(3) The report of the Office of the Assistant 
Secretary for Planning and Evaluation (ASPE), De-
partment of Health and Human Services (DHHS), 
‘‘Analysis of Supply, Distribution, Demand, and Ac-
cess Issues Associated with Immune Globulin Intra-
venous (IGIV)’’, issued in May 2007, found that 
IVIG manufacturing is complex and requires sub-
stantial upfront cash outlay and planning and takes 
between seven and 12 months from plasma collection 
at donor centers to FDA lot release. 
(4) The Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 changed Medi-
care’s reimbursement methodology for IVIG from 
average wholesale price (AWP) to average sales price 
plus 6 percent (ASP+6), effective January 1, 2005, 
for physicians, and January 1, 2006, for hospital 
outpatient departments, thereby reducing reimburse-
ment rates paid to these providers of IVIG on behalf 
of Medicare beneficiaries. 
(5) An Office of the Inspector General (OIG) 
April 2007 report, Intravenous Immune Globulin: 
Medicare Payment and Availability, found that 
Medicare reimbursement for IVIG was inadequate to 
cover the cost many providers must pay for the 
product. During the third quarter of 2006, 44 per-
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cent of IVIG sales to hospitals and 41 percent of 
sales to physicians by the three largest distributors 
occurred at prices above Medicare payment amounts. 
(6) The ASPE report notes that after the new 
reimbursement rules for physicians was instituted in 
2005, 42 percent of Medicare beneficiaries who had 
received their IVIG treatment in their physician’s of-
fice at the end of 2004 were shifted to the hospital 
outpatient setting by the beginning of 2006. This 
shift in site of care has resulted in lack of continuity 
of care and adverse impact on health outcomes and 
quality of life. 
(7) The OIG also reported that 61 percent of 
responding physicians indicated that they had sent 
patients to hospitals for IVIG treatment, largely be-
cause of their inability to purchase IVIG at prices 
below the Medicare payment amounts. In addition, 
OIG found that some physicians had stopped pro-
viding IVIG to Medicare beneficiaries altogether. 
(8) The OIG’s 2007 report concluded that 
whatever improvement some providers saw in the re-
lationship of Medicare reimbursement for IVIG to 
prices paid during the first three quarters of 2006 
would be eroded if manufacturers were to increase 
prices for IVIG in the future. 
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(9) The Centers for Medicare & Medicaid Serv-
ices, in recognition of dislocations experienced by pa-
tients and providers in obtaining IVIG since the 
change to the ASP+6 reimbursement methodology, 
has provided during 2006 and 2007 a temporary ad-
ditional payment for IVIG preadministration-related 
services to compensate physicians and hospital out-
patient departments for the extra resources they 
have had to expend in locating and obtaining appro-
priate IVIG products and in scheduling patient infu-
sions. 
(10) Approximately 10,000 Medicare bene-
ficiaries receive IVIG treatment for their primary 
immunodeficiency disease in a variety of different 
settings. They have no other effective treatment for 
their condition. 
(11) The Medicare Modernization Act of 2003 
(MMA) established an IVIG home infusion benefit 
for persons with primary immunodeficiency disease 
(PIDD), paying only for IVIG and specifically ex-
cluding coverage of items and services related to ad-
ministration of the product. 
(12) The ASPE report, Analysis of Supply, 
Distribution, Demand, and Access Issues Associated 
with Immune Globulin Intravenous (IGIV), found 
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