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.
 
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