MarketTransparencyProjectFOA.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Funding Opportunity Announcement

Market Transparency Project for Health IT Interoperability Services

Application Due Date: [07/31/2017]

Anticipated Award Date: [09/13/2017]

Table of Contents Executive Summary

A. Program Description/Purpose

Structure and Approach

Performance Goals/Program Milestones

B. Funding Opportunity Award Information

Key Award Parameters

Key Dates

Roles and Responsibilities Under a Cooperative Agreement Informational Session

Notice of Intent

C. Eligibility Information

D. Application and Submission Information

Application Package

Application Submission Instructions

Restrictions on Oral Conversations

E. Application Review Information

Screening Review

Merit Review

Pre-Award Risk Assessment

F. Federal Award Administration Information

Award Decisions

Notice of Grant Award

Terms and Conditions

G. Points of Contact

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

Executive Summary

The Market Transparency Project for Health IT Interoperability Services is a cooperative agreement funding opportunity to be funded under the Consolidated Appropriations Act, 2017, Pub. L. No. 115-31, Division H, Title II.

Among the National Coordinator for Health Information Technology’s duties laid out in the Health Information Technology for Economic and Clinical Health Act (HITECH Act),1 the National Coordinator is tasked with promoting “a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in health care services.”2 Further, the 21st Century Cures Act of 20163 includes focused and specific direction to the Secretary and National Coordinator to take several actions related to health information technology (health IT) interoperability. Specifically, the 21st Century Cures Act emphasizes several new actions to improve interoperability nationwide. Among other provisions, it requires new and increased transparency and reporting through the ONC Health IT Certification Program, the development of a trusted exchange framework (including a common agreement among health information networks), and establishes a new paradigm for the identification of information blocking and associated penalties.

In alignment with these statutory goals and objectives, this cooperative agreement aims to increase industry-led marketplace transparency and awareness efforts, by spurring the development of a non-governmental, publicly accessible online resource for the voluntary reporting, viewing, and comparison of crowdsourced cost data associated with the wide range of health IT interoperability services. Some examples of industry-led, marketplace transparency resources available in other sectors include Glassdoor, TrueCar, Angie’s List, Consumer Reports, and Yelp.

Health IT interoperability services and interface costs are often required to enable interoperability among health IT systems used by various stakeholders (including electronic health records (EHRs), laboratories, public health, registries, and third-party health applications). For the purposes of this project, interoperability services is meant to include, but is not limited to: the labor and software development associated with establishing connectivity among two or more different health IT systems;

transmission services for health data, such as lab orders and results, medication information, and images;

deployment, implementation, and use of “apps;” secure messaging; data translation and normalization services; quality reporting services; data aggregation and analysis services; and patient engagement services.

The lack of publicly available data on the costs associated with such interoperability services, limits industry transparency and the ability of different stakeholders to compare such costs for fairness and overall market value. As discussed in the 2016 Report to Congress on Health IT Progress, the lack of reliable information about health IT products and the high costs of switching imposed on health care providers has had an impact on health IT ecosystem and also impedes stakeholders’ ability to identify the use of unfair and inconsistent interface pricing practices. These challenges are particularly acute and diverse in the ambulatory setting among different specialties and scopes of practice. Additionally, having this information made accessible to those involved in pricing decisions and negotiations would assist all parties in determining a fair and competitive market value for their particular health IT service

1 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 (the Recovery Act)(Pub. L. 111-5),( February 17, 2009)..

2 42 U.S.C. § 300jj–11(b)(10).

3 Public Law 114-255, specifically Title IV https://www.glassdoor.com/index.htm https://www.truecar.com/#/ https://www.angieslist.com/ http://www.consumerreports.org/cro/index.htm https://www.yelp.com/search?cflt=homeservices&find_loc=Washington%2C+DC https://www.healthit.gov/sites/default/files/2016_report_to_congress_on_healthit_progress.pdf or interface. To ensure that the online resource is developed in a way that will adequately address the issues mentioned above, this cooperative agreement will also fund the necessary market research, and development of a crowd sourcing methodology specifically designed for the collection of voluntarily submitted information related to interoperability services costs, towards providing the most value possible to the marketplace.

