PKG00264934-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Office of Rural Health Policy Office for the Advancement of Telehealth

Evidence Based Telehealth Network Program

Funding Opportunity Number: HRSA-21-082 Funding Opportunity Type: New

Assistance Listings (CFDA) Number: 93.211

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date: April 2, 2021

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: January 12, 2021

Whitney Wiggins, MA Public Health Analyst, Office for the Advancement of Telehealth Telephone: (301) 443-4966 Email: wwiggins@hrsa.gov

Authority: 42 U.S.C. § 254c -14 (§ 330I of the Public Health Service Act) mailto:wwiggins@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2021 Evidence Based Telehealth Network Grant Program. The two-fold purpose of this program is (1) to demonstrate how health care systems can increase access to health care services utilizing Direct-to-Consumer (DTC) Telehealth technologies and (2) to conduct evaluations of those efforts to establish an evidence base for assessing the effectiveness of Direct-To-Patient Telehealth care for patients, providers, and payers.

Funding Opportunity Title: Evidence Based Telehealth Network

Program Funding Opportunity Number: HRSA-21-082 Due Date for Applications: April 2, 2021

Anticipated Total Annual Available FY 2021 Funding:

$4,900,000

Estimated Number and Type of Awards: Up to 14 cooperative agreements Estimated Award Amount: Up to $350,000 per year Cost Sharing/Match Required: No Period of Performance: September 01, 2021 through August 31, 2026 (5 years) Eligible Applicants: Eligible applicants shall be domestic public or private, non-profit or for-profit entities with demonstrated experience utilizing telehealth technologies to serve rural underserved populations. This includes faith-based, community-based organizations, and federally-recognized tribes and tribal organizations.

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

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Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this NOFO to do otherwise.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Tuesday, February 2, 2021 Time: 3 - 4:30 p.m. EST Call-In Number: 1-888-790-2022 Participant Code: 7490880 Weblink: https://hrsa.connectsolutions.com/nofo_technical_assistance_call/ Playback Number: 1-800-835-3844 Passcode: 20221 https://www.govinfo.gov/content/pkg/GPO-STYLEMANUAL-2016/pdf/GPO-STYLEMANUAL-2016.pdf https://hrsa.connectsolutions.com/nofo_technical_assistance_call/

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AW ARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER

TRANSITION TO THE UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD

MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AW ARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX: COMMON DEFINITIONS

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Evidence Based Telehealth Network Program (EB THNP). The two-fold purpose of this award is (1) to demonstrate how health networks can increase access to health care services utilizing telehealth technologies and (2) to conduct evaluations of those efforts to establish an evidence base for assessing the effectiveness of telehealth care for patients, providers, and payers.

The implementation of telehealth technology is rapidly expanding into health systems.1 HRSA defines telehealth as the use of electronic information and telecommunication technologies to support and promote long-distance clinical health care, patient and professional health-related education, public health and health administration.

Telehealth modalities that support clinical treatment may include video conferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications. Rising evidence supports that many health conditions can be addressed with a virtual in home visit from a doctor to his or her patient.2 In 2015, the American College of Physicians declared their position and support for Direct-to- Consumer (DTC) considering the patient has an established relationship with the providers, and the care meets in person standards of quality.3

For this NOFO, applicants must propose to provide DTC telehealth services to patients within established telehealth networks. This can be accomplished, in part, by identifying and partnering with local established health care facilities (especially primary care facilities) within the target service area, elevating the trusted patient-provider relationship, access, and quality of care directly to the patient via telehealth.

Also, this service will allow for the expansion of access to care in Medically Underserved Areas (MUA) and primary care or mental health defined Health Professional Shortage areas (HPSA). The EB THNP program presents the opportunity for network sites that are currently or have previously utilized telehealth as defined above to efficiently and effectively pilot and/or expand DTC telehealth care. Applicants for this EB THNP Program must utilize synchronous (real-time virtual visits) audio-visual technology and may include remote patient monitoring (RPM) to provide DTC telehealth care to patients (see Appendix). This EB THNP program will expand access to health services in three clinical primary focus areas: (1) Primary Care, (2) Acute Care, and (3) Behavioral Health Care (see Appendix). In addition, applicants have the option to address one of the following secondary focus areas: Maternal Care, Substance Use Disorder, or Chronic Care Management.

