A Data-Driven Roadmap for Psychedelic Therapies

Introduction

This memo provides a response to the PATH Caucus’s Request for Information (RFI) on developing frameworks for the safe and effective implementation and use of psychedelic therapies. Our recommendations are structured around six key domains—Service Delivery, Participant Protections, Community Engagement, Safeguarding Access, Best Practices for Data Standards, and Federal Workforce Capabilities—offering a comprehensive, data-driven approach to national implementation.

Inspired by the success of the President’s Emergency Plan for AIDS Relief (PEPFAR), we propose a similar nationwide strategy, which might be called the President’s Emergency Plan for Therapeutic Alternative Medicines (PEPTAM). Such an initiative would immediately establish a multi-agency, federal coordinating body responsible for overseeing the implementation of psychedelic therapies, ensuring a unified, data-driven, and scalable approach to rollout. The plan would prioritize high-need populations, particularly veterans and first responders struggling with PTSD, treatment-resistant depression, and substance use disorders, and align with the Trump administration’s “Make America Healthy Again” (MAHA) initiative, which emphasizes cost-effective solutions to chronic health challenges.

A successful national implementation plan requires more than just policy approval—it demands a structured “master plan” that includes clear guidelines on training, safety protocols, service delivery models, reimbursement mechanisms, and ongoing evaluation. This model also ensures fiscal efficiency by ensuring direction and oversight of government funds to the organizations that will deliver the greatest value to the plan objectives. PEPTAM would be modeled after PEPFAR’s proven structure, incorporating state-level flexibility within a federally coordinated framework to ensure therapies are deployed in the most effective and efficient manner at scale. This includes directives to:

Establish a national training and certification process to ensure all practitioners meet rigorous clinical and ethical standards.
Implement a real-world data collection and reporting infrastructure to track patient outcomes, safety, and cost-effectiveness.
Develop reimbursement pathways through federal and private payers to make therapies financially accessible.
Test service delivery models in high-need areas and scale those that prove most effective.
Preserve and coordinate the federal “Psychedelic Braintrust” across key agencies to ensure continuity of expertise.

By adopting a structured, PEPTAM-driven master plan, policymakers can ensure that psychedelic therapies are introduced in a way that is safe, scientifically rigorous, and economically efficient, providing life-changing treatments for veterans, first responders, and other vulnerable populations.

1. Service Delivery

Delivering psychedelic therapies safely requires a coordinated, nationwide service delivery model built on rigorous clinical standards and federal oversight. We recommend a structured framework that combines standardized training and credentialing with data-driven operational protocols and a comprehensive master implementation plan. This approach is designed to facilitate broad political support for innovative therapeutic models while ensuring consistency, efficiency, and excellence in care across diverse settings.

Standardized Training and Credentialing

Clinicians—including physicians, psychologists, social workers, and peer specialists—must complete an intensive training program that integrates clinical best practices with harm-reduction strategies. To achieve this, we recommend collaboration between leading academic institutions (e.g., Johns Hopkins University, Yale University, and the California Institute of Integral Studies) and established professional bodies (such as the American Psychological Association, American Psychiatric Association, Psychedelic Medicine Association (PMA), and the Psychedelic Pharmacists Association). Training programs should be accredited through an appropriate professional body, such as PMA, as with similar academic training programs. This partnership will ensure that training and credentialing processes meet the highest clinical and ethical standards.

Operational Protocols and National Coordination

We propose establishing clear, standardized protocols for every phase of therapy—from session preparation and medicine administration to post-session integration. A federal coordinating body, modeled on the President’s Emergency Plan for Therapeutic Alternative Medicines (PEPTAM), should be created to unite key agencies—including the VA, NIH, SAMHSA, FDA, CMS, ONDCP, and others—and lead a data-driven rollout. This task force would be responsible for mapping high-need areas, supporting state-level implementation, and ensuring continuous improvement through regular evaluations and inter-state learning exchanges.

Concrete Actions:

Form a Federal Coordinating Body (PAPTAM):
- Assemble a task force with key federal agencies (VA, NIH, SAMHSA, FDA, CMS, ONDCP, etc.) to oversee the data-driven rollout and coordinate with state-level programs.
Develop Comprehensive Training Curricula:
- Partner with academic institutions and harm reduction experts (e.g. Fireside Project and Psychedelic Safety Institute) to create evidence-based training programs integrating clinical best practices.
Establish a Robust Certification Process:
- Collaborate with the Psychedelic Medicine Association, American Psychological Association, and American Psychiatric Association to define and implement stringent credentialing pathways for practitioners.
Standardize Operational Protocols:
- Implement clear, step-by-step procedures for session preparation, dose administration, and integration, leveraging successful models such as the Zendo Project and SAMHSA’s framework.
Leverage Data for Targeted Rollout:
- Utilize epidemiological data to map high-need areas—such as regions with high veteran populations or significant mental health challenges—and deploy pilot programs with built-in evaluation and inter-state learning mechanisms.
Secure Funding and Support:
- Develop and deploy multi-agency grants, insurance partnerships, and state funding initiatives to support pilot projects and scale successful care models nationwide.

