Agency Information Collection Activities: Submission for OMB Review; Comment Request, 29264-29265 [2021-11491]
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Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
TTY (local): (301) 427–1130; Email:
pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background on Common Formats
Development
The Patient Safety and Quality
Improvement Act of 2005 (Patient Safety
Act), 42 U.S.C. 299b-21 to b-26, and the
related Patient Safety and Quality
Improvement Final Rule (Patient Safety
Rule), 42 CFR part 3, published in the
Federal Register on November 21, 2008,
73 FR 70731–70814, provide for the
formation of Patient Safety
Organizations (PSOs), which collect,
aggregate, and analyze confidential
information regarding the quality and
safety of health care delivery. The
collection of patient safety work product
allows for the aggregation of data that
help to identify and address underlying
causal factors of patient safety and
quality issues.
The Patient Safety Act provides for
AHRQ to develop standardized
reporting formats using common
language and definitions (Common
Formats) for reporting on health care
quality and patient safety that will
ensure that data collected by PSOs and
other entities have comparable clinical
meaning. The Common Formats
facilitate aggregation of comparable data
at local, PSO, regional and national
levels. In addition, the Common
Formats are intended to enhance the
reporting of information that is
standardized.
Since February 2005, AHRQ has
convened the Federal Patient Safety
Work Group (PSWG) to assist AHRQ in
developing and maintaining the
Common Formats. The PSWG includes
major health agencies within HHS as
well as the Departments of Defense and
Veterans Affairs. The PSWG helps
assure the consistency of definitions/
formats with those of relevant
government agencies. In addition,
AHRQ has solicited comments from the
private and public sectors, since 2008,
regarding proposed versions of the
Common Formats through a contract
with the National Quality Forum (NQF),
which is a non-profit organization
focused on health care quality. After
receiving comments, the NQF solicits
review of the formats by its Common
Formats Expert Panel. Subsequently,
NQF provides this input to AHRQ who
then uses it to refine the Common
Formats before issuing a production
version.
AHRQ previously developed and
maintains Common Formats for three
settings of care—acute care hospitals,
skilled nursing facilities, and
community pharmacies—for use by
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18:20 May 28, 2021
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healthcare providers and PSOs. AHRQlisted PSOs are required to collect
patient safety work product in a
standardized manner to the extent
practical and appropriate, a requirement
the PSO can meet by collecting such
information using Common Formats.
Additionally, health care providers and
other organizations not working with an
AHRQ-listed PSO can use the Common
Formats in their work to improve
quality and safety; however, they cannot
benefit from the federal confidentiality
and privilege protections of the Patient
Safety Act.
The CFER–DS is the first AHRQ
Common Formats for Event Reporting
that can be used across healthcare
settings. It is designed to capture
standardized, structured data to
facilitate the reporting of diagnostic
safety events for the purpose of learning
about how to improve diagnostic safety
and better support clinicians in the
diagnostic process.
The CFER–DS is not designed for
frontline incident reporting. It is
intended to facilitate the collection and
organization of a basic set of meaningful
data about diagnostic safety events that
can be used, aggregated and analyzed
for learning and improvement. Having a
common frame of reference and
standardized data elements is what
makes shared learning possible at local,
regional and national levels. Users
decide if and how to integrate collection
of specific data elements into their
incident reporting systems and other
existing work processes.
AHRQ is specifically interested in
receiving feedback in order to guide
improvement of the CFER–DS V0.1. As
with other Common Formats, the Event
Description is available for public
comment. Additionally, AHRQ is
seeking feedback on a user guide and a
form. Additional supporting
documentation will be finalized and
made available following AHRQ’s
receipt of comment from the public and
NQF’s Common Format Expert Panel.
Information on how to comment is
available at: https://
www.qualityforum.org/Project_Pages/
Common_Formats_for_Patient_Safety_
Data.aspx.
Additional information about the
AHRQ Common Formats can be
obtained through AHRQ’s PSO website:
https://pso.ahrq.gov/common-formats.
Dated: May 25, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–11386 Filed 5–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–29, CMS–437
and 10452]
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 July 1, 2021.
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, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
SUMMARY:
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Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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: Verification of
Clinic Data—Rural Health Clinic Form
and Supporting Regulations; Use: The
form is utilized as an application to be
completed by suppliers of Rural Health
Clinic (RHC) services requesting
participation in the Medicare program.
This form initiates the process of
obtaining a decision as to whether the
conditions for certification are met as a
supplier of RHC services. It also
promotes data reduction or introduction
to and retrieval from the Automated
Survey Process Environment (ASPEN)
and related survey and certification
databases by the CMS Regional Offices.
