[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:
---------------------------------------------------------------------------

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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