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SECOND REGULAR SESSION
HOUSE BILL NO. 2643
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE STINNETT .
6148H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o amend chapter 191, RSMo, by adding thereto seven new sections relating to access to
individualized investigational treatment.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto seven new sections, to
2 be known as sections 191.455, 191.457, 191.459, 191.461, 191.463, 191.465, and 191.467, to
3 read as follows:
191.455. 1. Sections 191.455 to 191.467 shall be known and may be cited as the
2 "Hope for Missouri Patients Act".
3 2. As used in sections 191.455 to 191.467, unless the context otherwise requ ires ,
4 the following terms mean:
5 (1) "Eligible facility", an institution that is operating under a Federalwide
6 Assurance (FW A) for the Pr otection of Human Subjects under 42 U.S.C. Section 289(a)
7 and 45 CFR Part 46 and that is subject to the FW A laws, regula tions, policies, and
8 guidelines, including renew als or updates;
9 (2) "Eligible patient", an individual who meets the following conditions:
10 (a) Has consider ed all other trea tment options curr ently appr oved by the United
11 States Food and Drug Administration;
12 (b) Has r eceived a r ecommendation fr om his or her physician for an
13 individualized investigational trea tment based on analysis of the patient's genomic
14 sequence; human chr omosomes; deoxyribonucleic acid; ribonucleic acid; genes; gene
15 pr oducts, such as enzymes and other types of protein s; or metabolites;
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.
16 (c) Has a life-thr eatening or sever ely debilitating illness, or a serious disease or
17 condition associated with morbidity that has a substantial impact on day-to-day
18 functioning, as attested to by the patient's tr eating physician;
19 (d) Has given written, informed consent for the use of the individualized
20 investigational drug, biological pr oduct, or device; and
21 (e) Has documentation fr om his or her physician that he or she meets the
22 r equir ements of paragraphs (a) to (d) of this subdivision;
23 (3) "Individualized investigational drug, biological pr oduct, or device", any
24 drug, biological pr oduct, or device that is unique to and pr oduced exclusively for use for
25 an individual patient based on the patient's own genetic pro file. The term
2 6 "individualized investigational drug, biological pr oduct, or device":
27 (a) Shall include, but not be limited to, individualized gene therapy antisense
28 oligonucleotides and individualized neoantigen vaccines; and
29 (b) Shall not include any drug, biological pro duct, or device derived fro m human
30 primary or secondary embryonic stem cells or cell lines, or tissues or cells derived fr om
31 abortion, but shall include any drug, biological product, or device derived fr om human
32 perinatal tissues, cells, and secr eted factors not obtained fr om an abortion;
33 (4) "Individualized investigational trea tment", tr eatment with an individualized
34 investigational drug, biological pr oduct, or device;
35 (5) "Life-threatenin g or sever ely debilitating illness", any disease or condition
36 that is life-threatenin g or sever ely debilitating, as such terms ar e defined in 21 CFR
37 312.81 or any successor law or r egulation, as applicable;
38 (6) "W ritten, informed consent", a written document that:
39 (a) Is signed by the patient or , if the patient is a minor , signed by any person
40 authorized to consent under section 431.061;
41 (b) Is attested to by the patient's physician and a witness; and
42 (c) At a minimum, includes all of the following:
43 a. An explanation of the curren tly appr oved pro ducts and tr eatments for the
44 illness, disease, or condition fr om which the patient suffers;
45 b. An attestation that the patient concurs with his or her physician in believing
46 that all curr ently appr oved and conventionally recogn ized trea tments are unlikely to
47 pr olong the patient's life;
48 c. Clear identification of the specific pr oposed individualized investigational
49 drug, biological pr oduct, or device that the patient is seeking to use;
50 d. A description of the potentially best and worst outcomes of using the
51 individualized investigational drug, biological pr oduct, or device and a r ealistic
52 description of the most likely outcome. The description shall include the possibility
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53 that new , unanticipated, differe nt, or worse symptoms might result and that death could
54 be hastened by the prop osed tr eatment. The description shall be based on the
55 physician's knowledge of the pr oposed tr eatment in conjunction with an awar eness of
56 the patient's condition;
57 e. A statement that the patient's health plan or third-party administrator and
58 pr ovider ar e not obligated to pay for any car e or trea tments consequent to the use of the
59 individualized investigational drug, biological prod uct, or device unless they are
60 specifically requ ired to do so by law or contract;
61 f. A statement that the patient's eligibility for hospice car e may be withdrawn if
62 the patient begins curative tr eatment with the individualized investigational drug,
63 biological pr oduct, or device and that care may be re instated if this tr eatment ends and
64 the patient meets hospice eligibility requi rem ents; and
65 g. A statement that the patient understands that he or she is liable for all
66 expenses consequent to the use of the individualized investigational drug, biological
67 pr oduct, or device and that this liability extends to the patient's estate unless a contract
68 between the patient and the manufactur er of the individualized investigational drug,
69 biological prod uct, or device states otherwise.
