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.     * * * * *