Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Health Resources and Services Administration Uniform Data System, 64058-64060 [2022-22867]
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64058
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Ouided Rouabhi, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G221, Silver Spring,
MD 20993–0002, 240–402–2672; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
Consistent with the goals of the
Breakthrough Devices Program, FDA is
proposing select updates to the
Breakthrough Devices Program guidance
that clarify how the program may be
applicable to certain medical devices
that provide for more effective treatment
or diagnosis of life-threatening or
irreversibly debilitating diseases or
conditions in populations impacted by
health and/or healthcare disparities.
The Breakthrough Devices Program may
expedite the availability of certain
medical devices that provide for more
effective treatment or diagnosis of lifethreatening or irreversibly debilitating
diseases or conditions in populations
impacted by health and/or healthcare
disparities, thereby promoting and
advancing health equity. Additionally,
FDA is proposing updates, consistent
with our obligations under the
SUPPORT Act (Food, Drug, and
Cosmetic Act section 515B (21 U.S.C.
360e-3)), to clarify that the Breakthrough
Devices Program may be available to
certain nonaddictive medical products
to treat pain or addiction.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Select Updates for the Breakthrough
Devices Program Guidance: Reducing
Disparities in Health and Healthcare.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidance-
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
OMB control
No.
21 CFR part; guidance; or FDA form
Topic
807, subpart E ............................................................................
814, subparts A through E .........................................................
814, subpart H ............................................................................
812 ..............................................................................................
860, subpart D ............................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
Premarket notification .................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ................................................
Investigational Device Exemption ..............................................
De Novo classification process ..................................................
Q-submissions ............................................................................
Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22878 Filed 10–20–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0193—Revision]
jspears on DSK121TN23PROD with NOTICES
documents-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Select Updates for
the Breakthrough Devices Program
Guidance: Reducing Disparities in
Health and Healthcare’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1833–R1 and
complete title to identify the guidance
you are requesting.
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Health
Resources and Services
Administration Uniform Data System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
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19:08 Oct 20, 2022
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ACTION:
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0756
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
SUMMARY:
Comments on this ICR must be
received no later than December 20,
2022.
DATES:
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA OMB PRA Officer,
Samantha Miller, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
HRSA Uniform Data System (UDS),
OMB No. 0915–0193—Revision.
Abstract: The Health Center Program,
administered by HRSA, is authorized
under section 330 of the Public Health
Service (PHS) Act (42 U.S.C. 254b).
Health centers are community-based
and patient-directed organizations that
deliver affordable, accessible, quality,
and cost-effective primary health care
services to patients regardless of their
ability to pay. Nearly 1,400 health
centers operate approximately 12,000
service delivery sites that provide
primary health care to more than 30
million people in every U.S. state, the
District of Columbia, Puerto Rico, the
U.S. Virgin Islands, and the Pacific
Basin. HRSA uses the UDS 1 for annual
reporting by Health Center Program
awardees (those funded under section
330 of the PHS Act), Health Center
Program look-alikes, and Nurse
Education, Practice, Quality and
Retention 2 Program awardees
(specifically those funded under the
practice priority areas of section 831(b)
of the PHS Act). Look-alikes do not
routinely receive federal funding under
section 330 of the PHS Act, but meet the
Health Center Program requirements for
designation under the program (42
U.S.C. 1395x(aa)(4)(A)(ii) and 42 U.S.C.
1396d(l)(2)(B)(ii)).
Need and Proposed Use of the
Information: UDS data collection
updates must be completed in a timely
manner for health centers to fulfill
Health Center Program requirements.
Approval of these changes is needed by
February 1, 2023, to implement the
changes in the data collection system
and to provide adequate information on
UDS reporting guidance to health
centers, partners, and key stakeholders.
HRSA plans to make the following
jspears on DSK121TN23PROD with NOTICES
ADDRESSES:
1 https://www.cms.gov/files/document/sgmclearinghouse-uds.pdf.
2 https://www.hrsa.gov/grants/find-funding/hrsa20-012.
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19:08 Oct 20, 2022
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updates for the performance year 2023
UDS data collection:
• Table 3B (Demographic
Characteristics), will be updated to
include additional subpopulations
selection options to better reflect the
diversity of patients served by health
centers. Race/ethnicity categories will
be updated to align with HHS data
standards.3 In accordance with Section
4302 within the Office of the Assistant
Secretary for Planning and
Evaluation 4 Implementation Guidance
on Data Standards for Race, Ethnicity,
Sex, Primary Language, and Disability
Status, the UDS will be updated to
include subpopulations categories for
Asian, Native Hawaiian, Other Pacific
Islanders, as well as a broader selection
for Hispanic ethnicity. The 2011 HHS
race and ethnicity categories maintains
alignment with the 1997 OMB 5
minimum categories for race and
ethnicity and allow for better
understanding of the cultural diversity
of patients served by health centers.
