Dispute Resolution for Discarded Drug Refunds (CMS-10835)

Manufacturers of drugs or biologicals for which refunds are owed may submit an error report to CMS. CMS will use this information to evaluate the refund amount and make any corrections or adjustments to the refund amount if CMS finds there was indeed an error. CMS would evaluate error reports and would decide whether the information (such as number of discarded billing units or refund amount calculation) requires correction based on the information provided. CMS proposes that if we find that a different refund amount is owed than what was stated on the report, we would issue a new report with updated discarded amounts and/or refund. CMS also proposes that if we disagree with the dispute, we would notify the manufacturer that refund amount on the report is still owed and should be paid.

The latest form for Dispute Resolution for Discarded Drug Refunds (CMS-10835) expires 2027-11-30 and can be found here.

Error Report Submission

Federal Enterprise Architecture: Health - Health Care Services