Texas 2023 - 88th Regular

Texas House Bill HB2641 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	88R8031 JG-D
2	2	By: A. Johnson of Harris H.B. No. 2641
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to Medicaid coverage and reimbursement for the provision
8	8	of rapid whole genome sequencing to certain infants with acute or
9	9	complex illnesses.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Subchapter B, Chapter 32, Human Resources Code,
12	12	is amended by adding Section 32.03125 to read as follows:
13	13	Sec. 32.03125. REIMBURSEMENT FOR RAPID WHOLE GENOME
14	14	SEQUENCING. (a) In this section:
15	15	(1) "Rapid whole genome sequencing" means an
16	16	investigation of the entire human genome, including coding and
17	17	noncoding regions and mitochondrial deoxyribonucleic acid, to
18	18	identify disease-causing genetic changes that returns preliminary
19	19	positive results not later than the fifth day after the date the
20	20	sequencing is ordered and final results not later than the 14th day
21	21	after the date the sequencing is ordered. The term includes
22	22	patient-only whole genome sequencing and duo and trio whole genome
23	23	sequencing of the patient and a biological parent or parents of the
24	24	patient.
25	25	(2) "Recipient" means a medical assistance recipient.
26	26	(b) The commission shall ensure medical assistance
27	27	reimbursement is provided for the provision of rapid whole genome
28	28	sequencing in accordance with this section to a recipient who:
29	29	(1) is younger than one year of age;
30	30	(2) has a complex or acute illness of unknown origin
31	31	that is not confirmed to be caused by:
32	32	(A) an environmental exposure;
33	33	(B) a toxic ingestion;
34	34	(C) an infection with a normal response to
35	35	therapy; or
36	36	(D) trauma; and
37	37	(3) is receiving inpatient hospital treatment in an
38	38	intensive care unit or high acuity pediatric care unit.
39	39	(c) The executive commissioner by rule shall establish a
40	40	medical assistance program reimbursement rate for the provision of
41	41	rapid whole genome sequencing to a recipient by a genome sequencing
42	42	provider.
43	43	(d) The provision of rapid whole genome sequencing may be
44	44	subject to applicable evidence-based utilization review required
45	45	by the commission that is based on whether:
46	46	(1) the recipient's symptoms suggest a broad
47	47	differential diagnosis that would require an evaluation by multiple
48	48	genetic tests if comprehensive genetic testing is not performed;
49	49	(2) the recipient's treating genome sequencing
50	50	provider determines that a timely identification of a molecular
51	51	diagnosis is necessary to guide clinical decision-making and
52	52	testing results may guide the treatment or management of the
53	53	recipient's condition; and
54	54	(3) the recipient has a complex or acute illness of
55	55	unknown origin that includes at least one of the following:
56	56	(A) congenital anomalies involving at least two
57	57	organ systems or complex or multiple congenital anomalies in one
58	58	organ system;
59	59	(B) specific organ malformations highly
60	60	suggestive of a genetic origin;
61	61	(C) abnormal laboratory tests or abnormal
62	62	chemistry profiles suggesting the presence of a genetic disease,
63	63	complex metabolic disorder, or inborn error of metabolism,
64	64	including an abnormal newborn screen, hyperammonemia, or severe
65	65	lactic acidosis not due to poor perfusion;
66	66	(D) refractory or severe hypoglycemia or
67	67	hyperglycemia;
68	68	(E) abnormal response to therapy related to an
69	69	underlying medical condition affecting vital organs or bodily
70	70	systems;
71	71	(F) severe muscle weakness, rigidity, or
72	72	spasticity;
73	73	(G) refractory seizures;
74	74	(H) high-risk stratification on evaluation for a
75	75	brief resolved unexplained event with:
76	76	(i) a lack of coordination;
77	77	(ii) a recurrent event without respiratory
78	78	infection;
79	79	(iii) a recurrent witnessed seizure-like
80	80	event; or
81	81	(iv) a recurrent cardiopulmonary
82	82	resuscitation;
83	83	(I) abnormal cardiac diagnostic testing results
84	84	suggestive of possible channelopathies, arrhythmias,
85	85	cardiomyopathies, myocarditis, or structural heart disease;
86	86	(J) abnormal diagnostic imaging studies
87	87	suggestive of an underlying genetic condition such as a storage
88	88	disorder or brain white matter disease;
89	89	(K) abnormal physiologic function studies
90	90	suggestive of an underlying genetic origin such as a bleeding
91	91	disorder or immune deficiency disorder; or
92	92	(L) family genetic history related to the
93	93	recipient's condition.
94	94	(e) Except as provided by Subsection (g), genetic data
95	95	created as a result of rapid whole genome sequencing provided in
96	96	accordance with this section must primarily be used to assist the
97	97	genome sequencing provider who ordered the test and other health
98	98	care providers treating the recipient who is the subject of the
99	99	sequencing in the diagnosis and treatment of the recipient.
100	100	(f) Genetic data described by Subsection (e) is subject to
101	101	the requirements applicable to protected health information under
102	102	the Health Insurance Portability and Accountability Act of 1996
103	103	(Pub. L. No. 104-191), the American Recovery and Reinvestment Act
104	104	of 2009 (Pub. L. No. 111-5), and the rules adopted under those laws,
105	105	including 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and
106	106	E.
107	107	(g) A person may use genetic data described by Subsection (e)
108	108	in scientific research if the person receives express consent for
109	109	that use by the recipient or the recipient's parent, legal
110	110	guardian, or managing conservator if the recipient is a minor. The
111	111	recipient or recipient's parent, legal guardian, or managing
112	112	conservator may provide a written revocation of that consent to the
113	113	person at any time, and the person shall cease using the data and
114	114	expunge the data from the person's data repository immediately on
115	115	receipt of the revocation.
116	116	(h) A recipient or the recipient's parent, legal guardian,
117	117	or managing conservator if the recipient is a minor may request
118	118	access to the results of rapid whole genome sequencing authorized
119	119	under this section for use in other clinical settings.
120	120	SECTION 2. If before implementing any provision of this Act
121	121	a state agency determines that a waiver or authorization from a
122	122	federal agency is necessary for implementation of that provision,
123	123	the agency affected by the provision shall request the waiver or
124	124	authorization and may delay implementing that provision until the
125	125	waiver or authorization is granted.
126	126	SECTION 3. This Act takes effect September 1, 2023.