Adopted Rules Title 22

TITLE 22. EXAMINING BOARDS

The Texas Medical Board (Board) adopts new rules §165.7, Definitions, §165.8, concerning Abortion Ban Exception Performance and Documentation, and §165.9, concerning Complaints Regarding Abortions Performed. The new rules are being adopted with non-substantive changes to the proposed text as published in the April 5, 2024, issue of the Texas Register (49 TexReg 2164) and will be republished.

New §165.7, titled Definitions, describes the specific definitions and their sources for certain terms used in the new rules.

New §165.8, titled Abortion Ban Exception Performance and Documentation, explains that physicians must comply with all applicable laws, rules, and court opinions related to abortion in Texas. The rule also provides the minimum required information that must be included in the patient's medical record. The rule additionally makes clear that imminence of the threat to life or impairment of a major bodily function is not required to perform an abortion.

New §165.9, titled Complaints Regarding Abortions Performed, explains the procedures that the Board will utilize in the event a complaint is received. The rule also explains the limitation of any Board decision and that possible criminal or civil action under the law is separate and independent of any Board decision.

The Board received a significant number of comments. These comments included both written and oral comments. The oral comments were taken at the March 22, 2024, Board meeting and a stakeholder meeting held on May 20, 2024.

The majority of comments shared common concern over the proposed rules as published. There was uniform concern regarding the definitions in §165.7; most commenters felt the statutory definitions were not medically accurate. However, the Board does not have the authority to change statutory definitions, so no changes were made in response to these comments. Almost all commenters had concern over §165.8 as creating burdens and additional documentation that would adversely impact care, particularly the documentation of "adequate time to transfer" in §165.8(b)(5). The Board made changes in response to these comments to ensure no additional burdens were created for physicians caring for patients.

The Board received written comments regarding the proposed new rules from Steve and Amy Bresnen; Texas Medical Association (TMA); Texas Hospital Association (THA); Baylor Scott and White (BSW); Susan B. Anthony Society; Charolette Lozier Institute; Center for Reproductive Rights; Catholic Bishops Conference; Society of Maternal Fetal Medicine; American College of Obstetrics and Gynecology (ACOG); Public Rights Project; Texas Women's Health Caucus; individual physicians; and hundreds of private individuals, including use of form letters by two groups, "everyaction.com" and Texas Impact.

A summary of comments relating to the new rules and the Board's responses are as follows:

Comment by Steve and Amy Bresnen: The Bresnens filed a petition for rulemaking and a proposed rule. The Board declined the petition; however, the Board did proceed with proposing a rule it had drafted. The Bresnens opposed the Board's proposed rule and expressed a need for more definitions, as well as opposition to the documentation requirements as being onerous, delaying care, and without authority. They also expressed the need to begin the entire rule writing process again. The Bresnens filed several proposed new rules along with comments.

The first proposal included a completely new rule that created a "non-exhaustive" list of possible exceptions to the prohibition. It also included the creation of a "Panel on High-Risk Pregnancies" to develop a non-exhaustive list of conditions that may necessitate an abortion; the posting of this list of conditions by the Board (and provision of the list to the Texas Health and Human Services Commission [HHSC]); the posting of information of conditions to report to Department of State Health Services from abortion facilities; and finally, a completely new process for hearings on abortion exceptions and affirmative defenses, if Board action or a non-TMB action were brought against a physician.

The second and later proposal from the Bresnens was received during the comment period and provided for an extensive and exhaustive list of standards that would apply in a Board hearing if a case concerned abortion.

Response: TMB declines to accept either proposal on multiple grounds. Both proposals fundamentally change the informal hearing process and the statutorily created expert panel review process historically utilized by the Board.

The first proposal again asks for a non-exhaustive list of possible exceptions and conditions allowing abortions. The idea of any list is opposed by medical professionals and related associations, as well as by the Board. In medicine every patient and situation are unique and the intricacies of medicine and medical treatment that may accompany a patient cannot be captured by a list.

