(a) General rule. Unless the ALJ dismisses the hearing, the ALJ will issue a written decision that gives the findings of fact, conclusions of law, and the reasons for the decision.
(1) For expedited hearings, the ALJ issues a written decision within the 10 calendar day adjudication timeframe under Sec. 423.2016(b)(5).
(2) The decision must be based on evidence offered at the hearing or otherwise admitted into the record.
(3) A copy of the decision should be mailed to the enrollee at his or her last known address.
(4) 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.
(b) Content of the notice. The decision must be provided in a manner calculated to be understood by an enrollee and must include--
(1) The specific reasons for the determination, including, to the extent appropriate, a summary of any clinical or scientific evidence used in making the determination;
(2) The procedures for obtaining additional information concerning the decision; and
(3) Notification of the right to appeal the decision to the MAC, including instructions on how to initiate an appeal under this section.
(c) Limitation on decision. When the amount of payment for the Part D drug is an issue before the ALJ, the ALJ may make a finding as to the amount of payment due. If the ALJ makes a finding concerning payment when the amount of payment was not an issue before the ALJ, the Part D plan sponsor may independently determine the payment amount. In either of the aforementioned situations, an ALJ'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 decision is a new coverage determination under Sec. 423.566.
(d) Timing of decision. For non-expedited hearings, the ALJ issues a decision no later than the end of the 90 calendar day period beginning on the date the request for hearing is received by the entity specified in the IRE's reconsideration, unless the 90 calendar day period is extended as provided in Sec. 423.2016. For expedited hearings, the ALJ issues a decision as expeditiously as the enrollee's health condition requires, but no later than the end of the 10 calendar day period beginning on the date the request for hearing is received by the entity specified in the IRE's reconsideration, unless the 10 calendar day period is extended as provided in Sec. 423.2016.
(e) Recommended decision. An ALJ issues a recommended decision if he or she is directed to do so in a MAC remand order. An ALJ may not issue a recommended decision on his or her own motion. The ALJ mails a copy of the recommended decision to the enrollee at his or her last known address.