PURPOSE: This rule establishes the MO HealthNet Division (MHD) process by which drugs may be restricted under Section 4401 of P.L. 101-508 (Omnibus Budget Reconciliation Act of 1990) and is determined to be appropriate for inclusion as a regular benefit of the MHD or through prior authorization.

1. (1) All persons eligible for medical assistance benefits shall have access to all pharmaceutical products for which there is federal financial participation except those drugs that may be restricted under Section 4401 of P.L. 101-508 (Omnibus Budget Reconciliation Act of 1990). MHD shall review drugs that may be restricted and present to the Prior Authorization Committee for possible inclusion as a regular benefit of MHD program or through prior authorization.

2. (2) MHD may require prior authorization for pharmaceutical products. MHD bases any restriction on medical and clinical criteria and Missouri-specific data. MHD shall develop this medical and clinical criteria based on predetermined standards consistent with the following:

   1. (A) The American Hospital Formulary Service Drug Information;
   2. (B) The United States Pharmacopoeia Drug Information; and
   3. (C) Peer-reviewed medical literature.
3. (3) MHD shall review drugs used to treat rare medical conditions with the Advisory Council on Rare Disease and Personalized Medicine. MHD shall develop medical and clinical criteria and make recommendations to the Advisory Council on Rare Disease and Personalized Medicine. MHD will present any proposals reviewed by the Advisory Council on Rare Disease and Personalized Medicine to the Prior Authorization Committee and Drug Utilization Review Board.
4. (4) The Prior Authorization Committee and Drug Utilization Review shall hold a public hearing at least once every quarter during which MHD shall make recommendations to the board and any final decision by MHD to require prior authorization for that pharmaceutical product, class, or category.

5. (5) MHD shall post the tentative meeting agenda on the MHD website (https://mydss.mo.gov/mhd/pharmacy-committees) at least seven (7) days before the meeting, and the agenda will include the therapeutic classes MHD plans to discuss.

   1. (A) MHD shall place the specific preferred drug list classes to be considered at the next regularly scheduled Prior Authorization Committee meeting on the current agenda or posted on the website approximately seven (7) days before the next scheduled meeting.
   2. (B) Any interested party shall be granted the opportunity for clinically relevant public comment for up to three (3) minutes per drug under review by the Prior Authorization Committee. The responsibility of scheduling the presentation shall rest with the interested party. Interested parties representing a manufacturer shall be granted three (3) minutes in the aggregate per therapeutic class under review by the Prior Authorization Committee.
   3. (C) After considering all presented information, the Prior Authorization Committee may recommend alterations to the proposal. The committee shall make their final recommendation to the MHD by a majority vote of the committee members present thereto in a recorded roll call vote.
6. (6) MHD shall coordinate the implementation of any changes after all recommendations have been reviewed. All pertinent information relating to the edit implementation schedule and the edit criteria shall be made available to the public by reasonable means, including but not limited to posting on the MHD website following the Prior Authorization Committee meeting.
7. (7) On an annual basis, the Prior Authorization Committee shall review all prior authorization criteria in place quarterly and may schedule more frequently if new clinical or fiscal information is available.
8. (8) Unless MHD is addressing an urgent market change, MHD shall not otherwise restrict the prescribing and dispensing of covered outpatient prescription drugs under this rule without consulting the Prior Authorization Committee.
9. (9) When implementing the provisions of this rule, Missouri-specific data shall consider use and cost data, pharmacoeconomic information, and prudent utilization of state funds, and shall include medical and clinical criteria.
10. (10) MHD may impose limitations on the minimum or maximum quantities per prescription, early refill, or the number of refills if such limitations are necessary to discourage waste and may address instances of fraud or abuse by individuals.

AUTHORITY: sections 208.201 and 660.017, RSMo 2016, and section 208.153, RSMo Supp. 2024.* Original rule filed Feb. 3, 1992, effective Aug. 6, 1992. Emergency amendment filed May 22, 2002, effective June 1, 2002, expired Nov. 27, 2002. Amended: Filed June 3, 2002, effective Nov. 30, 2002. Amended: Filed Dec. 14, 2004, effective June 30, 2005. Amended: Filed Sept. 26, 2013, effective March 30, 2014. Amended: Filed Sept. 16, 2020, effective March 30, 2021. Amended: Filed Dec. 17, 2024, effective July 30, 2025. *Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012, 2024; 208.201, RSMo 1987, amended 2007; and 660.017, RSMo 1993, amended 1995.