Texas Register Table of Contents
- 1 The Governor
- 2 State Board of Dental Examiners
- 3 Texas Department of State Health Services
- 3.0.1 Proposed Rules Re:
- 3.0.1.1 Amending 25 TAC §§133.201 – 133.211 to clarify requirements related to hospital level of care designations for maternal care.
- 3.0.1.2 Repealing 25 TAC §§414.751 – 414.765, concerning a transition of programs to HHSC and updated research protocols in order to align with applicable federal laws.
- 3.0.2 In Addition Re:
- 3.0.1 Proposed Rules Re:
- 4 Texas Health and Human Services Commission
- 4.0.1 Proposed Rules Re:
- 4.0.1.1 Amending 26 TAC §§567.2 and 567.6 to clarify existing definitions and existing language in a Certificate of Public Advantage (COPA).
- 4.0.1.2 Amending 26 TAC §§567.21, 567.22, 567.25, 567.26 to update words and the list of application items, and to clarify fees for Certificate of Public Advantage (COPA).
- 4.0.1.3 Repealing 26 TAC §§567.31 – 567.33, concerning terms, annual report, and voluntary termination of Certificate of Public Advantage (COPA).
- 4.0.1.4 New 26 TAC §§567.31 – 567.36, concerning terms, changes that may affect Certificate of Public Advantage (COPA), annual public hearing, annual report, voluntary termination, and supervision fees.
- 4.0.1.5 Amending 26 TAC §567.41 to clarify rate review requirements for hospitals operating under a Certificate of Public Advantage (COPA).
- 4.0.1.6 Amending 26 TAC §§567.52 – 567.54, concerning annual review, investigation, consequences, and corrective action plan.
- 4.0.1.7 New 26 TAC §§925.1 – 925.11 to describe components and use of an institutional review board for the review of certain research requests and activities pertaining to mental health, substance use, and intellectual or developmental disabilities services within HHSC.
- 4.0.2 Transferred Rules Re:
- 4.0.3 In Addition Re:
- 4.0.1 Proposed Rules Re:
- 5 Department of Aging and Disability Services
The Governor
Budget Execution Order
Transferring funds to support mental health and school safety initiatives.
OVERVIEW
Pursuant to Section 317.005(b) of the Government Code, the Governor ratifies the proposal dated June 27, 2022, which stated that there is an emergency pursuant to Section 317.002 of the Texas Government Code and recommended the transfer of funding between agencies as shown below.
BACKGROUND AND JUSTIFICATION
As the Legislative Budget Board noted, these funds are necessary to support additional mental health and school safety initiatives during the 2022-2023 state fiscal biennium and that need creates an emergency. There is no government function more critical than public safety. Though there is tremendous work that will need to be undertaken in the 88th Legislative Session, there are definitive actions we can take today that will improve safety and security for the upcoming school year. While no item is intended or imagined to address every conceivable outcome, when taken together with the steps Texas has already taken, the result will be that Texas school children, teachers, and families are safer.
DETAILS
Therefore, it is ordered that:
– $5,800,000 to the Higher Education Coordinating Board, for distribution by the Texas Child Mental Health Care Consortium, for expanding Texas Child Health Access Through Telemedicine (TCHATT) statewide;
– $4,725,000 to the Health and Human Services Commission for increasing of Multisystemic Therapy (MST) across the state;
– $950,000 to the Health and Human Services Commission for expanding Coordinated Specialty Care (CSC) teams across the state;
– From appropriations made to the Health and Human Services Commission by Senate Bill No. 1, General Appropriations Act, Acts of the 87th Legislature, Regular Session, 2021, an amount not to exceed $5,000,000 shall be used by the Health and Human Services Commission for a planning grant to the Hill Country Mental Health & Developmental Disabilities (MHDD) Center to assist the center in evaluating mental health services in the Uvalde community and preparing a needs assessment for submission to the Legislature. None of these funds may be used for real property acquisition or construction.
This fund transfer will not reduce the programs or benefits provided by the Texas Health and Human Services Commission from what was appropriated in the 2021 legislative session. To the extent this transfer results in a shortfall, it is the intent that the need will be fully addressed when the Legislature convenes in 2023.
Nothing in this proposal extends appropriation authority beyond August 31, 2023.
State Board of Dental Examiners
Proposed Rules Re:
Amending 22 TAC §104.2 to add Dental Risk Solutions, LLC as a Board approved continuing education course provider.
