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[Federal Register Volume 89, Number 226 (Friday, November 22, 2024)]
[Notices]
[Pages 92692-92694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Health Resources and Services Administration 
Uniform Data System

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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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 should be received no later than January 
21, 2025.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers 
Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the

[[Page 92693]]

proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Joella Roland, the 
HRSA Information Collection Clearance Officer, at (301) 443-3983.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    Information Collection Request Title: Health Resources and Services 
Administration (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 
15,500 service delivery sites that provide primary health care to more 
than 31 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 for annual reporting of program-specific data by 
Health Center Program awardees (those funded under section 330 of the 
PHS Act), Health Center Program look-alikes (entities meeting 
requirements of, but not funded under, section 330 of the PHS Act), and 
Nurse Education, Practice, Quality and Retention (NEPQR) and Advanced 
Nursing Education (ANE) Program awardees (specifically those funded 
under the practice priority areas of sections 831(b) and 811 of the PHS 
Act).
    Some NEPQR and ANE Program awardees establish and expand nursing 
practice arrangements in noninstitutional settings to demonstrate 
methods to improve access to primary health care in medically 
underserved communities. Nursing grantees implementing nursing practice 
arrangements have historically used the same data collection system as 
the Health Center Program.
    Need and Proposed Use of the Information: HRSA requires the 
collection of information through UDS to monitor and evaluate the 
performance of health centers under section 330 and select NEPQR and 
ANE recipients under sections 831(b) and 811. These data aid in program 
compliance, guide quality improvement initiatives, and inform federal 
health policy decisions. HRSA also leverages UDS data to assess the 
impact of health centers and NEPQR and ANE recipients on patient health 
outcomes and to allocate funding and resources effectively across the 
Health Center Program. To keep this instrument relevant and responsive 
to the health center program's needs and the evolving healthcare 
landscape, periodic updates are essential. HRSA plans to make the 
following updates for the performance year 2025 UDS data collection:

Table 6A (Selected Diagnoses and Services Rendered) Additions

     Tobacco Use Cessation Pharmacotherapies: A new measure is 
being added to line 26c2 to identify the number of visits where 
patients received tobacco cessation pharmacotherapies as an 
intervention and the number of patients who received this pharmacologic 
treatment. While the Preventive Care and Screening: Tobacco Use: 
Screening and Cessation Intervention electronic-specified clinical 
quality measures (CMS138v12) (Table 6B, Line 14a) that is currently 
reported in the UDS assesses for cessation, it lacks the capacity to 
disaggregate and report a distinct percentage for patients receiving 
counseling or recommendation to cessation pharmacotherapies. Adding a 
line for reporting of tobacco use cessation pharmacotherapies will 
promote greater understanding of the breadth of tobacco cessation 
interventions provided at health centers, specifically allowing HRSA to 
see differences in tobacco use cessation approaches.
     Medications for Opioid Use Disorder (MOUD): A new measure 
for MOUD services will be reported on line 26c3 for the number of 
visits where MOUD was administered and the number of patients who 
received this medication-based intervention. This new measure will 
enhance the existing MOUD related measures that health centers 
currently report on in Appendix E: Other Data Elements (e.g., number of 
providers who treat opioid use disorder with MOUD). The inclusion of 
this measure is critical for supporting public health efforts to 
address the ongoing opioid epidemic. Greater understanding of the use 
of MOUD in health centers is necessary both to understand existing 
services and identify remaining healthcare gaps.
     Alzheimer's Disease and Related Dementias (ADRD) 
Screening: A new measure is being added to line 26f to capture the 
number of visits where patients received ADRD screenings and the number 
of patients who received the screenings. This measure will encompass 
assessments representing standardized tools used for the evaluation of 
cognition and mental status of older adults. The addition of a measure 
to capture screening of ADRD will be valuable in understanding the 
level of need and resources required to continue to support the growing 
aging population served by the Health Center Program and will foster 
early detection for those at risk for ADRD.

