2006 proposed fee schedule - American Society of Clinical Oncology

calculated payment for all NDCs assigned to such drug or
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biological product. (See section 1847A(b)(4) of the Act.)
• During an initial period in which data on the prices
for sales for the drug or biological is not sufficiently
available from the manufacturer to compute an ASP. (See
section 1847A(c)(4) of the Act.)
In these instances, we must make the determination of
whether the payment amount is based on ASP or WAC.
Therefore, WAC is required for payment in all of these
instances.
On April 6, 2004, we published the ASP reporting
regulations in the Manufacturer Submission of Manufacturer’s
ASP Data for Medicare Part B Drugs and Biologicals interim
final rule with comment (66 FR 17935-17941). In that
interim final rule, we specified that manufacturers must
report the ASP data to us using the template provided in
Addendum A of that interim final rule. That template
included the manufacturer’s name, NDC, manufacturer’s ASP,
and number of units. The WAC was not included in the
template. Therefore, in order to report the WAC,
manufacturers have used several approaches. Some
manufacturers have appended the WAC to the template; others
have noted it in their written cover letters to their
submissions. Still others have sent the WAC to us using
electronic mail. Because a place for the WAC was not