2006 proposed fee schedule - American Society of Clinical Oncology

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included in the template, it is possible that manufacturers
may not have submitted the WAC even though it was required.
On a few occasions, we have contacted the manufacturer to
obtain the WAC when it was needed to determine the payment
amount. Therefore, because of the requirement to submit the
WAC and the confusion manufacturers have experienced in
submitting the WAC data we will propose, in a separate
information collection notice, to revise the reporting
template to include a place to report WAC. See the
discussion in section e. below for further details about
potential changes to the reporting format.
To clarify the instances when manufacturers are
required to report the WAC, in this proposed rule we are
clarifying that manufacturers are required to report
quarterly both the ASP and the WAC for NDCs assigned to a
single source drug or biological billing code.
Manufacturers are also required to report the WAC for use in
determining the payment during the initial period under
section 1847A(c)(4) of the Act. That is, the WAC is
reported for the reporting period prior to reporting the ASP
based on a full quarter of sales.
Because the WAC could change during a reporting period,
we are proposing that in reporting the WAC, manufacturers
would be required to report the WAC in effect on the last
day of the reporting period.