117 HR 2815 IH: Bolstering Innovative Options to Save Immediately on Medicines Act U.S. House of Representatives 2021-04-22 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS1st SessionH. R. 2815IN THE HOUSE OF REPRESENTATIVESApril 22, 2021Mr. Schrader (for himself and Mr. Kinzinger) 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 concernedA BILLTo 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.

1.

Short title

This Act may be cited as the Bolstering Innovative Options to Save Immediately on Medicines Act or the BIOSIM Act.

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, 2021, the 5-year period beginning on January 1, 2022; 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, 2022, and ending December 31, 2026, 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.