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A BILL TO BE ENTITLED
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AN ACT
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relating to the sale, design, and manufacture of orthodontic |
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devices. |
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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. ORTHODONTIC DEVICES. (a) In this section: |
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(1) "Orthodontic device" means any class II or class |
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III medical device, as defined by the United States Food and Drug |
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Administration under 21 U.S.C. Section 360c and 21 C.F.R. Section |
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860.3, excluding a retainer used to keep teeth in a fixed position, |
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that is: |
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(A) used in orthodontic treatment to move a |
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patient's teeth or jaw or correct a misalignment or malposition; |
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and |
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(B) manufactured to address the specific |
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orthodontic needs of an individual patient. |
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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 an orthodontic device to a patient |
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in this state or provide a service related to the design or |
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manufacture of an orthodontic device unless the person: |
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(1) is a dentist who has provided the services |
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prescribed by Subsection (c) to the patient; or |
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(2) receives written or electronic confirmation from a |
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dentist who has provided the services prescribed by Subsection (c) |
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to the patient. |
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(c) A person may not sell an orthodontic device or provide a |
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service related to the design or manufacture of an orthodontic |
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device to a patient in this state who has not received: |
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(1) an in-person intraoral dental examination and an |
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examination of the patient's head and neck; |
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(2) a review of recently performed x-rays, panoramic |
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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 patient conditions that preclude or contraindicate the |
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provision of safe orthodontic treatment, 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; |
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(E) fractured, cracked, or split teeth or roots; |
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or |
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(F) any other oral pathology or condition that |
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precludes orthodontic treatment; |
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(3) a prescription for an orthodontic device issued |
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by: |
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(A) the dentist who provided the examination |
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described by Subdivision (1) and reviewed the appropriate |
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diagnostic imaging described by Subdivision (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); |
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(4) subject to Subsection (d), 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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and |
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(5) a review of the patient's medical and dental health |
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histories. |
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(d) The required counsel under Subsection (c)(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 received the counsel. The |
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dentist providing the required counsel shall attach and maintain |
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the patient's written acknowledgment of counsel in the patient's |
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file. |
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(e) A person who sells an orthodontic device to a patient or |
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provides a service related to the design or manufacture of an |
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orthodontic device shall maintain any documents received under |
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Subsection (c) for not less than seven years after the date of sale |
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or provision of services. |
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(f) A dentist may not require a patient to agree to use a |
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particular type of orthodontic device as a condition of performing |
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the examination or review described by Subsections (c)(1) and |
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(c)(2). |
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(g) A dentist described by Subsection (c)(3)(A) shall |
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provide any records collected under Subsections (c)(1) and (c)(2) |
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to another dentist in accordance with Section 258.109, Occupations |
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Code, if: |
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(1) disclosure of a dental record is authorized under |
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Subchapter C, Chapter 258, Occupations Code; and |
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(2) the other dentist requests the records. |
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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 services related to the design or |
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manufacture of an orthodontic device that are provided or an |
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orthodontic device sold on or after the effective date of this Act. |
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Services related to the design or manufacture of an orthodontic |
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device that are provided or an orthodontic device sold before the |
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effective date of this Act are 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, 2025. |