1 Elliott, T., & Yopes, M. C. (2019). Direct-to-consumer telemedicine. Journal of Allergy and Clinical Immunology.in Practice, 7(8), 2546-2552.

doi:http://dx.doi.org.ezproxyhhs.nihlibrary.nih.gov/10.1016/j.jaip.2019.06.027 2 Gough, Frances & Budhrani, Sunil & Cohn, Ellen & Dappen, Alan & Leenknecht, Cindy & Lewis, Bill & Mulligan, Deborah & Randall, Deborah & Rheuban, Karen & Roberts, Lisa & Shanahan, Terrance & Webster, Kathy & Krupinski, Elizabeth & Bashshur, Rashid & Bernard, Jordana. (2015). ATA Practice Guidelines for Live, On Demand Primary and Urgent Care. Telemedicine journal and e-health: the official journal of the American Telemedicine Association. 21. 10.1089/tmj.2015.0008.

3 Welch, B. M., Harvey, J., O'Connell, N. S., & McElligott, J. T. (2017). Patient preferences for direct-to-consumer telemedicine services: a nationwide survey. BMC health services research, 17(1), 784. https://doi.org/10.1186/s12913-017-2744-8

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Changes to reimbursement policies related to in-home telehealth services and RPM in recent years, particularly in the Medicare program, have laid the framework to enable providers to feasibly integrate these technologies into their practices. For example, even prior to COVID-19, Medicare began to allow beneficiaries to receive telehealth services at home for a limited set of services/conditions including home dialysis and the treatment of a substance use disorder or a co-occurring mental health disorder.4 Home health is also an example of how the Medicare program has expanded the ability of home health agencies (HHAs) to use RPM technologies to augment the health care of the patients they serve. Recently, Medicare explicitly allowed HHAs to provide RPM services to their patients to help foster the adoption of emerging technologies by HHAs and result in more effective care planning.5,6 Such approaches, to the extent that they strengthen rather than supplant existing patterns and systems of care, reinforce the objectives of this funding opportunity. Namely, a key objective of this program is to demonstrate how providers can use DTC telehealth services in a way that enhances the existing health care infrastructure, as opposed to incentivizing care delivery that circumvents and disadvantages providers in local communities, including rural areas.

Applicants are encouraged to include populations that have historically suffered from poorer health outcomes, health disparities, and other inequities, as compared to the rest of the rural population, when addressing health care needs via telehealth. Examples of these populations include, but are not limited to, racial and ethnic minorities, person/persons experiencing homelessness, pregnant women, disabled individuals, youth and adolescents, etc.

2. Background

This program is authorized by Section 330I(d)(1) of the Public Health Service Act (42 USC §254c-14(d)(1)).

The Federal Office of Rural Health Policy (FORHP) is the focal point for rural health activities within Health and Human Services (HHS). The Office for the Advancement of Telehealth (OAT) is located within HRSA and supports a wide range of telehealth activities, including the EB THNP program.

Rural communities continue to face an increase in disparities for health outcomes compared to their urban counterparts. Often, rural communities are host to “health deserts” with high percentage of deaths from heart disease, stroke, and chronic lower respiratory disease. Moreover, over 6 million individuals suffer from mental health conditions.7 Telehealth can have several benefits in rural communities. For patients who

4 Center for Connected Health Policy. (January 2020). Billing for Telehealth Encounters, https://www.cchpca.org/sites/default/files/2020- 01/Billing%20Guide%20for%20Telehealth%20Encounters_FINAL.pdf 5 Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations, Final Rule with Comment Period. 83 Federal Register 56406. (2018, November 13). https://www.federalregister.gov/documents/2018/11/13/2018-24145/medicare-and-medicaid-programs-cy-2019-home-health-prospective-payment-system-rate-update-and-cy 6 Centers for Medicare & Medicaid Services. (2018, October 31). CMS Takes Action to Modernize Medicare Home Health.

https://www.cms.gov/newsroom/press-releases/cms-takes-action-modernize-medicare-home-health-0 7 Baird M. & Larson D. (2020, February 7) Telehealth’s untapped potential in rural America, Medical Economics.

