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EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted
and is intended to be omitted in the law.
SECOND REGULAR SESSION
SENATE BILL NO. 1682
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR MCCREERY .
7223S.01I KRISTINA MARTIN, Secretary
AN ACT
To repeal section 191.480, RSMo, and to enact in lieu thereof three 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Section A. Section 191.480, RSMo, is repealed and three 1
new sections enacted in lieu thereof, to be known as sections 2
191.479, 191.480, and 630.1170, to read as follows:3
191.479. 1. As used in this section, the following 1
terms mean: 2
(1) "Bona fide physician-patient relationship", a 3
relationship between a physician and a patient in which the 4
physician: 5
(a) Has completed an assessment of the patient's 6
medical history and current medical condition, including an 7
in-person examination of the patient; 8
(b) Has consulted with the patient with respect to the 9
patient's medical condition; and 10
(c) Is available to provide follow-up care and 11
treatment to the patient; 12
(2) "Facilitator", an individual who is present with a 13
person who uses psilocybin in order to facilitate the 14
therapeutic use of the psilocybin for the person; 15
(3) "First responder", the same meaning as in section 16
67.145; 17
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(4) "Veteran", any person defined as a veteran by the 18
United States Department of Veterans Affairs or its 19
successor agency. 20
2. Notwithstanding the provisions of chapter 195 or 21
579 or any other provision of law to the contrary, any 22
person who acquires, uses, produces, possesses, transfers, 23
or administers psilocybin for the person's own therapeutic 24
use shall not be in violation of state or local law and 25
shall not be subject to a civil fine, penalty, or sanction 26
so long as the following conditions are met: 27
(1) The person is a veteran or a first responder and 28
is twenty-one years of age or older; 29
(2) The person suffers from posttraumatic stress 30
disorder, major depressive disorder, or a substance use 31
disorder or requires end-of-life care; 32
(3) The person has enrolled in a study on the use of 33
psilocybin to treat posttraumatic stress disorder, major 34
depressive disorder, or substance use disorders or for end- 35
of-life care; 36
(4) The person informs the department of mental health 37
that the person plans to acquire, use, produce, possess, 38
transfer, or administer psilocybin in accordance with this 39
section; 40
(5) The person provides the department of mental 41
health with: 42
(a) Documentation from a physician with whom the 43
patient has a bona fide physician-patient relationship that 44
the person suffers from posttraumatic stress disorder, major 45
depressive disorder, or a substance use disorder or requires 46
end-of-life care; 47
(b) The name of the individual who will serve as the 48
person's facilitator; 49
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(c) The address of the location where the use of 50
psilocybin will take place; and 51
(d) The time period, not to exceed twelve months, 52
during which the person will use psilocybin; 53
(6) The person's use of psilocybin occurs only in the 54
presence of a facilitator who meets the following 55
requirements: 56
(a) Is: 57
a. A licensed physician; 58
b. A licensed mental health professional who earned a 59
doctor of psychology degree or a doctor of philosophy degree 60
in psychology; 61
c. A mental health therapist who has a master's degree 62
in a relevant field and who has full clinical licensure 63
including, but not limited to, a licensed clinical social 64
worker, a licensed marital and family therapist, a licensed 65
professional counselor, or an art therapist; 66
d. A licensed nurse who holds a doctorate in nursing 67
practice; 68
e. A licensed physician assistant; 69
f. A psychiatric mental health nurse practitioner; or 70
g. A licensed advanced practice registered nurse; 71
(b) Has completed a training program that is specific 72
to psilocybin and that: 73
a. Is consistent with the current professional 74
practice guidelines for psychedelic-assisted therapy 75
published by the American Psychological Association or the 76
American Psychedelic Practitioners Association and complies 77
with each such guideline; 78
b. Covers all content areas set forth in the 79
professional practice guidelines of the American 80
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Psychological Association or the American Psychedelic 81
Practitioners Association; and 82
c. Consists of at least thirty hours of synchronous 83
learning; 84
(c) Except for psychiatrists, psychiatric mental 85
health nurse practitioners, and holders of a doctorate 86
degree in psychology, completes ninety minutes of continuing 87
education on the Diagnostic and Statistical Manual of Mental 88
Disorders before serving as a facilitator for any person and 89
during each relevant licensure renewal period; and 90
(d) Has received training in end-of-life care or in 91
one or more of the following diagnostic categories: 92
a. Posttraumatic stress disorder; 93
b. Complex posttraumatic stress disorder; 94
c. Major depressive disorder; or 95
d. Substance use disorder; 96
(7) The person ensures that a laboratory licensed by 97
the state to test controlled substances tests the psilocybin 98
the person intends to ingest; and 99
(8) The person limits the use of psilocybin to no more 100
than one hundred fifty milligrams of psilocybin analyte (4- 101
phosphoryloxy-N, N-dimethyltryptamine) during any twelve- 102
month period. 103
3. Notwithstanding the provisions of chapter 195 or 104
579 or any other provision of law to the contrary: 105
(1) Any person twenty-one years of age or older who 106
assists another person in any of the acts allowed under 107
subsection 2 of this section shall not be in violation of 108
state or local law and shall not be subject to a civil fine, 109
