Organ Transplantation: Select or Deselect?

“I’m as proud of many of the things we haven’t done as the things we have done. Innovation is saying no to a thousand things.”
—Steve Jobs

Transplant is hot. Headlines tout donor matchmaking via Tinder/social media, a handful of “first-ever” exotic transplants, organogenesis from stem cells, xenotransplantation breakthroughs and even a White House Organ Summit. Organ transplantation has captured the imagination of the medical community, lay press and public for decades. It is tempting for many organizations to capture some of the inevitable and entirely justifiable “buzz” that surrounds transplantation.

Yet, as Steve Jobs articulated, sometimes the best decision is NOT to engage. Transplant in particular exemplifies the principle of strategic deployment or deselection. Read on for an examination of some of the key issues in this field, a current state assessment and a drill down into the implications of initiating a transplant program.

Strong Demand for Organ Transplants, Weak Supply
In 2014 there were 29,533 total organ transplants, while in 2015 there were 30,973. Both were record-breaking years. Indications thus far point to 2016 volumes exceeding 30,000.

Transplant offers an exceptional instance in health care where there is a timely and precise accounting of demand. The Organ Procurement and Transplantation Network (OPTN) maintains an up-to-the-minute accounting of transplant demand by organ type. Record numbers of waiting list candidates indicate high demand for these potentially high-margin and lifesaving procedures—nearly 120,000 Americans are currently in dire need of an organ. Indeed, it is estimated that 22 people die every day waiting for a transplant.

Thus, despite historically strong surgical volumes in the past few years, transplantation is characterized by a stark imbalance in supply and demand. Growth in transplantation is necessarily limited by the supply of organs, far short of demand. For any organization considering entry into this field, analysis of supply is just as important, perhaps more so, than demand forecast, unlike most other service line analyses. Irrespective of organ type, growth in transplantation continues to be completely supply limited.

Social Media, Tinder and Even the White House Drive Organ Donation Efforts Beyond the DMV
At a high level, the “holy grail” for the transplant community will be an unlimited supply of pristine organs to satisfy that demand and, indeed, there are multiple fronts to address this imbalance. Perhaps the oldest efforts have been in the field of organ donation. While 95% of Americans support organ donation, only about half of them register as organ donors. Each donor can save up to 8 lives, with additional tissue potentially improving scores of additional lives. The Department of Motor Vehicles (DMV) has effectively recruited organ donors since 1968. However, as one donor registry put it, 100% of Americans hate the DMV. After waiting in a line that seems as long as an organ-waiting list, can we really expect to catch presumptive donors at their peak altruism?

A far stretch from the DMV, so-called lean nonprofits such as ORGANIZE have arisen with the goal of attempting to create America’s first central registry (registering in 1 state currently does not make you a donor in another). ORGANIZE is attempting to get states to recognize social media posts (a social declaration) as evidence of your donor wishes. It has partnered with the White House Social and Behavioral Sciences Team to produce a soon-to-be-released definitive best practices report on organ donor registration messaging.

Earlier this year, Tinder announced ads encouraging users to sign up to become organ donors by “swiping right” to begin the process on this personal matchmaking/dating site. In addition, over 20 other major social networking sites, including Facebook, Twitter and Instagram, also have organ donation initiatives. Are we one viral awareness campaign away from a rapid expansion of the donor pool? Think ice-bucket challenge?

While these efforts are laudable and should be encouraged, the reality is that they will likely offer only incremental gains in supply.

Innovations in Xenotransplantation, Organogenesis Still Years Away From Clinical Application
There is great excitement surrounding innovations in transplant surgery from research laboratories around the globe. Xenotransplantation, the transplantation of organs from one species to another, has gained renewed attention recently. Although this approach has been around for years, human tolerance of transplanted organs from other species has been a stumbling block. CRISPR, a genomic scalpel, has made it practical to find ways to “humanize” animal genomes in order for the animal organs to become a more viable source for transplantation. Genomic advances have rekindled the hope of growing an unlimited supply of rejection-free organs.

