STAR HIE NOFO FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology (ONC)

Notice of Funding Opportunity

Strengthening the Technical Advancement & Readiness of Public Health via Health Information Exchange Program

(The STAR HIE Program)

Application Due Date: 09/01/2020

Anticipated Award Date: 09/30/2020

Table of Contents

Executive Summary

A. Program Description/Purpose Background

Purpose Program Approach Program Activities

Milestones and Performance Activities

B. Funding Opportunity Award Information Key Award Parameters Key Dates Roles and Responsibilities Under a Cooperative Agreement Informational Session Letter of Intent

C. Eligibility Criteria

D. Application and Submission Information Application Package Application Submission Instructions Restrictions on Oral Conversations

E. Application Review Information Screening Review Merit Review Pre-Award Risk Assessment

F. Federal Award Administration Information Award Decisions Notice of Award Terms and Conditions

G. Points of Contact

Appendix A – Tips for Writing a Strong Application Appendix B – Instructions – SF-424, Application for Federal Assistance Appendix C – Instructions – SF-424A, Budget Information for Non-Construction Programs Appendix D – Budget Narrative/Justification Template Appendix E – Letter of Commitment Template

Executive Summary

This Notice of Funding Opportunity (NOFO) is designed to strengthen and accelerate innovative uses of health information via health information exchanges (HIEs) within states, communities, and regions to support public health agencies’ abilities to advance data-driven prevention of, response to, and recovery from public health events, including disasters and pandemics such as Coronavirus Disease 2019 (COVID-19). Funding will be focused toward strengthening existing HIE infrastructure so that public health agencies are able to better access, share, and use health information.

This competitive NOFO is limited to only United States-based health information exchange (HIE) entities. This includes non-profit HIEs or for-profit HIEs. However, under 45 C.F.R. 75.216(b), no HHS funds may be paid as profit to any recipient even if the recipient is a commercial organization. The Office of the National Coordinator for Health Information Technology (ONC) anticipates that up to five

(5) awards will be made in the form of cooperative agreements. The number of awards could change based on additional availability of funds. The cooperative agreement will focus on improving HIE services in support of public health. The total funding available under this NOFO is $2,500,000.

Applications will be approved for up to a two-year (2) period of performance.

Entities may enter into multi-organizational and/or regional agreements to apply to this NOFO.

However, one singular entity must be the applicant; act as the responsible agent; submit the application on behalf of all partners, who must provide written documentation affirming the applicant’s role as their agent; and maintain accountability for the proper use of federal funds. ONC hopes to distribute funding throughout the country. ONC does not intend to award duplicative service areas.

A. Program Description/Purpose of the Funding Opportunity

Background

The U.S. Department of Health and Human Services (HHS) is committed to advancing the secure, interoperable exchange of health information which is critical to enhancing the health and well-being of all Americans.

In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. No.

116-136, March 27, 2020) was enacted. The CARES Act responds to the COVID-19 (i.e., coronavirus disease 2019) outbreak and its impact on the economy, public health, state and local governments, individuals, and businesses. The cooperative agreements under this notice of funding opportunity will be funded through funding from the CARES Act.

The Office of the National Coordinator for Health Information Technology (ONC) is the principal Federal entity charged with the coordination of nationwide efforts to implement and use the most advanced health IT and the electronic exchange of health information. ONC has two primary objectives

1) advance the development and use of health IT capabilities and 2) establish transparent expectations for data sharing. These two objectives work to successfully connect health care and health data through interoperable health IT.

Purpose

This NOFO provides an opportunity to strengthen and expand the ability of health information exchanges (HIEs) to support public health agencies in communities and states. There is a clear need for new data and new approaches for public health programs, including approaches made possible by modern computing. For example, case investigation and contact tracing can be augmented by new data and new approaches to better identify the sources of a disease and help prevent additional outbreaks.

Pandemics like Coronavirus Disease 2019 (COVID-19) stress our information infrastructure and can be best addressed when there are efficient modes to make information available where and when it is needed most. A key challenge that has emerged with the current COVID-19 response is around public health agencies’ access to clinical data (e.g., information on comorbidities, hospital admission/discharge, and/or detailed treatment information) and demographic information on patients who have tested positive for the disease.

The extensive amount of clinical data held by HIEs is often not accessible by public health agencies nor are the insights HIEs can provide regarding trends and a community’s longitudinal health. Better aligning HIEs with public health agencies can bring more and better data to bear on public health events, including the COVID-19 pandemic. Specifically, the rich data held by HIEs can support better knowledge generation around the epidemiology of diseases like COVID-19. For example, HIEs can support answering such questions as:

• What are reinfection rates for COVID-19 within the community?

