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

Forms and Documents

Document Name	Status
Form CMS-10146(SP) Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP) Form and Instruction	Modified
Justification 03 02 2017 [rev OSORA PRA].docx Justification for No Material/Nonsubstantive Change	2017-03-15
Denial_Notice_Instructions_rev 03 03 2017 redline (002).docx Supplementary Document	2017-03-15
Denial Notice_rev 03 01 2017 redline.docx Supplementary Document	2017-03-15
Copy of Crosswalk_CMS10146 03 03 2017.xlsx Supplementary Document	2017-03-15
CMS-10146 - Supporting Statement A - Passback1 rev CLEAN.doc Supporting Statement A	2017-02-02

IC Document Collections

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

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 201703-0938-010
Status: Historical Active	Previous ICR Reference No: 201609-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/10/2017
	Date Received in OIRA: 03/15/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	02/29/2020	02/29/2020
Responses	1,902,055	0	1,902,055
Time Burden (Hours)	475,514	0	475,514
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:
	81 FR 12904	03/11/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 62741	09/12/2016
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 and 10146SP)	CMS-10146(SP), CMS-10146	Notice of Denial of Medicare Prescription Drug Coverage ,   Notice of Denial of Medicare Part D Prescription Drug Coverage (English)

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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	1,902,055	1,902,055	0	0	0	0
Annual Time Burden (Hours)	475,514	475,514	0	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: The Part D denial notice has been revised for clarity and includes new language explaining to the enrollee that the notice should be shared with his/her doctor. A Crosswalk of the changes to the notice and the instructions is included with this package. None of the changes impact our currently approved burden estimates. There is an increase to the total hourly burden estimate for this collection. When this information collection was approved in February 2014, the estimate for the burden hours was 374,482 hours. The estimated annual hour burden for this package is now 475,514 (+101,032). Since the last collection was approved, there has been a slight decrease in the number of Part D plan sponsors used to estimate the burden, from 596 to 580 (-16), but the estimate for the total number of denial notices that will be issued across Part D plan sponsors has increased by 404,126 (to a total estimate of 1,902,055) and is based on the most recently validated Part D plan sponsor reported data (2014).

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Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 03/15/2017

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