We support an evidence-based uniform coverage policy for anemia management of Medicare patients undergoing chemotherapy treatment through the development of a National Coverage Determination (NCD), and share CMS' concern regarding the safety of Erythropoiesis Stimulating Agents (ESAs) when administered to patients who are above the hemoglobin (hgb) level of 12g/dL.
Over 40 scientific studies support the safe and effective use of ESAs in chemotherapy induced anemia when administered up to hgb 12g/dL. There is no evidence of tumor progression or increased mortality in the use of ESAs in accordance with the FDA label up to hgb 12g/dl.
The current NCD poses significant health risks to Medicare cancer patients. As no published research indicates that stopping ESAs at hgb of 10g/dL will be safe or effective, this policy exposes cancer patients to needless blood transfusions with associated risks.
The NCD, by limiting our ability to use supportive care drugs appropriately, hinders oncologists' ability to provide life saving or life prolonging treatments and will impose different, less effective cancer treatment regimens.
The NCD does not acknowledge the valuable improvements in quality of life which numerous studies have documented to be derived from appropriate ESA usage.
The NCD forces physicians and patients to choose between the standard of care versus what Medicare's coverage policy will reimburse thus creating a two-tiered system of care where Medicare patients receive substandard care.
We urge CMS to:
1- Acknowledge as the clinical standard of care for determining
medical necessity in the use of ESAs the October 22, 2007
evidence-based guidelines for patient treatment established by the
American Society of Clinical Oncology (ASCO) and the American
Society of Hematology (ASH);
2- Reconsider the ESA NCD and alter the final coverage determination to
reflect the ASC
|SOURCE US Oncology|
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