[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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