Bill Text: TX SB384 | 2023-2024 | 88th Legislature | Engrossed
Bill Title: Relating to the sale, design, and manufacture of clear aligners.
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2023-04-10 - Referred to Public Health [SB384 Detail]
Download: Texas-2023-SB384-Engrossed.html
By: Kolkhorst, West | S.B. No. 384 |
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relating to the sale, design, and manufacture of clear aligners. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subchapter B, Chapter 431, Health and Safety | ||
Code, is amended by adding Section 431.024 to read as follows: | ||
Sec. 431.024. CLEAR ALIGNERS. (a) In this section: | ||
(1) "Clear aligner" means a medical device, excluding | ||
a retainer used to keep teeth in a fixed position, that is: | ||
(A) used in orthodontic treatment to move a | ||
patient's teeth or jaw or correct a misalignment; and | ||
(B) manufactured to address the specific | ||
orthodontic needs of an individual patient. | ||
(2) "Dentist" means a person licensed to practice | ||
dentistry in this state under Subtitle D, Title 3, Occupations | ||
Code. | ||
(b) A person may not sell a clear aligner to a patient in | ||
this state or provide a service related to the design or manufacture | ||
of a clear aligner unless the person: | ||
(1) is a dentist who has provided the services | ||
prescribed by Subsection (c) to the patient; or | ||
(2) receives written or electronic confirmation from a | ||
dentist who has provided the services prescribed by Subsection (c) | ||
to the patient. | ||
(c) A person may not sell a clear aligner or provide a | ||
service related to the design or manufacture of a clear aligner to a | ||
patient in this state who has not received: | ||
(1) an in-person intraoral dental examination and an | ||
examination of the patient's head and neck; | ||
(2) a review of recently performed x-rays, panoramic | ||
x-rays, computed tomography, bone imaging scans, or other | ||
appropriate diagnostic imaging sufficient to allow the dentist to | ||
detect patient conditions that preclude or contraindicate the | ||
provision of safe orthodontic treatment, including: | ||
(A) untreated caries; | ||
(B) gingivitis and periodontal disease; | ||
(C) issues with the roots of teeth in the | ||
periodontium, including short roots; | ||
(D) the presence of an osseointegrated dental | ||
implant or other fixed dental appliance; | ||
(E) fractured, cracked, or split teeth or roots; | ||
or | ||
(F) any other oral pathology or condition that | ||
precludes orthodontic treatment; | ||
(3) a prescription for a clear aligner issued by: | ||
(A) the dentist who provided the examination | ||
described by Subdivision (1) and reviewed the appropriate | ||
diagnostic imaging described by Subdivision (2); or | ||
(B) the dentist who: | ||
(i) will conduct and monitor the patient's | ||
orthodontic treatment; and | ||
(ii) has either: | ||
(a) received a referral from the | ||
patient's dentist described by Paragraph (A); or | ||
(b) requested, received, and | ||
maintained clearance for orthodontic treatment from the patient's | ||
dentist described by Paragraph (A); | ||
(4) subject to Subsection (d), counsel by a dentist | ||
described by Subdivision (3) regarding available orthodontic | ||
treatment options and the risks associated with those treatments; | ||
and | ||
(5) a review of the patient's medical and dental health | ||
histories. | ||
(d) The required counsel under Subsection (c)(4) is valid | ||
only if the patient acknowledges and verifies in writing, with the | ||
patient's signature, that the patient received the counsel. The | ||
dentist providing the required counsel shall attach and maintain | ||
the patient's written acknowledgment of counsel in the patient's | ||
file. | ||
(e) A person who sells a clear aligner to a patient or | ||
provides a service related to the design or manufacture of a clear | ||
aligner shall maintain any documents received under Subsection (c) | ||
for not less than seven years after the date of sale or provision of | ||
services. | ||
(f) A dentist may not require a patient to agree to use a | ||
particular type of clear aligner as a condition of performing the | ||
examination or review described by Subsections (c)(1) and (2). | ||
(g) A dentist described by Subsection (c)(3)(A) shall | ||
provide any records collected under Subsections (c)(1) and (2) to | ||
another dentist in accordance with Section 258.109, Occupations | ||
Code, if: | ||
(1) disclosure of a dental record is authorized under | ||
Subchapter C, Chapter 258, Occupations Code; and | ||
(2) the other dentist requests the records. | ||
SECTION 2. Section 431.024, Health and Safety Code, as | ||
added by this Act, applies only to services related to the design or | ||
manufacture of a clear aligner that are provided or a clear aligner | ||
sold on or after the effective date of this Act. Services related | ||
to the design or manufacture of a clear aligner that are provided or | ||
a clear aligner sold before the effective date of this Act is | ||
governed by the law in effect immediately before the effective date | ||
of this Act, and that law is continued in effect for that purpose. | ||
SECTION 3. This Act takes effect September 1, 2023. |