CHAPTER 104. CONTINUING EDUCATION
22 TAC §104.2
OVERVIEW
The State Board of Dental Examiners (Board) proposes this amendment to 22 TAC §104.2, concerning continuing education providers. The proposed amendment adds Dental Risk Solutions, LLC as a Board approved continuing education course provider to subsection (e)(22).
Repealing 22 TAC §108.25 to eliminate unnecessary repetitive statutory language.
CHAPTER 108. PROFESSIONAL CONDUCT
SUBCHAPTER B. SANITATION AND INFECTION CONTROL
22 TAC §108.25
OVERVIEW
The State Board of Dental Examiners (Board) proposes this repeal of 22 TAC §108.25, concerning dental health care workers. The proposed rule repeal deletes unnecessary repetitive statutory language found in Chapter 85 of the Texas Health and Safety Code.
Texas Department of State Health Services
Proposed Rules Re:
CHAPTER 133. HOSPITAL LICENSING
SUBCHAPTER K. HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE
25 TAC §§133.201 – 133.211
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §133.201, concerning Purpose; §133.202, concerning Definitions; §133.203, concerning General Requirements; §133.204, concerning the Designation Process; §133.205, concerning Program Requirements; §133.206, concerning Maternal Designation Level I; §133.207, concerning Maternal Designation Level II; §133.208, concerning Maternal Designation Level III; §133.209, concerning Maternal Designation Level IV; §133.210, concerning Survey Team; and new §133.211, concerning Perinatal Care Regions (PCRs).
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the content and processes with the advances and practices since the rules were adopted in 2018. Senate Bill (S.B.) 749, 86th Legislature, Regular Session, 2019, amended Texas Health and Safety Code, Chapter 241. S.B. 749 requires language specific to waiver agreements, a three-person appeal panel for designation reviews, and language specific to telemedicine and telehealth be integrated into the maternal rules.
House Bill (H.B.) 1164, 87th Legislature, Regular Session, 2021, amended Texas Health and Safety Code, Chapter 241. H.B.1164 added statutes concerning patient safety practices for placenta accreta spectrum disorder in hospitals with maternal levels of care designation. As part of the standards for designation, hospitals must implement patient safety practices for screening, evaluation, diagnosis, treatment, management, and reporting of placenta accreta spectrum disorder for all maternal patients and integrate these measures into their maternal Quality Assessment and Performance Improvement (QAPI) plan.
DSHS worked in collaboration with the Perinatal Advisory Council’s (PAC) subcommittee assigned to address the placenta accreta spectrum disorder patient safety practices. The PAC used data collected by DSHS in its analysis and recommendations. The PAC considered recommendations and publications of the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, including the publication “Guidelines for Perinatal Care.” The PAC also reviewed guidelines by the Society of Maternal-Fetal Medicine, the geographic and varied needs of citizens of this state, and the patient safety practices adopted under Texas Health and Safety Code §241.1837. The PAC and DSHS solicited comments from physicians who practice in the evaluation, diagnosis, treatment, and management of placenta accreta spectrum disorder; other health professionals who practice in the evaluation, diagnosis, treatment, and management of placenta accreta spectrum disorder; health researchers with expertise in placenta accreta spectrum disorder; representatives of patient advocacy organizations; and other interested persons during the rule development.
A similar PAC subcommittee addressed the rule language specific to integrating the telehealth and telemedicine into the maternal rules.
The PAC formed a workgroup to collaborate with DSHS staff to review the comments received during an informal comment period. Fourteen different letters were received. All comments were reviewed by DSHS staff and the PAC workgroup to determine the most appropriate language to ensure the health and safety of pregnant patients and prevent any unnecessary burden on the facilities providing maternal care.
SECTION-BY-SECTION SUMMARY
- The proposed amendment to §133.201 adds the word “Texas” for clarity in the Health and Safety Code.
