Eye banks are facing external financial and regulatory challenges, as well as issues with surgeon participation and tissue preferences, contributing to rising fee costs. This article will discuss these external pressures, the effects on eye banks and how ophthalmologists can become more involved to minimize these issues in the future.
Rising Tissue Costs
Corneas cannot be sold in the United States. Like musculoskeletal tissues and solid organ donations, they are gifts. However, there is still a rising cost associated with corneas, and eye banks do charge a tissue-processing fee. This fee offsets the costs of retrieving, evaluating, preparing, testing, preserving and distributing corneal tissue. If the eye bank is doing additional services, such as preparing the corneal tissue for DSEK, it can also charge fees for that processing. While prices vary depending on location in the country and the particular eye bank, Christopher Rapuano, MD, director of the Cornea Service Department and co-director of the Refractive Surgery Department at Wills Eye Institute in Philadelphia, and professor of ophthalmology at Thomas Jefferson University, indicates that in the Northeast, the costs are between $2,500 and $3,500 a cornea.
For the past 15 to 20 years, these fees for services have been pass-through or borne by the hospital or surgery center, contributing to the rise in cost for corneal transplants. Dr. Rapuano explains that, “Medicare is pass-through, meaning that if the eye bank charges $3,000, then the hospital or ambulatory surgical center pays the eye bank and then they are reimbursed from Medicare.
“From a Medicare patient or surgeon standpoint, it doesn’t really matter, except that we all know there is a finite pie that this money is coming out of,” Dr. Rapuano says. “If the eye banks are taking huge percentages, not because they are greedy but because their costs are high, then there is less for everyone else.”
Patricia Aiken-O’Neill, the outgoing president of the Eye Bank Association of America, agrees that there is significant concern over continuing to receive adequate reimbursement for the costs related to retrieving and preparing corneas for surgeons, while Christine A. Curcio, PhD, a professor of ophthalmology in the Department of Ophthalmology at the University of Alabama School of Medicine, Birmingham and the science director for the Alabama Eye Bank (AEB), explains that skyrocketing costs extend beyond cornea surgeons to affect those doing research in age-related macular degeneration, glaucoma and other eye diseases for which there are no adequate animal models. These rising costs create a priority issue because research tissue is not reimbursed at the same rate that transplant tissue is. As Dr. Curcio notes, “If [an eye bank] gets two phone calls and one is for transplantable tissue and the other is for research, if there is only one technician on that shift, the technician is going to go out and get the reimbursable tissue because that is what keeps the whole operation going.”
In order to continue providing enough tissue for scheduled surgeries and researchers without incurring additional fee increases, Jake Requard, the president and CEO of the VisionShare consortium of eye banks, believes that eye banks will need to continue consolidating into larger, regional eye banks or consortiums. Doing so will create a more stable fee structure by consolidating expertise into a single location, allowing eye banks to continue offering the specialized tissues required for corneal transplants without incurring astronomical costs associated with specialized technicians. This is especially important because, according to Ms. Aiken-O’Neill, while in the past surgeons would typically prepare corneal tissues themselves immediately prior to the graft surgery, today three-quarters of all tissues acquired from eye banks are prepared and pre-cut by technicians at the banks.
In addition to cost increases from retrieving and preparating corneas, there are also testing and tracking costs. In the case of the AEB, Dr. Curcio explains that, “they have three full-time information technology members writing software to keep up with donor-to-recipient tracking. Every step of the way it is understood where the tissues are, what tests they’ve had, what reagents and supplies were used.” In fact, AEB even tracks the lot numbers of the gloves used by technicians during retrieval and preparation, in case there is contamination and recall.
Dr. Rapuano points out that there is a flipside to pass-through tissue costs, and that is contracted flat-fee services negotiated by many insurance companies with hospitals and ambulatory surgical centers. These flat fees are supposed to include the tissue, operating room, all the nurses and operating room time, yet are often less than the cost for the transplant tissue alone, creating a scenario in which it’s impossible to break even when performing full thickness transplants or DSEKs.
Tissue Testing Regulations
Ms. Aiken-O’Neill explains that another concern for the EBAA is that corneas are being swept up in other tissue regulation laws that are not necessary or necessarily applicable to the cornea, due to its avascular status. The Food and Drug Administration, through the Center for Biologics Evaluation and Research, regulates human cell, tissue and cellular or tissue-based products (HCT/P), which includes bone, ligaments, skin, heart valves, corneas and lenses. By requiring that corneas and other ocular tissues be tested for the same communicable agents as vascularized tissues, costs not only increase, but there is an additional and often significant delay between retrieval of the tissue and availability for surgeons and researchers. These regulatory challenges drive costs higher by creating another layer of protocol for eye banks to adhere to while simultaneously limiting an already-shrinking donor pool.
For example, Dr. Curcio says, “One of the things that happened in the last couple of years is that eye banks are no longer allowed to recover tissue from donors who have dementia, and some eye banks also exclude Alzheimer’s patients because of the potential for these diseases to be caused by prions or other infectious agents. Because these factors have not been conclusively ruled out, these tissues are not available for transplant, limiting the donor pool for transplant and research.”
This is not to suggest that the EBAA does not advocate strict guidelines for cornea transplants. The EBAA has been at the forefront of national guidelines for tissue transplantation since its inception in 1961. In 1980, the EBAA started a medical advisory board and was the first to require mandatory HIV, hepatitis and other infectious disease testing, as well as adverse reaction reporting. The FDA took many cues from the EBAA regarding national standards for all organ and tissue transplantation. But new regulations threaten to overwhelm eye banks with testing that is largely viewed as unnecessary for an avascular system.