The project also builds off of findings from the 2016 Report to Congress on the Feasibility of Mechanisms to Assist Providers in Comparing and Selecting Certified EHR Technology Products, which was based on substantial market analysis and insight from subject matter experts, including the ONC Certified Technology Comparison Task Force.

https://www.healthit.gov/sites/default/files/macraehrpct_final_4-2016.pdf https://www.healthit.gov/facas/health-it-policy-committee/hitpc-workgroups/certified-technology-comparison-task-force

A. Program Description/Purpose

Background: State of the Market and Existing Challenges

Together with industry stakeholders, ONC continues to lead substantial progress in health IT adoption across the country. Health information now flows more often among providers and to patients.

Stakeholders from across the care continuum are seeing the benefits of having the right information at the right time, in structured, electronic format. Interoperability, the ability of a system to exchange electronic health information with and use electronic health information from other systems without special effort on the part of the user, is a necessary foundation to support a nationwide transition toward value-based care among many other potential public health and safety benefits.

The constant influx of new technologies and services into the health care ecosystem combined with the complexity of health care data creates, at times, an overwhelming abundance of choices. For health care providers interested in maximizing their use of health IT, the absence of a simple, publicly available way to report, view, and compare cost data on health IT interoperability services limits industry transparency and competitive market dynamics. This is especially true in ambulatory settings and across specialties, where providers typically do not have substantial time and resources to conduct broad market research.

Indeed, ambulatory health care providers often convey difficulty in finding the information needed to make an informed choice before committing to a resource-intensive process to acquire and integrate a new health IT interoperability service (e.g., app integration, new technical interface). Similarly, third-party app developers report there is little transparency regarding terms of use, fees, and the resources that they will need to expend in order to connect with the different data sources, such as electronic health record (EHR) systems. This lack of transparency can impede innovation and inhibit providers from delivering improvements at the point of care through novel technologies.

Moreover, the lack of reliable, up-front information about costs and limitations of health IT services— including those related to technical interfaces and interoperability—contributes to information blocking and is a serious barrier to the flow of health information. This lack of transparency distorts the marketplace, making it difficult for providers and other stakeholders to effectively compare, select, and develop the solutions that are essential for success in new care delivery and payment models. Without the ability to effectively compare and select appropriate solutions, providers can become “locked in” to health IT platforms or systems that do not meet their needs, which in turn limits incentives for developers to respond to competitive pressures to innovate better technologies and solutions.

The 2016 Report to Congress on the Feasibility of Mechanisms to Assist Providers in Comparing and Selecting Certified EHR Technology Products found that while health IT comparison tools exist, they are insufficient in enabling the health care community’s ability to effectively compare and select certified health IT. The report found that mechanisms to address unmet needs include the market need to collect and share information on certified health IT and collaborate with stakeholders to develop comparison tools that better meet providers’ certified health IT comparison needs. By making this additional information on health IT interoperability services costs available, existing comparison tools could be improved while meeting provider needs for transparency into what may constitute fair-market pricing.

Furthermore, as noted in ONC’s Report to Congress on Health Information Blocking, providers compare and select health IT products in “a marketplace that is opaque and in which acquirers often lack up-front https://www.healthit.gov/sites/default/files/macraehrpct_final_4-2016.pdf http://healthit.gov/sites/default/files/reports/info_blocking_040915.pdf information.” 4 As part of efforts to promote greater transparency and access to information about certified health IT products and services, the 2015 Edition final rule requires that health IT developers disclose detailed, plain language information about certified health IT via their websites and marketing materials.5 These disclosures must include detailed information about limitations and types of costs that may affect the successful implementation and use of certified health IT capabilities. This information is intended to help customers understand and more effectively compare certified health IT and solutions that may meet their needs while avoiding unanticipated costs, limitations, and implementation or performance issues. However, although these disclosures contain valuable information, they do not require developers to disclose actual price information and other details that may be useful in fostering a more competitive health IT marketplace. Therefore, ONC seeks to address these additional gaps by spurring the development of an industry managed online transparency comparison tool, which will complement the goals of both the HITECH and 21st Century Cures Acts.

