88R3921 SRA-F
By: Kolkhorst S.B. No. 384
A BILL TO BE ENTITLED
AN ACT
relating to the sale 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. SALE OF 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 gradually
move a patient's teeth or jaw and correct a misalignment; and
(B) manufactured to address the patient's unique
orthodontic needs.
(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 unless the person has received written or electronic
confirmation from a dentist that the patient has received:
(1) an intraoral or extraoral dental examination;
(2) a review of new or recently conducted x-rays,
panoramic x-rays, computed tomography, bone imaging scans, or other
appropriate diagnostic imaging sufficient to allow the dentist to
detect conditions in the patient that would 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; or
(E) fractured, cracked, or split teeth or roots;
(3) a prescription for a clear aligner issued by:
(A) the dentist who provided the examination
described by Subsection (b)(1) and reviewed the appropriate
diagnostic imaging described by Subsection (b)(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); and
(4) subject to Subsection (c), counsel by a dentist
described by Subdivision (3) regarding available orthodontic
treatment options and the risks associated with those treatments.
(c) The required counsel under Subsection (b)(4) is valid
only if the patient acknowledges and verifies in writing, with the
patient's signature, that the patient has 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.
(d) A person who sells a clear aligner to a patient shall
maintain any documents received under Subsection (b) for not less
than seven years after the date of sale.
SECTION 2. Section 431.024, Health and Safety Code, as
added by this Act, applies only to a clear aligner sold on or after
the effective date of this Act. 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.