The policy allows ESAs to be initiated only when hemoglobin falls below 10 g/dL, although the products’ labels allow ESA use to maintain hemoglobin between 10 and 12 g/dL.
The survey, sponsored by US Oncology, appears to confirm an outcome that had concerned many in the oncology community when the CMS policy was announced, namely, that the stringent guidelines could impede delivery of chemotherapy-related symptom care. But despite lobbying by cancer organizations, CMS refused to modify the policy, claiming the NCD guidelines set scientifically proven hemoglobin thresholds designed solely to obviate anemia-induced blood transfusions in cancer patients.
Ironically, the survey’s primary finding was a rise in potentially avoidable blood transfusions (Table).
Although there have been growing anecdotal accounts of adverse patient events resulting from the NCD, the leadership at US Oncology felt it was important to quantify the real-life clinical effects of the policy.
“We knew of adverse events related to the NCD within our network, but the survey data confirmed that practices across the country are having similar ESA-related issues,” Dan Cohen, senior vice president of government relations and public policy for US Oncology, told ONI.
Community oncologists and hematologists were surveyed to determine how the NCD affected their Medicare patients, treatment protocols, and community practices. To ensure the results were representative of the national oncology community, the survey limited the number of US Oncology-affiliated oncologists to less than 20%.
Of the 307 respondents, 91% reported adverse patient events in the 12-week period following implementation of the NCD. On average, the number of patients requiring potentially avoidable transfusions accounted for approximately 17% of their Medicare patients in the 12-week period preceding the survey. However, 9% said that the NCD was creating an avoidable need for transfusions in 50% of their Medicare patients.
