PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 33. EARLY AND PERIODIC SCREENING, DIAGNOSIS, AND TREATMENT
SUBCHAPTER F. DENTAL SERVICES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §33.70, concerning Dental Preventive and Treatment Services.
BACKGROUND AND PURPOSE
The Texas Health and Human Services Commission (HHSC) proposes to amend §33.70, concerning Dental Preventative and Treatment Services, to implement House Bill (H.B.) 2056, 87th Legislature, Regular Session, 2021.
H.B. 2056 added a requirement for providers to be reimbursed for teledentistry dental services by amending Texas Government Code §§531.0216 and 531.02162(b) and (c), and adding Texas Government Code §531.02172. The purpose of the proposal is to amend §33.70 to implement teledentistry dental services under Medicaid in the Texas Health Steps Program.
Before proposing the amendment HHSC waited until after the Texas State Board of Dental Examiners adopted rules in 2022 to regulate the practice of teledentistry. HHSC also needed time to decide which dental services and treatments available through the Texas Health Steps Program could safely and effectively be provided as a teledentistry dental service to clients enrolled in the program.
The proposed amendment to §33.70 adds a new subsection (c) to require dental providers to perform dental services as described in the Texas Medicaid Provider Procedures Manual. The proposed amendment adds new subsection (d) to allow dental providers to conduct an oral evaluation as a teledentistry dental service, as defined in Texas Occupations Code §111.001, for established clients, using synchronous audiovisual technologies.
The proposed amendment allows flexibility for an established client and the dentist to use synchronous audiovisual technologies to conduct an oral evaluation, and thereby, makes oral evaluations more easily available to and prevents unnecessary travel for clients in the Texas Health Steps Program.
FISCAL NOTE
Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the proposed 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 create new regulations;
(6) the proposed rule will not expand, limit or repeal 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 rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.
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 is necessary to protect the health, safety, and welfare of the residents of Texas; 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
Emily Zalkovsky, State Medicaid Director, has determined that for each year of the first five years the rule is in effect, the public benefit will be: (1) increased access to dental care; (2) a rule that complies with state law; and (3) a rule that reflects current business practice.
Trey Wood has also determined that for the first five years the rule is in effect, there are not anticipated economic costs to persons who are required to comply with the proposed rule because participating in teledentistry dental services is optional.
TAKINGS IMPACT ASSESSMENT
HHSC has determined that the proposal does not restrict or limit an owner's right to his or her 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 mcsrulespubliccomments@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 the 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 faxing or emailing comments, please indicate "Comments on Proposed Rule 24R078" 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, Texas Government Code §531.0216, which provides that the Executive Commissioner of HHSC shall adopt rules to develop and implement a system to reimburse providers of services under Medicaid for services performed using teledentistry dental services, Texas Government Code §531.02162, which provides that the Executive Commissioner of HHSC shall by rule establish policies that permit reimbursement under Medicaid for services provided through teledentistry dental services to children with special health care needs, and Texas Government Code §531.02172, which provides HHSC by rule shall require each health and human services agency that administers a part of the Medicaid program to provide Medicaid reimbursement for teledentistry dental services provided by a dentist licensed to practice dentistry in this state.
The amendment affects Texas Government Code §§531.0055, 531.0216, 531.02162, and 531.02172.
§33.70.Dental Preventive and Treatment Services.
(a) In addition to dental check-ups, which may include radiographs and other diagnostic tests, clients are eligible to receive the following dental services and treatment, as described in detail in the TMPPM:
(1) diagnostic;
(2) preventive;
(3) therapeutic (including orthodontic)
(4) emergency; and
(5) medically necessary treatment.
(b) Prior authorization may be required for certain services and documentation requirements must be met, as described in detail in the TMPPM. All dental services are subject to utilization review, as described in §33.72 of this title (relating to Dental Utilization Reviews).
(c) THSteps dental providers are required to perform dental services as described in detail in the TMPPM.
(d) THSteps dental providers may conduct an oral evaluation as a teledentistry dental service, as defined in Texas Occupations Code §111.001, for established clients using synchronous audiovisual technologies.
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 October 10, 2024.
TRD-202404817
Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: November 24, 2024
For further information, please call: (512) 438-2910
SUBCHAPTER R. ADVISORY COMMITTEES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §37.401, concerning Maternal Mortality and Morbidity Task Force.
BACKGROUND AND PURPOSE
The Texas Maternal Mortality and Morbidity Review Committee (MMMRC) studies and reviews cases of pregnancy-related deaths and severe maternal morbidity to identify trends, rates, and disparities.
The purpose of the proposal is to implement House Bill (H.B.) 852, 88th Legislature, Regular Session, 2023, which amended Texas Health and Safety Code, Chapter 34. H.B. 852 added six new MMMRC members and amended the current community advocate MMMRC member position. New positions include physicians specializing in emergency care, cardiology, anesthesiology, oncology, and a representative of a managed care organization. Additionally, the former community advocate position was changed to two community members with experience in a relevant health care field involving the analysis of health care data. One of the community members must represent an urban area of this state, and another must represent a rural area.
H.B. 852 also staggered MMMRC membership terms, making one-third of the terms expire on every odd-numbered year.
This amendment will include changing the title of §37.401 from Maternal Mortality and Morbidity Task Force to Maternal Mortality and Morbidity Review Committee.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §37.401 changes the name of the rule from Maternal Mortality and Morbidity Task Force (committee) to Maternal Mortality and Morbidity Review Committee (MMMRC); adds the task of adopting bylaws to guide MMMRC operations; increases the number of voting members appointed by the DSHS Commissioner from 15 to 21; changes the number of members staggered for six-year terms from four or five members to one-third, or as near as possible to one-third, of the members' terms expiring February 1 of each odd-numbered year; adds training requirements for MMMRC members; adds reference to the current General Appropriations Act for MMMRC participation payment and travel reimbursement; and changes the abolishment and expiration date of the MMMRC from September 1, 2023, to September 1, 2027, to align with Texas Government Code Chapter 325 (Texas Sunset Act).
FISCAL NOTE
Christy Havel Burton, 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
DSHS has determined that during the first five years, 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 DSHS 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 DSHS;
(5) the proposed rule will not create a new regulation;
(6) the proposed rule will not expand, limit, or repeal existing regulations;
(7) the proposed rule will increase 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
Christy Havel Burton has determined that there is no adverse economic impact on small businesses, micro-businesses or rural communities related to the rule, as there is no requirement to alter current business practices. In addition, no rural communities' contract with HHSC and DSHS in any program or service is affected by the proposed rule.
LOCAL EMPLOYMENT IMPACT
The proposed rule will not affect the local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas, 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
Dr. Manda Hall, Associate Commissioner, Community Health Improvement Division, has determined that for each year of the first five years the rule is in effect, the public benefit will be reduced incidence of pregnancy-related deaths and severe maternal morbidity in this state.
Christy Havel Burton, Chief Financial Officer, 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 enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.
TAKINGS IMPACT ASSESSMENT
DSHS 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 DSHS, Maternal and Child Health Unit, P.O. Box 149347, Mail Code 1922, Austin, Texas 78714-9347 or street address 1100 West 49th Street, Austin, Texas 78756; or by email to maternalhealth@dshs.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 the 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 faxing or emailing comments, please indicate "Comments on Proposed Rule 24R040" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by 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 amendment is also required to comply with Texas Health and Safety Code Chapter 34.
The amendment implements Texas Government Code §531.0055 and Texas Health and Safety Code Chapters 34 and 1001.
§37.401.Maternal Mortality and Morbidity Review Committee [Task Force].
(a) The committee. The Maternal Mortality and Morbidity Review Committee (MMMRC) [Task Force (committee)]
is appointed under and governed by this subchapter [section
]. The MMMRC [committee] is established
under Texas Health and Safety Code (THSC)[,]
§§34.001 - 34.018.
(b) Purpose. The MMMRC studies [purpose
of the committee is to study] cases of pregnancy-related deaths
and trends in severe maternal morbidity and makes [to
make] recommendations to reduce the incidence of pregnancy-related
deaths and severe maternal morbidity in Texas.
(c) Tasks. The MMMRC [committee]:
(1) studies and reviews:
(A) cases of pregnancy-related deaths;
(B) trends, rates, or disparities in pregnancy-related deaths and severe maternal morbidity;
(C) health conditions and factors that disproportionately
affect the most at-risk populations as determined in the joint biennial
report required under THSC [Texas Health and Safety
Code,] §34.015; and
(D) best practices and programs operating in [other]
states with [that have] reduced rates of pregnancy-related deaths;
(2) compares rates of pregnancy-related deaths based on the socioeconomic status of the mother;
(3) determines the feasibility of the MMMRC [committee] studying [cases of] severe maternal morbidity cases; [and]
(4) in consultation with the Perinatal Advisory Council,
makes recommendations reducing [to help reduce]
the incidence of pregnancy-related deaths and severe maternal morbidity
in this state; and[.]
(5) adopts bylaws guiding MMMRC operations.
(d) Reporting requirements [Reports].
No later than September 1 of each even-numbered year, the MMMRC
and the Texas Department of State Health Services (DSHS) [committee
] must submit a joint biennial written report to
the Governor, Lieutenant Governor, Speaker of the House of Representatives,
and appropriate committees of the Texas Legislature.
(1) The report must include:
(A) MMMRC [the] findings [of
the committee] related to the [their]
study and review of cases and trends in pregnancy-related deaths and
severe maternal morbidity in this state; and
(B) [any] policy recommendations made to
the Texas Health and Human Services Commission (HHSC) [HHSC
] Executive Commissioner reducing [to help reduce]
the incidence of pregnancy-related deaths and severe maternal morbidity.
(2) DSHS must send [disseminate]
the report to [the] state professional associations and
organizations listed in THSC [Texas Health and Safety
Code,] §34.006(b).
[(e) Sunset Provision. The committee
is subject to Texas Government Code, Chapter 325, (Texas Sunset Act).
Unless continued in existence as provided by that chapter, the committee
is abolished and this section expires September 1, 2023.]
(e) [(f)] Composition.
