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. 31 32 Be It Enacted by the Legislature of the State of Florida: 33 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 (e) “Severe 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. 116 (7) ACTION AGAINST PHYSICIAN’S LICENSE PROHIBITED; 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. 131 (9) INSTITUTIONAL REVIEW BOARD RECORDS; REPORT.— 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.