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[Federal Register Volume 90, Number 8 (Tuesday, January 14, 2025)]
[Notices]
[Pages 3220-3222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00593]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10777, CMS-R-235 and CMS-10662]

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 March 17, 2025.

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-10777 Conditions of Participation for Intermediate Care Facilities 
for Individuals with Intellectual Disabilities (ICFs-IID)
CMS-R-235 Data Use Agreement (DUA) Limited Data Set (LDS) Forms 
Research Identifiable Files (FIF) Forms
CMS-10662 Administrative Simplification HIPAA Compliance Review

    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

[[Page 3221]]

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 Collections

    1. 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: 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.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Use 
Agreement (DUA) Limited Data Set (LDS) Forms Research Identifiable 
Files (FIF) Forms; Use: The Privacy Act of 1974, Sec.  552a requires 
the Centers for Medicare & Medicaid Services (CMS) to track all 
disclosures of the agency's Personally Identifiable Information (PII). 
CMS is also required by the Health Insurance Portability and 
Accountability Act (HIPAA) of 1996 and the Federal Information Security 
Management Act (FISMA) of 2002 to properly protect all Protected Health 
Information (PHI) data maintained by the agency and account for the 
disclosure of PHI. When entities, such as academic, Federal or State 
agency

[[Page 3222]]

researchers or CMS contractors request CMS PII/PHI data, they enter 
into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the 
recipient of CMS data must properly protect the data according to all 
applicable data security standards and provide for its appropriate 
destruction at the completion of the project/study or the expiration 
date of the DUA.
    CMS is permitted to disclose data files for approved research 
purposes in compliance with 45 CFR 164.512(I). Researchers requesting 
limited data set files (LDS) must, as part of the request process, 
complete a research request packet that provides CMS with information 
pertaining to the research study, including describing how the research 
results/findings will be disseminated, as well as the data files being 
requested. Should CMS approve the research request, the data requestor 
enters into a Data Use Agreement (DUA). This data collection is 
necessary to ensure that disclosures of data for research purposes 
comply with Federal laws and regulations as well as CMS policy. Form 
Number: CMS-R-235 (OMB control number 0938-0734); Frequency: 
Occasionally; Affected Public: Private Sector--State, Local, or Tribal 
Governments; and Business or other for-profits, Not-for-profits 
institutions and Federal Government Number of Respondents: 7,805; Total 
Annual Responses: 7,805; Total Annual Hours: 4,234. (For policy 
questions regarding this collection contact Rebecca Dorman at 410-786-
2095 or [email protected].)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Administrative 
Simplification HIPAA Compliance Review; Use: The purpose of this 
collection is to retrieve information necessary to conduct a compliance 
review and carry out the authority delegated to CMS as described in 
CMS-0014-N (68 FR 60694). These forms will be submitted to the Centers 
for Medicare & Medicaid Services (CMS), National Standards Group, from 
entities covered by HIPAA Administrative Simplification regulations. 
This collection is not applicable to HIPAA Privacy and Security Rules. 
Form Number: CMS-10662 (OMB control number 0938-1390); Frequency: 
Annually; Affected Public: Private Sector--State, Local, or Tribal 
Governments; and Business or other for-profits, Not-for-profits 
institutions and Federal Government; Number of Respondents: 100; Total 
Annual Responses: 140; Total Annual Hours: 3,040. (For policy questions 
regarding this collection contact Kevin Stewart at 410-786-6149 or 
[email protected].)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-00593 Filed 1-13-25; 8:45 am]
BILLING CODE 4120-01-P
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