https://www.medicaleconomics.com/view/telehealths-untapped-potential-rural-america https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center https://www.federalregister.gov/documents/2020/11/04/2020-24146/medicare-and-medicaid-programs-cy-2021-home-health-prospective-payment-system-rate-update-home https://www.medicaleconomics.com/view/telehealths-untapped-potential-rural-america

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reside in these communities, having increased access to virtual visits can reduce the distance traveled and time required to receive care, increase access to health care specialist, and increase privacy and confidentiality especially for patients overcoming stigma surrounding certain medical conditions.8

The recent Public Health Emergency revealed that DTC telehealth is a way to leverage value-based care for patients.9 For example, Accountable Care Organizations (see Appendix) continued to proactively engage patients utilizing DTC to conduct annual wellness visits. In this case, the patients are protected, the elements of the comprehensive assessment are performed, and lastly the value of the conversation and the patient provider relationship is maintained.10

DTC telehealth ideally allows patients to receive care on their own time and in an accessible way. Therefore, in efforts to ensure continuity of care and further reduce telehealth inequities, community health workers should have an essential role in program navigation and implementation.11 These individuals build the networks capacity to address health issues by creating connections between vulnerable populations and healthcare providers and help patients navigate healthcare and social service systems.

The EB THNP program supports and encourages projects that address the needs of a wide range of population groups, including, but not limited to, low-income populations, the elderly, pregnant women, youth, adolescents, ethnic and racial minorities, homeless populations, and individuals with special health care needs. It is important to note that rural racial and ethnic minority populations face even greater challenges in terms of access to care and related health care challenges that are often overlooked. Recognizing that within ethnic minority populations have a lower rate of participation in telemedicine, applicants are encouraged to identify and bridge the gap between social determinants of health and other systemic issues that could contribute to achieving health equity with regards to participating in telehealth services.12

You must base your proposed project on established practices. Applicants are encouraged to work with your National and Regional Telehealth Resource Center to identify best or promising practices in effectively integrating your proposed project into your existing health care practice. Applicants are also encouraged to visit the HHS Telehealth website, to find resources and best practices for providers. In addition, applicants may visit the HRSA Training and Technical Assistance Hub website, which houses all HRSA training and technical assistance resources to extend the reach of our training and technical assistance resources and further the impact of HRSA award recipients and stakeholders. Resources are organized by topic and some resources may be listed under multiple topics.

8 Majerol M., Nadler J., Schulte A. (2019, November 27), Narrowing the rural urban health divide: bringing virtual health to rural communities, Deloitte https://www2.deloitte.com/us/en/insights/industry/public-sector/virtual-health-telemedicine-rural-areas.html 9 Baile et al, 2020 Confronting Rural America’s Health Care Crisis, https://bipartisanpolicy.org/report/confronting-rural-americas-health-care-crisis/ 10 https://caravanhealth.com/CaravanHealth/media/Resources-Page/Telehealth_AWV_AWV-033-20200406-APP.pdf 11 https://www.ruralhealthinfo.org/toolkits/community-health-workers/1/introduction 12 https://www.healthtechmagazines.com/telehealth-and-addressing-health-equity/ http://www.telehealthresourcecenter.org/ http://www.telehealth.hhs.gov/ http://www.telehealth.hhs.gov/ https://www.hrsa.gov/library/index.html https://www2.deloitte.com/us/en/insights/industry/public-sector/virtual-health-telemedicine-rural-areas.html https://bipartisanpolicy.org/report/confronting-rural-americas-health-care-crisis/ https://bipartisanpolicy.org/report/confronting-rural-americas-health-care-crisis/ https://caravanhealth.com/CaravanHealth/media/Resources-Page/Telehealth_AWV_AWV-033-20200406-APP.pdf https://www.ruralhealthinfo.org/toolkits/community-health-workers/1/introduction https://www.healthtechmagazines.com/telehealth-and-addressing-health-equity/

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Lastly, all award recipients will have the opportunity to work closely with technical assistance (TA) providers throughout the five-year period of performance. The targeted TA will assist award recipients with achieving desired project outcomes, sustainability and strategic planning, and will ensure alignment of the awarded project with the EB THNP Program goals. The TA is provided to award recipients at no additional cost. This support is an investment made by HRSA in order to ensure the success of the awarded projects. HRSA has found that most award recipients benefit greatly from the support provided through these collaborations. If funded, award recipients will learn more about the targeted technical assistance and evaluation support.

