Debating organ procurement policy withoutillusions

Benjamin Hippen, MD, FASN

Metrolina Nephrology Associates, P.A. and

The Carolinas Medical Center

2711 Randolph Road, Building 400

Charlotte, NC 28207

Correspondence to:bhippen@metrolinanephrology.com

The authors of a Perspectives essay in last month’sissue of AJKD argue that a core premise underlying arguments in favor of financial incentives for organ procurement is false, or atany rate, “rarely challenged by market opponents.” (MS, 4) Specifically, they contend that defenders of financial incentives assume without argument the fact of an extant and growing disparity between the demand for and supply of organs, that the current system of organ procurement has not and cannot meet the growing demand, and then exploit this (alleged) disparity and system failure to create a sense of urgency among clinicians and policy-makers topermit a trial of financial incentives.

Though not referenced, the authors go on to recapitulate many of the arguments and conclusions of the 2006 Institute of Medicine report on the organ shortage, ratifying the IOM’s conclusion that a trial of financial incentives was not warranted “at this time” (Recommendation 8.1 from (1)). A decade later, and in the face of twenty years of discussion and concerted efforts, a general sense that the transplant community has not exhausted conventional organ procurement strategies still remains influential, as does the conclusion thata trial of incentives is (still) not justified “at this time.” In this essay, I shall argue

that the authors misinterpret waitlist data; incompletely account for other evidence of “unseen” demand for organs; and fail to account for extant clinical, regulatory and financial realities which govern dialysis facilities and transplant centers in ways that undermine their theses. Whether or not a trial of financial incentives is morally defensible or even capableof garnishing broad moral support, further debates over the shortage of organs and the success of organ procurement strategies should proceed free of illusions, rooted in current clinical, regulatory and financial realities.

Measuring demand - I. The waiting list – The “seen”

The authors worry that the magnitude of need represented by the waiting list may overstate the true demand for organs, highlighting the observation that 1/3 of the patients added to the waiting list are listed as inactive (hereafter “Status 7”) within a week of listing.Historically, candidates were listed Status 7 for a variety of reasons, the salient one being that accrued time on the waiting list was the chief means of achieving priority. In regions where median waiting times to transplant were more than 5 years for some blood groups, a delay

in listing until remediable barriers to candidacy were surmounted put candidates at an unjustifiable disadvantage. This use of Status 7 listing is just a feature of how transplant centers strategically coped with the long waiting times associated with the organ shortage.

In support of their thesis, the authors relate the results of a few studies which showed that 50% of Status 7 candidates became active within 12 months of listing, 1/3 remained inactive, and40% of those who died on the inactive list did so within 2 years of listing, implying that these patients were not candidates to begin with. From these data, they conclude that the waiting list “may therefore result in an overstatement of the gap between the supply and effective demand for kidneys.”

A closer examination of the data indicates otherwise. Approximately 10,500 candidates werelisted inactive (Status 7) in 2012, of whom 5,250 became active within 12 months of listing,and 1/3 (approximately 3,100) candidates remained inactive. Which is to say that in 2012, 57,903 candidates were listed active and another 5,250 candidates listed Status 7 became active within 12 months, a total of around 63,000 candidates. From the observation that

3,100 candidates listed Status 7 in the same time frame remained inactive at 24 months and may not have been viable candidates at all, the authors conclude that the demand for transplantable kidneys “may” be overstated, but the data they cite puts that overstatement of demand at a mere 5 percent. In 2008, the same trend was represented in a respected newspaper of record as a 30% overstatement of organ demand, replete with baseless charges of false advertising levelled against the transplant community by media-favored bioethicists (2).

However, there is a different reason why the waiting list will become a less reliable surrogate for demand: A key change in the U.S. kidney allocation system implemented in January,2015 (3), will change the approach to when patients are listed for a transplant. The salient change involves shifting how candidate waiting time is calculated from the date of listing (old system) to the date of ESRD on the CMS 2728 form. This means that a candidate who is referred with 5 years of ESRD and listed willimmediately accrue 5 “points,” and so on. This change renders obsolete the old use of Status 7 to accrue waiting time. Now, Status 7 listing only confers an advantage to those listed pre-ESRD, a small proportion of new referrals: In 2011, only 12.4% of all patients received a

deceased donor transplant within one year of initiating dialysis (4).

