Alignment for Progress: A National Strategy for Mental Health and Substance Use Disorders
It’s time for a meaningful national conversation about mental health and substance use care. We must remove the barriers to equitable and available coverage for these conditions so people can get the help they need.
Welcome To The National Strategy
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How Content Is Organized and How Best to Search/Sort the Recommendations
The National Strategy recommendations are organized by category, with impacted populations and topical areas providing additional nuance and the ability to narrow a search. We have also included the option to search recommendations by the relevant House and Senate committees of jurisdiction.
Recommendation Selection Methodologies and Criteria
After conducting a thorough review of the federal policy landscape, The Kennedy Forum team created this first-of-its-kind compilation of policy recommendations needed to transform our mental health and substance use systems. The recommendations have been sourced and vetted from numerous organizations, advocates, and experts across the country in order to capture a robust set of recommendations for lawmakers and federal agencies to act on.
All National Strategy Recommendations
These featured recommendations are highlighted based on their importance in beginning the national movement towards better care for everyone.
Develop a model training program on MH/SUD screening
The Department of Health and Human Services should develop a model training program to be disseminated to all levels of medical education (including all prescribers) on screening for mental health and substance use disorders (MH/SUD) to identify at-risk patients.[1]
According to the National Survey on Drug Use and Health (NSDUH), in 2021, nearly one in four adults reported having a mental health condition. The data also found that 46.3 million people, or 16.5 percent of the population, were living with a substance use disorder (SUD), and 94 percent did not receive any treatment.[2] Screening approaches allow providers to identify mental health and substance use challenges early on and are critical to early intervention and treatment.[3] The Substance Abuse and Mental Health Services Administration (SAMHSA) established the Screening, Brief Intervention, and Referral to Treatment (SBIRT) that focuses on the use of tools to assess early need and refer those in need to treatment services.[4] Since 2003, it has funded various training programs for medical and professional residents, but has not been incorporated nationally into medical curricula or applied as routine care.[1][4]
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Evaluate mobile health product effectiveness
Congress should designate a regulatory agency to evaluate mobile health product effectiveness in real-world settings.[1]
Mobile health (mHealth) technologies like smartphone applications (apps), wearable devices, and sensor technologies are expanding to unprecedented levels, including in the mental health and substance use space.[2] More than 10,000 mental health apps are available for patients to download and use.[3] Some apps monitor symptoms and deliver supplemental treatments. For example, they help to track mood symptoms and provide access to therapy-inspired exercises and lessons.[2]
Currently, there is no independent regulatory agency, such as the Food and Drug Administration (FDA), charged with consistently examining all mental and behavioral health apps. While the FDA may review certain apps (e.g. those that may require a prescription or function as a medical device), the agency uses its enforcement discretion with respect to many other mental health and substance use applications. The Federal Trade Commission (FTC) can also investigate potential false claims that an app developer may make.
Without a regulatory body charged with overseeing mental health and substance use health apps, the impact of these new technologies on patient outcomes remains unclear[1]. The American Psychiatric Association (APA) developed its App Evaluation Model to help health care providers determine if a mental health app is appropriate for patient use.[2] While this is a very positive step, there is still a need to ensure an expert regulatory body has the authority to evaluate the viability, risks, and impact of these novel medical technologies and protect patients.
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Expand patient mental health data privacy protections
Congress should expand patient data privacy protections for mental health and wellness applications.[1]
Patient privacy concerns are rising with expanded access and use of mental health and wellness applications.[1][4] The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires protected health information from being disclosed without an individual’s consent or knowledge.[3] However, the law applies only to health data and mobile applications connected to medical providers, health insurers, or their business associates.[1] HIPAA does not regulate wellness or mental health applications not associated with these kinds of healthcare entities, leaving healthcare consumers and their data potentially unprotected.[1]
While the Office of Civil Rights (OCR) offers HIPAA compliance guidance for mobile health (mHealth) developers [2], there’s a need for more rigorous oversight and regulation. Individuals using mobile applications must be made aware if their information is not protected and have the ability to consent to have their information shared.[1] Ultimately, Congress should ensure data collected by mobile health and wellness applications are protected under HIPAA.[1]
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Encourage FDA review of psychedelics
The U.S. Food and Drug Administration (FDA) should undertake the same type of thorough review on the safety and efficacy of new potential medications like psychedelics as it does for all possible medications.
