The Drug Utilization Review Board ("Board") is established in accordance with Social Security Act § 1927(g)(3) and Texas Government Code § 531.0736.

Texas Government Code § 2110.008 (Duration of Advisory Committees) does not apply to the Board. This Board will not be considered for abolition unless Social Security Act § 1927(g)(3) permits it.

The purpose of the Board is to advise the Texas Health and Human Services Commission (HHSC) on matters as described below:

• A. Federally required Medicaid Drug Utilization Review Program duties under 42 CFR § 456.703;
• B. Prospective drug utilization review (DUR) in compliance with 42 CFR § 456.716(d)(2) of use of restrictions or clinical prior authorization criteria on covered prescription drugs using recommended predetermined standards to monitor potential drug therapy problems;
• C. Retrospective DUR in compliance with 42 CFR § 456.716(d)(3) to identify standard care provided by health care professions with prescribing authority while allowing permitting sufficient professional prerogatives to allow for individualized drug therapy;
• D. Educational interventions for Medicaid providers to improve prescribing and dispensing practices and effectively improve the quality of drug therapy in compliance with 42 CFR § 456.716(d)(5) and 456.716(d)(6);
• E. Texas Medicaid preferred drug lists by HHSC under Texas Government Code § 531.072, which considers the drugs' efficacy, clinical significance, cost-effectiveness, and safety; and
• F. Other matters may be specified by law and within the Board's jurisdiction.

In addition to performing any other duties set out by federal law, the Board shall:

• A. Develop and submit to HHSC recommendations for preferred drug lists;
• B. Suggest to HHSC restrictions or clinical edits on prescriptions drugs;
• C. Recommend to HHSC educational interventions for Medicaid providers;
• D. Review drug utilization across Medicaid; and
• E. Perform other duties that may be specified by law and otherwise make recommendations to HHSC.

The Board's activities are detailed in an annual report to the Centers for Medicare & Medicaid Services prepared by HHSC Vendor Drug Program staff.

• Board: The Drug Utilization Review Board
• Clinical prior authorization: Prospective-DUR prior authorization tool used at the point of sale based on evidence-based clinical criteria and nationally recognized peer-reviewed information.
• 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.
• DUR: Drug Utilization Review is a process required by federal law in the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) to assure that prescriptions for covered outpatient drugs are appropriate, medically necessary, and not likely to result in adverse medical results.
• Drug Utilization Review Program: Program operated by the Vendor Drug Program to improve the quality of pharmaceutical care under Medicaid consisting of prospective drug review, retrospective drug use review, and educational program.  
• Educational interventions: Method of educating providers on identified common drug therapy problems needing improved prescribing or dispensing practices, usually identified as part of the retrospective DUR reviews.
• 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 of such an entity.
• 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).
• 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).
• HHS: Health and Human Services System
• HHSC: Health and Human Services Commission
• 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.
• Ownership or financial interest: An equity interest in an entity 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.
• Texas Medicaid Preferred Drug List (PDL): List of covered outpatient drugs reviewed by Board for their efficaciousness, clinical significance, cost-effectiveness, and safety for patients and recommended as either preferred or non-preferred. PDL is a subset of products on the Texas Medicaid formulary.
• Retrospective DUR: Review of prescription drug claims data to identify patterns of prescribing.

The Board is composed of 20 members appointed by the HHSC Executive Commissioner in accordance with Texas Government Code section 531.0736 and compliance with Social Security Act section 1927(g)(3). Except as specified, all members are voting members.

This membership includes:

1. 17 physicians and pharmacists providing services across the entire population of Medicaid recipients representing at least one of each of the following physician types:
   1. Provider of pediatrician services;
   2. Primary care physician;
   3. Provider of obstetrician and gynecologist services;
   4. Provider of child and adolescent psychiatry services; and
   5. Provider of adult psychiatry.
2. One physician provider representing Medicaid managed care organization (non-voting member);
3. One pharmacist provider representing Medicaid managed care organization (non-voting member); and
4. One consumer advocate representing the Medicaid population.

Physician and pharmacist members must:

1. Have experience in developing or practicing under a PDL.
2. Have recognized knowledge and expertise in one or more of the following:
   1. Clinically appropriate prescribing of outpatient drugs;
   2. Clinically appropriate dispensing and monitoring of outpatient drugs;
   3. DUR, evaluation, and intervention; and
   4. Medical quality assurance; and
3. Be licensed and in good standing with the Texas Medical Board or the Texas State Board of Pharmacy and actively provide services across the entire population of Medicaid in Texas.

