I 

112TH CONGRESS 

1ST SESSION H. R. 2195 

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 

JUNE 15, 2011 

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

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 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) The Medicare program is presently the only 

2 major health care payer in the country that does not 

3 provide comprehensive coverage of home infusion 

4 therapy. 

5 (2) As a result of the Medicare program not 

6 providing for comprehensive coverage of home infu7 sion therapy, many Medicare beneficiaries are unable 

8 to obtain infusion therapy in the most cost-effective 

9 and convenient setting of their homes. 

10 (3) The Medicare program is paying for institu11 tional care for the provision of infusion therapy in 

12 many instances when such institutional care could be 

13 avoided if the Medicare program provided coverage 

14 for home infusion therapy. 

15 (4) The Government Accountability Office 

16 found in a 2010 report that home infusion therapy 

17 is utilized widely by private payors providing health 

18 insurance coverage for individuals enrolled under 

19 such coverage and that such private payors generally 

20 are satisfied with the quality of care and the savings 

21 they achieve through avoided institutionalizations. 

22 SEC. 3. MEDICARE COVERAGE OF HOME INFUSION THER23 APY. 

24 (a) IN GENERAL.—Section 1861 of the Social Secu25 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 (EE); 

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

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

7 subparagraph: 

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

9 subsection (iii)(1));’’; and 

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

12 ‘‘Home Infusion Therapy 

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

14 following items and services furnished to an individual, 

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

16 by a qualified home infusion therapy provider under a plan 

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

18 established and periodically reviewed by a physician, which 

19 items and services are provided in an integrated manner 

20 in the individual’s home in conformance with uniform 

21 standards of care established by the Secretary (after tak22 ing into account the standards commonly used for home 

23 infusion therapy by Medicare Advantage plans and in the 

24 private sector and after consultation with all interested 


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1 stakeholders) and in coordination with the provision of 

2 covered infusion drugs under part D: 

3 ‘‘(A) Professional services other than nursing 

4 services provided in accordance with the plan (in5 cluding administrative, compounding, dispensing, 

6 distribution, clinical monitoring and care coordina7 tion services) and all necessary supplies and equip8 ment (including medical supplies such as sterile tub9 ing and infusion pumps, and other items and serv10 ices the Secretary determines appropriate) to admin11 ister infusion drug therapies to an individual safely 

12 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 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 ‘‘(p) 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(iii)(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(iii)(1) and to assure that Medicare beneVerDate Mar 15 2010 01:33 Jun 18, 2011 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2195.IH H2195

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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)) is amended— 

4 (A) by striking ‘‘and’’ before ‘‘(Z)’’; and 

5 (B) by inserting before the semicolon at 

6 the end the following: ‘‘, and (AA) with respect 

7 to home infusion therapy, the amounts paid 

8 shall be determined under section 1834(p)’’. 

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

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

11 1395u(b)(6)) is amended— 

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

13 (B) by inserting before the period at the 

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

15 home infusion therapy, payment shall be made 

16 to the qualified home infusion therapy pro17 vider’’. 

18 (3) EXCLUSION FROM DURABLE MEDICAL

19 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

20 1861 of such Act (42 U.S.C. 1395x) is amended— 

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

22 supplies used in the provision of home infusion 

23 therapy’’ after ‘‘excluding other drugs and 

24 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. 4. 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)) is amend13 ed— 

14 (1) in paragraph (1)— 

15 (A) by striking ‘‘or’’ at the end of subpara16 graph (A); 

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

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

19 (C) by inserting before the flush matter 

20 following subparagraph (B) the following new 

21 subparagraph: 

22 ‘‘(C) an infusion drug (as defined in para23 graph (5)),’’; and 

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

25 paragraph: 


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

2 of this part, the term ‘infusion drug’ means a paren3 teral drug or biological administered via an intra4 venous, intraspinal, intra-arterial, intrathecal, epidu5 ral, subcutaneous, or intramuscular access device in6 serted into the body, and includes a drug used for 

7 catheter maintenance and declotting, a drug con8 tained in a device, vitamins, intravenous solutions, 

9 diluents and minerals, and other components used in 

10 the provision of home infusion therapy.’’. 

