II 

Calendar No. 549 

115TH CONGRESS 

2D SESSION S. 2554 

To ensure that health insurance issuers and group health plans do not 

prohibit pharmacy providers from providing certain information to enrollees. 

IN THE SENATE OF THE UNITED STATES 

MARCH 14, 2018 

Ms. COLLINS (for herself, Mrs. MCCASKILL, Mr. BARRASSO, Ms. STABENOW, 

Mr. CASSIDY, Ms. SMITH, Mr. DONNELLY, Mrs. FEINSTEIN, Ms. MURKOWSKI, Mr. MENENDEZ, Ms. BALDWIN, Mr. KENNEDY, Ms. HASSAN, 

and Mr. BLUMENTHAL) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

JULY 31, 2018 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

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, 


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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 (a) EXCHANGE PLANS.—Section 1311(e) of the Pa7 tient Protection and Affordable Care Act (42 U.S.C. 

8 18031(e)) is amended by adding at the end the following: 

9 ‘‘(4) INFORMATION ON PRESCRIPTION

10 DRUGS.—The Exchange shall require health plans 

11 seeking certification as qualified health plans to en12 sure that— 

13 ‘‘(A) the health insurance issuer does not 

14 restrict any pharmacy that dispenses a pre15 scription drug to an enrollee in the plan from 

16 informing (or penalize such pharmacy for in17 forming) an enrollee of any differential between 

18 the price of the drug to the enrollee under the 

19 plan and the price the individual would pay for 

20 the drug if the enrollee obtained the drug with21 out using any health insurance coverage; and 

22 ‘‘(B) any entity that provides pharmacy 

23 benefits management services under a contract 

24 with any such health plan does not, with re25 spect to such plan or any health benefits plan 

26 that the entity contracts with to provide pharVerDate Sep 11 2014 23:39 Jul 31, 2018 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6401 E:\BILLS\S2554.RS S2554

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1 macy benefits management services and that is 

2 offered by an entity other than such sponsor or 

3 organization, restrict a pharmacy that dispenses 

4 a prescription drug from informing (or penalize 

5 such pharmacy for informing) an enrollee of 

6 any differential between the price of the drug to 

7 the enrollee under the plan and the price the in8 dividual would pay for the drug if the enrollee 

9 obtained the drug without using any health in10 surance coverage.’’. 

11 (b) OTHER HEALTH PLANS.—The provisions of sec12 tion 1311(e)(4) of the Patient Protection and Affordable 

13 Care Act (as added by subsection (a)) shall apply to all 

14 health insurance issuers with respect to health insurance 

15 coverage and to all group health plans (as such terms are 

16 defined in section 2791 of the Public Health Service Act 

17 (42 U.S.C. 300gg–91)). 

18 SECTION 1. SHORT TITLE. 

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

20 Drug Prices Act’’. 

21 SEC. 2. PROHIBITION ON LIMITING CERTAIN INFORMATION 

22 ON DRUG PRICES. 

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

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

25 by adding at the end the following: 


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

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

3 insurance issuer offering group or individual health insur4 ance coverage shall— 

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

6 pharmacy that dispenses a prescription drug to an 

7 enrollee in the plan or coverage from informing (or 

8 penalize such pharmacy for informing) an enrollee of 

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

10 cost under the plan or coverage with respect to acqui11 sition of the drug and the amount an individual 

12 would pay for acquisition of the drug without using 

13 any health plan or health insurance coverage; and 

14 ‘‘(2) ensure that any entity that provides phar15 macy benefits management services under a contract 

16 with any such health plan or health insurance cov17 erage does not, with respect to such plan or coverage, 

18 restrict, directly or indirectly, a pharmacy that dis19 penses a prescription drug from informing (or penal20 ize such pharmacy for informing) an enrollee of any 

21 differential between the enrollee’s out-of-pocket cost 

22 under the plan or coverage with respect to acquisition 

23 of the drug and the amount an individual would pay 

24 for acquisition of the drug without using any health 

25 plan or health insurance coverage. 


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

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

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

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

5 any deductible, copayment, or coinsurance) and, as deter6 mined by the Secretary, any other expenditure.’’. 

7 SEC. 3. MODERNIZING THE REPORTING OF BIOLOGICAL 

8 AND BIOSIMILAR PRODUCTS. 

9 Subtitle B of title XI of the Medicare Prescription 

10 Drug, Improvement, and Modernization Act of 2003 (Public 

11 Law 108–173) is amended— 

12 (1) in section 1111— 

13 (A) by redesignating paragraphs (3) 

14 through (8) as paragraphs (6) through (11), re15 spectively; 

16 (B) by inserting after paragraph (2) the fol17 lowing: 

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

19 term ‘biosimilar biological product’ means a biologi20 cal product for which an application under section 

21 351(k) of the Public Health Service Act is approved. 

22 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT APPLI23 CANT.—The term ‘biosimilar biological product appli24 cant’ means a person who has filed or received apVerDate Sep 11 2014 23:39 Jul 31, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\S2554.RS S2554

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1 proval for a biosimilar biological product under sec2 tion 351(k) of the Public Health Service Act. 

