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

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.

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.

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.

More than 95 percent of medical/surgical hospitals utilize EHRs, but only half of psychiatric hospitals do.[3] An important contributor to this gap was that MH/SUD providers were not eligible for $35 billion in federal assistance to adopt EHRs under the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 Act.[4]

Lower EHR utilization by MH/SUD providers causes large systemic issues that negatively affect individuals with MH/SUDs in profound, yet underappreciated, ways. For instance, EHRs enhance efficiency and information sharing and have become integral to health care delivery in America. MH/SUD providers who lack EHRs are inhibited in care integration because their paper-based systems cannot interact with physical health providers who have modern EHRs.[1] Additionally, paper-based records are easily lost or damaged. EHRs have also become critical to measuring patient outcomes, advancing value-based care, and conducting clinical research.[5] Thus, it is essential to expand EHR adoption among MH/SUD providers to improve the quality of care and create a modern MH/SUD delivery system.

Congress must act to address its failure to include many MH/SUD providers in previous efforts to advance EHR adoption by passing legislation like the Behavioral Health Information Technology Coordination Act, which would dedicate $20 million a year over five years to assist MH/SUD providers in adopting EHRs.[1][2]

In response to the growing overdose crisis and the need for a wider variety of tools to help prevent and treat SUDs, the 2017 President’s Commission on Combating Drug Addiction and the Opioid Crisis recommended that CMS, FDA, and USPSTF implement a fast-track review process for new evidence-based Technology-Assisted Monitoring and Treatment (TAMT).[1]

TAMT may improve health outcomes for high-risk and SUD patients.[1][2] New technologies such as wearable devices, home monitoring systems, digital therapies, or software-based applications are being leveraged to improve access to care for SUDs and track outcomes.[1] These advances have allowed access to SUD monitoring, treatment, and services through phones, laptops, and tablets.[2] Congress should invest additional resources into further developing this technology and accelerate its safe use.

While this is still an emerging area of technology and care delivery, once a product is deemed safe and effective for the treatment of SUDs, it is critical to provide timely access and reimbursement. Ensuring access to new technology requires joint efforts among entities that play different regulatory roles. The FDA may be tasked with reviewing the safety and effectiveness of a new product or application. CMS will be responsible for evaluating insurance coverage for Medicare beneficiaries. The USPSTF may also have a role to play, given its authority to determine which preventive services must be covered by health insurance plans as required by the Affordable Care Act. Regardless of these agencies' regulatory roles, they should have expedited review processes in place to ensure new and emerging TAMT reaches patients as quickly as possible.[1]

Active duty military, reserve service members, and veteran populations have unique physical and mental health challenges related to their service that can contribute to and exacerbate pain conditions. Combat-related injuries are commonly accompanied by post-traumatic stress disorder and traumatic brain injury. Nearly half of combat-wounded veterans report misusing prescription opioids, and drug overdose mortality rates among veterans increased by 53 percent from 2010-2019.[1]

Yet, the Department of Veterans Affairs (VA) National Formulary (VANF) currently does not include several Food and Drug Administration (FDA)-approved non-opioid analgesic products while covering a wide range of opioid-based analgesic products to manage acute pain symptoms. The exclusion of these safe and effective products results in VA patients having little choice in how they manage their pain. Clinically appropriate non-opioid therapies include products that are (1) Approved by the FDA and therefore deemed to be safe and effective; (2) Indicated for use in providing analgesic support for acute, postsurgical pain; and (3) Proven to reduce quantities of opioids prescribed.[2]

In 2022, Congress passed the Non-Opioids Prevent Addiction in the Nation Act (“NOPAIN Act”) to ensure non-opioid therapies are widely available to Medicare recipients who receive outpatient surgical procedures. The Centers for Medicare and Medicaid Services (CMS) must move quickly to fully implement this law to ensure Medicare access to non-opioid therapies is available. Additionally, the VA should ensure that all FDA-approved  non-opioid therapies are included in the VANF.[3]