Outcome and Assessment Information Set (OASIS-E2) (CMS-10545)

Forms and Documents

Document Name	Status
Form CMS-10545 Medicare and Medicaid OASIS Collection Requirements (Data Collection) Form and Instruction	Modified
CMS-10545.Supporting Statement Part A (proposed rule).docx Supporting Statement A	2025-07-07

IC Document Collections

IC ID	Document Title	Status
215972	Medicare and Medicaid OASIS Collection Requirements (Data Collection) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1279	ICR Reference No: 202507-0938-008
Status: Received in OIRA	Previous ICR Reference No: 202406-0938-007
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	Date Submitted to OIRA: 07/07/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2027
Responses	18,425,499	18,017,056
Time Burden (Hours)	16,936,624	16,683,290
Cost Burden (Dollars)	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV53	Proposed rulemaking	90 FR 29108	07/02/2025

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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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	OASIS-E2-All-Items-instrument 508

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	18,425,499	18,017,056	0	408,443	0	0
Annual Time Burden (Hours)	16,936,624	16,683,290	0	253,334	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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 has increased $171,243,927.30 from OASIS-E1 to OASIS-E2.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/07/2025

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