TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER A. INVESTIGATIONAL TREATMENTS FOR PATIENTS WITH SEVERE CHRONIC DISEASES

25 TAC §§1.1 - 1.4

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts new Subchapter A, §§1.1 - 1.4, concerning Investigational Treatments for Patients with Severe Chronic Diseases. The new rules are adopted without changes to the proposed text as published in the May 3, 2024, issue of the Texas Register (49 TexReg 2923). These rules will not be republished.

BACKGROUND AND JUSTIFICATION

The adoption implements Senate Bill 773, 88th Legislature, Regular Session, 2023, which added Chapter 490 to the Texas Health and Safety Code allowing access to investigational treatments for patients with severe chronic disease. Texas Health and Safety Code §490.002 requires DSHS to designate medical conditions considered to be severe chronic diseases. Texas Health and Safety Code §490.052 states that DSHS may prescribe a form for the informed consent required by the new subchapter.

COMMENTS

The 31-day comment period ended June 3, 2024.

During this period, DSHS did not receive any comments regarding the proposed rules.

STATUTORY AUTHORITY

The new rules are adopted under Texas Health and Safety Code Chapter 490. The new rules are also adopted under Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.

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 July 30, 2024.

TRD-202403506

Cynthia Hernandez

General Counsel

Department of State Health and Services

Effective date: August 19, 2024

Proposal publication date: May 3, 2024

For further information, please call: (512) 939-7575


CHAPTER 133. HOSPITAL LICENSING

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §133.46

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §133.46, concerning Billing Requirements.

The amendment to §133.46 is adopted without changes to the proposed text as published in the April 26, 2024, issue of the Texas Register (49 TexReg 2612). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to implement Senate Bill (S.B.) 490, 88th Legislature, Regular Session, 2023.

S.B. 490 added new Texas Health and Safety Code (HSC) Chapter 185, which requires a health care provider to send a written, itemized bill of the alleged cost of each health care service and supply when the provider requests payment from a patient after providing the patient with a health care service or related supply.

HSC §185.003, as added by S.B. 490, requires HHSC to take disciplinary action against a provider that violates HSC Chapter 185 on or after September 1, 2023, as if the provider violated an applicable licensing law.

The amendment is necessary to add information regarding these itemized-bill requirements.

COMMENTS

The 31-day comment period ended May 28, 2024.

During this period, HHSC received a comment regarding the proposed rule from the Texas Hospital Association (THA). A summary of the comment relating to the rule and HHSC's response follows.

Comment: THA stated they do not object to HHSC's proposed amendments to §133.46(a) and that they appreciate HHSC's citation of the relevant portions of the HSC, which already provides detailed information on itemized billing requirements. THA added that if the statute were to change, HHSC would not be required to enact new rules to carry it out and that THA appreciated this flexibility.

Response: HHSC acknowledges this comment.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and HSC §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals.

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 July 29, 2024.

TRD-202403485

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: August 18, 2024

Proposal publication date: April 26, 2024

For further information, please call: (512) 834-4591


CHAPTER 135. AMBULATORY SURGICAL CENTERS

SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

25 TAC §135.4

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §135.4, concerning Ambulatory Surgical Center (ASC) Operation.

The amendment to §135.4 is adopted without changes to the proposed text as published in the April 26, 2024, issue of the Texas Register (49 TexReg 2614). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to implement Senate Bill (S.B.) 490, 88th Legislature, Regular Session, 2023.

S.B. 490 added new Texas Health and Safety Code (HSC) Chapter 185, which requires a health care provider to send a written, itemized bill of the alleged cost of each health care service and supply when the provider requests payment from a patient after providing the patient with a health care service or related supply.

HSC §185.003, as added by S.B. 490, requires HHSC to take disciplinary action against a provider that violates HSC Chapter 185 on or after September 1, 2023, as if the provider violated an applicable licensing law.

The amendment is necessary to add information regarding these itemized-bill requirements.

COMMENTS

The 31-day comment period ended May 28, 2024.

During this period, HHSC did not receive any comments regarding the proposed rule.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; HSC §243.009, which requires HHSC to adopt rules for licensing of ASCs; and HSC §243.010, which requires those rules to include minimum standards applicable to ASCs.

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 July 29, 2024.

