Draft_Cert_FOA_7-12-17_CLEAN.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Funding Opportunity Announcement Certified Health IT Surveillance Capacity and Infrastructure

Improvement Cooperative Agreement Program

Application Due Date: August 14, 2017

Anticipated Award Date: September 18, 2017

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach Performance Goals/Program Milestones

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

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 (with SAMPLE information) Appendix E Letter of Commitment Template

Executive Summary

The Office of the National Coordinator for Health Information Technology (ONC) anticipates awarding one (1) to three (3) cooperative agreement awards to organizations to improve the surveillance capacity and infrastructure that exists for health information technology (health IT) certified under the ONC Health IT Certification Program (Program). The ONC Health IT Certification Program is a voluntary certification program established to provide for the certification of health IT standards, implementation specifications, and certification criteria adopted by the Secretary of Health and Human Services. In the 2015 Edition Health Information Technology (Health IT) Certification Criteria (2015 Edition), 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule, 80 FR 62601 (October 16, 2015) (2015 Edition final rule), ONC included expanded surveillance requirements for ONC-Authorized Certification Bodies (ONC-ACBs).

Subsequently, the 21st Century Cures Act (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.

The Cures Act also included a provision that calls for the creation of an EHR reporting program with which the conditions of certification are related.

Recipients under this cooperative agreement program are expected to use awarded funds to improve and expand existing surveillance capacity and infrastructure beyond current requirements to provide greater confidence to the public, purchasers, and users that health IT certified under the Program continues to perform in-the-field/health care setting(s) consistent with the expectations of certification. Such work is expected to be accomplished with the current ONC Health IT Certification Program requirements and the Cures Act conditions of certification in mind and in ways that seek to prototype and test new methods of surveillance and real world testing that can minimize industry burden while also maximizing effectiveness and scale. In order to achieve the cooperative agreement objectives, desired impact, and outcomes, the cooperative agreement will be executed in two distinct phases. Each recipient’s award will include a planning phase (Phase 1) and an implementation phase (Phase 2) during which each will develop and implement Strategic and Operational Plans, and deliver a Final Surveillance Report that will be made publicly available. Successful implementation of the Strategic and Operational Plans should provide the general public valuable information about the long-term sustainability of a comprehensive certified health IT surveillance approach to support the Program, deployed strategies to improve surveillance of certified health IT, and successes and challenges evaluating whether certified health IT in the implementation setting (“in-the-field”/ “real world” setting) is consistent with its certification and intended purposes, as specified under ONC regulations.

A. Program Description/Purpose

Background Information

ONC is the principal federal entity charged with coordination of nationwide efforts to implement and use health IT and the electronic exchange of health information. Created in 2004 through Executive Order and legislatively mandated in the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009, ONC is at the forefront of the federal government’s health IT efforts.

The ONC Health IT Certification Program, administered under section 3001(c)(5) of the Public Health Service Act, is a voluntary program that provides for the certification of health IT to standards, implementation specifications, and certification criteria adopted by the Secretary of Health and Human Services (HHS). In October 2015, ONC issued the 2015 Edition final rule, which included expanded surveillance requirements for ONC-ACBs. The 2015 Edition final rule also established specific performance expectations for the surveillance of certified health IT “in-the-field.” Additionally, the 21st Century Cures Act1 (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. The Cures Act also included a provision that calls for the creation of an EHR reporting program with which the conditions of certification are related.

Purpose

This Funding Opportunity Announcement (FOA) is aimed at improving the surveillance capacity and infrastructure that exists for health IT certified under the Program. Through this FOA, recipients are expected to improve and expand the in-the-field surveillance capacity and infrastructure for health IT certified under the Program, with a particular focus on capabilities that are directly related to interoperability2 and, thus, have the greatest potential impact to the health IT consumers and individuals (e.g., providers, hospitals, individual users). Such work is expected to be accomplished with the current ONC Health IT Certification Program requirements and the Cures Act conditions of certification in mind and in ways that seek to prototype and test new methods of surveillance and real world testing that can minimize industry burden while also maximizing effectiveness and scale.

