PART 7. TEXAS MEDICAL DISCLOSURE PANEL
CHAPTER 601. INFORMED CONSENT
The Texas Medical Disclosure Panel (Panel) adopts amendments to §601.5, concerning Disclosure and Consent Form for Radiation Therapy; and §601.9, concerning Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia). Sections 601.5 and 601.9 are adopted with changes to the proposed text as published in the November 4, 2022, issue of the Texas Register (47 TexReg 7389). The rules will be republished.
BACKGROUND AND JUSTIFICATION
These amendments are adopted in accordance with Texas Civil Practice and Remedies Code §74.103, which requires the Panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure. Section 601.5 contains the Disclosure and Consent Form for Radiation Therapy. Section 601.9 contains the Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia).
SECTION-BY-SECTION SUMMARY
Amendments to §601.5 replace the English and Spanish forms in Figure 25 TAC §601.5(1) and Figure 25 TAC §601.5(2) respectively and specify an effective date of September 1, 2023, for these forms.
Amendments to §601.9 replace the English and Spanish forms in Figure 25 TAC §601.9(1) and Figure 25 TAC §601.9(2) respectively and specify an effective date of September 1, 2023, for these forms.
PUBLIC COMMENT
The 31-day public comment period ended December 5, 2022. The Panel extended the comment period at its December 7, 2022, meeting to allow time for additional public comment until the Panel's next meeting, which was scheduled for February 1, 2023, and due to weather was postponed until April 4, 2023.
During the 31-day public comment period, the Panel received one comment from an individual regarding the proposed form language for §601.5.
Comment: The individual requested the Panel revise the form for §601.5 to include gender-neutral pronouns and inclusive language.
Response: The Panel revised the form accordingly.
During the 31-day and extended public comment periods, the Panel received 111 comments regarding the proposed form for §601.9 from three individuals and 11 organizations: the Texas Dental Association (TDA), the American Society of Dentist Anesthesiologists (ASDA), the Association of Dental Support Organizations (ADSO), the Texas Academy of Anesthesiologist Assistants (TAAA), the Texas Academy of Pediatric Dentistry (TAPD), the Texas Medical Association (TMA), the Texas Society of Oral and Maxillofacial Surgeons (TSOMS), the Texas Society of Periodontists (TSP), the Texas Association of Nurse Anesthetists (TANA), the Texas Academy of General Dentistry (TAGD), and the Texas Society of Anesthesiologists (TSA).
Comment: During the 31-day public comment period, the Panel received one comment from the TDA, one comment from the TAGD, one comment from the TSP and two comments from the ADSO. Each organization commented that the Panel reached out to some stakeholder groups but did not include dentistry stakeholder groups before the proposed revisions were published in the Texas Register. The TDA expressed concerns about the manner in which health care providers are identified and how the revised form in §601.9 works in conjunction with the Texas State Board of Dental Examiners' disclosure requirements. These organizations requested that the Panel delay adoption of the proposed amendments and allow an additional 30 days for comment, so that oral health stakeholders may provide additional input and participate in the rulemaking process.
Response: At its December 7, 2022, meeting, the Panel extended the public comment period until the Panel's next meeting, which was scheduled for February 1, 2023, and due to weather was postponed until April 4, 2023.
Comment: During the 31-day public comment period, the TAPD asked that the Panel not adopt §601.9 until after gathering input from all stakeholders impacted by it, including dentistry stakeholders. The TAPD noted that the American Academy of Pediatric Dentistry recommends "consent for sedation, general anesthesia, or behavior guidance techniques such as protective stabilization (i.e., immobilization) should be obtained separately from consent for other procedures." The TAPD also stated a "modified or customized form is preferred over a standard form" in pediatric dentistry and many of those basic requirements for valid consent are not to be found in the proposed document. The TAPD noted the Panel should consider the unique legal technicalities when dealing with pediatric patients, have a space to list the pediatric patient's legal name and date of birth, include a place for a dentist to sign the consent, and list the indications for the sedation or anesthetic procedure.
Response: At its December 7, 2022, meeting, the Panel extended the public comment period until the Panel's next meeting, which was scheduled for February 1, 2023, and due to weather was postponed until April 4, 2023. The Panel declined to make the suggested changes and noted that providers are free to modify the forms to fit their practice.
Comment: During the 31-day public comment period, the TMA urged the Panel to include delegation and supervision language in the new proposed form for the purpose of patient transparency. Specifically, TMA asked the Panel to incorporate the phrase "appropriate supervision" to provide better transparency to the patient. TMA also requested the Panel change "Resident Physician" to "Physician in Training Dr. [Name]" and move the option to the top in order with the other physician options, and also requested the Panel add a form date to the document to help determine which document version is valid.
Response: The Panel revised the form by adding "The Physician in Training" in the administration of anesthesia/analgesia being delegated/supervised. The Panel declined to make additional changes and noted that providers are free to modify the forms to fit their practice.
Comment: During the 31-day public comment period, the TSOMS asked the Panel to extend the time for public comment to allow for more input, and suggested adding a third check box following the options "Anesthesiologist" and "Non-Anesthesiologist Physician or Dentist."
Response: The Panel extended the comment period and added "Physician Anesthesiologist" and "Dentist Anesthesiologist" under the Administration of Anesthesia/Analgesia Planned approach.
Comment: During the 31-day public comment period, the TAAA commented that it is supportive of the draft form in §601.9 and suggested adding the words "delegation occurs" to the parenthetical statement on page one "(check all that apply, if any)" so that the statement would read "(check all that apply, if any delegation occurs)." This would provide greater clarity to the patient as to the delegated nature of the anesthetic they are to receive.
Response: The Panel revised the form by adding "if the administration of anesthesia/analgesia is being delegated/supervised by the above provider."
