Tracking Use and Impacts of Health IT on US Office Based Physicians FINAL.pdf

U.S. Department of Health and Human Services

Office of the National Coordinator for Health Information Technology

Notice of Funding Opportunity Tracking Use and Impacts of Health IT on U.S. Office-Based

Physicians

Application Due Date: 09/11/2020

Anticipated Award Date: September 30, 2020

Table of Contents

Executive Summary

A. Program Description/Purpose Structure and Approach Performance Goals/Program Milestones Roles and Responsibilities under a Cooperative Agreement Performance Goals

B. Funding Opportunity Award Information Key Award Parameters Key Dates

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 Award Terms and Conditions

G. Points of Contact

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

Executive Summary

Through this notice of funding opportunity (NOFO), the Office of the National Coordinator for Health Information Technology (ONC) is accepting applications for a cooperative agreement to measure the use of health information technology (IT) among office-based physicians. The purpose of this cooperative agreement is to measure the use and impacts of health IT, and level of interoperability among a nationally representative sample of U.S. office-based physicians. The cooperative agreement is intended to produce national-level data on interoperability and use of health IT by office-based physicians. These data shall provide national-level insights on the implementation and effects of federal health IT policies as well as identify disparities or unintended consequences resulting from their implementation. The cooperative agreement recipient is encouraged to make the key findings of the cooperative agreement publically available via their website; peer-reviewed publications in biomedical journals; presentations at conferences; webinars, and/or blog posts.

A. Program Description/Purpose

Background

According to section 4003 of the 21st Century Cures Act (Cures Act) enacted in 2016, the term 'interoperability,' with respect to health information technology, means such health information technology that— "(A) enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; "(B) allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law; and "(C) does not constitute information blocking as defined in section 3022(a).1 ONC research shows that physicians’ who have electronic health records (EHRs) that are interoperable are more likely to report that they have the information they need at the point of care.2 In 2017, approximately 80 percent of office-based physicians possessed a certified EHR. However, only 1 in 10 reported that they were interoperable (i.e.

able to electronically send, receive, find, and integrate data from outside sources).3

A number of federal health IT policies have sought to advance the use of health IT among health care providers over the last decade. In 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act incentivized the adoption and use of certified EHR technology and electronic exchange of health information.4 The Cures Act expands interoperability by supporting patients’ access and use of their electronic health information through standard-based application programming interfaces (APIs).

In addition, the Cures Act addresses barriers to interoperability including information blocking.

Regulations implementing health IT provisions of the Cures Act are underway to advance interoperability and leverage health IT to address public health priorities. For example, as mandated under the Cures Act, ONC released the report, Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs, to identify recommendations to reduce EHR-related burdens that affect care delivery.5 Additionally, the Coronavirus Disease 2019 (COVID-19) pandemic has brought to light the importance of telehealth technology in enabling access to patient care and the health IT infrastructure that supports public health efforts to respond to the pandemic. For example, rapid delivery of electronic laboratory test results is critical to contact tracing.

In light of the potential benefits of interoperability on patient care, ONC has supported national surveys of office-based physicians to monitor the use and impacts of health IT in office-based physician settings since 2009. Data from these surveys are made available to external researchers to facilitate the development of vital research on health IT policies. This data has also used by other stakeholders such as states and other federal agencies to inform their health IT activities. However, response rates for

1 https://www.govinfo.gov/content/pkg/PLAW-114publ255/pdf/PLAW-114publ255.pdf 2 Patel V, Pylypchuk Y, Parasrampuria S & Kachay L. (May 2019) Interoperability among Office-Based Physicians in 2015 and 2017. ONC Data Brief, no.47. Office of the National Coordinator for Health Information Technology: Washington D.C https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based- Physicians-in-2015-and-2017.pdf 3 ibid 4 https://www.govinfo.gov/content/pkg/PLAW-111publ5/pdf/PLAW-111publ5.pdf 5 Strategy on Reducing Regulatory and Administraive Burden Relating to the Use of Health IT and EHRs: Final Report As Required by the 21st Century Cures Act Public Law 114-255, Section 4001, The Office of the National Coordinator For Health Information Technology, February 2020 https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf https://www.govinfo.gov/content/pkg/PLAW-114publ255/pdf/PLAW-114publ255.pdf https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based-Physicians-in-2015-and-2017.pdf https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based-Physicians-in-2015-and-2017.pdf https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf

ONC’s prior surveys of office-based physicians have been declining. A copy of the 2018 survey is included in appendix for reference.