• What is the average time between a positive COVID-19 test until a negative COVID-19 test?

• What is the average time between a positive COVID-19 test until tested immunity?

• How do various patient characteristics correlate with COVID-19, including race, sex, ethnicity, and comorbidities?

This program seeks to respond to the needs facing public health agencies by leveraging the unique abilities and characteristics of HIEs. These include, for example, the following:

• HIEs serve as hubs for rich data from a multitude of sources.

• HIEs are often state, local, or regional entities, with a strong understanding of and experience with local health care environments, including policies dictating data use for public health agencies.

• HIEs facilitate competition within the healthcare system by acting as trusted third parties who work with otherwise competitive healthcare entities.

• HIEs either actively support public health agencies or have the ability to do so (e.g., activities such as supporting public health reporting, improving data quality, and other data services).

• Currently, there are approximately 100 HIE organizations in the United States.1 HIEs cover about 99% of the U.S. population, according to the national trade association of HIEs.2

This program will build upon previous and existing Federal investments in HIEs. It also will leverage work done by the industry to advance HIE services for the benefit of public health. The result of this would be improved linkages between public health agencies and the services that health information

1 Adler-Milstein, Julia; Sunny C. Lin; and Ashish K. Jha. “The Number Of Health Information Exchange Efforts Is Declining, Leaving The Viability Of Broad Clinical Data Exchange Uncertain.” Health Affairs 2016 35:7, 1278-1285. Retrieved from https://www.healthaffairs.org/action/showCitFormats?doi=10.1377%2Fhlthaff.2015.1439 on June 16, 2020.

2 Kendrick, David. “Health Information Exchange Organization impact.” January 28, 2020. Presentation at ONC 2020 Annual Meeting.

https://www.healthit.gov/sites/default/files/page/2020-02/DavidKendrickSHIEC.pdf. Retrieved on June 16, 2020.

https://www.healthaffairs.org/action/showCitFormats?doi=10.1377%2Fhlthaff.2015.1439 https://www.healthit.gov/sites/default/files/page/2020-02/DavidKendrickSHIEC.pdf exchanges are well situated to provide. These services include, but are not limited to, establishing or updating:

• Services that benefit public health registries,

• Connectivity services that benefit a public health agency, and/or

• Data services that benefit a public health agency.

The program has the following objectives:

1. Build innovative health information exchange services that benefit public health agencies.

Applicants must propose activities that would benefit public health agencies. This requirement is included in the NOFO because of the unique opportunity that HIEs present with regard to supporting public health agencies. The outcome of achieving this objective will be that public health agencies are more capable of responding to public health events, including pandemics such as COVID-19

2. Improve the health information exchange services available to support communities disproportionately impacted by the COVID-19 pandemic.

Applicants must describe how they would deploy services or functionalities to enable, enhance, or increase the use of health information exchange among relevant entities, including providers who care for vulnerable or at-risk populations. Applicants must describe how their activities under the cooperative agreement address communities disproportionately impacted by the COVID-19 pandemic, including as it relates to the stratifying factors of age, race, ethnicity, disability and sex. The outcome of achieving this objective will be to increase public health understanding of how COVID-19 has disproportionately impacted various communities and increase the capability of public health agencies and the healthcare system respond to that impact.

Program Approach

ONC expects to fund five (5) cooperative agreement awards for up to a two-year period of performance.

The program will be funded at $2,500,000 with funding contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public. ONC plans to award these five awards in the amount of up to $500,000 each.

During the period of performance, year one will include planning, development, and rapid implementation. Year two will focus on continued implementation and expansion.

Program Activities

This NOFO seeks to strengthen the health information exchange services available to public health agencies. Applicants must propose activities that benefit a public health agency.3

3 For the purposes of this NOFO the term public health agency is specifically an agency or authority of the United States government, a State, a territory, a political subdivision of a State or territory, or Indian tribe that is responsible for public health matters as part of its official mandate. This definition is derived from the definition of public health authority as defined in 45 CFR 164.501. The definition of public health agency as used in this NOFO excludes contractors or persons or entities to whom the public health agency has granted authority.

Public health agencies are vital to support healthy and resilient communities. It is important that public health agencies have access to timely and accurate data in order to make decisions on how, when, and where to implement services in order to improve community health outcomes.

HIEs are uniquely capable of providing connectivity as well as providing various services that can improve the volume or quality of data transmitted to or on behalf of public health agencies. During times of a public health emergency, public health agencies are often stretched to capacity and having the support of community partners, such as HIEs, to share and improve appropriate access to or use of timely and accurate data is critical.

