PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 133. HOSPITAL LICENSING
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §133.46, concerning Hospital Billing.
BACKGROUND AND PURPOSE
The proposal 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 proposed amendment is necessary to add information regarding these itemized-bill requirements.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §133.46 adds paragraph (2) in subsection (a), which requires a hospital to comply with the itemized billing requirements in HSC Chapter 185. The title of the section is revised to "Billing Requirements." Other minor stylistic edits are made to comply with current HHSC rulemaking guidelines, such as removing short titles to statutes, formatting punctuation and capitalization, and spelling out "HHSC."
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of HHSC employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to HHSC;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will expand existing regulations;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the proposed rule does not impose a cost or require small businesses, micro-businesses, or rural communities to alter their current business practices.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rule is in effect, the public will benefit from receiving itemized bills from licensed acute health care providers that are seeking payment from them for health care services and supplies and the public will also benefit from rules that are consistent with statutory requirements.
Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require persons subject to the rule to alter their current business practices; these entities are required to comply with the law as added by S.B. 490 and the proposed amendment only ensures consistency with current statutory requirements.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R004" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and HSC Chapter 185.
§133.46.[Hospital] Billing Requirements.
(a) Itemized statements. [A hospital shall adopt,
implement, and enforce a policy to ensure that the hospital complies
with the Health and Safety Code (HSC), §311.002 (Itemized Statement
of Billed Services).]
(1) A hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with Texas Health and Safety Code (HSC) §311.002.
(2) A hospital shall comply with the itemized bill requirements under HSC §185.002.
(b) Audits of billing. A hospital shall adopt, implement,
and enforce a policy to ensure that the hospital complies with HSC
[,] §311.0025(a) [(relating to Audits of Billing)].
(c) Balance billing [Billing].
(1) A hospital may not violate a law that prohibits the hospital from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.
(2) A hospital shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 - 21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the hospital.
(d) Complaint investigation procedures.
(1) A complaint submitted to the Texas Health
and Human Services Commission's [HHSC's] Complaint
and Incident Intake relating to billing must specify the patient for
whom the bill was submitted.
(2) Upon receiving a complaint warranting an investigation, Texas Health and Human Services Commission (HHSC) [HHSC]
shall send the complaint to the hospital requesting the hospital to
conduct an internal investigation. Within 30 days of the hospital's
receipt of the complaint, the hospital shall submit to HHSC:
(A) a report outlining the hospital's investigative process;
(B) the resolution or conclusions reached by the hospital with the patient, third party payor or complainant; and
(C) corrections, if any, in the hospital's policies or protocols which were made as a result of its investigative findings.
(3) In addition to the hospital's internal investigation, HHSC may also conduct an investigation to audit any billing and patient records of the hospital.
(4) HHSC shall inform in writing a complainant who identifies himself by name and address:
(A) of the receipt of the complaint;
(B) if the complainant's allegations are potential violations of the Act or this chapter warranting an investigation;
(C) whether the complaint will be investigated by HHSC;
(D) if the complaint was referred to the hospital for internal investigation;
(E) whether and to whom the complaint will be referred;
(F) of the results of the hospital's investigation and the hospital's resolution with the complainant; and
(G) of HHSC's findings if an on-site audit investigation was conducted.
(5) HHSC shall refer investigative reports of billing by health care professionals who have provided improper, unreasonable, or medically or clinically unnecessary treatments or billed for treatments which were not provided to the appropriate licensing agency.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2024.
TRD-202401441
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: May 26, 2024
For further information, please call: (512) 834-4591
SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §135.4, concerning Ambulatory Surgical Center (ASC) Operation.
BACKGROUND AND PURPOSE
The proposal 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 proposed amendment is necessary to add information regarding these itemized-bill requirements.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §135.4 adds subsection (n), which requires an ASC to comply with the itemized billing requirements in HSC Chapter 185. Other minor stylistic edits are made to comply with current HHSC rulemaking guidelines, such as deleting superfluous phrases, reorganizing paragraph (11)(B), adding "Texas" before a reference to a Texas statute, and deleting a lead-in phrase for consistency.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of HHSC employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to HHSC;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will expand existing regulations;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the proposed rule does not impose a cost or require small businesses, micro-businesses, or rural communities to alter their current business practices.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rule is in effect, the public will benefit from receiving itemized bills from licensed acute health care providers that are seeking payment from them for health care services and supplies and the public will also benefit from rules that are consistent with statutory requirements.
Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require persons subject to the rule to alter their current business practices; these entities are required to comply with the law as added by S.B. 490 and the proposed amendment only ensures consistency with current statutory requirements.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R004" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and HSC Chapter 185.
§135.4.Ambulatory Surgical Center (ASC) Operation.
(a) The ASC shall have a governing body that sets policy and assumes full legal responsibility for the total operation of the ASC.
(b) The governing body shall be responsible for assuring that medical staff bylaws are current and on file.
(c) The governing body shall address and is fully responsible,
either directly or by appropriate professional delegation, for the
operation and performance of the ASC. Governing body responsibilities
include[, but are not limited to]:
(1) determining the mission, goals, and objectives of the ASC;
(2) assuring that facilities and personnel are adequate and appropriate to carry out the mission;
(3) establishing an organizational structure and specifying functional relationships among the various components of the ASC;
(4) adopting bylaws or similar rules and regulations for the orderly development and management of the ASC;
(5) adopting policies or procedures necessary for the orderly conduct of the ASC;
(6) assuring that the quality of care is evaluated and that identified problems are addressed;
(7) reviewing all legal and ethical matters concerning the ASC and its staff and, when necessary, responding appropriately;
(8) maintaining effective communication throughout the ASC;
(9) establishing a system of financial management and accountability that includes an audit appropriate to the ASC;
(10) developing, implementing, and enforcing a policy on the rights of patients;
(11) approving all major contracts or arrangements
affecting the medical care provided under its auspices, including[,
but not limited to,] those concerning:
(A) the employment of health care practitioners;
(B) an effective procedure for the immediate transfer
to a hospital of patients requiring emergency care beyond the capabilities
of the ASC[. The ASC shall have a written transfer agreement
with a hospital or all physicians performing surgery at the ASC shall
have admitting privileges at a local hospital];
(i) the ASC shall have a written transfer agreement with a hospital; or
(ii) all physicians performing surgery at the ASC shall have admitting privileges at a local hospital;
(C) the use of external laboratories;
(D) an effective procedure for obtaining emergency laboratory, radiology, and pharmaceutical services if laboratory, X-ray, and pharmacy services are not provided on site; and
(E) the provision of education to students and postgraduate trainees if the ASC participates in such programs;
(12) formulating long-range plans in accordance with the mission, goals, and objectives of the ASC;
(13) operating the ASC without limitation because of race, creed, sex, or national origin;
(14) assuring that all marketing and advertising concerning the ASC does not imply that it provides care or services which it is not capable of providing; and
(15) developing a system of risk management appropriate
to the ASC including[, but not limited to]:
(A) periodic review of all litigation involving the ASC, its staff, and health care practitioners regarding activities in the ASC;
(B) periodic review of all incidents reported by staff and patients;
(C) review of all deaths, trauma, or adverse reactions occurring on premises; and
(D) evaluation of patient complaints.
(d) The governing body shall provide for full disclosure of ownership to the department.
(e) The governing body shall meet at least annually and keep such minutes or other records as may be necessary for the orderly conduct of the ASC.
(f) If the governing body elects, appoints, or employs officers and administrators to carry out its directives, the authority, responsibility, and functions of all such positions shall be defined.
(g) When a majority of its members are physicians, the governing body, either directly or by delegation, shall make (in a manner consistent with state law and based on evidence of the education, training, and current competence of the physician) initial appointments, reappointments, and assignment or curtailment of medical privileges. When a majority of the members of the governing body are not physicians, the ASC's bylaws or similar rules and regulations shall specify a procedure for establishing medical review for the purpose of making (in a manner consistent with state law and based on evidence of the education, training, and current competence of the physician) initial appointments, reappointments, and assignment or curtailment of medical privileges.
(h) The governing body shall provide (in a manner consistent with state law and based on evidence of education, training, and current competence) for the initial appointment, reappointment, and assignment or curtailment of privileges and practice for nonphysician health care personnel and practitioners.
(i) The governing body shall encourage personnel to participate in continuing education that is relevant to their responsibilities within the ASC.
(j) The governing body shall adopt, implement, and
enforce written policies to ensure compliance with Texas Health
and Safety Code[,] Chapter 324[, Consumer Access to
Health Care Information].
(k) The governing body shall adopt, implement, and enforce written policies to ensure compliance with applicable state laws.
(l) An ASC that performs abortions shall adopt, implement, and enforce a policy to ensure compliance with Texas Health
and Safety Code[,] Chapters 245 and 171, Subchapters A
and B [(relating to Abortion and Informed Consent)].
