OMB 0193_ Supporting Statement A Edited

Supporting Statement A

Health Resources and Service Administration Uniform Data System

OMB Control No. 0915-0193

Terms of Clearance: None

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration (HRSA) is requesting OMB approval for the revision of forms used to collect data in the Uniform Data System (UDS). HRSA utilizes the UDS for annual reporting by Health Center Program awardees (those funded under section 330 of the Public Health Service (PHS) Act), Health Center Program look-alikes, and the Bureau of Health Workforce (BHW) primary care clinic awardees (specifically those funded under the practice priority areas of section 831(b) of the PHS Act). The UDS forms are currently approved under OMB Control No. 0915-0193, and the current expiration date is February 23, 2023.

HRSA will implement changes to better align with U.S. Department of Health and Human Services (HHS) data standards¹ and emerging priorities. These changes include race and ethnic subpopulation characteristics, information on composition of pharmacy personnel, long COVID, developmental screening and evaluation services in children, continued alignment of clinical quality measures to electronic specifications, screening for social risk factors, and the transition to de-identified patient-level reporting with UDS Patient Level Submission (UDS+). These updates have led to the need to update the UDS instrument, and in turn, the performance reporting requirements.

HRSA is proposing the following modifications to the UDS:

1. Update to Table 3B: Demographic Characteristics, to include additional subpopulations to better reflect the diversity of patients served by health centers

The update will allow for a better understanding of the diversity of patients served by health centers as well as provide the ability to capture data for sub-group populations defined by race and ethnicity, identify health disparities, and develop quality improvement initiatives to advance health equity.

2. Update to Table 5: Staffing and Utilization, to include distinct lines for reporting Pharmacist, Clinical Pharmacist, Pharmacy Technician and Other Pharmacy Personnel

The update will allow BPHC to better understand the composition of the health center workforce and contributions of pharmacy personnel in health centers.

3. Update to Table 6A: Selected Services and Services Rendered to include a diagnostic measure representing long COVID

The update to this table will lead to a better understanding the impact of COVID-19 post-acute infection on health center patients.

4. Update to Table 6A: Selected Services and Services Rendered to track the number of children who receive developmental screening and evaluation services

The update with this measure will allow health centers to track the number of children who receive developmental screening and evaluation services.

5. Alignment of Quality of Care Measures with the Centers for Medicare and Medicaid Services (CMS) electronic-specified clinical quality measures (eCQMs)for the 2023 calendar year reporting, These include the following:

1. Childhood Immunization Status has been revised to align with CMS117v11

2. Cervical Cancer Screening has been revised to align with CMS124v11

3. Breast Cancer Screening has been revised to align with CMS125v11

4. Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents has been revised to align with CMS155v11

5. Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan has been revised to align with CMS69v11

6. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention has been revised to align with CMS138v11

7. Statin Therapy for the Prevention and Treatment of Cardiovascular Disease has been revised to align with CMS347v6

8. Colorectal Cancer Screening has been revised to align with CMS130v11

9. HIV Screening has been revised to align with CMS349v5

10. Preventive Care and Screening: Screening for Depression and Follow-Up Plan has been revised to align with CMS2v12

11. Depression Remission at Twelve Months has been revised to align with CMS159v11

12. Controlling High Blood Pressure has been revised to align with CMS165v11

13. Diabetes: Hemoglobin A1c (HbA1c) Poor Control (> 9%) has been revised to align with CMS122v11

Clinical performance measure alignment across national programs promotes data standardization and quality, and decreases reporting burden

6. Update to Appendix D: Health Center Health Information Technology (HIT) Capabilities Form asking health centers to: Provide the total number of patients that were screened for social risk factors during the calendar year.

This question provides a more accurate view of the impact of social risk factors on health center patient populations and continues to reinforce Social Determinants of Health (SDOH) as a priority area for improving health equity.

7. Update to report UDS +Patient Level data, beginning with the 2023 UDS, in fulfillment of measures on tables:

Table Patients by Zip Code (PBZC)

Table3A (Patients by Age and by Sex Assigned at Birth)

Table3B (Demographic Characteristics)

Table 4(Selected Patient Characteristics)

Table 6A (Selected Diagnoses and Services Rendered)

Table 6B (Quality of Care Measures)

Table 7(Health Outcomes and Disparities)

This electronic data reporting mechanism will reduce reporting burden and reliance on manual data entry to populate the annual UDS report while simultaneously increasing the fidelity, validity, and analytical value of UDS data.

