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Missouri Senate Bill SB90

Missouri 2025 Regular Session

Missouri Senate Bill SB90 Compare Versions

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1-1343S.02C
2- 1
3-SENATE COMMITTEE SUBSTITUTE
4-FOR
1+
2+EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted
3+and is intended to be omitted in the law.
4+FIRST REGULAR SESSION
55 SENATE BILL NO. 90
6+103RD GENERAL ASSEMBLY
7+INTRODUCED BY SENATOR WEBBER.
8+1343S.01I KRISTINA MARTIN, Secretary
69 AN ACT
7-To repeal section 191.480, RSMo, and to enact in lieu
8-thereof three new sections relating to alternative
9-therapies.
10+To repeal section 191.480, RSMo, and to enact in lieu thereof three new sections relating to
11+alternative therapies.
1012
1113 Be it enacted by the General Assembly of the State of Missouri, as follows:
12- Section A. Section 191.480, RSMo, is repealed and three
13-new sections enacted in lieu thereof, to be known as sections
14-191.479, 191.480, and 630.1170, to read as follows:
15- 191.479. 1. For the purpose of this section, a "bona
16-fide physician-patient relationship" means a relationship
17-between a physician and a patient in which the physician:
18- (1) Has completed an assessment of the patient's
19-medical history and current medical condition, including an
20-in-person examination of the patient;
21- (2) Has consulted with the patient with respect to the
22-patient's medical condition; and
23- (3) Is available to provide follow -up care and
24-treatment to the patient.
25- 2. Notwithstanding the provisions of chapter 195 or
26-579 or any other provisi on of law to the contrary, any
27-person who acquires, uses, produces, possesses, transfers,
28-or administers psilocybin for the person's own therapeutic
29-use shall not be in violation of state or local law and
30-shall not be subject to a civil fine, penalty, or sanction
31-so long as the following conditions are met:
32- (1) The person is a veteran, as defined in section
33-42.002, or a victim of sex trafficking, as defined in 22
34-U.S.C. Section 7102, as amended, who resides in Missouri;
35- (2) The person is twenty-one years of age or older;
36- 2
37- (3) The person suffers from posttraumatic stress
38-disorder, major depressive disorder, or a substance use
39-disorder or requires end -of-life care;
40- (4) The person has enrolled in a study regarding the
41-use of psilocybin to treat posttraumatic stress disorder,
42-major depressive disorder, or substance use disorders or for
43-end-of-life care;
44- (5) The person informs the department of mental health
45-that the person plans to acquire, use, produce, possess,
46-transfer, or administer psilocybin in accordance with this
47-section;
48- (6) The person provides the department with:
49- (a) Documentation from a physician with whom the
50-patient has a bona fide physician -patient relationship that
51-the person suffers from po sttraumatic stress disorder, major
52-depressive disorder, or a substance use disorder or requires
53-end-of-life care;
54- (b) The name of the facilitator who will be present
55-with the person when they use psilocybin, who is one of the
56-following:
57- a. A physician licensed under chapter 334;
58- b. A psychologist licensed under chapter 337;
59- c. A master's-level mental health therapist with full
60-clinical experience such as a licensed clinical social
61-worker, marital and family therapist, or profes sional
62-counselor, as such professions are licensed under chapter
63-337, or a registered art therapist;
64- d. A nurse licensed under chapter 335 with a doctor of
65-nursing practice degree;
66- e. A physician assistant licensed under chapter 334; or
67- f. An advanced practice registered nurse licensed
68-under chapter 335, including, but not limited to, a
69-psychiatric-mental health nurse practitioner;
70- 3
71- (c) The address of the location where the use of
72-psilocybin will take place; and
73- (d) The time period, not to exceed twelve months,
74-during which the person will use psilocybin;
75- (7) The person ensures that a laboratory licensed by
76-the state to test controlled substances tests the psilocybin
77-the person intends to ingest; and
78- (8) The person limits the use of psilocybin to no more
79-than one hundred and fifty milligrams of psilocybin analyte
80-(4-phosphoryloxy-N, N-dimethyltryptamine) during any twelve -
81-month period.
