HB717: HB717 Medical Practice Act; regulation of the administration of psychedelic-assisted treatment and therapy; provide

26 HB 717/AP House Bill 717 (AS PASSED HOUSE AND SENATE) By: Representatives Cooper of the 45th, Newton of the 127th, Silcox of the 53rd, Drenner of the 85th, and Au of the 50th A BILL TO BE ENTITLED AN ACT To amend Article 2 of Chapter 34 of Title 43 of the Official Co de of Georgia Annotated,1 relating to the "Medical Practice Act of the State of Georgia," so as to provide for the2 regulation of the administration of psychedelic-assisted treatment and therapy; to provide for3 definitions; to provide for standards; to provide for requireme nts; to provide for the4 establishment of rules and regulations; to provide for licensur e of clinics; to provide for5 statutory construction; to provide a criminal penalty; to provide for related matters; to repeal6 conflicting laws; and for other purposes.7 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:8 SECTION 1.9 Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to the10 "Medical Practice Act of the State of Georgia," is amended by a dding a new Code section11 to read as follows:12 "43-34-49.13 (a) As used in this Code section, the term:14 (1) 'Clinic' means a facility that offers the administration o f psychedelic-assisted15 treatment and therapy, including, but not limited to, intravenous infusion of ketamine.16 H. B. 717 - 1 - 26 HB 717/AP (2) 'Psychedelic-assisted treatment and therapy' means any tre atment or therapy using17 psychedelic, dissociative, or other related substances that have the potential to produce18 hallucinations or rapidly induce suggestibility in the user or profound changes in19 perceptions of reality or the self.20 (b) No later than December 31, 2026, the board shall establish rules and regulations for the21 administration of psychedelic-assisted treatment and therapy in clinics to establish22 consistent standards, ensure continuing competency, and promote patient safety. Such23 rules and regulations shall include requirements on:24 (1) A properly equipped and maintained clinic to ensure patien t safety, which may be25 demonstrated by appropriate accreditation or certification;26 (2) Competency of the physician using psychedelic-assisted treatment and therapy in the27 absence of an anesthesiologist, anesthesiologist assistant, or certified registered nurse28 anesthetist, including education and relevant training;29 (3) Proper prescribing and ordering of psychedelic-assisted treatment and therapy;30 (4) Proper administration and management of psychedelic-assist ed treatment and31 therapy;32 (5) Emergency care and transfer protocols in the event of a complication or emergency;33 (6) Maintenance of complete and accurate medical records;34 (7) Reporting of adverse events to the board;35 (8) Required continuing medical education;36 (9) Truth in advertising regarding the credentials, education, and training of the37 individuals administering psychedelic-assisted treatment and therapy; and38 (10) Inspection procedures.39 (c) Any physician, physician assistant, anesthesiologist assis tant, or certified registered40 nurse anesthetist administering, directing, or supervising psyc hedelic-assisted treatment41 and therapy in a clinic shall be subject to the rules and regulations established by the board42 pursuant to this Code section. The board may establish minimum standards of continuing43 H. B. 717 - 2 - 26 HB 717/AP medical education for all healthcare professionals owning a cli nic. All other licensed44 healthcare professionals practicing in a clinic may be subject to minimum standards of45 continuing education established by the respective licensing bo ard for such healthcare46 professionals.47 (d)(1) On and after July 1, 2027, all clinics shall be license d by the board and shall48 biennially renew their license with the board. In the event th at physicians in a clinic49 practice at more than one location, each such location shall be licensed by the board, and50 such license shall be nontransferable.51 (2) Upon the filing of an application for a license, the board may cause a thorough52 investigation of the applicant to be made and such investigation may include a criminal53 background check; provided, however, that the board shall cause a thorough investigation54 of a new applicant to be made, and such investigation shall include a background check. 