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Exemplar Health Information Exchange Governance Entities Program Federal grant opportunity
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HIEGE-HG-12-001
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Department of Health and Human Services

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U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology Exemplar Health Information Exchange Governance Entities Program Funding Opportunity Announcement

HIEGE-HG-12-001

Application Due Date: February 4, 2013 Anticipated Award Date: March 25, 2013

Table of Contents

Executive Summary3
Opportunity Overview4
I.Funding Opportunity Description5
A.Background and Purpose5
B.Project Structure and Scope of Services6
1.Approach6
2.General Funding Requirements6
3.National Priority Topics7
4.Project Goals8
5.Principles9
C.Statutory Authority9
II.Award Information10
A. Summary of Funding10
B. Substantial Involvement in Cooperative Agreements10
III.Eligibility Information12
A.Eligible Applicants12
B.Cost-Sharing or Matching12
C.Responsiveness and Screening Criteria12
Application Responsiveness Criteria12
Application Screening Criteria12
IV.Application and Submission Information14
A.Address to Request Application Package14
B.Content and Form of Application Submission14
1. Letter of Intent14
2. Project Abstract15
3. Project Narrative15
C. Submission Dates and Times19
D. Intergovernmental Review19
E. Funding Restrictions19
F. Application Submission Requirements20
V. Application Review Information21
A. Objective Review Criteria21
B. Review Process22
C. Considerations in Making Final Award Decisions22
D. Anticipated Announcement and Award Dates23
VI.Award Administration Information24
A.Award Notices24
B.Administrative and National Policy Requirements24
C.HHS Grants Policy Statement24
D.Record Retention24
E.Reporting25
F.Cooperative Agreement Terms and Conditions of Award26
VII.Agency Contacts29
Appendix A.30

Executive Summary The Exemplar Health Information Exchange Governance Entities Cooperative Agreement Program (Program) seeks to support a collaborative exchange within existing private or public sector organizations that have already established governance of health information exchange. The purpose of the Program is to work with existing governance entities to further develop and adopt policies, interoperability requirements, and business practice criteria that align with national priorities, overcome interoperability challenges, reduce implementation costs and assure the privacy and security of electronic exchange of health information. By advancing and further developing existing health information exchange governance models, this Program promises to increase the level of secure electronic health information exchange in the nation. Section 3011(a) of the Public Health Service Act (PHSA) authorizes the Secretary to invest in the infrastructure necessary to allow for and promote the electronic exchange and use of health information for each individual in the United States consistent with the goals of the Federal Health Information Technology Strategic Plan: 2011-2015, and more specifically, support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner. Total funding available for this initiative is $800,000.

Opportunity Overview U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) Funding Opportunity Title: Exemplar Health Information Exchange Governance Entities Program (“Program”) Announcement Type: Initial Cooperative Agreement Funding Opportunity Number: HIEGE-HG-12-001 Catalog of Federal Domestic Assistance (CFDA) Number: 93.239 Key Dates and Submission Information:

The award process for this cooperative agreement will take place according to the timeline below. All applicants will undergo an objective review. A successful application will result in the award of a 12-month cooperative agreement with the potential for an additional 1 year continuation award based upon satisfactory performance and subject to the availability of funds.

FOA Details
Date[footnoteRef:1] [1: The dates are approximate.]

Section Reference

Technical Assistance Teleconference
January 7, 2012 at 2:00 pm EST
Notice of Intent to Apply Due
January 11, 2013 by 5:00 pm EST
Section IV – Application and Submission Information
Application Due Date
February 4, 2013 by 5:00 pm EST
Section IV – Application and Submission Information
Anticipated Award Date
March 25, 2013
Section IV – Application and Submission Information
Total Funding
$800,000
I.Funding Opportunity Description
A.Background and Purpose

This funding opportunity announcement (FOA) will advance collaboration within private or public sector organizations that have already established governance of health information exchange. The purpose of the Program is to work with existing governance entities to further develop and adopt policies, interoperability requirements, and business practice criteria that align with national priorities, overcome interoperability challenges, reduce implementation costs and assure the privacy and security of electronic exchange of health information, in a manner consistent with section 3011(a) of the PHSA. As a cooperative agreement, as opposed to a grant, this award instrument of financial assistance ensures substantial involvement between the Office of the National Coordinator for Health Information Technology (ONC) and the recipients during the performance of the project.