Voting members have access to confidential drug pricing information and will attend the executive session. The managed care organization representatives will not attend the executive session or have access to confidential drug pricing information.

Under HHSC Policy and to the greatest extent possible, the HHSC Executive Commissioner appoints members who reflect the diversity of Texas.

Members shall be appointed to serve a four-year term. Individuals will normally serve only one term; however, at the discretion of the HHSC Executive Commissioner, an individual may re-apply and be appointed for one additional term. These terms may be served consecutively.

The expiration of membership terms occurs on Aug. 31 of each year. Regardless of the term limit, a member serves until his or her replacement has been appointed. This ensures sufficient, appropriate representation.

If any member of the Board wishes to resign, the member will contact, in writing, the current Chair and HHSC Board Liaison informing of the member's resignation date and requesting the appointment of a successor member.

In the event of a vacancy for any reason, agency staff will work with the HHSC Executive Commissioner to solicit applications as appropriate to fill the vacancy with a representative of the same membership category to serve the unexpired portion of the term of the vacant position. People who submitted applications within the previous year but were not selected through the HHSC may be reconsidered for membership.

Applicants may apply to become members of the Board by following the application process on the HHSC website.

In compliance with Government Code § 531.0736, Board members will elect a Chair.  The Chair must be a physician, a voting member, and will serve a term of two years.  The Chair will serve no more than two consecutive terms.  In the event that the Chair is unable to complete his or her term for any reason, a new chair will be elected by members.

The members will also elect a Vice-Chair every two years to serve in the Chair's temporary absence.  The Vice-Chair must be a physician or pharmacist, a voting member, and will serve a term of two years. Similar to the Chair, the Vice-Chair will serve no more than two consecutive terms.  In the event the Vice-Chair is unable to complete his or her term for any reason, a new Vice-Chair will be elected by members.

Regardless of member term, the Chair and Vice-Chair will serve until the Board elects a successor; however, a presiding officer may not remain in office past his or her membership term.

The role of the Chair and Vice-Chair is to:

1. Report to the HHSC;
2. Provide leadership in conducting Board meetings;
3. Promote, maintain, and encourage a participatory environment;
4. Ensure the Board adheres to its charge;
5. Confer with HHSC Board Liaison in:
   1. Identifying the need for and calling meetings to accomplish the work of the Board; and
   2. Agenda planning and preparation for Board meetings; and
6. Confer with HHSC Board Liaison to acquire the support needed for Board operations.

Information regarding drug rebates, pricing, and negotiations is confidential in accordance with Texas Government Code § 531.071. The voting members will discuss information that is confidential under § 531.071 in an executive session, in accordance with Texas Administrative Code, Title 1, Part 15, Chapter 354, Subchapter F, Division 8, Rule § 354.1941(c)(2). All executive sessions will comply with the procedural requirements of the Texas Open Meetings Act, Texas Government Code Chapter 551.

