I 

116TH CONGRESS 

1ST SESSION H. R. 4913 

To amend title XVIII of the Social Security Act to require PDP sponsors 

of a prescription drug plan under part D of the Medicare program 

that use a formulary to include certain generic drugs and biosimilar 

biological products on such formulary, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 30, 2019 

Mr. MCKINLEY (for himself and Ms. KUSTER of New Hampshire) 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 require 

PDP sponsors of a prescription drug plan under part 

D of the Medicare program that use a formulary to 

include certain generic drugs and biosimilar biological 

products on such formulary, and for other purposes. 

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


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1 SECTION 1. REQUIREMENTS FOR PDP SPONSORS OF PRE2 SCRIPTION DRUG PLANS UNDER PART D OF 

3 THE MEDICARE PROGRAM THAT USE 

4 FORMULARIES. 

5 (a) IN GENERAL.—Section 1860D–4(b)(3) of the So6 cial Security Act (42 U.S.C. 1395w–104(b)(3)) is amend7 ed by adding at the end the following new subparagraphs: 

8 ‘‘(I) REQUIRED INCLUSION OF CERTAIN

9 GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL

10 PRODUCTS.— 

11 ‘‘(i) IN GENERAL.—With respect to a 

12 plan year beginning on or after January 1, 

13 2021, the formulary shall include— 

14 ‘‘(I) each covered generic drug 

15 for which the wholesale acquisition 

16 cost is less than the wholesale acquisi17 tion cost of the reference drug of such 

18 covered generic drug; and 

19 ‘‘(II) each covered biosimilar bio20 logical product for which the whole21 sale acquisition cost is less than the 

22 wholesale acquisition cost of the ref23 erence biological product of such cov24 ered biosimilar biological product. 

25 ‘‘(ii) PROHIBITION ON CERTAIN LIM26 ITS ON ACCESS.—The PDP sponsor offerVerDate Sep 11 2014 04:00 Nov 06, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4913.IH H4913

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1 ing the prescription drug plan may not im2 pose limits on access to a covered generic 

3 drug required to be included on the for4 mulary under clause (i)(I) or a covered 

5 biosimilar biological product required to be 

6 included on the formulary under clause 

7 (i)(II), including through prior authoriza8 tion, utilization management, or step ther9 apy, that are more restrictive than any 

10 such limits imposed on access to the ref11 erence drug of such covered generic drug 

12 or reference biological product of such cov13 ered biosimilar biological product, respec14 tively, or that otherwise have the effect of 

15 giving preferred status to such reference 

16 drug or reference biological product over 

17 such covered generic drug or covered bio18 similar biological product, respectively. 

19 ‘‘(iii) DEFINITIONS.—In this subpara20 graph and subparagraph (J): 

21 ‘‘(I) COVERED BIOSIMILAR BIO22 LOGICAL PRODUCT.—The term ‘cov23 ered biosimilar biological product’ 

24 means a covered part D drug that is 


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1 a biosimilar biological product (as de2 fined in section 1847A(c)(6)(H)). 

3 ‘‘(II) COVERED GENERIC

4 DRUG.—The term ‘covered generic 

5 drug’ means a covered part D drug 

6 that is a drug described in section 

7 1860D–2(e)(1)(A) and approved 

8 under section 505(j) of the Federal 

9 Food, Drug, and Cosmetic Act. 

10 ‘‘(III) REFERENCE BIOLOGICAL

11 PRODUCT.—The term ‘reference bio12 logical product’ has the meaning given 

13 such term in section 1847A(c)(6)(I). 

14 ‘‘(IV) REFERENCE DRUG.—The 

15 term ‘reference drug’ means, with re16 spect to a covered generic drug, the 

17 listed drug (as described in clause (i) 

18 of section 505(j)(2)(A) of the Federal 

19 Food, Drug, and Cosmetic Act) that 

20 is referred to in the abbreviated appli21 cation for such covered generic drug 

22 under such section. 

23 ‘‘(V) WHOLESALE ACQUISITION

24 COST.—The term ‘wholesale acquisiVerDate Sep 11 2014 04:00 Nov 06, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4913.IH H4913

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1 tion cost’ has the meaning given such 

2 term in section 1847A(c)(6)(B). 

