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<dc:title>119 S4031 IS: Innovative Therapies Centers of Excellence Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2026-03-09</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>119th CONGRESS</congress><session>2d Session</session><legis-num>S. 4031</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20260309">March 9, 2026</action-date><action-desc><sponsor name-id="S432">Mr. Gallego</sponsor> (for himself and <cosponsor name-id="S433">Mr. McCormick</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSVA00">Committee on Veterans' Affairs</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend title 38, United States Code, to require the Secretary of Veterans Affairs to designate medical facilities of the Department of Veterans Affairs as innovative therapies centers of excellence, and for other purposes.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="H6D4C41CEC3CC437AB8D0C0CD7B985452"><section section-type="section-one" id="H46B68C6B151A438C89E3371DA824B612"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Innovative Therapies Centers of Excellence Act</short-title></quote>.</text></section><section id="HB3BAE90C5DE548DA9202D4E037565766"><enum>2.</enum><header>Department of Veterans Affairs designation of innovative therapies centers of excellence</header><subsection id="HB75F63CC06214E5582A79E7E56EE8199"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/38/73">chapter 73</external-xref> of title 38, United States Code, is amended by adding at the end the following new section:</text><quoted-block style="USC" display-inline="no-display-inline" id="H6DE99A70CF5541ED93034D2BA3AD9D9B"><section id="H4B6EC36B446B4CDB8B1B32E55A73536B"><enum>7330E.</enum><header>Innovative therapies centers of excellence</header><subsection id="HDA21842569694770801CA6E2D8CE2940"><enum>(a)</enum><header>Establishment of centers</header><paragraph commented="no" display-inline="no-display-inline" id="id7f1aeaf472924b57b99a6dc278743dc9"><enum>(1)</enum><header>Designation</header><text display-inline="yes-display-inline">The Secretary, upon the recommendation of the Under Secretary for Health, shall designate not fewer than five medical facilities of the Department as the locations for innovative therapies centers of excellence.</text></paragraph><paragraph display-inline="no-display-inline" id="H97F5F35FCDC14C80B463F80607C5A4A9"><enum>(2)</enum><header>Establishment and operation</header><text>Subject to the availability of appropriations for such purpose, the Secretary shall establish and operate innovative therapies centers of excellence at the locations designated pursuant to paragraph (1).</text></paragraph></subsection><subsection id="HB0FEC18E1B264A34B435B37279652374"><enum>(b)</enum><header>Geographic distribution of facilities</header><text display-inline="yes-display-inline">In designating medical facilities as centers of excellence under subsection (a)(1), the Secretary, upon the recommendation of the Under Secretary for Health, shall ensure appropriate geographic distribution of such facilities.</text></subsection><subsection id="H3C188EBAF63E4F1FAB2FB22516F67CB9"><enum>(c)</enum><header>Requirements for designation</header><paragraph commented="no" display-inline="no-display-inline" id="idcf04046bea5148c58210009106583f83"><enum>(1)</enum><header>Highest competitive standards</header><text display-inline="yes-display-inline">The Secretary may not designate a medical facility as a location for a center under subsection (a)(1) unless the peer review panel established under subsection (d) has determined under that subsection that the proposal submitted by such facility as a location for a new center under subsection (a)(1) is among those proposals that meet the highest competitive standards of scientific and clinical merit.</text></paragraph><paragraph id="HF405948BEB234DA2A1E208DA0D9C890C"><enum>(2)</enum><header>Other elements</header><text>The Secretary may not designate a medical facility as a location for a center under subsection (a)(1) unless the Secretary, upon the recommendation of the Under Secretary for Health, determines that the facility has, or may reasonably be anticipated to develop, each of the following:</text><subparagraph id="H86BDCBBD2F9644B497DFCF719655853E"><enum>(A)</enum><text>An arrangement with—</text><clause id="H854A815D72BF42F7990958C6FBC3B914"><enum>(i)</enum><text>an accredited medical school that provides education and training in innovative therapies and with which the facility is affiliated under which residents receive education and training in use of innovative therapies to treat covered conditions;</text></clause><clause id="H035E003E003D41F3A7F49A6DF7389280"><enum>(ii)</enum><text display-inline="yes-display-inline">an accredited school of psychiatry; and</text></clause><clause id="H2463EE34494D4863B0942D4D62DB2786"><enum>(iii)</enum><text>an accredited school of social work.