Recipients will develop and implement Strategic and Operational Plans and then deliver a Final Surveillance Report that will be made available to the public. By completing these steps, recipients will have identified and potentially established new ways to improve the surveillance capacity and infrastructure for certified health IT (i.e., the scale at which surveillance can be performed and the technology and techniques necessary to track surveillance enhancements and/or conduct new real-world testing, respectively). Enhanced surveillance capacity is intended to improve the scale and approaches by which surveillance can be performed in order to provide greater empirical evidence to users that certified health IT continues to perform as expected in the implementation/real-world setting. The Final Surveillance Report will include an analysis of findings as well as recommendations for future activities

1 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.

2 Per the 21st Century Cures Act of 2016, the term ‘interoperability’, with respect to health information technology, means such health information technology that: (A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; (B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and (C) does not constitute information blocking as defined in section 3022(a).

that can be applied to inform all aforementioned interested parties, and boost consumer confidence in certified health IT products.

Scope of Services

In order to achieve the cooperative agreement’s objectives, desired impact, and outcomes, it will be executed in two distinct phases. Each recipient’s award will include a planning phase (Phase 1) and an implementation phase (Phase 2). Phase 1 will be completed in the first 12 months of the award during which the recipients will develop draft and final versions of a Strategic Plan and an Operational Plan.

After the plans are complete, each recipient will focus on the early stage implementation of its Strategic and Operational Plans developed in Phase 1 to improve “real world”/in-the-field surveillance of certified health IT.

Phase 2 will be completed during year 2. In Phase 2, each recipient will fully implement its Strategic and Operational Plans, including performing enhanced in-the-field surveillance/real-world testing of certified health IT. Such work is expected to be accomplished with the current ONC Health IT Certification Program requirements and the Cures Act conditions of certification in mind and in ways that seek to prototype and test new methods of surveillance and real world testing that can minimize industry burden while also maximizing effectiveness and scale. The actions taken to implement the Strategic and Operational Plans must achieve the milestone objectives identified in this FOA and meet all existing certification criteria and regulatory requirements3, as well as those found in any new regulations ONC publishes as a result of the Cures Act. Each recipient will also submit a Final Surveillance Report, which will be made public at the conclusion of Phase 2.

Structure and Approach

Key Tasks, Deliverables, and Timeline

As stated above, this cooperative agreement will be executed in two phases: Phase 1 – Planning and Phase 2 – Implementation.

Phase 1: Planning

Specific Requirements for the First Year

The first year of this cooperative agreement is critical for certified health IT surveillance capacity building. As such, each recipient will complete a Strategic Plan and an Operational Plan to improve its surveillance capacity and infrastructure (i.e., the scale at which surveillance can be performed and the technology and techniques necessary to track surveillance enhancements and/conduct new real-world testing, respectively). Each recipient will submit its Draft Strategic (Task 1-1a) and Operational (Task 1- 2a) Plans to ONC for review, subsequently incorporate any ONC feedback, and submit Final Strategic (Task 1-1b) and Operational (Task 1-2b) Plans. Each recipient will also begin to implement the technical infrastructure, business practices, and personnel needed to be successful during year 2/Phase 2 (Task 1- 3). As such, funding available for drawdown in the first year will be based on meeting the required deliverables specified for Phase 1. The total amount of funds made available to each recipient under Phase 1 of this cooperative agreement is 65% of its total award. There will be future technical assistance and guidance regarding planning and implementation conducted during this phase.

3 https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations

In order to measure project success, each recipient should conduct a semi-annual review of its Strategic and Operational Plans. In consultation with ONC, updates should be made to the plans based upon findings from plan execution and any additional applicable ONC Health IT Certification Program requirements.

Strategic Plan – Task 1-1 The Strategic Plan shall describe the overall strategic and business approaches for specific activities the recipients will complete to improve their surveillance capacity and infrastructure. Each recipient must establish a Strategic Plan that addresses the vision, goals, objectives, business, and technical strategies to improve and expand their surveillance capacity and infrastructure, specifically its ability to perform in-the-field surveillance/real-world testing of certified health IT. In addition to the vision, goals, objectives, business, and technical strategies, the recipient’s Strategic Plan must address all four of the domains, further described below:

Surveillance Capacity Strategy Business and Financial Operations Technical Approach and Infrastructure Personnel

Surveillance Capacity Strategy Each recipient must address its expertise and knowledge of ONC Health IT Certification Program requirements, including, but not limited to, the health IT certification criteria and regulations4 and knowledge of the health care industry in order to identify current gaps and challenges associated with the surveillance/real-world testing of certified health IT. Moreover, a recipient’s surveillance capacity strategy should illustrate how to qualitatively and quantitatively improve surveillance activities/real-world testing of certified health IT with a focus on certified capabilities that directly support interoperability as those capabilities have the greatest potential impact to the health IT consumers and individuals (e.g., providers, hospitals, individual users).

