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) intro-
duced 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). 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medicare Patient IVIG Access Act of 2009’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
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 adminis-
tration of IVIG. 
Sec. 6. Reports. 
Sec. 7. Medicare coverage of disposable pumps as items of durable medical 
equipment in certain cases. 
SEC. 2. FINDINGS. 
(a) FINDINGS.—Congress finds the following: 
(1) The 2001 report of the Medicare Payment 
Advisory Commission to Congress states that ‘‘to 
help ensure beneficiaries’ access to high-quality care, 
Medicare payments should correspond to the cost ef-
ficient providers incur in furnishing this care’’. Pay-
ments that do not meet this objective may create 
barriers to access. 
(2) Intravenous immune globulin (IVIG) is a 
human blood plasma derived product, which over the 
past 25 years has become an invaluable therapy for 
many chronic conditions and illnesses, including pri-
mary immunodeficiency diseases, autoimmune and 
neurological disorders. For many of these disorders, 
IVIG is the most effective and viable treatment 
available, and has dramatically improved the quality 
of life for persons with these conditions and has be-
come a life-saving therapy for many. 
(3) The Food and Drug Administration (FDA) 
recognizes each IVIG brand as a unique biologic. 
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The differences in basic fractionation and the addi-
tion of various modifications for further purification, 
stabilization and virus inactivation/removal yield 
clearly different biological products. As a result, 
IVIG therapies are not interchangeable, with patient 
tolerance differing from one IVIG brand to another. 
(4) The report of the Office of the Assistant 
Secretary for Planning and Evaluation (ASPE), De-
partment of Health and Human Services (DHHS), 
‘‘Analysis of Supply, Distribution, Demand, and Ac-
cess Issues Associated with Immune Globulin Intra-
venous (IGIV)’’, issued in May 2007, found that 
IVIG manufacturing is complex and requires sub-
stantial upfront cash outlay and planning and takes 
between seven and 12 months from plasma collection 
at donor centers to FDA lot release. 
(5) The Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003 changed Medi-
care’s reimbursement methodology for IVIG from 
average wholesale price (AWP) to average sales price 
plus 6 percent (ASP+6), effective January 1, 2005, 
for physicians, and January 1, 2006, for hospital 
outpatient departments, thereby reducing reimburse-
ment rates paid to these providers of IVIG on behalf 
of Medicare beneficiaries. 
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(6) An Office of the Inspector General (OIG) 
April 2007 report, Intravenous Immune Globulin: 
Medicare Payment and Availability, found that 
Medicare reimbursement for IVIG was inadequate to 
cover the cost many providers must pay for the 
product. During the third quarter of 2006, 44 per-
cent of IVIG sales to hospitals and 41 percent of 
sales to physicians by the three largest distributors 
occurred at prices above Medicare payment amounts. 
(7) The ASPE report notes that after the new 
reimbursement rules for physicians were instituted 
in 2005, 42 percent of Medicare beneficiaries who 
had received their IVIG treatment in their physi-
cian’s office at the end of 2004 were shifted to the 
hospital outpatient setting by the beginning of 2006. 
This shift in site of care has resulted in lack of con-
tinuity of care and adverse impact on health out-
comes and quality of life. 
(8) The OIG also reported that 61 percent of 
responding physicians indicated that they had sent 
patients to hospitals for IVIG treatment, largely be-
cause of their inability to purchase IVIG at prices 
below the Medicare payment amounts. In addition, 
OIG found that some physicians had stopped pro-
viding IVIG to Medicare beneficiaries altogether. 
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(9) The OIG’s 2007 report concluded that 
whatever improvement some providers saw in the re-
lationship of Medicare reimbursement for IVIG to 
prices paid during the first three quarters of 2006 
would be eroded if manufacturers were to increase 
prices for IVIG in the future. 
(10) The Centers for Medicare & Medicaid 
Services, in recognition of dislocations experienced 
by patients and providers in obtaining IVIG since 
the change to the ASP+6 reimbursement method-
ology, has provided during 2006 and 2007 a tem-
porary 
additional 
payment 
for 
IVIG 
preadministration-related services to compensate 
physicians and hospital outpatient departments for 
the extra resources they have had to expend in locat-
ing and obtaining appropriate IVIG products and in 
scheduling patient infusions. 
