Tennessee 2025-2026 Regular Session

Tennessee Senate Bill SB0282 Compare Versions

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7		-	J enne&see Senate
8		-	PUBLIC CHAPTER NO. 45
9		-	SENATE BILL NO. 282
10		-	By Watson, Hensley, Massey, Bowling, Reeves, Crowe, Rose, Stevens, Walley, Yager
11		-	Substituted for: House Bill No. 192
12		-	By Terry, White, Hill, Powers, Hawk, Brock Martin, Davis, Zachary, Hardaway, Alexander, Littleton,
13		-	Garringer, Towns, Bricken, Burkhart, Helton-Haynes, Howell
14		-	AN ACT to amend Tennessee Code Annotated, Title 53 and Title 63, relative to medical treatment.
	1	+
	2	+	HOUSE BILL 192
	3	+	By Terry
	4	+
	5	+	SENATE BILL 282
	6	+	By Watson
	7	+
	8	+
	9	+	SB0282
	10	+	001074
	11	+	- 1 -
	12	+
	13	+	AN ACT to amend Tennessee Code Annotated, Title 53
	14	+	and Title 63, relative to medical treatment.
	15	+
15	16		BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
16		-	SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding ~~the~~
17		-	following as a new part:
	17	+	SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, is amended by adding
	18	+	the following as a new part:
18	19		63-6-1301.
19		-	This part is known and may be cited as the "Individualized ~~lnvestigational Treatment~~
20		-	Act."
	20	+	This part is known and may be cited as the "Individualized Investigational
	21	+	Treatment Act."
21	22		63-6-1302.
22	23		As used in this part:
23	24		(1) "Eligible facility" means an institution operating under principles of
24		-	Federalwide Assurance (FWA) for the Protection of Human Subjects in ~~accordance~~
25		-	with 45 C.F.R. § 46 and 42 U.S.C. § 289(a);
	25	+	Federalwide Assurance (FWA) for the Protection of Human Subjects in
	26	+	accordance with 45 C.F.R. § 46 and 42 U.S.C. § 289(a);
26	27		(2) "Eligible patient" means an individual who meets all of the following
27	28		criteria:
28		-	(A) Has a life-threatening or severely debilitating illness, attested to by
29		-	a treating physician;
30		-	(8) Has, in consultation with a treating physician, considered all other
31		-	treatment options currently approved by the United States food and drug
32		-	administration;
33		-	(C) Has received a recommendation from the treating physician for use
34		-	of an individualized investigational treatment for treatment of the life
35		-	threatening or severely debilitating illness;
	29	+	(A) Has a life-threatening or severely debilitating illness, attested
	30	+	to by a treating physician;
	31	+	(B) Has, in consultation with a treating physician, considered all
	32	+	other treatment options currently approved by the United States food and
	33	+	drug administration;
	34	+
	35	+
	36	+	- 2 - 001074
	37	+
	38	+	(C) Has received a recommendation from the treating physician
	39	+	for use of an individualized investigational treatment for treatment of the
	40	+	life-threatening or severely debilitating illness;
36	41		(D) Has given written, informed consent for the use of the
37	42		investigational drug, biological product, or device; and
38		-	(E) Has documentation from the patient's physician that the ~~patient~~
39		-	meets the requirements of this subdivision (2);
	43	+	(E) Has documentation from the patient's physician that the
	44	+	patient meets the requirements of this subdivision (2);
40	45		(3) "Individualized investigational treatment":
41		-	(A) Means drugs, biological products, or devices that are unique to and
42		-	produced exclusively for use for an individual patient, based on the patient's
43		-	own genetic profile; and
44		-	(8) Includes individualized gene therapy antisense oligonucleotides
45		-	and individualized neoantigen vaccines; SB 282
46		-	(4) "Institution" has the same meaning as defined in 45 C.F.R. § 46.102(f);
47		-	(5) "Life-threatening or severely debilitating illness" has the same meaning as
48		-	those terms are defined in 21 C.F.R. § 312.81; and
49		-	(6) "Written, informed consent" means a written document that is signed by
50		-	the patient, the patient's parent, if the patient is a minor, the patient's legal guardian,
51		-	or the patient's attorney-in-fact designated by the patient under title 34, chapter 6,
52		-	part 2, and attested to by the patient's physician and a witness, and that, at a
53		-	minimum, includes all of the following:
54		-	63-6-1303.
