PART 15. TEXAS HEALTH AND HUMAN SERVICES COMMISSION
CHAPTER 354. MEDICAID HEALTH SERVICES
SUBCHAPTER F. PHARMACY SERVICES
The Texas Health and Human Services Commission (HHSC) adopts amendments to §354.1832 and §354.1921, concerning Vendor Drug Program.
Section 354.1832 and §354.1921 are adopted without changes to the proposed text as published in the September 13, 2024, issue of the Texas Register (49 TexReg 7146). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The adopted rules implement House Bill (H.B.) 3286 and Senate Bill (S.B.) 241, 88th Legislature, Regular Session, 2023.
H.B. 3286 amended the Texas Government Code to add §531.0691, creating a new process for the Medicaid pharmacy benefit in which the Vendor Drug Program (VDP) will add drugs to the formulary on a provisional basis. H.B. 3286 also amended Texas Government Code Chapter 533 to add §533.071 which elaborates on an existing process in the Medicaid managed care program regarding Preferred Drug List (PDL) exceptions and when a non-preferred drug can be used by listing these exceptions. Section 533.071 also added new PDL exceptions.
S.B. 241 amended Texas Health and Safety Code Chapter 439 to add new Subchapter D, §439.102. Texas Health and Safety Code §439.102(a) requires a manufacturer of a brand name insulin prescription drug for which a generic or biosimilar prescription drug is not available and is included in the Medicaid VDP formulary, to submit to HHSC a written verification stating whether or not the unavailability of the generic or biosimilar prescription drug is the result, wholly or partly, (1) of a scheme by the manufacturer to pay a generic or biosimilar prescription drug manufacturer to delay manufacturing or marketing the generic or biosimilar drug; (2) a legal or business strategy to extend the life of a patent on the brand name prescription drug; (3) the manufacturer directly manipulating a patent on the brand name prescription drug; or (4) the manufacturer directly manipulating an action described in reasons (1)-(3) of this sentence on behalf of another entity.
Texas Health and Safety Code §439.102(b) requires HHSC to adopt rules that prescribe the form and manner for submission of the written verification required by §439.102(a).COMMENTS
The 31-day comment period ended October 14, 2024. During this period, HHSC received comments regarding the proposed rules from two commenters, the Texas Association of Health Plans and one individual. A summary of comments relating to the rules and HHSC's responses follows.
Comment: One commenter requested changes in proposed §354.1832(c) to include language to provide a denied formulary exception request for members who experience severe reactions to a medication for a rare genetic syndrome.
Response: This comment for requested changes is outside the scope of the proposed rule amendment. This project addresses prior authorization exceptions for drugs that exist on the formulary. This commenter is requesting a change regarding formulary exceptions, which is not addressed by this rule project. Therefore, HHSC declines to make changes to the proposed amendment based on the comment.
Comment: One commenter expressed support of the amendments to §354.1832 and §354.1921, stating that the rules provide essential patient protections that aim to reduce denials and enhance access to necessary medications for Medicaid patients, making a meaningful step towards better healthcare outcomes. The commenter also went into specifics about how the rule is clear about identifying exceptions for patients to maintain medication access.
Response: HHSC appreciates this stakeholder's support in the implementation of these rule amendments.
DIVISION 2. ADMINISTRATION
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which requires the Executive Commissioner of HHSC to adopt rules necessary to carry out the commission's duties under Chapter 531; Texas Human Resources Code §32.021(c), which requires the executive commissioner to adopt rules necessary for the proper and efficient operation of the medical assistance program; and Texas Government Code §533.071, which requires the commission to adopt rules allowing exceptions to the preferred drug list under certain specified conditions.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January 10, 2025.
TRD-202500052
Karen Ray
Chief Counsel
Texas Health and Human Services Commission
Effective date: January 30, 2025
Proposal publication date: September 13, 2024
For further information, please call: (512) 438-2910
STATUTORY AUTHORITY
The amendment is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; Texas Government Code §531.033, which requires the Executive Commissioner of HHSC to adopt rules necessary to carry out the commission's duties under Chapter 531; Texas Human Resources Code §32.021(c), which requires the executive commissioner to adopt rules necessary for the proper and efficient operation of the medical assistance program; and Texas Government Code §533.071, which requires the commission to adopt rules allowing exceptions to the preferred drug list under certain specified conditions.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on January 10, 2025.
TRD-202500053
Karen Ray
Chief Counsel
Texas Health and Human Services Commission
Effective date: January 30, 2025
Proposal publication date: September 13, 2024
For further information, please call: (512) 438-2910