highly trained and supervised individual responsible for all aspects of CM operation in a specific site. RESULTS AND CONCLUSIONS: The California Department of Health Care Services contracted with UCLA to develop and implement a robust evaluation of the Program; goals include evaluating the effectiveness of real-world implementation and facilitating quality improvement. The project will likely significantly impact the use of CM for StimUD nationally and may well reduce stimulant-related drug poisoning deaths.

The urgent need for contingency management among Tribal communities in the United States: Considerations for implementation, policy, and sovereignty.

In two randomized controlled trials, culturally adapted contingency management (i.e., incentives provided for substance-negative urine samples) was associated with reduced alcohol and drug use among geographically diverse American Indian and Alaska Native (AI/AN) adults. In response to interest in contingency management from other Tribal and AI/AN communities, our research team in collaboration with AI/AN behavioral health experts, translated the research into practice with new AI/AN community partners. Tenets of community-based participatory research were applied to develop, pilot, and refine contingency management training and implementation tools, and identify implementation challenges. In partnership with the AI/AN communities, four members of the university team developed tools and identified implementation and policy strategies to increase the successful uptake of contingency management in each location. Through our collaborative work, we identified policy barriers including inadequate federal funding of contingency management incentives and a need for further clarity regarding federal anti-kickback regulations. Adoption of contingency management is feasible and can strengthen Tribal communities' capacity to deliver evidence-based substance use disorder treatments to AI/AN people. Unfortunately, non-evidence-based limits to the use of federal funding for contingency management incentives discriminate against AI/AN communities. We recommend specific federal policy reforms, as well as other practical solutions for Tribal communities interested in contingency management.

Should the United States Government Repeal Restrictions on Buprenorphine/Naloxone Treatment?

Attention must be focused on needed changes to the current United States law that restricts physicians who prescribe buprenorphine for the detoxification or treatment of Opioid Use Disorder, to accepting no more than 100 patients. The current system does not provide comprehensive treatment as defined by the American Society of Addiction Medicine (ASAM) criteria. In addition, it suffers from both fragmentation and stigma and will require a significant change to comply with ASAM's call for integrated delivery of comprehensive addiction treatment. This commentary calls for the development and implementation of "best practice," by recommending caution in lifting the 100 patient limit until substantial achievement of this goal occurs. The authors call for an increase to 200 in the patient limit to be restricted to those physicians who are Board Certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) or in Addiction Psychiatry by the American Board of Psychiatry and Neurology (ABPN), or other responsible medical organizations. Any additional restriction lifting should follow a systemic evolution that rewards and documents competency. Such a system would involve the integration of treatment, treatment systems, and recovery with prescription medication. In addition, it should monitor emotional blunting, treatment progress and initiation of genetic addiction risk testing.

Contingency Management for Stimulant Use Disorder: Progress, Challenges, and Recommendations.

The United States is currently in the fourth wave of the overdose crisis wherein stimulants together with fentanyl are the major drivers of overdose deaths. To date, there has been limited effort outside the US Veterans Administration Health System health system to disseminate evidence-based treatment for people with stimulant use disorder. Contingency management, a behavioral intervention in which positive reinforcement is provided for a target behavior indicating treatment progress, has decades of empirical support but limited implementation in real-world, non-US Veterans Administration Health System settings. The purpose of the report is to provide an overview of contingency management, the barriers to adoption, and recommendations for overcoming these barriers.

PTSD / substance use disorder comorbidity: Treatment options and public health needs.

Purpose of Review: Posttraumatic stress disorder (PTSD) commonly co-occurs with substance use disorder (SUD) and is challenging to treat. We review all behavioral therapy models with at least one randomized controlled trial in a current PTSD/SUD population. We identify factors in selecting a model for clinical use, emphasizing a public health framework that balances the need for evidence with the need for feasibility in frontline settings. Recent Findings: Seven published models and 6 unpublished models are reviewed. Public health considerations for choosing a model include: whether it's been studied across a broad range of SUDs and in complex SUD patients; whether it can be conducted in group modality; its appeal to patients and providers; its cost; workforce requirements; and its ability to reduce substance use in addition to PTSD. Summary: There are two broad types of models: those that originated in the PTSD field versus the SUD field. Overall, the latter are stronger on public health factors and more feasible in SUD settings. Published models in this category include Relapse Prevention, BRENDA, and Seeking Safety. PTSD/SUD research is at an early stage and there is a need for methodology that quantifies "level of burden" (patients' socioeconomic disadvantages) across trials.

Policy and practice implications of epidemiological surveys on co-occurring mental and substance use disorders.

This article describes factors that influence national policy and practice, with particular focus on the implications of epidemiological survey research. Examples of areas of concern to policymakers include treatment-seeking patterns, access to care at points of service in public health and social service systems, evidence-based practices, workforce development, and the complexities of reimbursement. In responding to data on systemic barriers to care, the Substance Abuse and Mental Health Services Administration (SAMHSA) has sought to promote a no wrong door strategy to address the needs of persons with co-occurring disorders (CODs) involving their mental health and substance use. Examples of SAMHSA programs and policies addressing CODs discussed in this article include targeted partnerships with the states, mechanisms to enhance system infrastructure, technical assistance, and initiatives with special populations.

