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(1) "Acquisition cost" means the actual price paid by a provider for a drug.

(2) "Average manufacturer price (AMP)" means, with respect to a covered outpatient drug of a manufacturer for a rebate period, the average price paid to the manufacturer for the drug in the United States by wholesalers for drugs distributed to the retail pharmacy class of trade. The AMP is determined without regard to customary prompt pay discounts extended to wholesalers.

(3) "Best price" means with respect to a single source drug or innovator multiple source drug of a manufacturer (including the lowest price available to any entity for any such drug of a manufacturer that is sold under an approved new drug application) the lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity within the United States.

(4) "Estimated acquisition cost (EAC)" means the calculation of the provider's estimated cost of a drug for which no federal maximum allowable cost (FMAC) or state maximum allowable cost (SMAC) price has been determined. The EAC is the department's best estimate of what price providers are generally paying in the state for a drug in the package size providers buy most frequently. If actual wholesale cost is not available, the EAC is the lesser of:

(a) eighty-five percent of average wholesale price (AWP); or

(b) wholesale acquisition cost (WAC) plus 2%.

(5) "Federal maximum allowable cost" (FMAC) means the per unit amount the department reimburses a provider for a prescription drug included in the federal upper limit program. FMAC is the federal upper limit the department will pay for multi-source drugs as published by the Centers for Medicare and Medicaid Services (CMS) at https://www.cms.gov/Reimbursement/05_FederalUpperLimits.asp.

(6) "Legend drugs" means drugs that federal law prohibits dispensing without a prescription.

(7) "Maintenance medications" means oral tablet or capsule drugs:

(a) that have a low probability for dosage or therapy changes due to side effects;

(b) are subject to serum drug concentration monitoring or therapeutic response of a course of prolonged therapy;

(c) whose most common use is to treat a chronic disease state. Therapy with the drug is not considered curative or promoting of recover; and

(d) the drug is administered continuously rather than intermittently.

(8) "Multi-source" means a drug product sold under its generic name whose active ingredients are identical in chemical composition to one or more others sold under trademark that can be purchased from different manufacturers or distributors.

(9) "State maximum allowable cost (SMAC)" means the per unit amount the department reimburses a provider for a prescription drug included in the state maximum allowable cost program. SMAC is the upper limit the department will pay for multi-source drugs.

(10) "Outpatient drugs" means drugs which are obtained outside of a hospital.

(11) "Active Pharmaceutical Ingredient" (API) means a nonrebatable bulk drug substance, which is defined in 21 CFR 207.3(a)(4)(2011) as any substance that is represented for use in a drug and that, when used in manufacturing, processing, or packaging of a drug, becomes an active ingredient of the drug product.

History: 53-2-201, 53-6-113, MCA; IMP, 53-2-201, 53-6-101, 53-6-111, 53-6-113, MCA; NEW, 1998 MAR p. 495, Eff. 2/13/98; TRANS, from SRS, 2000 MAR p. 481; AMD, 2000 MAR p. 2313, Eff. 8/25/00; AMD, 2002 MAR p. 1788, Eff. 6/28/02; AMD, 2008 MAR p. 1157, Eff. 7/1/08; AMD, 2008 MAR p. 2669, Eff. 1/1/09; AMD, 2010 MAR p. 433, Eff. 3/1/10; AMD, 2010 MAR p. 2986, Eff. 1/1/11; AMD, 2011 MAR p. 2416, Eff. 11/11/11.

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