A key component of sound waitlist management is ensuring that listed candidates are evaluated ona regular basis, and that screening tests are upto date. With few exceptions (young patients, high cPRA), candidates who come to the list withvery little ESRD time are very unlikely to receive an organ offer from a deceased donor until they accrue enough “points” (read: waitingtime) to get close to the top of the list. Candidates with less ESRD time will be competingon a rolling basis with newly referred candidates with many years of ESRD, who once listed will immediately jump ahead of those withless ESRD time in the queue. From a transplantcenter perspective if a candidate with little ESRD time does not have an available living donor, it is poor stewardship to expend the timeand resources to even evaluate and list most candidates with few “points.” Since candidates with fewer points won’t get offers, listing themearly in their ESRD course will mean their testing would have to be repeated over multiple years. Instead, rational center behavior will include delaying evaluation until the candidate identifies a living donor or accrues enough ESRDtime to accrue sufficient points to get close tothe top of the list, ensuring that testing is

current and not unnecessarily redundant. Putting off the evaluation of candidates until they accrue sufficient points will predictably contract the size of the “active” waiting list, which will appear to show an overall reduction in the demand for kidneys. But, in actuality there is no overall reduction in demand, only the demand that is “seen” as a number on the waiting list, a false and misleading perception which is just an artifact of the current listingprocess and allocation system. Many otherwise viable transplant candidates whose evaluations are put off, perhaps for years, will simply jointhe ranks of the “unseen.” (5)

Measuring demand - II. Prevalent kidney diseaseand the “unseen.”

Behind the cohort of listed candidates are legions of patients who appear on no lists, and the benefit they might derive from transplantation, and the loss they suffer by being deprived of transplantation, is largely unappreciated. Schold et al. estimated that there are between 80-130,000 additional patientsjust with ESRD who have an “overlapping risk profile” with listed transplant candidates, but who are never referred, (6) a number which couldconceivably double the current waiting list for

kidneys. And, Schold et al.’s study doesn’t include the potential transplant candidates among the much larger group of the projected 9-11% of the prevalent U.S. Caucasian population, and 16-18% of African Americans who will developCKD 4 or worse in their lifetimes (7). Were even a fraction of the patients in these groups added to the list without proportionate growth in the number of available organs, median waiting times for deceased donor kidneys would exceed the expected life-span of all but the heartiest of candidates, and would do so at the expense of a physiologic toll on the survivors. But, being unseen, they don’t “count,” becauseif they did count, the inadequacies of current organ procurement regimes in the U.S. would be even more conspicuous, and the need for reforms even more pressing. And, as a moral asterisk to a focus on first-world problems, a recent study published in Lancet conservatively estimated thatin 2010, more than 2.3 million people worldwide who clinically warranted renal replacement therapy did not receive it (8), which in countries lacking health care resources amounts to a lack of access to transplantation. Even ifmeaningful solutions to the organ shortage whichcan garner broad moral support are lacking, perhaps the least we can do is acknowledge the reality of the plight of the seen and the unseen

who bear the true costs of inadequate organ procurement strategies.

Structural barriers to transplantation

The authors list a series of structural barriersfacing these unseen patients, but draw unfoundedconclusions. Two are worth examining in detail:

“Financial disincentives at the dialysis facility level” – The authors repeat an argument which enjoys currencyin the transplant community (9), namely that dialysis facilities have a powerful pecuniary interest in not referring patients for transplantation. But, this is a misunderstanding of the extant regulatory obligations and finances of dialysis facilities,a correct understanding of which supports the opposite conclusion. Patient education regarding transplantation as a therapeutic option and documentation of an evaluation of transplant candidacy for each patient at a dialysis facility is a requirement of the CMS Conditions for Coverage, (See (10), ❡494.70 and ❡ 494.80 #10) Dialysis facilities which fail to perform and document this activity risk regulatory jeopardy.

For poor patients, the primary payor for dialysis therapies is Medicare, Medicaid or somehybrid, unless they are ineligible for these programs. The profit margins of dialysis facilities with an average payor mix of Medicare, Medicaid and commercial insurance is 3-4% (11). Crucially, a facility comprised entirely of patients with Medicare and/or Medicaid as the primary payor is financially unsustainable, because payments to facilities on a per-treatment basis for patients whose primarypayor is Medicare is frequently less than the cost to the facility to provide the treatment depending on local labor and other overhead costs to the facility. Medicaid reimbursements vary by state, but typically reimburse below Medicare rates. Although a dialysis facility does require a minimum number of patients to cover labor and operational overhead costs, the total net margin of a typical facility is achieved through cross-subsidization from collections from commercially insured patients. The import of all this is that patients whose primary payor is either Medicare or Medicaid, once referred and (probably many years later) transplanted would not impact the net margin of a dialysis facility with an average payor mix.