Currently, the FDA mandates that all HCT/P donors, with certain reproductive HCT/P exemptions, be tested for the following communicable diseases: human immunodeficiency virus, types 1 and 2; hepatitis B and C; and syphilis. Dr. Curcio acknowledges that on the surface, it seems like HCT/Ps should be tested for communicable diseases like syphilis, but the reality is that “these are all tests that are needed to certify vascularized tissues,” rather than avascular systems.
Dr. Rapuano says, “Most ophthalmologists, including cornea specialists, just don’t know a lot about the nitty-gritty details of all of this testing. This is where the local eye bank’s medical advisory board really comes into play.” These boards educate ophthalmologists about potential new regulations, how they impact the eye bank and how an ophthalmologist can register concerns about new regulations with the FDA. (The federal government has a website, regulations.gov, where it is possible to submit comments on proposed regulations, sign up for e-mail alerts to track specific regulations, and submit applications, petitions or adjudication documents.)
The EBAA bylaws require that every eye bank have a medical director who is a trained cornea surgeon. Ms. Aiken-O’Neill notes that the EBAA has seen significantly fewer surgeons and young ophthalmologists becoming involved with eye banks, but there are plenty of opportunities for established ophthalmologists. Ms. Aiken-O’Neill explains that with more comprehensive issues facing the EBAA, from emerging infectious diseases to questions surrounding more complex techniques for corneal transplantation, there is a need for ophthalmic surgeons to participate in eye banks.
Dr. Rapuano is a member of his local eye bank’s MAB, and says that this voluntary position does not require “a huge amount of time, maybe an hour or two a month, although it does depend on the month.” There are also other ways for ophthalmologists to get involved, including committees and fundraising efforts.
Dr. Curcio adds that the AEB always finds it helpful when the surgeons who are using its tissues, especially patch grafts, provide “feedback on how the tissues were used in surgery and what can be done to improve the process.”
Transplant Tissue Preferences
“Cornea surgeons are very selective about what tissue they want to use [for transplant],” says Dr. Curcio. Part of the reason for this, explains Dr. Rapuano, “is just inertia. It is what we were taught, from basically lack of data: You don’t want to take 70-year-old tissue and put it into a 13-year-old patient. This makes sense. But the Cornea Donor Study does not support many surgeon preferences.”
The Cornea Donor Study has revealed that a host of assumptions, and EBAA regulations based on those assumptions, are incorrect. The CDS found that in terms of the five-year success of corneal grafts:
- there was no validation that EBAA temperature requirements and approval make a difference in graft success or failure;
- HLA matching has no positive or negative effect;
- cadaver storage time and refrigeration has no statistical effect;
- death-to-preservation time and death-to surgery-time made no difference in graft success rates.
In fact, graft rejection was not impacted by any variable tracked in the CDS; there is a 70 percent endothelial cell loss five years post-transplant, regardless of the age of the cornea donor.
Dr. Rapuano says, “The data from the CDS was from a limited population of generally older patients, but other studies have come out showing similar data.” Another criticism of the CDS is that it was limited to penetrating keratoplasty, because it recruited patients from 2000 to 2002. However, recent research suggests that the five-year graft survival rates for DSEK is similar to those reported by the CDS.1 In both PK and EK, long-term graft survival appears to correlate only with the six month postoperative endothelial cell density.
It’s not just tissue preference that influences how eye banks retrieve, process and provide tissue. Dr. Curcio notes that the AEB sees a constant pattern: “In advance of holiday weekends or the end-of-year holidays, it becomes increasingly difficult to place tissue. Surgeons like to do their transplants early in the week so they can get their postop rounds done later in the week. In order to maintain a large enough pool with very high cell counts, it means eye banks have to go get lots of tissue, and there’s often an excess of tissue that cannot be used on weekends or holidays. A lot of this ends up at the Global Sight Network, where it ends up as patch grafts, or is sent overseas.
“If surgeons would relax their criteria a bit, it would help to keep overall costs down,” Dr. Curcio continues. “Ultimately, it’s an argument for evidence-based medicine, and I hope this encourages people to realize that there is evidence on the topic and you don’t have to go with your instinct, which may not be right.”
While it is clear that cornea surgeons should be concerned about rising costs, shrinking donor pools and tissue preferences that are not supported by evidence-based medicine, it is also important for other ophthalmology specialists to be aware and involved in these issues; when they play out across the entire medical system, it’s not just costs that are raised. “A lot of research on human eye disease is done not in eye pathology labs that are part of university departments of ophthalmology or eye hospitals, but by researchers who raise their own money from grant proposals and work on big problems,” Dr. Curcio explains. “There is no good animal model for AMD, and the models for glaucoma are not that great. If you want to find out about human eye disease, you need an eye bank.”
Those in the industry believe that if ophthalmologists want new ideas and new treatments for the future, then keeping the system of retrieval, preparation and distribution functioning at a manageable cost, not just for tissue transplants but for research, is of the utmost importance. Participation from ophthalmologists, from regulatory advocacy to local eye bank participation and reasonable tissue requests grounded in evidence-based medicine, is necessary for the continued health of the system. REVIEW
1. Price MO, Fairchild KM, Price DA, Price FW. Descemet’s Stripping Endothelial Keratoplasty. Ophthalmology 2011;118:725-729.