Mo. Code Regs. tit. 13 § 70-20.300

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

Section 13 CSR 70-20.300 - Retrospective Drug Use Review Process

PURPOSE: The purpose of this amendment is to incorporate the current functions of the Drug Prior Authorization Committee into the Drug Utilization Review (DUR) Board.

PURPOSE: This rule establishes the division process by which the Drug Utilization Review Board will be established as required by Section 4401 of P.L. 101-508 (Omnibus Budget Reconciliation Act of 1990) and by section 208.175, RSMo.

(1) Drug Utilization Review (DUR) Board. This rule establishes a MO HealthNet DUR Board in the Department of Social Services, MO HealthNet Division. The board shall be composed as specified in section 208.175, RSMo.

(2) A chairperson shall be elected by the board members.

(3) The DUR Board shall meet at least once every ninety (90) days. A quorum of two-thirds (2/3) of the total members, including no fewer than three (3) physicians or three (3) pharmacists, is required for the board to act in its official capacity.

(4) Members shall serve four- (4-) year terms, except the terms of the original members, two (2) shall be appointed for a term of two (2) years, three (3) shall be appointed for a term of three (3) years, and three (3) shall be appointed for a term of four (4) years. Members may be reappointed, provided that minimum qualifications for membership continue to be met. Nominations shall be referred for final appointment by the governor subject to advice and consent of the senate. As vacancies occur, the DUR Board shall solicit and select a slate of nominees.

(5) The members of the DUR Board shall receive no compensation for their services other than reasonable expenses actually incurred in the performance of their official duties.

(6) The DUR Board shall hold a public hearing during which the MO HealthNet Division shall make recommendations to the board. The hearing shall be prior to any final decision by the division to require prior authorization for that pharmaceutical product, class, or category.

(7) 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.

(8) 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.

(9) The DUR Board shall provide, either directly or through contracts between the MO HealthNet Division and accredited health care schools, state medical societies, or state pharmacist associations or societies or other appropriate organizations, for educational outreach programs as required by P.L. 101-508, Section 4401, to educate practitioners on common drug therapy problems with the aim of improving prescribing and dispensing practices. This outreach shall include an educational newsletter to MO HealthNet providers including appropriate drug use guidelines and MO HealthNet utilization statistics. The board activities shall include:

(A) Establishment and implementation of medical standards and criteria for the prospective and retrospective DUR program;

(B) Development, selection, application, and assessment of educational interventions for physicians, pharmacists, and participants that improve care; and

(C) Administration of the Drug Prior Authorization Process as outlined in 13 CSR 70-20.200.

(10) As specified by P.L. 101-508, Section 4401, the DUR Board shall monitor drug use, and prescribing and dispensing practices in the MO HealthNet program. This monitoring shall include reviewing and refining therapeutic criteria modules used in both retrospective and prospective DUR, as well as overseeing retrospective DUR intervention methods used.

(11) The DUR Board shall advise the Department of Social Services regarding all activities associated with the DUR process, including identifying types of intervention methods to be initiated by the review committees, ranging from letters to physicians and pharmacists, face-to-face education, and educational symposiums for targeted providers. The board shall provide educational support and guidance as needed by the review committees. The review committees, in turn, shall report intervention results and make recommendations based on these results to the board.

(12) Patterns of inappropriate or aberrant prescribing or dispensing shall be identified and referred to the board in order for targeted education to be formulated.

(13) Agency Responsibility Regarding Confidentiality of Information. All information concerning applicants and MO HealthNet participants shall be confidential and any disclosure of this information shall be restricted to purposes directly related to the administration of the medical assistance program. Purposes directly related to administration of the medical assistance program include:

(A) Establishing eligibility;

(B) Determining the amount of medical assistance;

(C) Providing services for recipients; and

(D) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the program.

(14) Provider Responsibility Regarding Confidentiality of Information. All information concerning applicants and participants of medical services shall be confidential. Any disclosure of this information shall be restricted to purposes directly related to the treatment of the patient and promotion of improved quality of care. The confidential information includes:

(A) Names and addresses;

(B) Social Security number;

(C) Medical services provided;

(D) Social and economic conditions or circumstances;

(E) Medical data, including diagnosis and past history of disease or disability;

(F) Any information received for verifying income eligibility; and

(G) Any information received in connection with the identification of legally liable third-party resources.

13 CSR 70-20.300

AUTHORITY: sections 208.153, 208.175, and 208.201, RSMo Supp. 2013.* Original rule filed Dec. 14, 1992, effective June 7, 1993. Amended: Filed Sept. 16, 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 1973, 1989, 1990, 1991, 2007, 2012; 208.175, RSMo 1992, amended 1993, 2011 ; and 208.201, RSMo 1987, amended 2007.