340B Transparency Act

IB 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] VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 •HR 3290 RH A BILL To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6652 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 3 •HR 3290 RH Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘340B Transparency 4 Act’’. 5 SEC. 2. ENSURING TRANSPARENCY AND OVERSIGHT OF 6 THE 340B DRUG DISCOUNT PROGRAM. 7 (a) IN GENERAL.—Section 340B(a)(5) of the Public 8 Health Service Act (42 U.S.C. 256b(a)(5)) is amended— 9 (1) in subparagraph (C)— 10 (A) by striking ‘‘A covered entity shall per- 11 mit’’ and inserting: 12 ‘‘(i) DUPLICATE DISCOUNTS AND DRUG 13 RESALE.—A covered entity shall permit’’; 14 and 15 (B) by adding at the end the following new 16 clauses: 17 ‘‘(ii) USE OF SAVINGS.—A covered en- 18 tity shall permit the Secretary to audit, at 19 the Secretary’s expense, the records of the 20 entity to determine— 21 ‘‘(I) how savings (as defined in 22 subparagraph (E)(iv)) from covered 23 outpatient drugs subject to an agree- 24 ment under this section furnished by 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 •HR 3290 RH such entity are used by such entity; 1 and 2 ‘‘(II) such entity’s compliance 3 with subparagraph (E). 4 ‘‘(iii) RECORDS RETENTION.—Covered 5 entities shall retain such records and pro- 6 vide such records and reports as determined 7 necessary by the Secretary for carrying out 8 this subparagraph.’’; and 9 (2) by adding at the end the following new sub- 10 paragraph: 11 ‘‘(E) REPORTING.— 12 ‘‘(i) IN GENERAL.—During the first 13 year beginning on or after the date that is 14 14 months after the date of enactment of 15 this subparagraph and during each subse- 16 quent year, each covered entity described in 17 subparagraph (L) of paragraph (4) (and 18 any other covered entity specified by the 19 Secretary) shall report to the Secretary (at 20 a time and in a form and manner specified 21 by the Secretary) the following information 22 with respect to the preceding year: 23 ‘‘(I) With respect to such covered 24 entity and each off-campus outpatient 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 5 •HR 3290 RH department, as applicable, of such enti- 1 ty— 2 ‘‘(aa) the total number of in- 3 dividuals who were dispensed or 4 administered covered outpatient 5 drugs during such preceding year 6 that were subject to an agreement 7 under this section; and 8 ‘‘(bb) the number of such in- 9 dividuals described in a category 10 specified in clause (iv), broken 11 down by each such category. 12 ‘‘(II) With respect to such covered 13 entity and each off-campus outpatient 14 department, as applicable, of such enti- 15 ty— 16 ‘‘(aa) the percentage of the 17 total number of individuals fur- 18 nished items and services during 19 such preceding year who were dis- 20 pensed or administered covered 21 outpatient drugs during such pre- 22 ceding year that were subject to 23 an agreement under this section; 24 and 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 6 •HR 3290 RH ‘‘(bb) for each category speci- 1 fied in clause (iii), the percentage 2 of the total number of individuals 3 described in such category fur- 4 nished items and services during 5 such preceding year who were dis- 6 pensed or administered covered 7 outpatient drugs during such pre- 8 ceding year that were subject to 9 an agreement under this section. 10 ‘‘(III) With respect to such cov- 11 ered entity and each off-campus out- 12 patient department, as applicable, of 13 such entity, the total costs incurred 14 during the year at each such site and 15 the cost incurred at each such site for 16 charity care (as defined in line 23 of 17 worksheet S–10 to the Medicare cost re- 18 port, or in any successor form). 19 ‘‘(IV) With respect to such covered 20 entity and each off-campus outpatient 21 department, as applicable, of such enti- 22 ty, the costs incurred during the year 23 of furnishing items and services at 24 each such department to patients of 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 7 •HR 3290 RH such entity who were entitled to bene- 1 fits under part A of title XVIII of the 2 Social Security Act or enrolled under 3 part B of such title, enrolled in a State 4 plan under title XIX of such Act (or a 5 waiver of such plan), or who were un- 6 insured for services, minus the sum 7 of— 8 ‘‘(aa) payments under title 9 XVIII of such Act for such items 10 and services (including any cost 11 sharing for such items and serv- 12 ices); 13 ‘‘(bb) payments under title 14 XIX of such Act for such items 15 and services (including any cost 16 sharing for such items and serv- 17 ices); and 18 ‘‘(cc) payments by uninsured 19 patients for such items and serv- 20 ices. 21 ‘‘(V) With respect to such covered 22 entity and each off-campus outpatient 23 department, as applicable, of such enti- 24 ty, savings (as defined in clause (iv)) 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 8 •HR 3290 RH from covered outpatient drugs subject 1 to an agreement under this section fur- 2 nished by such entity or department. 