The entire process suggested in the first proposal goes beyond the disciplinary authority vested in the Board. The authority to enforce the majority of the provisions of Chapter 171 of the Health and Safety Code is vested in the HHSC Commissioner. See §171.005 of the Texas Health and Safety Code. Additionally, several provisions in Chapter 171 already allow for the hearing contemplated by this proposal, and the Board already has an exhaustive expert review and hearing process. Additionally, the proposal would create a redundant, duplicative, and completely unnecessary process. As to the proposed information gathering, reporting, and posting requirements, these items are already required and regulated by HHSC.

The Bresnens' second proposal includes a rebuttable presumption, application of the rules of evidence, and a clear and convincing standard in board hearings. This would transform the informal settlement conference into an evidentiary contested case hearing. The statutory standard in an informal board hearing is "to present facts that reasonably believe may be proven by competent evidence at a formal hearing." Additionally, the clear and convincing standard proposed alters the burden of proof well beyond the preponderance of evidence standard utilized for actual contested case hearings involving the board. The preponderance standard has been clearly established in multiple State Office of Administrative Hearings (SOAH) cases and substantial evidence reviews by state courts. The proposal exceeds any statutory authority of the Board, because it appears to set procedural and substantive rules for both SOAH hearings and civil courts reviewing a board action. For all these reasons, the Board declines to adopt these proposals.

Comment by Texas Medical Association (TMA): TMA opposed the Board's proposed rule. TMA asserted the need for more and medically accurate definitions, and they opposed the documentation requirements as being onerous, delaying care, and beyond the Board's authority. Generally, they stated the rule provided no help to physicians or patients and might lead to more confusion and uncertainty. They specifically objected to physicians having to follow all applicable court rulings as being burdensome and functionally difficult. TMA also asserted the rules could result in an inappropriate "checklist" approach to patient care.

Response: The Board cannot change statutory definitions and believes the definitions in the new rule are sufficient. Additionally, the Board does not believe that physicians being required to follow court rulings is burdensome and functionally difficult, as it is already a requirement under physician licensure. The Board also disagrees with TMA that rules could result in a "checklist" approach to patient care. However, the Board did make changes in response to the comment to documentation requirements to make clear that documentation is not required before a procedure can be performed and to clarify what items are required to be documented.

Comment by Texas Hospital Association (THA): THA opposed the Board's proposed rule. THA asserted the need for more and medically accurate definitions, and they opposed the documentation requirements as being onerous and delaying care. Generally, they stated the rule provided no help to physicians or patients. Further, THA implied that because a majority of these procedures take place in hospitals, the Board lacked authority to make rules related to the operation and regulation of hospitals.

Response: The Board cannot change statutory definitions and believes the definitions in the new rule are sufficient. The Board also disagrees that it lacks authority over physicians practicing in hospitals. However, the Board did make changes in response to the comment to documentation requirements to make clear that documentation is not required before a procedure can be performed and to clarify what items are required to be documented.

Comment by Baylor Scott and White (BSW): BSW opposed the Board's proposed rule. BSW asserted the need for expanded definitions, and they opposed the documentation requirements as being onerous, delaying care, and exceeding existing law related to documentation.

Response: The Board cannot change statutory definitions and believes the definitions in the new rule are sufficient. However, the Board did make changes in response to the comment to documentation requirements to make clear that documentation is not required before a procedure can be performed and to clarify what items are required to be documented.

Comment by Susan B. Anthony Society: The comment wanted more expanded definitions and explanation of certain statutory terms in the rule.

Response: The Board cannot change statutory definitions and believes the definitions in the new rule are sufficient. The Board declined to make any changes in response to this comment.

Comment by Charolette Lozier Institute: The comment expressed significant concerns which appeared to oppose the Board's proposed rule. The group asserted the need for expanded definitions; they asked for an explanation of the difference between a medically indicated separation and abortion. They also had concerns generally over certain documentation requirements.

Comment by Center for Reproductive Rights (CRR): The comment opposed the Board's proposed rule. CRR asserted the need for more expanded and medically accurate definitions, and they opposed the documentation requirements as being onerous and delaying care. Generally, they stated the rule provided no help to physicians or patients. They further asserted that the documentation rules contradict existing law in the Texas Health and Safety Code and that the proposed rules are beyond Board's statutory authority.

