Notice2025-11157
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
June 17, 2025
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 90 Issue 115 (Tuesday, June 17, 2025)</title>
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[Federal Register Volume 90, Number 115 (Tuesday, June 17, 2025)]
[Notices]
[Pages 25616-25618]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10330, CMS-10777 and CMS-10598]
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 July 17, 2025.
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: Notice of
Rescission of Coverage and Disclosure Requirements for Patient
Protection under the Affordable Care Act; Use: Section 2712 of the
Public Health Service Act (PHS Act), as added by the Affordable Care
Act, contains a rescission notice. The No Surprises Act, enacted as
part of the Consolidated
[[Page 25617]]
Appropriations Act, 2021, sunset the patient protections related to
choice of health care professional under section 2719A of the PHS Act
and recodified these patient protections in newly added section 9822 of
the Internal Revenue Code, section 722 of the Employee Retirement
Income Security Act, and section 2799A-7 of the PHS Act and extended
the applicability of these provisions to grandfathered health plans for
plan years beginning on or after January 1, 2022. The rescission notice
will be used by health plans and issuers to provide advance notice to
certain individuals that their coverage may be rescinded as a result of
fraud or intentional misrepresentation of material fact. The patient
protection notification will be used by certain health plans and
issuers to inform individuals of their right to choose a primary care
provider or pediatrician and to use obstetrical/gynecological services
without prior authorization. The related provisions are finalized in
the 2015 final regulations titled ``Final Rules under the Affordable
Care Act for Grandfathered Plans, Preexisting Condition Exclusions,
Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals,
and Patient Protections'' (80 FR 72192, November 18, 2015) and 2021
interim final regulations titled ``Requirements Related to Surprise
Billing; Part I'' (86 FR 36872, July 13, 2021). Form Number: CMS-10330
(OMB control number: 0938-1094); Frequency: Annual; Affected Public:
State, Local, or Tribal Governments, Private Sector; Number of
Respondents: 82,638; Total Annual Responses: 13,741,303; Total Annual
Hours: 10. (For policy questions regarding this collection, contact
Adam Pellillo at 667-290-9621.)
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Conditions of Participation for Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICFs-IID);
Use: This is a reinstatement of the information collection request that
expired on September 30, 2024. The previous iteration of this OMB
Control Number 0938-1402 (approved September 22, 2021) had an annual
burden of 114,478 hours and annual costs of $7,375,654. For this
requested reinstatement, with changes, the total annual burden hours
for industry is 75,721 hours and the annual burden costs are
$5,470,418.
During the COVID-19 Public Health Emergency (PHE), individuals
residing in congregate settings, such as ICFs-IID and Long-Term Care
(LTC) facilities were at greater risk of acquiring COVID-19 infections
and once infected, were at greater risk of severe illness or death. As
a result, the Centers for Medicare and Medicaid Services (CMS) revised
the Conditions of Participation (CoPs) for many of CMS' certified
providers including hospitals and institutional care settings in order
to reduce the risk of exposure to and the severity from contracting the
COVID-19 virus for medical and non-medical staff and patients. In
addition to the CoPs, health care facilities were obligated to
establish an infection control program that would protect the health
and safety of residents, personnel, and the general public under
Sections 1819(d)(3)(B) and 1919(d)(3) of the Act.
Individuals housed at ICFs-IID facilities are mentally and
intellectually impaired, receive Medicaid assistance, and live in
congregate settings. ICF-IID clients may also have other underlying
medical conditions such as visual or hearing impairments, or seizure
disorder. Based on their living situation and underlying health
conditions, these clients were at higher risk of exposure and severe
consequences from COVID-19 and continue to be at higher risk due to new
variants of COVID-19 and other similar acute respiratory illnesses.
In the interim final rule, entitled ``Medicare and Medicaid
Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC)
Facilities and Intermediate Care Facilities for Individuals with
Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff,''
86 FR 26306 (CMS-3414-IFC), that was published on May 13,
2021(hereinafter ``May 2021 Interim Final Rule''), CMS added new CoPs
which required ICF/IIDs facilities to: (1) develop policies and
procedures to educate clients, their representatives, and staff on the
benefits and risks, and potential side effects of the COVID-19 vaccine;
(2) educate and offer the COVID-19 vaccine per the policy and
procedures developed; (3) document that staff and clients were educated
and offered the vaccine; and (4) document whether or not a client or
staff member received the vaccine and if not, if it was due to medical
contraindications or refusal. The May 2021 Interim Final rule included
an estimate for the burden hours and costs to industry associated with
these specific information collection requests and which was
subsequently submitted to OMB as the initial PRA package for this
information collection request in 2021.
In November 2021, CMS issued ``Medicare and Medicaid Programs;
Omnibus COVID-19 Health Care Staff Vaccination,'' 86 FR 61555 (CMS-
3415-IFC)(hereinafter ``November 2021 Interim Final Rule''), which
mandated health care staff in all CMS certified facilities, including
ICFs-IID, to be vaccinated. Most significantly, health care staff were
no longer permitted to refuse being vaccinated and had to request an
exemption if they did not want to receive the COVID-19 vaccine. As a
result, ICFs-IID had to document that their staff were educated and
offered the vaccine, and also document whether their staff received a
vaccination or were approved for an exemption. Clients of ICFs-IID,
however, were still allowed to refuse taking the vaccine which would be
documented in their medical record.
