Trusted Exchange Framework RCE 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) -

Trusted Exchange Framework and Common Agreement - Recognized Coordinating Entity (RCE) Cooperative Agreement

Application Due Date: 06/17/2019

Anticipated Award Date: 08/30/2019

Table of Contents Executive Summary

1. Funding Opportunity Description

A. Purpose

B. Background

C. Program Description

D. Program Approach

2. Funding Opportunity Award Information

A. Key Award Parameters

B. Key Dates

C. Roles and Responsibilities Under a Cooperative Agreement

D. Information Session

E. Letter of Intent

3. Eligibility Information

A. Eligible Applicants

B. Cost-Sharing or Matching

C. Application Completeness Criteria

D. Application Responsiveness Criteria

4. Application and Submission Information

A. Address to Request Application Package

B. Content and Form of Application Submission

C. Application Submission Instructions

D. Restrictions on Oral Conversations

5. Application Review Information

A. Merit Review

B. Pre-Award Risk Assessment

6. Federal Award Administration Information

A. Award Decisions

B. Notice of Grant Award (NGA)

C. Terms and Conditions

7. 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 Intent Template

Executive Summary

This NOFO describes a full and open competition to make a single, 4-year award, through a Cooperative Agreement, for a non-profit entity with appropriate approvals from ONC, to develop, update, implement, and maintain the Common Agreement1 component of the Trusted Exchange Framework2 and Common Agreement (TEFCA). This entity, known as the Recognized Coordinating Entity (RCE)2 will also work with ONC to designate and monitor Qualified Health Information Networks (QHINs),3 modify and update an accompanying QHIN Technical Framework,4 engage with public stakeholders through virtual public listening sessions, adjudicate noncompliance with the Common Agreement, and propose sustainability strategies for an RCE to continue to support trusted data5 exchange through QHIN connectivity at the expiration of the term of the Cooperative Agreement. The program will be funded for the first year at $900,000, with funding in additional years contingent upon availability of funds and satisfactory completion of milestones.

In the 21st Century Cures Act (Cures Act),6 Congress identified the importance of interoperability by laying out a path for the establishment of interoperable exchange of electronic health information (EHI) and charging the Office of the National Coordinator for Health

1 Common Agreement: an agreement in the form published by ONC and signed by the RCE and a Provisional QHIN (which shall become a QHIN only upon Designation by the RCE as further described in the MRTCs). The Common Agreement shall consist of (a) the Minimum Required Terms and Conditions, (b) the Additional Required Terms and Conditions, and (c) such other terms as the RCE and the QHIN mutually agree upon; provided, however, that in the event of any conflict or inconsistency between or among Applicable Law, the MRTCs, the ARTCs, and any other terms and conditions, the following shall be the order of precedence to the extent of such conflict or inconsistency: (i) Applicable Law including the HIPAA Rules, (ii) the MRTCs, (iii) the ARTCs, and (iv) any other terms and conditions agreed to by the parties.

2 TEF: the Trusted Exchange Framework published in the Federal Register and on ONC’s website.

2 Recognized Coordinating Entity (RCE): the entity selected by ONC that will enter into agreements with QHINs in order to impose, at a minimum, the requirements of the Common Agreement and the QHIN Technical Framework on the QHINs and administer such requirements on an ongoing basis.

3 Qualified HIN (QHIN): a Health Information Network that is a party to a Common Agreement signed by the RCE and has been Designated a QHIN by the RCE after satisfying all the conditions of the Common Agreement and the QHIN Technical Framework.

4 QHIN Technical Framework: the document approved by ONC pursuant to the Common Agreement that includes:

(1) technical requirements, functional requirements, privacy and security related considerations required for the exchange of electronic health information (EHI) between QHINs; (2) intra-QHIN functional requirements; (3) technical, privacy, and security flow down requirements from the QHIN to the Participants and/or Participant Members (if any); and, (4) operational considerations that enable the exchange of EHI between QHINs.

5 Data: one or more elements of EHI (unless otherwise expressly specified).

6 Pub. L. 114–255 (Dec 13, 2016).

Information Technology (ONC) with the implementation of key interoperability provisions under Title IV of the Cures Act including advancing a Trusted Exchange Framework and Common Agreement to improve data exchange between health information networks (HINs).7 See § 4003(b) of the Cures Act, which added new subsection (9) to section 3001(c) of the Public Health Service Act (PHSA) (42 U.S.C. 300jj–11(c)).

The Cures Act’s focus on trusted exchange is an important step toward advancing the establishment of an interoperable health system that empowers individuals to use EHI to the fullest extent; enables providers and communities to deliver smarter, safer, and more efficient care; and promotes innovation at all levels.8

The RCE will have an important role in realizing the vision of the TEFCA and will have responsibilities including:

1. Develop a Common Agreement that includes the Minimum Required Terms & Conditions9 (MRTCs) and Additional Required Terms & Conditions (ARTCs)10 developed by the RCE and approved by ONC. The Common Agreement will be published on HealthIT.gov and in the Federal Register.

2. Virtually convene public listening sessions that will allow industry stakeholders to provide objective and transparent feedback to the RCE.

