Dispute Resolution for Discarded Drug Refunds (CMS-10835)
Revision of a currently approved collection
No
Regular
Approved without change
11/15/2024
08/08/2024
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
11/30/2027
36 Months From Approved
06/30/2026
37
0
10
535
0
400
0
0
0
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.
In the CY 2024 PFS final rule, we finalized an application process through which each manufacturer can request that we consider increasing the applicable percentage for a particular drug based on unique circumstances.
In the initial year, we estimate that the burden per respondent/applicant of drafting and submitting the unique circumstance application to be 5 hours. We anticipate 25 applications in the initial year that applications are available. In the initial year, we estimate a one-time burden of 125 hours (25 applications x 5 hr per respondent/applicant) to draft and submit the application.
In subsequent years we expect a smaller number of applications. In this regard we estimate an annual burden of 10 hours (2 applications x 5 hr per respondent/applicant) to draft and submit the application.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
CMS-10835 - Supporting Statement A (CMS-1784-F version 6).docx
Applications: Subsequent Years