[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3290 Reported in House (RH)]
<DOC>
Union Calendar No. 628
118th CONGRESS
2d Session
H. R. 3290
[Report No. 118-757]
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
November 20, 2024
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on May 15,
2023]
_______________________________________________________________________
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. SHORT TITLE.
This Act may be cited as the ``340B Transparency Act''.
SEC. 2. 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--
``(I) how savings (as defined in
subparagraph (E)(iv)) from covered
outpatient drugs subject to an
agreement under this section furnished
by such entity are used by such entity;
and
``(II) such entity's compliance
with subparagraph (E).
``(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, as applicable, of such
entity--
``(aa) the total number of
individuals who were dispensed
or administered covered
outpatient 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, as applicable, 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
covered outpatient drugs during
such preceding year that were
subject to an agreement under
this section; and
``(bb) for each category
specified in clause (iii), 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
covered outpatient 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, as applicable,
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, as applicable, 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 of 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, as applicable, of such
entity, savings (as defined in clause
(iv)) from covered outpatient 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) with
respect to a year 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), in a manner that
shows each category of data reported in the
aggregate and identified by the specific
covered entity submitting such data. The
Secretary shall include in such publication the
disproportionate patient percentage (as defined
in section 1886(d)(5)(F)(vi) of the Social
Security Act) of each such covered entity (if
applicable) for each cost reporting period
occurring during such year.
``(iii) 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 entitled to
benefits under part A or enrolled under
part B of title XVIII of the Social
Security Act.
``(III) Individuals enrolled under
a State plan under title XIX of such
Act (or a waiver of such plan).
``(IV) Individuals 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).
``(iv) 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 covered
outpatient 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 or information to
determine such price that such
entity would have so otherwise
paid is not available, 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) Enforcement.--Section 340B(d)(2)(B) of the Public Health
Service Act (42 U.S.C. 256b(d)(2)(B)) is amended by adding at the end
the following new clause:
``(vi) The imposition of civil monetary
penalties in amounts determined appropriate by
the Secretary in the case that the Secretary
determines that a covered entity is not in
compliance with subsection (a)(5)(E) .''.
(c) 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)(2).
Union Calendar No. 628
118th CONGRESS
2d Session
H. R. 3290
[Report No. 118-757]
_______________________________________________________________________
A BILL
To amend title III of the Public Health Service Act to ensure
transparency and oversight of the 340B drug discount program.
_______________________________________________________________________
November 20, 2024
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed