Supporting Statement

Supporting Statement for Indian Health Service

Uniform Data System and Supporting Regulations Contained in

Public Law 94-437, Indian Health Care Improvement Act,

Title V, Health Services for Urban Indians,

Section 507, Reports and Records (a)(1)(B)

Background

This is a request for a revision to the previously OMB approved information collection, IHS Urban Indian Health Program Common Reporting Requirements, 0917-0007. This collection utilizes the Uniform Data System (UDS), the annual reporting requirement for Urban Indian Health Programs (UIHPs) funded under Title V of Public Law 94-437 (Pub. L. 94-437), Indian Health Care Improvement Act, as amended by the Patient Protection and the Affordable Care Act of 2010 (Pub. L. 111-148). The Indian Health Service (IHS) has responsibility for the administration of the UIHPs under Title V.

The Office of Urban Indian Health Programs (OUIHP), in the IHS, has the responsibility for and oversight of programs designed to provide health services and case management to American Indians/Alaska Natives (AI/AN) residing in urban areas. Urban Indians not only share the same health problems as the general Indian population, their health problems are exacerbated in terms of mental and physical hardships because of the lack of family and traditional cultural environment. Urban Indian youth have a greater risk for serious mental health and substance abuse problems, suicide, increased gang activity, teen pregnancy, abuse, and neglect.

Title V of Pub. L. 94-437, authorizes the appropriation of funds for the UIHPs. Title V funds are one source of funding for the UIHPs. There are 34 UIHPs located in cities throughout the United States. Urban Indian primary care clinics and case management programs provide culturally acceptable, accessible, affordable, accountable, and available health services to an underserved off-reservation Urban Indian population. The 34 programs engage in a variety of activities, ranging from the delivery of primary health care to the provision of case management services. The UIHPs are independently operated through grants and contracts from IHS. Most UIHPs leverage IHS funds with competitive, supplemental resources from other Federal, State, local and private sources.

A. Justification

1. Need and Legal Basis

The significant growth of the UIHPs and the proliferation of information technology (IT) enhancements within the UIHPs are major factors that have heightened the need to evaluate and revise the performance reporting requirements of the OUIHP. As UIHPs receive reimbursement and support through multiple funding sources, improving performance reporting can also reduce the reporting burden of the OUIHP grantees by aligning reporting requirements on clinical performance measures with those of national quality improvement organizations. Furthermore, enhancing performance reporting will result in the ability to make evidence-based statements about the impact of UIHPs on improving access to cost-effective primary care and case management to the nation’s American Indian/Alaska Native (AI/AN) population.

A key component of success of the UIHPs has been the ability to demonstrate to payers and patients the value of care delivered to those receiving UIHP services. The expansion of the OUIHP and the resulting growth in the number of patients and services, along with provider incentive programs and technological advances, have underscored the importance of demonstrating UIHPs’ high quality care to the AI/AN population. This emphasis on demonstrating value is consistent with the Department of Health and Human Services’ initiatives to increase transparency in health care and promote value-based purchasing; transparency and IT are essential facilitators of increasing value in health care.

The IHS set of core quality improvement measures chosen are commonly used by Medicare and healthcare insurance/managed care organizations to assess the quality of healthcare services, and are likely already familiar to, and may already be in use by UIHP grantees. The quality measures are those recently selected - blood pressure control, diabetes control, appropriate childhood immunizations, and female cancer screening – and span the life cycle, represent clinically important conditions and services to the program population, and assess program impact.

2. Information Users

A core set of data are required annually to administer the grant programs funded under Title V. The Uniform Data System (UDS) is a tool that is used for monitoring and evaluating UIHP performance, and for ensuring compliance with legislative mandates. The UDS yields consistent information on patient characteristics and clinical conditions that can be compared with other national and state data. These data are also essential in assuring compliance with legislative mandates, facilitating Reports to Congress and reporting on the Government Performance Review Assessment (GPRA). The UDS is a mechanism used by IHS to obtain these standardized data elements from funded UIHPs.

The type of data requested in the UDS provides program information on the following: the total number of low income and/or uninsured people served; services utilized and diagnoses made; services offered that are distinct from other providers of primary care; and staffing for major service categories.

