[115th Congress Public Law 263]
[From the U.S. Government Publishing Office]
PATIENT RIGHT TO KNOW DRUG PRICES ACT
[[Page 132 STAT. 3672]]
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. <<NOTE: Oct. 10, 2018 - [S. 2554]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Patient Right to
Know Drug Prices Act.>>
SECTION 1. <<NOTE: 42 USC 201 note.>> 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. <<NOTE: 42 USC 300gg-19b.>> 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 <<NOTE: Determination.>> .--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.''.
[[Page 132 STAT. 3673]]
SEC. 3. <<NOTE: 21 USC 355.>> 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) <<NOTE: Definitions.>> 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. <<NOTE: Definitions.>> --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
[[Page 132 STAT. 3674]]
(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) <<NOTE: Time periods.>> 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
[[Page 132 STAT. 3675]]
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.
LEGISLATIVE HISTORY--S. 2554:
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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.
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