EYE OPENING: Eye donations sent out of state, local Lions' work diminished

- For decades the Lions Gift of Sight has been synonymous with eye donations in Minnesota, but in the last few months the non-profit has lost 15 hospitals in its network.  

Those hospitals, and the Ramsey County Medical Examiner, have signed new agreements with LifeSource of Minneapolis, which in turn will send eye tissue to SightLife, a Seattle non-profit, which distributes corneal tissue to surgeons through a for profit company, CorneaGen. 

"They’ve been gobbling up eye banks around the country," said Lyle Goff of the Minnesota Lions, referring to SightLife. "The understanding we have is all the eye tissue donations collected (in Minnesota) will be transferred to Seattle for processing and redistribution.”

The hospitals that have severed their relationship with Lions Gift of Sight include Regions, North Memorial, St. Cloud, St. Francis, and United.  Last week, all ten hospitals in the Allina network, including Abbott and Mercy, also signed a new contract with LifeSource as well.

Three of the hospitals; Regions, St. Cloud, and Mercy, also have presidents who sit on the LifeSource Board of Directors.

Altogether, they account for about a third of the Lions donor eye tissue.

The cornea is the clear membrane that helps the eye focus.  When it’s injured or diseased, doctors replace the layers of the cornea with a graft of tissue from a donor.

There were 51,000 corneal transplants in the U.S. last year.  There are 75 local eye banks around the country, like the Lions in Minnesota, which have been the backbone of the system for generations. 

“Eye banking system is so good we have an excess of cornea for you. Extra corneas to do research and support research overseas.  The system works,” said Dr. Joshua Hou, Medical Director of the Lions Gift of Sight.

A NEW, FOR PROFIT, PLAYER

“I would encourage you to, and I don’t know whether you want this on or off the record, is not be manipulated by a poor us story,” said Monty Montoya, the CEO of CorneaGen.  

Montoya is the former CEO of SightLife, the largest eye bank in the U.S., which two years ago spun off the for profit, CorneaGen, with Montoya as its new CEO.   

CorneaGen is currently in a second round of investor financing, with the goal of raising $50 million.  CorneaGen anticipates an initial public offering (IPO) in the next couple of years, becoming a publicly traded company.  

CorneaGen receives tissue from non-profit eye banks, including its non-profit cousin SightLife, then processes that tissue and distributes it to surgeons across the U.S. and around the world. 

Montoya likes to say CorneaGen is a mission-oriented company with the goal of eliminating corneal blindness around the world by 2040. 

The U.S. exports 26,652 corneas a year, but the need is estimated by some at 10 million. Montoya believes the only way to meet that global demand is through the innovation and resources of a for profit company. 

In a speech earlier this year, during a speech at Duke University, Montoya tearfully told the story of a clinic in China.

“I was handed this 18 month old boy and I had to hold him when his mom was told he couldn’t get a transplant,” he said.

A SLIPPERY SLOPE?

Montoya is less clear about how CorneaGen will repay its investors.  

“The revenue we generate is generated exactly the same way, as all the organizations providing tissue for transplant,” said Montoya. 

Under federal law, body parts and tissue can’t be sold for profit.  It’s a prohibition going back to the 19th century body snatchers, who dug up graves to sell cadavers to medical schools.  

Eye banks can charge a “reasonable” processing fee, however. Medicare pays for about 74% of all corneal transplants in the U.S.  According to the Centers for Medicaid and Medicare Services (CMS), the standard reimbursement rate is $3,610.75.

CorneaGen can turn a profit selling an entire catalogue of medical devices surgeons can use when transplanting corneas, as well as advanced techniques for preparing the tissue graft. 

The Lions believe as a non-profit, without investors to keep happy, they’re more committed to basic scientific research.

"Honestly, eye banks get reimbursed better for the tissue donated for transplantation. They're reimbursed at a much lower rate for research tissue, because we are supported by Lion’s we can do that,” said Dr. Hou of the Lions.  

