IHE NOFO FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Notice of Funding Opportunity (NOFO) Integrating the Healthcare Enterprise

(IHE) US Cooperative Agreement Program

Application Due Date: TBD

Anticipated Award Date: TBD

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach

B. Funding Opportunity Award Information Key Award Parameters Key Dates Roles and Responsibilities Under a Cooperative Agreement

C. Eligibility Information

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 Grant 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

The Office of the National Coordinator for Health Information Technology (ONC) intends to award a single source cooperative agreement to Integrating the Healthcare Enterprise (IHE) USA to complete the following:

• extend existing or develop new IHE Representational State Transfer(REST)ful based integration profiles;

• support real world testing of these integration profiles through IHE USA annual connect-a-thons, HL7 developer days and other related activities;

• coordinate and provide feedback to HL7 on challenges and lessons learned through the IHE USA profile development and testing process; and

• ensure the updated profiles and extension are available for public use by shepherding the profiles through the formal process to incorporate into the appropriate domain IHE Technical Framework.

This award will consist of a five-year period of performance. The anticipated first year performance/budget period will be XXXXX totaling $500,000. Future funding is subject to availability of funds.

The consistent implementation of established standards within health information technology (health IT) systems is necessary to achieve interoperability among health care providers and across many different use cases. In addition to establishing standardized ways to format and structure data to represent its meaning in an unambiguous computable ways, integrated transport and security mechanisms are critical to enable health care providers to reliably send, receive, find, and use patient data when and where it is needed. IHE profiles play an essential role in determining the transport standards used, as evident in separate publications from public-private partnerships such as CareQuality’s Query-Based Document Exchange Implementation Guide and not for profit trade associations such as the Commonwell Health Alliance’s CommonWell Health Alliance Services Specification . Both of these entities’ members transport millions of clinical transactions a day using integration profiles published from various IHE Technical Frameworks.

The FHIR standard’s data-focused approach to allow health IT systems to make health data available to third party applications and users is increasingly being leveraged by industry to support the Application Programming Interface (API) requirements in the ONC) 2015 Edition health IT certification criteria1.

Moreover, the 21st Century Cures Act2 (the Cures Act) was signed into law and expanded the scope and conditions on which certifications to health IT must be granted, including specific conditions of certification around information blocking, application programming interfaces, and “real world” testing using FHIR. As the FHIR standard matures and gains adoption, associated transport and security mechanism, will need to adapt to support it. The IHE and in particular the profiles created and updated by the IHE USA will play in important part in this transition.

1 See 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule,https://www.govinfo.gov/content/pkg/FR-2015-10-16/pdf/2015-25597.pdf ; 45 CFR part 170.315 (g)(7) - (g)(9).

2 See section 4002(a) of the 21st Century Cures Act, P. L. 114-255, (Dec. 13, 2016), which amends section 3001(c)(5) of the Public Health Service Act, https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf.

https://carequality.org/ https://s3.amazonaws.com/ceq-project/wp-content/uploads/2018/09/30162842/Implementation-Guide-v1.1-Effective-3-27-18.pdf https://s3.amazonaws.com/ceq-project/wp-content/uploads/2018/09/30162842/Implementation-Guide-v1.1-Effective-3-27-18.pdf https://www.commonwellalliance.org/ https://www.commonwellalliance.org/ https://www.commonwellalliance.org/wp-content/uploads/2019/01/CommonWell-Services-Specification_2.10.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-16/pdf/2015-25597.pdf https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf

The following tasks are envisioned in the co-operative agreement:

• Identify and update the suite of IHE Profiles that would support the use of the FHIR Standard as alternative or complementary to existing IHE document based exchange specifications

• Support real world testing and adoption of these profiles by health IT developers through IHE USA annual connect-a-thons, HL7 developer days and other related activities

• Encourage the IHE USA to provide continuous feedback back to HL7 based on lessons learned gleaned through profiling and real world testing

• Ensure that the IHE Profile and extensions created by IHE USA are compiled into IHE Technical Frameworks

A. Program Description/Purpose

Background Information

In order for a computer system to send or receives electronic health information from another system, secure exchange standards need to be agreed upon by both sender and receiver. Given the vast number of systems that exchange electronic health information, it’s impractical to require a system to separately negotiate with each and every exchange partner.

