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    CMS releases final rule for covered outpatient drugs


    Pharmacy reimbursement

    The final rule ensures that pharmacy reimbursement is aligned with the acquisition cost of drugs and that the states pay an appropriate professional dispensing fee.

    To that end, the final rule:

    • Creates an exception to the FUL calculation that allows for the use of a higher multiplier than 175% to calculate the FUL, based on acquisition costs for certain multiple-source drugs.

    • Establishes actual acquisition cost (AAC) as the basis by which states should determine their ingredient-cost reimbursement, so that payments are based on a more accurate estimate of the prices available in the marketplace, while still ensuring sufficient beneficiary access.

    • Implements the use of the term “professional dispensing fee” to ensure that the dispensing fee paid to pharmacies reflect the cost of the pharmacist’s professional services and cost to dispense the drug product to a Medicaid beneficiary.

    • Clarifies that states are required to evaluate the sufficiency of both the ingredient-cost reimbursement and the professional dispensing-fee reimbursement when proposing changes to either of these components.

    • Requires states to specify in the Medicaid state plan that reimbursement methodology to pharmacies that purchase drugs through the Federal Supply Schedule and the 340B Drug Pricing Program is consistent with overall AAC requirements.

    Additional comments

    CMS is still considering the comments received on the definition of line-extension drugs and has not finalized that portion of the regulation.

    At this time, manufacturers are to rely on the statutory definition of line extension at section 1927(c) (2) (C) of the Act, and where appropriate are permitted to use reasonable assumptions in their determination of whether their drug qualifies as a line-extension drug.

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...


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