Should any question arise regarding the
structure of the organization, this
information is readily available. Form
Number: CMS–29 (OMB control number
0938–0074); Frequency: Occasionally
(initially and then every six years);
Affected Public: Private Sector (Business
or other for-profit and Not-for-profit
institutions); Number of Respondents:
1,887; Total Annual Responses: 5,661;
Total Annual Hours: 1,269. (For policy
questions regarding this collection
contact Shonte Carter at 410–786–3532.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Psychiatric Unit
Criteria Work Sheet; Use: Certain
specialty hospitals and hospital
specialty distinct-part units may be
excluded from the Inpatient Medicare
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Prospective Payment System (IPPS) and
be paid at a different rate. These
specialty hospitals and distinct-part
units of hospitals include Inpatient
Rehabilitation Facilities (IRFs) units,
Inpatient Rehabilitation Facilities (IRFs)
hospitals and Inpatient Psychiatric
Facilities (IPFs).
CMS regulations at 42 CFR 412.20
through 412.29 describe the criteria
under which these specialty hospitals
and specialty distinct-part hospital units
are excluded from the IPPS. Form CMS–
437 is used by Inpatient Psychiatric
Facilities (IPFs) to attest to meeting the
necessary requirements that make them
exempt for receiving payment from
Medicare under the IPPS. These IPFs
must use CMS–437 to attest that they
meet the requirements for IPPS exempt
status prior to being placed into
excluded status. The IPFs must re-attest
to meeting the exclusion criteria
annually. Form Number: CMS–437
(OMB control number: 0938–0358);
Frequency: Annually; Affected Public:
Private sector—Business or other forprofits; Number of Respondents: 1,598;
Total Annual Responses: 1,598; Total
Annual Hours: 1,732. (For policy
questions regarding this collection
contact Caroline Gallaher at 410–786–
8705.)
3. Type of Information Collection
Request: Extension of a previously
approved collection; Title of
Information Collection: CMS Identity
Management (IDM) System; Use: HIPAA
regulations require covered entities to
verify the identity of the person
requesting Personal Health Information
(PHI) and the person’s authority to have
access to that information. Per the
HIPAA Security Rule, covered entities,
regardless of their size, are required
under Section 164.312(a)(2)(i) to ‘‘assign
a unique name and/or number for
identifying and tracking user identity.’’
A ‘user’ is defined in Section 164.304 as
a ‘‘person or entity with authorized
access’’. Accordingly, the Security Rule
requires covered entities to assign a
unique name and/or number to each
employee or workforce member who
uses a system that receives, maintains or
transmits electronic PHI, so that system
access and activity can be identified and
tracked by user. This pertains to
workforce members within health plans,
group health plans, small or large
provider offices, clearinghouses and
beneficiaries.
The information collected will be
gathered and used solely by CMS,
approved contractor(s), and state health
insurance exchanges to prove the
identity of an individual requesting
electronic access to CMS protected
information or services. Information
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29265
confidentiality will conform to the
Health Insurance Portability and
Accountability Act (HIPAA) of 1996 and
the Federal Information Security
Management Act (FISMA) requirements.
Respondents may also access CMS’
Terms of Service and Privacy Statement
on the CMS Portal and IDM websites.
CMS has moved from this centralized
on premise model for enterprise identity
management to a cloud-based solution,
IDM, with multiple products providing
specialized services: Okta Identity as a
Service (IDaaS), which includes MultiFactor Authentication (MFA) services;
Experian Remote Identity Proofing
(RIDP) services; and Cloud Computing
Services-Amazon Web Services/
Information Technology Operations
(CCS–AWS/ITOps) Hub Hosting. In
order to prove the identity of an
individual requesting electronic access
to CMS protected information or
services, IDM (leveraging Experian
Precise ID RIDP services) will collect a
core set of attributes about that
individual. Form Number: CMS–10452
(OMB control number: 0938–1236);
Frequency: Yearly; Affected Public:
Individuals and Households; Number of
Respondents: 560,000; Total Annual
Responses: 560,000; Total Annual
Hours: 186,667. (For policy questions
regarding this collection contact
Malachi Robinson at 410–786–1849).
Dated: May 26, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–11491 Filed 5–28–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–179 and CMS–
10775]
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 (the
PRA), federal agencies are required to
publish notice in the Federal Register
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29264-29265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11491]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-29, CMS-437 and 10452]
Agency Information Collection Activities: Submission for OMB
Review; 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 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 1, 2021.