Purpose / Impact

The purpose of this cooperative agreement is to improve transparency in the current market by funding the development of an independent, open, online resource (e.g., an interactive website/platform containing crowdsourced and voluntarily submitted data), whose design features and functionality is to be guided by market research to be performed by the recipient on costs frequently associated with health IT interoperability services. The online resource should focus distinctly on ambulatory health care providers as its target audience and make it easy for such stakeholders to voluntarily contribute cost data and other information about their health IT products and services and list them on the online resource. A crowd-sourcing methodology will also need to be developed, that specifically takes into account potential industry challenges and existing limitations that could keep individuals from voluntarily divulging their cost data (i.e., personal profit motives, restricted under confidentiality clauses).

All components of the online resource should be developed with a central focus on addressing the particular goals, challenges, and motivations of the end users (with a primary focus on ambulatory health care providers and those providing health IT services to that setting). The recipient can use existing technical platforms and tools to develop the online resource for this cooperative agreement. If the recipient elects to use existing technology to develop the online resource, it must obtain all rights, permissions, licenses, and clearances for such technology necessary to meet the terms and conditions of the FOA. Such resources will give providers and other health IT purchasers and licensees, third-party developers, product researchers, and other stakeholders the ability to easily compare associated costs with health IT interoperability services. Information must also be aggregated and presented through the open, online resource following human-centered design principles, with the additional goal of making it both engaging and intuitive for users to voluntarily report, review, and compare interoperability services costs.

The overall desired impact resulting from this cooperative agreement would be to help improve the transparency of costs associated with health IT interoperability services and move the overall market toward greater competition, thereby empowering stakeholders in the ambulatory health IT market to make better and more informed choices when pursuing such services in the future.

4 ONC, Report to Congress on Health Information Blocking (Apr. 2015), available at https://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf.

5 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule, 80 FR 62601 (October 16, 2015) (2015 Edition final rule); See 45 C.F.R. § 170.523(k)(1).

https://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic

Scope of Services

ONC began to address transparency concerns in the 2014 Edition final rule 6 and the 2015 Edition final rule, which established certification program requirements for health IT developers to make more information available about certified health IT products and capabilities.7 With the 2015 Edition final rule, developers must now disclose any known material limitations and types of costs associated with the certified capabilities of their health IT products, and ONC-Authorized Certification Bodies (ONC- ACBs) must engage in more extensive and more rigorous “in the field” surveillance of certified health IT capabilities to verify that they are functioning consistent with their certification in production environments. Developers must also address any identified non-conformities and address them, working with ONC-ACBs who then report any corrective action plans when surveillance reveals that certified health IT is not performing as required. Corrective action plans are regularly published on ONC’s upgraded Certified Health IT Product List (CHPL) and a new website, HealthIT.gov/transparency, which aggregates key product disclosure and transparency information in one place to make it easier for health IT consumers to access and compare this information.

Notwithstanding these previous advances to promote greater transparency and accountability in the health IT marketplace, there are limits to the types of information that ONC can require developers to disclose. Therefore, this cooperative agreement is intended to enable additional, voluntary-based avenues independent of government led activities, to enhance transparency in the marketplace.

In order to achieve the objectives of the cooperative agreement, the recipient will develop a project plan, complete market research on cost complexities associated with health IT interoperability services to guide the development of the online resource, develop a crowdsourcing methodology for the collection of data deemed valuable by the market research, develop and maintain an online resource which focuses on giving ambulatory health care providers and those providing health IT services to that setting a forum to voluntarily and easily report, review, and compare more detailed information about the specific costs, capabilities, limitations, and other performance characteristics of health IT interoperability services, and submit a post beta release analysis of the online resource. This non-governmental online resource will not only directly benefit ambulatory health care providers, but will also create stronger incentives for health IT developers and integrators to offer better and less costly interoperability services and solutions.