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a cooperative agreement. A cooperative agreement is a financial assistance mechanism where HRSA anticipates substantial involvement with the recipient during performance of the contemplated project.

HRSA program involvement will include:

• Reviewing and providing recommendations on the final work plan;

• Ongoing review of award activities and input on content or approach;

• Participating in conference calls or meetings with the award recipients;

• Supporting collaboration between the EB THNP program award recipients and the Telehealth-Focused Rural Health Research Center award recipient;

• Providing common measures that must be reported by all recipients;

• Reviewing products or publications before dissemination;

• Reviewing reimbursement requests for telehealth services that cannot be reimbursed by third party payers; and

• Reviewing and providing recommendations regarding additional uses of the telehealth beyond DTC services. This may include using related telehealth technologies for provider education, or to provide clinical services for patients, beyond the award’s primary focus of care.

The cooperative agreement recipient’s responsibilities will include:

• Adhering to HRSA guidelines pertaining to acknowledgement and disclaimer on all products produced by HRSA award funds, per Section 2.2 of the Application Guide (Acknowledgement of Federal Funding);

• Completing activities included in the final approved work plan, specifically data collection on measures identified by HRSA;

• Actively participating in efforts to contribute to the telehealth evidence- base;

• Participating in conference calls or meetings with HRSA and technical assistance provider;

• Networking with telehealth stakeholders;

• Engaging in webinars presented by TA providers (e.g., program best practices, sustainability, etc.);

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• Identifying professional opportunities to present, exhibit, or publish program findings that contribute to the telehealth evidence-base;

• Collaborating with HRSA in ongoing review of activities and budgets; and

• Responding timely to requests for information, including requests for data submissions, from HRSA or the Telehealth-Focused Rural Health Research Center award recipient (see Appendix).

2. Summary of Funding

HRSA estimates approximately $4,900,000 to be available annually to fund up to 14 recipients. You may apply for a ceiling amount of up to $350,000 total cost (includes both direct and indirect, facilities and administrative costs) per year. The period of performance is September 1, 2021 through August 31, 2026 (5 years). Funding beyond the first year is subject to the availability of appropriated funds for the EB THNP Program in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

The limitation on indirect cost rates is 15 percent (42 U.S.C. §254c-14(k)(7)).

III. ELIGIBILITY Information

1. Eligible Applicants

Eligible applicants shall be domestic public or private, non-profit or for-profit entities with demonstrated experience utilizing telehealth technologies to serve rural underserved populations. Faith-based, community-based organizations, and federally recognized tribes and tribal organizations are eligible to apply. Services must be provided to rural areas, although the applicant can be located in an urban area.

A. Geographic Requirements:

The applicant organization may be located in an urban or rural area. Applicants must include at least two distant sites located in rural areas and no more than two urban distant sites. HRSA encourages applicants in urban areas that choose to focus their program on providing primary care services, to collaborate with rural established providers as distant sites. For the purposes of this award, the originating site is the location of the patient at the time the service being furnished via a telecommunications system occurs. The originating site is required to be solely located in HRSA-defined rural areas in order to receive funds through this award. Urban originating site service areas are NOT eligible to receive funding through this award. Specifically, the applicant’s proposed service area must be located in a non-metropolitan county or in a rural census tract of a metropolitan county. All services must be provided in a non-metropolitan county or rural census tract. To ascertain rural eligibility, please refer to HRSA’s Rural Health Grants Eligibility Analyzer. This webpage allows you to search by county or street address and determine your rural eligibility.

https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/sequestration_reports/2017_data_act_section5_report.pdf?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://data.hrsa.gov/tools/rural-health?tab=Address

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In addition to the 50 states, only organizations in Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau are eligible. If you are located outside the 50 states, you must still meet eligibility requirements.