(m) An ASC shall comply with the following balance
billing requirements. [Balance Billing.]
(1) An ASC may not violate a law that prohibits the ASC from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.
(2) An ASC shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 - 21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the ASC.
(n) An ASC shall comply with the itemized bill requirements under Texas Health and Safety Code §185.002.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2024.
TRD-202401442
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: May 26, 2024
For further information, please call: (512) 834-4591
SUBCHAPTER D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §137.39, concerning General Requirements for the Provision and Coordination of Treatment and Services.
BACKGROUND AND PURPOSE
The proposal 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 proposed amendment is necessary to add information regarding these itemized-bill requirements.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §137.39 adds subsection (j), which requires a birthing center to comply with the itemized billing requirements in HSC Chapter 185. Other minor stylistic edits are made to comply with current HHSC rulemaking guidelines, such as deleting the lead-in phrase in subsection (i) for consistency.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of HHSC employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to HHSC;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will expand existing regulations;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the proposed rule does not impose a cost or require small businesses, micro-businesses, or rural communities to alter their current business practices.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rule is in effect, the public will benefit from receiving itemized bills from licensed acute health care providers that are seeking payment from them for health care services and supplies and the public will also benefit from rules that are consistent with statutory requirements.
Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require persons subject to the rule to alter their current business practices; these entities are required to comply with the law as added by S.B. 490 and the proposed amendment only ensures consistency with current statutory requirements.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R004" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and HSC Chapter 185.
§137.39.General Requirements for the Provision and Coordination of Treatment and Services.
(a) A center shall develop, implement, and enforce policies for the provision and coordination of treatment and services.
(b) The center is responsible for all care provided to center clients on its licensed premises.
(c) A center and the client shall have a written agreement
for services. The center shall obtain an acknowledgment of receipt
of the agreement. The center shall comply with the terms of the agreement.
The written agreement shall include[,] the following:
(1) services to be provided;
(2) who will provide the services; and
(3) charges for services rendered.
(d) When services are provided through a contract, a center must assure that these services are also provided in a safe and effective manner. If a center utilizes independent contractors, there shall be a written agreement between such independent contractors (i.e., per hour, per visit) and the center. The agreement shall be enforced by the center and clearly designate:
(1) that clients are accepted for care only by the center;
(2) the services to be provided by both parties;
(3) the necessity to conform to the Act, this chapter, and all applicable center policies, including personnel qualifications; and
(4) the manner in which services will be coordinated and evaluated by the center.
(e) A center shall not commit an intentional or negligent act that adversely affects the health or safety of a client.
(f) A center must ensure that its licensed health care professionals practice within the scope of their practice and within the constraints of applicable state laws and regulations governing their practice and must follow the facility's written policies and procedures.
(g) A center may accept student midwives to provide them with clinical experience.
(h) If a center has a contract or agreement with an accredited school of health care to use their center for a portion of a student's clinical experience, those students may provide care under the following conditions.
(1) Students may be used in centers, provided the instructor gives classroom supervision and assumes responsibility for all student activities occurring within the center.
(2) A student may administer medications only if:
(A) on assignment as a student enrolled in [of] their school of health care; and
(B) the birth attendant within their licensed scope of practice is on the premises and directly supervises the administration of medication by the student.
(3) Students shall not be considered when determining staffing needs required by the center.
(i) A center shall comply with the following balance
billing requirements. [Balance Billing.]
(1) A center may not violate a law that prohibits the center from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.
(2) A center shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 - 21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the center.
(j) A center shall comply with the itemized bill requirements under Texas Health and Safety Code §185.002.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2024.
TRD-202401443
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: May 26, 2024
For further information, please call: (512) 834-4591
SUBCHAPTER D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §139.60, concerning Other State and Federal Compliance Requirements.
BACKGROUND AND PURPOSE
The proposal 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 proposed amendment is necessary to add information regarding these itemized-bill requirements.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §139.60 adds subsection (o), which requires an abortion facility to comply with the itemized billing requirements in HSC Chapter 185. Other minor stylistic edits are made to comply with current HHSC rulemaking guidelines, such as formatting punctuation, removing short titles to statutes, adding "Texas" before a reference to a Texas statute, removing a lead-in phrase in subsection (n) for consistency, and abbreviating "Code of Federal Regulations." The subsections are renumbered to account for the addition of a subsection.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of HHSC employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to HHSC;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will expand existing regulations;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the proposed rule does not impose a cost or require small businesses, micro-businesses, or rural communities to alter their current business practices.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rule is in effect, the public will benefit from receiving itemized bills from licensed acute health care providers that are seeking payment from them for health care services and supplies, and the public will also benefit from rules that are consistent with statutory requirements.
Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require persons subject to the rule to alter their current business practices; these entities are required to comply with the law as added by S.B. 490 and the proposed amendment only ensures consistency with current statutory requirements.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R004" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and HSC Chapter 185.
§139.60.Other State and Federal Compliance Requirements.
(a) A licensed abortion facility shall be in compliance with all state and federal laws pertaining to handling of drugs.
(b) A licensed abortion facility that provides laboratory
services shall meet the Clinical Laboratory Improvement Amendments
of 1988, 42 United States Code[,] §263a, Certification
of Laboratories (CLIA 1988). CLIA 1988 applies to all facilities with
laboratories that examine human specimens for the diagnosis, prevention,
or treatment of any disease or impairment of, or the assessment of
the health of, human beings.
(c) A licensed abortion facility shall ensure that
its physicians comply with the Medical Practice Act, Texas Occupations
Code[,] Chapters 151 - 160 and 162 - 165, while functioning
in his or her capacity at or for the facility.
(d) A licensed abortion facility utilizing physician
assistant services [the services of a physician assistant(s)]
shall ensure that its physician assistants comply with the Physician
Assistant Licensing Act, Texas Occupations Code[,]
Chapter 204, while functioning in his or her capacity at or for the facility.
(e) A licensed abortion facility utilizing registered
nurse services [the services of a registered nurse]
shall ensure that its registered nurses comply with the Nursing Practice
Act, Texas Occupations Code[,] Chapters 301
and 304, while functioning in his or her capacity at or for the facility.
(f) A licensed abortion facility utilizing licensed
vocational nurse services [the services of a licensed vocational
nurse(s)] shall ensure that its vocational nurses [nurse(s)] comply with the Nursing Practice Act, Texas Occupations
Code[,] Chapters 301 and 304, while functioning in his
or her capacity at or for the facility.
(g) A licensed abortion facility that provides pharmacy
services shall obtain a license as a pharmacy if required by the Texas
Pharmacy Act, Texas Occupations Code[,] Chapters
551 - 569.
(h) A licensed abortion facility shall comply with the following federal Occupational Safety and Health Administration requirements:
(1) 29 Code of Federal Regulations (CFR),
Subpart E, §1910.38[, concerning emergency action plan]
and §1910.39[, concerning fire prevention plans];
(2) 29 CFR [Code of Federal Regulations],
Subpart I, §1910.132[, concerning general requirements for
personal protective
equipment];
(3) 29 CFR [Code of Federal Regulations],
Subpart I, §1910.133[, concerning eye and face protection];
(4) 29 CFR [Code of Federal Regulations],
Subpart I, §1910.138[, concerning hand protection];
(5) 29 CFR [Code of Federal Regulations],
Subpart K, §1910.151[, concerning medical services and first aid];
(6) 29 CFR [Code of Federal Regulations],
Subpart L, §1910.157[, concerning portable fire extinguishers];
(7) 29 CFR [Code of Federal Regulations],
Subpart Z, §1910.1030[, concerning bloodborne pathogens]; and
(8) 29 CFR [Code of Federal Regulations],
Subpart Z, §1910.1200, Appendices A - E[, concerning hazard
communication (hazardous use of chemicals)].
(i) A licensed abortion facility shall not use adulterated
or misbranded drugs or devices in violation of the Texas Health
and Safety Code[,] §431.021. Adulterated drugs and
devices are described in Texas Health and Safety Code[,] §431.111.
Misbranded drugs or devices are described in Texas Health
and Safety Code[,] §431.112.
(j) A licensed abortion facility shall not commit a
false, misleading, or deceptive act or practice as that term is defined
in the Deceptive Trade Practices-Consumer Protection Act, Business
and Commerce Code[,] §17.46.
(k) A licensed abortion facility shall comply with
the requirements of the Texas Family Code[,] §33.002[, relating to a Consent Form].
(l) A licensed abortion facility shall comply with
the requirements of Texas Health and Safety Code[,]
Chapter 171[, the Woman's Right to Know Act].
(m) A licensed abortion facility shall comply with
the requirements of Texas Occupations Code[,]
Chapter 102[, Solicitation of Patients].
(n) A licensed abortion facility shall comply
with the following balance billing requirements. [Balance Billing.]
