To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program.

Subjects: Health, Accounting and auditing, Government information and archives, Health care costs and insurance, Prescription drugs


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3290 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 3290

     To amend title III of the Public Health Service Act to ensure 
     transparency and oversight of the 340B drug discount program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2023

 Mr. Bucshon introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
     To amend title III of the Public Health Service Act to ensure 
     transparency and oversight of the 340B drug discount program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. ENSURING TRANSPARENCY AND OVERSIGHT OF THE 340B DRUG 
              DISCOUNT PROGRAM.

    (a) In General.--Section 340B(a)(5) of the Public Health Service 
Act (42 U.S.C. 256b(a)(5)) is amended--
            (1) in subparagraph (C)--
                    (A) by striking ``A covered entity shall permit'' 
                and inserting:
                            ``(i) Duplicate discounts and drug 
                        resale.--A covered entity shall permit''; and
                    (B) by adding at the end the following new clauses:
                            ``(ii) Use of savings.--A covered entity 
                        shall permit the Secretary to audit, at the 
                        Secretary's expense, the records of the entity 
                        to determine how savings (as defined in 
                        subparagraph (E)(iii)) from drugs subject to an 
                        agreement under this section furnished by such 
                        entity is used by such entity.
                            ``(iii) Records retention.--Covered 
                        entities shall retain such records and provide 
                        such records and reports as determined 
                        necessary by the Secretary for carrying out 
                        this subparagraph.''; and
            (2) by adding at the end the following new subparagraph:
                    ``(E) Reporting.--
                            ``(i) In general.--During the first year 
                        beginning on or after the date that is 14 
                        months after the date of enactment of this 
                        subparagraph and during each subsequent year, 
                        each covered entity described in subparagraph 
                        (L) of paragraph (4) (and any other covered 
                        entity specified by the Secretary) shall report 
                        to the Secretary (at a time and in a form and 
                        manner specified by the Secretary) the 
                        following information with respect to the 
                        preceding year:
                                    ``(I) With respect to such covered 
                                entity and each off-campus outpatient 
                                department of such entity--
                                            ``(aa) the total number of 
                                        individuals who were dispensed 
                                        or administered drugs during 
                                        such preceding year that were 
                                        subject to an agreement under 
                                        this section; and
                                            ``(bb) the number of such 
                                        individuals described in a 
                                        category specified in clause 
                                        (iv), broken down by each such 
                                        category.
                                    ``(II) With respect to such covered 
                                entity and each off-campus outpatient 
                                department of such entity--
                                            ``(aa) the percentage of 
                                        the total number of individuals 
                                        furnished items and services 
                                        during such preceding year who 
                                        were dispensed or administered 
                                        drugs during such preceding 
                                        year that were subject to an 
                                        agreement under this section; 
                                        and
                                            ``(bb) for each category 
                                        specified in clause (iv), the 
                                        percentage of the total number 
                                        of individuals described in 
                                        such category furnished items 
                                        and services during such 
                                        preceding year who were 
                                        dispensed or administered drugs 
                                        during such preceding year that 
                                        were subject to an agreement 
                                        under this section.
                                    ``(III) With respect to such 
                                covered entity and each off-campus 
                                outpatient department of such entity, 
                                the total costs incurred during the 
                                year at each such site and the cost 
                                incurred at each such site for charity 
                                care (as defined in line 23 of 
                                worksheet S-10 to the Medicare cost 
                                report, or in any successor form).
                                    ``(IV) With respect to such covered 
                                entity and each off-campus outpatient 
                                department of such entity, the costs 
                                incurred during the year of furnishing 
                                items and services at each such 
                                department to patients of such entity 
                                who were entitled to benefits under 
                                part A of title XVIII of the Social 
                                Security Act or enrolled under part B 
                                of such title, enrolled in a State plan 
                                under title XIX of such Act (or a 
                                waiver of such plan), or who were 
                                uninsured for services, minus the sum 
                                of--
                                            ``(aa) payments under title 
