The ESA controversy as seen from a payer's viewpoint

ABSTRACT: 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?

DR. NEWCOMER: Yes. About a year and a half ago, we did another pilot study at UnitedHealthcare showing that 12% of patients on Herceptin [trastuzumab] therapy did not overexpress the HER2 gene. We now prevent this by reviewing the HER2 test as a requirement of coverage beyond the first dose.

It's important to note that this policy is well over a year old and we are still getting submissions for underexpressed HER2 patients. So it has helped us understand what's going on in the field.

The oncologists were actually initiating treatment correctly; however, their actions were based on erroneous reports from pathologists. Our reviewers examine the original pathology report. Many of them are reported as "positive" in the summary, but the actual numerical results are negative, according to ASCO and CAP [College of American Pathologists] guidelines. We discovered the issue of incorrect reporting by directly reviewing the pathology reports.

HER2 testing has been examined in the literature, and studies indicate that there is about a 30% error rate in pathology reports. So there's a lot of refinement that needs to be done at the testing level.

CC&E: How can payers take a more active role in quality assurance?

DR. NEWCOMER: I think it's already beginning to happen. Speaking for UnitedHealthcare, we're starting to build some very good programs cooperating with the major organizations that sponsor practice guidelines. We have a scientific oncologic advisory board, and consequently both patients and oncologists are beginning to understand that coverage decisions, such as in the ESA case, are made by fairly reasonable scientific deduction.

We are asking physicians to adhere to their professional society's guidelines. In effect, we try to work with the oncology community in order to make better medical judgments for our patients.

CC&E: Any closing thoughts?

DR. NEWCOMER: A claims system isn't a perfect mechanism for clinical monitoring, but it can be a very effective tool in the process. Our goal is to use our claims system as a reminder to prevent clinical missteps before they reach patients in the doctor's office. Moreover, the experience with ESAs may provide the momentum to begin installing decision support systems in community oncology practices. After all, the common goal is to ensure safe, high-quality care for all of our cancer patients.