TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

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 Hospital Billing.

The amendment is adopted without changes to the proposed text as published in the December 18, 2020, issue of the Texas Register (45 TexReg 8970). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Senate Bill (S.B.) 1264, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules relating to consumer protections against certain medical and health care billing by out-of-network licensed health care facilities, including abortion facilities, ambulatory surgical centers, birthing centers, chemical dependency treatment facilities, crisis stabilization units, end stage renal disease facilities, freestanding emergency medical care facilities, general and special hospitals, narcotic treatment programs, private psychiatric hospitals, and special care facilities.

COMMENTS

The 31-day comment period ended January 19, 2021.

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 of and provision of health and human services by the health and human services system; Texas Health and Safety Code §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals; and Texas Insurance Code §752.0003, which authorizes regulatory agencies to take action against facilities and providers that violate a balance billing prohibition.

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 March 26, 2021.

TRD-202101320

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: December 18, 2020

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 is adopted without changes to the proposed text as published in the December 18, 2020, issue of the Texas Register (45 TexReg 8972). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Senate Bill (S.B.) 1264, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules relating to consumer protections against certain medical and health care billing by out-of-network licensed health care facilities, including abortion facilities, ambulatory surgical centers, birthing centers, chemical dependency treatment facilities, crisis stabilization units, end stage renal disease facilities, freestanding emergency medical care facilities, general and special hospitals, narcotic treatment programs, private psychiatric hospitals, and special care facilities.

COMMENTS

The 31-day comment period ended January 19, 2021.

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 of and provision of health and human services by the health and human services system; Texas Health and Safety Code §243.009, which requires HHSC to adopt rules for licensing of ASCs; Texas Health and Safety Code §243.010, which requires those rules to include minimum standards applicable to ASCs; and Texas Insurance Code §752.0003, which authorizes regulatory agencies to take action against facilities and providers that violate a balance billing prohibition.

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 March 26, 2021.

TRD-202101321

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: December 18, 2020

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 is adopted without changes to the proposed text as published in the December 18, 2020, issue of the Texas Register (45 TexReg 8974). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Senate Bill (S.B.) 1264, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules relating to consumer protections against certain medical and health care billing by out-of-network licensed health care facilities, including abortion facilities, ambulatory surgical centers, birthing centers, chemical dependency treatment facilities, crisis stabilization units, end stage renal disease facilities, freestanding emergency medical care facilities, general and special hospitals, narcotic treatment programs, private psychiatric hospitals, and special care facilities.

COMMENTS

The 31-day comment period ended January 19, 2021.

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 of and provision of health and human services by the health and human services system; Texas Health and Safety Code §244.009, which requires HHSC to adopt rules for licensing of birthing centers; Texas Health and Safety Code §244.010, which requires those rules to include minimum standards applicable to birthing centers; and Texas Insurance Code §752.0003, which authorizes regulatory agencies to take action against facilities and providers that violate a balance billing prohibition.

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 March 26, 2021.

TRD-202101322

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: December 18, 2020

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 is adopted without changes to the proposed text as published in the December 18, 2020, issue of the Texas Register (45 TexReg 8976). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Senate Bill (S.B.) 1264, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules relating to consumer protections against certain medical and health care billing by out-of-network licensed health care facilities, including abortion facilities, ambulatory surgical centers, birthing centers, chemical dependency treatment facilities, crisis stabilization units, end stage renal disease facilities, freestanding emergency medical care facilities, general and special hospitals, narcotic treatment programs, private psychiatric hospitals, and special care facilities.

COMMENTS

The 31-day comment period ended January 19, 2021.

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 of and provision of health and human services by the health and human services system; Texas Health and Safety Code §245.009, which requires HHSC to adopt rules for licensing of abortion facilities; Texas Health and Safety Code §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 Texas Health and Safety Code Chapter 171; and Texas Insurance Code §752.0003, which authorizes regulatory agencies to take action against facilities and providers that violate a balance billing prohibition.

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 March 26, 2021.

