Sec. 101. MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT
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## SEC. 101 MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT **[**[42 U.S.C. 1395l note](/us/usc/t42/s1395l)**]** ###
(a)Establishment 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 globin for the treatment of primary immune deficiency diseases. ###
(b)Duration and Scope ####
(1)Duration Beginning not later than one year after the date of enactment of this Act, the Secretary shall conduct the demonstration project for a period of 3 years and, subject to the availability of funds under subsection (g), the period beginning on October 1, 2017, and ending on December 31, 2023. ####
(2)Scope The Secretary shall enroll for participation in the demonstration project for the period beginning on October 1, 2014, and ending on September 30, 2020, not more than 4,000 Medicare beneficiaries who have been diagnosed with primary immunodeficiency disease and for the period beginning on October 1, 2014, and ending on December 31, 2023, not more than 6,500 Medicare beneficiaries who have been so diagnosed. A Medicare beneficiary may participate in the demonstration project on a voluntary basis and may terminate participation at any time. Subject to the preceding sentence, a Medicare beneficiary enrolled in the demonstration project on September 30, 2017, shall be automatically enrolled during the period beginning on the date of the enactment of the Disaster Tax Relief and Airport and Airway Extension Act of 2017 and ending on December 31, 2023, without submission of another application. ###
(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 The Secretary shall establish a per visit payment amount for items and services needed for the in-home administration of intravenous immune globin 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). ###
(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)Study and Report to Congress ####
(1)Interim evaluation and report Not later than three years after the date of enactment of this Act, the Secretary shall submit to Congress a report that contains an interim evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin. ####
(2)Updated evaluation and report Not later than 2 years after the date of the enactment of Consolidated Appropriations Act, 2021, the Secretary shall submit to Congress an updated report that contains the following: #####
(A)The total number of beneficiaries enrolled in the demonstration project during the updated report period. #####
(B)The total number of claims submitted for services during the updated report period, disaggregated by month. #####
(C)An analysis of the impact of the demonstration on beneficiary access to the in-home administration of intravenous immune globin, including the impact on beneficiary health. #####
(D)An analysis of the impact of in-home administration of intravenous immune globin on overall costs to Medicare, including the cost differential between in-home administration of intravenous immune globin and administration of intravenous immune globin in a healthcare facility. #####
(E)To the extent practicable, a survey of providers and enrolled beneficiaries that participated in the demonstration project that identifies barriers to accessing services, including reimbursement for items and services. #####
(F)Recommendations to Congress on the appropriateness of establishing a permanent bundled services payment for the in-home administration of intravenous immune globin for Medicare beneficiaries. ####
(3)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 the following: #####
(A)A final evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immune globin. #####
(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 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. ###
(g)Funding There shall be made available to the Secretary to carry out the demonstration project not more than $45,000,000 from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Social Security Act (42 U.S.C. 1395t). ###
(h)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 enrolled for benefits under part B of title XVIII of the Social Security Act. ####
(3)Secretary The term “Secretary” means the Secretary of Health and Human Services. ####
(4)Updated report period The term “updated report period” means the period beginning on October 1, 2014, and ending on September 30, 2020. # TITLE II STRENGTHENING MEDICARE SECONDARY PAYER RULES
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Sec. 101
MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT
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