Notice2024-18745
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 21, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 162 (Wednesday, August 21, 2024)</title>
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[Federal Register Volume 89, Number 162 (Wednesday, August 21, 2024)]
[Notices]
[Pages 67638-67639]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18745]
[[Page 67638]]
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
[[Page 67639]]
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
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</html>Indexed from Federal Register on August 21, 2024.
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