Supporting Statement A OAT PASSBACK_OAT responsesJan10

Supporting Statement A

OAT Telehealth Outcome Measures

OMB Control No. 0915-0311

Revision

1. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration’s (HRSA) Federal Office of Rural Health Policy (FORHP), Office for the Advancement of Telehealth (OAT) is requesting Office of Management and Budget (OMB) continued approval for telehealth outcome measures of the telehealth grantees. Specifically, we are asking for continued approval to use a performance measurement tool to collect data from grantees receiving funds under the Telehealth Network Grant Program.

The Telehealth Network Grant Program is authorized by Section 330I of the Public Health Service Act. The Health Care Safety Net Amendments of 2002 (Public Law 107-251) amended the Public Health Service Act by adding Section 330I. Under this authority, grants may be awarded to eligible entities to develop telehealth network projects in rural areas, in medically underserved areas, in frontier communities, and for medically underserved populations, to (a) expand access to, coordinate, and improve the quality of health care services; (b) improve and expand the training of health care providers; and (c) expand and improve the quality of health information available to health care providers, and patients and their families. The primary objective of the Telehealth Network Grant Program is to help communities build the human, technical, and financial capacity to develop sustainable telehealth programs and networks. The data collected with the performance measurement tool provides HRSA’s OAT with information about outcome measures including the effectiveness of service programs and monitor their progress through the use of performance reporting data. In addition, the data collected from grantees meets the administrative requirement of assessing programs via the Government Performance Review Act of 1993 (GPRA)¹.

The Telehealth Network Grant Program awards demonstration grants to networks that show how telehealth technologies can expand access to quality healthcare; improve and expand training of healthcare providers; and expand and improve the quality of health information available to providers and patients. Because the primary focus of the program has been to fund grantees to build and demonstrate the usefulness and financial viability of telehealth systems in providing health care, this tool provides the needed measures to determine the program's impact on clinical outcomes. As required by GPRA, all federal agencies must develop strategic plans describing their overall goal and objectives. HRSA’s OAT has worked with its grantees to develop performance measures to be used to evaluate and monitor the progress of the grantees. Specific categories were designed to be reported through a performance monitoring website.

The HRSA’s OAT was established in 1998 with the mission to lead, coordinate and promote the use of telehealth technologies. OAT fulfills this mission by fostering partnerships within HRSA and other Federal agencies, states and private sector groups. OAT also works to expand the field of telehealth by:

• administering telehealth grant programs;

• providing technical assistance; assessing technology investment strategies;

• developing distance learning and training programs for health care providers;

• evaluating the use of telehealth technologies;

• developing telehealth policy initiatives to improve access to quality health services; and

• promoting knowledge about “best practices.”

HRSA envisions the use of telehealth technology playing an integral role in facilitating linkages between health care institutions over distance to improve access to quality health care services in this nation and provide educational opportunities or those who would otherwise not have or would have difficulty accessing such opportunities. OAT is the operational focal point within HRSA’s Federal Office of Rural Health Policy for advancing the cost-effective use of telehealth technologies throughout the agency. OAT is responsible for allocating and administering funds, evaluating programs and their impact on the population served, and improving the quantity and quality of care. The Performance Improvement and Measurement System (PIMS) Database extracts valuable information on services provided that are critical to the mission of HRSA and provides valid and complete information about methods used to measure the impact of the telehealth program on improving access to healthcare services for residents of communities that did not have such services locally before the program. Projects are able to measure the impact of the telehealth program on hospitalization rates and emergency room visit rates per year for patients receiving disease management services for diabetes, congestive heart failure, stroke and other chronic diseases, as well for patients receiving home care/home monitoring services. Projects can measure impact of the telehealth program on controlling blood glucose levels in diabetic patients and can assure the impact of the telehealth program improving efficiency of health care. In addition, projects also measure the impact of the telehealth program on reducing medical errors and collect data to measure other clear outcomes.

Additionally, the performance measurement tool allows OAT to:

• Fulfill obligations for GPRA requirements and to report to Congress on impact of the OAT Telehealth Network Grant Program;

• justify budget requests;

• create a data-reporting tool for grantees to report on their projects’ performance relative to the mission of OAT/HRSA as well as individual goals and objectives of the program;

• collect uniform, consistent data which enables OAT to monitor programs;

• provide guidance to grantees on important indicators to track over time for their own internal program management;

• identify topics of interest for future special studies;

• identify changes of healthcare needs to rural communities allowing programs to shift focus in order to meet those needs, thereby improving access to needed services;

• reduce rural practitioner isolation;

• improve health system productivity and efficiency; and

• enhance quality of care.

