II 

112TH CONGRESS 

1ST SESSION S. 960 

To provide for a study on issues relating to access to intravenous immune 

globulin (IVIG) for Medicare beneficiaries in all care settings and a 

demonstration project to examine the benefits of providing coverage and 

payment for items and services necessary to administer IVIG in the 

home. 

IN THE SENATE OF THE UNITED STATES 

MAY 12, 2011 

Mr. KERRY (for himself, Mr. ALEXANDER, and Mr. WYDEN) introduced the 

following bill; which was read twice and referred to the Committee on Finance 

A BILL 

To provide for a study on issues relating to access to intravenous immune globulin (IVIG) for Medicare beneficiaries in all care settings and a demonstration project 

to examine the benefits of providing coverage and payment for items and services necessary to administer IVIG 

in the home. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare IVIG Access 

5 Act’’. 


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1 SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 

2 PROJECT. 

3 (a) ESTABLISHMENT.—The Secretary shall establish 

4 and implement a demonstration project under title XVIII 

5 of the Social Security Act to evaluate the benefits of pro6 viding payment for items and services needed for the ad7 ministration, within the homes of Medicare beneficiaries, 

8 of intravenous immune globin for the treatment of pri9 mary immune deficiency diseases. 

10 (b) DURATION AND SCOPE.— 

11 (1) DURATION.—Beginning not later than 6 

12 months after the date of enactment of this Act, the 

13 Secretary shall conduct the demonstration project 

14 for a period of 3 years. 

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

16 greater than 4,000 Medicare beneficiaries who have 

17 been diagnosed with primary immunodeficiency dis18 ease for participation in the demonstration project. 

19 A Medicare beneficiary may participate in the dem20 onstration project on a voluntary basis and may ter21 minate participation at any time. 

22 (c) REIMBURSEMENT.—The Secretary shall establish 

23 an hourly rate for payment for items and services needed 

24 for the administration of intravenous immune globin based 

25 on the low-utilization payment adjustment under the pro26 spective payment system for home health services estabVerDate Mar 15 2010 04:30 May 18, 2011 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S960.IS S960

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1 lished under section 1895 of the Social Security Act (42 

2 U.S.C. 1395fff). 

3 (d) STUDY AND REPORT TO CONGRESS.— 

4 (1) INTERIM EVALUATION AND REPORT.—Not 

5 later than 24 months after the date of enactment of 

6 this Act, the Secretary shall submit to Congress a 

7 report that contains the following: 

8 (A) An interim evaluation of the impact of 

9 the demonstration project on access for Medi10 care beneficiaries to items and services needed 

11 for the administration of intravenous immune 

12 globin within the home. 

13 (B) An analysis of the appropriateness of 

14 implementing a new methodology for payment 

15 for intravenous immune globulins in all care 

16 settings under part B of title XVIII of the So17 cial Security Act (42 U.S.C. 1395k et seq.). 

18 (C) An analysis of the feasibility of reduc19 ing the lag time with respect to data used to 

20 determine the average sales price under section 

21 1847A of the Social Security Act (42 U.S.C. 

22 1395w–3a). 

23 (D) An update to the report entitled 

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

25 Access Issues Associated with Immune Globulin 


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

2 by the Office of the Assistant Secretary for 

3 Planning and Evaluation of the Department of 

4 Health and Human Services. 

5 (2) FINAL EVALUATION AND REPORT.—Not 

6 later than July 1, 2015, the Secretary shall submit 

7 to Congress a report that contains a final evaluation 

8 of the impact of the demonstration project on access 

9 for Medicare beneficiaries to items and services 

10 needed for the administration of intravenous im11 mune globin within the home. 

12 (e) OFFSET.— 

13 (1) IN GENERAL.—Section 1861(n) of the So14 cial Security Act (42 U.S.C. 1395x(n)) is amended 

15 by adding at the end the following: ‘‘Such term in16 cludes disposable drug delivery systems, including 

17 elastomeric infusion pumps, for the treatment of 

18 colorectal cancer.’’. 

19 (2) EFFECTIVE DATE.—The amendment made 

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

21 or after the date of enactment of this Act. 

22 (f) DEFINITIONS.—In this Act: 

23 (1) DEMONSTRATION PROJECT.—The term 

24 ‘‘demonstration project’’ means the demonstration 

25 project conducted under this Act. 


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1 (2) MEDICARE BENEFICIARY.—The term 

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

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

4 title XVIII of the Social Security Act or enrolled for 

5 benefits under part B of such title. 

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

7 the Secretary of Health and Human Services. 

Æ 


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