7 Health Information Network or HIN means an individual or entity that satisfies one or both of the following—

(1) Determines, oversees, administers, controls, or substantially influences policies or agreements that define business, operational, technical, or other conditions or requirements for enabling or facilitating access, exchange, or use of electronic health information between or among two or more unaffiliated individuals or entities;

(2) Provides, manages, controls, or substantially influences any technology or service that enables or facilitates the access, exchange, or use of electronic health information between or among two or more unaffiliated individuals or entities.

8 This Cooperative Agreement is authorized through the Consolidated Appropriations Act, 2018, Pub. L. 115-141, Division H, Title II “for the development and advancement of interoperable health information technology”.

9 Minimum Required Terms and Conditions (MRTCs): ONC will develop the MRTCs, which will consist of mandatory minimum required terms and conditions with which Qualified Health Information Networks (QHINs) may voluntarily agree to comply. The MRTCs are not a full end-to-end trust agreement. Rather, the MRTCs focus on the areas of variation among currently existing trust agreements that impede nationwide interoperability. The Common Agreement would include the MRTCs, as well as additional required terms and conditions developed by the RCE. Draft 1 of the MRTCs was referred to as “Part B” in Draft 1 of the TEF. The MRTCs Draft 2 was released for public comment April 19, 2019 and can be found at https://www.healthit.gov/TEFCA.

10 Additional Required Terms and Conditions (ARTCs): the terms and conditions, written by the RCE and approved by ONC, which are in addition to the MRTCs.

http://uscode.house.gov/quicksearch/get.plx?title=42&section=300jj-11 https://www.healthit.gov/TEFCA

3. Designate and monitor QHINs that voluntarily agree to sign and adopt the Common Agreement.

4. Implement an ONC-approved process to adjudicate QHIN noncompliance with the Common Agreement, up to and including removal from ONC’s public directory on HealthIT.gov.

5. Implement a process to update the Common Agreement, as needed, for ONC final approval and publication on HealthIT.gov and in the Federal Register.

6. Modify and update the QHIN Technical Framework Draft 1 (QTF), for ONC approval, to detail proposed technical components for exchange between QHINs.

7. Propose strategies that an RCE could employ to sustain the Common Agreement at a national level after the expiration of the term of the Cooperative Agreement.

Entities may enter into multi-organizational agreements to apply to this notice of funding opportunity. However, one singular entity must be the Applicant; act as the responsible agent;

submit the application on behalf of all partners, who must provide written documentation affirming the Applicant’s role as their agent; and maintain accountability for the proper use of federal funds.

1. Funding Opportunity Description

A. Purpose

The purpose of this NOFO is to support efforts to advance nationwide interoperability of Electronic Health Information (EHI)11 through a Trusted Exchange Framework (TEF) and Common Agreement that (1) allows clinicians to access health information about their patients, regardless of where the patient received care; (2) empowers individuals to use their EHI to the fullest extent; (3) enables clinicians and communities to deliver smarter, safer, and more efficient care; and (4) promotes innovation at all levels. The TEF and the Common Agreement are two distinct components. ONC will maintain the TEF and will work with the RCE to develop, update, implement, and maintain the Common Agreement. ONC will have final approval of the Common Agreement and all subsequent updates. The TEF and the Common Agreement are further described below. The RCE will also work with ONC to identify and monitor QHINs, modify and update an accompanying QHIN Technical Framework, engage with public stakeholders through virtual public listening sessions, adjudicate noncompliance with the Common Agreement, and propose sustainability strategies for an RCE to continue to support trusted data exchange through QHIN connectivity at the expiration of the term of the Cooperative Agreement.

The Trusted Exchange Framework (TEF) – To support the Cures Act’s goal of advancing health information exchange among health information networks, the TEF creates a common set of principles that are designed to facilitate trust between HINs and by which all HINs should abide in order to enable widespread data exchange. These principles are standardization; transparency; cooperation and non-discrimination; privacy, security, and patient safety; access; and data driven accountability. These principles are non-binding, but are the foundational concepts that guide the development of the Common Agreement to support the ability of stakeholders to access, exchange, and use relevant EHI across disparate HINs and sharing arrangements.

The Common Agreement – The RCE will collaborate with ONC to develop, update, implement, and maintain an ONC-approved Common Agreement. The Common Agreement will be comprised of three parts:

11 Electronic Health Information (EHI): electronic protected health information, and any other information that identifies the individual, or with respect to which there is a reasonable basis to believe the information can be used to identify the individual and is transmitted by or maintained in “electronic media,” as defined at 45 CFR § 160.103, that relates to the past, present, or future health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

• Minimum Required Terms and Conditions (MRTCs): ONC will develop the MRTCs, which will consist of mandatory minimum required terms and conditions with which QHINs may voluntarily agree to comply. The MRTCs are not a full end-to-end trust agreement. Rather, the MRTCs focus on the areas of variation among currently existing trust agreements that impede nationwide interoperability.

The Common Agreement would include the MRTCs, as well as additional required terms and conditions developed by the RCE.

