By: Kolkhorst S.B. No. 384
(In the Senate - Filed January 12, 2023; February 15, 2023,
read first time and referred to Committee on Health & Human
Services; March 20, 2023, reported adversely, with favorable
Committee Substitute by the following vote: Yeas 8, Nays 1;
March 20, 2023, sent to printer.)
Click here to see the committee vote
COMMITTEE SUBSTITUTE FOR S.B. No. 384 By: Hall
A BILL TO BE ENTITLED
AN ACT
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.
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.
* * * * *