ONC will not own, host, or maintain the online resource, and as such, all deliverables are oriented towards ensuring the online resource will remain within the purview of non-governmental industry experts. Furthermore, the recipient must also provide a financial sustainability plan projecting three years after the end of the cooperative agreement’s period of performance, in order to demonstrate its ability to sustain the continued development and management of the online resource. The financial sustainability plan may include, but is not limited to: business model, pricing strategies, market research, public and private financing strategies, revenue streams, financial reporting, audits, and controls.

6 Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology, 77 FR 54163,( Sept. 4, 2012) (2014 Edition final rule).

7 45 CFR § 170.523(k); see also 80 FR 62719.

http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 http://www.westlaw.com/Link/Document/FullText?findType=l&pubNum=0001037&cite=UUID(I6A1A6920F65E11E1A7ACC86B50A57916)&originatingDoc=ICCDE69D073D311E592FCF72CBDF63FEF&refType=CP&fi=co_pp_sp_1037_54163&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.History*oc.UserEnteredCitation)#co_pp_sp_1037_54163 https://www.federalregister.gov/d/2015-25597/p-1537 https://www.healthit.gov/transparency

Structure and Approach For additional guidance on how to approach each of the following tasks and deliverables, please visit the U.S. Digital Services Playbook: https://playbook.cio.gov/.

Key Tasks, Deliverables, and Timeline

The recipient will primarily focus on areas of the ambulatory setting where health IT interoperability services cost data is needed to encourage greater market competition and use of health IT, including certified health IT products. In order to achieve this, the recipient must execute the following tasks associated with the scope of services:

1. Complete and submit a final project plan

a. The project plan of reference will be the applicant’s initially proposed project plan from its application, with any revisions made as a result of discussions with ONC, which is incorporated in the award.

b. Recipients will be required to track progress by collecting data about their activities and progress toward milestones and outcomes.

c. The project plan and any subsequent modifications must be reviewed and approved by

ONC.

2. Complete market research on health IT interoperability services costs

a. Create and execute a market research plan that encompasses geographic and organizational diversity, while incorporating an assessment of the unique needs of various potential stakeholders and eventual users of the online resource,

i. This market research is designed to aid in the recipient’s development of the online resource.

ii. At a minimum, the research must evaluate the needs of ambulatory health care providers and those providing health IT services to that setting.

b. Publication of a summary report, a form of which will be made publicly available, of the market research findings that will present and analyze the types of cost variables associated with health IT interoperability services. This research should:

i. identify and take into account the perspectives of various stakeholders involved in ambulatory settings that would benefit from having access to such information (i.e., physicians, healthcare CIOs, CFOs, contracting personnel, sales teams, EHR vendors, application developers, IT departments and among many others),

ii. be conducted using human-centered design principles and focus on improving market transparency in health IT interoperability services costs, and

iii. Identify and assess potential challenges and barriers that may exist with sharing information related to interoperability services costs (e.g., contract confidentiality clauses).

3. Develop a crowdsourcing methodology

a. Utilize the above market research to develop a methodology for the open crowd-sourced collection and validation of interoperability services cost data for health IT systems.

https://playbook.cio.gov/

b. Submit a report which details the methodology to be used for the effective crowdsourced collection and validation of various cost data associated with health IT interoperability services through an open, web enabled IT platform.

c. The report should specifically detail how the methodology will account for challenges associated with:

i. incentivizing participation in the voluntary submission of data, including ensuring that “positive” experiences are included;

ii. specifically addressing the challenges associated with any potential confidentiality clauses;

iii. validating the accuracy of such data; and

iv. maintaining the anonymity of individual(s) reporting, if such a feature is deemed necessary.