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, you may make
your request using one of following:
1. Access CMS' website address at website address at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
[[Page 29265]]
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: Verification of
Clinic Data--Rural Health Clinic Form and Supporting Regulations; Use:
The form is utilized as an application to be completed by suppliers of
Rural Health Clinic (RHC) services requesting participation in the
Medicare program. This form initiates the process of obtaining a
decision as to whether the conditions for certification are met as a
supplier of RHC services. It also promotes data reduction or
introduction to and retrieval from the Automated Survey Process
Environment (ASPEN) and related survey and certification databases by
the CMS Regional Offices. Should any question arise regarding the
structure of the organization, this information is readily available.
Form Number: CMS-29 (OMB control number 0938-0074); Frequency:
Occasionally (initially and then every six years); Affected Public:
Private Sector (Business or other for-profit and Not-for-profit
institutions); Number of Respondents: 1,887; Total Annual Responses:
5,661; Total Annual Hours: 1,269. (For policy questions regarding this
collection contact Shonte Carter at 410-786-3532.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Psychiatric Unit
Criteria Work Sheet; Use: Certain specialty hospitals and hospital
specialty distinct-part units may be excluded from the Inpatient
Medicare Prospective Payment System (IPPS) and be paid at a different
rate. These specialty hospitals and distinct-part units of hospitals
include Inpatient Rehabilitation Facilities (IRFs) units, Inpatient
Rehabilitation Facilities (IRFs) hospitals and Inpatient Psychiatric
Facilities (IPFs).
CMS regulations at 42 CFR 412.20 through 412.29 describe the
criteria under which these specialty hospitals and specialty distinct-
part hospital units are excluded from the IPPS. Form CMS-437 is used by
Inpatient Psychiatric Facilities (IPFs) to attest to meeting the
necessary requirements that make them exempt for receiving payment from
Medicare under the IPPS. These IPFs must use CMS-437 to attest that
they meet the requirements for IPPS exempt status prior to being placed
into excluded status. The IPFs must re-attest to meeting the exclusion
criteria annually. Form Number: CMS-437 (OMB control number: 0938-
0358); Frequency: Annually; Affected Public: Private sector--Business
or other for-profits; Number of Respondents: 1,598; Total Annual
Responses: 1,598; Total Annual Hours: 1,732. (For policy questions
regarding this collection contact Caroline Gallaher at 410-786-8705.)
3. Type of Information Collection Request: Extension of a
previously approved collection; Title of Information Collection: CMS
Identity Management (IDM) System; Use: HIPAA regulations require
covered entities to verify the identity of the person requesting
Personal Health Information (PHI) and the person's authority to have
access to that information. Per the HIPAA Security Rule, covered
entities, regardless of their size, are required under Section
164.312(a)(2)(i) to ``assign a unique name and/or number for
identifying and tracking user identity.'' A `user' is defined in
Section 164.304 as a ``person or entity with authorized access''.
Accordingly, the Security Rule requires covered entities to assign a
unique name and/or number to each employee or workforce member who uses
a system that receives, maintains or transmits electronic PHI, so that
system access and activity can be identified and tracked by user. This
pertains to workforce members within health plans, group health plans,
small or large provider offices, clearinghouses and beneficiaries.
The information collected will be gathered and used solely by CMS,
approved contractor(s), and state health insurance exchanges to prove
the identity of an individual requesting electronic access to CMS
protected information or services. Information confidentiality will
conform to the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 and the Federal Information Security Management Act
(FISMA) requirements. Respondents may also access CMS' Terms of Service
and Privacy Statement on the CMS Portal and IDM websites.
CMS has moved from this centralized on premise model for enterprise
identity management to a cloud-based solution, IDM, with multiple
products providing specialized services: Okta Identity as a Service
(IDaaS), which includes Multi-Factor Authentication (MFA) services;
Experian Remote Identity Proofing (RIDP) services; and Cloud Computing
Services-Amazon Web Services/Information Technology Operations (CCS-
AWS/ITOps) Hub Hosting. In order to prove the identity of an individual
requesting electronic access to CMS protected information or services,
IDM (leveraging Experian Precise ID RIDP services) will collect a core
set of attributes about that individual. Form Number: CMS-10452 (OMB
control number: 0938-1236); Frequency: Yearly; Affected Public:
Individuals and Households; Number of Respondents: 560,000; Total
Annual Responses: 560,000; Total Annual Hours: 186,667. (For policy
questions regarding this collection contact Malachi Robinson at 410-
786-1849).
Dated: May 26, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-11491 Filed 5-28-21; 8:45 am]
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