Keeping our "Eye on the Prize"

Currently, transplantation remains one of the most regulated areas of health care. A variety of groups, from payors to UNOS to CMS, have policies that ostensibly encourage the highest quality of patient care. However, these policies do not always align with each other or with the best interests of patients. I have invited my colleague Dr. Jesse Schold to share his thoughts on the current state of transplantation policies.

Jesse Schold, PhD, AST Board Member

Recently, Dr. Allan blogged about timely and important issues related to incentives and disincentives for living organ donors in the United States. A prominent theme in the discussion around this topic is how transplantation policies may influence behavior and ultimately patient outcomes.

Across many disease groups and patient populations, there has been a proliferation of quality metrics required from healthcare providers by both public and private entities. These metrics matter: particularly since the adoption of the Conditions of Participation by CMS in 2007, there has been emerging evidence that quality measures of transplant centers and OPOs influence practice. As such, we must carefully evaluate the impact these measures have on patient care. Are we tracking the right metrics?

I have heard anecdotally from many in our community how "displeased" they are (to put it nicely) about the magnitude of oversight and, in many cases, about the vilifying regulators who "punish" transplant centers after identifying "poor performance."

I have several thoughts about the current status of quality oversight in our field. First, while it may be a natural reaction to blame regulators (e.g. CMS, UNOS’ Membership & Professional Standards Committee, private insurance companies) for these issues, in many ways we have no one to blame but ourselves. For example, we measure and prioritize clinical outcomes such as 1-year graft survival. The original intent of measuring this type of outcome was not to “flag” low providers, yet these metrics are considered a standard in our field – without any clear alternatives for regulators to use when evaluating quality assurance. Moreover, we have not maximized the opportunity to learn from these metrics and share best practices – instead, they are largely only viewed as punitive measures.

The organs available for transplantation are scarce, while the list of patients who need a transplant continues to grow. In a perfect world, all of our donor organs would be an ideal match for our patients; in reality, we sometimes have transplant candidates and donors with numerous risk factors which may concern providers about the potential effect on metrics even if transplantation is the best option for these patients. So the question remains, how can we use metrics wisely to keep our patients safe and improve patient care without making our community more risk averse than necessary, in the interest of saving more lives?

We have an obligation to our patients to critically examine how we regulate quality in our field. Circling back to the title of my blog, we need to keep our "eye on the prize": metrics must improve patient outcomes; metrics must not place providers in circumstances where the best interest of patient is at odds with the best interest of the providers. This may include a paradigm shift incorporating different, or a combination of, measured endpoints (e.g. transplant rates, value of care, organ acceptance).

Robust scientific evidence indicates that transplantation increases life expectancy and quality of life. Metrics we develop for transplant centers, OPOs, and perhaps even pre-transplant providers (e.g. dialysis programs) must be strategically aligned to promote this intervention.

We must discuss the development and implementation of alternative approaches that can replace our current standards. As with any healthcare policy, we should:

  • clearly describe what the intended effects of quality metrics are,
  • carefully consider potential deleterious or unintended consequences of these metrics, and
  • articulate a clear analytical plan for measuring the effects in our population.

Beyond policy interventions, individual transplant centers and OPOs have the responsibility to reflect on their own practice patterns related to quality oversight. The familiar narrative of, “We received an SRTR flag, so we limited listing patients or donor organs with (fill in the blank with a risk factor)” statements may not always be accompanied by careful examination of whether these factors truly impact measured performance.

Vague notions of "poor risk adjustment" and "unfair metrics" that cloud judgment about selecting transplant candidates and donor organs should not be a prominent consideration affecting life and death decisions. Given the plethora of data available in our field, a critical examination of factors that affect outcomes should be a standard of care among centers to supplant any irrational (non-empirically based) behavior.

Be a part of the solution:

  1. Consider what your own program examines as appropriate indicators of program health or program success.
  2. Critically reflect on whether your own practice patterns have altered as a result of current quality oversight, and whether these changes are truly empirically supported or could be more carefully scrutinized.
  3. Proactively consider modifications which maintain quality assurance and prioritize outcomes.
  4. Participate in regional discussions on the topic of transplantation policies and metrics.
  5. Consider joining the AST’s Public Policy or OPTN/UNOS Policy Committees – email to express your interest.
  6. Take advantage of the opportunity to provide public comment feedback when proposals are out for consideration.

We have unique opportunities in our field to use data to support clinical care, share best practices, and improve patient outcomes. It is vitally important that we do this in parallel with regulatory activities while keeping our eye on the prize.


I am afraid that's not a simple. Even if quality metrics goals and effects would be clearly described, that does not stop regulators. They just do their job, and they need transplant metrics to evaluate transplant centers. The metrics could be used in combination with something or so. Konstantin Tchilikidi, M.D.

The phenomenon of "regulatory creep" is perhaps one of the biggest threats to health care today. An unregulated market is extremely efficient at generating low-cost, high-quality products (think of computers and smartphones). Unfortunately, in an unregulated market, these benefits are not always distributed fairly or equally to those in need. This is the reality that opens the door for regulation. Then, once regulation is introduced, inefficiencies occur, costs rise, and then someone else tries to solve these problems with more government intervention. If you look at the areas in our everyday life in which government intervention (regulation, subsidization) is greatest, namely health care and education, these are the same areas where costs have risen much higher than inflation. Unfortunately, this is the price that some of us pay, so that everyone can have access to health care or education. Ultimately, however, we will all end up with great access to something mediocre. Jim

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