Use of pharmacotherapies in the treatment of alcohol use disorders and opioid dependence in primary care.

Substance-related and addictive disorders are chronic relapsing conditions that substantially impact public health. Effective treatments for these disorders require addressing substance use/dependence comprehensively as well as other associated comorbidities. Comprehensive addressing of substance use in a medical setting involves screening for substance use, addressing substance use directly with the patient, and formulating an appropriate intervention. For alcohol dependence and opioid dependence, pharmacotherapies are available that are safe and effective when utilized in a comprehensive treatment paradigm, such as medication assisted treatment. In primary care, substance use disorders involving alcohol, illicit opioids, and prescription opioid abuse are common among patients who seek primary care services. Primary care providers report low levels of preparedness and confidence in identifying substance-related and addictive disorders and providing appropriate care and treatment. However, new models of service delivery in primary care for individuals with substance-related and addictive disorders are being developed to promote screening, care and treatment, and relapse prevention. The education and training of primary care providers utilizing approved medications for the treatment of alcohol use disorders and opioid dependence in a primary care setting would have important public health impact and reduce the burden of alcohol abuse and opioid dependence.

Moving from research to practice just in time: the treatment of cannabis use disorders comes of age.

This supplement issue on the treatment of marijuana use disorders describes two large multi-site field experiments: the Cannabis Youth Treatment (CYT) study with adolescents and the Marijuana Treatment Project (MTP) with adults. The papers cover multiple aspects of the treatment of cannabis users, including the rationale for studying cannabis use disorders, descriptions of the CYT and MTP studies,characteristics of adolescents and adults presenting for treatment of cannabis use disorders, court diversion issues, economic evaluation and confirmation of self-reported cannabis use, among other topics. This Introduction provides background information and an overview of the papers from the perspective of the funding agency.

The need and opportunity to expand substance use disorder treatment in school-based settings.

In this paper, we explore the unmet need for substance use disorder (SUD) treatment among youth, its consequences, and the opportunity to address this gap due to the expansion of behavioral health services to school-based settings under the Parity and Affordable Care Acts. We discuss the importance of using evidence-based approaches to assessment and treatment to ensure effectiveness and cost-effectiveness and show how the severity of SUD is related to a wide range of school, substance, mental, health, and health care utilization problems. Next, we introduce the other three articles in the special issue that further demonstrate the feasibility and impact of using these evidence-based practices in school-based settings, the challenges of identifying and interviewing with youth, and the need for a full continuum of interventions. In each of these areas we try to draw out the policy implication of these trends and papers.

Electronic health records: essential tools in integrating substance abuse treatment with primary care.

While substance use problems are considered to be common in medical settings, they are not systematically assessed and diagnosed for treatment management. Research data suggest that the majority of individuals with a substance use disorder either do not use treatment or delay treatment-seeking for over a decade. The separation of substance abuse services from mainstream medical care and a lack of preventive services for substance abuse in primary care can contribute to under-detection of substance use problems. When fully enacted in 2014, the Patient Protection and Affordable Care Act 2010 will address these barriers by supporting preventive services for substance abuse (screening, counseling) and integration of substance abuse care with primary care. One key factor that can help to achieve this goal is to incorporate the standardized screeners or common data elements for substance use and related disorders into the electronic health records (EHR) system in the health care setting. Incentives for care providers to adopt an EHR system for meaningful use are part of the Health Information Technology for Economic and Clinical Health Act 2009. This commentary focuses on recent evidence about routine screening and intervention for alcohol/drug use and related disorders in primary care. Federal efforts in developing common data elements for use as screeners for substance use and related disorders are described. A pressing need for empirical data on screening, brief intervention, and referral to treatment (SBIRT) for drug-related disorders to inform SBIRT and related EHR efforts is highlighted.

Substance Abuse Treatment, HIV/AIDS, and the Continuum of Response for People Who Inject Drugs.

The continuum of response (CoR) to HIV/AIDS is a framework for implementation of HIV prevention, care, and treatment programs based on a national strategic plan for HIV/AIDS services. The CoR for people who inject drugs (PWID) is an important extension of the developed CoR to HIV/AIDS. The CoR-PWID employs stakeholders who together plan, develop, pilot, and provide a full range of services that address the various prevention, care/support, and treatment needs of people, families, and communities infected or affected by HIV/AIDS and injection drug use. The CoR-PWID comprises a broad range of services that include but are not limited to the World Health Organization priority interventions for HIV/AIDS prevention, treatment, and care in the health sector and the package of essential interventions for the prevention, treatment, and care of HIV for people who inject drugs. Implementation of these well-defined, essential prevention, care/support, and treatment services, in addition to locally defined needed services, in a coordinated fashion is important to clients, their families, and communities. The CoR-PWID is, therefore, a necessary framework essential for service development for countries that address HIV/AIDS in populations of PWID.

Meaningful use of electronic behavioral health data in primary health care.

In August 2011, scientists and policy-makers held a conference entitled "Using IT to Improve Community Health: How Health Care Reform Supports Innovation." One of the conference sessions was entitled "Electronic health records: Meaningful use implementation challenges, innovation, and regulations." This Meeting Report discusses the meaningful use of behavioral health data for the treatment of mental health and substance abuse conditions and optimization of behavioral wellness by primary care physicians.