Each recipient must also include proposals to address qualitative and quantitative enhancement of in-the-field surveillance/real-world testing activities, capabilities in certified health IT that are directly related to interoperability, and transparency provided by health IT developers to the public/users regarding information that may adversely impact the interoperability of certified health IT. For clarity, such proposals would need to remain scoped within the specific capabilities and technical outcomes expressed by adopted certification criteria and could not go beyond the conformance expectations of such criteria. Each recipient should provide baseline metrics of current surveillance activities, if applicable, and a proposed structure to measure their improvements of surveillance activities during the cooperative agreement period-of-performance. Each recipient is expected to include a long-term strategy in the Strategic Plan to sustain enhanced surveillance activities throughout the project period and beyond the performance period of the cooperative agreement. The creation of a long-term strategy will provide added value to the industry as whole due to the potential for greater predictability and consistency for how surveillance would be performed over time.

Business and Financial Operations Each Recipient must assess its current business model and proposed expansion and enhancements to the surveillance of certified health IT. This section of the Strategic Plan should also address how a recipient plans to effectively generate funding and manage the resources necessary to implement the Strategic and Operational Plans during the full period-of-performance of the cooperative agreement as well as ways it intends to sustain its investments beyond the period-of-performance. This should include addressing

4 https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations https://www.healthit.gov/policy-researchers-implementers/standards-and-certification-regulations financial policies and implementing procedures to generate revenue, monitor spending, and overall fiscal responsibility so that investments made during the period-of-performance would be able to continue to be maintained after the cooperative agreement. Recipients will also address their strategy to establish a long-term strategic financial model that will consider that the costs of surveillance are distributed across health IT developers relative to their different types, sizes, technologies, past performance and market share.

Technical Approach and Infrastructure Each recipient must describe its technical approach to develop, implement, and report/publicly list the results of their enhanced in-the-field surveillance, to include real-world testing, of certified health IT with a focus on evaluating end-user(s)/implementation setting(s) access to conformant certified health IT and improving widespread interoperability. A recipient may describe how it will leverage previous experience from existing efforts and resources to conduct in-the-field surveillance/real-world testing of certified health IT. This section of the Strategic Plan should describe the surveillance capacity and infrastructure that will be improved and expanded upon to conduct in-the-field surveillance/real-world testing of certified health IT in order to meet the purpose of this FOA and the strategic goals of the recipient’s Surveillance Capacity Strategy section of the Strategic Plan. Each recipient should include proposals to implement creative mechanisms to conduct enhanced surveillance and real-world testing of certified health IT capabilities, with a particular focus on capabilities that are directly related to interoperability and, thus, have the greatest potential impact to the health IT consumers and individuals (e.g., providers, hospitals, individual users). This section of the Strategic Plan should include the recipient’s plans to maintain ISO/IEC 17065 accreditation throughout the project period and beyond the performance period of the cooperative agreement. Finally, a recipient must address its strategy to include any yet to-be-developed Conditions of Certification requirements developed by ONC as required by law (e.g., 21st Century Cures Act) in the implementation of its Strategic and Operational Plans.

Personnel Each recipient must include a personnel strategy for ensuring the recipient has adequate resources available to implement their Strategic and Operational Plans. The personnel plans may include a Business Development Specialist, which will be considered as key personnel. The personnel plans must include a long-term and financial strategy for outreach and retention to meet the recipient’s targeted personnel and operational goals.

Operational Plan – Task 1-2 The Operational Plan shall describe how the recipient will implement surveillance activities specifically focused on interoperability among users of certified health IT. The Operational Plan must contain specific details on how the Strategic Plan will be executed to enable the enhancement of a recipient’s surveillance capacity and achieve the vision, objectives, and goals of the Strategic Plan. A recipient’s plan must provide the specific actions and roles of various stakeholders in the development and implementation of the expanded and enhanced surveillance/in-the-field testing activities, to include reporting/public listing of the results of surveillance. In addition, the Operational Plan must include descriptions of any activities implemented, to date, with an explanation of how these prior activities inform and may be included into the recipient’s future plans for enhanced and expanded surveillance.

