1.Short title; table of
contents
(a)This Act may be cited
as the Medicare Patient IVIG Access
Act of 2009
.
(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
(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. Offset.
2.
(a)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
efficient providers incur in furnishing this care”. Payments 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 primary
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 become a life-saving therapy for many.
(3)The Food and Drug Administration (FDA)
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.
(4)The report of the Office of the Assistant
Secretary for Planning and Evaluation (ASPE), Department of Health and Human
Services (DHHS), Analysis of Supply, Distribution, Demand, and Access
Issues Associated with Immune Globulin Intravenous (IGIV)
, issued in
May 2007, found that IVIG manufacturing is complex and requires substantial
upfront cash outlay and planning and takes between 7 and 12 months from plasma
collection at donor centers to FDA lot release.
(5)The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 changed
Medicare’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 reimbursement rates paid to these providers of IVIG on behalf
of Medicare beneficiaries.
(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 percent 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
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
lack of continuity of care and adverse impact on health outcomes 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 because of their inability to
purchase IVIG at prices below the Medicare payment amounts. In addition, OIG
found that some physicians had stopped providing IVIG to Medicare beneficiaries
altogether.
(9)The OIG’s 2007
report concluded that whatever improvement some providers saw in the
relationship 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 methodology, has provided during 2006 and 2007 a temporary
additional payment 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.
(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
excluding coverage of items and services related to administration of the
product.
(12)The ASPE report,
Analysis of Supply, Distribution, Demand, and Access Issues Associated 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 supplies) in the home. As a consequence, the report found that
home infusion providers generally do not accept new PIDD patients with only
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)Physicians administering IVIG to Medicare
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 patient risk, and
prolonged nursing time to monitor the patient during infusion.
3.Medicare payment
for intravenous immune globulins (IVIG)
(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 before the period the following: ,
plus an additional amount (if applicable) under paragraph (7)
;
(2)in paragraph (7),
by striking (6)
and inserting (7)
and by
redesignating it 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
the enactment of the Medicare Patient IVIG Access 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 community and pricing data collected by
the Federal Government, on the access of individuals eligible for services
under this part to immune globulins.
(B)Upon completion of the review and
collection 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
appropriate, 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 furnishing of immune globulins, in an amount that the Secretary determines
to be appropriate. Such payment shall continue for a period of 2 years
beginning on the date such additional payment is first provided under this
subparagraph.
.
(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), in the matter preceding subclause (I), 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 immune globulins
(i)Data collection
and reviewNot later than 6
months after the date of the enactment of the Medicare Patient IVIG Access Act
of 2009, the Secretary shall—
(I)review available data, including survey
data presented by members of the IVIG community and pricing data collected by
the Federal Government, on the access of individuals eligible for services
under this part to immune globulins; and
(II)collect data on the differences, if any,
between payments for immune globulins under subparagraph (A)(iii) and costs
incurred for furnishing these products.
(ii)Additional
payment authorityUpon
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
Secretary shall provide, if appropriate, to hospitals 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 continue for a period of 2 years beginning
on the date such additional payment is first provided under this
clause.
.
4.Coverage and
payment of intravenous immune globulin in the home
(a)Including
coverage of administrationSection 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 such Act (42 U.S.C.
1395u(o)), as amended by section 3(a), 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, 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 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 2010 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.
.
(c)The amendments made by subsections (a) and (b) shall apply
to intravenous immune globulin administered on or after January 1, 2010.
5.Collection of
data and review of complexity codes for physician administration of
IVIG
(a)The Secretary of
Health and Human Services may enter into a contract for the collection of data,
by not later than 6 months after the date of the enactment of this Act, on the
practice of IVIG infusion, including collection of data on the complexity of
such infusions.
(b)Not later than 6 months after the date of the enactment of
this Act, the Secretary shall review data collected under such contract as well
as data submitted by members of the medical community related to the current
infusion payment codes under part B of title XVIII of the Social Security
Act.
(c)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 reimbursement under part B of
title XVIII of the Social Security Act; or
(2)submit to
Congress and the RBRUS Committee (RUC) a report on why an additional infusion
payment code is necessary.
6.
(a)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) 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) of such Act to provide an additional payment to
physicians furnishing intravenous immune 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)Not later than 2 years after the date of the 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 the
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.
7.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.
.