Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHA) (CMS-10539)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-10539 - Attachment A - 60-day comment.docx	Public Comments	Uploaded 2025-09-23	Available
CMS-10539 - Attachment A - Response to 60-day comment.docx	Public Comments	Uploaded 2025-09-23	Repair queued
CMS-10539 - Attachment A - Response to 60-day comment.docx	Supplementary Document	Uploaded 2025-09-23	Repair queued
CMS-10539 - Supporting Statement.docx	Supporting Statement A	Uploaded 2025-09-23	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
277699	484.65(b)&(c)		New
277697	484.105(i)(2)		New
245366	484.58(b)(1) and (2)		Modified
229393	484.70		Modified
229392	484.65(d)		Removed
229391	484.60(e)		Removed
229390	484.60(c)		Modified
229389	484.60(a)		Removed
217414	484.110(a) - content of clinical records		Removed
217412	484.105(i)(1)		Modified
217411	484.105(h) - existing		Modified
217410	484.100(a) - new agencies		Modified
217408	484.80(d) - in-service training		Modified
217407	484.80(b) - home health aide classroom and practical training		Modified
217406	484.80(c) - compentency evaluation		Modified
217404	484.80(a)		Modified
217403	484.65(a)(d) and (e) - quality assessment and performance		Modified
217401	484.60(a) care planning		Removed
217400	484.50(e)		Modified
217396	484.50(a) new agencies		Removed

ICR Details

OMB Control No: 0938-1299	ICR Reference No: 202509-0938-018
Status: Received in OIRA	Previous ICR Reference No: 202101-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHA) (CMS-10539)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/24/2025

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,470,272	0
Time Burden (Hours)	868,218	0
Cost Burden (Dollars)	0	0

---

Abstract: Home health agencies are required to maintain certain documentation within their own agency records that demonstrates compliance with specific Conditions of Participation for the Medicare program. This documentation is maintained on-site for use in the home health agency survey process.

---

Authorizing Statute(s): PL: Pub.L. 101 - 239 6005(b) Name of Law: Omnibus Reconciliation Act of 1989
   US Code: 42 USC 1395X Name of Law: Social Security Act
  

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:
	89 FR 79929	10/01/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 34276	07/21/2025
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 14

table that charts list of burden

IC Title	Form No.	Form Name
484.100(a) - new agencies
484.105(h) - existing
484.105(i)(1)
484.105(i)(2)
484.110(a) - content of clinical records
484.50(a) new agencies
484.50(e)
484.58(b)(1) and (2)
484.60(a)
484.60(a) care planning
484.60(c)
484.60(e)
484.65(a)(d) and (e) - quality assessment and performance
484.65(b)&(c)
484.65(d)
484.70
484.80(a)
484.80(b) - home health aide classroom and practical training
484.80(c) - compentency evaluation
484.80(d) - in-service training

---

ICR Summary of Burden

table that charts list 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	3,470,272	0	0	0	-54,320,466	57,790,738
Annual Time Burden (Hours)	868,218	0	0	0	-6,525,848	7,394,066
Annual Cost Burden (Dollars)	0	0	0	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: No

Burden Reduction Due to:

Short Statement: The currently approved information collection estimated the total annual burden hours to be 7,394,066 hours. We revise this to 868,218 hours a decrease of -6,524,066. The reduction is largely due to removing the one-time burden estimates that no longer apply.

---

Annual Cost to Federal Government: $0

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

---

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: 09/24/2025

---