Veterans Health Administration Novel Therapeutics Preparedness Act
Sponsored By: Senator Sheehy, Tim [R-MT]
In Committee
Summary
This bill would create a centralized VA Office of Novel Therapeutics to guide evaluation, training, and phased implementation of emerging mental health treatments for veterans. It focuses on building national standards, designated Centers of Excellence, and real-world testing to support safe, equitable access to new therapies.
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- Veterans and families: Establishes patient eligibility guidance, post-treatment integration, and peer support. It lets the program prioritize conditions like PTSD, treatment-resistant depression, substance use disorders, suicidality, traumatic brain injury, and chronic pain.
- VA medical centers and staff: Requires at least one prepared medical center in each Veterans Integrated Service Network (VISN). Sets national training and credentialing, workforce-readiness assessments, protected clinical time for clinicians, and facility and safety protocols for intensive therapeutic administration.
- Researchers and federal partners: Creates a Clinical Implementation Program to generate real-world evidence and align research priorities. Requires coordination with the Food and Drug Administration, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Department of Defense, and Drug Enforcement Administration, plus annual reporting to Congress and a Veteran Advisory Committee.
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Centers of Excellence for Therapies
If enacted, the bill would allow the VA to designate one or more medical centers as Centers of Excellence for novel therapeutics. Those centers would lead research, training, and technical assistance on new therapies. They would share best practices, train other VA sites, integrate peer support and post-treatment care, and coordinate with academic and external research partners. Centers would follow standards set by the Office of Novel Therapeutics.
New VA Office for Novel Therapies
If enacted, the bill would create an Office of Novel Therapeutics inside the VA under the Under Secretary for Health. The Office would write national policy, clinical models, and patient eligibility guidance for emerging mental health therapies. It would set training, credentialing, workforce-readiness, protected clinical time, and safety monitoring standards. The Office would distinguish clinical care from research and identify at least one medical center in each VA region to prepare.
VA program to test new therapies
If enacted, the bill would require a Clinical Implementation Program to test emerging therapeutic interventions in VA settings. The Program would measure clinical outcomes and real-world implementation (safety, feasibility, and scalability) using hybrid study models. It would test care delivery, eligibility rules, safety protocols, team models, and post-treatment integration. The Secretary could prioritize conditions like PTSD, treatment-resistant depression, substance use, suicidality, traumatic brain injury, chronic pain, and related conditions.
Veteran advisory and reporting rules
If enacted, the bill would create a Veteran Advisory Committee with veterans, caregivers, researchers, and experts to advise on safety, consent, access, and patient-centered design. The VA would be required to coordinate with HHS, FDA, CMS, DoD, and the DEA on regulatory, reimbursement, scheduling, and data needs. The VA would also report to Congress at least annually on research, clinical and patient outcomes, safety events, workforce readiness, and implementation barriers. The Secretary would deliver a national preparedness and implementation strategy to Congress within 180 days of enactment.
Sponsors & CoSponsors
Sponsor
Sheehy, Tim [R-MT]
MT • R
Cosponsors
Sen. Gallego, Ruben [D-AZ]
AZ • D
Sponsored 3/26/2026
Sen. Duckworth, Tammy [D-IL]
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