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 provi-
sions 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare IVIG Access 
Enhancement Act’’. 
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SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION 
PROJECT. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’) shall establish and implement a demonstration 
project under part B of title XVIII of the Social Security 
Act to evaluate the benefits of providing payment for items 
and services needed for the in-home administration of in-
travenous immune globulin for the treatment of chronic 
inflammatory demyelinating polyneuropathy or multifocal 
motor neuropathy. 
(b) DURATION AND SCOPE.— 
(1) DURATION.—Beginning not later than 1 
year after the date of enactment of this Act, the 
Secretary shall conduct the demonstration project 
for a period of 3 years. 
(2) SCOPE.—The Secretary shall enroll not 
greater than 3,000 Medicare beneficiaries who have 
been diagnosed with chronic inflammatory demyelin-
ating polyneuropathy or multifocal motor neurop-
athy for participation in the demonstration project. 
A Medicare beneficiary may participate in the dem-
onstration project on a voluntary basis and may ter-
minate participation at any time. 
(c) COVERAGE.—Except as otherwise provided in this 
section, items and services for which payment may be 
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made under the demonstration program shall be treated 
and covered under part B of title XVIII of the Social Se-
curity Act in the same manner as similar items and serv-
ices covered under such part. 
(d) PAYMENT.— 
(1) INTRAVENOUS IMMUNE GLOBULIN.—For in-
travenous immune globulin furnished under this sec-
tion, the Secretary shall make payment using the 
payment methodology under section 1847A of the 
Social Security Act (42 U.S.C. 1395w–3a). 
(2) OTHER ITEMS AND SERVICES.— 
(A) IN GENERAL.—The Secretary shall es-
tablish, subject to subparagraph (B), a per-visit 
payment amount for items and services (other 
than intravenous immune globulin) needed for 
the in-home infusion of intravenous immune 
globulin for the treatment of chronic inflam-
matory demyelinating polyneuropathy or multi-
focal motor neuropathy based on the national 
per visit low-utilization payment amount under 
the prospective payment system for home health 
services established under section 1895 of the 
Social Security Act (42 U.S.C. 1395fff). 
(B) LIMITATION.—The per-visit payment 
amount established under subparagraph (A) for 
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items and services described in such subpara-
graph shall not be less than the payment 
amount 
applied 
under 
the 
demonstration 
project established under section 101 of the 
Medicare IVIG Access and Strengthening Medi-
care and Repaying Taxpayers Act of 2012 
(Public Law 112–242) for comparable items 
and services needed for the in-home administra-
tion of intravenous immune globulin for the 
treatment of primary immune deficiency dis-
eases. 
(e) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of title XVIII of the Social Security Act 
as may be necessary to carry out the demonstration 
project. 
(f) REPORTS TO CONGRESS.— 
(1) INTERIM EVALUATION AND REPORT.—Not 
later than 3 years after the date of enactment of 
this Act, the Secretary shall submit to Congress a 
report that contains— 
(A) an evaluation of the impact of the 
demonstration project on access for Medicare 
beneficiaries with chronic inflammatory demye-
linating polyneuropathy and Medicare bene-
ficiaries with multifocal motor neuropathy to 
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items and services needed for the in-home ad-
ministration of intravenous immune globin; and 
(B) an analysis of the appropriateness of 
expanding or extending the demonstration 
project or implementing a new methodology for 
payment for intravenous immune globulins in 
all care settings under part B of title XVIII of 
the Social Security Act (42 U.S.C. 1395k et 
seq.) and, to the extent such analysis deter-
mines such an expansion, extension, or method-
ology appropriate, recommendations for such 
expansion, extension, or methodology, respec-
tively. 
(2) FINAL
EVALUATION
AND
REPORT.—Not 
later than one year after the date of completion of 
the demonstration project, the Secretary shall sub-
mit to Congress a report that contains— 
(A) a final evaluation of the impact de-
scribed in paragraph (1)(A); and 
(B) a final analysis and recommendations 
described in paragraph (1)(B). 
(g) DEFINITIONS.—In this section: 
(1) DEMONSTRATION
PROJECT.—The term 
‘‘demonstration project’’ means the demonstration 
project conducted under this Act. 
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(2) 
MEDICARE
BENEFICIARY.—The 
term 
‘‘Medicare beneficiary’’ means an individual who is 
enrolled for benefits under part B of title XVIII of 
the Social Security Act. 
Æ 
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