SEC. 2. MORATORIUM ON REGISTRATION OF CERTAIN NEW 
340B HOSPITALS AND ASSOCIATED SITES. 
Section 340B(a) of the Public Health Service Act (42 
U.S.C. 256b(a)) is amended— 
(1) in paragraph (4)(L), by striking ‘‘A sub-
section (d) hospital’’ and inserting ‘‘Subject to para-
graph (11), a subsection (d) hospital’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(11) MORATORIUM ON REGISTRATION OF CER-
TAIN HOSPITALS AND ASSOCIATED SITES OF SUCH 
HOSPITALS.—During the period beginning on the 
date of the enactment of this paragraph, and ending 
on the date that is 2 years after such date of enact-
ment— 
‘‘(A) an entity described in paragraph 
(4)(L) shall not be considered a covered entity 
under this section unless such entity had been 
identified as a covered entity under the system 
established under subsection (d)(2)(B)(iv) as of 
the day before the date of the enactment of this 
paragraph; and 
‘‘(B) in the case of an entity described in 
paragraph (4)(L) that is identified as a covered 
entity under such system, an off-site outpatient 
facility, clinic, eligible off-site location, or asso-
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ciated site of such entity (in this paragraph and 
subsection (f) referred to as a potential ‘child 
site’ of such entity) may not be identified under 
such system as a child site of the covered entity 
for purposes of this section unless such child 
site was so identified under such system, with 
respect to such covered entity, as of the day be-
fore the date of the enactment of this para-
graph.’’. 
SEC. 3. DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW 340B HOSPITAL 
COVERED ENTITIES PROVIDE CARE FOR PA-
TIENTS. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW HOSPITAL COVERED ENTI-
TIES PROVIDE CARE FOR PATIENTS.— 
‘‘(1) IN GENERAL.—Beginning on the date that 
is 14 months after the date of the enactment of this 
subsection, and annually thereafter, subject to sub-
paragraph (C), a covered entity described in sub-
paragraph (L) or (M) of subsection (a)(4), unless 
otherwise indicated, shall report on the following, 
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with respect to the previous year, in such a manner 
and form as specified by the Secretary: 
‘‘(A) The following information: 
‘‘(i) With respect to such covered enti-
ty and with respect to each child site of 
such entity (as referenced in paragraph 
(11)), the number and percentage of indi-
viduals who are dispensed or administered 
drugs that are subject to an agreement 
under this section, organized by form of 
health insurance coverage of such individ-
uals (including at least by the Medicare 
program under title XVIII of the Social 
Security Act, the Medicaid program under 
title XIX of such Act, health insurance 
coverage offered in the individual or group 
market or a group health plan (as such 
terms are defined in section 2791), and 
uninsured). 
‘‘(ii) With respect to each such child 
site of such entity, the total costs incurred 
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 Medi-
care cost report or in any successor form. 
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‘‘(B) The aggregate amount of gross reim-
bursement received by each such covered entity 
(including child sites of such entity) described 
in such subparagraph (L) or (M) for all drugs 
purchased that are subject to an agreement 
under this section and the entity’s aggregate 
acquisition cost for such drugs. 
‘‘(C) In the case of covered entity de-
scribed in subparagraph (L) of subsection 
(a)(4), at the time of application and recertifi-
cation (and at least annually thereafter), the 
contract that is the basis for eligibility under 
the requirement under clause (i) of such sub-
paragraph and any modifications to such con-
tract for purposes of review by the Secretary. 
‘‘(D) With respect to such covered entity 
and with respect to each child site of such enti-
ty, the name of all third-party vendors or other 
similar entities that the covered entity contracts 
with to provide services associated with the pro-
gram under this section. 
‘‘(2) AVAILABILITY OF INFORMATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
make data reported by covered entities under 
subparagraphs (A), (C), and (D) of paragraph 
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(1) available on the public website of the De-
partment of Health and Human Services in an 
electronic and searchable format, which may in-
clude the 340B Office of Pharmacy Affairs In-
formation System or a successor to such sys-
tem: 
‘‘(B) 
FORMAT.—Data 
made 
available 
under subparagraph (A) shall be made available 
in a manner that shows each category of data 
reported both in the aggregate and identified by 
covered entities described in subparagraphs (L) 
and (M) of subsection (a)(4) and child sites of 
such covered entities. In carrying out this para-
graph, with respect to data reported pursuant 
to paragraph (1)(C), the Secretary shall ensure 
that any proprietary information shall be re-
dacted from contracts submitted pursuant to 
such paragraph (1)(C) before posting such 
data. 
‘‘(3) INTERIM FINAL REGULATIONS.—The Sec-
retary shall issue interim final regulations no later 
than the date that is 6 months after the date of the 
enactment of this subsection, to carry out this sub-
section and shall finalize such regulations prior to 
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the end of the moratorium period to which sub-
section (a)(11) applies. 
‘‘(4) REPORTS TO CONGRESS.— 
‘‘(A) OIG REPORT.—Not later than 2 
years after the date of the enactment of this 
subsection, the Office of the Inspector General 
shall submit to Congress a final report on the 
level of charity care provided by covered entities 
described in subparagraphs (L) and (M) of sub-
section (a)(4) and separately by child sites of 
such covered entities, as reported in paragraph 
(1)(A). 
‘‘(B) GAO REPORTS.— 
‘‘(i) INITIAL REPORT.—Not later than 
1 year after the date of the enactment of 
this subsection, the Comptroller General of 
the United States shall submit to Congress 
a report— 
‘‘(I) analyzing the State and local 
government contracts intended to sat-
isfy the requirement under subsection 
(a)(4)(L)(i) for a covered entity to 
qualify as an entity described in sub-
paragraph (L) of subsection (a)(4); 
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‘‘(II) assessing the amount of 
care such contracts obligate such enti-
ty to provide to low-income individuals 
ineligible for Medicare under title 
XVIII of the Social Security Act and 
Medicaid under title XIX of such Act; 
and 
‘‘(III) analyzing how these con-
tracts define low-income individuals 
and whether the Secretary reviews 
such determinations. 
‘‘(ii) 
SUBSEQUENT
REPORT.—Not 
later than 2 years after the date of the en-
actment of this subsection, the Comptroller 
General of the United States shall submit 
to Congress a final report on the informa-
tion collected under paragraph (1)(B) re-
garding the difference between the aggre-
gate gross reimbursement and aggregate 
acquisition costs received by each such cov-
ered entity (including child sites of such 
entity) for drugs subject to an agreement 
under this section.’’. 
Æ 
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