II 

110TH CONGRESS 

2D SESSION S. 3505 

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

of home infusion therapy under the Medicare Program. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 17, 2008 

Mrs. LINCOLN (for herself, Ms. SNOWE, and 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 coverage of home infusion therapy 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. 

4 This Act may be cited as the ‘‘Medicare Home Infu5 sion Therapy Coverage Act of 2008’’. 

6 SEC. 2. MEDICARE COVERAGE OF HOME INFUSION THER7 APY. 

8 (a) IN GENERAL.—Section 1861 of the Social Secu9 rity Act (42 U.S.C. 1395x), as amended by section 152(b) 


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1 of the Medicare Improvements for Patients and Providers 

2 Act of 2008 (Public Law 110–275), is amended— 

3 (1) in subsection (s)(2)— 

4 (A) by striking ‘‘and’’ at the end of sub5 paragraph (DD); 

6 (B) by adding ‘‘and’’ at the end of sub7 paragraph (EE); and 

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

9 subparagraph: 

10 ‘‘(FF) home infusion therapy (as defined in 

11 subsection (hhh)(1));’’; and 

12 (2) by adding at the end the following new sub13 section: 

14 ‘‘Home Infusion Therapy 

15 ‘‘(hhh)(1) The term ‘home infusion therapy’ means 

16 the following items and services furnished to an individual, 

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

18 by a qualified home infusion therapy provider under a plan 

19 (for furnishing such items and services to such individual) 

20 established and periodically reviewed by a physician, which 

21 items and services are provided in an integrated manner 

22 in the individual’s home in conformance with uniform 

23 standards of care established by the Secretary (after tak24 ing into account the standards commonly used for home 

25 infusion therapy by Medicare Advantage plans and in the 


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1 private sector and after consultation with all interested 

2 stakeholders) and in coordination with the provision of 

3 covered infusion drugs under part D: 

4 ‘‘(A) Professional services other than nursing 

5 services (including administrative, compounding, dis6 pensing, distribution, clinical monitoring and care 

7 coordination services) and all necessary supplies and 

8 equipment (including medical supplies such as sterile 

9 tubing and infusion pumps, and other items and 

10 services the Secretary determines appropriate) to ad11 minister infusion drug therapies to an individual 

12 safely and effectively in the home. 

13 ‘‘(B) Nursing services provided in accordance 

14 with the plan, directly by a qualified home infusion 

15 therapy provider or under arrangements with an ac16 credited homecare organization, in connection with 

17 such infusion, except that such term does not in18 clude nursing services to the extent they are covered 

19 as home health services. 

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

21 ‘‘(A) The term ‘home’ means a place of resi22 dence used as an individual’s home and includes 

23 such other alternate settings as the Secretary deter24 mines. 


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1 ‘‘(B) The term ‘qualified home infusion therapy 

2 provider’ means any pharmacy, physician, or other 

3 provider licensed by the State in which the phar4 macy, physician, or provider resides or provides serv5 ices, whose State authorized scope of practice in6 cludes dispensing authority and that— 

7 ‘‘(i) has expertise in the preparation of 

8 parenteral medications in compliance with en9 forceable standards of the U.S. Pharmacopoeia 

10 and other nationally recognized standards that 

11 regulate preparation of parenteral medications 

12 as determined by the Secretary and meets such 

13 standards; 

14 ‘‘(ii) provides infusion therapy to patients 

15 with acute or chronic conditions requiring par16 enteral administration of drugs and biologicals 

17 administered through catheters or needles, or 

18 both, in a home; and 

19 ‘‘(iii) meets such other uniform require20 ments as the Secretary determines are nec21 essary to ensure the safe and effective provision 

22 and administration of home infusion therapy on 

23 a 7 day a week, 24 hour basis (taking into ac24 count the standards of care for home infusion 

25 therapy established by Medicare Advantage 


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1 plans and in the private sector), and the effi2 cient administration of the home infusion ther3 apy benefit. 

4 A qualified home infusion provider may subcontract 

5 with a pharmacy, physician, provider, or supplier to 

6 meet the requirements of this subsection.’’. 

