[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Notices]
[Pages 43406-43407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10307]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by July 16, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).
CMS-10307 Medical Necessity and Claims Denial Disclosures Under MHPAEA

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medical Necessity 
and Claims Denial Disclosures under MHPAEA; Use: The Paul Wellstone and 
Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 
(MHPAEA) (Pub. L.110-343) generally requires that group health plans 
and group health insurance issuers offering both medical and surgical 
(med/surg) and mental health or substance use disorder (MH/SUD) 
benefits 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. The Patient Protection 
and Affordable Care Act, Public Law 111-148, was enacted on March 23, 
2010, and the Health Care and Education Reconciliation Act of 2010, 
Public Law 111-152, was enacted on March 30, 2010. These statutes are 
collectively known as the ``Affordable Care Act'' (ACA). The ACA 
extended MHPAEA to apply to the individual health insurance market. 
Additionally, the Department of Health and Human Services (HHS) final 
regulation regarding essential health benefits (EHB) requires health 
insurance issuers offering non-grandfathered health insurance coverage 
in the individual and small group markets, through an Exchange or 
outside of an Exchange, to comply with the requirements of the MHPAEA 
regulations to satisfy the

[[Page 43407]]

requirement to cover EHB (45 CFR 147.150 and 156.115).

Medical Necessity Disclosure Under MHPAEA

    MHPAEA 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 Final Rules under MHPAEA 
set forth rules for providing criteria for medical necessity 
determinations. CMS administers MHPAEA with respect to self-insured, 
non-Federal governmental plans in all States, and health insurance 
issuers in two States.

Claims Denial Disclosure Under MHPAEA

    MHPAEA specifically amends the PHS Act to require plan 
administrators or health insurance issuers to provide, upon request, 
the reason for any denial or reimbursement of payment for MH/SUD 
services to the participant or beneficiary involved in the case. The 
Final Rules under MHPAEA at 45 CFR 146.136(d)(2) implement MHPAEA. CMS 
administers MHPAEA with respect to self-insured, non-Federal 
governmental plans in all States and health insurance issuers in two 
States, and the regulation provides a safe harbor such that non-Federal 
governmental plans (and issuers offering coverage in connection with 
such plans) are deemed to comply with requirements of paragraph (d)(2) 
of 45 CFR 146.136 if they provide the reason for claims denial in a 
form and manner consistent with ERISA requirements found in 29 CFR 
2560.503-1. Section 146.136(d)(3) clarifies that PHS Act section 2719 
governing internal claims and appeals and external review as 
implemented by 45 CFR 147.136, covers MHPAEA claims denials and 
requires that, when a non-quantitative treatment limitation (NQTL) is 
the basis for a claims denial, that a non-grandfathered plan or issuer 
must provide the processes, strategies, evidentiary standard, and other 
factors used in developing and applying the NQTL with respect to med/
surg benefits and MH/SUD benefits.

Disclosure Request Form

    Group health plan participants, beneficiaries, covered individuals 
in the individual market, or persons acting on their behalf, may use 
this optional model form to request information from plans regarding 
the medical necessity and claims denials disclosures referenced above. 
Form Number: CMS-10307 (OMB control number: 0938-1080); Frequency: On 
Occasion; Affected Public: State, Local, or Tribal Governments, Private 
Sector, Individuals; Number of Respondents: 282,657; Total Annual 
Responses: 1,125,558; Total Annual Hours: 93,797. (For policy questions 
regarding this collection contact Erik Gomez at 667-414-0682.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-10900 Filed 5-16-24; 8:45 am]
BILLING CODE 4120-01-P