(11) The Medicare Modernization Act of 2003 
(MMA) established an IVIG home infusion benefit 
for persons with primary immunodeficiency disease 
(PIDD), paying only for IVIG and specifically ex-
cluding coverage of items and services related to ad-
ministration of the product. 
(12) The ASPE report, Analysis of Supply, 
Distribution, Demand, and Access Issues Associated 
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with Immune Globulin Intravenous (IGIV), found 
that Medicare’s IVIG home infusion benefit is not 
designed to reimburse for more than the cost of 
IVIG and does not cover the cost of infusion services 
(for example, nursing and clinical services and sup-
plies) in the home. As a consequence, the report 
found that home infusion providers generally do not 
accept new PIDD patients with only Medicare cov-
erage. These limitations in service are caused by 
health care providers— 
(A) not being able to acquire IVIG at 
prices at or below the Medicare part B reim-
bursement level; and 
(B) not being reimbursed for the infusion 
services provided by a nurse. 
(13) Physicians administering IVIG to Medi-
care beneficiaries are reimbursed at the same low 
complexity level as the administration of antibiotics. 
However, the administration of IVIG requires special 
preparation and handling, involves significant pa-
tient risk, and prolonged nursing time to monitor 
the patient during infusion. 
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SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE 
GLOBULINS (IVIG). 
(a) IN GENERAL.—Section 1842(o) of the Social Se-
curity Act (42 U.S.C. 1395u(o)) is amended— 
(1) in paragraph (1)(E)(ii), by inserting before 
the period the following: ‘‘, plus an additional 
amount (if applicable) under paragraph (7)’’; 
(2) in paragraph (7), by striking ‘‘(6)’’ and in-
serting ‘‘(7)’’ and by redesignating it as paragraph 
(8); and 
(3) by inserting after paragraph (6) the fol-
lowing new paragraph: 
‘‘(7)(A) Not later than 6 months after the date 
of the enactment of the Medicare Patient IVIG Ac-
cess Act of 2009, the Secretary shall— 
‘‘(i) collect data on the differences, if any, 
between payments to physicians for immune 
globulins under paragraph (1)(E)(ii) and costs 
incurred by physicians for furnishing these 
products; and 
‘‘(ii) review available data, including survey 
data presented by members of the IVIG com-
munity and pricing data collected by the Fed-
eral Government, on the access of individuals 
eligible for services under this part to immune 
globulins. 
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‘‘(B) Upon completion of the review and collec-
tion of data under subparagraph (A), and not later 
than 7 months after the date of the enactment of 
this paragraph, the Secretary shall provide, if appro-
priate, to physicians furnishing immune globulins, a 
payment, in addition to the payment provided for in 
paragraph (1)(E)(ii), for all items related to the fur-
nishing of immune globulins, in an amount that the 
Secretary determines to be appropriate. Such pay-
ment shall continue, subject to subparagraph (C), 
for a period of 2 years beginning on the date such 
additional payment is first provided under this sub-
paragraph. 
‘‘(C) The Secretary shall consider the rec-
ommendations made by the Medicare Payment Advi-
sory Commission made under section 6 of the Medi-
care Patient IVIG Access Act of 2009 and shall con-
sult with members of the IVIG community to deter-
mine whether the additional payment under sub-
paragraph (B) improved beneficiary access to intra-
venous immune globulins and, if so, the Secretary 
may extend payment under such subparagraph be-
yond the 2-year period specified in such subpara-
graph. The Secretary shall submit to Congress a re-
port on the Secretary’s exercise (or non-exercise) of 
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authority under the previous sentence, including the 
reasons for such exercise (or non-exercise).’’. 
(b) AS PART
OF HOSPITAL OUTPATIENT SERV-
ICES.—Section 1833(t)(14) of such Act (42 U.S.C. 
