[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2002 Introduced in House (IH)]

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).

    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 Patient 
IVIG Access Act of 2009''.
    (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 (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.

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 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 seven 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.

SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE GLOBULINS (IVIG).

    (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 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, 
        subject to subparagraph (C), for a period of 2 years beginning 
        on the date such additional payment is first provided under 
        this subparagraph.
            ``(C) The Secretary shall consider the recommendations made 
        by the Medicare Payment Advisory Commission made under section 
        6 of the Medicare Patient IVIG Access Act of 2009 and shall 
        consult with members of the IVIG community to determine whether 
        the additional payment under subparagraph (B) improved 
        beneficiary access to intravenous immune globulins and, if so, 
        the Secretary may extend payment under such subparagraph beyond 
        the 2-year period specified in such subparagraph. The Secretary 
        shall submit to Congress a report on the Secretary's exercise 
        (or non-exercise) of authority under the previous sentence, 
        including the reasons for such exercise (or non-exercise).''.
    (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 immune globulins.--
                            ``(i) Data collection and review.--Not 
                        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 authority.--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 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. The Secretary shall consider the 
                        recommendations made by the Medicare Payment 
                        Advisory Commission made under section 6 of the 
                        Medicare Patient IVIG Access Act of 2009 and 
                        shall consult with members of the IVIG 
                        community to determine whether the additional 
                        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 nonexercise) of authority 
                        under the previous sentence, including the 
                        reasons for such exercise (or nonexercise).''.

SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE 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 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 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) 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 COMPLEXITY CODES FOR PHYSICIAN 
              ADMINISTRATION 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.
    (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 current 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 reimbursement under 
        part B of title XVIII of the Social Security Act; or
            (2) submit to Congress and the RBRVS Update Committee (RUC) 
        a report on why an additional infusion 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) 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) MedPAC Report.--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 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.

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 Security 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 infusion 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 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.
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