1. Meetings
   1. The Board meets quarterly during regular business hours.
   2. The Board is subject to the Texas Open Meetings Act as if it were a governmental body.
   3. Executive sessions are not open to the public nor the managed care organization Board representatives. The managed care organization representatives will not attend the executive session or have access to confidential drug pricing information.
2. Quorum
   1. Ten voting members constitute a quorum to transact official business. If less than a quorum of the Board is present, members may not vote upon action items but may take testimony and public comments so long as the meeting is being conducted in accordance with the Texas Open Meetings Act.
3. Voting
   1. Voting members have the right to vote on any subject listed on the agenda. However, members must abstain from deliberating or voting on issues that could present, or reasonably appear to present, a conflict of interest. A conflict of interest, as defined in Section 3 above and at Texas Administrative Code, Title 1, Part 15, Chapter 354. Subchapter F, Division 8, Rule Section 354.1942(a)(2), also arises from a situation that would provide monetary or other gain to the member's family member or relative.
   2. The Board may determine procedural matters by a majority vote of the members attending the meeting or may use Robert's Rules of Order as a guide to its operations and proceedings.
   3. Voting Board members may also vote on operational or procedural matters that come before the Board.
   4. A member may participate and if the member is a voting member, vote by telephone conference as deemed necessary by agency staff. A member who attends and participates by telephone will count towards the quorum tally.
   5. A member may not authorize another individual to represent the member by proxy.
   6. For all business except adopting or amending bylaws, a simple majority is needed on a motion duly made and seconded. (A simple majority is defined as more than half of the votes cast by persons entitled to vote who are in attendance with a quorum, excluding abstentions.)
4. Adoption and Revision to Bylaws
   1. Bylaws will be adopted and amended pursuant to a two-thirds vote (of members attending the meeting) on a motion duly made and seconded.
   2. Board members or HHSC staff may propose changes to these bylaws. All proposed changes from Board members, along with the rationale for the changes, should be submitted in writing to Board Liaison at least 45 days before the next Board meeting. The Board Liaison will ensure an item for bylaws discussion is included on the agenda to be posted on the Secretary of State's Open Meetings website. Proposed changes to bylaws must be distributed to the members before the meeting for their consideration.
   3. The Board will review the Bylaws by Dec. 31 of every even-numbered year. Board-proposed amendments that occur as a result of the biennial review will be considered in a meeting and will be passed and become effective based on a two-thirds vote of members attending the meeting, pending review and approval by HHSC staff.
   4. All proposed changes are subject to review and approval by HHSC staff.
   5. The Bylaws will become effective as of the date they are adopted or amended by the Board. The Board will make note of the date of the adoption or amendment of the Bylaws in its minutes. Members will sign a Statement by Members when bylaws are adopted or amended (see attached Statement).
5. Public Testimony, Written Testimony, and Other Materials
   1. HHS generally treats the process for submitting public comment and public testimony as interchangeable.
   2. Public Testimony
      1. The Board will hold a Public Comment/ session before voting on:
         1. Any changes in a PDL;
         2. The adoption of or changes to drug use criteria; or
         3. The adoption of prior authorization or DUR proposals.
      2. Public comment may be allowed on other agenda items.
      3. Members of the public who would like to testify must follow the testimony registration process posted on the HHSC website.
      4. Public testimony may be time-limited at the discretion of the Chair or HHSC. To accommodate testimony from a variety of organizations and individuals, testimony is limited to one individual per organization or drug manufacturer per agenda item.
      5. Members of the public who are testifying in person may provide relevant handouts to the Board at the time of testimony.
   3. Written testimony must be submitted to HHSC program staff via mail or e-mail within the prescribed time period and instructions as indicated on the HHS website. Written testimony is not to exceed ten pages.
   4. Other Materials: Audiovisual equipment and promotional or marketing materials are not allowed.

1. Attendance

Members are expected to attend all meetings in person. A member unable to attend a meeting should notify the HHSC Board Liaison in advance. The HHSC Board Liaison will notify the Chair and appropriate program staff. Members may not authorize another individual to represent the member by proxy at meetings.

If any member misses three meetings within a 12-month period, with or without notice to the Board Liaison, the member may be removed from the Board.

2. Member expectations
   1. Attend meetings in person;
   2. Review agendas and other information sent by HHSC staff prior to each meeting;
   3. Participate in discussions at meetings;
   4. Participate in DUR Board Executive sessions, if a voting member;
   5. Submit travel expenses (if reimbursement is desired) within 30 calendar days of the meeting;
   6. Abstain from deliberating or voting on issues that could present, or reasonably appear to present, a conflict of interest. A conflict of interest, as defined in Section 3 above and at Texas Administrative Code, Title 1, Part 15, Chapter 354, Subchapter F, Division 9, Rule § 354.1942(a)(2), includes a situation that would provide monetary or other gain to the member's family member or relative.
   7. Attend or participate in an orientation session, separate from the regular Board meeting, prior to new member's first meeting;
   8. Complete the full Texas Open Meetings Act Training and Public Information Act Training within 90 days of appointment and submit the Certificates of Completion to the Board Liaison. A member who has taken the training within the last five years of initial appointment may submit a copy of the Certificates of Completion to the HHSC Board Liaison in lieu of retaking the full training. The full Texas Open Meetings Act Training and Public Information Act Training must be completed every five years and refresher sessions as needed or as warranted.
   9. Sign and submit to the Board Liaison within 30 days after appointment, and annually thereafter, a Drug Utilization Review Board Annual Disclosure Form.
   10. Sign and submit to the Board Liaison the Statement by Members document within 30 days after appointment. This document includes a Conflict of Interest Statement and a Nondisclosure Agreement to which Board members must agree;
   11. Sign and submit to the HHSC Board Liaison immediately upon initial appointment and annually the Department of State Health Services Continuing Education Service Disclosure of Financial Interests;
   12. Review the HHS Ethics Policy, sign, and submit to the Board liaison within 30 days after the initial appointment and annually;
   13. Notify the Board Chair and HHSC Board Liaison if a change of member's licensure status results in loss of good licensure standing;
   14. Notify the Board Chair and Board Liaison if a change of status alters the category of membership the member was filling or if any circumstance occurs that prevents the member from being able to discharge his or her duties;
   15. Maintain a high level of integrity that warrants public trust, including complying with all applicable ethics guidance provided by HHSC's Ethics Officers and all aspects of the Texas Open Meetings Act and Public Information Act; and
   16. Hold and maintain in the strictest confidence all confidential information and all agency-generated information, including in draft form, until such time as the information or document is released and made public, the HHS Executive Commissioner has approved the release in writing or the HHS Ethics Policy permits release. This requirement survives the member's tenure on the Board. For purposes of these bylaws and the Nondisclosure Agreement, the term "confidential information" includes all information protected by the Health Insurance Portability and Accountability Act (HIPAA), information that has commercial value or use, such as trade secrets, and information communicated in confidence by the HHS System.

