I 

111TH CONGRESS 

1ST SESSION H. R. 2002 

To amend title XVIII of the Social Security Act to improve access of Medicare 

beneficiaries to intravenous immune globulins (IVIG). 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 21, 2009 

Mr. ISRAEL (for himself, Mr. BRADY of Texas, Ms. SCHWARTZ, Mr. MOORE

of Kansas, Mr. MCGOVERN, Mrs. BLACKBURN, and Mr. GRIJALVA) 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 improve 

access of Medicare beneficiaries to intravenous immune 

globulins (IVIG). 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Medicare Patient IVIG Access Act of 2009’’. 

6 (b) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 

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Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 

Sec. 3. Medicare payment for intravenous immune globulins (IVIG). 

Sec. 4. Coverage and payment of intravenous immune globulin in the home. 

Sec. 5. Collection of data and review of complexity codes for physician administration of IVIG. 

Sec. 6. Reports. 

Sec. 7. Medicare coverage of disposable pumps as items of durable medical 

equipment in certain cases. 

1 SEC. 2. FINDINGS. 

2 (a) FINDINGS.—Congress finds the following: 

3 (1) The 2001 report of the Medicare Payment 

4 Advisory Commission to Congress states that ‘‘to 

5 help ensure beneficiaries’ access to high-quality care, 

6 Medicare payments should correspond to the cost ef7 ficient providers incur in furnishing this care’’. Pay8 ments that do not meet this objective may create 

9 barriers to access. 

10 (2) Intravenous immune globulin (IVIG) is a 

11 human blood plasma derived product, which over the 

12 past 25 years has become an invaluable therapy for 

13 many chronic conditions and illnesses, including pri14 mary immunodeficiency diseases, autoimmune and 

15 neurological disorders. For many of these disorders, 

16 IVIG is the most effective and viable treatment 

17 available, and has dramatically improved the quality 

18 of life for persons with these conditions and has be19 come a life-saving therapy for many. 

20 (3) The Food and Drug Administration (FDA) 

21 recognizes each IVIG brand as a unique biologic. 

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1 The differences in basic fractionation and the addi2 tion of various modifications for further purification, 

3 stabilization and virus inactivation/removal yield 

4 clearly different biological products. As a result, 

5 IVIG therapies are not interchangeable, with patient 

6 tolerance differing from one IVIG brand to another. 

7 (4) The report of the Office of the Assistant 

8 Secretary for Planning and Evaluation (ASPE), De9 partment of Health and Human Services (DHHS), 

10 ‘‘Analysis of Supply, Distribution, Demand, and Ac11 cess Issues Associated with Immune Globulin Intra12 venous (IGIV)’’, issued in May 2007, found that 

13 IVIG manufacturing is complex and requires sub14 stantial upfront cash outlay and planning and takes 

15 between seven and 12 months from plasma collection 

16 at donor centers to FDA lot release. 

17 (5) The Medicare Prescription Drug, Improve18 ment, and Modernization Act of 2003 changed Medi19 care’s reimbursement methodology for IVIG from 

20 average wholesale price (AWP) to average sales price 

21 plus 6 percent (ASP+6), effective January 1, 2005, 

22 for physicians, and January 1, 2006, for hospital 

23 outpatient departments, thereby reducing reimburse24 ment rates paid to these providers of IVIG on behalf 

25 of Medicare beneficiaries. 

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1 (6) An Office of the Inspector General (OIG) 

2 April 2007 report, Intravenous Immune Globulin: 

3 Medicare Payment and Availability, found that 

4 Medicare reimbursement for IVIG was inadequate to 

5 cover the cost many providers must pay for the 

6 product. During the third quarter of 2006, 44 per7 cent of IVIG sales to hospitals and 41 percent of 

8 sales to physicians by the three largest distributors 

9 occurred at prices above Medicare payment amounts. 

10 (7) The ASPE report notes that after the new 

11 reimbursement rules for physicians were instituted 

12 in 2005, 42 percent of Medicare beneficiaries who 

13 had received their IVIG treatment in their physi14 cian’s office at the end of 2004 were shifted to the 

15 hospital outpatient setting by the beginning of 2006. 

16 This shift in site of care has resulted in lack of con17 tinuity of care and adverse impact on health out18 comes and quality of life. 

19 (8) The OIG also reported that 61 percent of 

20 responding physicians indicated that they had sent 

21 patients to hospitals for IVIG treatment, largely be22 cause of their inability to purchase IVIG at prices 

23 below the Medicare payment amounts. In addition, 

24 OIG found that some physicians had stopped pro25 viding IVIG to Medicare beneficiaries altogether. 

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1 (9) The OIG’s 2007 report concluded that 

2 whatever improvement some providers saw in the re3 lationship of Medicare reimbursement for IVIG to 

4 prices paid during the first three quarters of 2006 

5 would be eroded if manufacturers were to increase 

6 prices for IVIG in the future. 

