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 - Model disclosure template - FINAL.docx Supplementary Document	2019-08-30
CMS-10307 - Model disclosure template - Track Changes.docx Supplementary Document	2019-08-30
CMS-10307 - Crosswalk of Changes.docx Supplementary Document	2019-08-30
CMS-10307 - Non-Sub Change Justification.docx Justification for No Material/Nonsubstantive Change	2019-08-30
CMS-10307 Supporting Statement - 30d Final.docx Supporting Statement A	2018-05-16

IC Document Collections

IC ID	Document Title	Status
229441	Disclosure Request Form Form and Instruction	Modified
209346	Medical Necessity Disclosure under MHPAEA [Sent with Claims Denial Disclosure] [Processed By Issuer or Third Party Service] [Paper]	Unchanged
191609	Medical Necessity Disclosure under MHPAEA [Sent with Claims Denial Disclosure] [Processed By Issuer or Third Party Service] [Electronic]	Unchanged
191608	Medical Necessity Disclosure under MHPAEA [sent with Claims Denial Disclosure] [Processed In-House] [Paper]	Unchanged
191607	Medical Necessity Disclosure under MHPAEA [sent with Claims Denial Disclosure] [Processed In-House] [Electronic]	Unchanged
191606	Medical Necessity Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Paper]	Unchanged
191605	Medical Necessity Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Electronic]	Unchanged
191604	Medical Necessity Disclosure under MHPAEA [Processed In-House] [Paper]	Unchanged
191603	Medical Necessity Disclosure under MHPAEA [Processed In-House] [Electronic]	Unchanged
191602	Disclosure under MHPAEA [Processed By Issuer in the Individual Market]	Unchanged
191601	Claims Denial Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Paper]	Unchanged
191600	Claims Denial Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Electronic]	Unchanged
191599	Claims Denial Disclosure under MHPAEA [Processed In-House] [Paper]	Unchanged
191598	Claims Denial Disclosure under MHPAEA [Processed In-House] [Electronic]	Unchanged

ICR Details

OMB Control No: 0938-1080	ICR Reference No: 201908-0938-016
Status: Active	Previous ICR Reference No: 201712-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: 20948
Title: Medical Necessity Disclosure Under MHPAEA and Claims Denial Disclosure Under MHPAEA (CMS-10307)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/04/2019
	Date Received in OIRA: 08/30/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	05/31/2021	05/31/2021
Responses	1,081,928	0	1,081,928
Time Burden (Hours)	43,327	0	43,327
Cost Burden (Dollars)	1,369,301	0	1,369,301

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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:
	82 FR 30867	07/03/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 57984	12/08/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 14

IC Title	Form No.	Form Name
Medical Necessity Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Electronic]
Medical Necessity Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Paper]
Medical Necessity Disclosure under MHPAEA [Sent with Claims Denial Disclosure] [Processed By Issuer or Third Party Service] [Paper]
Disclosure Request Form	CMS-10307	Disclosure Request Form
Medical Necessity Disclosure under MHPAEA [sent with Claims Denial Disclosure] [Processed In-House] [Electronic]
Medical Necessity Disclosure under MHPAEA [sent with Claims Denial Disclosure] [Processed In-House] [Paper]
Claims Denial Disclosure under MHPAEA [Processed In-House] [Electronic]
Medical Necessity Disclosure under MHPAEA [Sent with Claims Denial Disclosure] [Processed By Issuer or Third Party Service] [Electronic]
Claims Denial Disclosure under MHPAEA [Processed In-House] [Paper]
Claims Denial Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Electronic]
Claims Denial Disclosure under MHPAEA [Processed By Issuer or Third Party Service] [Paper]
Disclosure under MHPAEA [Processed By Issuer in the Individual Market]
Medical Necessity Disclosure under MHPAEA [Processed In-House] [Electronic]
Medical Necessity Disclosure under MHPAEA [Processed In-House] [Paper]

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ICR Summary 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	1,081,928	1,081,928	0	0	0	0
Annual Time Burden (Hours)	43,327	43,327	0	0	0	0
Annual Cost Burden (Dollars)	1,369,301	1,369,301	0	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: The total burden decreased by approximately 50 hours because of a reduction in the estimated number of issuer/state combinations in the individual market (from 2,641 to 2,045) which reduced the number of medical necessity disclosures and related burden hours. Capital costs increased by approximately $325,895 due to an increase in labor and mailing costs. In addition, there is a new burden of 15,394 hours related to the optional disclosure request form.

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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? Uncollected

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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: 08/30/2019

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