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<strong>CMS</strong>-1403-FC<br />

Response: We disagree with this comment. While we<br />

currently believe that we have identified all of the drugs<br />

to which the special payment rule applies, it would be<br />

imprudent to expressly limit its application to albuterol<br />

and levalbuterol in the regulations text because the<br />

statute does not do so. The statute refers to certain<br />

drugs described in section 1842(o)(1)(G) of the Act. Thus,<br />

we believe the regulations text, as proposed, adequately<br />

specifies the drugs to which the special rule applies. We<br />

have committed, via postings on our web site, to proceeding<br />

transparently when making pricing determinations and have<br />

done so by posting our decisions on our web site. We will<br />

continue to do so in the future.<br />

After review of the public comments, we are finalizing<br />

our proposed regulatory text at §414.904.<br />

b. Average Manufacturer Price (AMP)/ Widely Available<br />

Market Prices (WAMP)<br />

Section 1847A(d)(1) of the Act states that “the<br />

Inspector General of HHS shall conduct studies, which may<br />

include surveys to determine the widely available market<br />

prices (WAMP) of drugs and biologicals to which this<br />

section applies, as the Inspector General, in consultation<br />

with the Secretary, determines to be appropriate.” Section<br />

1847A(d)(2) of the Act states that, “Based upon such<br />

149

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