Florida Senate - 2018 SB 1404
By Senator Simmons
9-00848A-18 20181404__
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; requiring the
20 Department of Health to use specified criteria in
21 reviewing and approving reimbursement programs;
22 requiring the department to adopt rules; providing an
23 effective date.
24
25 Be It Enacted by the Legislature of the State of Florida:
26
27 Section 1. Section 385.2021, Florida Statutes, is created
28 to read:
29 385.2021 Cancer clinical trials; communication with
30 prospective patients; offers to reimburse.—
31 (1) LEGISLATIVE FINDINGS AND INTENT.—The Legislature finds
32 that:
33 (a) The ability to translate medical findings from research
34 to practice relies on having robust and diverse patient
35 participation in cancer clinical trials. Low participation rates
36 or homogenous participant groups prevent segments of the
37 population from benefiting from advances achieved through
38 clinical research and create uncertainties over the
39 applicability of research findings. Diverse patient
40 participation in cancer clinical trials depends on the ability
41 of prospective participants to afford ancillary costs during
42 their course of participation, a financial challenge that
43 prevents the benefits of clinical research from being equitably
44 accessible by eligible prospective participants.
45 (b) Cancer clinical trials do not cover all of the costs of
46 participants, and there are often significant uncovered expenses
47 associated with enrollment in a clinical trial. These costs may
48 include travel expenses to and from clinical sites, such as
49 parking fees, car rentals, fuel, tolls, or lodging, and the
50 expenses incurred by the patient subject’s family, friends, or
51 chaperones who attend cancer clinical trial treatments as
52 caregivers to provide emotional, physical, and mental support to
53 the patient subject.
54 (c) The federal Food and Drug Administration has confirmed
55 that reimbursement of direct patient-incurred expenses is a
56 means to create equal access among potential clinical trial
57 subjects and is not considered an inducement. Despite the
58 federal Food and Drug Administration’s issuance of guidance to
59 clarify what constitutes an inducement, a fear of unknowingly
60 violating federal prohibitions against inducements has
61 unintentionally hindered the involvement in and expansion of
62 cancer clinical trials. Corporations, individuals, public and
63 private foundations, health care providers, and other
64 stakeholders remain hesitant to contribute to or accept funds
65 from programs that are organized to alleviate the financial
66 burdens of patients who wish to participate in clinical trials
67 and their caregivers.
68 (d) It is the intent of the Legislature to enact
69 legislation to distinguish between what may be considered an
70 inducement for a patient to participate and the reimbursement of
71 actual expenses associated with participation in a cancer
72 clinical trial.
73 (2) DEFINITIONS.—As used in this section, the term:
74 (a) “Cancer clinical trial” means a research study that
75 tests new cancer treatments on persons. Treatments tested may
76 include medications, chemotherapies, stem cell therapies, and
77 similar treatments.
78 (b) “Inducement” means paying money to a person in exchange
79 for his or her participation in a cancer clinical trial.
80 (c) “Patient subject” means a person participating in a
81 cancer clinical trial.
82 (3) COMMUNICATION WITH PROSPECTIVE PATIENTS; OFFERS TO
83 REIMBURSE.—
84 (a) Cancer clinical trial programs shall inform prospective
85 patient subjects before their involvement in a cancer clinical
86 trial that:
87 1. Reimbursement for travel and ancillary costs is
88 available to all patient subjects based on financial need;
89 2. Reimbursement for travel and ancillary costs is offered
90 to eliminate the financial barriers to participation and to help
91 retain patient subjects in clinical trials; and
92 3. Family, friends, or chaperones who attend the cancer
93 clinical trial treatments as caregivers to support the patient
94 subject are eligible for reimbursement for their travel and
95 ancillary expenses.
96 (b) The offer to reimburse travel and ancillary expenses
97 may not be coercive or exert an undue influence on a patient
98 subject or a potential patient subject and, in the absence of
99 such coercion or exertion of undue influence, is not considered
100 an inducement for participation in a cancer clinical trial.
101 (4) REIMBURSEMENT PROGRAMS.—
102 (a) Subject to applicable federal laws and this section,
103 corporations, individuals, public and private foundations,
104 health care providers, and other stakeholders may offer
105 financial support to cover ancillary costs through their support
106 of reimbursement programs offered by third-party nonprofit
107 corporations and public charities to increase the enrollment and
108 retention of minority patient subjects in cancer clinical
109 trials.
110 (b) A third-party nonprofit corporation or public charity
111 that offers a reimbursement program under this subsection shall
112 implement a process for securing the informed consent of patient
113 subjects. A patient subject must be informed of financial
114 eligibility guidelines and the reimbursement process. A patient
115 subject may not begin his or her participation in a cancer
116 clinical trial in the absence of a declaration of such informed
117 consent.
118 (c) The Department of Health shall review reimbursement
119 programs offered by third-party nonprofit corporations and
120 public charities to cover ancillary costs and travel expenses of
121 patient subjects and their caregivers. If the department
122 determines that patient subjects are fairly recruited and
123 adequately informed in a manner that is consistent with federal
124 regulations and guidance and that ancillary costs and travel
125 expenses are appropriate, it must approve such programs.
126 (5) RULEMAKING.—The department shall adopt rules to
127 administer this section.
128 Section 2. This act shall take effect July 1, 2018.