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.
   20  Be It Enacted by the Legislature of the State of Florida:
   22         Section 1. Section 385.2021, Florida Statutes, is created
   23  to read:
   24         385.2021Legislative 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.
   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.