2. Purpose and Use of Information Collection

HRSA collects UDS data annually to ensure compliance with legislative and regulatory requirements, improve health center performance and operations, and report overall program accomplishments. These data help to identify trends over time, enabling HRSA to establish or expand targeted programs and identify effective services and interventions to improve the health of medically underserved, geographically isolated, and vulnerable populations and communities served across the country by the Health Center Program. UDS data are compared with national health-related data and benchmarks to explore potential differences between health center patient populations and the U.S. population at-large. Comparisons to national data and benchmarks include the National Health Interview Survey² (NHIS), National Health and Nutrition Examination Survey³ (NHANES), Healthy People 2020 and 2030 ⁴objectives, and Million Hearts⁵ initiative. UDS data also inform Health Center Program partners and communities regarding the impact of health centers on access to care and outcomes. The HRSA Bureau of Health Workforce (BHW) uses the data to determine the impact of healthcare services, delivered through their funded primary care clinics, on patient outcomes and to train future providers of care. In addition, UDS data are used by these BHW award recipients for performance and operation improvements, patient forecasts, identification of trends/patterns, implication of access barriers, and cost analysis to support long-term Program sustainability.

3. Use of Improved Health Information Technology and Burden Reduction

Advancements in electronic health record (EHR) technology have been proceeding at a rapid pace. EHRs can help health centers achieve quality and efficiency goals, and the use of EHRs streamlines and simplifies health center reporting of UDS measures. At present, 99% of health centers have EHRs installed. Health Level 7 (HL7®) Fast Healthcare Interoperability Resources (FHIR)⁶ standards are a requirement based on the Office of the National Coordinator for Health Information Technology (ONC)’s final rule for the 21st Century Cures Act⁷. This rule supports patients and their healthcare providers in having secure access to health information and aims to increase market innovation and competition by fostering an ecosystem of new applications to provide patients with more health care choices. The transition to UDS patient level data reporting using FHIR standards is necessitated by the evolution of health information technologies. The functionalities and application of electronic health records (EHR) systems have grown immensely since the Meaningful Use Program^8. Broad-scale adoption of EHR systems have furthered the need to share data across settings, providers, and networks to support care quality and patient outcomes. The integration of these electronic systems decreases the time and effort that would be required to complete manual data extraction for reporting and will in turn shift reporting mechanisms for how health centers report UDS data, while simultaneously yielding efficiencies and burden reduction. Notably, it is imperative for collection of UDS data to be in alignment with interoperability standards and reporting requirements being adopted across the U.S. Department of Health and Human Services and the healthcare industry.

4. Efforts to Identify Duplication and Use of Similar Information

The information collected by these forms is unique to the Health Center Program and representative of the over 30 million patients served by health centers each year. Information is not captured in the same form and format elsewhere. There are no other existing sources that could be used for monitoring performance and administration of the Health Center Program.

5. Impact on Small Businesses or Other Small Entities

This activity does not have a substantial impact on small entities or small businesses.

6. Consequences of Collecting the Information Less Frequently

UDS data are required to be submitted by health centers annually in order to effectively monitor program performance and administer program funds. For look-alikes, UDS data are used to monitor program performance and for designation and recertification decisions.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The request fully complies with the regulation.

8. Comments in Response to the Federal Register Notice/ Outside Consultation

Proceeding OMB review, a 60-day Federal Register notice was published in Vol. 87, No. 203 pp. 64058-59 on 10/21/2022 for public comment with a close period of 12/20/2022. To follow, a 30-day Federal Register notice will be published for public comments and HRSAs response.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts; reporting is requirement of their Health Center Program funding and to maintain designation as look-alike.

10. Assurance of Confidentiality Provided to Respondents

The UDS does not involve the reporting of personally identifiable information (PII) about individuals.

11. Justification for Sensitive Questions

There are no questions of a sensitive nature.

12. Estimates of Annualized Hour and Cost Burden

Estimated Annualized Burden Hours:

Form Name	Estimated Number of Respondents	Estimated Number of Responses per Respondent	Average Burden per Response (in hours)	Estimated Total Burden Hours
Universal Report	Total : 1505 H80s 1370 LALs 117 BHW 18	1	238	358,190
Grant Report	Total : 438 438 Health Centers submitted 1 or more Grant Reports 1- 346 2-80 3-12	1.24	30	16,294
UTC Tests	35	3	8	840
Total	1978	5.24	276	375,324

The burden estimates for completing the UDS have been determined based on the experience of HRSA, factoring in minor modifications proposed by commenters and feedback received from outside consultation and key stakeholders. For 2021 UDS reporting, HRSA estimates that there were approximately 1505 respondents for completing the Universal Report and 438 for completing the Grant Report. For this collection, respondents are defined as the health center organization. HRSA is requesting that the organization respond, not an individual person.

The UDS report is completed by all Health Center Program award recipients, look-alikes, and - Bureau of Health Workforce (BHW) award recipients. The Universal Report is completed by all awardees and look-alikes, and the Grant Award Report is completed by a subset of awardees, who receive multiple BPHC grant awards. Look-alikes DO NOT receive regular federal funding under section 330 of the PHS Act (although they may receive funding during public health emergencies, such as COVID-19), but meet the Health Center Program requirements for designation under the program (42 U.S.C. 1395x⁹ (aa)(4)(A)(ii) and 42 U.S.C. 1396d(l)(2) (B)(ii)).

The average burden per response, for completing the Universal Reporting is estimated to take 238 hours and an estimated 30 hours for the Grant Report. Likewise, UTC testers are estimated to take eight hours to complete each test.

