1.Short
title; table of contents
(a)This Act may be cited
as the Medicare IVIG Access Act of
2008
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of
contents.
Sec. 2. Findings.
Sec. 3. Medicare payment for intravenous immune
globulins.
Sec. 4. Coverage and payment of intravenous immune globulin in
the home.
Sec. 5. Reports.
Sec. 6. Offset.
2.Congress makes the following
findings:
(1)Intravenous
immune globulin (IVIG) is a human blood plasma derived product, which over the
past 25 years has become an invaluable therapy for many primary
immunodeficiency diseases, as well as a number of neurological, autoimmune, and
other chronic conditions and illnesses. 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 become a
life-saving therapy for many.
(2)The Food and Drug
Administration recognizes each IVIG brand as a unique biologic. The differences
in basic fractionation and the addition 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.
(3)The report of the
Office of the Assistant Secretary for Planning and Evaluation of the Department
of Health and Human Services, Analysis of Supply, Distribution, Demand,
and Access Issues Associated with Immune Globulin Intravenous (IGIV)
,
that was issued in May 2007, found that IVIG manufacturing is complex and
requires substantial up-front cash outlay and planning and takes between 7 and
12 months from plasma collection at donor centers to lot release by the Food
and Drug Administration.
(4)The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law
108–173; 117 Stat. 2066) changed Medicare’s reimbursement methodology for IVIG
from average wholesale price (AWP) to average sales price plus 6 percent (ASP+6
percent), effective January 1, 2005, for physicians, and January 1, 2006, for
hospital outpatient departments, thereby reducing reimbursement rates paid to
those providers of IVIG on behalf of Medicare beneficiaries.
(5)An April 2007
report of the Office of Inspector General of the Department of Health and Human
Services, 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 percent of IVIG sales to hospitals and 41 percent of sales
to physicians by the 3 largest distributors occurred at prices above Medicare
payment amounts.
(6)The report of the
Office of the Assistant Secretary for Planning and Evaluation of the Department
of Health and Human Services, Analysis of Supply, Distribution, Demand,
and Access Issues Associated with Immune Globulin Intravenous (IGIV)
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 physician’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 a lack of continuity of care and has had an adverse impact
on health outcomes and quality of life.
(7)The Office of
Inspector General of the Department of Health and Human Services also reported
that 61 percent of responding physicians indicated that they had sent patients
to hospitals for IVIG treatment, largely because of their inability to purchase
IVIG at prices below the Medicare payment amounts. In addition, the Office of
Inspector General found that some physicians had stopped providing IVIG to
Medicare beneficiaries altogether.
(8)The Office of
Inspector General’s 2007 report concluded that whatever improvement some
providers saw in the relationship of Medicare reimbursement for IVIG to prices
paid during the first 3 quarters of 2006 would be eroded if manufacturers were
to increase prices for IVIG in the future.
(9)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 methodology, has provided a temporary additional payment during
2006 and 2007 for IVIG preadministration-related services to compensate
physicians and hospital outpatient departments for the extra resources they
have had to expend in locating and obtaining appropriate IVIG products and in
scheduling patient infusions.
(10)Approximately
10,000 Medicare beneficiaries receive IVIG treatment for their primary
immunodeficiency disease in a variety of different settings. Those
beneficiaries have no other effective treatment for their condition.
(11)The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 established an
IVIG home infusion benefit for persons with primary immune deficiency disease,
paying only for IVIG and specifically excluding coverage of items and services
related to administration of the product.
(12)The report of
the Office of the Assistant Secretary for Planning and Evaluation of the
Department of Health and Human Services, Analysis of Supply,
Distribution, Demand, and Access Issues Associated with Immune Globulin
Intravenous (IGIV)
, noted that, because of limitations in the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 provision,
Medicare’s IVIG home infusion benefit is not designed to provide reimbursement
for more than the cost of IVIG and does not cover the cost of infusion services
(such as nursing and clinical services and supplies) in the home. As a
consequence, the report found that home infusion providers generally do not
accept new patients who have primary immune deficiency disease and only have
Medicare coverage. 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 reimbursement level;
and
(B)not being
reimbursed for the infusion services provided by a nurse.
(13)Access to home
infusion of IVIG for patients with primary immune deficiency disease, who have
a genetic or intrinsic defect in their human immune system, will reduce their
exposure to infections at a time when their antibodies are compromised and will
improve the quality of care and health of the patient.
3.Medicare payment
for intravenous immune globulins
(a)Section 1842(o) of the Social Security Act (42 U.S.C.
1395u(o)) is amended—
(1)in paragraph
(1)(E)(ii), by inserting “, plus an additional amount (if applicable) under
paragraph (7)” before the period at the end;
(2)by redesignating
paragraph (7) as paragraph (8); and
(3)by inserting
after paragraph (6) the following new paragraph:
(7)(A)Not later than 6 months
after the date of enactment of the Medicare
IVIG Access Act of 2008, the Secretary shall—
(i)collect data on the differences, if
any, between payments to physicians for intravenous immune globulin under
paragraph (1)(E)(ii) and costs incurred by physicians for furnishing such
products; and
(ii)review available data, including
survey and pricing data collected by the Federal Government and data presented
by members of the intravenous immune globulin community on the access of
individuals eligible for services under this part to intravenous immune
globulin and the differences described in clause (i).