2. Purpose and Use of Information Collection

In order to evaluate existing programs, data are obtained from the OAT Performance Improvement Measurement System (PIMS), which can be accessed thru HRSA’s Electronic Handbook (EHB).² The data are used to identify quality improvements, disparities in health care, health status and clinical outcome measures. The tool is also used to address GPRA initiatives. This system provides the government, health centers, patients, general academic and constituent communities with critical information on health care issues that directly affect rural, minority and under-served populations.

There are two data reporting periods each year; during these biannual reporting periods data are reported for the previous six months of activity. Programs have approximately six weeks to enter their data into an interactive website designed by Abt Associates Inc. during each biannual reporting period. The interactive website was successfully migrated into HRSA’s EHB in 2008.

The instrument was developed with the following four goals in mind:

1. improving access to needed services,

2. reducing rural practitioner isolation,

3. improving health system productivity and efficiency, and

4. improving patient outcomes.

For each of these categories, specific indicators were designed and data are reported regularly through a performance monitoring website. In addition to providing the required GPRA data, OAT uses the reported information to demonstrate the "value-added" that telehealth services contribute to improving health care. OAT has incorporated these performance assessment tools into the routine reporting required as part of the mid-year and annual reports required of their grantees.

All grantees are asked to address access to telehealth technologies at their respective institutions. Telehealth activities include the practice of telemedicine, delivery of distance education in allied health fields health informatics, health care staff supervision from remote sites, and the provision of consumer health information using telecommunications technologies. Grantees will be asked to provide network members or satellite site information. Additionally, new measures have been included that address the four goals of the Telework Network Grant Program (TNGP).

User Level Data

1. A unique user identifier: Each grantee selects a member from the organization to submit data into PIMS. The selected staff member is assigned a unique EHB login and password code to access the system.

2. Configuration: This feature allows participants to establish sites, specialties and settings. Participants can update information when necessary.

Specialties and Services

This allows participants to report the number of encounters by specialty/service, by patient care setting and by the type of telemedicine encounter.

Specialty Areas: This allows users to indicate the medical specialties and services provided through their telehealth system for the current reporting period.

Settings Include:

• Hospital ER

• Hospital In-Patient

• Hospital Outpatient

• Non-Hospital Clinic (e.g., rural clinic, migrant health clinic)

• Private Medical Practice or Physician’s Office

• Health Department and Mental Health Agency

• Patient’s Home

• Licensed Nursing Home

• Assisted Living Facility

• School

• Prison

Encounter Types:

• Interactive/Real-Time Encounters: Encounters done in an interactive (real-time) video-conferencing format.

• Patient-Present Encounters: Interactive encounters in which the patient is present during the consultation.

• Patient-Not Present Encounters: Interactive encounters in which the patient is not present during the consultation.

• Store-and-Forward: Encounters done in a format where information/images are gathered and sent electronically to be viewed at a later time by a telehealth provider; therefore, encounters are not interactive and not in real-time.

• Biometric Monitoring Interactions: Store-and-forward interactions used for telemetry or patient-monitoring most commonly for home-bound patients. Every ‘patient-day’ (a day in which a patient received care) should be counted as a separate interaction. Multiple measurements recorded within a single day are counted as one.

• Other: All store-and-forward interactions that do not involve biometric monitoring.

• Patient-Care Encounters/Sessions: This information is obtained with a different form and

includes therapy and counseling (including nutritional, group counseling, etc) but not didactic education, community meetings or administrative sessions.

Service Availability in Remote Communities

Participants are asked to report information about the availability of services in the community. Specifically, they are asked to report whether a specialty/service is available in the community, whether a visiting specialist provides the service regularly, whether their OAT telemedicine program offers the services to the site, and whether another telemedicine program offers the service/specialty. Participants indicate how far one would have to drive from the community to see a specialist in-person.

Patient Travel

Users measure patient travel that is ‘saved’ or avoided through the use of telemedicine. Distance is measured between the hub site and the remote site (patients’ physical location). The number of sessions is also obtained in this area.

Number of Practitioner Referrals

This area focuses on the reliance of referring practitioners on telemedicine. Users track the number and type of patients each practitioner refers for telemedicine. The data are aggregated to show the percentage of referring rural practitioners who had 0-10 referrals, 11-20 referrals, etc. The data will also be aggregated to show the percentage of referring practitioners who referred patients for care in 0-5 specialties, 6-10 specialties, etc.

