TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 61. CHRONIC DISEASES

SUBCHAPTER F. DIABETES REGISTRY

25 TAC §61.91

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes the repeal of §61.91, concerning Diabetes Mellitus Glycosylated Hemoglobin Registry.

BACKGROUND AND PURPOSE

The purpose of the proposed repeal of §61.91 is necessary to implement Senate Bill (S.B.) 970, 87th Legislature, Regular Session, 2021, which repealed Texas Health and Safety Code, Chapter 95, Subchapter B, Diabetes Mellitus Registry. S.B. 970 removed the requirement for a diabetes registry.

The registry was established as a pilot program in accordance with House Bill (H.B.) 2132, 80th Legislature, Regular Session, 2007, and H.B. 1363, 81st Legislature, 2009. DSHS coordinated with the San Antonio Metropolitan Health District to establish the pilot registry.

S.B. 510, 82nd Legislature, Regular Session, 2011, amended Chapter 95 by adding Subchapter B, Diabetes Mellitus Registry, to make public health district participation in the diabetes mellitus registry voluntary and designated a public health district solely responsible for the cost of establishing and administering the registry program in their district. As a result, no data has been submitted since 2011.

SECTION-BY-SECTION SUMMARY

The repeal of §61.91 is proposed in its entirety to comply with S.B. 970, which eliminated the statutory requirement for a diabetes registry, thus making the rule no longer necessary.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the repeal will be in effect, enforcing or administering the repeal 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 repeal will be in effect:

(1) the proposed repeal will not create or eliminate a government program;

(2) implementation of the proposed repeal will not affect the number of DSHS employee positions;

(3) implementation of the proposed repeal will result in no assumed change in future legislative appropriations;

(4) the proposed repeal will not affect fees paid to DSHS;

(5) the proposed repeal will not create a new rule;

(6) the proposed repeal will repeal an existing rule;

(7) the proposed repeal will decrease the number of individuals subject to the rule; and

(8) the proposed repeal will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. Under the proposed repeal there are no requirements to alter current business practices and there are no costs imposed.

LOCAL EMPLOYMENT IMPACT

The proposed repeal will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.

PUBLIC BENEFIT AND COSTS

Dr. Manda Hall, Associate Commissioner of DSHS Community Health Improvement Division, has determined that the public may benefit from the elimination of reporting responsibilities for the diabetes registry, which are currently voluntary and inconsistent.

Donna Sheppard has also determined that there are no anticipated economic costs to persons impacted by the proposed rule because the rule is being repealed with no associated cost.

TAKINGS IMPACT ASSESSMENT

DSHS 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

Questions about the content of this proposal may be directed to the Diabetes Prevention and Control Program at (512)776-2834. Written comments on the proposal may be submitted to the Diabetes Prevention and Control Program at P.O. Box 149347, Mail Code 1965, Austin, Texas 78714; 1100 W 49th Street, Mail Code 1965, Austin, Texas 78756; or by e-mail to diabetes@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 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 22R021" in the subject line.

STATUTORY AUTHORITY

The repeal is authorized by Texas Government Code §531.0055, and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules and policies necessary for the operation and provision of services by the health and human services agencies, and efficient enforcement of Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules 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 repeal will implement Texas Government Code, Chapter 531 and Texas Health and Safety Code, Chapter 1001.

§61.91.Diabetes Mellitus Glycosylated Hemoglobin Registry.

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 May 23, 2022.

TRD-202202004

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (512) 776-2834


CHAPTER 98. TEXAS HIV MEDICATION PROGRAM

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes the repeal of Texas Administrative Code Title 25, Chapter 98, Subchapter A, §§98.1 - 98.13 and Subchapter C, Division 1, §§98.101 - 98.115, 98.117 - 98.119, and proposes new Subchapter C, Division 1, §§98.101 - 98.109, concerning the Texas HIV Medication Program (THMP).

BACKGROUND AND PURPOSE

The purpose of the proposal is to allow the THMP to comply with the findings and program improvement recommendations noted in the December 2019 program review conducted by the Health Resources and Services Administration (HRSA), the agency that provides federal funding, and the Medication Advisory Committee (MAC) recommendations.

The Texas Administrative Code, Title 25, Chapter 98 provides governing rules for the THMP, which provides medication for the treatment of HIV and its related complications for low-income Texans. Subchapter A establishes the Texas HIV State Pharmacy Assistance Program (SPAP). Subchapter C, Division 1 establishes the general provisions of THMP. DSHS proposes to repeal and replace Subchapter A and Subchapter C, Division 1 to update eligibility requirements for THMP.

SECTION-BY-SECTION SUMMARY

The proposed rules replace Subchapter A and Subchapter C, Division 1 with a consolidated set of rules in Subchapter C, Division 1. This will clarify insurance assistance that THMP may provide, replace a cumbersome program eligibility spenddown process with a universal standard deduction, and update language to be more reflective of current operations. These proposed changes will allow THMP to align with expectations from HRSA and allow all THMP programs to be accurately represented.

The new §§98.101 - 98.109 set forth the purpose, definitions, THMP eligibility criteria, specific program eligibility criteria, eligibility determination process, appeals process and exceptions, THMP benefits, limitations and cost containment, and nondiscrimination and confidentiality requirements for the THMP program.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules do 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 rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will create new rules;

(6) the proposed rules will repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect local economies.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas; do not impose a cost on regulated persons; and are necessary to receive a source of federal funds.

PUBLIC BENEFIT AND COSTS

Imelda Garcia, Associate Commissioner, has determined that for each year of the first five years the rules are in effect, the public benefit will be that a client-level income adjustment based on individual medication cost will be changed to a standard deduction that will more equitably adjust all clients' income by the average medication cost for all clients. Additionally, the rules were simplified to improve readability, including merging two subchapters into one subchapter in the Texas Administrative Code.

Donna Sheppard has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules because the rules do not change program requirements or eligibility requirements.

TAKINGS IMPACT ASSESSMENT

DSHS 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 the TB/HIV/STD Section, P.O. Box 149347, Mail Code 1873, Austin, Texas 78714-9347; comments may be hand delivered to the TB/HIV/STD Section at 201 W. Howard Lane, Austin, Texas, or emailed to HIVSTD@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 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 21R050" in the subject line.

SUBCHAPTER A. TEXAS HIV STATE PHARMACY ASSISTANCE PROGRAM

25 TAC §§98.1 - 98.13

STATUTORY AUTHORITY

The repeals are authorized by Texas Government Code §531.0055, which authorizes the Executive Commissioner of HHSC to adopt rules and policies 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. Texas Health and Safety Code §85.016 authorizes the Executive Commissioner to adopt rules concerning Acquired Immune Deficiency Syndrome and Human Immundeficiency Virus Infection, including those governing the THMP.

The repeals will implement Texas Health and Safety Code, Chapter 85 and Texas Government Code, Chapter 531.

§98.1.Purpose.

§98.2.Definitions.

§98.3.Medication Coverage.

§98.4.Nondiscrimination.

§98.5.General Eligibility Criteria; Renewal.

§98.6.Denial, Non-Renewal, and Termination of Benefits.

§98.7.Applications.

§98.8.Application Process.

§98.9.Residency, and Residency Documentation, Requirements.

§98.10.Limitations and Benefits Provided.

§98.11.Provision of Service.

§98.12.Appeal Procedures and Exceptions.

§98.13.Confidentiality.

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 May 23, 2022.

TRD-202202005

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (737) 255-4599


SUBCHAPTER C. TEXAS HIV MEDICATION PROGRAM

DIVISION 1. GENERAL PROVISIONS

25 TAC §§98.101 - 98.115, 98.117 - 98.119

STATUTORY AUTHORITY

The repeals are authorized by Texas Government Code §531.0055, which authorizes the Executive Commissioner of HHSC to adopt rules and policies 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. Texas Health and Safety Code §85.016 authorizes the Executive Commissioner to adopt rules concerning Acquired Immune Deficiency Syndrome and Human Immundeficiency Virus Infection, including those governing the THMP.

The repeals will implement Texas Health and Safety Code, Chapter 85 and Texas Government Code, Chapter 531.

§98.101.Purpose.

§98.102.Definitions.

§98.103.Medication Coverage.

§98.104.Nondiscrimination.

§98.105.Program Priority.

§98.106.General Eligibility Criteria.

§98.107.Medical Eligibility Criteria.

§98.108.Residency Eligibility Criteria.

§98.109.Financial Eligibility Criteria.

§98.110.Application Process; Verification; Renewal.

§98.111.Confidentiality.

§98.112.Program Distribution of Medications.

§98.113.Participating Pharmacies.

§98.114.Prescription Fees.

§98.115.Fiscal Planning.

§98.117.Denial, Non-Renewal, and Termination of Benefits.

§98.118.Appeal Procedures.

§98.119.Exceptions from Appeal Procedures.

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 May 23, 2022.