82- 3. (1) A facilitator described under subsection 2 of
83-this section, in order to serve as a facilitator, shall have
84-completed a training program specific to psilocybin
85-consistent with the most current American Psychedelic
86-Practitioners Association Professional Practice Guidelines
87-for Psychedelic-Assisted Therapy and shall comply with such
88-guidelines. The curriculum of a training program under this
89-subsection shall cover all content areas set forth in the
90-guidelines and shall consist of no less than thirty hours of
91-synchronous learning. Facilitators, excluding th ose who are
92-psychologists, psychiatrists, or psychiatric -mental health
93-nurse practitioners, shall complete one and one half
94-continuing education hours of training on the most current
95-version of the Diagnostic and Statistical Manual of Mental
96-Disorders within the facilitator's respective licensure
97-renewal period and prior to facilitating a psilocybin
98-session.
99- (2) An individual shall have training in posttraumatic
100-stress disorder, complex posttraumatic stress disorder,
101-major depressive disorder , substance use disorder, or end -of-
102-life care in order to serve as a facilitator for a person
103- 4
104-seeking psilocybin-assisted psychotherapy to treat such
105-conditions.
106- 4. Notwithstanding the provisions of chapter 195 or
107-579 or any other provision of la w to the contrary:
108- (1) Any person twenty-one years of age or older who
109-assists another person in any of the acts allowed under
110-subsection 2 of this section shall not be in violation of
111-state or local law and shall not be subject to a civil fine,
112-penalty, or sanction; and
113- (2) Any laboratory licensed by the state to test
114-controlled substances or cannabis that tests psilocybin for
115-a person engaged in acts allowed under subsection 2 of this
116-section shall not be in violation of state or local law and
117-shall not be subject to a civil fine, penalty, or sanction.
118- 5. Subject to appropriation, the department shall
119-provide grants totaling three million dollars for research
120-on the use and efficacy of psilocybin for persons described
121-in subsection 2 of this section.
122- 6. The department shall prepare and submit to the
123-governor, lieutenant governor, and the general assembly
124-annual reports on any information collected by the
125-department on the implementation and outcomes of the use of
126-psilocybin as described in subsection 2 of this section.
127- 7. The department shall maintain the confidentiality
128-of any personally identifiable protected information
129-collected from any persons who provide information to the
130-department under subsection 2 o f this section.
131- 8. Notwithstanding any other provision of law to the
132-contrary, the department, any health care providers, and any
133-other person involved in the acts described in subsection 2
134-of this section shall not be subject to criminal or civil
135-liability or sanction under the laws of this state for
136-providing care to a person engaged in acts allowed under
137- 5
138-subsection 2 of this section, except in cases of gross
139-negligence or willful misconduct. No health care provider
140-shall be subject to disc ipline against his or her
141-professional license for providing care to a person engaged
142-in acts allowed under subsection 2 of this section.
143- 9. Notwithstanding any other provision of law to the
144-contrary, a physician shall not be subject to criminal o r
145-civil liability or sanction under the laws of this state for
146-providing documentation that a person suffers from
147-posttraumatic stress disorder, major depressive disorder, or
148-a substance use disorder or requires end -of-life care, and
149-no state agency or regulatory board shall revoke, fail to
150-renew, or take any other action against a physician's
151-license issued under chapter 334 based solely on the
152-physician's provision of documentation that a person suffers
153-from posttraumatic stress disorder, major d epressive
154-disorder, or a substance use disorder or requires end -of-
155-life care.
156- 10. Notwithstanding any other provision of law to the
157-contrary, no state agency, including employees therein,
158-shall disclose to the federal government, any federal
159-government employee, or any unauthorized third party the
160-statewide list or any individual information of persons who
161-meet the requirements of this section.
