I 
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 Representa-
tives 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 per-
mit’’ and inserting: 
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‘‘(i) 
DUPLICATE
DISCOUNTS
AND 
DRUG RESALE.—A covered entity shall per-
mit’’; and 
(B) by adding at the end the following new 
clauses: 
‘‘(ii) USE OF SAVINGS.—A covered en-
tity 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 sub-
ject 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 pro-
vide such records and reports as deter-
mined necessary by the Secretary for car-
rying out this subparagraph.’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(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 subse-
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quent 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 sec-
tion; and 
‘‘(bb) the number of such in-
dividuals described in a category 
specified in clause (iv), broken 
down by each such category. 
‘‘(II) With respect to such cov-
ered entity and each off-campus out-
patient department of such entity— 
‘‘(aa) the percentage of the 
total number of individuals fur-
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nished 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 per-
centage of the total number of 
individuals described in such cat-
egory furnished items and serv-
ices during such preceding year 
who were dispensed or adminis-
tered drugs during such pre-
ceding year that were subject to 
an agreement under this section. 
‘‘(III) With respect to such cov-
ered entity and each off-campus out-
patient 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). 
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‘‘(IV) With respect to such cov-
ered entity and each off-campus out-
patient department of such entity, the 
costs incurred during the year of fur-
nishing 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 So-
cial 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 serv-
ices); 
‘‘(bb) payments under title 
XIX of such Act for such items 
and services (including any cost 
sharing for such items and serv-
ices); and 
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‘‘(cc) payments by uninsured 
patients for such items and serv-
ices. 
‘‘(V) With respect to such cov-
ered entity and each off-campus out-
patient 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 De-
partment 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 man-
ner that shows each category of data re-
ported 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 
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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 de-
partment 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 de-
fined 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 ‘sav-
ings’ means, with respect to a drug 
purchased by a covered entity, the dif-
ference between— 
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‘‘(aa) the price for such 
drug that such entity would have 
otherwise paid for such drug ob-
tained through a group pur-
chasing 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 out-
patient drugs through such an 
organization or arrangement had 
such requirement not applied, the 
wholesale acquisition cost (as de-
fined 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). 
Æ 
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