A core competency of HIEs is the ability to connect a wide range of health care entities, including public health information systems, to one another to support the appropriate sharing of health information.

ONC’s experience has shown that increasing connectivity has compounding beneficial effects, particularly when it is standards-based. This includes increased data for related, existing services, or even the creation of entirely novel services.

HIEs often function as data service providers, such as by enhancing data that is already available. HIEs perform such functions by leveraging their wide range of capabilities, which include such functions as identity management or provider directories. One particularly powerful aspect of HIEs is their ability to create a longitudinal record of a patient, and use that for enhancing treatment, care coordination, public health monitoring or enhancing quality of care.

All proposed activities are expected to take into account applicable law, including—for example— existing applicable public health, state, tribal, local, and/or territorial laws and policies.

The activities proposed within applications to this NOFO must include investments in health information technology (health IT). Health IT refers to the use of information and communication technologies in caring for patients, tracking diseases and protecting public health, conducting research, and improving the health of individuals and populations. For example, health IT would include software that enables a public health entity to properly match a patient to data in a system by comparing the initials, name, date of birth, or address to the name associated with the data. As another example, award recipients may buy or build the software systems required for connecting demographic information to a patient and identifying disparities within populations or cohorts. Along these lines, the cooperative agreement may also cover necessary testing and monitoring of technical capabilities to ensure ongoing successful implementation.

Applications may also include associated legal, policy, or governance activities. To be clear, these activities are not required. However, if they are proposed, these non-technical activities are expected to be in relation to and required for the successful implementation of providing technical services. For example, applicants may cover the costs of legal services required to design appropriate data use agreements, service-level agreements, or other applicable legal costs, if such agreements or legal costs are necessary for the technical service(s) being created. Along these lines, applicants may also propose ongoing monitoring costs to ensure compliance with the associated legal requirements of the proposed activities, if such costs are necessary to ensure the success of the technical service.

Applications may also include other related activities necessary for increasing public health interoperability. To be clear, these other related activities are not required. However, if such activities are proposed they are expected to be in relation to and required for the successful implementation of providing technical services. For example, proposals may include onboarding costs, workflow design and consultation, or change management activities for connected entities to successfully implement a technical service. There may be education, outreach, or marketing costs that would be necessary. Such education, outreach, or marketing must be necessary for the successful implementation of the technical service.

All applicants must include a letter of support or commitment from applicable state, tribal, local, or territorial (STLT) public health agency(ies). The letter should describe the public health agency(ies) level of involvement in the applicant’s proposed activities.

Applications should describe how the approach considers health IT standards and/or has conformance to health IT standards.4 Where there are standards for such services, applicants should be using them or proposing to improve or expand on them.

Examples of activities that benefit public health agencies include, but are not limited to:

1. Establishing or updating services that benefit public health registries. (The Promoting

Interoperability Public Health Task Force5 defines a public health registry “…as one that is administered by, or on behalf of, a local, state, territorial, or national public health agency and which collects data for public health purposes.”6)

a. Initiate activities that support increasing electronic reporting to public health registries, improving case investigation tasks, gathering data for situational awareness, and advancing other public health emergency preparedness and response functions.

b. Establish provider connectivity via HIEs to a public health registry (or data hubs) such as the Association of Public Health Laboratories (APHL) Informatics Messaging Services (AIMS) platform.

c. Improve provider access to state immunization information systems (IIS), such as for non-traditional vaccination providers (e.g., Emergency Medical Services (EMS), Long Term and Post Acute Care (LTPAC), others who may give adult immunizations), in anticipation of future mass vaccination efforts.

d. Support bidirectional exchange of immunization data, history of disease, vaccine forecast, including evidence of immunity to an Immunization Information System

(IIS).

e. Implement approaches which leverage existing federal investments (e.g., The Executive Office of Health and Human Services (HHS) Immunization Gateway via Association of Public Health Laboratories (APHL)).

2. Establishing or updating connectivity services that benefit a public health agency.

a. Facilitate exchange of electronic laboratory reporting of notifiable diseases to public health agencies.

4 For additional information on health IT standards, visit www.healthIT.gov and www.healthIT.gov/ISA.

5 The Public Health Promoting Interoperability Task Force is a collaboration between the Centers for Disease Control and Prevention (CDC), national non-profit public health associations, and public health practitioners from around the country.