Furthermore, the financial landscape for facilities is about to change dramatically. A

9.5% cut in ESRD Medicare reimbursement, phased in annually through 2018 for patients whose primary payor is Medicare, is already ensconced in federal legislation (11). Recalling that theaverage facility margin with an average payor mix is 3-4%, this cut means that serving patients with Medicare as the primary payor willbecome even less financially sustainable in the future, and will require further cross-subsidization from commercially insured patients, regardless of a facility’s “for-profit” or “not-for-profit” status. The point is that if these cuts are realized, a center which has to more aggressively cross-subsidize the cost of care for most of its patients will actually be better off financially if more of these patients are successfully transplanted.

Impecuniosity and patient access – The authors argue that “...without separate reforms to address theunderlying bases of these access disparities, good candidates currently unable to access the waiting list would be unlikely to benefit from the introduction of financial incentives (or other strategies to increase donor rates).”(MS, p. 6) To be sure, if patients are unable to afford the costs of the transplant itself, immunosuppression medications and post-transplant visits and testing, increasing the number of available organs will be of little

help. But, the proper comparison for the cost of financial incentives for organ procurement isthe cost of providing maintenance dialysis. So,unlike any other strategy to increase organ procurement rates, a comprehensive set of financial incentives which successfully increases the number of transplantable kidneys from living donors and which also covers the cost of the transplant, immunosuppression, and donor and recipient aftercare makes obvious financial sense to state-based and commercial payors compared to covering the costs associatedwith maintenance dialysis (12).

Stop wasting kidneys!

A staple of opponents of financial incentives isthat incentive proposals would not even bear consideration if transplant professionals would just stop wasting perfectly good kidneys. Citing a 19% rate of organ discard in the U.S., the authors argue that if only we biopsied more kidneys before turndown, made more use of KDPI >85% organs (previously known as expanded criteria donors) and increased utilization ratesof organ donation after circulatory death just like many European centers, we’d be a long way toward solving the problem.

These arguments betray a lack of understanding of the extant regulatory burdens and financial constraints on U.S. transplant centers. In the U.S., the expected risk-adjusted rate of death uncensored graft survival for a deceased donor kidney at one year is 96% (13, Fig 6.2), and oneyear expected patient survival is 98-99%. Theseoutcomes represent the expectations of transplant centers by CMS regulators, and failure to achieve these outcomes invites intense regulatory scrutiny under threat of involuntary closure (14). In the last several years, nearly 100 transplant programs in the U.S. have gone through expensive, stressful “mitigating factors” application with CMS to avoid involuntary closure because of reported outcomes which fell below risk-adjusted “expected” outcomes, and despite the fact the data and veracity of the methodology used to calculate risk-adjustment has been heavily criticized (15). With some frequency, scrutinized centers are required to enter into a“Systems Improvement Agreement,” essentially a contract with CMS to put oversight of the transplant program into a multi-year third-partyreceivership, at extravagant expense to the transplant center, until reported outcomes improve.

Regulatory scrutiny of programs which fall below“expected” outcomes is typically accompanied by denying “Center of Excellence” status by CMS. Loss of this designation often causes commercialinsurers to cancel insurance contracts and direct referrals to other programs which maintain this designation. This is a profound incentive to embrace risk aversion (15, 16). Refashioning insurance agreements and changing ingrained referral patterns is a slow process and can pose significant medium-term challenges to the financial stability of a transplant program long after the “quality” issues have been resolved to a regulator’s satisfaction.

Bearing this daunting regulatory reality in mind, consider the European experience with organs from DCD donors highlighted by the authors as exemplary of what the U.S. centers should be doing. Reporting on 2343 kidneys fromcontrolled-DCD donors from 2000-2008, Dominguez-Gil et al. reported a primary non-function rate of 5%, a delayed graft function rate of 50%, andone year death-uncensored graft survival of 85.1% (17). As the most recent OPTN/SRTR reporton kidney transplant outcomes shows, the rate inthe United States of primary non-function with kidneys from DCD fell from just over 6% in 2003 to a low of just over 2% in 2013 (13, Fig 6.1). Ostensibly this trend would suggest improvements

in the ability to successfully transplant kidneys from DCD donors, but it isn’t an accident that the rate of decline in rates of primary non-function corresponds to a leveling off of the rate of DCD kidney procurement at 15%of all deceased donor organs over the last few years (13, Fig 4.5). This flattening is indicative of deliberate cherry-picking and precautionary principle behavior. (18, 19). A U.S. program which accepted DCD organs conferring the degree of risk reported from Europe and reported similar outcomes would have to make an existential choice: Either risk accepting many DCD kidneys in order to achieve abetter than 85% one-year graft survival in that donor cohort, or accept nearly none. Using the European outcomes data, for every failed DCD kidney at one year, a center would have to successfully manage an additional 7 DCD kidneys to one year death-uncensored graft survival (death with graft function counts as a graft failure) and have no other patient deaths or graft failures that year, or risk regulatory scrutiny and accompanying vicissitudes. At a medium volume program, a single extra death or graft failure can be the tipping point triggering regulatory scrutiny at medium-volume programs. The flattening of organ utilization rates from deceased donors is the

operationalization of risk aversion in organ acceptance behaviors, in rational response to costly regulatory sanctions if a center chooses incorrectly.

