TITLE 25.HEALTH SERVICES

Part 2. TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION

Subchapter L. MENTAL RETARDATION LOCAL AUTHORITY (MRLA) PROGRAM

25 TAC §§409.501, 409.503, 409.505, 409.507, 409.509, 409.511, 409.513, 409.515, 409.517, 409.519, 409.523, 409.525, 409.527, 409.529 - 409.531, 409.533, 409.535, 409.537, 409.539, 409.541 - 409.544

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeals of §§409.501, 409.503, 409.505, 409.507, 409.509, 409.511, 409.513, 409.515, 409.517, 409.519, 409.523, 409.525, 409.527, 409.529 - 409.531, 409.533, 409.535, 409.537, 409.539, and 409.541 - 409.544 of Chapter 409, Subchapter L, governing Mental Retardation Local Authority (MRLA) Program, without changes to the proposal as published in the January 23, 2004, issue of the Texas Register (29 TexReg 586).

The rules are repealed because TDMHMR no longer operates the Mental Retardation Local Authority (MRLA) Program, a Medicaid waiver program authorized under §1915(c) of the Social Security Act. This implements Texas Health and Safety Code, §533.0355, added by House Bill 2292 of the 78th Legislature, which redefined the responsibilities of mental retardation authorities (MRAs), program providers, and TDMHMR under the MRLA Program. The redefined responsibilities describe a program model that more closely resembles that of the Home and Community-Based Services (HCS) Program than the MRLA Program. TDMHMR has determined that the most efficacious manner to implement the redefined waiver program responsibilities required by §533.0355 was to provide all waiver services and supports through the HCS Program. Therefore, coinciding with the September 1, 2003, effective date of the relevant provisions of House Bill 2292, TDMHMR has provided all Medicaid waiver services through the HCS Program.

No comments on the proposed repeal were received.

The repeal is adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Board of Mental Health and Mental Retardation with broad rulemaking authority; the Texas Government Code, §531.021(a), and the Texas Human Resources Code, §32.021(a), which provide the Texas Health and Human Services Commission (THHSC) with the authority to administer the federal medical assistance (Medicaid) program in Texas; Acts 1995, 74th Texas Legislature, Chapter 6, §1, (Senate Bill 509), which clarifies the authority of THHSC to delegate the operation of all or part of a Medicaid program to a health and human services agency; and the Human Resources Code, §32.021(c), which provides an agency operating part of the Medicaid program with the authority to adopt necessary rules for the proper and efficient operation of the program. THHSC has delegated to the department the authority to operate the MRLA Program.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 14, 2004.

TRD-200403852

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: July 4, 2004

Proposal publication date: January 23, 2004

For further information, please call: (512) 206-4516

Chapter 414. PROTECTION OF CONSUMERS AND CONSUMER RIGHTS

Subchapter P. RESEARCH IN TDMHMR FACILITIES

25 TAC §§414.751 - 414.764

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts the repeal of §§414.751 - 414.764 of Chapter 414, Subchapter P, concerning research in TDMHMR facilities, without changes to the proposal as published in the April 16, 2004, issue of the Texas Register (29 TexReg 3767). New §§414.751 - 414.765 of Chapter 414, Subchapter P, concerning the same, which replace the repealed sections, are contemporaneously adopted in this issue of the Texas Register .

The repeal allows for the adoption of new sections governing the same matters.

No comments on the proposal were received.

The repeal is adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board (board) with broad rulemaking authority, and §576.021, which states that a patient receiving mental health services under Subtitle C has the right to refuse to participate in a research program.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2004.

TRD-200403881

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: July 5, 2004

Proposal publication date: April 16, 2004

For further information, please call: (512) 206-4516

25 TAC §§414.751 - 414.765

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new §§414.751 - 414.765 of Chapter 414, Subchapter P, concerning research in TDMHMR facilities, without changes to the proposed text as published in the April 16, 2004, issue of the Texas Register (29 TexReg 3767). The repeal of existing §§414.751 - 414.764 of Chapter 414, Subchapter P, concerning the same, which the new sections replace, are contemporaneously adopted in this issue of the Texas Register .

The new sections establish uniform guidelines for the review, approval, conduct, and oversight of research in TDMHMR facilities. The sections describe TDMHMR's general principles for research in its facilities; describe four options under which a facility may choose an institutional review board (IRB) as its designated IRB; describe the functions and operations of a designated IRB, including the responsibilities and requirements for reviewing, approving, and monitoring research; and describe the requirements for procedures for obtaining informed consent from prospective human subjects. The new rules would also adopt by reference Title 45, Code of Federal Regulations (CFR), Part 46 (Protection of Human Subjects), Subparts A, B, and D, to ensure the protection of human subjects involved in research; "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" (April 18, 1979), to ensure ethical principles are maintained when research involving human subjects is conducted; and 42 CFR Part 50, Subpart A, (Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science), to ensure all research undertaken at TDMHMR facilities is conducted with a fundamental commitment to high ethical standards regarding the conduct of scientific research.

The key difference between the new sections and the repealed sections is that the new sections incorporate requirements related to privacy of health information by adopting by reference the Federal Standards for Privacy of Individually Identifiable Health Information, 45 CFR Part 160 and Part 164, Subparts A and E, which are promulgated by the U.S. Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Additionally, the new rules do not adopt by reference 45 CFR Part 46, Subpart C (Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects); however, they contain all the subpart's requirements that are applicable to a TDMHMR facility.

No comments on the proposal were received.

These sections are adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board (board) with broad rulemaking authority, and §576.021, which states that a patient receiving mental health services under Subtitle C has the right to refuse to participate in a research program.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 15, 2004.

TRD-200403880

Rodolfo Arredondo

Chair, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: July 5, 2004

Proposal publication date: April 16, 2004

For further information, please call: (512) 206-4516