HOUSE BILL NO. 2922 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE MYERS.
6591H.01I JOSEPH ENGLER, Chief Clerk
AN ACT To 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Section A. Section 191.480, RSMo, is repealed and one new section enacted in lieu 2 thereof, to be known as section 191.480, to read as follows: 191.480. 1.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-threatening condition or illness, or a 4 severely 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 threatening condition or illness, or severely debilitating condition or illness, that has
EXPLANATION — 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. HB 2922 2
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-threatening condition or illness", a disease or condition: 22 (a) Where the likelihood of death is high unless the course of the disease or 23 condition is interrupted; and 24 (b) With potentially fatal outcomes, where the end point of clinical trial analysis 25 is survival; 26 (4) "Severely debilitating condition or illness", a disease or condition that causes 27 major irreversible morbidity; 28 (5) "Terminal 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 affect other provisions or applications of this section that can HB 2922 3
54 be given effect 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 efficacy or toxicity, the drug shall not be 57 offered. 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-threatening 63 condition or illness, or a severely 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 effectiveness of the drug or device. ✔
Statutes affected: