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) introduced 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. MEDICARE PATIENT IVIG ACCESS DEMONSTRA4 TION PROJECT. 

5 (a) ESTABLISHMENT.—The Secretary shall establish 

6 and implement a demonstration project under title XVIII 

7 of the Social Security Act to evaluate the benefits of pro8 viding payment for items and services needed for the adVerDate Mar 15 2010 05:09 Jun 25, 2010 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5597.IH H5597

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1 ministration, within the homes of Medicare beneficiaries, 

2 of intravenous immune globin for the treatment of pri3 mary immune deficiency diseases. 

4 (b) DURATION AND SCOPE.— 

5 (1) DURATION.—Beginning not later than Jan6 uary 1, 2011, the Secretary shall conduct the dem7 onstration project for a period of 3 years. 

8 (2) SCOPE.—The Secretary shall enroll not 

9 greater than 4,000 Medicare beneficiaries who have 

10 been diagnosed with primary immunodeficiency dis11 ease for participation in the demonstration project. 

12 A Medicare beneficiary may participate in the dem13 onstration project on a voluntary basis and may ter14 minate participation at any time. 

15 (c) REIMBURSEMENT.—The Secretary shall establish 

16 an hourly rate for payment for items and services needed 

17 for the administration of intravenous immune globin based 

18 on the low-utilization payment adjustment under the pro19 spective payment system for home health services estab20 lished under section 1895 of the Social Security Act (42 

21 U.S.C. 1395fff). 

22 (d) STUDY AND REPORT TO CONGRESS.— 

23 (1) INTERIM EVALUATION AND REPORT.—Not 

24 later than 24 months after the date of enactment of 


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1 this Act, the Secretary shall submit to Congress a 

2 report that contains the following: 

3 (A) An interim evaluation of the impact of 

4 the demonstration project on access for Medi5 care beneficiaries to items and services needed 

6 for the administration of intravenous immune 

7 globin within the home. 

8 (B) An analysis of the appropriateness of 

9 implementing a new methodology for payment 

10 for intravenous immune globulins in all care 

11 settings under part B of title XVIII of the So12 cial Security Act (42 U.S.C. 1395k et seq.). 

13 (C) An analysis of the feasability of reduc14 ing the lag time with respect to data used to 

15 determine the average sales price under section 

16 1847A of the Social Security Act (42 U.S.C. 

17 1395w–3a). 

18 (D) An update to the report entitled 

19 ‘‘Analysis of Supply, Distribution, Demand, and 

20 Access Issues Associated with Immune Globulin 

21 Intravenous (IGIV)’’, issued in February 2007 

22 by the Office of the Assistant Secretary for 

23 Planning and Evaluation of the Department of 

24 Health and Human Services. 


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1 (2) FINAL EVALUATION AND REPORT.—Not 

2 later than July 1, 2014, the Secretary shall submit 

3 to Congress a report that contains a final evaluation 

4 of the impact of the demonstration project on access 

5 for Medicare beneficiaries to items and services 

6 needed for the administration of intravenous im7 mune globin within the home. 

8 (e) OFFSET.— 

9 (1) IN GENERAL.—Section 1861(n) of the So10 cial Security Act (42 U.S.C. 1395x(n)) is amended 

11 by adding at the end the following: ‘‘Such term in12 cludes disposable drug delivery systems, including 

13 elastomeric infusion pumps, for the treatment of 

14 colorectal cancer.’’. 

15 (2) EFFECTIVE DATE.—The amendment made 

16 by paragraph (1) shall apply to items furnished on 

17 or after the date of enactment of this Act. 

18 (f) DEFINITIONS.—In this section: 

19 (1) DEMONSTRATION PROJECT.—The term 

20 ‘‘demonstration project’’ means the demonstration 

21 project conducted under this section. 

22 (2) MEDICARE BENEFICIARY.—The term 

23 ‘‘Medicare beneficiary’’ means an individual who is 

24 entitled to, or enrolled for, benefits under part A of 


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1 title XVIII of the Social Security Act or enrolled for 

2 benefits under part B of such title. 

3 (3) SECRETARY.—The term ‘‘Secretary’’ means 

4 the Secretary of Health and Human Services. 

Æ 


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