115TH CONGRESS 

2D SESSION S. 2554 

AN ACT 

To ensure that health insurance issuers and group health 

plans do not prohibit pharmacy providers from providing 

certain information to enrollees. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
2 

†S 2554 ES

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Patient Right to Know 

3 Drug Prices Act’’. 

4 SEC. 2. PROHIBITION ON LIMITING CERTAIN INFORMATION 

5 ON DRUG PRICES. 

6 Subpart II of part A of title XXVII of the Public 

7 Health Service Act (42 U.S.C. 300gg–11 et seq.) is 

8 amended by adding at the end the following: 

9 ‘‘SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS. 

10 ‘‘(a) IN GENERAL.—A group health plan or a health 

11 insurance issuer offering group or individual health insur12 ance coverage shall— 

13 ‘‘(1) not restrict, directly or indirectly, any 

14 pharmacy that dispenses a prescription drug to an 

15 enrollee in the plan or coverage from informing (or 

16 penalize such pharmacy for informing) an enrollee of 

17 any differential between the enrollee’s out-of-pocket 

18 cost under the plan or coverage with respect to ac19 quisition of the drug and the amount an individual 

20 would pay for acquisition of the drug without using 

21 any health plan or health insurance coverage; and 

22 ‘‘(2) ensure that any entity that provides phar23 macy benefits management services under a contract 

24 with any such health plan or health insurance cov25 erage does not, with respect to such plan or cov26 erage, restrict, directly or indirectly, a pharmacy 
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†S 2554 ES

1 that dispenses a prescription drug from informing 

2 (or penalize such pharmacy for informing) an en3 rollee of any differential between the enrollee’s out4 of-pocket cost under the plan or coverage with re5 spect to acquisition of the drug and the amount an 

6 individual would pay for acquisition of the drug 

7 without using any health plan or health insurance 

8 coverage. 

9 ‘‘(b) DEFINITION.—For purposes of this section, the 

10 term ‘out-of-pocket cost’, with respect to acquisition of a 

11 drug, means the amount to be paid by the enrollee under 

12 the plan or coverage, including any cost-sharing (including 

13 any deductible, copayment, or coinsurance) and, as deter14 mined by the Secretary, any other expenditure.’’. 

15 SEC. 3. MODERNIZING THE REPORTING OF BIOLOGICAL 

16 AND BIOSIMILAR PRODUCTS. 

17 Subtitle B of title XI of the Medicare Prescription 

18 Drug, Improvement, and Modernization Act of 2003 (Pub19 lic Law 108–173) is amended— 

20 (1) in section 1111— 

21 (A) by redesignating paragraphs (3) 

22 through (8) as paragraphs (6) through (11), re23 spectively; 

24 (B) by inserting after paragraph (2) the 

25 following: 
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†S 2554 ES

1 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

2 term ‘biosimilar biological product’ means a biologi3 cal product for which an application under section 

4 351(k) of the Public Health Service Act is approved. 

5 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT APPLI6 CANT.—The term ‘biosimilar biological product ap7 plicant’ means a person who has filed or received ap8 proval for a biosimilar biological product under sec9 tion 351(k) of the Public Health Service Act. 

10 ‘‘(5) BIOSIMILAR BIOLOGICAL PRODUCT APPLI11 CATION.—The term ‘biosimilar biological product ap12 plication’ means an application for licensure of a bi13 ological product under section 351(k) of the Public 

14 Health Service Act.’’; 

15 (C) in paragraph (6), as so redesignated, 

16 by inserting ‘‘, or a biological product for which 

17 an application is approved under section 351(a) 

18 of the Public Health Service Act’’ before the pe19 riod; 

20 (D) in paragraph (7), as so redesignated— 

21 (i) by striking ‘‘paragraph (3)’’ and 

22 inserting ‘‘paragraph (6)’’; 

23 (ii) by inserting ‘‘or a reference prod24 uct in a biosimilar biological product appli25 cation’’ after ‘‘ANDA’’; and 
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†S 2554 ES

1 (iii) by inserting ‘‘or under section 

2 351(a) of the Public Health Service Act’’ 

3 before the period; and 

4 (E) by adding at the end the following: 

5 ‘‘(12) REFERENCE PRODUCT.—The term ‘ref6 erence product’ means a brand name drug for which 

7 a license is in effect under section 351(a) of the 

8 Public Health Service Act.’’; 

9 (2) in section 1112— 

10 (A) in subsection (a)— 

11 (i) in paragraph (1)— 

12 (I) by inserting ‘‘or a biosimilar 

13 biological product applicant who has 

14 submitted a biosimilar biological prod15 uct application for which a statement 

