Florida Senate - 2019                                     SB 954
       By Senator Berman
       31-00253C-19                                           2019954__
    1                        A bill to be entitled                      
    2         An act relating to stem cells; creating s. 385.301,
    3         F.S.; defining terms; requiring the Department of
    4         Health to adopt rules by a specified date; providing
    5         patient eligibility; requiring eligible patients to
    6         sign a written informed consent prior to receiving an
    7         investigational stem cell treatment; authorizing the
    8         department to adopt a form by rule for the informed
    9         consent; requiring an investigational stem cell
   10         treatment to be administered directly by a licensed
   11         and certified physician, overseen by an institutional
   12         review board, and provided at a certain facility;
   13         providing construction; prohibiting a licensing board
   14         from taking action against a physician’s license under
   15         certain circumstances; prohibiting a state entity
   16         responsible for Medicare certification from taking
   17         action against a physician’s Medicare certification
   18         under certain circumstances; prohibiting a state
   19         entity from interfering with an eligible patient’s
   20         access to or use of a stem cell treatment; requiring
   21         institutional review boards to keep records on the
   22         treatment of each patient; requiring each
   23         institutional review board to submit an annual report
   24         analyzing patient records to the Board of Medicine and
   25         the Board of Osteopathic Medicine; requiring that the
   26         report exclude the personal identifying information of
   27         patients and that it be made available to the public
   28         in both written and electronic form; amending s.
   29         873.01, F.S.; clarifying that the purchase or sale of
   30         stem cells is a felony; providing an effective date.
   32  Be It Enacted by the Legislature of the State of Florida:
   34         Section 1. Section 385.301, Florida Statutes, is created to
   35  read:
   36         385.301 Investigational stem cell treatments.—
   37         (1) DEFINITIONS.—As used in this section, the term:
   38         (a) “Adult stem cell means a living cell produced by or
   39  normally present within the body of a human being which
   40  functions to repair or to replace other cells and tissues within
   41  the human body and which is not obtained from a human embryo or
   42  fetus. The term also includes cells contained in an umbilical
   43  cord and placenta after the delivery of a newborn.
   44         (b“Department” means the Department of Health.
   45         (c) “Institutional review board” means a board that:
   46         1. Is affiliated with a hospital licensed under chapter 395
   47  which has at least 150 beds or an accredited medical school; and
   48         2. Has been approved by the department to certify the
   49  physician administration of and to oversee an investigational
   50  stem cell treatment in compliance with this section.
   51         (d) “Investigational stem cell treatment” means treatment
   52  using adult stem cells which:
   53         1. Is under an investigation in a clinical trial approved
   54  by the United States Food and Drug Administration;
   55         2. Is being administered to human participants in the
   56  clinical trial; and
   57         3. Has not been approved for general use by the United
   58  States Food and Drug Administration.
   59         (eSevere chronic disease” means a condition, injury, or
   60  illness that:
   61         1. May be treated;
   62         2. Is never cured or eliminated; and
   63         3. Entails significant functional impairment or severe
   64  pain.
   65         (f) “Terminal illness” means an advanced stage of a disease
   66  with an unfavorable prognosis that, without life-sustaining
   67  procedures, will soon result in death or a state of permanent
   68  unconsciousness from which recovery is unlikely.
   69         (2) RULEMAKING.—No later than January 1, 2020, the
   70  department shall adopt rules designating the medical conditions
   71  that constitute a severe chronic disease or terminal illness for
   72  purposes of this section, rules regarding institutional review
   73  boards, and any other rules necessary to administer this
   74  section.
   75         (3) PATIENT ELIGIBILITY.—A patient is eligible to access
   76  and use an investigational stem cell treatment under this
   77  section if:
   78         (a) The patient has been diagnosed by his or her treating
   79  physician with a severe chronic disease or terminal illness;
   80         (b) The physician, in consultation with the patient, has
   81  considered all other treatment options currently approved by the
   82  United States Food and Drug Administration and determined that
   83  those treatment options are unavailable or unlikely to alleviate
   84  the significant impairment or severe pain associated with the
   85  severe chronic disease or terminal illness; and
   86         (c) The physician has recommended or prescribed in writing
   87  that the patient use a specific class of investigational stem
   88  cell treatment.
