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2006 proposed fee schedule - American Society of Clinical Oncology

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number <strong>of</strong> 11-digit NDCs sold for each NDC assigned to the<br />

billing code, and then divide by the total number <strong>of</strong> NDCs<br />

sold. The ASP per billing unit for each NDC is weighted<br />

equally regardless <strong>of</strong> package size.<br />

d. Reporting WAC<br />

241<br />

In response to manufacturer’s questions about reporting<br />

WAC, we posted a Frequently Asked Question on this subject<br />

on our website (http://www.questions.cms.hhs.gov) last year.<br />

In the posting on the website, we state that manufacturers<br />

must report the WAC for a single source drug or biological<br />

if it is less than the ASP for a quarter and in cases where<br />

the ASP during the first quarter <strong>of</strong> sales is unavailable.<br />

Upon further review, we have determined that the WAC must be<br />

reported each quarter if required for payment to be made<br />

under section 1847A <strong>of</strong> the Act, in addition to the ASP, if<br />

available.<br />

Section 1927(b)(3)(A)(iii) <strong>of</strong> the Act specifies the ASP<br />

data manufacturers must report. Section<br />

1927(b)(3)(A)(iii)(II) <strong>of</strong> the Act specifies that the<br />

manufacturer must report the WAC, if it is required in order<br />

for payment to be made under section 1847A <strong>of</strong> the Act.<br />

Under section 1847A <strong>of</strong> the Act, the payment is based on WAC<br />

(as opposed to ASP) in the following cases:<br />

• For a single source drug or biological, when the<br />

WAC-based calculated payment is less than the ASP-based

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