I 
111TH CONGRESS 
2D SESSION 
H. R. 5597 
To establish a Medicare patient IVIG access demonstration project. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 24, 2010 
Ms. MATSUI (for herself, Mr. RUSH, Mr. BRALEY of Iowa, Mr. VAN HOLLEN, 
Mr. GERLACH, Mr. TERRY, Mr. BRADY of Texas, and Mr. PITTS) intro-
duced the following bill; which was referred to the Committee on Ways 
and Means, and in addition to the Committee on Energy and Commerce, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To establish a Medicare patient IVIG access demonstration 
project. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. MEDICARE PATIENT IVIG ACCESS DEMONSTRA-
TION PROJECT. 
(a) ESTABLISHMENT.—The Secretary shall establish 
and implement a demonstration project under title XVIII 
of the Social Security Act to evaluate the benefits of pro-
viding payment for items and services needed for the ad-
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ministration, within the homes of Medicare beneficiaries, 
of intravenous immune globin for the treatment of pri-
mary immune deficiency diseases. 
(b) DURATION AND SCOPE.— 
(1) DURATION.—Beginning not later than Jan-
uary 1, 2011, the Secretary shall conduct the dem-
onstration project for a period of 3 years. 
(2) SCOPE.—The Secretary shall enroll not 
greater than 4,000 Medicare beneficiaries who have 
been diagnosed with primary immunodeficiency dis-
ease for participation in the demonstration project. 
A Medicare beneficiary may participate in the dem-
onstration project on a voluntary basis and may ter-
minate participation at any time. 
(c) REIMBURSEMENT.—The Secretary shall establish 
an hourly rate for payment for items and services needed 
for the administration of intravenous immune globin based 
on the low-utilization payment adjustment under the pro-
spective payment system for home health services estab-
lished under section 1895 of the Social Security Act (42 
U.S.C. 1395fff). 
(d) STUDY AND REPORT TO CONGRESS.— 
(1) INTERIM EVALUATION AND REPORT.—Not 
later than 24 months after the date of enactment of 
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this Act, the Secretary shall submit to Congress a 
report that contains the following: 
(A) An interim evaluation of the impact of 
the demonstration project on access for Medi-
care beneficiaries to items and services needed 
for the administration of intravenous immune 
globin within the home. 
(B) An analysis of the appropriateness of 
implementing a new methodology for payment 
for intravenous immune globulins in all care 
settings under part B of title XVIII of the So-
cial Security Act (42 U.S.C. 1395k et seq.). 
(C) An analysis of the feasability of reduc-
ing the lag time with respect to data used to 
determine the average sales price under section 
1847A of the Social Security Act (42 U.S.C. 
1395w–3a). 
(D) An update to the report entitled 
‘‘Analysis of Supply, Distribution, Demand, and 
Access Issues Associated with Immune Globulin 
Intravenous (IGIV)’’, issued in February 2007 
by the Office of the Assistant Secretary for 
Planning and Evaluation of the Department of 
Health and Human Services. 
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(2) FINAL
EVALUATION
AND
REPORT.—Not 
later than July 1, 2014, the Secretary shall submit 
to Congress a report that contains a final evaluation 
of the impact of the demonstration project on access 
for Medicare beneficiaries to items and services 
needed for the administration of intravenous im-
mune globin within the home. 
(e) OFFSET.— 
(1) IN GENERAL.—Section 1861(n) of the So-
cial Security Act (42 U.S.C. 1395x(n)) is amended 
by adding at the end the following: ‘‘Such term in-
cludes disposable drug delivery systems, including 
elastomeric infusion pumps, for the treatment of 
colorectal cancer.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to items furnished on 
or after the date of enactment of this Act. 
(f) DEFINITIONS.—In this section: 
(1) DEMONSTRATION
PROJECT.—The term 
‘‘demonstration project’’ means the demonstration 
project conducted under this section. 
(2) 
MEDICARE
BENEFICIARY.—The 
term 
‘‘Medicare beneficiary’’ means an individual who is 
entitled to, or enrolled for, benefits under part A of 
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title XVIII of the Social Security Act or enrolled for 
benefits under part B of such title. 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
Æ 
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