Failure to comply with 6-16 above are grounds for dismissal and may result in removal from the Board.

3. A Board member may not:
   1. Claim or appear to represent HHSC or the Board in legislative or advocacy activities without written approval from the Board Chair and the HHS Ethics Office in coordination with the HHS Government Relations Office and the Board Liaison. A member may, however, represent him- or herself or another entity in the legislative or advocacy process.
   2. Accept payment for any services offered to the member because of his or her position on the Board.
   3. Disclose confidential information or draft information (from any source including grants, requests for proposals, and contracts) acquired through his or her participation on the Board until such time as that information or document is released and made public, the HHSC Executive Commissioner has approved the release in writing, or the HHS Ethics Policy permits release. This includes all forms of communication, including written, verbal, and social media.

A violation of any of these items is grounds for dismissal and may result in removal from the Board.

The HHSC Executive Commissioner may remove a member from the Board for the following reasons:

1. A member votes or deliberates on an issue that presents a conflict of interest. A conflict of interest, as defined in Section 3 above and at Texas Administrative Code, Title 1, Part 15, Chapter 354, Subchapter F, Division 8, Rule § 354.1942(a)(2), includes a situation that would provide monetary or other gain to the member's family member or relative, or an entity with which the member is closely affiliated.
2. A member refuses to sign or violates the Conflict of Interest statement or Nondisclosure Agreement or any documents required in the Bylaws or another Nondisclosure Agreement.
3. A member does not maintain a high level of integrity that warrants public trust, including complying with all applicable ethics guidance provided by HHSC's Ethics Officers and all aspects of the Texas Open Meetings Act and Public Information Act.
4. A member changes status that alters the category of membership that the member was filling.
5. A member loses his or her license or no longer actively practices.
6. A member claims or appears to represent HHSC or the Board in a legislative or advocacy without approval from the Board Chair and the HHS Ethics Office in coordination with the HHS Government Relations Office and the Board Liaison.
7. A member receives payment for any services requested because he or she holds a position on the Board.
8. A member discloses confidential, including draft, information acquired through his or her participation on the Board not in accordance with the Bylaws.
9. A member, in a 12-month period, misses three meetings with or without notice to HHSC Board Liaison.

Decisions to remove a member of the Board due to violations of this nature will require input from HHSC legal counsel.

HHSC recognizes the value of subject matter experts (SMEs) to provide information to the Board as it develops recommendations and initiatives relative to its charge(s).  The primary role of a SME is to provide objective, independent information and analysis to be considered by the Board.  SME participation will be subject to the request of voting Board members and will fall within the following guidelines:

1. A SME may be invited to provide information on specific subjects and topics at the discretion of voting Board members, the Chair or Vice-Chair, and HHSC staff;
2. An invited SME may be recognized by staff, the Board Chair, or Vice-Chair to provide information or analysis during allotted time periods at a specified Board;
3. SMEs will participate in questions and answers at the direction of the staff, Board Chair, or Vice-Chair;
4. All SMEs will participate and serve at the pleasure of the Board;
5. SMEs do not hold any official capacity on the Board and do not have rights of deliberation or the right to vote on any Board activities or decisions;
6. SMEs should disclose any conflicts of interest they may have before providing information to the Board; and
7. None of the information or guidance contained in this section shall prevent any individual from participating in or providing comments to the Board as allowed under the Texas Open Meetings Act.

