05.02.2013 Views

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

CMS-1503-FC 984<br />

should not be implemented until after CMS published regulations on the revised<br />

definition of AMP. A few commenters also recommended that CMS provide adequate<br />

notice to manufacturers prior to making a price substitution. One commenter suggested<br />

that additional OIG comparison studies are needed to examine the impact of the new<br />

definition of AMP. Several commenters requested clarification on and suggested<br />

changes to our proposed regulatory language. Another commenter requested clarification<br />

on the timing of price substitutions and suggested that any price substitution policies<br />

should not be implemented until the lag time between when the comparison is made and<br />

when the substitution would be implemented was decreased. One commenter noted that<br />

the OIG studies are not a reliable indicator of predicted savings since the substitution<br />

timeframes within the studies differed from that in our proposal. All commenters agreed<br />

that any price substitution policy should not be implemented until after the preliminary<br />

injunction is vacated.<br />

Moreover, several commenters provided additional in<strong>for</strong>mation related to the<br />

comparison between ASP and AMP, including:<br />

• How ASP and AMP each encompass different sales and rebate data and are<br />

calculated based on differing statutory definitions;<br />

• The impact of restated AMP data on comparisons; and<br />

• The effect of price substitutions on physician acquisition of drugs.<br />

Response: We appreciate the comments submitted regarding our price<br />

substitution proposal. As discussed above, recent legislative and regulatory changes have<br />

further affected this issue.

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!