B. Composition of the Telehealth Network:

The telehealth network shall include at least three (3) of the following entities as distant sites (at least one of which shall be a community-based health care provider):

a. Community or migrant health centers or other Federally Qualified Health Centers.

b. Health care providers, including pharmacists, in private practice.

c. Entities operating clinics, including Rural Health Clinics

d. Local health departments.

e. Nonprofit hospitals, including Critical Access Hospitals.

f. Other publicly funded health or social service agencies.

g. Long-term care providers.

h. Providers of health care services in the home.

i. Providers of outpatient mental health services and entities operating outpatient mental health facilities.

j. Local or regional emergency health care providers.

k. Institutions of higher education.

l. Entities operating dental clinics.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that exceeds the ceiling amount non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

Multiple applications from an organization are not allowable. HRSA recognizes a growing trend towards greater consolidation within the rural health care industry and the possibility that multiple organizations with the same EIN and/or DUNS number could be located in different rural service areas that have a need for telehealth services. Please refer to Attachment 11 for information on how to request an exception to this policy.

HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

https://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center

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Current Evidence Based Tele-behavioral Health Network Program recipients are eligible to apply for funds through this notice for the FY 2021 cycle if the proposed project is a new proposal (entirely new project). If previously funded through the Evidence Based Tele-behavioral Health Network Program, then the new Evidence Based Telehealth Network Program proposed project should not supplant an existing program. The proposal should differ significantly from the previous projects by expanding the service area of the project to rural communities.

In order to apply, if the applicant organization has a history of receiving funds under the Evidence- Based Tele-behavioral Health Network Program award, they must propose a project that is different from the previously funded project and have at least two (2) new health care partners. Applicants must submit abstracts from the previous Evidence Based Tele-behavioral Health Network Program award in Attachment 10.

Each state has a State Office of Rural Health (SORH), and HRSA recommends making every effort to contact the SORH entity early in the application process to advise them of your intent to apply. The SORH may be able to provide consultation to you regarding model programs, data resources, and technical assistance for consortiums, evaluation, partner organizations, or support of information dissemination activities. An EB THNP applicant should make every effort to seek consultation from its State Office of Rural Health.

IV. APPLICATION and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for each NOFO you are reviewing or preparing in the workspace application package in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this NOFO.

https://www.fapiis.gov/ https://grants-portal.psc.gov/Welcome.aspx https://www.grants.gov/web/grants/applicants.html

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2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 Application Guide provides instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract. You must submit the information outlined in the Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files included in the page limit may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit.

Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-21-082, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3321).

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 13: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Temporary Reassignment of State and Local Personnel during a Public Health Emergency

Section 319(e) of the Public Health Service (PHS) Act provides the Secretary of the Department of Health and Human Services (HHS) with discretion upon request by a state or tribal organization to authorize the temporary reassignment of state, tribal, and https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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local personnel during a declared federal public health emergency. The temporary reassignment provision is applicable to state, tribal, and local public health department or agency personnel whose positions are funded, in full or part, under PHS programs and allows such personnel to immediately respond to the public health emergency in the affected jurisdiction. Funds provided under the award may be used to support personnel who are temporarily reassigned in accordance with § 319(e). Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness (ASPR) website via http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract

See Section 4.1.ix of HRSA’s SF-424 Application Guide.

ABSTRACT HEADING CONTENT

Applicant Organization Information Applicant organization name; Applicant organization address (street, city, county, state, ZIP code); Applicant organization website, if applicable;

Designated Project Director Project Director Name & Title, Contact Phone Number and E-Mail Address EB THNP Project Project Title Requested Award Amount for each project year (1-5)

ABSTRACT BODY CONTENT

Applicant Organization Facility Type (See Section III.1.B for examples ) Primary Focus Area (must select at least one) Primary Care, Acute Care, Behavioral Health Secondary Focus Area (optional) Maternal Care, Substance Use Disorder, Chronic Care Management

Target Service Area Briefly identify the geographic service area that the health care system and partners serve or will serve, including its size and population. Note how many full and partial HPSAs and full and partial MUAs the service area contains. Also, note any mental health and/or dental HPSAs. Note any other critical characteristics of the service area and its population.