Furthermore, the current structure of reimbursement for transplantation does not adequately cover the costs of expected post-transplant complications in high-risk transplants. Researchers at the University of Michigan reported that delayed graft function alone (reported in 50% of DCD kidneys in the EU experience (17) and 40% in the U.S. experience (12)) results in a net loss to the transplant center of $4937 per case, and ECD kidneys resulted in a net loss of $5887 per case (20). As public and private payors move away from fee-for service to paying for population health management, where capitation and cost-containment is becoming the norm, there is no indication that in the near future transplant centers will be paid more for higher-risk transplants and be relieved from the need to shift costs from commercial payors to cover the costs of transplants with a higher complication rates. Commentators removed from these pressures might aver that this is but one more “structural barrier” that requires “reform,” butthis is an evasion, on par with the phrase “morestudy is needed.” Moralized exhortations to

“stop wasting kidneys,” uninformed by the clinical, regulatory, and financial realities governing the practice of transplantation in theU.S., are unhelpful.

A coda on the “promise” of financial incentives

Much ink has been spilled on the defensibility of financial incentives and interested readers can read and judge for themselves comprehensively argued briefs for financial incentives for organ procurement (21-26), consensus recommendations for a pilot trial (27), a canvassing of the data and arguments surrounding crowding-out concerns (28), or the vagaries of the Iranian system (29-30), just as a start. I’ll conclude with a few points.

The shortage of kidneys has long been with us. The existence of too many patients with kidney disease who will never enjoy the benefits of transplantation in our current “successful” system are barely acknowledged in the literature. Many of them are poor, many live ina state of precarity, many are disproportionately of a darker hue, and their plight causes insomnia for (too) few. There is no shortage of: Meetings, public debates, consensus statements, position papers, custodial

groups, press releases, point-counter-points (like this one), op-eds, and an avalanche of scholarship. An embedded ethnographer at a meeting to address the shortage can count on enthusiastic endorsements of margin-tweaking practice changes and imperatives for “further study,” with the promise to meet again, and maybe publish a paper. To take a recent example, all should hope the Consensus Conference on Best Practices in Live Kidney Donation (31) endorsed by the authors as a meansof reducing financial disincentives to living donation is successful, even if the initiative fails to increase the number of living donors byone: It is beneath argument that past and current living donors should not suffer financial penalty for giving the gift of life. But, there is little evidence that reducing financial disincentives will increase rates of living donation. While the emerging moral consensus around eliminating disincentives is heartening (32), it strikes me as the just latest in a series of well-intentioned but largely ineffectual policy improvisations over the last two decades.

Conceivably, I and my co-thinkers are wrong, andthe opponents of a pilot trial of financial incentives are correct that a trial of financial

incentives is just morally indefensible on its face. If so, perhaps we might all be spared another round of enthusiasms which pin the hopesof a dramatic improvement in organ procurement on the work of another “task force,” promising tangibly different results than the litany of similar which have been conducted in the last two decades, the wages of which have yielded, after a brief increase, flat rates of deceased donor organ procurement and flat-to-falling rates of living organ donation. Instead, perhaps we can be honest with ourselves and one another that the organ shortage is just a tragedy which our society has not been able to solve in a manner that most of our citizens can morally abide, the real costs of which are disproportionately borne by the unseen, who are quite often also those most vulnerable and leastcapable of bearing them. If so, rather than succumb to despair, this may be the opportune occasion for transplant physicians and surgeons to refocus on older professional virtues like Humean sympathy (33) and equanimity (34), to ameliorate suffering borne of a system problem which admits of no workable solution.

This paper includes data collected by the Scientific Registry of Transplant Recipients and the Organ Procurement and

Transplantation Network. The data is theirs, the interpretation is mine, and the two should not be confused.

The author would like to thank Arthur Matas, MD and Lisa Rasmussen Ph.D., for comments on the manuscript. Errors of fact, reasoning and interpretation are mine alone.

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