16 under section 351(l)(3)(B)(ii)(I) of 

17 the Public Health Service Act has 

18 been provided’’ after ‘‘Federal Food, 

19 Drug, and Cosmetic Act’’; and 

20 (II) by inserting ‘‘or the bio21 similar biological product that is the 

22 subject of the biosimilar biological 

23 product application, as applicable’’ 

24 after ‘‘the ANDA’’; and 

25 (ii) in paragraph (2)— 
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†S 2554 ES

1 (I) in the matter preceding sub2 paragraph (A), by inserting ‘‘or a bio3 similar biological product applicant’’ 

4 after ‘‘generic drug applicant’’; 

5 (II) in subparagraph (A)— 

6 (aa) by striking ‘‘mar7 keting’’ and inserting ‘‘mar8 keting,’’; and 

9 (bb) by inserting ‘‘or the 

10 reference product in the bio11 similar biological product applica12 tion’’ before ‘‘involved’’; 

13 (III) in subparagraph (B), by in14 serting ‘‘or of the biosimilar biological 

15 product for which the biosimilar bio16 logical product application was sub17 mitted’’ after ‘‘submitted’’; and 

18 (IV) by amending subparagraph 

19 (C) to read as follows: 

20 ‘‘(C) as applicable— 

21 ‘‘(i) the 180-day period referred to in 

22 section 505(j)(5)(B)(iv) of the Federal 

23 Food, Drug, and Cosmetic Act as it applies 

24 to such ANDA or to any other ANDA 

25 based on the same brand name drug; or 
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1 ‘‘(ii) the 1-year period referred to in 

2 section 351(k)(6)(A) of the Public Health 

3 Service Act as it applies to such biosimilar 

4 biological product application or to any 

5 other biosimilar biological product applica6 tion based on the same brand name 

7 drug.’’; and 

8 (B) in subsection (b)— 

9 (i) by amending paragraph (1) to read 

10 as follows: 

11 ‘‘(1) REQUIREMENT.— 

12 ‘‘(A) GENERIC DRUGS.—A generic drug 

13 applicant that has submitted an ANDA con14 taining a certification under section 

15 505(j)(2)(A)(vii)(IV) of the Federal Food, 

16 Drug, and Cosmetic Act with respect to a listed 

17 drug and another generic drug applicant that 

18 has submitted an ANDA containing such a cer19 tification for the same listed drug shall each file 

20 the agreement in accordance with subsection 

21 (c). The agreement shall be filed prior to the 

22 date of the first commercial marketing of either 

23 of the generic drugs for which such ANDAs 

24 were submitted. 
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†S 2554 ES

1 ‘‘(B) BIOSIMILAR BIOLOGICAL PROD2 UCTS.—A biosimilar biological product appli3 cant that has submitted a biosimilar biological 

4 product application for which a statement 

5 under section 351(l)(3)(B)(ii)(I) of the Public 

6 Health Service Act has been provided with re7 spect to a reference product and another bio8 similar biological product applicant that has 

9 submitted a biosimilar biological product appli10 cation for which such a statement for the same 

11 reference product has been provided shall each 

12 file the agreement in accordance with sub13 section (c). The agreement shall be filed prior 

14 to the date of the first commercial marketing of 

15 either of the biosimilar biological products for 

16 which such biosimilar biological product appli17 cations were submitted.’’; and 

18 (ii) in paragraph (2)— 

19 (I) by striking ‘‘between two ge20 neric drug applicants is an agree21 ment’’ and inserting ‘‘is, as applicable, 

22 an agreement between 2 generic drug 

23 applicants’’; and 

24 (II) by inserting ‘‘, or an agree25 ment between 2 biosimilar biological 
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1 product applicants regarding the 1- 

2 year period referred to in section 

3 351(k)(6)(A) of the Public Health 

4 Service Act as it applies to the bio5 similar biological product applications 

6 with which the agreement is con7 cerned’’ before the period; 

8 (3) in section 1115, by striking ‘‘or generic 

9 drug applicant’’ each place such term appears and 

10 inserting ‘‘, generic drug applicant, or biosimilar bio11 logical product applicant’’; and 

12 (4) in section 1117, by striking ‘‘, or any agree13 ment between generic drug applicants’’ and inserting 

14 ‘‘or a biosimilar biological product applicant, any 

15 agreement between generic drug applicants, or any 

16 agreement between biosimilar biological product ap17 plicants’’. 

Passed the Senate September 17, 2018. 

Attest: 

Secretary. 
115TH CONGRESS 

2D SESSION S. 2554 

AN ACT 

To ensure that health insurance issuers and group 

from providing certain information to enrollees. health plans do not prohibit pharmacy providers