Reps. Rose, Reed Lead Bipartisan Push for Accountability and Oversight of Organ Donations

WASHINGTON, Aug. 27 -- Rep. Max Rose, D-New York, issued the following news release:

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."

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August 26, 2020

To: The Honorable Alex M. Azar II, Secretary, U.S. Department of Health and Human Services, 200 Independence Ave., SW, Washington, DC 20201

Dear Secretary Azar,

We write today to strongly urge you to quickly issue a strong rule to bring much-needed accountability and oversight to our nation's 58 Organ Procurement Organizations (OPOs) and to the United Network for Organ Sharing (UNOS), the private organization that manages the nation's organ transplant system. As you know, OPOs each have a monopoly under a contract with the federal government for a U.S. region to recover life-saving organs for patients in need. First, we applaud the work you have done to date, including issuing a Notice of Proposed Rule Making on December 17, 2019 and the 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."

There are serious, widespread problems in our organ transplant system including OPOs self reporting and grading themselves on their performance. This is one factor that has led to grave consequences. According to the Associated Press, out of about 2.8 million deaths in 2018, there were only 10,721 deceased donors whose donations led to just 29,680 transplants. This number could be much higher. A University of Pennsylvania study that examined deaths, donations and health records calculated that a higher-preforming system could produce up to 28,000 more donated organs a year.

Research from the University of Pennsylvania also found that those self-reported metrics are wildly inflated. The OPO covering central New York state reported a 71% recovery rate between 2012-2014 but the study found that the real rate was around 27%. In north-central California, the reported rate was 82% but the real rate was 28%. This is completely unacceptable as over 1,000 Americans die waiting for an organ transplant every month.

Recent reporting from Kaiser Health News revealed "a startling number of life-saving organs are lost or delayed after being shipped on commercial flights, the delays often rendering them unusable" because UNOS uses a "primitive system of phone calls and paper manifests, with no GPS or other electronic tracking." According to HHS itself, OPOs are failing to do their jobs in recovering eligible organs as more than half of all OPOs out of compliance on standard performance measures. And yet all OPOs continue to be given a federal contract decade after decade.

This incompetence has also cost tremendous amounts of taxpayer dollars. As Andy Slavitt, the former head of the Centers for Medicare and Medicaid Services and FreedomWorks President Adam Brandon recently noted in a joint op-ed for USA Today, "because most patients in need of kidney transplants are placed on dialysis while they are waiting for a kidney to become available, dialysis now costs Medicare than $35 billion annually -- a full 1% of the federal budget. Simply by increasing the number of kidney transplants, however -- which is also the best medical outcome for those patients -- taxpayers could save up to $12 billion in just five years through avoided dialysis costs."

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. 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 under performing OPOs if they do not meet essential standards. We must inject competition into this sector of healthcare - too many lives are on the line.

Thank you for your time and attention to this time-sensitive and critical matter.

See signatories here https://maxrose.house.gov/UploadedFiles/2020.08.26_Rose_Reed_HHS_organ_donor_letter.pdf