• Table 5 (Staffing and Utilization),
will be updated to include four distinct
lines for reporting Pharmacy Personnel
categorized by Pharmacists, Clinical
Pharmacist, Pharmacy Technicians, and
Other Pharmacy Personnel. Health
center personnel are critical to the
functioning of health centers, collecting
inclusive information about the health
center workforce, and will allow HRSA
to better understand workforce
composition as well as improve the
ability to articulate the role that
pharmacy personnel play in an
integrated primary care.
• Table 6A (Selected Diagnoses and
Services Rendered), will be updated to
include a diagnostic measure
representing long COVID. This measure
is labeled Post COVID–19 condition,
unspecified, within the Selected
Infectious and Parasitic Diseases
grouping of measures. With this
measure, health centers are able to
report both number of patients with this
diagnosis as well as the number of
patient visits related to the diagnosis.6
The Centers for Disease Control and
Prevention classifies long COVID, also
known as post-COVID, conditions as a
3 https://aspe.hhs.gov/reports/hhsimplementation-guidance-data-collectionstandards-race-ethnicity-sex-primary-languagedisability-0.
4 https://aspe.hhs.gov/reports/hhsimplementation-guidance-data-collectionstandards-race-ethnicity-sex-primary-languagedisability-0#:∼:text=Section%204302%20requires
%20the%20Secretary,all%20national
%20population%20health%20surveys.
5 https://obamawhitehouse.archives.gov/omb/
fedreg_1997standards.
6 https://www.cdc.gov/coronavirus/2019-ncov/
long-term-effects/.
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64059
wide range of new, returning, or
ongoing health problems people can
experience four or more weeks after first
being infected with the virus that causes
COVID–19.7 Data on this measure will
lead to better understanding the impact
of COVID–19 post-acute infection on
health center patients.
• Table 6A (Selected Diagnoses and
Services Rendered), will be updated to
include a measure that tracks the
number of patients who receive
pediatric developmental screening and
evaluation services. The 2023 UDS will
include developmental screening,
behavioral screening/testing, and
administrative assessment International
Classification of Diseases diagnostic and
Current Procedural Terminology billing
codes for use to track the changes in the
number of children who receive
developmental screening and evaluation
services. Early childhood is a critical
period for physical, cognitive, and
social development, laying the
foundation for life-long health and wellbeing.8 Children who experience
poverty, particularly during early life,
are at risk of adverse health and
developmental outcomes.
• Table 6B (Quality of Care
Measures), and Table 7 (Health
Outcomes and Disparities), collected
UDS clinical quality measures 9 (CQMs)
where applicable. Collected UDS CQMs
will be updated in alignment with
specifications of the issued performance
year 2023 electronic-specified clinical
quality measures, released by the
Centers for Medicare and Medicaid
Services for use by eligible providers.
Clinical performance measure alignment
across national programs promotes data
standardization, quality, and
transparency and decreases reporting
burden for providers and organizations
participating in multiple federal
programs.
• Appendix D (Health Center Health
Information Technology {HIT}
Capabilities Form), will be updated with
a question asking health centers to
provide the total number of patients that
were screened for social risk factors,
using a standardized screener, during
the calendar year. This question
provides a more accurate view of the
impact of social risk on the health
center patient population and continues
to reinforce Social Determinants of
Health as a priority area intrinsically
linked with health equity.
7 https://www.cdc.gov/coronavirus/2019-ncov/
long-term-effects/.
8 https://www.hrsa.gov/grants/find-funding/hrsa22-091.
9 https://www.cms.gov/regulations-and-guidance/
legislation/ehrincentiveprograms/downloads/
guidetocqms_remediated_2011.pdf.
E:\FR\FM\21OCN1.SGM
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Federal Register / Vol. 87, No. 203 / Friday, October 21, 2022 / Notices
• Beginning with the 2023 UDS,
health centers will be able to submit
patient-level data in fulfillment of data
elements on Tables:
Æ Table PBZC (Patients by Zip Code)
Æ Table 3A (Patients by Age and Sex
Assigned at Birth)
Æ Table 3B (Demographic
Characteristics)
Æ Table 4 (Selected Characteristics)
Æ Table 6A (Selected Diagnoses and
Services Rendered)
Æ Table 6B (Quality of Care Measures)
Æ Table 7 (Health Outcomes and
Disparities
UDS+ Patent Level Reporting
leverages a methodological shift in the
process by which health centers submit
their annual UDS report while
maintaining historic UDS measures.
