Dispute Resolution for Discarded Drug Refunds (CMS-10835)
Revision of a currently approved collection
No
Regular
Comment filed on proposed rule and continue
07/01/2024
05/20/2024
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
06/30/2026
36 Months From Approved
06/30/2026
10
0
10
400
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 August 7, 2023 (88 FR 52262) CY 2024 PFS proposed rule (CMS-1784-P; RIN 0938-AV07), we are proposing 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) at a cost of $6,970 (125 hr x $55.76/hr) to draft and submit the application.
Once a manufacturer has applied for a drug and a decision has been made regarding whether an increased applicable percentage is appropriate, the manufacturer would not need to apply again.
In subsequent years we would expect a smaller number of applications. When evaluating the approval dates of these 25 drugs, we find that there is a range of 0 to 4 drugs per year approved that would be expected to owe a refund of more than $50,000 per year. From 2010â2020, the mean number of such approvals is 1.45 per year. If rounded up, we estimate that we would typically receive 2 applications per year except the initial application year. In this regard we estimate an annual burden of 10 hours (2 applications x 5 hr per respondent/applicant) at a cost of $558 (10 hr x $55.76/hr) 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-P version 4).docx
Applications: Subsequent Years