I 

110TH CONGRESS 

1ST SESSION H. R. 2567 

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 5, 2007 

Mr. ENGEL (for himself, Ms. GRANGER, Ms. BALDWIN, Mr. PICKERING, Mr. 

KUHL of New York, and Mr. TIERNEY) 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 2007’’. 

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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) is amended— 

5 (1) in subsection (s)(2)— 

6 (A) by striking ‘‘and’’ at the end of sub7 paragraph (Z); 

8 (B) by adding ‘‘and’’ at the end of sub9 paragraph (AA); and 

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

11 subparagraph: 

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

13 subsection (ccc)(1));’’; and 

14 (2) by adding at the end the following new sub15 section: 

16 ‘‘Home Infusion Therapy 

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

18 the following items and services furnished to an individual, 

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

20 by a qualified home infusion therapy provider under a plan 

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

22 established and periodically reviewed by a physician, which 

23 items and services are provided in an integrated manner 

24 in the individual’s home in conformance with uniform 

25 standards of care established by the Secretary (after tak26 ing into account the standards commonly used for home 

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1 infusion therapy by Medicare Advantage plans and in the 

2 private sector and after consultation with all interested 

3 stakeholders) and in coordination with the provision of 

4 covered infusion drugs under part D: 

5 ‘‘(A) Professional services other than nursing 

6 services (including administrative, compounding, dis7 pensing, distribution, clinical monitoring and care 

8 coordination services) and all necessary supplies and 

9 equipment (including medical supplies such as sterile 

10 tubing and infusion pumps, and other items and 

11 services the Secretary determines appropriate) to ad12 minister infusion drug therapies to an individual 

13 safely 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 seven day a week, twenty-four hour basis 

24 (taking into account the standards of care for 

25 home infusion therapy established by Medicare 

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1 Advantage plans and in the private sector), and 

2 the efficient administration of the home infu3 sion therapy 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 such Act (42 U.S.C. 1395m) is amended by 

9 adding at the end the following new subsection: 

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

11 The payment amount under this part for home infusion 

12 therapy is determined as follows: 

13 ‘‘(1) IN GENERAL.—The Secretary shall deter14 mine a per diem schedule for payment for the pro15 fessional services, supplies, and equipment described 

16 in section 1861(ccc)(1)(A) that reflects the reason17 able costs which must be incurred by efficiently and 

18 economically operated qualified home infusion ther19 apy providers to provide such services, supplies, and 

20 equipment in conformity with applicable State and 

21 Federal laws, regulations, and the uniform quality 

22 and safety standards developed under section 

23 1861(ccc)(1) and to assure that Medicare bene24 ficiaries have reasonable access to such therapy. The 

25 Secretary shall update such schedule from year to 

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1 year by the percentage increase in the consumer 

2 price index for all urban consumers (United States 

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

4 June of the preceding year. 

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

6 develop a methodology for the separate payment for 

7 nursing services described in section 1861(ccc)(1)(B) 

8 provided in accordance with the plan under such sec9 tion which reflects the reasonable costs incurred in 

10 the provision of nursing services in connection with 

11 infusion therapy in conformity with State and Fed12 eral laws, regulations, and the uniform quality and 

13 safety standards developed pursuant to this Act and 

14 to assure that Medicare beneficiaries have reason15 able access to nursing services for infusion therapy. 

16 The Secretary shall update such schedule from year 

17 to year by the percentage increase in the consumer 

18 price index for all urban consumers (United States 

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

20 June of the preceding year.’’. 

21 (c) CONFORMING AMENDMENTS.— 

22 (1) PAYMENT REFERENCE.—Section 

23 1833(a)(1) of the Social Security Act (42 U.S.C. 

24 13951(a)(1)) is amended— 

25 (A) by striking ‘‘and’’ before ‘‘(V)’’; and 

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1 (B) by inserting before the semicolon at 

2 the end the following: ‘‘, and (W) with respect 

3 to home infusion therapy, the amounts paid 

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

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

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

7 1395u(b)(6)) is amended— 

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

9 (B) by inserting before the period at the 

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

11 home infusion therapy, payment shall be made 

12 to the qualified home infusion therapy pro13 vider’’. 

14 (3) EXCLUSION FROM DURABLE MEDICAL

15 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

16 1861 of such Act (42 U.S.C. 1395x) is amended— 

17 (A) in subsection (m), by inserting ‘‘and 

18 supplies used in the provision of home infusion 

19 therapy’’ after ‘‘excluding other drugs and 

20 biologicals’’; and 

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

22 the following: ‘‘Such term does not include 

23 home infusion therapy, other than equipment 

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

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1 (4) APPLICATION OF ACCREDITATION PROVI2 SIONS.—The provisions of section 1865(b) of the So3 cial Security Act (42 U.S.C. 1395bb(b)) apply to the 

4 accreditation of qualified home infusion therapy pro5 viders in the manner they apply to other suppliers. 

