Texas Register July 29, 2023 Volume: 48 Number: 30

Texas Medical Disclosure Panel

Proposed Rules Re:

Repealing 25 TAC §§601.1 – 601.9, to remove previous rules concerning informed consent.

CHAPTER 601. INFORMED CONSENT
25 TAC §§601.1 – 601.9

OVERVIEW

The Texas Medical Disclosure Panel (Panel) is proposing a repeal of §§601.1 – 601.9, concerning Informed Consent, in the Texas Administrative Code, Title 25, Part 7, Chapter 601 and replacement with new §601.1 and §601.2, concerning General.

BACKGROUND AND JUSTIFICATION

The repeals and new rules are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.

The purpose of this project is to repeal current 25 TAC Chapter 601, Informed Consent, and replace it in a nonsubstantive manner with multiple chapters in order to make the Panel’s determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.

The proposed new Chapter 601 will contain the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel.

The proposed new Chapter 602 will list each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 603 will list each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 604 will contain general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules are published elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

The proposed repeal of §§601.1 – 601.9 removes the rules from Chapter 601, concerning Informed Consent, and places in new Chapters 601 – 604.


New 25 TAC §601.1, §601.2, to provide the general purpose of the chapter and provide a history of the procedures requiring disclosures.

CHAPTER 601. GENERAL
25 TAC §601.1, §601.2

OVERVIEW

The Texas Medical Disclosure Panel (Panel) is proposing a repeal of §§601.1 – 601.9, concerning Informed Consent, in the Texas Administrative Code, Title 25, Part 7, Chapter 601 and replacement with new §601.1 and §601.2, concerning General.

BACKGROUND AND JUSTIFICATION

The repeals and new rules are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.

The purpose of this project is to repeal current 25 TAC Chapter 601, Informed Consent, and replace it in a nonsubstantive manner with multiple chapters in order to make the Panel’s determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.

The proposed new Chapter 601 will contain the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel.

The proposed new Chapter 602 will list each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 603 will list each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 604 will contain general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules are published elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

  • The proposed new §601.1 outlines the purpose of the chapter, where the list of treatments and procedures requiring full disclosure by a physician or health care provider will be found, where the list of treatments and procedures requiring no disclosure by a physician or a health care provider will be found, and where the disclosure and consent forms adopted by the Panel will be found.
  • The proposed new §601.2 provides an overview of the history of the procedures requiring full disclosure–List A and the procedures requiring no disclosure–List B prior to this rule project.

New 25 TAC §§602.1 – 602.22, to outline a list of procedures which require full disclosure of the risks and hazards associated with them.

CHAPTER 602. PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS–LIST A
25 TAC §§602.1 – 602.22

OVERVIEW

The Texas Medical Disclosure Panel (Panel) is proposing new §§602.1 – 602.22, concerning Procedures Requiring Full Disclosure of Specific Risks and Hazards–List A, in the Texas Administrative Code, Title 25, Part 7, Chapter 602.

BACKGROUND AND JUSTIFICATION

These rule repeals and new rules are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.

The purpose of this project is to repeal current 25 TAC Chapter 601, Informed Consent, and replace it in a nonsubstantive manner with multiple chapters in order to make the Panel’s determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.

The proposed new Chapter 601 will contain the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 602 will list each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2.

The proposed new Chapter 603 will list each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 604 will contain general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules are published elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

  • Proposed new §602.1, Anesthesia treatments and procedures, lists the anesthesia treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.2, Cardiovascular system treatments and procedures, lists the cardiovascular system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.3, Digestive system treatments and procedures, lists the digestive system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.4, Ear treatments and procedures, lists the ear treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.5, Endocrine system treatments and procedures, lists the endocrine system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.6, Eye treatments and procedures, lists the eye treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.7, Female genital system treatments and procedures, lists the female genital system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.8, Hematic and lymphatic system treatments and procedures, lists the hematic and lymphatic system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.9, Breast surgery (non-cosmetic) treatments and procedures, lists the breast surgery (non-cosmetic) treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.10, Male genital system treatments and procedures, lists the male genital system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.11, Maternity and related cases treatments and procedures, lists the maternity and related cases treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.12, Musculoskeletal system treatments and procedures, lists the musculoskeletal system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.13, Nervous system treatments and procedures, lists the nervous system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.14, Radiology treatments and procedures, lists the radiology treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.15, Respiratory system treatments and procedures, lists the respiratory system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.16, Urinary system treatments and procedures, lists the urinary system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.17, Psychiatric treatments and procedures, lists the psychiatric treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.18, Radiation therapy treatments and procedures, lists the radiation therapy treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §601.19, Laparoscopic, thoracoscopic and robotic surgery treatments and procedures, lists the laparoscopic, thoracoscopic and robotic surgery treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.20, Pain management treatments and procedures, lists the pain management treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.21, Dental surgery treatments and procedures, lists the dental surgery treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.
  • Proposed new §602.22, Plastic surgery and surgery of the integumentary system treatments and procedures, lists the plastic surgery and surgery of the integumentary system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them.

New 25 TAC §§603.1 – 603.21, to list the procedures which require no disclosure of the risks and hazards associated with them.

CHAPTER 603. PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS–LIST B
25 TAC §§603.1 – 603.21

OVERVIEW

The Texas Medical Disclosure Panel (Panel) is proposing new §§603.1 – 603.21, concerning Procedures Requiring No Disclosure of Specific Risks and Hazards–List B in the Texas Administrative Code, Title 25, Part 7, Chapter 603.

BACKGROUND AND JUSTIFICATION

These rule repeals and new rules are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.

