I 

108TH CONGRESS 

1ST SESSION H. R. 2476

To amend title XVIII of the Social Security Act to provide for coverage 

of home infusion drug therapies under the Medicare Program. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 16, 2003

Mr. ENGEL (for himself, Mr. WELDON of Florida, Mr. MCNULTY, Mr. FROST, 

Mr. CASE, and Mr. PAUL) 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 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 coverage of home infusion drug therapies under the 

Medicare Program.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; PURPOSES. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Medicare Home Infusion Therapy Act of 2003’’. 

6 (b) PURPOSE.—The purposes of this Act are to en7 sure that medicare beneficiaries—
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1 (1) have the choice of receiving infusion drug 

2 therapies in the home when clinically appropriate 

3 rather than in an inpatient setting; and 

4 (2) are receiving high quality, safe, and efficient 

5 care with respect to home infusion drug therapies. 

6 SEC. 2. COVERAGE OF AND PAYMENT FOR HOME INFUSION 

7 DRUG THERAPY SERVICES. 

8 (a) COVERAGE.—

9 (1) IN GENERAL.—Section 1861(s) of the So10 cial Security Act (42 U.S.C. 1395x(s)) is amended—

11 (A) in the second sentence, by redesig12 nating paragraphs (16) and (17) as clauses (i) 

13 and (ii); and 

14 (B) in the first sentence—

15 (i) by striking ‘‘and’’ at the end of 

16 paragraph (14); 

17 (ii) by striking the period at the end 

18 of paragraph (15) and inserting ‘‘; and’’; 

19 and 

20 (iii) by adding after paragraph (15) 

21 the following new paragraph: 

22 ‘‘(16) home infusion drug therapy services (as 

23 defined in subsection (ww).’’. 

24 (2) CONFORMING AMENDMENTS.—Sections 

25 1864(a) 1902(a)(9)(C), and 1915(a)(1)(B)(ii)(I) of 
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1 such Act (42 U.S.C. 1395aa(a), 1396a(a)(9)(C), and 

2 1396n(a)(1)(B)(ii)(I)) are each amended by striking 

3 ‘‘paragraphs (16) and (17)’’ each place it appears 

4 and inserting ‘‘clauses (i) and (ii) of the second sen5 tence’’. 

6 (b) HOME INFUSION DRUG THERAPY DEFINED.—

7 Section 1861 of such Act (42 U.S.C. 1395x) is amended 

8 by adding at the end the following new subsection: 

9 ‘‘Home Infusion Drug Therapy Services 

10 ‘‘(ww)(1) The term ‘home infusion drug therapy serv11 ices’ means—

12 ‘‘(A) pharmacy, nursing, and related items and 

13 services (including medical supplies, intravenous 

14 fluids, drugs described in section 1834(n), home de15 livery, equipment, and other items and services the 

16 Secretary determines appropriate) to administer in17 fusion drug therapies to an individual safely and ef18 fectively in the home in conformance with clinical 

19 standards of care established by the Secretary; 

20 ‘‘(B) that are furnished by a qualified supplier 

21 via an intravenous, intra-arterial or intrathecal ac22 cess device inserted into the body; and 

23 ‘‘(C) provided under a plan of care established 

24 and periodically reviewed by a physician. 

25 ‘‘(2) In paragraph (1)—
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1 ‘‘(A) the term ‘home’ means a place of resi2 dence used as an individual’s home (or a provider of 

3 services used as the individual’s home if the drug is 

4 administered during a period of inpatient stay for 

5 which payment is not made to the provider of serv6 ices under part A); and 

7 ‘‘(B) the term ‘qualified supplier’ means any 

8 entity that meets such requirements as the Secretary 

9 determines are necessary to ensure the safe and ef10 fective provision of home infusion drug therapy serv11 ices.’’. 

12 (c) PAYMENT.—

13 (1) ESTABLISHMENT OF FEE SCHEDULE.—Sec14 tion 1834 of the Social Security Act (42 U.S.C. 

15 1395l) is amended by adding at the end the fol16 lowing new subsection: 

17 ‘‘(n) HOME INFUSION DRUG THERAPY SERVICES.—

18 ‘‘(1) ESTABLISHMENT OF FEE SCHEDULE.— 

19 The Secretary shall establish by regulation before 

20 the beginning of 2004 and each succeeding year a 

21 fee schedule for home infusion drug therapy services 

22 for which payment is made under this part. In so

23 doing, the Secretary shall ensure the adequacy of ag24 gregate payments for the drug and nondrug compo-
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1 nents of home infusion drug therapy, consistent with 

2 the requirements of paragraphs (2) and (3). 

