I 

111TH CONGRESS 

1ST SESSION H. R. 574 

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

of home infusion therapy under the Medicare Program. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 15, 2009 

Mr. ENGEL (for himself, Mr. TIM MURPHY of Pennsylvania, Ms. BALDWIN, 

and Ms. GRANGER) 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 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’’. 


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1 SEC. 2. MEDICARE COVERAGE OF HOME INFUSION THER2 APY. 

3 (a) IN GENERAL.—Section 1861 of the Social Secu4 rity Act (42 U.S.C. 1395x), as amended by section 152(b) 

5 of the Medicare Improvements for Patients and Providers 

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

7 (1) in subsection (s)(2)— 

8 (A) by striking ‘‘and’’ at the end of sub9 paragraph (DD); 

10 (B) by adding ‘‘and’’ at the end of sub11 paragraph (EE); and 

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

13 subparagraph: 

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

15 subsection (hhh)(1));’’; and 

16 (2) by adding at the end the following new sub17 section: 

18 ‘‘Home Infusion Therapy 

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

20 the following items and services furnished to an individual, 

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

22 by a qualified home infusion therapy provider under a plan 

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

24 established and periodically reviewed by a physician, which 

25 items and services are provided in an integrated manner 

26 in the individual’s home in conformance with uniform 


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1 standards of care established by the Secretary (after tak2 ing into account the standards commonly used for home 

3 infusion therapy by Medicare Advantage plans and in the 

4 private sector and after consultation with all interested 

5 stakeholders) and in coordination with the provision of 

6 covered infusion drugs under part D: 

7 ‘‘(A) Professional services other than nursing 

8 services provided in accordance with the plan (in9 cluding administrative, compounding, dispensing, 

10 distribution, clinical monitoring and care coordina11 tion services) and all necessary supplies and equip12 ment (including medical supplies such as sterile tub13 ing and infusion pumps, and other items and serv14 ices the Secretary determines appropriate) to admin15 ister infusion drug therapies to an individual safely 

16 and effectively in the home. 

17 ‘‘(B) Nursing services provided in accordance 

18 with the plan, directly by a qualified home infusion 

19 therapy provider or under arrangements with an ac20 credited homecare organization, in connection with 

21 such infusion, except that such term does not in22 clude nursing services to the extent they are covered 

23 as home health services. 

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


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1 ‘‘(A) The term ‘home’ means a place of resi2 dence used as an individual’s home and includes 

3 such other alternate settings as the Secretary deter4 mines. 

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

6 provider’ means any pharmacy, physician, or other 

7 provider licensed by the State in which the phar8 macy, physician, or provider resides or provides serv9 ices, whose State authorized scope of practice in10 cludes dispensing authority and that— 

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

12 parenteral medications in compliance with en13 forceable standards of the U.S. Pharmacopoeia 

14 and other nationally recognized standards that 

15 regulate preparation of parenteral medications 

16 as determined by the Secretary and meets such 

17 standards; 

18 ‘‘(ii) provides infusion therapy to patients 

19 with acute or chronic conditions requiring par20 enteral administration of drugs and biologicals 

21 administered through catheters or needles, or 

22 both, in a home; and 

23 ‘‘(iii) meets such other uniform require24 ments as the Secretary determines are nec25 essary to ensure the safe and effective provision 


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1 and administration of home infusion therapy on 

2 a 7 day a week, 24 hour basis (taking into ac3 count the standards of care for home infusion 

4 therapy established by Medicare Advantage 

5 plans and in the private sector), and the effi6 cient administration of the home infusion ther7 apy benefit. 

8 A qualified home infusion therapy provider may sub9 contract with a pharmacy, physician, provider, or 

10 supplier to meet the requirements of this sub11 section.’’. 