Purpose

The purpose of this cooperative agreement is to measure the use and impacts of health IT, and level of interoperability among a nationally representative sample of U.S. office-based physicians. The cooperative agreement shall produce national-level data on interoperability and use of health IT by office-based physicians. These data shall provide national-level insights on the implementation and effects of federal health IT policies as well as identify disparities or unintended consequences resulting from their implementation. The cooperative agreement recipient is encouraged to make the key findings of the cooperative agreement publically available via their website; peer-reviewed publications in biomedical journals; presentations at conferences; webinars, and/or blog posts.

Structure and Approach

The recipient is encouraged to submit a plan to ONC that outlines the methodological approach it intends to take to meet the purpose of the cooperative agreement and collaborate with ONC when developing this plan.

The plan and methodological approach may include, but are not limited to, the following components:

• Sampling approach

• Content for measurement: Examples of topics for consideration include:

• Use of certified health IT technology;

• Health information exchange activity and interoperability of health IT systems (e.g., ability to in query (or find), send, receive, incorporate and use electronic health information from sources outside their healthcare organization as described in ONC publications);6

• Barriers/benefits of interoperability;

• Provider burden associated with EHR use;

• Use of health IT functionalities for patient engagement;

• Use of telemedicine tools; and

• Health IT tools to prescribe and monitor the use of controlled substances (e.g., use of electronic prescription of controlled substances (EPCS) technology and prescription drug monitoring programs (PDMPs).

• Data collection methodology

• Data analysis and publication: The recipient is encouraged to coordinate and collaborate with ONC on data analysis, and produce data products and publications to highlight the recipient’s key findings. Collaboration and at minimum coordination is encouraged to avoid duplicative efforts by the recipient and ONC. The recipient may collaborate with ONC on the release and publication of the analyses and findings of this cooperative agreement. The recipient could consider leveraging

6 Patel V, Pylypchuk Y, Parasrampuria S & Kachay L. (May 2019) Interoperability among Office-Based Physicians in 2015 and 2017. ONC Data Brief, no.47. Office of the National Coordinator for Health Information Technology: Washington D.C https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based- Physicians-in-2015-and-2017.pdf https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based-Physicians-in-2015-and-2017.pdf https://www.healthit.gov/sites/default/files/page/2019-05/ONC-Data-Brief-47-Interoperability-among-Office-Based-Physicians-in-2015-and-2017.pdf their analysis to support third party research that examines the use and impacts of health IT in office-based physician settings.

• Data quality and delivery

Roles and Responsibilities under a Cooperative Agreement The funding instrument used for this program 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 not limited to the process of developing and fielding the survey, such as:

• Sampling approach

• Content for measurement: Examples of topics for consideration include:

• Data collection methodology

• Data analysis and publication

• Data quality and delivery

• Participate in the selection of key personnel, such as consultants

• Review and approval of substantive provisions of proposed sub awards or contracts

• Reviewing and approving deliverables

• Provide tactical guidance and feedback during project execution

Performance Goals A performance goal is a target level of performance expressed as a tangible, measurable objective, against which actual achievement can be compared. The performance goals of this cooperative agreement are as follows:

1. Develop key health IT measures related to interoperability and health IT use by U.S. office-based physicians.

2. Successfully obtain a nationally representative sample and respondents that reflect the U.S.

office-based physician population that will support national level measurement.

3. Collect data from nationally representative sample U.S. office based physicians to produce national level estimates on key health IT measures (as noted in #1 above).

4. Collaborate and coordinate with ONC on the analysis and interpretation of results, and publication of written products, which relate to the purpose of this cooperative agreement (e.g., assess interoperability and health IT use by U.S. office-based physicians).

B. Funding Opportunity Award Information

Key Award Parameters

Funding Opportunity Title: Tracking Use and Impacts of Health IT among U.S. Office- Based Physicians

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 Number: NAP-AX-20-001

Catalog of Federal Domestic Assistance (CFDA) Number: 93.851

Eligible Applicants: Eligible applicants include domestic public or private, non-profit or for-profit entities.

