[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2554 Enrolled Bill (ENR)]

        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 `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.''.
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
                        (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 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.