Monday, November 4, 2024
The bipartisan PATH Caucus is seeking feedback on how to create policies and programs for emerging therapies involving psychedelic or entactogenic substances in medically supervised, supportive settings. They aim to better inform Congressional members by educating them about innovative, evidence-based therapies involving psychedelics, as well as the considerations related to adopting proactive risk reduction and mitigation frameworks to protect public health safety. To read their request for information (RFI), please click here. Our response to the RFI is available below.
The Honorable Jack Bergman
Co-Chair Congressional PATH Caucus
U.S. House of Representatives
566 Cannon House Office Building
Washington, DC 20515
The Honorable J. Luis Correa
Co-Chair Congressional PATH Caucus
U.S. House of Representatives
2301 Rayburn House Office Building
Washington, DC 20515
Re: Response to Request for Information on a Framework for the Medical Use of Psychedelic Therapy
Dear Representatives Bergman and Correa:
BrainFutures applauds your leadership and ongoing commitment to alleviating the national mental health crisis through effective and safe medical use of psychedelic therapies. We appreciate this opportunity to contribute our expertise to the design and implementation of policies that will support equitable medical access to psychedelic therapies.
BrainFutures is a national nonprofit dedicated to accelerating the equitable access of effective, evidence-based, neuroscientific interventions that enhance mental health and wellbeing. The organization provides objective research analyses, supports real world implementation of these interventions, and develops strategies for policy change. Over the past three years, our work has focused primarily on the emerging field of psychedelics, helping key stakeholders prepare for the wide scale adoption and integration of psychedelic therapy into our healthcare system.
By many measures, the mental health crisis in the United States is worsening despite increases in access to treatment. According to the Centers for Disease Control, mental health-related deaths are rising while mortality from other common chronic diseases falls.1 Meanwhile, the Food and Drug Administration (FDA) has approved very few new psychiatric drugs over the past several decades, with some notable exceptions including the recent approval of Cobenfy for Schizophrenia, Auvelity for major depressive disorder, Spravato for treatment-resistant depression, and Zuranolone for postpartum depression. There is a great need for innovative new treatments, and several psychedelics have shown great promise in late-stage clinical trials for treating conditions such as post-traumatic stress disorder, major depression, treatment-resistant depression, and various forms of substance use disorders. Based on the strength of the data, BrainFutures is optimistic that one or more psychedelics will be approved for clinical use.
BrainFutures is focused on paving the way for widespread, equitable access to psychedelic therapies once approved by the FDA. Several of the questions that PATH caucus raised have direct pertinence to this end goal. Below, we are pleased to share our knowledge in several key domains.
The model of care practiced in many late-stage clinical trials of psychedelics and entactogens requires significant investment of clinical staff. Specifically, patients normally see clinicians several times before and after their medication administration session(s) and are monitored or supported by two professionals for the entire duration of their medication administration, often 6 hours or longer. If this model of care is translated to real-world clinical practice, it will be unaffordable for nearly all patients unless adequately reimbursed by third-party payers, both public and private. Key issues surrounding reimbursement include:
How will psychedelic services be documented and coded for reimbursement?
BrainFutures 2023 Guide to CPT and HCPCS Codes for Psychedelic-Assisted Therapy outlines potential reimbursement pathways using existing codes. However, challenges remain, particularly for the medication administration session. A new Category III CPT code was implemented in 2024 to describe monitoring during psychedelic medication administration, but because it is Category III it is both temporary (with a 5-year sunset period) and does not have a Relative Value Unit (RVU) assigned to it. Many payers do not reimburse for Category III codes, or only reimburse for them on a case-by-case basis negotiated with individual providers. Long-term sustainability of the psychedelic therapy business model will be significantly enhanced if this code is converted to a permanent, Category I code and assigned an RVU, which payers almost universally use.
How can the 2008 Mental Health Parity and Addiction Equity Act (MHPAEA) be used to support broad access to psychedelic therapy services?
