Most Americans whose kidneys fail (93%) qualify for the Medicare End Stage Renal Disease (ESRD) Program, which provides most of the health care they need, not just kidney disease treatment. Because Medicare is paying for most dialysis, the Medicare program makes the rules.

Before any new drug comes onto the market (including EPOGEN®, back in 1989) it must be approved by the U.S. Food and Drug Administration (FDA). The FDA approves a "package insert", which includes things like what health problem(s) the drug can be used for, what side effects have occurred, and what dose should be used. The EPOGEN® package insert stated that the drug should be used to reach a target Hct of 30% to 36%—well below normal levels for healthy people. Initially, Medicare decided to pay for enough EPOGEN® for patients to reach this target, and no higher.

DPC Joins With Dialysis Community for Anemia Policy Victory
DPC, in collaboration with the larger dialysis community, has succeeded in convincing Medicare to revise its April 2006 EPO Monitoring Policy (EMP) affecting anemia management in dialysis patients. 

The policy issued in April stated that if a dialysis patient’s Hematocrit (Hct) level went over 39% in one month, Medicare would cut the amount of EPOGEN® (EPO) it reimbursed for by 25% for the following month. In effect, this meant the doctor would cut the amount of EPO s/he prescribed the patient by 25% that next month.

DPC and the entire dialysis community were concerned that this policy was compromising patient care.  Dialysis centers bill Medicare on a monthly basis for amount they spend on EPO they give to patients. Under the April policy, Medicare paid for all claims for EPO where the patient’s concentration of red blood cells did not exceed a Hct level of 39% (or a Hemoglobin level of 13). (Note:  Normal Hct levels are 42% to 54% in healthy men and 36% to 48% in healthy women.)

The problem was that the April policy compared your Hct and EPO dose month by month.  But your doctor manages your anemia with EPO on a dose by dose basis.  The number of dialysis treatments you get in any given month varies from 12 to 14, due to the length of the month and how the days of the week fall.  (For instance, a MWF patient got 12 treatments in April 2006, and 14 treatments in May.)  Additionally, sometimes you miss a treatment in your home center due to travel or hospitalization.  If your Hct went over 39% in a month when you got fewer treatments, and your EPO was reduced by 25% for the following month when you got more treatments, the result could be that your EPO dose per treatment was cut drastically possibly sending you on the dreaded anemia “roller coaster ride”.

Over the summer, DPC joined with other members of the dialysis community to express our concerns to CMS’s Chief Medical Officer in a telephone conference. Both individually and united in a coalition called Kidney Care Partners, we sent letters to CMS outlining the risks of the policy to patient well-being.

In response to these concerns, in late August, CMS issued a revised EPO Monitoring Policy (“EMP”), which took effect October 2.  This revised policy removes the strict requirement of a 25% reduction over the prior month’s total EPO dose.  Instead, the physician can lower the EPO dose by any percentage at any point in the month to get the Hct level back down below 39%.  The policy generally says that that reduction should be maintained for the rest of the month (or billing cycle), but does recognize that in certain circumstances, such as a missed treatment or hospitalization, the dose could be increased again during the month.  These revisions should help avoid the roller coaster ride, and allow for more optimal maintenance of your Hct level.  The policy also clarifies that the EPO dose reduction requirements do not apply to, and should not have ever applied to, home dialysis patients.

All in all, DPC believes this modification to the April policy is a victory for dialysis patients, and a wonderful example of how important it is to make our voice heard. 

It is also important that we as patients continue to take an active role in our anemia management.  What can you do? Monitor your Hct level closely, and observe how you feel as it changes.  If you feel tired and would like to have more energy, talk to your doctor about what you can do in terms of EPO, as well as diet and lifestyle changes, to keep your Hct at a level that’s optimal for you.