Star Rating for Biosimilars Act

I 117TH CONGRESS 1ST SESSION H. R. 2855 To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to add a new set of measures to the 5-star rating system under the Medicare Advantage program in order to encourage increased access to biosimilar biological products. IN THE HOUSE OF REPRESENTATIVES APRIL 26, 2021 Mr. TONKO (for himself and Mr. GIBBS) 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 provi- sions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to add a new set of measures to the 5-star rating system under the Medicare Advantage program in order to encourage increased access to biosimilar biological 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 ‘‘Star Rating for 4 Biosimilars Act’’. 5 VerDate Sep 11 2014 02:47 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2855.IH H2855 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2855 IH SEC. 2. ADDITION OF NEW MEASURES BASED ON ACCESS 1 TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 2 THE 5-STAR RATING SYSTEM UNDER MEDI- 3 CARE ADVANTAGE. 4 (a) IN GENERAL.—Section 1853(o)(4) of the Social 5 Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 6 adding at the end the following new subparagraph: 7 ‘‘(E) ADDITION OF NEW MEASURES BASED 8 ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD- 9 UCTS.— 10 ‘‘(i) IN GENERAL.—For 2022 and 11 subsequent years, the Secretary shall add a 12 new set of measures to the 5-star rating 13 system based on access to biosimilar bio- 14 logical products covered under part B and, 15 in the case of MA–PD plans, such prod- 16 ucts that are covered part D drugs. Such 17 measures shall assess the impact a plan’s 18 benefit structure may have on enrollees’ 19 utilization of or ability to access biosimilar 20 biological products, including in compari- 21 son to the reference biological product, and 22 shall include measures, as applicable, with 23 respect to the following: 24 ‘‘(I) COVERAGE.—Assessing 25 whether a biosimilar biological prod- 26 VerDate Sep 11 2014 02:47 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2855.IH H2855 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2855 IH uct is on the plan formulary in lieu of 1 or in addition to the reference biologi- 2 cal product. 3 ‘‘(II) PREFERENCING.—Assess- 4 ing tier placement or cost sharing for 5 a biosimilar biological product relative 6 to the reference biological product. 7 ‘‘(III) UTILIZATION MANAGE- 8 MENT TOOLS.—Assessing whether and 9 how utilization management tools are 10 used with respect to a biosimilar bio- 11 logical product relative to the ref- 12 erence biological product. 13 ‘‘(IV) UTILIZATION.—Assessing 14 the percentage of enrollees prescribed 15 the biosimilar biological product when 16 the reference biological product is also 17 available. 18 ‘‘(ii) DEFINITIONS.—In this subpara- 19 graph, the terms ‘biosimilar biological 20 product’ and ‘reference biological product’ 21 have the meaning given those terms in sec- 22 tion 1847A(c)(6). 23 ‘‘(iii) PROTECTING PATIENT INTER- 24 ESTS.—In developing such measures, the 25 VerDate Sep 11 2014 02:47 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2855.IH H2855 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2855 IH Secretary shall ensure that each measure 1 developed to address coverage, preferenc- 2 ing, or utilization management is con- 3 structed such that patients retain equal ac- 4 cess to appropriate therapeutic options 5 without undue administrative burden.’’. 6 (b) CLARIFICATION REGARDING APPLICATION TO 7 PRESCRIPTION DRUG PLANS.—To the extent the Sec- 8 retary of Health and Human Services applies the 5-star 9 rating system under section 1853(o)(4) of the Social Secu- 10 rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system, 11 to prescription drug plans under part D of title XVIII of 12 such Act, the provisions of subparagraph (E) of such sec- 13 tion, as added by subsection (a) of this section, shall apply 14 under the system with respect to such plans in the same 15 manner as such provisions apply to the 5-star rating sys- 16 tem under such section 1853(o)(4). 17 Æ VerDate Sep 11 2014 02:47 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H2855.IH H2855 kjohnson on DSK79L0C42PROD with BILLS