• Additional Required Terms and Conditions (ARTCs): In addition to the

MRTCs, the Common Agreement will include additional required terms and conditions that are necessary for an effective data sharing agreement. These may include provisions that govern interactions between the RCE and the QHINs. For example, such provisions would cover determination of fee schedules and compliance; QHIN Application,12 Onboarding,13 and Designation14 requirements;

a process for surveilling and testing QHIN compliance with the Common Agreement; an arbitration process for adjudicating non-compliance; and an audit-appropriate process for accepting and investigating complaints, and for suspending and potentially terminating a non-compliant QHIN. The RCE will develop the ARTCs and will ensure that the ARTCs do not conflict with the MRTCs. ONC will have final approval of the Common Agreement.

• Qualified Health Information Network (QHIN) Technical Framework (QTF):

the RCE will work with ONC to develop the QTF, which will be incorporated by reference in the Common Agreement. Where the Common Agreement will include and detail the underlying policies and expectations for exchange between QHINs, the QHIN Technical Framework will focus on the technical components for exchange among QHINs, including, but not limited to identity proofing and authentication, and utilization of Connectivity Services. ONC developed the QHIN

12 QHIN Application: the written application of a HIN that wishes to become a QHIN that: (a) certifies which of the Common Agreement and QHIN Technical Framework requirements the HIN already satisfies with sufficient detail to allow the RCE to easily confirm such representations and (b) describes the HIN’s plan to satisfy all other requirements of the Common Agreement and the QHIN Technical Framework within a stated period after signing the Common Agreement.

13 Onboarding (including its correlative meanings “Onboard” and “Onboarded”): all implementation and other actions necessary for a QHIN, a Participant, or Participant Member to become operational in the live environment of the Framework Agreements to which it is a party. For a QHIN, the Onboarding requirements shall be set forth in the Common Agreement. For a Participant, the Onboarding requirements shall be set forth in the Participant-QHIN Agreement. For a Participant Member, the Onboarding requirements shall be set forth in the Participant Member Agreement.

14 Designation (including its correlative meanings “Designate”, “Designated”, and “Designating”): the RCE’s written confirmation to ONC that a Provisional QHIN has satisfied all the requirements of both the Common Agreement and the QHIN Technical Framework before the Provisional QHIN may become a QHIN.

Technical Framework Draft 1, and will work with the RCE and external stakeholders to modify and update Draft 1 per public comment.

B. Background

The U.S. Department of Health and Human Services (HHS) is committed to advancing the connectivity of patient health data and the interoperability of health information technology (health IT). In the Cures Act, Congress identified the importance of interoperability and directed ONC to work with federal agencies within HHS and with other federal partners to “develop or support a Trusted Exchange Framework, including a Common Agreement among health information networks nationally.” The Cures Act provides that the Common Agreement may include:

I. “a common method for authenticating trusted health information network participants;

II. “a common set of rules for trusted exchange;

III. “organizational and operational policies to enable the exchange of health information among networks, including minimum conditions for such exchange to occur; and

IV. “a process for filing and adjudicating noncompliance with the terms of the common agreement.”15

The first draft of the TEF was released for public comment on January 5, 2018 (“TEF Draft 1”). TEF Draft 1outlined the minimum set of principles, terms, and conditions to support the development of a Common Agreement that would enable data exchange across disparate networks. ONC reviewed all of the public comments on the TEF Draft 1 and released a modified draft for public comment on April 19, 2019. The modified draft is broken into three parts that are described further below. These parts include:

1. The TEF Draft 2, formerly “Part A—Principles for Trusted Exchange”;

2. The Minimum Required Terms and Conditions (MRTCs) Draft 2, formerly “Part B — Minimum Required Terms and Conditions for Trusted Exchange”; and

3. The QHIN Technical Framework Draft 1.

C. Program Description

This Cooperative Agreement will fund a single award with a 4-year program period of performance.16 The program will be funded for fiscal year 2019 at $900,000, with

15 Pub. L. 114-255 (Dec 13, 2016) (https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.xml#toc-

H920D7CEBEAB44045B3EC1233BB93E07A).

https://www.healthit.gov/tefca https://www.healthit.gov/tefca https://www.healthit.gov/tefca https://www.healthit.gov/tefca https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.xml#toc-H920D7CEBEAB44045B3EC1233BB93E07A https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.xml#toc-H920D7CEBEAB44045B3EC1233BB93E07A funding in additional years contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public.

To meet the goals of the Cures Act to build on existing work done by the industry, and to scale interoperability nationwide, ONC believes that an external entity is well suited to implement and monitor compliance with the Common Agreement on behalf of ONC.

ONC intends to work closely with the chosen RCE and will be continually involved in implementation of the Common Agreement throughout the Cooperative Agreement.

ONC intends to select a single RCE, through a competitive process, to develop, update, implement, and maintain the Common Agreement for ONC approval. The RCE will work closely with ONC to develop a single, all-encompassing Common Agreement that incorporates the latest versions of the ONC-developed MRTCs and the ONC-approved ARTCs to operationalize the Common Agreement. The ARTCs may not conflict with the MRTCs and ONC must approve them before they can be added to the Common Agreement. The RCE will also work with ONC to update, implement, and maintain the QHIN Technical Framework as needed. ONC will update, implement, and maintain the TEF as needed. Updates to the TEF, Common Agreement, and QHIN Technical Framework will be based on feedback from public comment periods, at least semi-annual listening sessions, and the Health Information Technology Advisory Committee (HITAC). ONC will have final approval of all updates made to the TEF, the Common Agreement, and QHIN Technical Framework. At the expiration of the term of the Cooperative Agreement, in order to maintain the Common Agreement and related components as an ongoing concern, the RCE will need to comply in a timely manner with all applicable obligations set forth in Section C (Terms and Conditions) of this NOFO.