Needs, Objectives, and Projected Outcomes Briefly describe the identified needs and expected demand for services, project objectives, and expected outcomes.

Clinical Services to be provided List proposed clinical services.

Actual Patients/Persons Served Specify the actual number of unduplicated patients/persons served throughout 2020 http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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(January 1 – December 31, 2020) at the distant sites proposed. Estimate (by distant site and year) the number of unduplicated patients/persons to receive DTC services at each distant site during the first year of the program and in subsequent years 2, 3, 4, and 5.

Self-Assessment Briefly describe how the applicant plans to measure their progress achieving the goals stated in their application.

Expected Outcome(s) Provide a brief description on the expected outcome(s) of the proposed services.

Sustainability Briefly describe activities to sustain the telehealth DTC services once federal funding ends.

Previous EB THNP Funding Indicate if you are a recipient of a current EB THNP award, and whether you serve/d as the applicant organization or a Originating Site; Indicate whether you have applied for an EB THNP award, and whether you applied as the applicant organization or an Originating Site.

How the applicant learned about funding (e.g., Telehealth Resource Centers, SORH, Grants.gov, HRSA news release, FORHP weekly announcements, etc.)

ii. Project Narrative

This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and well-organized so that reviewers can understand the proposed project.

Successful applications will contain the information below. Please use the following section headers for the narrative:

INTRODUCTION -- Corresponds to Section V’s Review Criterion(a) #1 (Need)

Succinctly (1-2 pages) describe the purpose of the proposed project. Include an overview of the telehealth network partners and collaborative plans for addressing the identified health care need in the rural communities in your proposed service area, including a list of the specific DTC telehealth services that will be offered.

You must include a data-driven estimate of the projected number of distant sites (including comparison sites) and unduplicated patients that will receive services and for whom data (including clinical and cost data) will be collected for research/evaluation purposes for each year of the period of performance.

Do not include information about network sites or patients who would not be active contributors or beneficiaries under this cooperative agreement. For example, if your health care system includes ten network sites but only eight distant sites will be actively participating/providing data in the proposed project, you should only discuss those eight distant sites in your application.

You are required to utilize HRSA’s Evidence Based Telehealth Network Program

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measures (also commonly referred to as Performance Improvement Measurement System (PIMS) measures) to help monitor your project progress. You are also required to utilize HRSA’s evaluation measures (to be identified upon award along with the Rural Telehealth-Focused Research Center) to collect evidence based data. In addition to the HRSA measures, applicants are encouraged to develop their own project specific measures that they can track throughout the period of performance.

Applicants should list the proposed project-specific measures and the projected impact in this section. Details about the proposed measures must be explained in the “Evaluation and Technical Support Capacity” section of the Project Narrative.

Please see the “Evaluation and Technical Support Capacity” section below for further instructions.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1 (Need)

This section outlines the needs of the community and/or organization. Describe and document the target population and its unmet health needs. Use and cite demographic data whenever possible to support the information provided. Discuss any relevant barriers in the service area that the project hopes to overcome. This section will help reviewers understand the community and/or organization that you will serve with the proposed project. Please use the following sub-headings (1) Target Population Details, (2) Target Area Details, (3) Stakeholder Involvement,

(4) DTC Evidence Base, (5) Community and Provider Need for DTC Services

Target Population Details A. Describe the target population. Consider disparities based on race, ethnicity, gender identity, sexual orientation, geography, socioeconomic status, disability status, primary language, health literacy, and other relevant elements. You should also consider people with disabilities; non- English speaking populations; minority populations; people with limited health literacy; or populations that may otherwise be overlooked when identifying target populations. The needs assessment should focus on telehealth needs in HRSA designated rural areas, including tribal entities.

