I 

116TH CONGRESS 

1ST SESSION H. R. 2905 

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 

MAY 22, 2019 

Mr. BLUMENAUER (for himself, Mr. HOLDING, and Mr. BUTTERFIELD) 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, subject to 

18 subsection (d), enroll not greater than 3,000 Medi19 care beneficiaries who have been diagnosed with 

20 chronic inflammatory demyelinating polyneuropathy 

21 or multifocal motor neuropathy for participation in 

22 the demonstration project. Subject to subsection (d), 

23 a Medicare beneficiary may participate in the dem24 onstration project on a voluntary basis and may ter25 minate participation at any time. 


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1 (c) COVERAGE.—Except as otherwise provided in this 

2 section, items and services for which payment may be 

3 made under the demonstration program shall be treated 

4 and covered under part B of title XVIII of the Social Se5 curity Act in the same manner as similar items and serv6 ices covered under such part. 

7 (d) ELIGIBILITY.—In order to participate in the dem8 onstration project, a Medicare beneficiary must— 

9 (1) be covered under the original Medicare fee10 for-service program under parts A and B of title 

11 XVIII of the Social Security Act and not enrolled in 

12 a Medicare Advantage plan under part C of such 

13 Act; 

14 (2) require intravenous immunoglobulin for the 

15 treatment of chronic inflammatory demyelinating 

16 polyneuropathy or multifocal motor neuropathy; and 

17 (3) meet any other eligibility requirements spec18 ified by the Secretary. 

19 (e) PAYMENT.— 

20 (1) INTRAVENOUS IMMUNE GLOBULIN.—For in21 travenous immune globulin furnished under this sec22 tion, the Secretary shall make payment using the 

23 payment methodology under section 1847A of the 

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

25 (2) OTHER ITEMS AND SERVICES.— 


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1 (A) IN GENERAL.—The Secretary shall es2 tablish, subject to subparagraph (B), a per-visit 

3 payment amount for items and services (other 

4 than intravenous immune globulin) needed for 

5 the in-home infusion of intravenous immune 

6 globulin for the treatment of chronic inflam7 matory demyelinating polyneuropathy or 

8 multifocal motor neuropathy based on the na9 tional per visit low-utilization payment amount 

10 under the prospective payment system for home 

11 health services established under section 1895 

12 of the Social Security Act (42 U.S.C. 1395fff). 

13 (B) LIMITATION.—In establishing the per14 visit payment amount established under sub15 paragraph (A) for items and services described 

16 in such subparagraph, the Secretary shall con17 sider— 

18 (i) including a component for requisite 

19 nursing care; 

20 (ii) establishing an appropriate fur21 nishing fee for intravenous immune glob22 ulin similar to the separate payment for 

23 clotting factors under section 1842(o)(5) of 

24 the Social Security Act (42 U.S.C. 

25 1395u(o)(5)); 


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1 (iii) otherwise acknowledging the 

2 length of infusions for individuals needing 

3 in-home infusion of intravenous globulin 

4 for treatment described in subparagraph 

5 (A); 

6 (iv) that, in total, such amount poten7 tially not being less than at least twice the 

8 payment amount applied under the dem9 onstration project established under section 

10 101 of the Medicare IVIG Access and 

11 Strengthening Medicare and Repaying 

12 Taxpayers Act of 2012 (Public Law 112– 

13 242) for items and services needed for the 

14 in-home administration of intravenous im15 mune globulin for the treatment of pri16 mary immune deficiency diseases in rec17 ognition of the fact that patients with 

18 chronic inflammatory demyelinating 

19 polyneuropathy or multifocal motor neu20 ropathy tend to have longer infusion times, 

21 require more product, and have additional 

22 health care needs related to underlying 

23 neuromuscular challenges; and 

24 (v) developing such amount in con25 sultation with stakeholders. 


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1 (f) WAIVER AUTHORITY.—The Secretary may waive 

2 such requirements of title XVIII of the Social Security Act 

3 as may be necessary to carry out the demonstration 

4 project. 

5 (g) FINAL EVALUATION AND REPORT.—Not later 

6 than one year after the date of completion of the dem7 onstration project, the Secretary shall submit to Congress 

8 a report that contains— 

9 (1) a final evaluation of the impact of the dem10 onstration project on access for Medicare bene11 ficiaries with chronic inflammatory demyelinating 

12 polyneuropathy and Medicare beneficiaries with 

13 multifocal motor neuropathy to items and services 

14 needed for the in-home administration of intra15 venous immune globin; and 

16 (2) a final analysis of the appropriateness of ex17 panding or extending the demonstration project or 

18 implementing a new methodology for payment for in19 travenous immune globulins in all care settings 

20 under part B of title XVIII of the Social Security 

21 Act (42 U.S.C. 1395k et seq.) and, to the extent 

22 such analysis determines such an expansion, exten23 sion, or methodology appropriate, recommendations 

24 for such expansion, extension, or methodology, re25 spectively. 


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1 (h) DEFINITIONS.—In this section: 

2 (1) DEMONSTRATION PROJECT.—The term 

3 ‘‘demonstration project’’ means the demonstration 

4 project conducted under this Act. 

5 (2) MEDICARE BENEFICIARY.—The term 

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

7 enrolled for benefits under part B of title XVIII of 

8 the Social Security Act. 

Æ 


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