Stakeholders in the health IT ecosystem have organized themselves under the auspices of standards development organizations (SDOs) to develop standardized data formats pertaining to specific purposes.

These organizations include, but are not limited to: Health Level 7 International (HL7), the National Council for Prescription Drug Plans (NCPDP), and Integrating the Healthcare Enterprise (IHE).

Additionally there are non-health IT SDOs such as Organization for Advancement of Structured Information Standards (OASIS), World Wide Web Consortium (W3C) and Internet Engineering Task Force (IETF) that develop the standards for the underpinnings of the internet that health IT builds upon for broad exchange. SDOs are primarily responsible for developing and maintaining the technical standards and any accompanying implementation specifications/profiles that provide additional implementation instructions to developers based on the particular purpose for which the standard is intended to be used.

The IHE is an organization, widely accepted by the health IT community that is responsible for the development and maintenance of various health Domain Technical Frameworks that incorporate the use of standards developed by SDOs within and external to the health IT community to enable exchange.

The IHE governs the processes by which these Technical Frameworks are issued and updated.

Additionally, IHE is the current chair of the Joint Initiative Council (JIC). The JIC is a collaborative of 8 international digital health standards formed to providing strategic leadership in the specification of sets of implementable standards for health information sharing.

Over the past several years, industry has rapidly adopted the FHIR standard that uses modern industry standards including JavaScript Object Notation (JSON) data formats and RESTful based API. The ONC regulations, in particular, the 2015 Edition related regulations have included application programming interface certification criteria that permits the use of FHIR. Moreover, the Cures Act t3 was signed into law and added conditions of certification and maintenance of certification requirements for health IT to be certified under the ONC Health IT Certification Program, including specific ones related to application programming interfaces, and real world use testing (a.k.a. “real world testing”).

This cooperative agreement reflects ONC’s intention to work directly with IHE USA in order to advance greater standardization and interoperability in areas of nationwide interest. This work will focus on the exchange of health IT data using the RESTful approach of the FHIR standard. With this approach, and with updated implementation profiles, the health IT community can implement consistent software solutions. The profiles, along with the process used to develop them, such as comprehensive testing by

3 See section 4002(a) of the 21st Century Cures Act, P. L. 114-255, (Dec. 13, 2016), which amends section 3001(c)(5) of the Public Health Service Act, https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/understanding/coveredentities/hitechact.pdf. -http://www.jointinitiativecouncil.org/ the community, and publication of the Domain Technical Frameworks are foundational to establishing consistency. Inclusion of these profiles in the Domain Technical Frameworks would encourage health IT developers migrate from the current use of Simple Object Access Protocol (SOAP) based webservices for the exchange of clinical documents to a modern exchange design, an API based infrastructure using JSON and RESTful technologies.

Purpose

To establish a cooperative agreement to support advancements in the technical standards necessary to achieve interoperability among health IT systems and to reach the milestones identified in the Nationwide Interoperability Roadmap4 and in support of section 4003 (Interoperability) of the Cures Act. The tasks discussed above will advance the implementation consistency and readiness of the current and new versions of IHE integration profiles that support the restful exchange of HL7 FHIR and other dependent technical standards for adoption by the healthcare industry.

Structure and Approach

Key Tasks, Deliverables, and Timeline

The tasks and deliverables listed below are explicitly for the IHE support of the FHIR standard and represent initial activities for IHE USA to submit as deliverables under this funding opportunity. The list of tasks can be expanded during the implementation phase; IHE USA and ONC shall conduct a biannual review based on the planned IHE release cycles, to reassess and adjust priorities and implementation activities as necessary.

Goal 1: Management of award

Task 1: Kickoff Meeting

Within one (1) week of award date, IHE USA and ONC shall conduct a Kick-Off Meeting to mutually determine priorities, discuss implementation activities and timelines, and establish a mutually agreeable regular meeting time. The Kick-Off Meeting shall also review all programmatic and financial reporting requirements. IHE USA attendees must include the Principal Investigator (PI)/Project Director (PD), other subject matter experts (SMEs) and key personnel, including a financial/grants manager.

Task 2: Implementation Plan

IHE USA shall submit a draft implementation plan on how IHE USA will meet the objectives and deliverables as described in this funding opportunity, including additional gaps or areas identified for improvement as determined by the environmental scan report (“Report”), and based on discussion from the Kick-Off Meeting and subsequent review and assessment of the Report with ONC within one (1) month of submitting the Report. The draft implementation plan must also include IHE USA’s proposed tasks, deliverables, timelines, resources, risks and risk mitigation strategy for each objective. The implementation plan is subject to final approval by ONC. Once approved, the Implementation Plan shall be reassessed and updated on a biannual basis in alignment with the IHE Technical Framework release cycle. In the event IHE USA identifies the need to update the plan, IHE USA will give written

4 From the Interoperability Vision for the Future section of “Connecting Health & Care for the Nation: A Shared Nationwide Roadmap”http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf notice to ONC. ONC will determine if IHE may initiate reassessment and updates to the Implementation Plan. ONC likewise may initiate reassessment and updates to the Implementation Plan in response to changes in the technical environment (e.g. new releases of the FHIR standard, new technologies), policy changes (e.g. new rule making), or other similar events. All plan updates are subject to final approval by

ONC.

Task 3: Monthly Progress Meetings

IHE USA shall set-up regular check-in meetings, no less than monthly, with ONC at a mutually agreeable time and frequency, for the duration of the cooperative agreement period-of-performance. At the Kick-Off Meeting, ONC and IHE USA will also establish the medium and format for these monthly progress meetings, including responsibilities for agenda setting and note taking.

Task 4: Quarterly Progress Reports

Quarterly progress reports submitted to ONC during the cooperative agreement period-of-performance regarding the implementation plan. The medium and format for these quarterly progress reports shall be established by ONC prior to the first quarterly report submission.

Task 5: Final Report and Associated Artifacts

The Final Report will contain following:

1. Summary of the work conducted under the cooperative agreement;

2. Summary of Environmental Scan findings;

3. Initial activities and priorities submitted in the Implementation Plan;

a. Subsequent additions/adjustments made to the Implementation Plan based on the biannual assessments

4. Documented list of all technical infrastructure upgrades made using funds from this cooperative agreement, and any known impacts (positive and negative) that it had on the IHE developer and user community;

5. Summary of findings, outcomes/deliverables, and lessons learned, and recommendations for future activities that would further support known interoperability needs of the IHE community.

Goal 2: Identify and update the suite of IHE Profiles that would support the use of the FHIR Standard as alternative or complementary to existing IHE document based exchange specifications

Task 6: Develop Environmental Scan Report and Gap Analysis

During the first six (6) months of this cooperative agreement, IHE USA is required to conduct an environmental scan and develop an Environmental Scan Report and Gap Analysis of the suite of IHE Implementation Profiles that are designed to support restful FHIR based exchange across networks and move away from document based exchanges using Cross Enterprise Document (XD)*. The environmental scan must identify potential gaps that may inhibit the Restful exchange of health information using FHIR and feedback from IHE implementers and standards developers that testing or using those IHE profiles. Additionally, the scan will identify potential ways for IHE USA and ONC to collaborate with HL7, IHE members, and industry partners to lead and participate in testing the updated IHE profiles at connect-a-thons, code-a-thons, development days and other similar events that promote and provide feedback to IHE and HL7 in order to promote and sustain the rapid adoption of the FHIR standard. The Report of findings will inform additional future activities and priorities under this cooperative agreement. Within two (2) weeks of the report submission, ONC and IHE USA shall convene a working session(s) to review and assess the findings of the Report; use the Gap Analysis to identify potential collaboration activates of the environmental scan; and mutually establish the priorities for tasks and specific deliverables for the next six (6) months of the cooperative agreement. Many internal and external factors may impact the Environmental Scan Report or Gap Analysis while this agreement is in place. Note that task 2: Implementation Plan describes the process to respond to change.

Goal 3: Promote and support the real world testing of these profiles through IHE annual connect-a-thons, HL7 developer days, and other related activities

Task 7: Conduct and report out on testing.

