Tennessee 2025-2026 Regular Session

Tennessee House Bill HB0413 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2	SENATE BILL 152
3	3	By Pody
4	4
5	5	HOUSE BILL 413
6	6	By Lynn
7	7
8	8
9	9	HB0413
10	10	000703
11	11	- 1 -
12	12
13	13	AN ACT to amend Tennessee Code Annotated, Title 53;
14	14	Title 63 and Title 68, relative to stem cell
15	15	treatment.
16	16
17	17	BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
18	18	SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding
19	19	the following as a new part:
20	20	63-6-901. Part definitions.
21	21	As used in this part:
22	22	(1) "Commissioner" means the commissioner of health;
23	23	(2) "Governmental entity" means this state or an agency or political
24	24	subdivision of this state;
25	25	(3) "Investigational stem cell treatment" means an adult stem cell
26	26	treatment that:
27	27	(A) Is under investigation in a clinical trial and being administered
28	28	to human participants in that trial; and
29	29	(B) Has not yet been approved for general use by the United
30	30	States food and drug administration;
31	31	(4) "Severe chronic disease" means a condition, injury, or illness that:
32	32	(A) May be treated;
33	33	(B) Is never cured or eliminated; and
34	34	(C) Entails significant functional impairment or severe pain; and
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39	39	(5) "Terminal illness" means an advanced stage of a disease with an
40	40	unfavorable prognosis that, without life-sustaining procedures, will soon result in
41	41	death or a state of permanent unconsciousness from which recovery is unlikely.
42	42	63-6-902. Patient eligibility.
43	43	A patient may access and use an investigational stem cell treatment under this
44	44	part if:
45	45	(1) The patient has a severe chronic disease or terminal illness listed in
46	46	the rules adopted under § 63-6-907 and attested to by the patient's treating
47	47	physician; and
48	48	(2) The patient's treating physician:
49	49	(A) In consultation with the patient, has considered all other
50	50	treatment options currently approved by the United States food and drug
51	51	administration and determined that those treatment options are
52	52	unavailable or unlikely to alleviate the significant impairment or severe
53	53	pain associated with the severe chronic disease or terminal illness; and
54	54	(B) Has recommended or prescribed in writing that the patient
55	55	use a specific class of investigational stem cell treatment.
56	56	63-6-903. Informed consent.
57	57	(a) Before receiving an investigational stem cell treatment, an eligible patient
58	58	must sign a written informed consent.
59	59	(b) If the patient is a minor or lacks the mental capacity to provide informed
60	60	consent, then a parent, guardian, or conservator may provide informed consent on the
61	61	patient's behalf.
62	62	(c) The commissioner may develop and make available to physicians a form for
63	63	the informed consent under this section.
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68	68	63-6-904. Effect on other law.
69	69	(a) This part does not affect the coverage of enrollees in clinical trials under §
70	70	56-7-2365.
71	71	(b) This part does not affect or authorize a person to violate any law regulating
72	72	the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or
73	73	human organs, including § 39-15-208.
74	74	63-6-905. Action against physician license prohibited.
75	75	Notwithstanding another law, the board of medical examiners and the board of
76	76	osteopathic examination shall not revoke, fail to renew, suspend, or take any action
77	77	against a physician's license based solely on the physician's recommendations to an
78	78	eligible patient regarding access to or use of an investigational stem cell treatment if the
79	79	care provided or recommendations made to the patient meet the standard of care and
80	80	the requirements of this part.
81	81	63-6-906. Governmental interference prohibited.
82	82	A governmental entity or an officer, employee, or agent of a governmental entity
83	83	shall not interfere with an eligible patient's access to or use of an investigational stem
84	84	cell treatment authorized under this part.
85	85	63-6-907. Rules.
86	86	The commissioner shall promulgate rules to effectuate this part. The rules must
87	87	include designating the medical conditions that constitute a severe chronic disease or
88	88	terminal illness for purposes of this part. Rules must be promulgated in accordance with
89	89	the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
90	90	SECTION 2. The headings to sections in this act are for reference purposes only and do
91	91	not constitute a part of the law enacted by this act. However, the Tennessee Code Commission
92	92	is requested to include the headings in any compilation or publication containing this act.
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97	97	SECTION 3. This act takes effect upon becoming a law, the public welfare requiring it.