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

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<strong>Iowa</strong><strong>Department</strong><strong>of</strong> <strong>Human</strong>Services<strong>Provider</strong> and Chapter<strong>Prescribed</strong> <strong>Drugs</strong>Chapter III. <strong>Provider</strong>-Specific PoliciesPage119DateAugust 1, 2013Exceptions to policy will not be granted if other sources for payment areavailable.11. 340B Drug Pricing ProgramIn order to become eligible to participate in the 340B Program, the providermust submit a request to the Office <strong>of</strong> Pharmacy Affairs (OPA) within theHealth Resources and Services Administration (HRSA). The OPA website ishttp://www.hrsa.gov/opa/. The request form is listed at the following link:ftp://ftp.hrsa.gov/bphc/pdf/opa/PrgmReg.pdf.It is very important that the OPA has accurate and up-to-date information,particularly your exact name and street address. It your responsibility to:♦ Contact the OPA with any changes in your information; and♦ Tell your wholesaler or manufacturer that you are registered for 340Bdiscount prices when you place an order.<strong>Provider</strong>s must enroll with <strong>Iowa</strong> Medicaid in order to bill and receivereimbursement for self-adminsitered drugs purchased through the 340BProgram.a. Covered Entity (CE)The covered entity (CE) has full responsibility and accountability forcompliance with all requirements to prevent diversion <strong>of</strong> covered drugsto individuals other than patients <strong>of</strong> the CE, and to prevent situations inwhich a drug is subject to both the 340B discount and a Medicaid rebateclaim.Use <strong>of</strong> a contract pharmacy arrangement (single or multiple) does notlessen a CE’s duty to ensure that the 340B Program is beingadministered in compliance with the statute and HRSA guidelines.It is imperative that all CEs participating in the 340B Program not onlycomply with program requirements but also be able to documentcompliance with those requirements in the event <strong>of</strong> an audit.

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