Medical Necessity Disclosure Under MHPAEA and Claims Denial Disclosure Under MHPAEA (CMS-10307)

Forms and Documents

Document Name	Status
Form CMS-10307 Disclosure Request Form Form and Instruction	Modified
CMS-10307 Supporting Statement 30-day_8-5-24.docx Supporting Statement A	2024-08-23

IC Document Collections

IC ID	Document Title	Status
229441	Disclosure Request Form Form and Instruction	Modified
191609	Medical Necessity Disclosure under MHPAEA sent with Claims Denial Disclosure	Modified
191606	Medical Necessity Disclosure under MHPAEA	Modified
191600	Claims Denial Disclosure under MHPAEA	Modified

ICR Details

OMB Control No: 0938-1080	ICR Reference No: 202408-0938-032
Status: Received in OIRA	Previous ICR Reference No: 202102-0938-014
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Medical Necessity Disclosure Under MHPAEA and Claims Denial Disclosure Under MHPAEA (CMS-10307)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	6,544,937	987,713
Time Burden (Hours)	93,797	82,310
Cost Burden (Dollars)	0	0

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Abstract: Medical Necessity Disclosure under MHPAEA The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) (P.L.110-343) 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 ensure that that they do not apply any more restrictive financial requirements (e.g., co-pays, deductibles) and/or treatment limitations (e.g., visit limits) to MH/SUD benefits than those requirements and/or limitations applied to substantially all med/surg benefits.Medical Necessity Disclosure under MHPAEA section 512(b) specifically amends the Public Health Service (PHS) Act to require plan administrators or health insurance issuers to provide, upon request, the criteria for medical necessity determinations made with respect to MH/SUD benefits to current or potential participants, beneficiaries, or contracting providers. The Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 2010) sets forth rules for providing criteria for medical necessity determinations. The final rules retain the provisions from the interim final rules and extend them to small employers and the individual market. CMS oversees non-Federal governmental plans or related health insurance and health insurance plans offered in the individual market.MHPAEA section 512(b) specifically amends the Public Health Service (PHS) Act to require plan administrators or health insurance issuers to supply, upon request, the reason for any denial of payment for MH/SUD services to the participant or beneficiary involved in the case.

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Authorizing Statute(s): US Code: 42 USC 300gg-5(a)(4) Name of Law: Public Health Service Act section 2705
   PL: Pub.L. 110 - 343 512(b) Name of Law: Mental Health Parity and Addiction Equity Act of 2008
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 343 512(b) Name of Law: Mental Health Parity and Addiction Equity Act of 2008
US Code: 42 USC 300gg-5(a)(4) Name of Law: Public Health Service Act section 2705

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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:
	89 FR 43406	05/17/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 67638	08/21/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Claims Denial Disclosure under MHPAEA
Disclosure Request Form	CMS-10307, CMS-10307, CMS-10307, CMS-10307, CMS-10307, CMS-10307, CMS-10307, CMS-10307, CMS-10307	Model Disclosure Template (English) ,   Model Disclosure Template (Arabic) ,   Model Disclosure Template (Korean_ ,   Model Disclosure Template (Tagalog) ,   Model Disclosure Template (Spanish) ,   Model Disclosure Template (Vietnamese) ,   Model Disclosure Template (Chinese) ,   Model Disclosure Template (Vietnamese) ,   Model Disclosure Template (Korean))
Medical Necessity Disclosure under MHPAEA
Medical Necessity Disclosure under MHPAEA sent with Claims Denial Disclosure

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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	6,544,937	987,713	0	0	5,557,224	0
Annual Time Burden (Hours)	93,797	82,310	0	6	11,481	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: The total burden related to medical necessity disclosures and claims denial disclosures increased by approximately 11,488 hours (from 82,309 to 93,797) largely due to an increase in the number of estimated denials (from 15% to 18%), which was not offset by the reduction in the estimated number of participants covered by State and local government plans (from 30.3 million to 25.7 million) or the reduction in the number of issuer/State combinations in the individual market (from 1,293 to 1,194). This change also resulted in the increase of burden related to the optional disclosure request form by approximately 1,997 hours (from 13,952 to 15,949). Capital costs have increased by approximately $58,492 (from $177,008 to $235,500) as a result of changes in postage costs and an increase in the number of disclosures delivered by mail (from 236,011 to 267,613).

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Annual Cost to Federal Government: $0

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: 08/26/2024

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