- The proposed amendment to §133.202 revises definitions for “attestation,” “corrective action plan,” “department,” “immediately,” “PCR,” “POC,” “QAPI Plan,” “RAC,” “TSA,” and “urgent.” The new definitions include “board-eligible,” “EMS,” “Focused Survey,” “gestational age,” “high-risk infant,” “inter-facility transport,” “Maternal Oversight Committee,” “PASD,” “telehealth service,” and “telemedicine medical service.” The definition of “commission,” “Executive Commissioner,” and “office” were removed as these definitions are no longer necessary. The revised and new definitions provide clarity to the rule language and ensure consistency in interpretation of the rules
- The proposed amendment to §133.203 provides clarity to the rule language. The amendment clarifies the Levels III and IV maternal facility requirement for outreach education. The Level IV requirements for a placenta accreta spectrum multidisciplinary care team is included in this section. Subsection (g)(5) clarifies the survey team needs access to QAPI documents during a survey process. Subsection (h) clarifies the potential for conflict of interest regarding site surveyors. Subsection (h)(2) defines that the site survey summary and record reviews performed by a surveyor with an identified conflict of interest may not be accepted by the department.
- The proposed amendment to §133.204 provides clarity to the rule language. Subsection (a)(1) outlines the designation application expectations. Subsection (a)(2) includes the designation fees located on DSHS’s maternal website. Subsection (a)(1)(B) clarifies that the completed maternal attestation and self-survey report for Level I applications or the documented maternal designation site survey summary for Level II, III, and IV facilities that validates the designation requirements are met must be submitted to the department no later than 90 days after the maternal designation site survey date. Subsection (d) clarifies that the facility must submit the required designation application documents to the department no later than 90 days before the facility’s current maternal designation expiration date. The application fee amounts were removed from subsection (d) since the fees are located on the DSHS’s maternal website. Subsection (f) clarifies that the facility seeking designation renewal to maintain continual designation and prevent interruption in designation. Subsection (q) defines the appeal process to include a “three-person appeal panel” as required by S.B. 749. Subsection (r)(2) defines the waiver agreement process also outlined in S. B. 749. Subsection (t) defines the process for a maternal facility to relinquish its level of designation. Subsection (u) defines that the hospital cannot claim it is a designated facility or imply it is a designated facility unless it has completed the maternal designation process.
- The proposed amendment to §133.205 provides clarity and integrates rule language specific to placenta accreta spectrum disorder, telehealth, and telemedicine. In addition, the language specific to the QAPI Plan provides clearer expectations for the facility. Subsection (b) clarifies the expectations of the Maternal Program Plan. Subsection (b)(E) defines the integration expectations for telehealth/telemedicine practices. Subsection (d) clarifies the role and expectations of the Maternal Medical Director. Subsection (e) clarifies the role of the Maternal Program Manager.
- The proposed amendment to §133.206 defines the Maternal Designation Level I requirements. Subsection (c)(13) integrates the expectations related to placenta accreta spectrum disorder. Subsection (c)(14)(C) further outlines the team expectations for placenta accreta spectrum disorder screening and education.
- The proposed amendment to §133.207 defines the Maternal Designation Level II requirements. Subsection (c)(4) includes the “board-eligible” maternal fetal medicine physician language. Subsection (c)(12)(C)(i) removes the requirement for having platelet products on site at all times. Subsection (c)(15) integrates the placenta accreta spectrum disorder guidelines and a written plan into the rule requirements. Subsection (c)(16)(C) further defines the team education and screening requirements for placenta accreta spectrum disorder.
- The proposed amendment to §133.208 defines the Maternal Designation Level III requirements. Subsection (d)(5) integrates the “board-eligible” into the requirements. Subsection (d)(5)(A)-(C) defines the expectations for telehealth and telemedicine. Subsection (d)(7) outlines the expectations for Level III facilities that serve as a referral center for placenta accreta spectrum disorder. Subsection (d)(15)(C) integrates the term “board-eligible” anesthesiologist. Subsection (d)(22) outlines the facility’s expectations for a written hospital preparedness and management plan for placenta accreta spectrum disorder. Subsection(d)(23)(C) defines the expectations for team education and screening for placenta accreta spectrum disorder.
- The proposed amendment to §133.209 defines the Maternal Designation Level IV requirements. Subsection (a)(6) outlines the requirement for Level IV facilities to have a placenta accreta spectrum disorder multidisciplinary team. Subsection (a)(9) defines the outreach education expectations. Subsection (d)(3) integrates the inclusion of a “board-eligible” obstetrics and gynecology physician. Subsection (d)(8) defines the expectations for the placenta accreta spectrum disorder multidisciplinary team. Subsection (d)(14)(C) integrates the “board-eligible” anesthesiologist. Subsection (d)(21) defines the requirement for a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder. Subsection (d)(22)(C) further defines the requirements for placenta accreta spectrum disorder to include the team education, risk factor assessment screening, evaluation, diagnosis, referral, treatment, and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases.
