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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2554 Engrossed in Senate (ES)]

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115th CONGRESS
  2d Session
                                S. 2554

_______________________________________________________________________

                                 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''.

            Passed the Senate September 17, 2018.

            Attest:

                                                             Secretary.
115th CONGRESS

  2d Session

                                S. 2554

_______________________________________________________________________

                                 AN ACT

 To ensure that health insurance issuers and group health plans do not 
   prohibit pharmacy providers from providing certain information to 
                               enrollees.
```