Comment: During the 31-day public comment period, the ASDA advised the Panel to amend the current form by adding the title "Dentist Anesthesiologist" among the different categories included.
Response: The Panel revised the form based on this comment.
Comment: During the 31-day public comment period, the TSA recommended adding space to account for a second witness line to account for when a phone consent is obtained for an emergency situation and specifying that a second witness is required when phone consent is obtained. TSA also advised adding the terms "delegating/supervising" when the form is referring to a non-attending physician. Additionally, two individuals with the Texas Society of Anesthesiologists at the December 7, 2022, meeting recommended adding "Check all that apply, if any, when delegating to/supervising the following providers; change "resident physician to physician in training" in the Administration of Anesthesia/Analgesia section near the top of page one; and adding a section at the end of the form to allow for a signature block to record a "second witness (required by phone consents)" signature and contact information.
Response: The Panel did not revise the form with a second witness line and "delegating/supervising" because medical providers are free to revise the form if the revision does not conflict with any existing requirements, and under Texas Civil Practice and Remedies Code §74.105, consent is considered effective if one witness signs the form. The Panel revised the form based on the "check all that apply" comment.
Comment: During the 31-day public comment period, the Panel received 93 emails with identical content indicating opposition to Certified Registered Nurse Anesthetist (CRNA) language proposed for the form in §601.9. Comments were received from individuals and members of the TxANA. One representative of TxANA also provided public comment at the December 7, 2022, meeting. These comments all expressed concern that when a CRNA is performing the anesthesia alongside a surgeon, the form would say, "the plan is for the anesthesia/analgesia to be provided by" a non-anesthesiologist physician and a CRNA." The commenters noted that in many circumstances, CRNAs not only perform the procedure but select the drug, dosage, and administration technique. In these cases, telling a patient that the plan is for anesthesia to be provided by a physician, like a surgeon, is misleading. Given that the CRNA selects the drug, dosage, and administration technique and then actually administers the anesthesia, the anesthesia care is clearly not being provided by a physician. The commenters advised the Panel to remove the "(Check one)" language and allow the care team to check any providers that will be providing anesthesia under the circumstances.
Response: The Panel revised the form to indicate specific provider types that may be providing anesthesia.
Comment: During the extended public comment period, one individual commenter thanked the group for acknowledging dentist anesthesiologists separately.
Response: The Panel acknowledges the comment.
Comment: During the extended public comment period, one individual commenter thanked the Panel for updating the Anesthesia Perioperative Pain Management and Disclosure Form in §601.9 to include dentist anesthesiologists as designated providers of anesthesia services, helping dentist anesthesiologists to be better recognized among our patients and peers.
Response: The Panel acknowledges the comment.
Comment: During the extended public comment period, the TAGD thanked the Panel for allowing time to review the form amendments to §601.9 and did not suggest any changes.
Response: The Panel acknowledges the comment.
Comment: During the extended public comment period, the TDA agreed with the Panel's proposed changes, and made a few recommendations including list "cardiac arrest" and "death" on the form in §601.9 as specific risks under General Anesthesia, Deep Sedation and Moderate Sedation "so that the patient is noticeably made aware of these possible outcomes no matter how slight that risk is"; and make the form's readability mirror that is utilized by HHSC in all patient-centric communications at or below a sixth-grade reading level as measured by the appropriate score on the Flesch-Kincaid Readability Test.
Response: The Panel did not revise the form as suggested because the specific risks mentioned were added at a higher level on the form and the forms are already written for a sixth-grade reading level.
Based on comments from Panel members, the Panel added language specifying the effective date for the forms in §601.5 and §601.9.
STATUTORY AUTHORITY
The amendments are authorized under Texas Civil Practice and Remedies Code §74.103, which requires the Panel to prepare lists of medical treatments and surgical procedures that do and do not require disclosure by physicians and health care providers of the possible risks and hazards, and to prepare the forms for the treatments and procedures which do require disclosure.
§601.5.Disclosure and Consent Form for Radiation Therapy.
The Texas Medical Disclosure Panel adopts the following form, effective September 1, 2023, to be used by a physician or health care provider to inform a patient or person authorized to consent for a patient of the possible risks and hazards involved in the radiation therapy named in the form. This form is to be used in lieu of the general disclosure and consent form adopted in §601.4(a) of this title (relating to Disclosure and Consent Form) for disclosure and consent relating to only radiation therapy procedures. If a surgical or anesthetic procedure is required in combination with a radiation therapy procedure, the general disclosure and consent form as adopted in §601.4(a) of this title and the form adopted in this section shall be used. The general disclosure and consent form shall be used for the surgical or anesthetic procedure and the radiation therapy disclosure and consent form shall be used for the radiation therapy procedure. Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Department of State Health Services.
(1) English form.
Figure: 25 TAC §601.5(1) (.pdf)
(2) Spanish form.
Figure: 25 TAC §601.5(2) (.pdf)
§601.9.Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia).
The Texas Medical Disclosure Panel adopts the following form, effective September 1, 2023, which shall be used to provide informed consent to a patient or person authorized to consent for the patient of the possible risks and hazards involved in anesthesia and/or perioperative pain management (analgesia). Providers shall have the form available in both English and Spanish language versions. Both versions are available from the Health and Human Services Commission.
(1) English form.
Figure: 25 TAC §601.9(1) (.pdf)
(2) Spanish form.
Figure: 25 TAC §601.9(2) (.pdf)
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on May 2, 2023.
TRD-202301603
Dr. Noah Appel
Panel Chairman
Texas Medical Disclosure Panel
Effective date: September 1, 2023
Proposal publication date: November 4, 2022
For further information, please call: (512) 438-2889