4. Develop an open, interactive and engaging online resource

a. Secure all necessary rights, permissions, and licenses required for the development and management of the online resource (if applicable).

b. Utilize the above market research and crowd-sourcing methodology deliverables to develop, launch and manage an open resource that will give stakeholders involved in ambulatory settings (including providers, developers, vendors, and other stakeholders) the ability to voluntarily self-report, easily search, and compare data on various health IT interoperability services costs.

c. Create and execute a user testing plan that incorporates best practices and principles of human-centered design and usability.

d. While the specific types of information included should be informed by the market research conducted in Task 1, examples of different types of relevant information may include, but are not limited to:

i. customer/user classifications (i.e., those submitting data on incurred costs)

ii. types/categories of interoperability services (i.e., those identified as areas of interest thorough the above market research)

iii. costs categories (e.g., for development, integration, staff, time)

iv. who performed the work (development, integrations, etc.)

v. health IT product(s)/app(s) involved.

e. Must adhere to all funding restrictions detailed on pg. 27, under Section F, Terms and Conditions for this FOA, with regard to the development of the online platform.

5. Complete and submit a post beta release analysis

a. Analyze initial beta release of the online resource based on user feedback, performance analytics, and summarize strengths and weaknesses.

b. Detail what changes and enhancements will be made as a result of the beta release analysis.

c. Provide a summarized report of the analysis with an estimated timeline for making any such changes.

6. Complete and submit a sustainability plan

a. Submit a business sustainability plan for the online resource that clearly sets out the recipient’s strategy to achieve sustainability of the online resource beyond the end of the period of performance and projecting three years beyond the end of the cooperative agreement.

b. The business sustainability plan may include but is not limited to: pricing strategies, market research, public and private financing strategies, revenue streams, financial reporting, business planning, audits, and controls.

Timeline for Required Deliverables Task Deliverable Due Date Task 1 – Final Project Plan

A project plan of reference will be the applicant’s initially proposed project plan from their application, with any revisions made as a result of discussions with ONC, which is incorporated in the award.

By the end of September 2017

Task 2 – Market Research Conduct market research on cost variables for health IT services necessary for the successful development, deployment, and utilization of IT solutions, primarily in ambulatory settings.

A report, a form of which will be publicly available, of the market research findings, which will present and analyze the types of cost variables and related transparency challenges, associated with health IT interoperability services.

January 2018

Task 3 – Crowdsourcing Methodology Develop a methodology for the open crowd-sourced collection and validation of cost data for health IT interoperability services.

A report, detailing the methodology for the effective crowdsourced collection and validation of various cost data associated with health IT interoperability services through an open, web enabled online resource.

March 2018

Task 4 – Online Resource Develop and manage a publicly accessible web-based tool for the ongoing collection, analysis, display, and querying of interoperability services cost data.

An online resource (e.g., interactive website) where ambulatory healthcare providers and other stakeholders can easily report, review, and compare relevant information about interoperability services costs often associated with health IT applications in ambulatory settings.

Beta release by June 2018

Task 5 – Post Beta Release Analysis Conduct an analysis of the performance and user-experience associated with the online tool.

A report, summarizing the analysis of the post-launch performance and user experience.

September 2018

Task 6 – Business Sustainability Plan

A business sustainability plan that clearly sets out the recipient’s strategy to achieve sustainability by the end of the period of performance and projecting three years beyond the end of the cooperative agreement.

Draft due in December

Final Due June 2019

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

1. Completion of market research on health IT interoperability services costs (first distribution, estimated 10% of funding awarded)

a. Create and execute a market research plan that encompasses geographic and organizational diversity, while incorporating the unique needs of stakeholders that would benefit from having access to such information (e.g., ambulatory health care providers and those providing health IT services for solutions in ambulatory settings).

b. Publish a summary report detailing the findings of market research to benefit the health IT community.

