Agency Information Collection Activities: Proposed Collection; Comment Request, 3220-3222 [2025-00593]
Download as PDF
<![CDATA[
3220
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING)—Continued
Setting ...................
Study Design ........
Inclusion criteria
Exclusion criteria
KQ 1—KQ 5. All clinical settings .................................................................................................
KQs 1, 2. Randomized controlled trials ......................................................................................
KQs 3–5. Randomized controlled trials. Comparative cohort studies with concurrent control
groups, conducted within the same clinical setting. Other observational studies with concurrent control groups, that control for confounders.
Studies conducted in countries rated as very high on the Human Development Index.a
NA
KQs 1, 2: Other designs.
KQs 3–5: Uncontrolled cohort studies, case-control
studies, case reports,
case series, cost-effectiveness and other modeling studies.
Studies using nonconcurrent comparators (e.g.,
historical controls).
Studies comparing methods
across different settings/
clinics.
Observational studies that
do not control for confounders.
Abbreviations: CF = conventionally fractionated external beam radiation therapy; CT = computed tomography; CRT = conventional radiotherapy; EBRT = external beam radiation therapy; ED = erectile dysfunction; GI = gastrointestinal issues; GU = genitourinary issues; Gy = gray;
IMPT = intensity modulated proton therapy; KQ = key question; MHF = moderately hypofractionated radiation therapy; MRI = magnetic resonance imaging; MR-linac = MRI-guided linear accelerator; NA = not applicable; OARs = organs at risk; PET = positron emission tomography; PICOTS = population, interventions, comparators, outcomes, timing, and setting; SABR = stereotactic ablative radiotherapy; SBPT = stereotactic
body proton therapy; SBRT = stereotactic body radiation therapy; UHF = ultra-hypofractionated radiation therapy; VMAT = volumetric modulated
arc therapy.
a United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/data-center/human-developmentindex#/indicies/HDI.
Dated: January 7, 2025.
Marquita Cullom,
Associate Director.
[FR Doc. 2025–00547 Filed 1–13–25; 8:45 am]
BILLING CODE 4160–90–P
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
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
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 https://
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: ll, 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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/PRAListing.
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
E:\FR\FM\14JAN1.SGM
14JAN1
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
khammond on DSK9W7S144PROD with NOTICES
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
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
3221
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-forprofits 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, § 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
E:\FR\FM\14JAN1.SGM
14JAN1
khammond on DSK9W7S144PROD with NOTICES
3222
Federal Register / Vol. 90, No. 8 / Tuesday, January 14, 2025 / Notices
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
rebecca.dorman@cms.hhs.gov.)
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 forprofits, Not-for-profits institutions and
Federal Government; Number of
Respondents: 100; Total Annual
Responses: 140; Total Annual Hours:
3,040. (For policy questions regarding
VerDate Sep<11>2014
22:42 Jan 13, 2025
Jkt 265001
this collection contact Kevin Stewart at
410–786–6149 or Kevin.stewart@
cms.hhs.gov.)
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10203]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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 February 13, 2025.
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.
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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/PRAListing.
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: Revision of a currently
approved collection; Title of
Information Collection: Medicare Health
Outcomes Survey; Use: The HOS is a
longitudinal patient-reported outcome
measure (PROM) that assesses selfreported beneficiary quality of life and
daily functioning. As a PROM, the HOS
measures the impact of services
provided by MAOs, whereas process
and patient experience measures only
provide a snapshot of activities or
experiences at a specific point in time.
PROM data collected by the HOS allows
CMS to continue to assess the health of
the Medicare Advantage population.
This older population is at increased
risk of adverse health outcomes,
including chronic diseases and mobility
impairments that may significantly
hamper quality of life. The HOS
supports CMS’s commitment to improve
health outcomes for beneficiaries while
reducing burden on providers. CMS
accomplishes this by focusing on highpriority areas for quality measurement
and improvement established in the
agency’s Meaningful Measures
Framework. The HOS uses quality
E:\FR\FM\14JAN1.SGM
14JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
https://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