191.457. 1. A manufactur er operating within an eligible facility and in
2 accordance with all applicable Federalwide Assurance laws and r egulations may make
3 available an individualized investigational drug, biological pr oduct, or device and an
4 eligible patient may req uest an individualized investigational drug, biological pr oduct,
5 or device fr om an eligible facility or manufactur er operating within an eligible facility
6 under sections 191.455 to 191.467. Sections 191.455 to 191.467 shall not req uire that a
7 manufactur er make available an individualized investigational drug, biological pr oduct,
8 or device to an eligible patient.
9 2. An eligible facility or manufactur er operating within an eligible facility may
10 do all of the following:
11 (1) Pr ovide an individualized investigational drug, biological pro duct, or device
12 to an eligible patient without r eceiving compensation; and
13 (2) Requir e an eligible patient to pay the costs of, or the costs associated with, the
14 manufactur e of the individualized investigational drug, biological pro duct, or device.
191.459. 1. Sections 191.455 to 191.467 shall not expand the coverage req uire d of
2 an insur er under chapter 376.
3 2. A health plan, third-party administrator , or governmental agency may , but is
4 not req uire d to, pro vide coverage for the cost of an individualized investigational drug,
5 biological pr oduct, or device or the cost of services rela ted to the use of an individualized
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6 investigational drug, biological pro duct, or device in accordance with sections 191.455 to
7 191.467.
8 3. Sections 191.455 to 191.467 shall not requi re any governmental agency to pay
9 costs associated with the use of or car e or tr eatment of a patient with an individualized
10 investigational drug, biological pr oduct, or device.
11 4. Sections 191.455 to 191.467 shall not req uire a hospital or facility licensed by
12 the department of health and senior services to pr ovide new or additional services unless
13 appr oved by the hospital or facility .
191.461. If a patient's death is pr oximately caused by tr eatment with an
2 individualized investigational drug, biological pr oduct, or device, the patient's estate,
3 heirs, or devisees shall not be liable for any debt r emaining after payment by insurance
4 for charges directly incurr ed for such tr eatment. However , this section shall not provi de
5 an exemption to liability for charges for nonexperimental tr eatments prov ided to the
6 patient, including nonexperimental tr eatments ren der ed to the patient due to
7 complications or consequences of the experimental tr eatment.
191.463. 1. A licensing board or disciplinary subcommittee shall not rev oke, fail
2 to ren ew , suspend, or take any action against a health car e pro vider's license based
3 solely on the health car e prov ider's reco mmendations to an eligible patient r egarding
4 access to or tr eatment with an individualized investigational drug, biological prod uct, or
5 device.
6 2. An entity res ponsible for Medicare certification shall not take action against a
7 health care pr ovider's Medicare certification based solely on the health car e prov ider's
8 r ecommendation that a patient have access to an individualized investigational drug,
9 biological prod uct, or device.
191.465. 1. An official, employee, or agent of this state shall not block or attempt
2 to block an eligible patient's access to an individualized investigational drug, biological
3 pr oduct, or device.
4 2. Counseling, advice, or a reco mmendation consistent with medical standards of
5 car e fr om a licensed health car e pr ovider shall not be a violation of this section.
191.467. 1. Sections 191.455 to 191.467 shall not cre ate a private cause of action
2 against a manufactur er of an individualized investigational drug, biological pr oduct, or
3 device or against any other person or entity involved in the care of an eligible patient
4 using the individualized investigational drug, biological prod uct, or device for any harm
5 done to the eligible patient res ulting fr om the individualized investigational drug,
6 biological prod uct, or device if the manufactur er or other person or entity has complied
7 in good faith with the terms of sections 191.455 to 191.467 and has exer cised reas onable
8 car e.
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9 2. Sections 191.455 to 191.467 shall not affect any health care coverage r equir ed
10 under section 376.429 for costs incurr ed due to participation in clinical trials.
✔
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