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

studies and other data for drugs and biologicals, the<br />

Inspector General shall compare the ASP under this section<br />

for drugs and biologicals with --<br />

and<br />

● The WAMP for such drugs and biologicals (if any);<br />

● The average manufacturer price (AMP) (as determined<br />

under section 1927(k)(1) of the Act for such drugs and<br />

biologicals.”<br />

Section 1847A(d)(3)(A) of the Act states that, “The<br />

Secretary may disregard the average sales price (ASP) for a<br />

drug or biological that exceeds the WAMP or the AMP for<br />

such drug or biological by the applicable threshold<br />

percentage (as defined in subparagraph (B)).” The<br />

applicable threshold percentage is specified in section<br />

1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For<br />

CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of<br />

the Act establishes that the applicable threshold<br />

percentage is “the percentage applied under this<br />

subparagraph subject to such adjustment as the Secretary<br />

may specify for the WAMP or the AMP, or both.” In CY 2006<br />

through CY 2008, we specified an applicable threshold<br />

percentage of 5 percent for both the WAMP and AMP<br />

comparisons. We based this decision on the limited data<br />

150

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