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 Code of Georgia Annotated, relating to the "Medical Practice Act of the State of Georgia," so as to provide for the regulation of the administration of psychedelic-assisted treatment and therapy; to provide for definitions; to provide for standards; to provide for requirements; to provide for the establishment of rules and regulations; to provide for licensure of clinics; to provide for statutory construction; to provide a criminal penalty; to provide for related matters; to repeal conflicting laws; and for other purposes. BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA: SECTION 1. Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to the "Medical Practice Act of the State of Georgia," is amended by adding a new Code section to read as follows: "43-34-49. (a) As used in this Code section, the term: (1) 'Clinic' means a facility that offers the administration of psychedelic-assisted treatment and therapy, including, but not limited to, intravenous infusion of ketamine. (2) 'Psychedelic-assisted treatment and therapy' means any treatment or therapy using psychedelic, dissociative, or other related substances that have the potential to produce hallucinations or rapidly induce suggestibility in the user or profound changes in perceptions of reality or the self. (b) No later than December 31, 2026, the board shall establish rules and regulations for the administration of psychedelic-assisted treatment and therapy in clinics to establish consistent standards, ensure continuing competency, and promote patient safety. Such rules and regulations shall include requirements on: (1) A properly equipped and maintained clinic to ensure patient safety, which may be demonstrated by appropriate accreditation or certification; (2) Competency of the physician using psychedelic-assisted treatment and therapy in the absence of an anesthesiologist, anesthesiologist assistant, or certified registered nurse anesthetist, including education and relevant training; (3) Proper prescribing and ordering of psychedelic-assisted treatment and therapy; (4) Proper administration and management of psychedelic-assisted treatment and therapy; (5) Emergency care and transfer protocols in the event of a complication or emergency; (6) Maintenance of complete and accurate medical records; (7) Reporting of adverse events to the board; (8) Required continuing medical education; (9) Truth in advertising regarding the credentials, education, and training of the individuals administering psychedelic-assisted treatment and therapy; and (10) Inspection procedures. (c) Any physician, physician assistant, anesthesiologist assistant, or certified registered nurse anesthetist administering, directing, or supervising psychedelic-assisted treatment and therapy in a clinic shall be subject to the rules and regulations established by the board pursuant to this Code section. The board may establish minimum standards of continuing medical education for all healthcare professionals owning a clinic. All other licensed healthcare professionals practicing in a clinic may be subject to minimum standards of continuing education established by the respective licensing board for such healthcare professionals. (d)(1) On and after July 1, 2027, all clinics shall be licensed by the board and shall biennially renew their license with the board. In the event that physicians in a clinic practice at more than one location, each such location shall be licensed by the board, and such license shall be nontransferable. (2) Upon the filing of an application for a license, the board may cause a thorough investigation of the applicant to be made and such investigation may include a criminal background check; provided, however, that the board shall cause a thorough investigation of a new applicant to be made, and such investigation shall include a background check. If satisfied that the applicant possesses the necessary qualifications, the board shall issue a license. However, the board may issue licenses with varying restrictions to such persons where the board deems it necessary for the purpose of safeguarding the public health, safety, and welfare. (3) Whenever an applicable rule requires or prohibits action by a clinic, responsibility shall be that of the owner and the physicians practicing in such clinic, whether the owner is a sole proprietor, partnership, association, corporation, or otherwise. (4) The board shall deny or refuse to renew a clinic license if it determines that the granting or renewing of such license would not be in the public interest. (5)(A) A clinic shall be owned by one or more physicians or certified registered nurse anesthetists licensed in this state who meet the competency requirements for psychedelic-assisted treatment and therapy established by the board, including, but not limited to, advanced airway management training. (B) Subparagraph (A) of this paragraph shall not apply to any clinic in existence and operational on the effective date of this Act; provided, however, that any such clinic shall be subject to and in compliance with all other provisions of this Code section in order to operate. (6) All licenses shall expire biennially unless renewed. All applications for renewal of a license shall be filed with the board prior to the expiration date, accompanied by the biennial renewal fee prescribed by the board. A license which has expired for failure of the holder to renew may be late renewed after application and payment of the prescribed late renewal fee within the time period established by the board and provided the applicant meets such requirements as the board may establish by rule. Any license which has not been renewed by the end of the late renewal period shall be considered revoked and subject to reinstatement at the discretion of the board after meeting such requirements as the board may establish. (e)(1) Each clinic licensed under this Code section shall: (A) Execute a hospital affiliation agreement with one or more hospitals licensed in this state within a reasonable distance from such clinic or have medical staff at such clinic with admitting privileges or other similar documented arrangements with such hospital or hospitals to ensure the necessary backup for medical complications; and (B) Have the capability to transfer a patient immediately to a hospital within a reasonable distance from such clinic with adequate emergency room services. (2) A hospital shall not unreasonably deny a transfer agreement with a clinic for the purposes set forth in paragraph (1) of this subsection. (f) Administration of psychedelic-assisted treatment and therapy in a clinic shall only be performed by: (1) A physician licensed in this state with advanced airway management training; (2) A certified registered nurse anesthetist licensed in this state under the direction and responsibility of a duly licensed physician; (3) An anesthesiologist assistant licensed in this state under the direct supervision of a duly licensed anesthesiologist; (4) A nurse practitioner licensed in this state who has airway management training, has at least five years of clinical experience, is acting pursuant to a nurse protocol agreement as described in Code Section 43-34-25, and has the express written approval of the board; or (5) A physician assistant licensed in this state who has airway management training, has at least five years of clinical experience, is acting pursuant to a job description as described in subsection (e.1) of Code Section 43-34-103, and has the express written approval of the board. (g) A review of the prescription drug monitoring program database established pursuant to Code Section 16-13-57 shall be completed for each patient and documented in the patient's medical record prior to the administration of any psychedelic-assisted treatment and therapy and all administration of any psychedelic-assisted treatment and therapy shall be reported to the prescription drug monitoring program by the clinic. (h) Except as otherwise provided in subsection (f) of this Code section, any person who administers psychedelic-assisted treatment and therapy in this state without a license to practice medicine from the board shall be deemed to be engaged in the unlawful practice of medicine and subject to the provisions of Code Sections 43-34-39 and 43-34-42. (i) Nothing in this Code section shall be construed to permit the use of drugs or substances not approved by the federal Food and Drug Administration. (j) Nothing in this Code section shall be construed to apply to the administration of psychedelic-assisted treatment and therapy in a clinic affiliated with a hospital or in a clinical trial approved by the federal Food and Drug Administration. (k) Nothing in this Code section shall be construed to apply to the administration of drugs approved by the federal Food and Drug Administration for such drugs' Food and Drug Administration approved on-label indication for use. (l) Any person convicted of operating a clinic in this state without a license in violation of paragraph (1) of subsection (d) of this Code section shall be guilty of a felony and shall be punished by imprisonment for not less than one year nor more than five years or by a fine of not less than $1,000.00 nor more than $5,000.00, or both." SECTION 2. All laws and parts of laws in conflict with this Act are repealed.