ONC had previously considered proposing the establishment of a voluntary accreditation process for the governance of health information exchange through a rulemaking process. A Request for Information (RFI) solicited feedback on whether ONC should establish this voluntary program and on the specific rules of the road that exchange entities should follow. Several of the responses to the RFI pointed out that there are already organizations engaged in health information exchange governance activities, and that ONC should work with these entities rather than set up a new process and program. Based on these and many other comments received, ONC decided not to pursue a governance approach through rulemaking at this time. Instead ONC is establishing a robust framework of leadership, guidance, engagement, listening and learning, and monitoring.

· We will identify and shine light on good practices that support robust, secure and interoperable exchange.

· We will actively engage with entities currently serving in governance/oversight roles to promote emerging good governance practices.

· We will continue to use our existing authorities and convening powers to create consensus and provide guidance and tools to address specific barriers to interoperability and exchange.

· We will continue to evaluate how and what consumer protections can be appropriately applied to health information exchange through existing regulatory frameworks.

· We will continue to monitor and learn from the wide range of activities occurring.

This FOA will enable ONC to work collaboratively through the cooperative agreement process with existing entities undertaking governance activities for the electronic exchange of health information to encourage them to develop and adopt scalable national policies, interoperability requirements and business practice requirements that reduce the cost and complexity of exchange, obviates the need for cumbersome legal agreements and reduces the cost and complexity of health information exchange, . The FOA is focused on working with existing governance entities to expand their rules of the road (i.e. policies, interoperability requirements and business practice requirements) for participating organizations. This work will support and advance the efforts of existing governance entities which will benefit consumers and providers by allowing health information to flow securely between unaffiliated healthcare organizations.

The cooperative agreement will provide funding to selected governance organizations to collaborate with ONC to:

· Develop and implement policies, interoperability requirements and business practice requirements that will facilitate directed “push” and/or query-based exchange[footnoteRef:2] and address operational challenges that are slowing adoption and use of either model of exchange [2: We define “directed push” exchange as a message sent from one participant to another, often to support anticipated and planned care. Examples include information that is sent by a hospital to another provider when a patient is referred or discharged from the hospital, lab results delivery or alerts to a primary care provider when a patient is seen in the emergency department. We define “query-based” exchange as models allowing providers to query for a patient’s health information, for instance when the patient arrives at an emergency department or at a specialist’s office without any clinical information. ]

· Identify potential opportunities to incorporate these solutions in national policy through certification of electronic health records, nationally adopted standards, incorporation into federal policy or additional governance activities

B.Project Structure and Scope of Services
1.Approach

ONC will enter into cooperative agreements with up to four awardees whose primary role is providing governance for participants’ directed “push” and/or query-based exchange. Applicants may address one or both of the exchange models. ONC is interested in funding at least one applicant that will provide governance for each exchange model. ONC will work with each awardee through the cooperative agreement process to determine the set of policies, interoperability requirements and business practice requirements that will be addressed under this cooperative agreement. Once the Exemplar Health Information Exchange Governance Entities cooperative agreement(s) are awarded, ONC will encourage State HIE Cooperative Agreement grantees to participate in the Exemplar Health Information Exchange Governance Entities awardee activities, as appropriate. Awardees will serve as key partners with ONC in demonstrating potential scalable national rules of the road for the electronic exchange of health information.

2. General Funding Requirements Applicants must:

1) Have operational governance for the electronic exchange of health information. This means the applicant has established and implemented policies, interoperability requirements and business practice requirements for participants’ query-based exchange, directed “push” exchange or both.

2) Support the exchange of health information between unaffiliated healthcare organizations, health information organizations and across multiple vendors’ products.

3) Have broad representation of stakeholders (i.e. as relevant healthcare providers, health IT vendors, consumers, health information organizations, etc.) in decision-making bodies and processes.

4) Adhere to principles outlined in Section I.B.5, Principles

3. National Priority Topics ONC will work with awardees to develop and implement governance policies, interoperability requirements and business practice requirements addressing the national priority topics outlined below. Addressing these topics will support health information exchange in stages one and two of meaningful use and will facilitate implementation of innovative payment models. In areas where ONC has existing recommendations from the HIT Policy Committee or the HIT Standards Committee that ONC has considered and decided to implement, or has Standards & Interoperability Framework activities, those will be used as the starting point to develop solutions.

