Florida Senate - 2019 SB 1602
By Senator Simmons
9-00661-19 20191602__
1 A bill to be entitled
2 An act relating to cancer clinical trials; creating s.
3 385.2021, F.S.; providing legislative findings and
4 intent; defining terms; requiring cancer clinical
5 trial programs to inform prospective patient subjects
6 of the specified reimbursements for ancillary costs
7 and travel expenses which may be available to them and
8 their caregivers if they participate in a cancer
9 clinical trial; specifying that reimbursement offers
10 may not be coercive or exert an undue influence and
11 are not considered inducements for participation;
12 authorizing corporations, individuals, public and
13 private foundations, health care providers, and other
14 stakeholders to offer financial assistance to support
15 approved reimbursements of ancillary costs and travel
16 expenses for patient subjects in a cancer clinical
17 trial and their caregivers; requiring certain entities
18 that offer reimbursement programs to secure the
19 informed consent of patient subjects; prohibiting a
20 patient subject from participating in a cancer
21 clinical trial without submitting a specified
22 statement of consent; requiring the Department of
23 Health to use specified criteria in reviewing and
24 approving reimbursement programs; requiring the
25 department to adopt rules; providing an effective
26 date.
27
28 Be It Enacted by the Legislature of the State of Florida:
29
30 Section 1. Section 385.2021, Florida Statutes, is created
31 to read:
32 385.2021 Cancer clinical trials; communication with
33 prospective patients; offers to reimburse.—
34 (1) LEGISLATIVE FINDINGS AND INTENT.—The Legislature finds
35 that:
36 (a) The ability to translate medical findings from research
37 to practice relies on having robust and diverse patient
38 participation in cancer clinical trials. Low participation rates
39 or homogeneous participant groups prevent segments of the
40 population from benefiting from advances achieved through
41 clinical research and create uncertainties over the
42 applicability of research findings. Diverse patient
43 participation in cancer clinical trials depends on the ability
44 of prospective participants to afford ancillary costs during
45 their course of participation, a financial challenge that
46 prevents the benefits of clinical research from being equitably
47 accessible by eligible prospective participants.
48 (b) Cancer clinical trials do not cover all of
49 participants’ costs, and there are often significant uncovered
50 expenses associated with enrollment in a clinical trial. These
51 costs may include travel expenses to and from clinical sites,
52 such as parking fees, car rentals, fuel, tolls, or lodging, and
53 the expenses incurred by the patient subject’s family, friends,
54 or chaperones who attend cancer clinical trial treatments as
55 caregivers to provide emotional, physical, and mental support to
56 the patient subject.
57 (c) The United States Food and Drug Administration has
58 confirmed that reimbursement of direct patient-incurred expenses
59 is a means to create equal access among prospective clinical
60 trial patient subjects and is not considered an inducement.
61 Despite the United States Food and Drug Administration’s
62 issuance of guidance to clarify what constitutes an inducement,
63 a fear of unknowingly violating federal prohibitions against
64 inducements has unintentionally hindered the involvement in and
65 expansion of cancer clinical trials. Corporations, individuals,
66 public and private foundations, health care providers, and other
67 stakeholders remain hesitant to contribute to or accept funds
68 from programs that are organized to alleviate the financial
69 burdens of patients who wish to participate in clinical trials
70 and their caregivers.
71 (d) It is the intent of the Legislature to enact
72 legislation to distinguish between what may be considered an
73 inducement for a patient to participate and the reimbursement of
74 actual expenses associated with participation in a cancer
75 clinical trial.
76 (2) DEFINITIONS.—As used in this section, the term:
77 (a) “Cancer clinical trial” means a research study that
78 tests new cancer treatments on persons. Treatments tested may
79 include medications, chemotherapies, stem cell therapies, and
80 similar treatments.
81 (b) “Inducement” means the payment of money to a person in
82 exchange for his or her participation in a cancer clinical
83 trial.
84 (c) “Patient subject” means a person participating in a
85 cancer clinical trial.
86 (3) COMMUNICATION WITH PROSPECTIVE PATIENTS; OFFERS TO
87 REIMBURSE.—
88 (a) Cancer clinical trial programs shall inform prospective
89 patient subjects before their involvement in a cancer clinical
90 trial that:
91 1. Reimbursement for travel and ancillary costs is
92 available to all patient subjects based on financial need;
93 2. Reimbursement for travel and ancillary costs is offered
94 to eliminate the financial barriers to participation and to help
95 retain patient subjects in clinical trials; and
96 3. Family, friends, or chaperones who attend the cancer
97 clinical trial treatments as caregivers to support the patient
98 subject are eligible for reimbursement for their travel and
99 ancillary expenses.
100 (b) The offer to reimburse travel and ancillary expenses
101 may not be coercive or exert an undue influence on a patient
102 subject or a potential patient subject and, in the absence of
103 such coercion or exertion of undue influence, is not considered
104 an inducement for participation in a cancer clinical trial.
105 (4) REIMBURSEMENT PROGRAMS.—
106 (a) Subject to applicable federal laws and this section,
107 corporations, individuals, public and private foundations,
108 health care providers, and other stakeholders may offer
109 financial support to cover travel and ancillary costs through
110 their support of reimbursement programs offered by third-party
111 nonprofit corporations and public charities to increase the
112 enrollment and retention of minority patient subjects in cancer
113 clinical trials.
114 (b) A third-party nonprofit corporation or a public charity
115 that offers a reimbursement program under this subsection shall
116 implement a process for securing the informed consent of patient
117 subjects. A patient subject may not begin participating in a
118 cancer clinical trial without first submitting a signed
119 statement that he or she has been informed of financial
120 eligibility guidelines and the reimbursement process and
121 consents to participating in the cancer clinical trial.
122 (c) The Department of Health shall review reimbursement
123 programs offered by third-party nonprofit corporations and
124 public charities to cover ancillary costs and travel expenses of
125 patient subjects and their caregivers. If the department
126 determines that patient subjects are fairly recruited and
127 adequately informed in a manner that is consistent with federal
128 regulations and guidance and that ancillary costs and travel
129 expenses are appropriate, it must approve such programs.
130 (5) RULEMAKING.—The department shall adopt rules to
131 administer this section.
132 Section 2. This act shall take effect July 1, 2019.