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HHS Proposed Rule Could Significantly Impact Drug Manufacturers, PBMs, and Other Stakeholders
Wilson Sonsini Goodrich & Rosati [Guidance Overview] Mar. 13, 2019 "The proposed rule ... adds a new safe harbor for point-of-sale price reductions ... [which] requires that the following criteria be met: [1] The reduced price must be set in advance with a plan sponsor under Medicare Part D, a Medicaid MCO, or the PBM acting under contract with either; [2] the sale does not involve a rebate unless the full value of the reduction in price is provided to the dispensing pharmacy through a chargeback or series of chargebacks, or is required by law; and [3] the reduction in price must be completely applied to the price of the prescription drug charged to the beneficiary at the point of sale." |
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