Notice: This CMS-approved document has been submitted - Philips ...

CMS-1403-FC
cautiously in this area and provide stakeholders,
particularly manufacturers of drugs impacted by potential
price substitutions, with adequate notice of our intentions
regarding such, including the opportunity to provide input
with regard to the processes for substituting the WAMP or
the AMP for the ASP. As part of our approach, we intend to
develop a better understanding of the issues that may be
related to certain drugs for which the WAMP and AMP may be
lower than the ASP over time.
We solicited comments on our proposal to continue the
applicable threshold at 5 percent for both the WAMP and AMP
for CY 2009.
The following is a summary of the comments we received
and our responses.
Comment: Most commenters supported maintaining the
threshold at 5 percent. Other commenters suggested that we
exercise caution in the determination of price
substitutions and that we develop a formal process and
criteria to determine when substitutions are necessary.
Commenters also recommended that we provide adequate notice
prior to making a price substitution.
Response: We appreciate the comments to maintain the
threshold at 5 percent. As we noted in the CY 2008 PFS
final rule with comment period (72 FR 66259), we understand
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