[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2990 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 2990

 To amend title XVIII of the Social Security Act to improve access of 
        Medicare beneficiaries to intravenous immune globulins.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 7, 2008

Mr. Kerry (for himself, Mr. Alexander, and Ms. Stabenow) introduced the 
 following bill; which was read twice and referred to the Committee on 
                                Finance

_______________________________________________________________________

                                 A BILL


 
 To amend title XVIII of the Social Security Act to improve access of 
        Medicare beneficiaries to intravenous immune globulins.

    Be it enacted by the Senate and House of Representatives 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 IVIG 
Access Act of 2008''.
    (b) Table of Contents.--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.

SEC. 2. FINDINGS.

    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.

SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE GLOBULINS.

    (a) In General.--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 Services.--Section 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 review.--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 
                                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 
                        rule.--Subject 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 authority.--Upon 
                        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.''.

SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE GLOBULIN IN THE 
              HOME.

    (a) In General.--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 
Home.--Section 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.''.

SEC. 5. REPORTS.

    (a) Report by the Secretary.--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) MedPAC Report.--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).

SEC. 6. OFFSET.

    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.''.
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