1) Directed “Push” Exchange Model

a) End user identity resolution and authentication

b) Discovery and management of digital certificates

c) Exchanging certificate trust bundles

d) Querying provider directories

2) Query-Based Exchange Model

a) Improving patient matching for a patient record query

b) Implementing meaningful patient choice to participate in HIE

c) Determining a treatment relationship exists before a patient record query is executed

d) Addressing liability concerns

Each applicant will work on national priority topics in their selected exchange model through this cooperative agreement and may also propose additional priority topics. ONC will work with each awardee to determine the final set of topics each awardee will work on under this cooperative agreement. If multiple awardees are working on the same or similar topics, ONC may instruct awardees to work together to establish a common solution.

4. Project Goals Awardees will be required to achieve the following goals during the one year cooperative agreement period:

1. Work Plan Subgoal 1.1: Initial Meeting - Each awardee shall meet with ONC staff within seven business days of the date of issuance of the Notice of Award of the grant. This meeting may be carried out in-person or via telephone conference call. The purpose of the meeting is to kick-off the project and discuss required elements for the project work plan.

Subgoal 1.2: Work Plan – Each awardee shall produce a draft work plan within three weeks of the initial meeting. The draft work plan shall reflect the discussions from the initial meeting. ONC staff will provide comments/approval of the plan within seven (7) business days.

2. Collaboration Among Awardees Subgoal 2.1: Initial Meeting – All awardees will be required to participate in a joint meeting with ONC staff within six weeks of award for a collaborative discussion about goals, strategies, and areas of coordination between grantees addressing similar priority topics.

Subgoal 2.2: Ongoing Collaboration – As requested by ONC, awardees will be required to participate in a collaborative process to ensure the development of common solutions across awardees in areas of overlap.

3. Data Reporting Each awardee must report aggregate statistics on user volume, user characteristics and transaction volume for the exchange model(s) that is facilitated by their governance approach. ONC will work with the awardee to determine, based on their exchange model, the format and specific data that must be reported. Data reporting will be requested no more frequently than quarterly.

4. Solution Development and Implementation The awardee will develop and implement a solution for the identified priority topics.

5. Participation in ONC Activities Each awardee should set aside resources in order to enable its participation in partnership activities identified by ONC. Awardees should expect this to include, at a minimum, participation in a public forum in the nature of a town hall meeting, which ONC expects to launch in the first quarter of calendar-year 2013. ONC anticipates that this forum will meet approximately 10 times in 2013 via teleconference and will enable individual participants to exchange facts and information and to provide their individual input on policies and practices for health information exchange organizations.

6. Performance Reports The awardee shall submit semi-annual progress reports related to their projects and overall project performance. A specific Performance Report format will be finalized between the awardee and ONC following the award date.

5. Principles Awardees in their operation and in their development and adoption of policies, interoperability requirements and business practice requirements must:

· Adhere to the principles of the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information http://www.healthit.gov/sites/default/files/nationwide-ps-framework-5.pdf.

· Ensure conformance to the requirements of the Privacy and Security Rules issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) (Pub. L. 111-5) and the Patient Protection and Affordable Care Act (ACA) (Pub. L. 111-148).

· Use national standards, implementation specifications and certification criteria/testing procedures adopted by U.S. Department of Health and Human Services except where ONC formally concurs with an awardee finding that the standards, implementation specifications and/or certification criteria/testing procedures are not applicable.

· Use the Standards and Interoperability Framework to address gaps where national standards have not been adopted or require refinement.

· Minimize time, complexity and effort to negotiate legal agreements by agreeing on common requirements.

C. Statutory Authority The Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5) was enacted on February 17, 2009. The HITECH Act amended the Public Health Service Act (PHSA) and established “Title XXX—Health Information Technology and Quality” to improve health care quality, safety, and efficiency through the promotion of HIT and the electronic exchange of health information. In particular, Section 3011(a) of the PHSA, authorizes the Secretary to invest in the infrastructure necessary to allow for and promote the electronic exchange and use of health information for each individual in the United States consistent with the goals of the Federal Health Information Technology Strategic Plan: 2011-2015, and more specifically, support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner.

II. Award Information A. Summary of Funding

Type of Award:
Cooperative Agreement
Approximate Amount of Funding Available:
$800,000
Award Floor:
$200,000
Award Ceiling:
$400,000
Approximate Number of Awards:
4
Program Period Length
12 months with the potential for an additional 1 year continuation award based upon satisfactory performance and subject to the availability of funds.
Anticipated Project Start Date
March 25, 2013

B. Substantial Involvement in Cooperative Agreements Awards will be in the form of cooperative agreements. Substantial Federal involvement in the Exemplar Health Information Exchange Governance Entities Program will be required, including ONC’s close collaboration with recipients to encourage the continued development and adoption of policies, interoperability requirements and business practice requirements that align with national standards and policy guidance that will increase the ease of electronic health information exchange, reduce implementation costs, and assure the privacy and security of data being exchanged.

