I 
111TH CONGRESS 
1ST SESSION 
H. R. 574 
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 
JANUARY 15, 2009 
Mr. ENGEL (for himself, Mr. TIM MURPHY of Pennsylvania, Ms. BALDWIN, 
and Ms. GRANGER) introduced the following bill; which was referred to 
the Committee on Energy and Commerce, and in addition to the Com-
mittee 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 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 2009’’. 
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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), as amended by section 152(b) 
of the Medicare Improvements for Patients and Providers 
Act of 2008 (Public Law 110–275), is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (DD); 
(B) by adding ‘‘and’’ at the end of sub-
paragraph (EE); and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(FF) home infusion therapy (as defined in 
subsection (hhh)(1));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘Home Infusion Therapy 
‘‘(hhh)(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 
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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 
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): 
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‘‘(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 
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 
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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. 
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: 
‘‘(n) 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(hhh)(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 
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equipment in conformity with applicable State and 
Federal laws, regulations, and the uniform quality 
and safety standards developed under section 
1861(hhh)(1) and to assure that Medicare bene-
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 
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the 12-month period ending with June of the pre-
ceding year.’’. 
(c) CONFORMING AMENDMENTS.— 
(1) 
PAYMENT
REFERENCE.—Section 
1833(a)(1) of the Social Security Act (42 U.S.C. 
13951(a)(1)), as amended by section 101(a)(2) of 
the Medicare Improvements for Patients and Pro-
viders Act of 2008 (Public Law 110–275), is amend-
ed— 
(A) by striking ‘‘and’’ before ‘‘(W)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, and (X) with respect 
to home infusion therapy, the amounts paid 
shall be determined under section 1834(n)’’. 
(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’’. 
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(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 
(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. 3. 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)), as amend-
ed by section 182 of the Medicare Improvements for Pa-
tients and Providers Act of 2008 (Public Law 110–275), 
is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘or’’ at the end of subpara-
graph (A); 
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