I 

113TH CONGRESS 

2D SESSION H. R. 5435 

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

of home as a site of care for infusion therapy under the Medicare Program. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 10, 2014 

Mr. ENGEL (for himself, Mr. TIBERI, Mr. LARSON of Connecticut, Mr. HARPER, Mr. MEEHAN, Ms. PINGREE of Maine, and Mr. PETERSON) 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 as a site of care for 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 Site of Care Act of 2014’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) The Medicare fee-for-service program covers 

2 infusion therapy in the hospital, skilled nursing facil3 ity, physician office, and hospital outpatient depart4 ment, but does not cover the full range of services 

5 for the provision of infusion therapies in a patient’s 

6 home. 

7 (2) The Medicare program is presently the only 

8 major health care payer in the United States that 

9 does not provide comprehensive coverage of home in10 fusion therapy. 

11 (3) As a result of the Medicare program not 

12 providing for comprehensive coverage of home infu13 sion therapy, many Medicare beneficiaries are unable 

14 to obtain infusion therapy in the most cost-effective 

15 and convenient setting of their home, and physicians 

16 are deprived of the ability to select the best site of 

17 care for their patients. 

18 (4) The Medicare program is paying for institu19 tional care for the provision of infusion therapy in 

20 many instances when such institutional care could be 

21 avoided if the Medicare program provided coverage 

22 for home infusion therapy. 

23 (5) The Government Accountability Office 

24 found in a 2010 report that home infusion therapy 

25 is utilized widely by private payers providing health 


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1 insurance coverage for individuals enrolled under 

2 such coverage and that such private payers generally 

3 are satisfied with the quality of care and the savings 

4 they achieve through avoided institutionalizations. 

5 (6) A recent study has reported a potential sav6 ings for Medicare if infusion therapies were covered 

7 in the home site of care. 

8 SEC. 3. MEDICARE COVERAGE OF HOME INFUSION THER9 APY. 

10 (a) IN GENERAL.—Section 1861 of the Social Secu11 rity Act (42 U.S.C. 1395x) is amended— 

12 (1) in subsection (s)(2)— 

13 (A) by striking ‘‘and’’ at the end of sub14 paragraph (EE); 

15 (B) by inserting ‘‘and’’ at the end of sub16 paragraph (FF); and 

17 (C) by inserting at the end the following 

18 new subparagraph: 

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

20 subsection (iii)(1));’’; and 

21 (2) by adding at the end the following new sub22 section: 

23 ‘‘Home Infusion Therapy 

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

25 items and services described in paragraph (2) furnished 


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1 to an individual, who is under the care of a physician, 

2 which are provided by a qualified home infusion therapy 

3 supplier under a plan (for furnishing such items and serv4 ices to such individual) established and periodically re5 viewed by a physician, which items and services are pro6 vided in an integrated manner in the individual’s home 

7 in conformance with uniform standards of care established 

8 by the Secretary and in coordination with the provision 

9 of covered infusion drugs under part D. The Secretary 

10 shall establish such standards after taking into account 

11 the standards commonly used for home infusion therapy 

12 by Medicare Advantage plans and in the private sector and 

13 after consultation with all interested stakeholders. 

14 ‘‘(2) The items and services described in this para15 graph are the following: 

16 ‘‘(A) Professional services, including nursing 

17 services (other than nursing services covered as 

18 home health services), provided in accordance with 

19 the plan (including administrative, compounding, 

20 dispensing, distribution, clinical monitoring, and 

21 care coordination services) and all necessary supplies 

22 and equipment (including medical supplies such as 

23 sterile tubing and infusion pumps). 

24 ‘‘(B) Other items and services the Secretary de25 termines appropriate to administer infusion drug 


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1 therapies to an individual safely and effectively in 

2 the home. 

3 ‘‘(3) For purposes of this subsection: 

4 ‘‘(A) The term ‘home’ means a place of resi5 dence used as an individual’s home and includes 

6 such other alternate settings as the Secretary deter7 mines. 