B. Describe the associated unmet health needs of the target population of the proposed project (if funded, this is the population that you will monitor and track). Describe the entire population of the service area and its demographics in relation to the population you will serve. When possible, incorporate any national and/or local rankings data to aid in illustrating the community’s need. Cite data for factors that are relevant to the project, such as: specific national, state, and regional health status indicators and unmet health need (as it relates to your primary focus area); percentage of target population with health insurance coverage and estimated proportion of major payers within this population (e.g., any commercial health plan, Medicare, Medicaid, dual Medicare-Medicaid, CHIP, TRICARE, Indian Health Service, uninsured/self-pay, etc.); percentage of target population without health insurance coverage that is likely eligible for health insurance coverage; and percentage of target population living below the federal poverty line, etc. Also, include information regarding the

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social determinants of health and health disparities affecting the population or communities served

C. Within your proposed service area, identify and describe the presence of any racial and ethnic minority subpopulations. Explain how your project will meet the needs of these populations in terms of racial and ethnic health disparities and barriers (social, cultural, infrastructure etc.) that affect their health status. If your organization has not historically served the identified racial and ethnic minority subpopulations in your proposed service area, describe the vehicles, data points and/or partnerships needed to make the project successful. If your service area does not include any racial and ethnic minority subpopulations, describe your population demographics and any unique disparities they face.

Target Service Area Details

A. Identify the target service area(s) for the proposed project. Describe any relevant geographical features of the service area that affect access to health care services.

B. Describe the health care services available in or near the target service area and any gaps in services. Keep in mind that it is important for reviewers to understand the number and types of relevant health and social service providers that are located in and near the service area of the project as well as their relation to the project. How does the proposed project incorporate and leverage the current services in the community?

C. Describe the existing primary health care providers, home health agencies, or other health networks in the region that are serving the area that you are incorporating as a part of your proposed program. Detail how this project would foster or/and enhance collaboration.

D. Provide details how the project will not compete with other regional health care service providers (e.g., changes in referral patterns, practice patterns, provider reimbursement impact, etc.).

Direct-to-Consumer (DTC) Telehealth Evidence Base

A. Describe how the proposed DTC health services can contribute to or add to the existing evidence-base around the effectiveness of DTC telehealth as a modality of health care for patients, providers, and payers.

Specifically, briefly describe what you see as the gaps or weaknesses in the existing evidence-base for DTC health services.

B. Discuss how information collected in this program could be analyzed to address the identified gaps and impact the field of telehealth. The target population of the project must be sufficiently large to permit rigorous data analysis (e.g., projects should not propose limited services to small demographic groups or uncommon clinical conditions). Quantitative data must be used when describing the demand for DTC telehealth services (specifically as it relates to your selected primary focus: Primary Care, Acute Care, or Behavioral Health Care).

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Community and Provider Need for Direct-to-Consumer (DTC) Telehealth Services

Describe the community and provider needs for DTC telehealth services in your proposed rural service area. Present evidence of the significant demand for DTC care health services among patients and existing providers in the proposed service area, the challenges existing primary care and other clinicians are facing in offering DTC services, and how they will be able to do so through the collaboration of this project.

METHODOLOGY -- Corresponds to Section V’s Review Criterion(a) #2

(Response) and #4 (Impact)

Propose methods that you will use to address the stated needs and meet each of the previously described program requirements and expectations in this NOFO.

Include a description of any innovative methods that you will use to address the stated needs. Please address these headings (1) Goals and objectives, (2) Delivery of services and, (3) Sustainability.

Goals and Objectives Define the specific goals and objective. The stated goals and objectives should be measurable, align with the intent to the EB THNP program, and achievable within the period of performance.

Delivery of Services You must describe how DTC telehealth services will be delivered to the target population in the proposed project in a manner that permits rigorous analysis and data collection but also promotes increased access to care. Include a discussion of the following:

A. Based on the information provided in the “Needs Assessment” section, describe the DTC telehealth services that you will offer under this award and the technical means by which they will be delivered;

B. Please describe how the identified practice model is appropriate for your proposed project, and effective in meeting the rural target population’s need. Detail how the model will address the Health Professional Shortage and/or amplify effective care provided by existing health care providers in the targeted rural area;

C. Provide a clear explanation and justification of how proposed network partners (distant sites) were selected and build on existing patterns and systems of care for face-to-face services for this application and how they will collaborate with you to maximize the number of DTC patient encounters and individuals for whom data can be collected and analyzed in a statistically rigorous manner;

D. Provide a clear explanation and justification of how proposed comparison sites (see Appendix) were selected for this application and how they will collaborate with you to maximize the number of patient encounters and individuals for whom data can be collected and analyzed in a statistically rigorous manner;

