The proposed data source for the denominator (unit sales used to calculate AMP) represents, in accordance with the definition of AMP at section 1927(k)(1) of the Act, (1) manufacturer sales to wholesalers for drugs distributed to retail community pharmacies, and (2) manufacturer sales to retail community pharmacies that purchase drugs directly from the manufacturer
E-cigarettes E-cigarettes or vapes are battery-operated devices that heat liquid into a gas
We explained that an approach of correcting even very minor errors might result in significant operational burdens for ACOs and CMS, including multiple financial reconciliation re-runs and off-cycle payment/recoupment activities that could have the potential for significant and unintended operational consequences, and could jeopardize the certainty of performance results for both ACOs and CMS
To implement the statutory requirement under section 1847A(i)(3)(G), CMS proposes to codify in subpart E of part 427 existing policies described in sections 50.10, 50.11, and 50.12 of the revised Medicare Part B Drug Inflation Rebate Guidance to reduce the total rebate amount owed by a manufacturer in each of these cases, as summarized in Table 50 and discussed later in this section
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