[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3808 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 3808

To provide for a demonstration project to further examine the benefits 
 of providing coverage and payment for items and services necessary to 
  administer intravenous immune globulin (IVIG) in the home, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 11, 2021

     Mr. Blumenauer (for himself, Mr. Smith of New Jersey, and Mr. 
 Butterfield) 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 provide for a demonstration project to further examine the benefits 
 of providing coverage and payment for items and services necessary to 
  administer intravenous immune globulin (IVIG) in the home, and for 
                            other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare IVIG Access Enhancement 
Act''.

SEC. 2. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.

    (a) Establishment.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall establish and 
implement a demonstration project under part B of title XVIII of the 
Social Security Act to evaluate the benefits of providing payment for 
items and services needed for the in-home administration of intravenous 
immune globulin for the treatment of chronic inflammatory demyelinating 
polyneuropathy or multifocal motor neuropathy.
    (b) Duration and Scope.--
            (1) Duration.--Beginning not later than 1 year after the 
        date of enactment of this Act, the Secretary shall conduct the 
        demonstration project for a period of 5 years.
            (2) Scope.--The Secretary shall, subject to subsection (d), 
        enroll not greater than 3,000 Medicare beneficiaries who have 
        been diagnosed with chronic inflammatory demyelinating 
        polyneuropathy or multifocal motor neuropathy for participation 
        in the demonstration project. Subject to subsection (d), a 
        Medicare beneficiary may participate in the demonstration 
        project on a voluntary basis and may terminate participation at 
        any time.
    (c) Coverage.--Except as otherwise provided in this section, items 
and services for which payment may be made under the demonstration 
program shall be treated and covered under part B of title XVIII of the 
Social Security Act in the same manner as similar items and services 
covered under such part.
    (d) Eligibility.--In order to participate in the demonstration 
project, a Medicare beneficiary must--
            (1) be covered under the original Medicare fee-for-service 
        program under parts A and B of title XVIII of the Social 
        Security Act and not enrolled in a Medicare Advantage plan 
        under part C of such Act;
            (2) require intravenous immunoglobulin for the treatment of 
        chronic inflammatory demyelinating polyneuropathy or multifocal 
        motor neuropathy; and
            (3) meet any other eligibility requirements specified by 
        the Secretary.
    (e) Payment.--
            (1) Intravenous immune globulin.--For intravenous immune 
        globulin furnished under this section, the Secretary shall make 
        payment using the payment methodology under section 1847A of 
        the Social Security Act (42 U.S.C. 1395w-3a).
            (2) Other items and services.--
                    (A) In general.--The Secretary shall establish, 
                subject to subparagraph (B), a per-visit payment amount 
                for items and services (other than intravenous immune 
                globulin) needed for the in-home infusion of 
                intravenous immune globulin for the treatment of 
                chronic inflammatory demyelinating polyneuropathy or 
                multifocal motor neuropathy based on the national per 
                visit low-utilization payment amount under the 
                prospective payment system for home health services 
                established under section 1895 of the Social Security 
                Act (42 U.S.C. 1395fff).
                    (B) Limitation.--In establishing the per visit 
                payment amount established under subparagraph (A) for 
                items and services described in such subparagraph, the 
                Secretary shall consider--
                            (i) including a component for requisite 
                        nursing care;
                            (ii) establishing an appropriate furnishing 
                        fee for intravenous immune globulin similar to 
                        the separate payment for clotting factors under 
                        section 1842(o)(5) of the Social Security Act 
                        (42 U.S.C. 1395u(o)(5));
                            (iii) otherwise acknowledging the length of 
                        infusions for individuals needing in-home 
                        infusion of intravenous globulin for treatment 
                        described in subparagraph (A);
                            (iv) that, in total, such amount 
                        potentially not being less than at least 2.5 
                        times the payment amount applied under the 
                        demonstration project established under section 
                        101 of the Medicare IVIG Access and 
                        Strengthening Medicare and Repaying Taxpayers 
                        Act of 2012 (Public Law 112-242) for items and 
                        services needed for the in-home administration 
                        of intravenous immune globulin for the 
                        treatment of primary immune deficiency diseases 
                        in recognition of the fact that patients with 
                        chronic inflammatory demyelinating 
                        polyneuropathy or multifocal motor neuropathy 
                        tend to have longer infusion times, require 
                        more product, and have additional healthcare 
                        needs related to underlying neuromuscular 
                        challenges; and
                            (v) developing such amount in consultation 
                        with stakeholders.
    (f) Waiver Authority.--The Secretary may waive such requirements of 
title XVIII of the Social Security Act as may be necessary to carry out 
the demonstration project.
    (g) Final Evaluation and Report.--Not later than one year after the 
third year of the demonstration project, the Secretary shall submit to 
Congress a report that contains--
            (1) a current and projected evaluation of the impact of the 
        demonstration project on access for Medicare beneficiaries with 
        chronic inflammatory demyelinating polyneuropathy and Medicare 
        beneficiaries with multifocal motor neuropathy to items and 
        services needed for the in-home administration of intravenous 
        immune globin that also draws upon information and data from 
        the ongoing home infusion demonstration project for primary 
        immunodeficiency diseases (Public Law 112-242) and the recent 
        effort to provide an adequate coverage benefit for therapies 
        infused through durable medical equipment (HCPCS CMS-1738-P); 
        and
            (2) a final analysis of the appropriateness of expanding or 
        extending the demonstration project, or 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.), or augmenting existing 
        benefits to provide proper access for home infusion of 
        intravenous immune globulins, and, to the extent such analysis 
        determines such an expansion, extension, or methodology 
        appropriate, recommendations for such expansion, extension, or 
        methodology, respectively, along with an explanation of how CMS 
        intends to implement or otherwise provide such a permanent 
        benefit or mechanism for access during the fifth year of the 
        demo to ensure nondisruptions in care for impacted patients.
    (h) Definitions.--In this section:
            (1) Demonstration project.--The term ``demonstration 
        project'' means the demonstration project conducted under this 
        Act.
            (2) Medicare beneficiary.--The term ``Medicare 
        beneficiary'' means an individual who is enrolled for benefits 
        under part B of title XVIII of the Social Security Act.
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