IHE USA is expected to coordinate with ONC, HL7, IHE members, and industry partners to lead and participate in testing the updated IHE profiles at connect-a-thons and other events that promote and sustain the adoption of FHIR standard. Specifically, the applicant will work with ONC, HL7, IHE members, and industry partners to refine and incorporate the testing of IHE profiles that promote the use of FHIR at IHE annual connect-a-thons. As a result of the connect-a-thons, IHE USA will validate that the IHE profiles meet the FHIR standard, as well as identifies, flaws, gaps, and other possibilities to enhance the future developments of IHE profiles and FHIR Standard. Additionally, IHE USA should participate and encourage the use of IHE FHIR based profiles at HL7 developer days and HL7 working group meetings and other similar meetings and workshops. Specifically, ONC and IHE USA will attend the workshops and IHE developer days to promote the newly created IHE profiles, gather feedback from the developers on the impact of the profiles, and to facilitate the adoption and implementation of the profiles. Feedback gleaned via the workshops, developer days, and related activities, will be consolidated and disseminated via the IHE website, through other outreach methods and opportunities;

with publicly available IHE guidance, software snippets, reference implementations, and other development support for health IT developers. All feedback activities will consider how to best expedite the adoption of these IHE profiles, reduce the development cycles necessary to achieve production implementation, and drive an increase in the maturity level of FHIR resources, all in the interest of increasing the rapid adoption FHIR based exchange and the resulting interoperability. )

Goal 4: Coordinate and provide timely feedback back to HL7

Task 8: Provide cross organizational collaboration and participation in standards processes

Using those existing, or newly required, HL7 standards identified through the analysis of the environmental scan, and prioritized in collaboration with ONC: IHE USA will directly collaborate with ONC and HL7 to develop and/or update existing IHE Profiles and related HL7 standards through the existing IHE and HL7 standard development processes IHE profiles will be published, housed, or referenced in FHIR as defined by existing processes and mechanisms such as published implementation guides or references in HL7 resources. IHE USA, in collaboration with ONC, will provide feedback from code-a-thon and other interoperability events to HL7 within 30 days of those events. Feedback deadlines may be shorter when required to meet HL7 process deadlines.

Goal 4: Ensure that the IHE Profile and extensions created by IHE USA are compiled into IHE Technical Frameworks.

Task 9: Provide deliverable documentation and cross references.

IHE USA will provide documentation of the final disposition of any implementation guides, FHIR standards, FHIR enhancements or other modifications across the IHE USA and HL7 spectrums. This will include reconciliation with the environmental scan report’s gap analysis and documentation of any FHIR standard, code or related project artifact in the standards process but still awaiting its final state (e.g. IG completed & balloted but awaiting publication). All documentation will be produced in consideration of how to best expedite the adoption of these IHE profiles, reduce the development cycles necessary to achieve production implementation, and drive an increase in the maturity level of FHIR resources, all in the interest of increasing the rapid adoption FHIR based exchange and the resulting interoperability. IHE USA will produce a final project summary report that summarizes the total effort and points to, and cross references, all internal (e.g. IHE USA) and external (e,g. HL7) artifacts referenced or impacted by this project.

Structure and Approach

Task Number Deliverable Due Date Task 1 – Kickoff Meeting

Conduct a Kick-Off Meeting in order to mutually determine priorities, discuss implementation activities and timelines, and establish a mutually agreeable regular meeting time

No Later Than (NLT) one (1) week from award date

Task 2:

Implementation Plan

Draft Implementation plan on how the recipient will meet the objectives and deliverables as described in this funding opportunity

NLT one (1) month from receiving feedback from ONC on Deliverable 2

Task 3: Monthly Progress Meetings

Set-up regular check-in meetings, no less than monthly, with ONC at a mutually agreeable time and frequency, for the duration of the cooperative agreement period-of-performance. At the Kick-Off Meeting, ONC and IHE USA will also establish the medium and format for these monthly progress meetings

Monthly; TBD at a mutually agreeable time between ONC and IHE USA NLT one (1) week from award date

Task 4:

Quarterly Progress Reports

Quarterly progress reports submitted to ONC during the cooperative agreement period-of-performance

Date to be determined after coordination between project officer and recipient

Task 5: Final Report and Associated Artifacts

Final Project Summary Report, containing:

• Summary of the work conducted under the cooperative agreement during the period of performance:

• Summary of Environmental Scan Report findings

• Initial activities and priorities

TBD 2024

submitted in the Implementation Plan o Subsequent additions/adjustments made to the Implementation Plan based on the biannual assessments

Task 6 Develop Environmental Scan Report and Gap Analysis

IHE USA is required to conduct an environmental scan of the suite of IHE mobile Implementation Profiles that are designed to support restful FHIR based exchange across networks and move away from document based exchanges using Cross Enterprise Document (XD)* and develops an Environmental Scan Report and Gap Analysis

No Later Than (NLT) eight (8) weeks from award date

Task 7: Conduct and report out on testing.