55		-	(A) An explanation of the currently approved products and treatments
56		-	for the disease or condition from which the patient suffers;
57		-	(B) An attestation that the patient concurs with the patient's physician
58		-	in believing that all currently approved and conventionally recognized
59		-	treatments are unlikely to prolong the patient's life;
	46	+	(A) Means drugs, biological products, or devices that are unique
	47	+	to and produced exclusively for use for an individual patient, based on the
	48	+	patient's own genetic profile; and
	49	+	(B) Includes individualized gene therapy antisense
	50	+	oligonucleotides and individualized neoantigen vaccines;
	51	+	(4) "Institution" has the same meaning as defined in 45 C.F.R. §
	52	+	46.102(f);
	53	+	(5) "Life-threatening or severely debilitating illness" has the same
	54	+	meaning as those terms are defined in 21 C.F.R. § 312.81; and
	55	+	(6) "Written, informed consent" means a written document that is signed
	56	+	by the patient, the patient's parent, if the patient is a minor, the patient's legal
	57	+	guardian, or the patient's attorney-in-fact designated by the patient under title 34,
	58	+	chapter 6, part 2, and attested to by the patient's physician and a witness, and
	59	+	that, at a minimum, includes all of the following:
	60	+	(A) An explanation of the currently approved products and
	61	+	treatments for the disease or condition from which the patient suffers;
	62	+
	63	+
	64	+	- 3 - 001074
	65	+
	66	+	(B) An attestation that the patient concurs with the patient's
	67	+	physician in believing that all currently approved and conventionally
	68	+	recognized treatments are unlikely to prolong the patient's life;
60	69		(C) Clear identification of the specific proposed individualized
61	70		investigational treatment that the patient is seeking to use;
62		-	(D) A description of the potentially best and worst outcomes of ~~using~~
63		-	the individualized investigational treatment and a realistic ~~description of the~~
64		-	most likely outcome. The description must include the ~~possibility that new,~~
65		-	unanticipated, different, or worse symptoms might ~~result and that death could~~
66		-	be hastened by the proposed treatment. The ~~description must be based on~~
67		-	the physician's knowledge of the proposed ~~treatment in conjunction with an~~
68		-	awareness of the patient's condition;
	71	+	(D) A description of the potentially best and worst outcomes of
	72	+	using the individualized investigational treatment and a realistic
	73	+	description of the most likely outcome. The description must include the
	74	+	possibility that new, unanticipated, different, or worse symptoms might
	75	+	result and that death could be hastened by the proposed treatment. The
	76	+	description must be based on the physician's knowledge of the proposed
	77	+	treatment in conjunction with an awareness of the patient's condition;
69	78		(E) A release of liability relative to the treating physician, licensed
70	79		healthcare providers, hospital, and manufacturer of the individualized
71	80		investigational treatment;
72	81		(F) A statement that the patient's health plan or third-party
73		-	administrator and provider are not obligated to pay for any care or treatments
74		-	consequent to the use of the individualized investigational treatment, unless
75		-	they are specifically required to do so by law or contract;
76		-	(G) A statement that the patient's eligibility for hospice care may be
77		-	withdrawn if the patient begins curative treatment with the individualized
78		-	investigational treatment and that care may be reinstated if such treatment
79		-	ends and the patient meets hospice eligibility requirements; and
80		-	(H) A statement that the patient understands that the patient is liable
81		-	for all expenses consequent to the use of the individualized investigational
82		-	treatment and that this liability extends to the patient's estate, unless a
83		-	contract between the patient and the manufacturer of the individualized
84		-	investigational treatment states otherwise.
