View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1279
ICR Reference No:
202507-0938-008
Status:
Historical Inactive
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
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
08/12/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/07/2025
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2027
36 Months From Approved
12/31/2027
Responses
18,017,056
0
18,017,056
Time Burden (Hours)
16,683,290
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
Proposed rulemaking
90 FR 29108
07/02/2025
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
OASIS-E2-All-Items-instrument 508
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.
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:
Denise King 410 786-1013 Denise.King@cms.hhs.gov
Common Form ICR:
No
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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