HB1296: HB1296 Mental health; pilot program to support clinical research of certain veterans and first responders suffering from certain conditions; provide

26 LC 52 1062S House Bill 1296 (COMMITTEE SUBSTITUTE) By: Representatives Momtahan of the 17th, Hitchens of the 161st, Bonner of the 73rd, Cannon of the 172nd, Prince of the 132nd, and others A BILL TO BE ENTITLED AN ACT To amend Article 1 of Chapter 1 of Title 37 of the Official Cod e of Georgia Annotated,1 relating to general provisions for governing and regulation of mental health, so as to provide2 for a pilot program to support clinical research of certain eli gible breakthrough treatments3 and provide such treatments to certain veterans and first responders suffering from certain4 conditions; to provide for definitions; to provide for funding and use of funds; to provide for5 eligibility; to provide for an annual report; to provide for ru les and regulations; to provide6 for termination and automatic repeal; to provide for related matters; to provide for contingent7 effectiveness upon appropriation of funds; to repeal conflicting laws; and for other purposes.8 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:9 SECTION 1.10 Article 1 of Chapter 1 of Title 37 of the Official Code of Geor gia Annotated, relating to11 general provisions for governing and regulation of mental healt h, is amended by adding a12 new Code section to read as follows:13 "37-1-8.14 (a) As used in this Code section, the term:15 (1) 'Eligible breakthrough treatment' means:16 H. B. 1296 (SUB) - 1 - 26 LC 52 1062S (A) Any medical device that has been granted breakthrough device designation by the17 United States Food and Drug Administration in effect on or after January 1, 2026;18 (B) Any approved or investigational drug that has been granted breakthrough therapy19 designation by the United States Food and Drug Administration i n effect on or after20 January 1, 2026;21 (C) Ibogaine or an ibogaine based therapeutic, including analogs;22 (D) Transcranial magnetic stimulation, including investigation al or approved23 accelerated transcranial magnetic stimulation protocols; or24 (E) Any other investigational or approved device or drug as de termined by the25 department; provided, however, that such investigational or app roved device or drug26 is substantially similar to a treatment described in this paragraph.27 (2) 'First responder' shall have the same meaning as set forth in Code Section 26-4-116.2.28 (3) 'Program' means the Breakthrough Treatments for Georgia Heroes Suicide Prevention29 Pilot Program developed by this Code section.30 (4) 'Veteran' shall have the same meaning as set forth in Code Section 50-5-131.31 (b) Beginning on January 1, 2027, subject to appropriations, the department shall develop,32 implement, and conduct a three-year pilot program to support clinical research and provide33 eligible breakthrough treatment to veterans and retired first r esponders suffering from34 post-traumatic stress disorder, treatment-resistant depression, major depressive disorder,35 traumatic brain injury, or other related conditions as determined in rules and regulations36 established by the department. Such program shall be known as the Breakthrough37 Treatments for Georgia Heroes Suicide Prevention Pilot Program.38 (c) Consistent with the program's purpose as described in subs ection (b) of this Code39 section, program funds may, without limitation, be used to:40 (1) Establish a network of approved program sites in diverse g eographic regions and41 treatment settings with required standardized data collection, sharing, and analysis across42 such sites;43 H. B. 1296 (SUB) - 2 - 26 LC 52 1062S (2) Conduct clinical research and implement studies of eligible breakthrough treatments,44 including, but not limited to:45 (A) Clinical trials of any breakthrough treatment for a relevant condition to support the46 approval of any such treatment by the United States Food and Drug Administration;47 (B) Clinical trials or real-world studies to inform optimal treatment delivery methods48 that improve scalability and cost effectiveness;49 (C) Comparative effectiveness trials; and50 (D) Cost effectiveness analyses of approved breakthrough treat ments and protocols51 approved by the United States Food and Drug Administration;52 (3) Subsidize the cost of eligible breakthrough treatments at approved program sites;53 (4) Invest in clinical infrastructure, to include without limitation, facility, equipment, and54 data collection system costs for approved program sites in underserved areas;55 (5) Provide healthcare workforce education and training at approved program sites; and56 (6) Establish and disseminate treatment guidelines for eligible breakthrough treatments.57 (d) The department is authorized to enter into partnerships, memoranda of understanding,58 or contracts with public and private postsecondary research institutions accredited by the59 Southern Association of Colleges and Schools Commission on Coll eges in the State of60 Georgia to facilitate the implementation and operation of the program.61 (e) The department may apply for, receive, administer, and use any grant, other financial62 assistance, or other funds made available to the department from any government or other63 source for furthering the purposes of the program.64 (f) The department shall provide an annual report by December 31 to the Governor, the65 President of the Senate, the Speaker of the House of Representatives, the chairpersons of66 the House Committee on Health and the Senate Health and Human Services Committee,67 and the chairpersons of the House Committee on Defense and Vete rans Affairs and the68 Senate Veterans, Military, and Homeland Security Committee. Such report shall include,69 H. B. 1296 (SUB) - 3 - 26 LC 52 1062S at a minimum, detailed information on the implementation and ef fectiveness of the70 program.71 (g) The department is authorized to promulgate rules and regulations as may be necessary72 to carry out and implement the provisions of this Code section.73 (h) The program developed by this Code section shall terminate on January 1, 2030, and74 this Code section shall be repealed by operation of law on such date."75 SECTION 2.76 (a) This Act shall become effective only if funds are specifically appropriated for purposes77 of this Act in an appropriations Act enacted by the General Assembly.78 (b) If funds are so appropriated, then this Act shall become effective on the later of:79 (1) The date on which such appropriations becomes effective; or80 (2) The beginning date of the fiscal year for which such appropriations are made.81 SECTION 3.82 All laws and parts of laws in conflict with this Act are repealed.83 H. 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