TRD-202202006

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (737) 255-4599


25 TAC §§98.101 - 98.109

STATUTORY AUTHORITY

The new sections are authorized by Texas Government Code §531.0055, which authorizes the Executive Commissioner of HHSC to adopt rules and policies 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. Texas Health and Safety Code §85.016 authorizes the Executive Commissioner to adopt rules concerning Acquired Immune Deficiency Syndrome and Human Immundeficiency Virus Infection, including those governing the THMP.

The new sections will implement Texas Health and Safety Code, Chapter 85 and Texas Government Code, Chapter 531.

§98.101.Purpose.

This subchapter establishes procedures and eligibility guidelines for programs under the Texas HIV Medication Program (THMP) as required in the Texas Health and Safety Code, §85.063.

(1) THMP operates in accordance with federal AIDS Drug Assistance Program legislation to assist low-income individuals living with HIV with direct medication assistance for medications on the program formulary or costs associated with eligible health insurance policies, including premiums and medication cost-sharing (deductibles, copayments, and coinsurance) and Medicare prescription drug plans.

(2) Program enrollment and services are subject to available funding.

§98.102.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Applicant--An individual who applies to the department for THMP services.

(2) Commissioner--The Commissioner of the Department of State Health Services.

(3) Department--The Department of State Health Services.

(4) Eligible health insurance policy--A state, federal, or private health insurance policy that is approved by the THMP and covers at least one drug from each class of HIV-antiretroviral medication and covers appropriate primary care services.

(5) Formulary--A list of drugs approved by the department that includes at least one drug from each class of HIV antiretroviral medications. https://www.dshs.texas.gov/hivstd/meds/files/formulary.pdf.

(6) Full-LIS--Full Low-income subsidy. The Social Security Administration provides full-LIS to applicants with income and assets below specified limits.

(7) HIV--Human immunodeficiency virus. Encompassing all stages of HIV, including HIV-related conditions and syndromes.

(8) Legally responsible person--A parent, managing conservator, or other person that is legally responsible for the support of a minor or a ward.

(9) Medicare prescription drug plan--A Medicare Part D prescription drug plan or the prescription drug component of a Medicare Part C Advantage Plan.

(10) Minor--A person who is younger than 18 years of age and who has not been emancipated by a court or who is not married or recognized as an adult by the state of Texas.

(11) Open enrollment--A time period during which one may freely enroll in or change one's selection of a health insurance plan or other benefit plan that is ordinarily subject to restrictions.

(12) Out-of-pocket costs--The premium, copay, coinsurance, and deductible amounts that an individual would be expected to pay when enrolled in a health insurance plan or Medicare prescription drug plan.

(13) Partial-LIS--Partial Low-income subsidy. The Social Security Administration provides partial-LIS to applicants with income and assets above the level of those qualifying for full-LIS, but still below specified limits.

(14) Payor of last resort--A funding source that may be used only after all other available public and private funding sources have been accessed.

(15) Qualifying event--A change of life circumstance that allows an individual to enroll in or change the selection of a health insurance plan or other benefit plan outside of open enrollment.

(16) SPAP--The State Pharmacy Assistance Program. The SPAP is available to low-income individuals living with HIV who also have Medicare Part D.

(17) Texas resident--An individual is considered a Texas resident if that person physically resides in Texas and intends to continue to reside within the state.

(18) THMP--The Texas HIV Medication Program, which includes the AIDS Drug Assistance Program (ADAP), SPAP, and TIAP.

(19) TIAP--Texas Insurance Assistance Program. TIAP provides premium and copay assistance with eligible health insurance policies.

§98.103.THMP Eligibility Criteria.

(a) The department shall give priority to participation in THMP to eligible women and infants and to individuals younger than 18 years of age as specified in 42 U.S.C. 300ff-21, and Texas Health and Safety Code §85.062.

(b) An individual is eligible to participate in THMP if the individual meets the following eligibility criteria:

(1) provides proof of diagnosis of HIV;

(2) is under the care of a physician, physician's assistant, or advanced practice nurse licensed to practice in the United States;

(3) is a Texas resident; and

(4) is at or below 200% of the federal poverty level and meets the financial eligibility criteria established by THMP Policy 220.001 https://www.dshs.texas.gov/hivstd/policy/policies/220-001.shtm; and:

(A) is not covered for approved THMP medications under the Texas Medicaid Program, or has exhausted Medicaid pharmacy benefits for the given month;

(B) does not qualify for assistance, receives less than full coverage, or needs assistance with out-of-pocket costs for approved THMP medications under any state compensation program, qualifying private health insurance policy, or under any other state or federal health benefits program;

(C) meets THMP's payor of last resort criteria that is in accordance with state law, department policy, and corresponding federal grant conditions, in which Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) (RWHAP) or State Services funds cannot be used as a payment source for any service that can be paid for or charged to any other billable source, and providers are expected to make reasonable efforts to secure other funding instead of RWHAP Part B or State Services funding, whenever possible; and

(D) has an annual income that meets guidance as determined by:

(i) an applicant's annual gross income (if single), or the combined annual gross income of the applicant and the applicant's spouse, minus a standard deduction applied in accordance with program policy;

(ii) for a minor child, the (combined) annual gross income of the child's parent or parents, minus a standard deduction, and only the income of the parent or parents living in the same household as the child at the time of application or renewal is used to determine financial eligibility; and

(iii) for an emancipated minor, financial eligibility is determined as set forth in this paragraph.

§98.104.Specific Program Eligibility Criteria.

(a) AIDS Drug Assistance Program (ADAP). In addition to §98.103 of this title (relating to THMP Eligibility Criteria), an individual must attest that the individual is not enrolled in any state, federal, or private health insurance policies or benefits programs that cover the individual's currently prescribed medications that are on the THMP formulary.

(b) SPAP. In addition to §98.103 of this title, an individual must be enrolled in a Medicare prescription drug plan that covers the individual's current medications that are on the formulary and apply for low-income subsidy (LIS) assistance. Those approved with full-LIS are disenrolled from the SPAP program, while those with partial-LIS and who are denied LIS remain eligible for participation in SPAP. (Information on Medicare eligibility, Medicare prescription drug plans, and LIS assistance can be found at http://www.medicare.gov.)

(c) TIAP. In addition to §98.103 of this title, an individual must be enrolled in an eligible health insurance policy that covers the individual's current medications on the formulary, as updated. An applicant may be screened for TIAP during open enrollment or when the applicant has experienced a qualifying event.

§98.105.Eligibility Determination Process.

(a) New applicants to THMP. An individual meeting the eligibility requirements must submit a complete application for benefits to THMP, in the format specified by THMP, certifying that the statements made within the application are factual and true, submitted as instructed, and accompanied by the required supporting documentation. To request an application packet, please follow current procedures on THMP's webpage found at www.dshs.texas.gov/hivstd/meds.

(b) Renewals. An individual must renew enrollment in THMP according to the procedures established by THMP. An individual must demonstrate continuing eligibility using THMP's renewal application and comply with all associated deadlines and requirements for accompanying documents.

(c) Eligibility Determination.

(1) Approved. If approved, the applicant is eligible for THMP services.

(2) Incomplete. Any application that does not meet all requirements of this section is considered incomplete. Incomplete applications are not processed further, and the applicant is contacted concerning the insufficiency of the application.

(3) Pending. THMP may, at the time of application and at any time during enrollment, verify the eligibility status of an enrolled individual to determine if the individual is continuing to meet the eligibility criteria of THMP. The individual must furnish requested documentation to THMP as directed. Until this is completed, the status of enrollment is considered pending.

(4) Denial, non-renewal, and termination of benefits. An individual may be denied enrollment, be denied renewal, or have enrollment in THMP terminated for any of the following reasons:

(A) failure to maintain Texas residency or, upon request, furnish evidence of such;

(B) failure to continue to meet income requirements for eligibility or to provide income data as requested, as THMP shall periodically verify the financial status of an enrolled individual to determine if the individual continues to meet financial eligibility criteria;

(C) failure to initially meet or continue to meet the medical requirements for eligibility;

(D) become eligible for the full-LIS under Medicare Part D;

(E) become incarcerated in a city, county, state, or federal jail or prison, in accordance with Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87), Health Resources and Services Administration (HRSA) Policy Clarification Notice (PCN) #18-02, and Texas Code of Criminal Procedure Article §104.002(a);

(F) admitted or committed to a Texas state hospital or state supported living facility;

(G) determined by THMP that the individual has made a material misstatement or misrepresentation on the individual's application or any document required to support the individual's application or renewal, or on submissions made to comply with subsection (a) or (b) of this section;

(H) failure to notify THMP of changes to permanent home address or insurance coverage;

(I) notified THMP in writing that the individual no longer wants to receive THMP benefits;

(J) failure to request or use services during any period of six consecutive months; or

(K) exhausted THMP program funds.

(d) Denial, modification, suspension, or termination of services. An applicant or individual is governed by the procedures required by §98.106 of this title (relating to Appeal Process and Exceptions).

§98.106.Appeals Process and Exceptions.