</text></clause></subparagraph><subparagraph id="H89D9D8C2FA5B41768BBA7C34C873FE4E"><enum>(B)</enum><text>The ability to attract the participation of scientists who are capable of ingenuity and creativity in medical research efforts.</text></subparagraph><subparagraph id="H707E3E5CA36C47B3B75DB1296D8055BF"><enum>(C)</enum><text>An advisory committee composed of veterans and appropriate medical and research representatives of the facility and of the affiliated school or schools to advise the directors of the facility and such center on policy matters pertaining to the activities of the center during the period of the operation of such center.</text></subparagraph><subparagraph id="HEC34A5973FAF4068B5DB0951CB5E80CB"><enum>(D)</enum><text>The capability to conduct effectively evaluations of the activities of such center.</text></subparagraph><subparagraph id="H275C259CDE1C4E8B8024A1D17B9773C5"><enum>(E)</enum><text>The capability to coordinate (as part of an integrated national system) education, clinical, and research activities within all facilities with such centers.</text></subparagraph><subparagraph id="H3ECD796C380D44BD9EE709D4B39A330A"><enum>(F)</enum><text>The capability to jointly develop a consortium of providers with interest in treating covered conditions with innovative therapies at facilities of the Department without such centers in order to ensure better access to state-of-the-art diagnosis, care, and education for innovative therapies throughout the medical system of the Department.</text></subparagraph><subparagraph id="HB9A246D90F074D75BF6510937AA50AF6"><enum>(G)</enum><text>The capability to develop a national repository in the medical system of the Department for the collection of data on health services delivered to veterans seeking innovative therapies.</text></subparagraph></paragraph></subsection><subsection id="H6B5F5645CC094F44944093B6A08F8D7F"><enum>(d)</enum><header>Peer review panel</header><paragraph commented="no" display-inline="no-display-inline" id="id48b84be5ed154eee99eae2a04d8d2f37"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Under Secretary for Health shall establish a panel to assess the scientific and clinical merit of proposals that are submitted to the Secretary for the establishment of centers under this section.</text></paragraph><paragraph id="H6D1E8D5D5AF64C8496AD1C9737108644"><enum>(2)</enum><header>Membership</header><subparagraph commented="no" display-inline="no-display-inline" id="idcc4e73bcf22e41cfbcce4733b9fde4ca"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The membership of the panel established under paragraph (1) shall consist of experts in innovative therapies.</text></subparagraph><subparagraph id="HAF7F6122C20C4DC3B5D8CA8C09711F7B"><enum>(B)</enum><header>Period of service</header><clause commented="no" display-inline="no-display-inline" id="idff045b155c2f48eab963845d21229f11"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Members of the panel established under paragraph (1) shall serve for a period of not more than two years, except as specified in clause (ii).</text></clause><clause id="HE3BBA8BA740E47DB86B32A0F58AF9128"><enum>(ii)</enum><header>Initial appointment</header><text>Of the members first appointed to the panel established under paragraph (1), one-half shall be appointed for a period of three years and one-half shall be appointed for a period of two years, as designated by the Under Secretary for Health at the time of appointment.</text></clause></subparagraph></paragraph><paragraph id="H45DE0EC54713402D9FCD8BA5D0632A5B"><enum>(3)</enum><header>Duties</header><text>The panel established under paragraph (1) shall review each proposal submitted to the panel by the Under Secretary for Health and shall submit its views on the relative scientific and clinical merit of each such proposal to the Under Secretary.</text></paragraph><paragraph id="H0D3FFA808401446FBA159D52657BE150"><enum>(4)</enum><header>Application of laws regarding Federal advisory committees</header><text>The panel established under paragraph (1) shall not be subject to <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/10">chapter 10</external-xref> of title 5.</text></paragraph></subsection><subsection id="H7ECBF5D0058E495AA714772612146635"><enum>(e)</enum><header>Annual report</header><paragraph commented="no" display-inline="no-display-inline" id="id5cf463b198d44eb7ae362a982e057437"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than two years after the date of the enactment of this section, and annually thereafter, the Under Secretary for Health shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on the activities of the centers established under subsection (a) during the period covered by the report.