CMS Finalizes Coverage Policy for ESAs; Changes Reflect ASH Recommendations

July xx – The Centers for Medicare and Medicaid Services (CMS) posted a <<<national coverage determination (NCD)>>> for coverage of ESAs for non-renal uses that includes coverage of treatment of anemia for patients with MDS, a decision ASH promoted through comments and meetings with agency officials.

The NCD specifies:

ASH was deeply concerned with CMS’s proposed coverage decision that was released in May because the proposal was not supported by scientific data and was in conflict with expert analysis.  ASH submitted comments and met with CMS officials as well as testified before FDA’s Oncology Drug Advisory Committee and met with FDA officials to discuss concerns and recommendations.  ASH and American Society of Clinical Oncology (ASCO) are scheduled to jointly publish an update of our guidelines on the appropriate use of EPO in September.

During the ASH annual meeting in December, the Practice Forum will address this issue. The Practice Forum, “Evidence, Safety, and Clinical Decision Making: The Case of ESAs” is scheduled for Saturday, December 8 at 6:00 p.m.