I
107TH CONGRESS
1ST SESSION
H. R. 2750
To amend title XVIII of the Social Security Act to provide for coverage
of home infusion drug therapies under the medicare program.
IN THE HOUSE OF REPRESENTATIVES
AUGUST 2, 2001
Mr. ENGEL (for himself, Ms. HART, Mr. TOWNS, and Mr. RUSH) 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 com-
mittee concerned
A BILL
To amend title XVIII of the Social Security Act to provide
for coverage of home infusion drug therapies under the
medicare program.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; PURPOSES.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Medicare Home Infusion Therapy Act of 2001’’.
(b) PURPOSE.—The purposes of this Act are to en-
sure that medicare beneficiaries—
(1) have the choice of receiving infusion drug
therapies in the home when clinically appropriate
rather than in an inpatient setting; and
(2) are receiving high quality, safe, and efficient
care with respect to home infusion drug therapies.
SEC. 2. COVERAGE OF AND PAYMENT FOR HOME INFUSION
DRUG THERAPY SERVICES.
(a) COVERAGE.—
(1) IN GENERAL.—Section 1861(s) of the So-
cial Security Act (42 U.S.C. 1395x(s)) is amended—
(A) in the second sentence, by redesig-
nating paragraphs (16) and (17) as clauses (i)
and (ii); and
(B) in the first sentence—
(i) by striking ‘‘and’’ at the end of
paragraph (14);
(ii) by striking the period at the end
of paragraph (15) and inserting ‘‘; and’’;
and
(iii) by adding after paragraph (15)
the following new paragraph:
‘‘(16) home infusion drug therapy services (as
defined in subsection (ww).’’.
(2) 
CONFORMING
AMENDMENTS.—Sections
1864(a) 1902(a)(9)(C), and 1915(a)(1)(B)(ii)(I) of
such Act (42 U.S.C. 1395aa(a), 1396a(a)(9)(C), and
1396n(a)(1)(B)(ii)(I)) are each amended by striking
‘‘paragraphs (16) and (17)’’ each place it appears
and inserting ‘‘clauses (i) and (ii) of the second sen-
tence’’.
(b) HOME INFUSION DRUG THERAPY DEFINED.—
Section 1861 of such Act (42 U.S.C. 1395x), as amended
by sections 102 and 105 of the Medicare, Medicaid, and
SCHIP Benefits Improvement and Protection Act of 2000
(114 Stat. 2763A–468, 471), as enacted into law by sec-
tion 1(a)(6) of Public Law 106–554, is amended by add-
ing at the end the following new subsection:
‘‘Home Infusion Drug Therapy Services
‘‘(ww)(1) The term ‘home infusion drug therapy serv-
ices’ means—
‘‘(A) pharmacy, nursing, and related items and
services (including medical supplies, intravenous
fluids, drugs described in section 1834(n), home de-
livery, equipment, and other items and services the
Secretary determines appropriate) to administer in-
fusion drug therapies to an individual safely and ef-
fectively in the home in conformance with clinical
standards of care established by the Secretary;
‘‘(B) that are furnished by a qualified supplier
via an intravenous, intra-arterial or intrathecal ac-
cess device inserted into the body; and
‘‘(C) provided under a plan of care established
and periodically reviewed by a physician.
‘‘(2) In paragraph (1)—
‘‘(A) the term ‘home’ means a place of resi-
dence used as an individual’s home (or a provider of
services used as the individual’s home if the drug is
administered during a period of inpatient stay for
which payment is not made to the provider of serv-
ices under part A); and
‘‘(B) the term ‘qualified supplier’ means any
entity that meets such requirements as the Secretary
determines are necessary to ensure the safe and ef-
fective provision of home infusion drug therapy serv-
ices.’’.
(c) PAYMENT.—
(1) ESTABLISHMENT OF FEE SCHEDULE.—Sec-
tion 1834 of the Social Security Act (42 U.S.C.
1395l), as amended by section 223(b) of the Medi-
care, Medicaid, and SCHIP Benefits Improvement
and Protection Act of 2000 (114 Stat. 2763A–487),
as enacted into law by section 1(a)(6) of Public Law
106–554, is amended by adding at the end the fol-
lowing new subsection:
‘‘(n) HOME INFUSION DRUG THERAPY SERVICES.—
‘‘(1) ESTABLISHMENT
OF
FEE
SCHEDULE.—
The Secretary shall establish by regulation before
the beginning of 2002 and each succeeding year a
fee schedule for home infusion drug therapy services
for which payment is made under this part. In so
doing, the Secretary shall ensure the adequacy of ag-
gregate payments for the drug and nondrug compo-
nents of home infusion drug therapy, consistent with
the requirements of paragraphs (2) and (3).
