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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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:

○ Table PBZC (Patients by ZIP Code)

○ Table 3A (Patients by Age and Sex Assigned at Birth)

○ Table 3B (Demographic Characteristics)

○ Table 4 (Selected Characteristics)

○ Table 6A (Selected Diagnoses and Services Rendered)

○ Table 6B (Quality of Care Measures)

○ 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® is a Health Level Seven International® 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® 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.

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:

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.

89 FR 92692