Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)

Forms and Documents

Document Name	Status
Form CMS-10146 Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146) Form	Modified
CMS-10146 - Supporting Statement_ Clean.docx Supporting Statement A	2024-09-17
CMS-10146 B- Crosswalk_508.pdf Supplementary Document	2024-09-13
CMS Response to Public Comments - CMS-10146.docx Supplementary Document	2024-09-13

IC Document Collections

IC ID	Document Title	Status
37928	Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146) Form	Modified

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 202409-0938-015
Status: Received in OIRA	Previous ICR Reference No: 202310-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/19/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2024
Responses	2,962,857	2,631,728
Time Burden (Hours)	740,714	657,932
Cost Burden (Dollars)	0	0

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Abstract: Pursuant to 42 CFR 423.568(e) and (f), if a Part D plan denies drug coverage it must give the enrollee written notice of the adverse coverage determination. The form and content of the written denial notice must comport with specific requirements, including a description of the appeals process.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1852
   US Code: 42 USC 1395w-104
   Statute at Large: 18 Stat. 1860
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 48901	06/10/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 76113	09/17/2024
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)	CMS-10146	Notice of Denial of Medicare Part D Prescription Drug Coverage

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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	2,962,857	2,631,728	0	0	331,129	0
Annual Time Burden (Hours)	740,714	657,932	0	0	82,782	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: An increased number of denial notices being issued is responsible for increase in our estimated burden for the Part D denial notice. Based on current validated 2022 data, the estimated annual hour burden for this package is 740,714.25 which represents an increase of 82,782.25 hours. From the time that this collection was approved in 2022, there has been an increase of Part D plan sponsors, from 743 sponsors with previous data to a current count of 772 plan sponsors based on 2022 validated data. This change represents an overall increase of 29 plan sponsors.

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Annual Cost to Federal Government: $1,324

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.     Yes

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: 09/19/2024

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