A-3.1. Policy Statement

The Conflict of Interest policy sets forth expectations relating to the ethical conduct of those persons who have been appointed to the Texas Drug Utilization Review (DUR) Board.

Persons appointed to the Board must be free of personal financial interests and relationships that may conflict with their duties as to the Medical DUR Program established under the Social Security Act §1927(g) and Texas Government Code section531.0735. Specifically, per Texas Government Code section 531.0737, a Board member must not have a contractual relationship with or an ownership interest or other interest in a pharmaceutical manufacturer or labeler or an entity engaged by the Texas Health and Human Services Commission (HHSC) to assist in the development of the preferred drug lists or administration of the Board.

People appointed to the Board are expected to maintain a high level of integrity that warrants public trust, including complying with all applicable ethics guidance provided by the HHS Ethics Office and all aspects of the Texas Open Meetings Act and Public Information Act.

The purpose of the policy, which applies to both voting and non-voting Board members, is to protect HHSC's interest when entering into a transaction or arrangement that could potentially benefit the private interest of a Board member or their family member or relative.

A-3.2. Definitions

  1. Board Member: A person who is appointed to the Texas Drug Utilization Review Board, either as a voting or non-voting member.
  2. Conflict of Interest: A situation that arises wherein a board member or any family member or relative has a financial relationship with an entity, ownership or financial interest with an entity, or any other interest where the member is in a position to derive a personal benefit from action or decisions made in their professional capacity, with an entity.
  3. Direct Payment or Other Transfer of Value: A payment or other transfer of value made by an applicable manufacturer/labeler directly to a Board member and/or their family member or relative.
  4. DUR Board: Drug Utilization Review Board
  5. Entity: Includes an individual, a corporation, organization, business trust, estate, trust, partnership, association, and any other legal entity that may have business come before the DUR Board or before the Medicaid Vendor Drug program. The term includes: (A) a pharmaceutical manufacturer or labeler with a product on the Texas Drug Code Index and any other entity HHSC has engaged to assist in developing the preferred drug list or in administering of the DUR Program; and (B) an "affiliate" or ""associate," as defined in Texas Business Organizations Code §1.002, of an entity.
  6. Family Member or relative: An individual who is related within the third degree by consanguinity or within the second degree by affinity, as defined by the Government Code, Chapter 573, Subchapter B (concerning Relationships by Consanguinity or by Affinity).
  7. Financial Relationship: A written or oral agreement between a board member and an entity that results in the payment of federally reportable income to the board member (i.e., income reported on IRS Form 1099 or Form W-2).
  8. High Level of Integrity: Behaving in an honest and morally upright way, at a level above a normal or average level, such that the public's trust in the member is warranted.
  9. Honoraria: Monetary or non-monetary compensation for services a public servant would not have been asked to provide but for the person's status as a public servant.
  10. Indirect Payment or Other Transfer of Value:& A payment or other transfer of value made by an applicable manufacturer/labeler to a Board member and/or their family member or relative through an intermediary, where the applicable manufacturer/labeler requires, instructs, directs, or otherwise causes the intermediary to provide the payment or transfer of value, in whole or in part, to a Board member and/or their family member or relative.
  11. Interested Party: A manufacturer/labeler with a covered outpatient drug or product on the Texas Drug Code Index (Formulary) and any other entity engaged by HHSC to assist in the administration of the Board.
  12. Manufacturer/Labeler: A manufacturer of prescription drugs as defined by §1927(k)(5) of the Social Security Act (42 U.S.C. §1396r-8(k)(5)), including a subsidiary or affiliate of a manufacturer or an entity that has a labeler code from the United State Food and Drug Administration under 21 C.F.R. Section 207.33 and receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale.
  13. Other Interest: Involvement in the affairs of an entity that impairs or may be perceived as impairing a Board member's independence of judgment regarding the board member's performance of duties for the DUR Board.
  14. Ownership or Financial Interest: An equity interest in where a Board member exercises control over the selection of investments and any other financial interest whose value cannot be readily determined through reference to public records.
  15. Personal Benefit: Anything reasonably regarded as economic gain or advantage, including a benefit to a family member or relative.
  16. Personal Financial Interest: Having a direct monetary interest in a matter or owing loyalty to an involved entity. Personal financial interest does not include the Board member's engagement in a profession, trade, or occupation when the Board member's interest is all others similarly engaged in the profession, trade, or occupation.

A-3.3. Conflict of Interest

  1. A conflict of interest may occur when a Board member can derive a personal benefit from actions or decisions made in their official capacity on the Board.
  2. Persons appointed to the Board must be free of personal financial interests and relationships that may present a conflict of interest with Board duties. A conflict of interest may exist whenever a Board member or their family member or relative has:
    1. A contractual relationship/financial relationship with or an ownership interest or other interest in a manufacturer/labeler, pharmacy benefits manager (PBM), or an entity HHSC has engaged to assist in developing the preferred drug lists or in administering the Board;
    2. A contractual relationship/financial relationship with a company, such as accepting employment or subcontracting with a manufacturer/labeler;
    3. A financial interest in an actual or proposed transaction or arrangement that may be of some business interest to HHSC or its affiliated organizations;
    4. Received direct or indirect payments or other transfers of value, gifts, compensation, royalties, rewards, or other goods or services valued at over $500 from a manufacturer/labeler with a financial interest in the outcome of a matter; or
    5. Other interests conflicting or interfering with the Board member's ability to perform their duties on the Board.
  3. Persons appointed to the Board must not knowingly do any of the following while serving as a Board member. These prohibitions also apply to the Board member's family members or relatives.
    1. Accept honoraria;
    2. Solicit, accept, or agree to accept any personal benefit that might reasonably tend to influence the Board member in the discharge of their official duties on the Board; or
    3. Solicit, accept, or agree to accept any personal benefit for having exercised his or her official powers or duties in favor of another person.
  4. Board members participating in a conference or meeting as presenters or panelists may accept reimbursement for actual travel, lodging, and meal expenses per the General Services Administration reimbursement rates.