3 ‘‘(J) COST-SHARING TIERING REQUIRE4 MENTS WITH RESPECT TO COVERED GENERIC

5 DRUGS AND COVERED BIOSIMILAR BIOLOGICAL

6 PRODUCTS.— 

7 ‘‘(i) GENERIC DRUG COST-SHARING

8 TIER.—With respect to a plan year begin9 ning on or after January 1, 2021, the 

10 PDP sponsor offering the prescription 

11 drug plan shall— 

12 ‘‘(I) have at least one cost-shar13 ing tier on the formulary that only in14 cludes covered generic drugs and cov15 ered biosimilar biological products; 

16 and 

17 ‘‘(II) apply a cost-sharing re18 quirement with respect to each cost19 sharing tier described in subclause (I) 

20 on the formulary that is meaningfully 

21 lesser than the lowest cost-sharing re22 quirement applicable with respect to 

23 any cost-sharing tier on such for24 mulary that includes a brand drug 

25 (referred to in this subparagraph as 


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1 the ‘lowest brand drug cost-sharing 

2 tier’). 

3 ‘‘(ii) SPECIALTY GENERIC DRUG COST4 SHARING TIER.—With respect to a plan 

5 year beginning on or after January 1, 

6 2021, if the PDP sponsor offering the pre7 scription drug plan has a cost-sharing tier 

8 for specialty brand drugs on the formulary, 

9 the PDP sponsor shall— 

10 ‘‘(I) have a cost-sharing tier on 

11 such formulary that only includes cov12 ered generic drugs and covered bio13 similar biological products— 

14 ‘‘(aa) for which the whole15 sale acquisition cost is greater 

16 than a threshold specified by the 

17 Secretary; and 

18 ‘‘(bb) with respect to which 

19 the reference drug for such a 

20 covered generic drug or the ref21 erence biological product for such 

22 a covered biosimilar biological 

23 product is either included on a 

24 cost-sharing tier on such for25 mulary with a cost-sharing reVerDate Sep 11 2014 04:00 Nov 06, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4913.IH H4913

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1 quirement that is greater than 

2 the cost-sharing requirement ap3 plied under subclause (II), or ex4 cluded from such formulary; and 

5 ‘‘(II) apply a cost-sharing re6 quirement with respect to the cost7 sharing tier required for the for8 mulary under subclause (I) that is 

9 meaningfully lesser than the cost10 sharing requirement applicable with 

11 respect to the cost-sharing tier for 

12 specialty brand drugs on such for13 mulary. 

14 ‘‘(iii) PLACEMENT OF CERTAIN GE15 NERIC DRUGS AND BIOSIMILAR BIOLOGI16 CAL PRODUCTS.—Each covered generic 

17 drug and each covered biosimilar biological 

18 product required to be included on the for19 mulary under subparagraph (I)(i) shall be 

20 included either on a cost-sharing tier de21 scribed in clause (i)(I) or, if applicable, the 

22 cost-sharing tier required for the formulary 

23 under clause (ii)(I). 

24 ‘‘(iv) DEFINITIONS.—In this subpara25 graph: 


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1 ‘‘(I) BRAND DRUG.—The term 

2 ‘brand drug’ means a covered part D 

3 drug that is a drug described in sec4 tion 1860D–2(e)(1)(A) and approved 

5 under section 505(c) of the Federal 

6 Food, Drug, and Cosmetic Act. 

7 ‘‘(II) MEANINGFULLY LESSER.— 

8 The term ‘meaningfully lesser’ 

9 means— 

10 ‘‘(aa) for purposes of sub11 clause (II) of clause (i), such a 

12 lesser cost-sharing requirement 

13 that the Secretary determines 

14 will likely significantly incentivize 

15 the utilization of covered generic 

16 drugs and covered biosimilar bio17 logical products on a cost-sharing 

18 tier described in subclause (I) of 

19 such clause on a formulary over 

20 covered part D drugs on the low21 est brand drug cost-sharing tier 

22 on such formulary; and 

23 ‘‘(bb) for purposes of sub24 clause (II) of clause (ii), such a 

25 lesser cost-sharing requirement 


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1 that the Secretary determines 

2 will likely significantly incentivize 

3 the utilization of covered generic 

4 drugs and covered biosimilar bio5 logical products on the cost-shar6 ing tier required for the for7 mulary under subclause (I) of 

8 such clause over covered part D 

9 drugs on the cost-sharing tier for 

10 specialty brand drugs on such 

11 formulary. 

12 ‘‘(III) SPECIALTY BRAND

13 DRUG.—The term ‘specialty brand 

14 drug’ means a brand drug for which 

15 the wholesale acquisition cost is great16 er than a threshold specified by the 

17 Secretary.’’. 

18 (b) CONFORMING AMENDMENT.—Section 1860D– 

19 2(b)(2)(B) of the Social Security Act (42 U.S.C. 1395w– 

20 102(b)(2)(B)) is amended by inserting before the period 

21 the following: ‘‘and section 1860D–4(b)(3)(J)’’. 

Æ 


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