1343S.02C
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SENATE COMMITTEE SUBSTITUTE
FOR
SENATE BILL NO. 90
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Section A. Section 191.480, RSMo, is repealed and three
new sections enacted in lieu thereof, to be known as sections
191.479, 191.480, and 630.1170, to read as follows:
191.479. 1. For the purpose of this section, a "bona
fide physician-patient relationship" means a relationship
between a physician and a patient in which the physician:
(1) Has completed an assessment of the patient's
medical history and current medical condition, including an
in-person examination of the patient;
(2) Has consulted with the patient with respect to the
patient's medical condition; and
(3) Is available to provide follow -up care and
treatment to the patient.
2. Notwithstanding the provisions of chapter 195 or
579 or any other provisi on of law to the contrary, any
person who acquires, uses, produces, possesses, transfers,
or administers psilocybin for the person's own therapeutic
use shall not be in violation of state or local law and
shall not be subject to a civil fine, penalty, or sanction
so long as the following conditions are met:
(1) The person is a veteran, as defined in section
42.002, or a victim of sex trafficking, as defined in 22
U.S.C. Section 7102, as amended, who resides in Missouri;
(2) The person is twenty-one years of age or older;
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(3) The person suffers from posttraumatic stress
disorder, major depressive disorder, or a substance use
disorder or requires end -of-life care;
(4) The person has enrolled in a study regarding the
use of psilocybin to treat posttraumatic stress disorder,
major depressive disorder, or substance use disorders or for
end-of-life care;
(5) The person informs the department of mental health
that the person plans to acquire, use, produce, possess,
transfer, or administer psilocybin in accordance with this
section;
(6) The person provides the department with:
(a) Documentation from a physician with whom the
patient has a bona fide physician -patient relationship that
the person suffers from po sttraumatic stress disorder, major
depressive disorder, or a substance use disorder or requires
end-of-life care;
(b) The name of the facilitator who will be present
with the person when they use psilocybin, who is one of the
following:
a. A physician licensed under chapter 334;
b. A psychologist licensed under chapter 337;
c. A master's-level mental health therapist with full
clinical experience such as a licensed clinical social
worker, marital and family therapist, or profes sional
counselor, as such professions are licensed under chapter
337, or a registered art therapist;
d. A nurse licensed under chapter 335 with a doctor of
nursing practice degree;
e. A physician assistant licensed under chapter 334; or
f. An advanced practice registered nurse licensed
under chapter 335, including, but not limited to, a
psychiatric-mental health nurse practitioner;
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(c) The address of the location where the use of
psilocybin will take place; and
(d) The time period, not to exceed twelve months,
during which the person will use psilocybin;
(7) The person ensures that a laboratory licensed by
the state to test controlled substances tests the psilocybin
the person intends to ingest; and
(8) The person limits the use of psilocybin to no more
than one hundred and fifty milligrams of psilocybin analyte
(4-phosphoryloxy-N, N-dimethyltryptamine) during any twelve -
month period.
3. (1) A facilitator described under subsection 2 of
this section, in order to serve as a facilitator, shall have
completed a training program specific to psilocybin
consistent with the most current American Psychedelic
Practitioners Association Professional Practice Guidelines
for Psychedelic-Assisted Therapy and shall comply with such
guidelines. The curriculum of a training program under this
subsection shall cover all content areas set forth in the
guidelines and shall consist of no less than thirty hours of
synchronous learning. Facilitators, excluding th ose who are
psychologists, psychiatrists, or psychiatric -mental health
nurse practitioners, shall complete one and one half
continuing education hours of training on the most current
version of the Diagnostic and Statistical Manual of Mental
Disorders within the facilitator's respective licensure
renewal period and prior to facilitating a psilocybin
session.
(2) An individual shall have training in posttraumatic
stress disorder, complex posttraumatic stress disorder,
major depressive disorder , substance use disorder, or end -of-
life care in order to serve as a facilitator for a person
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seeking psilocybin-assisted psychotherapy to treat such
conditions.