TRD-202101323

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: December 18, 2020

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 is adopted without changes to the proposed text as published in the December 18, 2020, issue of the Texas Register (45 TexReg 8993). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The amendment is necessary to comply with Senate Bill (S.B.) 1264, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules relating to consumer protections against certain medical and health care billing by out-of-network licensed health care facilities, including abortion facilities, ambulatory surgical centers, birthing centers, chemical dependency treatment facilities, crisis stabilization units, end stage renal disease facilities, freestanding emergency medical care facilities, general and special hospitals, narcotic treatment programs, private psychiatric hospitals, and special care facilities.

COMMENTS

The 31-day comment period ended January 19, 2021.

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 of and provision of health and human services by the health and human services system; Texas Health and Safety Code §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; and Texas Insurance Code §752.0003, which authorizes regulatory agencies to take action against facilities and providers that violate a balance billing prohibition.

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 March 26, 2021.

TRD-202101324

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: December 18, 2020

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


CHAPTER 289. RADIATION CONTROL

SUBCHAPTER E. REGISTRATION REGULATIONS

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts the repeal of §289.233 and new §289.233, concerning Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine. The repeal of §289.233 and new §289.233 are adopted without changes to the proposed text as published in the January 1, 2021, issue of the Texas Register (46 TexReg 51), and therefore will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the adoption is to repeal §289.233 and replace with new §289.233 due to extensive revisions made throughout the rule. The new section corrects rule citation references and defines registrant responsibilities. The new section aligns the rule with current requirements in Title 25, Texas Administrative Code (TAC) §289.204, concerning Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services; §289.205, concerning Hearing and Enforcement Procedures; and §289.226, concerning the Registration of Radiation Machine Use and Services.

New §289.233 reorganizes current requirements, adds new requirements from staff and stakeholder input, adds and clarifies definitions, and updates terminology. Changes to the new section strengthen qualifications for radiation safety officers, require radiation safety officers to review operating and safety procedures at least annually, clarify inspection compliance and hearing procedures, and clarify the requirement that an equipment performance evaluation be performed on radiation machines within 30 days of installation or reinstallation. In addition, the new section clarifies timelines and requirements for equipment performance evaluations on the radiation machines, adds safety requirements to the operating and safety procedures, adds requirements for controlling the operator's occupational radiation exposure, and strengthens the requirements for quality control of digital imaging.

Texas Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Texas Government Code, Chapter 2001 (Administrative Procedure Act). Section 289.233 has been reviewed and DSHS has determined that the reasons for adopting the sections continue to exist because a rule on this subject is needed to protect public health and safety and to fulfill DSHS's statutory responsibilities as the state's Radiation Control Agency.

COMMENTS

The 31-day comment period ended February 1, 2021.

During this period, DSHS received comments regarding the proposed rules from seven commenters, including The University of Texas System, Medical Imaging and Technology Alliance (MITA), West Physics, State of Texas Chapter of the Health Physics Society, Texas Veterinary Medical Association, and two individuals. A summary of comments relating to §289.233 and DSHS responses follows.

Comment: One commenter requested an amendment to §289.233(i)(5)(K)(i)(II) to reflect the same wording used in §289.226. In §289.226 machines on loan or at a site for demonstration for greater than 30 days require an equipment performance evaluation (EPE).

Response: DSHS disagrees and declines to revise the rule in response to this comment. The proposed rule language was not changed because, while the sentence structure is different, both sections allow a registrant to use a loaner or demonstration machine for 30 days before an EPE is required and the facility has to notify DSHS about their inventory change.

Comment: One commenter requested DSHS to increase the frequency requirement of EPEs from once every five years to once every two or three years in §289.233(i)(5)(K)(i)(II).

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS finds that an EPE frequency of once every five years is sufficient to ensure the safe use of veterinary radiation machines. DSHS believes that increasing the EPE frequency would increase the fiscal burden for rural veterinarians without a commensurate improvement in radiation safety.

