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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10146 Notice of Denial of Medicare Part D Prescription Drug Coverage	Form	Modified	Available
Form CMS-10146 Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)	Form	Modified	Available
CMS-10146 - Supporting Statement_.docx	Supporting Statement A	Uploaded 2023-10-27	Repair queued
CMS Response to Public Comments - CMS-10146.docx	Supplementary Document	Uploaded 2023-10-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
37928	Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)	Form	Modified	Notice of Denial of Medicare Part D Prescription Drug Coverage
37928	Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)	Form	Modified
37928	Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)	Instruction	Modified

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 202310-0938-007
Status: Historical Active	Previous ICR Reference No: 202303-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/18/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/27/2023
Terms of Clearance: CMS failed to address the terms of clearance or provide a plan for how it will address the terms of clearance. Prior to the re-submission of the information collection “Notice of Denial of Medical Coverage (or Payment) (NDMCP) (CMS-10003)” (0938-0829), the agency will evaluate the burden, usability, and clarity of the forms and appeals process. This evaluation will be guided by the principles and priorities set forth in the memorandum titled “Improving Access to Public Benefits Programs Through the Paperwork Reduction Act” (April 13, 2022) https://www.whitehouse.gov/wp-content/uploads/2022/04/M-22-10.pdf. The assessment will inform and be integrated in the agency’s next submission of this information collection. OMB recommends CMS use "Generic Clearance for Improving Customer Experience: OMB Circular A–11, Section 280 Implementation) (CMS-10710)" (0938-1382) to user test this form.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2024	36 Months From Approved	06/30/2024
Responses	2,631,728	0	2,627,898
Time Burden (Hours)	657,932	0	656,975
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 51320	08/03/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 73858	10/27/2023
Did the Agency receive public comments on this ICR? Yes

---

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

table that charts list of burden

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

---

ICR Summary of Burden

table that charts list of burden

	Total Approved	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	2,631,728	2,627,898	0	0	3,830	0
Annual Time Burden (Hours)	657,932	656,975	0	0	957	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: The total number of denial notices issued has increased since the 2021 approval of this collection. Based on current validated 2021 data, the estimated annual hour burden for this package is 657,932 which represents an increase of 957 hours. This is due to an increase of Part D plan sponsors, from 683 sponsors with previous data to a current count of 743 plan sponsors based on 2021 validated data. This change represents an overall increase of 60 plan sponsors. Also using 2021 validated data, 2,631,728 denial notices were issued, representing a increase of 3,830 denial notices. CMS believes these adjusted burden estimates

---

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

---

Common Form ICR:  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:

(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: 10/27/2023

---