penalty, or sanction; and 110
(2) Any laboratory licensed by the state to test 111
controlled substances or cannabis that tests psilocybin for 112
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a person engaged in acts allowed under subsection 2 of this 113
section shall not be in violation of state or local law and 114
shall not be subject to a civil fine, penalty, or sanction. 115
4. Subject to appropriation, the department of mental 116
health shall provide grants totaling two million dollars for 117
research on the use and efficacy of psilocybin for persons 118
described in subsection 2 of this section. 119
5. The department of mental health shall prepare and 120
submit to the governor, lieutenant governor, and the general 121
assembly annual reports on any information collected by the 122
department on the implementation and outcomes of the use of 123
psilocybin as described in subsection 2 of this section. 124
6. The department of mental health shall maintain the 125
confidentiality of any personally identifiable protected 126
information collected from any persons who provide 127
information to the department under subsection 2 of this 128
section. 129
7. Notwithstanding any other provision of law to the 130
contrary, the department of mental health, any health care 131
providers, and any other person involved in the acts 132
described in subsection 2 of this section shall not be 133
subject to criminal or civil liability or sanction under the 134
laws of this state for providing care to a person engaged in 135
acts allowed under subsection 2 of this section, except in 136
cases of gross negligence or willful misconduct. No health 137
care provider shall be subject to discipline against his or 138
her professional license for providing care to a person 139
engaged in acts allowed under subsection 2 of this section. 140
8. Notwithstanding any other provision of law to the 141
contrary, a physician shall not be subject to criminal or 142
civil liability or sanction under the laws of this state for 143
providing documentation that a person suffers from 144
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posttraumatic stress disorder, major depressive disorder, or 145
a substance use disorder or requires end-of-life care, and 146
no state agency or regulatory board shall revoke, fail to 147
renew, or take any other action against a physician's 148
license issued under chapter 334 based solely on the 149
physician's provision of documentation that a person suffers 150
from posttraumatic stress disorder, major depressive 151
disorder, or a substance use disorder or requires end-of- 152
life care. 153
9. Notwithstanding any other provision of law to the 154
contrary, no state agency or employee of a state agency 155
shall disclose to the federal government, any federal 156
government employee, or any unauthorized third party the 157
statewide list or any individual information of persons who 158
meet the requirements of this section. 159
191.480. 1. For purposes of this section, the 1
following terms shall mean: 2
(1) "Eligible patient", a person who meets all of the 3
following: 4
(a) Has a terminal condition or illness, a life- 5
threatening condition or illness, or a severely debilitating 6
condition or illness; 7
(b) Has considered all other treatment options 8
currently approved by the United States Food and Drug 9
Administration and all relevant clinical trials conducted in 10
this state; 11
(c) Has received a prescription or recommendation from 12
the person's physician for an investigational drug, 13
biological product, or device; 14
(d) Has given written informed consent which shall be 15
at least as comprehensive as the consent used in clinical 16
trials for the use of the investigational drug, biological 17
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product, or device or, if the patient is a minor or lacks 18
the mental capacity to provide informed consent, a parent or 19
legal guardian has given written informed consent on the 20
patient's behalf; and 21
(e) Has documentation from the person's physician that 22
the person has met the requirements of this subdivision; 23
(2) "Investigational drug, biological product, or 24
device", a drug, biological product, or device, any of which 25
are used to treat the patient's terminal condition or 26
illness, life-threatening condition or illness, or severely 27
debilitating condition or illness, that has successfully 28
completed phase one of a clinical trial but has not been 29
approved for general use by the United States Food and Drug 30
Administration and remains under investigation in a clinical 31
trial[. The term shall not include Schedule I controlled 32
substances]; 33
(3) "Life-threatening condition or illness", a disease 34
or condition: 35
(a) In which the likelihood of death is high unless 36
the course of the disease is interrupted; and 37
(b) With potentially fatal outcomes, where the end 38
point of clinical trial analysis is survival; 39
(4) "Severely debilitating condition or illness", a 40
disease or condition that causes major irreversible 41
morbidity; 42
(5) "Terminal condition or illness", a disease or 43
condition that without life-sustaining procedures will 44
result in death in the near future or a state of permanent 45
unconsciousness from which recovery is unlikely. 46
2. A manufacturer of an investigational drug, 47
biological product, or device may make available the 48
manufacturer's investigational drug, biological product, or 49
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device to eligible patients under this section. This 50
section does not require that a manufacturer make available 51
an investigational drug, biological product, or device to an 52
eligible patient. A manufacturer may: 53
(1) Provide an investigational drug, biological 54
product, or device to an eligible patient without receiving 55
compensation; or 56
(2) Require an eligible patient to pay the costs of or 57