A-3.4. Disclosure and Management Strategies

  1. Each Board member or a person under consideration for appointment to the Board must disclose any apparent or potential conflict of interest and take affirmative steps to mitigate the effect of each conflict of interest.
    1. Each Board member or a person under consideration for appointment to the Board must disclose:
      1. Any new or existing contractual or financial relationships with a company, ownership or investment or financial interests, or other interests in a manufacturer/labeler or PBM that the Board member, family member, or relative holds or acquires during the board member's tenure on the DUR Board or was held or acquired within the two years immediately preceding the Board member's appointment;
      2. Any financial interests in an actual or proposed transaction or arrangement that may be of some business interest to HHSC or its affiliated organizations;
      3. Any direct or indirect payments, gifts, compensation, royalties, rewards, or other goods or services valued at over $500 from a manufacturer/labeler with a financial interest in the outcome of a matter; and
      4. Other interests conflicting or interfering with the Board member's ability to perform their duties while serving on the Board.
    2. Each Board member or a person under consideration for appointment to the Board must:
      1. Complete and submit to HHSC the Texas Vendor Drug Program Drug Utilization Review Board Annual Disclosure form within 30 days after appointment to the Board and at the first Board meeting of each State Fiscal Year (Sept.-Aug.) while serving on the Board.
      2. Complete and submit to HHSC the DSHS Services Continuing Education Service Disclosure of Financial Interests form within 30 days after appointment to the Board and at the first Board meeting of each State Fiscal Year while serving on the Board.
      3. Complete and submit to HHSC the Statement by Members form within 30 days after appointment to the Board and after each amendment to the Texas DUR Board Bylaws while serving on the Board.
      4. Attend an in-person Ethics and Conflict of Interest training delivered by the HHS Ethics Office during the orientation session before a new Board member's first official DUR Board meeting and every two years thereafter while serving on the Board.
      5. Notify HHSC in writing within 15 business days of any changes in the Board member's status that may cause or have the appearance of a potential or actual conflict of interest while serving on the Board.
    3. HHSC will publish the Drug Utilization Review Board Annual Disclosure (HHS Form 1349) completed by each Board member at the first Board meeting of each state fiscal year. The forms will appear on the Texas Vendor Drug Program website. HHSC will publish and retain the forms per HHSC records management policies.

A-3.5. Determination and Procedures to Address Conflicts of Interest

  1. HHSC will review the required disclosures by the Board member and discuss with them whether HHSC determines a potential or actual conflict of interest exists.
  2. After the Board member discloses any potential or actual conflicts of interest, and if HHSC determines a conflict of interest exists, HHSC will perform the following actions:
    1. HHSC will determine whether the conflict of interest may impair the Board member's exercise of independent judgment. HHSC will examine the extent of the conflict of interest, the length of time the conflict of interest existed, and the impact of the conflict of interest on any matter the Board member may be required to deliberate or discuss.
      1. HHSC will consult with the Board member and the DUR Board chair regarding the conflict of interest.
      2. HHSC may require:
        1. Recusal of the Board member on any discussion or action related to a specific product marketed by a third party for which the Board member may have a conflict of interest.
        2. Recusal of the Board member on any discussion or action related to all products marketed to a third party for which the Board member may have a conflict of interest.
        3. Recusal of the Board member on any discussion or action that involves a class of pharmaceuticals for which the Board member may have a conflict of interest.
        4. Any other action HHSC determines necessary to avoid or mitigate a potential or actual conflict of interest.
    2. Any Board member who is recused will not participate in deliberations or debates and will not make recommendations, give advice, or in any way assume responsibility for or participate in any aspect of decision-making relating to the matter that poses a conflict of interest.

A-3.6. Violations of the Conflict of Interest Policy

  1. HHSC will inform the Board member if it has reasonable cause to believe the member failed to disclose potential or actual conflicts of interest, the basis for such belief, and allow the Board member to explain the alleged failure to disclose the information. If, after hearing the board member's response and making such further investigation as warranted, HHSC determines the Board member has failed to disclose a potential or actual conflict of interest, then HHSC will take appropriate corrective actions, which may include removal from the Board.
  2. Any Board member who violates the conflict of interest policy, refuses to sign any documents as a requirement for serving on the Board, or refuses to attend the ethics and conflict of interest training may be subject to removal from the Board.

A-3.7. Periodic Reviews

To ensure that the Texas DUR Board operates in a manner consistent with its purpose and ensures the objectivity and credibility of its recommendations concerning a PDL and prior authorization for medications for Medicaid and CHIP, HHSC will, at a minimum, complete the following:

  1. A biennial review of the Conflict of Interest Policy and the Texas Drug Utilization Review Board Bylaws during every even-numbered year.
  2. An annual review of all documents, forms, and training certificates completed by each Board member as a requirement for serving on the Board.
  3. A regular review of all documents, forms, and training certificates completed by each Board member as a requirement for serving on the Board.
  4. A review of the audio-visual recording of the Board meetings.