Update: OPO Advocacy & CMS Rule
Unfortunately, people who aren’t familiar with the organ donation process are trying to change it using erroneous assumptions and data, potentially costing thousands of lives.
On Friday, November 19, the Center of Medicaid and Medicare Services (CMS) issued the final rule specifying new performance requirements for Organ Procurement Organizations (OPOs). Here is the link to the fact sheet, and here is the actual rule.
LifeSource fully supports the intent of the rules to implement improvements which will lead to increases in the number of lives saved through transplantation. However, we are disappointed in the final rule as it failed to incorporate some critical input provided by industry leaders, donor family members and recipients. Many of you reached out to your Representatives and Senators to advocate for a more comprehensive approach which would produce positive improvements. I am grateful to each of you for taking the time and making your voices heard.
The new rule will be effective August 1, 2022 and the new metrics will be used for evaluation beginning in 2023 and recertification beginning in 2026. We are carefully reviewing the components of the new rule and identifying our next steps.
Please know that while the outcome is not what we wanted, it will not impact our operations and fulfillment of our mission. We remain confident in our strength as an organization and know we will be here to serve our customers, partners, donor families, transplant centers and our community in the future.
What is happening?
Did you know the United States has the strongest transplantation system in the world? Organ donation and transplantation has increased by nearly 50% across the country over the past seven years. Despite the near shutdown of transplantation in certain parts of the country due to COVID, 2020 is shaping up to be another record setting year with over 12,000 organ donors and 32,000 organs transplanted. This increase in donation and life-saving transplantation is the result of many things: new technologies, increases in the types of deaths that result in donation and more incredible families who say yes to donation.
In July 2019, the Trump administration signed an executive order aiming to improve kidney care in the United States – and included a small section to revise the way OPO’s reporting and evaluation evaluate practices (performance metrics).
A small group of politically-connected individuals began advocating for new performance metrics based on the erroneous Bridgespan Report. It includes incorrect, unverified and outdated data from 2014.
Center for Medicaid and Medicare Services (CMS) published proposed new regulations in a Notice of Public Rule Making in December 2019. Unfortunately, the new regulations as proposed would result in significant damage to organ donation and tremendous loss of life.
The recent Washington Post Letter to the Editor written by an OPO CEO, “Reforming the organ donation system must be done carefully (PDF),” responds to an Opinion Piece that ran the week prior called “Many die waiting for organs. The Trump administration could help (PDF).”
What’s wrong with the proposed metrics?
Proposed Metrics Do Not Measure Actual Donation Potential
The proposed metrics use data from death certificates as a measure for donation potential. Death certificates do not accurately reflect whether a patient was eligible for donation because they do not always document secondary health conditions which would make them ineligible, such as being COVID-19 positive or having metastatic cancer. A person must also pass away at a hospital, on a ventilator to become and organ donor and the death certificate would not reflect this information either.
If Implemented, 75% of OPOs Would Close, Costing 1,000s of Lives
Under the proposed rule, the bar to “pass” is arbitrarily set at the top 25th percentile without supporting rationale. As a result, 75% of OPOs would not meet the metrics and could be subject to decertification. Decertifying up to 75% of OPOs in a given year would destabilize the system without an identified path for OPO performance improvement potentially leading to loss of lives.
The proposed metric does not account for the many organizations involved in the process
As many as 200 people can be involved in just one organ transplant. We have strong, long-standing partnerships with transplant hospitals, medical examiners and others who work daily to make transplant happen. All of us must focus on efficiencies to improve the system, not just OPOs.
What are we asking?
For CMS to collaborate with us to revise the proposal and identify accurate metrics that will reflect donation potential and actually produce positive improvements. Dozens of organizations involved in the donation process have outlined how this can be done.
We beg CMS not to fall prey to the loud voices of people with political connections and Do No Harm. Revise your new regulations to make sensible changes that help OPOs make donation happen for the 100,000 people waiting for a life-saving organ and for the families who have lost loved ones to a tragedy.
What can you do?
Join our campaign to encourage the Department of Health and Human Services (HHS) to our address concerns with proposed metrics.
Submit an email to your elected officials:
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If you have further questions or comments, please contact Susan Mau Larson, LifeSource Director of Partner & Community Relations at firstname.lastname@example.org.