ACCESS for Biosimilars Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4597 To amend title XVIII of the Social Security Act to eliminate cost sharing for biosimilar biological products furnished under part B of the Medicare program. IN THE HOUSE OF REPRESENTATIVES OCTOBER 1, 2019 Mr. PETERS (for himself, Mr. BRINDISI, and Mr. KING of New York) intro- duced 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 eliminate cost sharing for biosimilar biological products furnished under part B of the Medicare program. 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 ‘‘Acting to Cancel 4 Copays and Ensure Substantial Savings for Biosimilars 5 Act of 2019’’ or the ‘‘ACCESS for Biosimilars Act of 6 2019’’. 7 VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 4597 IH SEC. 2. ELIMINATING COST SHARING FOR BIOSIMILAR BIO- 1 LOGICAL PRODUCTS FURNISHED UNDER 2 PART B OF THE MEDICARE PROGRAM. 3 Section 1833 of the Social Security Act (42 U.S.C. 4 1395l) is amended— 5 (1) in subsection (a)(1)(S), by inserting ‘‘(or, in 6 the case of such a biological that is a specified bio- 7 similar biological product (as defined in subsection 8 (cc)) furnished during a year (beginning with 2020) 9 to an individual who is a cost-sharing reduction eli- 10 gible individual (as defined in such subsection) with 11 respect to such year, 100 percent)’’ after ‘‘80 per- 12 cent’’; and 13 (2) by adding at the end the following new sub- 14 section: 15 ‘‘(cc) SPECIFIED BIOSIMILAR BIOLOGICAL PRODUCT 16 REDUCED COST-SHARING PROVISIONS.— 17 ‘‘(1) DEFINITIONS.— 18 ‘‘(A) COST-SHARING REDUCTION ELIGIBLE 19 INDIVIDUAL DEFINED.—For purposes of sub- 20 section (a)(1)(S) and with respect to a year, the 21 term ‘cost-sharing reduction eligible individual’ 22 means an individual who, as of January 1 of 23 such year— 24 ‘‘(i) is enrolled under this part; and 25 VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 4597 IH ‘‘(ii) does not have qualifying coverage 1 (as defined in subparagraph (B)). 2 ‘‘(B) QUALIFYING COVERAGE.— 3 ‘‘(i) IN GENERAL.—For purposes of 4 subparagraph (A), the term ‘qualifying 5 coverage’ means, with respect to an indi- 6 vidual, coverage— 7 ‘‘(I) under— 8 ‘‘(aa) a group health plan or 9 health insurance coverage (as 10 such terms are defined in section 11 2791 of the Public Health Serv- 12 ice Act); 13 ‘‘(bb) a Federal health care 14 program (as defined in section 15 1128B(f)), other than the pro- 16 gram established under this title; 17 ‘‘(cc) the health insurance 18 program under chapter 89 of 19 title 5, United States Code; 20 ‘‘(dd) a medicare supple- 21 mental policy under section 1882; 22 or 23 ‘‘(ee) an MA or MA–PD 24 plan; and 25 VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 4597 IH ‘‘(II) that meets— 1 ‘‘(aa) in the case of coverage 2 described in any of items (aa) 3 through (dd) of subclause (I), the 4 condition described in clause (ii); 5 and 6 ‘‘(bb) in the case of coverage 7 described in item (ee) of sub- 8 clause (I), the condition described 9 in clause (iii). 10 ‘‘(ii) CONDITION FOR COVERAGE 11 OTHER THAN PART C COVERAGE.—For 12 purposes of clause (i)(II)(aa), the condition 13 described in this clause, with respect to an 14 individual enrolled in coverage described in 15 any of items (aa) through (dd) of clause 16 (i)(I) during a year, is that such coverage 17 provides for the payment of all cost shar- 18 ing owed by such individual under this 19 part (or, if applicable, under an MA or 20 MA–PD plan) with respect to a specified 21 biosimilar biological product (as defined in 22 subparagraph (C)) furnished under this 23 part (or, if applicable, under an MA or 24 MA–PD plan) during such year, not taking 25 VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 4597 IH into account the application of any deduct- 1 ible under such coverage. 2 ‘‘(iii) CONDITION FOR PART C COV- 3 ERAGE.—For purposes of clause 4 (i)(II)(bb), the condition described in this 5 clause, with respect to an individual en- 6 rolled in an MA or MA–PD plan during a 7 year, is that such plan provides for no cost 8 sharing for such individual with respect to 9 a specified biological biosimilar product (as 10 defined in subparagraph (C)) furnished 11 under such plan during such year. 12 ‘‘(C) SPECIFIED BIOSIMILAR BIOLOGICAL 13 PRODUCT.—For purposes of subsection 14 (a)(1)(S), the term ‘specified biosimilar biologi- 15 cal product’ means a biosimilar biological prod- 16 uct (as defined in subsection (c)(6) of section 17 1847A) for which the payment amount deter- 18 mined under subsection (b)(8) of such section 19 for such product is less than the payment 20 amount determined under subsection (b)(4) of 21 such section for the reference biological product 22 (as defined in subsection (c)(6) of such section). 23 ‘‘(2) DETERMINATIONS.—The Secretary shall 24 establish a process— 25 VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 4597 IH ‘‘(A) for determining whether an individual 1 is a cost-sharing reduction eligible individual for 2 a year; and 3 ‘‘(B) for notifying MA organizations of 4 such a determination made with respect to an 5 individual enrolled under an MA plan or MA– 6 PD plan offered by such organization during 7 such year.’’. 8 Æ VerDate Sep 11 2014 21:21 Oct 07, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H4597.IH H4597 pamtmann on DSKBC07HB2PROD with BILLS