Cooperative Agreement Roles and Responsibilities:

a) Office of the National Coordinator for Health Information Technology (ONC) ONC will have substantial involvement in program awards, including, but not limited to, the elements outlined below:

· Topics – ONC will work with each awardee to determine the topics that each awardee will work on under the cooperative agreement.

· Collaboration – ONC will identify the collaborative structure to bring awardees under this cooperative agreement together to work on common or overlapping topics.

· Project Officers – ONC will assign specific Project Officers to each cooperative agreement award to support and monitor recipients throughout the project period.

· Monitoring – ONC Project Officers will monitor, on a regular basis, progress of each recipient. This monitoring may be by phone, document review, on-site visit, other meetings and by other appropriate means, such as reviewing program progress reports and Federal Financial Reports (SF425). This monitoring will be to determine compliance with programmatic and financial requirements as well as to assess the achievement of programmatic goals.

b) Awardees Awardees and assigned points of contact retain the primary responsibility and dominant role for planning, directing and executing the proposed project as outlined in the terms and conditions of the cooperative agreement and with substantial ONC involvement. Responsibilities include:

· Requirements – Awardees shall comply with all requirements of this FOA and the terms and conditions of the Award Notice.

· Topics – Awardees shall work on the topics identified in collaboration with ONC under this cooperative agreement. Awardees are required to receive ONC prior approval to modify the topics they are working on.

· Standards – Awardees are required, except in those circumstances where deviation is specifically authorized by ONC, to utilize national standards, implementation specifications and certification criteria/testing procedures adopted by U.S. Department of Health and Human Services.

· Collaboration – Awardees, at the request of ONC, will be instructed to collaborate with other awardees under this cooperative agreement. Awardees are required to collaborate with key stakeholders listed in this FOA, other recipients under this cooperative agreement, the ONC team and ONC supported initiatives, including but not limited to, the Standards and Interoperability Framework, cooperative agreements under Section 3013 of the PHSA as added by ARRA.

· Reporting – Awardees are required to comply with all reporting requirements outlined in this FOA and the terms and conditions of the cooperative agreement to ensure the timely release of funds.

III.Eligibility Information
A.Eligible Applicants

Eligible applicants must:

· Be a not-for-profit entity[footnoteRef:3], state government, or a component of state government; [3: For applicants awaiting not-for-profit status determination, ONC will work individually with these applicants on a case by case basis.]

· Have as a main focus the governance of health information exchange between unaffiliated healthcare organizations, health information organizations and across multiple vendor products;

· Have participating entities that are using policies, interoperability requirements and business practice requirements implemented by the applicant for the exchange of health information; and

· Have participating entities in three or more states.

B. Cost-Sharing or Matching None.

C. Responsiveness and Screening Criteria Application Responsiveness Criteria Applications that do not meet the following responsiveness criteria will be administratively eliminated and will not be sent forward for objective review:

· The applicant meets the eligibility criteria as required by Section III.A, Eligible Applicants.

· The application is received by the deadline required under Section IV.C, Submission Dates and Times.

Application Screening Criteria ONC will screen all applications to identify those that do not meet criteria outlined below. The application screening criteria are:

· The application meets the formatting and length requirements found in Section IV.B, Content and Form of Application Submission.

· The applicant submits a complete and timely application, including the timely submission of a letter of intent to apply.

· The application identifies which model(s) of exchange they will address (e.g., directed “push”, query-based or both).

· Appendices and attachments are not used as a mechanism to exceed page limits of the Project Narrative. NOTE: Letters of Support, List of Participants and Résumés of Key Project Personnel are not counted as part of the Project Narrative for purposes of the 30 page limit.

IV. Application and Submission Information A. Address to Request Application Package This FOA includes all needed materials to apply under this initiative. This FOA may be found online at http://www.Grants.gov.

If you have difficulty obtaining the application materials from the site above, please email ONC at StateHIE@hhs.gov.

APPLICATIONS CANNOT BE ACCEPTED THROUGH ANY EMAIL ADDRESS OR THROUGH ANY WEBSITE OTHER THAN http://www.Grants.gov. APPLICATIONS CANNOT BE RECEIVED VIA PAPER MAIL, FAX, COURIER, OR DELIVERY SERVICE.