(a) An individual whose application is denied or whose services have been terminated by THMP may appeal the department's decision within 60 days of postmark of the notification. An applicant, individual, or person legally responsible for an applicant or individual may initiate the appeal process by notifying the department's HIV/STD Prevention and Care Unit that the individual wishes to dispute the department's decision. The written notice must contain all arguments and supporting documents being put forward for the appeal. The notice should be addressed to the Department of State Health Services, HIV/STD Prevention and Care Unit, Texas HIV Medication Program, Attn: MSJA, Mail Code 1873, P.O. Box 149347, Austin, Texas 78714-3947 or in another manner allowed by the department.

(b) A department review panel will hear the appeal within 30 days of receipt of the written notice. The appellant will be notified by mail of the appeal. The panel shall consist of:

(1) the TB/HIV/STD Section Director;

(2) the HIV/STD Prevention and Care Unit Manager;

(3) the Texas HIV Medication Program Manager; and

(4) the Infectious Disease Medical Officer (or equivalent positions, in the event of a department reorganization).

(c) The appellant may present the case in person or in another manner allowed by the department before the panel or rely on the written submissions. The issues on appeal and the arguments in support of those issues are limited to those already submitted in writing. Following review of the materials, and hearing from the appellant (if applicable), the panel will issue a written decision within 60 days of the hearing. The panel's decision shall be final for the eligibility determination that is appealed. The appellant may reapply to the program at any time in the future.

(d) The department is not required to offer an opportunity to dispute the decision to deny, non-renew, or terminate if THMP's actions are the result of the exhaustion of THMP program funds.

§98.107.THMP Benefits.

THMP provides drugs at the best price available, including purchasing health insurance if the criteria are met, and THMP participates in the 340B Drug Pricing Program to ensure program medications are available at the best price.

(1) AIDS Drug Assistance Program (ADAP) Medication Coverage.

(A) The medications provided under ADAP are listed on the THMP formulary, found at https://www.dshs.texas.gov/hivstd/meds/files/formulary.pdf.

(B) THMP does not approve the dispensing of ADAP medications in excess of a 90-day supply, or full bottle increments, whichever is greater. The program may also dispense medications in 30-day or 60-day supplies.

(C) Prescribers must attest that certain medications meet specific prescribing requirements, including lab testing, before requesting these medications from THMP. These requirements are outlined in the THMP formulary found at www.dshs.texas.gov/hivstd/meds/document.shtm.

(D) The department may contract with a pharmaceutical wholesaler for purchase of drugs. The department distributes drugs to pharmacies participating in ADAP and to a mail order pharmaceutical distributor for the dispensing of drugs directly to individuals who reside outside areas covered by participating pharmacies.

(E) The department delivers services directly or through external pharmacies approved by THMP that have signed a Memorandum of Agreement with the department.

(F) A dispensing fee may be collected from the department by a participating pharmacy for each prescription dispensed in accordance with the existing Memorandum of Agreement with the department. Eligible individuals shall not be charged any dispensing fees directly by a participating pharmacy.

(2) SPAP and TIAP Medication Coverage.

(A) The department may contract with a claims processor to interface with plans that provide eligible health insurance plans on behalf of the programs.

(B) Benefits payable by THMP:

(i) Eligible health insurance policy out-of-pocket expenses, which include deductibles, copays, and coinsurance amounts.

(ii) THMP may assist eligible individuals in obtaining public or private health insurance by providing insurance premium payment assistance to the insurance company, and if paying for such health insurance, it can reasonably be expected to be cost effective for THMP.

§98.108.Limitations and Cost Containment.

(a) In the event of a statewide emergency declared by the Governor, THMP may temporarily adjust program operations to ensure that mission critical functions continue. These cost containment measures will be approved by the Commissioner in writing.

(b) THMP funds must be used as payor of last resort and coordinated with other local, state, and federal funds, including Medicaid and Medicare.

(1) To ensure THMP's expenditures do not exceed the budget, the department analyzes the latest actuarial projections for the upcoming year, including the average annual cost per individual and the projected number of individuals THMP will be able to serve using current budget figures. The department performs this analysis of THMP expenditures every quarter to determine if funds are sufficient to meet projected expenditures.

(2) To make certain that expenditures do not exceed the program's budget, the department may implement the following temporary cost-containment measures as necessary.

(c) If budgetary limitations exist, this information will be shared with stakeholders as soon as possible. The department has discretion to:

(1) Restrict or prioritize covered services based upon:

(A) medical necessity;

(B) other third-party eligibility and projected third party payments for the different treatment modalities; or

(C) caseloads and demands for services based on current or projected data.

(2) Discontinue use of the standard deduction adjusting the applicant's gross annual income described in §98.103(b)(4)(D) of this title (relating to THMP Eligibility Criteria).

(3) Lower the financial eligibility criteria established by THMP policy 220.001 https://www.dshs.texas.gov/hivstd/policy/policies/220-001.shtm to a level that is not lower than 125% of federal poverty level.

(4) Change covered services by adding or deleting specific services or entire categories, making changes proportionally across a category or categories, using a combination of these methods, or establishing a waiting list of eligible applicants.

(d) As funds become available, the department will rescind the cost-containment measures in a manner which the department judges most appropriate given the circumstances at that time.

§98.109.Nondiscrimination and Confidentiality.

(a) Nondiscrimination. The department operates the THMP in a manner that allows full participation of individuals, regardless of their race, color, national origin, age, or disability. For purposes of THMP, discrimination based on gender or sexual orientation is prohibited.

(b) Confidentiality. No information that could identify an individual applicant is released except as authorized by law and in accordance with §1.501 of this title (relating to Privacy of Health Information under the Health Insurance Portability and Accountability Act of 1996). An applicant is advised that, in addition to the department, the physicians, pharmacists, and designated Medicare prescription drug plan will be aware of the applicant's diagnosis.

(c) Disclose. The department may use or disclose individual health information to provide, coordinate, or manage health care or related services, as allowed by law. This includes referring the individual to other health care resources. The department may contact a THMP applicant or individual to discuss enrollment benefits, resources for treatment, or other health-related information as appropriate.

(d) Privacy notice. An individual may request a copy of the department's privacy notice by contacting the THMP.

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 May 23, 2022.

TRD-202202007

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (737) 255-4599


CHAPTER 157. EMERGENCY MEDICAL CARE

SUBCHAPTER B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES

25 TAC §157.11

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 §157.11, concerning the Requirements for an EMS Provider License.

BACKGROUND AND PURPOSE

The purpose of the proposed amendment to §157.11 is necessary to comply with Senate Bill (S.B.) 1876, 87th Legislature, Regular Session, 2021, which amended Texas Health and Safety Code §773.112, relating to the emergency transfer of a dialysis patient during a declared disaster. S.B. 1876 requires each emergency medical services (EMS) provider's medical director to approve a protocol to give preference to the emergency transfer of a dialysis patient during a declared disaster.

The amendment was reviewed by the Governor's EMS and Trauma Advisory Council (GETAC), as required by Texas Health and Safety Code §773.012, in public meetings held on November 22, 2021, and February 7, 2022. No comments were received from the advisory council.

SECTION-BY-SECTION SUMMARY

The proposed amendment provides language to §157.11(c)(7)(N) to reference Health and Safety Code §773.112(d). The amendment is based on S.B. 1876, which states that rules shall require that each applicable EMS medical director approve protocols that give preference to the emergency transfer of a dialysis patient from the patient's location directly to an outpatient end-stage renal disease facility during a declared disaster.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the amendment will be in effect, enforcing or administering the amendment 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 amendment will not create or eliminate a government program;

(2) implementation of the amendment will not affect the number of DSHS employee positions;

(3) implementation of the amendment will result in no assumed change in future legislative appropriations;

(4) the proposed amendment will not affect fees paid to DSHS;

(5) the proposed amendment will not create a new rule;

(6) the proposed amendment will expand an existing rule;

(7) the proposed amendment will not change the number of individuals subject to the rule; and

(8) the proposed amendment will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effects on small businesses, micro-businesses, or rural communities. Under the proposed amendment, there are no requirements to alter current business practices and there are no new fees or costs imposed.

LOCAL EMPLOYMENT IMPACT

The proposed amendment 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

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 dialysis patients will benefit from the EMS provider's planning for the dialysis patients' emergency transfer during a declared disaster.

Donna Sheppard has also determined that for each year of the first five years the rule is in effect that there are no anticipated economic costs to persons who are required to comply with the rule.

TAKINGS IMPACT ASSESSMENT

DSHS 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 Jorie Klein, MSN, MHA, BSN, RN, by P.O. Box 149347, Austin, Texas 78714-9347, or street address 1100 West 49th Street, Austin, Texas 78751; 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 22R022" 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 of the health and human services agencies; Texas Health and Safety Code, Chapter 773, Emergency Health Care Act, which allows DSHS to promulgate rules for the transfer of dialysis patients during a declared disaster; and Texas Health and Safety Code, §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and the administration of Texas Health and Safety Code, Chapter 1001.

