I 
114TH CONGRESS 
1ST SESSION 
H. R. 605 
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, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 28, 2015 
Mr. ENGEL (for himself, Mr. TIBERI, Mr. HARPER, Ms. PINGREE, Mr. LAR-
SON of Connecticut, and Mr. PETERSON) 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 subse-
quently 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, and for other pur-
poses. 
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 2015’’. 
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SEC. 2. 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 
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 
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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 
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. 
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‘‘(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 
‘‘(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 
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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: 
‘‘(r) 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 
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. 
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‘‘(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 
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. 
1395l(a)(1)) is amended— 
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(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(r)’’. 
(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— 
(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 
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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. 3. 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); 
(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 
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(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. 4. 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 
Medicare beneficiaries have timely and appropriate access 
to infusion therapy in their homes and that there is rapid 
and seamless coordination between drug coverage under 
part D of title XVIII of the Social Security Act and cov-
erage for home infusion therapy services under part B of 
such title to avoid the filing of duplicative or otherwise 
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improper claims. Specifically, the Secretary shall ensure 
that— 
(1) the benefit is practical and workable with 
minimal administrative burden for beneficiaries, 
qualified home infusion therapy suppliers, physi-
cians, prescription drug plans, MA–PD plans, and 
Medicare Advantage plans, and the Secretary shall 
consider the use of consolidated claims encompassing 
covered part D drugs and part B services, supplies, 
and equipment under such part B to ensure the effi-
cient operation of this benefit; 
(2) any prior authorization or utilization review 
process is expeditious, allowing Medicare bene-
ficiaries meaningful access to home infusion therapy; 
(3) medical necessity determinations for home 
infusion therapy will be made— 
(A) except as provided in subparagraph 
(B), by Medicare administrative contractors 
under such part B and communicated to the 
appropriate prescription drug plans; or 
(B) in the case of an individual enrolled in 
a Medicare Advantage plan, by the Medicare 
Advantage organization offering the plan; and 
an individual may be initially qualified for cov-
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erage for such benefit for a 90-day period and 
subsequent 90-day periods thereafter; 
(4) except as otherwise provided in this section, 
the benefit is modeled on current private sector cov-
erage and coding for home infusion therapy; and 
(5) prescription drug plans and MA–PD plans 
structure their formularies, utilization review proto-
cols, and policies in a manner that ensures that 
Medicare beneficiaries have timely and appropriate 
access to infusion therapy in their homes. 
(b) REPORT.—Not later than January 1, 2018, the 
Comptroller General of the United States shall submit to 
Congress a report on Medicare beneficiary access to home 
infusion therapy. Such report shall specifically address 
whether the objectives specified in subsection (a) have 
been met and shall make recommendations to Congress 
and the Secretary of Health and Human Services on how 
to improve the benefit and better ensure that Medicare 
beneficiaries have timely and appropriate access to infu-
sion therapy in their homes. 
SEC. 5. EFFECTIVE DATE. 
The amendments made by this Act shall apply to 
home infusion therapy furnished on or after January 1, 
2016. 
Æ 
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