New Jersey-2022-AR146-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, In the Further Consolidated Appropriations Act, 2020, the Congress of the United States requested that the National Academies of Sciences, Engineering, and Medicine (NASEM) conduct a study to review the fairness, equity, transparency, and cost-effectiveness in the system of procuring, allocating, and distributing deceased donor organs; and

Whereas, The purpose of the study was to ensure the best peer-reviewed science and the most up-to-date policy thinking is available to maintain a world-class, equitable, patient-focused organ donation and transplantation system that is equipped to save as many American lives as possible; and

Whereas, Instead of waiting for the peer-reviewed data and recommendations from the NASEM study, the prior administration hastily adopted a seemingly politically motivated rule that disregards the will of Congress; 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. The General Assembly of the State of New Jersey 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 the General Assembly 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.