[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5597 Introduced in House (IH)]

111th CONGRESS
  2d Session
                                H. R. 5597

   To establish a Medicare patient IVIG access demonstration project.


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                    IN THE HOUSE OF REPRESENTATIVES

                             June 24, 2010

Ms. Matsui (for herself, Mr. Rush, Mr. Braley of Iowa, Mr. Van Hollen, 
 Mr. Gerlach, Mr. Terry, Mr. Brady of Texas, and Mr. Pitts) introduced 
  the following bill; which was referred to the Committee on Ways and 
 Means, and in addition to the Committee on Energy and Commerce, 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 establish a Medicare patient IVIG access demonstration project.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.

    (a) Establishment.--The Secretary shall establish and implement a 
demonstration project under title XVIII of the Social Security Act to 
evaluate the benefits of providing payment for items and services 
needed for the administration, within the homes of Medicare 
beneficiaries, of intravenous immune globin for the treatment of 
primary immune deficiency diseases.
    (b) Duration and Scope.--
            (1) Duration.--Beginning not later than January 1, 2011, 
        the Secretary shall conduct the demonstration project for a 
        period of 3 years.
            (2) Scope.--The Secretary shall enroll not greater than 
        4,000 Medicare beneficiaries who have been diagnosed with 
        primary immunodeficiency disease for participation in the 
        demonstration project. A Medicare beneficiary may participate 
        in the demonstration project on a voluntary basis and may 
        terminate participation at any time.
    (c) Reimbursement.--The Secretary shall establish an hourly rate 
for payment for items and services needed for the administration of 
intravenous immune globin based on the low-utilization payment 
adjustment under the prospective payment system for home health 
services established under section 1895 of the Social Security Act (42 
U.S.C. 1395fff).
    (d) Study and Report to Congress.--
            (1) Interim evaluation and report.--Not later than 24 
        months after the date of enactment of this Act, the Secretary 
        shall submit to Congress a report that contains the following:
                    (A) An interim evaluation of the impact of the 
                demonstration project on access for Medicare 
                beneficiaries to items and services needed for the 
                administration of intravenous immune globin within the 
                home.
                    (B) An analysis of the appropriateness of 
                implementing a new methodology for payment for 
                intravenous immune globulins in all care settings under 
                part B of title XVIII of the Social Security Act (42 
                U.S.C. 1395k et seq.).
                    (C) An analysis of the feasability 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).
                    (D) An update to the report entitled ``Analysis of 
                Supply, Distribution, Demand, and Access Issues 
                Associated with Immune Globulin Intravenous (IGIV)'', 
                issued in February 2007 by the Office of the Assistant 
                Secretary for Planning and Evaluation of the Department 
                of Health and Human Services.
            (2) Final evaluation and report.--Not later than July 1, 
        2014, the Secretary shall submit to Congress a report that 
        contains a final evaluation of the impact of the demonstration 
        project on access for Medicare beneficiaries to items and 
        services needed for the administration of intravenous immune 
        globin within the home.
    (e) Offset.--
            (1) In general.--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.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall apply to items furnished on or after the date of 
        enactment of this Act.
    (f) Definitions.--In this section:
            (1) Demonstration project.--The term ``demonstration 
        project'' means the demonstration project conducted under this 
        section.
            (2) Medicare beneficiary.--The term ``Medicare 
        beneficiary'' means an individual who is entitled to, or 
        enrolled for, benefits under part A of title XVIII of the 
        Social Security Act or enrolled for benefits under part B of 
        such title.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
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