The Grant Report for Vulnerable Populations is completed by a subset of Special Population award recipients¹⁰ who receive Migrant Health Center (MHC), Health Care for the Homeless (HCH), and Health Centers for Residents of Public Housing funding (PHPC). These grant reports, (subset of universal report) for Special Population funding, are estimated to take 30 hours to complete and those organizations that receive multiple funds (MHC, HCH, and/or PHPC), are required to report on the different vulnerable populations they serve.

As part of HRSA’s efforts to modernize the UDS reporting structure and ultimately reduce burden, a UDS Test Cooperative (UTC), which consists of a diverse group of UDS stakeholders who test and offer feedback on proposed UDS changes and enhancements. The UTC, through proof- of- concept testing, tests changes to UDS content or reporting to help HRSA identify effective implementation strategies and is estimated to take eight hours to complete each UTC test. HRSA estimates that there will be approximately 35 respondents participating in the UDS UTC. HRSA is planning to conduct no more than three tests each calendar year and no more than one hundred health centers would participate in one test. Participation is voluntary and will not affect their funding status. This sample size is sufficient to conduct technical tests and determine if the innovation should be scaled across the UDS.

Estimated Annualized Burden Costs:

Form Name	Estimated Number of Respondents	Type of Respondent	Average Total Burden Hours	Hourly Wage Rate (average)	Estimated Total Respondent Costs
Universal Report	Total : 1505 H80s 1370 LALs 117 BHW 18	Medical 11Records/Health IT Technician12	358,190	$23.05	$8,256,279.50
Grant Report	Total : 438 438 Health Centers submitted 1 or more Grant Reports 1- 346 2-80 3-12	Medical Records/Health IT Technician	16,294	$23.05	$375,576.70
UTC Tests	35	Medical Records/Health IT Technician	840	$23.05	$19,362.00
Total	1978		375,324		$8,651,218.20

13. Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

Health centers may incur additional annual operation and maintenance costs for programming or re-programming their information technology systems to generate the data in the required format. Grant funds were awarded to support health centers through Health Center Controlled Networks¹³ (HCCNs), to support the transition to UDS+, including for use in supporting HIT systems interoperability, related to UDS reporting.

14. Annualized Cost to the Federal Government

The estimated annual cost to the government for contracts providing technical assistance, training and data reporting support, data processing, editing, and verification is $2,000,000. Additionally, UDS reporting is supported by a team of FTEs, where a portion of their time is dedicated to UDS. The estimated annual cost to the government for this composition of FTE time is $270,250 and through another contract, about $2,000,000 to support the IT Systems programming, testing, and interface currently used by health centers to submit annual UDS reports. Total estimated annual costs to the government are $4,270,250.

15. Explanation for Program Changes or Adjustments

HRSA is working to reduce the overall burden through research and development in measure alignment and leveraging HIT systems and electronic data standards to support automation of reporting. HRSA is additionally exploring supplementary electronic data standards and streamlined reporting opportunities to reduce the burden of UDS reporting time starting in calendar year (CY) 2023.

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16. Plans for Tabulation, Publication, and Project Time Schedule

Respondents submit their information between January 1 and February 15 of the calendar year and report on patient demographics, clinical measures, and financials related to primary care services provided to patients served by health centers over the previous calendar year. For example, 2023 UDS data are reported January 1 through February 15 of 2024. From February 15 to March 31, UDS reports are reviewed for data quality and consistency. Statistical analysis are conducted with the information collected. Please see Supporting Statement B for more detailed information. Summary descriptive reports of the information collected will be prepared and published by August of the calendar year to HRSA’s data website: https://data.hrsa.gov/tools/data-reporting

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB number and expiration date will continue to be displayed on the back cover of the UDS Manual’s electronic file.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 _{U.S. Department of Health and Human Services (HHS) data standards and emerging priorities}

2 https://www.cdc.gov/nchs/nhis/index.htm

3 https://www.cdc.gov/nchs/nhanes/index.htm

4 https://health.gov/healthypeople

5 _{https://millionhearts.hhs.gov/}

6 _{https://www.cdc.gov/nchs/nvss/modernization/pdf/fhir-implimentation-guidance-checklist.pdf}

7 _{https://www.congress.gov/bill/114th-congress/house-bill/34}

8 _{https://www.healthit.gov/topic/meaningful-use-and-macra/meaningful-use}

9 https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395x%20edition:prelim)

10 https://data.hrsa.gov/tools/data-reporting/special-populations

11 ^{https://www.bls.gov/ooh/healthcare/medical-records-and-health-information-technicians.htm#:~:text=%2445%2C760-,The%20median%20annual%20wage%20for%20medical%20records%20specialists%20was%20%2446%2C660,percent%20earned%20more%20than%20%2474%2C200.}

12 ^{https://www.bls.gov/oes/current/oes292099.htm}

13https://bphc.hrsa.gov/funding/funding-opportunities/health-center-controlled-networks-hccn

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