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

ICR 202409-0938-015

OMB: 0938-0976

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0938-0976 202409-0938-015
Received in OIRA 202310-0938-007
HHS/CMS CM-CPC
Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)
Revision of a currently approved collection   No
Regular 09/19/2024
  Requested Previously Approved
36 Months From Approved 12/31/2024
2,962,857 2,631,728
740,714 657,932
0 0

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.

Statute at Large: 18 Stat. 1852
   US Code: 42 USC 1395w-104
   Statute at Large: 18 Stat. 1860
  
None

Not associated with rulemaking

  89 FR 48901 06/10/2024
89 FR 76113 09/17/2024
Yes

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

  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
No
No
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.

$1,324
No
    Yes
    No
No
No
No
No
Stephan McKenzie 410 786-1943 [email protected]

  No

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.
09/19/2024


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