Comment by Catholic Bishops Conference: The comment generally favored the Board's proposed rule. The group, however, did assert the need to expand on the definition of ectopic pregnancy. They also opposed the documentation requirements as unnecessary. The group suggested current recordkeeping requirements in existing laws were adequate.

Comment by Society of Maternal Fetal Medicine: The comment opposed the Board's proposed rule. The group asserted the need for more and medically accurate definitions, and they opposed the documentation requirements as being onerous and delaying care. Generally, they stated the rule provided no help to physicians or patients.

Comment by American College of Obstetrics and Gynecology (ACOG): ACOG opposed the Board's proposed rule. ACOG asserted the definitions were redundant, and they opposed the documentation requirements as being onerous and delaying care. Generally, they stated the rule provided no help to physicians or patients. They also opposed creating any lists or "checklist" approach as advocated by some groups.

Comment by Public Rights Project: The comment opposed the Board's proposed rules. The group asserted the need for expanded definitions, and they opposed the requirements as being without statutory authority. Additionally, they believe the requirement for documentation goes beyond and conflicts with existing law such as Chapter 171 of the Health and Safety Code. Generally, they stated the rule provided no guidance to physicians.

Comment by Texas Women's Health Caucus: The comment opposed TMB's proposed rule. The group asserted the need for more and medically accurate definitions, and they opposed the documentation requirements as being onerous and delaying care. Generally, they stated the rules provided no help to physicians or patients.

There were a number of physicians that commented individually. They were generally opposed to the rule.

Summary of Comments: A majority of comments asked for further definitions of statutory terms and the addition of certain exceptions to the prohibition.

Response: The Board declines to make any changes in response to these comments. The Board has repeatedly clarified it cannot change the law or add exceptions for rape or incest. Nor can the Board add to statutory definitions. This is why the Board used references to existing statutes for certain terms such as "abortion," "reasonable medical judgment," and "major bodily function."

Summary of Comments: Numerous comments asserted that the definition of "abortion" was not medically accurate and that the use of the term "unborn child" was improper and instead should be "fetus."

Response: The Board declines to make changes in response to these comments because these are the statutory definitions, and any changes to the statutory definitions require legislative action.

Summary of Comments: Commenters wanted the definition of ectopic pregnancy to be expanded, added to, or examples included.

Response: In response, Board removed the proposed definition of ectopic pregnancy in §165.7. Many commenters asked that references to ectopic pregnancy more closely track with existing statutory references on the matter. Therefore, the Board made changes and the term "ectopic pregnancy" as used in §74.552 of the Texas Civil Practice & Remedies Code is now referenced in new §165.8(b)(6) and §165.9(e).

Summary of Comments: Almost every commenter said that Board needed to clarify that imminent risk of death to the patient is not required for an abortion.

Response: The Board made changes in response to this comment and clarified in new §165.8(d) that "imminence of death or impairment of a major bodily function is not required."

Summary of Comments: The comments asserted §165.8 overall added additional mandatory documentation requirements that were unnecessary. Several comments asked the Board to revise the rule to refer to documentation as set out in Chapter 171 of the Texas Health and Safety Code.

Response: The Board disagrees with these comments, and no changes were made in response to these comments. The rule does not change existing documentation requirements in §165.1. Rather, new §165.8 correlates with both existing rule (§165.1 of the Board's rules) and §171.008 of the Texas Health and Safety Code. Specifically, new §165.8 requires documentation of the medical emergency, while the corollary in §165.1 requires documentation of the reason for the visit and clinical assessment, and the corollary in §171.008 of the Texas Health and Safety Code requires documentation of the condition to be addressed. Section 165.8 requires documentation of the risk of death or substantial impairment of bodily function and why abortion was performed; the corollary in §165.1 requires relevant risk factors be identified and the treatment plan documented, and the corollary in §171.008 of the Texas Health and Safety Code requires documentation of the medical rationale for the abortion.

Summary of Comments: Commenters asserted they believed proposed §165.8 made documentation a requirement for physicians before performing an abortion on a patient experiencing a medical emergency.