Emphasis is on 3 types of referrals:

• Clinicians referring from remote site- These are referrals made by a clinician at the patient/patient data location, usually a rural site.

• Specialists using telemedicine to see their own patients- These are referrals made by a specialist at the consulting location. This is common for post-discharge follow-up encounters between specialist and patients.

• Patient ‘self-referrals’- This type of referral addresses the situation in which a patient presents at a remote/rural site requesting a telemedicine consult with a specialist but does not have a referral from any practitioner.

The performance measurement tool also collects outcomes measures for chronic conditions. The form gathers data on patients with chronic conditions for whom the program provided care other than home-health care, i.e. care provided in other settings or through other means not including tele-home health care. The form specifically addresses the five chronic conditions that are the most commonly served by telehealth programs (congestive heart failure, diabetes, asthma, chronic obstructive pulmonary disease, mental health, and other chronic conditions). Grantees now report on the number of (unduplicated) patients served during the six month reporting period, the number of unduplicated diabetic patients served for at least three months during the six month reporting period and the number of diabetics in good glucose control, served for at least three months during the six month reporting period. These measures were included to meet specific PART requirements of the long-term outcome measures of the Telehealth Network Grant Program involvement with chronic disease management.

3. Use of Improved Information Technology and Burden Reduction

The OAT PIMS tool is fully electronic within HRSA’s Electronic Handbook. The system design provides pre-formatted and interactive data entry that helps assure standardized data across the Telehealth Network Grant Programs and greatly simplifies the data entry process. The grantee provides sites and services information and the system only generates forms based on this data. Patient travel, chronic disease, dermatology and homecare information will be in spreadsheet format. The worksheets collect specific information about each service provided. Calculations in the spreadsheets are fully automated. Drop down menus are also used to simplify selections. Instructions are attached to each individual worksheet.

4. Efforts to Identify Duplication and Use of Similar Information

Data of the type required to evaluate or monitor the Telemedicine program are not available elsewhere. The information is not intended to reflect all telemedicine activity nationwide; it reflects only the activity of the telemedicine programs funded by HRSA’s OAT. As such, this gives an indication of telemedicine programs and services, but not the total volume of this activity nationwide. The OAT PIMS tool is necessary for the program to monitor the objectives that the funding initiative is designed to meet.

5. Impact on Small Businesses or Other Small Entities

This project does not significantly impact small business or small entities.

6. Consequences of Collecting the Information Less Frequently

Without semi-annual reporting on the use of Telehealth Network Grant Program funds, HRSA’s OAT would not be able to carry out its responsibility to oversee compliance with the intent of congressional appropriations in a timely manner. Because Telehealth is a critical component of health care, specifically in rural areas, semi-annual reporting of the characteristics of the Public Health Service Act, Section 330I - Telehealth Network Grants is necessary to determine whether the administration of the funds is responding to the changes in the affected population(s).

If the information is not collected at all, HRSA’s OAT will not be able to provide critical data that are needed to justify the GPRA, as mandated by OMB. The information being reported supports the following:

• whether program funds are being spent for their intended purposes;

• what types of and how many individuals are receiving services;

• whether there is an increase in the number of communities that have access to pediatric and adolescent, and adult mental health services where access did not exist in the community prior to the Telehealth Network Grant Program;

• helps determine if there is an increase in the number of diabetic patients enrolled in a telehealth diabetes case management program with ideal glycolic control; and

• whether there is an increase in the number of services and/or sites that provide access to health care as a result of the Telehealth Network Grant Program per federal program dollar expended.

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

The data is being collected in a manner fully consistent with the guidelines in 5 CFR 1320.5.

8. Consultation Outside the Agency

A 60-day Federal Register Notice was published in the Federal Register on August 10, 2016, vol. 81, No. 154; pp. 52880. There were no public comments.

OAT consulted and shared the reporting instructions, and measures for the monitoring system, with current grantees providing telemedicine services to their communities. Their expertise was crucial in identifying key performance measures/indicators to be used to evaluate and monitor the progress of the program. The representatives provided advice/input during the Spring of 2016. The names of these individuals are listed in the table below.