1395l(t)(14)) is amended— 
(1) in subparagraph (A)(iii), by striking ‘‘sub-
paragraph (E)’’ and inserting ‘‘subparagraphs (E) 
and (I)’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(I) ADDITIONAL PAYMENT FOR IMMUNE 
GLOBULINS.— 
‘‘(i) DATA
COLLECTION
AND
RE-
VIEW.—Not later than 6 months after the 
date of the enactment of the Medicare Pa-
tient IVIG Access Act of 2009, the Sec-
retary shall— 
‘‘(I) review available data, includ-
ing survey data presented by members 
of the IVIG community and pricing 
data collected by the Federal Govern-
ment, on the access of individuals eli-
gible for services under this part to 
immune globulins; and 
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‘‘(II) collect data on the dif-
ferences, if any, between payments for 
immune globulins under subparagraph 
(A)(iii) and costs incurred for fur-
nishing these products. 
‘‘(ii) ADDITIONAL PAYMENT AUTHOR-
ITY.—Upon completion of the review and 
collection of data under clause (i), and not 
later than 7 months after the date of the 
enactment of this subparagraph, the Sec-
retary shall provide, if appropriate, to hos-
pitals furnishing immune globulins as part 
of a covered OPD service, a payment, in 
addition to the payment provided for under 
subparagraph (A)(iii), for all items related 
to the furnishing of immune globulins, in 
an amount that the Secretary determines 
to be appropriate. Such payment shall con-
tinue for a period of 2 years beginning on 
the date such additional payment is first 
provided under this clause. The Secretary 
shall consider the recommendations made 
by the Medicare Payment Advisory Com-
mission made under section 6 of the Medi-
care Patient IVIG Access Act of 2009 and 
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shall consult with members of the IVIG 
community to determine whether the addi-
tional payment under the previous sentence 
improved beneficiary access to intravenous 
immune globulins and, if so, the Secretary 
may extend payment under such sentence 
beyond the 2-year period specified in such 
sentence. The Secretary shall submit to 
Congress a report on the exercise (or non-
exercise) of authority under the previous 
sentence, including the reasons for such 
exercise (or nonexercise).’’. 
SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IM-
MUNE GLOBULIN IN THE HOME. 
(a) INCLUDING COVERAGE OF ADMINISTRATION.— 
Section 1861 of the Social Security Act (42 U.S.C. 1395x) 
is amended— 
(1) in subsection (s)(2)(Z), by inserting ‘‘and 
items and services related to the administration of 
intravenous immune globulin’’ after ‘‘globulin’’; and 
(2) in subsection (zz), by striking ‘‘but not in-
cluding items or services related to the administra-
tion of the derivative,’’. 
(b) PAYMENT FOR INTRAVENOUS IMMUNE GLOBULIN 
ADMINISTRATION
IN
THE HOME.—Section 1842(o) of 
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such Act (42 U.S.C. 1395u(o)), as amended by section 
3(a), is amended— 
(1) in paragraph (1)(E)(ii), by striking ‘‘para-
graph (7)’’ and inserting ‘‘paragraph (7) or (8)’’; 
(2) by redesignating paragraph (8) as para-
graph (9); and 
(3) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(8)(A) Subject to subparagraph (B), in the 
case of intravenous immune globulins described in 
section 1861(s)(2)(Z) that are furnished on or after 
January 1, 2010, the Secretary shall provide for a 
separate payment for items and services related to 
the administration of such intravenous immune 
globulins in an amount that the Secretary deter-
mines to be appropriate based on a review of avail-
able published and unpublished data and informa-
tion, including the Study of Intravenous Immune 
Globulin Administration Options: Safety, Access, 
and Cost Issues conducted by the Secretary (CMS 
Contract #500–95–0059). Such payment amount 
may take into account the following: 
‘‘(i) Pharmacy overhead and related ex-
penses. 
‘‘(ii) Patient service costs. 
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‘‘(iii) Supply costs. 
‘‘(B) The separate payment amount provided 
under this paragraph for intravenous immune 
globulins furnished in 2010 or a subsequent year 
shall be equal to the separate payment amount de-
termined under this paragraph for the previous year 
increased by the percentage increase in the medical 
care component of the consumer price index for all 
urban consumers (United States city average) for 
the 12-month period ending with June of the pre-
vious year.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall apply to intravenous immune 
globulin administered on or after January 1, 2010. 
