Texas Register June 28, 2019 Volume: 44 Number: 26

Texas Register Table of Contents

Texas State Board of Pharmacy

 

Proposed Rules

Proposal to establish policy and procedures for resolving vendor protests relating to purchasing issues

22 TAC §281.14The Texas State Board of Pharmacy proposes a new rule §281.14, concerning Vendor Protest Procedures. The new rule, if adopted, establishes policy and procedures for resolving vendor protests relating to purchasing issues, as required by §2155.076 of the Government Code.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the proposed rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the proposed rule will be in effect, the public benefit anticipated as a result of enforcing the proposed rule will be to provide consistent standards for filing and resolving a vendor protest. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. An economic impact statement and regulatory flexibility analysis is not required because the proposed rule will not have an adverse economic effect on Texas small businesses or rural communities.


Texas State Board of Pharmacy

Proposed Rules

Propose repeal of §281.15, concerning Vehicle Inscription Information

22 TAC §281.15The Texas State Board of Pharmacy proposes the repeal of §281.15, concerning Vehicle Inscription Information. The proposed repeal of §281.15 provides for a more organized subchapter by moving the language from the previous §281.15 to an amended §281.19, allowing the agency to adopt a new §281.15, concerning Negotiated Rulemaking.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the repeal is in effect, there will be no fiscal implications for state or local government as a result of repealing the rule. Ms. Benz has determined that, for each year of the first five-year period the repeal is in effect, the public benefit anticipated as a result of the repeal will be to improve the organization of the agency’s regulations. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.


Texas State Board of Pharmacy

Proposed Rules

Propose new rule §281.15, concerning Negotiated Rulemaking

22 TAC §281.15The Texas State Board of Pharmacy proposes a new rule §281.15, concerning Negotiated Rulemaking. The new rule, if adopted, establishes policy and procedures for the use of negotiated rulemaking for the adoption of board rules in appropriate situations, as required by §554.0011 of the Pharmacy Act.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the proposed rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the proposed rule will be in effect, the public benefit anticipated as a result of enforcing the proposed rule will be a clear and consistent process for negotiated rulemaking. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. An economic impact statement and regulatory flexibility analysis is not required because the proposed rule will not have an adverse economic effect on Texas small businesses or rural communities.


Texas State Board of Pharmacy

Proposed Rules

Proposed new rule §281.16, concerning Alternative Dispute Resolution

22 TAC §281.16The Texas State Board of Pharmacy proposes a new rule §281.16, concerning Alternative Dispute Resolution. The new rule, if adopted, establishes policy and procedures for the use of alternative dispute resolution to resolve internal and external disputes, as required by section 554.0011 of the Pharmacy Act.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the proposed rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the proposed rule will be in effect, the public benefit anticipated as a result of enforcing the proposed rule will be to provide a clear and consistent process for resolving disputes through alternative dispute resolution. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. An economic impact statement and regulatory flexibility analysis is not required because the proposed rule will not have an adverse economic effect on Texas small businesses or rural communities.


Texas State Board of Pharmacy

Proposed Rules

Proposed new rule §281.16, concerning Alternative Dispute Resolution

22 TAC §281.16The Texas State Board of Pharmacy proposes a new rule §281.16, concerning Alternative Dispute Resolution. The new rule, if adopted, establishes policy and procedures for the use of alternative dispute resolution to resolve internal and external disputes, as required by section 554.0011 of the Pharmacy Act.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the proposed rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the proposed rule will be in effect, the public benefit anticipated as a result of enforcing the proposed rule will be to provide a clear and consistent process for resolving disputes through alternative dispute resolution. There is no anticipated impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. An economic impact statement and regulatory flexibility analysis is not required because the proposed rule will not have an adverse economic effect on Texas small businesses or rural communities.


Texas State Board of Pharmacy

Proposed Rules

Proposed amendments to §281.19, concerning Restrictions on Assignment of Vehicles

22 TAC §281.19The Texas State Board of Pharmacy proposes amendments to §281.19, concerning Restrictions on Assignment of Vehicles. The amendments, if adopted, update the section title, add updated vehicle inscription information (formerly located in §281.15), and remove outdated references to an agency pool car.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the amendments will be to improve the organization of the agency’s regulations, increase the effectiveness of agency field employees in detecting and investigating violations of state and federal laws relating to the practice of pharmacy, and provide clearer regulatory language by removing an outdated reference. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.