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

9 supplier’ means any pharmacy, physician, or other 

10 provider licensed by the State in which the phar11 macy, physician, or provider resides or provides serv12 ices, whose State authorized scope of practice in13 cludes dispensing authority and that— 

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

15 parenteral medications in compliance with en16 forceable standards of the United States Phar17 macopoeia and other nationally recognized 

18 standards that regulate preparation of paren19 teral medications as determined by the Sec20 retary and meets such standards; 

21 ‘‘(ii) provides infusion therapy to patients 

22 with acute or chronic conditions requiring par23 enteral administration of drugs and biologicals 

24 administered through catheters or needles, or 

25 both, in a home; and 


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1 ‘‘(iii) meets such other uniform require2 ments as the Secretary determines are nec3 essary to ensure the safe and effective provision 

4 and administration of home infusion therapy on 

5 a 7-day-a-week, 24-hour basis (taking into ac6 count the standards of care for home infusion 

7 therapy established by Medicare Advantage 

8 plans and in the private sector), and the effi9 cient administration of the home infusion ther10 apy benefit. 

11 ‘‘(4) A qualified home infusion therapy supplier may 

12 subcontract with a pharmacy, physician, provider, or sup13 plier to meet the requirements of paragraph (3)(B).’’. 

14 (b) PAYMENT FOR HOME INFUSION THERAPY.—Sec15 tion 1834 of the Social Security Act (42 U.S.C. 1395m) 

16 is amended by adding at the end the following new sub17 section: 

18 ‘‘(p) PAYMENT FOR HOME INFUSION THERAPY.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall deter20 mine a per diem schedule for payment for the pro21 fessional services (including nursing services), sup22 plies, and equipment described in section 

23 1861(iii)(2)(A) for each infusion therapy type that 

24 reflects the reasonable costs which must be incurred 

25 by efficiently and economically operated qualified 


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1 home infusion therapy suppliers to provide such 

2 services, supplies, and equipment in conformity with 

3 applicable State and Federal laws, regulations, and 

4 the uniform quality and safety standards developed 

5 under section 1861(iii)(1) and to assure that Medi6 care beneficiaries have reasonable access to such 

7 therapy. 

8 ‘‘(2) CONSIDERATIONS.—In developing the per 

9 diem schedule under this subsection, the Secretary 

10 shall consider recent credible studies about the costs 

11 of providing infusion therapy in the home, consult 

12 with home infusion therapy suppliers, consider pay13 ment amounts established by Medicare Advantage 

14 plans and private payers for home infusion therapy, 

15 and, if necessary, conduct a statistically valid na16 tional market analysis involving the costs of admin17 istering infusion drugs and of providing professional 

18 services necessary for the drugs’ administration. 

19 ‘‘(3) ANNUAL UPDATES.—The Secretary shall 

20 update such schedule from year to year by the per21 centage increase in the Consumer Price Index for all 

22 urban consumers (United States city average) for 

23 the 12-month period ending with June of the pre24 ceding year. The Secretary may modify the per diem 

25 schedule with respect to beneficiaries who qualify for 


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1 home infusion therapy services under section 

2 1861(iii)(1) but who receive nursing services as 

3 home health services.’’. 

4 (c) CONFORMING AMENDMENTS.— 

5 (1) PAYMENT REFERENCE.—Section 

6 1833(a)(1) of the Social Security Act (42 U.S.C. 

7 13951(a)(1)) is amended— 

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

9 (B) by inserting before the semicolon at 

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

11 to home infusion therapy, the amounts paid 

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

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

14 section 1842(b)(6) of the Social Security Act (42 

15 U.S.C. 1395u(b)(6)) is amended— 

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

17 (B) by inserting before the period at the 

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

19 home infusion therapy, payment shall be made 

20 to the qualified home infusion therapy sup21 plier’’. 