(B)Subject to subparagraph (C), in the case of
intravenous immune globulin furnished on or after the date of enactment of this
paragraph, the Secretary shall continue the IVIG preadministration-related
services payment established under the final rule promulgated by the Secretary
in the Federal Register on November 27, 2007 (72 Fed. Reg. 66254), until such
time as the Secretary determines that payment for intravenous immune globulin
is adequate.
(C)Upon collection of data and completion
of the review under subparagraph (A), the Secretary shall, during a 2-year
period beginning not later than 7 months after such date of enactment, provide,
if appropriate, to physicians furnishing intravenous immune globulins, a
payment, in addition to the payment under paragraph (1)(E)(ii) and instead of
the IVIG preadministration-related services payment under subparagraph (B), for
all items related to the furnishing of intravenous immune globulin, in an
amount the Secretary determines to be
appropriate.
.
(b)As part of
hospital outpatient servicesSection 1833(t)(14) of such Act (42 U.S.C.
1395l(t)(14)) is amended—
(1)in subparagraph
(A)(iii), by striking subparagraph (E)
and inserting
subparagraphs (E) and (I)
; and
(2)by adding at the
end the following new subparagraph:
(I)Additional
payment for intravenous immune globulin
(i)Data collection
and reviewNot later than 6 months after the date of enactment of
the Medicare IVIG Access Act of
2008, the Secretary shall—
(I)collect data on the differences, if any,
between payments of intravenous immune globulin under subparagraph (A)(iii) and
costs incurred by a hospital for furnishing such products; and
(II)review available
data, including survey and pricing data collected by the Federal Government and
data presented by members of the intravenous immune globulin community on the
access of individuals eligible for services under this part to intravenous
immune globulin and the differences described in subclause (I).
(ii)Continuation
of special payment ruleSubject to clause (iii), in the case of
intravenous immune globulin furnished on or after the date of enactment of this
subparagraph, the Secretary shall continue the IVIG preadministration-related
services payment established under the final rule promulgated by the Secretary
in the Federal Register on November 27, 2007 (72 Fed. Reg. 66697), until such
time as the Secretary determines that payment for intravenous immune globulin
is adequate.
(iii)Additional payment authorityUpon collection of data and completion of
the review under clause (i), the Secretary shall, during a 2-year period
beginning not later than 7 months after such date of enactment, provide, if
appropriate, to hospitals furnishing intravenous immune globulin as part of a
covered OPD service, in addition to the payment under subparagraph (A)(iii) and
instead of the IVIG preadministration-related services payment under clause
(ii), for all items related to the furnishing of intravenous immune globulin,
in an amount the Secretary determines to be
appropriate.
.
4.Coverage and
payment of intravenous immune globulin in the home
(a)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 including items or services related to the
administration of the derivative,
.
(b)Payment for
intravenous immune globulin administration in the homeSection
1842(o) of the Social Security Act (42 U.S.C. 1395u(o), as amended by section
3), is amended—
(1)in paragraph
(1)(E)(ii), by striking paragraph (7)
and inserting
paragraph (7) or (8)
;
(2)by redesignating
paragraph (8)
as paragraph (9)
; and
(3)by inserting
after paragraph (7) the following 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, 2008, 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 determines to be appropriate based on a review of available published
and unpublished data and information, 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
expenses.
(ii)Patient service costs.
(iii)Supply costs.
(B)The separate payment amount provided
under this paragraph for intravenous immune globulins furnished in 2009 or a
subsequent year shall be equal to the separate payment amount determined 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
previous
year.
.
5.
(a)Not later than 7 months after the date of enactment of
this Act, the Secretary of Health and Human Services (in this section referred
to as the Secretary
) 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) 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 authority under subparagraph (C) of such section
1842(o)(7) and clause (iii) of such section 1833(t)(14)(I) to provide an
additional payment to physicians furnishing intravenous immune
globulins.
(b)Not later than 2 years after the date of enactment of this
Act, the Medicare Payment 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 physicians
furnishing intravenous immune globulins during the preceding year, an analysis
of whether beneficiary access to intravenous immune globulins under the
Medicare program under title XVIII of the Social Security Act has improved as a
result of the Secretary's use of such authority.
(2)An analysis of
the appropriateness of implementing a new methodology for payment for
intravenous 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
average 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 Advisory
Commission determines appropriate, including recommendations for such
legislation and administrative action as the Commission determines is necessary
to implement any methodology analyzed under paragraph (2).
6.Section 1861(n) of the Social Security Act
(42 U.S.C. 1395x(n)) is amended by adding at the end the following: Such
term includes disposable drug delivery systems, including elastomeric infusion
pumps, for the treatment of colorectal cancer.
.