(1) The MMMRC [committee]
is composed of 23 [17] members.[:]
(2) [(1)] Twenty-one voting [fifteen] members appointed by the DSHS Commissioner include:
(A) four physicians specializing in obstetrics, at least one of whom is a maternal fetal medicine specialist;
(B) one certified nurse-midwife;
(C) one registered nurse;
(D) one nurse specializing in labor and delivery;
(E) one physician specializing in family practice;
(F) one physician specializing in psychiatry;
(G) one physician specializing in pathology;
(H) one epidemiologist, biostatistician, or researcher of pregnancy-related deaths;
(I) one social worker or social service provider;
(J) two [one] community members
with experience in a relevant health care field, including a field
involving the analysis of health care data, one of whom must represent
an urban area of this state and one of whom must represent a rural
area of this state [advocate in a relevant field];
(K) one medical examiner or coroner responsible for
recording deaths; [and]
(L) one physician specializing in critical care;
(M) one physician specializing in emergency care;
(N) one physician specializing in cardiology;
(O) one physician specializing in anesthesiology;
(P) one physician specializing in oncology; and
(Q) one representative of a managed care organization.
(3) [(2)] Two voting ex-officio
members include:
(A) a DSHS representative from
the Community Health Improvement Division [of DSHS's family
and community health programs;] and
(B) [(3)] the state epidemiologist
for DSHS or the epidemiologist's designee.
(4) In appointing members to the MMMRC [committee
], the DSHS Commissioner:
(A) includes members working in and representing diverse
communities [that are diverse] with regard to race,
ethnicity, immigration status, and English proficiency;
(B) includes members from differing geographic regions in the state, including both rural and urban areas;
(C) endeavors to include members [who are]
working in and representing communities [that are] affected
by pregnancy-related deaths and severe maternal morbidity and [by]
a lack of access to relevant perinatal and intrapartum care services; and
(D) ensures [that] the composition of the MMMRC [committee] reflects the racial, ethnic, and
linguistic diversity of Texas.
(5) [(g)] Terms of office.
(A) [(1)] MMMRC members [Members] are appointed for staggered six-year terms, with
one-third or as near as possible to one-third of the MMMRC members'
terms [with the terms of four or five members, as appropriate,
] expiring February 1st of each odd-numbered year. Regardless
of the term limit, an MMMRC member serves until a replacement has
been appointed. This guarantees sufficient and appropriate MMMRC member representation.
(B) [(2)] Exceptions may
be necessary to stagger terms so the term of each member is six years.
An MMMRC [A committee] member may apply to serve
more than one term.
(C) [(3)] If a vacancy occurs, the DSHS Commissioner will appoint a person [is appointed]
to serve the unexpired portion of a [that] term.
(f) [(h)] Officers. The DSHS
Commissioner appoints from among the MMMRC [committee]
members a presiding officer.
(1) The presiding officer presides at all MMMRC [committee] meetings at which he or she is in attendance, calls
meetings in accordance with this section, appoints subcommittees of
the MMMRC [committee] as necessary, and ensures
[causes] proper reports [to be made]
to the HHSC Executive Commissioner. The presiding officer may serve
as an ex officio member of any MMMRC subcommittee [of
the committee].
(2) The MMMRC [committee] may
reference the [its] presiding officer by another
term, such as chairperson.
(g) [(i)] Meetings. The MMMRC [committee] meets at least quarterly to conduct business, or
at the call of the DSHS Commissioner.
[(1) The committee meets at the call of the presiding officer.]
(1) [(2)] Meeting arrangements
are made by DSHS staff.
(2) [(3)] The MMMRC [committee] is subject to the Open Meetings Act, Texas Government
Code Chapter 551, except when the MMMRC [committee]
conducts a closed meeting to review cases under THSC [Texas
Health and Safety Code,] §34.007. Meetings may be conducted
in person, through teleconference call, or by means of other technology.
(3) [(4)] A simple majority of
the appointed MMMRC [committee] members,
identified in subsection (e)(2) and (3) of this section, constitutes
a quorum for the purpose of transacting official business.
(4) [(5)] The MMMRC [committee] is authorized to conduct [transact
official] business only when in a legally constituted meeting
with a quorum present.
(5) [(6)] The agenda for each MMMRC
[committee] meeting must include an opportunity
for new business or for any member to address the MMMRC [committee] on matters relating to MMMRC [committee]business.
(6) [(7)] The MMMRC must [committee shall] allow for public comment during at least one
public meeting each year.
(7) [(8)] The MMMRC must [committee shall] present in open session recommendations made
under THSC [Texas Health and Safety Code,] §34.005, reducing [to help reduce] the incidence of pregnancy-related
deaths and severe maternal morbidity in this state.
(8) [(9)] The MMMRC must [committee shall] post public notice for meetings conducted for
the sole purpose of reviewing cases for selection under THSC [Texas Health and Safety Code,] §34.007.
(h) [(j)] Attendance. Members
must attend MMMRC [committee] meetings as scheduled.
(1) An MMMRC [A] member must
notify the presiding officer or appropriate DSHS staff if [he
or she is] unable to attend a scheduled meeting.
(2) It is grounds for removal from the MMMRC [committee] if an MMMRC [a] member cannot conduct MMMRC member [discharge the member's] duties
for a substantial part of the term for which the MMMRC member
is appointed because of illness or disability, is absent from more
than half of the MMMRC [committee] meetings
during a calendar year, or is absent from at least three consecutive MMMRC [committee] meetings.
(3) The validity of an action of the MMMRC [committee] is not affected by the fact that it is taken when
grounds for removal of a member exists.
(i) [(k)] Staff. Staff support
for the MMMRC [committee] is provided by DSHS staff.
(j) [(l)] Confidentiality.
(1) Any information pertaining to a pregnancy-related death or severe maternal morbidity is confidential.
(2) Confidential information [that is] acquired
by DSHS, including [and that includes] identifying
information of an individual or health care provider, is
confidential and may not be disclosed to any person.
(3) Information is not confidential under this section if the information is general information that cannot be connected with any specific individual, case, or health care provider.
(4) The MMMRC [committee] may
publish statistical studies and research reports based on confidential
information [that is confidential] under this section,
provided [that] the information:
(A) is published in the aggregate;
(B) does not identify a patient or the patient's family;
(C) does not include any information that could be used to identify a patient or the patient's family; and
(D) does not identify a health care provider.
(5) DSHS [The department] will
adopt and implement practices and procedures confirming confidential
[to ensure that] information [that is confidential
under this section] is not disclosed in violation of state
and federal confidentiality laws [this section].
(6) As required by THSC [In accordance
with Texas Health and Safety Code,] §34.009, information held by DSHS or [in] the MMMRC pertaining to
pregnancy-related death or severe maternal morbidity [committee's
possession] is confidential and not subject to [excepted
from] disclosure under the Public Information Act, Texas Government
Code[,] Chapter 552.
(7) The MMMRC [committee] and
DSHS must comply with all state and federal laws and rules relating
to the transmission of health information, including the Health Insurance
Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and
rules adopted under that Act.
(k) [(m)] Statements by members.
(1) HHSC, DSHS, and the MMMRC [committee]
are not bound in any way by any statement, recommendation, or action
on the part of any MMMRC [committee] member,
except when a statement or action is in pursuit of specific instructions
from HHSC, DSHS, or the MMMRC [committee].
(2) The MMMRC [The committee]
and MMMRC [its] members may not participate
in legislative activity in the name of HHSC, DSHS, or the MMMRC [committee] except with approval through the DSHS [HHSC's
] legislative process. MMMRC [Committee]
members are not prohibited from representing themselves or other entities
in the legislative process.
(3) An MMMRC [A committee] member
must not accept or solicit any benefit that might reasonably [tend
to] influence the member in the conduct [discharge]
of the member's official duties.
(4) An MMMRC [A committee] member
must not disclose confidential information acquired through MMMRC [his or her committee] membership.
(5) An MMMRC [A committee] member
must not knowingly solicit, accept, or agree to accept any benefit
for having exercised the member's official powers or duties in favor
of another person.
(6) An MMMRC [A committee] member with [who has] a personal or private interest in
a matter pending before the MMMRC [committee]
must publicly disclose the fact in an MMMRC [a committee]
meeting and may not vote or otherwise participate in the matter. The
phrase "personal or private interest" means the MMMRC [committee
] member has a direct monetary [pecuniary]
interest in the matter but does not include the MMMRC [committee
] member's engagement in a profession, trade, or occupation
when the member's interest is the same as all others similarly engaged
in the profession, trade, or occupation.
(l) Required Training. Each MMMRC member must complete training on relevant statutes and rules; Texas Government Code Chapters 551, 552, and 2110; the Health and Human Services (HHS) Ethics Policy; the Advisory Committee Member Code of Conduct; and other relevant HHS policies. DSHS will provide the training.
(m) [(n)] Travel Reimbursement [Reimbursement for
expenses].
(1) Unless permitted by the current General Appropriations
Act, MMMRC members are not paid to participate in the MMMRC nor reimbursed
for travel to and from meetings [Members appointed to the
committee are not entitled to compensation for service on the committee
or reimbursement for travel or other expenses incurred by the member
while conducting the business of the committee].
(2) In carrying out [its] duties, the MMMRC
[committee] may use technology, including teleconferencing
or videoconferencing, to eliminate travel expenses.
(n) Sunset Provision. The MMMRC is subject to Texas Government Code Chapter 325 (Texas Sunset Act). Unless continued in existence as provided by that chapter, the MMMRC is abolished and this subchapter expires September 1, 2027.
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 October 9, 2024.
TRD-202404788
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: November 24, 2024
For further information, please call: (512) 776-7373
SUBCHAPTER B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendment to §157.11, concerning Requirements for an EMS Provider License.
BACKGROUND AND PURPOSE
The purpose of the proposal is to comply with Senate Bill (S.B.) 2133, 88th Legislature, Regular Session, 2023, that amended Texas Health and Safety Code (HSC) §773.050 by adding subsection (j). The new subsection requires emergency medical services (EMS) providers to have a plan for transporting dialysis patients directly to and from an outpatient end stage renal disease facility during a declared disaster, if the patient's normal and alternative modes of transportation cannot be used. Texas HSC §773.050(j) permits the EMS provider's plan to prioritize transporting a patient suffering from an acute emergency condition over transporting a dialysis patient. The proposed amendment to 25 TAC §157.11 aligns with the changes in Texas HSC §773.050.
Additionally, House Bill 4611, 88th Legislature, Regular Session, 2023, made certain non-substantive revisions to Subtitle I, Title 4, Texas Government Code, which governs HHSC, Medicaid, and other social services as part of the legislature's ongoing statutory revision program. This proposal is necessary to update a citation in the rule to Texas Government Code that becomes effective on April 1, 2025.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §157.11 revises language for clarity, consistency, plain language, and style throughout the rule; updates reference to current laws; and clarifies participation in the Regional Advisory Council triage plan to align with current practice throughout Texas and the nation. The proposed amendment adds language that an EMS provider must have a plan for providing transport for a dialysis patient who places an emergency 9-1-1 telephone call during a declared disaster and adds language that permits the EMS provider's plan to prioritize transporting a patient suffering from an acute emergency condition over transporting a dialysis patient. The proposed amendment also adds language that the liability of a unit of local government under this chapter is limited to money damages in a maximum amount of $100,000 for each person and $300,000 for each single occurrence for bodily injury or death and $100,000 for each single occurrence for injury to or destruction of property, as described in Texas Civil Practice and Remedies Code Section 101.023(d).