Response: The Board disagrees with this assertion; documentation is not required before addressing an emergency. However, to ensure it is clear documentation can be done after the procedure, if the situation does not allow for documentation before the procedure, the Board added §165.8(c) to clarify the required documentation must be completed within 7 days of the procedure.

Summary of Comments: Virtually every commenter objected to proposed §165.8(b)(7). This provision stated a physician must document in the patient's medical record "whether there was adequate time to transfer the patient, by any means available to a facility or physician with a higher level of care or expertise to avoid performing an abortion." The concern was that every time a patient presented there would need to be documentation saying why the physician did or did not transfer, and this would delay care.

Response: The Board disagrees that proposed §165.8(b)(7) was mandatory; as discussed previously, these considerations must be documented but only if applicable. However, due to the overwhelming concern stated, the Board removed this provision from §165.8 completely. In response, the Board revised subsection (c) of §165.9 to clarify that the existing statutory review process related to standard of care already considers relevant information including transfer decisions, if applicable, in any medical emergency situation being reviewed.

§165.7.Definitions.

The following words and terms, when used in this section, shall have the following meanings:

(1) "Abortion" means the act of using or prescribing an instrument, a drug, a medicine, or any other substance, device, or means with the intent to cause the death of an unborn child of a woman known to be pregnant. The term does not include birth control devices or oral contraceptives. An act is not an abortion if the act is done with the intent to:

(A) save the life or preserve the health of an unborn child;

(B) remove a dead, unborn child whose death was caused by spontaneous abortion; or

This definition is found at Chapter 245, §245.002(1) of the Texas Health and Safety Code.

(2) "Reasonable medical judgment" means medical judgment made by a reasonably prudent physician, knowledgeable about a case and the treatment possibilities for the medical conditions involved. This definition is found at Chapter 170A, §170A.001(4) of the Texas Health and Safety Code.

(3) "Medical emergency" means a life-threatening physical condition aggravated by, caused by, or arising from a pregnancy that, as certified by a physician, places the woman in danger of death or a serious risk of substantial impairment of a major bodily function unless an abortion is performed. This definition is found at Chapter 171, §171.002(3) of the Texas Health and Safety Code.

(4) "Major bodily function" includes but is not limited to, functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions. This definition is found at Chapter 21, §21.002(11-a) of the Texas Labor Code.

§165.8.Abortion Ban Exception Performance and Documentation.

(a) An abortion shall not be performed in this state unless it is performed in compliance with all provisions of Texas Health and Safety Code, Chapters 170, 170A, and 171, in addition to any other applicable federal and state statutes, rules, and court opinions.

(b) In addition to the requirements above, the physician must document in the patient's medical record:

(1) that the abortion is performed in response to a medical emergency;

(A) that places the woman in danger of death unless the abortion is performed or induced; or

(B) to prevent a serious risk of substantial impairment of a major bodily function of the patient unless the abortion is performed or induced;

(2) the major bodily function(s) at serious risk of substantial impairment;

(3) what placed the woman in danger of death, or what was the serious risk of substantial impairment;

(4) how the danger of death or serious risk was determined;

(5) if applicable, the rationale on why the abortion was performed pursuant to §170A.002 (b)(3) of the Texas Health and Safety Code; and

(6) if applicable, that the treatment was in response to an ectopic pregnancy at any location or a previable premature rupture of membranes, as those terms are used in §74.552 of the Texas Civil Practice and Remedies Code.

(c) The above documentation must be made before and/or after performing the procedure, but the initial documentation must be made within 7 days of the procedure.

(d) Imminence of the threat to life or impairment of a major bodily function is not required.

§165.9.Complaints Regarding Abortions Performed.

(a) The Texas Medical Board will review complaints and perform investigations regarding abortions using the Board's standard complaint process.

(b) If a complaint is determined to be jurisdictional to the Board, the Board will use independent expert physicians, as provided in §154.0561 of the Texas Occupations Code, to review the available information, including the patient's medical record.

(c) As done in other complaints, the independent expert physicians may review all relevant information including one or more of the following:

(1) how the decision was made to proceed with an abortion based on reasonable medical judgement including:

(A) what diagnostic imaging, test results, medical literature, second opinions, and/or medical ethics committees that were used or consulted; and

(B) what alternative treatments were attempted and failed or were ruled out; and

(2) whether there was adequate time to transfer the patient to a facility or physician with a higher level of care or expertise to avoid performing an abortion.

