I 

112TH CONGRESS 

1ST SESSION H. R. 1845 

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 HOUSE OF REPRESENTATIVES 

MAY 11, 2011 

Mr. BRADY of Texas (for himself, Ms. MATSUI, Mr. BURGESS, Mr. SARBANES, 

Mr. PAUL, Mr. VAN HOLLEN, Mr. TIBERI, Mr. RUPPERSBERGER, Mrs. 

BLACKBURN, Mr. SCHIFF, Ms. JENKINS, Mr. KIND, Ms. FUDGE, Ms. 

RICHARDSON, and Mr. RUSH) 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 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, 


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1 SECTION 1. SHORT TITLE. 

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

3 Act’’. 

4 SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 

5 PROJECT. 

6 (a) ESTABLISHMENT.—The Secretary shall establish 

7 and implement a demonstration project under title XVIII 

8 of the Social Security Act to evaluate the benefits of pro9 viding payment for items and services needed for the ad10 ministration, within the homes of Medicare beneficiaries, 

11 of intravenous immune globin for the treatment of pri12 mary immune deficiency diseases. 

13 (b) DURATION AND SCOPE.— 

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

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

16 Secretary shall conduct the demonstration project 

17 for a period of 3 years. 

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

19 greater than 4,000 Medicare beneficiaries who have 

20 been diagnosed with primary immunodeficiency dis21 ease for participation in the demonstration project. 

22 A Medicare beneficiary may participate in the dem23 onstration project on a voluntary basis and may ter24 minate participation at any time. 

25 (c) REIMBURSEMENT.—The Secretary shall establish 

26 an hourly rate for payment for items and services needed 


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1 for the administration of intravenous immune globin based 

2 on the low-utilization payment adjustment under the pro3 spective payment system for home health services estab4 lished under section 1895 of the Social Security Act (42 

5 U.S.C. 1395fff). 

6 (d) STUDY AND REPORT TO CONGRESS.— 

7 (1) INTERIM EVALUATION AND REPORT.—Not 

8 later than 24 months after the date of enactment of 

9 this Act, the Secretary shall submit to Congress a 

10 report that contains the following: 

11 (A) An interim evaluation of the impact of 

12 the demonstration project on access for Medi13 care beneficiaries to items and services needed 

14 for the administration of intravenous immune 

15 globin within the home. 

16 (B) An analysis of the appropriateness of 

17 implementing a new methodology for payment 

18 for intravenous immune globulins in all care 

19 settings under part B of title XVIII of the So20 cial Security Act (42 U.S.C. 1395k et seq.). 

21 (C) An analysis of the feasability of reduc22 ing the lag time with respect to data used to 

23 determine the average sales price under section 

24 1847A of the Social Security Act (42 U.S.C. 

25 1395w–3a). 


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1 (D) An update to the report entitled 

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

3 Access Issues Associated with Immune Globulin 

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

5 by the Office of the Assistant Secretary for 

6 Planning and Evaluation of the Department of 

7 Health and Human Services. 

8 (2) FINAL EVALUATION AND REPORT.—Not 

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

10 to Congress a report that contains a final evaluation 

11 of the impact of the demonstration project on access 

12 for Medicare beneficiaries to items and services 

13 needed for the administration of intravenous im14 mune globin within the home. 

15 (e) OFFSET.— 

16 (1) IN GENERAL.—Section 1861(n) of the So17 cial Security Act (42 U.S.C. 1395x(n)) is amended 

18 by adding at the end the following: ‘‘Such term in19 cludes disposable drug delivery systems, including 

20 elastomeric infusion pumps, for the treatment of 

21 colorectal cancer.’’. 

22 (2) EFFECTIVE DATE.—The amendment made 

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

24 or after the date of enactment of this Act. 

25 (f) DEFINITIONS.—In this Act: 


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1 (1) DEMONSTRATION PROJECT.—The term 

2 ‘‘demonstration project’’ means the demonstration 

3 project conducted under this Act. 

4 (2) MEDICARE BENEFICIARY.—The term 

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

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

7 title XVIII of the Social Security Act or enrolled for 

8 benefits under part B of such title. 

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

10 the Secretary of Health and Human Services. 

Æ 


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