FISCAL NOTE
Christy Havel Burton, 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
DSHS 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 DSHS 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 DSHS;
(5) the proposed rule will 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
Christy Havel Burton has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.
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 is necessary to protect the health, safety, and welfare of the residents of Texas, does not impose a cost on regulated persons, is adopted in response to a natural disaster, and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.
PUBLIC BENEFIT AND COSTS
Timothy Stevenson, DVM, Ph.D., Associate Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rule is in effect, the public benefit will be the safe operation of the Texas Emergency Medical Services concerning the transport of dialysis patients in a declared disaster.
Christy Havel Burton 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 amendment will not have an economic impact on an EMS provider operation.
TAKINGS IMPACT ASSESSMENT
DSHS 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 Texas State EMS Director, DSHS, Attn: Proposed Emergency Medical Services Rules, P.O. Box 149347, Mail Code 1876, Austin, Texas 78714-3247; or 1100 West 49th Street, Austin, Texas 78756; or emailed to EMSInfo@dshs.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 the 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 24R023" in the subject line.
STATUTORY AUTHORITY
The amendment is authorized by Texas Health and Safety Code Chapter 773, which allows DSHS to promulgate rules for the transfer of dialysis patients during a declared disaster; and Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHS 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 amendment implements Texas Government Code §531.0055 and Chapter 540 and Texas Health and Safety Code Chapters 773 and 1001.
§157.11.Requirements for an Emergency Medical Services (EMS) [EMS] Provider License.
(a) Purpose: Acquiring, issuing, and maintaining an
EMS provider license [Providers License].
(b) EMS in Texas is a delegated practice, as written
in Texas Occupations Code[,] §157.003.
(c) Application requirements for an EMS provider
license [Emergency Medical Services (EMS) Provider License].
(1) An applicant for an initial EMS provider license must [shall] submit a completed application to the
department on the required official forms, following the department's
written process.
(2) The nonrefundable application fee of $500 per provider
plus $180 for each EMS vehicle to be operated under the license must
[shall] accompany the application.
(3) The department will process the EMS provider license
application as per §157.3 of this chapter [title]
(relating to Processing EMS Provider Licenses and Applications for
EMS Personnel Certification and Licensure).
(4) An EMS provider holding a valid license or authorization
from another state is exempt from holding a Texas EMS provider
license if the provider:[;]
(A) serves an [whose service]
area that adjoins the State of Texas;
(B) has [who has in place]
a written mutual aid agreement[,] with a licensed Texas
EMS provider;[,]
(C) is [and who when]
requested to do so by a licensed Texas EMS provider;[,]
(D) responds into Texas for emergency mutual
aid assistance; and[,]
(E) is [may be exempt from
holding a Texas EMS provider license, but will be] obligated
to perform to the same medical standards of care required by
the [of EMS providers licensed by their] home state.
(5) A fixed-wing or rotor-wing air ambulance provider,
appropriately licensed by the state governments of New Mexico, Oklahoma,
Arkansas, Kansas, Colorado, or Louisiana, may
apply for a reciprocal [issuance of a] provider license.
The [, and the] application does [would]
not require staffing by Texas EMS certified or licensed personnel.
A nonrefundable administrative fee of $500 per provider in addition
to a nonrefundable fee of $180 for each EMS aircraft to be operated
in Texas under the reciprocal license must [shall]
accompany the application.
(6) An applicant for an EMS provider license that provides
emergency prehospital care is exempt from paying [payment
of] department licensing and authorization fees if the provider
[firm] is staffed with at least 75 percent [75%] volunteer personnel, has no more than five full-time staff
or equivalent, and [the firm] is recognized as a §501(c)(3)
nonprofit corporation by the Internal Revenue Service. An EMS provider
who compensates a physician to provide medical supervision will [may] be exempt from paying [the payment of]
department licensing and authorization fees if all other requirements
for fee exemption are met.
(7) Required documents that must [shall]
accompany a license application.
(A) Document verifying volunteer status, if applicable.
(B) Map and description of service area, a list of counties and cities in which applicant proposes to provide primary emergency service, and a list of all station locations with address and telephone and facsimile transmission numbers for each station.
(C) Declaration of organization type and profit status.
(D) Declaration of provider name [Provider Name].
(i) The legal name of the EMS provider cannot include
the name of the city, county, or regional advisory council (RAC) within or in part, unless written approval is given by
the individual city, county, or RAC [regional
advisory council] respectively.
(ii) [The EMS provider operational name cannot
include the name of the city, county or regional advisory council
within or in part, unless written approval is given by the individual
city, county or regional advisory council respectively.] A proposed
provider name is deemed to be the same name as [deceptively
similar to] an established licensed EMS provider if it meets
the conditions listed in [the Office of the Secretary of State
rule,] 1 Texas Administrative Code (TAC)[,]
§79.39 (relating to Same Defined) and therefore is not available
if a comparison of the names reveals no differences [Deceptively
Similar Name)].
(E) Declaration of ownership [Ownership].
(F) Declaration of the address for the main location
of the business, normal business hours, and [provide]
proof of ownership or lease of the [such] location.
(i) The normal business hours must be posted for public viewing.
(ii) A service area map must be provided.
(iii) Only one EMS provider license will be issued to each fixed address.
(iv) The applicant must [shall]
attest [that] no other licensed [license]
EMS provider is at the [provided] business location or
address provided.
(v) The EMS [emergency medical services]
provider must remain in the same physical location for the period
of licensure, unless the department approves a change in location.
(G) A statement of [Declaration of
the administrator of record and any subsequently filed declaration
of a new administrator shall declare the following, if the EMS provider
is required to have] an administrator of record under Texas [as per] Health and Safety Code[,] §773.0571
or §773.05712.
(H) The administrator of record statement must declare they:
(i) are [The administrator of record
is] not employed or otherwise compensated by another private
for-profit EMS provider;[.]
(ii) meet [The administrator of record
meets] the qualifications required for an emergency medical
technician certification or other health care professional license
with a direct relationship to EMS and currently hold [holds
] such certification or license issued by the State of
Texas;[.]
(iii) have [The administrator of record
has] submitted to a criminal history record check at the applicant's
expense as directed in §157.37 of this chapter [title
] (relating to Certification or Licensure of Persons With Criminal
Backgrounds);[.]
(iv) have [The administrator of record
has] completed an initial education course approved by the department
regarding state and federal laws and rules affecting [that
affect] EMS in the following areas:
(I) Texas Health and Safety Code[,]
Chapter 773 and 25 TAC [Texas Administrative Code,]
Chapter 157;
(II) EMS dispatch processes;
(III) EMS billing processes;
(IV) Medical control accountability; [and]
(V) Quality improvement processes for EMS operations;
and[.]
(v) have completed [The applicant will
assure that its administrator of record annually complete] eight
hours of continuing education related to the Texas and federal laws
and rules related to EMS.
[(vi) An EMS provider that is directly
operated by a governmental entity, is exempt from this subparagraph,
except for declaration of administrator of record.]
(I) [(vii)] If the [An] EMS provider [that] held a license on September
1, 2013, and has an administrator of record with [who
has] at least eight years of experience providing EMS, then the
administrator of record statement is exempt from subparagraph
(H)(ii) and (iii) of this paragraph [clauses (ii) and (iv)
of this subparagraph].
(J) EMS providers operated by a governmental entity are exempt from subparagraph (H) of this paragraph except for declaration of administrator of record.
(K) [(H)] Copies of Doing Business
Under Assumed Name Certificates (DBA).
(L) [(I)] Completed EMS personnel
form [Personnel Form].
(M) [(J)] Staffing Plan describing
[that describes] how the EMS provider provides continuous
coverage for the service area defined in documents submitted with
the EMS provider application. The EMS provider must [shall
] have a staffing plan that addresses coverage of the service
area or must [shall] have a formal system to
manage communication when not providing services after normal business hours.
(N) [(K)] Completed EMS vehicle
form [Vehicle Form].
(O) [(L)] Declaration of an employed
medical director and a copy of the signed contract or agreement with
a physician [who is] currently licensed in the State of
Texas, in good standing with the Texas Medical Board and[,] in compliance with Texas Medical Board rules, 22 TAC [Texas Administrative Code,] Chapter 197, and [in compliance
with Title 3 of the] Texas Occupations Code Title 3.
(P) [(M)] Completed medical
director information form [Medical Director Information Form].
(Q) [(N)] Treatment and transport
protocols [Transport Protocols] and policies addressing
the care to be provided to adult, pediatric, and neonatal patients,
and as stated in Texas Health and Safety Code §773.112
[§773.112(d)], must be approved and signed
by the medical director.
(R) [(O)] A list of equipment
as required on the EMS provider [Provider] initial and
renewal application, with identifiable or legible serial numbers,
supplies, and medications[;] approved and signed
by the medical director.
(S) [(P)] Documentation [The applicant shall attest] that all required equipment is permitted
to be used by the EMS provider and [provide] proof of ownership
or [hold a] long-term lease for all equipment necessary
for the safe operation.
(T) [(Q)] Documentation [The applicant shall attest] that each authorized vehicle will
have its own set of equipment required for such vehicles [each authorized vehicle] to operate at the level of the service
for which the provider is authorized.
(U) [(R)] Description of how
the EMS provider will conduct quality assurance in coordination with
the EMS provider medical director.
(V) [(S)] Documentation [The applicant shall provide an attestation or provide documentation]
that the applicant or the [it and/or its] management
staff will begin or continue [or continues]
to participate in the local RAC [regional advisory council].
(W) [(T)] Plan for how the provider
will respond to disaster incidents, including mass casualty
situations in coordination with local and regional plans.
(i) An EMS provider must have a plan for providing transport for a dialysis patient who places an emergency 9-1-1 telephone call during a declared disaster. An alternative mode of transport may be used to move the patient directly to and from an outpatient end stage renal disease facility if the patient's normal and alternative modes of transportation cannot be used during the disaster. The plan will include a communication plan with the receiving facility prior to the patient being transported to a receiving facility.
(ii) An EMS provider's plan under this subsection may prioritize providing transportation for a patient suffering from an acute emergency condition over transportation for a dialysis patient.