The Operational Plan must address all four of the domains, further described below:

Surveillance Capacity Strategy Business and Financial Operations Technical Approach and Infrastructure Personnel

Surveillance Capacity Strategy Each recipient must include specific planned actions and project plans that will achieve the goals of the Surveillance Capacity Strategy section of the Strategic Plan. This should include actions to achieve qualitative and quantitative enhancement of in-the-field surveillance activities, focus on certified health IT that is directly related to interoperability, and transparency provided by health IT developers regarding information that may adversely impact the interoperability of certified health IT. For clarity, such proposals need to remain scoped within the specific capabilities and technical outcomes expressed by adopted certification criteria and could not go beyond the conformance expectations of such criteria.

A recipient should describe its plans to implement mechanisms and gather data to measure improvements of surveillance activities during the cooperative agreement period-of-performance. The planned actions should also relate to the recipient’s long-term sustainability to maintain surveillance activities throughout the project period and beyond the performance period of the cooperative agreement.

Business and Financial Operations Each recipient must include specific planned actions to improve/expand its business model relating to the enhanced surveillance/real-world testing of certified health IT. This should include specific actions the recipient will take to effectively generate and manage funding necessary to implement the recipient’s Strategic Plan goals during the full period-of-performance. Recipients will also address their strategy to establish a long-term strategic financial model that will consider that the costs of surveillance are distributed across health IT developers relative to their different types, sizes, technologies, past performance and market share. The specific actions should relate to financial policies and procedures to generate revenue, monitor spending, and overall fiscal responsibility so that investments made during the period-of-performance would be able to continue to be maintained after the cooperative agreement.

Recipients should include planned actions in Phase 1 of the period-of-performance to implement the necessary business and financial structure to be successful in Phase 2.

Technical Approach and Infrastructure Each recipient must include specific planned actions to implement the technical approach to develop or facilitate enhanced in-the-field surveillance and real-world testing of certified health IT, with focus and priority given to the assessment of certified health IT performance as implemented in a “production environment.” The planned actions should show how the recipients will leverage previous experience from existing efforts and resources to conduct enhance and expanded in-the-field surveillance/real-world testing of certified health IT. This section of the Operational Plan should also describe the specific actions to be taken to implement the operational and surveillance administration infrastructure necessary to conduct in-the-field surveillance of certified health IT in meeting the strategic goals of the recipient’s technical approach and infrastructure section of the Strategic Plan.. The project plans should address planned actions to implement creative mechanisms to conduct widespread conformance assessment and/or testing for certified health IT capabilities that are directly related to interoperability among users of certified health IT. This section should also address specific actions the recipient will take to maintain ISO/IEC 17065 accreditation throughout the project period and beyond the performance period of the cooperative agreement. Each recipient must also include specific actions to address any yet to-be-developed Conditions of Certification requirements developed by ONC as required by law (e.g., 21st Century Cures Act) are periodically incorporated into its Strategic and Operational Plans. A recipient should include planned actions in Phase 1 of the period-of-performance to implement the necessary technical approach and infrastructure to be successful in Phase 2.

Personnel Each recipient must include specific planned actions to implement the personnel strategy for demonstrating the recipient has adequate resources available to implement their Strategic and

Operational Plans. This may include hiring a Business Development Specialist, which will be considered as key personnel. The personnel plans must include actions to enable a long-term and financial strategy for outreach and retention to meet the recipient’s targeted personnel goals. The recipient should plan to have the majority of their personnel plan filled by the end of Phase 1.

Phase 1 Implementation of Technical Infrastructure, Business Practices, and Personnel – Task 1-3

Once ONC accepts the recipients’ Final Strategic and Operational Plans, each recipient is expected to begin implementing key actions to establish the necessary business/financial structure, technical approach and infrastructure, and personnel resources in Phase 1 to ensure successful implementation and development of enhanced surveillance capacity in Phase 2. As described above, each recipient should include Phase 1 planned actions in these domains in its Operational Plan.

