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

required changes. As a result of the legislation, we<br />

proposed to revise §414.904 to codify the changes to the<br />

determination of payment amounts as required by section 112<br />

of the MMSEA. We solicited comments on the proposed<br />

regulatory text.<br />

The following is a summary of the comments we received<br />

and our responses.<br />

Comment: We received a number of comments regarding<br />

our proposed regulatory text. All of comments we received<br />

strongly supported our proposed regulatory text. Several<br />

comments strongly urged <strong>CMS</strong> to ensure that the methodology<br />

is properly applied to all drugs paid under the ASP<br />

methodology.<br />

Response: We appreciate the support from the public<br />

with regard to the implementation of this statutory<br />

provision. We have <strong>been</strong> applying the revised methodology<br />

since April 2008 and are unaware of payment issues<br />

resulting from its usage. The new methodology is being<br />

applied consistently across all Part B drugs subject to the<br />

ASP methodology.<br />

Comment: One commenter requested that we limit the<br />

application of the special payment rule, established by<br />

section 112(b) of MMSEA to only albuterol and levalbuterol.<br />

148

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