(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: 
‘‘(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 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)(5) of such Act, as added by 
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subsection (a)). The Secretary of Health and Human 
Services shall request the United States Pharmacopeia to 
develop, in consultation with representatives of qualified 
home infusion therapy providers and other interested 
stakeholders, a model formulary approach for home infu-
sion 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’’. 
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, 
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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; 
(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 
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(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 
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; 
(2) also include representatives of the following: 
(1) Patient organizations. 
(2) Hospital discharge planners, care coordina-
tors, or social workers. 
(3) Prescription drug plan sponsors and Medi-
care Advantage organizations. 
(c) REPORT.—Not later than January 1, 2012, 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 
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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. 
SEC. 5. EFFECTIVE DATE. 
The amendments made by this Act shall apply to 
home infusion therapy furnished on or after January 1, 
2010. 
Æ 
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