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OMB Control No: 0938-1279	ICR Reference No: 202512-0938-012
Status: Active	Previous ICR Reference No: 202507-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Outcome and Assessment Information Set (OASIS-E2) (CMS-10545)
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: 03/09/2026
	Date Received in OIRA: 12/10/2025
Terms of Clearance: terms of clearance Prior to the re-submission of the information collection “Outcome and Assessment Information Set (OASIS-E2) (CMS-10545)” (0938-1279), the agency will assess its respondent burden. This assessment will 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	12/31/2028	36 Months From Approved	12/31/2027
Responses	18,425,499	0	18,017,056
Time Burden (Hours)	16,936,624	0	16,683,290
Cost Burden (Dollars)	0	0	0

Abstract: Abstract (2000 characters maximum) This request is for OMB PRA approval of a version update of the Outcome and Assessment Information Set (OASIS). The updated version of the OASIS item set is titled OASIS –E2 . OASIS is a core standard assessment data set that Home Health Agencies (HHAs) integrate into their own patient-specific, comprehensive assessment to identify each patient’s need for home care that meets the patient’s medical, nursing, rehabilitative, social, and discharge planning needs. Since 1999, the Medicare Conditions of Participation (CoPs) have mandated that HHAs use the OASIS data set when evaluating adult, non-maternity patients receiving skilled services. OASIS data are used for both home health quality measurement and payment adjustment. OASIS-E2 is scheduled for implementation on April 1, 2026, to comply with changes noted in the CY2025 HH Final Rule. The changes for OASIS-E2 include the removal of the A1250 Transportation item which will be replaced by the revised A1255 Transportation item align with an item collected in other CMS programs. Subregulatory changes include CMS adding the B1000 Hearing, B0200 Vision, and A1110 Language items to the resumption of care (ROC) timepoint.A0810 Sex will replace the M0069 Gender item. Lastly, CMS will remove the O0350 Patient's COVID-19 vaccination is up to date item.

Authorizing Statute(s): PL: Pub.L. 105 - 33 4601(e) Name of Law: Balanced Budget Act of 1997
   US Code: 42 USC 1395x Name of Law: Definitions of Services, Institutions,etc: Home Health Agency
   PL: Pub.L. 109 - 171 5201(c)(2) Name of Law: Deficit Reduction Act of 2005: Home health - pay for reporting of quality information

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV53	Final or interim final rulemaking	90 FR 55342	12/02/2025

Federal Register Notices & Comments
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
Medicare and Medicaid OASIS Collection Requirements (Data Collection)	CMS-10545

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	18,425,499	18,017,056	408,443
Annual Time Burden (Hours)	16,936,624	16,683,290	253,334
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The hourly burden increased 253,334.28 hours from OASIS-E1 to OASIS-E2. Cost increased $171,243,927.30 from OASIS-E1 to OASIS-E2.

Annual Cost to Federal Government: $2,994,473

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. Yes

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. Yes

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: Sandra Bastinelli 410 786-3630

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