SEC. 5. COLLECTION OF DATA AND REVIEW OF COM-
PLEXITY CODES FOR PHYSICIAN ADMINIS-
TRATION OF IVIG. 
(a) DATA COLLECTION.—The Secretary of Health 
and Human Services shall enter into a contract for the 
collection of data if the Secretary determines, by not later 
than 6 months after the date of the enactment of this Act, 
that collection of additional data on the practice of IVIG 
infusion, including collection of data on the complexity of 
such infusions, are necessary. 
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(b) DATA REVIEW.—The Secretary shall review data 
collected under such contract as well as data submitted 
by members of the medical community related to the cur-
rent infusion payment codes under part B of title XVIII 
of the Social Security Act. 
(c) MODIFICATION OF CODES.—Upon completion of 
any data collection under subsection (a) and the review 
under subsection (b) and not later than 7 months after 
the date of the enactment of this Act, the Secretary 
shall— 
(1) provide notice to the appropriate Medicare 
administrative contractors regarding which existing 
infusion codes shall be used for purposes of IVIG re-
imbursement under part B of title XVIII of the So-
cial Security Act; or 
(2) submit to Congress and the RBRVS Update 
Committee (RUC) a report on why an additional in-
fusion payment code is necessary. 
SEC. 6. REPORTS. 
(a) REPORT BY THE SECRETARY.—Not later than 7 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall submit a 
report to Congress on the following: 
(1) The results of the data collection and review 
conducted by the Secretary under subparagraph (A) 
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of section 1842(o)(7) of the Social Security Act, as 
added by section 3(a), and clause (i) of section 
1833(t)(14)(I) of such Act, as added by section 3(b). 
(2) Whether the Secretary plans to use the au-
thority under subparagraph (C) of such section 
1842(o)(7) 
and 
clause 
(iii) 
of 
such 
section 
1833(t)(14)(I) of such Act to provide an additional 
payment to physicians furnishing intravenous im-
mune globulins and, if the Secretary does not plan 
to use such authority, the reasons why the payment 
is appropriate without such an additional payment 
based on the data collected and reviewed. 
(b) MEDPAC REPORT.—Not later than 2 years after 
the date of the enactment of this Act, the Medicare Pay-
ment Advisory Commission shall submit a report to the 
Secretary and to Congress that contains the following: 
(1) In the case where the Secretary has used 
the authority under sections 1842(o)(7)(C) and 
1833(t)(14)(I)(iii) of the Social Security Act, as 
added by subsections (a) and (b), respectively, of 
section 3 to provide an additional payment to physi-
cians furnishing intravenous immune globulins dur-
ing the preceding year, an analysis of whether bene-
ficiary access to intravenous immune globulins under 
the Medicare program under title XVIII of the So-
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cial Security Act has improved as a result of the 
Secretary’s use of such authority. 
(2) An analysis of the appropriateness of imple-
menting a new methodology for payment for intra-
venous immune globulins under part B of title 
XVIII of the Social Security Act (42 U.S.C. 1395k 
et seq.). 
(3) An analysis of the feasibility of reducing the 
lag time with respect to data used to determine aver-
age sales price under section 1847A of the Social 
Security Act (42 U.S.C. 1395w–3a). 
(4) Recommendations for such legislation and 
administrative action as the Medicare Payment Ad-
visory Commission determines appropriate. 
SEC. 7. MEDICARE COVERAGE OF DISPOSABLE PUMPS AS 
ITEMS OF DURABLE MEDICAL EQUIPMENT IN 
CERTAIN CASES. 
(a) IN GENERAL.—Section 1861(n) of the Social Se-
curity Act (42 m 1395x(n)) is amended by inserting before 
the semicolon the following: ‘‘and includes a disposable 
pump prescribed, instead of a non-disposable external in-
fusion pump, for administration of a drug used as part 
of a chemotherapy regimen for the treatment of colorectal 
cancer if a non-disposable external infusion pump would 
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have been covered under this subsection to administer the 
same drug for the same indication as of July 1, 2008’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to disposable pumps furnished 
on or after January 1, 2010. 
Æ 
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