I 
112TH CONGRESS 
1ST SESSION H. R. 2195 
To amend title XVIII of the Social Security Act to provide for the coverage 
of home infusion therapy under the Medicare Program. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 15, 2011 
Mr. ENGEL (for himself, Mr. MURPHY of Pennsylvania, and Ms. BALDWIN) 
introduced the following bill; which was referred to the Committee on En-
ergy 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 jurisdic-
tion of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to provide 
for the coverage of home 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 Therapy Coverage Act of 2011’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) The Medicare program is presently the only 
major health care payer in the country that does not 
provide comprehensive coverage of home infusion 
therapy. 
(2) 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 homes. 
(3) 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. 
(4) The Government Accountability Office 
found in a 2010 report that home infusion therapy 
is utilized widely by private payors providing health 
insurance coverage for individuals enrolled under 
such coverage and that such private payors generally 
are satisfied with the quality of care and the savings 
they achieve through avoided institutionalizations. 
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— 
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(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (EE); 
(B) by adding ‘‘and’’ at the end of sub-
paragraph (FF); and 
(C) by adding 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 
following items and services furnished to an individual, 
who is under the care of a physician, which are provided 
by a qualified home infusion therapy provider under a plan 
(for furnishing such items and services to such individual) 
established and periodically reviewed by a physician, which 
items and services are provided in an integrated manner 
in the individual’s home in conformance with uniform 
standards of care established by the Secretary (after tak-
ing 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 
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stakeholders) and in coordination with the provision of 
covered infusion drugs under part D: 
‘‘(A) Professional services other than nursing 
services provided in accordance with the plan (in-
cluding administrative, compounding, dispensing, 
distribution, clinical monitoring and care coordina-
tion services) and all necessary supplies and equip-
ment (including medical supplies such as sterile tub-
ing and infusion pumps, and other items and serv-
ices the Secretary determines appropriate) to admin-
ister infusion drug therapies to an individual safely 
and effectively in the home. 
‘‘(B) Nursing services provided in accordance 
with the plan, directly by a qualified home infusion 
therapy provider or under arrangements with an ac-
credited homecare organization, in connection with 
such infusion, except that such term does not in-
clude nursing services to the extent they are covered 
as home health services. 
‘‘(2) For purposes of paragraph (1): 
‘‘(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 
provider’ 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 U.S. Pharmacopoeia 
and other nationally recognized standards that 
regulate preparation of parenteral medications 
as determined by the Secretary 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. 
A qualified home infusion therapy provider may sub-
contract with a pharmacy, physician, provider, or 
supplier to meet the requirements of this sub-
section.’’. 
(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.— 
The payment amount under this part for home infusion 
therapy is determined as follows: 
‘‘(1) IN GENERAL.—The Secretary shall deter-
mine a per diem schedule for payment for the pro-
fessional services, supplies, and equipment described 
in section 1861(iii)(1)(A) that reflects the reason-
able costs which must be incurred by efficiently and 
economically operated qualified home infusion ther-
apy providers 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 Medicare bene-
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ficiaries have reasonable access to such therapy. The 
Secretary shall update such schedule from year to 
year by the percentage increase in the consumer 
price index for all urban consumers (United States 
city average) for the 12-month period ending with 
June of the preceding year. 
‘‘(2) NURSING SERVICES.—The Secretary shall 
develop a methodology for the separate payment for 
nursing 
services 
described 
in 
section 
1861(hhh)(1)(B) provided in accordance with the 
plan under such section which reflects the reason-
able costs incurred in the provision of nursing serv-
ices in connection with infusion therapy in con-
formity with State and Federal laws, regulations, 
and the uniform quality and safety standards devel-
oped pursuant to this Act and to assure that Medi-
care beneficiaries have reasonable access to nursing 
services for infusion therapy. The Secretary shall up-
date such schedule from year to year by the percent-
age 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.’’. 
(c) CONFORMING AMENDMENTS.— 
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(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 
such 
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 pro-
vider’’. 
(3) EXCLUSION
FROM
DURABLE
MEDICAL 
EQUIPMENT AND HOME HEALTH SERVICES.—Section 
1861 of such Act (42 U.S.C. 1395x) is amended— 
(A) in subsection (m)(5), by inserting ‘‘and 
supplies used in the provision of home infusion 
therapy’’ after ‘‘excluding other drugs and 
biologicals’’; and 
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(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(b) of the So-
cial Security Act (42 U.S.C. 1395bb(b)) apply to the 
accreditation of qualified home infusion therapy pro-
viders in the manner they apply to other suppliers. 
SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS. 
(a) IN GENERAL.—Section 1860D–2(e)(1) of the So-
cial Security Act (42 U.S.C. 1395w–102(e)(1)) is amend-
ed— 
(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 before the flush matter 
following 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: 
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‘‘(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 in-
serted into the body, and includes a drug used for 
catheter maintenance and declotting, a drug con-
tained in a device, vitamins, intravenous solutions, 
diluents and minerals, and other components used in 
the provision of home infusion therapy.’’. 
(b) INFUSION DRUG FORMULARIES.—For the first 2 
years after the date of the enactment of this Act, notwith-
standing any other provision of law, prescription drug 
plans and MA–PD plans under title XVIII of the Social 
Security Act shall maintain open formularies for infusion 
drugs (as defined in section 1860D–2(e)(5) of such Act, 
as added by subsection (a)). The Secretary of Health and 
Human Services shall request the United States Pharma-
copeia to develop, in consultation with representatives of 
qualified home infusion therapy providers and other inter-
ested stakeholders, a model formulary approach for home 
infusion drugs for use by such plans after such 2-year pe-
riod. 
(c) PART D DISPENSING FEES.—Section 1860D– 
2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 
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102(d)(1)(B)) is amended by inserting after ‘‘any dis-
pensing fees for such drugs’’ the following: ‘‘, other than 
for an infusion drug’’. 
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 
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. Specifically, the Secretary shall ensure that— 
(1) the benefit is practical and workable with 
minimal administrative burden for beneficiaries, 
qualified home infusion therapy providers, 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; 
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(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-
erage for such benefit for a 90-day period and sub-
sequent 90-day periods thereafter; 
(4) the benefit is modeled on current private 
sector coverage and coding for home infusion ther-
apy; 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) HOME INFUSION THERAPY ADVISORY PANEL.— 
In implementing such home infusion therapy benefit and 
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meeting the objectives specified in subsection (a), the Sec-
retary shall establish an advisory panel to provide advice 
and recommendations. Such panel shall— 
(1) be comprised primarily of qualified home in-
fusion therapy providers and their representative or-
ganizations; and 
(2) also include representatives of the following: 
(A) Patient organizations. 
(B) Hospital discharge planners, care coor-
dinators, or social workers. 
(C) Prescription drug plan sponsors and 
Medicare Advantage organizations. 
(c) REPORT.—Not later than January 1, 2014, and 
every 2 years thereafter, the Comptroller General of the 
United States shall submit a report to Congress on Medi-
care beneficiary access to home infusion therapy. Each 
such report shall specifically address whether the objec-
tives specified in subsection (a) have been met and shall 
make recommendations to Congress and the Secretary on 
how to improve the benefit and better ensure that Medi-
care beneficiaries have timely and appropriate access to 
infusion therapy in their homes. 
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SEC. 6. EFFECTIVE DATE. 
The amendments made by this Act shall apply to 
home infusion therapy furnished on or after January 1, 
2012. 
Æ 
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