The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts the repeal of 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 adopts new Subchapter C, Division 1, §§98.101 - 98.109, concerning the Texas HIV Medication Program (THMP).

New §98.108 is adopted with changes to the proposed text as published in the June 10, 2022, issue of the Texas Register (47 TexReg 3399). This rule will be republished.

The repeal of §§98.1 - 98.13, 98.101 - 98.115, 98.117 - 98.119 and new §§98.101 - 98.107 and 98.109 are adopted without changes to the proposed text as published in the June 10, 2022, issue of the Texas Register (47 TexReg 3399). These rules will not be republished.

DSHS Rider 26 requires DSHS notify providers and other relevant stakeholders at least 60 days before implementing any cost containment measures for the Texas HIV Medication Program. Therefore, DSHS will implement the repeal of §§98.101 - 98.107 and 98.109, and new §§98.101 - 98.109, on April 1, 2023.

BACKGROUND AND JUSTIFICATION

The adoption of the rules allows 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 adopts the repeals and replaces Subchapter A and Subchapter C, Division 1 to update eligibility requirements for THMP.

COMMENTS

The 31-day comment period ended on July 11, 2022.

During this period, DSHS received comments regarding the proposed rules from five commenters, including Gilead Sciences, Inc., Legacy Community Health, Texas Association of Community Health Centers, ViiV Healthcare, and Vivent Health. A summary of comments relating to the rules and DSHS's responses follows.

Comment: One commenter expressed concerns that the state of Texas does not allow for insurance purchasing for AIDS Drug Assistance Program (ADAP) enrollees, which is allowed by HRSA.

Response: DSHS declines to revise the rules in response to this comment as the comment is beyond the scope of the rules. The THMP Texas Insurance Assistance Program (TIAP) is supported by state general revenue funds and not Ryan White HIV Program funding. The Legislature struck the insurance language from 2021-22 General Appropriations Act, Senate Bill (S.B.) 1, 87th Legislature, Regular Session, 2021 (Article II-31, DSHS, Rider 26). THMP may not expand insurance assistance by enrolling clients in insurance plans.

Comment: Two commenters requested clarification regarding the eligibility requirement for insurance plans to offer "at least one drug from each class of HIV-antiretroviral medication." This comment is relating to §98.102(4), the definition of an eligible health insurance policy.

Response: DSHS declines to revise the rule in response to this comment as the comment is beyond the scope of the rules. The Ryan White HIV/AIDS Program Legislation and the HRSA have established this as a minimum requirement for ADAP formularies. This meets the HRSA requirements for ADAP - one HIV antiretroviral medication per class minimum.

Comment: Two commenters expressed support for the change in the method of income adjustment from an individual income to a standard deduction outlined in §98.103(b)(4)(D)(i) and (ii).

Response: DSHS appreciates the feedback of the support.

Comment: Two commenters requested clarification regarding §98.106(b)(4), as to who the Infectious Disease Medical Officer and the alternate will be involved in the THMP appeals process in the event of a DSHS reorganization.

Response: DSHS disagrees and declines to revise the rule in response to this comment. The Infectious Disease Medical Officer is part of the DSHS executive team. In the event of a DSHS reorganization or vacancy, the equivalent or acting position will be identified.

Comment: One commenter expressed concern that the rules allowed for cost-containment measures in §98.108 to be instituted without stakeholder engagement.

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS is committed to transparency about the reasons for cost containment measures. It is important that stakeholders have an opportunity to ask questions and propose other strategies for THMP long-term sustainability. DSHS makes communication a priority, especially for programs that directly impact clients such as THMP outlined in §98.108.

Comment: Three commenters requested language be added to the proposed rules reflecting language found in DSHS Rider 26 of the Fiscal Year 2022-23 state budget, stating that "DSHS shall notify providers and other relevant stakeholders at least 60 days before implementing any cost containment measures for the Texas HIV Medication Program."

Response: DSHS agrees and has revised §98.108(c) to comply with the language stated in 2021-22 General Appropriations Act, S.B. 1, 87th Legislature, Regular Session, 2021 (Article II-31, DSHS, Rider 26).

Comment: One commenter encouraged THMP to pursue all available federal funding before implementing proposed cost-containment measures outlined in §98.108.

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS is committed to pursuing all available federal funding sources before implementing cost-containment measures. 2021-22 General Appropriations Act, S.B. 1, 87th Legislation, Regular Session, 2021 (Article II-31, DSHS, Rider 26) requires DSHS to apply for maximum funds available for THMP.

DSHS added the following language in §98.108(c)(4), concerning a waiting list, which was inadvertently left out of the June 10th issue of the Texas Register. DSHS also added the language "women and infants and to" in the sentence "In the event of a waiting list, the department shall give priority to participation in THMP to eligible women and infants and to individuals younger than 18 years of age." This language in §98.108(c)(4) is consistent with the language in §98.103(a).

"Appropriate information is collected from each applicant who is placed on a waiting list. The information is used to facilitate contacting the applicant when benefits become available and to allow efficient enrollment application processing if the budgetary limitations loosen. In the event of a waiting list, the department shall give priority to participation in THMP to eligible women and infants and to individuals younger than 18 years of age."

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.