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

12 years after the date of the enactment of this Act, notwith13 standing any other provision of law, prescription drug 

14 plans and MA–PD plans under title XVIII of the Social 

15 Security Act shall maintain open formularies for infusion 

16 drugs (as defined in section 1860D–2(e)(5) of such Act, 

17 as added by subsection (a)). The Secretary of Health and 

18 Human Services shall request the United States Pharma19 copeia to develop, in consultation with representatives of 

20 qualified home infusion therapy providers and other inter21 ested stakeholders, a model formulary approach for home 

22 infusion drugs for use by such plans after such 2-year pe23 riod. 

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

25 2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 


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1 102(d)(1)(B)) is amended by inserting after ‘‘any dis2 pensing fees for such drugs’’ the following: ‘‘, other than 

3 for an infusion drug’’. 

4 SEC. 5. ENSURING BENEFICIARY ACCESS TO HOME INFU5 SION THERAPY. 

6 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec7 retary of Health and Human Services shall implement the 

8 Medicare home infusion therapy benefit under the amend9 ments made by this Act in a manner that ensures that 

10 Medicare beneficiaries have timely and appropriate access 

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

12 and seamless coordination between drug coverage under 

13 part D of title XVIII of the Social Security Act and cov14 erage for home infusion therapy services under part B of 

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

16 (1) the benefit is practical and workable with 

17 minimal administrative burden for beneficiaries, 

18 qualified home infusion therapy providers, physi19 cians, prescription drug plans, MA–PD plans, and 

20 Medicare Advantage plans, and the Secretary shall 

21 consider the use of consolidated claims encompassing 

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

23 and equipment under such part B to ensure the effi24 cient operation of this benefit; 


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1 (2) any prior authorization or utilization review 

2 process is expeditious, allowing Medicare bene3 ficiaries meaningful access to home infusion therapy; 

4 (3) medical necessity determinations for home 

5 infusion therapy will be made— 

6 (A) except as provided in subparagraph 

7 (B), by medicare administrative contractors 

8 under such part B and communicated to the 

9 appropriate prescription drug plans; or 

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

11 a Medicare Advantage plan, by the Medicare 

12 Advantage organization offering the plan; 

13 and an individual may be initially qualified for cov14 erage for such benefit for a 90-day period and sub15 sequent 90-day periods thereafter; 

16 (4) the benefit is modeled on current private 

17 sector coverage and coding for home infusion ther18 apy; and 

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

20 structure their formularies, utilization review proto21 cols, and policies in a manner that ensures that 

22 Medicare beneficiaries have timely and appropriate 

23 access to infusion therapy in their homes. 

24 (b) HOME INFUSION THERAPY ADVISORY PANEL.— 

25 In implementing such home infusion therapy benefit and 


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1 meeting the objectives specified in subsection (a), the Sec2 retary shall establish an advisory panel to provide advice 

3 and recommendations. Such panel shall— 

4 (1) be comprised primarily of qualified home in5 fusion therapy providers and their representative or6 ganizations; and 

7 (2) also include representatives of the following: 

8 (A) Patient organizations. 

9 (B) Hospital discharge planners, care coor10 dinators, or social workers. 

11 (C) Prescription drug plan sponsors and 

12 Medicare Advantage organizations. 

13 (c) REPORT.—Not later than January 1, 2014, and 

14 every 2 years thereafter, the Comptroller General of the 

15 United States shall submit a report to Congress on Medi16 care beneficiary access to home infusion therapy. Each 

17 such report shall specifically address whether the objec18 tives specified in subsection (a) have been met and shall 

19 make recommendations to Congress and the Secretary on 

20 how to improve the benefit and better ensure that Medi21 care beneficiaries have timely and appropriate access to 

22 infusion therapy in their homes. 


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1 SEC. 6. EFFECTIVE DATE. 

2 The amendments made by this Act shall apply to 

3 home infusion therapy furnished on or after January 1, 

4 2012. 

Æ 


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