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View ICR - OIRA Conclusion

OMB Control No: 0938-0964	ICR Reference No: 202302-0938-009
Status: Active	Previous ICR Reference No: 202204-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Prescription Drug Benefit Program - IRASA (CMS-10141)
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: 03/27/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/22/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2025	36 Months From Approved	09/30/2025
Responses	695,802,400	0	668,128,349
Time Burden (Hours)	25,506,943	0	54,509,330
Cost Burden (Dollars)	599,698,399	0	584,811,068

Abstract: The purpose of this revision is to account for the burden resulting from the submission of an IRASA reconciliation file. In order for CMS to pay the statutorily-mandated IRA subsidy amount for contract year 2023, Part D sponsors must submit data necessary for CMS to determine that subsidy through the IRASA reconciliation file. The burden associated with the IRASA reconciliation file relates to compiling and sending the file to CMS. The reconciliation file will only be submitted for contract year 2023. In addition, the drug management program (DMP) sections have been revised to remove one-time burden associated with establishing DMPs and initial programming of standardized and model communications. As all Part D sponsors were required to have a DMP by January 1, 2022, this burden is no longer needed. Also, there is a revision associated with a change in burden estimate to create business continuity plans to account for the net increase in responses to account for new plans required to develop business continuity strategies and to account for the increased number of expected exception requests. Part D plans and, to the extent applicable, MA organizations will use the information discussed below to comply with the eligibility and other requirements associated with their participation in Part D. CMS will use this information from plan sponsors and States to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. The new information collection will allow CMS to ensure sponsors have plans in place to restore business operations following a disruption of regular operations. Medicare beneficiaries will use the information provided by the Part D sponsors to make decisions regarding Part D enrollment as well as grievance and appeal requests.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	695,802,400	668,128,349	27,674,048	3
Annual Time Burden (Hours)	25,506,943	54,509,330	-29,002,107	-280
Annual Cost Burden (Dollars)	599,698,399	584,811,068	14,887,331	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Total responses decreased by 27,674,048 and the annual burden hours decreased by 29,002,387. The net change in burden primarily reflects revisions to the burden estimate for § 423.153(f) Drug management Programs to remove the one-time burden associated with establishing DMPs and initial programming of standardized and model communications. We also note the change in burden estimate to create business continuity plans to account for the net increase in responses to account for new plans required to develop business continuity strategies and to account for the increased number of expected exception requests and the added burden estimate to account for the new requirement for Part D sponsors to submit an IRASA reconciliation file.

Annual Cost to Federal Government: $838

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. No

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

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov