Mont. Admin. R. 37.86.1101 - OUTPATIENT DRUGS, DEFINITIONS
(1)
"Acquisition cost" means the actual price paid by a provider for a drug.
(2) "Active pharmaceutical
ingredient (API)" means a nonrebatable bulk drug substance, 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.
(3) "Allowed
ingredient cost" means the "Average Acquisition Cost (AAC)" or "submitted
ingredient cost," whichever is lower. If AAC is not available, drug
reimbursement is determined at the lesser of "Wholesale Acquisition Cost
(WAC)", "Federal Maximum Allowable Cost (FMAC)," or the "submitted ingredient
cost."
(4) "Average acquisition
cost (AAC)" means the calculated average drug ingredient cost per drug
determined by direct pharmacy survey, wholesale survey, and other relevant cost
information.
(5) "Average
manufacturer price" means the price as defined at 42 CFR Part 447.504(a).
(6) "Best price" means with
respect to a single source drug or innovator multiple source drug of a
manufacturer 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. Best price
includes the lowest price available to any entity for any such drug of a
manufacturer that is sold under an approved new drug application.
(7) "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.medicaid.gov/medicaid-chip-program-information/by-topics/benefits/prescription-drugs/pharmacy-pricing.html.
(8) "Legend drugs" means drugs that federal
law prohibits dispensing without a prescription.
(9) "Maintenance medications" means oral
tablet or capsule drugs that:
(a) 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) the most common use is to treat a chronic
disease state;
(d) therapeutically
are not considered curative or promoting of recovery; and
(e) are administered continuously rather than
intermittently.
(10)
"Multi-source" means a drug product sold under its generic name for which the
active ingredients are identical in chemical composition to one or more other
drugs sold under trademark that can be purchased from different manufacturers
or distributors.
(11) "Outpatient
drugs" means drugs that are obtained outside of a hospital.
(12) "Preferred drug list (PDL)" means
selected drugs that have a significant clinical benefit over other agents in
the same therapeutic class and also represent good value to the department
based on total cost.
(13)
"Submitted ingredient cost" means a pharmacy's actual ingredient cost. For
drugs purchased under the 340B Drug Pricing Program, "submitted ingredient
cost" means the actual 340B purchase price. For drugs purchased under the
Federal Supply Schedule (FSS), "submitted ingredient cost" means the actual FSS
purchase price.
(14) "Usual and
customary charge" means the price the provider charges a typical customer in
the provider's typical course of business.
(15) "Wholesale acquisition cost (WAC)" is
the cost as defined in
42 USC
1395w-3a(c)(6)(B).
Notes
AUTH: 53-2-201, 53-6-113, MCA; IMP: 53-2-201, 53-6-101, 53-6-111, 53-6-113, MCA
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