When regulations and quality of life clash

ORLANDO--A nurse at the session on quality measures during the American Nephrology Nurses Association annual conference, held here last week, had a dilemma, and shared it with the audience. Her home dialysis patient was enjoying the benefits of a hemoglobin of 12.5 g/dL. But the clinic knew that maintaining that high range would get them "dinged" by CMS' new Quality Incentive Program. So the clinic wanted to ratchet down the patient's ESA dose, and subsequently his hemoglobin below the allowable 12. The patient wanted nothing to do with it.

What next?

It's easy to imagine that many clinics may be facing the same problem. In fact, recent data presented by the Dialysis Outcomes Practice Pattern Study group suggests many already have: ESA use (based on dose) was down 23% in 2011, as was the number of doses delivered. Even more specific to the nurse's dilemma: from August 2010 through December 2011, the percentage of patients with hemoglobin greater than 12 g/dL declined from 32% to 22%--a 10% drop.

Patients have seen erythropoiesis-stimulating agents, like Amgen's Epogen and Affymax's new drug Omontys, as a means of helping them cope with dialysis. Think of being tired after a long day at work. Imagine that feeling after each treatment. ESAs help correct the problem. But now, patients are being told those 'good feelings' may change as clinics abide by the new QIP.

And there is some concern that the pendulum may be swinging too far the other way. The DOPPS data show that the percentage of patients with hemoglobin less than 10 g/dL has increased from 9% to 16%, and the percentage with hemoglobin less than 9 g/dL increased from 3.0% to 5.2%. To summarize: more patients are not only being pushed below their favored >12 g/dL, but below even 10.

The QIP is not necessarily the culprit; CMS had little choice but to follow the FDA changes to the ESA black box warnings (which now suggest the drug(s) only be used to "avoid transfusions"), and recent research suggesting that higher hemoglobins may be putting patients at risk. Not necessarily the high hemoglobins, but the heavy use of ESAs to get people to those high hemoglobins. Unfortunately, regulators –- and the nephrology speciality –- aren't quite sure yet how to separate the two.

So bringing this full circle: What do you tell patients? The ESA black box warning on both Omontys and Epogen says it all: "ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression orrecurrence."

Those are indeed risks. But well-being and quality of life is important too. How do we find the happy medium?