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OMB Control No: 0938-0976	ICR Reference No: 201307-0938-022
Status: Historical Active	Previous ICR Reference No: 201008-0938-019
Agency/Subagency: HHS/CMS	Agency Tracking No: 20159
Title: Notice of Denial of Medicare Prescription Drug Coverage
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/21/2013
	Date Received in OIRA: 07/30/2013
Terms of Clearance: The large burden estimate increase was updated after receiving validated plan reporting data in 2011. Prior to this, CMS was using estimates of how many denial notices were being sent. Earlier estimates underestimated the number of denial notices issued by Part D plan sponsors because CMS did not have plan reported data. CMS believes the actual burden will not increase significantly, but rather the estimated burden has become more accurate due to plan reporting.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2016	36 Months From Approved	11/30/2013
Responses	1,497,929	0	290,344
Time Burden (Hours)	374,527	0	145,172
Cost Burden (Dollars)	0	0	0

Abstract: Pursuant to 42 CFR 423.568(c) and (d), 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. Pursuant to a 2009 change in regulations at 423.580 and 423.582, a prescriber may now request a standard redetermination (plan level appeal) on behalf of an enrollee. It is necessary to incorporate this change in the description of the appeals process contained on the Notice of Denial of Medicare Prescription Drug Coverage.

Authorizing Statute(s): Statute at Large: 18 Stat. 1860
   Statute at Large: 18 Stat. 1852
   US Code: 42 USC 1395w-104

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:
	78 FR 26053	05/03/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 42957	07/18/2013
Did the Agency receive public comments on this ICR? No

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,497,929	290,344	1,207,585
Annual Time Burden (Hours)	374,527	145,172	229,355
Annual Cost Burden (Dollars)	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 optional language for Part D plan sponsors to use when explaining their denial rationale. Specifically, CMS has added optional language in the denial rationale section of the notice to allow plans to populate text explaining that a drug denied under Part D may be (or is) covered under a different benefit, such as Part B. The instructions have also been changed to guide plans on when to use this optional text. A Crosswalk of the changes has been added to this package. There is an increase to the total hourly burden estimate for this collection. When this information collection was approved in November 2010, the estimate for the burden hours was 145,172 hours. The estimated annual hour burden for this package is now 374,482. Since the last collection was approved, there has been an increase in the number of Part D plan sponsors used to estimate the burden, from 456 to 596. The estimate for the total number of denial notices that will be issued across Part D plan sponsors has increased by 1,207,585 (to a total estimate of 1,497,929) and is based on the most recently validated Part D plan sponsor reported data (2011). The increase in the number of Part D plan sponsors, combined with the availability of validated plan reported data on coverage determinations, results in an increase of $6,684,987 in the total estimated cost burden. We believe the availability and use of validated plan reported data enhances the accuracy of the burden estimates for the Part D denial notice. Based on these estimates (and as noted in section 12 above), the average annual cost per plan sponsor to notify enrollees of their appeal rights through issuance of this standardized denial notice is $18,146.

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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