S. 4220

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4220 Introduced in Senate (IS)]

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119th CONGRESS
2d Session
S. 4220

To amend title 38, United States Code, to establish within the Veterans 
Health Administration an Office of Novel Therapeutics, and for other 
purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

March 26, 2026

Mr. Sheehy (for himself, Mr. Gallego, Ms. Duckworth, and Mr. Boozman) 
introduced the following bill; which was read twice and referred to the 
Committee on Veterans' Affairs

_______________________________________________________________________

A BILL

To amend title 38, United States Code, to establish within the Veterans 
Health Administration an Office of Novel Therapeutics, and for other 
purposes.

Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Veterans Health Administration Novel 
Therapeutics Preparedness Act''.

SEC. 2. FINDINGS.

Congress finds the following:
(1) Emerging therapeutic interventions, including certain 
psychedelic-assisted therapies under evaluation by the Food and 
Drug Administration as of the date of the enactment of this 
Act, may significantly alter the treatment landscape for post-
traumatic stress disorder, depression, and other mental health 
conditions affecting veterans.
(2) The administration of certain emerging therapies may 
require intensive clinical engagement, interdisciplinary teams, 
dedicated clinical space, structured preparation, and post-
treatment integration that differ substantially from 
traditional outpatient mental health services.
(3) The Department of Veterans Affairs is uniquely 
positioned to deliver integrated, veteran-centered care that 
combines medical, mental health, and peer support services 
within a single system of care.
(4) Absent centralized governance and implementation 
planning, the Department may face delays, safety risks, or 
inconsistent access following regulatory approval of such 
therapies.
(5) Establishing a dedicated Office of Novel Therapeutics 
will ensure that the Department is prepared to responsibly 
evaluate, research, and implement emerging treatment modalities 
consistent with patient safety and evidence-based practice.

SEC. 3. ESTABLISHMENT OF OFFICE OF NOVEL THERAPEUTICS WITHIN VETERANS 
HEALTH ADMINISTRATION.

(a) Establishment.--
(1) In general.--Chapter 73 of title 38, United States 
Code, is amended by adding at the end the following new 
subchapter:

