3rd Party Study Mini-Supporting Statement REVISED - Clinical Center (2)

Clearance Request:

NIH Clinical Center

Office of the Director

Survey of NIH Clinical Center Patients:

3^rd Party Reimbursement Feasibility Project

Point of Contact:

Laura M Lee

301-496-8025

[email protected]

Mini Supporting Statement

Section A

A.1 Circumstances Requiring the Collection of Data

This survey will help fulfill the requirements of:

• Executive Order 12862, “Setting Customer Service Standards,” which directs Agencies to continually reform their management practices and operations to provide service to the public that matches or exceeds the best service available in the private sector; and

• Directives included in the FY 11 Preliminary Congressional Appropriation Committee Reports (CACRS)

A.2 Purposes and Uses of the Data

The survey data will provide the NIH Clinical Center (NIH CC) information about NIH CC research participants’ health insurance coverage and their perceptions/attitudes about the CC billing their insurance carriers for standard care provided at the NIH CC. These data will be used to inform the feasibility of collecting third party reimbursement at the NIH CC.

A.3 Use of Information Technology to Reduce Burden

As appropriate, automated information technology will be used to collect and process information for this survey to reduce the burden on the public. The survey will be conducted at the NIH CC and will be administered to NIH CC research participants via personal interviews. Data will be collected manually and managed and analyzed electronically.

A.4 Efforts to Identify Duplication

Users will be asked to complete the survey only once

A.5. Small Business

NA

A.6 Consequences of Not Collecting the Information

Absent this survey, data regarding the types of insurance that NIH CC research participants have and their perceptions about third party recovery will not be available for the feasibility study.

A7. Special Circumstances Justifying Inconsistencies with Guidelines in 5 C.F.R. 1320.5

This survey will be implemented in a manner that fully complies with 5 C.F.R. 1320.5.

A.8. Consultation Outside the Agency

N/A

A.9. Payments or Gifts to Respondents

No payment or gift will be provided to survey participants

A.10. Assurance of Confidentiality

Individual respondents will not be identified and participation will be strictly voluntary. Respondents will be assured that neither their participation/non-participation nor any responses to items will have any effect on their eligibility for, or receipt of, services.

A.11 Questions of a Sensitive Nature

No questions will be asked of a personal or sensitive nature.

A.12Estimates of Response of Burden

Estimates of Annual Hours Burden
Types of Respondents	Number of Respondents	Frequency of Response	Average Response Time	Annual Hour Burden
Clinical Research Participants/Patients	378	1	6 min	37.8

Annualized Cost to Respondents
Types of Respondents	Number of Respondents	Frequency of Response	Hourly Wage Rate	Respondent Cost
Clinical Research Participants/Patients	378	1	$10.00	$378.00

A.13. Estimate of Total Capital and Startup Costs/Operation and Maintenance Costs to Respondents or Record Keepers

N/A

A.14. Estimates of Costs to the Federal Government

This survey is part of a larger study currently funded by the NIH CC.

A.15. Changes in Burden

N/A

A.16. Plans for Publication, analysis and Schedule

There are no plans to publish these data in professional journals. The information collected is intended for use in internal agency reports.

A.17. Approval to Not Display Expiration Date

We are not requesting an exemption to the display of the OMB Expiration date.

A.18 Exceptions to Item 19 of OMB form 83-I

These surveys will comply with the requirements in 5 CFR 1320.9.

Section B

B.1. Respondent Universe and Sampling Methods

The survey will obtain information from clinical research participants enrolled in clinical research protocols at the NIH Clinical Center (NIH CC). The survey data will provide the NIH CC with information about research participants’ health insurance coverage and their perceptions/attitudes about the NIH CC billing their insurance carriers for standard care provided at the CC. These data will be used to inform the feasibility of collecting third party reimbursement at the NIH CC.

The survey target sample size of 378.  This figure is the minimum number of survey participants needed to target a confidence level of 95% with 5% precision.  This calculation was derived using a various factors, including the number of unique patients seen at the NIH CC in FY10 (22,103), the survey instrument, and survey population information.

B.2. Information Collection Procedures/Limitations of the Study

The NIH CC will collect all information in a manner that is consistent with the following principles:

• Appropriate sample sizes have been determined for the survey so that the burden is minimized while reliable estimates are produced. As stated above, the survey target sample size of 378.  This figure is the minimum number of survey participants needed to target a confidence level of 95% with 5% precision.  This calculation was derived using a various factors, including the number of unique patients seen at the NIH CC in FY10 (22,103), the survey instrument, and survey population information.

• Participation in the survey is full voluntary. Non participation will have no impact on eligibility for, or receipt of, future care and services provided as a research participant at the National Institutes of Health Clinical Center.

• Collected information will be limited to that included on the survey questionnaire which is needed to adequately address the data requirements needed to complete the aforementioned feasibility study.

B.3. Methods for Maximizing the Response Rate and Addressing Issues of Nonresponse

The survey will be administered by professionals with experience in survey administration. The survey will be fielded as an in-person interview to participants in various NIH Clinical Center clinics and patient care units. Staff will be available and able to address issues that potential responders may have about the survey and/or the use of the data.

B.4. Tests of Procedures of Methods

The survey tool to be used for data collection has been tested for inter-rater reliability and question validity.

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NIH-CC (0925-0458)