The Centers for Medicare & Medicaid Services (CMS) today announced a national strategy for monitoring claims for the drugs epoetin alfa (Epogen®) and darbepoetin alfa (Aranesp®) for anemia management in patients with End Stage Renal Disease (ESRD) and who are dialyzed in renal facilities.

CMS’ new monitoring policy supports the Agency’s existing policies on Epogen® and Aranesp® administration, and considers both hematocrit/hemoglobin levels and erythropoietin (EPO) dosage levels.  Specifically, the monitoring policy examines dosing levels of EPO or Aranesp® that are in line with the hematocrit/hemoglobin “target ranges” identified in the drug labeling approved by the Food and Drug Administration (FDA).

“Our agency has worked to review the literature and consult with experts in the field to develop a means of monitoring erythropoietin usage without the risk of a negative impact on the healthcare outcomes of this vulnerable population,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.  “We are pleased to have found a reasonable means for monitoring erythropoietin dosages that are in line with the FDA-approved labeling for these drugs and with kidney disease industry guidelines without establishing dosage limits.”

Nearly all patients with ESRD suffer from debilitating anemia.  Much of this anemia can be managed through pharmacologic therapy.  CMS has had a quality initiative for years to encourage appropriate management of anemia in ESRD patients.

Anemia severity is commonly monitored by measuring the hematocrit, a simple blood test that measures the proportion of red blood cells in whole blood.  The hematocrit result is expressed as a percentage.  Alternatively, the hemoglobin concentration in whole blood may also be used to monitor anemia.  The hemoglobin result is expressed in grams per deciliter (g/dl).  As a practical matter, the numeric value of the hematocrit is generally three times the value of the hemoglobin measured simultaneously, though they are expressed using different units.  Thus, for example, a hematocrit of 30 percent corresponds to a hemoglobin concentration of 10 g/dl.

Current kidney disease industry guidelines call for maintaining the hematocrit level within a narrow target range of 33-36 percent.  However, because many factors such as nutritional status, infection, and bleeding may cause the hematocrit to fluctuate, it is not easy to manage patients to this narrow range.  Some patients are above the target in one month and below it in another.

ESRD facilities submit claims monthly for Epogen® and Aranesp®.  The claim form includes fields where the facility must report the beneficiary’s hematocrit or hemoglobin test result.  Commonly, a dialysis patient is tested many times during a month.  Under the claims monitoring policy, the facility will report the hemoglobin or hematocrit result from immediately before the start of the current billing period.  Thus, the dose of Epogen® or Aranesp® administered for the billing month can be related to the test result on which the month’s dose was based.

Also under the monitoring policy, CMS will initiate monitoring if the hematocrit reaches 39.0 percent (hemoglobin 13.0 g/dl).  If the ESRD facility has reduced the dosage by 25 percent in the month where the starting hematocrit is above 39.0 percent (hemoglobin 13.0), it must report this by using modifier GS on the claim form.  If the facility has not reduced the dosage, and there is no medical documentation to support the higher dosage, CMS will reduce payment to the level it would have been had the facility reduced dosage by 25 percent.  In these circumstances, we will give the individual or entity the appropriate notice and an opportunity to appeal our determination under the existing appeals regulations.

The monitoring policy also puts in place an edit for maximum dosage of and Aranesp® in a single month.  The maximum level for Epogen® is 500,000 IU per month.  For Aranesp®, the maximum is 1500 mcg per month.  These levels far exceed what we would reasonably expect to see for the dosage.  Thus claims with higher dosages are likely to indicate a typographical error in reporting the dosage rather than a medically necessary dosage of the drug.

“This step signals CMS’ commitment to ensuring that its existing policies on Epogen® and Aranesp® coverage are implemented as they were intended—to battle the anemia that plagues most patients with chronic kidney disease,” Dr. McClellan said.   “CMS will continue to devote resources to monitoring the administration of this key facet of end-stage kidney disease management.” 

CMS initially announced its intent to develop this policy in the fall of 2003 with a solicitation for scientific literature from the industry.  After analyzing the literature, CMS developed a proposed policy that it announced in July 2004 and solicited public comment for 90 days.  The final policy announced today is significantly different than that announced last year and was largely shaped by the comments CMS received.

“We are optimistic that this claims policy is going to meet our needs and the needs of Medicare beneficiaries,” said Barry Straube, M.D., a nephrologist acting as CMS’ Chief Medical Officer and also serving as the Acting Director of CMS’ Office of Clinical Standards and Quality.

The new monitoring policy will become effective for services furnished on or after April 1, 2006.   More information may be found at https://www.cms.hhs.gov/coverage/8b5.pdf.