85		-	(a) A manufacturer operating within an eligible facility and pursuant to all applicable
86		-	FWA laws and regulations may make available an individualized investigative treatment and
87		-	an eligible patient may request an individualized investigational treatment from an eligible
88		-	facility or manufacturer operating within an eligible facility under this part. This part does not
89		-	require that a manufacturer make available an individualized investigational treatment to an
90		-	eligible patient.
91		-	(b) An eligible facility or manufacturer operating within an eligible facility may do all of
92		-	the following:
93		-	(1) Provide an individualized investigational treatment to an eligible patient
94		-	without receiving compensation; and
95		-	(2) Require an eligible patient to pay the costs of, or the costs associated with,
96		-	the manufacture of the individualized investigational treatment.
	82	+	administrator and provider are not obligated to pay for any care or
	83	+	treatments consequent to the use of the individualized investigational
	84	+	treatment, unless they are specifically required to do so by law or
	85	+	contract;
	86	+	(G) A statement that the patient's eligibility for hospice care may
	87	+	be withdrawn if the patient begins curative treatment with the
	88	+	individualized investigational treatment and that care may be reinstated if
	89	+	such treatment ends and the patient meets hospice eligibility
	90	+	requirements; and
	91	+
	92	+
	93	+	- 4 - 001074
	94	+
	95	+	(H) A statement that the patient understands that the patient is
	96	+	liable for all expenses consequent to the use of the individualized
	97	+	investigational treatment and that this liability extends to the patient's
	98	+	estate, unless a contract between the patient and the manufacturer of the
	99	+	individualized investigational treatment states otherwise.
	100	+	63-6-1303.
	101	+	(a) A manufacturer operating within an eligible facility and pursuant to all
	102	+	applicable FWA laws and regulations may make available an individualized investigative
	103	+	treatment and an eligible patient may request an individualized investigational treatment
	104	+	from an eligible facility or manufacturer operating within an eligible facility under this part.
	105	+	This part does not require that a manufacturer make available an individualized
	106	+	investigational treatment to an eligible patient.
	107	+	(b) An eligible facility or manufacturer operating within an eligible facility may do
	108	+	all of the following:
	109	+	(1) Provide an individualized investigational treatment to an eligible
	110	+	patient without receiving compensation; and
	111	+	(2) Require an eligible patient to pay the costs of, or the costs associated
	112	+	with, the manufacture of the individualized investigational treatment.
97	113		63-6-1304.
98		-	2 SB 282
99	114		(a) This part does not expand the coverage required of an insurer under title 56,
100	115		chapter 7.
101		-	(b) A health plan, third-party administrator, or governmental agency may, but is not
102		-	required to, provide coverage for the cost of an individualized investigational treatment, or
103		-	the cost of services related to the use of an individualized investigational treatment under this
104		-	part.
105		-	(c) This part does not require any governmental agency to pay costs associated with
106		-	the use, care, or treatment of a patient with an individualized investigational treatment.
107		-	( d) This part does not require any hospital or facility licensed under title 68, chapter
108		-	11, or any physician or healthcare provider to provide any items or services unless a request
109		-	by an eligible patient is approved by the hospital, facility, physician, and healthcare provider.
	116	+	(b) A health plan, third-party administrator, or governmental agency may, but is
	117	+	not required to, provide coverage for the cost of an individualized investigational
	118	+	treatment, or the cost of services related to the use of an individualized investigational
	119	+	treatment under this part.
	120	+
	121	+
	122	+	- 5 - 001074
	123	+
	124	+	(c) This part does not require any governmental agency to pay costs associated
	125	+	with the use, care, or treatment of a patient with an individualized investigational
	126	+	treatment.
	127	+	(d) This part does not require any hospital or facility licensed under title 68,
	128	+	chapter 11, or any physician or healthcare provider to provide any items or services
	129	+	unless a request by an eligible patient is approved by the hospital, facility, physician, or
	130	+	healthcare provider.
110	131		63-6-1305.
111		-	If a patient dies while being treated by an individualized investigational treatment, ~~the~~
112		-	patient's heirs are not liable for any outstanding debt related to the treatment or lack of
113		-	insurance due to the treatment.
