[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2914 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 2914

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2007

   Mr. Brady of Texas (for himself, Mr. Israel, Mrs. Blackburn, Mr. 
   Burgess, Mrs. Cubin, Mr. English of Pennsylvania, Mr. Herger, Mr. 
 Hinchey, Mr. Meeks of New York, Mr. McNulty, Mr. Nunes, Mr. Paul, Mr. 
 Ramstad, Mr. Sessions, Mrs. Tauscher, Ms. Roybal-Allard, Mr. Smith of 
 New Jersey, and Mr. Young of Florida) 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 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 2007''.
    (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 immune globulins.
Sec. 4. Coverage and payment of intravenous immune globulin in the 
                            home.
Sec. 5. Patient access surveys and reports.

SEC. 2. FINDINGS.

    (a) Findings.--Congress finds the following:
            (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 (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.
            (3) 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.
            (4) 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.
            (5) 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.
            (6) The ASPE report notes that after the new reimbursement 
        rules for physicians was 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.
            (7) 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.
            (8) 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.
            (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 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.
            (10) Approximately 10,000 Medicare beneficiaries receive 
        IVIG treatment for their primary immunodeficiency disease in a 
        variety of different settings. They have no other effective 
        treatment for their condition.
            (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) Access to home infusion of IVIG for PIDD patients, 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 their care and their health.

SEC. 3. MEDICARE PAYMENT FOR IMMUNE GLOBULINS.

    (a) In General.--Section 1842(o)(1)(E) of the Social Security Act 
(42 U.S.C. 1395u(o)(1)(E)) 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 IVIG Access Act of 2007, 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 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.
            ``(C) In the case of immune globulins furnished on or after 
        January 1, 2007, the Secretary shall continue the 
        preadministration-related services payment established under 
        the Final Physician Fee Schedule Rule issued by the Centers for 
        Medicare & Medicaid Services on November 1, 2006 (CMS-1321-FC), 
        until such time as the Secretary determines that payment for 
        immune globulins is adequate or until a new payment methodology 
        is implemented.''.
    (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 IVIG Access Act of 
                        2007, the Secretary shall--
                                    ``(I) review available data, 
                                including survey data presented by 
                                members of the IVIG community, 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.
                            ``(iii) Continuation of special payment 
                        rule.--In the case of immune globulins 
                        furnished on or after January 1, 2007, the 
                        Secretary shall continue the preadministration-
                        related services payment established under the 
                        Final Hospital Outpatient Rule issued by the 
                        Centers for Medicare & Medicaid Services 
                        November 1, 2006 (CMS-1506-FC), until such time 
                        as the Secretary determines that payment for 
                        immune globulins is adequate or until a new 
                        payment methodology is implemented.''.

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

    (a) Including Coverage of Administration.--
            (1) In general.--Section 1861 of the Social Security Act 
        (42 U.S.C. 1395x) is amended--
                    (A) in subsection (s)(2)(Z), by inserting before 
                the semicolon at the end the following: ``, regardless 
                of whether the individual receiving the globulin is 
                eligible to receive home health services under this 
                title''; and
                    (B) in subsection (zz), by striking ``but not 
                including items or services related to the 
                administration of the derivative''.
            (2) Conforming home health amendment.--Section 1814(a) of 
        such Act (42 U.S.C. 1395f(a)) is amended by adding at the end 
        the following: ``An individual eligible for intravenous immune 
        globulin under section 1861(s)(2)(Z) shall not be considered 
        eligible for home health services under paragraph (2)(C) or 
        section 1835(a)(2)(A) solely on the basis of meeting the 
        requirements of such subsection or section 1861(zz).''.
    (b) Payment for Intravenous Immune Globulin Administration in the 
Home.--Section 1834 of such Act (42 U.S.C. 1395m) is amended by adding 
at the end the following new subsection:
    ``(n) Payment for Intravenous Immune Globulin in the Home.--The 
Secretary shall review available published and unpublished data and 
information, including the Study of Intravenous Immune Globulin 
Administration Options: Safety, Access, and Cost Issues (CMS Contract 
#500-95-0059), on confirming the appropriateness of administration of 
intravenous immune globulin in the home setting, and (as appropriate) 
calculate the amount, in addition to that made under section 
1842(o)(1)(E)(ii) for immune globulins, that should be paid to 
providers for clinical, compliance, and complication management 
services for ensuring safe and efficacious delivery of immune globulins 
in the home setting under 1861(s)(2)(Z). The Secretary shall pay such 
amounts no later than January 1, 2008.''.
    (c) Application of Criminal Record Request Provisions to IVIG In-
Home Providers.--Section 124(i)(1) of the Departments of Commerce, 
Justice, State, the Judiciary, and Related Agencies Appropriations Act, 
1999 (as contained in section 1(b) of Public Law 105-277; 112 Stat. 
2681-74) is amended by adding at the end the following: ``Such term 
includes an entity providing intravenous immune globulin under part B 
of title XVIII of the Social Security Act in a home.''.
    (d) Effective Date.--The amendments made by subsections (a) and (b) 
shall apply to intravenous immune globulin administered on or after 
January 1, 2008.

SEC. 5. PATIENT ACCESS SURVEYS AND REPORTS.

    (a) Surveys.--The Secretary of Health and Human Services shall 
conduct, not later than 3 years after the date of the enactment of this 
Act, two surveys of Medicare and non-Medicare patients who need immune 
globulins for the purpose of measuring changes in patient access to 
those products (and providers furnishing those products), as well as 
changes in the health care status of those patients. The Secretary may 
enter into contracts with organizations or entities qualified to 
conduct such surveys.
    (b) Survey Reports.--Each of the surveys shall include a report to 
the Secretary and the Committees on Energy and Commerce and Ways and 
Means of the House of Representatives and the Committee on Finance of 
the Senate on findings from the survey, as well as a discussion of 
reasons for observed changes, if any.
    (c) Congressional Reports.--On the basis of findings from such 
surveys, the Secretary shall submit to Congress reports that include 
recommendations on necessary adjustments in payments for immune 
globulins under the Medicare program in order to assure beneficiary 
access to those products and providers that furnish those products. The 
first such report shall be submitted no later than 2 years after the 
date of the enactment of this Act and the second report no later than 
four years after such date.
                                 <all>