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.