The FDA’s thorough process for evaluating clinical data of potential medications prior to approval is essential to ensuring that FDA-approved medications are both effective and safe. Increased use of psychedelics like psilocybin or methylenedioxymethamphetamine (MDMA) in an attempt to treat mental health and substance use disorders (MH/SUDs) without such a thorough evaluation by the FDA could have deeply harmful effects, subjecting individuals to MH/SUD to medications that are not therapeutic and/or could threaten their health and safety. The FDA has already granted both psilocybin and MDMA “breakthrough therapy status,” which will facilitate FDA guidance on clinical trials and expedited reviews after completed Phase III studies.[1]
The American Psychiatric Association’s position statement on the use of psychedelics notes that there is promising preliminary research on psychedelics “for the treatment of serious and disabling conditions such as treatment-resistant depression and posttraumatic stress disorder….”[2] However, the position statement notes that the use of psychedelics is “investigational” and that they have not been fully reviewed for safety and efficacy.
Such rigor is not only important to ensure the safety and efficacy of medications, but also to ensure the health care system reimburses for demonstrated safe and effective therapeutics. Health insurance will, appropriately, refuse to reimburse for medications that have not been demonstrated by the FDA to be safe and effective.
One area where adjustments may be needed is to the standard FDA process for “maintenance of effect” studies. Such studies are important for oral or injectable medications that are taken for chronic conditions on a regular basis. However, these studies likely do not make sense for substances like psychedelics, which may only have two or three doses for an entire course of treatment (paired with integrative therapy). While long-term follow-up is essential, the FDA should ensure that trials designed for older generations of medications do not inhibit evaluation of potentially paradigm-shifting medication/psychotherapy treatments.
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Pass the Mental Health Research Accelerator Act
Congress should pass legislation such as the Mental Health Research Accelerator Act to provide a tax credit to offset expenses for translational research relating to neurodegenerative diseases and psychiatric conditions.
Neurodegenerative diseases and mental health conditions are major public health challenges that affect millions of people in the U.S. Despite the enormous impact of these conditions and many effective treatments, there is still an urgent need for more research to understand the causes, mechanisms, biomarkers, and therapeutic targets of these disorders.[1]
Translational research is a type of research that aims to bridge the gap between basic science and clinical applications. It involves the translation of discoveries from the laboratory to the clinic, and vice-versa. Translational research can accelerate the development of new diagnostics, therapeutics, and preventive interventions for neurodegenerative diseases and psychiatric conditions, but currently there is insufficient funding for such research.[2]
To encourage more translational research, Congress should pass legislation to provide a tax credit to offset expenses for this research such as the Mental Health Research Accelerator Act of 2022, which would allow a tax credit through 2031 for 25 percent of expenses for translational research for neurodegenerative diseases and psychiatric conditions.[3] This bill would provide an incentive and support for researchers and organizations to conduct more translational research in these fields, increasing innovation and ultimately effective treatments.
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Develop medications to treat substance use disorder
Congress should provide additional resources to the National Institutes of Health to increase research in concert with the pharmaceutical industry to develop and test innovative medications for substance use disorders (SUDs), including long-acting injectables, more potent opioid antagonists to reverse overdose, drugs used for detoxification, and vaccines, and treatments for stimulant use disorder.[1]
More scientific research is needed to reduce the devastating impact of SUDs.[1] Research efforts launched by the federal government are already underway, but greater investments are needed. For example, the National Institutes of Health’s (NIH) Helping to End Addiction Long-term (HEAL) Initiative is an effort that spans multiple institutes and centers at the NIH. HEAL’s research priorities include a focus on developing preventive measures for opioid use disorder (OUD), new treatment options for people with SUDs and OUD as well as examining new options to manage pain without opioids.[2] A critical component of this initiative includes public-private partnerships with pharmaceutical companies to develop and test new therapies.[1] While these efforts are critical, there is still a tremendous need to develop new treatment strategies, including the potential to use vaccines to prevent SUDs.[1] Congress should continue to invest in programs like the HEAL Initiative, as well as the research being conducted at individual NIH institutes and centers to identify and develop new tools to prevent and address SUDs.