Bill Text: FL S0840 | 2020 | Regular Session | Introduced
Bill Title: Cancer Clinical Trials
Spectrum: Partisan Bill (Republican 1-0)
Status: (Failed) 2020-03-14 - Died in Health Policy [S0840 Detail]
Download: Florida-2020-S0840-Introduced.html
Florida Senate - 2020 SB 840
By Senator Simmons
9-00940-20 2020840__
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 specified reimbursements for ancillary and travel
7 expenses which may be available to them and their
8 caregivers if they participate in a cancer clinical
9 trial; specifying that reimbursement offers may not be
10 coercive or exert an undue influence and are not
11 considered inducements for participation; authorizing
12 corporations, individuals, public and private
13 foundations, health care providers, and other
14 stakeholders to offer financial assistance to support
15 approved reimbursements of ancillary 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; requiring that a
20 patient subject be informed of financial eligibility
21 guidelines and the reimbursement process; providing
22 that participation in a cancer clinical trial may not
23 begin without such informed consent; requiring the
24 Department of Health to review certain reimbursement
25 programs; requiring the department to approve programs
26 that meet certain criteria; requiring the department
27 to adopt rules; providing an effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31 Section 1. Section 385.2021, Florida Statutes, is created
32 to read:
33 385.2021 Cancer clinical trials; communication with
34 prospective patients; offers to reimburse.—
35 (1) LEGISLATIVE FINDINGS AND INTENT.—
36 (a) The Legislature finds that:
37 1. The ability to translate medical findings from research
38 to practice relies on having robust and diverse patient
39 participation in cancer clinical trials. Low participation rates
40 or homogenous participant groups prevent segments of the
41 population from benefiting from advances achieved through
42 clinical research and create uncertainties regarding the
43 applicability of research findings. Diverse patient
44 participation in cancer clinical trials depends on the ability
45 of prospective participants to afford ancillary expenses during
46 the course of participation, a financial challenge that prevents
47 the benefits of clinical research from being equitably
48 accessible by eligible prospective participants.
49 2. Cancer clinical trials do not cover all of participants’
50 expenses, and there are often significant uncovered expenses
51 associated with enrollment in a clinical trial. These expenses
52 may include travel expenses to and from clinical sites, such as
53 parking fees, car rentals, fuel, tolls, or lodging, and the
54 expenses incurred by the patient subject’s family, friends, or
55 individuals who attend cancer clinical trial treatments as
56 caregivers to provide emotional, physical, and mental support to
57 the patient subject.
58 3. The United States Food and Drug Administration has
59 confirmed that reimbursement of direct patient-incurred expenses
60 is a means to create equal access among potential clinical trial
61 subjects and is not considered an inducement. Despite the United
62 States Food and Drug Administration’s guidance issued to clarify
63 what constitutes an inducement, a fear of unknowingly violating
64 federal prohibitions against inducements has unintentionally
65 hindered the participation in and expansion of cancer clinical
66 trials. Corporations, individuals, public and private
67 foundations, health care providers, and other stakeholders
68 remain hesitant to contribute to or accept funds from programs
69 that are established to alleviate the financial burdens of
70 patients who wish to participate in clinical trials and their
71 caregivers.
72 (b) It is the intent of the Legislature to:
73 1. Enact legislation to distinguish between what may be
74 considered an inducement for a patient to participate and the
75 reimbursement of actual expenses associated with participation
76 in a cancer clinical trial.
77 2. Increase enrollment and retention of minority patient
78 subjects in cancer clinical trials.
79 (2) DEFINITIONS.—As used in this section, the term:
80 (a) “Cancer clinical trial” means a research study that
81 tests new cancer treatments on individuals. Treatments tested
82 may include medications, chemotherapies, stem cell therapies,
83 and similar treatments.
84 (b) “Inducement” means paying money to an individual in
85 exchange for his or her participation in a cancer clinical
86 trial.
87 (c) “Patient subject” means an individual participating in
88 a cancer clinical trial.
89 (3) COMMUNICATION WITH PROSPECTIVE PATIENTS; OFFERS TO
90 REIMBURSE.—
91 (a) Cancer clinical trial programs shall inform prospective
92 patient subjects before their participation in a cancer clinical
93 trial that:
94 1. Reimbursement for travel and ancillary expenses is
95 available to all patient subjects based on financial need;
96 2. Reimbursement for travel and ancillary expenses is
97 offered to eliminate the financial barriers to participation and
98 to help retain patient subjects in clinical trials; and
99 3. Family, friends, or individuals who attend cancer
100 clinical trial treatments as caregivers to support the patient
101 subject are eligible for reimbursement for travel and ancillary
102 expenses.
103 (b) The offer to reimburse travel and ancillary expenses
104 may not be coercive or exert an undue influence on a patient
105 subject or a potential patient subject and, in the absence of
106 such coercion or exertion of undue influence, is not considered
107 an inducement for participation in a cancer clinical trial.
108 (4) REIMBURSEMENT PROGRAMS.—
109 (a) Subject to applicable federal laws and this section,
110 corporations, individuals, public and private foundations,
111 health care providers, and other stakeholders may offer
112 financial support to cover ancillary expenses through their
113 support of reimbursement programs offered by third-party
114 nonprofit corporations and public charities to increase the
115 enrollment and retention of minority patient subjects in cancer
116 clinical trials.
117 (b) A third-party nonprofit corporation or public charity
118 that offers a reimbursement program under this subsection shall
119 implement a process for securing the informed consent of patient
120 subjects. A patient subject must be informed of financial
121 eligibility guidelines and the reimbursement process. A patient
122 subject may not begin his or her participation in a cancer
123 clinical trial in the absence of a declaration of such informed
124 consent.
125 (c) The Department of Health shall review reimbursement
126 programs offered by third-party nonprofit corporations and
127 public charities to cover ancillary and travel expenses of
128 patient subjects and their caregivers. If the department
129 determines that patient subjects are fairly recruited and
130 adequately informed in a manner that is consistent with federal
131 regulations and guidance and that ancillary and travel expenses
132 are appropriate, it must approve such programs.
133 (5) RULEMAKING.—The department shall adopt rules to
134 administer this section.
135 Section 2. This act shall take effect July 1, 2020.