4. Notwithstanding the provisions of chapter 195 or
579 or any other provision of la w to the contrary:
(1) Any person twenty-one years of age or older who
assists another person in any of the acts allowed under
subsection 2 of this section shall not be in violation of
state or local law and shall not be subject to a civil fine,
penalty, or sanction; and
(2) Any laboratory licensed by the state to test
controlled substances or cannabis that tests psilocybin for
a person engaged in acts allowed under subsection 2 of this
section shall not be in violation of state or local law and
shall not be subject to a civil fine, penalty, or sanction.
5. Subject to appropriation, the department shall
provide grants totaling three million dollars for research
on the use and efficacy of psilocybin for persons described
in subsection 2 of this section.
6. The department shall prepare and submit to the
governor, lieutenant governor, and the general assembly
annual reports on any information collected by the
department on the implementation and outcomes of the use of
psilocybin as described in subsection 2 of this section.
7. The department shall maintain the confidentiality
of any personally identifiable protected information
collected from any persons who provide information to the
department under subsection 2 o f this section.
8. Notwithstanding any other provision of law to the
contrary, the department, any health care providers, and any
other person involved in the acts described in subsection 2
of this section shall not be subject to criminal or civil
liability or sanction under the laws of this state for
providing care to a person engaged in acts allowed under
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subsection 2 of this section, except in cases of gross
negligence or willful misconduct. No health care provider
shall be subject to disc ipline against his or her
professional license for providing care to a person engaged
in acts allowed under subsection 2 of this section.
9. Notwithstanding any other provision of law to the
contrary, a physician shall not be subject to criminal o r
civil liability or sanction under the laws of this state for
providing documentation that a person suffers from
posttraumatic stress disorder, major depressive disorder, or
a substance use disorder or requires end -of-life care, and
no state agency or regulatory board shall revoke, fail to
renew, or take any other action against a physician's
license issued under chapter 334 based solely on the
physician's provision of documentation that a person suffers
from posttraumatic stress disorder, major d epressive
disorder, or a substance use disorder or requires end -of-
life care.
10. Notwithstanding any other provision of law to the
contrary, no state agency, including employees therein,
shall disclose to the federal government, any federal
government employee, or any unauthorized third party the
statewide list or any individual information of persons who
meet the requirements of this section.
191.480. 1. For purposes of this section, the
following terms shall mean:
(1) "Eligible patient", a person who meets all of the
following:
(a) Has a terminal, life-threatening, or severely
debilitating condition or illness;
(b) Has considered all other treatment options
currently approved by the United States Food a nd Drug
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Administration and all relevant clinical trials conducted in
this state;
(c) Has received a prescription or recommendation from
the person's physician for an investigational drug,
biological product, or device;
(d) Has given written informed consent which shall be
at least as comprehensive as the consent used in clinical
trials for the use of the investigational drug, biological
product, or device or, if the patient is a minor or lacks
the mental capacity to provide informed cons ent, a parent or
legal guardian has given written informed consent on the
patient's behalf; and
(e) Has documentation from the person's physician that
the person has met the requirements of this subdivision;
(2) "Investigational drug, biolog ical product, or
device", a drug, biological product, or device, any of which
are used to treat the patient's terminal illness, that has
successfully completed phase one of a clinical trial but has
not been approved for general use by the United States Food
and Drug Administration and remains under investigation in a
clinical trial[. The term shall not include Schedule I
controlled substances ];
(3) "Life-threatening", diseases or conditions:
(a) Where the likelihood of death is high unle ss the
course of the disease is interrupted; and
(b) With potentially fatal outcomes, where the end
point of clinical trial analysis is survival;
(4) "Severely debilitating", diseases or conditions
that cause major irreversible morbidity;
(5) "Terminal illness", a disease that without life -
sustaining procedures will result in death in the near
future or a state of permanent unconsciousness from which
recovery is unlikely.
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2. A manufacturer of an investigational drug,
biological product, or device may make available the
manufacturer's investigational drug, biological product, or
device to eligible patients under this section. This
section does not require that a manufacturer make available
an investigational drug, biologica l product, or device to an
eligible patient. A manufacturer may:
(1) Provide an investigational drug, biological
product, or device to an eligible patient without receiving
compensation; or
(2) Require an eligible patient to pay the costs o f or
associated with the manufacture of the investigational drug,
biological product, or device.