The amendment will implement Texas Government Code, Chapter 531, and Texas Health and Safety Code, Chapters 773 and 1001.

§157.11.Requirements for an EMS Provider License.

(a) Purpose: Acquiring, issuing, and maintaining an EMS Providers License.

(b) EMS in Texas is a delegated practice, as written in Occupations Code, §157.003.

(c) Application requirements for an Emergency Medical Services (EMS) Provider License.

(1) An applicant for an initial EMS provider license 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 shall accompany the application.

(3) The department will process the EMS provider license application as per §157.3 of this 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; whose service area adjoins the State of Texas; who has in place a written mutual aid agreement, with a licensed Texas EMS provider, and who when requested to do so by a licensed Texas EMS provider, responds into Texas for emergency mutual aid assistance, may be exempt from holding a Texas EMS provider license, but will be obligated to perform to the same medical standards of care required 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, and the application 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 shall accompany the application.

(6) An applicant for an EMS provider license that provides emergency prehospital care is exempt from payment of department licensing and authorization fees if the firm is staffed with at least 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 may be exempt from the payment of department licensing and authorization fees if all other requirements for fee exemption are met.

(7) Required documents that 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.

(i) The legal name of the EMS provider 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.

(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 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, §79.39 (relating to Deceptively Similar Name).

(E) Declaration of Ownership.

(F) Declaration of the address for the main location of the business, normal business hours and provide proof of ownership or lease of 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 shall attest that no other license EMS provider is at the provided business location or address.

(v) The 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) 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 as per Health and Safety Code, §773.0571 or §773.05712.

(i) The administrator of record is not employed or otherwise compensated by another private for-profit EMS provider.

(ii) 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 holds such certification or license issued by the State of Texas.

(iii) The administrator of record has submitted to a criminal history record check at the applicant's expense as directed in §157.37 of this title (relating to Certification or Licensure of Persons With Criminal Backgrounds).

(iv) The administrator of record has completed an initial education course approved by the department regarding state and federal laws and rules that affect EMS in the following areas:

(I) Health and Safety Code, Chapter 773 and 25 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.

(v) The applicant will assure that its administrator of record shall 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.

(vii) An EMS provider that held a license on September 1, 2013, and has an administrator of record who has at least eight years of experience providing EMS, the administrator of record is exempt from clauses (ii) and (iv) of this subparagraph.

(H) Copies of Doing Business Under Assumed Name Certificates (DBA).

(I) Completed EMS Personnel Form.

(J) Staffing Plan 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 shall have a staffing plan that addresses coverage of the service area or shall have a formal system to manage communication when not providing services after normal business hours.

(K) Completed EMS Vehicle Form.

(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, in compliance with Texas Medical Board rules, 22 Texas Administrative Code, Chapter 197, and in compliance with Title 3 of the Texas Occupations Code.

(M) Completed Medical Director Information Form.

(N) Treatment and Transport Protocols and policies addressing the care to be provided to adult, pediatric, and neonatal patients, and as stated in Health and Safety Code §773.112(d), must be approved and signed by the medical director.

(O) A list of equipment as required on the EMS Provider initial and renewal application, with identifiable or legible serial numbers, supplies and medications; approved and signed by the medical director.

(P) 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.

(Q) The applicant shall attest that each authorized vehicle will have its own set of equipment required for each authorized vehicle to operate at the level of the service for which the provider is authorized.

(R) Description of how the EMS provider will conduct quality assurance in coordination with the EMS provider medical director.

(S) The applicant shall provide an attestation or provide documentation that it and/or its management staff will or continues to participate in the local regional advisory council.

(T) Plan for how the provider will respond to disaster incidents including mass casualty situations in coordination with local and regional plans.

(U) Copies of written Mutual Aid and/or Inter-local Agreements with EMS providers.

(V) Documentation as required for subscription or membership program, if applicable.

(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, 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 shall maintain motor vehicle liability insurance as required under the Texas Transportation Code.

(ii) The applicant shall maintain professional liability insurance coverage in the minimum amount of $500,000 per occurrence, or as necessary per state law, with a company licensed or deemed eligible by the Texas Department of Insurance to do business in Texas 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.

(X) 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.

(Y) The applicant shall provide documentation of the following, showing that the applicant, including its management staff possesses sufficient professional experience and qualifications 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;

(ii) proof of one year experience or education provided by a nationally recognized organization on emergency medical dispatch processes;

(iii) proof of one year experience or education provided by a nationally recognized organization concerning EMS billing processes;

(iv) proof of one year experience or education provided by a nationally recognized organization on medical control accountability; and

(v) proof of one year experience or education provided by a nationally recognized organization on quality improvement processes for EMS operations.

(Z) A copy of a letter of credit for the obtaining or renewing of an EMS Providers license, issued by a federally insured bank or savings institution:

(i) in the amount of $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) in the amount of $75,000 for renewal of the license on the fourth anniversary of the date the initial license is issued;

(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) in the amount of $25,000 for renewal of the license on the eighth anniversary of the date the initial license is issued;

(v) that shall include the names of all of the parties involved in the transaction;

(vi) that shall include the names of the persons or entity, who owns the EMS provider operation and to whom the bank is issuing the letter of credit;

(vii) that shall include the name of the person or entity, receiving the letter of credit; and

(viii) an EMS provider that is directly operated by a governmental entity is exempt from this subsection.

(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 Human Resources Code, Chapter 32, the Medicaid managed care program operated under Government Code, Chapter 533, or the child health plan program operated under Health and Safety Code, Chapter 62. An EMS provider that is directly operated by a governmental entity is exempt from this subparagraph.

(BB) Documentation evidencing applicant or management team has not been excluded from participation in the state Medicaid program.

(CC) A copy of a governmental entity letter of approval that 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) 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) include the attestation that the addition of another licensed EMS provider will remedy an existing provider shortage that cannot be resolved through the use of the licensed EMS providers operating in the municipality or county; and

(v) 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)(CC) of this subsection does not apply to renewal of an EMS provider license or 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 renewal of an EMS provider license or 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.

(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 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/manages or who/which has operated/managed any portion of an EMS provider service which has been sanctioned by or which has a proposed disciplinary 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 which shall be prominently displayed in a public area of the provider's primary place of business.

(F) An EMS Provider License issued by the department shall not be transferable to another person or entity.

(2) Vehicle Authorization.

(A) The department will issue an authorization for each vehicle to be operated by the applicant which meets all criteria for approval as defined in subsection (d) of this section.

(B) A vehicle authorization shall be issued for the following levels of service, 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 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) Advanced Life Support (ALS);

(v) ALS with MICU capability;

(vi) Mobile Intensive Care Unit (MICU);

(vii) Air Medical:

(I) Rotor wing; or

(II) Fixed wing; and

(viii) Specialized.

(C) Change of Vehicle Authorization. To change an authorization to a different level the provider shall submit a request with appropriate documentation to the department verifying the provider's ability to perform at the requested level. A fee of $30 shall be required for each new authorization requested. The provider 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 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 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 the name for which the license is issued, the applicant shall submit certified copies of assumed name certificates.

(B) A change in the operational name which the service is operated will require a new application and a prorated fee as determined by the department. A new provider number will be issued.

(C) Name of Administrator of Record must be declared. The applicant shall submit a notarized document declaring the full name of the chief administrator, his/her mailing address and telephone number to whom the department shall address all official communications in regard to the license.

(e) Vehicles.

(1) All EMS vehicles must be adequately constructed, equipped, maintained and operated to render patient care, comfort and transportation of adult, pediatric, and neonatal patients safely and efficiently. A pediatric and neonatal equipment list 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) All vehicles shall have an environmental system capable of heating or cooling the patient(s) and staff, in accordance with the manufacturer specifications, within the patient compartment at all times when in service and which allows for protection of medication, according to manufacturer specifications, from extreme temperatures if it becomes environmentally necessary. The provider shall provide evidence of an operational policy which shall list the parenteral pharmaceuticals authorized by the medical director and which shall define the storage and/or FDA recommendations. Compliance with the policy shall be incorporated into the provider's Quality Assurance process and shall be documented on unit readiness reports.

(5) EMS vehicles 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 using the form provided by the department.

(6) EMS vehicles 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 shall have the name of the provider and a current department issued EMS provider license number prominently displayed on both sides of the vehicle in at least 2 inch lettering and in contrasting color. The license number shall have the letters TX prior to the license number. This requirement does not apply to fixed or rotor wing aircraft.

(f) Substitution, replacement and additional EMS vehicles.

(1) The EMS provider 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 shall notify the department if the EMS provider adds a vehicle to the provider's operational fleet prior to making the vehicle response-ready. A vehicle authorization request shall be submitted with a nonrefundable vehicle fee prior to the vehicle being placed into service.

(g) Staffing Plan Required.

(1) The applicant shall submit a completed EMS Personnel Form listing each response person assigned to staff EMS vehicles by name, certification level, and 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 shall publish public notices in local media of its inability to provide continuous response capability and shall include the days and hours of its operation. The EMS provider shall notify all the public safety-answering points and all dispatch centers of the days and hours when unable to provide coverage. The EMS provider shall submit evidence that reasonable attempts to secure coverage from other EMS providers have been made.

