The coverage determination is binding on the Part D plan sponsor and the enrollee unless it is reviewed and revised under Sec. 423.580 through Sec. 423.604 and Sec. 423.1970 through Sec. 423.1976 or is reopened and revised under Sec. 423.1978. [70 FR 4525, Jan. 28, 2005, as amended at 74 FR 65363, Dec. 9, 2009]