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OMB Control No: 0938-1080	ICR Reference No: 202408-0938-032
Status: Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/20/2024
	Date Received in OIRA: 08/26/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2027	36 Months From Approved	11/30/2024
Responses	6,544,937	0	987,713
Time Burden (Hours)	93,797	0	82,310
Cost Burden (Dollars)	0	0	0

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.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

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	, , , , , , , ,
Medical Necessity Disclosure under MHPAEA
Medical Necessity Disclosure under MHPAEA sent with Claims Denial Disclosure

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	6,544,937	987,713	0	5,557,224
Annual Time Burden (Hours)	93,797	82,310	6	11,481
Annual Cost Burden (Dollars)	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).

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

Agency Contact: Jamaa Hill 301 492-4190

View ICR - OIRA Conclusion