Phase 2: Implementation

Phase 2, which is to occur during year 2 of this cooperative agreement, is focused on the implementation of the recipient’s Strategic and Operational Plans. In addition, each recipient will deliver a public Final Surveillance Report that identifies ways to improve and expand the surveillance capacity and infrastructure related to certified health IT. The implementation of the recipient’s aforementioned plans should demonstrate expansion and improvement of the surveillance of certified health IT and result in early identification and resolution of conformity issues in the implementation setting, as well as more effective and efficient surveillance/in-the-field testing approaches (e.g., 10% more certified health IT surveilled in the implementation setting; efficiencies gained via “connect-a-thon” testing). This expanded surveillance, early identification of issues and return to conformity will provide greater confidence to the public, health IT consumers, and individual users that health IT certified under the Program continues to perform in-the-field/health care setting(s) consistent with the expectations of certification. The total amount of funds made available to each recipient under Phase 2 of this cooperative agreement is 35% of the total award.

Successful Implementation of the Strategic Plan and Operational Plan – Task 2-1

In order to qualify for the milestone payments, each recipient must meet the performance milestones as described below and detailed in their Final Strategic and Operational Plans accepted by ONC during Phase I. The recipients will work with ONC in identifying and further scoping its strategic and business approach, identification of current gaps and challenges in surveillance, and implementing approaches to qualitatively and quantitatively expand and enhance surveillance/real-world testing activities in the implementation environment with a focus on capabilities that are directly related to interoperability.

Moreover, the recipient’s enhanced and expanded surveillance of certified health IT in the implementation setting should provide greater confidence to the public, health IT consumers, and individual users that health IT certified under the Program continues to perform in-the-field/health care setting(s) consistent with the expectations of certification.

Funds available for drawdown in Phase 2 for Task 2-1 will be allocated accordingly:

(Task 2-1a) Successful implementation and appropriate documentation to ONC of the Strategic and Operational Plans in two of the four domains: Surveillance Capacity Strategy; Business and Financial Operations; Technical Approach and Infrastructure; or Personnel by the end of the fourth month of Phase 2; and

(Task 2-1b) Successful implementation and appropriate documentation to ONC of the Strategic and Operational Plans in the two remaining domains by the end of the seventh month of Phase 2.

Final Surveillance Report – Task 2-2 A critical component of this cooperative agreement is the Final Surveillance Report. It is anticipated that the recipients will create a Draft Final Surveillance Report (Task 2-2a) for ONC to review and provide feedback on the report. Furthermore, each recipient should incorporate the comments received from ONC and prepare the Final Surveillance Report (Task 2-2b). Final Surveillance Report should include a full evaluation of the cooperative agreement period-of-performance, analysis of findings from implementation of the Strategic and Operational Plans, metrics demonstrating enhanced surveillance capacity, and recommendations for future activities that can be applied to strengthen confidence in certified health IT. This Final Surveillance Report will be made public and may be used by ONC to inform future ONC Health IT Certification Program and/or 21st Century Cures Act-related regulations as well as other non-regulatory ONC programmatic investments and coordination opportunities with health IT stakeholders to improve certified health IT’s ability to be assessed for conformance in real world settings as expected by certified health IT consumers and individuals (e.g., providers, hospitals, individual users).

Structure and Approach Task Number

Task Deliverable Due Date

Task 1-0 Kick-Off Meeting with ONC Kick-Off Meeting with ONC and Key Recipient Personnel

Within 5 business days of award

Task 1-1a Draft Strategic Plan – A draft strategic plan that includes the requirements and domains as detailed above.

Draft Strategic Plan Within 2 months of award

Task 1-1b Final Strategic Plan – A final strategic plan that includes the requirements and domains as detailed above and incorporating feedback from ONC.

Final Strategic Plan Within 4 months of award

Task 1-2a Draft Operational Plan – A draft operational plan that includes the requirements and domains as detailed above, including project management plan and timeline for implementation of surveillance activities in Phases 1 and 2.

Draft Operational Plan Within 7 months of award

Task 1-2b Final Operational Plan – A final operational plan that includes the requirements and domains as detailed above, including project management plan and timeline for implementation of surveillance activities in Phases 1 and 2, and incorporating feedback from ONC.

