Florida Senate - 2015                        COMMITTEE AMENDMENT
       Bill No. PCS (592332) for CS for SB 1052
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/21/2015           .                                

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