D. Program Approach

I. Program Overview

SCOPE OF SERVICES

The RCE will be responsible for developing, updating, implementing, and maintaining the ONC-approved Common Agreement, to which QHINs will agree to adhere. The RCE will also be responsible for soliciting and reviewing applications from HINs who wish to become QHINs, evaluating Provisional QHINs,17 and

16 All referenced terms in this Notice of Funding Opportunity pertain to the period of performance.

17 Provisional QHIN: A HIN that has signed a Common Agreement that has also been signed by the RCE after approval as described in Section 2 of the MRTCs. A Provisional QHIN has not yet completed all of the requirements of the Common Agreement and the QHIN Technical Framework, and has not been Designated by the RCE as a QHIN as described in Section 2 of the MRTCs.

providing Provisional QHINs with a final written Designation18 of their QHIN status. This process is described in detail in Milestone 3.

The RCE will monitor/surveil ongoing QHIN compliance with the Common Agreement's requirements and future updates throughout the period of performance Such monitoring will include collecting metrics from the QHINs.19 Through such efforts, the RCE will investigate and be responsible for addressing the QHIN's conduct per the processes and procedures developed in the Common Agreement. If a QHIN is found to be noncompliant by the RCE and if the QHIN disagrees, the RCE will implement an arbitration process, as established in the ARTCs, and shall notify ONC. If the QHIN does not disagree, the RCE may impose a corrective action plan on the QHIN. If such corrective action plan fails to bring the QHIN into compliance, the RCE may, if necessary, revoke a QHIN's Designation and terminate the Common Agreement with a QHIN, up to and including removal from ONC’s public directory on HealthIT.gov. Additional details around the scope of services will be defined in the Principles of Proper Conduct (PoPC) and as mutually agreed upon between ONC and the RCE.

The RCE must make progress toward achieving the milestones below, as outlined in the RCE’s budget and program narrative, over the course of the 4-year funding period. ONC will work with the RCE once awarded to determine the appropriate targets and reporting requirements. The RCE's milestones under the Cooperative Agreement include the following:

1. Develop a Common Agreement that includes the MRTCs and ARTCs, for ONC approval and publication on HealthIT.gov and in the Federal Register.

2. Virtually convene public listening sessions that will allow industry stakeholders to provide objective and transparent feedback to the RCE.

3. Designate and monitor QHINs that voluntarily agree to sign and adopt the Common Agreement.

4. Implement an ONC-approved process to adjudicate QHIN noncompliance with the Common Agreement, up to and including removal from ONC’s public directory on HealthIT.gov.

5. Implement a process to update the Common Agreement, as needed, for ONC final approval and publication on HealthIT.gov and in the Federal Register.

18 Designation (including its correlative meanings “Designate”, “Designated”, and “Designating”): the RCE’s written confirmation to ONC that a Provisional QHIN has satisfied all the requirements of both the Common Agreement and the QHIN Technical Framework before the Provisional QHIN may become a QHIN.

19 These metrics will be reported by the RCE to ONC to allow for ONC programmatic oversight. Such information will also be used by ONC for interoperability research purposes, including publication of relevant reports for the public’s benefit. For example, metrics related to the number of QHINs connected to the network and the number of data transactions by each will allow ONC to monitor the success of the RCE and publish relevant reports.

6. Modify and update the QHIN Technical Framework Draft 1, for ONC approval, to detail proposed technical components for exchange between QHINs.

7. Propose strategies that an RCE could employ to sustain the Common Agreement at a national level after the expiration of the term of the Cooperative Agreement.

II. Program Evaluation and Measurement ONC will measure the success of the RCE through the reporting of progress on milestones and metrics. The RCE will develop an audit-appropriate process for validating milestone achievement. ONC will evaluate the RCE’s performance to ensure that the project is meeting stated objectives and that funding drawn down by the RCE is commensurate with milestones achieved. For each milestone, ONC will work with the RCE to determine the appropriate targets and reporting requirements.

Budget Year 1

Program Support and Engagement Funding (approximately 25% of Year 1 funds): Establish financial and reporting requirements, developing resources to conduct initial outreach, development of a program monitoring plan, and development of an audit appropriate process for validating each milestone.

Milestone tasks include:

• Engage subject matter experts (SMEs) and program support staff, to include but not be limited to legal counsel.

• Create and submit a baseline Program Monitoring Plan to support the authorized level of total award from ONC.

• Sign and comply with the PoPC developed by ONC and incorporated by reference in the Notice of Grant Award (NGA) Terms and Conditions.20

• Determine appropriate metrics for QHINs to report to the RCE to demonstrate compliance with the Common Agreement, including both process and outcome measures. This will also include appropriate timeframes for QHIN reporting to the RCE.

• Develop a public website that will keep the public abreast of pertinent information such as documents and updates including:

• Listening session details (date, time, location, registration information, objectives, etc.)