(I) A "disaster" has the meaning assigned by Texas Government Code §418.004 and §418.014.
(II) "End stage renal disease facility" has the meaning assigned by Texas Health and Safety Code §251.001(7).
(X) [(U)] Copies of written Mutual
Aid or [and/or] Inter-local Agreements with
EMS providers.
(Y) [(V)] Documentation as required
for subscription or membership program, if applicable.
(Z) [(W)] Certificate of Insurance,
provided by the insurer, identifying the department as the certificate
holder and indicating at least minimum motor vehicle liability coverage
for each vehicle to be operated, and professional liability
coverage. If applicant is a government subdivision, applicant
must submit evidence of financial responsibility by self-insuring
to the limit imposed by the tort claims provisions of the Texas Civil
Practice and Remedies Code.
(i) The applicant must [shall]
maintain motor vehicle liability insurance as required under the Texas
Transportation Code.
(ii) The applicant must [shall]
maintain professional liability insurance coverage in the minimum
amount of $500,000 for each single [per] occurrence for bodily injury or death and $100,000 for each single occurrence
for injury to or destruction of property, as described in Texas Civil
Practice and Remedies Code §101.023(c), or as
necessary per state law, with a company licensed or deemed eligible
by the Texas Department of Insurance to do business in Texas.
Alternatively, the applicant may provide [or] acceptable
proof of self-insurance or captive insurance in order to secure payment
for any loss or damage resulting from any occurrence arising out of,
or caused by the care, or lack of care, of a patient.
(iii) Liability of a unit of local government under this chapter is limited to money damages in a maximum amount of $100,000 for each person and $300,000 for each single occurrence for bodily injury or death and $100,000 for each single occurrence for injury to or destruction of property, as described in Texas Civil Practice and Remedies Code §101.023(d).
(AA) [(X)] Copies [The
applicant shall provide copies] of vehicle titles, vehicle lease
agreements, [copies of] exempt registrations if applicant
is a government subdivision, or an affidavit identifying applicant
as the owner, lessee, or authorized operator for each vehicle to be
operated under the license.
(BB) [(Y)] Documentation [The applicant shall provide documentation of the following,]
showing [that] the applicant and [, including
its] management staff possess [possesses]
sufficient EMS professional experience and qualifications as follows [related to EMS]:
(i) [an] attestation that [its]
management staff have read the Texas Emergency Healthcare Act and
the department's EMS rules in this chapter; and
(ii) proof of one year experience or education provided by a nationally recognized organization on:
(I) emergency medical dispatch processes;
(II) [(iii)] [proof of one
year experience or education provided by a nationally recognized organization
concerning] EMS billing processes;
(III) [(iv)] [proof of one
year experience or education provided by a nationally recognized organization
on] medical control accountability; and
(IV) [(v)] [proof of one
year experience or education provided by a nationally recognized organization
on] quality improvement processes for EMS operations.
(CC) [(Z)] A copy of a letter
of credit for [the] obtaining or renewing [of]
an EMS provider [Providers] license, issued
by a federally insured bank or savings institution:
(i) in the amount of:
(I) $100,000 for the initial license and for renewal of the license on the second anniversary of the date the initial license is issued;
(II) [(ii)] [in the amount
of] $75,000 for renewal of the license on the fourth anniversary
of the date the initial license is issued;
(III) [(iii)] [in the amount
of] $50,000 for renewal of the license on the sixth anniversary
of the date the initial license is issued;
(IV) [(iv)] [in the amount
of] $25,000 for renewal of the license on the eighth anniversary
of the date the initial license is issued;
(ii) [(v)] that includes: [shall include]
(I) the names of all [of] the
parties involved in the transaction;
(II) [(vi)] [that shall
include] the name [names] of the person [persons] or entity[,] who owns the EMS provider operation
and to whom the bank is issuing the letter of credit;
(III) [(vii)] [that shall
include] the name of the person or entity[,] receiving
the letter of credit; and
(IV) [(viii)] an EMS provider
[that is] directly operated by a governmental entity is
exempt from this subsection.
(DD) [(AA)] A copy of the surety
bond in the amount of $50,000 issued to and provided to the Health
and Human Services Commission by the applicant[,] participating
in the medical assistance program operated under Texas Human
Resources Code[,] Chapter 32, the Medicaid Managed
Care Program [managed care program] operated under Texas Government Code[,] Chapter 540 [533
], or the child health plan program operated under Texas Health
and Safety Code[,] Chapter 62. An EMS provider [that
is] directly operated by a governmental entity is exempt from
this subparagraph.
(EE) [(BB)] Documentation showing
[evidencing] applicant or management team has not
been excluded from participation in the state Medicaid program.
(FF) [(CC)] A copy of a governmental
entity letter of approval that must [shall]:
(i) be from the governing body of the municipality in which the applicant is located and is applying to provide EMS;
(ii) be from the commissioner's court of the county in which the applicant is located and is applying to provide EMS, if the applicant is not located in a municipality;
(iii) attest [include the attestation
that] the addition of another licensed EMS provider will not
interfere with or adversely affect the provision of EMS by the licensed
EMS providers operating in the municipality or county;
(iv) attest, if applicable, [include
the attestation that] the addition of another licensed EMS provider
will remedy an existing provider shortage that cannot be resolved using
[through the use of] the licensed EMS providers
operating in the municipality or county; and
(v) attest [include the attestation
that] the addition of another licensed EMS provider will not
cause an oversupply of licensed EMS providers in the municipality
or county.
(8) Paragraph (7)(FF) [(CC)]
of this subsection does not apply to the renewal of an
EMS provider license, or to a municipality,
county, emergency services district, hospital, or EMS volunteer provider
organization in this state that applies for an EMS provider license.
(9) An EMS provider is prohibited from expanding operations to or stationing any EMS vehicles in a municipality or county other than the municipality or county from which the provider obtained the letter of approval under this subsection until after the second anniversary of the date the provider's initial license was issued, unless the expansion or stationing occurs in connection with:
(A) a contract awarded by another municipality or county for the provision of EMS;
(B) an emergency response made in connection with an existing mutual aid agreement; or
(C) an activation of a statewide emergency or disaster response by the department.
(10) Paragraph (9) of this subsection does not apply to the renewal of an EMS provider license or to a municipality, county, emergency services district, hospital, or EMS volunteer provider organization in this state that applies for an EMS provider license.
(11) Paragraph (9) of this subsection does not apply to fixed or rotor wing EMS providers.
(d) EMS Provider License Issuance.
(1) License.
(A) Applicants who have submitted all required documents
and who have met all the criteria for licensure will be issued a provider
license [to be] effective for a period of two years from
the date of issuance.
(B) Licenses must [shall] be
issued in the name of the applicant.
(C) License expiration dates may be adjusted by the department to create licensing periods less than two years for administrative purposes.
(D) An application for an initial license or for the
renewal of a license may be denied to a person or legal entity who
owns or [who] has owned any portion of an EMS provider
service or who operates or manages [operates/manages]
or [who/which] has operated or managed [operated/managed
] any portion of an EMS provider service that [which
] has been sanctioned by or that [which]
has a proposed disciplinary action or sanction [action/sanction
] pending against it by the department or any other local, state, or federal agency.
(E) The license will be issued in the form of a certificate that must [which shall] be prominently displayed
in a public area of the provider's primary place of business.
(F) An EMS provider license [Provider
License] issued by the department is [shall]
not [be] transferable to another person or entity.
(2) Vehicle Authorization.
(A) The department issues [will issue]
an authorization for each vehicle [to be] operated by the
applicant meeting [which meets] all criteria
for approval as defined in this subsection [(d) of
this section].
(B) A vehicle authorization is [shall
be] issued for the following levels of service. A [, and a] provider may operate at a higher level of service based
on appropriate staffing, equipment, and medical direction
for that level. A vehicle authorization includes [will
include] a level of care designation at one of the following levels:
(i) Basic Life Support (BLS);
(ii) BLS with Advanced Life Support (ALS) capability;
(iii) BLS with Mobile Intensive Care Unit (MICU) capability;
(iv) ALS; [Advanced Life Support (ALS);]
(v) ALS with MICU capability;
(vi) MICU; [Mobile Intensive Care Unit (MICU);]
(vii) Air Medical:
(I) Rotor-wing [Rotor wing]; or
(II) Fixed-wing [Fixed wing]; and
(viii) Specialized.
(C) Change of Vehicle Authorization. To change an authorization
to a different level, the provider must [shall
] submit a request with appropriate documentation to the department
verifying the provider's ability to perform at the requested level.
A $30 fee is [of $30 shall be] required
for each new authorization requested. The provider must not operate
a vehicle until authorized by [shall allow sufficient time
for] the department [to verify the documentation and conduct
necessary inspections before implementing service at the requested
authorization level].
(D) Vehicle Authorizations are not required to be specific
to particular vehicles and may be interchangeably placed in other
vehicles as necessary. The original Vehicle Authorization for the
appropriate level of service must [shall] be
prominently displayed in the patient compartment of each
vehicle.[:]
(E) Vehicle Authorizations are not transferable between providers.
(F) A replacement of a lost or damaged license or authorization may be issued, if requested, with a nonrefundable fee of $10.
(3) Declaration of Business Operational Name and Administration.
(A) The applicant must [shall]
submit a list of all business operational names under which the service
is operated. If the applicant intends to operate the service under
a name or names different from that on the issued
license [name for which the license is issued], the
applicant must [shall] submit certified copies
of assumed name certificates.
(B)A change in the operational name in which
the service is operated requires [will require]
a new application and a prorated fee as determined by the department. The department will issue a [A] new provider number
[will be issued].
(C) Name of Administrator of Record must be declared.
The applicant must [shall] submit a notarized
document declaring the full name, mailing address, email address,
and telephone number of the chief administrator to[, his/her mailing address and telephone number to] whom the
department addresses [shall address] all official
communications in regard to the license.
(e) Vehicle Requirements [Vehicles].
(1) All EMS vehicles must be adequately constructed,
equipped, maintained, and operated to safely and efficiently
render patient care, comfort, and transportation
of adult, pediatric, and neonatal patients [safely and efficiently].
A pediatric and neonatal equipment list must [should]
be based on endorsed pediatric equipment national standards within
the approved equipment list required by the medical director.
(2) EMS vehicles must allow the proper and safe storage
and use of [all] required equipment, supplies, and
medications and must allow [all] required procedures to
be carried out in a safe and effective manner.
(3) As approved by the department, EMS vehicles must meet a practical, efficient minimum national ambulance vehicle body type, dimension, and safety criteria standards.
