,,ii #aaith ,,congress #b;d ,session ,s4 #dbbj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #bf1 #bjbf,mr4 ,sheehy 7for himself1 ,mr4 ,gallego1 ,ms4 ,duckworth1 and ,mr4 ,boozman7 introduced the following bill2 which was read twice and referred to the ,committee on ,veterans' ,affairs ,a ,,bill ,to amend title #ch1 ,united ,states ,code1 to establish within the ,veterans ,health ,administration an ,office of ,novel ,therapeutics1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,veterans ,health ,administration ,novel ,therapeutics ,preparedness ,act4 #b4 ,findings ,congress finds the following3 7#a7 ,emerging therapeutic interventions1 including certain psychedelic-assisted therapies under evaluation by the ,food and ,drug ,administration as of the date of the enactment of this ,act1 may significantly alter the treatment landscape for post-traumatic stress disorder1 depression1 and other mental health conditions affecting veterans4 7#b7 ,the administration of certain emerging therapies may require intensive clinical engagement1 interdisciplinary teams1 dedicated clinical space1 structured preparation1 and post-treatment integration that differ substantially from traditional outpatient mental health services4 7#c7 ,the ,department of ,veterans ,affairs is uniquely positioned to deliver integrated1 veteran-centered care that combines medical1 mental health1 and peer support services within a single system of care4 7#d7 ,absent centralized governance and implementation planning1 the ,department may face delays1 safety risks1 or inconsistent access following regulatory approval of such therapies4 7#e7 ,establishing a dedicated ,office of ,novel ,therapeutics will ensure that the ,department is prepared to responsibly evaluate1 research1 and implement emerging treatment modalities consistent with patient safety and evidence-based practice4 #c4 ,establishment of ,office of ,novel ,therapeutics within ,veterans ,health ,administration 7a7 ,establishment 7#a7 ,in general ,chapter #gc of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new subchapter3 ,,vi ,novel ,therapeutics #gcia4 ,definitions ,in this subchapter3 7#a7 ,center of excellence ,the term center of excellence means a medical center of the ,department designated under section #gcid of this title as a center of excellence for novel therapeutics to advance research1 training1 and implementation of emerging therapeutic interventions4 7#b7 ,emerging therapeutic intervention ,the term emerging therapeutic intervention means a pharmacological1 biological1 or other therapeutic modality under evaluation or review by the ,food and ,drug ,administration4 #gcib4 ,office of ,novel ,therapeutics 7a7 ,establishment ,there is established within the ,veterans ,health ,administration1 under the ,office of the ,under ,secretary for ,health1 an ,office of ,novel ,therapeutics 7in this section referred to as the ,office74 7b7 ,director ,the head of the ,office shall be the ,director of the ,office of ,novel ,therapeutics1 who shall be appointed by the ,under ,secretary for ,health and who shall-- 7#a7 possess demonstrated expertise in clinical research and implementation science2 and 7#b7 report directly to the ,under ,secretary for ,health4 7c7 ,coordinating authority ,the ,office shall serve as the primary coordinating authority within the ,veterans ,health ,administration for matters relating to emerging and novel therapeutic interventions4 7d7 ,duties ,the ,office shall-- 7#a7 develop and oversee national policy1 guidance1 and clinical standards for the evaluation1 research1 and potential implementation by the ,veterans ,health ,administration of emerging and novel therapeutic interventions for mental health conditions affecting veterans2 7#b7 develop a national clinical model for the administration of intensive therapeutic interventions1 including structured preparation1 monitored administration1 and post-administration integration2 7#c7 develop guidance regarding patient eligibility and candidacy for emerging therapeutic interventions1 ensuring that utilization management or step therapy requirements do not unduly restrict access where clinically appropriate2 7#d7 develop implementation-readiness plans for therapies that may receive approval from the ,food and ,drug ,administration1 including-- 7,a7 facility infrastructure requirements2 7,b7 interdisciplinary team composition standards2 7,c7 allocation of protected clinical time necessary to safely administer intensive therapeutic interventions1 including full session and integration requirements2 7,d7 patient safety and adverse event monitoring and response protocols2 and 7,e7 integration with suicide prevention1 post-traumatic stress disorder1 and substance use disorder programs2 7#e7 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 training1 supervision1 and clinical capacity necessary to support safe and effective implementation of such interventions2 7#f7 establish national training and credentialing standards for clinicians administering novel therapeutics2 7#g7 develop a standardized1 competency-based training framework for clinicians and peer support specialists participating in emerging therapeutic interventions1 including preparation1 monitored administration1 integration1 safety monitoring1 interdisciplinary collaboration1 and culturally competent care2 7#h7 distinguish between research protocols and clinical implementation standards to ensure that patient care models are not constrained solely by sponsor-driven research design2 7#i7 coordinate with the ,office of ,research and ,development-- 7,a7 to align research priorities with implementation-readiness needs2 7,b7 to recommend specialized review pathways for research involving emerging therapeutic interventions2 and 7,c7 to develop standards for allocation of protected research time for clinicians participating in research involving emerging therapeutic interventions1 including clarification that patients seen under approved research protocols shall be counted toward standard clinical productivity metrics2 7#aj7 develop guidance to ensure continuity of care1 including-- 7,a7 post-administration integration services2 7,b7 incorporation of peer support specialists2 and 7,c7 coordination with community-based organizations for aftercare support as appropriate2 7#aa7 identify not