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OMB Control No: 0938-0236	ICR Reference No: 202508-0938-016
Status: Active	Previous ICR Reference No: 202205-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Independent Renal Dialysis Facility Cost Report (CMS-265-11)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/22/2025
	Date Received in OIRA: 08/19/2025
Terms of Clearance: Prior to the re-submission of the cost report information collection, the agency will assess its respondent burden and opportunities for streamlining Medicare cost reporting practices to ensure compliance and enhance efficiency. While cost reports are essential for ensuring accurate Medicare reimbursement, the process places a significant administrative burden on facilities. Cost reports require extensive documentation and compliance with various regulations. Preparing this report demands significant time, expertise, and attention to detail, and often necessitating dedicated finance staff and/or external consultants. The assessment of the cost reporting should be guided by the principles and priorities set forth in the Executive Order 14192 title "Unleashing Prosperity Through Deregulation" (January 21, 2025) https://www.whitehouse.gov/presidential-actions/2025/01/unleashing-prosperity-through-deregulation/. The assessment will inform future rulemaking and be integrated in the agency’s next revision of this information collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2027	36 Months From Approved	12/31/2025
Responses	7,329	0	7,541
Time Burden (Hours)	483,714	0	497,706
Cost Burden (Dollars)	0	0	0

Abstract: CMS requires the Form CMS-265-11 to determine an ESRD facility’s reasonable costs incurred in furnishing medical services to Medicare beneficiaries. ESRD facilities paid under the ESRD prospective payment system (PPS) may receive reimbursement in addition to the ESRD PPS payment for Medicare reimbursable bad debts. CMS uses the Form 265-11 for annual rate setting; payment refinement activities, including developing a ESRD market basket; and Medicare Trust Fund projections; and to support program operations. Additionally, the Medicare Payment Advisory Commission (MedPAC) uses the cost report data to calculate Medicare margins (a measure of the relationship between Medicare’s payments and providers’ Medicare costs) and analyze data to formulate Medicare Program recommendations to Congress.

Authorizing Statute(s): PL: Pub.L. 110 - 275 153 Name of Law: Medicare Improvements for Patients and Providers Act
US Code: 42 USC 1395g Name of Law: Payment of Providers of Services

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:
	90 FR 23687	06/04/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 38981	08/13/2025
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
Renal Dialysis Facility Cost Report	CMS-265-11

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	7,329	7,541	-212
Annual Time Burden (Hours)	483,714	497,706	-13,992
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The decrease in burden is due to a decrease in the number of respondents.

Annual Cost to Federal Government: $8,312,097

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: Malcolm Wilson 667 414-0087 malcolm.wilson@cms.hhs.gov

View ICR - OIRA Conclusion