B. Content and Form of Application Submission

1. Letter of Intent Applicants must submit a non-binding letter of intent to apply for this funding opportunity. Those organizations which do not submit a letter of intent to apply will not be considered eligible, and their applications will not be reviewed. This letter must include the name of the applicant organization, type of organization (non-profit, state government, or a component of state government), the city and state in which it is located, and the exchange model(s) which the applicant proposes to work on (query-based exchange, directed “push” exchange, or both). The letter must demonstrate that the applicant meets the requirements of Section III.A Eligible Applicants:

· Be a not-for-profit entity[footnoteRef:4], state government, or a component of state government; [4: For applicants awaiting not-for-profit status determination, ONC will work individually with these applicants on a case by case basis.]

· Have as a main focus the governance of health information exchange between unaffiliated healthcare organizations, health information organizations and across multiple vendor products;

· Have participating entities that are using policies, interoperability requirements and business practice requirements implemented by the applicant for the exchange of health information; and

· Have participating entities in three or more states.

The letter must be received by the deadline required in Section IV.C, Submission Dates and Times. Notices of intent should be sent to StateHIE@hhs.gov. The letter of intent should not exceed 4 pages.

2. Project Abstract Applicants shall include an abstract of the application of no more than two pages single spaced and 500 words. This abstract is often distributed to provide information to the public and Congress and represents a high-level summary of the project. Applicants should prepare a clear, accurate, and concise abstract that can be understood without reference to other parts of the application and which gives a description of the proposed project, including: the project’s goal(s), objectives, exchange model(s) addressed, overall approach, anticipated outcomes and products.

The Project Abstract must have a font size of not less than 11 point font.

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 Address Contact Name Contact Phone Numbers (Voice, Fax) E-Mail Address Web Site Address, if applicable Exchange model(s) the applicant will address Geographic coverage of the applicant’s governance activities

3. Project Narrative The Project Narrative is the most important part of the application because it is the primary information used to score applications during the objective review process. In the Project Narrative, the applicant shall provide a detailed understanding of their experience with operating governance for the electronic exchange of health information, demonstrate the organizational capacity and stakeholder buy-in needed to perform the proposed work, describe existing policies, interoperability requirements or business practice requirements followed by participants, clearly describe the proposed approach to developing and implementing governance solutions to identified topics and provide other information needed to evaluate the application.

The Project Narrative must be on 8 ½” x 11” size sheets with 1” or larger margins on all sides, and a font size of not less than 11. Smaller font sizes may be used to fill in the Standard Forms and Sample Formats. The maximum length for the Project Narrative is 30 pages single spaced. Letters of Support, List of Participants and Résumés of Key Project Personnel are not counted as part of the Project Narrative for purposes of the 30 page limit.

The Project Narrative must follow the outline provided below and include the information required under each section.

Approach, Work Plan, and Activities Applicant Capabilities and Collaboration and Letters of Support from Key Participants Existing Rules of the Road Budget, Level of Effort, and Justification Section 1: Approach, Work Plan, and Activities This section must set out the approach and strategy proposed to address the identified exchange model(s) the applicant proposes to address. This section must include:

A description of the applicant’s approach to governance including:

· A description of the organizational structure, participants, operational structure and roles and responsibilities of officers and participants.

· An indication of the exchange model(s) (directed “push”, query-based) you currently support through your governance activities, and which you would like to work on as part of this Cooperative Agreement.

· How your organization prioritizes, develops and implements rules of the road with participants to address policy, interoperability and participants’ business practices issues.

How the applicant supports the exchange of health information between unaffiliated healthcare organizations, health information organizations and across multiple vendors’ products. Please include in the appendix a list of current actively participating healthcare organizations, health information organizations and vendors. The list of participants will not count as part of the Project Narrative for purposes of the 30 page limit.

· Identify the priority topics for the applicant’s chosen exchange model(s) (see Section I, B.3 National Priority Topics). The applicant may also propose additional topics it wants to address through this cooperative agreement. For all identified topics the applicant must include a clear and concise description of its planned approach for addressing the topic (including what policies, interoperability requirements and business practice requirements will be developed) and how the approach will support the principles outlined in Section I, B.5 Principles.

Section 2: Applicant Capabilities and Collaboration and Letters of Support from Key Participants This section must clearly demonstrate that the organizational and personnel capabilities of the applicant support its ability to implement the project. It must also demonstrate the applicant’s ability to bring together all of the stakeholders and resources necessary to perform the proposed work. This section must include:

· The organization’s capabilities relevant to the exchange model(s) selected and the partners and collaborative relationships with healthcare stakeholders that will support the project’s success.