(4) When in service, all [All]
vehicles must [shall] have an environmental
system within the patient compartment capable of heating
or cooling the patient [patient(s)] and staff,
in accordance with the manufacturer specifications[, within the
patient compartment at all times when in service] and that [which] allows for protection of medication, according to manufacturer
specifications, from extreme temperatures [if it becomes environmentally
necessary].
(A) The provider must [shall]
provide evidence of an operational policy that lists [which
shall list] the parenteral pharmaceuticals authorized by the
medical director.
(B) The provider must document and
describe the storage of pharmaceuticals authorized by the medical
director and stored in accordance with the manufacturer and U.S. Federal
Drug Administration (FDA) recommendations [and which shall
define the storage and/or FDA recommendations].
(C) Compliance with the policy must [shall] be incorporated into the provider's Quality Assurance
process and must [shall] be documented on unit
readiness reports.
(5) EMS vehicles must [shall]
have operational two-way communication capable of contacting appropriate
medical resources and as outlined in the current Texas interoperability
plan unless the vehicle is designated as being out of service with [using] the form provided by the department.
(6) EMS vehicles must comply [shall
be in compliance] with all applicable federal, state, and
local requirements unless the vehicle is designated out of service
with the form provided by the department.
(7) All EMS vehicles must [shall]
have the name of the provider and a current department-issued [department issued] EMS provider license number prominently displayed
on both sides of the vehicle in at least 2-inch [2
inch] lettering and in contrasting color. The license number must
[shall] have the letters TX prior to the license
number. This requirement does not apply to fixed or rotor wing aircraft.
(f) Substitution, Replacement, [replacement
] and Additional [additional] EMS Vehicles
[vehicles].
(1) The EMS provider must [shall]
notify the department within five business days if the EMS provider
substitutes or replaces a vehicle. No fee is required for a vehicle
substitution or replacement.
(2) The EMS provider must [shall]
notify the department if the EMS provider adds a vehicle to the provider's
operational fleet prior to making the vehicle response ready [response-ready]. A vehicle authorization request must [shall] be submitted with a nonrefundable vehicle fee prior to
the vehicle being placed into service.
(g) Staffing Plan Required.
(1) The applicant must [shall]
submit a completed EMS Personnel Form listing each response person
assigned to staff EMS vehicles by name, certification level, and department-issued
certification or license [department issued certification/license
] identification number.
(2) An EMS provider responsible for an emergency response
area [that is] unable to provide continuous coverage within
the declared service areas must [shall] publish
public notices in local media, to include social media, of
its inability to provide continuous response capability and [shall]
include the days and hours of its operation. The EMS provider must [shall] notify all public safety answering [the
public safety-answering] points and all dispatch centers of
the days and hours when unable to provide coverage. The EMS provider must [shall] submit evidence that reasonable attempts
to secure coverage from other EMS providers were [have
been] made.
(3) The applicant must provide proof at license
initiation [initial] and renewal [of license]
that all licensed or certified personnel [have] completed
a jurisprudence examination approved by the department on state and
federal laws and rules affecting [that affect] EMS.
(h) Minimum Staffing Required.
(1) BLS--When response ready [response-ready
] or in-service, authorized EMS vehicles operating at the BLS
level must [shall] be staffed at a minimum with
two emergency care attendants (ECAs) or higher certified or licensed staff.
(2) BLS with ALS capability--When response ready [response-ready] or in-service, authorized EMS vehicles
operating below the ALS level must be staffed
with two ECAs. Full ALS status becomes active when staffed by
[at least] an advanced emergency medical technician (AEMT) [(EMT)-Intermediate or AEMT] and [at
least] an emergency medical technician (EMT) or higher
certified or licensed staff [EMT].
(3) BLS with MICU capability--When response ready [response-ready] or in-service, authorized EMS vehicles
operating below the MICU level must be staffed
with two ECAs. Full MICU status becomes active when staffed
by [at least] a certified or licensed paramedic and an
EMT or higher certified or licensed staff [at least an EMT].
(4) ALS--When response ready [response-ready
] or in-service, authorized EMS vehicles operating at the ALS
level must [shall] be staffed with one
AEMT and one EMT or higher certified or licensed staff [at
a minimum with one EMT Basic and one AEMT or EMT- Intermediate].
(5) ALS with MICU capability--When response ready [response-ready] or in-service, authorized EMS vehicles
operating below the MICU level must be staffed
with [shall require] one [EMT-Intermediate or]
AEMT and one EMT. Full MICU status becomes active when staffed by
[at least] a certified or licensed paramedic and [at
least] an EMT or higher certified or licensed staff.
(6) MICU--When response ready [response-ready
] or in-service, authorized EMS vehicles operating at the MICU
level must [shall] be staffed at a minimum with
[one EMT Basic and] one certified or licensed paramedic
and one EMT or higher certified or licensed staff [EMT-Paramedic].
(7) Specialized--When response ready [response-ready
] or in-service, EMS vehicles authorized to operate for a specialized
purpose must [shall] be staffed with a minimum
of two personnel appropriately licensed or [and/or]
certified as determined by the type and application of the specialized
purpose and as approved by the medical director and the department.
(8) For air ambulance staffing requirements refer to
§157.12(f) of this subchapter [title] (relating
to Rotor-wing Air Ambulance Operations) or §157.13(g) of this subchapter
[title] (relating to Fixed-wing [Fixed-
wing] Air Ambulance Operations).
(9) When response ready [response-ready]
or in-service, authorized EMS vehicles may operate at a lower level
than licensed by the department. When operating at the BLS level with
an ALS MICU [ALS/MICU] ambulance, the EMS provider
must have an approved security plan for the ALS MICU [ALS/MICU
] medication as approved by the EMS provider medical director's
protocol and [and/or] policy.
(10) As justified by patient needs, providers may utilize
appropriately certified or [and/or] licensed
medical personnel in addition to those [which are] required
by the [their] designation levels. In addition
to the care rendered by the required staff, the provider must [shall] be accountable for care rendered by any additional personnel.
(i) Treatment and Transport Protocols Required. The protocols must include:
(1) [The applicant shall submit] written policies
related to patient care and delegated standing orders for patient
treatment and transport, [protocols and policies related
to patient care which have been] approved and signed by the
provider's medical director;[.]
(2) [The protocols shall have] an effective
date;[.]
(3) [The protocols shall address] the use
of non-EMS certified or licensed medical personnel who, in addition
to the EMS staff, may provide patient care on behalf of the provider or [and/or] in the provider's EMS
vehicles;[.]
(4) [The protocols shall address] the use
of all required, additional, or [and/or] specialized
medical equipment, supplies, and pharmaceuticals carried on each EMS
vehicle in the provider's fleet;[.]
(5) identified [The protocols shall
identify] delegated procedures for each EMS certification [Certification] or license level utilized by the provider;and[.]
(6) the EMS medical director's approved protocols
to be followed by on-duty EMS [The protocols shall indicate
specific applications, including geographical area and duty status
of] personnel within the EMS provider's geographical location,
unless otherwise specified.
(j) EMS Equipment, Supplies, Medical Devices,
Parenteral Solutions, and Pharmaceuticals [supplies, medical
devices, parenteral solutions and pharmaceuticals].
(1) The EMS provider must [shall]
submit a list, approved and signed by the medical director and fully
supportive of and consistent with the treatment and transport protocols,
of all medical equipment, supplies, medical devices, parenteral solutions, and pharmaceuticals to be carried. The list must [shall] specify the quantities of each item to be carried and
[shall specify] the sizes and types of each item necessary
to provide appropriate care for all age ranges appropriate to the
needs of [their] patients. The quantities listed must [shall] be appropriate to the provider's call volume, transport
times, and restocking capabilities.
(2) All patient care equipment[,] and medical
devices must be operational, appropriately secured in the vehicle
at the time of providing patient care, and response ready. Supplies must [, and supplies shall] be clean and
fully operational. All patient care powered equipment must [shall] have a manual mechanical feature,
spare batteries, or an alternative power source[,
if applicable].
(3) All solutions and pharmaceuticals must [shall] be up to date and [shall] be stored and maintained
in accordance with the manufacturer's and [and/or]
U.S. FDA [Federal Drug Administration (FDA)] recommendations.
(4) The requirements for air ambulance equipment and
supplies are listed in §157.12(h) and [157.12(h)
of this title or] §157.13(h) of this subchapter [title].
(k) The following equipment must [shall]
be present on each [EMS] in-service EMS vehicle
and on, or immediately available for, each response ready [response-ready] vehicle as [specified in the equipment
list as] required by the medical director's approved equipment
list to include all state-required [state required]
equipment. The equipment list must [shall] include
equipment required for treatment and transport of adult, pediatric,
and neonatal patients.
(1) Basic Life Support (BLS):
(A) equipment [Equipment] required
to administer the BLS scope of practice and incorporate [incorporates] the knowledge, competencies, and basic
skills of an EMT or ECA [EMT/ECA] and additional
skills as authorized by the EMS provider medical director; all[. All] BLS ambulances must [shall] be
able to transport patients and perform [treatment
and transport patients receiving] the following treatments
[skills]:
(i) airway, ventilation, oxygenation [airway/ventilation/oxygenation
];
(ii) cardiovascular circulation;
(iii) immobilization;
(iv) medication administration - routes; and
(v) single and multi-system trauma patients;[.]
(B) oropharyngeal airways;
(C) portable and vehicle mounted suction;
(D) bag valve mask units, oxygen capable;
(E) portable and vehicle mounted oxygen;
(F) oxygen delivery devices;
(G) dressing and bandaging materials;
(H) commercial tourniquet;
(I) rigid cervical immobilization devices;
(J) spinal immobilization devices;
(K) extremity splints;
(L) equipment to meet special patient needs;
(M) equipment for determining and monitoring patient vital signs, condition or response to treatment;
(N) pharmaceuticals, as required by the medical director
[director's] protocols;
(O) an external cardiac defibrillator appropriate to the staffing level with two sets of adult and two sets of pediatric pads;
(P) a patient-transport device capable of being secured
to the vehicle;[, and] the patient must be fully
restrained per manufacturer recommendations; and
(Q) an epinephrine auto injector or similar device capable of treating anaphylaxis.
