Read the full stored bill text
SECOND REGULAR SESSION
HOUSE BILL NO. 2922
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE MYERS.
6591H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o repeal section 191.480, RSMo, and to enact in lieu thereof one new section 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Section A. Section 191.480, RSMo, is repealed and one new section enacted in lieu
2 thereof, to be known as section 191.480, to read as follows:
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
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 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) Wher e 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:
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. This section does not require a health care insurer to provide coverage for the cost
41 of any investigational drug, biological product, or device. A health care insurer may provide
42 coverage for an investigational drug, biological product, or device.
43 4. This section does not require the department of corrections to provide coverage for
44 the cost of any investigational drug, biological product, or device.
45 5. Notwithstanding any other provision of law to the contrary , no state agency or
46 regulatory board shall revoke, fail to renew , or take any other action against a physician's
47 license issued under chapter 334 based solely on the physician's recommendation to an
48 eligible patient regarding prescription for or treatment with an investigational drug, biological
49 product, or device. Action against a health care provider's Medicare certification based solely
50 on the health care provider's recommendation that a patient have access to an investigational
51 drug, biological product, or device is prohibited.
52 6. If a provision of this section or its application to any person or circumstance is held
53 invalid, the invalidity does not af fect other provisions or applications of this section that can
HB 2922 2
54 be given ef fect without the invalid provision or application, and to this end the provisions of
55 this section are severable.
56 7. If the clinical trial is closed due to lack of ef ficacy or toxicity , the drug shall not be
57 of fered. If notice is given on a drug, product, or device taken by a patient outside of a clinical
58 trial, the pharmaceutical company or patient's physician shall notify the patient of the
59 information from the safety committee of the clinical trial.
60 8. Except in the case of gross negligence or willful misconduct, any person who
61 manufactures, imports, distributes, prescribes, dispenses, or administers an investigational
62 drug or device to an eligible patient with a terminal condition or illness, a life-threateni ng
63 condition or illness, or a sever ely debilitating condition or illness in accordance with this
64 section shall not be liable in any action under state law for any loss, damage, or injury arising
65 out of, relating to, or resulting from:
66 (1) The design, development, clinical testing and investigation, manufacturing,
67 labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or
68 use of the drug or device; or
69 (2) The safety or ef fectiveness of the drug or device.
✔
HB 2922 3