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

Forms and Documents

Document Name	Status
Crosswalk_CMS10146 2020 30 day edits.xlsx Supplementary Document	2020-04-07
CMS Response to Public Comments Received 30 day.docx Supplementary Document	2020-04-07
CMS-10146 - Supporting Statement A - 30-day edits.docx Supporting Statement A	2020-04-07
CMS Response to Public Comments Received 60 day.pdf Supplementary Document	2020-02-28
Crosswalk_CMS10146 2020 60-day v508.pdf Supplementary Document	2020-02-28

IC Document Collections

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

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 202002-0938-017
Status: Active	Previous ICR Reference No: 201805-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/09/2020
	Date Received in OIRA: 03/03/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved
Responses	2,887,866	0	0
Time Burden (Hours)	721,967	0	0
Cost Burden (Dollars)	0	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 Name of Statute: null
   US Code: 42 USC 1395w-104 Name of Law: null
   Statute at Large: 18 Stat. 1860 Name of Statute: null
  

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:
	84 FR 6365	11/18/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 12303	03/02/2020
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 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	2,887,866	0	0	0	985,811	1,902,055
Annual Time Burden (Hours)	721,967	0	0	0	246,453	475,514
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 estimated annual hour burden for this package is 721,967 which represents an increase of 264,453 hours. This was due to the total number of denial notices issued has increased since the 2017 approval of this collection. At the last approval of this package, 1,902,055 denial notices were issued by plans. Using 2017 validated data, 2,887,866 denial notices were issued, representing an increase of 985,811 denial notices.

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Annual Cost to Federal Government: $0

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: 03/03/2020

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