    [United States Statutes at Large, Volume 132, 115th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    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 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 `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 3673]]

    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

    [[Page 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) <>  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 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:
    ---------------------------------------------------------------------------

    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.