162- 191.480. 1. For purposes of this section, the
163-following terms shall mean:
164- (1) "Eligible patient", a person who meets all of the
165-following:
166- (a) Has a terminal, life-threatening, or severely
167-debilitating condition or illness;
168- (b) Has considered all other treatment options
169-currently approved by the United States Food a nd Drug
170- 6
171-Administration and all relevant clinical trials conducted in
172-this state;
173- (c) Has received a prescription or recommendation from
174-the person's physician for an investigational drug,
175-biological product, or device;
176- (d) Has given written informed consent which shall be
177-at least as comprehensive as the consent used in clinical
178-trials for the use of the investigational drug, biological
179-product, or device or, if the patient is a minor or lacks
180-the mental capacity to provide informed cons ent, a parent or
181-legal guardian has given written informed consent on the
182-patient's behalf; and
183- (e) Has documentation from the person's physician that
184-the person has met the requirements of this subdivision;
185- (2) "Investigational drug, biolog ical product, or
186-device", a drug, biological product, or device, any of which
187-are used to treat the patient's terminal illness, that has
188-successfully completed phase one of a clinical trial but has
189-not been approved for general use by the United States Food
190-and Drug Administration and remains under investigation in a
191-clinical trial[. The term shall not include Schedule I
192-controlled substances ];
193- (3) "Life-threatening", diseases or conditions:
194- (a) Where the likelihood of death is high unle ss the
195-course of the disease is interrupted; and
196- (b) With potentially fatal outcomes, where the end
197-point of clinical trial analysis is survival;
198- (4) "Severely debilitating", diseases or conditions
199-that cause major irreversible morbidity;
200- (5) "Terminal illness", a disease that without life -
201-sustaining procedures will result in death in the near
202-future or a state of permanent unconsciousness from which
203-recovery is unlikely.
204- 7
205- 2. A manufacturer of an investigational drug,
206-biological product, or device may make available the
207-manufacturer's investigational drug, biological product, or
208-device to eligible patients under this section. This
209-section does not require that a manufacturer make available
210-an investigational drug, biologica l product, or device to an
211-eligible patient. A manufacturer may:
212- (1) Provide an investigational drug, biological
213-product, or device to an eligible patient without receiving
214-compensation; or
215- (2) Require an eligible patient to pay the costs o f or
216-associated with the manufacture of the investigational drug,
217-biological product, or device.
218- 3. This section does not require a health care insurer
219-to provide coverage for the cost of any investigational
220-drug, biological product, or device. A health care insurer
221-may provide coverage for an investigational drug, biological
222-product, or device.
223- 4. This section does not require the department of
224-corrections to provide coverage for the cost of any
225-investigational drug, biological product , or device.
226- 5. Notwithstanding any other provision of law to the
227-contrary, no state agency or regulatory board shall revoke,
228-fail to renew, or take any other action against a
229-physician's license issued under chapter 334 based solely on
230-the physician's recommendation to an eligible patient
231-regarding prescription for or treatment with an
232-investigational drug, biological product, or device. Action
233-against a health care provider's Medicare certification
234-based solely on the health care provider's recommendation
235-that a patient have access to an investigational drug,
236-biological product, or device is prohibited.
237- 8
238- 6. If a provision of this section or its application
239-to any person or circumstance is held invalid, the
240-invalidity does not affect other provisions or applications
241-of this section that can be given effect without the invalid
242-provision or application, and to this end the provisions of
243-this section are severable.
244- 7. If the clinical trial is closed due to lack of
245-efficacy or toxicity, the drug shall not be offered. If
246-notice is given on a drug, product, or device taken by a
247-patient outside of a clinical trial, the pharmaceutical
248-company or patient's physician shall notify the patient of
249-the information from the safety comm ittee of the clinical
250-trial.
251- 8. Except in the case of gross negligence or willful
252-misconduct, any person who manufactures, imports,
253-distributes, prescribes, dispenses, or administers an
254-investigational drug or device to an eligible patient with a
255-terminal illness in accordance with this section shall not
256-be liable in any action under state law for any loss,
257-damage, or injury arising out of, relating to, or resulting
258-from:
259- (1) The design, development, clinical testing and
260-investigation, manufacturing, labeling, distribution, sale,
261-purchase, donation, dispensing, prescription,
262-administration, or use of the drug or device; or
263- (2) The safety or effectiveness of the drug or device.
264- 630.1170. 1. Notwithstanding the pr ovisions of
265-chapter 195 or 579 to the contrary, the department of mental
266-health, in collaboration with a hospital operated by an
267-institution of higher education in this state or contract
268-research organizations conducting trials approved by the
269-United States Food and Drug Administration, shall conduct a
270-study on the efficacy of using alternative medicine and
271- 9
272-therapies, including, the use of psilocybin, in the
273-treatment of patients who suffer from posttraumatic stress
274-disorder, major depressive disor der, or substance abuse
275-disorders or who require end -of-life care.
