P.L. 112–242, Approved January 10, 2013 (125 Stat. 2374)

SECTION. 1. [42 U.S.C. 1305 note]  SHORT TITLE.

This Act may be cited as the “Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012”.

TITLE I—MEDICARE IVIG ACCESS

SEC. 101. [42 U.S.C. 1395l note]  MEDICARE PATIENT IVIG ACCESS DEMONSTRATION PROJECT.

(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.

(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.

(2)  Scope.—The Secretary shall enroll not more 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.

(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.

(2)  Scope.—The Secretary shall enroll not more 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)  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.—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.

(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)  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.