Texas 2025 - 89th Regular

Texas House Bill HB4070 Compare Versions

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

Old	New	Differences
1	1	89R17899 TYPED
2	2	By: Johnson H.B. No. 4070
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7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to the sale, design, and manufacture of orthodontic
10	10	devices.
11	11	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
12	12	SECTION 1. Subchapter B, Chapter 431, Health and Safety
13	13	Code, is amended by adding Section 431.024 to read as follows:
14	14	Sec. 431.024. ORTHODONTIC DEVICES. (a) In this section:
15	15	(1) "Orthodontic device" means any class II or class
16	16	III medical device, as defined by the United States Food and Drug
17	17	Administration under 21 U.S.C. Section 360c and 21 C.F.R. Section
18	18	860.3, excluding a retainer used to keep teeth in a fixed position,
19	19	that is:
20	20	(A) used in orthodontic treatment to move a
21	21	patient's teeth or jaw or correct a misalignment or malposition;
22	22	and
23	23	(B) manufactured to address the specific
24	24	orthodontic needs of an individual patient.
25	25	(2) "Dentist" means a person licensed to practice
26	26	dentistry in this state under Subtitle D, Title 3, Occupations
27	27	Code.
28	28	(b) A person may not sell an orthodontic device to a patient
29	29	in this state or provide a service related to the design or
30	30	manufacture of an orthodontic device unless the person:
31	31	(1) is a dentist who has provided the services
32	32	prescribed by Subsection (c) to the patient; or
33	33	(2) receives written or electronic confirmation from a
34	34	dentist who has provided the services prescribed by Subsection (c)
35	35	to the patient.
36	36	(c) A person may not sell an orthodontic device or provide a
37	37	service related to the design or manufacture of an orthodontic
38	38	device to a patient in this state who has not received:
39	39	(1) an in-person intraoral dental examination and an
40	40	examination of the patient's head and neck;
41	41	(2) a review of recently performed x-rays, panoramic
42	42	x-rays, computed tomography, bone imaging scans, or other
43	43	appropriate diagnostic imaging sufficient to allow the dentist to
44	44	detect patient conditions that preclude or contraindicate the
45	45	provision of safe orthodontic treatment, including:
46	46	(A) untreated caries;
47	47	(B) gingivitis and periodontal disease;
48	48	(C) issues with the roots of teeth in the
49	49	periodontium, including short roots;
50	50	(D) the presence of an osseointegrated dental
51	51	implant or other fixed dental appliance;
52	52	(E) fractured, cracked, or split teeth or roots;
53	53	or
54	54	(F) any other oral pathology or condition that
55	55	precludes orthodontic treatment;
56	56	(3) a prescription for an orthodontic device issued
57	57	by:
58	58	(A) the dentist who provided the examination
59	59	described by Subdivision (1) and reviewed the appropriate
60	60	diagnostic imaging described by Subdivision (2); or
61	61	(B) the dentist who:
62	62	(i) will conduct and monitor the patient's
63	63	orthodontic treatment; and
64	64	(ii) has either:
65	65	(a) received a referral from the
66	66	patient's dentist described by Paragraph (A); or
67	67	(b) requested, received, and
68	68	maintained clearance for orthodontic treatment from the patient's
69	69	dentist described by Paragraph (A);
70	70	(4) subject to Subsection (d), counsel by a dentist
71	71	described by Subdivision (3) regarding available orthodontic
72	72	treatment options and the risks associated with those treatments;
73	73	and
74	74	(5) a review of the patient's medical and dental health
75	75	histories.
76	76	(d) The required counsel under Subsection (c)(4) is valid
77	77	only if the patient acknowledges and verifies in writing, with the
78	78	patient's signature, that the patient received the counsel. The
79	79	dentist providing the required counsel shall attach and maintain
80	80	the patient's written acknowledgment of counsel in the patient's
81	81	file.
82	82	(e) A person who sells an orthodontic device to a patient or
83	83	provides a service related to the design or manufacture of an
84	84	orthodontic device shall maintain any documents received under
85	85	Subsection (c) for not less than seven years after the date of sale
86	86	or provision of services.
87	87	(f) A dentist may not require a patient to agree to use a
88	88	particular type of orthodontic device as a condition of performing
89	89	the examination or review described by Subsections (c)(1) and
90	90	(c)(2).
91	91	(g) A dentist described by Subsection (c)(3)(A) shall
92	92	provide any records collected under Subsections (c)(1) and (c)(2)
93	93	to another dentist in accordance with Section 258.109, Occupations
94	94	Code, if:
95	95	(1) disclosure of a dental record is authorized under
96	96	Subchapter C, Chapter 258, Occupations Code; and
97	97	(2) the other dentist requests the records.
98	98	SECTION 2. Section 431.024, Health and Safety Code, as
99	99	added by this Act, applies only to services related to the design or
100	100	manufacture of an orthodontic device that are provided or an
101	101	orthodontic device sold on or after the effective date of this Act.
102	102	Services related to the design or manufacture of an orthodontic
103	103	device that are provided or an orthodontic device sold before the
104	104	effective date of this Act are governed by the law in effect
105	105	immediately before the effective date of this Act, and that law is
106	106	continued in effect for that purpose.
107	107	SECTION 3. This Act takes effect September 1, 2025.