12 (b) PAYMENT FOR HOME INFUSION THERAPY.—Sec13 tion 1834 of the Social Security Act (42 U.S.C. 1395m) 

14 is amended by adding at the end the following new sub15 section: 

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

17 The payment amount under this part for home infusion 

18 therapy is determined as follows: 

19 ‘‘(1) IN GENERAL.—The Secretary shall deter20 mine a per diem schedule for payment for the pro21 fessional services, supplies, and equipment described 

22 in section 1861(hhh)(1)(A) that reflects the reason23 able costs which must be incurred by efficiently and 

24 economically operated qualified home infusion ther25 apy providers to provide such services, supplies, and 


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1 equipment in conformity with applicable State and 

2 Federal laws, regulations, and the uniform quality 

3 and safety standards developed under section 

4 1861(hhh)(1) and to assure that Medicare bene5 ficiaries have reasonable access to such therapy. The 

6 Secretary shall update such schedule from year to 

7 year by the percentage increase in the consumer 

8 price index for all urban consumers (United States 

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

10 June of the preceding year. 

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

12 develop a methodology for the separate payment for 

13 nursing services described in section 

14 1861(hhh)(1)(B) provided in accordance with the 

15 plan under such section which reflects the reason16 able costs incurred in the provision of nursing serv17 ices in connection with infusion therapy in con18 formity with State and Federal laws, regulations, 

19 and the uniform quality and safety standards devel20 oped pursuant to this Act and to assure that Medi21 care beneficiaries have reasonable access to nursing 

22 services for infusion therapy. The Secretary shall up23 date such schedule from year to year by the percent24 age increase in the consumer price index for all 

25 urban consumers (United States city average) for 


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1 the 12-month period ending with June of the pre2 ceding year.’’. 

3 (c) CONFORMING AMENDMENTS.— 

4 (1) PAYMENT REFERENCE.—Section 

5 1833(a)(1) of the Social Security Act (42 U.S.C. 

6 13951(a)(1)), as amended by section 101(a)(2) of 

7 the Medicare Improvements for Patients and Pro8 viders Act of 2008 (Public Law 110–275), is amend9 ed— 

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

11 (B) by inserting before the semicolon at 

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

13 to home infusion therapy, the amounts paid 

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

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

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

17 1395u(b)(6)) is amended— 

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

19 (B) by inserting before the period at the 

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

21 home infusion therapy, payment shall be made 

22 to the qualified home infusion therapy pro23 vider’’. 


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1 (3) EXCLUSION FROM DURABLE MEDICAL

2 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

3 1861 of such Act (42 U.S.C. 1395x) is amended— 

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

5 supplies used in the provision of home infusion 

6 therapy’’ after ‘‘excluding other drugs and 

7 biologicals’’; and 

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

9 the following: ‘‘Such term does not include 

10 home infusion therapy, other than equipment 

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

12 (4) APPLICATION OF ACCREDITATION PROVI13 SIONS.—The provisions of section 1865(b) of the So14 cial Security Act (42 U.S.C. 1395bb(b)) apply to the 

15 accreditation of qualified home infusion therapy pro16 viders in the manner they apply to other suppliers. 

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

18 (a) IN GENERAL.—Section 1860D–2(e)(1) of the So19 cial Security Act (42 U.S.C. 1395w–102(e)(1)), as amend20 ed by section 182 of the Medicare Improvements for Pa21 tients and Providers Act of 2008 (Public Law 110–275), 

22 is amended— 

23 (1) in paragraph (1)— 

24 (A) by striking ‘‘or’’ at the end of subpara25 graph (A); 


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

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

3 (C) by inserting before the flush matter 

4 following subparagraph (B) the following new 

5 subparagraph: 

6 ‘‘(C) an infusion drug (as defined in para7 graph (5)),’’; and 

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

9 paragraph: 

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

11 of this part, the term ‘infusion drug’ means a paren12 teral drug or biological administered via an intra13 venous, intraspinal, intra-arterial, intrathecal, epidu14 ral, subcutaneous, or intramuscular access device in15 serted into the body, and includes a drug used for 

16 catheter maintenance and declotting, a drug con17 tained in a device, vitamins, intravenous solutions, 

18 diluents and minerals, and other components used in 

19 the provision of home infusion therapy.’’. 