‘‘(2) REQUIREMENTS.—The Secretary shall en-
sure that the coverage, reimbursement, and stand-
ards for covered home infusion drug therapy services
adequately reflect the various components of care
(including the services, drugs, supplies, equipment,
and related costs) necessary to ensure the safe and
effective provision of home infusion drug therapy. In
so doing, the Secretary shall—
‘‘(A) take into account the definitions, re-
quirements, and clinical standards commonly
used for home infusion drug therapy by private
health plans and accrediting organizations;
‘‘(B) ensure the adequacy of the aggregate
payment levels for home infusion drug therapy
services, without regard to whether payments
for drug and nondrug components are bundled
or partially bundled by the Secretary;
‘‘(C) ensure that sufficient numbers of geo-
graphically distributed and qualified home infu-
sion drug therapy providers participate in the
part B program so that enrolled beneficiaries
have meaningful access to home infusion drug
therapy services provided in accordance with
the established quality of care standards; and
‘‘(D) consult with providers and trade as-
sociations specializing in home infusion drug
therapy.
‘‘(3) PUBLICATION OF LIST OF COVERED HOME
INFUSION DRUGS.—Not later than January 1, 2002
(and quarterly thereafter), the Secretary shall pub-
lish a list of the drugs, and indications for such
drugs, that are covered home infusion drugs, with
respect to which home infusion drug therapy may be
provided under this title. This list shall include the
following:
‘‘(A) All intravenous antibiotic drugs un-
less the Secretary has determined for a specific
drug and indication that the drug cannot gen-
erally be administered safely and effectively in
a home setting.
‘‘(B) All infusion drug therapies requiring
an external infusion pump for safe and effective
administration that were, as of June 30, 2001,
covered by reason of 1861(s)(6).
‘‘(C) Parenterally administered blood-de-
rived products.
‘‘(D) Any other infusion drug for which
the Secretary has determined that, with respect
to a specific drug or the indication to which the
drug is applied, the drug can be administered
safely and effectively in the home (as defined in
section 1861(ww)(2)(A).’’.
(2) CONFORMING AMENDMENTS.—(A) Section
1833(a)(1) of such Act (42 U.S.C. 1395l(1)), as
amended by sections 105(c) and 223(c) of the Medi-
care, Medicaid, and SCHIP Benefits Improvement
and Protection Act of 2000 (114 Stat. 2763A–
YYY472, 489), as enacted into law by section
1(a)(6) of Public Law 106–554, is amended—
(i) by striking ‘‘and (U)’’ and inserting
‘‘(U)’’; and
(ii) by inserting before the semicolon at the
end the following: ‘‘, and (V) with respect to
home infusion drug therapy services (as defined
in section 1861(ww)(1)), the amounts paid shall
be 80 percent of the lesser of the actual charge
or the amount determined under the fee sched-
ule established under section 1834(n)’’.
(B) The first sentence of section 1862(a) of
such Act (42 U.S.C. 1395y(a)) is amended—
(i) by striking ‘‘or’’ at the end of para-
graph (20);
(ii) by striking the period at the end of
paragraph (21) and inserting ‘‘; or’’; and
(iii) by inserting after paragraph (21) the
following new paragraph:
‘‘(22) in the case of home infusion drug therapy
services under section 1861(ww)—
‘‘(A) that are not furnished in the home
(as defined in paragraph (2)(A) of that section;
‘‘(B) that do not meet the standards of
clinical care established by the Secretary;
‘‘(C) that include drugs not listed under
section 1834(n)(3);
‘‘(D) that are items and services other
than items and services that Secretary deter-
mines appropriate under that section; and
‘‘(E) for which payment may be made
under this title other than under section
1833(a)(1)(V).’’.
(d) EXCLUSION FROM DEFINITION
OF DURABLE
MEDICAL EQUIPMENT.—Section 1861(n) of such Act (42
U.S.C. 1395x(n)) is amended by adding at the end the
following: ‘‘Such term does not include home infusion drug
therapy services (as defined in subsection (ww)).’’.
(e) EFFECTIVE DATE.—The amendments made by
this section shall apply to items and services furnished on
or after January 1, 2002. The Secretary shall publish a
rule under this subsection in the Federal Register by not
later than the January 1, 2002. Such rule shall be effec-
tive and final immediately on an interim basis, but is sub-
ject to change and revision after public notice and oppor-
tunity for a period (of not less than 60 days) for public
comment.
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