- The proposed amendment to §133.210 outlines and clarifies the role and expectations of the maternal designation survey teams for Levels II, III, and IV facilities.
- New §133.211 outlines the maternal facility’s expectations regarding participation in the Perinatal Care Regions.
Repealing 25 TAC §§414.751 – 414.765, concerning a transition of programs to HHSC and updated research protocols in order to align with applicable federal laws.
CHAPTER 414. RIGHTS AND PROTECTIONS OF PERSONS RECEIVING MENTAL HEALTH SERVICES
SUBCHAPTER P. RESEARCH IN TDMHMR FACILITIES
25 TAC §§414.751 – 414.765
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes the repeal of Title 25, Part 1, Chapter 414, Subchapter P, consisting of §414.751, concerning Purpose; §414.752, concerning Application; §414.753, concerning Definitions; §414.754, concerning General Principles; §414.755, concerning Designated Institutional Review Board (IRB); §414.756, concerning IRB Functions and Operations; §414.757, concerning Review and Approval of Proposed Research; §414.758, concerning Informed Consent; §414.759, concerning Research Involving Offenders as Human Subjects; §414.760, concerning Using and Disclosing Protected Health Information (PHI) in Research; §414.761, concerning Investigation of Allegations of Misconduct in Science; §414.762, concerning Responsibilities of the Office of Research Administration (ORA); §414.763, concerning Exhibits; §414.764, concerning References; and §414.765, concerning Distribution.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to reflect the transition of programs from the Department of State Health Services to HHSC by repealing rules in Texas Administrative Code (TAC) Title 25, Part 1, Chapter 414, Subchapter P and simultaneously proposing new rules in 26 TAC Chapter 925. The new rules are published elsewhere in this issue of the Texas Register. The new rules reflect the transition of programs to HHSC; and update research protocols to align with applicable federal laws.
SECTION-BY-SECTION SUMMARY
The proposed repeal of 25 TAC Chapter 414, Subchapter P, deletes the rules as no longer necessary because the content of the rules are being proposed in new 26 TAC Chapter 925.
In Addition Re:
PUBLIC HEARING NOTICE: Legislative Appropriations Request (LAR) – Notice of Stakeholder Meeting for 2024-2025 Biennium LAR
OVERVIEW
DSHS will conduct a stakeholder meeting to receive input on public health program funding for the 2024-2025 biennium Legislative Appropriations Request. Stakeholder input is a critical element of this process.
Texas Health and Human Services Commission
Proposed Rules Re:
Amending 26 TAC §§567.2 and 567.6 to clarify existing definitions and existing language in a Certificate of Public Advantage (COPA).
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER A. GENERAL PROVISIONS
26 TAC §§567.2 – 567.6
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes the amendments to §567.2, concerning Definitions; §567.6, concerning Scope.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
- The proposed amendment to §567.2 clarifies existing definitions and defines the term “terms or conditions” to provide additional clarity to stakeholders.
- The proposed amendment to §567.6 clarifies the existing language and adds language to clarify that any COPA terms or conditions are separate from the COPA and that HHSC retains the authority to amend the terms or conditions.
Amending 26 TAC §§567.21, 567.22, 567.25, 567.26 to update words and the list of application items, and to clarify fees for Certificate of Public Advantage (COPA).
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER B. APPLICATION AND ISSUANCE
26 TAC §§567.21, 567.22, 567.25, 567.26
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §567.21, concerning Changes That Could Affect the Certificate of Public Advantage; §567.22, concerning Application; §567.25, concerning Fees; §567.26, concerning Conditions for Issuing a Certificate of Public Advantage.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
- The proposed amendment to §567.21 replaces “could” with “may” and adds “application” for clarity in the section title. The amendment updates the timeframe for notifying HHSC of changes under this section, removes “termination of the merger agreement” from the list of changes in this section, and makes other non-substantive clarifications.
- The proposed amendment to §567.22 replaces the specific list of application items with a more general requirement for applicants to submit an application as specified by HHSC and clarifies an application is not complete until it contains all supplementary information and the application fee. The proposed amendment also clarifies the requirements for redacting application data from public release and the start date for HHSC’s deadline to grant or deny the application.