7 (10) The Centers for Medicare & Medicaid 

8 Services, in recognition of dislocations experienced 

9 by patients and providers in obtaining IVIG since 

10 the change to the ASP+6 reimbursement method11 ology, has provided during 2006 and 2007 a tem12 porary additional payment for IVIG 

13 preadministration-related services to compensate 

14 physicians and hospital outpatient departments for 

15 the extra resources they have had to expend in locat16 ing and obtaining appropriate IVIG products and in 

17 scheduling patient infusions. 

18 (11) The Medicare Modernization Act of 2003 

19 (MMA) established an IVIG home infusion benefit 

20 for persons with primary immunodeficiency disease 

21 (PIDD), paying only for IVIG and specifically ex22 cluding coverage of items and services related to ad23 ministration of the product. 

24 (12) The ASPE report, Analysis of Supply, 

25 Distribution, Demand, and Access Issues Associated 

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1 with Immune Globulin Intravenous (IGIV), found 

2 that Medicare’s IVIG home infusion benefit is not 

3 designed to reimburse for more than the cost of 

4 IVIG and does not cover the cost of infusion services 

5 (for example, nursing and clinical services and sup6 plies) in the home. As a consequence, the report 

7 found that home infusion providers generally do not 

8 accept new PIDD patients with only Medicare cov9 erage. These limitations in service are caused by 

10 health care providers— 

11 (A) not being able to acquire IVIG at 

12 prices at or below the Medicare part B reim13 bursement level; and 

14 (B) not being reimbursed for the infusion 

15 services provided by a nurse. 

16 (13) Physicians administering IVIG to Medi17 care beneficiaries are reimbursed at the same low 

18 complexity level as the administration of antibiotics. 

19 However, the administration of IVIG requires special 

20 preparation and handling, involves significant pa21 tient risk, and prolonged nursing time to monitor 

22 the patient during infusion. 

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1 SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE 

2 GLOBULINS (IVIG). 

3 (a) IN GENERAL.—Section 1842(o) of the Social Se4 curity Act (42 U.S.C. 1395u(o)) is amended— 

5 (1) in paragraph (1)(E)(ii), by inserting before 

6 the period the following: ‘‘, plus an additional 

7 amount (if applicable) under paragraph (7)’’; 

8 (2) in paragraph (7), by striking ‘‘(6)’’ and in9 serting ‘‘(7)’’ and by redesignating it as paragraph 

10 (8); and 

11 (3) by inserting after paragraph (6) the fol12 lowing new paragraph: 

13 ‘‘(7)(A) Not later than 6 months after the date 

14 of the enactment of the Medicare Patient IVIG Ac15 cess Act of 2009, the Secretary shall— 

16 ‘‘(i) collect data on the differences, if any, 

17 between payments to physicians for immune 

18 globulins under paragraph (1)(E)(ii) and costs 

19 incurred by physicians for furnishing these 

20 products; and 

21 ‘‘(ii) review available data, including survey 

22 data presented by members of the IVIG com23 munity and pricing data collected by the Fed24 eral Government, on the access of individuals 

25 eligible for services under this part to immune 

26 globulins. 

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1 ‘‘(B) Upon completion of the review and collec2 tion of data under subparagraph (A), and not later 

3 than 7 months after the date of the enactment of 

4 this paragraph, the Secretary shall provide, if appro5 priate, to physicians furnishing immune globulins, a 

6 payment, in addition to the payment provided for in 

7 paragraph (1)(E)(ii), for all items related to the fur8 nishing of immune globulins, in an amount that the 

9 Secretary determines to be appropriate. Such pay10 ment shall continue, subject to subparagraph (C), 

11 for a period of 2 years beginning on the date such 

12 additional payment is first provided under this sub13 paragraph. 

14 ‘‘(C) The Secretary shall consider the rec15 ommendations made by the Medicare Payment Advi16 sory Commission made under section 6 of the Medi17 care Patient IVIG Access Act of 2009 and shall con18 sult with members of the IVIG community to deter19 mine whether the additional payment under sub20 paragraph (B) improved beneficiary access to intra21 venous immune globulins and, if so, the Secretary 

22 may extend payment under such subparagraph be23 yond the 2-year period specified in such subpara24 graph. The Secretary shall submit to Congress a re25 port on the Secretary’s exercise (or non-exercise) of 

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1 authority under the previous sentence, including the 

2 reasons for such exercise (or non-exercise).’’. 

3 (b) AS PART OF HOSPITAL OUTPATIENT SERV4 ICES.—Section 1833(t)(14) of such Act (42 U.S.C. 

