II 

111TH CONGRESS 

1ST SESSION S. 254 

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 

JANUARY 15, 2009 

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 2009’’. 

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 provided in accordance with the plan (in6 cluding administrative, compounding, dispensing, 

7 distribution, clinical monitoring and care coordina8 tion services) and all necessary supplies and equip9 ment (including medical supplies such as sterile tub10 ing and infusion pumps, and other items and serv11 ices the Secretary determines appropriate) to admin12 ister infusion drug therapies to an individual safely 

13 and effectively in the home. 

14 ‘‘(B) Nursing services provided in accordance 

15 with the plan, directly by a qualified home infusion 

16 therapy provider or under arrangements with an ac17 credited homecare organization, in connection with 

18 such infusion, except that such term does not in19 clude nursing services to the extent they are covered 

20 as home health services. 

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

22 ‘‘(A) The term ‘home’ means a place of resi23 dence used as an individual’s home and includes 

24 such other alternate settings as the Secretary deter25 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 therapy provider may sub5 contract with a pharmacy, physician, provider, or 

6 supplier to meet the requirements of this sub7 section.’’. 

8 (b) PAYMENT FOR HOME INFUSION THERAPY.—Sec9 tion 1834 of the Social Security Act (42 U.S.C. 1395m) 

10 is amended by adding at the end the following new sub11 section: 

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

13 The payment amount under this part for home infusion 

14 therapy is determined as follows: 

15 ‘‘(1) IN GENERAL.—The Secretary shall deter16 mine a per diem schedule for payment for the pro17 fessional services, supplies, and equipment described 

18 in section 1861(hhh)(1)(A) that reflects the reason19 able costs which must be incurred by efficiently and 

20 economically operated qualified home infusion ther21 apy providers to provide such services, supplies, and 

22 equipment in conformity with applicable State and 

23 Federal laws, regulations, and the uniform quality 

24 and safety standards developed under section 

25 1861(hhh)(1) and to assure that Medicare beneVerDate Nov 24 2008 03:53 Jan 17, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S254.IS S254

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1 ficiaries have reasonable access to such therapy. The 

2 Secretary shall update such schedule from year to 

3 year by the percentage increase in the consumer 

4 price index for all urban consumers (United States 

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

6 June of the preceding year. 

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

8 develop a methodology for the separate payment for 

9 nursing services described in section 

10 1861(hhh)(1)(B) provided in accordance with the 

11 plan under such section which reflects the reason12 able costs incurred in the provision of nursing serv13 ices in connection with infusion therapy in con14 formity with State and Federal laws, regulations, 

15 and the uniform quality and safety standards devel16 oped pursuant to this Act and to assure that Medi17 care beneficiaries have reasonable access to nursing 

18 services for infusion therapy. The Secretary shall up19 date such schedule from year to year by the percent20 age increase in the consumer price index for all 

21 urban consumers (United States city average) for 

22 the 12-month period ending with June of the pre23 ceding year.’’. 

24 (c) CONFORMING AMENDMENTS.— 


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1 (1) PAYMENT REFERENCE.—Section 

2 1833(a)(1) of the Social Security Act (42 U.S.C. 

3 13951(a)(1)), as amended by section 101(a)(2) of 

4 the Medicare Improvements for Patients and Pro5 viders Act of 2008 (Public Law 110–275), is amend6 ed— 

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

8 (B) by inserting before the semicolon at 

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

10 to home infusion therapy, the amounts paid 

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

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

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

14 1395u(b)(6)) is amended— 

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

16 (B) by inserting before the period at the 

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

18 home infusion therapy, payment shall be made 

19 to the qualified home infusion therapy pro20 vider’’. 

21 (3) EXCLUSION FROM DURABLE MEDICAL

22 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

23 1861 of such Act (42 U.S.C. 1395x) is amended— 

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

25 supplies used in the provision of home infusion 


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1 therapy’’ after ‘‘excluding other drugs and 

2 biologicals’’; and 

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

4 the following: ‘‘Such term does not include 

5 home infusion therapy, other than equipment 

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

7 (4) APPLICATION OF ACCREDITATION PROVI8 SIONS.—The provisions of section 1865(b) of the So9 cial Security Act (42 U.S.C. 1395bb(b)) apply to the 

10 accreditation of qualified home infusion therapy pro11 viders in the manner they apply to other suppliers. 