· Relevant organizational resources available to perform the proposed project such as facilities, equipment, and other resources.

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

· A description of the qualifications of the proposed key staff. Résumés may be included as attachments and will not be counted within the 30 page maximum for the project narrative.

The applicant shall demonstrate support for this application from key participants in the applicant’s governance structure, such as participating providers, vendors, health information organizations or health information service providers. Letters of support should be included as attachments and will not be counted within the 30 page maximum for the project narrative.

The applicant shall demonstrate broad representation of stakeholders (i.e. as relevant providers, vendors, consumers, health information organizations etc) in decision making.

Because this is a collaborative effort, discuss the willingness of your organization to collaborate with other awardees to address common topics, if requested by ONC.

Section 3: Existing Rules of the Road The applicant must have operational governance for the electronic exchange of health information. This means the applicant has established and implemented policies, interoperability requirements and business practice requirements for participants’ query-based exchange, directed “push” exchange or both that are in use by participants.[footnoteRef:5] [5: Participants are organizations that directly subscribe to the services of a governance entity. User means the individuals or organizations within a participant of a governance entity. For instance Speedy Health Information Exchange is a participant of the Exemplar Governance Organization. Providers at Hospital A, which is a member of the Speedy Health Information Exchange, are users. ]

Applicants must describe their current approach, if any, to the following topics for participants’ exchange activity under the applicant’s governance approach:

1) Are participants required to ensure that all exchange users have been identity-proofed and are authenticated, either directly or indirectly? What are the requirements?

2) What, if any, is the approach to ensure that individuals whose information is exchanged by participants using a query model have a meaningful choice in whether their information is exchanged?

3) What, if any, is the approach to ensure that individually identifiable health information (IIHI) that is exchanged is encrypted?

4) Do participants make available a notice of data practices describing why IIHI is collected, how it is used, and to whom and for what reason it is disclosed? If so, how is this provided?

5) If participants assemble or aggregate health information that results in a unique set of IIHI: Are policies established around providing individuals with electronic access to their unique set of IIHI? If so what are the policies? What policies do you have for providing individuals with the right to request a correction, and/or annotation to this unique set of IIHI?

6) Is there an approach for verifying that a treatment relationship exists before a user can query for a patient’s health information? If so, what is the approach?

7) Does your approach to authentication rely on digital certificates? If so what is the approach for participants and users to establish, discover, and use digital certificates in the exchange of health information? Are there other methods of authentication used?

8) What is the approach to verify and match the subject of a message, including the ability to locate a potential source of information, for query-based exchange?

9) What interoperability standards has your organization adopted to facilitate the exchange model(s) covered by your governance structure? Are these standards required to be used by participants? Have you adopted national standards (Meaningful Use Stage 1 and 2) or NwHIN Portfolio Standards (see appendix 1) for relevant use cases? Are there areas in which you have diverged from national standards? If so why? In areas where national standards do not exist how have you filled the gap? (please be as specific as possible in all responses).

10) Does your organization validate and enforce participants’ adherence to adopted policies, interoperability requirements and business practice requirements? If so, how?

11) What policies, if any, does your organization have related to financial or other preconditions to exchange between entities participating within your governance structure? For entities outside your governance structure?

12) Do participants make available provider directories for query by other participants? If so what is the approach?

Section 4: Budget, Level of Effort, and Justification Applicant is required to outline proposed costs that support all project activities in the Budget Narrative/Justification. The application must include the allowable activities that will take place during the funding period and outline the estimated costs that will be used specifically in support of the program. Costs are not allowed to be expended until the start date listed in the Notice of Grant Award. Whether direct or indirect, all costs must be allowable, allocable, reasonable and necessary under the applicable OMB Cost Circular: http://www.whitehouse.gov/omb/circulars and based on the programmatic requirements for administering the program. The budget period will be equivalent to the project period.

C. Submission Dates and Times

· Notices of Intent to Apply should be submitted electronically, no later than 5:00 p.m. Eastern Standard Time on January 11, 2012.

· Applications must be submitted via http://www.grants.gov/ no later than 5:00 p.m. EST on February 4, 2013.

· Applications that fail to meet the application due date will not be reviewed and will receive no further consideration.