Table 6B (Quality of Care Measures) Addition

     Initiation and Engagement of Substance Use Disorder 
Treatment: A new measure with two distinct rates is being added to 
Lines 23a and b to capture the initiation and engagement of substance 
use disorder treatment, in alignment with electronic-specified clinical 
quality measure CMS137v13. This measure will report on the percentage 
of patients 13 years and older with a new substance use disorder 
episode who received treatment, including (a) those who initiated 
treatment within 14 days and (b) those who engaged in ongoing treatment 
within 34 days. By incorporating this measure, HRSA strengthens its 
alignment with national performance standards and gains greater insight 
into how effectively health centers are initiating and engaging 
patients in substance use disorder treatment.

Table 6B (Quality of Care Measures) and Table 7 (Health Outcomes and 
Disparities)

Updates

     Tables 6B and 7 collect UDS clinical quality measures,\1\ 
and where applicable, clinical quality measures will be updated in 
alignment with specifications of the issued performance year 2025 
electronic-specified clinical quality measures. These specifications 
were released by the Centers for Medicare and Medicaid Services (CMS) 
on May 2, 2024, for use by eligible providers.\2\ 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.
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    \1\ https://www.cms.gov/medicare/quality/measures.
    \2\ https://ecqi.healthit.gov/now-available-updated-ecqm-specifications-and-implementation-resources-2025-performance/reporting-period.

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[[Page 92694]]

UDS+ Test Submissions for Health Centers

     Beginning with the 2024 UDS, health centers will be able 
to submit de-identified, 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+ Patient-Level Reporting leverages a shift in processes by 
which health centers will submit their annual UDS reports while 
maintaining historic UDS measures. Health Centers are encouraged to 
submit data through UDS+.
    UDS+ is currently in the testing phase and data submission supports 
system capacity building and progress towards full implementation. The 
technical test will inform next steps for scaling this innovation. 
High-quality accessible data are critical to strategically meeting the 
unique needs of health center patients and identifying training and 
technical assistance opportunities for clinical process improvement. 
The growth in health information technology coupled with the near 
universal adoption of electronic health records across health centers 
has transformed patient care delivery and underscored the need for 
secure and rapid exchange of health data between disparate systems. 
Fast Healthcare Interoperability Resources[supreg] is a Health Level 
Seven International[supreg] standard for exchanging health care 
information electronically.\3\ The health care community is adopting 
this next generation exchange framework to advance interoperability.\4\ 
Leveraging Fast Healthcare Interoperability Resources[supreg] to 
collect patient-level data through the UDS+ system will support 
improved data granularity, allowing for the development of robust HRSA-
supported patient care programs and improved equitable access to HRSA-
supported high-quality, cost-effective 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.
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    \3\ https://ecqi.healthit.gov/fhir.
    \4\ https://ecqi.healthit.gov/fhir.
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    Likely Respondents: Respondents will include Health Center Program 
award recipients and Health Center Program look-alikes carrying out 
programs under section 330 of the PHS Act and NEPQR and ANE award 
recipients funded under the practice priority areas of section 831(b) 
and 811 of the PHS Act.
    Burden Statement: Burden in this context means 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 utilize technology and 
systems for the purpose of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below.
    Total Estimated Annualized Burden Hours:

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                                                                     Estimated
                                                     Estimated       number of    Average burden     Estimated
                    Form name                        number of     responses per   per response    total burden
                                                    respondents     respondent      (in hours)         hours
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Universal Report................................         * 1,538            1.00             238         366,044
Grant Report....................................          ** 420            1.22              22          11,273
UDS+ Test Submissions...........................           1,507            1.25              10          18,838
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    Total.......................................           3,465  ..............             270         396,155
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* Consists of 1,363 health center program awardees, 133 Health Center Look-alikes, and 42 NEPQR and ANE
  respondents.
** Health Centers submitted one or more grant reports in 2023: 339 (1 report), 70 (2 reports), 11 (3 reports).

    HRSA specifically requests comments on: (1) the necessity and 
utility 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. 2024-27394 Filed 11-21-24; 8:45 am]
BILLING CODE 4165-15-P
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