An act to ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees
PL 115-263 (S.2554), enacted 10/10/2018

132 STAT. 3672 
PUBLIC LAW 115–263—OCT. 10, 2018 
Public Law 115–263 
115th Congress 
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 phar-
macy that dispenses a prescription drug from informing (or 
penalize such pharmacy for informing) an enrollee of any dif-
ferential 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 cov-
erage. 
‘‘(b) DEFINITION.—For purposes of this section, the term ‘out- 
of-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.’’. 
Determination. 
42 USC 
300gg–19b. 
42 USC 201 note. 
Patient Right to 
Know Drug 
Prices Act. 
Oct. 10, 2018 
[S. 2554] 
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132 STAT. 3673 
PUBLIC LAW 115–263—OCT. 10, 2018 
SEC. 3. MODERNIZING THE REPORTING OF BIOLOGICAL AND BIO-
SIMILAR 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 ‘bio-
similar 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 ‘‘para-
graph (6)’’; 
(ii) by inserting ‘‘or a reference product in a bio-
similar 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 state-
ment under section 351(l)(3)(B)(ii)(I) of the Public 
Health Service Act has been provided’’ after ‘‘Fed-
eral 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 
Definitions. 
Definitions. 
21 USC 355. 
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132 STAT. 3674 
PUBLIC LAW 115–263—OCT. 10, 2018 
(bb) by inserting ‘‘or the reference product 
in the biosimilar biological product applica-
tion’’ before ‘‘involved’’; 
(III) in subparagraph (B), by inserting ‘‘or of 
the biosimilar biological product for which the bio-
similar biological product application was sub-
mitted’’ 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 con-
taining 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 accord-
ance 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 bio-
similar 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 
Time periods. 
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132 STAT. 3675 
PUBLIC LAW 115–263—OCT. 10, 2018 
LEGISLATIVE HISTORY—S. 2554: 
CONGRESSIONAL RECORD, Vol. 164 (2018): 
Sept. 17, considered and passed Senate. 
Sept. 25, considered and passed House. 
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2018): 
Oct. 10, Presidential remarks. 
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’’. 
Approved October 10, 2018. 
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