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.
   25  Be It Enacted by the Legislature of the State of Florida:
   27         Section 1. Section 385.2021, Florida Statutes, is created
   28  to read:
   29         385.2021Cancer 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.
   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.