The purpose of this project is to repeal current 25 TAC Chapter 601, Informed Consent, and replace it in a nonsubstantive manner with multiple chapters in order to make the Panel’s determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.

The proposed new Chapter 601 will contain the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 602 will list each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 603 will list each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate chapter, instead of in a single section at the repealed §601.3.

The proposed new Chapter 604 will contain general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms. These new rules are published elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

  • Proposed new §603.1, Anesthesia treatments and procedures, lists the anesthesia treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.2, Cardiovascular system treatments and procedures, lists the cardiovascular system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.3, Digestive system treatments and procedures, lists the digestive system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.4, Ear treatments and procedures, lists the ear treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.5, Endocrine system treatments and procedures, lists the endocrine system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.6, Eye treatments and procedures, lists the eye treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.7, Female genital system treatments and procedures, lists the female genital system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.8, Hematic and lymphatic system treatments and procedures, lists the hematic and lymphatic system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.9, Breast surgery (non-cosmetic) treatments and procedures, lists the breast surgery (non-cosmetic) treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.10, Male genital system treatments and procedures, lists the male genital system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.11, Maternity and related cases treatments and procedures, lists the maternity and related cases treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.12, Musculoskeletal system treatments and procedures, lists the musculoskeletal system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.13, Nervous system treatments and procedures, lists the nervous system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.14, Radiology treatments and procedures, lists the radiology treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.15, Respiratory system treatments and procedures, lists the respiratory system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.16, Urinary system treatments and procedures, lists the urinary system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.17, Psychiatric treatments and procedures, lists the psychiatric treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.18, Radiation treatments and procedures, lists the radiation treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.19, Laparoscopic/Thoracoscopic surgery treatments and procedures, lists the laparoscopic/thoracoscopic surgery treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.20, Pain management treatments and procedures, lists the pain management treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.
  • Proposed new §603.21, Plastic surgery and surgery of the integumentary system treatments and procedures, lists the plastic surgery and surgery of the integumentary system treatments and procedures that the Panel has determined require no disclosure of the risks and hazards associated with them.

New 25 TAC §§604.1 – 604.5, to outline the requirements for consent forms for procedures requiring full disclosures of risks and hazards.

CHAPTER 604. DISCLOSURE FORMS
25 TAC §§604.1 – 604.5

OVERVIEW

The Texas Medical Disclosure Panel (Panel) is proposing new §§604.1 – 604.5, concerning Disclosure Forms, in the Texas Administrative Code, Title 25, Part 7, Chapter 604.

BACKGROUND AND JUSTIFICATION

These rule repeals and new rules are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created 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.

The purpose of this project is to repeal current 25 TAC Chapter 601, Informed Consent, and replace it in a nonsubstantive manner with multiple chapters in order to make the Panel’s determinations regarding risks and hazards related to medical care and surgical procedures more accessible to the public and more user-friendly.

The proposed new Chapter 601 will contain the purpose and history of the rules at 25 TAC Part 7, Texas Medical Disclosure Panel. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 602 will list each type of treatment and procedure that the Panel has determined requires full disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.2. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 603 will list each type of treatment and procedure that the Panel has determined requires no disclosure of the risks and hazards associated with it in a separate section, instead of in a single section at the repealed §601.3. These new rules are published elsewhere in this issue of the Texas Register.

The proposed new Chapter 604 will contain general, radiation therapy, electroconvulsive therapy, hysterectomy, and anesthesia and/or perioperative pain management disclosure and consent forms.

SECTION-BY-SECTION SUMMARY

  • Proposed new §604.1, Disclosure and Consent Form, lists the disclosure and consent forms that the Panel has determined are required to disclose risks and hazards associated with the procedures listed in Chapters 602 and 603.
  • Proposed new §604.2, Disclosure and Consent Form for Radiation Therapy, lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with radiation therapy procedures.
  • Proposed new §604.3, Informed Consent for Electroconvulsive Therapy, sets out disclosure requirements and options for electroconvulsive therapy.
  • Proposed new §604.4, Disclosure and Consent Form for Hysterectomy, lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with hysterectomy procedures.
  • Proposed new §604.5, Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia), lists the disclosure and/or consent forms that the Panel has determined are required to disclose risks and hazards associated with anesthesia and/or perioperative pain management (analgesia) procedures.

Texas Health and Human Services Commission

Adopted Rules Re:

Amending 26 TAC §554.2312, to address policies and procedures for surety bonds or letters of credit.

CHAPTER 554. NURSING FACILITY REQUIREMENTS FOR LICENSURE AND MEDICAID CERTIFICATION
SUBCHAPTER X. REQUIREMENTS FOR MEDICAID-CERTIFIED FACILITIES
26 TAC §554.2312

OVERVIEW

The Texas Health and Human Services Commission (HHSC) adopts the repeal of §554.2312, concerning Surety Bonds or Letters of Credit.

The repeal of §554.2312 is adopted without changes to the proposed text as published in the March 17, 2023, issue of the Texas Register (48 TexReg 1517). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the adopted repeal is to align the Texas Administrative Code to current HHSC policies and procedures concerning surety bonds or letters of credit. The repealed rule provided an optional procedure for issuing a surety bond to expedite the release of vendor holds. Under the repealed rule, the surety bond may only be issued after all cost reports have been submitted and recoupments pertaining to staffing have been paid in full. HHSC’s standard procedure is to release the vendor hold after the provider submits the cost report and pays any recoupment in full. Recoupments are offset against new claims or held payments. The standard procedure is efficient, and providers have not used the optional surety bond procedure to expedite the release of vendor holds. The repealed rule was last amended in 2004.