[Federal Register Volume 89, Number 162 (Wednesday, August 21, 2024)]
[Notices]
[Pages 67638-67639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18745]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10307 and CMS-R-263]


Agency Information Collection Activities: Submission for OMB 
Review; 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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by September 20, 2024.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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 Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    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 
as applied to 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 
in order to satisfy the 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

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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: Occasionally; 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.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: On-Site 
Inspection for Durable Medical Equipment (DME) Supplier Location and 
Supporting Regulations in 42 CFR, Section 424.57; Use: CMS is mandated 
to identify and implement measures to prevent fraud and abuse in the 
Medicare program. To meet this challenge, CMS has moved forward to 
improve the quality of the process for enrolling suppliers into the 
Medicare program by establishing a uniform application for enumerating 
suppliers of durable medical equipment, prosthetics, orthotics, and 
supplies (DMEPOS). Implementation of enhanced procedures for verifying 
the enrollment information has also improved the enrollment process. As 
part of this process, verification of compliance with supplier 
standards is necessary. The site investigation form has been used in 
the past to aid the Medicare contractor (the National Supplier 
Clearinghouse and/or its subcontractors) in verifying compliance with 
the required supplier standards found in 42 CFR 424.57(c). The primary 
function of the site investigation form is to provide a standardized, 
uniform tool to gather information from a DMEPOS supplier that tells us 
whether it meets certain qualifications to be a DMEPOS supplier (as 
found in 42 CFR 424.57(c)) and where it practices or renders its 
services. Form Number: CMS-R-263 (OMB control number: 0938-0749); 
Frequency: Yearly; Affected Public: Private sector, Business or other 
for-profits; Number of Respondents: 48,087; Number of Responses: 
48,087; Total Annual Hours: 48,087. (For policy questions regarding 
this collection contact Alisha Sanders at 410-786-0671.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-18745 Filed 8-20-24; 8:45 am]
BILLING CODE 4120-01-P