TRD-202403482

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: August 18, 2024

Proposal publication date: April 26, 2024

For further information, please call: (512) 834-4591


CHAPTER 137. BIRTHING CENTERS

SUBCHAPTER D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES

25 TAC §137.39

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §137.39, concerning General Requirements for the Provision and Coordination of Treatment and Services.

The amendment to §137.39 is adopted without changes to the proposed text as published in the April 26, 2024, issue of the Texas Register (49 TexReg 2616). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to implement Senate Bill (S.B.) 490, 88th Legislature, Regular Session, 2023.

S.B. 490 added new Texas Health and Safety Code (HSC) Chapter 185, which requires a health care provider to send a written, itemized bill of the alleged cost of each health care service and supply when the provider requests payment from a patient after providing the patient with a health care service or related supply.

HSC §185.003, as added by S.B. 490, requires HHSC to take disciplinary action against a provider that violates HSC Chapter 185 on or after September 1, 2023, as if the provider violated an applicable licensing law.

The amendment is necessary to add information regarding these itemized-bill requirements.

COMMENTS

The 31-day comment period ended May 28, 2024.

During this period, HHSC did not receive any comments regarding the proposed rule.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; HSC §244.009, which requires HHSC to adopt rules for licensing of birthing centers; and HSC §244.010, which requires those rules to include minimum standards applicable to birthing centers.

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 July 29, 2024.

TRD-202403484

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: August 18, 2024

Proposal publication date: April 26, 2024

For further information, please call: (512) 834-4591


CHAPTER 139. ABORTION FACILITY REPORTING AND LICENSING

SUBCHAPTER D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES

25 TAC §139.60

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §139.60, concerning Other State and Federal Compliance Requirements.

The amendment to §139.60 is adopted without changes to the proposed text as published in the April 26, 2024, issue of the Texas Register (49 TexReg 2618). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to implement Senate Bill (S.B.) 490, 88th Legislature, Regular Session, 2023.

S.B. 490 added new Texas Health and Safety Code (HSC) Chapter 185, which requires a health care provider to send a written, itemized bill of the alleged cost of each health care service and supply when the provider requests payment from a patient after providing the patient with a health care service or related supply.

HSC §185.003, as added by S.B. 490, requires HHSC to take disciplinary action against a provider that violates HSC Chapter 185 on or after September 1, 2023, as if the provider violated an applicable licensing law.

The amendment is necessary to add information regarding these itemized-bill requirements.

COMMENTS

The 31-day comment period ended May 28, 2024.

During this period, HHSC did not receive any comments regarding the proposed rule.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; HSC §245.009, which requires HHSC to adopt rules for licensing of abortion facilities; and HSC §245.010, which requires those rules to include minimum standards to protect the health and safety of a patient of an abortion facility and comply with HSC Chapter 171.

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 July 29, 2024.

TRD-202403486

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: August 18, 2024

Proposal publication date: April 26, 2024

For further information, please call: (512) 834-4591


CHAPTER 229. FOOD AND DRUG

SUBCHAPTER J. MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS

25 TAC §229.144

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §229.144, concerning State and Federal Statutes and Regulations.

The amendment to §229.144 is adopted without changes to the proposed text as published in the April 26, 2024, issue of the Texas Register (49 TexReg 2620). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to implement Senate Bill (S.B.) 490, 88th Legislature, Regular Session, 2023.

S.B. 490 added new Texas Health and Safety Code (HSC) Chapter 185, which requires a health care provider to send a written, itemized bill of the alleged cost of each health care service and supply when the provider requests payment from a patient after providing the patient with a health care service or related supply.

HSC §185.003, as added by S.B. 490, requires HHSC to take disciplinary action against a provider that violates HSC Chapter 185 on or after September 1, 2023, as if the provider violated an applicable licensing law.

The amendment is necessary to add information regarding these itemized-bill requirements.

COMMENTS

The 31-day comment period ended May 28, 2024.

During this period, HHSC did not receive any comments regarding the proposed rule.

STATUTORY AUTHORITY

The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; and HSC §466.004, which authorizes HHSC to administer and enforce rules to ensure the proper use of approved narcotic drugs in the treatment of persons with a narcotic drug dependency.

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 July 29, 2024.

TRD-202403483

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: August 18, 2024

Proposal publication date: April 26, 2024

For further information, please call: (512) 834-4591