High-quality accessible data are critical
to strategically meeting the needs of
patients and identifying opportunities
for clinical process improvement. The
growth in health information technology
coupled with the increased adoption of
electronic health records has
transformed patient care delivery and
underscored the need for secure and
rapid exchange of health data between
disparate systems. Health Level Seven
International 10 developed Fast
Healthcare Interoperability Resources 11
(FHIR) to standardize the electronic
exchange of patient data across systems.
FHIR, which is the current gold
standard, has the flexibility to support
a variety of user needs and enhances
interoperability by transmitting health
data rapidly and more securely than
ever before. It is important for the
collection of UDS data to align with
interoperability standards and reporting
requirements across HHS and the
healthcare industry. Leveraging FHIR to
collect UDS patient-level data will
improve data granularity, allow for the
development of robust patient
management programs, and improve
equitable access to high-quality, costeffective primary care services.
This electronic reporting mechanism
will reduce reliance on manual data
entry to populate the annual UDS
report, in turn yielding a reduction in
reporting effort burden, and will greatly
increase the analytical value of UDS
data for informing policy and program
decision-making.
Likely Respondents: Likely
respondents will include Health Center
Program award recipients, Health Center
Program look-alikes, and Nurse
Education, Practice, Quality and
Retention Program awardees funded
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Form name
Universal Report ..............................................................
UTC Tests ........................................................................
Total: 1,505
H80s: 1,370
LALs: 117
BHW: 18
Total: 438
438 Health Centers submitted one or more Grant Reports.
1: 346
2: 80
3: 12
35 ....................................................................................
Total ..........................................................................
1,978 ...............................................................................
Grant Report ....................................................................
jspears on DSK121TN23PROD with NOTICES
under the practice priority areas of
section 831(b) of the PHS Act.
Burden Statement: Burden includes
the time expended by persons to
generate, maintain, retain, disclose, or
provide the information requested. This
includes the time needed to review
instructions; to develop, acquire, install,
and use technology and systems for the
purpose of collecting, validating and
verifying information, processing and
maintaining information, disclosing and
providing information. It also accounts
for time to train personnel, respond to
a collection of information, search data
sources, complete and review the
collection of information, and transmit
or otherwise disclose the information. It
will also include testing information
necessary to support the UDS Test
Cooperative (UTC). No more than three
tests will be conducted each calendar
year and no more than one hundred
health centers will participate in one
test. Participation is voluntary and will
not affect their funding status. This
sample size is sufficient to conduct a
technical test and determine if the
innovation should be scaled across the
UDS. The total annual burden hours
estimated for this ICR are summarized
in the forthcoming table.
HRSA specifically requests comments
on: (1) the necessity and feasibility of
the proposed information collection for
the proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
10 https://www.hl7.org/.
19:08 Oct 20, 2022
Health Resources and Services
Administration
[OMB No. 0906–0043–Extension]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: EvidenceBased Telehealth Network Program
Measures
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
[FR Doc. 2022–22867 Filed 10–20–22; 8:45 am]
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
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Estimated
total burden
hours
1.00
238
358,190
1.24
30
16,294
3.00
8
840
5.24
........................
375,324
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than December 20,
2022.
SUMMARY:
11 https://ecqi.healthit.gov/fhir.
Jkt 259001
Average
burden per
response
(in hours)
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]]>Agencies
[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64058-64060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22867]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
[OMB No. 0915-0193--Revision]
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Health
Resources and Services Administration Uniform Data System
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR must be received no later than December 20,
2022.
[[Page 64059]]
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call the HRSA OMB PRA
Officer, Samantha Miller, at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: HRSA Uniform Data System
(UDS), OMB No. 0915-0193--Revision.
Abstract: The Health Center Program, administered by HRSA, is
authorized under section 330 of the Public Health Service (PHS) Act (42
U.S.C. 254b). Health centers are community-based and patient-directed
organizations that deliver affordable, accessible, quality, and cost-
effective primary health care services to patients regardless of their
ability to pay. Nearly 1,400 health centers operate approximately
12,000 service delivery sites that provide primary health care to more
than 30 million people in every U.S. state, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. HRSA uses
the UDS \1\ for annual reporting by Health Center Program awardees
(those funded under section 330 of the PHS Act), Health Center Program
look-alikes, and Nurse Education, Practice, Quality and Retention \2\
Program awardees (specifically those funded under the practice priority
areas of section 831(b) of the PHS Act). Look-alikes do not routinely
receive federal funding under section 330 of the PHS Act, but meet the
Health Center Program requirements for designation under the program
(42 U.S.C. 1395x(aa)(4)(A)(ii) and 42 U.S.C. 1396d(l)(2)(B)(ii)).