   89         (4) INFORMED CONSENT.—
   90         (a) An eligible patient must sign a written informed
   91  consent before receiving an investigational stem cell treatment.
   92         (b) If the eligible patient is a minor or lacks the mental
   93  capacity to provide informed consent, a parent, guardian, or
   94  conservator may provide informed consent on the patient’s
   95  behalf.
   96         (c) The department may adopt a form by rule for the
   97  informed consent required under this section.
   98         (5) TREATMENT REQUIREMENTS.—
   99         (a) Treatment provided under this section must be:
  100         1. Administered directly by a physician licensed under
  101  chapter 458 or chapter 459 who is certified by an institutional
  102  review board to provide such treatment;
  103         2. Overseen by an institutional review board; and
  104         3. Provided at a hospital or ambulatory surgical center
  105  licensed under chapter 395 or an accredited medical school.
  106         (b) A physician administering an investigational stem cell
  107  treatment under this section shall comply with all applicable
  108  Board of Medicine or Board of Osteopathic Medicine rules.
  109         (6) EFFECT ON OTHER LAW.
  110         (a)This section does not expand the coverage that an
  111  insurer must provide under the Florida Insurance Code and does
  112  not affect mandatory health coverage for participation in
  113  clinical trials.
  114         (b) This section does not authorize a person to sell a
  115  human organ or tissue in violation of s. 873.01.
  117  MEDICARE.—A licensing board may not revoke, fail to renew,
  118  suspend, or take any action against a physician’s license issued
  119  under chapter 458 or chapter 459 based solely on the physician’s
  120  recommendations to an eligible patient regarding access to or
  121  use of an investigational stem cell treatment. A state entity
  122  responsible for Medicare certification may not take action
  123  against a physician’s Medicare certification based solely on the
  124  physician’s recommendation that an eligible patient access or
  125  use an investigational stem cell treatment.
  126         (8) GOVERNMENTAL INTERFERENCE PROHIBITED.—A state entity or
  127  an officer, employee, or agent of a governmental entity may not
  128  interfere with an eligible patient’s access to or use of an
  129  investigational stem cell treatment authorized under this
  130  section.
  132         (a) An institutional review board overseeing an
  133  investigational stem cell treatment under this section shall
  134  keep a record on each patient to whom a physician administers
  135  the treatment and document in the record the provision of each
  136  treatment and the effects of the treatment on the patient
  137  throughout the period the treatment is administered to the
  138  patient.
  139         (b) Each institutional review board overseeing an
  140  investigational stem cell treatment under this section shall
  141  submit an annual report to the Board of Medicine and the Board
  142  of Osteopathic Medicine which analyzes the patient records
  143  described in paragraph (a). A report may not include the
  144  personal identifying information of any patient and must be made
  145  available to the public in both written and electronic form.
  146         Section 2. Subsection (3) of section 873.01, Florida
  147  Statutes, is amended, and subsections (1), (2), and (4) of that
  148  section are republished, to read:
  149         873.01 Purchase or sale of human organs and tissue
  150  prohibited.—
  151         (1) No person shall knowingly offer to purchase or sell, or
  152  purchase, sell, or otherwise transfer, any human organ or tissue
  153  for valuable consideration.
  154         (2) No for-profit corporation or any employee thereof shall
  155  transfer or arrange for the transfer of any human body part for
  156  valuable consideration.
  157         (3)(a) The human organs and tissues subject to the
  158  provisions of this section are the eye, cornea, kidney, liver,
  159  heart, lung, pancreas, bone, stem cells, and skin or any other
  160  organ or tissue adopted by rule by the Agency for Health Care
  161  Administration for this purpose.
  162         (b) As used in this section, the term “valuable
  163  consideration” does not include the reasonable costs associated
  164  with the removal, storage, and transportation of a human organ
  165  or tissue.
  166         (4) A person who violates the provisions of this section is
  167  guilty of a felony of the second degree, punishable as provided
  168  in s. 775.082, s. 775.083, or s. 775.084.
  169         Section 3. This act shall take effect July 1, 2019.