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

1. (1) The following definitions shall be used in the interpretation and enforcement of this rule:

   1. (A) “Clinical editing” shall be defined as that process which screens the use of specific medications on the basis of clinical appropriateness by requiring evidence of appropriate indications for use, and to achieve a cost savings, may require the initial use of less expensive agents.
   2. (B) “Fiscal editing” shall be defined as a process that screens the use of specific medications to reimburse based on the least expensive dosage forms in order to achieve a cost savings.
   3. (C) “Open access” shall be defined as the availability of a product without being subjected to prior authorization, clinical edits or step therapy but shall not preclude fiscal and utilization edits.
   4. (D) “Preferred Drug List” shall be defined as a list of medications within a functional 13 CSR 70-20

therapeutic class that are available via open access on the basis of supplemental rebate status and consideration of available evidence-based clinical review findings.

1. (E) “Step therapy” shall be defined as a process that specifies the sequence in which different prescription drugs are to be reimbursed.
2. (F) “Utilization edits” are defined as prospective screening edits used to review the appropriate use of medication and may be advisory or preemptory.

1. (2) This rule establishes a MO HealthNet Drug Prior Authorization Committee in the Department of Social Services, MO HealthNet Division. The committee shall be composed of three (3) practicing physicians licensed pursuant to Chapter 334, RSMo; three (3) practicing pharmacists licensed pursuant to Chapter 338, RSMo, one (1) of whom shall hold a doctoral degree in pharmacy (Pharm. D.); and one (1) registered professional nurse, as defined in Chapter 335, RSMo, practicing in a long-term care setting. All members shall be appointed by the director of the Department of Social Services. The members shall serve for a term of four (4) years. Members of the committee shall receive no compensation for their services, but shall be reimbursed for their actual and necessary expenses incurred, as approved by the MO HealthNet Division out of appropriations made for that purpose. The MO HealthNet Drug Prior Authorization Committee shall meet quarterly. The proposed dates for the meetings shall be announced for one (1) calendar year at the last meeting of the previous calendar year. If a meeting date is changed the new date must be posted at www.dss.mo.gov/mhd for at least thirty (30) days prior to the originally scheduled meeting.
2. (3) 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). The MO HealthNet Drug Prior Authorization Committee shall review those drugs that may be restricted and recommend those appropriate for inclusion as a regular benefit of the MO HealthNet program or through prior authorization.

3. (4) The department or the division may require prior authorization of pharmaceutical products. Any such restriction shall be based on medical and clinical criteria, and Missourispecific data. The committee 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.
4. (5) If the division finds that the data enumerated in section (4) of this rule has been documented, the MO HealthNet Drug Prior Authorization Committee shall hold a public hearing prior to making recommendations to the department and prior to any final decision by the division to require prior authorization for that pharmaceutical product, class, or category.

5. (6) The tentative meeting agenda of the MO HealthNet Drug Prior Authorization Committee with the classes to be discussed shall be posted on the MO HealthNet Division website (www.dss.mo.gov/mhd) approximately fourteen (14) days prior but no less than seven (7) days prior to the meeting.

   1. (A) The specific therapeutic class or classes to be considered at the next regularly scheduled MO HealthNet Drug Prior Authorization Committee meeting shall be placed on the current agenda or posted on the website approximately thirty (30) days prior to the scheduled meeting.
   2. (B) Any interested party shall be granted the opportunity for clinically relevant public comment for up to fifteen (15) minutes in the aggregate per medication under review by the committee. The responsibility of scheduling the presentation shall rest with the manufacturer of the drug product.
   3. (C) Following the consideration of all presented information, the committee shall make their final recommendation to the MO HealthNet Division by a majority vote of the members of the committee present thereto in a recorded roll call vote.
   4. (D) The specific therapeutic class or classes recommended for restriction by means of step therapy, clinical edit, fiscal edit, or preferred drug list shall be available on the division website at www.dss.mo.gov/mhd approximately fifteen (15) calendar days after the meeting.
6. (7) The recommendations from the MO HealthNet Drug Prior Authorization Committee shall be referred to the Drug Utilization Review (DUR) Board for placement upon the agenda of the next regularly scheduled meeting. The DUR board may accept or alter the recommendations from the MO HealthNet Drug Prior Authorization Committee in arriving at their recommendation for the MO HealthNet Division. If provided to the division fourteen (14) days in advance of the DUR board meeting, clinically relevant written material shall be presented before the recommendation is considered by the DUR board. The DUR board, at their sole discretion, may entertain clinically relevant public comment up to fifteen (15) minutes in aggregate per medication. The responsibility of scheduling the presentation shall rest with the manufacturer of the drug product. Any changes recommended by the DUR board shall be made available via the approved minutes of the DUR board meeting in a timely fashion, at least thirty (30) days prior to the implementation of the recommendations.
7. (8) After all recommendations have been reviewed and accepted, the MO HealthNet Division staff shall coordinate the implementation of the recommendations. All pertinent information relating to edit schedule and edit criteria shall be made available to the public by reasonable means, including, but not limited to, posting on the division website in a timely fashion following the DUR board meeting. Changes to the MO HealthNet pharmacy benefit will be posted on a timely basis on the division website. In addition, information on covered medications shall be made available to the public for use with a personal digital assistant device. As determined by the division, patients stabilized on certain restricted medications shall be allowed to access such medication through the MO HealthNet program for as long as the MO HealthNet program determines that it is fiscally prudent and clinically supported.
8. (9) On an annual basis, the MO HealthNet Drug Prior Authorization Committee shall review all criteria in place, including prior authorization, step therapy, clinical edits, fiscal edits, and the preferred drug list. Annual reviews will be staggered and scheduled to occur at the scheduled meeting closest to completion of a full calendar year after approval of the criteria. If additional clinical or fiscal information is available since the original consideration, interested parties shall have the opportunity to address the committee and request reconsideration of prior authorization, step therapy, clinical edits, fiscal edits, and preferred drug list criteria. All requests shall be scheduled with the division fourteen (14) days in advance of the meeting. All such presentations shall be clinically relevant and limited to a maximum of fifteen
9. (15) minutes. The responsibility of scheduling the presentation shall rest with the manufacturer of the drug product.
10. (10) The division shall not otherwise restrict the prescribing and dispensing of covered outpatient prescription drugs (other than Drug Efficacy Study Implementation (DESI) drugs as designated by federal law) pursuant to this rule without consulting the Drug Prior Authorization Committee. The division may limit the number of prescriptions allowed for each medical assistance participant.
11. (11) As used in the rule, DESI drugs are drugs described in section 107(c)(3) of the Drug Amendments of 1962 and identical, similar or related drugs (within the meaning of section 310.6(b)(1) of Title 21 of the Code of Federal Regulations).
12. (12) When implementing the provisions of section (4), Missouri-specific data shall include the consideration of use and cost data, pharmacoeconomic information and prudent utilization of state funds, and shall include medical and clinical criteria.

AUTHORITY: sections 208.153 and 208.201, RSMo Supp. 2013.* 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. *Original authority: 208.153, RSMo 1967, amended, 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended 2007.