Texas 2023 - 88th Regular

Texas Senate Bill SB989 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	S.B. No. 989
2	2
3	3
4	4	AN ACT
5	5	relating to health benefit plan coverage for certain biomarker
6	6	testing.
7	7	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
8	8	SECTION 1. Subtitle E, Title 8, Insurance Code, is amended
9	9	by adding Chapter 1372 to read as follows:
10	10	CHAPTER 1372. COVERAGE FOR BIOMARKER TESTING
11	11	Sec. 1372.001. DEFINITIONS. In this chapter:
12	12	(1) "Biomarker" means a characteristic that is
13	13	objectively measured and evaluated as an indicator of normal
14	14	biological processes, pathogenic processes, or pharmacologic
15	15	responses to a specific therapeutic intervention. The term
16	16	includes:
17	17	(A) gene mutations; and
18	18	(B) protein expression.
19	19	(2) "Biomarker testing" means the analysis of a
20	20	patient's tissue, blood, or other biospecimen for the presence of a
21	21	biomarker. The term includes:
22	22	(A) single-analyte tests;
23	23	(B) multiplex panel tests; and
24	24	(C) whole genome sequencing.
25	25	(3) "Consensus statements" means statements that:
26	26	(A) address specific clinical circumstances
27	27	based on the best available evidence for the purpose of optimizing
28	28	clinical care outcomes; and
29	29	(B) are developed by an independent,
30	30	multidisciplinary panel of experts that uses a transparent
31	31	methodology and reporting structure and is subject to a conflict of
32	32	interest policy.
33	33	(4) "Nationally recognized clinical practice
34	34	guidelines" means evidence-based clinical practice guidelines
35	35	that:
36	36	(A) establish a standard of care informed by a
37	37	systematic review of evidence and an assessment of the benefits and
38	38	costs of alternative care options;
39	39	(B) include recommendations intended to optimize
40	40	patient care; and
41	41	(C) are developed by an independent organization
42	42	or medical professional society that uses a transparent methodology
43	43	and reporting structure and is subject to a conflict of interest
44	44	policy.
45	45	Sec. 1372.002. APPLICABILITY OF CHAPTER. (a) This chapter
46	46	applies only to a health benefit plan that provides benefits for
47	47	medical or surgical expenses incurred as a result of a health
48	48	condition, accident, or sickness, including an individual, group,
49	49	blanket, or franchise insurance policy or insurance agreement, a
50	50	group hospital service contract, or an individual or group evidence
51	51	of coverage or similar coverage document that is offered by:
52	52	(1) an insurance company;
53	53	(2) a group hospital service corporation operating
54	54	under Chapter 842;
55	55	(3) a health maintenance organization operating under
56	56	Chapter 843;
57	57	(4) an approved nonprofit health corporation that
58	58	holds a certificate of authority under Chapter 844;
59	59	(5) a multiple employer welfare arrangement that holds
60	60	a certificate of authority under Chapter 846;
61	61	(6) a stipulated premium company operating under
62	62	Chapter 884;
63	63	(7) a fraternal benefit society operating under
64	64	Chapter 885;
65	65	(8) a Lloyd's plan operating under Chapter 941; or
66	66	(9) an exchange operating under Chapter 942.
67	67	(b) Notwithstanding any other law, this chapter applies to:
68	68	(1) a small employer health benefit plan subject to
69	69	Chapter 1501, including coverage provided through a health group
70	70	cooperative under Subchapter B of that chapter;
71	71	(2) a standard health benefit plan issued under
72	72	Chapter 1507;
73	73	(3) a basic coverage plan under Chapter 1551;
74	74	(4) a basic plan under Chapter 1575;
75	75	(5) a primary care coverage plan under Chapter 1579;
76	76	(6) a plan providing basic coverage under Chapter
77	77	1601;
78	78	(7) the state Medicaid program, including the Medicaid
79	79	managed care program operated under Chapter 533, Government Code;
80	80	(8) the child health plan program under Chapter 62,
81	81	Health and Safety Code; and
82	82	(9) a self-funded health benefit plan sponsored by a
83	83	professional employer organization under Chapter 91, Labor Code.
84	84	Sec. 1372.003. COVERAGE REQUIRED. (a) Subject to
85	85	Subsection (b), a health benefit plan must provide coverage for
86	86	biomarker testing for the purpose of diagnosis, treatment,
87	87	appropriate management, or ongoing monitoring of an enrollee's
88	88	disease or condition to guide treatment when the test is supported
89	89	by the following kinds of medical and scientific evidence:
90	90	(1) a labeled indication for a test approved or
91	91	cleared by the United States Food and Drug Administration;
92	92	(2) an indicated test for a drug approved by the United
93	93	States Food and Drug Administration;
94	94	(3) a national coverage determination made by the
95	95	Centers for Medicare and Medicaid Services or a local coverage
96	96	determination made by a Medicare administrative contractor;
97	97	(4) nationally recognized clinical practice
98	98	guidelines; or
99	99	(5) consensus statements.
100	100	(b) A health benefit plan issuer must provide coverage under
101	101	Subsection (a) only when use of biomarker testing provides clinical
102	102	utility because use of the test for the condition:
103	103	(1) is evidence-based;
104	104	(2) is scientifically valid based on the medical and
105	105	scientific evidence described by Subsection (a);
106	106	(3) informs a patient's outcome and a provider's
107	107	clinical decision; and
108	108	(4) predominately addresses the acute or chronic issue
109	109	for which the test is being ordered, except that a test may include
110	110	some information that cannot be immediately used in the formulation
111	111	of a clinical decision.
112	112	(c) A health benefit plan must provide coverage under
113	113	Subsection (a) in a manner that limits disruptions in care,
114	114	including limiting the number of biopsies and biospecimen samples.
115	115	SECTION 2. If before implementing any provision of this Act
116	116	a state agency determines that a waiver or authorization from a
117	117	federal agency is necessary for implementation of that provision,
118	118	the agency affected by the provision shall request the waiver or
119	119	authorization and may delay implementing that provision until the
120	120	waiver or authorization is granted.
121	121	SECTION 3. The change in law made by this Act applies only
122	122	to a health benefit plan that is delivered, issued for delivery, or
123	123	renewed on or after January 1, 2024.
124	124	SECTION 4. This Act takes effect September 1, 2023.
125	125	______________________________ ______________________________
126	126	President of the Senate Speaker of the House
127	127	I hereby certify that S.B. No. 989 passed the Senate on
128	128	April 12, 2023, by the following vote: Yeas 26, Nays 4.
129	129	______________________________
130	130	Secretary of the Senate
131	131	I hereby certify that S.B. No. 989 passed the House on
132	132	May 16, 2023, by the following vote: Yeas 114, Nays 24, two
133	133	present not voting.
134	134	______________________________
135	135	Chief Clerk of the House
136	136	Approved:
137	137	______________________________
138	138	Date
139	139	______________________________
140	140	Governor