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Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
CMS-1403-FC In the CY 2009 PFS proposed rule, we noted that the Office of the Inspector General’s (OIG) study on the availability and pricing of IVIG published in a April 2007 report entitled, “Intravenous Immune Globulin: Medicare Payment and Availability (OEI-03-05-00404),” found that for the third quarter of CY 2006, just over half of IVIG sales to hospitals and physicians were at prices below Medicare payment amounts. Relative to the previous three quarters, this represented a substantial increase of the percentage of sales with prices below Medicare amounts. During the third quarter of 2006, 56 percent of IVIG sales to hospitals and over 59 percent of IVIG sales to physicians by the largest 3 distributors occurred at prices below the Medicare payment amounts. We reviewed national claims data for IVIG drug utilization as well as utilization of the preadministration–related services HCPCS code. The data show modest increases in the utilization of IVIG drugs and the preadministration-related services code, which suggest that IVIG pricing and access may be improving. In the CY 2009 PFS proposed rule, we noted that these factors, taken as a whole, suggested a lessening of the instability of the IVIG market. As a result of these developments, we proposed to discontinue the preadministration-related service payment in 2009 for HCPCS 124
CMS-1403-FC code G0332. For CY 2009, under the Outpatient Prospective Payment System (OPPS), a proposal was made to package payment for HCPCS code G0332 (73 FR 41457). The following is a summary of the comments received and our responses. Comment: We received several comments from beneficiaries, patient advocate groups, manufacturers, and physicians. Most commenters opposed the elimination of the preadministration-related services payment. A few commenters requested that the preadministration-related services payment become permanent for both the PFS and the OPPS. Some commenters stated that the market conditions for IVIG are not fundamentally different than they were when CMS initially instituted the preadministration-related services payment in CY 2006. The commenters requested that CMS continue the separate payment until there is more stability in the IVIG market. Several commenters stated that the information CMS presented in the CY 2009 PFS proposed rule did not conclusively prove that the IVIG market was stabilizing. The commenters stated that significant access problems remain. In response to the findings of the OIG report, some commenters stated that the lag inherent in the ASP pricing system may have played a role in substantially increasing 125
- Page 73 and 74: Code CMS-1403-FC 2008/9 Description
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<strong>CMS</strong>-1403-FC<br />
In the CY 2009 PFS proposed rule, we noted that the<br />
Office of the Inspector General’s (OIG) study on the<br />
availability and pricing of IVIG published in a April 2007<br />
report entitled, “Intravenous Immune Globulin: Medicare<br />
Payment and Availability (OEI-03-05-00404),” found that for<br />
the third quarter of CY 2006, just over half of IVIG sales<br />
to hospitals and physicians were at prices below Medicare<br />
payment amounts. Relative to the previous three quarters,<br />
this represented a substantial increase of the percentage<br />
of sales with prices below Medicare amounts. During the<br />
third quarter of 2006, 56 percent of IVIG sales to<br />
hospitals and over 59 percent of IVIG sales to physicians<br />
by the largest 3 distributors occurred at prices below the<br />
Medicare payment amounts. We reviewed national claims data<br />
for IVIG drug utilization as well as utilization of the<br />
preadministration–related services HCPCS code. The data<br />
show modest increases in the utilization of IVIG drugs and<br />
the preadministration-related services code, which suggest<br />
that IVIG pricing and access may be improving.<br />
In the CY 2009 PFS proposed rule, we noted that these<br />
factors, taken as a whole, suggested a lessening of the<br />
instability of the IVIG market. As a result of these<br />
developments, we proposed to discontinue the<br />
preadministration-related service payment in 2009 for HCPCS<br />
124