2. Development of a crowdsourcing methodology (second distribution, estimated 10% of funding awarded)

a. Utilize the above market research to develop a methodology for the open crowd-sourced collection and validation of interoperability services cost data for health IT systems in ambulatory settings.

b. Address the challenges associated with soliciting public participation, while maintaining the validity and balance of such data being shared publicly through the online resource.

3. Development of an interactive and engaging online resource (third distribution, estimated 65% of funding awarded)

a. If applicable, secure all necessary rights, permissions, and licenses for the development and management of the online resource.

b. Develop an open resource that will focus on giving ambulatory health care providers and other stakeholders involved in ambulatory settings, the ability to voluntarily self-report, easily search, and compare data on various health IT interoperability services costs.

c. Create and execute a user testing plan that incorporates best practices and principles of human-centered design and usability.

4. Completion of post beta release analysis (fourth distribution, estimated 10% of funding awarded)

a. Analyze initial beta release of online resource based on user feedback and summarize strengths and weaknesses.

b. Detail what changes and enhancements will be made as a result of the beta release analysis.

c. Provide an estimated timeline for making any such changes.

5. Completion and submission of a sustainability plan (last distribution, estimated 5% of funding awarded)

a. Submit a business sustainability plan that clearly sets out the recipient’s strategy to achieve sustainability by the end of the period of performance and projecting three years beyond the end of the cooperative agreement.

b. The business sustainability plan may include but is not limited to: pricing strategies, market research, public and private financing strategies, revenue streams, financial reporting, business planning, audits, and controls.

The recipient’s progress toward performance-based key milestones and outcomes will be regularly monitored on an ongoing basis. In the event a recipient’s progress is lagging, the ONC project officer for that award will work with the recipient to furnish technical assistance aimed at improving the recipient’s performance.

Recipients may also be expected to participate in a more formal assessment of performance against key milestones, outcomes, and accomplishments expected semi-annually, pursuant to the applicant’s project plan for activities under this award. This assessment may occur via a project site visit or through telecommunications technologies.

B. Funding Opportunity Award Information

Key Award Parameters

Title: Market Transparency Project for Health IT Interoperability Services

Federal Funding Agency: Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Announcement Type: Cooperative Agreement.

Application Type: New

Funding Opportunity Announcement Number: NAP-AX-17-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.983

Eligible Applicants:

Private nonprofit institutions/organizations, public nonprofit institutions/organizations, and private or for profit organizations with proven knowledge of and familiarity working with either Health IT interoperability services, developing online tools for crowd sourced reporting, or a combination of the two.

Legislative Authority:

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

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

Anticipated Number of Awards: 1

Approximately Amount of Each Award: $250,000

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

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

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

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

Program Income: There are four potential ways in which ONC may require that a recipient apply program income as specified in the Notice of Grant Award (NGA): 1) deduct it from total allowable project/program costs to determine the net allowable costs on which the Federal share of costs is based;

2) add it to funds otherwise available for the project, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.

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

Intergovernmental Review: This program is excluded from Executive Order 12372

Key Dates Milestone Date

FOA Released

06/30/2017

Informational Session

07/10/2017

Notice of Intent Due

07/17/2017

Applications Due

07/31/2017

Anticipated Award Date

09/13/2017

Anticipated Project Start Date

09/18/2017

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

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

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

participating in the selection of key personnel releasing funds based on achievement of performance goals/project milestones reviewing and approving of substantive provisions of proposed subawards or contracts reviewing and accepting deliverables reviewing and approving budgets selecting meeting/panel members participating in communities of practice providing tactical guidance and feedback during project execution engaging with leadership of the recipient’s organization to ensure successful execution of the cooperative agreement ending an activity if performance specifications are not met

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

Discuss the background, purpose, scope, terms and conditions, and other provisions in the FOA Explain the eligibility and application requirements Describe the application review process Provide an opportunity for interested parties to ask questions

Further details about the informational session – including the date, time, and instructions for joining – are available at https://www.healthit.gov/.

