89R17899 TYPED
By: Johnson H.B. No. 4070
A BILL TO BE ENTITLED
AN ACT
relating to the sale, design, and manufacture of orthodontic
devices.
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. ORTHODONTIC DEVICES. (a) In this section:
(1) "Orthodontic device" means any class II or class
III medical device, as defined by the United States Food and Drug
Administration under 21 U.S.C. Section 360c and 21 C.F.R. Section
860.3, 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 or malposition;
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 an orthodontic device to a patient
in this state or provide a service related to the design or
manufacture of an orthodontic device 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 an orthodontic device or provide a
service related to the design or manufacture of an orthodontic
device 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 an orthodontic device 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 an orthodontic device to a patient or
provides a service related to the design or manufacture of an
orthodontic device 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 orthodontic device as a condition of performing
the examination or review described by Subsections (c)(1) and
(c)(2).
(g) A dentist described by Subsection (c)(3)(A) shall
provide any records collected under Subsections (c)(1) and (c)(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 an orthodontic device that are provided or an
orthodontic device sold on or after the effective date of this Act.
Services related to the design or manufacture of an orthodontic
device that are provided or an orthodontic device sold before the
effective date of this Act are 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, 2025.