On June 5, 2023, CMS issued a final rule, ``Medicare and Medicaid
Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health
Care Staff Vaccination Requirements; Additional Policy and Regulatory
Changes to the Requirements for Long-Term Care (LTC) Facilities and
Intermediate Care Facilities for Individuals With Intellectual
Disabilities (ICFs-IID) To Provide COVID-19 Vaccine Education and Offer
Vaccinations to Residents, Clients, and Staff; Policy and Regulatory
Changes to the Long Term Care Facility COVID-19 Testing,'' 88 FR 36485
(CMS-3415-F, 3414-F, and 3401-F)(hereinafter ``June 2023 Final Rule''),
which eliminated the vaccine mandate on health care staff and finalized
the CoPs related to the ``educate and offer'' activity for COVID-19
vaccines in LTCs and ICF-IID. Currently, ICFs-IID must continue to
educate on the risks and benefits of the COVID vaccine and offer the
vaccine to clients and staff and must continue to document this
activity for clients in their medical records. However, when the June
2023 Final Rule removed the staff vaccine mandate by eliminating the
CoPs at 483.430(f) in its entirety, documentation of the educate and
offer activity for staff was also eliminated. Thus, ICFs-IID must
continue to ``educate and offer'' the COVID-19 vaccine to both staff
and clients, but the current CoPs require facilities to document this
task only for their clients. Although the COVID-19 PHE ended in May
2023, the COVID-19 related CoPs for ICF-IID as updated in the June 2023
Final Rule remain in effect post-PHE in order to protect clients and
staff from the same risks as before that may be due to new COVID-19
variants.
This reinstatement estimates the new burden hours for ICFs-IID
based on the revised CoPs. The burden of the information collections
for LTC facilities is included in OMB Control Number 0938-1363. Form
Number:
[[Page 25618]]
CMS-10777 (OMB control number 0938-1402); Frequency: Annually; Affected
Public: Private Sector--Business or other for-profits and not-for-
profits institutions; Number of Respondents: 5,523; Total Annual
Responses: 5,523; Total Annual Hours: 75,721. (For policy questions
regarding this collection contact Claudia Molinar at 410-786-8445.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Evaluation of
Stakeholder Training and Program Support; Use: The Centers for Medicare
and Medicaid Services (CMS) provides training and technical assistance
primarily through weekly, bi-weekly, monthly, or quarterly webinars,
conferences, and Computer Based Trainings (CBTs). In addition, CMS
provides one-time web-based training and support sessions as needed.
Evaluation instruments are electronically sent to participants
immediately after each session. Current data collections include online
and onsite training session evaluations.
CMS uses information from the data collection activities to
determine the extent to which the goals of each training and support
session were achieved and to help CMS make improvements for future
training and support sessions. The collected data helps CMS address its
Government Performance and Results Act (GPRA) requirements, as well as
CMS and HHS goals for support for, and open dialogue with,
stakeholders.
The Affordable Care Act (ACA) was enacted to assist millions of
Americans in obtaining affordable health care services and to allow
more employers to offer insurance coverage to their employees in a
cost-effective manner. Since the implementation of ACA in 2014,
individuals and small businesses have been able to purchase private
health insurance through competitive marketplaces called the ``Health
Insurance Marketplace'' (Marketplace). CMS issued regulations for the
establishment and practices of Marketplaces in States. The cooperation
and coordination of States, health insurance issuers, the Federal
Government and other key stakeholders is essential to the continued
success of the Marketplace.
The Consolidated Appropriations Act (CAA) of 2021 became law on
December 27, 2020. It is a $1.4 trillion omnibus spending agreement
that encompasses many different provisions. Two (2) acts within the law
apply to the Centers for Medicare and Medicaid Services (CMS) Center
for Consumer Information and Insurance Oversight (CCIIO): Title I, ``No
Surprises Act'' and Title II, ``Transparency'' (NST). Beginning in
2022, new protections through the No Surprises Act are in place to
shield millions of consumers from surprise medical bills.
CMS is strongly committed to providing training, outreach, and
technical assistance to stakeholders participating in the Marketplace
and/or programs mandated by the ACA or NST. In addition, CMS recognizes
that the success of Marketplaces and associated programs relies on the
cooperation and coordination of States, issuers, Assisters, self-
insured health plans, third-party administrators (TPA) of self-insured
health plans, agents and brokers, Providers/Facilities, and other
stakeholders. Therefore, CMS expects to design and conduct various
consumer satisfaction and feedback surveys, usability tests, and focus
groups for these respondents to complete. Form Number: CMS-10598 (OMB
control number: 0938-1331); Frequency: Annually; Affected Public:
Individuals and Households, Private Sector, State, Local, and Tribal
Governments, Federal Government, Business or other for-profit, and not-
for-profit institutions; Number of Respondents: 9,588; Number of
Responses: 9,588 Total Annual Hours: 2,397 hours. (For policy questions
regarding this collection contact Sonia Henderson at 301-492-4320.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-11157 Filed 6-16-25; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on June 17, 2025.
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