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E. Describe how your EB THNP network sites will maintain rural commitment throughout the period of performance;

F. Describe the patient level data collection capabilities of the distant sites G. Discuss and demonstrate the willingness of the administrators, providers, and community members to deliver/receive DTC telehealth care using telehealth technology (if applicable, including RPM devices);

H. Discuss the telehealth reimbursement environment for DTC health care services and if Medicare, Medicaid, and/or private insurance in the applicant state(s) cover the proposed services. HRSA encourages applicants to reach out to the state Medicaid office and include any specific information received regarding reimbursement for project activities;

I. Describe the technology requirements and each type of equipment that will be employed along with its relevance to the project, how it contributes to cost-effective and quality care, and ease of use; and

J. Describe plans and activities to implement the technology with assurances that the technology complies with existing federal and industry standards, that the technologies are interoperable, and that the proposed technology can be easily integrated into health care practice.

Sustainability

A. Describe the methods by which you will sustain program activities beyond the period of performance; and

B. Describe some of the potential sources of support for achieving sustainability. Sources of support could include but are not limited to financial, in-kind, or the absorption of activities by your network.

WORK PLAN -- Corresponds to Section V’s Review Criterion(a) #2 (Response) and #4 (Impact)

Submit this section as Attachment 6. This section should describe the specific activities or steps that you will take to: (1) increase access to health care services via DTC in rural and frontier communities in a way that complements the existing prevailing patterns of care; (2) how local primary care practices and other local community providers were incorporated into the network and ensure that the project will not be bringing new primary care providers into the service region to offer DTC in a way that would supplant or put at risk the existing clinicians serving the area; (3) contribute to the evidence base assessing the effectiveness of DTC health care services for patients, providers, and payers; and (4) effectively manage the project. A work plan is an “action” guide with a time line used during program implementation; the work plan provides the “how to” steps. As appropriate, identify meaningful support and collaboration with key stakeholders in planning, designing, and implementing all activities, including developing the application. The timeline should include goals, objectives, and the following:

Increase Access to Health Care Services

A. Describe how telehealth care services will be implemented at the patients location (originating site) (e.g., scheduling, identifying potential patients, educating staff and providers on how to integrate telehealth services into existing workflows, etc.); and

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B. Provide a timeline with specific milestones for each network site.

Contribute to the Evidence Base

A. Provide a detailed explanation of how data will be collected from the originating sites (e.g., manual chart abstraction, extraction from electronic health records, etc.);

B. Provide an explanation of data quality control processes; and C. Provide an explanation of internal review board and/or data use agreement processes.

Project Management

A. Provide a detailed explanation of how your organization will actively manage this project to ensure that all aspects of the project (both care delivery and data collection) are proceeding effectively; and

B. Provide a detailed explanation of specific responsibilities for data management key personnel.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion

#4 (Impact)

This section should identify challenges that you may encounter in designing and implementing the activities described in your work plan and the approaches that you will use to resolve those challenges. These challenges may include those related to: (1) the provision and operation of DTC telehealth care services in conjunction with existing primary clinics, home health agencies, etc., or (2) the required data collection and cross-program evaluation and analysis. You should consider scenarios including:

A. Staff turnover and/or loss of telehealth champion(s) at your applicant site and distant sites;

B. Broadband and other infrastructural issues related to providing telehealth services directly to patient;

C. Addressing underutilization of DTC telehealth services in the proposed network and incorporating into local existing distant sites pattern of health care delivery;

D. Data collection throughout distant sites; and E. Need for technical assistance at the distant sites and patients location to optimize the provision of DTC telehealth care services.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criterion #3 (Evaluative Measures) and #5 (Resources/Capabilities)

Technical Support Capacity

A. This section should demonstrate your organization’s capability to collaborate (including data sharing) with the Telehealth-Focused Rural Health Research Center on across-award recipient program evaluation/analyses designed to contribute to the DTC telehealth care evidence base. HRSA will collaborate with the Telehealth-Focused Rural

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Health Research Center and award recipients to establish a full list of required measures at the beginning of the performance.

B. Describe how each distant sites will be supported, through financial and resources, to ensure quality data collection.

C. Include…