(1) This rule applies to all prescribed drug service providers enrolled in the Florida Medicaid program that provide services under the fee-for-service delivery system in accordance with Rule 59G-4.250, Florida Administrative Code (F.A.C.).
    (2) Definitions.
    (a) Actual Acquisition Cost for Prescribed Drugs – (AAC) – The National Average Drug Acquisition Cost (NADAC) will be used for the AAC, when available. If the NADAC is unavailable, the AAC will be equal to the wholesaler acquisition cost.
    (b) Average Sales Price – (ASP) – The average sales price as reported by prescribed drug manufacturers to the Centers for Medicare and Medicaid Services (CMS).
    (c) State Maximum Allowable Cost – (SMAC) – The maximum allowable unit cost established by the state; SMAC may be manually set.
    (d) Usual and Customary Charge — (U&C Charge) — The average charge to all other customers in any quarter for the same drug, quantity, and strength.
    (e) Wholesaler Acquisition Cost — (WAC) – The cost wholesalers pay for a prescribed drug.
    (3) Reimbursement Methodology.
    (a) Florida Medicaid reimburses for drugs dispensed by an approved Florida Medicaid pharmacy provider, or a provider enrolled as a dispensing practitioner, in an amount not to exceed the lesser of:
    1. The AAC plus a professional dispensing fee (PDF) of $10.24.
    2. The WAC plus a PDF of $10.24.
    3. The SMAC plus a PDF of $10.24.
    4. The provider’s U&C Charge.
    (b) The above reimbursement methodology applies to all of the following:
    1. Covered outpatient drugs dispensed by a retail community pharmacy.
    2. Specialty drugs dispensed primarily through the mail.
    3. Drugs not purchased pursuant to the 340B program by a covered entity, as defined in section 340B(a)(4) of the federal Public Health Service Act.
    4. Drugs dispensed in an institutional or long-term care pharmacy, when not included as part of the floor stock contained in the institution’s cost report.
    (4) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via the Federal Supply Schedule.
    (5) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via nominal price.
    (6) Florida Medicaid reimburses for drugs purchased under the 340B program at the actual purchased drug price, which cannot exceed the 340B ceiling price, plus a dispensing fee of $10.24. This provision only applies to covered entities, Indian Health Services, tribal organizations, urban Indian pharmacies and federally qualified health centers that dispense drugs purchased at prices authorized under section 340B of the Public Health Services Act.
    (7) Florida Medicaid reimburses for clotting factor to the vendor(s) awarded the state’s hemophilia contract(s) at the negotiated price.
    (8) Florida Medicaid reimburses for prescribed drugs administered by a licensed practitioner in an office setting at 106 percent of ASP, as provided by CMS quarterly in the format of drug pricing files, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html; or, when no ASP rate is available, at WAC.
    (9) Florida Medicaid reimburses for prescribed drugs purchased under the 340B program administered in an outpatient facility at an amount not to exceed the 340B ceiling price.
    (10) Florida Medicaid does not reimburse for investigational or experimental drugs.
    (11) The rule is in effect for five years from its effective date.
Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.912 FS. History-New 1-28-09, Amended 8-23-09, 5-20-12, 6-2-16, 3-29-18, 12-20-21.