,,ib ,union ,calendar ,no4 #gce #aaith ,,congress #b;d ,session ,h4 ,r4 #fiic ,report ,no4 #aai-hch ,,in ,,the ,,house ,,of ,,representatives ,january #i1 #bjbf,mr4 ,bergman 7for himself1 ,ms4 ,elfreth1 ,ms4 ,king-,hinds1 ,mr4 ,davis of ,north ,carolina1 ,mr4 ,van ,orden1 and ,mr4 ,luttrell7 introduced the following bill2 which was referred to the ,committee on ,veterans' ,affairs ,october #a1 #bjbf;,additional sponsors3 ,mr4 ,subramanyam1 ,mr4 ,la,lota1 ,ms4 ,sewell1 ,mr4 ,pfluger1 ,mr4 ,sorensen1 ,mr4 ,crank1 ,mr4 ,olszewski1 and ,mr4 ,van ,drew ,october #a1 #bjbf,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed,strike out all after the enacting clause and insert the part printed in italic,for text of introduced bill1 see copy of bill as introduced on ,january #i1 #bjbf ,a ,,bill ,to direct the ,secretary of ,veterans ,affairs to carry out programs to award grants to eligible entities to conduct research with respect to treatments for traumatic brain injury prospective randomized control trials for neurorehabilitation treatments1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,veterans ,,tbi ,breakthrough ,exploration of ,adaptive ,care ,opportunities ,nationwide ,act of #bjbf or the ,,beacon ,act of #bjbf4 #b4 ,department of ,veterans ,affairs grant program for supplemental neurorehabilitation approaches to chronic mild ,,tbi treatment 7a7 ,grant program 7#a7 ,in general ,the ,secretary of ,veterans ,affairs shall carry out a three-year program 7to be known as the ,,tbi ,innovation ,grant ,program7 under which the ,secretary shall award grants to eligible entities described in subsection 7b7 for the development1 implementation1 and evaluation of approaches and methodologies for prospective randomized control trials for neurorehabilitation treatments for the treatment of chronic mild traumatic brain injury 7in this ,act referred to as m,t,b,i7 in veterans4 7#b7 ,relationship to other ,department activities ,the grant program required under paragraph 7#a7 shall be carried out in a manner that-- 7,a7 supplements1 and does not supplant1 other clinical care and research of the ,department of ,veterans ,affairs relating to m,t,b,i2 and 7,b7 facilitates1 as practicable1 coordination with ,veterans ,health ,administration facilities for referral1 continuity of care1 and dissemination of findings4 7b7 ,eligible entities described ,an eligible entity described in this subsection is any of the following3 7#a7 ,a nonprofit organization with demonstrated capability to conduct clinical trials and to deliver or research effective neurorehabilitation treatments for m,t,b,i1 including through patient care delivery4 7#b7 ,an academic institution that conducts significant research on m,t,b,i and has demonstrated capability to conduct clinical trials relating to neurorehabilitation treatments4 7#c7 ,a non-,department health care provider with expertise in neurorehabilitative therapies and demonstrated capability to conduct clinical trials and to evaluate m,t,b,i treatments through patient care delivery4 7#d7 ,a partnership or consortium of two or more entities described in paragraphs 7#a7 through 7#c74 7c7 ,use of funds ,an eligible entity in receipt of a grant under this section shall use such grant to support activities that include-- 7#a7 designing and testing novel or integrative treatments for m,t,b,i that prioritize patient-centered care1 including non-pharmacological therapies2 7#b7 conducting clinical studies and assessments to measure the effectiveness of funded approaches to-- 7,a7 improve mental health outcomes among veterans2 7,b7 reduce suicidality1 and common risk factors for completing suicide1 including depression and substance use disorders among veterans2 and 7,c7 mitigate long-term effects of m,t,b,i and1 to the extent outcomes are collected under the applicable clinical protocol1 measure durability of outcomes at approximately six months following completion of treatment2 7#c7 providing training for clinicians and outreach to veterans and their families to improve awareness and accessibility of innovative m,t,b,i treatments1 including information on available ,department resources and pathways to access such resources2 and 7#d7 establishing partnerships with community organizations1 academic institutions1 and health care facilities1 including1 as practicable1 coordination with ,veterans ,health ,administration facilities to facilitate referral of eligible veterans1 continuity of care1 and dissemination of aggregate findings4 7d7 ,limitation on grant amount ,the ,secretary may not award an eligible entity a grant under this section in an amount that exceeds #e1jjj1jjj for any fiscal year4 7e7 ,program administration 7#a7 ,applications ,an eligible entity desiring a grant under this section shall submit to the ,secretary an application in such form1 at such time1 and containing such information and assurances as the ,secretary determines appropriate1 including a detailed description of-- 7,a7 activities proposed to be conducted using the grant2 7,b7 expected outcomes of such activities2 7,c7 plans for evaluating the effectiveness of such activities2 7,d7 how the eligible entity will coordinate1 as practicable1 with ,veterans ,health ,administration facilities for referral and continuity of care for veterans who participate in activities carried out using grant funds1 and for dissemination of aggregate findings2 7,e7 the budget of the entity for the use of the grant1 including a narrative justification and an identification of the estimated amount of grant funds to be used for administrative or overhead costs2 and 7,f7 assurances of compliance with applicable ,federal laws and regulations relating to human subjects protections and patient safety4 7#b7 ,priority ,in awarding grants under this section1 the ,secretary shall give priority to eligible entities that have demonstrated the capacity to coordinate with the ,department to facilitate referral and continuity of care for veterans who participate in activities carried out using grant funds4 7#c7 ,periodic reports ,as a condition of receiving a grant under this section1 an eligible entity shall1 not less frequently than annually during the grant period and not later than #ahj days after the end of the grant period1 submit to the ,secretary a report that includes1 with respect to the period covered by the report-- 7,a7 a description of how the eligible entity used such grant2 7,b7 a summary of the progress of activities funded with amounts from such grant2 7,c7 measured outcomes relating to such activities2 7,d7 a detailed accounting of expenditures of grant funds1 including administrative or overhead costs2 7,e7 to the extent collected under the applicable clinical protocol or in the ordinary course of care1 a description of any adverse events and serious adverse events1 including self-harm or suicide-related events2 and 7,f7 a description of actions taken pursuant to the coordination plan described in paragraph 7#a77;,d74 7#d7 ,oversight2 annual evaluations ,the ,secretary shall-- 7,a7 ensure rigorous oversight of the grant program under this section1 including by monitoring financial compliance and timely receipt of the reports required under paragraph 7#b72 and 7,b7 on an annual basis until the termination date specified in subsection 7i77#a71 evaluate the efficacy of activities carried out using grant funds based on the reports submitted under paragraph 7#b7 and other appropriate information4 7#e7 ,rule of construction ,nothing in this section shall be construed to authorize the ,secretary to require prior approval of1 or changes to1 any clinical protocol1 study design1 outcome measures1 or follow-up schedule of an eligible entity that receives a grant under this section1 except as necessary to ensure compliance with applicable ,federal laws and regulations relating to human subjects protections and patient safety4 7#f7 ,enforcement authority ,the ,secretary may suspend1 modify1 or terminate a grant awarded under this section1 if the ,secretary determines that the recipient of such grant has failed to comply with reporting requirements under paragraph 7#b7 or other applicable terms and conditions of the grant4 7f7 ,available amounts2 authorization of appropriations 7#a7 ,available amounts ,the ,secretary may carry out the program under this section using amounts available to the ,secretary for general mental health care programs1 if the use of such amounts supplements1 and does not supplant1 amounts otherwise available for ,department mental health and traumatic brain injury programs4 7#b7 ,authorization of appropriations ,there is authorized to be appropriated to the ,secretary #aj1jjj1jjj for each of fiscal years #bjbf through #bjbh to carry out this section4 7g7 ,duration2 annual review 7#a7 ,duration ,the authority of the ,secretary to carry out the grant program under this section shall terminate on the date that is three years after the date of the enactment of this ,act1 except that the ,secretary may continue to use amounts made available to carry out this section after such date solely for the purpose of administering activities and obligations incurred before such termination date4 7#b7 ,annual review ,during such three-year period1 the ,secretary shall1 on an annual basis1 review the effectiveness of the grant program to determine the potential of such grant program for continuation or expansion4 #c4 ,department