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House Bill 4455
116th Congress(2019-2020)
BIOSIM Act
Introduced
Introduced
Introduced in House on Sep 20, 2019
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Introduced in House 
Sep 20, 2019
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Introduced in House(Sep 20, 2019)
Sep 20, 2019
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H. R. 4455 (Introduced-in-House)


116th CONGRESS
1st Session
H. R. 4455


To amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.

IN THE HOUSE OF REPRESENTATIVES

September 20, 2019

Mr. Schrader (for himself and Mr. Gianforte) 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 amend title XVIII of the Social Security Act to provide for a temporary payment increase under the Medicare program for certain biosimilar biological products to encourage the development and use of such products.

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 “Bolstering Innovative Options to Save Immediately on Medicines Act” or the “BIOSIM Act”.

SEC. 2. Temporary increase in Medicare part B payment for certain biosimilar biological products.

Section 1847A(b)(8) of the Social Security Act (42 U.S.C. 1395w–3a(b)(8)) is amended—

(1) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and moving the margin of each such redesignated clause 2 ems to the right;

(2) by striking “product.—The amount” and inserting the following: “product.—

    “(A) IN GENERAL.—Subject to subparagraph (B), the amount”; and

(3) by adding at the end the following new subparagraph:

    “(B) TEMPORARY PAYMENT INCREASE.—

    “(i) IN GENERAL.—In the case of a qualifying biosimilar biological product that is furnished during the applicable 5-year period for such product, the amount specified in this paragraph for such product with respect to such period is the sum determined under subparagraph (A), except that clause (ii) of such subparagraph shall be applied by substituting ‘8 percent’ for ‘6 percent’.

    “(ii) APPLICABLE 5-YEAR PERIOD.—For purposes of clause (i), the applicable 5-year period for a biosimilar biological product is—

    “(I) in the case of such a product for which payment was made under this paragraph as of December 31, 2019, the 5-year period beginning on January 1, 2020; and

    “(II) in the case of such a product for which payment is first made under this paragraph during a calendar quarter during the period beginning January 1, 2020, and ending December 31, 2024, the 5-year period beginning on the first day of such calendar quarter during which such payment is first made.

    “(iii) QUALIFYING BIOSIMILAR BIOLOGICAL PRODUCT DEFINED.—For purposes of this subparagraph, the term ‘qualifying biosimilar biological product’ means a biosimilar biological product described in paragraph (1)(C) with respect to which—

    “(I) in the case of a product described in clause (ii)(I), the average sales price is not more than the average sales price for the reference biological product; and

    “(II) in the case of a product described in clause (ii)(II), the wholesale acquisition cost is not more than the wholesale acquisition cost for the reference biological product”.