Alternatively, what about using a patient’s own stem cells to grow solid organs? Indeed, significant advances in organogenesis or tissue engineering have been achieved: this is a very exciting line of research. Finally, some researchers are pursuing the manufacture of artificial organs that can be implanted, thereby sidestepping issues of tolerance and rejection.

Although all of these lines of research are promising and may eventually solve the supply challenge, the reality is that clinically useful results are at least 5 years, and, more likely, greater than 10 years away. Be prepared for exciting stories in the press about advances, but in terms of bending the supply curve, we should not expect much change from the present state, despite significant efforts in organ donation and research domains. Accordingly, we do not forecast significant market growth in transplantation—the most an individual program can hope for is to steal market share from competing programs. Any program considering entry into this field must be circumspect about this reality.

Transplantation Programs Face Significant Procedural and Regulatory Barriers
The complexity of surgical transplantation requires multidisciplinary expertise well beyond the transplant surgeon. Assuming an organization can recruit and organize the necessary talent and personnel, the program must then contend with significant regulatory challenges.

For example, for kidney transplantation (the most common type of organ transplantation and the typical cornerstone of most programs), Medicare is essentially the only payer in town. Accordingly, CMS and HHS have considerable clout to establish criteria for transplant center certification and they publish up-to-date lists of all certified transplant centers. OPTN publishes detailed policies and rules that govern the operation of all transplant programs, which must be followed to remain certified. Although the minimum volumes to maintain certification are not onerous, most experts would agree that these are well below the numbers needed to maintain a competent program.

When considering transplant data by system, for all organs in 2015 the median number of transplants was 69; for kidneys it was 48. Regarding  the 12 newly minted kidney transplant centers that entered the field in the last 5 years, only 5 entered with the minimum volume for certification (n = 3); the remaining 7 entered with an average of 12 transplants in their first year. Meanwhile 12 systems dropped out of the game altogether, indicating no net gain of kidney transplant centers in the US during the past 5 years, emphasizing the formidable challenge of starting and sustaining a viable center.

Beyond numbers, CMS views quality and outcomes very carefully, in a risk-adjusted manner. Given the plethora of data surrounding each transplant patient and the completeness of the data set, guidelines are very stringent: even reputable transplant programs have faced accreditation challenges. There is really no other area of surgery, and perhaps of all health care, that undergoes the same degree of clinical scrutiny as transplant surgery. Obviously, many programs are able to succeed, but new programs need to be prepared for an unparalleled degree of external monitoring.

Transplant: Exciting, But Not for Everyone
There is no doubt that a transplant program adds prestige and excitement to any organization. However, the barriers to entry (recruitment and maintenance of a varied and sophisticated workforce) and sustainability (ensuring quality outcomes under the watchful eye of accrediting bodies) make this a difficult program to start and nurture. And if these challenges were not enough, the relatively static supply suggests that market growth will be severely limited for the foreseeable future. Accordingly, only those programs that have robust resources and are located in a geographic area where competition is limited should seriously consider this offering; for most, they are best served to “deselect” this option until the supply/demand imbalance tips in their favor.

Sources: Mesiwala A et al. Saving lives and giving hope by reducing the organ waiting list. The White House Blog. June 13, 2016; NHS hooks up with dating app Tinder on organ donations. BBC News. December 14, 2015; Tan ZY. Organ donation via an app? Tinder is on board. Chicago Tribune. July 28, 2016; Organ Procurement and Transplantation Network. OPTN Data Website; CMS. Transplant Program Application Requirements.; Office of the Press Secretary. Fact Sheet: Obama Administration Announces Key Actions to Reduce the Organ Waiting List. The White House Statements & Releases. June 13, 2016; Dolgin NH et al. J Am Coll Surg. 2016;22:1054–1065; Organ Procurement and Transplantation Network. OPTN Policies Website. Last updated November 11, 2016; Sg2 Analysis, 2016. All websites accessed December 2016.

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