6 Public Health Promoting Interoperability Task Force. “Public Health Agency Readiness for Promoting Interoperability Programs, 2019 Onward. Guidance and Recommendations.” Version 3.9 (Updated 7/25/2019) Retrieved from https://www.cdc.gov/ehrmeaningfuluse/docs/Promoting_Interoperability_Public_Health_Task_Force_Guidance-Version-3.9_508.pdf June 16, 2020.

http://www.healthit.gov/ http://www.healthit.gov/ISA https://www.cdc.gov/ehrmeaningfuluse/docs/Promoting_Interoperability_Public_Health_Task_Force_Guidance-Version-3.9_508.pdf

b. Support submission of electronic case reporting, in alignment with applicable standards/requirements. For example, this could include support for an electronic case reporting translation engine and related activities.

c. Support submission of syndromic surveillance data, in alignment with current public health standards/requirements.

d. Facilitate exchange of data to other public health registries (e.g., immunization, cancer registries, etc.).

e. Facilitate access to clinical records during disasters.

3. Establishing or updating data services that benefit a public health agency.

a. Advance services that enable public health agencies to enhance demographic information for patient lab results.

b. Create mechanisms to reduce or eliminate duplicative data flows for public health.

c. De-identification and/or anonymization solutions for public health.

d. Build individual data access services for public health systems. For example, a health information exchange may connect to an immunization information system (IIS) to allow individuals to query for their immunization data via an HIE patient portal.

e. Provide support for contract tracing and case investigation. For example, augment clinical information for public health agencies to improve timely COVID-19 case investigation capabilities.

f. Create dashboards in collaboration with public health agencies.

Milestones and Performance Activities Funding will be released pursuant to milestones established by each award. Upon successful completion of Milestones 0, 1 & 2 subsequent funding will then be released for Milestones 4, 5 and 6.

Recipients are expected to work with ONC to establish reporting mechanisms to track and monitor progress towards milestones (qualitative and quantitative). Recipients are also expected to work with ONC to refine performance activities throughout the period of performance where applicable. Where appropriate, there will be standardized milestones and activities to ensure comparability and tracking across recipients. However, there may also be customized performance activities, created in consultation with the recipient, to demonstrate progress toward and completion of the milestone. Example performance activities are described in the chart below.

Milestones

Milestone 0: Program Support and Engagement Funding This funding is provided upon award and may be used to meet initial programmatic needs to include the following :

• Travel to and from ONC meetings where applicable.

• Development of processes for ongoing program monitoring activities (bi-weekly calls with ONC, monthly reports, and quarterly and annual progress reports).

• Development of a draft Program Monitoring Plan that should reflect and be consistent with the project narrative and budget and should cover all years of the period of performance. The plan should identify important milestones and each major task or action step needed to reach those milestones. For each major task or action step, the work plan should identify timeframes involved, including start- and end-dates. Learning and collaboration efforts (participating in workgroups).

• Identifying and documenting of initial challenges and bright spots.

• Establishing evaluation processes.

• Establishing financial and programmatic reporting requirements.

• Establish reporting mechanisms to track and monitor progress towards outcomes

(qualitative and quantitative).

• Developing resources to conduct initial outreach, education, and/or implementation.

• Within six (6) months of receiving the Notice of Grant Award (NGA), recipients must submit to ONC a Memorandum of Understanding (MOU), Memorandum of Agreement (MOA), or Notarized Agreement from the STLT public health agency(ies) and/or emergency management agency(ies) (e.g., public health preparedness program), that are necessary for achieving the goals of program. The initiation of work on this MOU/MOA is expected to begin under Milestone 0.

Milestone 1. Completed Final Program Monitoring Plan Within three (3) months of receiving the Notice of Grant Award (NGA), recipients are expected to complete a Final Program Monitoring Plan.

The Final Program Monitoring Plan should reflect and be consistent with the project narrative and budget and should cover all years of the period of performance. The plan should identify milestones and each major task or action step needed to reach those milestones. For each major task or action step, the plan should identify timeframes involved, including start and end dates.

If a technical solution build out is required for the activities under the proposal, then the plan is expected to include, but not be limited to, a timeline and testing plan. Additional system testing processes and procedures may also need to be included. The Final Program Monitoring Plan is expected to describe how the program will be deployed and managed, as well as the stakeholders involved.

Milestone 2. Documentation of Engagement with Public Health Agency/Authority (and Health Information Exchange(s))

Within six (6) months of receiving the Notice of Grant Award (NGA), recipients must submit to ONC a Memorandum of Understanding (MOU), Memorandum of Agreement (MOA), or Notarized Agreement from the STLT public health authority(ies)/agency(ies) that are necessary for achieving the goals of program. Note that the public entities described here may be broader than strictly governmental agencies. ONC and recipients will work collaboratively on defining the appropriate agency(ies)/authority(ies) for which documentation of engagement is required.