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

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

The Notice of Intent is requested by 11:59 P.M. Eastern Standard Time on July 17, 2017, and should be sent to ONC.TechLab@hhs.gov. The notice should identify the name of the applicant organization, the city and state in which the applicant organization is located, and the Funding Opportunity Announcement title and number.

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

C. Eligibility Information

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

D. Application and Submission Information

Application Package

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

Project Abstract Project Narrative Form SF-424, Application for Federal Assistance Form SF-424A, Budget Information for Non-Construction Programs Form SF-424B, Assurances for Non-Construction Programs Form SF-LLL, Disclosure of Lobbying Activities Budget Narrative Letters of Commitment Proof of Non-Profit Status (if applicable) Indirect Cost Agreement(s) – including recipient, sub- recipient, and contractors agreements (if applicable) Draft operational plan

Appendix A, Tips for Writing a Strong Application, can be used as a resource. Plain English and user-friendly language should be used throughout the application. For additional guidance on how to structure the application’s project plan, please see the U.S. Digital Services Playbook and other resources made available by 18F, including but not limited to:

U.S. Digital Services Playbook: https://playbook.cio.gov/ 18F Agile Guidelines: https://pages.18f.gov/agile/ 18F Design Methods: https://methods.18f.gov/

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

Project Abstract Applicants shall include a one-page abstract that is no more than 500 words single space. This abstract is often distributed to the public and Congress and represents a high-level summary of the project. As a result, applicants should prepare a clear, accurate, concise abstract that can be understood without reference to other parts of the application and that provides a description of the proposed project, including: the project’s goal(s), objectives, overall approach, anticipated outcomes, products, and duration.

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

• Project Title

• Applicant Name

• Physical Address https://playbook.cio.gov/ https://pages.18f.gov/agile/ https://methods.18f.gov/

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Project Narrative The project narrative provides the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative should address the elements articulated in the Project Description/Purpose and Structure and Approach sections of this FOA. The project narrative should also align with the Performance Goals/Project Milestones and Merit Review Evaluation criteria presented in this FOA (e.g., organizational experience, past performance). Specifically, the project narrative must include an initial project plan that illustrates how the applicant intends to: 1) conduct the market research, and 2) build the online resource as key deliverable requirements of this funding opportunity. For further guidance, please refer to the merit review criteria under section E. Application Review Information.

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 10 pages. A Project Narrative that exceeds the 10-page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 10-page limit.

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

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

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

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

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

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

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

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

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

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

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

Proof of Non-Profit Status (if applicable) Non-profit applicants must submit proof of non-profit status. Any of the following constitutes acceptable proof of such status:

A copy of a currently valid IRS tax exemption certificate.

A statement from a state taxing body, state attorney general, or other appropriate state official certifying that the applicant organization has a non-profit status and that none of the net earnings accrue to any private shareholders or individuals.

A certified copy of the organization’s certificate of incorporation or similar document that clearly establishes non-profit status.

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

Application Submission Instructions

1) You must access the electronic application for this project via http://www.grants.gov. You can search the downloadable application page by the Funding Opportunity Announcement Number NAP-AX-17-002 or CFDA number 93.983.

2) Applicants will be able to download a copy of the application packet and complete it off-line.

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

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

ACCEPTED THROUGH ANY OTHER WEBSITE, AND WILL NOT BE ACCEPTED

THROUGH PAPER MAIL, COURIER, OR DELIVERY SERVICE.

In order to upload applications into Grants.gov:

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

The following website depicts the SAM registration process:

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

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

A depiction of the Grants.gov application process can be found at http://www.grants.gov/web/grants/applicants/apply-for-grants.html

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

The deadline for the submission of applications under this Funding Opportunity Announcement is 11:59 Eastern Standard Time on July 31, 2017. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

http://fedgov.dnb.com/webform http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/apply-for-grants.html

Restrictions on Oral Conversations

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds.