Dispute Resolution for
Discarded Drug Refunds (CMS-10835)
New
collection (Request for a new OMB Control Number)
No
Regular
10/06/2022
Requested
Previously Approved
36 Months From Approved
10
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.
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.