119-hr4470

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4470 Introduced in House

    (IH) ]

<DOC>

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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