I 
113TH CONGRESS 
2D SESSION 
H. R. 5435 
To amend title XVIII of the Social Security Act to provide for the coverage 
of home as a site of care for infusion therapy under the Medicare Program. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 10, 2014 
Mr. ENGEL (for himself, Mr. TIBERI, Mr. LARSON of Connecticut, Mr. HAR-
PER, Mr. MEEHAN, Ms. PINGREE of Maine, and Mr. PETERSON) intro-
duced 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 amend title XVIII of the Social Security Act to provide 
for the coverage of home as a site of care for infusion 
therapy 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. 
This Act may be cited as the ‘‘Medicare Home Infu-
sion Site of Care Act of 2014’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) The Medicare fee-for-service program covers 
infusion therapy in the hospital, skilled nursing facil-
ity, physician office, and hospital outpatient depart-
ment, but does not cover the full range of services 
for the provision of infusion therapies in a patient’s 
home. 
(2) The Medicare program is presently the only 
major health care payer in the United States that 
does not provide comprehensive coverage of home in-
fusion therapy. 
(3) As a result of the Medicare program not 
providing for comprehensive coverage of home infu-
sion therapy, many Medicare beneficiaries are unable 
to obtain infusion therapy in the most cost-effective 
and convenient setting of their home, and physicians 
are deprived of the ability to select the best site of 
care for their patients. 
(4) The Medicare program is paying for institu-
tional care for the provision of infusion therapy in 
many instances when such institutional care could be 
avoided if the Medicare program provided coverage 
for home infusion therapy. 
(5) The Government Accountability Office 
found in a 2010 report that home infusion therapy 
is utilized widely by private payers providing health 
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insurance coverage for individuals enrolled under 
such coverage and that such private payers generally 
are satisfied with the quality of care and the savings 
they achieve through avoided institutionalizations. 
(6) A recent study has reported a potential sav-
ings for Medicare if infusion therapies were covered 
in the home site of care. 
SEC. 3. MEDICARE COVERAGE OF HOME INFUSION THER-
APY. 
(a) IN GENERAL.—Section 1861 of the Social Secu-
rity Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (EE); 
(B) by inserting ‘‘and’’ at the end of sub-
paragraph (FF); and 
(C) by inserting at the end the following 
new subparagraph: 
‘‘(GG) home infusion therapy (as defined in 
subsection (iii)(1));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘Home Infusion Therapy 
‘‘(iii)(1) The term ‘home infusion therapy’ means the 
items and services described in paragraph (2) furnished 
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to an individual, who is under the care of a physician, 
which are provided by a qualified home infusion therapy 
supplier under a plan (for furnishing such items and serv-
ices to such individual) established and periodically re-
viewed by a physician, which items and services are pro-
vided in an integrated manner in the individual’s home 
in conformance with uniform standards of care established 
by the Secretary and in coordination with the provision 
of covered infusion drugs under part D. The Secretary 
shall establish such standards after taking into account 
the standards commonly used for home infusion therapy 
by Medicare Advantage plans and in the private sector and 
after consultation with all interested stakeholders. 
‘‘(2) The items and services described in this para-
graph are the following: 
‘‘(A) Professional services, including nursing 
services (other than nursing services covered as 
home health services), provided in accordance with 
the plan (including administrative, compounding, 
dispensing, distribution, clinical monitoring, and 
care coordination services) and all necessary supplies 
and equipment (including medical supplies such as 
sterile tubing and infusion pumps). 
‘‘(B) Other items and services the Secretary de-
termines appropriate to administer infusion drug 
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therapies to an individual safely and effectively in 
the home. 
‘‘(3) For purposes of this subsection: 
‘‘(A) The term ‘home’ means a place of resi-
dence used as an individual’s home and includes 
such other alternate settings as the Secretary deter-
mines. 
‘‘(B) The term ‘qualified home infusion therapy 
supplier’ means any pharmacy, physician, or other 
provider licensed by the State in which the phar-
macy, physician, or provider resides or provides serv-
ices, whose State authorized scope of practice in-
cludes dispensing authority and that— 
‘‘(i) has expertise in the preparation of 
parenteral medications in compliance with en-
forceable standards of the United States Phar-
macopoeia and other nationally recognized 
standards that regulate preparation of paren-
teral medications as determined by the Sec-
retary and meets such standards; 
‘‘(ii) provides infusion therapy to patients 
with acute or chronic conditions requiring par-
enteral administration of drugs and biologicals 
administered through catheters or needles, or 
both, in a home; and 
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‘‘(iii) meets such other uniform require-
ments as the Secretary determines are nec-
essary to ensure the safe and effective provision 
and administration of home infusion therapy on 
a 7-day-a-week, 24-hour basis (taking into ac-
count the standards of care for home infusion 
therapy established by Medicare Advantage 
plans and in the private sector), and the effi-
cient administration of the home infusion ther-
apy benefit. 
‘‘(4) A qualified home infusion therapy supplier may 
subcontract with a pharmacy, physician, provider, or sup-
plier to meet the requirements of paragraph (3)(B).’’. 