The program data and clinical measures are used to track UIHP performance and monitor use of grant funds. They also will result in IHS’ ability to make stronger statements about the OUIHP through performance measurement, as well as providing trend statistics related to AI/AN populations served within the UIHP setting.

As required by the GPRA, the OUIHP has developed annual program goals and objectives and related performance indicators. Examples of GPRA indicators that the UDS addresses are: HbA1c level; childhood and adult immunizations; and cancer screenings. The UDS provides data for these and other performance indicators. In addition, the UDS provides information to address the following OMB approved efficiency measure:

• OMB Efficiency Measure: Cost per service user in dollars per year.

The UDS provides uniformly defined data for OUIHP’s urban grant programs using standard formats and definitions. In addition, it yields consistent information on patient characteristics and clinical conditions that can be compared with other national and state data.

The UDS consists of two separate components.

The first component is the Universal Report, which is completed by all grantees and contains nine tables. The Universal Report reports data on services, staffing, and financing for the entire health activity. The report is a source of unduplicated data on the UIHPs. UIHP funded programs must report on their entire health activity even though it may be supported only in part by IHS contract(s) and grant(s). If the reporting grantee provides services through a contract with another organization that is the direct recipient of a UIHP grant, both entities report the patients, and the utilization, costs and revenues associated with those patients. IHS funded programs that include food distribution should integrate the utilization, staffing, costs, revenues and expenditures associated with these services into what they report. However, monies received for food and associated food distribution costs should not be reported since the program is merely acting as a conduit for the funds.

The second component is the AI/AN Report. The AI/AN Report reports selected information on AI/AN patients served by the OUIHP funded program. The report repeats all or part of the elements of five of the Universal report tables.

All UIHPs are required to provide both reports.

3. Improved Information Technology

UDS reporting is completed by grantees via the IHS Site Module (UDS Grantee Reporting Software). The IHS Module supports grantees’ entering, checking, submitting and revising UDS data. The Site Module incorporates utilities for electronically submitting the completed UDS tables to the Contractor. The Grantee Software supports printing of a complete set of UDS Tables, a Site Summary Report and Preliminary Measures, and electronically transmitted required changes to the UDS editor during the editing process. Business rules that check for quantitative and qualitative edit checks are applied to ensure that the data submitted meets the legislative and programmatic requirements. The site software module and all supporting documentation are delivered on a production- ready CD ROM for distribution. In addition, OUIHP has a toll free hotline (1-866-UDS-HELP) and email address (submituihpuds@uihpdats.net) to address questions and provide assistance, including Management Information System (MIS) concerns and constraints.

4. Duplication of Similar Information

Every effort has been made to ensure that the UDS contains the minimum amount of data necessary to meet important legislated monitoring and reporting requirements. Duplicative reporting has been eliminated. The UDS builds on data currently collected and maintained by grantees for internal administrative and clinical needs. As such, the UDS imposes few additional data collection demands on its grantees beyond what they are already collecting for internal purposes.

5. Small Business

IHS explored alternative sources for the cost information and found that, because of difference in coverage and definitions, there are no other existing sources that could be used for grant monitoring and administration.

6. Less Frequent Collection

Grant and contract dollars are awarded annually; therefore, the UDS data are required annually in order to monitor program compliance and administer programs funds.

7. Special Circumstances

There are no special circumstances for collecting the UDS.

8. Federal Register Notice/Outside Consultation

No comments were received in response to the November 18, 2009,

Federal Register notice (74 FR 59544).

9. Payment/Gift to Respondents

Respondents will not receive payment/gifts.

10. Confidentiality

No patient/user level information is reported. Only aggregated data are collected. The UDS does not involve the reporting of personally identifiable information about individuals. The UDS specifies the reporting of aggregate data on users and the services they receive, in addition to descriptive information about each funded grantee and its operations and financial systems.

11. Sensitive Questions

There are no questions of a sensitive nature. All information is reported in an aggregate format. Individuals cannot be identified based on these aggregate totals. Grantees leave blank any cells where the total is less than five.

12. Burden Estimate (Total Hours and Wages)

12A. Estimated Annualized Burden Hours

Data Collection Instrument(s)	No. of Respondents	No. of Responses per Respondent	Total Annual Responses	Average Burden per Response (in hours)	Total Burden Hours
OUIHP Uniform Data System Manual	33	1	33	24	792

The basics for the estimates:

• Types of data collection instruments, Number of respondents, Responses per respondent, Total annual responses, Average burden hours per response, and Total annual burden hours.

