External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 (CMS-R-305)

Forms and Documents

Document Name	Status
Form CMS-R-305 (State Gov't) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 Form and Instruction	Modified
Form CMS-R-305 (Private Sector) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 Form and Instruction	Modified
R5_2019_07_22 CMSR305 Support State B.docx Supporting Statement B	2019-09-20
R3_CMS-R-305 - Supporting Statement A (2019 version 2) CLEAN.docx Supporting Statement A	2019-09-20
R12_ 2019_07_19 CMSR305 Responses to Comments_Clean.docx Supplementary Document	2019-09-20
R12_ 2019_07_19 CMSR305 Responses to Comments_Clean.docx Supplementary Document	2019-09-20
Summary of EQR Protocol Changes (version 2).DOCX Supplementary Document	2019-09-20

IC Document Collections

IC ID	Document Title	Status
8551	(State Gov't) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 Form and Instruction	Modified
216824	(Private Sector) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0786	ICR Reference No: 201909-0938-009
Status: Historical Active	Previous ICR Reference No: 201611-0938-016
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364 (CMS-R-305)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/24/2019
	Date Received in OIRA: 09/20/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	06/30/2020
Responses	4,979	0	4,828
Time Burden (Hours)	460,308	0	426,476
Cost Burden (Dollars)	0	0	0

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Abstract: The results of Medicare reviews, Medicare accreditation surveys, and Medicaid external quality reviews will be used by States in assessing the quality of care provided to Medicaid beneficiaries provided by managed care organizations and to provide information on the quality of the care provided to the general public upon request.

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Authorizing Statute(s): PL: Pub.L. 105 - 33 4705 Name of Law: BBA of 1997
   US Code: 42 USC 1396 Name of Law: External Independent Review of Managed Care Activities
   Statute at Large: 19 Stat. 1932 Name of Statute: null
   PL: Pub.L. 111 - 3 403 Name of Law: CHIPRA of 2009
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 3 403 Name of Law: CHIPRA of 2009

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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:
	84 FR 4075	02/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 47958	09/11/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
(State Gov't) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364	CMS-R-305	External Quality Review (EQR) Protocols
(Private Sector) External Quality Review of Medicaid MCOs and Supporting Regulations in 42 CFR 438.360, 438.362, and 438.364	CMS-R-305	External Quality Review (EQR) Protocols

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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	4,979	4,828	0	0	151	0
Annual Time Burden (Hours)	460,308	426,476	0	0	33,832	0
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: This 2019 information collection request revises the eight existing EQR protocols. The revisions have no impact on any of our currently approved burden estimates. The revisions consist of: (1) consolidating the protocols and associated worksheets and appendices into one document; (2) restructuring and revising the documents to simplify the narrative flow and usability; (3) updating the protocols to include current best practices; and (4) aligning the protocols, appendices, and worksheets with the 2016 final rule. See the Crosswalk for details. When considering the 15 hour adjustment and the 33,817 hour correction, this iteration’s burden reconciliation consists of adding 33,832 hours (33,817 hr + 15 hr).

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Annual Cost to Federal Government: $18,406,423

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: 09/20/2019

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