Notice: This CMS-approved document has been submitted - Philips ...

CMS-1403-FC
Response: The separate payment for IVIG
preadministration-related service was designed to
compensate the physician practice for the additional,
unusual, and temporary costs associated with obtaining IVIG
products and scheduling patient infusions during a
temporary period of market instability. This payment was
never intended to subsidize payment for drugs made under
the ASP system.
In the CY 2009 PFS proposed rule, we referred to data
from the OIG study that indicated that for the third
quarter of 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. We agree with
the commenters that it is likely that increased ASP
payments were the result of previous price increases from
past quarters influencing future ASP data. Furthermore,
the new HCPCS codes for IVIG products allow the physician
to report and receive payment for the specific product
furnished to the patient. We stated clearly in the CY 2006
PFS final rule with comment period that the
preadministration-related services payment policy was a
temporary measure to pay physicians for the unusual and
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