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OMB Control No: 0938-1210	ICR Reference No: 201608-0938-015
Status: Historical Active	Previous ICR Reference No: 201301-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: 18578
Title: (CMS-10455) Report of a Hospital Dealth Associated with Restraint or Seclusion
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: 02/17/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/25/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	02/28/2017
Responses	6,225	0	24,500
Time Burden (Hours)	2,054	0	8,085
Cost Burden (Dollars)	0	0	0

Abstract: The Hospital Restraint/Seclusion Death Report Worksheet historically has been used by RO's internally as a data collection tool for hospitals reporting restraint/seclusion deaths as required by 482.13. In response to the Executive Order 13563 by reducing unnecessarily burdensome rules and thereby increasing the ability of hospitals and CAHs to devote resources to providing high quality patient care. The Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation CMS-3244-F final rule responds. Within this rule is the change to 482.13 reducing the burden of reporting 2-point soft wrist restraint deaths. Additionally, it increases the methods for which hospitals may report all other restraint/seclusion related deaths, to include telephone, facsimile, and electronic. The Hospital Restraint/Seclusion Death Report Worksheet will now be used by all hospitals for required reporting by facsimile and electronic. Sections 1861(e)(1) through (8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals furnished services in the institution. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR Part 482, CoPs for Hospitals. Section 1905(a) of the Act provides that Medicaid payments from States may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii), 42 CFR 440.20(a)(3)(ii), and 42 CFR 440.140, hospitals are required to meet the Medicare CoPs in order to participate in Medicaid.

Authorizing Statute(s): US Code: 42 USC 591, 592, Name of Law: Public Health Service Act
US Code: 42 USC 186 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:
	81 FR 41307	06/24/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 57916	08/24/2016
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
Hospital Restraint/Seclusion Death Report Worksheet	CMS-10455, CMS-10455, CMS-10455	Intake , Screenshot , Health Death Report Form

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	6,225	24,500	-18,275
Annual Time Burden (Hours)	2,054	8,085	-6,031
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated burden decreased with this collection. S&C memo: 14-27-Hospital-CAH/DPU, under 42 CFR §482.13(g), requires CAH’s with DPUs to submit the hospital reporting of deaths associated with use of restraint or seclusion; since CAH DPUs are subject to the Hospital Conditions of Participation. This memo also excludes reporting of deaths in which only 2-point soft wrist restraints were used and the patient was not in seclusion at the time of death.

Annual Cost to Federal Government: $109,046

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

View ICR - OIRA Conclusion