S. 2554 

One Hundred Fifteenth Congress 

of the 

United States of America 

AT THE SECOND SESSION 

Begun and held at the City of Washington on Wednesday, 

the third day of January, two thousand and eighteen 

An Act 

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

pharmacy providers from providing certain information to enrollees. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

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

Prices Act’’. 

SEC. 2. PROHIBITION ON LIMITING CERTAIN INFORMATION ON DRUG 

PRICES. 

Subpart II of part A of title XXVII of the Public Health Service 

Act (42 U.S.C. 300gg–11 et seq.) is amended by adding at the 

end the following: 

‘‘SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS. 

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

issuer offering group or individual health insurance coverage shall— 

‘‘(1) not restrict, directly or indirectly, any pharmacy that 

dispenses a prescription drug to an enrollee in the plan or 

coverage from informing (or penalize such pharmacy for 

informing) an enrollee of any differential between the enrollee’s 

out-of-pocket cost under the plan or coverage with respect to 

acquisition of the drug and the amount an individual would 

pay for acquisition of the drug without using any health plan 

or health insurance coverage; and 

‘‘(2) ensure that any entity that provides pharmacy benefits 

management services under a contract with any such health 

plan or health insurance coverage does not, with respect to 

such plan or coverage, restrict, directly or indirectly, a pharmacy that dispenses a prescription drug from informing (or 

penalize such pharmacy for informing) an enrollee of any differential between the enrollee’s out-of-pocket cost under the 

plan or coverage with respect to acquisition of the drug and 

the amount an individual would pay for acquisition of the 

drug without using any health plan or health insurance coverage. 

‘‘(b) DEFINITION.—For purposes of this section, the term ‘outof-pocket cost’, with respect to acquisition of a drug, means the 

amount to be paid by the enrollee under the plan or coverage, 

including any cost-sharing (including any deductible, copayment, 

or coinsurance) and, as determined by the Secretary, any other 

expenditure.’’. 
S. 2554—2 

SEC. 3. MODERNIZING THE REPORTING OF BIOLOGICAL AND BIOSIMILAR PRODUCTS. 

Subtitle B of title XI of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 2003 (Public Law 108– 

173) is amended— 

(1) in section 1111— 

(A) by redesignating paragraphs (3) through (8) as 

paragraphs (6) through (11), respectively; 

(B) by inserting after paragraph (2) the following: 

‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT.—The term ‘biosimilar biological product’ means a biological product for which 

an application under section 351(k) of the Public Health Service 

Act is approved. 

‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT APPLICANT.—The 

term ‘biosimilar biological product applicant’ means a person 

who has filed or received approval for a biosimilar biological 

product under section 351(k) of the Public Health Service Act. 

‘‘(5) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION.—The 

term ‘biosimilar biological product application’ means an 

application for licensure of a biological product under section 

351(k) of the Public Health Service Act.’’; 

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

‘‘, or a biological product for which an application is 

approved under section 351(a) of the Public Health Service 

Act’’ before the period; 

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

(i) by striking ‘‘paragraph (3)’’ and inserting ‘‘paragraph (6)’’; 

(ii) by inserting ‘‘or a reference product in a biosimilar biological product application’’ after ‘‘ANDA’’; 

and 

(iii) by inserting ‘‘or under section 351(a) of the 

Public Health Service Act’’ before the period; and 

(E) by adding at the end the following: 

‘‘(12) REFERENCE PRODUCT.—The term ‘reference product’ 

means a brand name drug for which a license is in effect 

under section 351(a) of the Public Health Service Act.’’; 

(2) in section 1112— 

(A) in subsection (a)— 

(i) in paragraph (1)— 

(I) by inserting ‘‘or a biosimilar biological 

product applicant who has submitted a biosimilar 

biological product application for which a statement under section 351(l)(3)(B)(ii)(I) of the Public 

Health Service Act has been provided’’ after ‘‘Federal Food, Drug, and Cosmetic Act’’; and 

(II) by inserting ‘‘or the biosimilar biological 

product that is the subject of the biosimilar 

biological product application, as applicable’’ after 

‘‘the ANDA’’; and 

(ii) in paragraph (2)— 

(I) in the matter preceding subparagraph (A), 

by inserting ‘‘or a biosimilar biological product 

applicant’’ after ‘‘generic drug applicant’’; 

(II) in subparagraph (A)— 

(aa) by striking ‘‘marketing’’ and inserting 

‘‘marketing,’’; and 
S. 2554—3 

(bb) by inserting ‘‘or the reference product 

in the biosimilar biological product application’’ before ‘‘involved’’; 

(III) in subparagraph (B), by inserting ‘‘or of 

the biosimilar biological product for which the biosimilar biological product application was submitted’’ after ‘‘submitted’’; and 

(IV) by amending subparagraph (C) to read 

as follows: 

‘‘(C) as applicable— 

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

505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic 

Act as it applies to such ANDA or to any other ANDA 

based on the same brand name drug; or 

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

351(k)(6)(A) of the Public Health Service Act as it 

applies to such biosimilar biological product application 

or to any other biosimilar biological product application 

based on the same brand name drug.’’; and 

(B) in subsection (b)— 

(i) by amending paragraph (1) to read as follows: 

‘‘(1) REQUIREMENT.— 

‘‘(A) GENERIC DRUGS.—A generic drug applicant that 

has submitted an ANDA containing a certification under 

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

Cosmetic Act with respect to a listed drug and another 

generic drug applicant that has submitted an ANDA containing such a certification for the same listed drug shall 

each file the agreement in accordance with subsection (c). 

The agreement shall be filed prior to the date of the first 

commercial marketing of either of the generic drugs for 

which such ANDAs were submitted. 

‘‘(B) BIOSIMILAR BIOLOGICAL PRODUCTS.—A biosimilar 

biological product applicant that has submitted a biosimilar 

biological product application for which a statement under 

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

has been provided with respect to a reference product and 

another biosimilar biological product applicant that has 

submitted a biosimilar biological product application for 

which such a statement for the same reference product 

has been provided shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior 

to the date of the first commercial marketing of either 

of the biosimilar biological products for which such biosimilar biological product applications were submitted.’’; 

and 

(ii) in paragraph (2)— 

(I) by striking ‘‘between two generic drug 

applicants is an agreement’’ and inserting ‘‘is, as 

applicable, an agreement between 2 generic drug 

applicants’’; and 

(II) by inserting ‘‘, or an agreement between 

2 biosimilar biological product applicants regarding 

the 1-year period referred to in section 351(k)(6)(A) 

of the Public Health Service Act as it applies to 

the biosimilar biological product applications with 
S. 2554—4 

which the agreement is concerned’’ before the 

period; 

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

each place such term appears and inserting ‘‘, generic drug 

applicant, or biosimilar biological product applicant’’; and 

(4) in section 1117, by striking ‘‘, or any agreement between 

generic drug applicants’’ and inserting ‘‘or a biosimilar biological 

product applicant, any agreement between generic drug 

applicants, or any agreement between biosimilar biological 

product applicants’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.