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

13 (a) IN GENERAL.—Section 1860D–2(e)(1) of the So14 cial Security Act (42 U.S.C. 1395w–102(e)(1)), as amend15 ed by section 182 of the Medicare Improvements for Pa16 tients and Providers Act of 2008 (Public Law 110–275), 

17 is amended— 

18 (1) in paragraph (1)— 

19 (A) by striking ‘‘or’’ at the end of subpara20 graph (A); 

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

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

23 (C) by inserting before the flush matter 

24 following subparagraph (B) the following new 

25 subparagraph: 


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1 ‘‘(C) an infusion drug (as defined in para2 graph (5)),’’; and 

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

4 paragraph: 

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

6 of this part, the term ‘infusion drug’ means a paren7 teral drug or biological administered via an intra8 venous, intraspinal, intra-arterial, intrathecal, epidu9 ral, subcutaneous, or intramuscular access device in10 serted into the body, and includes a drug used for 

11 catheter maintenance and declotting, a drug con12 tained in a device, vitamins, intravenous solutions, 

13 diluents and minerals, and other components used in 

14 the provision of home infusion therapy.’’. 

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

16 years after the effective date of this Act, notwithstanding 

17 any other provision of law, prescription drug plans and 

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

19 shall maintain open formularies for infusion drugs (as de20 fined in section 1860D–2(e)(5) of such Act, as added by 

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

22 Services shall request the United States Pharmacopeia to 

23 develop, in consultation with representatives of qualified 

24 home infusion therapy providers and other interested 


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1 stakeholders, a model formulary approach for home infu2 sion drugs for use by such plans after such 2-year period. 

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

4 2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 

5 102(d)(1)(B)) is amended by inserting after ‘‘any dis6 pensing fees for such drugs’’ the following: ‘‘, other than 

7 for an infusion drug’’. 

8 SEC. 4. ENSURING BENEFICIARY ACCESS TO HOME INFU9 SION THERAPY. 

10 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec11 retary of Health and Human Services shall implement the 

12 Medicare home infusion therapy benefit under the amend13 ments made by this Act in a manner that ensures that 

14 Medicare beneficiaries have timely and appropriate access 

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

16 and seamless coordination between drug coverage under 

17 part D of title XVIII of the Social Security Act and cov18 erage for home infusion therapy services under part B of 

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

20 (1) the benefit is practical and workable with 

21 minimal administrative burden for beneficiaries, 

22 qualified home infusion therapy providers, physi23 cians, prescription drug plans, MA–PD plans, and 

24 Medicare Advantage plans, and the Secretary shall 

25 consider the use of consolidated claims encompassing 


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

2 and equipment under such part B to ensure the effi3 cient operation of this benefit; 

4 (2) any prior authorization or utilization review 

5 process is expeditious, allowing Medicare bene6 ficiaries meaningful access to home infusion therapy; 

7 (3) medical necessity determinations for home 

8 infusion therapy will be made— 

9 (A) except as provided in subparagraph 

10 (B), by medicare administrative contractors 

11 under such part B and communicated to the 

12 appropriate prescription drug plans; or 

13 (B) in the case of an individual enrolled in 

14 a Medicare Advantage plan, by the Medicare 

15 Advantage organization offering the plan; 

16 and an individual may be initially qualified for cov17 erage for such benefit for a 90-day period and sub18 sequent 90-day periods thereafter; 

19 (4) the benefit is modeled on current private 

20 sector coverage and coding for home infusion ther21 apy; and 

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

23 structure their formularies, utilization review proto24 cols, and policies in a manner that ensures that 


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1 Medicare beneficiaries have timely and appropriate 

2 access to infusion therapy in their homes. 

3 (b) HOME INFUSION THERAPY ADVISORY PANEL.— 

4 In implementing such home infusion therapy benefit and 

5 meeting the objectives specified in subsection (a), the Sec6 retary shall establish an advisory panel to provide advice 

7 and recommendations. Such panel shall— 

8 (1) be comprised primarily of qualified home in9 fusion therapy providers and their representative or10 ganizations; 

11 (2) also include representatives of the following: 

12 (A) Patient organizations. 

13 (B) Hospital discharge planners, care coor14 dinators, or social workers. 

15 (C) Prescription drug plan sponsors and 

16 Medicare Advantage organizations. 

17 (c) REPORT.—Not later than January 1, 2012, and 

18 every 2 years thereafter, the Comptroller General of the 

19 United States shall submit a report to Congress on Medi20 care beneficiary access to home infusion therapy. Each 

21 such report shall specifically address whether the objec22 tives specified in subsection (a) have been met and shall 

23 make recommendations to Congress and the Secretary on 

24 how to improve the benefit and better ensure that MediVerDate Nov 24 2008 03:53 Jan 17, 2009 Jkt 079200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S254.IS S254

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1 care beneficiaries have timely and appropriate access to 

2 infusion therapy in their homes. 

3 SEC. 5. EFFECTIVE DATE. 

4 The amendments made by this Act shall apply to 

5 home infusion therapy furnished on or after January 1, 

6 2010. 

Æ 


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