Late Friday, the US Centers for Medicare & Medicaid Services (CMS) announced it is strengthening its monitoring policy with regard to erythropoiesis stimulating agents (ESAs)—the Amgen drugs Epogen and Aranesp—used in the treatment of anemia in end-stage dialysis patients on dialysis.
This was an expected move after studies released earlier this year found an increased risk of heart attack and death in dialysis patients who had been given the drugs to increase hemoglobin levels above 13 g/dL. The US Food and Drug Administration (FDA) has approved the drugs for the treatment of anemia in dialysis patients by maintaining hemoglobin levels between 10-12 g/dL. Earlier this year, the FDA issued a “black box” warning for overuse of the drugs to treat anemia in dialysis patients.
While the Medicare guidelines will continue to stipulate that hemoglobin levels be maintained between 10-12 g/dL, a new provision will provide for closer monitoring of hemoglobin levels, monitoring levels over a three-month sample instead of the current six-month sample. Further, Medicare will no longer pay for doses of Epogen larger than 400,000 IUs per month or doses of Aranesp larger than 1,200 mcg per month.
Overall, this is a good step in the right direction, but it predictably doesn’t go quite far enough. The ESAs were over-prescribed because that’s where the money is. Medicare pays a flat fee for dialysis services and the ESAs are reimbursed separately. The common-sense, rational solution would be to bind the ESA and dialysis services together, and raise the composite reimbursement rate according to the new policy. And what about the odd patient that requires more than 400,000 IUs of Epogen per month to maintain a hemoglobin level between 10-12 g/dL.
Even if, like me, you’re a dialysis patient with private insurance (almost all dialysis patients are covered by Medicare regardless of age), your treatment is almost surely tied to some reimbursement algorithm based on the Medicare reimbursement rate. But of course, like the other fees paid on our behalf by our insurers, that’s a closely-held trade secret.
I absolutely believe that single-payer universal coverage is the morally appropriate and fiscally responsible solution to the US health care crisis, but the elected representatives in the pocket of the insurance and pharmacy industries continue to drag their heels. At least let us know the true prices we’re paying for our care—not the ginned-up prices on our explanation of benefits—the amounts that are really being billed and paid. How else are we supposed to exercise personal responsibility with regard to our health care?
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