No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3290 Introduced in House (IH)]
<DOC>
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).
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by the Yeas and Nays: 16 - 12 .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by the Yeas and Nays: 29 - 22.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-757.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-757.
Placed on the Union Calendar, Calendar No. 628.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line