(b) PAYMENT FOR HOME INFUSION THERAPY.—Sec-
tion 1834 of the Social Security Act (42 U.S.C. 1395m) 
is amended by adding at the end the following new sub-
section: 
‘‘(p) PAYMENT FOR HOME INFUSION THERAPY.— 
‘‘(1) IN GENERAL.—The Secretary shall deter-
mine a per diem schedule for payment for the pro-
fessional services (including nursing services), sup-
plies, 
and 
equipment 
described 
in 
section 
1861(iii)(2)(A) for each infusion therapy type that 
reflects the reasonable costs which must be incurred 
by efficiently and economically operated qualified 
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home infusion therapy suppliers to provide such 
services, supplies, and equipment in conformity with 
applicable State and Federal laws, regulations, and 
the uniform quality and safety standards developed 
under section 1861(iii)(1) and to assure that Medi-
care beneficiaries have reasonable access to such 
therapy. 
‘‘(2) CONSIDERATIONS.—In developing the per 
diem schedule under this subsection, the Secretary 
shall consider recent credible studies about the costs 
of providing infusion therapy in the home, consult 
with home infusion therapy suppliers, consider pay-
ment amounts established by Medicare Advantage 
plans and private payers for home infusion therapy, 
and, if necessary, conduct a statistically valid na-
tional market analysis involving the costs of admin-
istering infusion drugs and of providing professional 
services necessary for the drugs’ administration. 
‘‘(3) ANNUAL UPDATES.—The Secretary shall 
update such schedule from year to year by the per-
centage increase in the Consumer Price Index for all 
urban consumers (United States city average) for 
the 12-month period ending with June of the pre-
ceding year. The Secretary may modify the per diem 
schedule with respect to beneficiaries who qualify for 
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home infusion therapy services under section 
1861(iii)(1) but who receive nursing services as 
home health services.’’. 
(c) CONFORMING AMENDMENTS.— 
(1) 
PAYMENT
REFERENCE.—Section 
1833(a)(1) of the Social Security Act (42 U.S.C. 
13951(a)(1)) is amended— 
(A) by striking ‘‘and’’ before ‘‘(Z)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, and (AA) with respect 
to home infusion therapy, the amounts paid 
shall be determined under section 1834(p)’’. 
(2) DIRECT PAYMENT.—The first sentence of 
section 1842(b)(6) of the Social Security Act (42 
U.S.C. 1395u(b)(6)) is amended— 
(A) by striking ‘‘and’’ before ‘‘(H)’’; and 
(B) by inserting before the period at the 
end the following: ‘‘, and (I) in the case of 
home infusion therapy, payment shall be made 
to the qualified home infusion therapy sup-
plier’’. 
(3) EXCLUSION
FROM
DURABLE
MEDICAL 
EQUIPMENT AND HOME HEALTH SERVICES.—Section 
1861 of the Social Security Act (42 U.S.C. 1395x) 
is amended— 
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(A) in subsection (m)(5)— 
(i) by striking ‘‘and’’ before ‘‘durable 
medical 
equipment’’ 
and 
inserting 
a 
comma; and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘, and supplies 
used in the provision of home infusion 
therapy after excluding other drugs and 
biologicals’’; and 
(B) in subsection (n), by adding at the end 
the following: ‘‘Such term does not include 
home infusion therapy, other than equipment 
and supplies used in the provision of insulin.’’. 
(4) APPLICATION
OF
ACCREDITATION
PROVI-
SIONS.—The provisions of section 1865(a) of the So-
cial Security Act (42 U.S.C. 1395bb(a)) apply to the 
accreditation of qualified home infusion therapy sup-
pliers in the same way as they apply to other sup-
pliers. 
SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS. 
Section 1860D–2(e) of the Social Security Act (42 
U.S.C. 1395w–102(e)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘or’’ at the end of subpara-
graph (A); 
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(B) by striking the comma at the end of 
subparagraph (B) and inserting, ‘‘; or’’; and 
(C) by inserting after subparagraph (B) 
the following new subparagraph: 
‘‘(C) an infusion drug (as defined in para-
graph (5)),’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(5) INFUSION DRUG DEFINED.—For purposes 
of this part, the term ‘infusion drug’ means a paren-
teral drug or biological administered via an intra-
venous, intraspinal, intra-arterial, intrathecal, epidu-
ral, subcutaneous, or intramuscular access device or 
injection, and may include a drug used for catheter 
maintenance and declotting, a drug contained in a 
device, additives including but not limited to vita-
mins, minerals, solutions, and diluents, and other 
components used in the provision of home infusion 
therapy.’’. 
SEC. 5. ENSURING BENEFICIARY ACCESS TO HOME INFU-
SION THERAPY. 
(a) OBJECTIVES
IN IMPLEMENTATION.—The Sec-
retary of Health and Human Services shall implement the 
Medicare home infusion therapy benefit under the amend-
ments made by this Act in a manner that ensures that 
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