Notice of Medical Necessity Criteria under the Mental Health Parity and Addiction Equity Act of 2008

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SS_1545-2165_FINAL.docx	Supporting Statement A	Uploaded 2025-08-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
191315	Notice of Medical Necessity Criteria under the Mental Health Parity and Addiction Equity Act of 2008		Modified

ICR Details

OMB Control No: 1545-2165	ICR Reference No: 202508-1545-005
Status: Active	Previous ICR Reference No: 202309-1545-007
Agency/Subagency: TREAS/IRS	Agency Tracking No:
Title: Notice of Medical Necessity Criteria under the Mental Health Parity and Addiction Equity Act of 2008
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: 11/14/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/20/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2028	36 Months From Approved	11/30/2025
Responses	478,980	0	1,413,420
Time Burden (Hours)	235,984	0	31,574
Cost Burden (Dollars)	1,651,695	0	4,235,310

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Abstract: The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) was enacted on October 3, 2008 as sections 511 and 512 of the Tax Extenders and Alternative Minimum Tax Relief Act of 2008 (Division C of Public Law 110-343). MHPAEA amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), and the Internal Revenue Code of 1986 (Code). In 1996, Congress enacted the Mental Health Parity Act of 1996, which required parity in aggregate lifetime and annual dollar limits for mental health benefits and medical and surgical benefits. Those mental health parity provisions were codified in section 712 of ERISA, section 2705 of the PHS Act, and section 9812 of the Code. The changes made by MHPAEA are codified in these same sections and consist of new requirements as well as amendments to several of the existing mental health parity provisions applicable to group health plans and health insurance coverage offered in connection with a group health plan. MHPAEA and the interim final regulations do not apply to small employers who have between two and 50 employees. The changes made by MHPAEA are generally effective for plan years beginning after October 3, 2009. MHPAEA and the final regulations (29 CFR 2590.712(d)) require plan administrators to disclose the criteria for medical necessity determinations with respect to mental health and substance use disorder benefits. These third-party disclosures are information collection requests for purposes of the Paperwork Reduction Act. In response to provisions of the Cures Act requires the Departments of Labor (DOL), Health and Human Services, and the Treasury (collectively, the Departments), are providing a model form that participants, enrollees, or their authorized representatives could use to request information from their health plan or issuer regarding NQTLs that may affect their MH/SUD benefits, or to obtain documentation after an adverse benefit determination involving MH/SUD benefits to support an appeal.

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Authorizing Statute(s): PL: Pub.L. 110 - 343 511 and 512 Name of Law: Paul Wellstone and Pete Domenici Mental Health Parity and Addicition Equity Act of 2008
   US Code: 26 USC 9812 Name of Law: Parity in the application of certain limits to mental health benefits
  

Citations for New Statutory Requirements: PL: Pub.L. 116 - 260 103 Name of Law: The Consolidated Appropriations Act of 2021

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1545-BQ29	Final or interim final rulemaking	89 FR 77586	09/23/2024

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Notice of Medical Necessity Criteria under the Mental Health Parity and Addiction Equity Act of 2008

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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	478,980	1,413,420	0	-934,440	0	0
Annual Time Burden (Hours)	235,984	31,574	0	204,410	0	0
Annual Cost Burden (Dollars)	1,651,695	4,235,310	0	-2,583,615	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: These final rules amend the regulations implementing MHPAEA and add new regulations implementing the NQTL comparative analyses requirements under MHPAEA, as amended by the Consolidated Appropriations Act, 2021 (CAA, 2021). Specifically, these final rules amend the existing NQTL standard to prohibit plans and issuers from using NQTLs to place greater restrictions on access to mental health and substance use disorder benefits as compared to medical/surgical benefits.

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Annual Cost to Federal Government: $24,598,080

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.     Yes

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: 08/20/2025

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