- The proposed amendment to §567.25 updates the section title to “Application Fees,” clarifies the fees under subsection (a) are “application” fees, makes non-substantive stylistic changes, and removes the supervision fee information from this section. The supervision fee requirements are proposed in new §564.36.
- The proposed amendment to §567.26 relocates the language regarding terms or conditions of compliance currently at §567.31 to this section and makes other non-substantive stylistic changes.
Repealing 26 TAC §§567.31 – 567.33, concerning terms, annual report, and voluntary termination of Certificate of Public Advantage (COPA).
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
26 TAC §§567.31 – 567.33
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposing repealing of §567.31, concerning Terms; §567.32, concerning Annual Report; §567.33, concerning Voluntary Termination.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
The proposed repeals of §§567.31 – 567.33 are necessary to reorganize Subchapter C. The information in these sections is proposed for relocation in other sections of this chapter.
New 26 TAC §§567.31 – 567.36, concerning terms, changes that may affect Certificate of Public Advantage (COPA), annual public hearing, annual report, voluntary termination, and supervision fees.
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
26 TAC §§567.31 – 567.36
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposing new §567.31, concerning Terms; §567.32, concerning Changes that May Affect the Certificate of Public Advantage; §567.33, concerning Annual Public Hearing; §567.34, concerning Annual Report; §567.35, concerning Voluntary Termination; and §567.36, concerning Supervision Fees.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
- Proposed new §567.31 requires a hospital operating under a COPA to comply with all terms and conditions required in the issuance of a COPA.
- Proposed new §567.32 adds language requiring a hospital operating under a COPA to notify HHSC when certain changes occur that may affect the COPA.
- Proposed new §567.33 requires a hospital operating under a COPA to conduct an annual public hearing to obtain public input regarding the hospital’s COPA. The new section lists the requirements for the public hearing and requires the hospital operating under the COPA to provide information about the hearing in the annual report submitted to HHSC under proposed §567.34.
- Proposed new §567.34 contains the relocated annual report language from current §567.32. The new section updates the time frame a hospital operating under a COPA must submit the annual report to HHSC and clarifies HHSC may require more frequent reporting as a condition of the COPA but limits the more frequent reporting to no more than quarterly.
- Proposed new §567.35 contains information regarding voluntary termination relocated from current §567.34 and adds a reference to Texas Health and Safety Code §314A.058 to clarify the statutory reference for this section.
- Proposed new §567.36 contains relocated supervision fee information from current §567.25 and clarifies HHSC may assess an annual supervision fee of at least $75,000, but not more than $200,000, for each hospital operating under a COPA in accordance with Texas Health and Safety Code §314A.105. The new section sets the annual supervision fee at $100,000 and allows HHSC to decrease the fee to the statutory minimum or increase, in an interval of no more than 25% of the previous annual supervision fee, the amount to the statutory maximum by the amount needed to cover the reasonable costs incurred for supervising hospitals operating under a COPA.
Amending 26 TAC §567.41 to clarify rate review requirements for hospitals operating under a Certificate of Public Advantage (COPA).
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER D. RATE REVIEW
26 TAC §567.41
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposing amending §567.41, concerning Rate Reviews for Hospitals Operating Under a Certificate of Public Advantage.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §567.41 clarifies the requirements for applying to HHSC for a rate review and the required time frame and deadline for submitting a rate review application under this section. The proposed amendment also makes other non-substantive stylistic changes to this section.
Amending 26 TAC §§567.52 – 567.54, concerning annual review, investigation, consequences, and corrective action plan.
CHAPTER 567. CERTIFICATE OF PUBLIC ADVANTAGE
SUBCHAPTER E. ENFORCEMENT
26 TAC §§567.52 – 567.54
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposing amending §567.52, concerning Annual Review; §567.53, concerning Investigation; Consequences; and §567.54, concerning Corrective Action Plan.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to update the rules regarding a Certificate of Public Advantage (COPA). The proposal provides additional clarity to stakeholders, updates supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by House Bill 3301, 86th Legislature, Regular Session, 2019.
SECTION-BY-SECTION SUMMARY
- The proposed amendment to §567.52 updates the reference to the annual report section to proposed new §567.34.
- The proposed amendment to §567.53 adds language to clarify HHSC’s inspection authority regarding a hospital operating under a COPA or ancillary service area to ensure the activities of the hospital continue to benefit the public.
