Regulation and Accountable Care in Kidney Transplantation: Are There Unintended Consequences?

By Jesse D. Schold, PhD, MStat, MEd

The benefits of kidney transplantation have been well documented for more than a decade. For the typical kidney transplant candidate, transplantation is associated with improved life expectancy, quality of life and reduced costs compared to maintenance dialysis.

Moreover, this benefit is applicable for patients with multiple comorbid conditions, in countries with diverse healthcare delivery systems, and with the use of donor organs with increased risk factors.

The primary barrier to kidney transplantation is the limited donor supply relative to the number of candidates.

From 1989 to 2006, the number of national solitary kidney transplants in the United States increased in each consecutive year (Figure 1). In 2006, there were 17,095 transplants performed, including 9,913 from deceased and 6,572 from living donors.

Figure 1. National Kidney Transplant Volume by Year

Since that time, the national volume of transplants has remained stagnant despite an increase in the number of candidates from 32,356 in 2006 to 36,396 in 2013. Currently there are more than 108,000 patients on the national kidney transplant waiting list.

Linking Transplant Outcomes with Funding

A significant change in the field of kidney transplantation has been the increased impact of quality oversight. In 2007, the Centers for Medicare and Medicaid Services issued a Conditions of Participation for transplant centers that explicitly links transplant center performance, as measured by risk-adjusted graft and patient survival, with the availability of public funding. Centers that fail to meet these quality standards may lose Medicare support and are unlikely to continue to sustain a transplant program.

An important ongoing question is whether the stagnation in national transplant rates is associated with the increased emphasis on quality oversight. Members of the transplant community have raised this concern and one national study1 has demonstrated that, on average, centers that receive low performance evaluations significantly reduced their transplant volumes while other centers continued to increase rates during the same time period.

Risk Aversion?

A potential mechanism for this relationship is that centers become risk- averse – less likely to accept candidates or donor organs with perceived heightened risk for poor outcomes. Importantly, because quality metrics are based on risk-adjusted models (accounting for many factors associated with graft loss and patient death), this type of risk aversion may or may not improve center performance but reduces access to care for candidates who may benefit from the procedure.

Quality assurance clearly has an important role in healthcare. The many emerging quality metrics are not unique to transplantation. Moreover, quality oversight likely provides important benefits to the field of transplantation.

However, there is probably a balance that should be struck between regulatory oversight and the potential (and unintended) reactions it may generate among healthcare providers.

In kidney transplantation, the wealth of empirical evidence suggests that increasing transplant rates has clear benefits for end-stage renal disease patients. The degree to which outcome quality regulation has impacted transplant rates is not completely clear but is important to monitor.

In addition, metrics that incentivize the growth of transplantation may be important to consider in conjunction with current outcome measures. In the end, prioritizing policies that stimulate access to transplantation – such as incentives for early referral and evaluation of candidates – likely will have the greatest public health benefits.

Dr. Schold is an associate staff member of Cleveland Clinic’s Department of Quantitative Health Sciences and Director of Outcomes Research for the Kidney Transplant Program. He can be reached at scholdj@ccf.org or 216.444.6254.

References

1. Schold JD, Buccini LD, Srinivas TR, Srinivas RT, Poggio ED, Flechner SM, et al. The association of center performance evaluations and kidney transplant volume in the United States. Am J Transplant. 2013;13(1):67-75.