276- 2. (1) In conducting this study, the department, in
277-collaboration with the hospitals or research organizations
278-described in subsection 1 of this section and subject to
279-appropriation, shall:
280- (a) Perform a study on the therapeutic efficacy of
281-using psilocybin in the treatment of patients who suffer
282-from posttraumatic stress disorder, major depressive
283-disorder, or substance use disorders or who require end -of-
284-life care; and
285- (b) Review current literature regarding:
286- a. The safety and efficacy of psilocybin in the
287-treatment of patients who suffer from posttraumatic stress
288-disorder, major depressive disorder, or substance use
289-disorders or who require end -of-life care; and
290- b. The access that patients have to psilocybin for
291-such treatment.
292- (2) The department shall prepare and submit to the
293-governor, lieutenant governor, and the general assembly the
294-following:
295- (a) Quarterly reports on the progress of the study; and
296- (b) A written report, submitted one year following the
297-commencement of the study, which shall:
298- a. Contain the results of the study and any
299-recommendations for legislative or regulatory action; and
300- b. Highlight those clinical practices that appear to
301-be most successful as well as any safety or health concerns.
302- 3. The department shall maintain the confidentiality
303-of any personally identifiable protected information
304-collected during the study described in this se ction.
305- 10
306- 4. Notwithstanding any other provision of law to the
307-contrary, the department, any health care providers, and any
308-other person involved in the study described in this section
309-shall not be subject to criminal or civil liability or
310-sanction under the laws of this state for participating in
311-the study, except in cases of gross negligence or willful
312-misconduct. No health care provider shall be subject to
313-discipline against his or her professional license for
314-participation in the study.
315- 5. Notwithstanding any other provision of law to the
316-contrary, a physician shall not be subject to criminal or
317-civil liability or sanction under the laws of this state for
318-referring a patient to the study described in this section,
319-and no state agency or regulatory board shall revoke, fail
320-to renew, or take any other action against a physician's
321-license issued under chapter 334 based solely on the
322-physician's referral of a patient to the study described in
323-this section.
14+ Section A. Section 191.480, RSMo, is repealed and three 1
15+new sections enacted in lieu thereof, to be known as sections 2
16+191.479, 191.480, and 630.1170, to read as follows:3
17+ 191.479. 1. For the purpose of this section, a "bona 1
18+fide physician-patient relationship" means a relationship 2
19+between a physician and a patient in which the physician: 3
20+ (1) Has completed an assessment of the patient's 4
21+medical history and current med ical condition, including an 5
22+in-person examination of the patient; 6
23+ (2) Has consulted with the patient with respect to the 7
24+patient's medical condition; and 8
25+ (3) Is available to provide follow -up care and 9
26+treatment to the patient. 10
27+ 2. Notwithstanding the provisions of chapter 195 or 11
28+579 or any other provision of law to the contrary, any 12
29+person who acquires, uses, produces, possesses, transfers, 13
30+or administers psilocybin for the person's own therapeutic 14
31+use shall not be in violation of s tate or local law and 15
32+shall not be subject to a civil fine, penalty, or sanction 16
33+so long as the following conditions are met: 17 SB 90 2
34+ (1) The person is a veteran, as defined in section 18
35+42.002, who resides in Missouri; 19
36+ (2) The person is twenty -one years of age or older; 20
37+ (3) The person suffers from posttraumatic stress 21
38+disorder, major depressive disorder, or a substance use 22
39+disorder or requires end -of-life care; 23
40+ (4) The person has enrolled in a study regarding the 24
41+use of psilocybin to tr eat posttraumatic stress disorder, 25
42+major depressive disorder, or substance use disorders or for 26
43+end-of-life care; 27
44+ (5) The person informs the department of mental health 28
45+that the person plans to acquire, use, produce, possess, 29
46+transfer, or adminis ter psilocybin in accordance with this 30
47+section; 31
48+ (6) The person provides the department with: 32
49+ (a) Documentation from a physician with whom the 33
50+patient has a bona fide physician -patient relationship that 34
51+the person suffers from posttraumatic s tress disorder, major 35
52+depressive disorder, or a substance use disorder or requires 36
53+end-of-life care; 37
54+ (b) The name of the facilitator who will be present 38
55+with the person when they use psilocybin, who is one of the 39
56+following: 40
57+ a. A physician licensed under chapter 334; 41
58+ b. A psychologist licensed under chapter 337; 42