Planning and participation in and documentation of testing activities in monthly status reports, updates to planning documents, and updates to related IHE USA and HL7 test documentation methods.

As dictated by IHE USA and HL7 development life cycle schedules and reflected in the implementation plan (task 2).

Task 8: Provide cross organizational collaboration and participation in standards processes

Planning and participation in, and documentation of, IHE and HL7 standard development processes and activities in monthly status reports, updates to planning documents, and updates to related IHE USA and HL7 test documentation methods.

As dictated by IHE USA and HL7 development life cycle schedules and reflected in the implementation plan (task 2).

Task 9: Provide deliverable documentation and cross references.

Preparation and, inclusion in the final project summary report, of documentation cross referencing all relationships between the IHE USA work products

Interim deliveries for review to be indicated in Implementations Plan (task 2); final product to be delivered with Final Report (task 5)

Task Number Deliverable Due Date

Task 5: Final Report and Associated Artifacts cont.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Integrating the Healthcare Enterprise (IHE) FHIR Cooperative Agreement Program

Federal Funding Agency: Department of Health and Human Services Office of the National Coordinator for Health Information Technology

Announcement Type: Cooperative Agreement

Application Type: New

Notice of Funding Opportunity Number: NAP-AX-19-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.691

Eligible Applicants: This is a non-competitive funding opportunity and is restricted to the Integrating the Healthcare Enterprise. Organizations not designated as such are not eligible to apply for this opportunity, and therefore should not submit an application. Applications submitted by organizations not referenced in this section will not be considered.

Legislative Authority: Consolidated Appropriations Act, 2019, Pub. L. 115-245, Division B, Title II

Approximate Amount of Available Funding (inclusive of direct and indirect costs) :

Anticipated Number of Awards: 1

Approximate Amount of Award: $500,000

Project Period: 08/30/2019

Budget Period(s): 08/29/2024

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.

The recipient may anticipate a total budget of $500,000 from ONC for the first year. Continued funding will be contingent on the recipient continuing to meet all the milestones and the availability of funds.

In accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are incorporated into this award by reference. Failing to comply with these requirements may result in suspension or termination of the award and/or ONC's recovery of award funds.

Cost-Sharing Requirements: There are no matching or cost share requirements for this program.

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 project/program 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, the recipient must use 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: This program is excluded from Executive Order 12372

Sole Source Justification

IHE USA is the only source ONC can utilize to update IHE integration profiles. This cooperative agreement between IHE USA and ONC will enable substantial involvement from ONC in the IHE integration Profile development. This funding opportunity for a co-operative agreement between ONC and IHE USA conforms to the organization of and governance procedures established by the IHE This work is integral to supporting the health IT community in its next phase of interoperable exchange.

The IHE USA and IHE organization and governance procedures are described below:

Integrating the Healthcare Enterprise USA (IHE USA) is a Section 501(c) (3) not-for-profit corporation organized in the State of Illinois. IHE USA is one of many national and regional organizations that create implementation profiles and extensions of those profiles on behalf of their jurisdictions. All national and regional IHE organizations publish their materials through Integrating the Healthcare Enterprise International (IHE) as described in accordance with the IHE International, Incorporated Principles of Governance. The Healthcare Information and Management Systems Society (HIMSS) and the Radiological Society of North America (RSNA) sponsor IHE USA.

Integrating the Healthcare Enterprise International (IHE) is a Section 501(c) (3) not-for-profit corporation organized in the State of Illinois. IHE serves as the overarching parent of national and regional IHE organizations. In addition the IHE provides healthcare clinical domain workgroups, for work that is not specific to a jurisdiction, but to a clinical domain. This is to strive to enable seamless and secure access to health information at an International Scale. The IHE promotes the coordinated use of established standards by compiling all of the IHE Profiles created by the domain, global and regional workgroups and into a set of domain specific IHE Technical Frameworks. The resulting technical documents serve as implementation guides for the designated domains. Systems developed in accordance with IHE Technical Frameworks interoperate better, are easier to implement, and enable efficient use of information. The IHE engages clinicians, health authorities, industry, and users to develop, test, and implement standards-based solutions to meet essential health information exchange needs.

https://www.iheusa.org/ https://www.ihe.net/ https://www.ihe.net/wp-content/uploads/2018/07/IHE-International-Principles-of-Governance.pdf https://www.ihe.net/

Key Dates

Milestone Date NOFO Released 06/14/2019

Applications Due 07/15/2019

Anticipated Award Date 08/30/2019

Anticipated Project Start Date 08/30/2019

Roles and Responsibilities Under a Cooperative Agreement The funding instrument used for this project will be the 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.

