Urges U.S. Department of Health and Human Services and federal Centers for Medicare and Medicaid Services to reconsider implementation of new rules concerning organ procurement organizations.

AR143

ASSEMBLY RESOLUTION No. 143

STATE OF NEW JERSEY

222nd LEGISLATURE

�

INTRODUCED JUNE 4, 2026

Sponsored by:

Assemblywoman� HEATHER SIMMONS

District 3 (Cumberland, Gloucester and Salem)

SYNOPSIS

���� Urges U.S. Department of Health and Human Services
and federal Centers for Medicare and Medicaid Services to reconsider
implementation of new rules concerning organ procurement organizations.

CURRENT VERSION OF TEXT

���� As introduced.

��

An Assembly
Resolution
calling on the U.S. Department of Health and Human Services
and the federal Centers for Medicare and Medicaid Services to reconsider
implementation of new rules concerning organ procurement organizations.

Whereas,

Organ donation and transplantation are an important component of the U.S.
healthcare system, providing the opportunity for patients experiencing
potentially fatal organ disease to continue to live full, satisfying,
high-quality lives; and

Whereas,

In 2021, the organ procurement and transplant systems set an all-time record of
over 40,000 transplants, which reflects the results of more than a decade of
continuing year-over-year increases in organ procurement and transplantation
rates in the U.S.; and

Whereas,

On December 2, 2020, under the aegis of the prior administration, the federal
Centers for Medicare and Medicaid Services (CMS) adopted a final rule entitled,
�Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for
Coverage:� Revisions to the Outcome Measure Requirements for Organ Procurement
Organizations�; and

Whereas,

The final rule went into partial effect February 21, 2021, with the remaining
provisions taking effect July 31, 2022 and implementation of the rule
commencing on August 1, 2022; and

Whereas,

According to the notice of final rule adoption published in the Federal
Register at 85 FR 77898, the purpose of the new rules is �to increase donation
rates and organ transplantation rates by replacing the current outcome measures
with new transparent, reliable, and objective outcome measures and increasing
competition for open donation service areas (DSAs)�; and

Whereas,

Organ procurement organizations (OPOs) were created in 1984 under the National
Organ Transplant Act, Pub.L. 98-507, to facilitate the national organ
procurement and transplantation process; and

Whereas,

There are currently 57 OPOs operating nationwide, with each OPO serving a
distinct DSA that may encompass part or all of a state or that may span several
states; and

Whereas,

According to the Association of Organ Procurement Organizations, OPOs provide
services that assist multiple stakeholders in the organ donation and
transplantation process, including providing clinical management of organ
donors, performing assessments of medical suitability for organ donation,
providing support to the families of donors, educating the public about organ
donation, conducting community engagement, participating in tissue donation and
research, and providing professional education to health care workers, medical
examiners, and funeral directors; and

Whereas,

Although the current system of OPOs may benefit from evidence-based changes
designed to improve the overall system of organ procurement and organ
transplantation, the U.S. organ procurement system is currently considered the
�gold standard� for the rest of the world; and

Whereas,

As of September 2021, more than 106,000 people throughout the United States
remain on the national transplant lists; and

Whereas,

Although each person can potentially donate up to eight lifesaving organs,
including the kidneys, lungs, heart, liver, pancreas, and intestines, only
three out of every 1,000 people die in a manner that allows for organ donation;
and

Whereas,

According to the Office of Minority Health in the U.S. Department of Health and
Human Services, in 2019, the number of organ transplants performed on Black
patients represented only one-quarter of the total number of Black patients on
the national transplant lists, whereas the number of organ transplants
performed on white patients represented nearly half of the total number of
white patients on the national transplant lists; and

Whereas,

Although the new CMS rule purports to create �transparent, reliable, and
objective outcome measures,� in reality it will likely upend the nation�s
existing organ procurement network by requiring the majority of OPOs to compete
with one another to continue serving their current DSAs, while establishing a
process to decertify other OPOs that do not meet certain performance metrics;
and