3 ‘‘(ii) PUBLICATION.—The Secretary 4 shall publish data reported under clause (i) 5 with respect to a year annually on the pub- 6 lic website of the Department of Health and 7 Human Services in an electronic and 8 searchable format, which may include the 9 340B Office of Pharmacy Affairs Informa- 10 tion System (or a successor to such system), 11 in a manner that shows each category of 12 data reported in the aggregate and identi- 13 fied by the specific covered entity submit- 14 ting such data. The Secretary shall include 15 in such publication the disproportionate pa- 16 tient percentage (as defined in section 17 1886(d)(5)(F)(vi) of the Social Security 18 Act) of each such covered entity (if applica- 19 ble) for each cost reporting period occurring 20 during such year. 21 ‘‘(iii) CATEGORIES SPECIFIED.—For 22 purposes of clause (i), the categories speci- 23 fied in this clause are the following: 24 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 9 •HR 3290 RH ‘‘(I) Individuals covered under a 1 group health plan or group or indi- 2 vidual health insurance coverage (as 3 such terms are defined in section 4 2791). 5 ‘‘(II) Individuals entitled to bene- 6 fits under part A or enrolled under 7 part B of title XVIII of the Social Se- 8 curity Act. 9 ‘‘(III) Individuals enrolled under 10 a State plan under title XIX of such 11 Act (or a waiver of such plan). 12 ‘‘(IV) Individuals enrolled under 13 a State child health plan under title 14 XXI of such Act (or a waiver of such 15 plan). 16 ‘‘(V) Individuals not described in 17 any preceding subclause and not cov- 18 ered under any Federal health care 19 program (as defined in section 1128B 20 of such Act but including the program 21 established under chapter 89 of title 5, 22 United States Code). 23 ‘‘(iv) DEFINITIONS.—For purposes of 24 this subparagraph: 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 10 •HR 3290 RH ‘‘(I) OFF-CAMPUS OUTPATIENT 1 DEPARTMENT.—The term ‘off-campus 2 outpatient department’ means a de- 3 partment of a provider (as defined in 4 section 413.65 of title 42, Code of Fed- 5 eral Regulations, or any successor reg- 6 ulation) that is not located— 7 ‘‘(aa) on the campus (as de- 8 fined in such section) of such pro- 9 vider; or 10 ‘‘(bb) within the distance (de- 11 scribed in such definition of cam- 12 pus) from a remote location of a 13 hospital facility (as defined in 14 such section). 15 ‘‘(II) SAVINGS.—The term ‘sav- 16 ings’ means, with respect to a covered 17 outpatient drug purchased by a covered 18 entity, the difference between— 19 ‘‘(aa) the price for such drug 20 that such entity would have other- 21 wise paid for such drug obtained 22 through a group purchasing orga- 23 nization or other group pur- 24 chasing arrangement had the re- 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 11 •HR 3290 RH quirement described in paragraph 1 (4)(L)(iii) not applied (or, in the 2 case such entity would not have 3 obtained covered outpatient drugs 4 through such an organization or 5 arrangement had such require- 6 ment not applied or information 7 to determine such price that such 8 entity would have so otherwise 9 paid is not available, the whole- 10 sale acquisition cost (as defined in 11 section 1847A(c)(6)(B) of the So- 12 cial Security Act) for such drug); 13 and 14 ‘‘(bb) the ceiling price for 15 such drug.’’. 16 (b) ENFORCEMENT.—Section 340B(d)(2)(B) of the 17 Public Health Service Act (42 U.S.C. 256b(d)(2)(B)) is 18 amended by adding at the end the following new clause: 19 ‘‘(vi) The imposition of civil monetary 20 penalties in amounts determined appro- 21 priate by the Secretary in the case that the 22 Secretary determines that a covered entity 23 is not in compliance with subsection 24 (a)(5)(E) .’’. 25 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB 12 •HR 3290 RH (c) RULEMAKING.—Not later than 180 days after the 1 date of the enactment of this Act, the Secretary of Health 2 and Human Services shall issue an interim final rule to 3 carry out section 340B(a)(5)(E) of the Public Health Serv- 4 ice Act, as added by subsection (a)(2). 5 VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB Union Calendar No. 628 118TH CONGRESS 2D SESSION H. R. 3290 [Report No. 118–757] A BILL To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program. NOVEMBER 20, 2024 Reported with an amendment, committed to the Com- mittee of the Whole House on the State of the Union, and ordered to be printed VerDate Sep 11 2014 23:51 Nov 20, 2024 Jkt 059200 PO 00000 Frm 00014 Fmt 6651 Sfmt 6651 E:\BILLS\H3290.RH H3290 kjohnson on DSK7ZCZBW3PROD with $$_JOB