This documentation ensures that recipients are actively and adequately engaging appropriate public health officials on all efforts throughout the period of performance. Specifically, this means that if proposed functionality requires a technical interface with a public health agency, then the MOU (or MOA or Notarized Agreement) must describe the shared understanding that such a technical interface will be created within the period of performance.

Milestone 3. Implementation Experience Collaboration

The purpose of this milestone is to create mechanisms to ensure that recipients are successful.

ONC’s experience with similar programs has shown that recipients gain significant benefit from networking, experience/information sharing, and/or collaborating with other recipients via in-person or virtual events and activities. This has also included through such activities as communities of practice, specific group meetings, and other cross-recipient collaboration opportunities. ONC will require recipient participation in such collaboration activities and seek technical assistance support via their external consulting networks. Such activities may occur at the ONC Annual Meeting or similar federal meetings. ONC believes that participation in such activities will be helpful for recipients at all steps within the period of performance.

Milestone 4. Achievement of Primary Performance Activity (e.g., “Go Live”) This milestone will demarcate, for the purposes of effective cooperative agreement collaboration, the initial creation of new HIE services. In most cases, this will be the first live data exchange enabled by the program (often called “Go Live”). However, the primary performance goal may be customized in consultation with the recipient and depending on the proposed activities. For example, if the recipient seeks to create mechanism to reduce or eliminate duplicative data flows, the successful achievement of the primary performance goal may be to turn off a data exchange activity.

The activities to achieve this milestone will include all potential work described in the Performance Activities section above. The activities for this milestone will commence upon successful completion of Milestone 1 and Milestone 2. Recipients will then be expected to report on the major tasks and action steps within the Program Monitoring plan as a means of demonstrating progress toward the achievement of the milestone. Activities within this milestone could include testing and potentially pilots, provided they provide a path to production.

These major tasks and action steps will be devised in keeping with project management best practices. Furthermore, agile development processes and robust approaches (e.g., test-driven development) are strongly encouraged.

ONC seeks to ensure nationwide improvement of data quality for public health purposes.

Therefore, where applicable, we encourage recipients to consider using the ONC C-CDA Scorecard to demonstrate baseline measurements of data quality and to improve C-CDA content quality. Improved data quality should support enhanced ability to run longitudinal assessments, population stratification and other services that correspond to ensuring providers can more readily find solutions during a public health event, including COVID-19.

Milestone 5. Operations and Maintenance This milestone ensures that after an entity (e.g., a provider or laboratory) has subscribed or enrolled for services under this program, actual exchange of health information is continuously enabled and actively used.

This Milestone will include activities to expand the volume or quality of connections or service offerings. For example, it would include deployment of marketing materials to facilitate customer interest or improvements to onboarding processes. This includes ongoing stakeholder outreach efforts. It would also include technical and policy monitoring of connections, and optimization activities requiring technical or policy refinements.

Milestone 6. Completed Sustainability Plan ONC expects recipients complete a sustainability plan to ensure the ongoing success and replicability of efforts to strengthen and expand the ability of HIEs to support public health agencies. Recipients are encouraged to consult with partners/stakeholders in the development of the plan.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Strengthening the Technical Advancement and Readiness of Public Health via Health Information Exchange Program (STAR HIE Program)

Federal Funding Agency: Department of Health and Human Services (HHS)

The Office of the National Coordinator for Health Information Technology (ONC)

Announcement Type: Cooperative Agreement

Application Type: New

Funding Opportunity Number: COVID-C3-20-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.462

Eligible Applicants: This is a limited competition. It is limited to United States-based health information exchange (HIE) entities. This includes non-profit HIEs or for-profit HIEs. However, under 45 C.F.R.

75.216(b), no HHS funds may be paid as profit to any recipient even if the recipient is a commercial organization. Entities may enter into multi-organizational and/or regional agreements to apply to this

NOFO.

Legislative Authority: Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. No.

116-136, March 27, 2020), and Section 3011 of the Public Health Service Act

(PHSA).

Approximate Amount of Available Funding (inclusive of direct and indirect costs) : $2,500,000

Anticipated Number of Awards: 5

Approximate Amount of Each Award: $500,000

Project Period: 09/30/2020 to 09/30/2022

Budget Period: 09/30/2020 to 09/30/2022

Funding of future non-competing continuation awards is conditioned on the availability of funds, satisfactory progress by the recipient, and an awarding office determination that continued funding of the award is in the best interests of the Government.

ONC reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selections for awards are expected to be made no later than 12 months after the original selection decision. ONC hopes to distribute funding throughout the country. ONC does not intend to award duplicative service areas.

The two-year cooperative agreements created by this award will be made to HIE entities.