5 1395l(t)(14)) is amended— 

6 (1) in subparagraph (A)(iii), by striking ‘‘sub7 paragraph (E)’’ and inserting ‘‘subparagraphs (E) 

8 and (I)’’; and 

9 (2) by adding at the end the following new sub10 paragraph: 

11 ‘‘(I) ADDITIONAL PAYMENT FOR IMMUNE

12 GLOBULINS.— 

13 ‘‘(i) DATA COLLECTION AND RE14 VIEW.—Not later than 6 months after the 

15 date of the enactment of the Medicare Pa16 tient IVIG Access Act of 2009, the Sec17 retary shall— 

18 ‘‘(I) review available data, includ19 ing survey data presented by members 

20 of the IVIG community and pricing 

21 data collected by the Federal Govern22 ment, on the access of individuals eli23 gible for services under this part to 

24 immune globulins; and 

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1 ‘‘(II) collect data on the dif2 ferences, if any, between payments for 

3 immune globulins under subparagraph 

4 (A)(iii) and costs incurred for fur5 nishing these products. 

6 ‘‘(ii) ADDITIONAL PAYMENT AUTHOR7 ITY.—Upon completion of the review and 

8 collection of data under clause (i), and not 

9 later than 7 months after the date of the 

10 enactment of this subparagraph, the Sec11 retary shall provide, if appropriate, to hos12 pitals furnishing immune globulins as part 

13 of a covered OPD service, a payment, in 

14 addition to the payment provided for under 

15 subparagraph (A)(iii), for all items related 

16 to the furnishing of immune globulins, in 

17 an amount that the Secretary determines 

18 to be appropriate. Such payment shall con19 tinue for a period of 2 years beginning on 

20 the date such additional payment is first 

21 provided under this clause. The Secretary 

22 shall consider the recommendations made 

23 by the Medicare Payment Advisory Com24 mission made under section 6 of the Medi25 care Patient IVIG Access Act of 2009 and 

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1 shall consult with members of the IVIG 

2 community to determine whether the addi3 tional payment under the previous sentence 

4 improved beneficiary access to intravenous 

5 immune globulins and, if so, the Secretary 

6 may extend payment under such sentence 

7 beyond the 2-year period specified in such 

8 sentence. The Secretary shall submit to 

9 Congress a report on the exercise (or non10 exercise) of authority under the previous 

11 sentence, including the reasons for such 

12 exercise (or nonexercise).’’. 

13 SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IM14 MUNE GLOBULIN IN THE HOME. 

15 (a) INCLUDING COVERAGE OF ADMINISTRATION.— 

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

17 is amended— 

18 (1) in subsection (s)(2)(Z), by inserting ‘‘and 

19 items and services related to the administration of 

20 intravenous immune globulin’’ after ‘‘globulin’’; and 

21 (2) in subsection (zz), by striking ‘‘but not in22 cluding items or services related to the administra23 tion of the derivative,’’. 

24 (b) PAYMENT FOR INTRAVENOUS IMMUNE GLOBULIN

25 ADMINISTRATION IN THE HOME.—Section 1842(o) of 

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1 such Act (42 U.S.C. 1395u(o)), as amended by section 

2 3(a), is amended— 

3 (1) in paragraph (1)(E)(ii), by striking ‘‘para4 graph (7)’’ and inserting ‘‘paragraph (7) or (8)’’; 

5 (2) by redesignating paragraph (8) as para6 graph (9); and 

7 (3) by inserting after paragraph (7) the fol8 lowing new paragraph: 

9 ‘‘(8)(A) Subject to subparagraph (B), in the 

10 case of intravenous immune globulins described in 

11 section 1861(s)(2)(Z) that are furnished on or after 

12 January 1, 2010, the Secretary shall provide for a 

13 separate payment for items and services related to 

14 the administration of such intravenous immune 

15 globulins in an amount that the Secretary deter16 mines to be appropriate based on a review of avail17 able published and unpublished data and informa18 tion, including the Study of Intravenous Immune 

19 Globulin Administration Options: Safety, Access, 

20 and Cost Issues conducted by the Secretary (CMS 

21 Contract #500–95–0059). Such payment amount 

22 may take into account the following: 

23 ‘‘(i) Pharmacy overhead and related ex24 penses. 

25 ‘‘(ii) Patient service costs. 

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1 ‘‘(iii) Supply costs. 

2 ‘‘(B) The separate payment amount provided 

3 under this paragraph for intravenous immune 

4 globulins furnished in 2010 or a subsequent year 

5 shall be equal to the separate payment amount de6 termined under this paragraph for the previous year 

7 increased by the percentage increase in the medical 

8 care component of the consumer price index for all 

9 urban consumers (United States city average) for 

10 the 12-month period ending with June of the pre11 vious year.’’. 

