Oncologists Point to Science, Quality Outcomes, Safety Concerns and Interference with Doctors' Expertise as Reasons to Revisit NCD
CHICAGO, Oct. 24 /PRNewswire-USNewswire/ -- Leading oncologists from across the country gathered in Chicago today to discuss concerns and reach consensus over the new National Coverage Decision (NCD) for the use of Erythropoiesis Stimulating Agents (ESAs) in cancer treatments for Medicare patients. The meeting, which brought together approximately 50 of the nation's leading oncologists, was chaired by Dr. Peter Ellis, Medical Director of the University of Pittsburgh's Medical Center (UPMC) Cancer Centers.
ESAs are used to boost patients' red blood cell counts when undergoing chemotherapy, which allows them to better cope with the treatment regimen. The NCD is putting restrictions on Medicare reimbursement for hemoglobin levels at 10g/dL. Since the new NCD guidelines were first introduced in late July by the Centers for Medicare and Medicaid Services (CMS), oncologists and patients from across the country have come forward expressing concern over what many regard as interference by the government on cancer doctors' medical decisions for their patients.
The oncologists created a statement today based on remarks from leading health policy experts and a satellite briefing from Washington, DC featuring physicians who had participated in meetings at the Centers for Medicare and Medicaid Services (CMS) where they discussed revisiting the NCD allowing doctors to administer ESAs before a patient's hemoglobin level drops below 10. Since Medicare will not reimburse at any amount above a hemoglobin level of 10, patients could be subjected to blood transfusions which many oncologists regard as unnecessary and expose the patient to added health risks.
The final statement, which is being sent to policymakers in Washington and widely distributed among their peers and patient groups across the country, reads as follows:
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 ASCO-ASH guidelines.
|SOURCE US Oncology|
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