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OMB Control No: 0938-1037	ICR Reference No: 201608-0938-010
Status: Historical Active	Previous ICR Reference No: 200712-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Testing Experience and Functional Tools: Functional Assessment Standardized Items (FASI) Based on the CARE Tool (CMS-10243)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/23/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/12/2016
Terms of Clearance: We appreciate CMS' agreement to submit non-substantive revisions to forms as a non-substantive change and to a 30-day comment period for substantive form revisions, if any.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	03/31/2011
Responses	5,650	0	244,234
Time Burden (Hours)	2,825	0	179,341
Cost Burden (Dollars)	0	0	0

Abstract: In 2012, the Disabled & Elderly Health Programs Group (DEHPG), within the Center for Medicaid and Children’s Health Insurance Program Services (CMCS) of the Centers for Medicare & Medicaid Services (CMS), funded a project entitled, Technical Assistance to States for Testing Experience and Functional Tools (TEFT) Grants. One component of this demonstration is to amend and test the reliability of a setting-agnostic, interoperable set of data elements, called “items,” that can support standardized assessment of individuals across the continuum of care. Items that were created for use in post-acute care settings using the Continuity Assessment Record and Evaluation (CARE) tool have been adopted, modified, or supplemented for use in community-based long-term services and supports (CB-LTSS) programs. This project will test the reliability and validity of the function-related assessment items, now referred to as Functional Assessment Standardized Items (FASI), when applied in community settings, and in various populations: elders (65 years and older); younger adults (18-64) with physical disabilities; and adults of any age with intellectual or developmental disabilities, with severe mental illness, or with traumatic brain injury. Data will be collected through interviews with individuals, conducted in their homes or another setting of their choosing. Assessment interviews will be conducted by trained assessors who already work with these clients to conduct assessments for the Medicaid Home and Community-Based Services (HCBS) coverage. Data will be collected using a modification of their current form in an electronic PDF format and uploaded to Truven Health Analytics through a secure electronic transfer file (ETF) application.

Authorizing Statute(s): PL: Pub.L. 111 - 148 2701 Name of Law: Patient Protection and Affordable Care 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 26235	05/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 51914	08/05/2016
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	5,650	244,234	-238,584
Annual Time Burden (Hours)	2,825	179,341	-176,516
Annual Cost Burden (Dollars)	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: This is a request to use the reinstated CARE tool authorization. The PAC CARE was established in 2007 for use in the Post-Acute Care Payment Reform Demonstration. Some of the items have since been incorporated into the Federal assessment tools required in the nursing facilities (e.g., the Minimum Data Set (MDS), and other related assessment tools used in Medicare payment and quality reporting requirements related to post-acute care services. The TEFT demonstration would like to use the reinstated authorization so that the adapted CARE items in the FASI can be tested for reliability and validity in the community-based long term services and supports (CB-LTSS) populations. The data burden for the FASI items is much smaller than the earlier CARE item set as the average time to complete each section is five minutes and the total burden estimate for the complete set of FASI items is 28 minutes. The title of the package is also being changed to reflect that the FASI item set is only a subset of the original CARE items. The new title reflects this while also referring back to the source items in the CARE tool.

Annual Cost to Federal Government: $1,131,951

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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]? Yes

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: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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