Scope.

(a) This subpart sets forth the requirements relating to the following: (1) Part D plan sponsors with respect to grievances, coverage determinations, and redeterminations. (2) Part D IRE with respect to reconsiderations. (3) Part D enrollees' rights with respect to grievances, coverage determinations, redeterminations, and reconsiderations. (4) Review of at-risk determinations made under a drug management program in accordance with § 423.153(f). (b) The requirements regarding reopenings, ALJ hearings and ALJ and attorney adjudicator decisions, Council review, and judicial review are set forth in subpart U of this chapter. [74 FR 65363, Dec. 9, 2009, as amended at 82 FR 5125, Jan. 17, 2017; 83 FR 16750, Apr. 16, 2018]