To facilitate appropriate involvement, during the period of this cooperative agreement, ONC and the recipient will be in contact monthly and more frequently when appropriate.

In a cooperative agreement, ONC staff are substantially involved with the project activities, above and beyond routine grant monitoring. ONC activities for this project include but are not limited to:

a. Conduct regular meetings with IHE USA;

b. Provide substantive input and policy direction as appropriate, in the prioritization and number of FHIR-based IHE integration Profiles that IHE USA shall develop and/or update and make available for public use. ONC may also request testing demonstrations of these profiles in the duration of this cooperative agreement;

c. Provide substantive input and policy direction as appropriate, in the development, deployment, and/or augmentation of FHIR-based IHE integration Profiles. ONC may also request and participation in testing demonstrations of these services for the duration of this cooperative agreement;

d. Conduct, on a biannual basis and in alignment with IHE Technical Framework release cycle, a reassessment and, in collaboration, update the Implementation Plan and any other related activities and priorities. The Implementation Plan and any other related activities and priorities may also be reassessed and adjusted at any time if deemed necessary by ONC and/or IHE USA; and

e. Engage with IHE USA leadership as necessary, to ensure successful execution of the cooperative agreement

Specific tasks and activities may be shared between the recipient and ONC.

Specific activities in which ONC may assume full or substantial involvement include, but are not limited to:

a. Releasing funds based on achievement of performance tasks/project milestones

b. Reviewing and approving substantive provisions of proposed sub-awards or subcontracts

c. Reviewing and accepting deliverables

d. Providing tactical guidance and feedback during project execution

e. Ending an activity if performance tasks/project milestones are not met

f. Meeting with recipient(s) monthly at a minimum, and more frequently as requested by the recipient(s) or ONC

C. Eligibility Information

See Section B, Funding Opportunity Award Information, for eligibility, cost-sharing, and other key award information.

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 Commitment

• Proof of Non-Profit Status (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 Applicants 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 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 should address the elements articulated in the Program Description/Purpose and Structure and Approach sections of this NOFO. The project narrative should also align with the Performance Tasks/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (e.g., organizational experience, past performance).

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 font size of not less than 11 point. The maximum length allowed for the Project Narrative is 20 pages. A Project Narrative that exceeds the 20-page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 10-page limit. The specific sections that must be included in the Project Narrative are detailed below.

Form SF-424, Application for Federal Assistance Appendix B provides line-by-line instructions to complete the form. Please note that the SF-424 is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix B in lieu of the standard instructions attached to SF-424.

Form SF-424A, Budget Information for Non-Construction Programs Appendix C provides line-by-line instructions to complete the form. Please note that the SF-424A is used for a wide variety of Federal grant programs, and Federal agencies have the discretion to require some or all of the information on these forms. Accordingly, when completing the form, please use the instructions in Appendix C in lieu of the standard instructions attached to SF-424A. All direct and indirect costs must be allowable, allocable, reasonable and necessary.

Form SF-424B, Assurances for Non-Construction Programs This form contains laws and other assurances applicants must comply with under the discretionary funds programs administered by the Office of the National Coordinator for Health Information Technology.

Please note that a duly authorized representative of the applicant organization must certify that the organization is in compliance with these assurances.

Form SF-LLL, Disclosure of Lobbying Activities This form contains the name and address of lobbying registrants. Please note that a duly authorized representative of the applicant organization must sign the disclosure form. Failure to complete and sign the form may result in civil penalties ranging from $10,000 to $100,000.

Budget Narrative The budget narrative describes how the proposed budget, as articulated in the SF-424A, aligns with the applicant’s project narrative. That is to ensure that costs are realistic (not artificially too low) and reasonable (not inflated) in view of programmatic requirements. Appendix D provides a template to complete the budget narrative populated with sample information.

