Florida Senate - 2017 SB 1250
By Senator Simmons
9-00520-17 20171250__
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; providing definitions; requiring cancer
5 clinical trial programs to inform potential
6 participants of the specified reimbursements for
7 ancillary costs and travel expenses which may be
8 available to them if they participate in a cancer
9 clinical trial; authorizing corporations, individuals,
10 public and private foundations, health care providers,
11 and other stakeholders to offer financial assistance
12 to support approved reimbursements of ancillary costs
13 and travel expenses for participants in a cancer
14 clinical trial; requiring the Department of Health to
15 use specified criteria in reviewing and approving
16 ancillary costs and travel expense reimbursements;
17 authorizing the department to adopt rules; providing
18 an effective date.
19
20 Be It Enacted by the Legislature of the State of Florida:
21
22 Section 1. Section 385.2021, Florida Statutes, is created
23 to read:
24 385.2021 Legislative intent.—
25 (1) FINDINGS AND PURPOSE.—The Legislature finds and
26 declares the following:
27 (a) The ability to translate medical findings from research
28 to practice relies on having robust and diverse patient
29 participation in cancer clinical trials. A low participation
30 rate or a homogenous participant group prevents segments of the
31 population from benefiting from advances achieved through
32 clinical research and creates uncertainties over the
33 applicability of research findings. Diverse patient
34 participation in cancer clinical trials depends on the ability
35 of potential participants to afford ancillary costs during their
36 course of participation, which prevents the benefits of clinical
37 research from being equitably accessible among eligible
38 potential participants.
39 (b) Cancer clinical trials do not cover all of the costs of
40 participants, and there are often significant uncovered expenses
41 associated with enrollment in a clinical trial. These expenses
42 may include travel expenses to and from clinical sites, such as
43 parking fees, car rental, gas, tolls, or lodging; fees for child
44 care; and the expenses of the patient’s family, friends, or
45 chaperones who attend cancer clinical trial treatments to
46 provide emotional, physical, and mental support to the
47 participant.
48 (c) Some corporations, individuals, public and private
49 foundations, health care providers, and other stakeholders are
50 hesitant to contribute to or accept funds from programs that are
51 organized to alleviate the financial burdens of patients who
52 wish to participate in clinical trials and their caregivers.
53 Federal regulations prohibiting inducements have unintentionally
54 hindered the involvement and expansion of cancer clinical
55 trials.
56 (d) It is the intent of the Legislature to enact
57 legislation to distinguish between what may be considered an
58 inducement for a patient to participate and the reimbursement of
59 actual expenses associated with participation in a cancer
60 clinical trial.
61 (2) DEFINITIONS.—As used in this section, the term:
62 (a) “Cancer clinical trials” means research studies that
63 test new cancer treatments on persons. Testing may include
64 medications, chemotherapies, stem cell therapies, and similar
65 treatments.
66 (b) “Inducement” means paying money to a person in exchange
67 for his or her participation in a cancer clinical trial.
68 (c) “Patient subject” means a person participating in a
69 cancer clinical trial.
70 (3) COMMUNICATION WITH PATIENTS; OFFERS TO REIMBURSE.—
71 (a) Cancer clinical trial programs shall inform potential
72 participants before their involvement in a cancer clinical trial
73 that:
74 1. Reimbursement for travel and ancillary costs is
75 available to all enrollees based on financial need;
76 2. Coverage of the travel and ancillary costs is offered to
77 eliminate the financial barriers of enrollment in order to
78 retain participants in clinical trials; and
79 3. Family, friends, or chaperones that attend the cancer
80 clinical trial treatments to support the patient subject are
81 eligible for reimbursement for their travel and ancillary
82 expenses.
83 (b) The offer to reimburse travel and ancillary expenses
84 may not be coercive or exert an undue influence on a patient
85 subject and, in the absence of such coercion or exertion of
86 undue influence, is not considered an inducement for
87 participation in a cancer clinical trial.
88 (4) REIMBURSEMENT PROGRAMS.—
89 (a) Subject to applicable federal laws and this section,
90 corporations, individuals, public and private foundations,
91 health care providers, and other stakeholders may offer
92 financial support to cover ancillary costs through their support
93 of reimbursement programs offered by third-party nonprofit
94 corporations and public charities to increase enrollment,
95 retention, and minority participation in cancer clinical trials.
96 (b) A third-party nonprofit corporation or public charity
97 that offers a reimbursement program under this subsection shall
98 implement a process for securing the informed consent of
99 participating patient subjects. A patient subject must be
100 informed of financial eligibility guidelines and the
101 reimbursement process. A patient subject may not begin his or
102 her participation in a cancer clinical trial in the absence of a
103 demonstration of such informed consent.
104 (c) The Department of Health shall review reimbursement
105 programs offered by such nonprofit corporations and public
106 charities to cover ancillary costs and travel expenses. If the
107 department determines that patient subjects are fairly recruited
108 and adequately informed and that ancillary costs and travel
109 expenses are appropriate, it shall approve such programs.
110 (6) The department shall adopt rules to administer this
111 section.
112 Section 2. This act shall take effect July 1, 2017.