``Subchapter VI--Novel Therapeutics

``Sec. 7391. Definitions
``In this subchapter:
``(1) Center of excellence.--The term `center of 
excellence' means a medical center of the Department designated 
under section 7394 of this title as a center of excellence for 
novel therapeutics to advance research, training, and 
implementation of emerging therapeutic interventions.
``(2) Emerging therapeutic intervention.--The term 
`emerging therapeutic intervention' means a pharmacological, 
biological, or other therapeutic modality under evaluation or 
review by the Food and Drug Administration.
``Sec. 7392. Office of Novel Therapeutics
``(a) Establishment.--There is established within the Veterans 
Health Administration, under the Office of the Under Secretary for 
Health, an Office of Novel Therapeutics (in this section referred to as 
the `Office').
``(b) Director.--The head of the Office shall be the Director of 
the Office of Novel Therapeutics, who shall be appointed by the Under 
Secretary for Health and who shall--
``(1) possess demonstrated expertise in clinical research 
and implementation science; and
``(2) report directly to the Under Secretary for Health.
``(c) Coordinating Authority.--The Office shall serve as the 
primary coordinating authority within the Veterans Health 
Administration for matters relating to emerging and novel therapeutic 
interventions.
``(d) Duties.--The Office shall--
``(1) develop and oversee national policy, guidance, and 
clinical standards for the evaluation, research, and potential 
implementation by the Veterans Health Administration of 
emerging and novel therapeutic interventions for mental health 
conditions affecting veterans;
``(2) develop a national clinical model for the 
administration of intensive therapeutic interventions, 
including structured preparation, monitored administration, and 
post-administration integration;
``(3) develop guidance regarding patient eligibility and 
candidacy for emerging therapeutic interventions, ensuring that 
utilization management or step therapy requirements do not 
unduly restrict access where clinically appropriate;
``(4) develop implementation-readiness plans for therapies 
that may receive approval from the Food and Drug 
Administration, including--
``(A) facility infrastructure requirements;
``(B) interdisciplinary team composition standards;
``(C) allocation of protected clinical time 
necessary to safely administer intensive therapeutic 
interventions, including full session and integration 
requirements;
``(D) patient safety and adverse event monitoring 
and response protocols; and
``(E) integration with suicide prevention, post-
traumatic stress disorder, and substance use disorder 
programs;
``(5) conduct a workforce-readiness assessment to identify 
clinicians and peer support specialists with prior training or 
certification relevant to emerging therapeutic interventions 
and gaps in training, supervision, and clinical capacity 
necessary to support safe and effective implementation of such 
interventions;
``(6) establish national training and credentialing 
standards for clinicians administering novel therapeutics;
``(7) develop a standardized, competency-based training 
framework for clinicians and peer support specialists 
participating in emerging therapeutic interventions, including 
preparation, monitored administration, integration, safety 
monitoring, interdisciplinary collaboration, and culturally 
competent care;
``(8) distinguish between research protocols and clinical 
implementation standards to ensure that patient care models are 
not constrained solely by sponsor-driven research design;
``(9) coordinate with the Office of Research and 
Development--
``(A) to align research priorities with 
implementation-readiness needs;
``(B) to recommend specialized review pathways for 
research involving emerging therapeutic interventions; 
and
``(C) to develop standards for allocation of 
protected research time for clinicians participating in 
research involving emerging therapeutic interventions, 
including clarification that patients seen under 
approved research protocols shall be counted toward 
standard clinical productivity metrics;
``(10) develop guidance to ensure continuity of care, 
including--
``(A) post-administration integration services;
``(B) incorporation of peer support specialists; 
and
``(C) coordination with community-based 
organizations for aftercare support as appropriate;
``(11) identify not fewer than one medical center in each 
Veterans Integrated Service Network to develop infrastructure 
and workforce-readiness for emerging therapeutic models; and
``(12) establish criteria for the designation of centers of 
excellence and oversee compliance with national standards.
``Sec. 7393. Clinical Implementation Program for Emerging Therapeutics
``(a) Establishment.--The Secretary, acting through the Office of 
Novel Therapeutics, shall establish a Clinical Implementation Program 
for Emerging Therapeutics (in this section referred to as the 
`Program') to evaluate the effectiveness, feasibility, safety, and 
scalability of emerging therapeutic interventions within the 
Department.
``(b) Purpose.--The Program shall--
``(1) utilize effectiveness-implementation hybrid models to 
evaluate both clinical outcomes and real-world implementation 
factors with respect to emerging therapeutic interventions;
``(2) test and refine care delivery models, including 
patient eligibility criteria, safety protocols, 