- The proposed amendment to §567.54 clarifies the deadline under subsections (b) and (c).
New 26 TAC §§925.1 – 925.11 to describe components and use of an institutional review board for the review of certain research requests and activities pertaining to mental health, substance use, and intellectual or developmental disabilities services within HHSC.
CHAPTER 925. RESEARCH INVOLVING HEALTH AND HUMAN SERVICES COMMISSION SERVICES
26 TAC §§925.1 – 925.11
OVERVIEW
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes in Title 26, Part 1, new Chapter 925, concerning Research Involving Health and Human Services Commission Services, consisting of §925.1, concerning Purpose; §925.2, concerning Application; and §925.3, concerning Definitions; §925.4, concerning General Principles; §925.5, concerning Designated Institutional Review Board; §925.6, concerning Designated Institutional Review Board Functions and Operations; §925.7, concerning Review and Approval of Proposed Research; §925.8, concerning Informed Consent; §925.9, concerning Using and Disclosing Protected Health Information in Research; §925.10, concerning Investigation of Allegations of Misconduct in Science; and §925.11, concerning Responsibilities of the Institutional Review Board 2.
BACKGROUND AND JUSTIFICATION
The purpose of the proposed new rules is to move HHSC rules in Texas Administrative Code (TAC) Title 25, Chapter 414, Subchapter P and 40 TAC Chapter 4, Subchapter P to 26 TAC Chapter 925 as part of consolidating HHSC rules. The current rules will be repealed, updated, and placed in 26 TAC Chapter 925. The proposed rules have updated agency information, revised research protocols to align with applicable federal laws, appropriate population language, and greater clarity with plain language where possible. The repeal of those rules is proposed simultaneously elsewhere in this issue of the Texas Register.
The rules describe the components and use of an institutional review board for the review of research requests and activities pertaining to mental health, substance use, and intellectual or developmental disabilities services within HHSC, involving one or more of the following:
- HHSC in-patient or community-based mental health services;
- HHSC community-based substance use services;
- HHSC intellectual or developmental disabilities services;
- data owned or created regarding individuals receiving HHSC services; or
- related HHSC resources (e.g., employees, property, and non-public information).
SECTION-BY-SECTION SUMMARY
- Proposed new §925.1 states the purpose of the new chapter.
- Proposed new §925.2 states that the rules apply to HHSC inpatient and residential services and HHSC-contracted community-based mental health, substance use, and intellectual and developmental disabilities services.
- Proposed new §925.3 provides the definitions used in the chapter.
- Proposed new §925.4 describes the general principals of research.
- Proposed new §925.5 describes the requirements and responsibilities of a designated institutional review board (IRB).
- Proposed new §925.6 describes the functions and operations of the designated IRB.
- Proposed new §925.7 provides the process for obtaining review and approval of proposed research.
- Proposed new §925.8 outlines the requirements of obtaining informed consent of research subjects.
- Proposed new §925.9 provides guidelines for the use and disclosure of protected health information in research.
- Proposed new §925.10 describes the process for investigating allegations of misconduct in research.
- Proposed new §925.11 states the responsibilities of the Institutional Review Board 2.
Transferred Rules Re:
Transferring DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 44, Consumer Managed Personal Attendant Services (CMPAS) Program to Texas Administrative Code, Title 26, Part 1, Chapter 275, Consumer Managed Personal Attendant Services (CMPAS) Program.
OVERVIEW
During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 44, Consumer Managed Personal Attendant Services (CMPAS) Program are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 275, Consumer Managed Personal Attendant Services (CMPAS) Program.
For more information, please visit this week’s issue of the Texas Register at 47 Tex Reg 3983.
In Addition Re:
Notice of Public Hearing on Long-Range Planning for State Supported Living Centers
BACKGROUND AND JUSTIFICATION
The purpose of the hearing is to receive public comment on the long-range planning for State Supported Living Centers including resident quality of care, community-based services, services to transition back to the community, and availability of services as required by 533A.032. This is the second of two public hearings on this topic.
Notice of Public Hearing on Long-Range Planning for State Supported Living Centers – July 11, 2022
BACKGROUND AND JUSTIFICATION
The purpose of the hearing is to receive public comment on the long-range planning for State Supported Living Centers including resident quality of care, community-based services, services to transition back to the community, and availability of services as required by 533A.032. This is the first of two public hearings; the second public hearing on the same topic is scheduled for July 18, 2022 (see subsequent notice for additional information).
