(a) General PDE submission timeliness requirements. Unless paragraph (b) of this section applies, a Part D sponsor must submit PDE records to CMS as follows:

(1) Initial PDE records within 30 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.

(2) Adjustment or deletion PDE records within 90 calendar days of the Part D sponsor (or its contracted first tier, downstream, or related entity) discovering or receiving notification of an issue that requires a change to the previously submitted PDE record.

(3) Revised PDE records to resolve CMS rejected records within 90 calendar days of the rejection.

(b) Selected Drugs PDE submission timeliness requirement. A Part D sponsor must submit initial PDE records for selected drugs (as described at section 1192(c) of the Act) within 7 calendar days from the date the Part D sponsor (or its contracted first tier, downstream, or related entity) receives the claim.