I 

115TH CONGRESS 

1ST SESSION H. R. 4724 

To provide for a demonstration project to further examine the benefits of 

providing coverage and payment for items and services necessary to 

administer intravenous immune globulin (IVIG) in the home, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 21, 2017 

Mr. HOLDING (for himself, Mr. BLUMENAUER, Mr. LANCE, Mr. 

BUTTERFIELD, and Mr. MEEHAN) introduced the following bill; which 

was referred to the Committee on Energy and Commerce, and in addition 

to the Committee on Ways and Means, 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 demonstration project to further examine 

the benefits of providing coverage and payment for items 

and services necessary to administer intravenous immune 

globulin (IVIG) in the home, and for other purposes. 

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 Enhancement Act’’. 


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1 SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 

2 PROJECT. 

3 (a) ESTABLISHMENT.—The Secretary of Health and 

4 Human Services (in this section referred to as the ‘‘Sec5 retary’’) shall establish and implement a demonstration 

6 project under part B of title XVIII of the Social Security 

7 Act to evaluate the benefits of providing payment for items 

8 and services needed for the in-home administration of in9 travenous immune globulin for the treatment of chronic 

10 inflammatory demyelinating polyneuropathy or multifocal 

11 motor neuropathy. 

12 (b) DURATION AND SCOPE.— 

13 (1) DURATION.—Beginning not later than 1 

14 year after the date of enactment of this Act, the 

15 Secretary shall conduct the demonstration project 

16 for a period of 3 years. 

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

18 greater than 3,000 Medicare beneficiaries who have 

19 been diagnosed with chronic inflammatory demyelin20 ating polyneuropathy or multifocal motor neurop21 athy 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) COVERAGE.—Except as otherwise provided in this 

26 section, items and services for which payment may be 


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1 made under the demonstration program shall be treated 

2 and covered under part B of title XVIII of the Social Se3 curity Act in the same manner as similar items and serv4 ices covered under such part. 

5 (d) PAYMENT.— 

6 (1) INTRAVENOUS IMMUNE GLOBULIN.—For in7 travenous immune globulin furnished under this sec8 tion, the Secretary shall make payment using the 

9 payment methodology under section 1847A of the 

10 Social Security Act (42 U.S.C. 1395w–3a). 

11 (2) OTHER ITEMS AND SERVICES.— 

12 (A) IN GENERAL.—The Secretary shall es13 tablish, subject to subparagraph (B), a per-visit 

14 payment amount for items and services (other 

15 than intravenous immune globulin) needed for 

16 the in-home infusion of intravenous immune 

17 globulin for the treatment of chronic inflam18 matory demyelinating polyneuropathy or multi19 focal motor neuropathy based on the national 

20 per visit low-utilization payment amount under 

21 the prospective payment system for home health 

22 services established under section 1895 of the 

23 Social Security Act (42 U.S.C. 1395fff). 

24 (B) LIMITATION.—The per-visit payment 

25 amount established under subparagraph (A) for 


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1 items and services described in such subpara2 graph shall not be less than the payment 

3 amount applied under the demonstration 

4 project established under section 101 of the 

5 Medicare IVIG Access and Strengthening Medi6 care and Repaying Taxpayers Act of 2012 

7 (Public Law 112–242) for comparable items 

8 and services needed for the in-home administra9 tion of intravenous immune globulin for the 

10 treatment of primary immune deficiency dis11 eases. 

12 (e) WAIVER AUTHORITY.—The Secretary may waive 

13 such requirements of title XVIII of the Social Security Act 

14 as may be necessary to carry out the demonstration 

15 project. 

16 (f) REPORTS TO CONGRESS.— 

17 (1) INTERIM EVALUATION AND REPORT.—Not 

18 later than 3 years after the date of enactment of 

19 this Act, the Secretary shall submit to Congress a 

20 report that contains— 

21 (A) an evaluation of the impact of the 

22 demonstration project on access for Medicare 

23 beneficiaries with chronic inflammatory demye24 linating polyneuropathy and Medicare bene25 ficiaries with multifocal motor neuropathy to 


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1 items and services needed for the in-home ad2 ministration of intravenous immune globin; and 

3 (B) an analysis of the appropriateness of 

4 expanding or extending the demonstration 

5 project or implementing a new methodology for 

6 payment for intravenous immune globulins in 

7 all care settings under part B of title XVIII of 

8 the Social Security Act (42 U.S.C. 1395k et 

9 seq.) and, to the extent such analysis deter10 mines such an expansion, extension, or method11 ology appropriate, recommendations for such 

12 expansion, extension, or methodology, respec13 tively. 

14 (2) FINAL EVALUATION AND REPORT.—Not 

15 later than one year after the date of completion of 

16 the demonstration project, the Secretary shall sub17 mit to Congress a report that contains— 

18 (A) a final evaluation of the impact de19 scribed in paragraph (1)(A); and 

20 (B) a final analysis and recommendations 

21 described in paragraph (1)(B). 

22 (g) DEFINITIONS.—In this section: 

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 enrolled for benefits under part B of title XVIII of 

4 the Social Security Act. 

Æ 


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