Tennessee 2025-2026 Regular Session

Tennessee Senate Bill SB0152 Compare Versions

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2-HOUSE BILL 413
3- By Lynn
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54 SENATE BILL 152
65 By Pody
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98 SB0152
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1312 AN ACT to amend Tennessee Code Annotated, Title 53;
1413 Title 63 and Title 68, relative to stem cell
1514 treatment.
1615
1716 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
1817 SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding
1918 the following as a new part:
2019 63-6-901. Part definitions.
2120 As used in this part:
2221 (1) "Commissioner" means the commissioner of health;
2322 (2) "Governmental entity" means this state or an agency or political
2423 subdivision of this state;
2524 (3) "Investigational stem cell treatment" means an adult stem cell
2625 treatment that:
2726 (A) Is under investigation in a clinical trial and being administered
2827 to human participants in that trial; and
2928 (B) Has not yet been approved for general use by the United
3029 States food and drug administration;
3130 (4) "Severe chronic disease" means a condition, injury, or illness that:
3231 (A) May be treated;
3332 (B) Is never cured or eliminated; and
3433 (C) Entails significant functional impairment or severe pain; and
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3938 (5) "Terminal illness" means an advanced stage of a disease with an
4039 unfavorable prognosis that, without life-sustaining procedures, will soon result in
4140 death or a state of permanent unconsciousness from which recovery is unlikely.
4241 63-6-902. Patient eligibility.
4342 A patient may access and use an investigational stem cell treatment under this
4443 part if:
4544 (1) The patient has a severe chronic disease or terminal illness listed in
4645 the rules adopted under § 63-6-907 and attested to by the patient's treating
4746 physician; and
4847 (2) The patient's treating physician:
4948 (A) In consultation with the patient, has considered all other
5049 treatment options currently approved by the United States food and drug
5150 administration and determined that those treatment options are
5251 unavailable or unlikely to alleviate the significant impairment or severe
5352 pain associated with the severe chronic disease or terminal illness; and
5453 (B) Has recommended or prescribed in writing that the patient
5554 use a specific class of investigational stem cell treatment.
5655 63-6-903. Informed consent.
5756 (a) Before receiving an investigational stem cell treatment, an eligible patient
5857 must sign a written informed consent.
5958 (b) If the patient is a minor or lacks the mental capacity to provide informed
6059 consent, then a parent, guardian, or conservator may provide informed consent on the
6160 patient's behalf.
6261 (c) The commissioner may develop and make available to physicians a form for
6362 the informed consent under this section.
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6867 63-6-904. Effect on other law.
6968 (a) This part does not affect the coverage of enrollees in clinical trials under §
7069 56-7-2365.
7170 (b) This part does not affect or authorize a person to violate any law regulating
7271 the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or
7372 human organs, including § 39-15-208.
7473 63-6-905. Action against physician license prohibited.
7574 Notwithstanding another law, the board of medical examiners and the board of
7675 osteopathic examination shall not revoke, fail to renew, suspend, or take any action
7776 against a physician's license based solely on the physician's recommendations to an
7877 eligible patient regarding access to or use of an investigational stem cell treatment if the
7978 care provided or recommendations made to the patient meet the standard of care and
8079 the requirements of this part.
8180 63-6-906. Governmental interference prohibited.
8281 A governmental entity or an officer, employee, or agent of a governmental entity
8382 shall not interfere with an eligible patient's access to or use of an investigational stem
8483 cell treatment authorized under this part.
8584 63-6-907. Rules.
8685 The commissioner shall promulgate rules to effectuate this part. The rules must
8786 include designating the medical conditions that constitute a severe chronic disease or
8887 terminal illness for purposes of this part. Rules must be promulgated in accordance with
8988 the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
9089 SECTION 2. The headings to sections in this act are for reference purposes only and do
9190 not constitute a part of the law enacted by this act. However, the Tennessee Code Commission
9291 is requested to include the headings in any compilation or publication containing this act.
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9796 SECTION 3. This act takes effect upon becoming a law, the public welfare requiring it.