Title: Drug Discount Accountability Act
Policy area: Health

Summary:
Drug Discount Accountability Act
This bill requires the Health Resources and Services Administration to collect a user fee from certain entities participating in the 340B drug pricing program, including critical access hospitals, for activities relating to program oversight and improvement.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6240 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6240

To amend the Public Health Service Act to provide for certain user fees 
                 under the 340B drug discount program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 27, 2018

    Mr. Collins of New York (for himself and Mr. Carter of Georgia) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide for certain user fees 
                 under 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. SHORT TITLE.

    This Act may be cited as the ``Drug Discount Accountability Act''.

SEC. 2. USER FEES UNDER THE 340B DRUG DISCOUNT PROGRAM.

    Section 340B of the Public Health Service Act (42 U.S.C. 256b) is 
amended by adding at the end the following new subsection:
    ``(f) User Fees.--
            ``(1) In general.--Subject to paragraph (6), the Secretary 
        shall assess and collect a user fee from covered entities 
        described in subparagraph (L), (M), (N), or (O) of subsection 
        (a)(4). In carrying out this subsection, the Secretary shall 
        not require manufacturers to collect any user fee or to 
        administer the user fee program established under this 
        subsection.
            ``(2) Payment.--A covered entity described in subparagraph 
        (L), (M), (N), or (O) of subsection (a)(4) shall pay to the 
        Secretary a fee assessed under paragraph (1) by such date that 
        is the later of--
                    ``(A) the date of the certification or 
                recertification of the covered entity, as applicable; 
                or
                    ``(B) the date that is 30 days after the date of 
                the enactment of an appropriations Act providing for 
                the collection and obligation of fees under this 
                subsection for a fiscal year.
            ``(3) Amount of fee.--The amount of a fee under paragraph 
        (1) shall be equal to the amount determined by the Secretary 
        under paragraph (4).
            ``(4) Determination of amount of fee.--
                    ``(A) In general.--The Secretary shall, not later 
                than 180 days before the start of each fiscal year that 
                begins after September 30, 2019, establish, for the 
                next fiscal year, the amount of the fee payable under 
                this subsection by a covered entity using purchase data 
                submitted by covered entities described in paragraph 
                (1), and using data submitted by manufacturers on sales 
                to covered entities of covered outpatient drugs subject 
                to an agreement under this section, pursuant to 
                regulations to be issued by the Secretary. Such amount, 
                with respect to a covered entity and year, shall not 
                exceed 0.1 percent of the total paid during the 
                previous year by such covered entity to manufacturers 
                for purchases of covered outpatient drugs subject to an 
                agreement under this section.
            ``(5) Use of fees.--
                    ``(A) In general.--Any fee collected under 
                paragraph (1) shall be used for purposes of 
                administering this section, enhancing program integrity 
                and oversight activities under this section (including 
                through audits under this section of covered entities 
                and manufacturers), and promoting access to clinical 
                and cost-effective pharmacy services among safety net 
                clinics and hospitals that participate under this 
                section, such as through--
                            ``(i) the development of a multi-functional 
                        web-based system to collect fees under 
                        paragraph (1);
                            ``(ii) the improvement of the integrity, 
                        transparency, security, and reliability of the 
                        Office of Pharmacy Affairs Information System, 
                        including to ensure that the database continues 
                        to meet the needs of external stakeholders; and
                            ``(iii) improvements to the compliance tool 
                        of the Office of Pharmacy Affairs, used to 
                        integrate all information related to covered 
                        entities and manufacturers with agreements 
                        under this section.
                    ``(B) Supplement not supplant.--Any fee collected 
                under paragraph (1) shall be used to supplement and not 
                supplant the amount otherwise provided in 
                appropriations Acts to carry out this section.
            ``(6) Availability of fees.--Fees authorized under 
        paragraph (1) shall be collected and available for obligation 
        only to the extent and in the amount provided in advance in 
        appropriations Acts. Such fees are authorized to remain 
        available until expended.
            ``(7) Regulations.--Not later than 180 days after the date 
        of enactment of this subsection, the Secretary shall promulgate 
        final regulations through notice-and-comment rulemaking to 
        implement the user fee collection pursuant to this subsection.
            ``(8) Oversight of user fee program.--
                    ``(A) Study.--The Inspector General of the 
                Department of Health and Human Services shall conduct 
                an annual review of the user fee program established by 
                this subsection.
                    ``(B) Report.--Not later than July 1 of each year 
                (beginning with 2019), the Inspector General of the 
                Department of Health and Human Services shall submit to 
                the appropriate committees of Congress a report on the 
                study conducted under subparagraph (A), together with 
                such recommendations as the Inspector General 
                determines appropriate.''.

SEC. 3. DIRECT-HIRE AUTHORITY.

    Section 340B(d) of the Public Health Service Act (42 U.S.C. 
256b(d)) is amended by adding at the end the following new paragraph:
            ``(5) Direct-hire authority.--Notwithstanding section 
        3304(a)(3) of title 5, United States Code, and sections 3309 
        through 3318 of such title, and section 337 of title 5 of the 
        Code of Federal Regulations (or any successor regulations), the 
        Secretary may, beginning on the date of the enactment of this 
        paragraph, exercise direct-hire authority to appoint a minimum 
        of ten qualified candidates to permanent positions within the 
        competitive service in order to carry out management and 
        oversight activities under this section.''.
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