20 Details about the PoPC are further described in Section 2C of this NOFO, “Roles and Responsibilities Under a Cooperative Agreement”.

• QHIN application and Designation processes

• QHIN members

• Other information as mutually agreed upon between the RCE and

ONC

• Prepare for ongoing program monitoring activities throughout the Cooperative Agreement.

• Bi-weekly calls with ONC

• Quarterly and annual progress reports that provide updates on the

Program Monitoring Plan

• Perform other tasks as mutually agreed upon between the RCE and ONC.

Budget Year 1

Milestone 1 (approximately 50% of Year 1 funds): Develop a Common Agreement, for ONC approval and publication on HealthIT.gov and the Federal Register that includes the MRTCs and the ARTCs as described above in Section 1A. The RCE may modify their existing data sharing agreement to include the MRTCs.

Completion of this milestone will require engagement of legal professionals. If the RCE does not have existing legal staff on board, they will need to bring such staff on board. ONC may assign ONC staff to provide technical assistance and subject matter expertise for development of the Common Agreement as needed. Milestone tasks include:

• Develop the initial draft of the Common Agreement (“Common Agreement Draft 1”) for ONC approval:

• Develop ARTCs, to include:

Administrative procedures for designating and terminating

QHINs.

Provisions related to RCE monitoring/ surveillance of QHIN compliance with the Common Agreement.

An audit-appropriate process for accepting and investigating complaints regarding QHINs, including investigation of complaints regarding QHIN noncompliance with the Common Agreement. The RCE will also be responsible for making a determination regarding whether a QHIN’s Designation should be terminated and for implementing such termination.

A process for adjudicating QHIN noncompliance with the Common Agreement, up to and including removal from ONC’s public directory on HealthIT.gov.

A standard operating procedure (SOP) for placing a QHIN on a corrective action plan to address QHIN noncompliance with the Common Agreement. Such SOP shall also include the procedures and timelines for an RCE to report such corrective action plan or loss of QHIN Designation to ONC. Such SOP shall also include procedures and timelines for QHINs to be notified of corrective action plan or loss of Designation.

Additional terms and conditions, as mutually agreed upon by ONC and the RCE.

• Incorporate by reference in Common Agreement Draft 1, the QHIN Technical Framework. The RCE will also be required to attend ONC workgroup meetings to ensure alignment between the QHIN Technical Framework and the Common Agreement.

• Revise Common Agreement Draft 1 per ONC feedback.

• Revise Common Agreement Draft 1 per public comment and listening session feedback (see Milestone 2), per ONC approval.

• Submit final Common Agreement Version 1 to ONC for publication on HealthIT.gov and the Federal Register.

• Establish a process for updating the Common Agreement Version 1, as ONC deems necessary— throughout the Cooperative Agreement – to account for new technologies, policies, and use cases.

• Coordinate and collaborate with ONC subject matter experts, collaborating organizations, and other critical stakeholders, such as the National Institute for Standards and Technology (NIST) to ensure alignment across the most updated versions of the TEF, the ONC-approved Common Agreement, and the ONC-approved QHIN Technical Framework.

• Perform other tasks as mutually agreed upon between the RCE and ONC.

Budget Years 1-4

Milestone 2 (approximately 20% of annual funds): Convene virtual public listening sessions at least on a semiannual basis that will allow the industry to provide objective and transparent feedback to the RCE around the development of updates to the Common Agreement, QHIN Technical Framework, and other activities, as needed. Listening sessions should be fairly balanced in terms of the points of view represented and should be made up of broad stakeholder representation.

Stakeholders represented may include, but are not limited to, healthcare systems, payers, purchasers, care providers (e.g., long-term and post-acute care, behavioral health, community-based and safety net providers, and emergency medical services), health IT developers; QHINs, HINs, federal stakeholders, individuals, and/or other stakeholders that enable widespread health information exchange to occur. Milestone tasks include:

• Develop and publish ONC-approved procedures for holding virtual public listening sessions in coordination with ONC, including:

o Plans to solicit and convene stakeholders across the industry, including updating the RCE’s website to inform stakeholders of listening sessions.

o Listening session objectives, which should include a commitment to neutrality, transparency, and non-preferential treatment of stakeholders.

o A process for recording stakeholder input.

• Coordinate and collaborate with ONC subject matter experts, collaborating organizations, and other stakeholders, such as the National Institute for Standards and Technology (NIST).

• Launch and maintain listening sessions in accordance with ONC-approved published procedures.

• Carryout other tasks as mutually agreed upon between the RCE and ONC.

Budget Years 2-4

Milestone 3 (approximately 50% of Year 2 funds and 40% of Years 3 & 4 funds):

Designate and monitor QHINs that voluntarily agree to adopt and sign onto the Common Agreement. This includes reviewing and approving QHIN Applications and launching, at a minimum, semi-annual Cohorts21 for Provisional QHINs to be evaluated for compliance with the Common Agreement as a function of gaining QHIN Designation.22 Milestone tasks include:

• Solicit, collect, and evaluate QHIN Applications from HINs who wish to receive QHIN Designation.23

21 Cohort: a group of one or more Provisional QHINs as specified in writing by the RCE that are attempting to be Designated by the RCE as QHINs by the same Cohort Deadline.