· Grants.gov will automatically send applicants a tracking number and date of receipt verification electronically once the application has been successfully received and validated in Grants.gov. After the Office of Grants Management retrieves the application form from Grants.gov, a return receipt will be emailed to the applicant contact. This will be in addition to the validation number provided by Grants.gov.

D. Intergovernmental Review This program is excluded from Executive Order 12372.

E. Funding Restrictions Funds under this announcement cannot be used for the following purposes:

To supplant or replace current public or private funding.

To supplant on-going or usual activities of any organization involved in the project.

To purchase or improve land, or to purchase, construct, or make permanent improvements to any building.

To reimburse pre-award costs.

F. Application Submission Requirements ONC requires that applications for this and all other announcements be submitted electronically through http://www.Grants.gov by the deadline required in Section IV.C, Submission Dates and Times. The Grants.gov registration process can take several days. If your organization is not currently registered with http://www.grants.gov, please begin this process immediately. Instructions on how to register, tutorials and FAQs are available on the Grants.gov web site at http://www.grants.gov. Assistance is also available 24 hours a day, seven days a week (excluding Federal holidays) from the Grants.gov help desk at support@grants.gov or by phone at 1-800-518-4726. When using Grants.gov, you will be able to download a copy of the application packet, complete it off-line, and then upload and submit the application via the Grants.gov website.

Grants.gov Registration Registration with Grants.gov typically takes approximately 3-5 business days. However, the process can take up to 4 weeks to complete. Applicants are strongly encouraged to register, locate and test current logins and passwords for this system well in advance of the deadline date. For assistance with registration please go to; http://www.grants.gov/applicants/get_registered.jsp.

V. Application Review Information A. Objective Review Criteria Applications that meet the requirements of Section III.C, Responsiveness and Screening Criteria, will be forwarded for objective review. Panels will review applications against a standard scoring sheet that reflects the review criteria outlined below. Applicants will be scored by assigning a maximum of 100 points across five criteria.

· Approach, Work Plan, and Activities - (35 points)

· Applicant Capabilities and Collaboration and Letters of Support from Key Participants - (25 points)

· Existing Rules of the Road - (35 points)

· Budget, Level of Effort, and Justification - (5 points)

Section 1: Approach, Work Plan, and Activities (35 points)

· The extent to which the applicant outlines a credible, clear and concise description of its approach for developing solutions to the proposed priority topics and how its approach will support the principles outlined in Section I, B.5 Principles.

· Strength of evidence of the applicant’s experience supporting the exchange of health information between unaffiliated healthcare organizations, health information organizations and across multiple vendors’ products.

· The extent to which the applicant’s proposed approach is feasible within the cooperative agreement timelines.

Section 2: Applicant Capabilities and Collaboration and Letters of Support from Key Participants (25 points)

· Strength of evidence that the applicant brings the organizational and personnel capabilities needed for successful project implementation.

· The extent to which the applicant demonstrates support from key participants such as providers, vendors, health information organizations or health information service providers, including through letters of support.

· The applicant expresses a willingness to collaborate with other awardees to address common priorities, if requested by ONC.

Section 3: Existing Rules of the Road (35 points) The extent to which the applicant’s existing approach adheres to the principles outlined in Section I, B.5 Principles, including:

· The extent to which the applicant’s existing policies, interoperability requirements and business practice requirements will achieve the principles of the Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health Information.

· As applicable, the extent to which the applicant’s current adopted standards, implementation guides and certification criteria/testing procedures align with those adopted by the U.S. Department of Health and Human Services.

· The extent to which the applicant’s policies and approaches can reduce the cost and implementation burden of exchange, including negotiation of legal agreements among participants.

· Strength of evidence of the applicant’s experience establishing solutions to key policy, interoperability requirements or business practice issues to advance the exchange of health information.

Section 4: Budget, Level of Effort, and Justification (5 points)

· Reasonableness of the proposed budget and its justification in context of the proposed work.

B. Review Process ONC will appoint multiple objective review panelists. These panelists will consist of unbiased subject matter experts assigned to review applications. These reviewers may be internal or external to HHS and will be qualified to review the approach and/or technical aspects of the application. As part of the objective review, all invited applications will:

· be independently reviewed and scored by each objective review panel member;

· be discussed and scored by the panel; and

· be documented with a written critique.

C. Considerations in Making Final Award Decisions Final award decisions will be made by The National Coordinator for Health Information Technology. In making these decisions, the National Coordinator for Health Information Technology will take into consideration the application scores determined by the objective review panel; the topic areas proposed by the applicants; the geographic coverage of the potential awardees’ governance activities; the geographic distribution of potential awardees; the distribution of potential awardees across identified exchange model(s); the policy, technology, and other priorities of ONC and HHS; and availability of funds at the time of award.