22 (3) EXCLUSION FROM DURABLE MEDICAL

23 EQUIPMENT AND HOME HEALTH SERVICES.—Section 

24 1861 of the Social Security Act (42 U.S.C. 1395x) 

25 is amended— 


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1 (A) in subsection (m)(5)— 

2 (i) by striking ‘‘and’’ before ‘‘durable 

3 medical equipment’’ and inserting a 

4 comma; and 

5 (ii) by inserting before the semicolon 

6 at the end the following: ‘‘, and supplies 

7 used in the provision of home infusion 

8 therapy after excluding other drugs and 

9 biologicals’’; and 

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

11 the following: ‘‘Such term does not include 

12 home infusion therapy, other than equipment 

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

14 (4) APPLICATION OF ACCREDITATION PROVI15 SIONS.—The provisions of section 1865(a) of the So16 cial Security Act (42 U.S.C. 1395bb(a)) apply to the 

17 accreditation of qualified home infusion therapy sup18 pliers in the same way as they apply to other sup19 pliers. 

20 SEC. 4. MEDICARE COVERAGE OF HOME INFUSION DRUGS. 

21 Section 1860D–2(e) of the Social Security Act (42 

22 U.S.C. 1395w–102(e)) 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 after subparagraph (B) 

4 the following new subparagraph: 

5 ‘‘(C) an infusion drug (as defined in para6 graph (5)),’’; and 

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

8 paragraph: 

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

10 of this part, the term ‘infusion drug’ means a paren11 teral drug or biological administered via an intra12 venous, intraspinal, intra-arterial, intrathecal, epidu13 ral, subcutaneous, or intramuscular access device or 

14 injection, and may include a drug used for catheter 

15 maintenance and declotting, a drug contained in a 

16 device, additives including but not limited to vita17 mins, minerals, solutions, and diluents, and other 

18 components used in the provision of home infusion 

19 therapy.’’. 

20 SEC. 5. ENSURING BENEFICIARY ACCESS TO HOME INFU21 SION THERAPY. 

22 (a) OBJECTIVES IN IMPLEMENTATION.—The Sec23 retary of Health and Human Services shall implement the 

24 Medicare home infusion therapy benefit under the amend25 ments made by this Act in a manner that ensures that 


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1 Medicare beneficiaries have timely and appropriate access 

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

3 and seamless coordination between drug coverage under 

4 part D of title XVIII of the Social Security Act and cov5 erage for home infusion therapy services under part B of 

6 such title to avoid the filing of duplicative or otherwise 

7 improper claims. Specifically, the Secretary shall ensure 

8 that— 

9 (1) the benefit is practical and workable with 

10 minimal administrative burden for beneficiaries, 

11 qualified home infusion therapy suppliers, physi12 cians, prescription drug plans, MA–PD plans, and 

13 Medicare Advantage plans, and the Secretary shall 

14 consider the use of consolidated claims encompassing 

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

16 and equipment under such part B to ensure the effi17 cient operation of this benefit; 

18 (2) any prior authorization or utilization review 

19 process is expeditious, allowing Medicare bene20 ficiaries meaningful access to home infusion therapy; 

21 (3) medical necessity determinations for home 

22 infusion therapy will be made— 

23 (A) except as provided in subparagraph 

24 (B), by Medicare administrative contractors 


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1 under such part B and communicated to the 

2 appropriate prescription drug plans; or 

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

4 a Medicare Advantage plan, by the Medicare 

5 Advantage organization offering the plan; and 

6 an individual may be initially qualified for cov7 erage for such benefit for a 90-day period and 

8 subsequent 90-day periods thereafter; 

9 (4) except as otherwise provided in this section, 

10 the benefit is modeled on current private sector cov11 erage and coding for home infusion therapy; and 

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

13 structure their formularies, utilization review proto14 cols, and policies in a manner that ensures that 

15 Medicare beneficiaries have timely and appropriate 

16 access to infusion therapy in their homes. 

17 (b) REPORT.—Not later than January 1, 2018, the 

18 Comptroller General of the United States shall submit a 

19 report to Congress on Medicare beneficiary access to home 

20 infusion therapy. Such report shall specifically address 

21 whether the objectives specified in subsection (a) have 

22 been met and shall make recommendations to Congress 

23 and the Secretary of Health and Human Services on how 

24 to improve the benefit and better ensure that Medicare 


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1 beneficiaries have timely and appropriate access to infu2 sion therapy in their homes. 

3 SEC. 6. EFFECTIVE DATE. 

4 The amendments made by this Act shall apply to 

5 home infusion therapy furnished on or after January 1, 

6 2015. 

Æ 


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