PURPOSE: This rule establishes provisions for prospective drug use review and patient 13 CSR 70-20

counseling for Medicaid beneficiaries, as required by Section 4401 or Public Law 101- 508 (Omnibus Budget Reconciliation Act of 1990) and by section 208.176, RSMo.

1. (1) Prospective Drug Use Review (DUR). This rule establishes a Medicaid prospective drug use review process within the Department of Social Services, Division of Medical Services, as specified in section 208.176, RSMo.
2. (2) Electronic Point-of-Sale Review. The Division of Medical Services shall provide for electronic point-of-sale review of drug therapy using predetermined standards before each prescription is dispensed to the nonnursing home Medicaid recipient or Medicaid recipient’s caregiver for the current date of service. The process will provide screening for potential drug therapy problems using clinical modules which have been reviewed and approved for use by the Missouri Drug Use Review Board.

3. (3) Federal Prospective DUR screening requirements for Medicaid beneficiaries. 42 CFR part 456.705(b) requires that the state plan must provide for a point of distribution review of drug therapy using predetermined standards before each prescription is filled or delivered to the recipient or the recipient’s caregiver. The review, performed with or without online access to the Pharmacy Point of Service system, must include screening to identify potential drug therapy problems of the following types:

   1. (A) Incorrect drug dosage, that is, the dosage lies outside the daily dosage range specified in predetermined standards as necessary to achieve therapeutic benefit. Dosage range is the strength multiplied by the quantity dispensed divided by days supply;
   2. (B) Adverse drug-drug interaction, that is, the potential for, or occurrence of, an adverse medical effect as a result of the recipient using two (2) or more drugs together;

   3. (C) Drug-disease contraindication, that is the potential for, or occurrence of—

      1. 1. An undesirable alteration of the ther-

apeutic effect of a given prescription because of the presence, in the patient for whom it is prescribed, of a disease condition; or

1. 2. An adverse effect of the drug on the

patient’s disease condition.

1. (D) Therapeutic duplication, that is, the prescribing and dispensing of two (2) or more drugs from the same therapeutic class so that the combined daily dose puts the recipient at risk of an adverse medical result or incurs additional program costs without additional therapeutic benefit;
2. (E) Incorrect duration of drug treatment, that is, the number of days of prescribed therapy exceeds or falls short of the recommendations contained in the predetermined standards;
3. (F) Drug-allergy interactions, that is, the significant potential for, or the occurrence of, an allergic reaction as a result of drug therapy; and
4. (G) Clinical abuse/misuse, that is, the occurrence of situations referred to in the definitions of abuse, gross overuse, overutilization and underutilization, as defined in 42 CFR 456.702, and incorrect dosage and incorrect duration, as defined in subsections (3)(A) and (E) of this rule.

1. (4) Screens Available for Medicaid Beneficiaries. The following screens will be provided by the Pharmacy Point of Service system:

   1. (A) Drug Disease Contraindications.

      1. 1. Drug (actual) disease precaution.
      2. 2. Inferred Drug Disease precaution;
   2. (B) Drug to Drug Interactions;

   3. (C) Side Effects.

      1. 1. Additive toxicity side effects.
      2. 2. Medical condition/additive side

effect.

1. 3. Side effect.
2. 4. Drug indicated for side effect of pre-

viously prescribed drug;

1. (D) Dose Range Checking.

   1. 1. High dose alert.
   2. 2. Low dose alert;

2. (E) Minimum/Maximum Daily Dose.

   1. 1. High dose alert.
   2. 2. Low dose alert;

3. (F) Duplicate Therapy Checking.

   1. 1. Therapeutic duplication.
   2. 2. Ingredient duplication; and

4. (G) Duration of Therapy (H2).

   1. 1. Excessive duration alert.

1. (5) Medicaid Patient Counseling. As part of the prospective DUR program, participating pharmacies shall perform Medicaid patient counseling according to the standards established by the Board of Pharmacy under 4 CSR 220-2.190.

2. (6) Medicaid Patient Profiles. The term, reasonable effort means that each time a Medicaid patient or caregiver presents a prescription, the pharmacist or pharmacist’s designee should request profile information verbally or in writing. For example, if the patient presents the prescription in person, the request should be make verbally, and if the prescription is received by mail, the request should be made in writing. This does not imply that the service should be denied solely on the basis of the patient’s refusal to supply this information. Pharmacies must make a reasonable effort to obtain records and maintain patient profiles containing, at a minimum:

   1. (A) The name, address, telephone number, date of birth (or age) and gender of the patient;
   2. (B) Individual medical history, if significant, including disease states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
   3. (C) Pharmacist’s comments relevant to the individual’s drug therapy.
3. (7) Documentation of Offer to Counsel. The pharmacist shall document for each Medicaid patient’s prescription in a uniform fashion, whether the offer to counsel was accepted or refused by the patient or the patient’s agent.

4. (8) Agency Responsibility Regarding Confidentiality of Information. All information concerning applicants and recipients of medical services shall be kept confidential by the Division of Medical Services, 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:

   1. (A) Establishing eligibility;
   2. (B) Determining the amount of medical assistance;
   3. (C) Providing services for recipients; and
   4. (D) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the program.

5. (9) Provider Responsibility Regarding Confidentiality of Medicaid Beneficiary Information. All information concerning applicants and recipients of medical services shall be confidential. Any disclosure of this information by the pharmacy provider shall be restricted to purpose directly related to the treatment of the patient and promotion of improved quality of care, or conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the program. The confidential information includes:

   1. (A) Names and addresses;
   2. (B) Social Security number;
   3. (C) Medical services provided;
   4. (D) Social and economic conditions or circumstances;
   5. (E) Medical data, including diagnosis and past history of disease or disability;
   6. (F) Any information received for verifying income eligibility; and
   7. (G) Any information received in connection with the identification of legally liable third party resources.

AUTHORITY: sections 208.153, RSMo Supp. 1991 and 208.201 RSMo Supp. 1987.* Original rule filed June 3, 1993, effective Dec. 9, 1993. *Original authority 208.153, RSMo 1967, amended 1973, 1989, 1990, 1991 and 208.201, RSMo 1987.