(3) The applicant must provide proof at 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 that affect EMS.

(h) Minimum Staffing Required.

(1) BLS--When response-ready or in-service, authorized EMS vehicles operating at the BLS level shall be staffed at a minimum with two emergency care attendants (ECAs).

(2) BLS with ALS capability--When response-ready or in-service below ALS two ECAs. Full ALS status becomes active when staffed by at least an emergency medical technician (EMT)-Intermediate or AEMT and at least an EMT.

(3) BLS with MICU capability--When response-ready or in-service below MICU two ECAs. Full MICU status becomes active when staffed by at least a certified or licensed paramedic and at least an EMT.

(4) ALS--When response-ready or in-service, authorized EMS vehicles operating at the ALS level shall be staffed at a minimum with one EMT Basic and one AEMT or EMT-Intermediate.

(5) ALS with MICU capability--When response-ready or in-service below MICU 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.

(6) MICU--When response-ready or in-service, authorized EMS vehicles operating at the MICU level shall be staffed at a minimum with one EMT Basic and one certified or licensed EMT-Paramedic.

(7) Specialized--When response-ready or in-service, EMS vehicles authorized to operate for a specialized purpose shall be staffed with a minimum of two personnel appropriately licensed 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 title (relating to Rotor-wing Air Ambulance Operations) or §157.13(g) of this title (relating to Fixed-wing Air Ambulance Operations).

(9) When 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 ambulance, the EMS provider must have an approved security plan for the ALS/MICU medication as approved by the EMS provider medical director's protocol and/or policy.

(10) As justified by patient needs, providers may utilize appropriately certified and/or licensed medical personnel in addition to those which are required by their designation levels. In addition to the care rendered by the required staff, the provider shall be accountable for care rendered by any additional personnel.

(i) Treatment and Transport Protocols Required.

(1) The applicant shall submit written 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 and/or in the provider's EMS vehicles.

(4) The protocols shall address the use of all required, additional, and/or specialized medical equipment, supplies, and pharmaceuticals carried on each EMS vehicle in the provider's fleet.

(5) The protocols shall identify delegated procedures for each EMS Certification or license level utilized by the provider.

(6) The protocols shall indicate specific applications, including geographical area and duty status of personnel.

(j) EMS Equipment, supplies, medical devices, parenteral solutions and pharmaceuticals.

(1) The EMS provider shall submit a list, approved and signed by the medical director and fully supportive of and consistent with the protocols, of all medical equipment, supplies, medical devices, parenteral solutions and pharmaceuticals to be carried. The list 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 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, and supplies shall be clean and fully operational. All patient care powered equipment shall have manual mechanical, spare batteries or an alternative power source, if applicable.

(3) All solutions and pharmaceuticals shall be up to date and shall be stored and maintained in accordance with the manufacturer's and/or U.S. Federal Drug Administration (FDA) recommendations.

(4) The requirements for air ambulance equipment and supplies are listed in 157.12(h) of this title or §157.13(h) of this title.

(k) The following equipment shall be present on each EMS in-service vehicle and on, or immediately available for, each response-ready vehicle as specified in the equipment list as required by the medical director's approved equipment list to include all state required equipment. The equipment list shall include equipment required for treatment and transport of adult, pediatric, and neonatal patients.

(1) Basic Life Support (BLS):

(A) Equipment required to administer the BLS scope of practice and incorporates the knowledge, competencies and basic skills of an EMT/ECA and additional skills as authorized by the EMS provider medical director. All BLS ambulances shall be able to perform treatment and transport patients receiving the following skills:

(i) 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'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 incorporates the knowledge, competencies and basic and advanced skills of an AEMT and additional skills as authorized by the EMS provider medical director. All ALS ambulances shall be able to perform treatment and transport patients receiving the following skills, including all required BLS equipment to perform treatment and transport patients receiving the following skills:

(i) airway/ventilation/oxygenation;

(ii) cardiovascular circulation;

(iii) immobilization;

(iv) medication administration - routes; and

(v) intravenous (IV) initiation/maintenance fluids.

(B) all required BLS equipment;

(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) 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 MICU ambulances shall be able to perform treatment and transport patients receiving the following skills:

(i) airway/ventilation/oxygenation;

(ii) cardiovascular circulation;

(iii) immobilization;

(iv) medication administration - routes; and

(v) intravenous (IV) initiation/maintenance fluids.

(B) all required BLS and ALS equipment;

(C) with transmitting 12-lead capability cardiac 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 or response ready at the ALS level; and

(B) all required ALS equipment, when in service or response ready at the ALS level.

(5) BLS with MICU Capability:

(A) all required BLS equipment, even when in service or response ready at the MICU level; and

(B) all required MICU equipment, when in service or response ready at the MICU level.

(6) ALS with MICU Capability:

(A) all required ALS equipment, even when in service or response ready at the MICU level; and

(B) all MICU equipment, when in service or response ready at the MICU level.

(7) In addition to medical supplies and equipment as defined in 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 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 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 guide book, or an electronic version that is available to the crew (for hazardous materials); and

(J) each vehicle will carry 25 triage tags in coordination with the Regional Advisory Council (RAC).

(8) As justified by specific patient needs, and when qualified personnel are available, EMS providers may appropriately utilize equipment in addition to that which is required by their authorization levels. Such equipment must be consistent with protocols and/or patient- specific orders and must correspond to personnel qualifications.

(l) National 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 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 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 shall meet all the requirements for an EMS provider license as established by the Health and Safety Code, Chapter 773, 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 shall:

(1) Obtain written authorization from the highest elected official (County Judge or Mayor) of the political subdivision(s) where subscriptions will be sold. Written authorization must be obtained from each County Judge if subscriptions are to be sold in multiple counties.

(A) The County Judge must provide written authorizations, if subscriptions are to be sold throughout a county.

(B) The 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 subscription plan stating that the EMS Provider is not the primary emergency provider in this area. A copy of this documentation 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) The EMS provider shall maintain a current file of all advertising for the service. 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 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; 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 period(s). Subscription service period shall not exceed one year. Subscribers 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. During the license period, the EMS provider's responsibilities shall include:

(1) assuring that all 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 protocols and policies;

(2) each EMS provider shall develop, implement, maintain, and evaluate an effective, ongoing, system-wide, data-driven, interdisciplinary quality assessment and performance improvement program. 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'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 insure that quality of care is maintained in accordance with the existing standards of care and the provider medical director's signed, approved protocols;

(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) provide an attestation or provide documentation that its management staff will or continue to participate in the local regional advisory council;

(4) when an air ambulance is initiated through any other method than the local 911 system the air service providing the air ambulance is required to notify the local 911 center or the appropriate local response system for the location of the response at time of launch. This would not include interfacility transports or 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 provider may utilize an alternative identification system in 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/Transport Refusal forms are signed by all persons refusing service, or documenting incidents when a signed Informed 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 Texas Administrative Code, Chapter 103;

(10) assuring that patient care reports are provided to facilities receiving the patient:

(A) whenever operationally feasible, the report shall be provided to the receiving facility at the time the patient is delivered or a full written or 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 shall be provided at the time the patient is delivered and a completed written or computer generated report shall be delivered to the facility within 24 hours of the delivery of the patient;

(C) the abbreviated report shall document, at a minimum, the patient's name, 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 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 and the EMS Provider Medical Director;

(15) Maintenance of medical reports.

(A) A licensed EMS provider 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 a patient was younger than 18 years of age when last treated by the provider, the medical reports of the patient shall be maintained by the EMS provider until the patient reaches age 21 or for seven years from the date of last treatment, whichever is longer.

(C) 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 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 of medical records shall be done in a manner that ensures continued confidentiality.

(G) 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, transferring the business to ensure the maintenance of the medical record as outlined in subparagraph (E) of this paragraph.

(H) 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 at the appropriate level are maintained on each response-ready vehicle;

(18) monitoring and enforcing compliance with all policies and protocols;

(19) assuring provisions for the appropriate disposal of medical 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 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 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 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; and

(G) there is a change of the administrator of record.

(26) assuring that when a change of the medical director has occurred the department is notified within one business day;

(27) develop, implement and enforce written operating policies and procedures required under this chapter and/or adopted by the licensee. Assure that each employee (including volunteers) is provided a copy upon employment and whenever such policies and/or procedures are changed. A copy of the written operating policies and procedures shall be made available to the department on request. Policies at a minimum 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 has been documented.

(G) credentialing of new response personnel before being assigned primary care responsibilities. The credentialing process shall include 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;

(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/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;

(33) insuring continuous coverage for the service area defined in documents submitted with the EMS provider application;

(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 and/or local plans, when authorized;

(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;

(36) assuring all EMS personnel receive continuing education on the provider's anaphylaxis treatment protocols. The provider shall maintain education and training records to include date, time, and location of such education or training for all its EMS personnel;

(37) immediately notify the department in writing when operations cease in any service area;

(38) assure that all patients transported by stretcher must be in a department authorized EMS vehicle; and

(39) develop or adopt and then implement policies, procedures and protocols necessary for its operations as an EMS provider, and enforce all such policies, procedures and protocols.