22 In order to apply for QHIN Designation, a HIN must meet certain prerequisites, including already operating a network that provides the ability to locate and transmit EHI between multiple persons or entities electronically, with existing persons or entities exchanging EHI in a live clinical environment; and providing the RCE with a written plan of how it will achieve all of the requirements of the Common Agreement within a specified time period. A HIN must submit a QHIN Application to the RCE documenting that it meets these prerequisites, and the RCE must certify in writing that the HIN in question has satisfied these prerequisites. Once the RCE has approved a QHIN Application, the HIN becomes a Provisional QHIN and is assigned to a Cohort to complete the remainder of the requirements in the Common Agreement and QHIN Technical Framework. A Provisional QHIN is only Designated a QHIN once the RCE has confirmed and documented that the Provisional QHIN in question has satisfied the requirements of the Common Agreement and the QHIN Technical Framework. The RCE will also be responsible for monitoring QHINs on an ongoing basis and adjudicating noncompliance with the Common Agreement, up to and including removal from ONC’s public directory on HealthIT.gov, when necessary.

23 As described in Section 2.1 of the MRTCs.

o This includes updating the RCE’s website to allow stakeholders to submit QHIN Applications, and for the RCE to publicly post QHIN members.

• Approve or reject each QHIN Application, in writing, within a stated period after receipt of a completed QHIN Application.

o No QHIN Application shall be approved by the RCE unless the HIN certifies in writing and the RCE has confirmed and documented that the HIN in question has satisfied all applicable requirements of the Common Agreement and the QHIN Technical Framework only to the extent they are prerequisites24 to the RCE signing the Common Agreement with the HIN.

• Provide written approval of each HIN’s QHIN application, and provide each HIN with a copy of the Common Agreement for signature by each HIN.

o Upon return to the RCE of the Common Agreement signed by the HIN, the RCE shall promptly sign it, return a fully executed copy to the HIN, and assign the HIN in writing to a Cohort, specifying the applicable Cohort Deadline.25

• Launch Cohorts for Provisional QHINs that sign the Common Agreement.

o The RCE may, in its reasonable discretion, assign the Provisional

QHIN to other Cohorts with later Cohort Deadlines.

• Monitor and evaluate Provisional QHINs through collection of metrics and reports that confirm they meet the definition of a QHIN26 and are in compliance with the Common Agreement.27

• This includes collection of Breach28 notifications from QHINs and reporting them to ONC.

• Designate QHINs after confirming and documenting that the Provisional QHIN in question has satisfied the applicable requirements of the Common Agreement and the QHIN Technical Framework.

• Simultaneously provide Provisional QHINs and ONC with written documentation of QHIN Designation.

24 Minimum prerequisites are further described in Section 2.1.3 of the MRTCs.

25 Cohort Deadline: the date established by the RCE for a completion of all Onboarding and other actions necessary for the Provisional QHINs in the Cohort to be designated by the RCE as QHINs.

26 As described in Section 2 of the MRTCs.

27 Metrics to be developed as part of Program Support and Engagement Funding.

28 Breach: has the meaning assigned to such term in 45 CFR § 164.402 regarding PHI as if it applied to EHI and arises from an act or omission of a QHIN, Participant or Participant Member in the context of any of the Framework Agreements that involves the EHI that was exchanged, Used, or Disclosed pursuant to any of the Framework Agreements.

• Perform other tasks as mutually agreed upon between the RCE and ONC.

Budget Years 2-4

Milestone 4 (approximately 5% of Years 2-4 funds): Implement the ONC-approved Common Agreement developed in Milestone 1, including QHIN Designation and reviewing potential noncompliance by QHINs to the provisions of the Common Agreement. Milestone examples include, but are not limited to:

• Monitor ongoing QHIN compliance with the Common Agreement throughout the period of performance and implement an arbitration process for adjudicating noncompliance, up to and including removal from ONC’s public directory on HealthIT.gov, when necessary.

• Conduct ongoing surveillance to assess whether QHINs comply with the Common Agreement. This includes collecting ONC-approved metrics developed in Milestone 1 and, if necessary, assessment, revision and/or updates of metrics (subject to ONC approval).

In the event that a QHIN is found to be noncompliant with the Common Agreement, the RCE will be responsible for implementing the processes and procedures in the Common Agreement (as described above for addressing QHIN noncompliance) and the PoPC. The RCE will also be responsible for other tasks that are mutually agreed upon by the RCE and ONC.

• Budget Years 2-4

Milestone 5 (approximately 15% of Years 2-4 funds): Implement an RCE-established process to update the Common Agreement, for ONC final approval and publication on HealthIT.gov and the Federal Register, including:

• Collect listening session feedback.

• Revise Common Agreement per public comment feedback.

• Submit the revised Common Agreement to ONC for approval.

• Perform other tasks as mutually agreed upon between the RCE and ONC.