(d) Any decision by the Board, to either dismiss the complaint or discipline the physician who is the subject of a complaint, is separate and independent of any other possible criminal or civil action under the law. If the Board is aware the licensee is subject to a pending criminal or civil action, then the Board may defer or delay action. Depending on the outcome of criminal or civil action, the Board retains authority to investigate and potentially take disciplinary action.

(e) The Board shall not take any disciplinary action against a physician who exercised reasonable medical judgment in providing medical treatment to a pregnant woman as described by §74.552 of the Texas Civil Practice and Remedies Code.

The new rules are adopted under the authority of the Texas Occupations Code, §153.001, which provides authority for the Board to recommend and adopt rules and bylaws as necessary to govern its own proceedings and perform its duties.

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 June 27, 2024.

TRD-202402831

Scott Freshour

General Counsel

Texas Medical Board

Effective date: July 17, 2024

Proposal publication date: April 5, 2024

For further information, please call: (512) 305-7030

PART 41. TEXAS BEHAVIORAL HEALTH EXECUTIVE COUNCIL

CHAPTER 882. APPLICATIONS AND LICENSING

SUBCHAPTER A. LICENSE APPLICATIONS

22 TAC §882.2

The Texas Behavioral Health Executive Council adopts amendments to §882.2, relating to General Application File Requirements. Section 882.2 is adopted without changes to the proposed text as published in the April 12, 2024, issue of the Texas Register (49 TexReg 2249) and will not be republished.

Reasoned Justification.

The adopted amendments clarify what information Council staff can rely upon when verifying an applicant's out-of-state licensure. The amendments allow the Council to rely on official verifications received directly from the other jurisdiction, information reflected on a government website, or verbal or email verification directly from the other jurisdiction. The sources of verification will assist the Council in more efficiently and effectively verifying an applicant's out-of-state licensure.

List of interested groups or associations against the rule.

None.

Summary of comments against the rule.

One commenter opposed the rule amendment on the grounds that they believe the Council should be eliminated and regulation returned solely to individual professional boards. Another commenter opposed the amendment on the grounds that the Council makes too many rule changes. A third commenter disagreed with the proposed amendment, but focused their comments on opposition to fingerprinting requirements.

List of interested groups or associations for the rule.

None.

Summary of comments for the rule.

One commenter expressed enthusiastic support for the proposed change in the hopes that the amendment will help streamline the licensure process. Another commenter expressed neutrality toward the proposal but supported the overall goal of addressing upstream issues in the licensure process. One commenter supported the amendment but asked whether documentation of licensure requirements will be required to be submitted again when changing license types.

Agency Response.

The Council declines to not adopt the rule as requested by commenters. The proposed amendment is a necessary rule change to improve the process by with the Council approves license applications. In addition, the Council can neither abolish the agency nor eliminate fingerprinting requirements, both of which are required by statute.

The Council thanks commenters for their supportive comments, and notes one comment was received which neither supported nor opposed the rule change, but rather asked a question unrelated to the rule proposal.

Statutory Authority.

The rule is adopted under Tex. Occ. Code, Title 3, Subtitle I, Chapter 507, which provides the Texas Behavioral Health Executive Council with the authority to make all rules, not inconsistent with the Constitution and Laws of this State, which are reasonably necessary for the proper performance of its duties and regulations of proceedings before it.

Additionally, the Executive Council adopts this rule pursuant to the authority found in §507.152 of the Tex. Occ. Code which vests the Executive Council with the authority to adopt rules necessary to perform its duties and implement Chapter 507 of the Tex. Occ. Code.

The Executive Council also adopts this rule under the authority found in §2001.004 of the Tex. Gov't Code which requires state agencies to adopt rules of practice stating the nature and requirements of all available formal and informal procedures.

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 June 26, 2024.

TRD-202402806

Darrel D. Spinks

Executive Director

Texas Behavioral Health Executive Council

Effective date: July 16, 2024

Proposal publication date: April 12, 2024

For further information, please call: (512) 305-7706