Senate Bill 840 (2020) — Cancer clinical trials
SB 840
Florida Bills
Florida Senate - 2020 SB 840 By Senator Simmons 9-00940-20 2020840__ Page 1 of 5 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1
An act relating to cancer clinical trials; creating s. 2 385.2021, F.S.; providing legislative findings and 3 intent; defining terms; requiring cancer clinical 4 trial programs to inform prospective patient subjects 5 of specified reimbursements for ancillary and travel 6 expenses which may be available to them and their 7 caregivers if they participate in a cancer clinical 8 trial; specifying that reimbursement offers may not be 9 coercive or exert an undue influence and are not 10 considered inducements for participation; authorizing 11 corporations, individuals, public and private 12 foundations, health care providers, and other 13 stakeholders to offer financial assistance to support 14 approved reimbursements of ancillary and travel 15 expenses for patient subjects in a cancer clinical 16 trial and their caregivers; requiring certain entities 17 that offer reimbursement programs to secure the 18 informed consent of patient subjects; requiring that a 19 patient subject be informed of financial eligibility 20 guidelines and the reimbursement process; providing 21 that participation in a cancer clinical trial may not 22 begin without such informed consent; requiring the 23 Department of Health to review certain reimbursement 24 programs; requiring the department to approve programs 25 that meet certain criteria; requiring the department 26 to adopt rules; providing an effective date. 27 28 Be It Enacted by the Legislature of the State of Florida: 29
Florida Senate - 2020 SB 840 9-00940-20 2020840__ Page 2 of 5 CODING: Words stricken are deletions; words underlined are additions. 30
Section
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.— 35 (
a) The Legislature finds that: 36 1. 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 homogenous participant groups prevent segments of the 40 population from benefiting from advances achieved through 41 clinical research and create uncertainties regarding 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 expenses during 45 the course of participation, a financial challenge that prevents 46 the benefits of clinical research from being equitably 47 accessible by eligible prospective participants. 48 2. Cancer clinical trials do not cover all of participants’ 49 expenses, and there are often significant uncovered expenses 50 associated with enrollment in a clinical trial.
These expenses 51 may include travel expenses to and from clinical sites, such as 52 parking fees, car rentals, fuel, tolls, or lodging, and the 53 expenses incurred by the patient subject’s family, friends, or 54 individuals who attend cancer clinical trial treatments as 55 caregivers to provide emotional, physical, and mental support to 56 the patient subject. 57 3. The United States Food and Drug Administration has 58
Florida Senate - 2020 SB 840 9-00940-20 2020840__ Page 3 of 5 CODING: Words stricken are deletions; words underlined are additions. confirmed that reimbursement of direct patient-incurred expenses 59 is a means to create equal access among potential clinical trial 60 subjects and is not considered an inducement. Despite the United 61 States Food and Drug Administration’s guidance issued to clarify 62 what constitutes an inducement, a fear of unknowingly violating 63 federal prohibitions against inducements has unintentionally 64 hindered the participation in and expansion of cancer clinical 65 trials.
Corporations, individuals, public and private 66 foundations, health care providers, and other stakeholders 67 remain hesitant to contribute to or accept funds from programs 68 that are established to alleviate the financial burdens of 69 patients who wish to participate in clinical trials and their 70 caregivers. 71 (
b) It is the intent of the Legislature to: 72 1. Enact legislation to distinguish between what may be 73 considered an inducement for a patient to participate and the 74 reimbursement of actual expenses associated with participation 75 in a cancer clinical trial. 76 2. Increase enrollment and retention of minority patient 77 subjects in cancer clinical trials. 78
(2) DEFINITIONS.—As used in this section, the term: 79 (a) “Cancer clinical trial” means a research study that 80 tests new cancer treatments on individuals. Treatments tested 81 may include medications, chemotherapies, stem cell therapies, 82 and similar treatments. 83 (b) “Inducement” means paying money to an individual in 84 exchange for his or her participation in a cancer clinical 85 trial. 86 (c) “Patient subject” means an individual participating in 87
Florida Senate - 2020 SB 840 9-00940-20 2020840__ Page 4 of 5 CODING: Words stricken are deletions; words underlined are additions. a cancer clinical trial. 88
(3) COMMUNICATION WITH PROSPECTIVE PATIENTS; OFFERS TO 89 REIMBURSE.— 90 (
a) Cancer clinical trial programs shall inform prospective 91 patient subjects before their participation in a cancer clinical 92 trial that: 93 1. Reimbursement for travel and ancillary expenses is 94 available to all patient subjects based on financial need; 95 2. Reimbursement for travel and ancillary expenses is 96 offered to eliminate the financial barriers to participation and 97 to help retain patient subjects in clinical trials; and 98 3. Family, friends, or individuals who attend cancer 99 clinical trial treatments as caregivers to support the patient 100 subject are eligible for reimbursement for travel and ancillary 101 expenses. 102 (
b) The offer to reimburse travel and ancillary expenses 103 may not be coercive or exert an undue influence on a patient 104 subject or a potential patient subject and, in the absence of 105 such coercion or exertion of undue influence, is not considered 106 an inducement for participation in a cancer clinical trial. 107
(4) REIMBURSEMENT PROGRAMS.— 108 (
a) Subject to applicable federal laws and this section, 109 corporations, individuals, public and private foundations, 110 health care providers, and other stakeholders may offer 111 financial support to cover ancillary expenses through their 112 support of reimbursement programs offered by third-party 113 nonprofit corporations and public charities to increase the 114 enrollment and retention of minority patient subjects in cancer 115 clinical trials. 116
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b) A third-party nonprofit corporation or public charity 117 that offers a reimbursement program under this subsection shall 118 implement a process for securing the informed consent of patient 119 subjects. A patient subject must be informed of financial 120 eligibility guidelines and the reimbursement process. A patient 121 subject may not begin his or her participation in a cancer 122 clinical trial in the absence of a declaration of such informed 123 consent. 124 (
c) The Department of Health shall review reimbursement 125 programs offered by third-party nonprofit corporations and 126 public charities to cover ancillary and travel expenses of 127 patient subjects and their caregivers. If the department 128 determines that patient subjects are fairly recruited and 129 adequately informed in a manner that is consistent with federal 130 regulations and guidance and that ancillary and travel expenses 131 are appropriate, it must approve such programs. 132
(5) RULEMAKING.—The department shall adopt rules to 133 administer this section. 134