I 
110TH CONGRESS 
1ST SESSION H. R. 2567 
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 5, 2007 
Mr. ENGEL (for himself, Ms. GRANGER, Ms. BALDWIN, Mr. PICKERING, Mr. 
KUHL of New York, and Mr. TIERNEY) 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 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 2007’’. 
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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 (Z); 
(B) by adding ‘‘and’’ at the end of sub- 
paragraph (AA); and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(BB) home infusion therapy (as defined in 
subsection (ccc)(1));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘Home Infusion Therapy 
‘‘(ccc)(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 
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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 (including administrative, compounding, dis-
pensing, distribution, clinical monitoring and care 
coordination services) and all necessary supplies and 
equipment (including medical supplies such as sterile 
tubing and infusion pumps, and other items and 
services the Secretary determines appropriate) to ad-
minister 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 seven day a week, twenty-four hour basis 
(taking into account the standards of care for 
home infusion therapy established by Medicare 
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Advantage plans and in the private sector), and 
the efficient administration of the home infu-
sion therapy benefit. 
A qualified home infusion provider may subcontract 
with a pharmacy, physician, provider, or supplier to 
meet the requirements of this subsection.’’. 
(b) PAYMENT FOR HOME INFUSION THERAPY.—Sec-
tion 1834 of such Act (42 U.S.C. 1395m) is amended by 
adding at the end the following new subsection: 
‘‘(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(ccc)(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(ccc)(1) and to assure that Medicare bene-
ficiaries have reasonable access to such therapy. The 
Secretary shall update such schedule from year to 
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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(ccc)(1)(B) 
provided in accordance with the plan under such sec-
tion which reflects the reasonable costs incurred in 
the provision of nursing services in connection with 
infusion therapy in conformity with State and Fed-
eral laws, regulations, and the uniform quality and 
safety standards developed pursuant to this Act and 
to assure that Medicare beneficiaries have reason-
able access to nursing services for infusion 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.’’. 
(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 ‘‘(V)’’; and 
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(B) by inserting before the semicolon at 
the end the following: ‘‘, and (W) 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’’. 
(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), 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.’’. 
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(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)) 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 after subparagraph (B) 
the following new subparagraph: 
‘‘(C) an infusion drug (as defined in para-
graph (4)),’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(4) 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-
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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 effective date of this Act, notwithstanding 
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 de-
fined in section 1860D–2(e)(4) of such Act. The Secretary 
of Health and Human Services shall request the United 
States Pharmacopeia to develop, in consultation with rep-
resentatives of qualified home infusion therapy providers 
and other interested stakeholders, a model formulary ap-
proach for home infusion drugs for use by such plans after 
such 2-year period. 
(c) PART D DISPENSING FEES.—Section 1860D– 
2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 
102(d)(1)(B)) is amended by inserting after ‘‘any dis-
pensing fees for such drugs’’ the following: ‘‘, other than 
for an infusion drug’’. 
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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. 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 
MA 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 efficient 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 by Medicare adminis-
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