of ,veterans ,affairs grant program for independent third-party research studies and treatment with respect to supplemental neurorehabilitation treatments for m,t,b,i 7a7 ,establishment ,the ,secretary of ,veterans ,affairs shall establish and carry out a research grant program to award grants to eligible entities described in subsection 7b7 to be used to carry out studies and applied programs on approaches and methodologies for the treatment of m,t,b,i in veterans4 7b7 ,eligible entities described ,an eligible entity described in this subsection is any of the following3 7#a7 ,a nonprofit organization that has demonstrated the capability to conduct clinical trials and to evaluate traumatic brain injury treatments through patient care delivery4 7#b7 ,an academic institution that conducts significant research on traumatic brain injury and has demonstrated the capability to conduct clinical trials relating to neurorehabilitation treatments 7#c7 ,a partnership or consortium of two or more entities described in paragraphs 7#a7 and 7#b74 7c7 ,applications ,an eligible entity desiring a grant under this section shall submit to the ,secretary an application in such form1 at such time1 and containing such information and assurances as the ,secretary determines appropriate1 including a summary of-- 7#a7 the research and treatment activities proposed to be carried out using grant funds2 7#b7 the methodology to be used for such activities2 7#c7 the expected outcomes of such activities2 7#d7 how the eligible entity will coordinate1 as practicable1 with ,veterans ,health ,administration facilities for referral and continuity of care for veterans who participate in activities carried out using grant funds1 and for dissemination of aggregate findings2 7#e7 the budget of the entity for the use of the grant1 including a narrative justification and an identification of the estimated amount of grant funds to be used for administrative or overhead costs2 and 7#f7 assurances of compliance with applicable ,federal laws and regulations relating to human subjects protections and patient safety4 7d7 ,administration 7#a7 ,grant categories ,in carrying out the grant program under this section1 each fiscal year the ,secretary shall-- 7,a7 subject to the requirement under paragraph 7#b71 award four grants for exploratory or pilot research and treatment projects1 each of which shall be in an amount of not more than #fbe1jjj2 and 7,b7 award five grants for collaborative or multidisciplinary research and treatment initiatives1 each of which shall be in an amount of not more than #a1ejj1jjj4 7#b7 ,priority ,of the grants awarded under paragraph 7#a77;,a71 the ,secretary shall award not fewer than three to nonprofit organizations4 7#c7 ,enforcement authority ,the ,secretary may suspend1 modify1 or terminate a grant awarded under this section1 if the ,secretary determines that the recipient of such grant has failed to comply with the applicable terms and conditions of the grant4 7e7 ,agreement with independent organization 7#a7 ,in general ,the ,secretary shall seek to enter into an agreement with an independent organization that is not a component of the ,department and that has demonstrated expertise in randomized controlled trials1 neurorehabilitation outcomes evaluation1 and research integrity1 under which the organization agrees to-- 7,a7 administer the research grant program under this section2 7,b7 carry out studies and implement efforts that include-- 7i7 analyzing data from m,t,b,i treatment methodologies developed pursuant to the research grant program to assess the effect1 among veterans1 of such methodologies on enhanced brain health outcomes1 mental health1 and long-term recovery1 including1 to the extent outcomes are collected under the applicable clinical protocol1 durability of outcomes at approximately six months following completion of treatment2 7ii7 identifying data-driven best practices and providing recommendations for further research or clinical application1 including recommendations for dissemination to ,veterans ,health ,administration clinicians and facilities 7as appropriate72 and 7iii7 randomized1 controlled clinical trials to-- 7,i7 validate and deliver treatments2 7,,ii7 establish a standard of care2 and 7,,iii7 improve access to such treatments for veterans2 7,c7 submit to the ,secretary not less frequently than annually a report describing activities carried out under this section1 including outcome data and methodology2 and 7,d7 make available to the ,secretary all data and findings from the grants made under this section1 consistent with applicable ,federal law1 regulation1 and ,department policies relating to patient protections1 data security1 