---------------------------------------------------------------------------
\1\ https://www.cms.gov/files/document/sgm-clearinghouse-uds.pdf.
\2\ https://www.hrsa.gov/grants/find-funding/hrsa-20-012.
---------------------------------------------------------------------------
Need and Proposed Use of the Information: UDS data collection
updates must be completed in a timely manner for health centers to
fulfill Health Center Program requirements. Approval of these changes
is needed by February 1, 2023, to implement the changes in the data
collection system and to provide adequate information on UDS reporting
guidance to health centers, partners, and key stakeholders. HRSA plans
to make the following updates for the performance year 2023 UDS data
collection:
Table 3B (Demographic Characteristics), will be updated to
include additional subpopulations selection options to better reflect
the diversity of patients served by health centers. Race/ethnicity
categories will be updated to align with HHS data standards.\3\ In
accordance with Section 4302 within the Office of the Assistant
Secretary for Planning and Evaluation \4\ Implementation Guidance on
Data Standards for Race, Ethnicity, Sex, Primary Language, and
Disability Status, the UDS will be updated to include subpopulations
categories for Asian, Native Hawaiian, Other Pacific Islanders, as well
as a broader selection for Hispanic ethnicity. The 2011 HHS race and
ethnicity categories maintains alignment with the 1997 OMB \5\ minimum
categories for race and ethnicity and allow for better understanding of
the cultural diversity of patients served by health centers.
---------------------------------------------------------------------------
\3\ https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0.
\4\ https://aspe.hhs.gov/reports/hhs-implementation-guidance-
data-collection-standards-race-ethnicity-sex-primary-language-
disability-
0#:~:text=Section%204302%20requires%20the%20Secretary,all%20national%
20population%20health%20surveys.
\5\ https://obamawhitehouse.archives.gov/omb/fedreg_1997standards.
---------------------------------------------------------------------------
Table 5 (Staffing and Utilization), will be updated to
include four distinct lines for reporting Pharmacy Personnel
categorized by Pharmacists, Clinical Pharmacist, Pharmacy Technicians,
and Other Pharmacy Personnel. Health center personnel are critical to
the functioning of health centers, collecting inclusive information
about the health center workforce, and will allow HRSA to better
understand workforce composition as well as improve the ability to
articulate the role that pharmacy personnel play in an integrated
primary care.
Table 6A (Selected Diagnoses and Services Rendered), will
be updated to include a diagnostic measure representing long COVID.
This measure is labeled Post COVID-19 condition, unspecified, within
the Selected Infectious and Parasitic Diseases grouping of measures.
With this measure, health centers are able to report both number of
patients with this diagnosis as well as the number of patient visits
related to the diagnosis.\6\ The Centers for Disease Control and
Prevention classifies long COVID, also known as post-COVID, conditions
as a wide range of new, returning, or ongoing health problems people
can experience four or more weeks after first being infected with the
virus that causes COVID-19.\7\ Data on this measure will lead to better
understanding the impact of COVID-19 post-acute infection on health
center patients.
---------------------------------------------------------------------------
\6\ https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/.
\7\ https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/.
---------------------------------------------------------------------------
Table 6A (Selected Diagnoses and Services Rendered), will
be updated to include a measure that tracks the number of patients who
receive pediatric developmental screening and evaluation services. The
2023 UDS will include developmental screening, behavioral screening/
testing, and administrative assessment International Classification of
Diseases diagnostic and Current Procedural Terminology billing codes
for use to track the changes in the number of children who receive
developmental screening and evaluation services. Early childhood is a
critical period for physical, cognitive, and social development, laying
the foundation for life-long health and well-being.\8\ Children who
experience poverty, particularly during early life, are at risk of
adverse health and developmental outcomes.
---------------------------------------------------------------------------
\8\ https://www.hrsa.gov/grants/find-funding/hrsa-22-091.
---------------------------------------------------------------------------
Table 6B (Quality of Care Measures), and Table 7 (Health
Outcomes and Disparities), collected UDS clinical quality measures \9\
(CQMs) where applicable. Collected UDS CQMs will be updated in
alignment with specifications of the issued performance year 2023
electronic-specified clinical quality measures, released by the Centers
for Medicare and Medicaid Services for use by eligible providers.