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id522762e8f4ad418bbc5ed74ac33e321f"><enum>(2)</enum><header>Elements</header><text display-inline="yes-display-inline">Each report required under paragraph (1) shall include—</text><subparagraph id="HF3D233A7FFA848069B4DBEDB13DC3479"><enum>(A)</enum><text display-inline="yes-display-inline">a summary of activities carried out by the centers established under subsection (a) during such period;</text></subparagraph><subparagraph id="H734FAFF767B342F9A8BDA3B99BA09ABC"><enum>(B)</enum><text>an identification of key findings made at such centers during such period;</text></subparagraph><subparagraph id="H92A2B97BDEE94323B3BF1977E7F41A5A"><enum>(C)</enum><text>recommendations to improve the delivery of innovative therapies to veterans; and</text></subparagraph><subparagraph id="H7CAC20C9862F48DBABE2E8A6F4E10B15"><enum>(D)</enum><text>such other matters as the Under Secretary determines relevant.</text></subparagraph></paragraph></subsection><subsection id="H04C67E2E28FB460E9C3BD3303B072838"><enum>(f)</enum><header>Authorization of appropriations</header><paragraph commented="no" display-inline="no-display-inline" id="idcd2f42c646ab4c33847a43360c3f564f"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">There are authorized to be appropriated $30,000,000 for each fiscal year to support the research and education activities of the centers established under subsection (a).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id63c42610be1e43d8bf444ac5fbc69e12"><enum>(2)</enum><header>Allocation of additional amounts</header><text display-inline="yes-display-inline">The Under Secretary for Health shall allocate to the centers established under subsection (a) from other amounts appropriated generally for the medical services account and medical and prosthetics research account of the Department, as appropriate, such amounts as the Under Secretary determines appropriate.</text></paragraph></subsection><subsection id="H759DA847D94C49ADB62733D1690AF5B8"><enum>(g)</enum><header>Definitions</header><text>In this section:</text><paragraph id="HDD46B60AE0E6420E85245121208C01CD"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>covered condition</term> means any of the following:</text><subparagraph id="H9924E0FB35484FE59C3316E8B49E6F16"><enum>(A)</enum><text>Anxiety.</text></subparagraph><subparagraph id="H46EE8BCEC84E4A84A347F4F003B68F3C"><enum>(B)</enum><text>Bipolar disorder.</text></subparagraph><subparagraph id="H0CBC0D7985EE4908BF6608CB0888148A"><enum>(C)</enum><text>Chronic pain.</text></subparagraph><subparagraph id="H889049FB935642F1BA26859CF8CE7C17"><enum>(D)</enum><text>Depression.</text></subparagraph><subparagraph id="H4DE557D050D04EF3BBC058C3F9AE26E0"><enum>(E)</enum><text>Parkinson’s disease.</text></subparagraph><subparagraph id="H43788354787F4911A039A7F6AAA51D1E"><enum>(F)</enum><text display-inline="yes-display-inline">Post-traumatic stress disorder.</text></subparagraph><subparagraph id="H14FE46149BF448C08D964C3D998BA684"><enum>(G)</enum><text>Substance use disorder.</text></subparagraph><subparagraph id="H74B4C0FAA0E741B297D55D0DDE6C3894"><enum>(H)</enum><text>Such other conditions as may be designated by the Under Secretary for Health.</text></subparagraph></paragraph><paragraph id="HAA86CE583C9546EEB99A4821869A4852"><enum>(2)</enum><text>The term <term>innovative therapy</term> means any of the following:</text><subparagraph id="H1F32B45BAC874F258EA0B85F3D86F78F"><enum>(A)</enum><text display-inline="yes-display-inline">3,4-Methylenedioxy-methamphetamine.</text></subparagraph><subparagraph id="HBCF23F019B454A229350E2B605CADA33"><enum>(B)</enum><text>5-Methoxy-N,N-dimethyltryptamine.</text></subparagraph><subparagraph id="HA9ED5D53ECDF49F0B2D8C7B768A870D8"><enum>(C)</enum><text>Ibogaine.</text></subparagraph><subparagraph id="H2A33E23984DC45B48F5410ADEA80DC00"><enum>(D)</enum><text>Ketamine.</text></subparagraph><subparagraph id="HDACEB42A0F0541B0B811E4C1799F398E"><enum>(E)</enum><text>Psilocybin.</text></subparagraph><subparagraph id="HD1632829BFAB4A5C9FBF31704A0A06B5"><enum>(F)</enum><text>Such other therapies as may be designated by the Under Secretary for Health.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HD984CC18D89D4B76816ED048B8A0E712"><enum>(b)</enum><header>Clerical amendment</header><text>The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 7330D the following new item:</text><quoted-block style="USC" display-inline="no-display-inline" id="H7214DC189EE342BEAE556B14FECC0E5E"><toc regeneration="no-regeneration"><toc-entry level="section">7330E. Innovative therapies centers of excellence.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></legis-body></bill> 