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

21 years after the effective date of this Act, notwithstanding 

22 any other provision of law, prescription drug plans and 

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

24 shall maintain open formularies for infusion drugs (as de25 fined in section 1860D–2(e)(5) of such Act, as added by 


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

2 Services shall request the United States Pharmacopeia to 

3 develop, in consultation with representatives of qualified 

4 home infusion therapy providers and other interested 

5 stakeholders, a model formulary approach for home infu6 sion drugs for use by such plans after such 2-year period. 

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

8 2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 

9 102(d)(1)(B)) is amended by inserting after ‘‘any dis10 pensing fees for such drugs’’ the following: ‘‘, other than 

11 for an infusion drug’’. 

12 SEC. 4. ENSURING BENEFICIARY ACCESS TO HOME INFU13 SION THERAPY. 

14 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec15 retary of Health and Human Services shall implement the 

16 Medicare home infusion therapy benefit under the amend17 ments made by this Act in a manner that ensures that 

18 Medicare beneficiaries have timely and appropriate access 

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

20 and seamless coordination between drug coverage under 

21 part D of title XVIII of the Social Security Act and cov22 erage for home infusion therapy services under part B of 

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

24 (1) the benefit is practical and workable with 

25 minimal administrative burden for beneficiaries, 


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1 qualified home infusion therapy providers, physi2 cians, prescription drug plans, MA–PD plans, and 

3 Medicare Advantage plans, and the Secretary shall 

4 consider the use of consolidated claims encompassing 

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

6 and equipment under such part B to ensure the effi7 cient operation of this benefit; 

8 (2) any prior authorization or utilization review 

9 process is expeditious, allowing Medicare bene10 ficiaries meaningful access to home infusion therapy; 

11 (3) medical necessity determinations for home 

12 infusion therapy will be made— 

13 (A) except as provided in subparagraph 

14 (B), by medicare administrative contractors 

15 under such part B and communicated to the 

16 appropriate prescription drug plans; or 

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

18 a Medicare Advantage plan, by the Medicare 

19 Advantage organization offering the plan; 

20 and an individual may be initially qualified for cov21 erage for such benefit for a 90-day period and sub22 sequent 90-day periods thereafter; 

23 (4) the benefit is modeled on current private 

24 sector coverage and coding for home infusion ther25 apy; and 


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

2 structure their formularies, utilization review proto3 cols, and policies in a manner that ensures that 

4 Medicare beneficiaries have timely and appropriate 

5 access to infusion therapy in their homes. 

6 (b) HOME INFUSION THERAPY ADVISORY PANEL.— 

7 In implementing such home infusion therapy benefit and 

8 meeting the objectives specified in subsection (a), the Sec9 retary shall establish an advisory panel to provide advice 

10 and recommendations. Such panel shall— 

11 (1) be comprised primarily of qualified home in12 fusion therapy providers and their representative or13 ganizations; 

14 (2) also include representatives of the following: 

15 (1) Patient organizations. 

16 (2) Hospital discharge planners, care coordina17 tors, or social workers. 

18 (3) Prescription drug plan sponsors and Medi19 care Advantage organizations. 

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

21 every 2 years thereafter, the Comptroller General of the 

22 United States shall submit a report to Congress on Medi23 care beneficiary access to home infusion therapy. Each 

24 such report shall specifically address whether the objec25 tives specified in subsection (a) have been met and shall 


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1 make recommendations to Congress and the Secretary on 

2 how to improve the benefit and better ensure that Medi3 care beneficiaries have timely and appropriate access to 

4 infusion therapy in their homes. 

5 SEC. 5. EFFECTIVE DATE. 

6 The amendments made by this Act shall apply to 

7 home infusion therapy furnished on or after January 1, 

8 2010. 

Æ 


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