External Quality Review (EQR) of Medicaid and Children’s Health Insurance Program (CHIP) Managed Care, EQR Protocols, and Supporting Regulations (CMS-R-305)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-R-305 External Quality Review (EQR) Protocols	Form and Instruction	Modified	Available
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	Repair queued
Form CMS-R-305 External Quality Review (EQR) Protocols	Form and Instruction	Modified	Available
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	Repair queued
CMS-R-305_SupportingStatementPartB_(May 2022).pdf	Supporting Statement B	Uploaded 2022-10-25	Repair queued
CMS-R-305 - Supporting Statement A (2022 version 7) CLEAN.docx	Supporting Statement A	Uploaded 2022-10-25	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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	External Quality Review (EQR) Protocols
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	External Quality Review (EQR) Protocols
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: 202208-0938-011
Status: Historical Active	Previous ICR Reference No: 201910-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: External Quality Review (EQR) of Medicaid and Children’s Health Insurance Program (CHIP) Managed Care, EQR Protocols, and Supporting Regulations (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: 12/28/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/25/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	12/31/2022
Responses	6,049	0	4,979
Time Burden (Hours)	448,551	0	460,308
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): US Code: 42 USC 1396 Name of Law: External Independent Review of Managed Care Activities
   Statute at Large: 19 Stat. 1932
   PL: Pub.L. 105 - 33 4705 Name of Law: BBA of 1997
   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:
	87 FR 28831	05/11/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 48032	08/05/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
(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
(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

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ICR Summary of Burden

table that charts list 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	6,049	4,979	0	156	914	0
Annual Time Burden (Hours)	448,551	460,308	0	4,720	-16,477	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This 2022 information collection request proposes to revise the active EQR protocols (which were last revised in 2019). The revisions would: (1) align the existing protocols, appendices, and worksheets with the November 13, 2020, Medicaid managed care final rule (RIN 0938-AT40, CMS-2408-F), and (2) add a new protocol, Validation of Network Adequacy. A summary of these changes includes, but is not limited to: adding three elements to § 438.358(b)(1)(iii) to include a review of elements § 438.56, 438.100, and 438.114; establishing the first protocol for the new mandatory activity described in §438.358(b)(1)(iv) for network adequacy validation for MCOs, PIHPs, and PAHPs; and other formatting changes. See section 15 of the attached Supporting Statement for a more complete discussion of the changes.

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Annual Cost to Federal Government: $32,976,671

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? No

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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: 10/25/2022

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