When more than 33% of a project’s total budget falls under a contractual expense, a detailed budget narrative/justification must be provided for each sub-contractor or sub-recipient. Applicants requesting funding for multi-year grant programs are required to provide a combined multi-year budget narrative/justification, as well as a detailed budget narrative/justification for each year of potential grant funding. A separate budget narrative/justification is also required for each potential year of grant funding requested.

The full Budget Narrative/Justification should be included in the application immediately following the SF 424 forms. The Budget Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point.

The duration of this award is for a maximum of 5 years. The budget and justification must reflect the costs for the initial 12- month budget period.

Applicants must submit a proposal which covers the full 5-year project period. Although initial funding awarded through this NOFO will cover only the first 12-month budget period of the 60 month project period, applicants must still submit an estimated budget for each budget period (years 1, 2, 3, 4, and 5).

In subsequent years, the recipient will be able to revise their budget, based on actual funding available from HHS, as part of their non-competing continuation application which will be required from the recipient prior to the end of each budget period. The budget proposal must include:

1. An explanation of how the proposed budget supports the proposed Project and is reasonable to meet the Project’s needs;

2. How proposed costs support Project activities; and

3. A description of how the proposed expenditures align with Project Plan.

Please see the Budget Detail in Appendix B for instructions for completing the SF424, and Appendices C through E for instructions for completing the SF424A, Budget Narrative, Justification, and other required forms. A non-competing continuation application is a financial assistance request (in the form of an application or performance/progress report) for a subsequent budget period within a previously approved project period for which a recipient does not have to compete with other applicants. Approval of this application will allow the recipient to continue implementing their project plan and to receive its next 12-month increment of funding. Non-competing continuation applications should be submitted no later than 90 days before the end of the current budget period (i.e., if the budget period will end on August 10, submit the non-competing continuation application by May 10). Exact due dates will be laid out in the terms and conditions that accompany each recipient’s Notice of Grant Award.

Continued funding throughout the 5 year project period will be contingent on timely submission of the non-competing continuation application, strong performance during the previous budget period(s), funding availability, and the recipient’s ability to continue meeting all eligibility requirements laid out in this NOFO. Due to their non-competitive nature, continuation applications will not be reviewed or scored by an Objective Review Committee. Instead, all continuation applications will be reviewed by ONC staff. Strong performance during the previous budget period(s) will be evaluated by looking at a) the recipient’s ability to meet their performance metrics, b) the quality and timeliness of its report submissions, c) the recipient’s compliance with the terms and conditions provided with their Notice of Award including compliance with all applicable statutory and regulatory requirements, and d) the recipient’s ability to communicate with and respond in a timely manner to requests from its project officer throughout the project period.

Letters of Commitment Include letters of commitment confirming the support to the project (should it be funded) made by key collaborating organizations and agencies. Any organization that is specifically named to have a significant coordination role in carrying out the project should be considered an essential collaborator such as interstate, intrastate, and regional partners. At a minimum, the letter must explain the demonstrated commitment to the project and how they will advance coordination and collaboration among critical stakeholders. See Appendix E for an example letter of commitment.

Applicants will also provide a letter of commitment from entities that will be responsible for generating reports based on transactional data (e.g., health information service providers, technology vendors, or others). These entities should have the capacity and resources to produce required reports on adoption and use in a timely manner. See Appendix E for an example letter of commitment.

These letters should not be considered as part of the page limit. Signed letters of commitment should be scanned and included as attachments.

Indirect Cost Agreement(s) Applicants that have included indirect costs in their budgets must include a copy of the current indirect cost rate agreement approved by the Department of Health and Human Services or another federal agency. This is optional for applicants that have not included indirect costs in their budgets. Further, if any sub-contractors or sub-recipients are requesting indirect costs, copies of their indirect cost agreements must also be included with the application.

Application Submission Instructions

1) You must access the electronic application for this program via http://www.grants.gov. You can search the downloadable application page by the Notice of Funding Opportunity Number NAP-AX-19- 002 or CFDA number 93.691.

2) Applicants will be able to download a copy of the application packet and complete it off-line. In order to complete the application, an organization must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number. A DUNS number can be obtained via http://fedgov.dnb.com/webform and typically takes 1 to 2 business days. Please plan accordingly.