Advisory Board of Athletic Trainers

Proposed Rules

Proposed amendments to §283.11, concerning Examination Retake Requirements

22 TAC §283.11The Texas State Board of Pharmacy proposes amendments to §283.11, concerning Examination Retake Requirements. The amendments, if adopted, update the examination retake requirements and remove outdated references to an examination retake committee.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the amendments will be to provide accurate requirements and procedures for requesting an examination retake by removing outdated references. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.


Texas State Board of Pharmacy

Proposed Rules

Proposed amendments to §291.6, concerning Pharmacy License Fees

22 TAC §291.6The Texas State Board of Pharmacy proposes amendments to §291.6, concerning Pharmacy License Fees. The amendments, if adopted, will increase pharmacy license fees based on expected expenses.


Texas State Board of Pharmacy

Proposed Rules

Proposed amendments to §295.8, concerning Continuing Education Requirements

22 TAC §295.8The Texas State Board of Pharmacy proposes amendments to §295.8, concerning Continuing Education Requirements. The amendments, if adopted, clarify the definition of initial license period, remove an outdated reference to the Commission for Certification in Geriatric Pharmacy, and correct grammatical errors.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the amendments will be to provide clearer regulatory language and grammatically correct regulations. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.


Texas State Board of Pharmacy

Proposed Rules

Proposed amendments to §295.8, concerning Continuing Education Requirements

22 TAC §295.8The Texas State Board of Pharmacy proposes amendments to §295.8, concerning Continuing Education Requirements. The amendments, if adopted, clarify the definition of initial license period, remove an outdated reference to the Commission for Certification in Geriatric Pharmacy, and correct grammatical errors.Allison Vordenbaumen Benz, R.Ph., M.S., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Benz has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the amendments will be to provide clearer regulatory language and grammatically correct regulations. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.


Texas Health and Human Services Commission

Adopted Rules

Repeal of Title 1, Part 15, Chapter 354, Subchapter C, Case Management for Children Who Are Blind and Visually Impaired, in its entirety

CHAPTER 354. MEDICAID HEALTH SERVICESSUBCHAPTER C. CASE MANAGEMENT FOR CHILDREN WHO ARE BLIND AND VISUALLY IMPAIRED1 TAC §§354.1501, 354.1503, 354.1505, 354.1507, 354.1509, 354.1511The Texas Health and Human Services Commission (HHSC) adopts the repeal of Title 1, Part 15, Chapter 354, Subchapter C, Case Management for Children Who Are Blind and Visually Impaired, in its entirety, including §354.1501, concerning Definitions; §354.1503, concerning Eligible Individuals; §354.1505, concerning Case Management Services; §354.1507, concerning Service Limitations; §354.1509, concerning Provider Qualifications; and §354.1511, concerning Right to Appeal.The repeal of §§354.1501, 354.1503, 354.1505, 354.1507, 354.1509, and 354.1511 are adopted without changes to the proposed text, as published in the January 11, 2019, issue of the Texas Register (44 TexReg 173), and therefore will not be republished.The repeal of the rules aligns with Medicaid State Plan changes effective February 15, 2017. The Centers for Medicare & Medicaid Services approved an administrative change for HHSC to continue to provide case management services for blind and visually impaired children and bill for service reimbursements through administrative claiming rather than the Medicaid fee-for-service reimbursement model. HHSC employees continue to provide uninterrupted case management services to eligible children who are blind or visually impaired.

Texas Health and Human Services Commission

Adopted Rules

Adopts new Chapter 303, Preadmission Screening and Resident Review (PASRR)