Research tissue is reimbursed at a rate between $300 and $1,200, one-third the rate for transplant.  

The Lions Gift of Sight is second in the nation in providing eye tissue for basic research.  And not just corneas, but the retina, and the rest of the eye. 

“They’re (CorneaGen) definitely more interested in corneas because that’s what their investor is interested in,” said Dr. Hou.

Dr. Hou worries that CorneaGen is on a slippery slope.  

“Operating outside the normal system of non-profits. The amount that eye banks get for reimbursement begins to matter.  I think that would be detrimental not just eye banks as a whole but the field of ophthalmology as a whole, everyone would be effected,” said Hou.

“I don’t know if the general public would be happy to find out their loved ones generous gift turned into a bottom line profit item out there,” said Goff, of the Minnesota Lions.

CASTING SHADE

“The real issue is quality,” said Montoya of CorneaGen.  “There’s a reason surgeons, before CorneaGen, were getting their tissue from other eye banks outside Minneapolis, there’s a reason for that,” Montoya responded.

The FOX 9 Investigators checked with the Food & Drug Administration (FDA), which regulates eye banks and discovered the Lions Gift of Sight scored 100% on its last inspection. CorneaGen received the same results in their FDA inspection. 

“I’ll just say the Minnesota eye bank has been hands down the easiest to work with,” said University of Virginia professor Brad Gelfand, who is studying age-related macular degeneration.  

“It (eye tissue) is preserved in pristine manner, it allows us to do the highly challenging work we do in our lab,” said Gelfand.  

In a February letter provided to the FOX 9 Investigators, the chair of Mayo Clinic’s Ophthalmology Department, defended the Lions, “(We) are all extremely happy with the quality and service provided by the Lions Gift of Sight and none have a desire to change this relationship.”

HOSPITALS RESPOND

Even the hospitals which are no longer working with the Lions say it’s about streamlining donations.  In a statement to FOX 9, Regions Hospital said their patients and families “..will benefit from only having one number to call.” 

LifeSource of Minneapolis is a $43 million dollar non-profit is the big player in the upper Midwest for organ and tissue donation, and is a federally designated Organ Procurement Organization (OPO).  LifeSource only became involved in eye tissue donation in 2016.

LifeSource declined an on-camera interview, but in a statement said:

“We have a long history of managing organ and tissue donation, and we expanded our programs to include eye donation in 2016 in response to requests from our hospital partners, dozens of partners who recognize what is best for both grieving families and hospital teams." "Our eye donation partner, SightLife, was carefully chosen and has a strong commitment to quality and innovation.”

In their statement LifeSource does not mention the for-profit CorneaGen or that Minnesota eye donations will be sent out of state, and outside the U.S. 

Statement from Allina Health:

“Allina Health has partnered with LifeSource for all organs, except eye donations, for many years. Our decision to change to LifeSource for all donations is based on direct feedback from families of potential donors. Families are grieving and are often faced with a critical and emotional decision of supporting their loved one’s wishes. Most families prefer to work with only one organization to coordinate the entire donation process.”

A MOTHER’S STORY

“I can’t even say enough about the Lions and what they have done for me and my daughter,” said Corrine Rockstad, whose daughter donated her corneas to the Lions.

Corrine Rockstad’s daughter, Lizzie, became an eye donor after she died five years ago from an accidental overdose.

“I do know Lizzie’s corneas stayed in Minnesota.  It was a man and woman who received her corneas in Minneapolis.  She would have loved that,” Rockstad said. "I call it the silver lining to the tragedy.  Even knowing the tragedy and how hard it is to talk about, knowing what they’ve done, for me, the Lions Gift of Sight.” 

For many, local eye banks are still worth keeping but it’s also true that profit and medical innovation often go hand in hand.

"Isn’t it a blessing that we have the gift of donation? Really, when you think about it. I think what Liz would say is 'I’ve been recycled'.  And she would love that.”

Lions Gift of Sight: https://www.lionsgiftofsight.org/

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