(1) A licensed abortion facility may not violate a law that prohibits the licensed abortion facility from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.
(2) A licensed abortion facility shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 - 21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the licensed abortion facility.
(o) A licensed abortion facility shall comply with the itemized bill requirements under Texas Health and Safety Code §185.002.
(p) [(o)] A licensed abortion
facility shall comply with human trafficking signage requirements
in accordance with Texas Health and Safety Code §245.025 [(relating
to Human Trafficking Signs Required)].
(q) [(p)] A licensed abortion
facility shall not discriminate based on a patient's disability and
shall comply with Texas Health and Safety Code Chapter 161, Subchapter
S [(relating to Allocation of Kidneys and Other Organs Available
for Transplant)].
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2024.
TRD-202401444
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: May 26, 2024
For further information, please call: (512) 834-4591
SUBCHAPTER J. MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §229.144, concerning State and Federal Statutes and Regulations.
BACKGROUND AND PURPOSE
The proposal 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 proposed amendment is necessary to add information regarding these itemized-bill requirements.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §229.144 adds new subsection (d), which requires a narcotic treatment program (NTP) to comply with the itemized billing requirements in HSC Chapter 185. Other minor stylistic edits are made to comply with current HHSC rulemaking guidelines, such as removing superfluous phrases, adding "Texas" before references to Texas statutes, removing short titles to statutes, formatting punctuation and removing a lead-in phrase for consistency. Subsections are renumbered to account for the addition of a subsection.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
GOVERNMENT GROWTH IMPACT STATEMENT
HHSC has determined that during the first five years that the rule will be in effect:
(1) the proposed rule will not create or eliminate a government program;
(2) implementation of the proposed rule will not affect the number of HHSC employee positions;
(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;
(4) the proposed rule will not affect fees paid to HHSC;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will expand existing regulations;
(7) the proposed rule will not change the number of individuals subject to the rule; and
(8) the proposed rule will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the proposed rule does not impose a cost or require small businesses, micro-businesses, or rural communities to alter their current business practices.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rule is in effect, the public will benefit from receiving itemized bills from licensed acute health care providers that are seeking payment from them for health care services and supplies and the public will also benefit from rules that are consistent with statutory requirements.
Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the rule does not require persons subject to the rule to alter their current business practices; these entities are required to comply with the law as added by S.B. 490 and the proposed amendment only ensures consistency with current statutory requirements.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R004" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment implements Texas Government Code §531.0055 and HSC Chapter 185.
§229.144.State and Federal Statutes and Regulations.
(a) A permit holder shall assure that the narcotic
treatment program (NTP) is in compliance with all State of Texas laws
and rules regulating chemical dependency treatment facilities including
[, but not limited to,] the following laws: Texas Health
and Safety Code [,] Chapters 464 and 466; the Medical Practice
Act, Texas Occupations Code [,] Chapters 151-160
[,] and 162-165; the Nurse Practice Act, Texas Occupations
Code [,] Chapter 301; the Texas Pharmacy Act, Texas Occupations
Code [,] Chapters 551-566; and the Licensed Professional
Counselor Act, Texas Occupations Code [,] Chapter 503.
(b) The permit holder shall assure the NTP is in compliance
with Title 42, Code of Federal Regulations, Part 8. [,
titled, "Opioid Drugs in Maintenance and Detoxification Treatment
of Opiate Addiction."] To the extent that the Code of Federal
Regulation conflicts with these sections, these sections shall prevail.
(c) An NTP shall comply with the following balance
billing requirements. [Balance Billing.]
(1) An NTP may not violate a law that prohibits the NTP from billing a patient who is an insured, participant, or enrollee in a managed care plan an amount greater than an applicable copayment, coinsurance, and deductible under the insured's, participant's, or enrollee's managed care plan or that imposes a requirement related to that prohibition.
(2) An NTP shall comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter OO, §§21.4901 -21.4904 (relating to Disclosures by Out-of-Network Providers) to the extent this subchapter applies to the NTP.
(d) An NTP shall comply with the itemized bill requirements under Texas Health and Safety Code §185.002.
(e) [(d)] All citations in these
sections to statutes or regulations include those statutes or regulations
as amended.
(f) [(e)] An NTP shall not discriminate
based on a patient's disability and shall comply with Texas Health
and Safety Code Chapter 161, Subchapter S [(relating to Allocation
of Kidneys and Other Organs Available for Transplant)].
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on April 10, 2024.
TRD-202401445
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: May 26, 2024
For further information, please call: (512) 834-4591