D. Anticipated Announcement and Award Dates ONC anticipates making award announcements regarding selected applications on March 25, 2013. The project periods for approved projects will begin on March 26, 2013.

VI.Award Administration Information
A.Award Notices

The applicant will receive notification of the outcome of the review process outlined in Section V. If applicant is accepted, it will be required to accept the terms and conditions placed on its application before funding can proceed. Letters of notification acknowledge that an award was funded, but do not provide authorization for the applicant to begin performance and expend funds associated with the award until the start date of the award as indicated in the notice. Applicant may request a summary of the expert committee’s assessment of the application’s merits and weaknesses.

The Notice of Grant Award (NGA) contains details on the amount of funds awarded, the terms and conditions of the cooperative agreement, the effective date of the award, the budget period for which support will be given, and the total project period timeframe. This NGA is then signed by the ONC Grants Management Officer, sent to the applicant agency’s Authorized Representative, and will be considered the official authorizing document for this award. Successful applicants will receive an electronic NGA. Unsuccessful applicants will be notified within 30 days of the final funding decision and will receive a disapproval letter via e-mail or U.S. mail.

B. Administrative and National Policy Requirements The award is subject to Department of Health and Human Services Administrative Requirements, which can be found in 45 CFR Parts 74 and 92 and the Standard Terms and Conditions implemented through the HHS Grants Policy Statement (HHS GPS) located at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

C. HHS Grants Policy Statement ONC awards are subject to the requirements of the HHS GPS that are applicable to the grant/cooperative agreement based on recipient type and purpose of award. This includes, as applicable, any requirements in Parts I and II of the HHS GPS that apply to the award, as well as any requirements of Part IV. The HHS GPS is available at http://www.hhs.gov/grantsnet/adminis/gpd/. The general terms and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award-specific.

Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of an award, or may reasonably be considered pertinent to a grant/cooperative agreement.

D. Record Retention Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of three years from the date the final annual Federal Financial Report (SF 425) or any other forms as determined is submitted and approved. See 45 CFR 74.53 and 92.42 for the general requirements for, as well as the potential exceptions to and qualifications of, the three-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the three-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including indirect cost proposals and property records. See also, 45 CFR 74.48 and 92.36 (governing contractual requirements regarding record retention and access requirements for contracts under grants).

E. Reporting All reporting requirements will be provided to applicant, adherence to which is a required condition of any award. In general, applicants must comply with the following reporting and review activities:

a. Audit Requirements The grantee shall comply with audit requirements of OMB Circular A-133. Information on the scope, frequency, and other aspects of the audits can be found on the Internet at http://www.whitehouse.gov/omb/circulars;

b. Financial Status Reports The grantee shall submit an annual Federal Financial Report (FFR) using the web-based Online Data Collection (OLDC) tool. The reporting period for the FFR is October 1 through September 30, due to HHS no later than December 30 of each year the award is active.

The grantee shall also submit a FFR Cash Transaction Report (lines 10a-c) of the SF-425 via the Payment Management System (PMS). The FFR Cash Transaction Report is due within 30 days after the end of the each calendar quarter (January 30, April 30, July 30, and October 30) for the life of the award.

Failure to submit these reports timely could affect future funding.

c. Program and Performance Reports The grantee must report aggregate statistics on users and transaction volume for exchange that is facilitated by their services. ONC will work with the grantee to determine, based on their exchange model, the format and specific data that must be reported. Data reporting will be requested no more frequently than quarterly.

The awardee shall submit semi-annual progress reports related to their projects and overall Project performance. A specific Performance Report format will be finalized between the awardee and ONC following the award date.

F. Cooperative Agreement Terms and Conditions of Award This section details the specific terms and conditions applicable to successful awarding of full applications, not preliminary applications. Upon award of a cooperative agreement, the following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, and other applicable HHS, PHS, and ONC grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, in which substantial ONC programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the ONC purpose is to support and stimulate recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among recipients and ONC as defined below. 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. Requests to modify or amend the cooperative agreement or the work plan may be made by ONC or the recipient at any time. Modifications and/or amendments to the cooperative agreement or work plan shall be effective upon the mutual agreement of both parties, except where ONC is authorized under the Terms and Conditions of award, 45 CFR Part 74 or 92, or other applicable regulation or statute to make unilateral amendments.

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