Budget Years 1-4

Milestone 6 (approximately 15% of Year 1 funds and 10% of Years 2-4 funds):

Modify the QHIN Technical Framework Draft 1 developed by ONC and update it during the period of performance, for ONC approval. The RCE will be expected to collaborate with ONC, as needed, in Year 1 to ensure alignment of the Common Agreement with the draft QHIN Technical Framework (Milestone 1). ONC may assign staff to provide technical assistance and subject matter expertise for updates to the QHIN Technical Framework, as needed. Milestone tasks include:

• Modify and update QHIN Technical Framework Draft 1 for ONC approval, per listening session(s) and public comment feedback.

• After receiving ONC approval, release the final QHIN Technical Framework Version 1 for production.

• Establish and publish an ONC-approved process for ongoing receipt of comments on the QHIN Technical Framework Version 1, as well as a process for maintaining the QHIN Technical Framework and for providing suggestions to ONC on potential updates such as:

o Adding population-level EHI exchange.

o Adding and updating technical components and use cases over time and as necessary.

• Perform other tasks as mutually agreed upon between the RCE and ONC.

Budget Years 3 & 4

Milestone 7 (approximately 10% of Year 3 & 4 funds): Propose strategies that an RCE could employ to sustain the Common Agreement at a national level at the expiration of the term of the Cooperative Agreement.

• Submit a proposed sustainability strategy for an RCE to continue to support trusted data exchange through QHIN connectivity at the expiration of the term of the Cooperative Agreement.

• Revise sustainability strategy per ONC feedback.

• Perform other tasks as mutually agreed upon between the RCE and ONC.

29 Drawdowns of funds over the course of the program are contingent upon availability of funds, satisfactory completion of milestones, and a determination that continued funding is in the best interest of the federal government and the public.

Milestone Examples for Milestone Achievement29 Due Dates

Program Support and Engagement

Funding (approximately 25% of Year 1 funds)

Engage SMEs and program support staff, to include but not be limited to, legal counsel

September 30, 2019

Create and submit a baseline Program Monitoring Plan to support the authorized level of total award from ONC

Sign and comply with the PoPC developed by ONC and incorporated by reference in the

NGA Terms and Conditions

Determine appropriate metrics for QHINs to report to the RCE to demonstrate compliance

March 30, Milestone Examples for Milestone Achievement29 Due Dates

Program Support and Engagement

Funding (approximately 25% of Year 1 funds) continued with the Common Agreement, including both process and outcome measures.

September 30, 2019 continued

Develop a public website that will keep the public abreast of pertinent information

Prepare for ongoing program monitoring activities throughout the Cooperative

Agreement

Perform other tasks as mutually agreed upon between the RCE and ONC. Ongoing

Milestone 1 (approximately 40% of Year 1 funds)

Develop Common Agreement Draft 1 for ONC approval

November 29, 2019

Revise Common Agreement Draft 1 per ONC feedback

Revise Common Agreement Draft 1 per public comment and listening session feedback

June 29, Submit Common Agreement Version 1 to ONC July 6, 2020

Establish a process for updating the Common Agreement, as ONC deems necessary— throughout the Cooperative Agreement – to account for new technologies, policies, and use cases.

July 13, Coordinate and collaborate with ONC subject matter experts, collaborating organizations, and other critical stakeholders, such as the

National Institute for Standards and Technology (NIST) to ensure alignment across the most updated versions of the TEF, the ONC-approved Common Agreement, and the ONC-approved QHIN Technical

Ongoing

Milestone Examples for Milestone Achievement29 Due Dates

Milestone 1 (approximately 40% of Year 1 funds) continued

Framework. Ongoing

Perform other tasks as mutually agreed upon between the RCE and ONC. Ongoing

Milestone 2 (approximately 20% of annual funds)

Develop and publish procedures for holding virtual public listening sessions in coordination with ONC

November 13, 2019

Coordinate and collaborate with ONC subject matter experts, collaborating organizations, and other critical stakeholders, such as the

National Institute for Standards and Technology (NIST) to ensure alignment across the most updated versions of the TEF, the ONC-approved Common Agreement, and the ONC-approved QHIN Technical Framework.

Ongoing

Launch and maintain listening sessions in accordance with published procedures

Ongoing

Perform other tasks as mutually agreed upon between the RCE and ONC. Ongoing

Milestone 3 (approximately 50% of Year 2 funds and 40% of Years 3 & 4 funds)

Solicit, collect, and evaluate QHIN Applications from HINs who wish to receive

QHIN Designation

August 31, 2020 for first Cohort and ongoing

Approve or reject each QHIN Application, in writing, within a stated period after receipt of a completed QHIN Application

Provide written approval of each HIN’s QHIN application, and provide each HIN with a copy of the Common Agreement for signature by each HIN

Milestone 3 (approximately 50% of Year 2 funds and 40% of Years 3 & 4 funds) continued

Launch Cohorts for Provisional QHINs that sign the Common Agreement

August 31, 2020 for first Cohort and ongoing

Monitor and evaluate Provisional QHINs through collection of metrics and reports that confirm they meet the definition of a QHIN and are in compliance with the Common Agreement and the QHIN Technical

Framework

Ongoing

Designate QHINs after confirming and documenting that the Provisional QHIN in question has satisfied the applicable requirements of the Common Agreement and the QHIN Technical Framework

Simultaneously provide Provisional QHINs and ONC with written documentation of

QHIN Designation

Perform other tasks as mutually agreed upon between the RCE and ONC

Milestone 4 (approximately 5% of Years 2-4 funds)

Monitor ongoing QHIN compliance with the Common Agreement throughout the

Cooperative Agreement and implement an arbitration process for adjudicating noncompliance.

