Evaluation of the CMS Quality Improvement Organizations: Medication Safety and Adverse Drug Event Prevention (CMS-10675)

Forms and Documents

Document Name	Status
Form CMS-10675 Evaluation of the CMS Quality Improvement Organizations: Medication Safety and Adverse Drug Event Prevention Form and Instruction	New
CMS-10675_Attachment_4_Response_to_Public_Comments_111418 (summarized response)v4_508.doc Supplementary Document	2018-12-04
CMS-10675_Sup_Statement_Part_B_Revised_102918_508.docx Supporting Statement B	2018-12-04
CMS-10675_Sup_Statement_Part_A_Revised_11-01-18_508.docx Supporting Statement A	2018-12-04

IC Document Collections

IC ID	Document Title	Status
234410	Evaluation of the CMS Quality Improvement Organizations: Medication Safety and Adverse Drug Event Prevention Form and Instruction	New

ICR Details

OMB Control No: 0938-1356	ICR Reference No: 201812-0938-002
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Evaluation of the CMS Quality Improvement Organizations: Medication Safety and Adverse Drug Event Prevention (CMS-10675)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/04/2019
	Date Received in OIRA: 12/06/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	36 Months From Approved
Responses	1,200	0	0
Time Burden (Hours)	300	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Sections 1152-1154 of the Social Security Act requires the Centers for Medicare & Medicaid Services (CMS) to direct the Quality Improvement Organization (QIO) Program, one of the largest federal programs dedicated to improving healthcare quality for Medicare beneficiaries. QIOs help Medicare providers with quality improvement throughout the spectrum of care and review quality concerns for the protection of beneficiaries and the Medicare Trust Fund. This program is a key component of the U.S. Department of Health and Human Services' National Quality Strategy and the CMS Quality Strategy, with the overarching goals to achieve better healthcare, better health and lower costs of care. The purpose of this Information Collection Request (ICR) is to conduct a survey to inform the evaluation of one of the tasks of the QIO Program’s 11th Scope of Work (SOW). This ICR focuses on data collection to assess Task C.3-6 Increasing Medication Safety and Preventing Adverse Drug Events. The survey will be completed by prescribers, pharmacists and nursing home administrators/directors of nursing who are participating in the QIO program and those not involved with the QIO program in order to evaluate the effect of the QIO program on quality improvement efforts in community settings.

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Authorizing Statute(s): US Code: 42 USC 1320-C1 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 34593	07/20/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 61383	11/29/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Evaluation of the CMS Quality Improvement Organizations: Medication Safety and Adverse Drug Event Prevention	CMS-10675, CMS-10675	Appendix A.1 Medication Safety and Adverse Drug Event Prevention Survey Screenshots ,   Appendix A: Survey Instrument - Medication Safety and Adverse Drug Event Prevention (A Web-based Survey)

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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	1,200	0	0	1,200	0	0
Annual Time Burden (Hours)	300	0	0	300	0	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $90,285

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

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

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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: 12/06/2018

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