The ESA controversy as seen from a payer's viewpoint

October 1, 2007

In May, the FDA issued a "Black Box" warning outlining new safety information about the use of erythropoiesis-stimulating agents (ESAs). In response, the Centers for Medicare & Medicaid Services (CMS) issued its own ruling that restricts coverage of ESAs in the cancer setting. Many oncologists feel that CMS restrictions go further than what is "reasonable and necessary." As we know, where Medicare goes, private insurance companies tend to follow. To shed light on this important discussion from the payer's side, Cancer Care & Economics (CC&E) spoke with Lee Newcomer, MD, senior vice president of oncology services at UnitedHealthcare, Minneapolis.

CC&E: When the FDA issued its "Black Box" warning on ESAs, what was the reaction at UnitedHealthcare?

DR. NEWCOMER: Actually, we had been planning to institute our own policy regarding ESAs for 9 months prior to the FDA's impending "Black Box" warning.

Our policy was based on a pilot preauthorization program in our Oxford plan, which required adherence to ASCO and NCCN guidelines for ESA coverage. Based on that pilot, we put the guidelines into place, and within 6 months we saw a 30% decrease in ESA usage.

Due to the results of the Oxford program, we initiated a national policy requiring ESA claims to include a hematocrit level. If the hematocrit level exceeds 36%, the claim is denied, based on the ASCO guidelines.

CC&E: How many ESA claims does UnitedHealthcare handle per year?

DR. NEWCOMER: We process more than 500 million ESA claims annually. To accommodate such a large volume, we make certain compromises. For instance, we don't allow dosage adjustment above a hematocrit of 36% because claims systems can't read "half doses," patients don't have symptoms with a one or two point change in hematocrit, and the FDA recommends target levels of 30% to 33%.

CC&E: Do you have another example where your claims policy helped prevent unnecessary or inappropriate treatments?

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The ESA controversy as seen from a payer's viewpoint

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