I 

115TH CONGRESS 

1ST SESSION H. R. 4710 

To amend the Public Health Service Act to establish a moratorium on 

the registration of certain new 340B hospitals and associated sites, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 21, 2017 

Mr. BUCSHON (for himself and Mr. PETERS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to establish a moratorium on the registration of certain new 340B hospitals 

and associated sites, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘340B Protecting Ac5 cess for the Underserved and Safety-net Entities Act’’ or 

6 the ‘‘340B PAUSE Act’’. 


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1 SEC. 2. MORATORIUM ON REGISTRATION OF CERTAIN NEW 

2 340B HOSPITALS AND ASSOCIATED SITES. 

3 Section 340B(a) of the Public Health Service Act (42 

4 U.S.C. 256b(a)) is amended— 

5 (1) in paragraph (4)(L), by striking ‘‘A sub6 section (d) hospital’’ and inserting ‘‘Subject to para7 graph (11), a subsection (d) hospital’’; and 

8 (2) by adding at the end the following new 

9 paragraph: 

10 ‘‘(11) MORATORIUM ON REGISTRATION OF CER11 TAIN HOSPITALS AND ASSOCIATED SITES OF SUCH

12 HOSPITALS.—During the period beginning on the 

13 date of the enactment of this paragraph, and ending 

14 on the date that is 2 years after such date of enact15 ment— 

16 ‘‘(A) an entity described in paragraph 

17 (4)(L) shall not be considered a covered entity 

18 under this section unless such entity had been 

19 identified as a covered entity under the system 

20 established under subsection (d)(2)(B)(iv) as of 

21 the day before the date of the enactment of this 

22 paragraph; and 

23 ‘‘(B) in the case of an entity described in 

24 paragraph (4)(L) that is identified as a covered 

25 entity under such system, an off-site outpatient 

26 facility, clinic, eligible off-site location, or assoVerDate Sep 11 2014 01:22 Dec 23, 2017 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4710.IH H4710

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1 ciated site of such entity (in this paragraph and 

2 subsection (f) referred to as a potential ‘child 

3 site’ of such entity) may not be identified under 

4 such system as a child site of the covered entity 

5 for purposes of this section unless such child 

6 site was so identified under such system, with 

7 respect to such covered entity, as of the day be8 fore the date of the enactment of this para9 graph.’’. 

10 SEC. 3. DATA REPORTING TO IMPROVE THE TRANS11 PARENCY REGARDING HOW 340B HOSPITAL 

12 COVERED ENTITIES PROVIDE CARE FOR PA13 TIENTS. 

14 Section 340B of the Public Health Service Act (42 

15 U.S.C. 256b) is amended by adding at the end the fol16 lowing new subsection: 

17 ‘‘(f) DATA REPORTING TO IMPROVE THE TRANS18 PARENCY REGARDING HOW HOSPITAL COVERED ENTI19 TIES PROVIDE CARE FOR PATIENTS.— 

20 ‘‘(1) IN GENERAL.—Beginning on the date that 

21 is 14 months after the date of the enactment of this 

22 subsection, and annually thereafter, subject to sub23 paragraph (C), a covered entity described in sub24 paragraph (L) or (M) of subsection (a)(4), unless 

25 otherwise indicated, shall report on the following, 


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1 with respect to the previous year, in such a manner 

2 and form as specified by the Secretary: 

3 ‘‘(A) The following information: 

4 ‘‘(i) With respect to such covered enti5 ty and with respect to each child site of 

6 such entity (as referenced in paragraph 

7 (11)), the number and percentage of indi8 viduals who are dispensed or administered 

9 drugs that are subject to an agreement 

10 under this section, organized by form of 

11 health insurance coverage of such individ12 uals (including at least by the Medicare 

13 program under title XVIII of the Social 

14 Security Act, the Medicaid program under 

15 title XIX of such Act, health insurance 

16 coverage offered in the individual or group 

17 market or a group health plan (as such 

18 terms are defined in section 2791), and 

19 uninsured). 

20 ‘‘(ii) With respect to each such child 

21 site of such entity, the total costs incurred 

22 at each such site and the cost incurred at 

23 each such site for charity care as defined 

24 in line 23 of worksheet S–10 to the Medi25 care cost report or in any successor form. 


