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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

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:
	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

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	,

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,902,055	1,902,055
Annual Time Burden (Hours)	475,514	475,514
Annual Cost Burden (Dollars)	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).

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

Agency Contact: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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