	132	+	If a patient dies while being treated by an individualized investigational treatment,
	133	+	the patient's heirs are not liable for any outstanding debt related to the treatment or lack
	134	+	of insurance due to the treatment.
114	135		63-6-1306.
115	136		A licensing board or disciplinary subcommittee shall not revoke, fail to renew,
116		-	suspend, or take any action against a healthcare provider's license issued under this title,
117		-	based solely on the healthcare provider's recommendations to an eligible patient regarding
118		-	access to or treatment with an individualized investigational treatment. An entity responsible
119		-	for medicare certification shall not take action against a healthcare provider's medicare
120		-	certification based solely on the healthcare provider's recommendation that a patient have
121		-	access to an individualized investigational treatment.
	137	+	suspend, or take any action against a healthcare provider's license issued under this
	138	+	title, based solely on the healthcare provider's recommendations to an eligible patient
	139	+	regarding access to or treatment with an individualized investigational treatment. An
	140	+	entity responsible for medicare certification shall not take action against a healthcare
	141	+	provider's medicare certification based solely on the healthcare provider's
	142	+	recommendation that a patient have access to an individualized investigational
	143	+	treatment.
122	144		63-6-1307.
123	145		An official, employee, or agent of this state shall not block or attempt to block an
124	146		eligible patient's access to an individualized investigational treatment. The rendering of
125		-	counseling, advice, or a recommendation consistent with medical standards of care from a
126		-	licensed healthcare provider is not a violation of this section.
	147	+	counseling, advice, or a recommendation consistent with medical standards of care from
	148	+	a licensed healthcare provider is not a violation of this section.
	149	+
	150	+
	151	+	- 6 - 001074
	152	+
127	153		63-6-1308.
128		-	(a) This part does not create a private cause of action against a manufacturer of an
129		-	individualized investigational treatment or against any other person or entity involved ~~in the~~
130		-	care of an eligible patient using the individualized investigational treatment for any ~~harm~~
131		-	done to the eligible patient resulting from the individualized investigational ~~treatment, if the~~
132		-	manufacturer or other person or entity is complying in good faith with the ~~terms of this part~~
133		-	and has exercised reasonable care.
134		-	(b) This part does not affect any mandatory healthcare coverage for participation in
135		-	clinical trials under § 56-7-2365.
136		-	SECTION 2. If any provision of this act or its application to any person or circumstance is
137		-	held invalid, then the invalidity does not affect other provisions or applications of the act that ~~can be~~
138		-	given effect without the invalid provision or application, and to that end, the provisions of ~~this act are~~
139		-	severable.
	154	+	(a) This part does not create a private cause of action against a manufacturer of
	155	+	an individualized investigational treatment or against any other person or entity involved
	156	+	in the care of an eligible patient using the individualized investigational treatment for any
	157	+	harm done to the eligible patient resulting from the individualized investigational
	158	+	treatment, if the manufacturer or other person or entity is complying in good faith with the
	159	+	terms of this part and has exercised reasonable care.
	160	+	(b) This part does not affect any mandatory healthcare coverage for participation
	161	+	in clinical trials under § 56-7-2365.
	162	+	SECTION 2. If any provision of this act or its application to any person or circumstance
	163	+	is held invalid, then the invalidity does not affect other provisions or applications of the act that
	164	+	can be given effect without the invalid provision or application, and to that end, the provisions of
	165	+	this act are severable.
140	166		SECTION 3. This act takes effect July 1, 2025, the public welfare requiring it.
141		-	3 PASSED:
142		-	SENATE BILL NO. 282
143		-	March 6, 2025
144		-	,~ .. ~ .... ~._..-1.....~ .... \.a...
145		-	' -~~=~McNALL Y
146		-	SPEAKER OF THE SENATE
147		-	CAMl!!MONSEXTON,SPEAKER
148		-	HOUSE OF REPRESENTATIVES
149		-	APPROVED this ~ day of (V'\otet, 2025
150		-	UA.
151		-	'
152		-	BILL LEE, GOVERNOR