CHAPTER 303. PREADMISSION SCREENING AND RESIDENT REVIEW (PASRR)The Texas Health and Human Services Commission (HHSC) adopts new Chapter 303, Preadmission Screening and Resident Review (PASRR), comprising §§303.101 – 303.103, 303.201 – 303.204, 303.301 – 303.303, 303.401, 303.501 – 303.504, §303.601, 303.602, 303.701 – 303.703, and 303.801, in Title 26, Part 1, Texas Administrative Code (TAC). Sections 303.102, 303.201, 303.301, 303.302, 303.504, 303.601, 303.602, and 303.701 are adopted with changes to the proposed text as published in the February 8, 2019, issue of the Texas Register (44 TexReg 530). These sections will be republished. Sections 303.101, 303.103, 303.202 – 303.204, 303.303, 303.401, 303.501 – 303.503, 303.702, 303.703, and 303.801 are adopted without changes to the proposed text as published in the February 8, 2019, issue of the Texas Register (44 TexReg 530). These sections will not be republished.BACKGROUND AND JUSTIFICATIONThe Texas Secretary of State created Title 26, Part 1, of the TAC to consolidate rules that govern functions of HHSC. These rules are currently in Titles 1, 25, and 40. As part of the consolidation into Title 26, HHSC adopts new rules in Title 26, Chapter 303 to replace rules in Title 40, Chapter 17, Preadmission Screening and Resident Review (PASRR). The rules in Chapter 17 are repealed elsewhere in this issue of the Texas Register.The new rules describe the responsibilities of a local intellectual and developmental disability authority (LIDDA), a local mental health authority (LMHA), and a local behavioral health authority (LBHA) related to PASRR. PASRR is a federal requirement in the Code of Federal Regulations, Title 42, Part 483, Subpart C. PASRR is a process to identify individuals with a mental illness (MI), an intellectual disability (ID), or a developmental disability (DD) who choose admission into a Medicaid-certified nursing facility (NF) or who are residing in a NF. PASRR is intended to ensure that a NF admission is appropriate and that an individual with MI, ID, or DD receives specialized services as appropriate.The new Subchapters E, F, G, and H contain provisions that were not in Title 40, Chapter 17. The new provisions in Subchapters E, F, and G describe the role and responsibilities of a LIDDA for providing habilitative service planning and transition planning for a designated resident. A designated resident is a NF resident who is a Medicaid recipient age 21 years or older with ID or DD. Since 2015, LIDDAs have provided service coordination to designated residents. Service coordination includes habilitative service planning, monitoring specialized services, providing information about community living options, and transition planning. In accordance with a Medicaid State Plan amendment approved by the Centers for Medicare & Medicaid (CMS), a new Medicaid-funded service “habilitation coordination” will replace all LIDDA service coordination activities for a designated resident, except for transition planning. The new rules reflect this change. The new rule in Subchapter H allows HHSC to review a LIDDA’s compliance with the requirements in Chapter 303.The new rules change references to the Department of Aging and Disability Services (DADS) that were in Chapter 17 to HHSC to reflect that DADS was abolished effective September 1, 2017, and its functions have transferred to HHSC.


Texas Health and Human Services Commission

Adopted Rules

EARLY CHILDHOOD INTERVENTION SERVICES: Adopts amendments, repeals, and new rules to increase administrative efficiencies, improve processes for contractors, and align the rules with the Code of Federal Regulations

