Texas Register Spotlight – July 8th Edition

Below is a spotlight on the emergency, proposed, and adopted rules in the July 8^th edition of the Texas Register.

Healthcare:

DEPARTMENT OF STATE HEALTH SERVICES

Proposed Rules:

DSHS proposes amendments, concerning General Requirements, the Designation Process, Program Requirements, Maternal Designation Levels I-IV, Survey Team, and Perinatal Care Regions (PCRs). The proposal aims to update the content and processes with the advances and practices since the rules were adopted in 2018. SB 749 86(R) amended Texas Health and Safety Code, 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. HB 1164 87(R) 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. Earliest Possible Date of Adoption is August 7, 2022

DSHS proposes the repeal of sections concerning the Designated Institutional Review Board, IRB Functions and Operations, Review and Approval of Proposed Research, Informed Consent, Research Involving Offenders as Human Subjects, Using and Disclosing Protected Health Information (PHI) in Research, Investigation of Allegations of Misconduct in Science, Responsibilities of the Office of Research Administration. 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 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. Earliest Possible Date of Adoption is August 7, 2022

TEXAS HEALTH AND HUMAN SERVICES COMMISSION

Proposed Rules

HHSC proposes the amendments concerning Changes That Could Affect the Certificate of Public Advantage, Conditions for Issuing a Certificate of Public Advantage, Rate Reviews for Hospitals Operating Under a Certificate of Public Advantage, Annual Review, Corrective Action Plan, Annual Public Hearing, Voluntary Termination, and Supervision Fees. The proposal aims to update the rules regarding a Certificate of Public Advantage. The proposal aims to add additional clarity to stakeholders, update supervision fees and reporting requirements, and ensures consistency between COPA rules and Texas Health and Safety Code Chapter 314A, as added by HB 3301 86(R). Earliest possible date of adoption: August 7, 2022

HHSC proposes a new chapter concerning Research Involving Health and Human Services Commission Services, Responsibilities of the Institutional Review Board 2. The purpose of the proposed new rules is to move HHSC rules in Texas Administrative Code 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 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).

Other

Proposed Rules

TEXAS PARKS AND WILDLIFE DEPARTMENT

The Texas Parks and Wildlife Department proposes amendments concerning Disease Detection and Response. The proposed amendments would establish one new containment zone (CZ) 6, expand existing CZ 3, create a new surveillance zone (SZ) 8, and modify existing SZ 5 to either implement or improve surveillance efforts as part of the agency’s effort to manage chronic wasting disease (CWD). Chronic wasting disease (CWD) is a fatal neurodegenerative disorder that affects some cervid species, including white-tailed deer, mule deer, elk, red deer, sika, and their hybrids (referred to collectively as susceptible species). It is classified as a TSE (transmissible spongiform encephalopathy), a family of diseases that includes scrapie (found in sheep), bovine spongiform encephalopathy (BSE, found in cattle and commonly known as “Mad Cow Disease”), and variant Creutzfeldt-Jakob Disease (vCJD) in humans. The proposed amendment would enlarge current CZ 3 in Medina County in response to the detection of CWD in another deer within the current CZ. On February 3, 2022, the department received confirmation that a free-ranging 5.5-year-old female white-tailed deer within the current CZ had tested positive for CWD. The action enlarges the current CZ in order to comport the CZ with existing parameters for containment zones and is necessary to provide for additional surveillance within the recalculated parameters. Earliest possible date of adoption: August 7, 2022