Saturday, February 15, 2020

Transplantation under scrutiny in Washington and the media: compilation of recent links by Greg Segal, via Frank McCormick

The organ transplant ecology is complex, with sometimes perverse incentives in the interfaces among OPOs (Organ Procurement Organizations), donor hospitals, and transplant centers (not to mention dialysis clinics, nephrology practices, government agencies, and subcontractors like UNOS).  Frank McCormick forwards the following compilation distributed by Greg Segal, mostly focused on recent criticisms (some more informed than others) of OPOs. (Having recently spent a day talking to OPO leaders, and not long before that to those running transplant centers, I'm aware that there are different opinions on the multiple causes of  problems afflicting transplantation

Frank writes:
"Greg Segal (founder & CEO of Organize, which is attempting to reduce the U.S. organ donation shortage) sends along this excellent compilation of references for those who want to comment on two current proposals by agencies of the Department of Health and Human Services (HHS):

a.    Health Resources and Services Administration (HRSA): “Removing Financial Disincentives to Living Organ Donation” (deadline – 2/18/20)


b.    Center for Medicare and Medicaid Services (CMS): “Revisions to the Outcome Measure Requirements for Organ Procurement Organization” (deadline – 2/21/20)





Key points for comments (due by February 21st at 5pm ET, via submission here)

  • Although 95% of Americans support organ donation, objective research suggests that organ procurement organizations (OPOs) only recover about 35% of potential donors, leaving as many as 28,000 organs unrecovered every year.
  • Because the majority of patients on the organ waiting list are in need of kidneys, OPO underperformance contributes to a $35 billion annual expense to Medicare. 
  • As Senators from the Finance Committee wrote in a February 10th 2019 oversight letter: “Because OPOs operate as regional monopolies, rigorous oversight is critical to ensure that all 58 OPOs are faithfully executing their mission of organ recovery.”
  • As Secretary of Health and Human Services Alex Azar said: “We’re going to stop looking the other way while lives are lost and hold OPOs accountable."
  • With almost 115,000 patients waiting for a lifesaving organ transplant, it is imperative that CMS implements the proposed metrics as strongly and quickly as possible, especially since the majority of OPOs (37 of 58) are failing one or both key metrics.

Context on why OPO reform is critical to helping more patients access organ transplants

  • Every day, 33 Americans die or are removed from the organ waiting list because a transplant is unavailable. Additionally, because there is such a large gap between supply and demand, many Americans in need of transplant never even reach the waiting list. Research indicates that the true death toll may be as high as 118 Americans per day just from the kidney shortage alone.
  • The shortage of deceased donor organs results in part from inefficiency from federal monopoly contractors, called organ procurement organizations (OPOs), which too often fail to recover organs for transplant. (See NYT whistleblower video.) 
  • Research cited by the Trump Administration shows that a more efficient organ donation system could recover up to 28,000 more organs for transplant each year.
    • This includes 17,000 kidneys; almost 8,000 livers; 1,500 hearts; and 1,500 lungs.
    • Because of costs to Medicare, OPO reform could also save up to $12 billion over 5 years in avoided dialysis costs.
  • A key problem is OPOs are allowed to self-interpret and self-report their own performance, leading to a lack of transparency and accountability. As a result, no OPO has lost a government contract in decades.
    • In fact, reporting suggests the current standards are unenforceable.
  • The New York Times Editorial Board highlighted “an astounding lack of accountability and oversight in the nation’s creaking, monopolistic organ transplant system is allowing hundreds of thousands of potential organ donations to fall through the cracks.” 
  • HHS/CMS’s proposed rule, published on December 17th, moves to objective data from the Centers for Disease Control, and shows the majority of the nation’s 58 OPOs are failing proposed performance metrics.
    • CMS estimates that just bringing OPOs up to minimum compliance standards would mean 5,000 more deceased donor transplants every year. 
  • Responses to the proposed rule are due by February 21st at 5pm ET.

Additional Resources

  • Day One Project paper co-authored by Donna Cryer (President & CEO of Global Liver Institute), Jennifer Erickson (former Obama staffer), Crystal Gadegbeku (Council member, American Society of Nephrology and Section Chief of Nephrology, Temple University), Greg Segal (founder & CEO of Organize), and Abe Sutton (former Trump staffer)
  • Senate Finance Committee oversight letter to Inspector General inquiring about OPO underperformance, fraud, waste and abuse, and conflicts of interest
  • Senate Finance Committee oversight letter to UNOS inquiring about abdication of oversight responsibilities over OPOs 
  • Representative Katie Porter oversight letter regarding OPOs, specifically the LA-based OPO known as One Legacy
  • Senators Elizabeth Warren and Richard Blumenthal oversight letter to CMS regarding OPO performance and evaluation metrics
  • Patient groups writing to Administrator Verma calling for OPO accountability: American Association of Kidney Patients, American Society of Nephrology, Cholangiocarcinoma Foundation, Fatty Liver Foundation, Global Liver Institute, Liver Education Advocacy and Prevention Services, Renal Physicians Association
  • Politico Pulse Podcast interview with Greg Segal about the need for OPO reform

News

Op eds
  • USA Today: Andy Slavitt and Adam Brandon, “Here's how organ donation reform could save thousands of lives, billions in tax dollars”
  • The Hill: Jennifer Erickson & Abe Sutton, “It’s Time to Provide Needed Reform to the Organ Donation System”
  • New York Post: Dara Kass, “America’s Deadly Failure on Organ Donations”
  • CNN: Bakari Sellers, “Dealing with a broken organ donation system after my 4 month old had liver failure”
  • STAT: Laura and John Arnold, “A simple bureaucratic organ donation fix will save thousands of lives”
  • Washington Post: “The Trump administration is actually doing something great on health care”
  • Washington Post: Erika Zak, 39-year old mother who died during transplant, “A posthumous letter to my daughter”

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