Texas 2023 - 88th Regular

Texas House Bill HB3188 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	88R7022 RDS-F
2	2	By: Bonnen H.B. No. 3188
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to health benefit plan coverage for certain biomarker
8	8	testing.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Subtitle E, Title 8, Insurance Code, is amended
11	11	by adding Chapter 1372 to read as follows:
12	12	CHAPTER 1372. COVERAGE FOR BIOMARKER TESTING
13	13	Sec. 1372.001. DEFINITIONS. In this chapter:
14	14	(1) "Biomarker" means a characteristic that is
15	15	objectively measured and evaluated as an indicator of normal
16	16	biological processes, pathogenic processes, or pharmacologic
17	17	responses to a specific therapeutic intervention. The term
18	18	includes:
19	19	(A) gene mutations; and
20	20	(B) protein expression.
21	21	(2) "Biomarker testing" means the analysis of a
22	22	patient's tissue, blood, or other biospecimen for the presence of a
23	23	biomarker. The term includes:
24	24	(A) single-analyte tests;
25	25	(B) multiplex panel tests; and
26	26	(C) whole genome sequencing.
27	27	(3) "Consensus statements" means statements that:
28	28	(A) address specific clinical circumstances
29	29	based on the best available evidence for the purpose of optimizing
30	30	clinical care outcomes; and
31	31	(B) are developed by an independent,
32	32	multidisciplinary panel of experts that uses a transparent
33	33	methodology and reporting structure and is subject to a conflict of
34	34	interest policy.
35	35	(4) "Nationally recognized clinical practice
36	36	guidelines" means evidence-based clinical practice guidelines
37	37	that:
38	38	(A) establish a standard of care informed by a
39	39	systematic review of evidence and an assessment of the benefits and
40	40	costs of alternative care options;
41	41	(B) include recommendations intended to optimize
42	42	patient care; and
43	43	(C) are developed by an independent organization
44	44	or medical professional society that uses a transparent methodology
45	45	and reporting structure and is subject to a conflict of interest
46	46	policy.
47	47	Sec. 1372.002. APPLICABILITY OF CHAPTER. (a) This chapter
48	48	applies only to a health benefit plan that provides benefits for
49	49	medical or surgical expenses incurred as a result of a health
50	50	condition, accident, or sickness, including an individual, group,
51	51	blanket, or franchise insurance policy or insurance agreement, a
52	52	group hospital service contract, or an individual or group evidence
53	53	of coverage or similar coverage document that is offered by:
54	54	(1) an insurance company;
55	55	(2) a group hospital service corporation operating
56	56	under Chapter 842;
57	57	(3) a health maintenance organization operating under
58	58	Chapter 843;
59	59	(4) an approved nonprofit health corporation that
60	60	holds a certificate of authority under Chapter 844;
61	61	(5) a multiple employer welfare arrangement that holds
62	62	a certificate of authority under Chapter 846;
63	63	(6) a stipulated premium company operating under
64	64	Chapter 884;
65	65	(7) a fraternal benefit society operating under
66	66	Chapter 885;
67	67	(8) a Lloyd's plan operating under Chapter 941; or
68	68	(9) an exchange operating under Chapter 942.
69	69	(b) Notwithstanding any other law, this chapter applies to:
70	70	(1) a small employer health benefit plan subject to
71	71	Chapter 1501, including coverage provided through a health group
72	72	cooperative under Subchapter B of that chapter;
73	73	(2) a standard health benefit plan issued under
74	74	Chapter 1507;
75	75	(3) a basic coverage plan under Chapter 1551;
76	76	(4) a basic plan under Chapter 1575;
77	77	(5) a primary care coverage plan under Chapter 1579;
78	78	(6) a plan providing basic coverage under Chapter
79	79	1601;
80	80	(7) health benefits provided by or through a church
81	81	benefits board under Subchapter I, Chapter 22, Business
82	82	Organizations Code;
83	83	(8) the state Medicaid program, including the Medicaid
84	84	managed care program operated under Chapter 533, Government Code;
85	85	(9) the child health plan program under Chapter 62,
86	86	Health and Safety Code;
87	87	(10) a regional or local health care program operated
88	88	under Section 75.104, Health and Safety Code;
89	89	(11) a self-funded health benefit plan sponsored by a
90	90	professional employer organization under Chapter 91, Labor Code;
91	91	(12) county employee group health benefits provided
92	92	under Chapter 157, Local Government Code; and
93	93	(13) health and accident coverage provided by a risk
94	94	pool created under Chapter 172, Local Government Code.
95	95	Sec. 1372.003. COVERAGE REQUIRED. (a) Subject to
96	96	Subsection (b), a health benefit plan must provide coverage for
97	97	biomarker testing for the purpose of diagnosis, treatment,
98	98	appropriate management, or ongoing monitoring of an enrollee's
99	99	disease or condition to guide treatment when the test is supported
100	100	by medical and scientific evidence, including:
101	101	(1) a labeled indication for a test approved or
102	102	cleared by the United States Food and Drug Administration;
103	103	(2) an indicated test for a drug approved by the United
104	104	States Food and Drug Administration;
105	105	(3) a national coverage determination made by the
106	106	Centers for Medicare and Medicaid Services or a local coverage
107	107	determination made by a Medicare administrative contractor;
108	108	(4) nationally recognized clinical practice
109	109	guidelines; or
110	110	(5) consensus statements.
111	111	(b) A health benefit plan issuer must provide coverage under
112	112	Subsection (a) only when use of biomarker testing provides clinical
113	113	utility because use of the test for the condition:
114	114	(1) is evidence-based;
115	115	(2) is scientifically valid;
116	116	(3) is outcome focused; and
117	117	(4) predominately addresses the acute issue for which
118	118	the test is being ordered, except that a test may include some
119	119	information that cannot be immediately used in the formulation of a
120	120	clinical decision.
121	121	(c) A health benefit plan must provide coverage under
122	122	Subsection (a) in a manner that limits disruptions in care,
123	123	including limiting the number of biopsies and biospecimen samples.
124	124	SECTION 2. If before implementing any provision of this Act
125	125	a state agency determines that a waiver or authorization from a
126	126	federal agency is necessary for implementation of that provision,
127	127	the agency affected by the provision shall request the waiver or
128	128	authorization and may delay implementing that provision until the
129	129	waiver or authorization is granted.
130	130	SECTION 3. The change in law made by this Act applies only
131	131	to a health benefit plan that is delivered, issued for delivery, or
132	132	renewed on or after January 1, 2024.
133	133	SECTION 4. This Act takes effect September 1, 2023.