Notice of Public Hearing on Proposed Updates to Medicaid Payment Rates
OVERVIEW
The effective date of the proposed payment rates for the Medical Transportation Program is July 1, 2022.
BACKGROUND AND JUSTIFICATION
The proposed payment rates were calculated in accordance with Title 1 of the Texas Administrative Code:
§355.8561, which addresses the reimbursement methodology for the Medical Transportation Program.
Department of Aging and Disability Services
Proposed Rules Re:
Repealing 40 TAC §§4.751 – 4.765 to reflect the transition of programs from the Department of Aging and Disability Services (DADS) to the Texas Health and Human Services Commission (HHSC).
CHAPTER 4. RIGHTS AND PROTECTION OF INDIVIDUALS RECEIVING INTELLECTUAL DISABILITY SERVICES
SUBCHAPTER P. RESEARCH IN STATE FACILITIES
40 TAC §§4.751 – 4.765
OVERVIEW
As required by Texas Government Code §531.0202(b), the Department of Aging and Disability Services (DADS) was abolished effective September 1, 2017, after all of its functions were transferred to the Texas Health and Human Services Commission (HHSC) in accordance with Texas Government Code §531.0201 and §531.02011. Rules of former DADS are codified in Title 40, Part 1, and will be repealed or administratively transferred to Title 26, Health and Human Services, as appropriate. Until such action is taken, the rules in Title 40, Part 1 govern functions previously performed by DADS that have transferred to HHSC. Texas Government Code §531.0055, requires the Executive Commissioner of HHSC to adopt rules for the operation and provision of services by the health and human services system, including rules in Title 40, Part 1.
Therefore, the Executive Commissioner of HHSC proposes the repeal of Title 40, Part 1, Chapter 4, Subchapter P, consisting of §4.751, concerning Purpose; §4.752, concerning Application; §4.753, concerning Definitions; §4.754, concerning General Principles; §4.755, concerning Designated Institutional Review Board (IRB); §4.756, concerning IRB Functions and Operations; §4.757, concerning Review and Approval of Proposed Research; §4.758, concerning Informed Consent; §4.759, concerning Research Involving Offenders as Human Subjects; §4.760, concerning Using and Disclosing Protected Health Information (PHI) in Research; §4.761, concerning Investigation of Allegations of Misconduct in Science; §4.762, concerning Responsibilities of the Office of Research Administration (ORA); §4.763, concerning Exhibits; §4.764, concerning References; and §4.765, concerning Distribution.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to reflect the transition of programs from DADS to HHSC by repealing rules in Texas Administrative Code (TAC) Title 40, Part 1, Chapter 4, Subchapter P and simultaneously proposing new rules in 26 TAC Chapter 925. The new rules are published elsewhere in this issue of the Texas Register. The new rules will reflect the transition of programs to HHSC and update research protocols to align with applicable federal laws.
SECTION-BY-SECTION SUMMARY
The proposed repeal of 40 TAC Chapter 4, Subchapter P, deletes the rules as no longer necessary because the content of the rules are being proposed in new 26 TAC Chapter 925.
Transferred Rules Re:
Transferring DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 44, Consumer Managed Personal Attendant Services (CMPAS) Program to Texas Administrative Code, Title 26, Part 1, Chapter 275, Consumer Managed Personal Attendant Services (CMPAS) Program.
OVERVIEW
During the 84th Legislative Session, the Texas Legislature passed Senate Bill 200, addressing the reorganization of health and human services delivery in Texas. As a result, some agencies were abolished and their functions transferred to the Texas Health and Human Services Commission (HHSC). Texas Government Code, §531.0202(b), specified the Department of Aging and Disability Services (DADS) be abolished September 1, 2017, after all its functions were transferred to HHSC in accordance with Texas Government Code, §531.0201 and §531.02011. The former DADS rules in Texas Administrative Code, Title 40, Part 1, Chapter 44, Consumer Managed Personal Attendant Services (CMPAS) Program are being transferred to Texas Administrative Code, Title 26, Part 1, Chapter 275, Consumer Managed Personal Attendant Services (CMPAS) Program.
For more information, please visit this week’s issue of the Texas Register at 47 Tex Reg 3983.