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42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
70 FR 4525, Jan. 28, 2005, unless otherwise noted.
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(a) Responsibility for the notice. When the IRE makes its reconsideration determination, it is responsible for mailing a notice of its determination to the enrollee and the Part D plan sponsor, and for sending a copy to CMS. When the prescribing physician or other prescriber requests the reconsideration on behalf of the enrollee, the IRE is also responsible for notifying the prescribing physician or other prescriber of its decision.
(b) Content of the notice. The notice must—
(1) State the specific reasons for the IRE's decision in understandable language;
(2) If the reconsideration determination is adverse (that is, does not completely reverse the adverse coverage determination or redetermination by the Part D plan sponsor), inform the enrollee of his or her right to an ALJ hearing if the amount in controversy meets the threshold requirement under § 423.2006;
(3) Describe the procedures that must be followed to obtain an ALJ hearing; and
(4) Comply with any other requirements specified by CMS.
[70 FR 4525, Jan. 28, 2005, as amended at 74 FR 65363, Dec. 9, 2009; 77 FR 22171, Apr. 12, 2012; 83 FR 16752, Apr. 16, 2018; 84 FR 19872, May 7, 2019]