Final Operational Plan Within 10 months of award

Task Number

Task Deliverable Funds Available for Drawdown

Task 1-3 Phase 1 Implementation of Technical Approach and Infrastructure, Business Practices, and Personnel

Acceptance of the Final Strategic and Operational Plans and implementing key technical, business, and personnel actions to ensure successful implementation of the plans in Phase 2.

Within 12 months of award

Task 2-0 Phase 2 Kick-Off Meeting with

ONC

Kick-Off Meeting with ONC and Key Recipient Personnel

Within 5 business days of receiving approval from ONC to proceed to Phase 2

Task 2-1a Successful Implementation of Strategic and Operational Plans.

Implementation of two of the four milestones from the Final Strategic and Operational Plans.

Within 16 months of award

Task 2-1b Successful Implementation of Strategic and Operational Plans.

Implementation of milestones from the Final Strategic and Operational Plans in the two remaining domains.

Within 19 months of award

Task 2-2a Draft Final Surveillance Report – a draft final report that includes the requirements detailed above.

Draft Final Surveillance Report

Within 22 months of award

Task 2-2b Final Surveillance Report – a final report that includes the requirements detailed above and incorporating feedback from ONC.

Final Surveillance Report

Within 24 months of award

Performance Goals/Program Milestones A performance goal/program milestone is a target level of performance expressed as a tangible, measurable objective, against which actual achievement can be compared. The performance goals/program milestones associated with this FOA, and ensuing award, are as follows:

Task Number

Task Deliverable Funds Available for Drawdown

Task 1-0 Kick-Off Meeting with ONC Kick-Off Meeting with ONC and Key Recipient Personnel

0% of total award

Task 1-1a Draft Strategic Plan – A draft strategic plan that includes the requirements and domains as detailed above.

Draft Strategic Plan 10% of total award

Task Deliverable Funds Available for Drawdown

Task 1-1b Final Strategic Plan – A final strategic plan that includes the requirements and domains as detailed above and incorporating feedback from ONC.

Final Strategic Plan 20% of total award

Task 1-2a Draft Operational Plan – A draft operational plan that includes the requirements and domains as detailed above, including project management plan and timeline for implementation of surveillance activities in Phases 1 and 2.

Draft Operational Plan 10% of total award

Task 1-2b Final Operational Plan – A final operational plan that includes the requirements and domains as detailed above, including project management plan and timeline for implementation of surveillance activities in Phases 1 and 2, and incorporating feedback from ONC

Final Operational Plan 15% of total award

Task 1-3 Phase 1 Implementation of Technical Infrastructure, Business Practices, and Personnel

Documentation to ONC detailing successful implementation of Phase 1 milestones from the Final Strategic and Operational Plans for business/financial practices, technical infrastructure, and personnel needs needed to be successful in Phase 2

10% of total award

Task 2-0 Phase 2 Kick-Off Meeting with

ONC

Kick-Off Meeting with ONC and Key Recipient Personnel

0% of total award

Task Deliverable Funds Available for Drawdown

Task 2-1a Successful Implementation of Strategic and Operational Plans in two of the four domains;

Surveillance Capacity Strategy;

Business and Financial Operations;

Technical Approach and Infrastructure; or Personnel.

Documentation to ONC detailing successful implementation of milestones from the Final Strategic and Operational Plans in two of the four domains; Surveillance Capacity Strategy;

Business and Financial Operations; Technical Approach and Infrastructure; or Personnel

15% of total award

Task 2-1b Successful Implementation of Strategic and Operational Plans in Two Remaining Domains

Documentation to ONC detailing successful implementation of milestones from the Final Strategic and Operational Plans in two remaining domains

10% of total award

Task 2-2a Draft Final Surveillance Report – a draft final report that includes the requirements detailed above and incorporating feedback from ONC.

Draft Final Surveillance Report

0% of total award

Task 2-2b Final Surveillance Report – a final report that includes the requirements detailed above and incorporating feedback from ONC.

Final Surveillance Report

10% of total award

B. Funding Opportunity Award Information

Key Award Parameters

Title: Certified Health IT Surveillance Capacity and Infrastructure Improvement

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

Funding Opportunity Announcement Number: NAP-AX-17-003

Catalog of Federal Domestic Assistance (CFDA) Number: 93.355

Eligible Applicants: Specialized Groups and For Profit Organizations, who have ISO/IEC17065 Accreditation in good standing through the American National Standards Institute (ANSI).

