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) 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 eliminate 

cost sharing for biosimilar biological products furnished 

under part B of the Medicare program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Acting to Cancel 

5 Copays and Ensure Substantial Savings for Biosimilars 

6 Act of 2019’’ or the ‘‘ACCESS for Biosimilars Act of 

7 2019’’. 


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1 SEC. 2. ELIMINATING COST SHARING FOR BIOSIMILAR BIO2 LOGICAL PRODUCTS FURNISHED UNDER 

3 PART B OF THE MEDICARE PROGRAM. 

4 Section 1833 of the Social Security Act (42 U.S.C. 

5 1395l) is amended— 

6 (1) in subsection (a)(1)(S), by inserting ‘‘(or, in 

7 the case of such a biological that is a specified bio8 similar biological product (as defined in subsection 

9 (cc)) furnished during a year (beginning with 2020) 

10 to an individual who is a cost-sharing reduction eli11 gible individual (as defined in such subsection) with 

12 respect to such year, 100 percent)’’ after ‘‘80 per13 cent’’; and 

14 (2) by adding at the end the following new sub15 section: 

16 ‘‘(cc) SPECIFIED BIOSIMILAR BIOLOGICAL PRODUCT

17 REDUCED COST-SHARING PROVISIONS.— 

18 ‘‘(1) DEFINITIONS.— 

19 ‘‘(A) COST-SHARING REDUCTION ELIGIBLE

20 INDIVIDUAL DEFINED.—For purposes of sub21 section (a)(1)(S) and with respect to a year, the 

22 term ‘cost-sharing reduction eligible individual’ 

23 means an individual who, as of January 1 of 

24 such year— 

25 ‘‘(i) is enrolled under this part; and 


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1 ‘‘(ii) does not have qualifying coverage 

2 (as defined in subparagraph (B)). 

3 ‘‘(B) QUALIFYING COVERAGE.— 

4 ‘‘(i) IN GENERAL.—For purposes of 

5 subparagraph (A), the term ‘qualifying 

6 coverage’ means, with respect to an indi7 vidual, coverage— 

8 ‘‘(I) under— 

9 ‘‘(aa) a group health plan or 

10 health insurance coverage (as 

11 such terms are defined in section 

12 2791 of the Public Health Serv13 ice Act); 

14 ‘‘(bb) a Federal health care 

15 program (as defined in section 

16 1128B(f)), other than the pro17 gram established under this title; 

18 ‘‘(cc) the health insurance 

19 program under chapter 89 of 

20 title 5, United States Code; 

21 ‘‘(dd) a medicare supple22 mental policy under section 1882; 

23 or 

24 ‘‘(ee) an MA or MA–PD 

25 plan; and 


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1 ‘‘(II) that meets— 

2 ‘‘(aa) in the case of coverage 

3 described in any of items (aa) 

4 through (dd) of subclause (I), the 

5 condition described in clause (ii); 

6 and 

7 ‘‘(bb) in the case of coverage 

8 described in item (ee) of sub9 clause (I), the condition described 

10 in clause (iii). 

11 ‘‘(ii) CONDITION FOR COVERAGE

12 OTHER THAN PART C COVERAGE.—For 

13 purposes of clause (i)(II)(aa), the condition 

14 described in this clause, with respect to an 

15 individual enrolled in coverage described in 

16 any of items (aa) through (dd) of clause 

17 (i)(I) during a year, is that such coverage 

18 provides for the payment of all cost shar19 ing owed by such individual under this 

20 part (or, if applicable, under an MA or 

21 MA–PD plan) with respect to a specified 

22 biosimilar biological product (as defined in 

23 subparagraph (C)) furnished under this 

24 part (or, if applicable, under an MA or 

25 MA–PD plan) during such year, not taking 


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1 into account the application of any deduct2 ible under such coverage. 

3 ‘‘(iii) CONDITION FOR PART C COV4 ERAGE.—For purposes of clause 

5 (i)(II)(bb), the condition described in this 

6 clause, with respect to an individual en7 rolled in an MA or MA–PD plan during a 

8 year, is that such plan provides for no cost 

9 sharing for such individual with respect to 

10 a specified biological biosimilar product (as 

11 defined in subparagraph (C)) furnished 

12 under such plan during such year. 

13 ‘‘(C) SPECIFIED BIOSIMILAR BIOLOGICAL

14 PRODUCT.—For purposes of subsection 

15 (a)(1)(S), the term ‘specified biosimilar biologi16 cal product’ means a biosimilar biological prod17 uct (as defined in subsection (c)(6) of section 

18 1847A) for which the payment amount deter19 mined under subsection (b)(8) of such section 

20 for such product is less than the payment 

21 amount determined under subsection (b)(4) of 

22 such section for the reference biological product 

23 (as defined in subsection (c)(6) of such section). 

24 ‘‘(2) DETERMINATIONS.—The Secretary shall 

25 establish a process— 


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1 ‘‘(A) for determining whether an individual 

2 is a cost-sharing reduction eligible individual for 

3 a year; and 

4 ‘‘(B) for notifying MA organizations of 

5 such a determination made with respect to an 

6 individual enrolled under an MA plan or MA– 

7 PD plan offered by such organization during 

8 such year.’’. 

Æ 


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