(2) Advanced Life Support (ALS):
(A) equipment required to administer the ALS scope
of practice and incorporate [incorporates] the
knowledge, competencies, and basic and advanced skills
of an AEMT and additional skills as authorized by the EMS provider
medical director; all[. All] ALS ambulances must
[shall] be able to transport patients and perform
[treatment and transport patients receiving] the following treatments [skills, including all required BLS equipment
to perform treatment and transport patients receiving the following
skills]:
(i) airway, ventilation, oxygenation [airway/ventilation/oxygenation];
(ii) cardiovascular circulation;
(iii) immobilization;
(iv) medication administration - routes; [and]
(v) intravenous (IV) initiation and maintenance
of [initiation/maintenance] fluids;
and[.]
(vi) single and multi-system trauma patients;
(B) all required BLS equipment; and
(C) advanced airway equipment.[;]
[(D) IV equipment and supplies;]
[(E) pharmaceuticals as required by medical director protocols; and]
[(F) wave form capnography or state approved carbon dioxide detection equipment must be used after January 1, 2018, when performing or monitoring endotracheal intubation.]
(3) Mobile Intensive Care Unit (MICU) [MICU]:
(A) equipment required to administer the knowledge,
competencies, and advanced skills of a paramedic, and additional
skills as authorized by the EMS provider medical director; all[. All] MICU ambulances must [shall] be
able to transport patients and perform [treatment
and transport patients receiving] the following treatments
[skills]:
(i) airway, ventilation, oxygenation [airway/ventilation/oxygenation];
(ii) cardiovascular circulation;
(iii) immobilization;
(iv) medication administration - routes; [and]
(v) IV initiation and maintenance of fluids;
[(v) intravenous (IV) initiation/maintenance fluids.]
(B) all required BLS and ALS equipment;
(C) [with] transmitting 12-lead capability cardiac monitor-defibrillator [monitor/defibrillator by January 1, 2020]; and
(D) pharmaceuticals as required by medical director protocols.
(4) BLS with ALS Capability:
(A) all required BLS equipment, even when in-service [ in service] or response ready at the ALS level; and
(B) all required ALS equipment, when in-service [ in service] or response ready at the ALS level.
(5) BLS with MICU Capability:
(A) all required BLS equipment, even when in-service [in service] or response ready at the MICU level; and
(B) all required MICU equipment, when in-service [in service] or response ready at the MICU level.
(6) ALS with MICU Capability:
(A) all required ALS equipment, even when in-service [in service] or response ready at the MICU level; and
(B) all MICU equipment, when in-service [in
service] or response ready at the MICU level.
(7) Wave form capnography or carbon dioxide detection equipment must be used when performing or monitoring endotracheal intubation.
(8) [(7)] In addition to medical supplies and equipment as defined in this subsection [(k) of this section], EMS vehicles must also have:
(A) a complete and current copy of written or electronic formatted protocols approved and signed by the medical director,[ ;] with a current and complete equipment, supply, and medication list available to the crew;
(B) operable emergency warning devices;
(C) personal protective equipment for the EMS vehicle staff, including at least:
(i) protective, non-porous gloves;
(ii) medical eye protection;
(iii) medical respiratory protection [must be]
available per crew member, meeting National Institute for Occupational
Safety and Health (NIOSH)-approved [(NIOSH) approved]
N95 or greater standards;
(iv) medical protective gowns or equivalent; and
(v) personal cleansing supplies;
(D) sharps container;
(E) biohazard bags;
(F) portable, battery-powered flashlight (not a pen-light);
(G) a mounted, currently inspected, 5-pound [5 pound] ABC fire extinguisher (not applicable to air ambulances);
(H) "No Smoking" signs posted in the patient compartment and cab of vehicle;
(I) a current emergency response guidebook [guide book], or an electronic version that is available to the
crew (for hazardous materials); and
(J) [each vehicle will carry] 25 triage
tags, or participation in [coordination with]
the RAC triage plan [Regional Advisory Council (RAC)].
(9) [(8)] As justified by specific
patient needs, and when qualified personnel are available, EMS providers
may appropriately utilize equipment in addition to what [that which] is required by the [their]
authorization levels. Such equipment must be consistent with protocols and patient-specific [and/or patient- specific] orders
and must correspond to personnel qualifications.
(l) National Accreditation [accreditation].
If a provider has been accredited through a national accrediting organization
approved by the department and adheres to Texas staffing level requirements,
the department may exempt the provider from portions of the license
process. In addition to other licensing requirements, accredited providers must [shall] submit:
(1) an accreditation self-study;
(2) a copy of the formal accreditation certificate; and
(3) any correspondence or updates to or from the accrediting
organization that [which] impact the provider's status.
(m) Subscription or Membership Services. An EMS provider
that operates or intends to operate a subscription or membership program
for the provision of EMS within the provider's service area must [shall] meet all the requirements for an EMS provider license
as established by, and rules adopted under, Texas [the]
Health and Safety Code[,] Chapter 773. An EMS provider
must[, and the rules adopted thereunder, and shall]
obtain department approval prior to soliciting, advertising, or
collecting subscription or membership fees. To obtain department approval
for a subscription or membership program, the EMS provider must
complete the following. [shall:]
(1) Obtain written authorization from the highest elected
official (county judge or mayor) [(County Judge or
Mayor)] of the political subdivision [subdivision(s)
] where subscriptions will be sold. Written authorization must
be obtained from each county judge [County Judge]
if subscriptions are to be sold in multiple counties.
(A) The county judge [County Judge]
must provide written authorization [authorizations,]
if subscriptions are to be sold throughout a county.
(B) The mayor [Mayor] may provide
written authorization if subscriptions are sold exclusively within
the boundaries of an incorporated town or city.
(C) If an EMS provider is not the primary emergency
provider in any area where they are going to sell a subscription plan,
written notification must be provided to the participants receiving a subscription plan stating [that] the EMS provider
[Provider] is not the primary emergency provider
in that [this] area. A copy of this documentation must [should] be provided to the primary emergency
provider and the department within 30 days before the beginning of
any enrollment period.
(2) Submit a copy of the contract used to enroll participants.
(3) Maintain [The EMS provider shall
maintain] a current file of all advertising for the service and
submit[. Submit] a copy of all advertising used to
promote the subscription service within 30 days before the beginning
of any enrollment period.
(4) Comply with all state and federal regulations regarding billing and reimbursement for participants in the subscription service.
(5) Provide evidence of financial responsibility by:
(A) obtaining a surety bond payable to the department in an amount equal to the funds to be subscribed. The surety bond must be on a department bond form and be issued by a company licensed by or eligible to do business in the State of Texas; or
(B) submitting satisfactory evidence of self-insurance in an amount equal to the funds to be subscribed if the provider is a function of a governmental entity.
(6) Not deny emergency medical services to non-subscribers or subscribers of non-current status.
(7) Be reviewed at least every year. The [; and the] subscription program may be reviewed by the department
at any time.
(8) Furnish a list after each enrollment period with the names, addresses, dates of enrollment of each subscriber, and subscription fee paid by each subscriber.
(9) Furnish the department beginning and ending dates
of enrollment periods [period(s)]. Subscription
service period must [shall] not exceed one year.
Subscribers must [shall] not be charged more
than a prorated fee for the remaining subscription service period
[that they subscribe for].
(10) Furnish the department with the total amount of funds collected each year.
(11) Not offer membership nor accept members into the program who are Medicaid clients.
(n) Responsibilities of the EMS Provider [provider]. During the license period, the EMS provider's responsibilities must [shall] include:
(1) assuring [that] all response ready [response-ready] and in-service vehicles are available 24 hours
a day and seven days a week, maintained, operated, equipped, and
staffed in accordance with the requirements of the provider's license,
to include staffing, equipment, supplies, required insurance, and
additional requirements per the current EMS provider's medical director-approved
[director-approved] protocols and policies;
(2) developing, implementing, maintaining, and
evaluating [each EMS provider shall develop, implement,
maintain, and evaluate] an effective, ongoing, system-wide,
data-driven, interdisciplinary quality assessment and performance
improvement program, that must[. The program shall]
be individualized to the provider and [shall, at a minimum,] include:
(A) the standard of patient care as directed by [the]
medical director [director's] protocols and
medical director input into the provider's policies and standard operating procedures;
(B) a complaint management system;
(C) monitoring the quality of patient care provided
by the personnel and taking appropriate and immediate corrective action
to ensure [insure that] quality of care is maintained
in accordance with the existing standards of care and the [provider]
medical director [director's] signed, approved protocols; and
(D) [the program shall include, but not be limited
to,] an ongoing program that achieves measurable improvement
in patient care outcomes and reduction of medical errors;
(3) providing [provide] an attestation
or [provide] documentation [that] its management
staff will begin or continue to participate in the local RAC [regional advisory council];
(4) when an air ambulance is initiated through any
other method than the local 9-1-1 [911] system, requiring the air service providing the air ambulance [is
required] to notify the local 9-1-1 [911]
center or the appropriate local response of [system
for] the location of the response at time of launch; this[. This] would not include interfacility transports or scheduled
[schedule] transports;
(5) ensuring [that] all personnel are currently
certified or licensed by the department;
(6) assuring [that] all personnel, when
on an in-service vehicle or when on the scene of an emergency, are
prominently identified by[, at least,] the last name and
the first initial of the first name, the certification or license
level, and the EMS provider's name; a[.
A] provider may utilize an alternative identification system
in incident-specific [incident-specific] situations
that pose a potential for danger if the individuals are identified
by name;
(7) assuring the confidentiality of [all]
patient information [is] in compliance with [all]
federal and state laws;
(8) assuring [that] Informed Treatment
or Transport [Treatment/Transport] Refusal forms
are signed by all persons refusing service, or documenting incidents
when a signed Informed Treatment or Transport [Treatment/Transport
] Refusal form cannot be obtained;
(9) assuring [that] patient care reports
are completed accurately [for all patients] and meet standards
as outlined in 25 TAC [Texas Administrative Code,]
Chapter 103;
(10) assuring [that] patient care reports
are provided to facilities receiving the patient:
(A) whenever operationally feasible, the report must [shall] be provided to the receiving facility at the time the
patient is delivered, or a full written or computer-generated
[computer-generated] report [shall be]
delivered to the facility within 24 hours of the delivery of the
patient;[,]
(B) if in a response-pending status, an abbreviated
documented report must [shall] be provided at
the time the patient is delivered and a completed written or computer-generated
[computer-generated] report [shall be]
delivered to the facility within 24 hours of the delivery of the patient;
(C) the abbreviated report must [shall]
document[, at a minimum,] the patient's name and[, patient's] condition upon arrival at the scene; the prehospital
care provided; the patient's condition during transport, including
signs, symptoms, and responses to treatment during the transport;
the call initiation time; dispatch time; scene arrival time; scene
departure time; hospital arrival time; and[,] the identification
of the ambulance staff; and
(D) in lieu of subparagraph (C) of this paragraph,
personnel may follow the RAC [Regional Advisory Council's
] process for providing abbreviated documentation to the receiving
facility;[.]
