Prescribed Drugs Provider Manual - Iowa Department of Human ...

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IowaDepartmentof HumanServicesProvider and ChapterPrescribed DrugsChapter III. Provider-Specific PoliciesPage3DateAugust 1, 2013Less than effective drug or DESI drug means a drug for which:♦ The Food and Drug Administration (FDA) has withdrawn approval of thedrug application for safety or efficacy reasons as a result of the drugefficacy study implementation (DESI) review; or♦ The secretary of the U.S. Department of Health and Human Services hasissued a notice of a hearing under section 505(e) of the federal Food,Drug, and Cosmetic Act on a proposed order to withdraw approval of thedrug application because the secretary has determined that the drug isless than effective for some or all of the conditions of use prescribed,recommended, or suggested in the drug’s labeling.♦ Medicaid Carve-Out is a billing mechanism available to covered entitiesthat implements the 340B requirement protecting manufacturers fromgiving a 340B discount and paying a Medicaid rebate on the same drug.If a covered entity implements the carve-out option, the covered entityonly purchases through the 340B Program drugs dispensed to non-Medicaid patients. Drugs dispensed to Medicaid patients are purchasedoutside the 340B Program.Medically accepted indication means any use for a covered outpatientdrug which is approved under the federal Food, Drug, and Cosmetic Act, orthe use of which is supported by one or more citations included or approvedfor inclusion in any of the compendia described in section 1927(g)(1)(B)(i) ofthe Social Security Act.National drug code (NDC) means the eleven-digit number themanufacturer or labeler assigns to a pharmaceutical product and attaches tothe product container at the time of packaging that identifies the product’smanufacturer, dose form and strength, and package size.Nonpreferred drug means a drug on the Preferred Drug List that requiresprior authorization, with the primary criteria being failure on the preferredagents rather than clinical guidelines. A nonpreferred drug is designated “N”on the Preferred Drug List.Nonprescription drugs or over-the-counter (OTC) drugs means drugsthat may be lawfully sold without a prescription.
IowaDepartmentof HumanServicesProvider and ChapterPrescribed DrugsChapter III. Provider-Specific PoliciesPage4DateAugust 1, 2013Nonrecommended drug means a drug placed on a voluntary list (designedto inform prescribers of cost-effective alternatives) that does not require aprior authorization but if used will be more costly to the Medicaid program. Anonrecommended drug is designated “NR” on the recommended drug list.Pharmaceutical and Therapeutics (P&T) Committee means a committeeof nine members appointed by the Governor that is charged with developingand providing ongoing review of the Preferred Drug List pursuant to IowaCode section 249A.20A.Preferred drug means a drug on the Preferred Drug List that providesmedical equivalency to the Medicaid member in a cost-effective manner (byvirtue of OBRA ’90 and Supplemental Rebate) and does not require a priorauthorization. A preferred drug is designated “P” on the Preferred Drug List.Preferred Drug List (PDL) means a list comprised of drugs recommendedto the Iowa Department of Human Services by the Iowa MedicaidPharmaceutical and Therapeutics Committee that have been identified asbeing therapeutically equivalent within a drug class and that provide costbenefit to the Medicaid program.Preferred drug with conditions means a drug has “preferred” agents butbefore getting the drug a patient must meet medical criteria and guidelinesthat coincide with current prior authorization guidelines. A preferred drugwith conditions is designated “P” on the Preferred Drug List and has a numberin the comments column to indicate a prior authorization is required, asdefined on the first page of the Preferred Drug List (PDL).Prior authorization (PA) means obtaining approval for a drug before thedrug is provided to a member, as a precondition for provider reimbursement.Prior authorization is requested at the prescriber level and is a prescriber faxonlysystem using the forms provided by the Iowa Medicaid Enterprise.Professional dispensing fee means payment provided for the costsincurred by a pharmacy to dispense a drug. The fee reflects the pharmacist’sprofessional services and costs associated with ensuring that possession ofthe appropriate covered outpatient drug is transferred to a Medicaid member.Prospective drug utilization review (Pro-DUR) means a process in whicha request for a drug product for a particular patient is screened for potentialdrug therapy problems before the product is dispensed.
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