12 (c) EFFECTIVE DATE.—The amendments made by 

13 subsections (a) and (b) shall apply to intravenous immune 

14 globulin administered on or after January 1, 2010. 

15 SEC. 5. COLLECTION OF DATA AND REVIEW OF COM16 PLEXITY CODES FOR PHYSICIAN ADMINIS17 TRATION OF IVIG. 

18 (a) DATA COLLECTION.—The Secretary of Health 

19 and Human Services shall enter into a contract for the 

20 collection of data if the Secretary determines, by not later 

21 than 6 months after the date of the enactment of this Act, 

22 that collection of additional data on the practice of IVIG 

23 infusion, including collection of data on the complexity of 

24 such infusions, are necessary. 

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1 (b) DATA REVIEW.—The Secretary shall review data 

2 collected under such contract as well as data submitted 

3 by members of the medical community related to the cur4 rent infusion payment codes under part B of title XVIII 

5 of the Social Security Act. 

6 (c) MODIFICATION OF CODES.—Upon completion of 

7 any data collection under subsection (a) and the review 

8 under subsection (b) and not later than 7 months after 

9 the date of the enactment of this Act, the Secretary 

10 shall— 

11 (1) provide notice to the appropriate Medicare 

12 administrative contractors regarding which existing 

13 infusion codes shall be used for purposes of IVIG re14 imbursement under part B of title XVIII of the So15 cial Security Act; or 

16 (2) submit to Congress and the RBRVS Update 

17 Committee (RUC) a report on why an additional in18 fusion payment code is necessary. 

19 SEC. 6. REPORTS. 

20 (a) REPORT BY THE SECRETARY.—Not later than 7 

21 months after the date of the enactment of this Act, the 

22 Secretary of Health and Human Services shall submit a 

23 report to Congress on the following: 

24 (1) The results of the data collection and review 

25 conducted by the Secretary under subparagraph (A) 

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1 of section 1842(o)(7) of the Social Security Act, as 

2 added by section 3(a), and clause (i) of section 

3 1833(t)(14)(I) of such Act, as added by section 3(b). 

4 (2) Whether the Secretary plans to use the au5 thority under subparagraph (C) of such section 

6 1842(o)(7) and clause (iii) of such section 

7 1833(t)(14)(I) of such Act to provide an additional 

8 payment to physicians furnishing intravenous im9 mune globulins and, if the Secretary does not plan 

10 to use such authority, the reasons why the payment 

11 is appropriate without such an additional payment 

12 based on the data collected and reviewed. 

13 (b) MEDPAC REPORT.—Not later than 2 years after 

14 the date of the enactment of this Act, the Medicare Pay15 ment Advisory Commission shall submit a report to the 

16 Secretary and to Congress that contains the following: 

17 (1) In the case where the Secretary has used 

18 the authority under sections 1842(o)(7)(C) and 

19 1833(t)(14)(I)(iii) of the Social Security Act, as 

20 added by subsections (a) and (b), respectively, of 

21 section 3 to provide an additional payment to physi22 cians furnishing intravenous immune globulins dur23 ing the preceding year, an analysis of whether bene24 ficiary access to intravenous immune globulins under 

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1 cial Security Act has improved as a result of the 

2 Secretary’s use of such authority. 

3 (2) An analysis of the appropriateness of imple4 menting a new methodology for payment for intra5 venous immune globulins under part B of title 

6 XVIII of the Social Security Act (42 U.S.C. 1395k 

7 et seq.). 

8 (3) An analysis of the feasibility of reducing the 

9 lag time with respect to data used to determine aver10 age sales price under section 1847A of the Social 

11 Security Act (42 U.S.C. 1395w–3a). 

12 (4) Recommendations for such legislation and 

13 administrative action as the Medicare Payment Ad14 visory Commission determines appropriate. 

15 SEC. 7. MEDICARE COVERAGE OF DISPOSABLE PUMPS AS 

16 ITEMS OF DURABLE MEDICAL EQUIPMENT IN 

17 CERTAIN CASES. 

18 (a) IN GENERAL.—Section 1861(n) of the Social Se19 curity Act (42 m 1395x(n)) is amended by inserting before 

20 the semicolon the following: ‘‘and includes a disposable 

21 pump prescribed, instead of a non-disposable external in22 fusion pump, for administration of a drug used as part 

23 of a chemotherapy regimen for the treatment of colorectal 

24 cancer if a non-disposable external infusion pump would 

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1 have been covered under this subsection to administer the 

2 same drug for the same indication as of July 1, 2008’’. 

3 (b) EFFECTIVE DATE.—The amendment made by 

4 subsection (a) shall apply to disposable pumps furnished 

5 on or after January 1, 2010. 

Æ 

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