Mo. Code Regs. tit. 13 § 70-20.200

Current through Register Vol. 49, No. 23, December 2, 2024

Section 13 CSR 70-20.200 - Drug Prior Authorization Process

PURPOSE: The purpose of this amendment is to incorporate the functions of the Drug Prior Authorization Committee into the Drug Utilization Review Board and to dissolve the Drug Prior Authorization Committee.

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

(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 ;

(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 ;

(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 ;

(D) "Preferred Drug List" shall be defined as a list of medications within a functional therapeutic class that are available via open access on the basis of supplemental rebate status and consideration of available evidence-based clinical review findings ;

(E) "Step therapy" shall be defined as a process that specifies the sequence in which different prescription drugs are to be reimbursed ; and

(F) "Utilization edits" are defined as prospective screening edits used to review the appropriate use of medication and may be advisory or preemptory.

(2) 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 Division shall review those drugs that may be restricted and recommend to the Drug Utilization Review (DUR) Board those appropriate for inclusion as a regular benefit of the MO HealthNet program or through prior authorization.

(3) The department or the division may require prior authorization of pharmaceutical products. Any such restriction shall be based on medical and clinical criteria, and Missouri-specific data. The MO HealthNet Division shall develop this medical and clinical criteria based on predetermined standards consistent with the following:

(A) The American Hospital Formulary Service Drug Information;

(B) The United States Pharmacopoeia Drug Information; and

(C) Peer-reviewed medical literature.

(4) The MO HealthNet Division shall review medications used to treat rare medical conditions with the Rare Disease Advisory Council. The MO HealthNet Division shall develop medical and clinical criteria and make recommendations to the Rare Disease Advisory Council. Proposals approved by the Rare Disease Advisory Council shall be presented to the DUR Board.

(5) The DUR Board shall hold a public hearing at least once every ninety (90) days during which the MO HealthNet Division shall make recommendations to the board and prior to any final decision by the division to require prior authorization for that pharmaceutical product, class, or category.

(6) The tentative meeting agenda of the DUR Board with the therapeutic 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.

(A) The specific therapeutic class or classes to be considered at the next regularly scheduled DUR Board meeting shall be placed on the current agenda or posted on the website approximately thirty (30) days prior to the scheduled meeting.

(B) Any interested party shall be granted the opportunity for clinically relevant public comment for up to five (5) minutes per medication under review by the DUR Board. The responsibility of scheduling the presentation shall rest with the interested party. Interested parties representing a manufacturer shall be granted five (5) minutes in the aggregate per medication under review by the DUR Board.

(C) Following the consideration of all presented information, the DUR Board may accept or alter the recommendations from the MO HealthNet Division. The board 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.

(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.

(7) 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 implementation 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. As determined by the division, patients stabilized on certain restricted medications may 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) On an annual basis, the DUR Board 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 board and request reconsideration of prior authorization, step therapy, clinical edits, fiscal edits, and preferred drug list criteria as part of the annual review. All such presentations shall be clinically relevant and limited to a maximum of five (5) minutes. The responsibility of scheduling the presentation shall rest with the interested party.

(9) 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 DUR Board. The division may limit the number of prescriptions allowed for each medical assistance participant.

(10) 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).

(11) When implementing the provisions of section (3) of this rule, 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.

13 CSR 70-20.200

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.

Amended by Missouri Register February 16, 2020/Volume 46, Number 04, effective 3/31/2021

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