I 
117TH CONGRESS 
1ST SESSION H. R. 3808 
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 
JUNE 11, 2021 
Mr. BLUMENAUER (for himself, Mr. SMITH of New Jersey, 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. 
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 5 years. 
(2) SCOPE.—The Secretary shall, subject to 
subsection (d), enroll not greater than 3,000 Medi-
care beneficiaries who have been diagnosed with 
chronic inflammatory demyelinating polyneuropathy 
or multifocal motor neuropathy for participation in 
the demonstration project. Subject to subsection (d), 
a Medicare beneficiary may participate in the dem-
onstration project on a voluntary basis and may ter-
minate participation at any time. 
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(c) COVERAGE.—Except as otherwise provided in this 
section, items and services for which payment may be 
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) ELIGIBILITY.—In order to participate in the dem-
onstration project, a Medicare beneficiary must— 
(1) be covered under the original Medicare fee- 
for-service program under parts A and B of title 
XVIII of the Social Security Act and not enrolled in 
a Medicare Advantage plan under part C of such 
Act; 
(2) require intravenous immunoglobulin for the 
treatment of chronic inflammatory demyelinating 
polyneuropathy or multifocal motor neuropathy; and 
(3) meet any other eligibility requirements spec-
ified by the Secretary. 
(e) 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.— 
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(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 
multifocal motor neuropathy based on the na-
tional 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.—In establishing the per 
visit payment amount established under sub-
paragraph (A) for items and services described 
in such subparagraph, the Secretary shall con-
sider— 
(i) including a component for requisite 
nursing care; 
(ii) establishing an appropriate fur-
nishing fee for intravenous immune glob-
ulin similar to the separate payment for 
clotting factors under section 1842(o)(5) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395u(o)(5)); 
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(iii) 
otherwise 
acknowledging 
the 
length of infusions for individuals needing 
in-home infusion of intravenous globulin 
for treatment described in subparagraph 
(A); 
(iv) that, in total, such amount poten-
tially not being less than at least 2.5 times 
the payment amount applied under the 
demonstration project established under 
section 101 of the Medicare IVIG Access 
and Strengthening Medicare and Repaying 
Taxpayers Act of 2012 (Public Law 112– 
242) for items and services needed for the 
in-home administration of intravenous im-
mune globulin for the treatment of pri-
mary immune deficiency diseases in rec-
ognition of the fact that patients with 
chronic inflammatory demyelinating poly-
neuropathy or multifocal motor neuropathy 
tend to have longer infusion times, require 
more product, and have additional health-
care needs related to underlying neuromus-
cular challenges; and 
(v) developing such amount in con-
sultation with stakeholders. 
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(f) 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. 
(g) FINAL EVALUATION AND REPORT.—Not later 
than one year after the third year of the demonstration 
project, the Secretary shall submit to Congress a report 
that contains— 
(1) a current and projected evaluation of the 
impact of the demonstration project on access for 
Medicare beneficiaries with chronic inflammatory 
demyelinating polyneuropathy and Medicare bene-
ficiaries with multifocal motor neuropathy to items 
and services needed for the in-home administration 
of intravenous immune globin that also draws upon 
information and data from the ongoing home infu-
sion demonstration project for primary immuno-
deficiency diseases (Public Law 112–242) and the 
recent effort to provide an adequate coverage benefit 
for therapies infused through durable medical equip-
ment (HCPCS CMS–1738–P); and 
(2) a final analysis of the appropriateness of ex-
panding or extending the demonstration project, or 
implementing a new methodology for payment for in-
travenous immune globulins in all care settings 
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under part B of title XVIII of the Social Security 
Act (42 U.S.C. 1395k et seq.), or augmenting exist-
ing benefits to provide proper access for home infu-
sion of intravenous immune globulins, and, to the 
extent such analysis determines such an expansion, 
extension, or methodology appropriate, recommenda-
tions for such expansion, extension, or methodology, 
respectively, along with an explanation of how CMS 
intends to implement or otherwise provide such a 
permanent benefit or mechanism for access during 
the fifth year of the demo to ensure nondisruptions 
in care for impacted patients. 
(h) DEFINITIONS.—In this section: 
(1) DEMONSTRATION
PROJECT.—The term 
‘‘demonstration project’’ means the demonstration 
project conducted under this Act. 
(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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