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A BILL TO BE ENTITLED
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AN ACT
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relating to the sale of clear aligners. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter B, Chapter 431, Health and Safety |
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Code, is amended by adding Section 431.024 to read as follows: |
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Sec. 431.024. SALE OF CLEAR ALIGNERS. (a) In this section: |
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(1) "Clear aligner" means a medical device, excluding |
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a retainer used to keep teeth in a fixed position, that is: |
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(A) used in orthodontic treatment to gradually |
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move a patient's teeth or jaw and correct a misalignment; and |
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(B) manufactured to address the patient's unique |
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orthodontic needs. |
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(2) "Dentist" means a person licensed to practice |
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dentistry in this state under Subtitle D, Title 3, Occupations |
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Code. |
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(b) A person may not sell a clear aligner to a patient in |
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this state unless the person has received written or electronic |
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confirmation from a dentist that the patient has received: |
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(1) an intraoral or extraoral dental examination; |
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(2) a review of new or recently conducted x-rays, |
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panoramic x-rays, computed tomography, bone imaging scans, or other |
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appropriate diagnostic imaging sufficient to allow the dentist to |
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detect conditions in the patient that would preclude or |
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contraindicate the provision of safe orthodontic treatment, |
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including: |
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(A) untreated caries; |
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(B) gingivitis and periodontal disease; |
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(C) issues with the roots of teeth in the |
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periodontium, including short roots; |
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(D) the presence of an osseointegrated dental |
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implant or other fixed dental appliance; or |
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(E) fractured, cracked, or split teeth or roots; |
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(3) a prescription for a clear aligner issued by: |
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(A) the dentist who provided the examination |
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described by Subsection (b)(1) and reviewed the appropriate |
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diagnostic imaging described by Subsection (b)(2); or |
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(B) the dentist who: |
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(i) will conduct and monitor the patient's |
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orthodontic treatment; and |
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(ii) has either: |
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(a) received a referral from the |
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patient's dentist described by Paragraph (A); or |
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(b) requested, received, and |
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maintained clearance for orthodontic treatment from the patient's |
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dentist described by Paragraph (A); and |
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(4) subject to Subsection (c), counsel by a dentist |
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described by Subdivision (3) regarding available orthodontic |
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treatment options and the risks associated with those treatments. |
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(c) The required counsel under Subsection (b)(4) is valid |
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only if the patient acknowledges and verifies in writing, with the |
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patient's signature, that the patient has received the counsel. |
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The dentist providing the required counsel shall attach and |
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maintain the patient's written acknowledgment of counsel in the |
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patient's file. |
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(d) A person who sells a clear aligner to a patient shall |
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maintain any documents received under Subsection (b) for not less |
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than seven years after the date of sale. |
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SECTION 2. Section 431.024, Health and Safety Code, as |
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added by this Act, applies only to a clear aligner sold on or after |
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the effective date of this Act. A clear aligner sold before the |
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effective date of this Act is governed by the law in effect |
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immediately before the effective date of this Act, and that law is |
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continued in effect for that purpose. |
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SECTION 3. This Act takes effect September 1, 2023. |