59+ c. A master's-level mental health therapist with full 43
60+clinical experience such as a licensed clinical social 44
61+worker, marital and family therapist, or professional 45
62+counselor, as such professions are licensed under chapter 46
63+337, or a registered art therapist; 47
64+ d. A nurse licensed under chapter 335 with a doctor of 48
65+nursing practice degree; 49 SB 90 3
66+ e. A physician assistant licensed under chapter 334; or 50
67+ f. An advanced practice registered nurse licensed 51
68+under chapter 335, including, but not limited to, a 52
69+psychiatric-mental health nurse practitioner; 53
70+ (c) The address of the location where the use of 54
71+psilocybin will take place; and 55
72+ (d) The time period, not to exceed twelve months, 56
73+during which the person will use psilocybin; 57
74+ (7) The person ensures that a laboratory licensed by 58
75+the state to test controlled substances tests the psilocybin 59
76+the person intends to ingest; and 60
77+ (8) The person limits the use of psilocybin to no more 61
78+than one hundred and fifty milligrams of psilocybin analyte 62
79+(4-phosphoryloxy-N, N-dimethyltryptamine) during any twelve - 63
80+month period. 64
81+ 3. (1) A facilitator described under subsection 2 of 65
82+this section, in order t o serve as a facilitator, shall have 66
83+completed a training program specific to psilocybin 67
84+consistent with the most current American Psychedelic 68
85+Practitioners Association Professional Practice Guidelines 69
86+for Psychedelic-Assisted Therapy and shall comply with such 70
87+guidelines. The curriculum of a training program under this 71
88+subsection shall cover all content areas set forth in the 72
89+guidelines and shall consist of no less than thirty hours of 73
90+synchronous learning. Facilitators, excluding those who are 74
91+psychologists, psychiatrists, or psychiatric -mental health 75
92+nurse practitioners, shall complete one and one half 76
93+continuing education hours of training on the most current 77
94+version of the Diagnostic and Statistical Manual of Mental 78
95+Disorders within the f acilitator's respective licensure 79
96+renewal period and prior to facilitating a psilocybin 80
97+session. 81 SB 90 4
98+ (2) An individual shall have training in posttraumatic 82
99+stress disorder, complex posttraumatic stress disorder, 83
100+major depressive disorder, substance u se disorder, or end-of- 84
101+life care in order to serve as a facilitator for a person 85
102+seeking psilocybin-assisted psychotherapy to treat such 86
103+conditions. 87
104+ 4. Notwithstanding the provisions of chapter 195 or 88
105+579 or any other provision of law to the cont rary: 89
106+ (1) Any person twenty-one years of age or older who 90
107+assists another person in any of the acts allowed under 91
108+subsection 2 of this section shall not be in violation of 92
109+state or local law and shall not be subject to a civil fine, 93
110+penalty, or sanction; and 94
111+ (2) Any laboratory licensed by the state to test 95
112+controlled substances or cannabis that tests psilocybin for 96
113+a person engaged in acts allowed under subsection 2 of this 97
114+section shall not be in violation of state or local law and 98
115+shall not be subject to a civil fine, penalty, or sanction. 99
116+ 5. Subject to appropriation, the department shall 100
117+provide grants totaling three million dollars for research 101
118+on the use and efficacy of psilocybin for persons described 102
119+in subsection 2 of thi s section. 103
120+ 6. The department shall prepare and submit to the 104
121+governor, lieutenant governor, and the general assembly 105
122+annual reports on any information collected by the 106
123+department on the implementation and outcomes of the use of 107
124+psilocybin as described in subsection 2 of this section. 108
125+ 7. The department shall maintain the confidentiality 109
126+of any personally identifiable protected information 110
127+collected from any persons who provide information to the 111
128+department under subsection 2 of this sectio n. 112 SB 90 5
129+ 8. Notwithstanding any other provision of law to the 113
130+contrary, the department, any health care providers, and any 114
131+other person involved in the acts described in subsection 2 115
132+of this section shall not be subject to criminal or civil 116
133+liability or sanction under the laws of this state for 117
134+providing care to a person engaged in acts allowed under 118
135+subsection 2 of this section, except in cases of gross 119
136+negligence or willful misconduct. No health care provider 120
137+shall be subject to discipline agains t his or her 121
138+professional license for providing care to a person engaged 122
139+in acts allowed under subsection 2 of this section. 123
140+ 9. Notwithstanding any other provision of law to the 124
141+contrary, a physician shall not be subject to criminal or 125
142+civil liability or sanction under the laws of this state for 126