Legislative Authority: H.R. 1865 Further Consolidated Appropriations Act, 2020, Pub. L. 116-94, Division A-DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2020, Title II, Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology.

Anticipated Total Approximate Amount of Available Funding (inclusive of direct and indirect costs): $290,000

Anticipated Number of Awards: 1

Anticipated Amount of Each Award: $290,000

Project Period: September 30, 2020 to September 29, 2023

Budget Period(s): September 30, 2020 to September 29, 2021

Funding of future 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/Match Requirements: Not required

Program Income:

There are four potential ways in which ONC may require that a recipient apply program income as specified in the NGA: 1) deduct it from total allowable program costs to determine the net allowable costs on which the Federal share of costs is based; 2) add it to funds otherwise available for the program, generally resulting in an increase to the total approved budget; 3) use it to meet a matching or cost sharing requirement; or 4) a combination of these alternatives.

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

Intergovernmental Review : Applications for this Cooperative Agreement are not subject to review by states under Executive Order 12372, “Intergovernmental Review of Federal Programs” (45 CFR 100).

Please check box “C” on item 19 of the SF 424 (Application for Federal Assistance) as Review by State Executive Order 12372, does not apply to this Cooperative Agreement.

Key Dates

Milestone Date NOFO Released

08/12/2020

Informational Session

08/20/2020

Notice of Intent Due

08/24/2020

Applications Due

09/11/2020

Anticipated Award Date

09/30/2020

Anticipated Project Start Date

09/30/2020

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)

Appendix A, Tips for Writing a Strong Application, can be used as a resource.

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

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

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

• Project Title

• Applicant Name

• Physical Address

• Contact Name

• Contact Phone Numbers (Voice, Fax)

• E-Mail Address

• Web Site Address, if applicable

Project Narrative The project narrative provides is the most substantive information regarding the proposed project in a clear and concise manner. To that end, the project narrative should address the elements articulated in the Program Description/Purpose and Structure and Approach sections of this NOFO. The project narrative should also align with the Performance Goals/Program Milestones and Merit Review Evaluation criteria presented in this NOFO (e.g. organizational experience, past performance etc.).

The Project Narrative must be double-spaced, formatted to 8 ½” x 11” (letter-size) pages, 1” or larger margins on all sides, and a font size of not less than 11 point. The maximum length allowed for the Project Narrative is 20 pages. A Project Narrative that exceeds the 20 page limit will not be accepted.

Resumes of Key Personnel, if requested, are not counted as part of the Project Narrative and are not included in the 20 page limit.

Your project narrative should include the following components. These components will be counted as part of the page limit. The suggested lengths of the sections, given below, are guidelines to help applicants create a balanced document, and not mandatory restrictions:

Discussion and Understanding of the Project (1-2 pages)

This section should describe the applicant’s understanding of the project and the broader context related to the goals of the cooperative agreement. This would include a brief discussion about the current state of health IT in office-based care settings including describing the current health IT policy and regulatory landscape (e.g., 21st Century Cures Act, HITECH Act, the ONC Health IT Certification Program, etc.)

related to the goals of the cooperative agreement.

Personnel Qualification, Past Performance, Management Plan, and Budget (2-5 pages)

This section should describe the applicant’s personnel qualification and past performance demonstrating experience consistent with successfully meeting the goals of the cooperative agreement. This section should discuss the overall project management approach and the types and level of staffing, resources and infrastructure in place to support measurement. This would include identifying the roles of key staff, identifying the role of subcontractors and/or any other external consultants or subject matter experts, communication strategy with ONC to provide updates and progress reports. The applicant must provide the names of staff that will be overseeing the analysis of the data and preparation of the ongoing reports. This section should also include any quality assurance or quality control processes your organization plans to conduct throughout the project. This section should also include the proposed budget.

Technical approach (5-10 pages)

This section should describe the applicant’s methodological approach to meet the goals of the cooperative agreement. The following aspects should be addressed in this section:

Content for Measurement This section should describe how your organization plans to finalize the measures to be included in the data collection to meet the goals of the cooperative agreement. The applicant should list the prioritized set of topics and measures. The applicant should describe how they plan to ensure the selected measures will be well understood and valid.

