S4220119th CongressWALLET

Veterans Health Administration Novel Therapeutics Preparedness Act

Sponsored By: Senator Tim Sheehy

Introduced

Summary

Creates an Office of Novel Therapeutics within the Veterans Health Administration to coordinate evaluation and safe rollout of emerging mental health treatments. The bill would set national clinical models, training standards, and designate centers of excellence to prepare VA sites for intensive therapies such as psychedelic-assisted care.

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  • Veterans and families: Would build eligibility guidance and clinical pathways to expand appropriate access for conditions like PTSD, treatment-resistant depression, substance use disorder, suicidality, and other clinically appropriate conditions.
  • Clinicians and VA sites: Would require a workforce-readiness assessment, national training and credentialing standards, protected clinical time for preparation and integration, and designation of centers of excellence with at least one center in each Veterans Integrated Service Network to build infrastructure and staff capacity.
  • Research, oversight, and coordination: Would create a Clinical Implementation Program to generate real-world evidence and refine care models, establish a Veteran Advisory Committee, and require coordination with HHS, the FDA, CMS, the Department of Defense, and the DEA for regulatory, reimbursement, and safety planning.

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Bill Overview

Analyzed Economic Effects

7 provisions identified: 7 benefits, 0 costs, 0 mixed.

Annual VA Report on New Therapies

If enacted, the bill would require the Secretary to report to Congress at least once a year on VA research and the Clinical Implementation Program. The report would cover clinical and patient‑reported outcomes, safety events, workforce readiness, training capacity, and implementation barriers. The report must also include recommendations for legislative or administrative action.

Centers of Excellence for New Therapies

If enacted, the bill would let the Secretary designate VA medical centers as centers of excellence for novel therapeutics. Designated centers would lead research, training, and implementation and share best practices with other VA sites. They would provide technical assistance, integrate peer support and post‑treatment services, and follow standards set by the Office of Novel Therapeutics.

Interagency Coordination for Therapies

If enacted, the bill would require VA to coordinate with HHS, FDA, CMS, DoD, and DEA on regulatory readiness, reimbursement and billing, scheduling issues, and shared data for safety and outcomes. This coordination would align VA clinical plans with external rules and payment systems.

National Preparedness Plan for Therapies

If enacted, the bill would require the Secretary to submit a national preparedness and implementation strategy to Congress within 180 days. The plan must include workforce capacity assessments, facility modification needs, projected phased timelines, and barriers to implementation. The plan is intended to guide VA planning for broader clinical adoption of emerging therapeutics.

Program to Test Emerging Therapies

If enacted, the bill would require a Clinical Implementation Program for Emerging Therapeutics run by the Office. The Program would test care delivery models, safety protocols, and real‑world outcomes. It would generate evidence on feasibility, workforce needs, costs, and scalability. The Secretary could prioritize conditions like PTSD, treatment‑resistant depression, substance use disorders, suicidality, traumatic brain injury, and chronic pain.

VA Office for Novel Therapies

If enacted, the bill would create an Office of Novel Therapeutics inside the VA's Veterans Health Administration. The Under Secretary for Health would appoint a Director to run the Office. The Office would set national policy, clinical standards, workforce training, and readiness plans. It would also define 'center of excellence' and 'emerging therapeutic intervention' and pick at least one medical center in each Veterans Integrated Service Network to build readiness.

Veteran Advisory Committee on Therapies

If enacted, the bill would create a Veteran Advisory Committee on Novel Therapeutics to advise the Office. The Secretary would appoint veterans with lived VA mental‑health experience, research participants, caregivers, academic experts, and other specialists. The Committee would advise on patient safety, informed consent, access barriers, and patient‑centered care design.

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Sponsors & CoSponsors

Sponsor

Tim Sheehy

MT • R

Cosponsors

  • Ruben Gallego

    AZ • D

    Sponsored 3/26/2026

  • Tammy Duckworth

    IL • D

    Sponsored 3/26/2026

  • John Boozman

    AR • R

    Sponsored 3/26/2026

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov

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