Clinical performance measure alignment across national programs
promotes data standardization, quality, and transparency and decreases
reporting burden for providers and organizations participating in
multiple federal programs.
---------------------------------------------------------------------------
\9\ https://www.cms.gov/regulations-and-guidance/legislation/ehrincentiveprograms/downloads/guidetocqms_remediated_2011.pdf.
---------------------------------------------------------------------------
Appendix D (Health Center Health Information Technology
{HIT{time} Capabilities Form), will be updated with a question asking
health centers to provide the total number of patients that were
screened for social risk factors, using a standardized screener, during
the calendar year. This question provides a more accurate view of the
impact of social risk on the health center patient population and
continues to reinforce Social Determinants of Health as a priority area
intrinsically linked with health equity.
[[Page 64060]]
Beginning with the 2023 UDS, health centers will be able
to submit patient-level data in fulfillment of data elements on Tables:
[cir] Table PBZC (Patients by Zip Code)
[cir] Table 3A (Patients by Age and Sex Assigned at Birth)
[cir] Table 3B (Demographic Characteristics)
[cir] Table 4 (Selected Characteristics)
[cir] Table 6A (Selected Diagnoses and Services Rendered)
[cir] Table 6B (Quality of Care Measures)
[cir] Table 7 (Health Outcomes and Disparities
UDS+ Patent Level Reporting leverages a methodological shift in the
process by which health centers submit their annual UDS report while
maintaining historic UDS measures. High-quality accessible data are
critical to strategically meeting the needs of patients and identifying
opportunities for clinical process improvement. The growth in health
information technology coupled with the increased adoption of
electronic health records has transformed patient care delivery and
underscored the need for secure and rapid exchange of health data
between disparate systems. Health Level Seven International \10\
developed Fast Healthcare Interoperability Resources \11\ (FHIR) to
standardize the electronic exchange of patient data across systems.
FHIR, which is the current gold standard, has the flexibility to
support a variety of user needs and enhances interoperability by
transmitting health data rapidly and more securely than ever before. It
is important for the collection of UDS data to align with
interoperability standards and reporting requirements across HHS and
the healthcare industry. Leveraging FHIR to collect UDS patient-level
data will improve data granularity, allow for the development of robust
patient management programs, and improve equitable access to high-
quality, cost-effective primary care services.
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\10\ https://www.hl7.org/.
\11\ https://ecqi.healthit.gov/fhir.
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This electronic reporting mechanism will reduce reliance on manual
data entry to populate the annual UDS report, in turn yielding a
reduction in reporting effort burden, and will greatly increase the
analytical value of UDS data for informing policy and program decision-
making.
Likely Respondents: Likely respondents will include Health Center
Program award recipients, Health Center Program look-alikes, and Nurse
Education, Practice, Quality and Retention Program awardees funded
under the practice priority areas of section 831(b) of the PHS Act.
Burden Statement: Burden includes the time expended by persons to
generate, maintain, retain, disclose, or provide the information
requested. This includes the time needed to review instructions; to
develop, acquire, install, and use technology and systems for the
purpose of collecting, validating and verifying information, processing
and maintaining information, disclosing and providing information. It
also accounts for time to train personnel, respond to a collection of
information, search data sources, complete and review the collection of
information, and transmit or otherwise disclose the information. It
will also include testing information necessary to support the UDS Test
Cooperative (UTC). No more than three tests will be conducted each
calendar year and no more than one hundred health centers will
participate in one test. Participation is voluntary and will not affect
their funding status. This sample size is sufficient to conduct a
technical test and determine if the innovation should be scaled across
the UDS. The total annual burden hours estimated for this ICR are
summarized in the forthcoming table.
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Estimated
Estimated number of number of Average burden Estimated
Form name respondents responses per per response total burden
respondent (in hours) hours
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Universal Report...................... Total: 1,505 1.00 238 358,190
H80s: 1,370.............
LALs: 117...............
BHW: 18.................
Grant Report.......................... Total: 438 1.24 30 16,294
438 Health Centers
submitted one or more
Grant Reports.
1: 346..................
2: 80...................
3: 12...................
UTC Tests............................. 35...................... 3.00 8 840
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Total............................. 1,978................... 5.24 .............. 375,324
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HRSA specifically requests comments on: (1) the necessity and
feasibility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-22867 Filed 10-20-22; 8:45 am]
BILLING CODE 4165-15-P
