Tennessee 2025-2026 Regular Session

Tennessee House Bill HB0484 Compare Versions

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

Old	New	Differences
1	1
2	2	SENATE BILL 435
3	3	By Reeves
4	4
5	5	HOUSE BILL 484
6	6	By Martin B
7	7
8	8
9	9	HB0484
10	10	001522
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13	13	AN ACT to amend Tennessee Code Annotated, Title 56
14	14	and Title 71, relative to coverage of biomarker
15	15	testing.
16	16
17	17	BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
18	18	SECTION 1. Tennessee Code Annotated, Title 56, Chapter 7, Part 23, is amended by
19	19	adding the following as a new section:
20	20	(a) As used in this section:
21	21	(1) "Biomarker":
22	22	(A) Means a characteristic that is objectively measured and
23	23	evaluated as an indicator of normal biological processes, pathogenic
24	24	processes, or pharmacologic responses to a specific therapeutic
25	25	intervention, including known gene-drug interactions for medications
26	26	being considered for use or already being administered; and
27	27	(B) Includes gene mutations, characteristics of genes, and protein
28	28	expression;
29	29	(2) "Biomarker testing":
30	30	(A) Means the analysis of a patient's tissue, blood, or other
31	31	biospecimen for the presence of a biomarker; and
32	32	(B) Includes single-analyte tests, multi-plex panel tests, protein
33	33	expression, and whole exome, whole genome, and whole transcriptome
34	34	sequencing;
35	35	(3) "Consensus statement" means a statement developed by an
36	36	independent, multidisciplinary panel of experts utilizing a transparent
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41	41	methodology and reporting structure that includes a conflict of interest policy, that
42	42	is aimed at specific clinical circumstances, and that bases the statement on the
43	43	best available evidence for the purpose of optimizing the outcomes of clinical
44	44	care;
45	45	(4) "Health benefit plan" means health insurance coverage as defined in
46	46	§ 56-7-109;
47	47	(5) "Health insurer" means a health insurance entity as defined in § 56-7-
48	48	109; and
49	49	(6) "Nationally recognized clinical practice guideline" means an evidence-
50	50	based clinical practice guideline developed by an independent organization or
51	51	professional medical society utilizing a transparent methodology and reporting
52	52	structure that includes a conflict of interest policy, and that establishes standards
53	53	of care informed by a systematic review of evidence and an assessment of the
54	54	benefits and risks of alternative care options, including recommendations
55	55	intended to optimize patient care.
56	56	(b) A health insurer that issues, amends, delivers, or renews a contract or
57	57	agreement for a health benefit plan to take effect on or after January 1, 2026, shall
58	58	include coverage for biomarker testing pursuant to subsection (c).
59	59	(c) A health benefit plan must provide coverage for biomarker testing for the
60	60	purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of an
61	61	enrollee's disease or condition when the test is supported by medical and scientific
62	62	evidence, including, but not limited to:
63	63	(1) Labeled indications for a federal food and drug administration (FDA)-
64	64	approved or FDA-cleared test;
65	65	(2) Indicated tests for an FDA-approved drug;
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70	70	(3) Warnings and precautions on FDA-approved drug labels;
71	71	(4) Centers for medicare and medicaid services national coverage
72	72	determinations or medicare administrative contractor local coverage
73	73	determinations; or
74	74	(5) Nationally recognized clinical practice guidelines and consensus
75	75	statements.
76	76	(d) A health insurer shall ensure that biomarker testing coverage under this
77	77	section is provided in a manner that limits disruptions in care, including the need for
78	78	multiple biopsies or biospecimen samples.
79	79	(e) If utilization review, including, but not limited to, prior authorization is
80	80	required, then the health insurer, nonprofit health service plan, health maintenance
81	81	organization, utilization review entity, or a third party acting on behalf of an organization
82	82	or entity subject to this section must approve or deny a prior authorization request and
83	83	notify the enrollee, the enrollee's healthcare provider, and each entity requesting