interdisciplinary team models, and post-administration 
integration services;
``(3) generate real-world evidence to inform potential 
systemwide adoption; and
``(4) assess workforce, infrastructure, cost, and 
operational requirements necessary for broader implementation.
``(c) Covered Conditions.--In carrying out the Program, the 
Secretary may prioritize one or more brain or mental health conditions 
affecting veterans, including--
``(1) post-traumatic stress disorder;
``(2) treatment-resistant depression;
``(3) substance use disorders;
``(4) suicidality;
``(5) traumatic brain injury;
``(6) repetitive low-level blast exposure;
``(7) chronic pain;
``(8) co-occurring conditions; and
``(9) other clinically appropriate conditions as determined 
appropriate by the Secretary.
``(d) Site Selection.--The Secretary may conduct the Program at--
``(1) one or more centers of excellence; and
``(2) such other medical centers as the Secretary 
determines appropriate.
``Sec. 7394. Centers of excellence for novel therapeutics
``(a) Designation.--The Secretary may designate one or more medical 
centers of the Department as centers of excellence for novel 
therapeutics.
``(b) Functions.--Each center of excellence designated under 
subsection (a) shall--
``(1) serve as a national leader in research, clinical 
training, and implementation of emerging therapeutic 
interventions;
``(2) develop and disseminate best practices and clinical 
standards across the Veterans Health Administration;
``(3) provide technical assistance and training to other 
medical centers of the Department;
``(4) integrate interdisciplinary care models, including 
peer support and post-administration integration services;
``(5) incorporate veteran advisory input into program 
development; and
``(6) coordinate with academic affiliates and external 
research partners, as appropriate.
``(c) Coordination.--Centers of excellence designated under 
subsection (a) shall operate in coordination with, and under standards 
established by, the Office of Novel Therapeutics.
``Sec. 7395. Veteran Advisory Committee on Novel Therapeutics
``(a) Establishment.--The Secretary shall establish a Veteran 
Advisory Committee on Novel Therapeutics (in this section referred to 
as the `Committee') to advise the Office of Novel Therapeutics.
``(b) Membership.--The Secretary shall select the members of the 
Committee, which shall include the following:
``(1) Veterans with lived experience of mental health 
treatment furnished by the Department.
``(2) Veterans who have participated in clinical research 
involving emerging therapeutic interventions, as applicable.
``(3) Family members or caregivers of veterans described in 
paragraph (1) or (2).
``(4) Representatives from academic institutions affiliated 
with the Department with expertise in clinical research, 
behavioral health, or emerging therapeutic interventions.
``(5) Subject matter experts as determined appropriate by 
the Secretary.
``(c) Duties.--With respect to the use of novel therapeutics, the 
Committee shall provide input on--
``(1) patient safety considerations;
``(2) informed consent practices;
``(3) implementation and access barriers; and
``(4) patient-centered care design.
``Sec. 7396. Interagency coordination
``In carrying out this subchapter, the Secretary shall coordinate 
with the Secretary of Health and Human Services, the Commissioner of 
Food and Drugs, the Administrator of the Centers for Medicare & 
Medicaid Services, the Secretary of Defense, and the Administrator of 
the Drug Enforcement Administration to support--
``(1) regulatory readiness;
``(2) development of reimbursement and billing pathways;
``(3) scheduling and rescheduling considerations, as 
appropriate; and
``(4) shared data infrastructure for monitoring safety, 
quality, and outcomes.
``Sec. 7397. Annual report
``Not less frequently than annually, the Secretary shall submit to 
Congress a report describing--
``(1) research activities of the Department relating to 
emerging therapeutic interventions;
``(2) clinical outcomes and patient-reported outcomes under 
the Clinical Implementation Program for Emerging Therapeutics 
under section 7393 of this title;
``(3) safety events and adverse outcomes;
``(4) workforce readiness and training capacity;
``(5) implementation barriers, including staffing, 
procurement, and infrastructure needs; and
``(6) recommendations for legislative or administrative 
action relating to novel therapeutics.''.
(2) Clerical amendment.--The table of sections at the 
beginning of chapter 73 of such title is amended by adding at 
the end the following:

``subchapter vi--novel therapeutics

``Sec.
``7391. Definitions.
``7392. Office of Novel Therapeutics.
``7393. Clinical Implementation Program for Emerging Therapeutics.
``7394. Centers of excellence for novel therapeutics.
``7395. Veteran Advisory Committee on Novel Therapeutics.
``7396. Interagency coordination.
``7397. Annual report.''.
(b) National Preparedness and Implementation Strategy.--Not later 
than 180 days after the date of the enactment of this Act, the 
Secretary of Veterans Affairs shall submit to Congress a national 
preparedness and implementation strategy of the Veterans Health 
Administration for emerging mental health therapeutics, including--
(1) workforce capacity assessments;
(2) facility modification needs;
(3) projected timelines for phased implementation; and
(4) barriers to implementation.
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