§ 423.2046 Notice of an ALJ or attorney adjudicator decision. ( a ) *Decisions on requests for hearing* — ( 1 ) *General rule.* Unless the ALJ or attorney adjudicator dismisses or remands the request for hearing, the ALJ or attorney adjudicator will issue a written decision that gives the findings of fact, conclusions of law, and the reasons for the decision. ( i ) The decision must be based on evidence offered at the hearing or otherwise admitted into the record, and shall include independent findings and conclusions.
( ii ) A copy of the decision should be mailed or otherwise transmitted to the enrollee at his or her last known address.
( iii ) A copy of the written decision should also be provided to the IRE that issued the reconsideration determination, and to the Part D plan sponsor that issued the coverage determination or at-risk determination.
( 2 ) *Content of the notice.* The decision must be provided in a manner calculated to be understood by an enrollee and must include— ( i ) The specific reasons for the determination, including, to the extent appropriate, a summary of any clinical or scientific evidence used in making the determination;
( ii ) The procedures for obtaining additional information concerning the decision; and
( iii ) Notification of the right to appeal the decision to the Council, including instructions on how to initiate an appeal under this section.
( 3 ) *Limitation on decision.* When the amount of payment for the Part D drug is an issue before the ALJ or attorney adjudicator, the ALJ or attorney adjudicator may make a finding as to the amount of payment due. If the ALJ or attorney adjudicator makes a finding concerning payment when the amount of payment was not an issue before the ALJ or attorney adjudicator, the Part D plan sponsor may independently determine the payment amount. In either of the aforementioned situations, an ALJ's or attorney adjudicator's decision is not binding on the Part D plan sponsor for purposes of determining the amount of payment due. The amount of payment determined by the Part D plan sponsor in effectuating the ALJ's or attorney adjudicator's decision is a new coverage determination under § 423.566.
( b ) *Decisions on requests for review of an IRE dismissal* — ( 1 ) *General rule.* Unless the ALJ or attorney adjudicator dismisses the request for review of an IRE dismissal, or the dismissal is vacated and remanded, the ALJ or attorney adjudicator will issue a written decision affirming the IRE's dismissal. OMHA mails or otherwise transmits a copy of the decision to the enrollee.
( 2 ) *Content of the notice.* The decision must be written in a manner calculated to be understood by an enrollee and must include— ( i ) The specific reasons for the determination, including a summary of the evidence considered and applicable authorities;
( ii ) The procedures for obtaining additional information concerning the decision; and
( iii ) Notification that the decision is binding and is not subject to further review, unless reopened and revised by the ALJ or attorney adjudicator.
( c ) *Recommended decision.* An ALJ or attorney adjudicator issues a recommended decision if he or she is directed to do so in the Council's remand order. An ALJ or attorney adjudicator may not issue a recommended decision on his or her own motion. The ALJ or attorney adjudicator mails a copy of the recommended decision to the enrollee at his or her last known address.
[82 FR 5134, Jan. 17, 2017, as amended at 83 FR 16754, Apr. 16, 2018]