Cost-Sharing Requirements: There are no cost sharing requirements associated with this award.

Program Income: There are four potential ways in which ONC may require that a recipient apply program income as specified in the Notice of Grant Award (NGA):

1) deduct it from total allowable costs to determine the net allowable costs on which the Federal share of costs is based;

2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget;

3) use it to meet a matching or cost sharing requirement; or

4) a combination of these alternatives.

If program income is generated, ONC recipients must us the additive method. Costs paid by program income generally are subject to the applicable cost principles and other Federal requirements and must be disbursed for project purposes before requesting additional payments of Federal funds. In the event program income remains at the end of the award, the additional income is considered part of the award funding and must be returned to ONC.

Intergovernmental Review:

Applications for this Cooperative Agreement are not subject to review by states under Executive Order 12372, “Intergovernmental Review of Federal Programs” (45 CFR 100). Please check box “C” on item 19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does not apply to this Cooperative Agreement.

ONC’s Match Requirement: There are no match requirements for this program.

Intergovernmental Review:

Applications for this Cooperative Agreement are not subject to review by states under Executive Order 12372, “Intergovernmental Review of Federal Programs” (45 CFR 100). Please check box “C” on item 19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does not apply to this Cooperative Agreement.

Key Dates

Milestone Date NOFO Released

08/12/2020

Informational Session

08/19/2020

Notice of Intent Due

08/21/2020

Applications Due

09/01/2020

Anticipated Award Date

09/30/2020

Anticipated Project Start Date

09/30/2020

Roles and Responsibilities Under a Cooperative Agreement

The funding instrument used for this program will be a Cooperative Agreement, an assistance mechanism, in which substantial ONC programmatic involvement is anticipated during the project period. Under the Cooperative Agreement, the ONC purpose is to support and stimulate the recipient’s activities by involvement in, and otherwise working jointly with, each recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this premise, the dominant role and prime responsibility resides with the recipient for the project as a whole.

For example, ONC expects to provide limited technical assistance in support of recipient activities. To facilitate appropriate involvement, during the period of this Cooperative Agreement, ONC and the recipient will be in contact at least monthly and more frequently when appropriate.

Specific tasks and activities that may be shared between the recipient and ONC include, but are not limited to:

• Participating in the selection of key personnel;

• Releasing funds based on achievement of performance activities/project milestones;

• Agency review and approval of substantive provisions of proposed sub awards or contracts;

• Recipients are also expected to work with ONC to refine performance activities throughout the period of performance where applicable;

• Selecting meeting/panel members;

• Participating in communities of practice;

• Providing tactical guidance and feedback during project execution;

• Engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement;

• Ending an activity if performance specifications are not met;

• Technical Assistance – this includes federal guidance on the evolution of interoperability and exchange in accordance with current and future ONC regulatory efforts, the ONC HIT Certification Program, 21st Century Cures Act, Federal Health IT Strategic Plan, Trusted Exchange Framework and Common Agreement, or other programs established by the Secretary;

• Monitoring – ONC Project Officers in conjunction with the ONC Procurement and Grants Division will monitor, on a regular basis, progress of each recipient. This monitoring may be by phone, document review, on-site visit, other meeting and by other appropriate means, such as reviewing program progress reports and Federal Financial Reports (FFR 425);

• Coordination – To facilitate compliance with the terms of the cooperative agreement and to more effectively support recipients , ONC will actively coordinate with critical stakeholders. Release of Funds Approval – ONC Project Officers will be responsible for requesting authorization for the release of funds for their assigned projects;

• Monitoring & Evaluation – ONC Project Officers in conjunction with the ONC Procurement and Grants Division and the Technical Strategy and Analysis Division will monitor, on a regular basis, progress of each recipient. This monitoring may be by phone, document review, on-site visit, and by other appropriate means, such as reviewing program progress reports.

• As part of the cooperative agreement, recipient attendance is required, as applicable, at ONC Annual Meetings, workshops, and public webinars.

Informational Session

ONC will conduct an informational session, via a webinar, to:

• Discuss the background, purpose, scope, terms and conditions and other provisions in the NOFO

• Explain the eligibility and application requirements

• Describe the application review process

• Provide an opportunity for interested parties to ask questions

Further details about the informational session – including the date, time, and instructions for joining – are available at https://www.zoomgov.com/webinar/register/WN__kvUMUWlSJuHJQI-oEFllg.

To ensure that ONC addresses all comments and questions regarding this announcement during the information session, please submit any comments and questions, via email, to STARHIENOFO@hhs.gov no later than three days prior to the call.

