Tennessee 2025-2026 Regular Session

Tennessee Senate Bill SB0435 Compare Versions

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

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2	2	<BillNo> <Sponsor>
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4	4	SENATE BILL 435
5	5	By Reeves
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8	8	SB0435
9	9	001522
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12	12	AN ACT to amend Tennessee Code Annotated, Title 56
13	13	and Title 71, relative to coverage of biomarker
14	14	testing.
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16	16	BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
17	17	SECTION 1. Tennessee Code Annotated, Title 56, Chapter 7, Part 23, is amended by
18	18	adding the following as a new section:
19	19	(a) As used in this section:
20	20	(1) "Biomarker":
21	21	(A) Means a characteristic that is objectively measured and
22	22	evaluated as an indicator of normal biological processes, pathogenic
23	23	processes, or pharmacologic responses to a specific therapeutic
24	24	intervention, including known gene-drug interactions for medications
25	25	being considered for use or already being administered; and
26	26	(B) Includes gene mutations, characteristics of genes, and protein
27	27	expression;
28	28	(2) "Biomarker testing":
29	29	(A) Means the analysis of a patient's tissue, blood, or other
30	30	biospecimen for the presence of a biomarker; and
31	31	(B) Includes single-analyte tests, multi-plex panel tests, protein
32	32	expression, and whole exome, whole genome, and whole transcriptome
33	33	sequencing;
34	34	(3) "Consensus statement" means a statement developed by an
35	35	independent, multidisciplinary panel of experts utilizing a transparent
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40	40	methodology and reporting structure that includes a conflict of interest policy, that
41	41	is aimed at specific clinical circumstances, and that bases the statement on the
42	42	best available evidence for the purpose of optimizing the outcomes of clinical
43	43	care;
44	44	(4) "Health benefit plan" means health insurance coverage as defined in
45	45	§ 56-7-109;
46	46	(5) "Health insurer" means a health insurance entity as defined in § 56-7-
47	47	109; and
48	48	(6) "Nationally recognized clinical practice guideline" means an evidence-
49	49	based clinical practice guideline developed by an independent organization or
50	50	professional medical society utilizing a transparent methodology and reporting
51	51	structure that includes a conflict of interest policy, and that establishes standards
52	52	of care informed by a systematic review of evidence and an assessment of the
53	53	benefits and risks of alternative care options, including recommendations
54	54	intended to optimize patient care.
55	55	(b) A health insurer that issues, amends, delivers, or renews a contract or
56	56	agreement for a health benefit plan to take effect on or after January 1, 2026, shall
57	57	include coverage for biomarker testing pursuant to subsection (c).
58	58	(c) A health benefit plan must provide coverage for biomarker testing for the
59	59	purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an
60	60	enrollee's disease or condition when the test is supported by medical and scientific
61	61	evidence, including, but not limited to:
62	62	(1) Labeled indications for a federal food and drug administration (FDA)-
63	63	approved or FDA-cleared test;
64	64	(2) Indicated tests for an FDA-approved drug;
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69	69	(3) Warnings and precautions on FDA-approved drug labels;
70	70	(4) Centers for medicare and medicaid services national coverage
71	71	determinations or medicare administrative contractor local coverage
72	72	determinations; or
73	73	(5) Nationally recognized clinical practice guidelines and consensus
74	74	statements.
75	75	(d) A health insurer shall ensure that biomarker testing coverage under this
76	76	section is provided in a manner that limits disruptions in care, including the need for
77	77	multiple biopsies or biospecimen samples.
78	78	(e) If utilization review, including, but not limited to, prior authorization is
79	79	required, then the health insurer, nonprofit health service plan, health maintenance
80	80	organization, utilization review entity, or a third party acting on behalf of an organization
81	81	or entity subject to this section must approve or deny a prior authorization request and
82	82	notify the enrollee, the enrollee's healthcare provider, and each entity requesting
83	83	authorization of the service within seventy-two (72) hours of a non-urgent request or
84	84	within twenty-four (24) hours of an urgent request.
85	85	(f) A patient and prescribing practitioner shall have access to a clear, readily
86	86	accessible, and convenient process to request an exception to a coverage policy or an
87	87	adverse utilization review determination of a health insurer, nonprofit health service plan,
88	88	or health maintenance organization. The process must be made readily accessible on
89	89	the public website of the health insurer, nonprofit health service plan, or health
90	90	maintenance organization.
91	91	SECTION 2. Tennessee Code Annotated, Title 71, Chapter 5, Part 1, is amended by
92	92	adding the following as a new section:
93	93	(a) As used in this section:
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98	98	(1) "Biomarker" has the same meaning as defined in SECTION 1;
99	99	(2) "Biomarker testing" has the same meaning as defined in SECTION 1;
100	100	(3) "Consensus statement" has the same meaning as defined in
101	101	SECTION 1;
102	102	(4) "Health benefit plan" means health insurance coverage as defined in
103	103	§ 56-7-109;
104	104	(5) "Health insurer" means a health insurance entity as defined in § 56-7-
105	105	109;
106	106	(6) "Nationally recognized clinical practice guideline" has the same
107	107	meaning as defined in SECTION 1; and
108	108	(7) "TennCare health benefit plan" means a health benefit plan issued by
109	109	a health insurer pursuant to an agreement with the bureau of TennCare to
110	110	provide health insurance coverage for an enrollee in the medical assistance
111	111	program.
112	112	(b) A TennCare health benefit plan that is issued, amended, or renewed to take
113	113	effect on or after January 1, 2026, must provide coverage for biomarker testing.
114	114	(c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
115	115	appropriate management, or ongoing monitoring of an enrollee's disease or condition
116	116	when the test is supported by medical and scientific evidence, including, but not limited
117	117	to:
118	118	(1) Labeled indications for a federal food and drug administration (FDA)-
119	119	approved or FDA-cleared test;
120	120	(2) Indicated tests for an FDA-approved drug;
121	121	(3) Warnings and precautions on FDA-approved drug labels;
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126	126	(4) Centers for medicare and medicaid services national coverage
127	127	determinations or medicare administrative contractor local coverage
128	128	determinations; or
129	129	(5) Nationally recognized clinical practice guidelines and consensus
130	130	statements.
131	131	(d) A health insurer that issues a TennCare health benefit plan shall provide
132	132	biomarker testing within the same scope, and at the same duration and frequency, that
133	133	other TennCare benefits are provided to enrollees.
134	134	(e) If utilization review, including, but not limited to, prior authorization is
135	135	required, then the health insurer, nonprofit health service plan, health maintenance
136	136	organization, utilization review entity, or a third party acting on behalf of an organization
137	137	or entity subject to this section must approve or deny a prior authorization request and
138	138	notify the enrollee, the enrollee's healthcare provider, and each entity requesting
139	139	authorization of the service within seventy-two (72) hours of a non-urgent request or
140	140	within twenty-four (24) hours of an urgent request.
141	141	(f) An enrollee and participating provider must have access to a clear, readily
142	142	accessible, and convenient process to request an exception to a coverage policy of, or
143	143	an adverse utilization review by, a health insurer that issues a TennCare health benefit
144	144	plan. The process must be made readily accessible on the public website of TennCare
145	145	and each health insurer that issues TennCare health benefit plans.
146	146	(g) The director of TennCare is authorized to seek any federal waiver the
147	147	director deems necessary to effectuate this section.
148	148	SECTION 3. The commissioner of commerce and insurance is authorized to promulgate
149	149	rules to effectuate Section 1 of this act. The rules must be promulgated in accordance with the
150	150	Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
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155	155	SECTION 4. This act takes effect upon becoming a law, the public welfare requiring it.