(CMS-R-39) Home Health Medicare Conditions of Participation (CoP) and Supporting Regulations

Forms and Documents

Document Name	Status
CMS-R-39 Emergency package memo.pdf Supplementary Document	2017-03-01
HHA PRA Supporting Statement 2-27-17.docx Supporting Statement A	2017-03-01

IC Document Collections

IC ID	Document Title	Status
8006	Home Health Medicare Conditions of Participation (CoP) Information Collection Requirements as outlined in Regulations -- 42 CFR 484.10, 484.12, 484.14, 484.16,....	Unchanged

ICR Details

OMB Control No: 0938-0365	ICR Reference No: 201703-0938-001
Status: Historical Active	Previous ICR Reference No: 201311-0938-012
Agency/Subagency: HHS/CMS	Agency Tracking No: 20916
Title: (CMS-R-39) Home Health Medicare Conditions of Participation (CoP) and Supporting Regulations
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 04/05/2017
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/09/2018
	Date Received in OIRA: 03/02/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	6 Months From Approved
Responses	13,577	0	0
Time Burden (Hours)	6,422,694	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: 42 CFR 484 outlines Home Health Agency Medicare CoP to ensure HHAs meet the Federal patient health and safety regulations.

Emergency Justfication: The Centers for Medicare and Medicaid Services (CMS) is requesting a Paperwork Reduction Act (PRA) package related to the Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies and Supporting Regulations at 42 CFR part 484, to be processed under the emergency clearance process associated with 5 CFR 1320.13(a)(2)(i). Public harm is reasonably likely to ensue if the normal, non-emergency clearance procedures are followed. The approval of this information collection package is necessary because in the absence of such approval CMS will be unable to effectively enforce these essential health and safety requirements. Among other things, CMS will be unable to enforce requirements that HHAs must provide a notice of rights to each patient, assure the proper training of home health aides before those aides provide hands-on care to patients, and disclose the names and addresses of all individuals with an ownership or management position so that we can assure that those with a history of fraud are not involved in HHA operations. Being unable to enforce these rules would harm patient health and safety, as well as create risks to the integrity of the Medicare and Medicaid programs.

---

Authorizing Statute(s): US Code: 42 USC 1395x Name of Law: Definitions
  

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

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
Home Health Medicare Conditions of Participation (CoP) Information Collection Requirements as outlined in Regulations -- 42 CFR 484.10, 484.12, 484.14, 484.16,....

---

ICR Summary 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	13,577	0	0	0	0	13,577
Annual Time Burden (Hours)	6,422,694	0	0	0	0	6,422,694
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:

---

Annual Cost to Federal Government: $131,153,820

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? Uncollected

---

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: 03/02/2017

---