Legislative Authority:

Consolidated Appropriations Act, 2017, Pub. L. No. 115-31, Division H, Title II

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

Anticipated Number of Awards: 1-3

Approximately Amount of Each Award: $400,000 - $1,250,000

Project Period: 9/18/2017 to 9/17/2019

Budget Period(s): 9/18/2017 to 9/17/2019

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.

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.

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

Key Dates

Milestone Date FOA Released

July 13, 2017

Informational Session

July 20, 2017

Notice of Intent Due

July 27, 2017

Applications Due

August 14, 2017

Anticipated Award Date

September 18, 2017

Anticipated Project Start Date

September 18, 2017

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.

Specific tasks and activities may be shared between the recipients and ONC. ONC will assist each recipient in the planning and implementation of the four domains to enhance the effectiveness of the recipient’s surveillance/real-world testing of certified health IT.

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

Releasing funds based on achievement of performance goals/project milestones Reviewing and approving substantive provisions of proposed subawards or subcontracts Reviewing and accepting deliverables Providing tactical guidance and feedback during project execution Ending an activity if performance goals/project milestones are not met Meeting with recipient(s) monthly at a minimum, and more frequently as requested by the recipient(s) or ONC

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 FOA 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.healthit.gov/.

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 ONC.Certification@hhs.gov, subject line: “Certified Health IT Surveillance Capacity and Infrastructure Improvement Cooperative Agreement Program” no later than three (3) 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 July 27, 2017 and should be sent to ONC.Certification@hhs.gov, subject line: “Certified Health IT Surveillance Capacity and Infrastructure Improvement Cooperative Agreement Program.” The notice should identify the name of the applicant organization, the city and state in which the applicant organization is located, and the Funding Opportunity Announcement title and number.

https://www.healthit.gov/ mailto:ONC.Certification@hhs.gov

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) Indirect Cost Agreement(s) – including recipient, sub-recipient, and contractors agreements (if applicable) Proof of ISO/IEC17065 Accreditation in good standing through the American National

Standards Institute (ANSI) and the applicant is expected to maintain this accreditation through the project period and beyond the performance period of the cooperative agreement.

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 FOA. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this FOA (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 20-page limit. The specific sections that must be included in the Project Narrative are detailed below.

Problem Statement The Problem Statement must describe, from the applicant’s perspective, identified gaps and other challenges in current in-the-field surveillance and testing activities of certified health IT. (<1 page)

Project Scope The Project Scope must include a proposed strategy to improve and expand the in-the-field surveillance/real-world testing capacity and infrastructure for certified health IT ( i.e., the scale at which surveillance can be performed and the technology and techniques necessary to track and/or conduct new real-world testing, respectively), with a particular focus on capabilities that are directly related to interoperability and, thus, have the greatest potential impact to the health IT consumers and individuals (e.g., providers, hospitals, individual users).

Applicants must also describe their approach to develop the capability to effectively generate funding and manage the resources necessary to implement the Strategic and Operational Plans during the full period-of-performance of the cooperative agreement as well as ways it intends to sustain its investments beyond the period-of-performance. This should include addressing financial policies and implementing procedures to generate revenue, monitor spending, and overall fiscal responsibility so that investments made during the period-of-performance would be able to continue to be maintained after the cooperative agreement. Recipients will also address their strategy to establish a long-term strategic financial model that will consider that the costs of surveillance are distributed across health IT developers relative to their different types, sizes, technologies, past performance and market share.

(10-15 pages)

Organizational Experience and Knowledge of Health IT Certification and Surveillance The applicant must be able to demonstrate organizational experience in achieving the programmatic goals and objectives of this FOA. This includes an assessment of the applicant’s current business model and proposed expansion and enhancements to the surveillance of certified health IT in order to evaluate continued conformance and recommendations for ongoing improvement. This will ensure effective, accurate, reliable, and financially sustainable in-the-field surveillance and testing of certified health IT within the scope of the health IT’s certification. The applicant must also demonstrate plans to support the long-term capabilities for surveillance and real-world testing activities, for a more comprehensive approach for assessing continued conformance of certified health IT, in order to advance interoperable exchange of health information across the health care continuum. (3-4 pages)

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.

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.