§ 423.346 Reopening. ( a ) CMS may conduct a global or targeted reopening to reopen and revise an initial or reconsidered final payment determination (including a determination on the final amount of direct subsidy described in § 423.329(a)(1), final reinsurance payments described in § 423.329(c), the final amount of the low income subsidy described in § 423.329(d), or final risk corridor payments as described in § 423.336) or the Coverage Gap Discount Reconciliation (as described at § 423.2320(b))— ( 1 ) For any reason, within 12 months from the date of the notice of the final determination to the Part D sponsor
( 2 ) After that 12-month period, but within 6 years after the date of the notice of the initial or reconsidered determination to the Part D sponsor, upon establishment of good cause for reopening; or
( 3 ) At any time, in instances of fraud or similar fault of the Part D sponsor or any subcontractor of the Part D sponsor.
( b ) For purposes of this section, CMS will find good cause if— ( 1 ) New and material evidence that was not readily available at the time the final determination was made is furnished;
( 2 ) A clerical error in the computation of payments was made; or
( 3 ) The evidence that was considered in making the determination clearly shows on its face that an error was made.
( c ) For purposes of this section, CMS will not find good cause if the only reason for reopening is a change of legal interpretation or administrative ruling upon which the final determination was made.
( d ) A decision not to reopen under this section is final and is not subject to review.
( e ) CMS notifies the sponsor(s) that will be included in the reopening of its intention to conduct a global or targeted reopening when it is necessary for the sponsor(s) to submit prescription drug event (PDE) data or direct and indirect remuneration (DIR) for the reopening. The notification to sponsor(s) must include the following: ( 1 ) The date by which PDE or DIR data must be accepted by CMS to be included in the reopening, which is at least 90 calendar days after the date of the notification.
( 2 ) A statement indicating the Part D contracts or types of contracts that is included in the reopening.
( f ) CMS announces when it has completed a reopening and provide the sponsor(s) with all of the following information: ( 1 ) A description of the data used in the reopening.
( 2 ) A statement indicating the Part D contracts or types of contracts that were included in the reopening.
( 3 ) The date by which reports describing the reopening results is available to the sponsor.
( 4 ) The date by which a sponsor must submit an appeal, in accordance with § 423.350, if the sponsor disagrees with the reopening results.
( g ) Inclusion criteria— ( 1 ) For a global reopening, CMS includes only those Part D sponsor contracts that were in effect for the contract year being reopened and for whom CMS has not sent the “Notice of final settlement,” as described at § 423.521(a), as of the date CMS announces the completion of the reopening in accordance with paragraph (f) of this section.
( 2 ) For a target reopening, CMS includes only Part D sponsor contracts that meet the criteria for inclusion in a global reopening as specified in paragraph (1) of this section and that CMS specifies for inclusion in the reopening as provided in paragraph (e)(2) or (f)(2) of this section.
[70 FR 4525, Jan. 28, 2005, as amended at 80 FR 7964, Feb. 12, 2015; 89 FR 30837, Apr. 23, 2024]