TAMPA, Fla.—After two months of review, the Centers for Medicare & Medicaid Services (CMS) said it will not change its payment policy on erythropoiesis stimulating agents (ESAs) used to treat anemia in kidney disease.
This decision comes just months after CMS indicated it would not issue a national coverage determination (NCD) for ESAs because of a lack of evidence on whether their use makes kidney transplant patients less likely to reject the organ. Just two months prior, the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) also said there is not enough evidence to make any scientific decision on ESAs.
“We welcome the announcement by CMS to not move forward with a policy that would have limited the treatment options available to kidney patients and the latitude doctors have in determining the best treatment in conjunction with their patients,” stated American Association of Kidney Patients (AAKP) Vice President and Chair of the AAKP Public Policy Committee Paul T. Conway. “AAKP appreciates the opportunity to have been involved in the process and thanks all patients who had the courage to make their voices known and all officials who worked on this decision. We especially thank the professional staff at the Government Accountability Office (GAO) for their objective and balanced report on this issue.”
Patients who suffer from anemia who do not receive an ESA must get a blood transfusion. However, it is AAKP’s belief that there is strong evidence that repeated blood transfusions lead to the development of antibodies that will fight a transplant kidney. “We are happy to see CMS listened to the voices of all the stakeholders which include patients, doctors and industry—in a unifying voice that said no to payment policy for ESAs,” stated AAKP Executive Director Karen Ryals. “Many patients recall their compromised health status prior to the availability of ESAs, when suffering the debilitating fatigue and adverse symptoms associated with anemia. We did not want to return to that nor did we want to frighten patients away from being treated with these valuable life-enhancing medicines.”
There is no national payment policy for ESAs. CMS pays for the drug on a region-by-region basis.