and privacy4 7#b7 ,rule of construction ,nothing in this section shall be construed to authorize the ,secretary1 or an independent organization that enters into an agreement with the ,secretary under paragraph 7#a71 to require prior approval of1 or changes to1 any clinical protocol1 study design1 outcome measures1 or follow-up schedule established by an eligible entity that receives a grant under this section1 except as necessary to ensure compliance with applicable ,federal laws and regulations relating to human subjects protections and patient safety4 7#c7 ,report ,an agreement under paragraph 7#a7 shall include a requirement that the independent organization submits to ,congress and the ,secretary a comprehensive report that includes-- 7,a7 the findings of the studies required under such agreement2 7,b7 recommendations with respect to the expansion of successful ,,tbi treatment methodologies and standard of care recommendations1 if any1 developed pursuant to the research grant program2 and 7,c7 to the extent available from the reports and study materials of grant recipients1 a summary of-- 7i7 the durability of outcomes at approximately six months following completion of treatment1 if collected under the applicable clinical protocol2 7ii7 adverse events and serious adverse events1 including self-harm or suicide-related events1 if collected under the applicable clinical protocol or in the ordinary course of care2 and 7iii7 aggregate expenditures of grant funds1 including administrative or overhead costs4 7#d7 ,surveys ,the ,secretary may conduct surveys of any independent organization that enters into an agreement with the ,secretary under paragraph 7#a7 in order to assess the effectiveness of such organization in administering the research grant program under this section4 7f7 ,available amounts2 authorization of appropriations 7#a7 ,available amounts ,the ,secretary may use amounts available to the ,secretary for the operating budget of the ,national ,center for ,posttraumatic ,stress ,disorder to carry out the research grant program under this section1 if the use of such amounts supplements1 and does not supplant1 amounts otherwise available for ,department programs and services4 7#b7 ,authorization of appropriations ,there is authorized to be appropriated to the ,secretary #aj1jjj1jjj for each of fiscal years #bjbf through #bjbh to carry out this section4 7g7 ,termination date ,the authority of the ,secretary to carry out the research grant program under this section shall terminate on the date that is three years after the date of the enactment of this ,act4 #d4 ,reports to ,congress ,not later than two years after the date on which the ,secretary commences the research grant program under tsection #b1 and on an annual basis thereafter until the termination date specified in subsection 7h7 of such section1 the ,secretary shall submit to ,congress a report on the grant programs under sections #b and #c4 ,each such report shall include-- 7#a7 the findings of the studies under section #b7;f77#b72 7#b7 a description of any agreement entered into by the ,secretary under section #c7;e77#a72 7#c7 recommendations of the ,secretary with respect to policy and programmatic improvements to services of the ,department to treat m,t,b,i among veterans2 7#d7 any findings derived from surveys conducted under section #c7;e77#d71 including any recommendations of the ,secretary for improvements to the structure1 oversight1 administration1 or performance of the independent organization that enters into an agreement with the ,secretary under section #c7;e77#a72 and 7#e7 such other matters as the ,secretary determines appropriate4 #e4 ,modification of certain housing loan fees ,the loan fee table in section #cgbi7;b77#b7 of title #ch1 ,united ,states ,code1 is amended by striking ,june #i1 #bjcd each place it appears and inserting ,july #ad1 #bjcd4 #f4 ,definitions ,in this ,act3 7#a7 ,the terms chronic mild traumatic brain injury and m,t,b,i mean a mild traumatic brain injury with symptoms that persist for not fewer than six months after the inciting injury1 as determined using validated clinical criteria4 7#b7 ,the term nonprofit organization-- 7,a7 means an organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf and exempt from taxation under section #eja7;a7 of such ,code2 and 7,b7 includes such an organization that is a hospital1 nonprofit health system1 academic medical center1 or clinic that delivers neurorehabilitation care or conducts clinical research relating to m,t,b,i4 7#c7 ,the term veteran has the meaning given such term in section #aja of title #ch1 ,united ,states ,code4 ,october #a1 #bjbf,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed