Press Releases

MEDICARE TO MODIFY ITS CLAIMS MONITORING POLICY FOR USE OF ESAS FOR ANEMIA TREATMENT IN DIALYSIS

MEDICARE TO MODIFY ITS CLAIMS MONITORING POLICY FOR USE OF ESAS FOR ANEMIA TREATMENT IN DIALYSIS

The Centers for Medicare & Medicaid Services (CMS) announced today it is strengthening its erythropoiesis stimulating agent (ESA) Monitoring Policy (EMP) for claims for ESAs used to treat anemia in Medicare beneficiaries who are receiving dialysis treatment for end stage renal disease (ESRD).

Since the last modification to this policy in October 2006, there have been several publications and a Food and Drug Administration “black box” warning that emphasize the risks facing ESRD patients who receive large doses of ESAs and have hemoglobin levels above 12 g/dL.  Current Medicare coverage policy continues to provide that the hemoglobin be maintained between 10 and 12 g/dL.  In response to the safety concerns, we are modifying the ESA monitoring policy to provide greater restrictions on the dosage amounts of ESAs for which payment is made for patients with levels that rise  above 13 g/dL. 
 
“CMS is committed to establishing and maintaining policies in all areas of Medicare that promote efficient and appropriate use of medical interventions, protect beneficiaries, and enable providers to furnish high quality care,” said Leslie V. Norwalk, CMS acting administrator. 

Medicare’s current EMP requires a 25 percent reduction in the reported ESA dosage used by the dialysis facility for which payment will be made if the facility reports that the patient’s hemoglobin level exceeds 13 g/dl the facility includes a code, the GS modifier, on the claim.  The GS modifier signifies that the facility has reduced the patient’s ESA dosage as a response to the hemoglobin/hematocrit level.

In the revised policy, CMS is adding a provision that will reduce by 50 percent the reported ESA dosage used by the dialysis facility for which payment will be made if the facility reports that the beneficiary’s hemoglobin has exceeded 13 g/dL for three consecutive months including the current billed month.  CMS will reduce the reported dosage even if the GS modifier is included on the claim.

In addition, under the revised policy Medicare will not pay for dosages of epoetin alpha (Epogen) in excess of 400,000 IUs per month or darbepoetin alpha (Aranesp) in excess of 1200 mcg per month.  Dosages at these levels are unlikely and are generally the result of typographical errors rather than accurate dosage reports.  CMS has lowered these limits from 500,000 IU and 1500 mcg respectively, after reviewing data from the current EMP.

While we are issuing the above as a final policy, we are encouraging the public to comment on this modification.  CMS will use these comments to decide whether the Agency should further revise the policy.  The final ESA claims monitoring policy can reviewed at http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=11.dialyssis

ESAs are man-made versions of erythropoietin, a hormone that is produced naturally in the kidney and stimulates the bone marrow to make more red blood cells.  ESAs are used to treat anemia and reduce the need for blood transfusions in patients with ESRD and chronic kidney failure.  Medicare covers the use of ESAs in the treatment of anemia in beneficiaries with ESRD to maintain a hematocrit level between 30.0 and 36.0 percent.  This is consistent with the Food and Drug Administration (FDA) label instructions for erythropoietin.

“We feel strongly that these revisions will support the clinically sound and prudent management of anemia in dialysis patients,” said Barry Straube, MD, CMS’ Chief Medical Officer and a nephrologist,
The revised policy will be effective for claims of service on and after Jan 1, 2008.