This strategic framework lays the foundation for a robust, scalable service delivery model for psychedelic therapies. Subsequent sections will address participant protections, community engagement, safeguarding access, and best practices for data standards.

2. Participant Protections

Ensuring the safety and well-being of participants in psychedelic therapies is paramount. We recommend a robust framework of participant protections that balances inclusive real-world implementation with rigorous safeguards. Unlike controlled clinical trials that may exclude individuals with comorbidities, real-world programs must be designed to assist those with complex health profiles—while still excluding individuals for whom the risks are prohibitively high.

Comprehensive Screening and Informed Consent

We suggest that screening protocols be designed to identify individuals who can benefit from therapy, including those with manageable comorbid conditions, while excluding those at acute risk—such as individuals with a personal or family history of psychosis, unstable medical conditions (particularly cardiovascular issues), or active suicidal ideation.

Drawing on best practices from leading institutions like Yale and Johns Hopkins, and developed in collaboration with bodies such as the American Psychiatric Association and American Psychological Association, these protocols will ensure that only those most likely to benefit and least likely to experience harm are enrolled. Informed consent materials should clearly outline both potential risks—such as transient anxiety, psychological distress, and rare but serious adverse events—and the anticipated benefits, using models like the Yale Manual for Psilocybin-Assisted Therapy and guidelines developed by other appropriate professional organizations operating in the field of psychedelics.

Risk Mitigation and Adverse Event Monitoring

A dual approach to risk mitigation is essential. Pre-dose evaluations should establish participants’ baseline physical and mental health statuses, and continuous monitoring during sessions is recommended using validated instruments such as the Clinician-Administered Dissociative States Scale (CADSS) to detect any early signs of adverse reactions. Post-session monitoring should capture delayed effects, while data collection from poison control centers and emergency rooms will provide real-time surveillance.

We recommend leveraging the pioneering work of Rocky Mountain Poison & Drug Safety (RMPDS), which currently monitors Spravato through its specialized postmarketing surveillance initiatives, to systematically capture and analyze adverse event data for psychedelic therapies. Their fit-for-purpose tools—such as the Sentinel Poison Center Program and the National Survey Investigating Hallucinogenic Trends (NSIHT)—capture detailed, real-time safety signals not only for Spravato but are also being adapted for use with other psychedelic substances. Establishing such continuous monitoring systems, supported by independent Data Safety Monitoring Boards (DSMBs) akin to those utilized in oncology trials, will ensure that any emerging adverse events are rapidly identified and managed.

Coordination with crisis centers such as the Fireside Project and the National Suicide Prevention Lifeline (988) will ensure that participants have immediate access to emergency support if needed.

Coordinated National Oversight

Under the federal coordinating framework (PEPTAM), it is recommended that uniform implementation of screening, informed consent, and monitoring protocols be maintained across all states. This coordinated approach facilitates routine data collection and quarterly reviews, allowing for continuous improvement of participant protections based on emerging evidence and local learning.

Concrete Actions:

Develop Standardized Screening Tools and Consent Templates:
- Create comprehensive checklists and informed consent documents based on established models from Yale, Johns Hopkins, and APPA.
Collaborate with Professional Bodies:
- Partner with the American Psychiatric Association and the American Psychological Association to refine screening criteria and consent protocols, ensuring integration of both psychiatric and physical health assessments.
Implement Continuous Monitoring Systems:
- Establish systematic processes for pre-session evaluations and post-session adverse event reporting using validated instruments (e.g., CADSS) and surveillance tools developed by organizations like RMPDS.
Integrate Crisis Response Mechanisms:
- Coordinate with crisis centers such as the Fireside Project and the National Suicide Prevention Lifeline (988) to provide immediate support during emergencies.
Form Independent DSMBs:
- Ensure each treatment center partners with an independent Data Safety Monitoring Board to regularly review safety data and promptly address any emerging issues.

This participant protection framework, reinforced by federal coordination through PEPTAM, establishes a comprehensive, effective, and adaptable system to safeguard individuals undergoing psychedelic therapies.

