20 kidneys failed to be transplanted due to transportation problems so far this year–a completely preventable issue–while industry groups push for delay to new regulations that could save thousands of lives

U.S. Representatives Max Rose (NY-11) and Tom Reed (NY-23) are leading a bipartisan push today with 23 other Members of Congress urging the Administration to finalize regulations to quickly issue a strong rule to bring greater oversight and accountability to Organ Procurement Organizations (OPOs) and the United Network for Organ Sharing (UNOS), the private organization that manages the nation's organ transplant system.

Since Kaiser Health News and the Center for Investigative Reporting sounded the alarm in January on this issue, another 20 kidneys failed to be transplanted after transportation problems--a completely preventable tragedy with life-threatening consequences that should never occur with current technology and standards. Additionally, a strong rule is needed to correct major issues in the organ procurement system including that OPOs, which each have a monopoly contract with the federal government for a geographic area of the U.S., and are currently allowed to score themselves on their performance instead of being graded independently. An University of Pennsylvania study found that a higher-preforming system could produce up to 28,000 more donated organs a year through increased donation and better coordination and transport of organs.

"Each successful organ donation is a life saved and yet there is almost zero accountability or oversight into these networks, leading to incredible inefficiencies and tragically, lives lost," Rose said "It's encouraging that this Administration understands action is needed, because this isn't about politics, it's about righting a wrong and doing so without delay."

"The greatest country in the world should be able to ensure suffering patients have fair access to life-saving organ transplants," Reed said. "As Co-Chair of the Diabetes Caucus, I know just how important successful kidney transplants are as an alternative to more expensive and medically fraught dialysis options. We must act immediately to hold organ procurement systems accountable and reduce the number of unnecessary failed transplants."

Today's bipartisan effort follows an Executive Order President Trump issued on July 10, 2019 that requires the Department of Health and Human Services (HHS) to "revise Organ Procurement Organization rules and evaluation metrics" and a Notice of Proposed Rule Making on December 17, 2019 from HHS which has yet to be finalized--and is under pressure by industry groups to be further delayed due to COVID-19.

"We are disturbed that OPOs are now asking that the proposed accountability measures in this upcoming rule be delayed because of the COVID-19 pandemic," wrote the bipartisan Members of Congress in a letter to Secretary of Health and Human Services Alex Azar. "We strongly urge that you issue the rule without delay and that it is not watered down to appease the OPOs. Now is the time for bold action. Simply put, if the worst preforming OPOs were held to higher standards and became as high preforming as the best OPOs, we would save of thousands of lives every year. We need the new rule to dramatically boost oversight and accountability through independent outcome measures and auditing as well as setting up a process to decertify and replace underperforming OPOs if they do not meet essential standards."

Joining Rose and Reed in this bipartisan effort are the Co-Chairs of the Congressional Kidney Caucus, Reps. Suzan DelBene (WA-01) and Larry Bucshon, MD (IN-08), and fellow Reps. Terri Sewell (AL-07), Neal P. Dunn, MD (FL-02), Tom Suozzi (NY-03), Kenny Marchant (TX-24), Diana DeGette (CO-01), Buddy Carter (GA-01), Gil Cisneros (CA-39), John Curtis (UT-03), Cindy Axne (IA-03), Jodey C. Arrington (TX-19), Abigail Spanberger (VA-07), Brian Fitzpatrick (PA-01), Karen Bass (CA-37), Ben Cline (VA-06), Jamie Raskin (MD-08), Katie Porter (CA-45), John Yarmuth (KY-03), Grace Meng (NY-06), Danny K. Davis (IL-07), Steven Horsford (NV-04), and John B. Larson (CT-01).

"Organ Procurement Organizations serve a vital role in our national transplant system, and it is imperative that their performance be assessed using objective and verifiable measures," said Anupam Agarwal, MD, FASN, President of the American Society of Nephrology. "The more than 100,000 Americans waiting for transplants deserve greater transparency and accountability when it comes to organ procurement, and ASN commends Congress' efforts to ensure that happens. Ultimately, these changes will lead to tens of thousands of more Americans with kidney failure receiving a life-saving transplant."

"As a transplant recipient I believe every patient waiting deserves to have the same opportunity for a life-saving transplant as I have had and every donor and donor family should have their gift honored," said Donna R. Cryer, JD, founder and Chief Executive Officer of the Global Liver Institute. "This final rule will help the patient and medical communities make much needed, long awaited advances to accomplishing both of these goals, which is why I appreciate Reps. Rose and Reed for leading this effort."

"I've had loved ones die because of OPO failures. This isn't a game; Congress and the Administration need to put patients first by finally holding OPOs accountable," Greg Segal, CEO of Organize, a nonprofit dedicated to advocating for reforms to increase the number of lifesaving organ transplants. "OPOs are like the wild west and this reckoning is long overdue, and families like mine should all be incredibly grateful for Reps. Rose and Reed's leadership on this issue."

"As an ER doctor I had seen OPOs fail patients for years," said Dr. Dara Kass, an emergency room physician in New York and organ donor advocate. "When my own son needed a liver transplant, I was grateful to serve as his living donor, partially because I could save my son without depending on the inefficient and broken OPO system. This is such an important and fixable problem, and I'm so thankful to Reps. Rose and Reed for fighting for transplant patients."

Full text of the letter HERE https://maxrose.house.gov/UploadedFiles/2020.08.26_Rose_Reed_HHS_organ_donor_letter.pdf.

Read this original document at: https://maxrose.house.gov/news/documentsingle.aspx?DocumentID=2746