I 
119TH CONGRESS 
1ST SESSION H. R. 5256 
To amend the Public Health Service Act to reform the 340B drug pricing 
program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 10, 2025 
Mr. CARTER of Georgia (for himself and Mrs. HARSHBARGER) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend the Public Health Service Act to reform the 340B 
drug pricing program, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘340B Affording Care for Communities and Ensuring a 
Strong Safety-net Act’’ or the ‘‘340B ACCESS Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
VerDate Sep 11 2014 
04:32 Sep 17, 2025
Jkt 059200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5256.IH
H5256
kjohnson on DSK7ZCZBW3PROD with $$_JOB
Sec. 1. Short title; table of contents. 
Sec. 2. Definitions. 
Sec. 3. Prevention of Medicaid duplicate discounts; oversight of covered entities. 
Sec. 4. Hospital child site requirements. 
Sec. 5. Contract pharmacies. 
Sec. 6. Ensuring patient affordability of drugs purchased under section 340B. 
Sec. 7. Requirements for nonhospital covered entities and subgrantees. 
Sec. 8. Claims modifiers; covered entity data submission. 
Sec. 9. Covered entity reporting on scope of grant, contract, and project. 
Sec. 10. Ensuring covered entity transparency. 
Sec. 11. Revisions to existing 340B hospital eligibility requirements. 
Sec. 12. Additional requirements for 340B hospitals. 
Sec. 13. 340B program. 
Sec. 14. Audits of private nonhospital contracts with State and local govern-
ments. 
Sec. 15. Ensuring covered entity compliance with transparency requirements. 
Sec. 16. 340B claims data clearinghouse. 
Sec. 17. Limitation on administrator service fees and contract pharmacy fees. 
Sec. 18. Clarification. 
Sec. 19. Ensuring the equitable treatment of 340B covered entities and phar-
macies participating in the 340B drug discount program. 
Sec. 20. Effective date. 
SEC. 2. DEFINITIONS. 
(a) DEFINITION OF PATIENT.—Section 340B(b) of 
the Public Health Service Act (42 U.S.C. 256b(b)) is 
amended by adding at the end the following: 
‘‘(3) PATIENT.— 
‘‘(A) IN
GENERAL.—In this section, the 
term ‘patient’ means, with respect to a covered 
entity described in subsection (a)(4), an indi-
vidual who, on a prescription-by-prescription or 
order-by-order basis— 
‘‘(i) is dispensed or administered a 
covered outpatient drug that is— 
‘‘(I) directly related to the service 
described in clause (iii); 
VerDate Sep 11 2014 
04:32 Sep 17, 2025
Jkt 059200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5256.IH
H5256
kjohnson on DSK7ZCZBW3PROD with $$_JOB
‘‘(II) ordered or prescribed by a 
covered entity provider described in 
clause (ii) as a result of the service 
described in clause (iii); and 
‘‘(III) dispensed or administered 
on site at a covered entity location, a 
child site (as defined in subsection 
(a)(5)(E)), or an entity pharmacy (as 
defined in subsection (a)(5)(F)) listed 
in the identification system described 
in subsection (d)(2)(B)(iv), or on site 
at a contract pharmacy in accordance 
with subsection (a)(5)(F) or dispensed 
through a mail order pharmacy in ac-
cordance with subsection (a)(5)(F); 
‘‘(ii) receives the health care service 
described in clause (iii) from a ‘covered en-
tity provider’, meaning a health care pro-
fessional who either— 
‘‘(I) is an employee or inde-
pendent contractor of the covered en-
tity, such that the covered entity bills 
for services furnished by the health 
care professional and is responsible 
VerDate Sep 11 2014 
04:32 Sep 17, 2025
Jkt 059200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5256.IH
H5256
kjohnson on DSK7ZCZBW3PROD with $$_JOB