84	84	authorization of the service within seventy-two (72) hours of a non-urgent request or
85	85	within twenty-four (24) hours of an urgent request.
86	86	(f) A patient and prescribing practitioner shall have access to a clear, readily
87	87	accessible, and convenient process to request an exception to a coverage policy or an
88	88	adverse utilization review determination of a health insurer, nonprofit health service plan,
89	89	or health maintenance organization. The process must be made readily accessible on
90	90	the public website of the health insurer, nonprofit health service plan, or health
91	91	maintenance organization.
92	92	SECTION 2. Tennessee Code Annotated, Title 71, Chapter 5, Part 1, is amended by
93	93	adding the following as a new section:
94	94	(a) As used in this section:
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99	99	(1) "Biomarker" has the same meaning as defined in SECTION 1;
100	100	(2) "Biomarker testing" has the same meaning as defined in SECTION 1;
101	101	(3) "Consensus statement" has the same meaning as defined in
102	102	SECTION 1;
103	103	(4) "Health benefit plan" means health insurance coverage as defined in
104	104	§ 56-7-109;
105	105	(5) "Health insurer" means a health insurance entity as defined in § 56-7-
106	106	109;
107	107	(6) "Nationally recognized clinical practice guideline" has the same
108	108	meaning as defined in SECTION 1; and
109	109	(7) "TennCare health benefit plan" means a health benefit plan issued by
110	110	a health insurer pursuant to an agreement with the bureau of TennCare to
111	111	provide health insurance coverage for an enrollee in the medical assistance
112	112	program.
113	113	(b) A TennCare health benefit plan that is issued, amended, or renewed to take
114	114	effect on or after January 1, 2026, must provide coverage for biomarker testing.
115	115	(c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
116	116	appropriate management, or ongoing monitoring of an enrollee's disease or condition
117	117	when the test is supported by medical and scientific evidence, including, but not limited
118	118	to:
119	119	(1) Labeled indications for a federal food and drug administration (FDA)-
120	120	approved or FDA-cleared test;
121	121	(2) Indicated tests for an FDA-approved drug;
122	122	(3) Warnings and precautions on FDA-approved drug labels;
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127	127	(4) Centers for medicare and medicaid services national coverage
128	128	determinations or medicare administrative contractor local coverage
129	129	determinations; or
130	130	(5) Nationally recognized clinical practice guidelines and consensus
131	131	statements.
132	132	(d) A health insurer that issues a TennCare health benefit plan shall provide
133	133	biomarker testing within the same scope, and at the same duration and frequency, that
134	134	other TennCare benefits are provided to enrollees.
135	135	(e) If utilization review, including, but not limited to, prior authorization is
136	136	required, then the health insurer, nonprofit health service plan, health maintenance
137	137	organization, utilization review entity, or a third party acting on behalf of an organization
138	138	or entity subject to this section must approve or deny a prior authorization request and
139	139	notify the enrollee, the enrollee's healthcare provider, and each entity requesting
140	140	authorization of the service within seventy-two (72) hours of a non-urgent request or
141	141	within twenty-four (24) hours of an urgent request.
142	142	(f) An enrollee and participating provider must have access to a clear, readily
143	143	accessible, and convenient process to request an exception to a coverage policy of, or
144	144	an adverse utilization review by, a health insurer that issues a TennCare health benefit
145	145	plan. The process must be made readily accessible on the public website of TennCare
146	146	and each health insurer that issues TennCare health benefit plans.
147	147	(g) The director of TennCare is authorized to seek any federal waiver the
148	148	director deems necessary to effectuate this section.
149	149	SECTION 3. The commissioner of commerce and insurance is authorized to promulgate
150	150	rules to effectuate Section 1 of this act. The rules must be promulgated in accordance with the
151	151	Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
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156	156	SECTION 4. This act takes effect upon becoming a law, the public welfare requiring it.