(11) assuring [that] all pharmaceuticals
are stored according to conditions specified in the pharmaceutical
storage policy approved by the EMS provider's medical director;
(12) assuring [that] staff completes a readiness
inspection as written by the EMS provider's policy;
(13) assuring [that] there is a preventive
maintenance plan for vehicles and equipment;[.]
(14) assuring [that] staff has reviewed
policies and procedures as approved by the EMS provider [Provider] and the EMS provider medical director [Provider
Medical Director];
(15) maintaining [Maintenance of]
medical reports:[.]
(A) a [A] licensed EMS provider must [shall] maintain adequate medical reports of
a patient for a minimum of seven years from the anniversary date of
the date of last treatment by the EMS
provider;[.]
(B) if [If] a patient was younger
than 18 years of age when last treated by the provider, the medical
reports of the patient must [shall] be maintained
by the EMS provider until the patient reaches age 21 years or
for seven years from the date of last treatment, whichever is
longer;[.]
(C) an [An] EMS provider may
destroy medical records that relate to any civil, criminal, or
administrative proceeding only if the provider knows the proceeding
has been finally resolved;[.]
(D) EMS providers must [shall]
retain medical records for a longer length of time [than that
imposed herein] when mandated by other federal or state statute
or regulation;[.]
(E) EMS providers may transfer ownership of records
to another licensed EMS provider only if the EMS provider, in writing,
assumes ownership of the records and maintains the records consistent
with this chapter;[.]
(F) destruction [Destruction]
of medical records must [shall] be done in a
manner that ensures continued confidentiality;[.]
(G) at [At] the time of initial
licensing and at each license renewal, the EMS provider and medical
director must attest or provide documentation to the department, a
plan for [the] going out of business, selling, or transferring
the business to ensure the proper maintenance of [the]
medical records [record] as outlined in subparagraph
(E) of this paragraph; and[.]
(H) the EMS [The emergency medical
services] provider must maintain all patient care records in
the physical location that is the provider's primary place of business,
unless the department approves an alternate location;[.]
(16) assuring [that] all requested patient
records are made promptly available to the medical director, hospital, or department [when
requested];
(17) assuring [that] current protocols,
equipment, supply and medication lists, and the correct original vehicle
authorization [Vehicle Authorization] at the appropriate
level, are maintained on each response ready [response-ready] vehicle;
(18) monitoring and enforcing compliance with all policies and protocols;
(19) assuring provisions for the appropriate disposal
of medical or [and/or] biohazardous waste materials;
(20) assuring ongoing compliance with the terms of first responder agreements;
(21) assuring that all documents, reports, or information provided to the department and hospital are current, accurate, and complete;
(22) assuring compliance with all federal and state laws and regulations and all local ordinances, policies, and codes, at all times;
(23) assuring [that] all response data required
by the department are [is] submitted in accordance
with §103.5 of this title (relating to Reporting Requirements
for EMS Providers);
(24) assuring [that], whenever there is
a change in the EMS provider's name or the service's operational assumed
name, the printed name on the vehicles is [are]
changed accordingly within 30 days of the change;
(25) assuring [that] the department is notified
within 30 business days whenever:
(A) a vehicle is sold, substituted, or replaced;
(B) there is a change in the level of service;
(C) there is a change in the declared service area as written on an initial or renewal application;
(D) there is a change in the official business mailing address;
(E) there is a change in the physical location of the
business or [and/or] substations;
(F) there is a change in the physical location of patient
report file storage, to assure [that] the department has
access to these records at all times; or [and]
(G) there is a change of the administrator of record;
[.]
(26) assuring the department is notified within
one business day [that] when there is a
change of the medical director [has occurred the department is
notified within one business day];
(27) developing, implementing, and enforcing [develop, implement and enforce] written operating policies and
procedures required under this chapter or [and/or]
adopted by the licensee, assuring[. Assure that]
each employee (including volunteers) is provided a copy upon employment
and whenever such policies or [and/or] procedures
are changed; a[. A] copy of the written operating
policies and procedures must [shall] be made
available to the department on request, and policies [.
Policies] at a minimum must [shall] adequately address:
(A) personal protective equipment;
(B) immunizations available to staff;
(C) infection control procedures;
(D) management of possible exposure to communicable disease;
(E) emergency vehicle operation;
(F) contact information for the designated infection
control officer for whom education based on U.S. Code[,]
Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 [§300ff- 136] has been
documented;[.]
(G) credentialing of new response personnel before
being assigned primary care responsibilities, which must[. The credentialing process shall] include at [as]
a minimum:
(i) a comprehensive orientation session of the services,
policies, [and] procedures, treatment and transport
protocols, safety precautions, and the quality management process; and
(ii) an internship period in which all new personnel
practice under the supervision of, and are evaluated by, another more
experienced person;[.]
(H) appropriate documentation of patient care; [and]
(I) vehicle checks, equipment, and readiness inspections; and
(J) the security of medications, fluids, and
controlled substances in compliance with local, state, and
federal laws or rules;[.]
(28) assuring [that] manufacturers' operating
instructions for all critical patient care electronic and [and/or] technical equipment utilized by the provider are available
for all response personnel;
(29) assuring [that] the department is notified
within five business days of a collision involving an in-service or
response ready EMS vehicle that results in vehicle damage whenever:
(A) the vehicle is rendered disabled and inoperable at the scene of the occurrence; or
(B) there is a patient on board;[.]
(30) assuring [that] the department is notified
within one business day of a collision involving an in-service or
response ready EMS vehicle that results in vehicle damage whenever
there is personal injury or death to any person;
(31) maintaining motor vehicle liability insurance as required under the Texas Transportation Code;
[(32) maintaining professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed or deemed eligible by the Texas Department of Insurance to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of, or caused by the care, or lack of care, of a patient;]
(32) [(33)] ensuring [ insuring] continuous coverage for the service area defined in documents submitted with the EMS provider application;
(33) [(34)] responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty
situation according to national, state, regional, or [and/or
] local plans, when authorized;
(34) [(35)] providing written
notice to the department, RAC, and Emergency Medical Task
Force, if the EMS provider will make staff and equipment available
during a declared emergency or mass casualty situation, for a state
or national mission, when authorized;
(35) [(36)] assuring all EMS
personnel receive continuing education on the provider's anaphylaxis
treatment protocols, and the[. The] provider must
[shall] maintain education and training records
to include date, time, and location of such education or training
for all its EMS personnel;
(36) [(37)] immediately notifying
[notify] the department in writing when operations
cease in any service area;
(37) [(38)] assuring [assure that] all patients transported by stretcher are [must be] in a department-authorized [department-authorized
] EMS vehicle; and
(38) [(39)] developing or
adopting [develop or adopt] and then implementing [implement] policies, procedures, and protocols necessary
for its operations as an EMS provider, and enforcing [enforce
] all such policies, procedures, and
protocols.
(o)
License Renewal Process [renewal process].
(1) The provider is responsible for requesting [It shall be the responsibility of the provider to request] license
renewal application information.
(2) EMS providers must [shall]
submit a completed application, all other required documentation, and
a nonrefundable license renewal fee, no later than 90 calendar days
prior to the expiration date of the current license.
(A) If [When] a complete renewal
application is received by the department 90 or more calendar
days prior to the expiration date of the current license, [that is to be renewed,] the applicant must [shall]
submit a nonrefundable application fee of $400 per provider plus $180
for each EMS vehicle.
(B) If [When] a complete renewal
application is received by the department 60 or more days,
but less than 90 calendar days, prior to the
expiration date of the current license, [that is to
be renewed,] the applicant must [shall]
submit a nonrefundable application fee of $450 per provider plus $180
for each EMS vehicle.
(C) If [When] a complete renewal
application is received by the department less than 60 days
prior to the expiration of the current license, the applicant must [shall] submit a nonrefundable application fee of $500 per provider
plus $180 for each EMS vehicle.
(D) If the application for renewal is received by the
department after the expiration date of the current license, [it
is deemed to be untimely filed and] that license expires on
its expiration date. The EMS provider will be required to file a new
initial application and follow the initial application process.
(E) An EMS provider may not operate after its license has expired.
(p) Provisional License. The department may issue an
EMS provisional license if an urgent need exists in a service area
when the department finds [that] the applicant is in substantial
compliance with the provisions of this section and if the public interest
would be served. A provisional license is [shall be]
effective for no more than 30 days from the date of issuance.
(1) An EMS provider may apply for a provisional license by submitting a written request and a nonrefundable fee of $30.
(2) A provisional license issued by the department
may be revoked at any time by the department, with written notice
to the provider, when the department finds [that] the provider
is failing to provide appropriate service in accordance with this
section or [that] the provider is in violation of any of
the requirements of this chapter.
(q) Advertisements.
(1) Any advertising by an EMS provider must [shall] not be misleading, false, or deceptive. When an EMS provider
advertises in Texas or [and/or] conducts business
in Texas by regularly transporting patients from[,] or
within Texas, the provider is [shall be] required
to have a Texas EMS provider license [Provider License].
(2) An EMS provider must [shall]
not advertise levels of patient care that [which]
it cannot provide at all times. The provider must [shall]
not use a name, logo, artwork [art work], phrase, or language that could mislead the public to believe a higher
level of care is being provided.
(3) An EMS provider that has more than five paid staff,
but is composed of at least 75 percent [75%]
volunteer EMS personnel, may advertise as a volunteer service.
(r) Surveys, Inspections, [Surveys/Inspections
] and Investigations.
(1) The department may conduct scheduled or unannounced
on-site inspection or investigation of a provider's vehicles, offices,
headquarters, and stations [office(s), headquarter(s) and/or
station(s)] (hereinafter operations), at any reasonable time,
including while services are being provided, to ensure compliance
with Texas Health and Safety Code[,] Chapter
773 and this chapter.
(2) An applicant or licensee, by applying for or holding
a license, consents to entry and inspection or investigation of any
of its operations by the department, as provided for by Texas [the] Health and Safety Code[,] Chapter 773 and this chapter.
(3) Department [Department's]
inspections or investigations to evaluate an EMS provider's compliance
with the requirements of Texas [the] Health
and Safety Code[,] Chapter 773 and this chapter, may include:
(A) initial, prelicensure, and change in status inspections for the issuance of a new license;
(B) routine inspection conducted at the department's [departments'] discretion or prior to renewal;
(C) follow-up on-site inspection, conducted to evaluate implementation of a plan of correction for deficiencies cited during a department investigation or inspection;
(D) a complaint investigation, conducted in response to a report or complaint, as described in subsection (u) of this section, relating to complaint investigations; and
(E) an inspection to determine if a person, company,
or organization is offering or providing EMS service [service(s)
] without a license, or to determine if EMS vehicles are being
staffed by persons who do not hold Texas EMS certification or license.