(o) License renewal process.

(1) It shall be the responsibility of the provider to request license renewal application information.

(2) EMS providers shall submit a completed application, all other required documentation and a nonrefundable license renewal fee, no later than 90 days prior to the expiration date of the current license.

(A) When a complete application is received by the department 90 or more days prior to the expiration date of the current license that is to be renewed, the applicant shall submit a nonrefundable application fee of $400 per provider plus $180 for each EMS vehicle.

(B) When a complete application is received by the department 60 or more days, but less than 90 days prior to the expiration date of the current license that is to be renewed, the applicant shall submit a nonrefundable application fee of $450 per provider plus $180 for each EMS vehicle.

(C) When a complete application is received by the department less than 60 days prior to the expiration of the current license, the applicant 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 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 shall not be misleading, false, or deceptive. When an EMS provider advertises in Texas and/or conducts business in Texas by regularly transporting patients from, or within Texas, the provider shall be required to have a Texas EMS Provider License.

(2) An EMS provider shall not advertise levels of patient care which it cannot provide at all times. The provider shall not use a name, logo, 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% volunteer EMS personnel may advertise as a volunteer service.

(r) Surveys/Inspections and Investigations.

(1) The department may conduct scheduled or unannounced on-site inspection or investigation of a provider's vehicles, office(s), headquarter(s) and/or station(s) (hereinafter operations), at any reasonable time, including while services are being provided, to ensure compliance with 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 the Health and Safety Code, Chapter 773 and this chapter.

(3) Department's inspections or investigations to evaluate an EMS provider's compliance with the requirements of 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 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(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 shall cooperate with any department investigation or inspection, and 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 shall permit the department, consistent with applicable law, to interview members of the governing authority, personnel and patients.

(5) The EMS provider shall, consistent with applicable law, permit the department to copy or reproduce, or 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 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 will include an evaluation of compliance with 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, inform the EMS provider's governing authority or designee of the preliminary findings and 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 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 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 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.

(B) The EMS provider's governing authority, designee, or person in charge at the time 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.

(C) No later than 30 calendar days after the EMS provider's receipt of the deficiency report, the EMS provider 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 will determine if the written plan of correction and proposed timeframes for implementation are acceptable. If the plan is not acceptable, the department will notify the provider in writing no later than 30 days after receipt and request a modified plan. The EMS provider 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 shall correct the identified deficiencies and submit documentation to the department verifying completion of the corrective action within the 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 three days after mailing.

(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 title (relating to Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties).

(10) The department inspector 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, when there is disagreement with deficiencies cited by the inspector or investigator, 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 shall refer issues and complaints relating to the conduct or actions by licensed professionals to their appropriate licensing boards.

(12) All initial applicants and their medical director 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 and/or records to ensure compliance with this title at any time, including nights or weekends.

(14) If a re-survey/inspection to ensure correction of a deficiency is conducted, the provider 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 EMS provider of a critically ill or injured patient requiring specialized interventions, monitoring and/or staffing. To qualify to function as a Specialty Care Transport the following minimum criteria 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 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); 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 shall be available at the time of the transport.

(3) Minimum Required Staffing. 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, a currently certified EMT-Basic and a currently certified or licensed paramedic accompanied by at least one of the following: a Registered Nurse with special knowledge of the patient's care needs; a certified Respiratory Therapist; a licensed physician; or, any other licensed health care professional designated by the transferring physician.

(4) Additional Required Education and Training for Certified/Licensed Paramedics: Evidence of successful completion of post-paramedic education, training and appropriate periodic skills verification in management of patients on ventilators, 12 lead EKG and/or other critical care monitoring devices, drug infusion pumps, and cardiac and/or other critical care medications, or 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 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 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 shall inform persons that they may direct a complaint to the Department of State Health Services, EMS Compliance Group, by phone, or by email. The statement 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 and/or EMS personnel. Any complaint submitted to the department 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 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/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/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 Human Resources Code, Chapter 48 and 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 findings of an EMS provider's internal investigation will be reviewed by the department and may result in an additional investigation by the department, a request for a plan of correction to be completed by the provider in accordance with subsection (q) of this section (relating to inspections and investigations) and/or a proposal to take action against the provider under §157.16 of this title.

(B) The EMS provider under investigation 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 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 May 24, 2022.

TRD-202202008

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (512) 484-5470


CHAPTER 229. FOOD AND DRUG

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §229.661, concerning Cottage Food Production Operations and §§229.702 - 229.704, concerning Farmers' Markets.

BACKGROUND AND PURPOSE

The purpose of the proposal is to comply with amendments to Texas Health and Safety Code Chapter 437, Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, And Roadside Food Vendors as promulgated in Senate Bill (S.B.) 617, 87th Legislature, Regular Session, 2021. S.B. 617 clarifies who may sell products at a farmers' market by changing the definition of "farmers' market" at Texas Health and Safety Code §437.020(a)(1) and adding a new definition for "food producer" at Texas Health and Safety Code §437.020(a)(3). The two definitions effectively prohibit a jurisdiction from construing the statute to exclude non-farmers or non-farm-related vendors and products from farmers' markets within its jurisdiction.

S.B. 617 also amends Texas Health and Safety Code §437.0065, which clarifies which food vendors may be permitted to sell food at a farmers' market and necessitates amendment of the statutory parameters for permitting in §229.703. This includes a $100/per annum cap on a single permit that is valid at any farmers' market in the jurisdiction of the permitting authority.

In addition, it is necessary to make editorial changes to the rules due to the changes of the Retail Food Establishment rules in 25 TAC, Chapter 228, which includes the adoption by reference of the U.S. Food and Drug Administration Food Code 2017 (Food Code). Rule citations in Chapter 229, Subchapters EE and FF are changed from Chapter 228 to the Food Code. The revisions update the definition of "food establishment" in §229.661(b)(9); change cooking times and requirements; and update references to "time and temperature control for safety food (TCS food)" in §229.704. Other editorial changes are made for consistency and clarity throughout the subchapters.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.661(b)(7) changes the definition of "farmers' market" to correspond with the amended definition at Texas Health and Safety Code §437.020(a)(1).

The proposed amendment to §229.661(b)(9) changes the definition of "food establishment" to correspond with the definition contained in the Food Code.

The proposed amendment adds Subpart F to the previous citation from the Code of Federal Regulations at §229.661(d)(5).

The proposed amendment to §229.702(2) adds a definition of "farmer" to clarify the term in the rules.

The proposed amendment to §229.702(3) changes the definition of "farmers' market" to correspond with Texas Health and Safety Code §437.020(a)(1). In addition, DSHS added verbiage for clarification.

The proposed amendments to §229.702(4) and (11) change the rule citations from the former Retail Food Establishment rules to the Food Code.

New §229.702(6) adds a new definition for "food producer" to correspond with the new definition at Texas Health and Safety Code §437.020(a)(3).

The proposed amendment to §229.702(8) deletes the definition of "producer," which is replaced by the new definition of "food producer" at §229.702(6).

Section 229.702(2) - (10) are renumbered to paragraphs (3) - (11) to account for the addition of new paragraphs (2) and (6) and the deletion of previous paragraph (8).

The proposed amendment to §229.703 clarifies requirements for a permit to sell food at a farmers' market to correspond with Texas Health and Safety Code §437.0065.

The proposed amendments to §229.704 change references to "potentially hazardous food" to the more current usage that is "Time and temperature control for safety (TCS food)."

The proposed amendment to §229.704(c) deletes the phrase "at all times" to avoid redundancy.

The proposed amendments to §229.704(d)(1) and (2) change cooking times to reflect requirements in the Food Code.

The proposed amendments to §229.704(d)(5)(A) and (f) change the rule citations from the former Retail Food Establishment rules to the Food Code.

The proposed amendments add the word "Texas" for clarity in the Health and Safety Code and agency names throughout the subchapters.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules do not have foreseeable implications relating to costs or revenues of the state.

Donna Sheppard has also determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules may have foreseeable implications relating to costs or revenues of local and county governments due to the cap of $100 permitting fee that food vendors will pay to the local governments. DSHS is unable to estimate the number of businesses operating or about to operate at farmers' markets in local health departments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will not create a new rule;

(6) the proposed rules will expand existing rules;

(7) the proposed rules will increase the number of individuals subject to the rules due to the requirement that food producers may sell food products at farmers' markets; and

(8) the proposed rules will have a positive effect on the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that any adverse economic effect due to rural communities being required to comply with the $100/per annum fee limitation will be at least partially mitigated by expanded access to farmers' markets by non-farm-related vendors in some jurisdictions that previously interpreted the farmers' market language in Texas Health and Safety Code, Chapter 437 and 25 TAC Chapter 229, Subchapter FF to prevent them access.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Dr. Timothy Stevenson, Associate Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public benefit will be expansion of access to farmers' markets to non-farm-related vendors in some jurisdictions that previously interpreted the farmers' market statute and rules so as to prevent them access. This provides a potential new market to some "food producers" and greater diversity of goods to consumers who buy food products at farmers' markets.