Notice of Intent

Although not required, applicants are strongly encouraged to submit a non-binding e-mail notice of intent to apply for this funding opportunity. This notice of intent will assist ONC in planning for the application review process.

The notice of intent is requested by 11:59 P.M. Eastern Standard Time on August 21, 2020 and should be sent to STARHIENOFO@hhs.gov. The notice should identify the name of the applicant organization, the city and state in which the applicant organization is located, and the Notice of Funding Opportunity title and number.

C. Eligibility Criteria

The funding opportunity is a limited competition. It is limited to U.S.-based HIE entities. This includes non-profit or for-profit HIE entities. However, recipients are not able to make a profit on activities funded by the cooperative agreement per federal requirements.

https://www.zoomgov.com/webinar/register/WN__kvUMUWlSJuHJQI-oEFllg

Applicants must provide an attestation that the applicant is a Health Information Exchange or Health Information Network as defined in 45 CFR171.102.7

Entities may enter into multi-organizational and/or regional agreements to apply to this NOFO.

However, one singular entity must be the applicant; act as the responsible agent; submit the application on behalf of all entities involved, who must provide written documentation affirming the applicant’s role as their agent; and maintain accountability for the proper use of federal funds.

D. Application and Submission Information

Application Package

The following documents comprise, as applicable, the application package. Additional information regarding each of these documents is further provided.

• Project Abstract

• Project Narrative

• Form SF-424, Application for Federal Assistance

• Form SF-424A, Budget Information for Non-Construction Programs

• Form SF-424B, Assurances for Non-Construction Programs

• Form SF-LLL, Disclosure of Lobbying Activities

• Budget Narrative

• Letters of Support or Commitment

• Indirect Cost Agreement(s) – including recipient, sub-recipient, and contractors agreements (if applicable)

Appendix A, Tips for Writing a Strong Application, can be used as a resource.

The Project Narrative and Budget Narrative sections of the application must be double-spaced, on 8-1/2” X 11” plain white paper with 1” margins on all sides, and use either Cambria or Times New Roman font size of not less than 11 point. Smaller font sizes may be used to fill in the Standard Forms, exhibits, and figures, though all text in forms, exhibits, and figures must not be smaller than 8 point font.

Project Abstract

Recipients shall include a one-page abstract that is no more than 500 words. This abstract is often distributed to the public and Congress and represents a high-level summary of the project. As a result, applicant should prepare a clear, accurate, concise abstract that can be understood without reference to

7 The definition of Health Information Exchange or Health Information Network as defined in 45 CFR171.102 is as follows:

Health information network or health information exchange means an individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information:

(1) Among more than two unaffiliated individuals or entities (other than the individual or entity to which this definition might apply) that are enabled to exchange with each other; and

(2) That is for a treatment, payment, or health care operations purpose, as such terms are defined in 45 CFR 164.501 regardless of whether such individuals or entities are subject to the requirements of 45 CFR parts 160 and 164.

other parts of the application and that provides a description of the proposed project, including: the project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.

The applicant shall place the following information at the top of the Project Abstract (this information is not included in the 500 word maximum):

• Project Title

• Applicant Name

• Physical Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable.

Project Narrative

The project narrative provides the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative must address the elements articulated in the Program Description/Purpose sections of this NOFO. The project narrative must also factor in and align with the Performance activities/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (e.g. organizational experience, past performance, etc.).

Successful applications are expected to provide a complete description and justification of how the applicant will use funds based on the following objectives:

• Build innovative health information exchange services that benefit public health agencies..

Improve the health information exchange services available to support communities disproportionately impacted by the COVID-19 pandemic.

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a Times New Roman or Cambria font size of not less than 11 point. The maximum length allowed for the Project Narrative is [25] pages. A Project Narrative that exceeds the [25] page limit will not be reviewed past the requested number of pages. Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the [25] page limit.

The project narrative must follow the outline provided below and include the information required under each section. These components will be counted as part of the page limit. The suggested lengths of the sections, given below, are guidelines to help recipients create a balanced document, and not mandatory restrictions.

• Section 1: Purpose and Impact – 1 page

• Section 2: Approach, Work Plan, and Program Activities – 10 pages

• Section 3: Organizational and Technical Capabilities – 4 pages

• Section 4: Collaborator Involvement and Partnerships – 5 pages

• Section 5: Budget, Level of Effort, and Justification – 4 pages

• Section 6: Sustainability and/or Replicability of Proposed Project – 1 page

Section 1: Purpose and Impact This section must demonstrate an understanding of health information exchange and public health data needs, requirements, and capacities.

It must reflect requirements in Section A of the NOFO, “Program Description/Purpose of the Funding Opportunity,” particularly the sections “Background” and “Purpose.”

