ASN recently sent a letter to the Centers for Medicare and Medicaid Services (CMS) supporting the agency’s proposal not to change existing policy regarding erythropoiesis stimulating agents (ESAs) at this time. This would maintain nephrologists’ flexibility in prescribing ESAs for patients with kidney disease.
If issued by CMS, a National Coverage Determination (NCD) could specify the exact indications—potentially including hemoglobin ranges—for which the agency would provide reimbursement for the drug for people with kidney disease. The CMS proposal currently being considered recommends that CMS not issue an NCD at this time (See April KN for more details).
“Overall I am pleased that CMS has proposed that no NCD is appropriate at this time,” said ASN Comparative Effectiveness Research Task Force and ASN Public Policy Board member Wolfgang Winkelmayer, MD, ScD, FASN. “Maintaining reasonable latitude for patients and their physicians to make individualized decisions about these medications, within FDA guidelines, is crucial. However, the vital need for comparative effectiveness research to close the evidence gap regarding the optimal role of ESAs in the treatment of relatively severe anemia remains.”
CMS’ proposed decision memorandum quoted ASN’s previously stated positions that “current ESAs may be dangerous if used for overly aggressive treatment targets compared with practices that are compatible with current treatment guidelines. [ASN] also believes that continued access to ESAs is required to give both dialysis and non-dialysis patients with CKD a better chance at receiving and maintaining the function of a kidney transplant.” In addition to ASN, patient advocacy groups emphasized to CMS the important role ESAs play in maintaining quality of life for people with kidney disease.
“I’m heartened to see that CMS incorporated these vitally important points into the proposed decision memorandum, especially since they provide support for the proposal not to issue an NCD,” said ASN Public Policy Chair Thomas Hostetter, MD. “This memorandum, and CMS’ proposal, speaks to the strength of ASN’s advocacy ability.”
CMS will announce whether or not it is finalizing the decision memorandum as proposed on June 16, 2011. For more information about ASN’s advocacy work on this and other issues, please visit ASN’s public policy webpage at http://www.asn-online.org/policy_and_public_affairs.
