Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)

Forms and Documents

Document	Type	Status	Availability
CMS-10338 - Supporting Statementf.docx	Supporting Statement A	Uploaded 2026-02-12	Repair queued
CMS-10338 - 60 day comment.docx	Public Comments	Uploaded 2025-12-18	Repair queued
CMS-10338 - 60-day comment response_Sep 2025.pdf	Supplementary Document	Uploaded 2025-12-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
249636	Internal Claims and Appeals and External Review Procedures		Modified
193861	Burden Estimates - Appeals	Other-Model - Notice of Internal Adverse Benefit Determination	Modified

ICR Details

OMB Control No: 0938-1099	ICR Reference No: 202512-0938-019
Status: Received in OIRA	Previous ICR Reference No: 202504-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/12/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	489,980,891	0
Time Burden (Hours)	866,105	0
Cost Burden (Dollars)	142,092,824	0

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Abstract: These interim final regulations set forth rules implementing revisions to the Public Health Service (PHS) Act section 2719 for internal claims and appeals and external review processes to implement Section 110 of the No Surprises Act (NSA), which protects participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from receiving surprise medical bills when they receive emergency services, non-emergency services from non-participating providers at participating facilities, and air ambulance services, under certain circumstances. Specifically Section 110 of the NSA amends section 2719 of the PHS Act to require the external review process to apply to participants, beneficiaries, and enrollees of such plans with respect to any adverse determination by a plan or issuer under section 2799A-1 or 2799A-2 of the PHS Act. These protections also extend to grandfathered plans.

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Authorizing Statute(s): US Code: 45 USC 147.136 Name of Law: Internal claims and appeals and external review processes
   PL: Pub.L. 110 - 110 No Surprises Act Name of Law: Consolidated Appropriations Act, 2021
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 110 No Surprises Act Name of Law: Consolidated Appropriations Act, 2021
US Code: 45 USC 147.136 Name of Law: Internal claims and appeals and external review processes

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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:
	90 FR 30940	07/11/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 57473	12/11/2025
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
Burden Estimates - Appeals
Internal Claims and Appeals and External Review Procedures

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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	489,980,891	0	0	0	-26,600,175	516,581,066
Annual Time Burden (Hours)	866,105	0	0	0	-332,587	1,198,692
Annual Cost Burden (Dollars)	142,092,824	0	0	0	-7,714,008	149,806,832

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: Due to adjustments in the number of respondents and expected claims in the appeals and external review process based on recent data, HHS’s total annual hour burden has decreased from 1,198,692 hours to 866,105 hours. As a result, the annual total cost burden has decreased from $149,806,832 to $57,428,960.

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Annual Cost to Federal Government: $9,230

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? 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? 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: 02/12/2026

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