                                        XVIII such Act for such items 
                                        and services (including any 
                                        cost sharing for such items and 
                                        services);
                                            ``(bb) payments under title 
                                        XIX of such Act for such items 
                                        and services (including any 
                                        cost sharing for such items and 
                                        services); and
                                            ``(cc) payments by 
                                        uninsured patients for such 
                                        items and services.
                                    ``(V) With respect to such covered 
                                entity and each off-campus outpatient 
                                department of such entity, savings (as 
                                defined in clause (v)) from drugs 
                                subject to an agreement under this 
                                section furnished by such entity or 
                                department.
                            ``(ii) Publication.--The Secretary shall 
                        publish data reported under clause (i) annually 
                        on the public website of the Department of 
                        Health and Human Services in an electronic and 
                        searchable format, which may include the 340B 
                        Office of Pharmacy Affairs Information System 
                        (or a successor to such system), and in a 
                        manner that shows each category of data 
                        reported in the aggregate and identified by the 
                        specific covered entity submitting such data.
                            ``(iii) Audit of records.--A covered entity 
                        shall permit the Secretary to audit, at the 
                        Secretary's expense, the records of the entity 
                        that directly pertain to the entity's 
                        compliance with the requirement of clause (i).
                            ``(iv) Categories specified.--For purposes 
                        of clause (i), the categories specified in this 
                        clause are the following:
                                    ``(I) Individuals covered under a 
                                group health plan or group or 
                                individual health insurance coverage 
                                (as such terms are defined in section 
                                2791).
                                    ``(II) Individuals who are entitled 
                                to benefits under part A or enrolled 
                                under part B of title XVIII of the 
                                Social Security Act.
                                    ``(III) Individuals who enrolled 
                                under a State plan under title XIX of 
                                such Act (or a waiver of such plan).
                                    ``(IV) Individuals who were 
                                enrolled under a State child health 
                                plan under title XXI of such Act (or a 
                                waiver of such plan).
                                    ``(V) Individuals not described in 
                                any preceding subclause and not covered 
                                under any Federal health care program 
                                (as defined in section 1128B of such 
                                Act but including the program 
                                established under chapter 89 of title 
                                5, United States Code).
                            ``(v) Definitions.--For purposes of this 
                        subparagraph:
                                    ``(I) Off-campus outpatient 
                                department.--The term `off-campus 
                                outpatient department' means a 
                                department of a provider (as defined in 
                                section 413.65 of title 42, Code of 
                                Federal Regulations, or any successor 
                                regulation) that is not located--
                                            ``(aa) on the campus (as 
                                        defined in such section) of 
                                        such provider; or
                                            ``(bb) within the distance 
                                        (described in such definition 
                                        of campus) from a remote 
                                        location of a hospital facility 
                                        (as defined in such section).
                                    ``(II) Savings.--The term `savings' 
                                means, with respect to a drug purchased 
                                by a covered entity, the difference 
                                between--
                                            ``(aa) the price for such 
                                        drug that such entity would 
                                        have otherwise paid for such 
                                        drug obtained through a group 
                                        purchasing organization or 
                                        other group purchasing 
                                        arrangement had the requirement 
                                        described in paragraph 
                                        (4)(L)(iii) not applied (or, in 
                                        the case such entity would not 
                                        have obtained covered 
                                        outpatient drugs through such 
                                        an organization or arrangement 
                                        had such requirement not 
                                        applied, the wholesale 
                                        acquisition cost (as defined in 
                                        section 1847A(c)(6)(B) of the 
                                        Social Security Act) for such 
                                        drug); and
                                            ``(bb) the ceiling price 
                                        for such drug.''.
    (b) Rulemaking.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue an interim final rule to carry out section 340B(a)(5)(E) of the 
Public Health Service Act, as added by subsection (a)(3).
                                 &lt;all&gt;
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