Read the full stored bill text
SECOND REGULAR SESSION
HOUSE BILL NO. 1643
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE OVERCAST .
4265H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o 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Section A. Section 191.480, RSMo, is repealed and two new sections enacted in lieu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 pre scriber -patient
2 r elationship" means a re lationship 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 curren t
6 medical condition, including an in-person examination of the patient;
7 (2) Has consulted with the patient with res pect to the patient's medical
8 condition; and
9 (3) Is available to pr ovide follow-up car e and tr eatment to the patient.
10 2. Notwithstanding the pr ovisions of chapter 195 or 579 or any other pr ovision of
11 law to the contrary , any person who acquires , uses, pr oduces, 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 ar e met:
15 (1) The person is twenty-one years of age or older;
16 (2) The person r equir es end-of-life care or suffers fr om posttraumatic str ess
17 disorder , major depr essive disorder , a substance use disorder , or any other condition for
EXPLANA TION — 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.
18 which tr eatment with psilocybin has shown efficacy in clinical trials r egistered with the
19 United States Food and Drug Administration;
20 (3) The person pr ovides the department of mental health with:
21 (a) Documentation fr om a physician or certified nurse practitioner with whom
22 the patient has a bona fide prescribe r -patient relat ionship that the person req uires end-
23 of-life care or suffers fr om 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 pr ofessional counselor ,
31 as such pr ofessions 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 r egistere d nurse licensed under chapter 335 including,
35 but not limited to, a psychiatric-mental health nurse practitioner;
36 (c) The addr ess 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 controll ed
40 substances tests the psilocybin the person intends to ingest; and
41 (5) The person limits the use of psilocybin to no mor e than one hundr ed 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 prog ram that is specific to
46 psilocybin and that has been appr oved for continuing education credi t by the American
47 Psychological Association. The curriculum of the training pr ogram req uire d under this
48 subsection shall consist of at least thirty hours of synchr onous learning. Facilitators,
49 excluding those who ar e psychologists, psychiatrists, or psychiatric-mental health nurse
50 practitioners, shall complete ninety minutes of continuing education training on the
51 most curren t version of the Diagnostic and Statistical Manual of Mental Disorders
52 befor e serving as a facilitator for any person and during each relev ant licensur e renew al
53 period.
HB 1643 2
54 (2) An individual shall have training in end-of-life care, posttraumatic str ess
55 disorder , complex posttraumatic stres s disorder , major depr essive 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 tr eat
58 such conditions.
59 4. Notwithstanding the pr ovisions of chapter 195 or 579 or any other pr ovision 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 regi stered by the state to test controll ed
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 pr otected information collected from any persons who prov ide
70 information to the department under this section.
71 6. Notwithstanding any other pro vision of law to the contrary , the department of
72 mental health, any health care or mental health care pr oviders, 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 pro viding car e to a
75 person engaged in acts allowed under subsection 2 of this section, except in cases of
76 gr oss negligence or willful misconduct. No health care pro vider shall be subject to
77 discipline against his or her profession al license for pr oviding car e to a person engaged
78 in acts allowed under subsection 2 of this section.
79 7. Notwithstanding any other pr ovision 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 pr oviding documentation that a person requ ires end-of-
82 life care or suffers fr om a disorder or condition described in subdivision (2) of
83 subsection 2 of this section, and no state agency or regula tory board shall revok e, fail to
84 r enew , 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 pr ovision of
86 documentation that a person requi res end-of-life care or suffers fro m a disorder or
87 condition described in subdivision (2) of subsection 2 of this section.
88 8. Notwithstanding any other pro vision 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 3
90 government employee, or any unauthorized third party the statewide list or any
91 individual information of persons who meet the requ irem ents 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-threa tening condition or illness, or a
4 sever ely 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 thr eatening condition or illness, or sever ely 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-threateni ng 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) W ith potentially fatal outcomes, wher e the end point of clinical trial analysis
25 is survival;
26 (4) "Severel y debilitating condition or illness", a disease or condition that causes
27 major irreversibl e morbidity;
28 (5) "T erminal 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 4
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 manufactur er of any investigational drug, biological prod uct, or device shall
41 r egister with the department of health and senior services. Befor e November 1, 2026,
42 the department of health and senior services shall cr eate a r egistry of such
4 3 manufactur ers that manufactur e any investigational drug, biological pr oduct, 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 af fect other provisions or applications of this section that
59 can be given ef fect 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 ef ficacy or toxicity , the drug shall not
62 be offere d. 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 5
73 (2) The safety or ef fectiveness of the drug or device.
✔
HB 1643 6