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

7 (a) IN GENERAL.—Section 1860D–2(e)(1) of the So8 cial Security Act (42 U.S.C. 1395w–102(e)(1)) is amend9 ed— 

10 (1) in paragraph (1)— 

11 (A) by striking ‘‘or’’ at the end of subpara12 graph (A); 

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

14 subparagraph (B) and inserting ‘‘, or’’; and 

15 (C) by inserting after subparagraph (B) 

16 the following new subparagraph: 

17 ‘‘(C) an infusion drug (as defined in para18 graph (4)),’’; and 

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

20 paragraph: 

21 ‘‘(4) INFUSION DRUG DEFINED.—For purposes 

22 of this part, the term ‘infusion drug’ means a paren23 teral drug or biological administered via an intra24 venous, intraspinal, intra-arterial, intrathecal, epidu25 ral, subcutaneous, or intramuscular access device inmstockstill on PROD1PC66 with BILLS

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1 serted into the body, and includes a drug used for 

2 catheter maintenance and declotting, a drug con3 tained in a device, vitamins, intravenous solutions, 

4 diluents and minerals, and other components used in 

5 the provision of home infusion therapy.’’. 

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

7 years after the effective date of this Act, notwithstanding 

8 any other provision of law, prescription drug plans and 

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

10 shall maintain open formularies for infusion drugs (as de11 fined in section 1860D–2(e)(4) of such Act. The Secretary 

12 of Health and Human Services shall request the United 

13 States Pharmacopeia to develop, in consultation with rep14 resentatives of qualified home infusion therapy providers 

15 and other interested stakeholders, a model formulary ap16 proach for home infusion drugs for use by such plans after 

17 such 2-year period. 

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

19 2(d)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 

20 102(d)(1)(B)) is amended by inserting after ‘‘any dis21 pensing fees for such drugs’’ the following: ‘‘, other than 

22 for an infusion drug’’. 

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1 SEC. 4. ENSURING BENEFICIARY ACCESS TO HOME INFU2 SION THERAPY. 

3 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec4 retary of Health and Human Services shall implement the 

5 Medicare home infusion therapy benefit under the amend6 ments made by this Act in a manner that ensures that 

7 Medicare beneficiaries have timely and appropriate access 

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

9 and seamless coordination between drug coverage under 

10 part D of title XVIII of the Social Security Act and cov11 erage for home infusion therapy services under part B of 

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

13 (1) the benefit is practical and workable with 

14 minimal administrative burden for beneficiaries, 

15 qualified home infusion therapy providers, physi16 cians, prescription drug plans, MA–PD plans, and 

17 MA plans, and the Secretary shall consider the use 

18 of consolidated claims encompassing covered part D 

19 drugs and part B services, supplies, and equipment 

20 under such part B to ensure the efficient operation 

21 of this benefit; 

22 (2) any prior authorization or utilization review 

23 process is expeditious, allowing Medicare bene24 ficiaries meaningful access to home infusion therapy; 

25 (3) medical necessity determinations for home 

26 infusion therapy will be made by Medicare adminismstockstill on PROD1PC66 with BILLS

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1 trative contractors under such part B and commu2 nicated to the appropriate prescription drug plans 

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

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

5 period and subsequent 90-day periods thereafter; 

6 (4) the benefit is modeled on current private 

7 sector coverage and coding for home infusion ther8 apy; and 

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

10 structure their formularies, utilization review proto11 cols, and policies in a manner that ensures that 

12 Medicare beneficiaries have timely and appropriate 

13 access to infusion therapy in their homes. 

14 (b) HOME INFUSION THERAPY ADVISORY PANEL.— 

15 In implementing such home infusion therapy benefit and 

16 meeting the objectives specified in subsection (a), the Sec17 retary shall establish an advisory panel comprised of quali18 fied home infusion therapy providers and their representa19 tive organizations as well as representatives of the fol20 lowing to provide advice and recommendations: 

21 (1) Patient organizations. 

22 (2) Hospital discharge planners, care coordina23 tors or social workers. 

24 (3) Prescription drug plan sponsors and Medi25 care Advantage organizations. 

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1 (c) REPORT.—Not later than January 1, 2010, and 

2 every two years thereafter, the Comptroller General of the 

3 United States shall submit a report to Congress on Medi4 care beneficiary access to home infusion therapy. Each 

5 such report shall specifically address whether the objec6 tives specified in subsection (a) have been met and shall 

7 make recommendations to Congress and the Secretary on 

8 how to improve the benefit and better ensure that Medi9 care beneficiaries have timely and appropriate access to 

10 infusion therapy in their homes. 

11 SEC. 5. EFFECTIVE DATE. 

12 The amendments made by this Act shall apply to 

13 home infusion therapy furnished on or after January 1, 

14 2008. 

Æ 

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