Optimizing Clinical Outcomes: Are We Really All in this Together?

The prospective payment system for dialysis services has been in effect since January 1, 2011. Included in the payment starting in 2012 is a 2% withhold to create a pool of money to fund a Quality Incentive Program (QIP). If facilities meet identified quality metrics related to hemoglobin (percent of patients with hemoglobin <10 g/dL; percent of patients with hemoglobin >12g/dL) and adequacy (percent of patients with URR≥65%) they may earn back the 2% withhold. There is no reward for outstanding or superior performance—the best performers get back the payment they would have received prior to the QIP being developed. While structurally this approach has been shown repeatedly to be a poor driver of improved outcomes, it is the one we have currently and the renal community has actively engaged CMS in trying to make it as effective and transparent a program as possible.

The playing field shifted drastically in June, however, when the FDA announced a new label for erythropoietic stimulating agents (ESAs) after a long negotiating process with Amgen. The new label was designed to stress safety—the black box now says that one should not target a hemoglobin >11g/dL (formerly 12g/dL), for example. On the low hemoglobin end, however, many clinicians and patients were surprised by the removal of any lower limit of hemoglobin target. The combination of these two changes essentially altered the entire paradigm of anemia management, with the elimination of any target hemoglobin range, and the recommendation that individualization of therapy was key—decisions to be made by clinicians and patients on a case-by-case basis.

CMS has quickly followed the FDA lead by announcing preliminary rules for QIP going forward, eliminating the hemoglobin <10g/dL metric to conform to the new label.  Many in the renal community, including patient groups and advocates, as well as provider group are concerned that we must all keep our eye on the low hemoglobin ball. Even though we can debate what the safe/appropriate lower hemoglobin level is, it is clear that a return to the days of severe anemia seen prior to 1989 and the introduction of EPO would be undesirable. So the renal community is trying to convince CMS to at least collect data on and report outcomes for low hemoglobin, until such time as sufficient data is amassed to allow return of a low hemoglobin metric for payment in the QIP.

Physician groups have been staunch supporters of this approach and have been strong advocates for focusing on patient safety at the extremes of hemoglobin levels. This is not only because the first and foremost responsibility of physicians is to do no harm, but it is the physicians who decide, after discussion with their patients, what hemoglobin to target, and how much EPO (and iron) is needed to achieve this hemoglobin. This puts some physicians in an awkward and uncomfortable position, trying to always maintain their role as patient advocates when evidence for benefit and harm is unclear or changing. In addition, they must be appropriate stewards of the public trust, in this case, largely Medicare resources when decisions involve costly treatments.

The challenge to practicing physicians is to be able to follow the lead of physician organizations and accept our role as the arbiter at the intersection of quality care and costs of care. The area of anemia management brings this right to the forefront, where costly therapy and a lack of clarity on the hard evidence of risk versus harm is front and center. A recent article by Bob Brook of Rand brings this issue front and center (Brook RH.  The role of physicians in controlling medical care costs and reducing waste.  JAMA 306:  650-651, 2011). Dr. Brook is one of the gurus of health outcomes research and has pioneered the use of medical evidence to determine how best to treat individual patients as well as populations. With our shrinking healthcare budget, can we justify treating all patients to a hemoglobin of 11 or higher? Would that be the best use of resources, some of which could be better spent on other more impactful care? Similarly, undertreating anemia is also wasteful—patients are more likely to require costly, and at times morbid, blood transfusions or to be hospitalized for complications of anemia. The human cost in terms of quality of life is also potentially huge.

It is clear that the way out of this conundrum is not a one-size-fits-all approach to patient care, but one that minimizes variation in care that is harmful and costly, while addressing the needs of each individual patient. Only a physician can do the latter, while collaboration between physician and provider, with use of protocols and algorithms, can achieve the former. We need to all be held accountable for the outcomes that derive from these approaches.

As the renowned lawyer Louis Nizer said, “When a man points a finger at someone else, he should remember that four of his fingers are pointing at himself.”

I look forward to your comments, until next time.

Striving to bring quality to life,

Allen R. Nissenson, MD

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