3. This section does not require a health care insurer
to provide coverage for the cost of any investigational
drug, biological product, or device. A health care insurer
may provide coverage for an investigational drug, biological
product, or device.
4. This section does not require the department of
corrections to provide coverage for the cost of any
investigational drug, biological product , or device.
5. Notwithstanding any other provision of law to the
contrary, no state agency or regulatory board shall revoke,
fail to renew, or take any other action against a
physician's license issued under chapter 334 based solely on
the physician's recommendation to an eligible patient
regarding prescription for or treatment with an
investigational drug, biological product, or device. Action
against a health care provider's Medicare certification
based solely on the health care provider's recommendation
that a patient have access to an investigational drug,
biological product, or device is prohibited.
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6. If a provision of this section or its application
to any person or circumstance is held invalid, the
invalidity does not affect other provisions or applications
of this section that can be given effect without the invalid
provision or application, and to this end the provisions of
this section are severable.
7. If the clinical trial is closed due to lack of
efficacy or toxicity, the drug shall not be offered. If
notice is given on a drug, product, or device taken by a
patient outside of a clinical trial, the pharmaceutical
company or patient's physician shall notify the patient of
the information from the safety comm ittee of the clinical
trial.
8. Except in the case of gross negligence or willful
misconduct, any person who manufactures, imports,
distributes, prescribes, dispenses, or administers an
investigational drug or device to an eligible patient with a
terminal illness in accordance with this section shall not
be liable in any action under state law for any loss,
damage, or injury arising out of, relating to, or resulting
from:
(1) The design, development, clinical testing and
investigation, manufacturing, labeling, distribution, sale,
purchase, donation, dispensing, prescription,
administration, or use of the drug or device; or
(2) The safety or effectiveness of the drug or device.
630.1170. 1. Notwithstanding the pr ovisions of
chapter 195 or 579 to the contrary, the department of mental
health, in collaboration with a hospital operated by an
institution of higher education in this state or contract
research organizations conducting trials approved by the
United States Food and Drug Administration, shall conduct a
study on the efficacy of using alternative medicine and
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therapies, including, the use of psilocybin, in the
treatment of patients who suffer from posttraumatic stress
disorder, major depressive disor der, or substance abuse
disorders or who require end -of-life care.
2. (1) In conducting this study, the department, in
collaboration with the hospitals or research organizations
described in subsection 1 of this section and subject to
appropriation, shall:
(a) Perform a study on the therapeutic efficacy of
using psilocybin in the treatment of patients who suffer
from posttraumatic stress disorder, major depressive
disorder, or substance use disorders or who require end -of-
life care; and
(b) Review current literature regarding:
a. The safety and efficacy of psilocybin in the
treatment of patients who suffer from posttraumatic stress
disorder, major depressive disorder, or substance use
disorders or who require end -of-life care; and
b. The access that patients have to psilocybin for
such treatment.
(2) The department shall prepare and submit to the
governor, lieutenant governor, and the general assembly the
following:
(a) Quarterly reports on the progress of the study; and
(b) A written report, submitted one year following the
commencement of the study, which shall:
a. Contain the results of the study and any
recommendations for legislative or regulatory action; and
b. Highlight those clinical practices that appear to
be most successful as well as any safety or health concerns.
3. The department shall maintain the confidentiality
of any personally identifiable protected information
collected during the study described in this se ction.
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4. Notwithstanding any other provision of law to the
contrary, the department, any health care providers, and any
other person involved in the study described in this section
shall not be subject to criminal or civil liability or
sanction under the laws of this state for participating in
the study, except in cases of gross negligence or willful
misconduct. No health care provider shall be subject to
discipline against his or her professional license for
participation in the study.
5. Notwithstanding any other provision of law to the
contrary, a physician shall not be subject to criminal or
civil liability or sanction under the laws of this state for
referring a patient to the study described in this section,
and no state agency or regulatory board shall revoke, fail
to renew, or take any other action against a physician's
license issued under chapter 334 based solely on the
physician's referral of a patient to the study described in
this section.