7 (b) PAYMENT FOR HOME INFUSION THERAPY.—Sec8 tion 1834 of the Social Security Act (42 U.S.C. 1395m) 

9 is amended by adding at the end the following new sub10 section: 

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

12 The payment amount under this part for home infusion 

13 therapy is determined as follows: 

14 ‘‘(1) IN GENERAL.—The Secretary shall deter15 mine a per diem schedule for payment for the pro16 fessional services, supplies, and equipment described 

17 in section 1861(hhh)(1)(A) that reflects the reason18 able costs which must be incurred by efficiently and 

19 economically operated qualified home infusion ther20 apy providers to provide such services, supplies, and 

21 equipment in conformity with applicable State and 

22 Federal laws, regulations, and the uniform quality 

23 and safety standards developed under section 

24 1861(hhh)(1) and to assure that Medicare bene25 ficiaries have reasonable access to such therapy. The 


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1 Secretary shall update such schedule from year to 

2 year by the percentage increase in the consumer 

3 price index for all urban consumers (United States 

4 city average) for the 12-month period ending with 

5 June of the preceding year. 

6 ‘‘(2) NURSING SERVICES.—The Secretary shall 

7 develop a methodology for the separate payment for 

8 nursing services described in section 

9 1861(hhh)(1)(B) provided in accordance with the 

10 plan under such section which reflects the reason11 able costs incurred in the provision of nursing serv12 ices in connection with infusion therapy in con13 formity with State and Federal laws, regulations, 

14 and the uniform quality and safety standards devel15 oped pursuant to this Act and to assure that Medi16 care beneficiaries have reasonable access to nursing 

17 services for infusion therapy. The Secretary shall up18 date such schedule from year to year by the percent19 age increase in the consumer price index for all 

20 urban consumers (United States city average) for 

21 the 12-month period ending with June of the pre22 ceding year.’’. 

23 (c) CONFORMING AMENDMENTS.— 

24 (1) PAYMENT REFERENCE.—Section 

25 1833(a)(1) of the Social Security Act (42 U.S.C. 


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1 13951(a)(1)), as amended by section 101(a)(2) of 

2 the Medicare Improvements for Patients and Pro3 viders Act of 2008 (Public Law 110–275), is amend4 ed— 

5 (A) by striking ‘‘and’’ before ‘‘(W)’’; and 

6 (B) by inserting before the semicolon at 

7 the end the following: ‘‘, and (X) with respect 

8 to home infusion therapy, the amounts paid 

9 shall be determined under section 1834(n)’’. 

10 (2) DIRECT PAYMENT.—The first sentence of 

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

12 1395u(b)(6)) is amended— 

13 (A) by striking ‘‘and’’ before ‘‘(H)’’; and 

14 (B) by inserting before the period at the 

15 end the following: ‘‘, and (I) in the case of 

16 home infusion therapy, payment shall be made 

17 to the qualified home infusion therapy pro18 vider’’. 

19 (3) EXCLUSION FROM DURABLE MEDICAL

20 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

21 1861 of such Act (42 U.S.C. 1395x) is amended— 

22 (A) in subsection (m)(5), by inserting ‘‘and 

23 supplies used in the provision of home infusion 

24 therapy’’ after ‘‘excluding other drugs and 

25 biologicals’’; and 


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1 (B) in subsection (n), by adding at the end 

2 the following: ‘‘Such term does not include 

3 home infusion therapy, other than equipment 

4 and supplies used in the provision of insulin.’’. 

5 (4) APPLICATION OF ACCREDITATION PROVI6 SIONS.—The provisions of section 1865(b) of the So7 cial Security Act (42 U.S.C. 1395bb(b)) apply to the 

8 accreditation of qualified home infusion therapy pro9 viders in the manner they apply to other suppliers. 

10 SEC. 3. MEDICARE COVERAGE OF HOME INFUSION DRUGS. 

11 (a) IN GENERAL.—Section 1860D–2(e)(1) of the So12 cial Security Act (42 U.S.C. 1395w–102(e)(1)), as amend13 ed by section 182 of the Medicare Improvements for Pa14 tients and Providers Act of 2008 (Public Law 110–275), 

15 is amended— 

16 (1) in paragraph (1)— 

17 (A) by striking ‘‘or’’ at the end of subpara18 graph (A); 

19 (B) by striking the comma at the end of 

20 subparagraph (B) and inserting ‘‘; or’’; and 

21 (C) by inserting before the flush matter 

22 following subparagraph (B) the following new 

23 subparagraph: 

24 ‘‘(C) an infusion drug (as defined in para25 graph (5)),’’; and 


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1 (2) by adding at the end the following new 

2 paragraph: 

3 ‘‘(5) INFUSION DRUG DEFINED.—For purposes 

4 of this part, the term ‘infusion drug’ means a paren5 teral drug or biological administered via an intra6 venous, intraspinal, intra-arterial, intrathecal, epidu7 ral, subcutaneous, or intramuscular access device in8 serted into the body, and includes a drug used for 

9 catheter maintenance and declotting, a drug con10 tained in a device, vitamins, intravenous solutions, 

11 diluents and minerals, and other components used in 

12 the provision of home infusion therapy.’’. 

