Florida Senate - 2015                      CS for CS for SB 1052
       By the Committees on Fiscal Policy; and Health Policy; and
       Senator Brandes
       594-04436-15                                          20151052c2
    1                        A bill to be entitled                      
    2         An act relating to experimental treatments for
    3         terminal conditions; creating s. 499.0295, F.S.;
    4         providing a short title; providing definitions;
    5         providing conditions for a manufacturer to provide
    6         certain drugs, products, or devices to an eligible
    7         patient; specifying insurance coverage requirements
    8         and exceptions; providing conditions for the provision
    9         of certain services by a hospital or health care
   10         facility; providing immunity from liability; providing
   11         protection from disciplinary or legal action against a
   12         physician who makes certain treatment recommendations;
   13         providing that a cause of action may not be asserted
   14         against the manufacturer of certain drugs, products,
   15         or devices or a person or entity caring for a patient
   16         using such drugs, products, or devices under certain
   17         circumstances; providing applicability; providing an
   18         effective date.
   20  Be It Enacted by the Legislature of the State of Florida:
   22         Section 1. Section 499.0295, Florida Statutes, is created
   23  to read:
   24         499.0295 Experimental treatments for terminal conditions.—
   25         (1) This section may be cited as the “Right to Try Act.”
   26         (2) As used in this section, the term:
   27         (a) “Eligible patient” means a person who:
   28         1. Has a terminal condition that is attested to by the
   29  patient’s physician and confirmed by a second independent
   30  evaluation by a board-certified physician in an appropriate
   31  specialty for that condition;
   32         2. Has considered all other treatment options for the
   33  terminal condition currently approved by the United States Food
   34  and Drug Administration;
   35         3. Has given written informed consent for the use of an
   36  investigational drug, biological product, or device; and
   37         4. Has documentation from his or her treating physician
   38  that the patient meets the requirements of this paragraph.
   39         (b) “Investigational drug, biological product, or device”
   40  means a drug, biological product, or device that has
   41  successfully completed phase 1 of a clinical trial but has not
   42  been approved for general use by the United States Food and Drug
   43  Administration and remains under investigation in a clinical
   44  trial approved by the United States Food and Drug
   45  Administration.
   46         (c) “Terminal condition” means a progressive disease or
   47  medical or surgical condition that causes significant functional
   48  impairment, is not considered by a treating physician to be
   49  reversible even with the administration of available treatment
   50  options currently approved by the United States Food and Drug
   51  Administration, and, without the administration of life
   52  sustaining procedures, will result in death within 1 year after
   53  diagnosis if the condition runs its normal course.
   54         (d) “Written informed consent” means a document that is
   55  signed by a patient, a parent of a minor patient, a court
   56  appointed guardian for a patient, or a health care surrogate
   57  designated by a patient and includes:
   58         1. An explanation of the currently approved products and
   59  treatments for the patient’s terminal condition.
   60         2. An attestation that the patient concurs with his or her
   61  physician in believing that all currently approved products and
   62  treatments are unlikely to prolong the patient’s life.
   63         3. Identification of the specific investigational drug,
   64  biological product, or device that the patient is seeking to
   65  use.
   66         4. A realistic description of the most likely outcomes of
   67  using the investigational drug, biological product, or device.
   68  The description shall include the possibility that new,
   69  unanticipated, different, or worse symptoms might result and
   70  that death could be hastened by the proposed treatment. The
   71  description shall be based on the physician’s knowledge of the
   72  efficacy of proposed treatment for the patient’s terminal
   73  condition.
   74         5. A statement that the patient’s health plan or third
   75  party administrator and physician are not obligated to pay for
   76  care or treatment consequent to the use of the investigational
   77  drug, biological product, or device unless required to do so by
   78  law or contract.
   79         6. A statement that the patient’s eligibility for hospice
   80  care may be withdrawn if the patient begins treatment with the
   81  investigational drug, biological product, or device and that
   82  hospice care may be reinstated if the treatment ends and the
   83  patient meets hospice eligibility requirements.
   84         7. A statement that the patient understands that he or she
   85  is liable for all expenses consequent to the use of the
   86  investigational drug, biological product, or device and that
   87  liability extends to the patient’s estate, unless a contract
   88  between the patient and the manufacturer of the investigational
   89  drug, biological product, or device states otherwise.
   90         (3) Upon the request of an eligible patient, a manufacturer
   91  may:
   92         (a) Make its investigational drug, biological product, or
   93  device available under this section.
   94         (b) Provide an investigational drug, biological product, or
   95  device to an eligible patient without receiving compensation.
   96         (c) Require an eligible patient to pay the costs of, or the
   97  costs associated with, the manufacture of the investigational
   98  drug, biological product, or device.
   99         (4) A health plan, third-party administrator, or
  100  governmental agency may provide coverage for the cost of, or the
  101  cost of services related to the use of, an investigational drug,
  102  biological product, or device.
  103         (5) A hospital or health care facility licensed under
  104  chapter 395 is not required to provide new or additional
  105  services unless those services are approved by the hospital or
  106  health care facility.
  107         (6) If an eligible patient dies while using an
  108  investigational drug, biological product, or device pursuant to
  109  this section, the patient’s heirs are not liable for any
  110  outstanding debt related to the patient’s use of the
  111  investigational drug, biological product, or device.
  112         (7) A licensing board may not revoke, fail to renew,
  113  suspend, or take any action against a physician’s license issued
  114  under chapter 458 or chapter 459 based solely on the physician’s
  115  recommendations to an eligible patient regarding access to or
  116  treatment with an investigational drug, biological product, or
  117  device. A state entity responsible for Medicare certification
  118  may not take action against a physician’s Medicare certification
  119  based solely on the physician’s recommendation that an eligible
  120  patient have access to an investigational drug, biological
  121  product, or device.
  122         (8) This section does not create a private cause of action
  123  against the manufacturer of an investigational drug, biological
  124  product, or device; against a person or entity involved in the
  125  care of an eligible patient who is using the investigational
  126  drug, biological product, or device; or for any harm to the
  127  eligible patient that is a result of the use of the
  128  investigational drug, biological product, or device if the
  129  manufacturer or other person or entity complies in good faith
  130  with the terms of this section and exercises reasonable care.
  131         (9) This section does not expand the coverage an insurer
  132  must provide under the Florida Insurance Code and does not
  133  affect mandatory health coverage for participation in clinical
  134  trials.
  135         Section 2. This act shall take effect July 1, 2015.