Donna Sheppard has also determined that for the first five years the rules are in effect, persons who are required to comply with the proposed rules may incur economic costs because of the $100 per annum cost of the permit that will accompany greater accessibility to farmers' markets.

TAKINGS IMPACT ASSESSMENT

DSHS 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 Joe Williams or Jason Guzman at DSHS Consumer Protection Division/Public Sanitation and Retail Food Safety Branch, Mail Code 1987, P.O. Box 149347, Austin, Texas 78714-9347, hand-delivered to 1100 West 49th Street, M428.6, Austin, Texas 78756, by voicemail to (512) 834-6753, by fax to (512) 834-6683, or by email to foodestablishments@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. CST on the last working day of the comment period; or (3) faxed or emailed before midnight CST on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule 22R004" in the subject line.

SUBCHAPTER EE. COTTAGE FOOD PRODUCTION OPERATIONS

25 TAC §229.661

STATUTORY AUTHORITY

The proposed amendment is authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the efficient enforcement of Texas Health and Safety Code, Chapter 437; and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules 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 proposed amendment implements Texas Government Code, Chapter 531 and Texas Health and Safety Code, Chapters 437 and 1001.

§229.661.Cottage Food Production Operations.

(a) Purpose. The purpose of this section is to implement Texas Health and Safety Code, Chapter 437, related to cottage food production operations, which requires the department to adopt rules for labeling and production of foods by cottage food production operations.

(b) Definitions. The following words and terms, when used in this subchapter, [shall] have the following meanings, unless the context clearly indicates otherwise.

(1) Acidified canned goods--Food with a finished equilibrium pH value of 4.6 or less that is thermally processed before being placed in an airtight container.

(2) Baked good--A food item prepared by baking the item in an oven, which includes cookies, cakes, breads, Danishes, donuts, pastries, pies, and other items that are prepared by baking.

(3) Cottage food production operation (operator)--An individual, operating out of the individual's home, who:

(A) produces at the individual's home:

(i) a baked good that is not a time and temperature control for safety food (TCS food), as defined in paragraph (13) of this subsection;

(ii) candy;

(iii) coated and uncoated nuts;

(iv) unroasted nut butters;

(v) fruit butters;

(vi) a canned jam or jelly;

(vii) a fruit pie;

(viii) dehydrated fruit or vegetables, including dried beans;

(ix) popcorn and popcorn snacks;

(x) cereal, including granola;

(xi) dry mix;

(xii) vinegar;

(xiii) pickled fruit or vegetables, including beets and carrots, that are preserved in vinegar, brine, or a similar solution at an equilibrium pH value of 4.6 or less;

(xiv) mustard;

(xv) roasted coffee or dry tea;

(xvi) a dried herb or dried-herb mix;

(xvii) plant-based acidified canned goods;

(xviii) fermented vegetable products, including products that are refrigerated to preserve quality;

(xix) frozen raw and uncut fruit or vegetables; or

(xx) any other food that is not a TCS food, as defined in paragraph (13) of this subsection.

(B) has an annual gross income of $50,000 or less from the sale of food described by subparagraph (A) of this paragraph;

(C) sells foods produced under subparagraph (A) of this paragraph only directly to consumers; and

(D) delivers products to the consumer at the point of sale or another location designated by the consumer.

(4) Department--The Texas Department of State Health Services.

(5) Executive Commissioner--The Executive Commissioner of the Texas Health and Human Services Commission.

(6) Farm stand--A premises owned and operated by a producer of agricultural food products at which the producer or other persons may offer for sale produce or foods described in paragraph (3) of this subsection.

(7) Farmers' market--A designated location used for a recurring event at which a majority of the vendors are farmers or other food producers who sell food directly to consumers. A farmers' market must include vendors who meet the definition of "farmer" defined at §229.702(2) of this title (relating to Definitions) and may include vendors who meet the definition of "food producer" as defined at §229.702(6) of this title. [A designated location used primarily for the distribution and sale directly to consumers of food by farmers or other producers.]

(8) Fermented vegetable product--A low-acid vegetable food product subjected to the action of certain microorganisms that produce acid during their growth and reduce the pH value of the food to 4.6 or less.

(9) Food establishment--

(A) Food establishment is [means] an operation that [stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:]:

(i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food for human consumption, such as a restaurant, [;] retail food store, [;] satellite or catered feeding location, [;] catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, [;] market, [;] vending machine location, [;] self-service food market, conveyance used to transport people, [;] institution, [;] or food bank; and

(ii) [that] relinquishes possession of food to a consumer directly, or indirectly through a delivery service, such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

(B) Food establishment includes:

(i) an element of the operation, such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location, unless the vending or feeding location is permitted by the regulatory authority; and

(ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location and [;] where consumption is on or off the premises, [; and] regardless of whether there is a charge for the food.

(C) Food establishment does not include:

(i) an establishment that offers only prepackaged foods that are not TCS foods;

(ii) a produce stand that only offers whole, uncut fresh fruit [fruits] and vegetables;

(iii) a food processing plant, including one that is [those that are] located on the premises of a food establishment;

(iv) a cottage food production operation; [a kitchen in a private home if only food that is not TCS food is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law;]

(v) a bed and breakfast limited as defined in §228.223 of this title (relating to Bed and Breakfast); or [an area where food that is prepared as specified in clause (iv) of this subparagraph is sold or offered for human consumption;]

(vi) a private home that receives catered or home-delivered food. [a Bed and Breakfast Limited establishment as defined in §228.2 of this title (relating to Definitions) concerning food establishments;]

[(vii) a private home that receives catered or home-delivered food; or]

[(viii) a cottage food production operation.]

(10) Herbs--The leafy green parts of a plant (either fresh or dried) used for culinary purposes and not for medicinal uses.

(11) Home--A primary residence that contains a kitchen and appliances designed for common residential usage.

(12) Process authority--A person who has expert knowledge acquired through appropriate training and experience in the pickling, fermenting, or acidification and processing of pickled, fermented, or acidified foods.

(13) Time and temperature control for safety food (TCS food)--A food that requires time and temperature control for safety to limit pathogen growth or toxin production. The term includes a food that must be held under proper temperature controls, such as refrigeration, to prevent the growth of bacteria that may cause human illness. A TCS food may include a food that contains protein and moisture and is neutral or slightly acidic, such as meat, poultry, fish, and shellfish products, pasteurized and unpasteurized milk and dairy products, raw seed sprouts, baked goods that require refrigeration, including cream or custard pies or cakes, and ice products. The term does not include a food that uses TCS food as ingredients if the final food product does not require time or temperature control for safety to limit pathogen growth or toxin production.

(c) Complaints. The department shall maintain a record of a complaint made by a person against an operator.

(d) Packaging and labeling requirements for cottage food production operations. All foods prepared by an operator shall be packaged and labeled in a manner that prevents product contamination.

(1) The label information shall include:

(A) the name and physical address of the cottage food production operation;

(B) the common or usual name of the product;

(C) disclosure of any major food allergens, such as eggs, nuts, soy, peanuts, milk, wheat, fish, or shellfish used in the product; and

(D) the following statement: "This food is made in a home kitchen and is not inspected by the Texas Department of State Health Services or a local health department."

(2) Labels must be legible.

(3) A food item is not required to be packaged if it is too large or bulky for conventional packaging. For these food items, the information required under paragraph (1) of this subsection shall be provided to the consumer on an invoice or receipt.

(4) A label for frozen raw and uncut fruit or vegetables must include the following statement in at least 12-point font when sold: "SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria, keep this food frozen until preparing for consumption" on the label or on an invoice or receipt provided with the frozen fruit or vegetables.

(5) Advertising media of cottage food products for health, disease, or other claims must be consistent with those claims allowed by the Code of Federal Regulations Title 21, Part 101, Subparts D, [and] E, and F.

(e) Certain sales by cottage food production operations prohibited or restricted.

(1) An operator may not sell any of the foods described in this section at wholesale.

(2) An operator may sell a food described in this section in this state through the internet or by mail-order only if:

(A) the consumer purchases the food through the internet or by mail-order from the operator and the operator personally delivers the food to the consumer; and

(B) subject to paragraph (3) of this subsection, before the operator accepts payment for the food, the operator provides all labeling information required by subsection (d) of this section to the consumer by:

(i) posting a legible statement on the cottage food production operation's internet website;

(ii) publishing the information in a catalog; or

(iii) otherwise communicating the information to the consumer.

