I 117TH CONGRESS 1ST SESSION H. R. 2815 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 prod- ucts. IN THE HOUSE OF REPRESENTATIVES APRIL 22, 2021 Mr. 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 subse- quently 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 en- courage the development and use of such products. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Bolstering Innovative 4 Options to Save Immediately on Medicines Act’’ or the 5 ‘‘BIOSIM Act’’. 6 VerDate Sep 11 2014 22:32 Jun 07, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2815.IH H2815 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 2815 IH SEC. 2. TEMPORARY INCREASE IN MEDICARE PART B PAY- 1 MENT FOR CERTAIN BIOSIMILAR BIOLOGI- 2 CAL PRODUCTS. 3 Section 1847A(b)(8) of the Social Security Act (42 4 U.S.C. 1395w–3a(b)(8)) is amended— 5 (1) by redesignating subparagraphs (A) and 6 (B) as clauses (i) and (ii), respectively, and moving 7 the margin of each such redesignated clause 2 ems 8 to the right; 9 (2) by striking ‘‘PRODUCT.—The amount’’ and 10 inserting the following: ‘‘PRODUCT.— 11 ‘‘(A) IN GENERAL.—Subject to subpara- 12 graph (B), the amount’’; and 13 (3) by adding at the end the following new sub- 14 paragraph: 15 ‘‘(B) TEMPORARY PAYMENT INCREASE.— 16 ‘‘(i) IN GENERAL.—In the case of a 17 qualifying biosimilar biological product 18 that is furnished during the applicable 5- 19 year period for such product, the amount 20 specified in this paragraph for such prod- 21 uct with respect to such period is the sum 22 determined under subparagraph (A), ex- 23 cept that clause (ii) of such subparagraph 24 shall be applied by substituting ‘8 percent’ 25 for ‘6 percent’. 26 VerDate Sep 11 2014 22:32 Jun 07, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2815.IH H2815 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 2815 IH ‘‘(ii) APPLICABLE 5-YEAR PERIOD.— 1 For purposes of clause (i), the applicable 2 5-year period for a biosimilar biological 3 product is— 4 ‘‘(I) in the case of such a product 5 for which payment was made under 6 this paragraph as of December 31, 7 2021, the 5-year period beginning on 8 January 1, 2022; and 9 ‘‘(II) in the case of such a prod- 10 uct for which payment is first made 11 under this paragraph during a cal- 12 endar quarter during the period be- 13 ginning January 1, 2022, and ending 14 December 31, 2026, the 5-year period 15 beginning on the first day of such cal- 16 endar quarter during which such pay- 17 ment is first made. 18 ‘‘(iii) QUALIFYING BIOSIMILAR BIO- 19 LOGICAL PRODUCT DEFINED.—For pur- 20 poses of this subparagraph, the term 21 ‘qualifying biosimilar biological product’ 22 means a biosimilar biological product de- 23 scribed in paragraph (1)(C) with respect to 24 which— 25 VerDate Sep 11 2014 22:32 Jun 07, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2815.IH H2815 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 2815 IH ‘‘(I) in the case of a product de- 1 scribed in clause (ii)(I), the average 2 sales price is not more than the aver- 3 age sales price for the reference bio- 4 logical product; and 5 ‘‘(II) in the case of a product de- 6 scribed in clause (ii)(II), the wholesale 7 acquisition cost is not more than the 8 wholesale acquisition cost for the ref- 9 erence biological product’’. 10 Æ VerDate Sep 11 2014 22:32 Jun 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H2815.IH H2815 pamtmann on DSKBC07HB2PROD with BILLS