CHAPTER 108. EARLY CHILDHOOD INTERVENTION SERVICESAs required by Texas Government Code §531.0202(a), the Department of Assistive and Rehabilitative Services (DARS) was abolished effective September 1, 2017, after all of its functions were transferred to the Texas Health and Human Services Commission (HHSC) in accordance with Texas Government Code §531.0201. Rules of the former DARS are codified in Title 40, Part 2, and will be repealed or administratively transferred to Title 26, Health and Human Services, as appropriate. Until such action is taken, the rules in Title 40, Part 2 govern functions previously performed by DARS that have transferred to HHSC. Texas Government Code §531.0055, requires the Executive Commissioner of HHSC to adopt rules for the operation and provision of services by the health and human services system, including rules in Title 40, Part 2. Therefore, the Executive Commissioner of HHSC adopts amendments to Title 40, Part 2, Chapter 108, §§108.101, 108.201, 108.203, 108.207, 108.211, 108.213, 108.215, 108.217, 108.219, 108.237, 108.303, 108.309 – 108.313, 108.315, 108.409, 108.411, 108.417, 108.503, 108.505, 108.507, 108.607, 108.609, 108.611, 108.613, 108.615, 108.617, 108.709, 108.809, 108.811, 108.813, 108.815, 108.817, 108.821, 108.825, 108.829, 108.835, 108.837, 108.1003, 108.1004, 108.1007, 108.1009, 108.1015 – 108.1017, 108.1019, 108.1107, 108.1108, 108.1111, 108.1207, 108.1209, 108.1213, 108.1217, 108.1221, 108.1301, 108.1307, 108.1309, 108.1405, 108.1407, 108.1409, 108.1413, 108.1421, 108.1423, 108.1431, and 108.1439; new §§108.218, 108.314, 108.405, 108.415, 108.707, and 108.708; and the repeal of §§108.102, 108.205, 108.206, 108.218, 108.302, 108.317, 108.319, 108.405, 108.415, 108.603, 108.702, 108.706, 108.707, 108.803, 108.1002, 108.1011, 108.1102, 108.1106, 108.1202, 108.1303, 108.1403, and 108.1432, concerning Subchapter A, General Rules; Subchapter B, Procedural Safeguards and Due Process Procedures; Subchapter C, Staff Qualifications; Subchapter D, Case Management for Infants and Toddlers with Developmental Disabilities; Subchapter E, Specialized Skills Training; Subchapter F, Public Outreach; Subchapter G, Referral, Pre-Enrollment, and Developmental Screening; Subchapter H, Eligibility, Evaluation, and Assessment; Subchapter J, Individualized Family Service Plan (IFSP); Subchapter K, Service Delivery; Subchapter L, Transition; Subchapter M, Child and Family Outcomes; and Subchapter N, Family Cost Share System. The amendments are adopted without changes to the proposed text as published in the December 21, 2018, issue of the Texas Register (43 TexReg 8238), and therefore will not be republished.The amendments to §§108.103, 108.204, 108.233, 108.403, 108.501, 108.704, 108.823, 108.1104, 108.1105, and 108.1425; and new §108.706, concerning Subchapter A, General Rules; Subchapter B, Procedural Safeguards and Due Process Procedures; Subchapter D, Case Management for Infants and Toddlers with Developmental Disabilities; Subchapter E, Specialized Rehabilitative Services; Subchapter H, Eligibility, Evaluation, and Assessment; Subchapter K, Service Delivery; and Subchapter N, Family Cost Share System are adopted with changes to the proposed text as published in the December 21, 2018, issue of the Texas Register (43 TexReg 8238), and will be republished.BACKGROUND AND PURPOSEThe purpose of the amendments, repeals, and new rules is to increase administrative efficiencies, improve processes for contractors, and align the rules with the Code of Federal Regulations.The changes also contain non-substantive changes that will: (1) improve readability and understanding; (2) make the wording of the rule consistent with the new changes in this chapter; and (3) update state organizational changes as a result of Senate Bill (SB) 200, 84th Legislature, Regular Session, 2015.The amendments, repeals, and new rules are a result of HHSC Early Childhood Intervention (ECI) Program conducting a review of current rules and visiting with current ECI contractors and stakeholders to identify ways to improve the long-term sustainability of the program. These rules address a number of areas including clarifying eligibility determination, programmatic requirements, and additional needs identified by current contractors. Additionally, this rule project has allowed the ECI program to identify opportunities to clarify targeted case management, which will assist in meeting the requirements of the 2018-19 General Appropriations Act, SB 1, 85th Legislature, Regular Session, 2017 (Article II, HHSC, Rider 114).


Texas State Board of Pharmacy

In Addition

Notice of intent to review Chapter 291, Subchapter A (§§291.1 – 291.3, 291.5 – 291.11, 291.14 – 291.19, 291.22 – 291.24, 291.27 – 291.29), concerning Pharmacies (All Classes of Pharmacies)

Title 22, Part 15The Texas State Board of Pharmacy files this notice of intent to review Chapter 291, Subchapter A (§§291.1 – 291.3, 291.5 – 291.11, 291.14 – 291.19, 291.22 – 291.24, 291.27 – 291.29), concerning Pharmacies (All Classes of Pharmacies), pursuant to the Texas Government Code §2001.039, regarding Agency Review of Existing Rules.Comments regarding whether the reason for adopting the rule continues to exist may be submitted to Megan G. Holloway, Assistant General Counsel, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-500, Austin, Texas 78701, FAX (512) 305-8061. Comments must be received by 5:00 p.m., July 31, 2019.