13 (b) INFUSION DRUG FORMULARIES.—For the first 2 

14 years after the effective date of this Act, notwithstanding 

15 any other provision of law, prescription drug plans and 

16 MA–PD plans under title XVIII of the Social Security Act 

17 shall maintain open formularies for infusion drugs (as de18 fined in section 1860D–2(e)(5) of such Act, as added by 

19 subsection (a)). The Secretary of Health and Human 

20 Services shall request the United States Pharmacopeia to 

21 develop, in consultation with representatives of qualified 

22 home infusion therapy providers and other interested 

23 stakeholders, a model formulary approach for home infu24 sion drugs for use by such plans after such 2-year period. 


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1 (c) PART D DISPENSING FEES.—Section 1860D– 

2 2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 

3 102(d)(1)(B)) is amended by inserting after ‘‘any dis4 pensing fees for such drugs’’ the following: ‘‘, other than 

5 for an infusion drug’’. 

6 SEC. 4. ENSURING BENEFICIARY ACCESS TO HOME INFU7 SION THERAPY. 

8 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec9 retary of Health and Human Services shall implement the 

10 Medicare home infusion therapy benefit under the amend11 ments made by this Act in a manner that ensures that 

12 Medicare beneficiaries have timely and appropriate access 

13 to infusion therapy in their homes and that there is rapid 

14 and seamless coordination between drug coverage under 

15 part D of title XVIII of the Social Security Act and cov16 erage for home infusion therapy services under part B of 

17 such title. Specifically, the Secretary shall ensure that— 

18 (1) the benefit is practical and workable with 

19 minimal administrative burden for beneficiaries, 

20 qualified home infusion therapy providers, physi21 cians, prescription drug plans, MA–PD plans, and 

22 Medicare Advantage plans, and the Secretary shall 

23 consider the use of consolidated claims encompassing 

24 covered part D drugs and part B services, supplies, 


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1 and equipment under such part B to ensure the effi2 cient operation of this benefit; 

3 (2) any prior authorization or utilization review 

4 process is expeditious, allowing Medicare bene5 ficiaries meaningful access to home infusion therapy; 

6 (3) medical necessity determinations for home 

7 infusion therapy will be made by Medicare adminis8 trative contractors under such part B and commu9 nicated to the appropriate prescription drug plans 

10 and MA–PD plans and an individual may be initially 

11 qualified for coverage for such benefit for a 90-day 

12 period and subsequent 90-day periods thereafter; 

13 (4) the benefit is modeled on current private 

14 sector coverage and coding for home infusion ther15 apy; and 

16 (5) prescription drug plans and MA–PD plans 

17 structure their formularies, utilization review proto18 cols, and policies in a manner that ensures that 

19 Medicare beneficiaries have timely and appropriate 

20 access to infusion therapy in their homes. 

21 (b) HOME INFUSION THERAPY ADVISORY PANEL.— 

22 In implementing such home infusion therapy benefit and 

23 meeting the objectives specified in subsection (a), the Sec24 retary shall establish an advisory panel comprised of quali25 fied home infusion therapy providers and their representaVerDate Aug 31 2005 03:19 Sep 18, 2008 Jkt 069200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3505.IS S3505

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1 tive organizations as well as representatives of the fol2 lowing to provide advice and recommendations: 

3 (1) Patient organizations. 

4 (2) Hospital discharge planners, care coordina5 tors, or social workers. 

6 (3) Prescription drug plan sponsors and Medi7 care Advantage organizations. 

8 (c) REPORT.—Not later than January 1, 2011, and 

9 every 2 years thereafter, the Comptroller General of the 

10 United States shall submit a report to Congress on Medi11 care beneficiary access to home infusion therapy. Each 

12 such report shall specifically address whether the objec13 tives specified in subsection (a) have been met and shall 

14 make recommendations to Congress and the Secretary on 

15 how to improve the benefit and better ensure that Medi16 care beneficiaries have timely and appropriate access to 

17 infusion therapy in their homes. 

18 SEC. 5. EFFECTIVE DATE. 

19 The amendments made by this Act shall apply to 

20 home infusion therapy furnished on or after January 1, 

21 2009. 

Æ 


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