MHPAEA requires most health plans that offer mental health and substance use benefits, including Medicaid managed care plans, to be no more restrictive of mental health and substance use services than medical and surgical services. We believe that MHPAEA will ensure coverage of psychedelic therapy on most plans, if adequately enforced. Our paper, A Path Toward Parity: Ensuring Equitable Access to Psychedelic-Assisted Therapy, outlines key areas where payers may seek to restrict access, including through utilization management techniques such as prior authorization. Once psychedelic therapies are approved by the FDA, it will be critical that the Department of Labor and CMS (which share enforcement authority for MHPAEA) are on the lookout for restrictions on these services which are more stringent than those applied to medical and surgical benefits. For example, if health plans require fail-first protocols that are more restrictive than the drug’s FDA clinical trials/approved indication, this is likely to be a parity violation that would have significant consequences for patient access.
What types of guidance documents may be necessary for those who provide close supervision/monitoring of participants using psychedelics or entactogens?
Organizations such as the American Psychological Association and American Psychiatric Association release and update clinical practice guidelines on the treatment of specific diseases such as depression or obsessive compulsive disorder. Other types of guidance documents cover the treatment of specific populations or areas of practice. These guidance documents inform providers on best practices and provide an important guidepost to other stakeholders in the medical and academic systems. For example, healthcare payers may look to these guidelines to evaluate whether a particular treatment should be reimbursed, and institutional review boards may reference guidelines when evaluating research protocols.
In 2023, BrainFutures and the American Psychedelic Practitioners Association (APPA) released Professional Practice Guidelines for Psychedelic-Assisted Therapy, which guide practitioners in this area. These are the first comprehensive guidelines for mental health providers practicing psychedelic-assisted therapy. The process of drafting these guidelines generated debate and consensus around professional standards for this treatment modality. They describe a benchmark of high-quality care as informed by existing clinical research and expert consensus in this area.
Over time, we anticipate that provider organizations such as the American Psychological Association may incorporate psychedelic treatment modalities into their existing guidance documents. However, it is important that the field continue to reevaluate best practices specific to psychedelic therapy as science and practice evolve. A robust set of practice guidelines will smooth the path to widespread clinical adoption of psychedelics once approved by the FDA.
What training will psychedelic therapy practitioners need?
It is standard practice to combine psychotherapy or psychological support/intervention as an adjunct to psychotropic medication in the treatment of many psychiatric disorders. However, the often intense experiential effects of psychedelic medications and the cognitive shifts these experiences can potentially induce will be unfamiliar to many practitioners. BrainFutures recognizes that some level of additional training in psychedelic therapy may be desirable or necessary in order to deliver these treatments safely and effectively or to meet requirements from healthcare payers and malpractice insurers. The training a provider needs will depend on the provider’s profession (e.g., nurse or counselor) and role in treatment (e.g., prescriber or patient monitor).
The current psychedelic therapy training and education field varies widely in cost, curricula, and quality, and there is an urgent need for affordable and appropriate training options on par with other areas of healthcare. At present, there is no standard core curriculum or set of learning objectives for psychedelic therapy training. If psychedelic therapy is to be widely available to patients post-approval, training programs will need to both scale up to accommodate more providers and streamline to ensure that the investment required to get trained is not a major barrier to adoption. Going forward, a shared set of minimum training standards that are specific to the role of the clinician could facilitate broader adoption of psychedelic therapy. These standards should be informed by the best available evidence and expert opinion and should be in line with training practices for other specialized areas of medicine.
BrainFutures believes that psychedelic medicine holds significant promise for treating a range of psychiatric disorders. We are grateful to the PATH Caucus for providing this opportunity to contribute to the development of systems that can deliver psychedelic therapy safely and equitably as psychedelic drug developers seek and potentially receive FDA approval. We urge the Caucus to give special consideration to issues surrounding reimbursement—which is a prerequisite for affordable and equitable access—and guidelines for both practicing psychedelic therapy and training practitioners. If the Caucus would like further information about any of these topics, we would be happy to meet with your members and/or staff to discuss these important issues. Please contact our Interim Executive Director, Jazz Glastra, at jglastra@brainfutures.org.
Sincerely,
Henry Harbin, MD
Board Member, Advisor, Co-Founder
BrainFutures
Jazz Glastra
Interim Executive Director
BrainFutures
Jonathan Book, MD
Senior Medical Advisor
BrainFutures
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