Comment: Several commenters requested the removal of the requirement in §289.233(j)(8)(A)(v), §289.233(j)(8)(B)(iii)(I)(-a-), and §289.233(j)(8)(C)(iii)(I)(-a-) that the physicist who develops written operating and safety procedures and who performs surveys, calibrations, and spot checks on therapeutic radiation machines, simulators, or electronic brachytherapy devices must have a certification with a specialty in therapeutic radiological physics. The commenters believe that the proposed rule conflicts with 22 TAC Chapter 160 because the Texas Medical Board does not specify a specialty (therapy or diagnostic) for the certification of a licensed medical physicist who evaluates radiation machines used in human treatment or diagnosis.

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS finds that therapeutic radiation machines, simulators, and electronic brachytherapy devices present a high risk of radiation exposure to the operator and the public. DSHS believes a physicist with knowledge of the machines used in radiation therapy and having experience with the radiation safety issues of a radiation therapy facility is qualified to perform the duties required by §289.233(j)(8). DSHS also does not agree that §289.233 conflicts with 22 TAC Chapter 160. Section 289.233(j)(8) deals with radiation therapy machines used on animals in veterinary medicine, 22 TAC Chapter 160 deals with the role of a medical physicist with machines used in human medicine.

Comment: One commenter requested to remove the quality assurance/quality control (QA/QC) requirement in §289.233(j)(12).

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS finds that a QA/QC program that includes digital image testing on a quarterly schedule ensures an optimal image with the lowest exposure setting. This reduces the radiation exposure to the veterinary technician because the machine is set at the lowest setting needed for the image during exposure and prevents "repeat" exposures caused by poor images. The rule allows facilities to follow QA/QC procedures outlined by the manufacturer of the equipment or use the digital QC testing protocols provided in the rule using a common object with three densities.

Due to a publishing error by the Texas Register, the text in 25 TAC §289.233(d)(33) was published incorrectly. A correction of error was published in the "IN ADDITION SECTION" in the January 15, 2021, issue of the Texas Register to correct the rule text as follows.

Effective dose equivalent (HE)--The sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (WT) applicable to each of the body organs or tissues that are irradiated (HE = ΣWTHT).

Due to a publishing error by the Texas Register, the text in 25 TAC §289.233(d)(22) was published incorrectly. A correction of error is published in the "IN ADDITION SECTION" in this same issue of the Texas Register to correct the rule text as follows.

Committed Effective Dose Equivalent (HE, 50)--The sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE, 50= ΣWTHT.50).

25 TAC §289.233

STATUTORY AUTHORITY

The repeal is authorized by Texas Health and Safety Code, Chapter 401 (the Texas Radiation Control Act), which provides for DSHS radiation control rules and regulatory program to be compatible with federal standards and regulation; §401.051, which provides the required authority to adopt rules and guidelines relating to the control of sources of radiation; §401.064, which provides for the authority to adopt rules related to inspection of x-ray equipment; §401.101, providing for DSHS registration of facilities possessing sources of radiation; Chapter 401, Subchapter J, which authorizes enforcement of the Act; and Texas Government Code, §531.0055; and Texas Health and Safety Code, §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies 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 review of the rules implements Texas Government Code, §2001.039, regarding review of existing rules.

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 March 26, 2021.

TRD-202101334

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: January 1, 2021

For further information, please call: (512) 834-6655


25 TAC §289.233

STATUTORY AUTHORITY

The new rule is authorized by Texas Health and Safety Code, Chapter 401 (the Texas Radiation Control Act), which provides for DSHS radiation control rules and regulatory program to be compatible with federal standards and regulation; §401.051, which provides the required authority to adopt rules and guidelines relating to the control of sources of radiation; §401.064, which provides for the authority to adopt rules related to inspection of x-ray equipment; §401.101, providing for DSHS registration of facilities possessing sources of radiation; Chapter 401, Subchapter J, which authorizes enforcement of the Act; and Texas Government Code, §531.0055; and Texas Health and Safety Code, §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies 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 review of the rules implements Texas Government Code, §2001.039, regarding review of existing rules.

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 March 26, 2021.

TRD-202101335

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: April 15, 2021

Proposal publication date: January 1, 2021

For further information, please call: (512) 834-6655