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Peer Reviewed Science Continues to Show Major Flaws in CMS Governing RULE
A growing body of scientific research continues to show the fatal flaws in the Centers for Medicare and Medicaid Services (CMS) RULE governing organ donation and donation. The November 2020 Rule was adopted using flawed data and that has now been proven. See the research abstracts and analyses with links.
What You Need To Know
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Peer Reviewed Data Should Inform New Rule
One research abstract and published analysis after another confirms the need to dramatically alter the metrics in the governing RULE to avoid chaos in 2026. Compounding the 2020 error CMS recently censored release of public funded peer-reviewed science at the American Transplant Congress.
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CMS’s Flawed Rule
The new regulations hold OPOs responsible for discarded organs when OPOs have no control once the organs are delivered to the centers. OPO performance measures should be based on reliable data – ventilated hospital deaths and organ yield measures already in place. Instead, the new regulations use death certificates, which are unreliable when verified health records are …
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NASEM Study
The National Academies of Sciences, Engineering, and Medicine (NASEM) completed in 2022 a Congressionally authorized and funded report entitled Realizing the Promise of Equity in the Organ Transplantation System. Its key peer-reviewed recommendations to instill accountability, improve performance metrics, increase equity, and …
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HMA Report
Health Management Associates (HMA) is a leading independent, national research and consulting firm with a focus on improving the administration and delivery of public health. “It is vital to utilize a data source to evaluate OPOs; however, utilizing death certificate data does not provide the level of clinical detail needed to accurately …”
SID&T Facts and Reform
Misinformation and ad hominem attacks on the non-profit organ donation system continue and demand with even more urgency that true peer-reviewed science, and not special interest politics, be the guiding principle to achieve greater effectiveness in the donation and transplant ecosystem.
While everyone concerned with the field desires optimal results, the special interest rhetoric of a “failing” system is simply a false narrative.
More on The Science
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2023 Donation and Transplant Statistics
ORGAN DONATION AND TRANSPLANT FACTS
According to the official figures of the United Network for Organ Sharing
● More than 46,300 organ transplants in 2023 setting another record.
● Total kidney transplants exceeded 25,000 for the first year ever
● Annual records also set for liver, heart and lung transplants
● Deceased donation continues 12-year record trend
● Donate Life America estimates that the Rule will result in five thousand fewer donations than under the previous Rule over the next five years. (this finding ignored by CMS and Congress to date)
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Congress Needs Science Based Hearings on the RULE
In the past both the Senate Finance Committee and House Oversight Commitee relied on politically motivated sponsored “data” and cherry-picked testimony that did not reflect research reality. ontent Everyone wants the waiting lists reduced and to maximize the number of viable organs made available for transplant. There has been (because there cannot be) any medically or ethically viable pushback to the peer-reviewed science given to CMS in the comment period to the Rule’s adoption, the responses to the RFI CMS issued and to the NASEM Report.
HHS does not arbitrarily shut 42% of the nation’s so-called underperforming hospitals from unsupportable metrics. It demands remedial action based on best practices. CMS arbitrarily decertifying 25% or more of the nation’s non-profit system based on faulty science will inevitably lead to Federal court chaos—and a disruption to the system
NASEM and peer-reviewed science call for the proper metrics and alignment to ensure improvement and the use of best practices.
No one supports “underperforming” OPOs but by current measure it is impossible to tell which are. Tiers change annually often for reasons OPOs have no control over (transplant rates) or the wide disparity in geographical areas of underlying medical issue impacting the availability of viable organs. The RULE ignores this.
The sensitive nature of organ donation and procurement begs Congress and HHS/CMS to protect, nurture and improve the community-based nonprofit system based on evidence-based science, not special interest politics.
Legitimate hearings need to be held featuring respected researchers leading to the need to work for the adoption of the NASEM principles and recommendations.
The New Hampshire Bulletin on July 29 Published an Insightful Article on New England Donor Services and the Issues With CMS Flaws
Dan Decoteau was on life support at Massachusetts General Hospital with a traumatic brain injury, hours from death, when the organ donor team asked his family to make an excruciating decision. Would they donate his organs and tissue to save other lives? Decoteau, 39, of Milford, hadn’t joined the donor registry, so the decision was theirs.
The family talked with each other and the team. They had disparate thoughts about organ donation, his mother, Michele Decoteau, of Mason, said but agreed on …