§ 423.522 Requesting an appeal of the final settlement amount. ( a ) *Appeals process.* If a Part D sponsor does not agree with the final settlement amount described in § 423.521(a) of this section, it may appeal under the following three-level appeal process: ( 1 ) *Reconsideration.* A Part D sponsor may request reconsideration of the final settlement amount described in § 423.521(a) according to the following process: ( i ) *Manner and timing of request.* A written request for reconsideration must be filed within 15 days from the date that CMS issued the notice of final settlement to the Part D sponsor.
( ii ) *Content of request.* The written request for reconsideration must do all of the following: ( A ) Specify the calculation with which the Part D sponsor disagrees and the reasons for its disagreement.
( B ) Include evidence supporting the assertion that CMS's calculation of the final settlement amount is incorrect.
( C ) Not include new reconciliation data or data that was submitted to CMS after the final settlement notice was issued. CMS does not consider information submitted for the purposes of retroactively adjusting a prior reconciliation.
( iii ) *Conduct of reconsideration.* In conducting the reconsideration, the CMS reconsideration official reviews the calculations that were used to determine the final settlement amount and any additional evidence timely submitted by the Part D sponsor.
( iv ) *Reconsideration decision.* The CMS reconsideration official informs the Part D sponsor of its decision on the reconsideration in writing.
( v ) *Effect of reconsideration decision.* The decision of the CMS reconsideration official is final and binding unless a timely request for an informal hearing is filed in accordance with paragraph (a)(2) of this section.
( 2 ) *Informal hearing.* A Part D sponsor dissatisfied with CMS's reconsideration decision made under paragraph (a)(1) of this section is entitled to an informal hearing as provided for under paragraphs (a)(2)(i) through (a)(2)(iv) of this section. ( i ) *Manner and timing of request.* A request for an informal hearing must be made in writing and filed with CMS within 15 calendar days of the date of CMS's reconsideration decision.
( ii ) *Content of request.* The request for an informal hearing must include a copy of the reconsideration decision and must specify the findings or issues in the decision with which the Part D sponsor disagrees and the reasons for its disagreement.
( iii ) *Informal hearing procedures.* The informal hearing is conducted in accordance with the following: ( A ) The CMS Hearing Officer provides written notice of the time and place of the informal hearing at least 30 calendar days before the scheduled date.
( B ) The CMS reconsideration official provides a copy of the record that was before CMS when CMS made its decision to the hearing officer.
( C ) The hearing officer review is conducted by a CMS hearing officer who neither receives testimony nor accepts any new evidence. The CMS hearing officer is limited to the review of the record that was before CMS when CMS made its decision.
( iv ) *Decision of the CMS hearing officer.* The CMS hearing officer decides the case and sends a written decision to the Part D sponsor explaining the basis for the decision.
( v ) *Effect of hearing officer's decision.* The hearing officer's decision is final and binding, unless the decision is reversed or modified by the CMS Administrator in accordance with paragraph (a)(3) of this section.
( 3 ) *Review by the Administrator.* The Administrator's review is conducted in the following manner: ( i ) *Manner and timing of request.* A Part D sponsor that has received a hearing officer's decision may request review by the Administrator within 15 calendar days of the date of issuance of the hearing officer's decision under paragraph (a)(2)(iv) of this section. The Part D sponsor may submit written arguments to the Administrator for review.
( ii ) *Discretionary review.* ( A ) After receiving a request for review, the Administrator has the discretion to elect to review the hearing officer's determination in accordance with paragraph (a)(3)(iii) of this section or to decline to review the hearing officer's decision within 30 calendar days of receiving the request for review.
( B ) If the Administrator declines to review the hearing officer's decision, the hearing officer's decision is final and binding.
( iii ) *Electing to review.* If the Administrator elects to review the hearing officer's decision, the Administrator reviews the hearing officer's decision, as well as any information included in the record of the hearing officer's decision and any written argument submitted by the Part D sponsor, and determine whether to uphold, reverse, or modify the hearing officer's decision.
( iv ) *Effect of Administrator's decision.* The Administrator's decision is final and binding.
( b ) *Matters subject to appeal and burden of proof.* ( 1 ) The Part D sponsor's appeal is limited to CMS's calculation of the final settlement amount. CMS does not consider information submitted for the purposes of retroactively adjusting a prior reconciliation.
( 2 ) The Part D sponsor bears the burden of proof by providing evidence demonstrating that CMS' calculation of the final settlement amount is incorrect.
( c ) *Stay of financial transaction until appeals are exhausted.* If a Part D sponsor requests review of the final settlement amount, the financial transaction associated with the issuance or payment of the final settlement amount is stayed until all appeals are exhausted. Once all levels of appeal are exhausted or the Part D sponsor fails to request further review within the applicable 15-calendar-day timeframe, CMS communicates with the Part D sponsor to complete the financial transaction associated with the issuance or payment of the final settlement amount, as appropriate.
( d ) *Continued compliance with other law required.* Nothing in this section limits a Part D sponsor's responsibility to comply with any other statute or regulation.
[89 FR 30839, Apr. 23, 2024, as amended at 89 FR 63828, Aug. 6, 2024]