3 ‘‘(2) REQUIREMENTS.—The Secretary shall en4 sure that the coverage, reimbursement, and stand5 ards for covered home infusion drug therapy services 

6 adequately reflect the various components of care 

7 (including the services, drugs, supplies, equipment, 

8 and related costs) necessary to ensure the safe and 

9 effective provision of home infusion drug therapy. In 

10 so doing, the Secretary shall—

11 ‘‘(A) take into account the definitions, re12 quirements, and clinical standards commonly 

13 used for home infusion drug therapy by private 

14 health plans and accrediting organizations; 

15 ‘‘(B) ensure the adequacy of the aggregate 

16 payment levels for home infusion drug therapy 

17 services, without regard to whether payments 

18 for drug and nondrug components are bundled 

19 or partially bundled by the Secretary; 

20 ‘‘(C) ensure that sufficient numbers of geo21 graphically distributed and qualified home infu22 sion drug therapy providers participate in the 

23 part B program so that enrolled beneficiaries 

24 have meaningful access to home infusion drug 
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1 therapy services provided in accordance with 

2 the established quality of care standards; and 

3 ‘‘(D) consult with providers and trade as4 sociations specializing in home infusion drug 

5 therapy. 

6 ‘‘(3) PUBLICATION OF LIST OF COVERED HOME

7 INFUSION DRUGS.—Not later than January 1, 2004 

8 (and quarterly thereafter), the Secretary shall pub9 lish a list of the drugs, and indications for such 

10 drugs, that are covered home infusion drugs, with 

11 respect to which home infusion drug therapy may be 

12 provided under this title. This list shall include the 

13 following: 

14 ‘‘(A) All intravenous antibiotic drugs un15 less the Secretary has determined for a specific 

16 drug and indication that the drug cannot gen17 erally be administered safely and effectively in 

18 a home setting. 

19 ‘‘(B) All infusion drug therapies requiring 

20 an external infusion pump for safe and effective 

21 administration that were, as of June 30, 2003, 

22 covered by reason of 1861(s)(6). 

23 ‘‘(C) Parenterally administered blood-de24 rived products. 
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1 ‘‘(D) Any other infusion drug for which 

2 the Secretary has determined that, with respect 

3 to a specific drug or the indication to which the 

4 drug is applied, the drug can be administered 

5 safely and effectively in the home (as defined in 

6 section 1861(ww)(2)(A)).’’. 

7 (2) CONFORMING AMENDMENTS.—(A) Section 

8 1833(a)(1) of such Act (42 U.S.C. 1395l(1)) is 

9 amended—

10 (i) by striking ‘‘and (U)’’ and inserting 

11 ‘‘(U)’’; and 

12 (ii) by inserting before the semicolon at the 

13 end the following: ‘‘, and (V) with respect to 

14 home infusion drug therapy services (as defined 

15 in section 1861(ww)(1)), the amounts paid shall 

16 be 80 percent of the lesser of the actual charge 

17 or the amount determined under the fee sched18 ule established under section 1834(n)’’. 

19 (B) The first sentence of section 1862(a) of 

20 such Act (42 U.S.C. 1395y(a)) is amended—

21 (i) by striking ‘‘or’’ at the end of para22 graph (20); 

23 (ii) by striking the period at the end of 

24 paragraph (21) and inserting ‘‘; or’’; and 
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1 (iii) by inserting after paragraph (21) the 

2 following new paragraph: 

3 ‘‘(22) in the case of home infusion drug therapy 

4 services under section 1861(ww)—

5 ‘‘(A) that are not furnished in the home 

6 (as defined in paragraph (2)(A) of that sec7 tion); 

8 ‘‘(B) that do not meet the standards of 

9 clinical care established by the Secretary; 

10 ‘‘(C) that include drugs not listed under 

11 section 1834(n)(3); 

12 ‘‘(D) that are items and services other 

13 than items and services that the Secretary de14 termines appropriate under that section; and 

15 ‘‘(E) for which payment may be made 

16 under this title other than under section 

17 1833(a)(1)(V).’’. 

18 (d) EXCLUSION FROM DEFINITION OF DURABLE

19 MEDICAL EQUIPMENT.—Section 1861(n) of such Act (42 

20 U.S.C. 1395x(n)) is amended by adding at the end the 

21 following: ‘‘Such term does not include home infusion drug 

22 therapy services (as defined in subsection (ww)).’’. 

23 (e) EFFECTIVE DATE.—The amendments made by 

24 this section shall apply to items and services furnished on 

25 or after January 1, 2004. The Secretary shall publish a 
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1 rule under this subsection in the Federal Register by not 

2 later than January 1, 2004. Such rule shall be effective 

3 and final immediately on an interim basis, but is subject 

4 to change and revision after public notice and opportunity 

5 for a period (of not less than 60 days) for public comment.

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