fewer than one medical center in each ,veterans ,integrated ,service ,network to develop infrastructure and workforce-readiness for emerging therapeutic models2 and 7#ab7 establish criteria for the designation of centers of excellence and oversee compliance with national standards4 #gcic4 ,clinical ,implementation ,program for ,emerging ,therapeutics 7a7 ,establishment ,the ,secretary1 acting through the ,office of ,novel ,therapeutics1 shall establish a ,clinical ,implementation ,program for ,emerging ,therapeutics 7in this section referred to as the ,program7 to evaluate the effectiveness1 feasibility1 safety1 and scalability of emerging therapeutic interventions within the ,department4 7b7 ,purpose ,the ,program shall-- 7#a7 utilize effectiveness-implementation hybrid models to evaluate both clinical outcomes and real-world implementation factors with respect to emerging therapeutic interventions2 7#b7 test and refine care delivery models1 including patient eligibility criteria1 safety protocols1 interdisciplinary team models1 and post-administration integration services2 7#c7 generate real-world evidence to inform potential systemwide adoption2 and 7#d7 assess workforce1 infrastructure1 cost1 and operational requirements necessary for broader implementation4 7c7 ,covered conditions ,in carrying out the ,program1 the ,secretary may prioritize one or more brain or mental health conditions affecting veterans1 including-- 7#a7 post-traumatic stress disorder2 7#b7 treatment-resistant depression2 7#c7 substance use disorders2 7#d7 suicidality2 7#e7 traumatic brain injury2 7#f7 repetitive low-level blast exposure2 7#g7 chronic pain2 7#h7 co-occurring conditions2 and 7#i7 other clinically appropriate conditions as determined appropriate by the ,secretary4 7d7 ,site selection ,the ,secretary may conduct the ,program at-- 7#a7 one or more centers of excellence2 and 7#b7 such other medical centers as the ,secretary determines appropriate4 #gcid4 ,centers of excellence for novel therapeutics 7a7 ,designation ,the ,secretary may designate one or more medical centers of the ,department as centers of excellence for novel therapeutics4 7b7 ,functions ,each center of excellence designated under subsection 7a7 shall-- 7#a7 serve as a national leader in research1 clinical training1 and implementation of emerging therapeutic interventions2 7#b7 develop and disseminate best practices and clinical standards across the ,veterans ,health ,administration2 7#c7 provide technical assistance and training to other medical centers of the ,department2 7#d7 integrate interdisciplinary care models1 including peer support and post-administration integration services2 7#e7 incorporate veteran advisory input into program development2 and 7#f7 coordinate with academic affiliates and external research partners1 as appropriate4 7c7 ,coordination ,centers of excellence designated under subsection 7a7 shall operate in coordination with1 and under standards established by1 the ,office of ,novel ,therapeutics4 #gcie4 ,veteran ,advisory ,committee on ,novel ,therapeutics 7a7 ,establishment ,the ,secretary shall establish a ,veteran ,advisory ,committee on ,novel ,therapeutics 7in this section referred to as the ,committee7 to advise the ,office of ,novel ,therapeutics4 7b7 ,membership ,the ,secretary shall select the members of the ,committee1 which shall include the following3 7#a7 ,veterans with lived experience of mental health treatment furnished by the ,department4 7#b7 ,veterans who have participated in clinical research involving emerging therapeutic interventions1 as applicable4 7#c7 ,family members or caregivers of veterans described in paragraph 7#a7 or 7#b74 7#d7 ,representatives from academic institutions affiliated with the ,department with expertise in clinical research1 behavioral health1 or emerging therapeutic interventions4 7#e7 ,subject matter experts as determined appropriate by the ,secretary4 7c7 ,duties ,with respect to the use of novel therapeutics1 the ,committee shall provide input on-- 7#a7 patient safety considerations2 7#b7 informed consent practices2 7#c7 implementation and access barriers2 and 7#d7 patient-centered care design4 #gcif4 ,interagency coordination ,in carrying out this subchapter1 the ,secretary shall coordinate with the ,secretary of ,health and ,human ,services1 the ,commissioner of ,food and ,drugs1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,secretary of ,defense1 and the ,administrator of the ,drug ,enforcement ,administration to support-- 7#a7 regulatory readiness2 7#b7 development of reimbursement and billing pathways2 7#c7 scheduling and rescheduling considerations1 as appropriate2 and 7#d7 shared data infrastructure for monitoring safety1 quality1 and outcomes4 #gcig4 ,annual report ,not less frequently than annually1 the ,secretary shall submit to ,congress a report describing-- 7#a7 research activities of the ,department relating to emerging therapeutic interventions2 7#b7 clinical outcomes and patient-reported outcomes under the ,clinical ,implementation ,program for ,emerging ,therapeutics under section #gcic of this title2 7#c7 safety events and adverse outcomes2 7#d7 workforce readiness and training capacity2 7#e7 implementation barriers1 including staffing1 procurement1 and infrastructure needs2 and 7#f7 recommendations for legislative or administrative action relating to novel therapeutics4 4 7#b7 ,clerical amendment ,the table of sections at the beginning of chapter #gc of such title is amended by adding at the end the following3 ,,subchapter ,,vi--,novel ,therapeutics,sec4#gcia4 ,definitions4#gcib4 ,office of ,novel ,therapeutics4#gcic4 ,clinical ,implementation ,program for ,emerging ,therapeutics4#gcid4 ,centers of excellence for novel therapeutics4#gcie4 ,veteran ,advisory ,committee on ,novel ,therapeutics4#gcif4 ,interagency coordination4#gcig4 ,annual report4 4 7b7 ,national preparedness and implementation strategy ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,veterans ,affairs shall submit to ,congress a national preparedness and implementation strategy of the ,veterans ,health ,administration for emerging mental health therapeutics1 including-- 7#a7 workforce capacity assessments2 7#b7 facility modification needs2 7#c7 projected timelines for phased implementation2 and 7#d7 barriers to implementation4