MD

Document ID: CMS-2010-0219-0009
Document Type: Public Submission
Agency: Centers For Medicare & Medicaid Services
Received Date: September 09 2010, at 12:00 AM Eastern Daylight Time
Date Posted: September 20 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: August 12 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: September 24 2010, at 11:59 PM Eastern Standard Time
Tracking Number: 80b49f20
View Document:  View as format xml

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I would like to comment on the Anemia management in patients with End Stage Renal Disease. In your bundling plan the reimbersement takes into account the Hemoglobin level in the hemodialysis patients. You suggested a weighted score depending on the Hemoglobin levels less that 10 g/dl or more than 12 g/dl. Please take into account the new regulation by the FDA and Amgen that resulted in the Medication Guide for the Erythropoesis stimulating agents including Aranesp that clearlly states that a patient can " Die" if he or she is treated to a Hemoglobin level more than 12 g/dl. This is very serious and the patients are taking note of that. Accordingly, as a Nephrologist I am aiming to keep all the Hemoglobins of my patients below 12 g/dl for the reasons specified in the " Medication Guide for Aranesp" and to avoid litigation issues in the future. Because of that I will have patients with Hemoglobins less than 10 g/dl but hopefully not lower than 9 g/dl and accept that very well as there is no evidence based medicine to say a hemoglobin of 10 g/dl is better than 9 g/dl. But we know that patients can "Die" if there hemoglobin is above 12 g/dl. Because of the fact that patients can "Die" if their hemoglobin is above 12 g/dl we should accept a very small percentage of these patients achieving this level and accept more patients with hemoglobin levels below 10 g/dl but not below 9 g/dl. Therefore, please do not use the National Performance Standard for Hemoglobin to base your weighted score and accordingly your reimbersement for the Hemodialysis units. Essentially you need to revise this anemia management completely to avoid litigation issues that you and me know can be desastorous. I thank you for your attention to this matter. Elias Ghandour.

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