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 believe it would be appropriate to provide an increase that cannot be substantiated by the best data available. Therefore, we are finalizing our proposal to provide a zero update to the drug add-on adjustment for CY 2009. If the statute had included, instead of the word “increase,” a broader term, we believe we would have had authority to decrease the rate to take into account the projected reduction. 4. Final Growth Update to the Drug Add-On Adjustment for 2009. As we indicated earlier, we have decided not to use CY 2007 expenditure data to estimate utilization growth for CY 2009, because of the potential distortion of our estimates due to the implementation of the ESA monitoring policy in 2007. Therefore, for this final rule with comment period, we are using the same data we use to estimate growth in utilization for CY 2008 as outlined in the CY 2008 PFS final rule with comment period (72 FR 66282). That is, for CY 2009, we estimate no growth in per patient utilization of ESRD drugs for CY 2009. Similar to the CY 2009 PFS proposed rule, we estimated growth in ESRD drug prices using ASP pricing data for CYs 2006, 2007 and 2008. In the proposed rule, we had only 2 quarters of data for 2008, but for this final rule all 176
CMS-1403-FC four quarters of ASP pricing data are available. We calculated the weighted price change for the top eleven ESRD drugs. Tables 8 and 9 show the average ASP prices and the 2007 weights used. We note that the final CY 2007 weights are derived from the final CY 2007 ESRD facility claims file as of June 30, 2008. For CY 2006 and CY 2007, we calculated a weighted average price reduction of 1.8 percent. We also calculated a weighted average price reduction of 1.9 percent between CY 2007 and CY 2008. The overall average price reduction is 1.8 percent over the 3-year period. Thus, the weighted average ESRD drug pricing change projected for CY 2009 is a reduction of 1.8 percent. We project that the combined growth in per patient utilization and pricing of ESRD drugs for CY 2009 would result in a negative update equal to -1.8 percent (1.00 * 0.982 = 0.982). If we implement this decrease in the update to the drug-on adjustment, the resulting savings would have been $14 million. However, as indicated above, for this final rule with comment period, we are applying no update to the drug add-on adjustment for CY 2009. Thus, we are applying a zero update to the $20.33 per treatment drug add-on amount for CY 2009. After adjusting for the MIPPA changes as discussed earlier in this section, the final 177
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<strong>CMS</strong>-1403-FC<br />
four quarters of ASP pricing data are available. We<br />
calculated the weighted price change for the top eleven<br />
ESRD drugs. Tables 8 and 9 show the average ASP prices and<br />
the 2007 weights used. We note that the final CY 2007<br />
weights are derived from the final CY 2007 ESRD facility<br />
claims file as of June 30, 2008. For CY 2006 and CY 2007,<br />
we calculated a weighted average price reduction of<br />
1.8 percent. We also calculated a weighted average price<br />
reduction of 1.9 percent between CY 2007 and CY 2008. The<br />
overall average price reduction is 1.8 percent over the<br />
3-year period. Thus, the weighted average ESRD drug<br />
pricing change projected for CY 2009 is a reduction of<br />
1.8 percent.<br />
We project that the combined growth in per patient<br />
utilization and pricing of ESRD drugs for CY 2009 would<br />
result in a negative update equal to -1.8 percent<br />
(1.00 * 0.982 = 0.982). If we implement this decrease in<br />
the update to the drug-on adjustment, the resulting savings<br />
would have <strong>been</strong> $14 million. However, as indicated above,<br />
for this final rule with comment period, we are applying no<br />
update to the drug add-on adjustment for CY 2009. Thus, we<br />
are applying a zero update to the $20.33 per treatment drug<br />
add-on amount for CY 2009. After adjusting for the MIPPA<br />
changes as discussed earlier in this section, the final<br />
177