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2006 proposed fee schedule - American Society of Clinical Oncology

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calculation. We also discuss the submission <strong>of</strong> ASP data,<br />

including WAC, and our intent to propose, in a separate<br />

notice, the collection <strong>of</strong> additional information from<br />

235<br />

manufacturers, using a revised reporting format, to ensure<br />

more accurate calculation <strong>of</strong> the Medicare payment amounts.<br />

Also, included in this section is a discussion <strong>of</strong> the<br />

weighting methodology we follow to establish the Medicare<br />

payment amounts using the ASP data.<br />

a. Estimation Methodology for Lagged Price Concessions<br />

Section 1847A(c)(5)(A) <strong>of</strong> the Act states that the ASP<br />

is to be calculated by the manufacturer on a quarterly<br />

basis. As a part <strong>of</strong> that calculation, manufacturers are to<br />

take into account price concessions such as--<br />

● Volume discounts.<br />

● Prompt pay discounts.<br />

● Cash discounts.<br />

● Free goods that are contingent on any purchase<br />

requirement.<br />

● Chargebacks.<br />

● Rebates (other than rebates under the Medicaid drug<br />

rebate programs).<br />

If the data on these price concessions are lagged, then<br />

the manufacturer is required to estimate costs attributable<br />

to these price concessions. Specifically, the manufacturer<br />

sums the price concessions for the most recent 12-month

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