II 

110TH CONGRESS 

1ST SESSION S. 870 

To amend title XVIII of the Social Security Act to provide for the consolidated coverage of home infusion therapy under part B of the Medicare 

program. 

IN THE SENATE OF THE UNITED STATES 

MARCH 14, 2007 

Mr. ISAKSON introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to provide 

for the consolidated coverage of home infusion therapy 

under part B of 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. 

4 This Act may be cited as the ‘‘Medicare Home Infu5 sion Therapy Consolidated Coverage Act of 2007’’. 

6 SEC. 2. CONSOLIDATION OF MEDICARE COVERAGE OF 

7 HOME INFUSION THERAPY UNDER PART B. 

8 (a) IN GENERAL.—Section 1861 of the Social Secu9 rity Act (42 U.S.C. 1395x) is amended— 

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1 (1) in subsection (s)(2)— 

2 (A) by striking ‘‘and’’ at the end of sub3 paragraph (Z); 

4 (B) by adding ‘‘and’’ at the end of sub5 paragraph (AA); and 

6 (C) by adding at the end the following new 

7 subparagraph: 

8 ‘‘(BB) home infusion therapy (as defined in 

9 subsection (ccc)(1));’’; and 

10 (2) by adding at the end the following new sub11 section: 

12 ‘‘Home Infusion Therapy 

13 ‘‘(ccc)(1) The term ‘home infusion therapy’ means 

14 the following items and services furnished to an individual, 

15 who is under the care of a physician, which are provided, 

16 except as provided in subparagraph (B), by a qualified 

17 home infusion therapy provider under a plan (for fur18 nishing such items and services to such individual) estab19 lished and periodically reviewed by a physician, which 

20 items and services are provided in an integrated manner 

21 in the individual’s home in conformance with clinical 

22 standards of care established by the Secretary (after tak23 ing into account the standards commonly used for home 

24 infusion therapy by Medicare Advantage organizations 

25 and accreditation organizations)— 

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1 ‘‘(A) infusion drugs (as defined in para2 graph (2)(B)); 

3 ‘‘(B) nursing services provided, directly or 

4 by an accredited homecare organization under 

5 arrangements made, by the qualified home infu6 sion therapy provider, in connection with such 

7 infusion; and 

8 ‘‘(C) other professional services (including 

9 pharmacy and care coordination services) and 

10 related items and services (including medical 

11 supplies, intravenous fluids, home delivery, 

12 equipment, and other items and services the 

13 Secretary determines appropriate) to administer 

14 infusion drug therapies to an individual safely 

15 and effectively in the home; 

16 except that such term does not include nursing serv17 ices to the extent they are covered as home health 

18 services. 

19 ‘‘(2) For purposes of paragraph (1): 

20 ‘‘(A) The term ‘home’ means a place of 

21 residence used as an individual’s home and in22 cludes such alternate settings as the Secretary 

23 determines. 

24 ‘‘(B) The term ‘infusion drugs’ means par25 enteral drugs and biologicals administered via 

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1 an intravenous, intraspinal, intra-arterial, 

2 intrathecal, subcutaneous, or intramuscular ac3 cess device inserted into the body. 

4 ‘‘(C) The term ‘qualified home infusion 

5 therapy provider’ means any pharmacy that— 

6 ‘‘(i) has expertise in the preparation 

7 of compounded sterile preparations in com8 pliance with enforceable standards of the 

9 U.S. Pharmacopoeia or other nationally 

10 recognized standards that regulate 

11 compounding of sterile preparations as de12 termined by the Secretary; 

13 ‘‘(ii) provides infusion therapy to pa14 tients with acute or chronic conditions re15 quiring parenteral administration of drugs 

16 and biologicals administered through cath17 eters or needles, or both, in a home; and 

18 ‘‘(iii) meets such requirements as the 

19 Secretary determines are necessary to en20 sure the safe and effective provision of 

21 home infusion therapy (taking into account 

22 the standards of care for home infusion 

23 therapy established by private payers).’’. 

24 (b) PAYMENT FOR HOME INFUSION THERAPY.— 

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1 (1) IN GENERAL.—Section 1834 of such Act 

2 (42 U.S.C. 1395m) is amended by adding at the end 

3 the following new subsection: 

4 ‘‘(n) PAYMENT FOR HOME INFUSION THERAPY.— 

5 The payment amount under this part for home infusion 

6 therapy is determined as follows: 

7 ‘‘(1) IN GENERAL.—Except as provided in this 

8 subsection, the Secretary shall determine a per diem 

9 schedule for payment for home infusion therapy (in10 cluding pharmacy services, administration services, 

11 care coordination services, supplies and equipment 

12 necessary to safely and properly administer a home 

13 infusion drug or biological in accordance with the re14 quirements and clinical standards commonly used 

15 for home infusion therapy) which reflects the reason16 able costs which must be incurred by efficiently and 

17 economically operated qualified home infusion ther18 apy providers to provide such therapy in conformity 

19 with applicable State and Federal laws, regulations, 

20 and quality and safety standards and to assure that 

21 Medicare beneficiaries have reasonable access to 

22 such therapy. 

23 ‘‘(2) INFUSION DRUGS.— 

24 ‘‘(A) IN GENERAL.—Except as provided in 

25 subparagraph (B), the provisions of section 

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1 1847A shall apply to payment under this part 

2 for drugs included in home infusion therapy. 

3 ‘‘(B) SPECIAL RULE.—In applying sub4 paragraph (A), the determination of average 

5 sales prices under section 1847A shall be lim6 ited to such prices for infusion drug sales to 

7 home infusion therapy pharmacies.’’. 

8 (2) CONFORMING AMENDMENTS.— 

9 (A) Section 1833(a)(1) of such Act (42 

10 U.S.C. 1395l(a)(1)) is amended by striking 

11 ‘‘and’’ before ‘‘(V)’’ and by inserting before the 

12 semicolon at the end the following: ‘‘, and (W) 

13 with respect to home infusion therapy, the 

14 amounts paid shall be determined under section 

15 1834(n)’’. 

16 (B) The first sentence of section 

17 1842(b)(6) of such Act (42 U.S.C. 

18 1395u(b)(6)) is amended by striking ‘‘and’’ be19 fore ‘‘(H)’’ and by inserting before the period 

20 at the end the following: ‘‘, and (I) in the case 

21 of home infusion therapy, payment shall be 

22 made to the qualified home infusion therapy 

23 provider responsible for furnishing the ther24 apy’’. 

25 (c) OTHER CONFORMING PROVISIONS.— 

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1 (1) EXCLUSION FROM DURABLE MEDICAL

2 EQUIPMENT BENEFIT.—Section 1861(n) of such Act 

3 (42 U.S.C. 1395x(n)) is amended by adding at the 

4 end the following: ‘‘Such term does not include home 

5 infusion therapy.’’. 

6 (2) APPLICATION OF ACCREDITATION ORGANI7 ZATION PROVISIONS.—The provisions of section 

8 1865(b) of the Social Security Act (42 U.S.C. 

9 1395bb(b)) apply to accreditation of qualified home 

10 infusion therapy providers (as defined in section 

11 1861(cc)(2)(C) of such Act, as added by subsection 

12 (a)). 

13 (d) EFFECTIVE DATE.—The amendments made by 

14 this section shall apply to home infusion therapy furnished 

15 on or after January 1, 2008. 

Æ 

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