[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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