Sampling Strategy and Targeting Respondents This section should describe the applicant’s methodological approach to obtain data from a nationally representative sample of U.S. office based physicians. This section should include discussion on how the applicant shall collect data from U.S. office-based physicians that represent diverse range of practice settings (e.g. rural vs. urban, specialty type, practice group size, etc). The proposal shall also include the applicant’s approach for identifying and targeting office-based physicians in non-federal settings who provide direct patient care, as opposed to front desk or office staff. This discussion should include any anticipated challenges in reaching U.S. office-based physicians, and strategies that may be used to address these challenges. A description of your organization’s outreach efforts should be included.

Data Collection Methodology This section should describe your organization’s approach for data collection. This discussion should include a description of the method (qualitative, quantitative survey) and modality (e.g.

telephone, mail, or online) and its strengths and limitations. This section should also describe your organization’s strategy for achieving a high response rate with U.S. office-based physicians, such as your approach for following-up with non-respondents to the data collection approach.

Data Analysis, and Publication This section should describe the applicant’s approach for analyzing the data and disseminating the results. This section should also include a description of the data analysis plan and strategy for disseminating data findings.

Data Quality and Delivery This section should describe how the applicant shall provide the final data set and related documentation, including formats and level of information. This section should include a description of the processes for properly coding and cleaning the final dataset and processes in place to assuring the quality and completeness of the data, including the types of quality checks performed.

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

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

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

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

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

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

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

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

Letters of Commitment Include letters of commitment confirming the support to the project (should it be funded) made by key collaborating organizations and agencies. Any organization that is specifically named to have a significant coordination role in carrying out the project should be considered an essential collaborator such as interstate, intrastate, and regional partners. 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.

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 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. Cost allocation plans are not accepted.

Application Submission Instructions

1) You must access the electronic application for this program via http://www.grants.gov. You can search the downloadable application page by the Notice of Funding Opportunity Number NAP-AX-20- 001 or CFDA number 93.851.

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.

b) Please note that entities registering in SAM must submit a notarized letter appointing their authorized Entity Administrator. This will not impact the registration approval process, but is required as part of your registration. For additional information, read SAM’s updated FAQs to learn more about changes to the notarized letter review process and other system improvements.

The following website depicts the SAM registration process:

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

c) 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 a tracking number and date of receipt verification confirming that the application was received, the date and time the application was received, and a tracking number. This notification does not ensure that your application could be opened and read -- only that the application was received.

http://fedgov.dnb.com/webform https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/apply-for-grants.html mailto:support@Grants.gov

The deadline for the submission of applications under this Funding Opportunity is 12:00 NOON Eastern Standard Time on 09/11/2020. Applications that fail to meet the application deadline will not be reviewed and will receive no further consideration.

Restrictions on Oral Conversations

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

This restriction applies unless:

• The communication is purely logistical

• The communication is made at a widely attended gathering

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

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

• The communication is initiated by the federal agency official

E. Application Review Information

Screening Review

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

• The applicant meets the eligibility criteria

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

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

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

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

Merit Review

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

1. Discussion and Understanding of the Project – 10 points maximum

The applicant demonstrates knowledge and understanding of the adoption of EHRs and survey methodology.

2. Technical Approach – 25 points maximum

The applicant’s approach is succinct and logical in format and demonstrates methods consistent with the goals to be accomplished. The applicant proposes a clear and detailed approach for collecting and analyzing the survey data. The applicant must clearly identify an approach for verifying the accuracy of the data through audit or other approved means.

3. Personnel Qualification and Past Performance – 40 points maximum

The applicant must demonstrate and provide evidence of experience for the items listed below. All evidence must be provided in the specific format outlined below and be submitted as an appendix to the applicant’s proposal.

• 3.1: An existing data collection effort on health IT/digital health at the national level among U.S.

office-based physicians and quality of that data collection effort.

• 3.2: Evidence of past work producing reports and publications from these past data collection efforts on health IT/digital health.

• 3.3 Existing infrastructure and resources to measure interoperability and use of health IT at the national level among a nationally representative sample of U.S. office-based physicians.

http://www.grants.gov/

• 3.4 Existing physicians on staff with subject matter expertise in health IT and interoperability that can support measurement development needed for this cooperative agreement.

