[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4470 Introduced in House (IH)]
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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 Energy
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 programs to establish
certain notification procedures with respect to organ procurement
agencies.
Be it enacted by the Senate and House of Representatives 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''.
SEC. 2. NOTIFYING ORGAN PROCUREMENT AGENCIES WITH RESPECT TO POTENTIAL
ORGAN DONORS.
(a) In General.--Section 1138(a) of the Social Security 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 Donation
Act, with respect to such a potential
organ donor, such hospital's designated
organ procurement agency is issued an
automated electronic notification 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 potential organ
donor is deceased or that the death of
such potential organ 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 access requirement.--
``(A) Exemptions.--
``(i) In general.--The Secretary may exempt
a hospital or critical access hospital from the
automated electronic notification and remote
access requirement under paragraph
(1)(A)(iii)(II) for a period of 3 years if the
Secretary determines that meeting such
requirement would result in a significant
hardship, such as in the case of a hospital or
critical access hospital located in a rural
area without sufficient Internet access, or
other exceptional circumstances demonstrated by
the hospital.
``(ii) Automatic exemption.--The Secretary
shall grant an exemption described 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 defined 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 satisfaction of
the Secretary that such an extension is
necessary.
``(B) Report.--Not later than 2 years after the
date of the enactment of the Removing 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 Committee on Health,
Education, Labor, and Pensions 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, disrupt,
deny, degrade, or destroy information system
resources of the hospital, including the
information itself;
``(ii) affects the confidentiality,
integrity or availability of data, information,
or operational technology system resources of
the hospital; or
``(iii) poses any other threat to the
information, information systems, technology,
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 of Health and Human
Services shall issue guidance to hospitals, critical access
hospitals, organ procurement agencies, and electronic health
record companies 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 subsection (a). Such guidance shall be based upon
the experiences of entities that have previous experience with
the implementation of similar automated electronic
notifications and remote access, and shall provide 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 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 subsection (a), to organ donors, potential organ
donors, and the family members of such donors 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 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 subsection (a), that takes into account--
(A) the cost of implementing the automated
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 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 related to the
outcomes of organ transplants performed 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 respect to those issues; and
(C) any recommendations for further action, as
appropriate.
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