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CMS ANNOUNCES DRAFT REVISED POLICY FOR MONITORING EPO
The Centers for Medicare & Medicaid Services (CMS) announced today a draft, revised policy for monitoring claims for erythropoietin (EPO) for end stage renal disease (ESRD) patients.
The draft monitoring policy proposes to consider both hemocrit/hemoglobin levels and EPO dosage levels. The policy seeks to monitor incentives to keep hemocrit/hemoglobin levels in the target range while discouraging excessive dosing of EPO.
The draft policy was posted today on the CMS coverage website at http://www.cms.hhs.gov/coverage/8b.asp. CMS is inviting public comment on the draft. Instructions on how to submit comments can be found at this site.
“Anemia is a critical health problem for Medicare beneficiaries with ESRD, and we want to make sure our payment for erythropoietin – a critical treatment for many cases of anemia – is based on the best scientific evidence available and works in practice,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “We invite the ESRD community, national experts, and patients to provide comments on this specific proposal and its potential effects on patient outcomes.”
In the fall of 2003, CMS solicited scientific information from the ESRD community to assist the agency in ensuring its EPO monitoring policy reflects current scientific evidence.
Medicare’s current policy restricts review of EPO claims to post-payment review based on a 90-day rolling average of claims. Beneficiaries with a rolling average hematocrit level of 37.5 percent or greater may be targeted for further review and potentially may not have a claim for EPO reimbursement. The treating physician may submit documentation that demonstrates a medical need for the higher hematocrit levels.
The scientific literature and comments Medicare received concluded that there is considerable natural variability in individual patient hematocrit levels making it difficult to consistently maintain a hematocrit level within the narrow range of 33-36 as is currently recommended by the National Kidney Foundation.
The draft monitoring policy proposes to consider both hematocrit/hemoglobin levels and EPO dosage levels. The policy aims to monitor incentives to keep hemoglobin/hematocrit levels in the target range while discouraging excessive dosing of EPO.
The proposed policy was developed after the public solicitation of scientific evidence was issued last fall. CMS will not issue a final EPO monitoring policy until it receives input on today’s draft from the ESRD expert community.
Persons with ESRD are typically anemic, a condition characterized by an insufficient amount of red blood cells. Anemia contributes to a variety of symptoms including weakness and fatigue. The standard of red blood cell adequacy is hematocrit. The hematocrit describes the fraction of whole blood that is comprised of packed red blood cells after a blood sample has been separated into plasma and cellular components. In most patients the normal hematocrit level is between 38 percent and 54 percent.
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