The HHSC Board Liaison and support staff will be present at the Board meeting and will provide reasonable administrative and technical support and coordination for all Board activities. HHSC will coordinate as needed to provide reasonable accommodations and support needed by a Board member who has a disability to enable them to fully participate in Board meetings and activities.

The HHSC Board Liaison and support staff are expected to perform the following tasks:

1. Develop effective working relationships with Board members;
2. Solicit nominations for membership in accordance with the appropriate HHSC procedures;
3. Prepare the Centers for Medicare & Medicaid Services DUR annual report;
4. Serve as liaison between members and operating agencies' staff; and
5. Plan, coordinate, and organize Board meetings and activities, including:
   1. Schedule meeting dates and ensure meeting sites are set up;
   2. Notify members of upcoming meeting dates, times, and locations;
   3. Develop agenda and support materials for each meeting;
   4. Prepare and oversee that the agenda is posted on the Secretary of State's Open Meetings website and on the HHS website in a timely manner;
   5. Serve as point of contact for the public, including ensuring contact information, agendas, and meeting support materials are easily accessible on the HHS website;
   6. Prepare and distribute information and materials for member review;
   7. Prepare and maintain Board records and documentation in accordance with the HHSC records retention policy; and
   8. Assist eligible members with travel arrangements and reimbursement.
6. Coordinate as needed to provide reasonable accommodations and supports required for a Board member who has a disability to enable the member to fully participate in Board meetings and activities; and
7. Staff may perform other duties within staff discretion provided the necessary resources are available.

To the extent permitted by the current General Appropriations Act, a member of the Drug Utilization Review Board may be reimbursed for their travel expenses to and from Board meetings if funds are available and in accordance with the HHSC Travel Policy.

Members eligible for such reimbursement are subject to rates established in the General Appropriations Act. HHSC support staff will assist members in requesting reimbursement. Board members are responsible for providing the required information as per instructions provided within 30 calendar days of the meeting.

A member who would like to seek travel reimbursement must:

1. Keep an accurate record of allowable travel expenses (as per the HHS Travel Policy) during travel to attend Board meetings, and
2. Submit receipts and appropriate documentation to the Board Liaison in a timely manner.

• The HHSC and the Drug Utilization Review Board (Board) are not bound in any way by any statement or action on the part of any Board member except when a statement or action is in pursuit of specific instructions from HHSC or the Board.
• The Board and its members may not claim or appear to represent HHSC or the Board in any legislative or advocacy activity without approval from the Board Chair and the HHS Ethics Office in coordination with the Government Relations Office. A member may, however, represent him- or herself or another entity in the legislative or advocacy process.
• A Board member may not accept payment for services that are requested because of the member’s title or position on this Board.
• A Board member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official Board duties.
• A Board member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.
• A Board member shall complete the full Texas Open Meetings Act Training and the Public Information Act Training within 90 days of appointment and submit the Certificates of Completion to the Board Liaison. A member who has taken the training within the last five years may submit a copy of the Certificate of Completion to the Board Liaison in lieu of retaking the training. A Board member shall complete full Texas Open Meetings Act Training and the Public Information Act Training every five years and complete refresher sessions as needed or as warranted.
• Nondisclosure agreement. A Board member may not disclose confidential information or agency-generated information in draft form acquired through his or her Board membership unless HHSC has released and made public the information or document, the HHS Executive Commissioner has approved the release in writing or the HHS Ethics Policy permits release. This requirement survives the member's tenure on the Board. For purposes of the Nondisclosure Agreement, the term "confidential information" includes all information protected by the Health Insurance Portability and Accountability Act (HIPAA), information that has commercial value or use, such as trade secrets, and information communicated in confidence by the HHS System.
• Conflict of Interest Statement. I agree to disclose any personal or private conflict of interest that myself or my family member or relative have in a measure, proposal, or decision pending before HHSC. ("Personal or private interest" does not include the member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation, or if the member merely provides a personal experience, with no personal or private financial conflict of interest, in giving feedback on the subject matter.) If there is a direct personal or financial conflict of interest in a motion under consideration, I further agree to disclose that fact in a public meeting and will recuse myself from any Board deliberations or decisions on that matter.

I have been provided a copy of the Drug Utilization Review Board bylaws. I understand that as a member of the Board I must adhere to the bylaws.

Board Member Signature
Printed Name
Date