Ongoing

Conduct ongoing surveillance to assess whether QHINs comply with the Common Agreement. This includes collecting ONC-approved metrics developed in Milestone 1 and, if necessary, assessment, revision and/or updates of metrics (subject to ONC approval).

In the event that a QHIN is found to be noncompliant with the Common Agreement, the RCE will be responsible for implementing the processes and procedures in the Common

Milestone 4 (approximately 5% of Years 2-4 funds) continued

Agreement and the PoPC.

Ongoing

Perform other tasks as mutually agreed upon between the RCE and ONC.

Milestone 5

(approximately 15% of Years 2-4 funds)

Collect listening session feedback

Ongoing

Collect public comment feedback

Revise Common Agreement per listening session feedback

Revise Common Agreement per public comment feedback

Submit revised Common Agreement to ONC for approval

Perform other tasks as mutually agreed upon between the RCE and ONC

Milestone 6 (approximately 15% of Year 1 funds and 10% of Years 2-4 funds)

Modify and update the QHIN Technical Framework Draft 1 for ONC approval, per listening session(s) and public comment feedback

February 28, 2020

After receiving ONC approval, release for production the final QHIN Technical

Framework Version 1

April 29, Establish and publish an ONC-approved process for ongoing receipt of comments on the QHIN Technical Framework Version 1, as well as a process for maintaining the QHIN

Technical Framework and for providing suggestions to ONC on potential updates

July 29, Perform other tasks as mutually agreed upon between the RCE and ONC Ongoing

Milestone 7 (approximately

10% of Year 3 & 4 funds)

Submit a proposed sustainability strategy for an RCE to continue to support trusted data exchange through QHIN connectivity at the expiration of the term of the Cooperative

Agreement

No later than

February 10, 2023

Revise sustainability strategy per ONC feedback

No later than June 12, 2023

Perform other tasks as mutually agreed upon between the RCE and ONC Ongoing

2. Funding Opportunity Award Information

A. Key Award Parameters

Title: Trusted Exchange Framework and Common Agreement Recognized Coordinating Entity (RCE) Cooperative Agreement Program

Federal Funding Agency: Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC)

Announcement Type: Cooperative Agreement

Application Type: New

Notice of Funding Opportunity Number: NAP-AX-19-001

Catalog of Federal Domestic Assistance (CFDA) Number: 93.347

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):

$900,000 for Year 1

Anticipated Number of Awards: 1

Approximately Amount of Award: $900,000 for Year 1

Program Period: 08/30/2019-08/29/2023

Budget Period(s): 08/30/2019-08/29/2023

Funding of future noncompeting 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.

This will be a cost-based reimbursable award. It is important to note that progress must be made toward achieving the milestones as outlined in the RCE’s approved budget and program narrative.

This NOFO does not overlap or otherwise duplicate other HHS or other federally funded health IT initiatives and is meant to leverage, supplement, and build upon existing efforts.

Cost-Sharing Requirements: There is no cost-sharing or matching requirement.

Program Income: There are four potential ways in which ONC may require that a recipient apply program income as specified in the NGA: 1) deduct it from total allowable 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 program, 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 program 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. If program income is generated, the recipient must use the additive method.

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

B. Key Dates

Milestone Date

NOFO Released 04/19/2019

Informational Session 04/30/2019

Letter of Intent Due 05/17/2019

Applications Due 06/17/2019

Anticipated Award Date 08/30/2019

Anticipated Program Start Date 08/30/2019

C. Roles and Responsibilities Under a Cooperative Agreement

The funding instrument used for this program will be a Cooperative Agreement, an assistance mechanism in which substantial ONC programmatic involvement is anticipated throughout the program period. Under the Cooperative Agreement, ONC’s purpose is for the development and advancement of interoperable health IT and support and stimulate the RCE’s activities by involvement in, and otherwise working jointly with the RCE; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this premise, the prime responsibility resides with the RCE for the program as a whole. To facilitate appropriate involvement, during the period of this Cooperative Agreement, ONC and the recipient will be in close, continuous contact.

ONC may provide technical assistance, including, but not limited to, federal guidance on the evolution of the Common Agreement and QHIN Technical Framework in accordance with current and future ONC regulatory efforts. ONC may also provide technical assistance to the RCE to support meeting programmatic goals. To facilitate compliance with the terms of the Cooperative Agreement and to more effectively support the RCE, ONC will actively coordinate and collaborate with critical stakeholders. In accordance with the Cooperative Agreement, ONC may assign staff to provide technical assistance and subject matter expertise throughout the period of performance of the Cooperative Agreement.

• The RCE will be required to sign and comply with Principles of Proper Conduct (PoPC) developed by ONC and incorporated by reference in the NGA Terms and Conditions. The PoPC will include:

o Appropriate metrics and timeframes for the RCE to report to ONC to monitor milestone progress o Timeframes and process for notifying ONC of any QHIN noncompliance with the Common Agreement, including privacy and security breaches Participants are to report any breaches to HINs, HINs are…