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1 ‘‘(B) The aggregate amount of gross reim2 bursement received by each such covered entity 

3 (including child sites of such entity) described 

4 in such subparagraph (L) or (M) for all drugs 

5 purchased that are subject to an agreement 

6 under this section and the entity’s aggregate 

7 acquisition cost for such drugs. 

8 ‘‘(C) In the case of covered entity de9 scribed in subparagraph (L) of subsection 

10 (a)(4), at the time of application and recertifi11 cation (and at least annually thereafter), the 

12 contract that is the basis for eligibility under 

13 the requirement under clause (i) of such sub14 paragraph and any modifications to such con15 tract for purposes of review by the Secretary. 

16 ‘‘(D) With respect to such covered entity 

17 and with respect to each child site of such enti18 ty, the name of all third-party vendors or other 

19 similar entities that the covered entity contracts 

20 with to provide services associated with the pro21 gram under this section. 

22 ‘‘(2) AVAILABILITY OF INFORMATION.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall 

24 make data reported by covered entities under 

25 subparagraphs (A), (C), and (D) of paragraph 


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1 (1) available on the public website of the De2 partment of Health and Human Services in an 

3 electronic and searchable format, which may in4 clude the 340B Office of Pharmacy Affairs In5 formation System or a successor to such sys6 tem: 

7 ‘‘(B) FORMAT.—Data made available 

8 under subparagraph (A) shall be made available 

9 in a manner that shows each category of data 

10 reported both in the aggregate and identified by 

11 covered entities described in subparagraphs (L) 

12 and (M) of subsection (a)(4) and child sites of 

13 such covered entities. In carrying out this para14 graph, with respect to data reported pursuant 

15 to paragraph (1)(C), the Secretary shall ensure 

16 that any proprietary information shall be re17 dacted from contracts submitted pursuant to 

18 such paragraph (1)(C) before posting such 

19 data. 

20 ‘‘(3) INTERIM FINAL REGULATIONS.—The Sec21 retary shall issue interim final regulations no later 

22 than the date that is 6 months after the date of the 

23 enactment of this subsection, to carry out this sub24 section and shall finalize such regulations prior to 


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1 the end of the moratorium period to which sub2 section (a)(11) applies. 

3 ‘‘(4) REPORTS TO CONGRESS.— 

4 ‘‘(A) OIG REPORT.—Not later than 2 

5 years after the date of the enactment of this 

6 subsection, the Office of the Inspector General 

7 shall submit to Congress a final report on the 

8 level of charity care provided by covered entities 

9 described in subparagraphs (L) and (M) of sub10 section (a)(4) and separately by child sites of 

11 such covered entities, as reported in paragraph 

12 (1)(A). 

13 ‘‘(B) GAO REPORTS.— 

14 ‘‘(i) INITIAL REPORT.—Not later than 

15 1 year after the date of the enactment of 

16 this subsection, the Comptroller General of 

17 the United States shall submit to Congress 

18 a report— 

19 ‘‘(I) analyzing the State and local 

20 government contracts intended to sat21 isfy the requirement under subsection 

22 (a)(4)(L)(i) for a covered entity to 

23 qualify as an entity described in sub24 paragraph (L) of subsection (a)(4); 


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1 ‘‘(II) assessing the amount of 

2 care such contracts obligate such enti3 ty to provide to low-income individuals 

4 ineligible for Medicare under title 

5 XVIII of the Social Security Act and 

6 Medicaid under title XIX of such Act; 

7 and 

8 ‘‘(III) analyzing how these con9 tracts define low-income individuals 

10 and whether the Secretary reviews 

11 such determinations. 

12 ‘‘(ii) SUBSEQUENT REPORT.—Not 

13 later than 2 years after the date of the en14 actment of this subsection, the Comptroller 

15 General of the United States shall submit 

16 to Congress a final report on the informa17 tion collected under paragraph (1)(B) re18 garding the difference between the aggre19 gate gross reimbursement and aggregate 

20 acquisition costs received by each such cov21 ered entity (including child sites of such 

22 entity) for drugs subject to an agreement 

23 under this section.’’. 

Æ 


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