3. Community Engagement

Engaging communities is essential to ensure that psychedelic therapies reach those who need them most. We recommend a community engagement strategy that uses data to identify high-need areas and builds trust through community-informed, locally led outreach. This approach recognizes that while clinical trials often exclude groups with complex challenges, real-world programs must reach populations—such as veterans and first responders with PTSD—to deliver effective treatment.

We suggest using epidemiological data to map areas with high rates of mental health challenges, including PTSD, treatment-resistant depression, and substance use disorders. Local voices—veteran peers and community leaders—should be engaged to develop clear, accessible educational materials that explain how these therapies work and why they are safe when properly administered. Partnerships among healthcare providers, community organizations, and local governments will be key in tailoring outreach efforts to the unique needs of each community.

Concrete Actions:

Map High-Need Areas:
- Use data on mental health challenges and population demographics to identify communities with high rates of PTSD, treatment-resistant depression, and substance use disorders.
Develop Community-Specific Educational Materials:
- Create easy-to-read information packets that reflect local cultural contexts and include input from veteran peers and community leaders.
Establish Local Outreach Teams:
- Form teams comprised of doctors, community leaders, and trained peer supporters to conduct town halls, workshops, and one-on-one outreach initiatives that build trust and educate community members about psychedelic therapies.
Foster Collaborative Partnerships:
- Encourage collaboration between healthcare providers, local governments, and community organizations to share best practices and continuously refine outreach efforts based on community feedback.

This community engagement framework is designed to build trust and deliver tailored information, ensuring that innovative psychedelic therapies are effectively communicated and adopted in communities with the greatest need.

4. Safeguarding Access

Ensuring that psychedelic therapies reach those who need them most is crucial for saving lives and reducing healthcare costs. We recommend a comprehensive approach that uses data to identify high-need areas, establishes affordable payment models, and creates flexible service delivery models—all while ensuring a safe and steady supply of treatments.

Our strategy begins with analyzing epidemiological data to pinpoint communities with high rates of PTSD, treatment-resistant depression, and substance use disorders. This data-driven approach will allow decision-makers to target resources where they can make the biggest impact, such as veteran communities that face disproportionate mental health challenges.

Affordability is another key pillar. We suggest integrating these therapies into existing payment frameworks like VA coverage and private insurance plans. In support of this, initiatives like the Health Outcomes and Psychedelic Economics (HOPE) project will provide robust, real-world health economic evidence by leveraging claims data from CMS, commercial insurers, and the VA.

The HOPE project, led by the Collaborative for the Economics of Psychedelics at UC Berkeley and bolstered by academic partners from Yale, Johns Hopkins, and The University of Texas at Austin, will use advanced modeling techniques to evaluate cost-effectiveness and budget impact across multiple delivery scenarios. These analyses will generate actionable insights demonstrating that, despite initial investments, these treatments can yield billions in long-term savings by reducing overall healthcare utilization and improving quality of life. This research and analysis should be funded, and the outcomes considered in policy decisions.

Moreover, we recommend testing various delivery models in pilot programs—whether in VA clinics or local community centers—to determine the most effective and scalable approaches. These pilots should also include flexible dosing and group session options to tailor care to local needs. Close coordination with the FDA will be essential to maintain clear production and distribution standards, ensuring a safe, consistent supply of medications.

Concrete Actions:

Data-Driven Targeting:
- Use epidemiological data to map high-need communities, such as areas with high rates of PTSD and depression among veterans.
Affordable Payment Models:
- Develop reimbursement frameworks and secure insurance partnerships, including VA coverage, to ensure treatments remain accessible and affordable.
Pilot Testing of Service Models:
- Launch pilot programs in diverse settings (e.g., VA clinics, local centers, and university hospitals) to test different delivery models and dosing strategies.
Regulatory Collaboration for Supply Stability:
- Work with the FDA to establish clear guidelines for manufacturing and distribution, ensuring a safe and consistent supply of medications.
Support the HOPE Project:
- Fund and expand the Health Outcomes and Psychedelic Economics initiative to generate hard evidence on cost savings and clinical benefits, strengthening the case for widespread adoption.

This multi-pronged approach safeguards access by ensuring that therapies are not only available but are also affordable and effective, thereby aligning with broader public health and economic goals.

5. Best Practices for Data Standards

Good data standards are the backbone of effective psychedelic therapy programs. We recommend establishing clear, shared rules for data collection that enable us to determine what works, for whom, and under what conditions—ensuring accountability, continuous improvement, and cost efficiency.

