TITLE 25. HEALTH SERVICES

PART 7. TEXAS MEDICAL DISCLOSURE PANEL

CHAPTER 601. INFORMED CONSENT

25 TAC §601.9

The Texas Medical Disclosure Panel (panel) proposes an amendment to §601.9, concerning informed consent of patients.

BACKGROUND AND PURPOSE

The amendment is proposed in accordance with the Texas Civil Practice and Remedies Code, §74.102, 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 601.9 contains the disclosure and consent form for anesthesia and/or perioperative pain management (analgesia).

SECTION-BY-SECTION SUMMARY

Language is being revised in §601.9 to update language that replaces the legacy agency from the "Department of State Health Services" to the "Health and Human Services Commission."

The proposed amendment to §601.9 revises the disclosure and consent form in English and Spanish for anesthesia and/or perioperative pain management (analgesia) to modify language ensuring the physician delegating/supervising or performing the anesthetic will be privileged with the rebuttable presumption intended.

FISCAL NOTE

Dr. Noah Appel, Chairman, has determined that for each year of the first five years that the section will be in effect, there will be no fiscal impact to state or local governments as a result of administering the section as proposed.

GOVERNMENT GROWTH IMPACT STATEMENT

The panel has determined that during the first five years that the section will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of employee positions;

(3) implementation of the proposed rule will not require an increase or decrease in future legislative appropriations to the agency;

(4) the proposed rule will not affect fees paid to the agency;

(5) the proposed rule will not create new rules;

(6) the proposed rule will expand an existing rule;

(7) the proposed rule will not change the number of individuals subject to the rule; and

(8) the proposed rule will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Dr. Noah Appel has also determined that there will be no anticipated economic costs to small businesses, micro-businesses or rural communities required to comply with the amendment as proposed because regulated facilities already have an obligation to disclose risks and hazards related to medical care and surgical procedures. The amendment will not add additional costs.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT AND COSTS

In addition, Dr. Noah Appel has determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of enforcing or administering the amended disclosure rule will be that patients are better informed about the risks and hazards related to medical and surgical procedures they are considering.

In addition, Dr. Noah Appel, has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require any additional conduct for compliance.

REGULATORY ANALYSIS

The panel has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The panel has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking for which an assessment is required under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Pamela Adams, Manager, Health Facility Licensing, Health and Human Services Commission, Mail Code 2835, P.O. Box 149347, Austin, Texas 78714-9347, phone (512) 834-4571, by fax to (512) 834-4514, or by email to pamela.adams@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered at 8407 Wall Street, Austin, Texas 78754 before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a weekend or holiday, comments that are postmarked, shipped, faxed, or emailed before midnight on the following business day will be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule" in the subject line.

STATUTORY AUTHORITY

The amendment is authorized under the Texas Civil Practice and Remedies Code, §74.102, which provides the Texas Medical Disclosure Panel with the authority 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 form(s) for the treatments and procedures which do require disclosure.

The amendment implements the Texas Civil Practice and Remedies Code, Chapter 74.

§601.9.Disclosure and Consent Form for Anesthesia and/or Perioperative Pain Management (Analgesia).

The Texas Medical Disclosure Panel adopts the following form 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 [Department of State Health Services].

(1) English form.

Figure: 25 TAC §601.9(1) (.pdf)

[Figure: 25 TAC §601.9(1)]

(2) Spanish form.

Figure: 25 TAC §601.9(2) (.pdf)

[Figure: 25 TAC §601.9(2)]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on October 21, 2019.

TRD-201903831

Noah Appel, M.D.

Chairman

Texas Medical Disclosure Panel

Earliest possible date of adoption: December 1, 2019

For further information, please call: (512) 776-6972