February 11, 2011

Louis Jacques, M.D.
Office of Clinical Standards and Quality, Coverage and Analysis Group
S3-18-17
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Jacques,

On behalf of Dialysis Patient Citizens (DPC), America’s largest dialysis patient organization, I am writing today to express our organization’s grave concerns about the presentations and line of questioning used at the January 19, 2011 MEDCAC meeting. On a wide variety of issues, DPC seeks to ensure the patients’ point of view is heard and considered by decision makers.  As CMS considers a National Coverage Determination (NCD), we feel it is important the agency consider the realities patients experience with ESA use. To this end, I would like to highlight three major concerns our organization has in relation to the discussions that came out of the January 19th meeting.

1. The questions presented to the panel were too limiting in their focus on patients who have received a transplant. This is unfortunate because this MEDCAC panel was unable to vote on or deliberate the impact ESAs have on patients who are awaiting a kidney transplant and may not be able to receive one or those who experience longer wait times due to high panel reactive antibodies (PRA) associated with transfusions. In addition, the panel was unable to consider the impact transfusions versus ESAs have on those dialysis patients who will never be eligible for a transplant.
    
2. Evidence presented at the meeting completely disregarded patients’ self-reported quality of life. While we understand how patients feel or the quality of life they experience at different hemoglobin levels is difficult, if not impossible, to measure, this does not give reason to dismiss it. During the CMS presentation by Dr. Elizabeth Koller, she stated there was no evidence patients experienced improved quality of life with ESAs and that hemoglobin levels in the range of 6g/dl – 10g/dl did not require a blood transfusion.  Avoidance of a blood transfusion, while important is not the only issue patients experience with lower hemoglobin levels. Patients at the MEDCAC meeting and those at the previous meeting have attested to being able to “feel” changes in their hemoglobin, and when their hemoglobin is lowered, they experience greater fatigue, weakness and inability to think clearly, among other symptoms. Patients have reported this experience with even the slightest lowering of their hemoglobin. The assertion by employees of CMS that there is no evidence of improved quality of life with ESA use leads us to be very concerned that patients’ testaments to improved quality of life with ESA use are being disregarded by the CMS Coverage and Analysis Group.
    
3. The Coverage and Analysis Group appears to be investigating a very different path from the Quality and Improvement Group. According to the FDA, ESAs are indicated to treat dialysis patients with anemia to maintain their hemoglobin levels between 10-12 g/dl. In addition, the new ESRD Quality Incentive Program (QIP) has finalized measures to hold dialysis facilities accountable to maintaining hemoglobin levels above 10g/dl, but less than 12g/dl. The QIP recognizes the importance of maintaining dialysis patients’ hemoglobin above 10 g/dl by placing an additional weight on the performance score for that measure. Any coverage and subsequent reimbursement decision must be in alignment to ensure dialysis facilities receive adequate reimbursement to achieve these important quality goals for patients.

Ultimately, we believe physicians and patients should be the decision makers about patient care. We acknowledge the FDA and clinical studies have shown there to be risks associated with ESA use. The FDA has taken steps to ensure patients are made aware of these risks, as has our organization and others representing kidney patients and nephrologists. As with all medical decisions, we believe every patient should be informed of the risks and benefits of available medical treatments and be given the opportunity to weigh those risks and benefits so they can ultimately make an informed decision. Reimbursement should not limit or otherwise interfere with this patient-physician decision making relationship. 

Before deciding on issuing an NCD we believe it is necessary the Coverage and Analysis Group consider dialysis patients’ point of view, experience with ESA use and role in making decisions about their own health care. We are happy to engage in further dialogue and put you in direct contact with more patients if you wish to hear further testimony. Please do not hesitate to contact us if we can be of further assistance in your decision making process.

Sincerely,
 
Tonya L. Saffer
Interim Executive Director

Cc: James Rollins, Director Division of Items and Devices