Outcome and Assessment Information Set (OASIS-E1) (CMS-10545)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10545 Oasis-E-Data Item Set	Form and Instruction	Removed	Available
Form CMS-10545 Medicare and Medicaid Programs OASIS Collection Requirement (Training)	Form and Instruction	Removed	Repair queued
Form CMS-10545 OASIS-E Item Set	Form and Instruction	Modified	Available
Form CMS-10545 Medicare and Medicaid OASIS Collection Requirements (Data Collection)	Form and Instruction	Modified	Repair queued
CMS-10545 OASIS-E1_PRA_Supporting Statement_3-22-24.docx	Supporting Statement A	Uploaded 2024-06-17	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
215973	Medicare and Medicaid Programs OASIS Collection Requirement (Training)	Form and Instruction	Removed	Oasis-E-Data Item Set
215973	Medicare and Medicaid Programs OASIS Collection Requirement (Training)	Form and Instruction	Removed
215973	Medicare and Medicaid Programs OASIS Collection Requirement (Training)	Instruction	Removed
215972	Medicare and Medicaid OASIS Collection Requirements (Data Collection)	Form and Instruction	Modified	OASIS-E Item Set
215972	Medicare and Medicaid OASIS Collection Requirements (Data Collection)	Form and Instruction	Modified
215972	Medicare and Medicaid OASIS Collection Requirements (Data Collection)	Instruction	Modified

ICR Details

OMB Control No: 0938-1279	ICR Reference No: 202406-0938-007
Status: Historical Active	Previous ICR Reference No: 202301-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Outcome and Assessment Information Set (OASIS-E1) (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 with change	Conclusion Date: 12/11/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/20/2024
Terms of Clearance: Approved consistent with the understanding that the agency will update the race/ethnicity question in this information collection to be in compliance with the updated SPD 15 (effective as of March 28, 2024) in CY 2027 after the FY/CY 2026 payment rulemaking season.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2027	36 Months From Approved	11/30/2025
Responses	18,017,056	0	18,042,120
Time Burden (Hours)	16,683,290	0	13,012,051
Cost Burden (Dollars)	0	0	0

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Abstract: 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 –E1. 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-E1 is scheduled for implementation on January 1, 2025, to comply with changes noted in the CY2024 HH Final Rule. The changes for OASIS-E1 include addition of one new item: O0350. COVID-19 Vaccine, and removal of two items: M0110. Episode Timing andM2200 Therapy Need due to no longer being used in the HH QRP or for other purposes in CMS programs. Also, Discharge Goals, Column 2 in GG0130 Self-Care and Column 2 in GG0170 Mobility are removed, with their associated instructions due to retiring the quality measure: Application of Percent of Long-Term Care Hospital Patients with an Admission & Discharge Functional Assessment and a Care Plan that Addresses Function Discharge. Instructions for Part C of item D0150. Patient Mood Interview PHQ-2 to 9 are revised to clarify directions for completing the interview.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 24008	04/05/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 50589	06/14/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Medicare and Medicaid OASIS Collection Requirements (Data Collection)	CMS-10545	OASIS-E Item Set
Medicare and Medicaid Programs OASIS Collection Requirement (Training)	CMS-10545	Oasis-E-Data Item Set

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	18,017,056	18,042,120	0	-25,064	0	0
Annual Time Burden (Hours)	16,683,290	13,012,051	0	3,671,239	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden hours have increased from 13,012,051 to 16,683,290. The cost has increased from $983,717.408.37 to $1,294,803,517.77. The training IC was deleted so the last approved does not show 13,012,051 in the ROCIS system.

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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: 06/20/2024

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