associated with the manufacture of the investigational drug, 58
biological product, or device. 59
3. This section does not require a health care insurer 60
to provide coverage for the cost of any investigational 61
drug, biological product, or device. A health care insurer 62
may provide coverage for an investigational drug, biological 63
product, or device. 64
4. This section does not require the department of 65
corrections to provide coverage for the cost of any 66
investigational drug, biological product, or device. 67
5. Notwithstanding any other provision of law to the 68
contrary, no state agency or regulatory board shall revoke, 69
fail to renew, or take any other action against a 70
physician's license issued under chapter 334 based solely on 71
the physician's recommendation to an eligible patient 72
regarding prescription for or treatment with an 73
investigational drug, biological product, or device. Action 74
against a health care provider's Medicare certification 75
based solely on the health care provider's recommendation 76
that a patient have access to an investigational drug, 77
biological product, or device is prohibited. 78
6. If a provision of this section or its application 79
to any person or circumstance is held invalid, the 80
invalidity does not affect other provisions or applications 81
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of this section that can be given effect without the invalid 82
provision or application, and to this end the provisions of 83
this section are severable. 84
7. If the clinical trial is closed due to lack of 85
efficacy or toxicity, the drug shall not be offered. If 86
notice is given on a drug, product, or device taken by a 87
patient outside of a clinical trial, the pharmaceutical 88
company or patient's physician shall notify the patient of 89
the information from the safety committee of the clinical 90
trial. 91
8. Except in the case of gross negligence or willful 92
misconduct, any person who manufactures, imports, 93
distributes, prescribes, dispenses, or administers an 94
investigational drug or device to an eligible patient [with 95
a terminal illness] in accordance with this section shall 96
not be liable in any action under state law for any loss, 97
damage, or injury arising out of, relating to, or resulting 98
from: 99
(1) The design, development, clinical testing and 100
investigation, manufacturing, labeling, distribution, sale, 101
purchase, donation, dispensing, prescription, 102
administration, or use of the drug or device; or 103
(2) The safety or effectiveness of the drug or device. 104
630.1170. 1. Notwithstanding the provisions of 1
chapter 195 or 579 to the contrary, the department of mental 2
health, in collaboration with a hospital operated by an 3
institution of higher education in this state or with 4
contract research organizations conducting studies approved 5
by the U.S. Food and Drug Administration, shall conduct a 6
study on the efficacy of using alternative medicine and 7
therapies, including the use of psilocybin, in the treatment 8
of veterans who suffer from posttraumatic stress disorder, 9
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major depressive disorder, or substance use disorders or who 10
require end-of-life care. 11
2. (1) In conducting the study, the department of 12
mental health, in collaboration with the hospital or 13
contract research organizations described in subsection 1 of 14
this section and subject to appropriation, shall: 15
(a) Perform a study on the therapeutic efficacy of 16
using psilocybin in the treatment of veterans and first 17
responders who suffer from posttraumatic stress disorder, 18
major depressive disorder, or substance use disorders or who 19
require end-of-life care; and 20
(b) Review current literature regarding: 21
a. The safety and efficacy of psilocybin in the 22
treatment of veterans and first responders who suffer from 23
posttraumatic stress disorder, major depressive disorder, or 24
substance use disorders or who require end-of-life care; and 25
b. The access that veterans and first responders have 26
to psilocybin for such treatment. 27
(2) The department of mental health shall prepare and 28
submit to the governor, lieutenant governor, and the general 29
assembly the following: 30
(a) Quarterly reports on the progress of the study; and 31
(b) A written report, submitted one year following the 32
commencement of the study, that shall: 33
a. Contain the results of the study and any 34
recommendations for legislative or regulatory action; and 35
b. Highlight those clinical practices that appear to 36
be most successful as well as any safety or health concerns. 37
3. The department of mental health shall maintain the 38
confidentiality of any personally identifiable protected 39
information collected during the study under this section. 40
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4. Notwithstanding any other provision of law to the 41
contrary, the department of mental health, any health care 42
providers, and any other person involved in the study under 43
this section shall not be subject to criminal or civil 44
liability or sanction under the laws of this state for 45
participating in the study, except in cases of gross 46
negligence or willful misconduct. No health care provider 47
shall be subject to discipline against his or her 48
professional license for participation in the study. 49
5. Notwithstanding any other provision of law to the 50
contrary, a physician shall not be subject to criminal or 51
civil liability or sanction under the laws of this state for 52
referring a veteran to the study under this section, and no 53
state agency or regulatory board shall revoke, fail to 54
renew, or take any other action against a physician's 55
license issued under chapter 334 based solely on the 56
physician's referral of a veteran or a first responder to 57
the study under this section. 58
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