Name	Location	Address/Phone Number
Madan Dharmar, MBBS, PhD	University of California Davis, CA	Assistant Research Professor Pediatric Telemedicine Program UC Davis Childrens Hospital Center for Health and Technology Education Building 4610 X Street, Suite 2301 Sacramento, CA  95817 916-734-2354 Email: mdharmar@ucdavis.edu
Rob Sprang, MBA	University of Kentucky Lexington, KY	Director, Kentucky TeleCare University of Kentucky, UK HealthCare Co-Project Manager, Kentucky TeleHealth Network 859-257-6404 rsprang@uky.edu http://www.mc.uky.edu/kytelecare
Todd Lawley	St. Joseph’s Hospital & Health Center Fargo, ND	Director, Strategy and Business Dvlp Foundation Fargo Division 4784 Amber Valley Parkway Fargo ND 58104 ph 701.237.8174 email: toddlawley@catholichealth.net
Kari B. Law, MD	West Virginia University Morgantown, WV	Assistant Professor, Adult, Child & Adolescent, & Forensic Psychiatry Director, Telepsychiatry West Virginia University Department of Behavioral Medicine 930 Chestnut Ridge Road Morgantown, WV  26505 (304) 293-5181 - office (304) 598-4860 - fax klaw@hsc.wvu.edu
Gordon Low, MSN, MSW, FNP-BC, APN, RN	University of Arkansas for Medical Sciences (UAMS) Little Rock, AR	University of Arkansas for Medical Sciences (UAMS) 4301 W. Markham St., #812 / Little Rock, Arkansas (AR) 72205 Phone 501-686-8845 GMLOW@UAMS.EDU
Robert Cuoio, MBA	The Hospital Cooperative Pocatello, ID	Executive Director The Hospital Cooperative 500 South 11th Avenue, Suite 503 Pocatello, ID 83201 Phone: (208) 239-1952 robert@hospitalcooperative.org  www.hospitalcooperative.org
Sanjay Rughani	San Juan County Public Hospital Bellingham, WA	Program Manager Telehealth Strategies and System of Care Support 2901 Squalicum Parkway| Bellingham, WA 98226 Office 360.788.6816 srughani@peacehealth.org
Angie Gorn	Norton Sound Health Corp. Nome, AK	Angie Gorn Norton Sound Health Corporation PO Box 966 Nome, Alaska  99762 907-443-3286 agorn@NSHCORP.ORG

9. Explanation of any Payment/Gift to Respondents

Respondents will not be remunerated.

10. Assurance of Confidentiality Provided to Respondents

The OAT PIMS does not require any information that could identify individual clients. Names and personal identifiers will not be included in an aggregate data report. All reports and tabulated data that will be released to the general public will be summaries of information across grantees.

11. Justification for Sensitive Questions

There are no questions of a sensitive nature collected through the OAT PIMS. No patient or client-level identifying data will be reported. Identification of the grantees as recipients of telemedicine funds is a matter of public record, as these recipients receive funds directly from HRSA.

12A. Estimated Annualized Burden Hours

The average annual burden hours of 2,800 are displayed in the table below. The estimate is based on trials regarding the amount of time it would take to review and complete data entry.

Form	Number of Respondents	Responses per Respondent	Total Responses	Hour Burden	Total Burden Hours
OAT Performance Measurement Tool	200	2	400	7	2,800

12B. Estimated Annualized Burden Costs

Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
Nursing, Psychiatric and Home Health Aides	1400	$11.69	$16,366
Medical Records and Health Information Technicians	1400	$17.68	$24,752
Total	2800		$41,118

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

There are no capital or start up costs for respondents related to this effort.

13. Annualized Cost to Federal Government

The cost of the contract to collect the information is $50,000. A Grade 13 Federal employee with a salary of $92,145 will work on this project 15% of the time for 13,821.75. Therefore, the total annual cost to the Federal Government is $63,821.75.

13. Explanation for Program Changes or Adjustments

The current inventory for this information collection is 9,800 hours. The number of active sites committed to the grant project fluctuates from year to year and, therefore, in the “Estimates of Annualized Hour and Cost Burden”, the “Number of Respondents” was decreased from “700” to “200” to better reflect this fluctuation thus reducing the hour burden estimate to 2,800.

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

The OAT data web application that grantees access was migrated into HRSA’s EHB immediately following OMB’s initial approval of this information collection request.

A HRSA contractor currently provides support both for the Web application system and technical assistance to grantees as they complete and submit their OAT data reporting requirements.

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

The expiration date will be displayed.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

1 GPRA is a law that passed in 1993 which requires that federally funded agencies develop and implement an accountability system based on performance measurement including setting goals and objectives and measuring progress toward achieving them.

2 The EHB allows business processes such as grants management to be broken down into discrete role-based handbooks. The EHB contains electronic forms which can be used in real-time.

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