We suggest setting common outcome measures at the national level—such as improvements in symptom relief, safety indicators, and reductions in healthcare costs. While states can incorporate additional metrics, all must adhere to a core set of standards that foster multi-state learning and collaboration. Under the leadership of a federal coordinating body like PEPTAM, data from various jurisdictions will feed into a national hub, answering critical questions about treatment impact, scalability, and efficiency.

Drawing lessons from successful initiatives like PEPFAR and the Ryan White CARE Act, we propose creating a coordinated data collection system that spans clinical settings and community programs. This real-world data will capture outcomes, safety profiles, and cost metrics for diverse populations—including those with complex comorbidities often excluded from clinical trials.

We further recommend integrating advanced tracking tools such as RADARS to rapidly detect adverse events and continuously monitor program performance. This approach will not only provide empirical evidence of human health and cost savings but also drive iterative improvements in therapy delivery.

Concrete Actions:

Set National Outcome Measures:
- Establish standardized metrics—such as symptom relief, safety, and cost savings—that all states will adopt to track therapy impact.
Develop a Unified Data System:
- Integrate state-collected data into a national platform modeled on PEPFAR, facilitating cross-validation from clinical records, community feedback, and public health surveillance.
Leverage Real-World Data:
- Ensure that data collection extends beyond clinical trials to capture the full spectrum of real-world experiences and outcomes, including those of high-risk populations.
Establish a PAPTAM Data Team:
- Form a dedicated team responsible for continuous analysis, quality improvement, and dissemination of data insights, supporting a systematic, multi-state learning agenda.

By adopting these best practices, we can ensure that every dollar spent translates into measurable improvements in health outcomes and cost efficiency—driving the “Make America Healthy Again” vision through evidence-based, data-driven program implementation.

6. Ensure Federal Workforce Capabilities

The successful implementation of psychedelic therapies depends critically on preserving and coordinating the existing “Psychedelic Braintrust” within the federal government—a network of experienced personnel with specialized knowledge in psychedelic medicine. This institutional expertise, developed across agencies including NIH, FDA, SAMHSA, OASH, VA, DoD, and ONDCP, represents an invaluable resource for effectively deploying psychedelic therapies nationwide. Without deliberate retention and coordination strategies, this expertise could be lost during administrative transitions, potentially delaying implementation of evidence-based psychedelic frameworks.

We recommend developing formal structures to preserve this institutional knowledge and enhance cross-agency collaboration. This includes creating specialized career tracks for psychedelic medicine regulation, establishing interagency coordination mechanisms, and implementing knowledge management systems to capture and transfer expertise. By formalizing the role of this braintrust, the federal government can ensure continuous, coordinated advancement of psychedelic therapies across multiple domains, including clinical applications, veterans’ care, and risk reduction programs.

Concrete Actions:

Prioritize Personnel Retention:
- Develop targeted strategies to retain subject matter experts in psychedelics across key federal agencies, including specialized career tracks and professional development opportunities.
Establish Federal Coordination Council:
- Create a formalized interagency working group dedicated to psychedelic medicine implementation with clear authority and reporting structures.
Implement Knowledge Documentation Systems:
- Develop comprehensive repositories to capture institutional expertise on psychedelic regulation and oversight.
Create Succession Planning Frameworks:
- Implement systematic approaches to identify and develop the next generation of federal psychedelic medicine experts.
Develop Specialized Training Programs:
- Partner with academic institutions to create a curriculum for federal employees working on psychedelic initiatives.
Formalize Multi-Agency Frameworks:
- Establish clear protocols for addressing key domains including therapeutic applications, veterans issues, risk monitoring, and education programs.

This strategic investment in federal workforce capabilities ensures that the specialized knowledge required for successful psychedelic therapy implementation remains within government, properly coordinated across agencies, and continues to develop as the field evolves.

Conclusion

Our recommendations present a comprehensive, multi-level master plan for implementing psychedelic therapies that is data-driven, scalable, and informed by prior successful government initiatives. By integrating coordinated service delivery, robust participant protections, targeted community engagement, safeguarding equitable access, rigorous data standards, and strategic federal workforce development, this framework ensures that innovative therapeutic models are delivered safely and effectively. Anchored by a federal coordinating body modeled on successful initiatives like PEPFAR and the Ryan White CARE Act, this master plan will not only improve mental health outcomes but also drive long-term cost savings and efficiency in the healthcare system.

The urgency of the mental health crisis—especially among high-risk populations such as veterans and first responders—demands a unified, immediate response. Our proposed approach provides a clear, actionable roadmap based on real-world data, evidence-based protocols, strategic partnerships, and the retention of critical federal expertise. Every dollar invested can be linked to measurable improvements in patient outcomes, ensuring that these innovative therapies truly transform mental health care.