Dispute Resolution for Discarded Drug Refunds (CMS-10835)

Forms and Documents

Document Name	Status
CMS-10835.Supporting Statement Part A.docx Supporting Statement A	2022-10-06

IC Document Collections

IC ID	Document Title	Status
256302	Error Report Submission	New

ICR Details

OMB Control No:	ICR Reference No: 202210-0938-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Dispute Resolution for Discarded Drug Refunds (CMS-10835)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/06/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	10	0
Time Burden (Hours)	400	0
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 117 - 9 90004 Name of Law: Infrastructure Investment and Jobs Act
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 9 90004 Name of Law: Infrastructure Investment and Jobs Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU81	Proposed rulemaking	87 FR 44502	07/29/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Error Report Submission

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	10	0	10	0	0	0
Annual Time Burden (Hours)	400	0	400	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $12,731

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 10/06/2022

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