Whereas,

There is little evidence to suggest that decertifying OPOs that fail to meet
performance benchmarks will foster greater improvements in the organ donation
and transplantation systems than would be achieved by providing
lower-performing OPOs with support, guidance, and information concerning best
practices; and

Whereas,

Reducing the overall number of OPOs through the decertification process will
increase the burden on existing OPOs to provide services to larger geographic
areas and expanded population bases, while potentially disrupting the
availability of organ procurement and transplant services in those DSAs during
the process of transferring the DSA to a new OPO; and

Whereas,

Requiring the majority of OPOs to periodically bid to retain their own DSAs or
to expand into new DSAs will detract from the OPOs� core mission, and will
foster ongoing uncertainty within DSAs as to which provider will be serving the
area from year to year; and

Whereas,

Disruptions in the national organ procurement and transplant system will likely
result in fewer organs being procured and transplanted into waiting patients,
which is a problem that will likely disproportionately affect patients from
racial and ethnic minorities, who already experience significantly lower
transplantation rates than white patients; and

Whereas,

Although steps have been taken to resolve racial and ethnic inequities in the
health care system, it remains incumbent on policymakers to continue to work to
eliminate racial disparities in access to health care, while taking care to not
establish new barriers to access or exacerbate existing barriers; and

Whereas,

The new CMS rule fails to account for local and regional differences in
population health, disease rates, attitudes towards organ donation and health
care in general, and access to organ procurement and transplantation services,
which differences require close analysis and careful consideration when
contemplating changes to the organ procurement and transplantation systems; and

Whereas,

Moreover, it is important to consider that there are issues with the organ
transplantation process that are outside the control of OPOs.� Not only will
the new CMS rule not address those issues, experts have called for increased
alignment between the organ procurement and organ transplantation systems which
would not be realized under the new rule; and

Whereas,

At least one dozen members of Congress have been persuaded there is a need
expedite the implementation of the OPO competition and decertification process
under the new CMS rule, making the need for reconsideration of the new rule all
the more urgent in order to avoid the disruptions to the organ procurement and
transplantation systems that are likely to occur under the new rule; now,
therefore,

����
Be It
Resolved
by the General Assembly of the State
of New Jersey:

���� 1.��� This House respectfully
urges the U.S. Secretary of Health and Human Services and the Director of the
federal Centers for Medicare and Medicaid Services to reconsider implementation
of new rules revising the outcome measure requirements for, and establishing
procedures to decertify and create competitive bidding requirements for, organ
procurement organizations.

���� 2.��� Copies of this
resolution, as filed with the Secretary of State, shall be transmitted by the
Clerk of the General Assembly to the Secretary of the U.S. Department of Health
and Human Services and the Director of the federal Centers for Medicare and
Medicaid Services.

STATEMENT

���� This resolution respectfully
urges the U.S. Secretary of Health and Human Services and the Director of the
federal Centers for Medicare and Medicaid Services to reconsider implementation
of new rules revising the outcome measure requirements, and establishing
procedures to decertify and create competitive bidding requirements, for organ
procurement organizations (OPOs).� OPOs perform a key role in the organ
procurement and transplantation process, helping identify candidates for organ
donation and providing support services to organ donors and their families.�
New rules adopted by the federal Centers for Medicare and Medicaid Services
under the prior administration would change how OPOs are evaluated, and
establish a process for decertifying OPOs that fail to meet certain performance
metrics.� The new rules would also require the majority of OPOs to engage in a
competitive bidding process to maintain the designated service areas they
serve, as well as for OPOs to compete for a designated service area that was
served by a decertified OPO.

���� It is anticipated that the
changes that would be implemented under the new rules would be disruptive to
organ procurement and transplantation systems, both in New Jersey and
nationwide, likely resulting in reduced numbers of organ procurements and
transplants.� This, in turn, would adversely affect the lives of all patients
on national organ transplant waiting lists, and in particular patients from
racial and ethnic minorities, who already experience significant disparities in
access to organ transplants.

���� It is the sentiment of this
House that the U.S. Department of Health and Human Services and the federal
Centers for Medicare and Medicaid Services should reconsider implementing the
new rules adopted under the prior administration.