This section must set out an important, coherent, issue or set of issues related to the project’s purpose, and an overall approach and strategy for how to address the issue or issues. This section must also include:

• A discussion and understanding of the project theme along with an explanation of why the project theme is a priority for HIE infrastructure and a public health agency(ies). Clearly identify the problem and how the proposed solution will solve the problem.

• A description of the specific geographic area and populations targeted by this project and the impact that it will have, including the estimated number of target participants or the populations they serve (e.g., providers, individuals, labs, and other stakeholders). This description must describe specific vulnerable or at-risk populations, particularly those communities disproportionately impacted by the COVID-19 pandemic.

Section 2: Approach, Work Plan, and Program Activities This section must set out the approach, work plan, and program activities. It must reflect requirements in Section A of the NOFO, “Program Description/Purpose of the Funding Opportunity,” particularly the sections “Program Activities” and “Milestones and Performance activities.”

This section must demonstrate the applicant’s ability to bring together all resources, including leveraging others existing infrastructure and capabilities required to perform the proposed work within a two-year time frame.

This section must also include:

• A clear description of the project approach and activities and how they will provides a solution to addressing a particular problem in line with the NOFO’s purpose.

o Applications must specify how proposed work addresses the requirements of the “Program Activities” section of this NOFO. Applications should specify those aspects of the “Program Activities” section that are encouraged.

• The project description must describe the technical activities required to achieve a successful project. Where applicable, it must also describe the policy and legal activities, and other related necessary activities (e.g., education, outreach, etc.)

o This could also include governance activities that will support the applicants planned efforts.

• Description of how the proposal considers health IT standards and/or has conformance to health IT standards. Where there are standards for such services, applicants should be using them or proposing to improve or expand on them.

• Description of the infrastructure/technology is “live” or in the real world and used by other participants, and will be employed in this project.

• A program work plan that reflects and is consistent with the budget and sustainability plan, covering all years of the program period.

o The work plan should identify important milestones and each major task or action step needed to reach those milestones. It should identify timeframes involved, including start and end dates for each major task or action step.

o The work plan should explain the timeline in a way that fully demonstrates the project’s feasibility and includes clear benchmarks and performance metrics to achieve the program goals.

o The work plan should reflect and be consistent with the entire project narrative, the budget, and covers the entire period of performance.

• Description of how the project will coordinate with, not duplicate, but build upon existing efforts. Description of how the project will leverage existing federal investments.

• A clear delineation of the roles and responsibilities of project staff, consultants and collaborating organizations. This would specify who would have day-to-day responsibility for key tasks such as:

o Leadership of the project.

o Project monitoring of tasks.

o Technical and policy work.

o Conducting outreach efforts for: recruitment, education, enrollment/onboarding, technical assistance provision, etc.

• Approach to project management that is focused on data collection and reporting.

• Demonstrate the types of reporting or tracking mechanisms that exist or will be developed to report on project progress and outcomes for sharing with ONC and other appropriate stakeholders.

Section 3: Organizational and Technical Capabilities This section must clearly demonstrate that the organizational and personnel capabilities of the applicant support its ability to implement the project. This section must include:

• The organization’s overall capabilities relevant to the proposed project(s).

o Description of current policies that demonstrate strong understanding of and experience with state, tribal, local, and/or territorial healthcare environments, including policies dictating data use for public health.

o Description of how the entity currently connects disparate health care entities in a way that could benefit the project (e.g., serve as a neutral, trusted third party between competitive entities).

• Technical Capabilities o The health IT standards currently being used by the applicant.

o Description of what infrastructure/technology it currently has “live” and can be leveraged for the project.

o Description of how the entity currently, actively supports STLT public health agencies or emergency management agencies.

o Description of the entity’s existing capabilities to provide longitudinal patient-level clinical information from a variety of sources.

• A description of qualified key staff, including:

o Leadership.

o A project manager.

o A staff person with grants/financial expertise.

o Staff with technical expertise and experience, including relevant standards knowledge and experience.

o Staff with legal expertise and experience, particularly around data sharing/use agreements and public health data use.

(Note that resumes may be included as attachments and will not count towards the page maximum for the project narrative.)

• The capabilities of the applicant not included in other portions of the project narrative, such as any current or previous relevant experience and/or the record of the project team in conducting the proposed activities.

• Where applicable, description of applicant’s experience and capabilities to create new modifications or upgrades to existing technical or policy infrastructure to accomplish programmatic goals.

Section 4: Collaborator Involvement, Partnerships, and Sub-recipients

• Description of the applicant’s experience and ability to successfully collaborate with partner organizations.

• Description of existing partnerships with all…