2006 proposed fee schedule - American Society of Clinical Oncology

period available associated with all sales subject to the
ASP reporting requirements. The manufacturer then
calculates a percentage using this summed amount as the
numerator and the corresponding total sales data as the
denominator. This results in a 12-month rolling average
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price concession percentage that is applied to the total in
dollars for the sales subject to the ASP reporting
requirement for the quarter being submitted to determine the
price concession estimate for the quarter. The methodology
is specified in §414.804(a)(3) and was published in the
Manufacturer Submission of Manufacturer’s ASP Data for
Medicare Part B Drugs and Biologicals final rule published
on September 16, 2004 (69 FR 55763).
Our goal is to ensure that the ASP data submitted by
manufacturers reflects an appropriate estimate of lagged
price concessions. Since publication of the
September 16, 2004 final rule, we have identified a
refinement of the ASP calculation and lagged price
concession estimation methodology related to chargebacks
that we believe will improve the accuracy of the estimate.
As a result, we are proposing to clarify the ASP calculation
in this proposed rule.
b. Price Concessions: Wholesaler Chargebacks
Wholesaler chargebacks are a type of price concession,
generally paid on a lagged basis, that apply to sales to