Notice: This CMS-approved document has been submitted - Philips ...
Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
CMS-1403-FC studies and other data for drugs and biologicals, the Inspector General shall compare the ASP under this section for drugs and biologicals with -- and ● The WAMP for such drugs and biologicals (if any); ● The average manufacturer price (AMP) (as determined under section 1927(k)(1) of the Act for such drugs and biologicals.” Section 1847A(d)(3)(A) of the Act states that, “The Secretary may disregard the average sales price (ASP) for a drug or biological that exceeds the WAMP or the AMP for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)).” The applicable threshold percentage is specified in section 1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of the Act establishes that the applicable threshold percentage is “the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the WAMP or the AMP, or both.” In CY 2006 through CY 2008, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP comparisons. We based this decision on the limited data 150
CMS-1403-FC available to support a change in the current threshold percentage. For CY 2009, we proposed to specify an applicable threshold percentage of 5 percent for the WAMP and the AMP comparisons. As we stated in the proposed rule, the OIG is continuing its ongoing comparison of both the WAMP and the AMP. However, information on how recent changes to the ASP weighting methodology may affect the comparison of WAMP/AMP to ASP was not available in time for consideration prior to developing our proposal to maintain the applicable threshold percentage at 5 percent for CY 2009. Although we have recently received reports comparing ASP to AMP in which the OIG states it has applied the new volume-weighting methodology consistently, we have not had sufficient time to analyze these reports. Thus, we do not have data suggesting a more appropriate level for the threshold at this time. Therefore, we believe that continuing the 5 percent applicable threshold percentage for both the WAMP and AMP comparisons is appropriate for CY 2009. As we noted in the CY 2008 PFS final rule with comment period (72 FR 66259), we understand that there are complicated operational issues associated with potential payment substitutions. We will continue to proceed 151
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<strong>CMS</strong>-1403-FC<br />
available to support a change in the current threshold<br />
percentage.<br />
For CY 2009, we proposed to specify an applicable<br />
threshold percentage of 5 percent for the WAMP and the AMP<br />
comparisons. As we stated in the proposed rule, the OIG is<br />
continuing its ongoing comparison of both the WAMP and the<br />
AMP. However, information on how recent changes to the ASP<br />
weighting methodology may affect the comparison of WAMP/AMP<br />
to ASP was not available in time for consideration prior to<br />
developing our proposal to maintain the applicable<br />
threshold percentage at 5 percent for CY 2009. Although we<br />
have recently received reports comparing ASP to AMP in<br />
which the OIG states it <strong>has</strong> applied the new<br />
volume-weighting methodology consistently, we have not had<br />
sufficient time to analyze these reports. Thus, we do not<br />
have data suggesting a more appropriate level for the<br />
threshold at this time. Therefore, we believe that<br />
continuing the 5 percent applicable threshold percentage<br />
for both the WAMP and AMP comparisons is appropriate for<br />
CY 2009.<br />
As we noted in the CY 2008 PFS final rule with comment<br />
period (72 FR 66259), we understand that there are<br />
complicated operational issues associated with potential<br />
payment substitutions. We will continue to proceed<br />
151