143+providing documentation that a person suffers from 127
144+posttraumatic stress disorder, major depressive disorder, or 128
145+a substance use disorder or requires end -of-life care, and 129
146+no state agency or regulatory board shall revoke, fail to 130
147+renew, or take any other action against a physician's 131
148+license issued under chapter 334 based solely on the 132
149+physician's provision of documentation that a person suffers 133
150+from posttraumatic stress disorder, major depressive 134
151+disorder, or a substance use disorder or requires end -of- 135
152+life care. 136
153+ 10. Notwithstanding any other provision of law to the 137
154+contrary, no state agency, including employees therein, 138
155+shall disclose to the federal government, any federal 139
156+government employee, or any unauthorized third party the 140
157+statewide list or any individual information of persons who 141
158+meet the requirements of this section. 142
159+ 191.480. 1. For purposes of this section, the 1
160+following terms shall mean: 2 SB 90 6
161+ (1) "Eligible patient", a person who meets all of the 3
162+following: 4
163+ (a) Has a terminal, life-threatening, or severely 5
164+debilitating condition or illness; 6
165+ (b) Has considered all other treatment options 7
166+currently approved by the United States Food and Drug 8
167+Administration and all relevant clinical trials conducted in 9
168+this state; 10
169+ (c) Has received a prescription or recommendation from 11
170+the person's physician for an investigational drug, 12
171+biological product, or device; 13
172+ (d) Has given written informed consent which shall be 14
173+at least as comprehensive as the consent used in clinical 15
174+trials for the use of the investigational drug, biological 16
175+product, or device or, if the patient is a minor or lacks 17
176+the mental capacity to provide informed consent, a par ent or 18
177+legal guardian has given written informed consent on the 19
178+patient's behalf; and 20
179+ (e) Has documentation from the person's physician that 21
180+the person has met the requirements of this subdivision; 22
181+ (2) "Investigational drug, biological produ ct, or 23
182+device", a drug, biological product, or device, any of which 24
183+are used to treat the patient's terminal illness, that has 25
184+successfully completed phase one of a clinical trial but has 26
185+not been approved for general use by the United States Food 27
186+and Drug Administration and remains under investigation in a 28
187+clinical trial[. The term shall not include Schedule I 29
188+controlled substances ]; 30
189+ (3) "Life-threatening", diseases or conditions: 31
190+ (a) Where the likelihood of death is high unless the 32
191+course of the disease is interrupted; and 33 SB 90 7
192+ (b) With potentially fatal outcomes, where the end 34
193+point of clinical trial analysis is survival; 35
194+ (4) "Severely debilitating", diseases or conditions 36
195+that cause major irreversible morbidity; 37
196+ (5) "Terminal illness", a disease that without life - 38
197+sustaining procedures will result in death in the near 39
198+future or a state of permanent unconsciousness from which 40
199+recovery is unlikely. 41
200+ 2. A manufacturer of an investigational drug, 42
201+biological product, or device may make available the 43
202+manufacturer's investigational drug, biological product, or 44
203+device to eligible patients under this section. This 45
204+section does not require that a manufacturer make available 46
205+an investigational drug, biological product, or device to an 47
206+eligible patient. A manufacturer may: 48
207+ (1) Provide an investigational drug, biological 49
208+product, or device to an eligible patient without receiving 50
209+compensation; or 51
210+ (2) Require an eligible patient to pay the costs of or 52
211+associated with the manufacture of the investigational drug, 53
212+biological product, or device. 54
213+ 3. This section does not require a health care insurer 55
214+to provide coverage for the cost of any investigational 56
215+drug, biological product, or device. A health care insurer 57
216+may provide coverage for an investigational drug, biological 58
217+product, or device. 59
218+ 4. This section does not require the department of 60
219+corrections to provide coverage for the cost of any 61
220+investigational drug, biological product, or devic e. 62
221+ 5. Notwithstanding any other provision of law to the 63
222+contrary, no state agency or regulatory board shall revoke, 64
223+fail to renew, or take any other action against a 65 SB 90 8
224+physician's license issued under chapter 334 based solely on 66
225+the physician's recommendation to an eligible patient 67
226+regarding prescription for or treatment with an 68
227+investigational drug, biological product, or device. Action 69
228+against a health care provider's Medicare certification 70
229+based solely on the health care provider's recommend ation 71
