Nephrologists would maintain current flexibility in prescribing erythropoiesis stimulating agents (ESAs) to patients on dialysis and to those with chronic kidney disease (CKD) who are not on dialysis under a Centers for Medicare and Medicaid Services (CMS) proposed memorandum.
If the proposal not to issue a National Coverage Decision (NCD) for ESAs is finalized, the current policy for ESA coverage would remain in place with no changes.
The March 16 release of the proposed memorandum marks the end of an approximately yearlong CMS examination of the evidence regarding the effects of ESAs on health outcomes for patients with CKD, both those receiving and those not receiving dialysis, known as a National Coverage Analysis (NCA). Based on the findings of an NCA, CMS often issues a National Coverage Determination (NCD), which specifies the exact indications for which CMS will provide reimbursement for the drug. CMS concluded that the evidence gathered in the NCA on ESAs did not generate sufficient evidence to warrant a policy change.
CMS’ proposal not to issue an NCD at this time is widely viewed in the renal community as a positive outcome. Prior to the release of the proposed memorandum, concern existed that CMS might issue an NCD that would permit reimbursement for ESA administration only to patients with certain hemoglobin levels—specifically, to patients with hemoglobin levels below the 10–12 g/dL range specified by the ESRD Quality Improvement Program (QIP), which takes effect on January 1, 2012. The discrepancy between reimbursement policy and the QIP quality measures would have almost certainly posed a challenge for nephrologists and providers, with potential effects on patient care.
“I am generally pleased that CMS has proposed not to issue an NCD for ESAs at this time,” commented ASN Public Policy Board Chair Thomas Hostetter. “CMS clearly took into account the comments and testimony ASN submitted to CMS regarding the NCA on ESAs. If finalized, I believe this will enable patients and their nephrologists to continue to make individualized decisions about ESAs and at least has avoided a potential conflict with the recently introduced QIP for care of anemia in ESRD.”
The potential lack of any NCD has for some, however, raised questions about what could happen at the local level in terms of ESA coverage. Technically, when no NCD exists, regional Medicare contractors have the option to consider instituting a Local Coverage Decision (LCD) for products and services. However, it is highly unlikely that a regional contractor would choose to attempt to change the current policy of reimbursing ESA administration for three reasons.
First, because no NCD for ESAs existed in the past, regional contractors have long had the potential to conduct an LCD but have historically chosen not to do so. If CMS decides to finalize its proposal not to issue an NCD, it does not create any opportunities for regional contractors to consider LCDs that did not previously exist. Second, the U.S. Food and Drug Administration did not recommend any changes to current labeling for patients either on dialysis or not on dialysis at its most recent meeting examining the safety and efficacy of ESAs. Third, because CMS was unable to generate sufficient evidence to warrant a change in ESA coverage at the national level, it is unlikely that a regional contractor would be able to do so.
CMS is accepting public comments on its proposal not to issue an NCD until April 15, 2011, and expects to issue a final memorandum in mid-June 2011.
To learn more about ASN’s advocacy efforts with CMS regarding the NCA, please visit the ASN patient care public policy webpage at www.asn-online.org/policy_and_public_affairs.