3) Completed applications are uploaded into Grants.gov. APPLICATIONS WILL NOT BE

ACCEPTED THROUGH ANY OTHER WEBSITE, AND WILL NOT BE ACCEPTED THROUGH

PAPER MAIL, COURIER, OR DELIVERY SERVICE.

In order to upload applications into Grants.gov:

a) An applicant must be registered in the System for Award Management (SAM), at sam.gov, which requires having a DUNS number. The SAM registration process takes 7 to 10 business days so please plan accordingly. If you have already registered with SAM, but have not renewed your registration in the last 12 months, you must renew your registration.

The following website depicts the SAM registration process:

http://www.grants.gov/web/grants/applicants/organization-registration.html

b) An applicant must be registered in Grants.gov which can take several days. To that end, applicants are strongly encouraged to register and test Grants.gov logins and passwords well in advance of the application deadline date. For assistance with www.grants.gov, please contact them at support@Grants.gov or 1-800-518-4726. Resources are available 24 hours a day/7 days a week.

A depiction of the Grants.gov application process can be found at http://www.grants.gov/web/grants/applicants/apply-for-grants.html http://fedgov.dnb.com/webform http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/apply-for-grants.html mailto:support@grants.gov

4) After electronically submitting your application, Grants.gov will generate an email tracking number and date of receipt verification confirming that the application was received, the date and time the application was received, and a tracking number. This notification does not ensure that your application could be opened and read -- only that the application was received.

5) ONC opens the application submission in Grants.gov, to ensure the application can be downloaded and read during the application review processes. ONC issues an email to the applicant indicating the files were received and able to be successfully opened and read.

The deadline for the submission of applications under this Notice of Funding Opportunity is 11:59 PM Eastern Standard Time on July 15, 2019. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

Restrictions on Oral Conversations

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a competitive grant or other competitive form of federal financial assistance, whether or not the initiating party is a federally registered lobbyist.

This restriction applies unless:

• The communication is purely logistical

• The communication is made at a widely attended gathering

• The communication is to or from a federal agency official and another federal Government employee

• The communication is to or from a federal agency official and an elected chief executive of a state, local, or tribal government, or to or from a federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature

• The communication is initiated by the federal agency official

E. Application Review Information

Screening Review

Applicants that do not meet the following screening criteria will be eliminated and will not be sent forward for merit review:

• The applicant meets the eligibility criteria

• The application is received by the required deadline through http://www.grants.gov

• The application contains all required components (e.g., Project Abstract, Project Narrative, SF-424)

• The application meets the formatting and length requirements. The Project Narrative must not exceed 20 pages. The Project Abstract and resumes do not count as part of the Project Narrative length limitation.

• Appendices and attachments are not used as a mechanism to exceed page limits of the Project Narrative

Merit Review

An independent review panel, of at least three individuals, will evaluate applications that meet the screening criteria identified above. These reviewers will be experts in their field from academic institutions, non-profit organizations, and local and Federal government agencies. Reviewers will review, evaluate, and score applications, in accordance with the criteria identified below:

1. Discussion and Understanding of the Project – 25 points maximum The applicant demonstrates knowledge and understanding of the implementation challenges of the technical standards specified in the cooperative agreement. The applicant provides guidance that specifies solutions to overcome these challenges and leads to consistent implementation and adoption of technical standards.

2. Technical Approach – 25 points maximum The applicant’s approach is succinct and logical in format and demonstrates methods consistent with the tasks to be accomplished. The applicant must propose a clear and detailed actionable plan which includes specific list of activities and deliverables to achieve the tasks specified in the cooperative agreement.

3. Personnel Qualification and Past Performance – 25 points maximum The applicant must demonstrate and provide evidence of technical experience for identifying, assessing and determining improvements to be made to technical standards and specifications listed in the cooperative agreement. The technical experts to perform tasks on Notice of Funding Opportunity (NOFO) must have the expertise to be able to successfully complete the tasks. The applicant must demonstrate ability to successfully manage projects of similar size and ability to engage with health IT industry stakeholders. All evidence of their past work must be provided in the personnel resumes in the appendix of the applicant’s proposal.

4. Management Plan – 15 points maximum The applicant must provide a draft implementation plan that includes a detailed plan to carry out each of the activities proposed in the response, monthly progress meetings, progress reports and a timeline for draft and final…