(3) The operator that sells a food described by subsection (b)(3)(A) of this section in this state in the manner described by paragraph (2) of this subsection:

(A) is not required to include the address of the cottage food production operation in the labeling information required under subsection (d)(1)(A) of this section before the operator accepts payment for the food; and

(B) shall provide the address of the cottage food production operation on the label of the food in the manner required by subsection (d)(1)(A) of this section after the operator accepts payment for the food.

(f) Requirements for sale of certain cottage food products.

(1) An operator that sells to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods shall:

(A) use a recipe that:

(i) is from a source approved by the department under paragraph (4) of this subsection;

(ii) has been tested by an appropriately certified laboratory that confirmed the finished fruit or vegetable product[,] or plant-based acidified canned good has an equilibrium pH value of 4.6 or less; or

(iii) is approved by a qualified process authority; or

(B) if the operation does not use a recipe described by subparagraph (A) of this paragraph, test each batch of the recipe with a calibrated pH meter to confirm the finished fruit or vegetable[,] product[,] or plant-based acidified canned good has an equilibrium pH value of 4.6 or less.

(2) An operator may not sell to consumers pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods before the operator complies with paragraph (1) of this subsection.

(3) For each batch of pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods, an operator must:

(A) label the batch with a unique number; and

(B) for a period of at least 12 months, keep a record that includes:

(i) the batch number;

(ii) the recipe used by the producer;

(iii) the source of the recipe or testing results as applicable; and

(iv) the date the batch was prepared.

(4) The department shall:

(A) approve sources for recipes that an operator may use to produce pickled fruit or vegetables, fermented vegetable products, or plant-based acidified canned goods; and

(B) semiannually post on the department's internet website a list of the approved sources for recipes, appropriately certified laboratories, and qualified process authorities.

(5) This subsection does not apply to a pickled cucumber preserved in vinegar, brine, or similar solution.

(g) Requirements for the sale of frozen raw and uncut fruit or vegetables. An operator that sells to consumers frozen raw and uncut fruit or vegetables shall:

(1) store and deliver the frozen raw and uncut fruit or vegetables at an air temperature of not more than 32 degrees Fahrenheit; and

(2) label the frozen raw and uncut fruit or vegetables in accordance with subsection (d)(4) of this section.

(h) A cottage food production operation is not exempt from meeting the application of Texas Health and Safety Code, §431.045, Emergency Order; §431.0495, Recall Orders; and §431.247, Delegation of Powers or Duties. The department or local health authority may act to prevent an immediate and serious threat to human life or health.

(i) Prohibition for Cottage Food Production Operations. A cottage food production operation may not sell TCS foods to customers.

(j) Production of Cottage Food Products - Basic Food Safety Education or Training Requirements.

(1) An individual who operates a cottage food production operation must have successfully completed a basic food safety education or training program for food handlers accredited under Texas Health and Safety Code, Chapter 438, Subchapter D.

(2) An individual may not process, prepare, package, or handle cottage food products unless the individual:

(A) meets the requirements of paragraph (1) of this subsection;

(B) is directly supervised by an individual described by paragraph (1) of this subsection; or

(C) is a member of the household in which the cottage food products are produced.

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 May 23, 2022.

TRD-202202002

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (512) 231-5653


SUBCHAPTER FF. FARMERS' MARKETS

25 TAC §§229.702 - 229.704

STATUTORY AUTHORITY

The proposed amendments are authorized by Texas Government Code, §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the efficient enforcement of Texas Health and Safety Code, Chapter 437; and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules 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 proposed amendments implement Texas Government Code, Chapter 531 and Texas Health and Safety Code, Chapters 437 and 1001.

§229.702.Definitions.

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Department--The Texas Department of State Health Services.

(2) Farmer--A person or entity that produces agricultural products by practice of the agricultural arts upon land that the person or entity controls.

(3) [(2)] Farmers' market--A designated location used for a recurring event at which a majority of the vendors are farmers or other food producers who sell food directly to consumers. A farmers' market must include vendors who meet the definition of "farmer" as defined in paragraph (2) of this section and may include vendors who meet the definition of "food producer" as defined in paragraph (6) of this section. [A designated location used primarily for the distribution and sale directly to consumers of food by farmers and other producers.]

(4) [(3)] Fish--As defined in the U.S. Food and Drug Administration Food Code 2017 (Food Code) §1-201.10(B) [§228.2 of this title (relating to Definitions)].

(5) [(4)] Food--An agricultural, apicultural, horticultural, silvicultural, viticultural, or vegetable product for human consumption, in either its natural or processed state, that has been produced or processed or otherwise has had value added to the product in this state. The term includes:

(A) fish or other aquatic species;

(B) livestock, a livestock product, or livestock by-product;

(C) planting seed;

(D) poultry, a poultry product, or a poultry by-product;

(E) wildlife processed for food or by-products;

(F) a product made from a product described in this paragraph by a farmer or other producer who grew or processed the product; or

(G) produce.

(6) Food producer--A person who grew, raised, processed, prepared, manufactured, or otherwise added value to the food product the person is selling. The term does not include a person who only packaged or repackaged a food product.

(7) [(5)] Potable water--Drinking water.

(8) [(6)] Poultry--A live or dead domesticated bird.

(9) [(7)] Produce--Fresh fruit [fruits] or vegetables.

[(8) Producer--A person or entity that produces agricultural products by practice of the agricultural arts upon land that the person or entity controls.]

(10) [(9)] Sample--A bite-sized portion of food or foods offered free of charge to demonstrate its characteristics and does not include a whole meal, an individual portion, or a whole sandwich.

(11) [(10)] Time and temperature control for safety food (TCS food) [Time/Temperature Control for Safety (TCS) food--] (formerly Potentially Hazardous Food)--As defined in the Food Code §1-201.10(B) [§228.2 of this title].

§229.703.Permits.

The department or the local health department may issue a permit to a farmer or food producer [person] who sells food [potentially hazardous food (time/temperature control for safety food)] at a farmers' market. Regardless of what the permit is called, the following parameters from Texas Health and Safety Code §437.0065(c) apply. The permit:

(1) must be valid for a term of not less than one year;

(2) may impose an annual fee in an amount not to exceed $100.00 for issuance or renewal; and

(3) must cover sales at all farmers' markets, farm stands, and farms within the jurisdiction of the permitting authority.

§229.704.Temperature Requirements.

(a) TCS food [Potentially hazardous food (time/temperature control for safety food)] sold, distributed, or prepared on-site at a farmers' market, and TCS food [potentially hazardous food (time/temperature control for safety food)] transported to or from a farmers' market, shall meet the requirements of this section.

(b) Frozen food. Stored frozen foods shall be maintained frozen.

(c) Hot and cold holding. TCS food [All potentially hazardous food] sold at, prepared on site at, or transported to or from a farm or farmers' market [at all times] shall be maintained at:

(1) 5 degrees Celsius (41 degrees Fahrenheit) or below; or

(2) 54 degrees Celsius (135 degrees Fahrenheit) or above.

(d) Cooking of raw animal foods. Raw animal foods shall be cooked to heat all parts of the food to the following applicable temperatures:

(1) poultry, ground poultry, stuffing with poultry, meat, and fish to 74 degrees Celsius (165 degrees Fahrenheit) for < 1 second (instantaneous) [15 seconds];

(2) ground meat, ground pork, ground fish, and injected meats to 68 degrees Celsius (155 degrees [degree] Fahrenheit) for 17 [15] seconds;[)]

(3) beef, pork, meat, fish, and raw shell eggs for immediate service to 63 degrees Celsius (145 degrees Fahrenheit) for 15 seconds;

(4) prepackaged TCS food [, potentially hazardous food (time/temperature control for safety food),] that has been commercially processed[,] to 57 degrees [degree] Celsius (135 degrees Fahrenheit);

(5) a raw or undercooked whole-muscle, intact beef steak may be served if:

(A) the steak is labeled to indicate that it meets the definition of "whole-muscle, intact beef" as defined in the Food Code §1-201.10(B) [§228.2 of this title (relating to Definititions)]; and [or]

(B) the steak is cooked on both the top and bottom to a surface temperature of 63 degrees Celsius (145 degrees Fahrenheit) or above and a cooked color change is achieved on all external surfaces; and [.]

(6) raw animal foods cooked in a microwave oven shall be:

(A) rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat;

(B) covered to retain surface moisture;

(C) heated to a temperature of at least 74 degrees Celsius (165 degrees Fahrenheit) in all parts of the food; and

(D) allowed to stand covered for 2 minutes after cooking to obtain temperature equilibrium.

(e) Cooking fruit [fruits] and vegetables. Fruit [Fruits] and vegetables that are cooked shall be heated to a temperature of 57 degrees Celsius (135 degrees Fahrenheit).

(f) Eggs. A farmer or egg producer that sells eggs directly to the consumer at a farm or farmers' market shall maintain the eggs at an ambient air temperature of 7 degrees Celsius (45 degrees Fahrenheit) as specified in the Food Code §3-501.16(B) [§228.63 of this title (relating to Specifications for Receiving)].

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 May 23, 2022.

TRD-202202003

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: July 10, 2022

For further information, please call: (512) 231-5653