[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3808 Introduced in House (IH)]
<DOC>
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 Representatives 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''.
SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.
(a) Establishment.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') 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 intravenous
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 Medicare 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 demonstration
project on a voluntary basis and may terminate participation at
any time.
(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 Security Act in the same manner as similar items and services
covered under such part.
(d) Eligibility.--In order to participate in the demonstration
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 specified by
the Secretary.
(e) Payment.--
(1) Intravenous immune globulin.--For intravenous immune
globulin furnished under this section, 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 establish,
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 inflammatory demyelinating polyneuropathy or
multifocal 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.--In establishing the per visit
payment amount established under subparagraph (A) for
items and services described in such subparagraph, the
Secretary shall consider--
(i) including a component for requisite
nursing care;
(ii) establishing an appropriate furnishing
fee for intravenous immune globulin 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));
(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
potentially 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 immune globulin for the
treatment of primary immune deficiency diseases
in recognition of the fact that patients with
chronic inflammatory demyelinating
polyneuropathy or multifocal motor neuropathy
tend to have longer infusion times, require
more product, and have additional healthcare
needs related to underlying neuromuscular
challenges; and
(v) developing such amount in consultation
with stakeholders.
(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
beneficiaries 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 infusion demonstration project for primary
immunodeficiency diseases (Public Law 112-242) and the recent
effort to provide an adequate coverage benefit for therapies
infused through durable medical equipment (HCPCS CMS-1738-P);
and
(2) a final 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.), or augmenting existing
benefits to provide proper access for home infusion of
intravenous immune globulins, and, to the extent such analysis
determines such an expansion, extension, or methodology
appropriate, recommendations 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.
<all>