Alignment for Progress: 
A National Strategy for Mental Health and Substance Use Disorders

The ongoing addiction crisis highlights the need for health professionals to receive training on substance use disorders (SUDs).[2] According to the Substance Abuse and Mental Health Services Administration, “[i]ncorporating training on SUD into routine healthcare will enable practitioners to screen more widely for SUDs, treat pain appropriately, prevent substance misuse, and engage people in life-saving interventions.”[2][3] In conjunction with its repeal of the harmful requirement that prescribers have a separate waiver (the X-waiver) to prescribe lifesaving buprenorphine, the 2023 Medication Access and Training Expansion (MATE) Act requires Drug Enforcement Administration (DEA) registered practitioners to complete eight hours of training on opioid and SUD prevention, treatment, and care.[2][3][4] All federally funded medical training programs (e.g., federal graduate medical education (GME) programs) should include similar training requirements.

Racial and ethnic minorities are disproportionately impacted by mental health and substance use disorders (MH/SUDs).[4] However, MH/SUD professional training programs often do not reflect the diverse needs of these communities.[5] The Minority Fellowship Program (MFP)[6][7] is designed to increase provider education on issues related to prevention, treatment, and recovery support for MH/SUDs among racial and ethnic minority populations.[3][4] The program improves the quality of MH/SUD services and treatments and increases the number of culturally competent educators, researchers, and service providers.[8] The President’s FY 2024 Budget included $36.7 million for the MFP.[1][2] Congress should fully fund this request and maintain funding levels to meet future needs.

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]

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.

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]

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.