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OMB Control No: 0938-1393	ICR Reference No: 202609-0938-017
Status: Received in OIRA	Previous ICR Reference No: 202409-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Non-Quantitative Treatment Limitation Analyses and Compliance Under MHPAEA (CMS-10773)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	189,731	0
Time Burden (Hours)	1,004,156	0
Cost Burden (Dollars)	0	0

Abstract: The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) (P.L.110-343) generally requires that group health plans and group health insurance issuers offering mental health or substance use disorder (MH/SUD) benefits in addition to medical and surgical (med/surg) benefits do not apply any more restrictive financial requirements (e.g., co-pays, deductibles) and/or treatment limitations (e.g., visit limits, prior authorizations) to MH/SUD benefits than those requirements and/or limitations applied to substantially all med/surg benefits. The Patient Protection and Affordable Care Act, Pub. L. 111-148, was enacted on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152, was enacted on March 30, 2010. These statutes are collectively known as the “Affordable Care Act.” The Affordable Care Act extended MHPAEA to apply to the individual health insurance market. The Consolidated Appropriations Act of 2021 (the Appropriations Act) was enacted on December 27, 2020. The Appropriations Act amended MHPAEA, in part, by expressly requiring group health plans and health insurance issuers offering group or individual health insurance coverage that offer both medical/surgical benefits and MH/SUD benefits and that impose non-quantitative treatment limitations (NQTLs) on MH/SUD benefits to perform and document their comparative analyses of the design and application of NQTLs. Further, beginning 45 days after the date of enactment of the Appropriations Act, group health plans and health insurance issuers offering group or individual health insurance coverage must make their comparative analyses available to the Departments of Labor, Health and Human Services (HHS), and the Treasury or applicable state authorities, upon request. The Appropriations Act also requires the Secretary of HHS to submit to Congress, and make publicly available, an annual report on the conclusions of the reviews.

Authorizing Statute(s): PL: Pub.L. 116 - 260 203 Name of Law: Consolidated Appropriations Act, 2021

Citations for New Statutory Requirements: PL: Pub.L. 116 - 260 203 Name of Law: Consolidated Appropriations Act, 2021

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU93	Final or interim final rulemaking	89 FR 77586	09/23/2024

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 51552	08/03/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 77586	09/23/2024
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Request	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	189,731	120,497	69,234
Annual Time Burden (Hours)	1,004,156	-1,885,002	2,889,158
Annual Cost Burden (Dollars)	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: Although there was a decrease in the estimated number of issuers (from 1,553 to 1,467), the estimated burden related to the NQTL comparative analyses documentation and data requirements for issuers has increased by 327,933 hours (from 82,827 to 410,760). This is due to the new data requirements necessary to comply with the 2024 final rules. In contrast, due to a decrease in the assumed number of self-funded non-Federal governmental plans that will do their own comparative analysis, the estimated burden related to the NQTL comparative analyses documentation and data requirements for self-funded non-Federal governmental plans has decreased by approximately 353,027 hours (from 930,107 to 577,080). This is largely driven by the understanding that TPAs heavily support self-funded non-Federal governmental plan sponsors to meet the NQTL comparative analysis documentation and data requirements. The estimated burden to issuers and self-funded non-Federal governmental plans associated with the initial submission of comparative analyses has increased by 100 hours (from 0 to 100). The estimated burden to issuers and self-funded non-Federal governmental plans associated with the submission of additional documentation for comparative analyses has increased by 50 hours (from 50 to 100), due to an increase in the number of plans and issuers that are expected to submit additional documentation (from 10 to 20). Further, due to an increase in the estimated number of issuers and self-funded non-Federal governmental plans needing to complete corrective actions (from 8 to 18) to bring their NQTLs into compliance, the estimated burden related to corrective actions has increased by 520 hours (from 200 to 720). Additionally, there is a new burden to issuers and non-Federal governmental plans associated with consumer requests for comparative analyses (of approximately 7,696 hours). Lastly, there is a new burden to issuers and non-Federal governmental plans associated with the recordkeeping requirement in the 2024 final rules (of approximately 7,696 hours). Therefore, total burden hours have decreased by approximately 9,032 hours (from 1,013,185 to 1,004,153).

Annual Cost to Federal Government: $2,000,000

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

Agency Contact: Jamaa Hill 301 492-4190

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