The UDS includes two components:

• The Universal Report reports data on services, staffing, and financing for the entire health activity. The Universal Report is the source of unduplicated data on the UIHP programs. The OUIHP funded programs must report on their entire health activity even though it may be supported on in part by the IHS contract(s) and grant(s). If the reporting grantee provides services through a contract with another organization that is a direct recipient of a UIHP grant, then both entities must report the patients, and the utilization, costs and revenues associated with those patients. The Universal Report consists of 9 tables captured in the UDS reporting. The Universal Report is the source of unduplicated data on OUIHP programs.

• The AI/AN Report reports selected information on the American Indian/Alaska Native patients served by the OUIHP funded program. The AI/AN Report repeats all or part of the elements of five of the Universal Report tables (3a, 4, 5, 6a, 6b).

Estimates of burden for the proposed UDS were obtained using prior averages of time needed to complete the former reporting system, the UIHPs’ Common Reporting Requirements (UCRR), which were provided through consultation with the grantees. The programs will utilize existing systems or sampled charts to report. The burden per respondent varies across grantees due to program type/services provided. While some programs use automated systems to generate the required reports, systems vary with their use and flexibility. Some programs have hierarchically - structured systems requiring time consuming processes for retrieving data in the required format. The majority of the programs are expected to experience a level of burden near the average cited.

The data reports for Table 3A, 3B and 4 represent tables in the former reporting system UCRR that were completed by a staff in the GS-5, Step 1 range. For Table 2, 5, 6A, 6B and 7 these represent tables in the former reporting system UCRR that were completed by a higher level staff in a clinical/medical position using the average of $45/hour. Tables 8A, 9D and 9E are completed by the financial office of the programs with a

mid-level staff person in the GS-9, Step 1 range.

The number of charts selected for chart reviews will be based on the patient population of the specific condition. The number of charts sampled and audited for any measure will not exceed 67 charts. To minimize the burden associated with sample size determination and to ensure that all grantees are using standard processes, the UDS reporting framework will include an electronic interface that auto-calculates the appropriate sample size for each measure based on the size of the grantee’s service population.

The burden here will differ based on the size of the patient population, the number of grant reports an organization must complete, or if the inclusion criteria of the measure relates to the grantee’s service population.

12B. Estimate Annualized Cost Per Respondent

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Administrative	264	$15.00	$3,960
Clinical	330	$45.00	$14,850
Financial	198	$23.00	$4,554
Total	792	-	$23,364

13.

Capital Costs (Maintenance of Capital Costs)

There will be no capital costs associated with this data collection instrument. As this is similar to the UCRR, all systems, equipment, staffing, etc. are in place at the UIHP grantee programs.

14. Cost to the Federal Government

The annual contract cost to the Federal government for Technical Assistance, training and data reporting, data processing, editing, and verification is $267,829. In addition, costs include one FTE at 5% time at a GS 12 level for $6,910. Total costs to the government are $274,729.

15. Program or Burden Changes

The former estimated burden was 515 hours for the UCRR reporting. The UDS will increase the burden to approximately 792 hours, for an overall increase of 277 hours. The change is due to the following: 1) the majority of the programs have not used the UDS reporting and will require training to complete the UDS report; and 2) tables in the UDS report were not reported on the UCRR. It should be noted that in the case of six grantees, that are 330 - funded community health centers, this UDS reporting for the urban Indian health program will actually decrease their burden of reporting due to the fact that these programs were completing not only the UCRR for the UIHP, but also the UDS for Health Resources and Services Administration (HRSA). It is also anticipated that the burden hours will decrease as the programs become familiar with reporting and will require less time to complete the UDS report accurately.

Overall urban Indian health program effectiveness can be better demonstrated to responsible federal government agencies using improved outcome measures.

16. Publication and Tabulation Dates

The grantees are required to submit the reports 61 days after the end of the calendar year. No statistical analyses are planned; only summary descriptive reports from the tables will be prepared.

17. Expiration Date

The expiration date will be displayed.

18. Certification Statement

There are no exceptions to the certification.

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