230+that a patient have access to an investigational drug, 72
231+biological product, or device is prohibited. 73
232+ 6. If a provision of this section or its application 74
233+to any person or circumstance is held invalid, the 75
234+invalidity does not affect other pro visions or applications 76
235+of this section that can be given effect without the invalid 77
236+provision or application, and to this end the provisions of 78
237+this section are severable. 79
238+ 7. If the clinical trial is closed due to lack of 80
239+efficacy or toxicity, t he drug shall not be offered. If 81
240+notice is given on a drug, product, or device taken by a 82
241+patient outside of a clinical trial, the pharmaceutical 83
242+company or patient's physician shall notify the patient of 84
243+the information from the safety committee of t he clinical 85
244+trial. 86
245+ 8. Except in the case of gross negligence or willful 87
246+misconduct, any person who manufactures, imports, 88
247+distributes, prescribes, dispenses, or administers an 89
248+investigational drug or device to an eligible patient with a 90
249+terminal illness in accordance with this section shall not 91
250+be liable in any action under state law for any loss, 92
251+damage, or injury arising out of, relating to, or resulting 93
252+from: 94
253+ (1) The design, development, clinical testing and 95
254+investigation, manufactur ing, labeling, distribution, sale, 96 SB 90 9
255+purchase, donation, dispensing, prescription, 97
256+administration, or use of the drug or device; or 98
257+ (2) The safety or effectiveness of the drug or device. 99
258+ 630.1170. 1. Notwithstanding the provision s of 1
259+chapter 195 or 579 to the contrary, the department of mental 2
260+health, in collaboration with a hospital operated by an 3
261+institution of higher education in this state or contract 4
262+research organizations conducting trials approved by the 5
263+United States Food and Drug Administration, shall conduct a 6
264+study on the efficacy of using alternative medicine and 7
265+therapies, including, the use of psilocybin, in the 8
266+treatment of patients who suffer from posttraumatic stress 9
267+disorder, major depressive disorder, or substance abuse 10
268+disorders or who require end -of-life care. 11
269+ 2. (1) In conducting this study, the department, in 12
270+collaboration with the hospitals or research organizations 13
271+described in subsection 1 of this section and subject to 14
272+appropriation, shall: 15
273+ (a) Perform a study on the therapeutic efficacy of 16
274+using psilocybin in the treatment of patients who suffer 17
275+from posttraumatic stress disorder, major depressive 18
276+disorder, or substance use disorders or who require end -of- 19
277+life care; and 20
278+ (b) Review current literature regarding: 21
279+ a. The safety and efficacy of psilocybin in the 22
280+treatment of patients who suffer from posttraumatic stress 23
281+disorder, major depressive disorder, or substance use 24
282+disorders or who require end -of-life care; and 25
283+ b. The access that patients have to psilocybin for 26
284+such treatment. 27 SB 90 10
285+ (2) The department shall prepare and submit to the 28
286+governor, lieutenant governor, and the general assembly the 29
287+following: 30
288+ (a) Quarterly reports on the progress of the study; and 31
289+ (b) A written report, submitted one year following the 32
290+commencement of the study, which shall: 33
291+ a. Contain the results of the study and any 34
292+recommendations for legislative or regulatory action; and 35
293+ b. Highlight those clinical practices that appear to 36
294+be most successful as well as any safety or health concerns. 37
295+ 3. The department shall maintain the confidentiality 38
296+of any personally identifiable protected information 39
297+collected during the study described in this section. 40
298+ 4. Notwithstanding any other provision of law to the 41
299+contrary, the department, any health care providers, and any 42
300+other person involved in the study described in this section 43
301+shall not be subject to criminal or civil liability or 44
302+sanction under the laws of this state for participating in 45
303+the study, except in cases of gross negligence or willful 46
304+misconduct. No health care provider shall be subject to 47
305+discipline against his or her professional license for 48
306+participation in the study. 49
307+ 5. Notwithstanding any other provision of law to the 50
308+contrary, a physician shall not be subject to criminal or 51
309+civil liability or sanction under the laws of this state for 52
310+referring a patient to the study described in this section, 53
311+and no state agency or re gulatory board shall revoke, fail 54
312+to renew, or take any other action against a physician's 55
313+license issued under chapter 334 based solely on the 56
314+physician's referral of a patient to the study described in 57
315+this section. 58
316+