I 
119TH CONGRESS 
1ST SESSION H. R. 4470 
To amend title XI of the Social Security Act to require hospitals participating 
in the Medicare and Medicaid programs to establish certain notification 
procedures with respect to organ procurement agencies. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 16, 2025 
Ms. VAN DUYNE (for herself, Ms. DELBENE, Mrs. MILLER of West Virginia, 
and Mr. COSTA) introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committee on En-
ergy and Commerce, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To amend title XI of the Social Security Act to require 
hospitals participating in the Medicare and Medicaid pro-
grams to establish certain notification procedures with 
respect to organ procurement agencies. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Removing Burdens 
From Organ Donation Act’’. 
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SEC. 2. NOTIFYING ORGAN PROCUREMENT AGENCIES WITH 
RESPECT TO POTENTIAL ORGAN DONORS. 
(a) IN GENERAL.—Section 1138(a) of the Social Se-
curity Act (42 U.S.C. 1320b–8(a)) is amended— 
(1) in paragraph (1)(A)(iii)— 
(A) by adding ‘‘and’’ at the end; 
(B) by striking ‘‘that such’’ and inserting 
‘‘that— 
‘‘(I) such’’; and 
(C) by adding at the end the following new 
subclause: 
‘‘(II) subject to paragraph (4), 
beginning on the date that is 2 years 
after the date of the enactment of the 
Removing Burdens From Organ Do-
nation Act, with respect to such a po-
tential organ donor, such hospital’s 
designated organ procurement agency 
is issued an automated electronic noti-
fication and is provided electronic and 
remote access to the electronic health 
records of such potential organ donor 
when such electronic health records 
are updated to indicate that such po-
tential organ donor is deceased or 
that the death of such potential organ 
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donor is imminent, as determined in 
accordance with the protocol described 
in section 482.45(a)(1) of title 42, 
Code of Federal Regulations (or any 
successor regulation);’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(4) EXEMPTIONS FROM AUTOMATED EHR AC-
CESS REQUIREMENT.— 
‘‘(A) EXEMPTIONS.— 
‘‘(i) IN
GENERAL.—The Secretary 
may exempt a hospital or critical access 
hospital from the automated electronic no-
tification and remote access requirement 
under paragraph (1)(A)(iii)(II) for a pe-
riod of 3 years if the Secretary determines 
that meeting such requirement would re-
sult in a significant hardship, such as in 
the case of a hospital or critical access hos-
pital located in a rural area without suffi-
cient Internet access, or other exceptional 
circumstances demonstrated by the hos-
pital. 
‘‘(ii) AUTOMATIC
EXEMPTION.—The 
Secretary shall grant an exemption de-
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scribed in clause (i) to a hospital or critical 
access hospital for a period of 1 year if the 
Secretary determines that such hospital is 
affected by a cybersecurity attack (as de-
fined in subparagraph (C)), or is located in 
an area affected by a major disaster (as 
defined in section 5122(2) of title 42, 
United States Code) or any other natural 
or man-made disaster, and shall notify 
such hospital or critical access hospital of 
such exemption. 
‘‘(iii) 
EXTENSION.—The 
Secretary 
may extend an exemption granted under 
clause (i) or (ii) if the hospital or critical 
access hospital demonstrates to the satis-
faction of the Secretary that such an ex-
tension is necessary. 
‘‘(B) REPORT.—Not later than 2 years 
after the date of the enactment of the Remov-
ing Burdens From Organ Donation Act, and 
not less frequently than annually thereafter, the 
Secretary shall submit to the Committee on 
Ways and Means and the Committee on Energy 
and Commerce of the House of Representatives, 
and to the Committee on Finance and the Com-
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mittee on Health, Education, Labor, and Pen-
sions of the Senate, a report on the number of 
exemptions granted under subparagraph (A) 
during the previous year and the reason for 
granting each such exemption. 
‘‘(C) CYBERSECURITY ATTACK DEFINED.— 
For purposes of subparagraph (A), the term 
‘cybersecurity attack’ means, with respect to a 
hospital or a critical access hospital, any kind 
of malicious activity that— 
‘‘(i) attempts to collect, modify, dis-
rupt, deny, degrade, or destroy information 
system resources of the hospital, including 
the information itself; 
‘‘(ii) affects the confidentiality, integ-
rity or availability of data, information, or 
operational technology system resources of 
the hospital; or 
‘‘(iii) poses any other threat to the in-
formation, 
information 
systems, 
tech-
nology, or technological capabilities of the 
hospital, as determined by the Secretary.’’. 
(b) GUIDANCE ON BEST PRACTICES.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary 
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of Health and Human Services shall issue guidance 
to hospitals, critical access hospitals, organ procure-
ment agencies, and electronic health record compa-
nies regarding best practices for complying with the 
automated electronic notification and remote access 
requirement 
under 
subclause 
(II) 
of 
section 
1138(a)(1)(A)(iii) of the Social Security Act (42 
U.S.C. 1320b–8(a)(1)(A)(iii)), as added by sub-
section (a). Such guidance shall be based upon the 
experiences of entities that have previous experience 
with the implementation of similar automated elec-
tronic notifications and remote access, and shall pro-
vide insights on what worked well and what did not. 
(2) EXPLANATION
OF
CHANGES
TO
DONORS 
AND FAMILY MEMBERS.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services shall issue guidance 
to State health agencies (or such other State agency, 
department, or authority as the Governor of each 
State may determine appropriate) regarding best 
practices for explaining the automated electronic no-
tification and remote access requirement under sub-
clause (II) of section 1138(a)(1)(A)(iii) of the Social 
Security Act (42 U.S.C. 1320b–8(a)(1)(A)(iii)), as 
added by subsection (a), to organ donors, potential 
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organ donors, and the family members of such do-
nors and potential donors. 
(c) GAO REPORT
AND STUDY.—The Comptroller 
General of the United States (in this subsection referred 
to as the ‘‘Comptroller General’’) shall— 
(1) carry out a study on the implementation of 
the automated electronic notification and remote ac-
cess requirement under subclause (II) of section 
1138(a)(1)(A)(iii) of the Social Security Act (42 
U.S.C. 1320b–8(a)(1)(A)(iii)), as added by sub-
section (a), that takes into account— 
(A) the cost of implementing the auto-
mated electronic notification and remote access 
requirement described in such paragraph; 
(B) the impact of hospital location on the 
implementation of such requirement, including 
the impact of limited broadband access in rural 
areas, and improvements that could be made to 
facilitate such implementation; and 
(C) the reports submitted by the Secretary 
pursuant to paragraph (4)(B) of section 
1138(a) of such Act (42 U.S.C. 1320b–8(a)), 
as added by subsection (a); and 
(2) not later than 3 years after the date of the 
enactment of the Removing Burdens from Organ 
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Donation Act, submit to Congress a report on the 
results of the study carried out under paragraph (1) 
that includes— 
(A) an analysis of data maintained by the 
Department of Health and Human Services re-
lated to the outcomes of organ transplants per-
formed after the enactment of the Removing 
Burdens from Organ Donation Act; 
(B) a review of issues related to securing 
patient data and the roles of the Centers for 
Medicare & Medicaid Services and the Health 
Resources and Services Administration with re-
spect to those issues; and 
(C) any recommendations for further ac-
tion, as appropriate. 
Æ 
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