,i #aaith ,,congress #b;d ,session ,h4 ,r4 #gjia ,,in ,,the ,,house ,,of ,,representatives ,january #ae1 #bjbf,mr4 ,bergman 7for himself and ,mr4 ,correa7 introduced the following bill2 which was referred to the ,committee on ,veterans' ,affairs ,a ,,bill ,to direct the ,secretary of ,veterans ,affairs to establish an investigational research and extended access treatment program utilizing innovative treatments and emerging therapies to address conditions with unmet medical needs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,expanding ,veterans' ,access to ,emerging ,treatments ,act4 #b4 ,sense of congress ,it is the sense of ,congress that-- 7#a7 ,many conditions1 such as chronic pain1 post-traumatic stress disorder1 and substance use disorders1 continue to challenge the veteran community amid a lack of new innovative treatments and emerging therapies4 7#b7 ,these and other conditions represent an urgent unmet medical need among veterans4 7#c7 ,the ,department of ,veterans ,affairs should continue to advance research and facilitate timely access to innovative treatments and emerging therapies1 including psychedelic- and entactogenic-assisted therapies1 for veterans with such unmet treatment needs4 #c4 ,research program of the ,department of ,veterans ,affairs on innovative treatments and emerging therapies for certain covered conditions 7a7 ,establishment ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,veterans ,affairs shall develop an investigational research program for the treatment of veterans diagnosed with a covered condition using innovative treatments and emerging therapies1 consistent with applicable ,federal law1 including laws governing investigational medical products and controlled substances4 ,not later than #fj days after the date of the enactment of this ,act1 the ,secretary shall designate a lead administrator to carry out the research and treatment program under this section4 7b7 ,investigational research program ,the ,department of ,veterans ,affairs may-- 7#a7 conduct one or more clinical trials for the treatment of a covered condition that include veterans as participants in the clinical trial using innovative treatments and emerging therapies1 which may be selected following a review of their efficacy1 safety1 and ease of administration2 and 7#b7 develop a compassionate or extended access protocol that facilitates consideration of1 and as appropriate access to1 innovative treatments and emerging therapies4 7c7 ,participation in clinical trials or extended access ,the ,secretary shall establish a process under which a veteran diagnosed with a covered condition may-- 7#a7 participate in a clinical trial conducted under this section2 or 7#b7 be considered for access to an innovative treatment or emerging therapy under a compassionate or extended access protocol1 as clinically appropriate4 7d7 ,additional authority ,in addition to carrying out the activities under this section1 the ,secretary may1 using amounts otherwise authorized to be appropriated and otherwise available to the ,department of ,veterans ,affairs1 support one or more clinical research trials using innovative treatments and emerging therapies described in subsection 7g74 7e7 ,report required ,not later than one year after the date of the enactment of this ,act1 the ,secretary shall submit to the ,committees on ,veterans' ,affairs of the ,house of ,representatives and the ,senate a report1 including the following3 7#a7 ,identification of clinics designated to host activities under such a protocol under this section and the number of veterans expected to participate in a clinical trial conducted in subsection 7b72 7#b7 ,information on the findings and outcomes of such clinical trials1 including preliminary outcomes2 and 7#c7 ,a review of all innovative treatments and emerging therapies utilized for the treatment of covered conditions1 including safety and efficacy studies1 cost1 regulatory1 and logistical considerations associated with each4 7f7 ,sunset ,not later than two years after the date of enactment of this ,act1 the investigational program shall be reviewed by the ,secretary of ,veterans ,affairs1 who may then choose to extend or terminate the program at their discretion4 7g7 ,definitions ,in this section3 7#a7 ,the term innovative treatment means any of the following3 7,a7 #c1d-,methylenedioxy-methamphetamine2 7,b7 #e-,methoxy-,n1,n-dimethyltryptamine2 7,c7 #e-,methoxy-#b-;aminoindane2 7,d7 ,ibogaine2 7,e7 ,ketamine2 7,f7 ,psilocybin2 and 7,g7 ,such other treatments as may be designated by the ,secretary4 7#b7 ,the term emerging therapies means any of the following3 7,a7 ,investigational pharmaceutical candidates that meet the ,government's ,definition of ,recovery2 7,b7 ,investigational medical devices1 such as deep brain neurostimulation or hyperbaric oxygen therapy2 and 7,c7 ,such other therapeutic interventions as may be designated by the ,secretary4 7#c7 ,the term covered condition means any of the following3 7,a7 ,anxiety2 7,b7 ,chronic pain2 7,c7 ,depression2 7,d7 ,post-traumatic stress disorder2 7,e7 ,substance use disorders1 including but not limited to alcohol use and cocaine use disorders2 7,f7 ,traumatic brain injury2 and 7,g7 ,such other conditions as may be designated by the ,secretary4 7h7 ,rule of construction ,nothing in this section shall be construed to require or direct the ,secretary to act in a manner inconsistent with applicable ,federal law1 including laws governing investigational medical products and controlled substances4