3 ‘‘(5) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA4 TION.—The term ‘biosimilar biological product appli5 cation’ means an application for licensure of a bio6 logical product under section 351(k) of the Public 

7 Health Service Act.’’; 

8 (C) in paragraph (6), as so redesignated, by 

9 inserting ‘‘, or a biological product for which an 

10 application is approved under section 351(a) of 

11 the Public Health Service Act’’ before the period; 

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

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

14 inserting ‘‘paragraph (6)’’; 

15 (ii) by inserting ‘‘or a reference prod16 uct in a biosimilar biological product appli17 cation’’ after ‘‘ANDA’’; and 

18 (iii) by inserting ‘‘or under section 

19 351(a) of the Public Health Service Act’’ be20 fore the period; and 

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

22 ‘‘(12) REFERENCE PRODUCT.—The term ‘ref23 erence product’ means a brand name drug for which 

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

25 Health Service Act.’’; 


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1 (2) in section 1112— 

2 (A) in subsection (a)— 

3 (i) in paragraph (1)— 

4 (I) by inserting ‘‘or a biosimilar 

5 biological product applicant who has 

6 submitted a biosimilar biological prod7 uct application for which a statement 

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

9 Public Health Service Act has been 

10 provided’’ after ‘‘Federal Food, Drug, 

11 and Cosmetic Act’’; and 

12 (II) by inserting ‘‘or the bio13 similar biological product that is the 

14 subject of the biosimilar biological 

15 product application, as applicable’’ 

16 after ‘‘the ANDA’’; and 

17 (ii) in paragraph (2)— 

18 (I) in the matter preceding sub19 paragraph (A), by inserting ‘‘or a bio20 similar biological product applicant’’ 

21 after ‘‘generic drug applicant’’; 

22 (II) in subparagraph (A)— 

23 (aa) by striking ‘‘marketing’’ 

24 and inserting ‘‘marketing,’’; and 


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1 (bb) by inserting ‘‘or the ref2 erence product in the biosimilar 

3 biological product application’’ 

4 before ‘‘involved’’; 

5 (III) in subparagraph (B), by in6 serting ‘‘or of the biosimilar biological 

7 product for which the biosimilar bio8 logical product application was sub9 mitted’’ after ‘‘submitted’’; and 

10 (IV) by amending subparagraph 

11 (C) to read as follows: 

12 ‘‘(C) as applicable— 

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

14 section 505(j)(5)(B)(iv) of the Federal Food, 

15 Drug, and Cosmetic Act as it applies to 

16 such ANDA or to any other ANDA based on 

17 the same brand name drug; or 

18 ‘‘(ii) the 1-year period referred to in 

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

20 Service Act as it applies to such biosimilar 

21 biological product application or to any 

22 other biosimilar biological product applica23 tion based on the same brand name drug.’’; 

24 and 

25 (B) in subsection (b)— 


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

2 as follows: 

3 ‘‘(1) REQUIREMENT.— 

4 ‘‘(A) GENERIC DRUGS.—A generic drug ap5 plicant that has submitted an ANDA containing 

6 a certification under section 

7 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, 

8 and Cosmetic Act with respect to a listed drug 

9 and another generic drug applicant that has sub10 mitted an ANDA containing such a certification 

11 for the same listed drug shall each file the agree12 ment in accordance with subsection (c). The 

13 agreement shall be filed prior to the date of the 

14 first commercial marketing of either of the ge15 neric drugs for which such ANDAs were sub16 mitted. 

17 ‘‘(B) BIOSIMILAR BIOLOGICAL PRODUCTS.— 

18 A biosimilar biological product applicant that 

19 has submitted a biosimilar biological product 

20 application for which a statement under section 

21 351(l)(3)(B)(ii)(I) of the Public Health Service 

22 Act has been provided with respect to a reference 

23 product and another biosimilar biological prod24 uct applicant that has submitted a biosimilar bi25 ological product application for which such a 


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1 statement for the same reference product has been 

2 provided shall each file the agreement in accord3 ance with subsection (c). The agreement shall be 

4 filed prior to the date of the first commercial 

5 marketing of either of the biosimilar biological 

6 products for which such biosimilar biological 

7 product applications were submitted.’’; and 

8 (ii) in paragraph (2)— 

9 (I) by striking ‘‘between two ge10 neric drug applicants is an agreement’’ 

11 and inserting ‘‘is, as applicable, an 

12 agreement between 2 generic drug ap13 plicants’’; and 

14 (II) by inserting ‘‘, or an agree15 ment between 2 biosimilar biological 

16 product applicants regarding the 1- 

17 year period referred to in section 

18 351(k)(6)(A) of the Public Health Serv19 ice Act as it applies to the biosimilar 

20 biological product applications with 

21 which the agreement is concerned’’ be22 fore the period; 

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

24 applicant’’ each place such term appears and insertVerDate Sep 11 2014 23:39 Jul 31, 2018 Jkt 079200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\S2554.RS S2554

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1 ing ‘‘, generic drug applicant, or biosimilar biological 

2 product applicant’’; and 

3 (4) in section 1117, by striking ‘‘, or any agree4 ment between generic drug applicants’’ and inserting 

5 ‘‘or a biosimilar biological product applicant, any 

6 agreement between generic drug applicants, or any 

7 agreement between biosimilar biological product ap8 plicants’’. 


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Calendar No. 549 

115TH CONGRESS 

2D SESSION S. 2554 

A BILL 

To ensure that health insurance issuers and group 

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

JULY 31, 2018 

Reported with an amendment 


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