55 If satisfied that the applicant possesses the necessary qualifications, the board shall issue56 a license. However, the board may issue licenses with varying restrictions to such57 persons where the board deems it necessary for the purpose of s afeguarding the public58 health, safety, and welfare.59 (3) Whenever an applicable rule requires or prohibits action by a clinic, responsibility60 shall be that of the owner and the physicians practicing in such clinic, whether the owner61 is a sole proprietor, partnership, association, corporation, or otherwise.62 (4) The board shall deny or refuse to renew a clinic license i f it determines that the63 granting or renewing of such license would not be in the public interest.64 (5)(A) A clinic shall be owned by one or more physicians or certified registered nurse65 anesthetists licensed in this state who meet the competency req uirements for66 psychedelic-assisted treatment and therapy established by the board, including, but not67 limited to, advanced airway management training.68 (B) Subparagraph (A) of this paragraph shall not apply to any clinic in existence and69 operational on the effective date of this Act; provided, howeve r, that any such clinic70 H. B. 717 - 3 - 26 HB 717/AP shall be subject to and in compliance with all other provisions of this Code section in71 order to operate.72 (6) All licenses shall expire biennially unless renewed. All applications for renewal of73 a license shall be filed with the board prior to the expiration date, accompanied by the74 biennial renewal fee prescribed by the board. A license which has expired for failure of75 the holder to renew may be late renewed after application and payment of the prescribed76 late renewal fee within the time period established by the boar d and provided the77 applicant meets such requirements as the board may establish by rule. Any license which78 has not been renewed by the end of the late renewal period shall be considered revoked79 and subject to reinstatement at the discretion of the board after meeting such requirements80 as the board may establish.81 (e)(1) Each clinic licensed under this Code section shall:82 (A) Execute a hospital affiliation agreement with one or more hospitals licensed in this83 state within a reasonable distance from such clinic or have medical staff at such clinic84 with admitting privileges or other similar documented arrangements with such hospital85 or hospitals to ensure the necessary backup for medical complications; and86 (B) Have the capability to transfer a patient immediately to a hospital within a87 reasonable distance from such clinic with adequate emergency room services.88 (2) A hospital shall not unreasonably deny a transfer agreemen t with a clinic for the89 purposes set forth in paragraph (1) of this subsection.90 (f) Administration of psychedelic-assisted treatment and therapy in a clinic shall only be91 performed by:92 (1) A physician licensed in this state with advanced airway management training;93 (2) A certified registered nurse anesthetist licensed in this state under the direction and94 responsibility of a duly licensed physician;95 (3) An anesthesiologist assistant licensed in this state under the direct supervision of a96 duly licensed anesthesiologist;97 H. B. 717 - 4 - 26 HB 717/AP (4) A nurse practitioner licensed in this state who has airway management training, has98 at least five years of clinical experience, is acting pursuant to a nurse protocol agreement99 as described in Code Section 43-34-25, and has the express written approval of the board;100 or101 (5) A physician assistant licensed in this state who has airway management training, has102 at least five years of clinical experience, is acting pursuant to a job description as103 described in subsection (e.1) of Code Section 43-34-103, and ha s the express written104 approval of the board.105 (g) A review of the prescription drug monitoring program database established pursuant106 to Code Section 16-13-57 shall be completed for each patient an d documented in the107 patient's medical record prior to the administration of any psychedelic-assisted treatment108 and therapy and all administration of any psychedelic-assisted treatment and therapy shall109 be reported to the prescription drug monitoring program by the clinic.110 (h) Except as otherwise provided in subsection (f) of this Code section, any person who111 administers psychedelic-assisted treatment and therapy in this state without a license to112 practice medicine from the board shall be deemed to be engaged in the unlawful practice113 of medicine and subject to the provisions of Code Sections 43-34-39 and 43-34-42.114 (i) Nothing in this Code section shall be construed to permit the use of drugs or substances115 not approved by the federal Food and Drug Administration.116 (j) Nothing in this Code section shall be construed to apply t o the administration of117 psychedelic-assisted treatment and therapy in a clinic affiliat ed with a hospital or in a118 clinical trial approved by the federal Food and Drug Administration.119 (k) Nothing in this Code section shall be construed to apply to the administration of drugs120 approved by the federal Food and Drug Administration for such d rugs' Food and Drug121 Administration approved on-label indication for use.122 (l) Any person convicted of operating a clinic in this state w ithout a license in violation123 of paragraph (1) of subsection (d) of this Code section shall be guilty of a felony and shall124 H. B. 717 - 5 - 26 HB 717/AP be punished by imprisonment for not less than one year nor more than five years or by a125 fine of not less than $1,000.00 nor more than $5,000.00, or both."126 SECTION 2.127 All laws and parts of laws in conflict with this Act are repealed.128 H. B. 717 - 6 -