Texas 2023 - 88th Regular

Texas Senate Bill SB384 Compare Versions

Version 1 (Old)

Version 2 (New)

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1	1	By: Kolkhorst, West S.B. No. 384
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4	4	A BILL TO BE ENTITLED
5	5	AN ACT
6	6	relating to the sale, design, and manufacture of clear aligners.
7	7	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
8	8	SECTION 1. Subchapter B, Chapter 431, Health and Safety
9	9	Code, is amended by adding Section 431.024 to read as follows:
10	10	Sec. 431.024. CLEAR ALIGNERS. (a) In this section:
11	11	(1) "Clear aligner" means a medical device, excluding
12	12	a retainer used to keep teeth in a fixed position, that is:
13	13	(A) used in orthodontic treatment to move a
14	14	patient's teeth or jaw or correct a misalignment; and
15	15	(B) manufactured to address the specific
16	16	orthodontic needs of an individual patient.
17	17	(2) "Dentist" means a person licensed to practice
18	18	dentistry in this state under Subtitle D, Title 3, Occupations
19	19	Code.
20	20	(b) A person may not sell a clear aligner to a patient in
21	21	this state or provide a service related to the design or manufacture
22	22	of a clear aligner unless the person:
23	23	(1) is a dentist who has provided the services
24	24	prescribed by Subsection (c) to the patient; or
25	25	(2) receives written or electronic confirmation from a
26	26	dentist who has provided the services prescribed by Subsection (c)
27	27	to the patient.
28	28	(c) A person may not sell a clear aligner or provide a
29	29	service related to the design or manufacture of a clear aligner to a
30	30	patient in this state who has not received:
31	31	(1) an in-person intraoral dental examination and an
32	32	examination of the patient's head and neck;
33	33	(2) a review of recently performed x-rays, panoramic
34	34	x-rays, computed tomography, bone imaging scans, or other
35	35	appropriate diagnostic imaging sufficient to allow the dentist to
36	36	detect patient conditions that preclude or contraindicate the
37	37	provision of safe orthodontic treatment, including:
38	38	(A) untreated caries;
39	39	(B) gingivitis and periodontal disease;
40	40	(C) issues with the roots of teeth in the
41	41	periodontium, including short roots;
42	42	(D) the presence of an osseointegrated dental
43	43	implant or other fixed dental appliance;
44	44	(E) fractured, cracked, or split teeth or roots;
45	45	or
46	46	(F) any other oral pathology or condition that
47	47	precludes orthodontic treatment;
48	48	(3) a prescription for a clear aligner issued by:
49	49	(A) the dentist who provided the examination
50	50	described by Subdivision (1) and reviewed the appropriate
51	51	diagnostic imaging described by Subdivision (2); or
52	52	(B) the dentist who:
53	53	(i) will conduct and monitor the patient's
54	54	orthodontic treatment; and
55	55	(ii) has either:
56	56	(a) received a referral from the
57	57	patient's dentist described by Paragraph (A); or
58	58	(b) requested, received, and
59	59	maintained clearance for orthodontic treatment from the patient's
60	60	dentist described by Paragraph (A);
61	61	(4) subject to Subsection (d), counsel by a dentist
62	62	described by Subdivision (3) regarding available orthodontic
63	63	treatment options and the risks associated with those treatments;
64	64	and
65	65	(5) a review of the patient's medical and dental health
66	66	histories.
67	67	(d) The required counsel under Subsection (c)(4) is valid
68	68	only if the patient acknowledges and verifies in writing, with the
69	69	patient's signature, that the patient received the counsel. The
70	70	dentist providing the required counsel shall attach and maintain
71	71	the patient's written acknowledgment of counsel in the patient's
72	72	file.
73	73	(e) A person who sells a clear aligner to a patient or
74	74	provides a service related to the design or manufacture of a clear
75	75	aligner shall maintain any documents received under Subsection (c)
76	76	for not less than seven years after the date of sale or provision of
77	77	services.
78	78	(f) A dentist may not require a patient to agree to use a
79	79	particular type of clear aligner as a condition of performing the
80	80	examination or review described by Subsections (c)(1) and (2).
81	81	(g) A dentist described by Subsection (c)(3)(A) shall
82	82	provide any records collected under Subsections (c)(1) and (2) to
83	83	another dentist in accordance with Section 258.109, Occupations
84	84	Code, if:
85	85	(1) disclosure of a dental record is authorized under
86	86	Subchapter C, Chapter 258, Occupations Code; and
87	87	(2) the other dentist requests the records.
88	88	SECTION 2. Section 431.024, Health and Safety Code, as
89	89	added by this Act, applies only to services related to the design or
90	90	manufacture of a clear aligner that are provided or a clear aligner
91	91	sold on or after the effective date of this Act. Services related
92	92	to the design or manufacture of a clear aligner that are provided or
93	93	a clear aligner sold before the effective date of this Act is
94	94	governed by the law in effect immediately before the effective date
95	95	of this Act, and that law is continued in effect for that purpose.
96	96	SECTION 3. This Act takes effect September 1, 2023.