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

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
CMS-R-305-Supporting_Statement B_CMS-2439-P-CLEAN.docx Supporting Statement B	2023-08-31
CMS-R-305_Supporting_Statement_A_(CMS-2439-P_version 5).docx Supporting Statement A	2023-08-31

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: 202307-0938-002
Status: Received in OIRA	Previous ICR Reference No: 202208-0938-011
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	Date Submitted to OIRA: 08/31/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	10,249	6,049
Time Burden (Hours)	483,784	448,551
Cost Burden (Dollars)	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:
0938-AU99	Proposed rulemaking	88 FR 28092	05/03/2023

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 28092	05/03/2023
Did the Agency receive public comments on this ICR? No

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

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

	Total Request	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	10,249	6,049	0	4,200	0	0
Annual Time Burden (Hours)	483,784	448,551	0	35,233	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: Our May 3, 2023 (88 FR 28092) NPRM (CMS-2439-P; RIN 0938-AU99) would revise the EQR activities to remove the requirement for PCCM entities to conduct EQR, and to add a new optional activity to support states in conducting quality-related evaluations, as well as a few other technical changes to the way EQR results are reported, and the timing of EQR. We are also proposing to require states to maintain a 5-year archive of EQR reports on their websites and to require states notify CMS via email or other electronic correspondence when they have posted their EQR reports to their websites, and to share a link. For the private sector burden, our currently approved annualized time and cost increased. Our annualized total cost increased by $870,037 (from $6,713,741 to $7,583,778). Our annualized total time increased by 14,880 hours from (116,624 hours to 131,504 hours). For the public sector burden, our currently approved annualized time and cost increased. Our annualized total cost increased by $1,942,919 (from $26,262,930 to $28,205,849). Our annualized total time increased by 20,353 hours (from 331,927 hours to 352,280 hours).

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Annual Cost to Federal Government: $23,540,976

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: 08/31/2023

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