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.