I 115th CONGRESS 1st Session H. R. 4724 IN THE HOUSE OF REPRESENTATIVES December 21, 2017 Mr. Holding (for himself, Mr. Blumenauer , Mr. Lance , Mr. Butterfield , and Mr. Meehan ) 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.

1. Short title This Act may be cited as the Medicare IVIG Access Enhancement Act . 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 3 years. (2) Scope The Secretary shall 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. 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) 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 The per-visit payment amount established under subparagraph (A) for items and services described in such subparagraph shall not be less than 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 comparable items and services needed for the in-home administration of intravenous immune globulin for the treatment of primary immune deficiency diseases. (e) 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. (f) Reports to Congress (1) Interim evaluation and report Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to Congress a report that contains— (A) an 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; and (B) an 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.) and, to the extent such analysis determines such an expansion, extension, or methodology appropriate, recommendations for such expansion, extension, or methodology, respectively. (2) Final evaluation and report Not later than one year after the date of completion of the demonstration project, the Secretary shall submit to Congress a report that contains— (A) a final evaluation of the impact described in paragraph (1)(A); and (B) a final analysis and recommendations described in paragraph (1)(B). (g) 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.