HOUSE BILL NO. 1643 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE OVERCAST.
4265H.01I JOSEPH ENGLER, Chief Clerk
AN ACT To repeal section 191.480, RSMo, and to enact in lieu thereof two new sections relating to alternative therapies.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Section 191.480, RSMo, is repealed and two new sections enacted in lieu 2 thereof, to be known as sections 191.479 and 191.480, to read as follows: 191.479. 1. As used in this section, the term "bona fide prescriber-patient 2 relationship" means a relationship between a patient and a physician or certified nurse 3 practitioner as defined in section 335.016 in which the physician or certified nurse 4 practitioner: 5 (1) Has completed an assessment of the patient's medical history and current 6 medical condition, including an in-person examination of the patient; 7 (2) Has consulted with the patient with respect to the patient's medical 8 condition; and 9 (3) Is available to provide follow-up care and treatment to the patient. 10 2. Notwithstanding the provisions of chapter 195 or 579 or any other provision of 11 law to the contrary, any person who acquires, uses, produces, possesses, transfers, or 12 administers psilocybin for the person's own therapeutic use shall not be in violation of 13 state or local law and shall not be subject to a civil fine, penalty, or sanction so long as 14 the following conditions are met: 15 (1) The person is twenty-one years of age or older; 16 (2) The person requires end-of-life care or suffers from posttraumatic stress 17 disorder, major depressive disorder, a substance use disorder, or any other condition for
EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language. HB 1643 2
18 which treatment with psilocybin has shown efficacy in clinical trials registered with the 19 United States Food and Drug Administration; 20 (3) The person provides the department of mental health with: 21 (a) Documentation from a physician or certified nurse practitioner with whom 22 the patient has a bona fide prescriber-patient relationship that the person requires end- 23 of-life care or suffers from a disorder or condition described in subdivision (2) of this 24 subsection; 25 (b) The name of the facilitator who will be present with the person when the 26 person uses psilocybin and who is one of the following: 27 a. A physician licensed under chapter 334; 28 b. A psychologist licensed under chapter 337; 29 c. A master's level mental health therapist with full clinical experience such as a 30 licensed clinical social worker, marital and family therapist, or professional counselor, 31 as such professions are licensed under chapter 337; 32 d. A nurse licensed under chapter 335 with a doctor of nursing practice degree; 33 e. A physician assistant licensed under chapter 334; or 34 f. An advanced practice registered nurse licensed under chapter 335 including, 35 but not limited to, a psychiatric-mental health nurse practitioner; 36 (c) The address of the location where the use of psilocybin will take place; and 37 (d) The time period, not to exceed twelve months, during which the person will 38 use psilocybin; 39 (4) The person ensures that a laboratory licensed by the state to test controlled 40 substances tests the psilocybin the person intends to ingest; and 41 (5) The person limits the use of psilocybin to no more than one hundred fifty 42 milligrams of psilocybin analyte (4-phosphoryloxy-N, N-dimethyltryptamine) or its 43 naturalistic equivalent during any twelve-month period. 44 3. (1) In order to serve as a facilitator described under subsection 2 of this 45 section, an individual shall have completed a training program that is specific to 46 psilocybin and that has been approved for continuing education credit by the American 47 Psychological Association. The curriculum of the training program required under this 48 subsection shall consist of at least thirty hours of synchronous learning. Facilitators, 49 excluding those who are psychologists, psychiatrists, or psychiatric-mental health nurse 50 practitioners, shall complete ninety minutes of continuing education training on the 51 most current version of the Diagnostic and Statistical Manual of Mental Disorders 52 before serving as a facilitator for any person and during each relevant licensure renewal 53 period. HB 1643 3
54 (2) An individual shall have training in end-of-life care, posttraumatic stress 55 disorder, complex posttraumatic stress disorder, major depressive disorder, substance 56 use disorder, or the specific condition for which psilocybin therapy is indicated in order 57 to serve as a facilitator for a person seeking psilocybin-assisted psychotherapy to treat 58 such conditions. 59 4. Notwithstanding the provisions of chapter 195 or 579 or any other provision of 60 law to the contrary: 61 (1) Any person twenty-one years of age or older who assists another person in 62 any of the acts allowed under subsection 2 of this section shall not be in violation of state 63 or local law and shall not be subject to a civil fine, penalty, or sanction; and 64 (2) Any laboratory licensed or registered by the state to test controlled 65 substances or cannabis that tests psilocybin for a person engaged in acts allowed under 66 subsection 2 of this section shall not be in violation of state or local law and shall not be 67 subject to a civil fine, penalty, or sanction. 68 5. The department of mental health shall maintain the confidentiality of any 69 personally identifiable protected information collected from any persons who provide 70 information to the department under this section. 71 6. Notwithstanding any other provision of law to the contrary, the department of 72 mental health, any health care or mental health care providers, and any other person 73 involved in the acts described in subsection 2 of this section shall not be subject to 74 criminal or civil liability or sanction under the laws of this state for providing care to a 75 person engaged in acts allowed under subsection 2 of this section, except in cases of 76 gross negligence or willful misconduct. No health care provider shall be subject to 77 discipline against his or her professional license for providing care to a person engaged 78 in acts allowed under subsection 2 of this section. 79 7. Notwithstanding any other provision of law to the contrary, a physician or 80 certified nurse practitioner shall not be subject to criminal or civil liability or sanction 81 under the laws of this state for providing documentation that a person requires end-of- 82 life care or suffers from a disorder or condition described in subdivision (2) of 83 subsection 2 of this section, and no state agency or regulatory board shall revoke, fail to 84 renew, or take any other action against a license issued under chapter 334 or 335 to a 85 physician or certified nurse practitioner based solely on the licensee's provision of 86 documentation that a person requires end-of-life care or suffers from a disorder or 87 condition described in subdivision (2) of subsection 2 of this section. 88 8. Notwithstanding any other provision of law to the contrary, no state agency or 89 employee of a state agency shall disclose to the federal government, any federal HB 1643 4
