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

Forms and Documents

Document Name	Status
CMS-10539 HHA Final Supporting Statement 1-12-21.docx Supporting Statement A	2021-01-15

IC Document Collections

IC ID	Document Title	Status
245366	484.58(b)(2)	New
229393	484.70	Modified
229392	484.65(d)	Modified
229391	484.60(e)	Modified
229390	484.60(c)	Modified
229389	484.60(a)	Modified
217414	484.110(a) - content of clinical records	Modified
217412	484.105(h)	Modified
217411	484.105(h) - existing	Modified
217410	484.100(a) - new agencies	Modified
217409	484.100(a) - existing	Removed
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(e) - quality assessment and performance	Modified
217401	484.60(a) care planning	Modified
217400	484.50(e)	Modified
217398	484.50(a) existing agencies	Removed
217396	484.50(a) new agencies	Modified

ICR Details

OMB Control No: 0938-1299	ICR Reference No: 202101-0938-006
Status: Received in OIRA	Previous ICR Reference No: 201712-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: (CMS-10539) Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHA)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/19/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2021
Responses	57,790,738	40,135,877
Time Burden (Hours)	7,394,066	4,462,295
Cost Burden (Dollars)	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS59	Final or interim final rulemaking	84 FR 51836	11/30/2019

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 68126	11/03/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 51836	09/30/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

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

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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	57,790,738	40,135,877	0	17,726,636	-71,775	0
Annual Time Burden (Hours)	7,394,066	4,462,295	0	2,950,909	-19,138	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: While the number of Medicare participating HHA’s has slightly decreased over the last 3 years, the number of new HHA’s entering the program has almost doubled and the number of HHA patients in Medicare participating HHA’s has remained the same. There is one new burden added at 484.58 Discharge Planning. On September 30, 2019, CMS published a final rule Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (51836 FR Vol. 84 No. 189). This new CoP requires HHA’s develop and implement an effective discharge planning process. This new requirement added over $207 million to the overall burden. The burden hours inceased from 4,462,295 to 7,394,066 from the last approval. Also, the hourly rate of most of the HHA staff noted in this package has significantly increased from 2017.

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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

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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: 01/19/2021

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