(4) The provider and medical director must [shall] cooperate with any department investigation or inspection,
and must [shall], consistent with applicable
law, permit the department to examine the provider's grounds, buildings,
books, records, and other documents and information maintained
by or on behalf of the provider, that are necessary to evaluate compliance
with applicable statutes, rules, plans of correction, and
orders with which the EMS provider is required to comply. The EMS
provider must [shall] permit the department,
consistent with applicable law, to interview members of the governing
authority, personnel, and patients.
(5) The EMS provider must [shall],
consistent with applicable law, permit the department to copy or reproduce,
or must [shall] provide photocopies to the department
of any requested records or documents. If it is necessary for the
department to remove records or other information (other than photocopies)
from the provider's premises, the department will provide the EMS
provider's governing authority or designee with a written statement
of this fact, describing the information being removed and when it
is expected to be returned. The department will make a reasonable
effort, consistent with the circumstances, to return the records the
same day.
(6) The department holds [will hold]
an entrance conference with the EMS provider, governing authority, or
designee before beginning the inspection or investigation, to explain,
consistent with applicable law, the nature, scope, and
estimated time schedule of the inspection or investigation.
(7) Except for a complaint investigation or a follow-up
visit, an inspection includes [will include]
an evaluation of compliance with Texas [the]
Health and Safety Code[,] Chapter 773 and the rules of
this chapter. During the inspection, the department representative
[will], unless otherwise provided for by law, informs [inform] the EMS provider's governing authority or designee of
the preliminary findings and gives [give] the
provider a reasonable opportunity to submit additional facts or other
information to the department representative in response to those findings.
(8) When the inspection is complete, the department holds
[will hold] an exit conference with the provider,
unless otherwise provided for by law, to inform the provider, to the
extent permitted by law, of any preliminary findings of the inspection
or investigation and gives [to give] the EMS
provider the opportunity to provide additional information regarding
the deficiencies cited. If no deficiencies are identified at the time
of inspection, a statement indicating this fact may be left with the
EMS provider's governing authority or designee. Such a statement does
not constitute a department finding or certification [that]
the facility is in compliance.
(9) If deficiencies are cited,[:]
[(A)]
the department provides [will provide] the EMS provider's administrator of record and
medical director with a written deficiency report no more than 30
calendar days after the exit conference.
(A) [(B)] The EMS provider's
governing authority, designee, or person in charge at the time must [shall] sign an acknowledgement of the inspection and receipt
of the written deficiency report and return it to the department.
The signature does not indicate the EMS provider's agreement with,
or admission to, the cited deficiencies unless the agreement
or admission is explicitly stated.
(B) [(C)] No later than 30 calendar
days after the EMS provider's receipt of the deficiency report, the
EMS provider must [shall] return a written plan
of correction to the department for each deficiency, including time
frames for implementation, together with any additional evidence of
compliance the EMS provider may have, regarding any cited deficiency.
The department determines [will determine] if
the written plan of correction and proposed time frames [timeframes] for implementation are acceptable. If the plan is
not acceptable, the department notifies [will notify]
the provider in writing no later than 30 days after receipt and requests
[request] a modified plan. The EMS provider must [shall] modify and resubmit the plan of correction no later than
30 calendar days after the EMS provider's receipt of the request.
The EMS provider must [shall] correct the identified
deficiencies and submit documentation to the department verifying
completion of the corrective action within the time frames [timeframes] set forth in the plan of correction accepted by
the department, or as otherwise specified by the department. The provider
will be deemed to have received the deficiency report or other department
correspondence mailed under this subparagraph once the department
receives delivery notification from the postal service [three
days after mailing].
(C) [(D)] Regardless of the EMS
provider's compliance with this subsection, the department's acceptance
of the provider's plan of correction, or the provider's utilization
of an informal compliance group review under paragraph (10) of this
subsection, the department may, at any time, propose to take action
as appropriate under §157.16 of this subchapter [title
] (relating to Emergency Suspension, Suspension, Probation,
Revocation, Denial of a Provider License or Administrative Penalties).
(10) The department inspector informs [will
inform] the provider's chief executive officer, designee, or
person in charge at the time of the inspection, of the provider's
right to an informal compliance group review. This review is
available[,] when there is disagreement with deficiencies
cited by the inspector or investigator, which [that]
the provider was unable to resolve through submission of information
to the inspector or additional information bearing on the deficiencies cited.
(11) The department refers [shall refer]
issues and complaints relating to the conduct or actions by licensed
professionals to the [their] appropriate licensing boards.
(12) All initial applicants and the [their
] medical director must [shall be required to]
have an initial compliance survey by the department that evaluates
all aspects of the applicant's proposed operations, including
clinical care components and an inspection of all vehicles prior to
the issuance of a license.
(13) At renewal, randomly, or in response to a complaint,
the department may conduct an unannounced compliance survey that includes
inspection of a provider's vehicles, operations, or [and/or
] records to ensure compliance with this title at any time,
including nights or weekends.
(14) If a re-survey or inspection [re-survey/inspection
] to ensure correction of a deficiency is conducted, the provider must [shall] pay a nonrefundable fee of $30 per vehicle
needing a re-inspection.
(s) Specialty Care Transports. A Specialty Care Transport
is defined as the interfacility transfer by a department-licensed [department-licensed] EMS provider of a critically ill or injured
patient requiring specialized interventions, monitoring, or [and/or] staffing. To qualify to function as a Specialty Care
Transport the following minimum criteria must [shall]
be met.[:]
(1) Qualifying Interventions:
(A) patients with one or more of the following IV infusions:
vasopressors; vasoactive compounds; antiarrhythmics; fibrinolytics;
tocolytics; blood; [or] blood products;
or [and/or] any other parenteral pharmaceutical unique
to the patient's special health care needs; and
(B) one or more of the following special monitors or procedures: mechanical ventilation; multiple monitors; cardiac balloon pump; external cardiac support (ventricular assist devices, etc.); and any other specialized device, vehicle, or procedure unique to the patient's health care needs.
(2) Equipment. All specialized equipment and supplies
appropriate to the required interventions must [shall]
be available at the time of the transport.
(3) Minimum Required Staffing.
(A) One currently certified EMT-Basic and
one currently certified or licensed paramedic with the additional
training as defined in paragraph (4) of this subsection; or[,]
(B) a currently certified EMT-Basic and a currently certified or licensed paramedic accompanied by at least one of the following:
(i) a registered nurse [Registered
Nurse] with special knowledge of the patient's care needs;
(ii) a certified respiratory therapist [Respiratory
Therapist];
(iii) a licensed physician; or[,]
(iv) any other licensed health care professional designated by the transferring physician.
(4) Additional Required Education and Training for Certified
or Licensed [Certified/Licensed] Paramedics:
(A) evidence [Evidence]
of successful completion of post-paramedic education;[,]
(B) training and [appropriate]
periodic skills verification in management of patients on
ventilators;[,]
(C) training and periodic skills verification
in 12 lead Electrocardiography (EKG) or [EKG
and/or] other critical care monitoring devices;[,]
(D) training and periodic skill verification
in drug infusion pumps, and cardiac or [and/or]
other critical care medications; and [,
or]
(E) training in any other specialized procedures or devices determined at the discretion of the EMS provider's medical director.
(t) For all initial applications and renewal applications,
the department is authorized to collect subscription and convenience
fees, in amounts determined by Texas Government Code Section
2054.252 (relating to State Electronic Internet Portal Project), [the Texas Online Authority] to recover costs associated with
the initial application and renewal application processing [through
Texas Online].
(u) Complaint Investigations.
(1) Upon request, all licensed EMS providers must [Providers shall] make available for a patient or [its]
legal guardian a written statement, supplied by the department,
identifying the department as the responsible agency for conducting
EMS provider and EMS personnel complaint investigations. The statement must [shall] inform persons [that] they
may direct a complaint to the Department of State Health Services,
EMS Compliance Unit [Group], by phone, or by
email. The statement must [shall] provide the
most current contact information, including the appropriate department
group, address, local and toll-free telephone number, and email address
for filing a complaint.
(2) The department evaluates all complaints made against
EMS providers or [and/or] EMS personnel. Any
complaint submitted to the department must [shall]
be submitted by telephone, electronically, or in writing, using the
department's current contact information for that purpose, as described
in paragraph (1) of this subsection.
(3) The department documents, evaluates, and prioritizes
[will document, evaluate and prioritize] complaints
and information received, based on the seriousness of the alleged
violation and the level of risk to patients, personnel, and [and/or] the public.
(A) Allegations [determined to be] within
the department's regulatory jurisdiction relating to emergency medical
services are authorized for investigation under this chapter. Complaints
received that are outside the department's jurisdiction may be referred
to another appropriate agency for response.
(B) The investigation is conducted on-site, by telephone, and [and/or] through written correspondence.
(4) The department conducts a prompt and thorough investigation
of all reports or complaint allegations that may pose a threat of
harm to the health and safety of patients or participants. Reports
or complaints received by the department concerning alleged abuse,
neglect, and exploitation will be addressed in accordance
with Texas Human Resources Code[,] Chapter 48
and Texas Family Code[,] §261.101[(d)].
(5) The department evaluates complaint allegations that do not pose a significant risk of harm to patients. Based on the nature and severity of the alleged incident, the department determines whether to investigate the complaint directly or to require the provider to conduct an internal investigation and submit its findings and supporting evidence to the department.
(A) The department reviews findings of an
EMS provider's internal investigation [will be reviewed by the
department] and may perform [result in]
an additional investigation by the department. The department
may [, a] request [for] a plan of correction
[to] be completed by the provider in accordance with subsection (r) [(q)] of this section (relating to inspections
and investigations), and [and/or] a proposal
to take action against the provider under §157.16 of this subchapter
[title].
(B) The EMS provider under investigation must [shall] provide department staff access to all documents, evidence, and individuals related to the alleged violation, including
all evidence and documentation relating to any internal investigations.
(6) Once an internal EMS provider investigation or [and/or] department investigation is complete, the department
reviews the evidence from the investigation to evaluate whether the
evidence substantiates the complaint and what corrective action, if
any, is needed.
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 October 9, 2024.
TRD-202404803
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: November 24, 2024
For further information, please call: (512) 834-6737