Bill Text: FL S0954 | 2019 | Regular Session | Introduced
Bill Title: Stem Cells
Spectrum: Bipartisan Bill
Status: (Failed) 2019-05-03 - Died in Health Policy [S0954 Detail]
Download: Florida-2019-S0954-Introduced.html
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.
