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 Missouri Medicaid program or through prior authorization.

Editor’s Note: The secretary of state has determined that the publication of this rule in its entirety would be unduly cumbersome or expensive. The entire text of the material referenced has been filed with the secretary of state. This material may be found at the Office of the Secretary of State or at the headquarters of the agency and is available to any interested person at a cost established by state law.

1. (1) This rule establishes a Medicaid drug prior authorization committee in the Department of Social Services, Division of Medical Services. 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, except that of the members first appointed, two (2) shall be appointed for one (1) year, two (2) shall be appointed for two (2) years and three (3) shall be appointed for three (3) 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 Division of Medical Services out of appropriations made for that purpose.
2. (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 which may be restricted under Section 4401 of P.L. 101-508 (Omnibus Budget Reconciliation Act of 1990). The Medicaid drug prior authorization committee shall review those drugs which may be restricted and recommend those appropriate for inclusion as a regular benefit of the Missouri Medicaid program or through prior authorization.
3. (3) The department or the division may require prior authorization of pharmaceutical 13 CSR 70-20

products. Any such restriction shall be based on medical and clinical criteria, and Missouri-specific 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;
3. (C) The American Medical Association Drug Evaluations; and
4. (D) Peer-reviewed medical literature.

1. (4) If the division finds that the data enumerated in section (3) of this rule has been documented, the Medicaid drug prior authorization committee shall hold a public hearing in order to make recommendations to the department prior to any final decision by the division to require prior authorization for that pharmaceutical product, class or category.
2. (5) If, after the hearing required pursuant to section (4) of this rule, prior authorization of the pharmaceutical product is required, this prior authorization requirement shall be reviewed at least once every twelve (12) months by the Medicaid drug prior authorization committee.
3. (6) The division shall not otherwise restrict the prescribing and dispensing of covered outpatient prescription drugs (other than Drug Efficacy Implementation Study (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 recipient.
4. (7) 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).

AUTHORITY: sections 208.153, RSMo Supp. 1991 and 208.201, RSMo Supp. 1987.* Original rule filed Feb. 3, 1992, effective Aug. 6, 1992. *Original authority: 208.153, RSMo 1967, amended, 1973, 1989, 1990, 1991 and 208.201, RSMo 1987.