90 government employee, or any unauthorized third party the statewide list or any 91 individual information of persons who meet the requirements of this section. 191.480. 1. For purposes of this section, the following terms shall mean: 2 (1) "Eligible patient", a person who meets all of the following: 3 (a) Has a terminal condition or illness, a life-threatening condition or illness, or a 4 severely debilitating condition or illness; 5 (b) Has considered all other treatment options currently approved by the United 6 States Food and Drug Administration and all relevant clinical trials conducted in this state; 7 (c) Has received a prescription or recommendation from the person's physician for an 8 investigational drug, biological product, or device; 9 (d) Has given written informed consent which shall be at least as comprehensive as 10 the consent used in clinical trials for the use of the investigational drug, biological product, or 11 device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a 12 parent or legal guardian has given written informed consent on the patient's behalf; and 13 (e) Has documentation from the person's physician that the person has met the 14 requirements of this subdivision; 15 (2) "Investigational drug, biological product, or device", a drug, biological product, or 16 device, any of which are used to treat the patient's terminal condition or illness, life- 17 threatening condition or illness, or severely debilitating condition or illness, that has 18 successfully completed phase one of a clinical trial but has not been approved for general use 19 by the United States Food and Drug Administration and remains under investigation in a 20 clinical trial[. The term shall not include Schedule I controlled substances]; 21 (3) "Life-threatening condition or illness", a disease or condition: 22 (a) In which the likelihood of death is high unless the course of the disease or 23 condition is interrupted; and 24 (b) With potentially fatal outcomes, where the end point of clinical trial analysis 25 is survival; 26 (4) "Severely debilitating condition or illness", a disease or condition that causes 27 major irreversible morbidity; 28 (5) "Terminal condition or illness", a disease or condition that without life- 29 sustaining procedures will result in death in the near future or a state of permanent 30 unconsciousness from which recovery is unlikely. 31 2. A manufacturer of an investigational drug, biological product, or device may make 32 available the manufacturer's investigational drug, biological product, or device to eligible 33 patients under this section. This section does not require that a manufacturer make available 34 an investigational drug, biological product, or device to an eligible patient. A manufacturer 35 may: HB 1643 5
36 (1) Provide an investigational drug, biological product, or device to an eligible patient 37 without receiving compensation; or 38 (2) Require an eligible patient to pay the costs of or associated with the manufacture 39 of the investigational drug, biological product, or device. 40 3. A manufacturer of any investigational drug, biological product, or device shall 41 register with the department of health and senior services. Before November 1, 2026, 42 the department of health and senior services shall create a registry of such 43 manufacturers that manufacture any investigational drug, biological product, or 44 device that involves a controlled substance. 45 4. This section does not require a health care insurer to provide coverage for the cost 46 of any investigational drug, biological product, or device. A health care insurer may provide 47 coverage for an investigational drug, biological product, or device. 48 [4.] 5. This section does not require the department of corrections to provide coverage 49 for the cost of any investigational drug, biological product, or device. 50 [5.] 6. Notwithstanding any other provision of law to the contrary, no state agency or 51 regulatory board shall revoke, fail to renew, or take any other action against a physician's 52 license issued under chapter 334 based solely on the physician's recommendation to an 53 eligible patient regarding prescription for or treatment with an investigational drug, biological 54 product, or device. Action against a health care provider's Medicare certification based solely 55 on the health care provider's recommendation that a patient have access to an investigational 56 drug, biological product, or device is prohibited. 57 [6.] 7. If a provision of this section or its application to any person or circumstance is 58 held invalid, the invalidity does not affect other provisions or applications of this section that 59 can be given effect without the invalid provision or application, and to this end the provisions 60 of this section are severable. 61 [7.] 8. If the clinical trial is closed due to lack of efficacy or toxicity, the drug shall not 62 be offered. If notice is given on a drug, product, or device taken by a patient outside of a 63 clinical trial, the pharmaceutical company or patient's physician shall notify the patient of the 64 information from the safety committee of the clinical trial. 65 [8.] 9. Except in the case of gross negligence or willful misconduct, any person who 66 manufactures, imports, distributes, prescribes, dispenses, or administers an investigational 67 drug or device to an eligible patient [with a terminal illness] in accordance with this section 68 shall not be liable in any action under state law for any loss, damage, or injury arising out of, 69 relating to, or resulting from: 70 (1) The design, development, clinical testing and investigation, manufacturing, 71 labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or 72 use of the drug or device; or HB 1643 6
73 (2) The safety or effectiveness of the drug or device. ✔
Statutes affected: