‘‘(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) 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 2004 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, 2004 
(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, 2003, 
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)) 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 sec-
tion); 
‘‘(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 the Secretary de-
termines 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, 2004. The Secretary shall publish a
rule under this subsection in the Federal Register by not 
later than January 1, 2004. Such rule shall be effective 
and final immediately on an interim basis, but is subject 
to change and revision after public notice and opportunity 
for a period (of not less than 60 days) for public comment.
Æ