4. Management Plan – 10 points maximum

The applicant must provide the names of staff that will be involved in the management and technical approach of this project, including the sampling approach, developing the content of the survey, overseeing the analysis of the data and preparation of the ongoing reports.

5. Budget—15 points maximum

The applicant must detail their budget and align it with the proposed level of funding for the project.

MAXIMUM TECHNICAL SCORE = 100 POINTS

Pre-Award Risk Assessment ONC is required to conduct a risk assessment to assess the risk posed by a potential recipient, prior to issuing an award. In doing so, ONC will take into account the applicant’s financial stability, quality of management systems, history of performance, reports and findings from audits, and the applicant’s ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities. To facilitate this assessment, ONC may review information available in systems, such as the Excluded Parties List System, review documentation, such as previous audits, and/or desk reviews or site visits conducted from previous awards. ONC may elect not to fund applicants with management or financial instability that directly relates to the organization’s ability to implement statutory, regulatory or other requirement s (45 CFR Part 75.205.)

F. Federal Award Administration Information

Award Decisions The final award decision will be made by the National Coordinator for Health Information Technology taking into consideration several factors such as the results of the merit review process, results of the pre-award risk assessment, compliance with programmatic and grants management requirements; the reasonableness of the estimated costs, available funding, geographical dispersion, program priorities;

and the likelihood that the proposed project will result in the benefits expected. All applicants will receive a summary of the objective review panel’s assessment of the application’s strengths, weaknesses, and score.

Notice of Award Successful applicants will receive a letter of notification acknowledging that an award was funded, but does not provide authorization for the applicant to begin performance and expend funds associated with the award.

Following this notice, successful applicants will receive a Notice of Award (NOA). The NOA will include, at a minimum, the following:

• Legal name and address of the organization or institutions to whom ONC has issued an award

• Award number assigned by ONC

• Project period, specifying the amount of time ONC intends to support the project without requiring re-competition for funds

• Total amount of financial assistance approved by ONC during the project period

• Budget period, specifying the increments in which the project will be funded, subject to the availability of funds

• Applicable award terms and conditions

• Performance goals, indicators, milestones, or expected outcomes (such as outputs, or services performed or public impacts of any of these) with an expected timeline for accomplishment

The successful applicants’ Authorized Representatives will receive the NOA electronically from ONC. The Recipient accepts the award by drawing down funds. By accepting an ONC award, the recipient assumes legal, financial, administrative, and programmatic responsibility for administering the award in accordance with the terms and conditions of the award, as well as applicable laws, rules, regulations, and Executive Orders governing HHS assistance awards, all of which are to be incorporated into the award by reference. Failure to comply with these requirements may result in suspension or termination of the awards and/or ONC’s recovery of award funds.

Terms and Conditions

Incorporated by Reference The NOA is subject to, by reference, the terms and conditions incorporated in the following documents:

• 45 CFR, Part 75—Uniform Administrative Requirements, Cost Principles, and Audit Requirements

For HHS Awards http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5

• HHS Grants Policy Statement https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Specific terms and conditions, incorporated by reference above, are further delineated below due to their importance in terms of integrity, achieving programmatic objectives, and/or sound financial stewardship of federal funds.

Performance Reporting ONC Program Progress Reports (PPR) are due semi-annually. The PPR will address, to the extent applicable:

• degree to which performance goals were attained (actual performance versus targeted performance)

• data source and validation method for performance measures

• opportunities to address performance deficiencies

• accomplishments

• next steps

• challenges

• barriers

• recommendations to address challenges and barriers

ONC will provide specific guidance regarding the content and format of the PPR before the reports are due.

Financial Reporting Expenditures must be reported, on a semi-annual basis, using the SF-425, Federal Financial Report (FFR). Reports are due to HHS no later than April 30 of each year the award is active for funds expended between October and March, and no later than October 31 for funds expended between April and September. The semi-annual FFR will be submitted using the Payment Management System. ONC will not accept reports sent directly to the ONC Grants mailbox.

The FFR Cash Transaction Report, a subset of the SF-425, Federal Financial Report, is submitted via the Payment Management System (PMS) every calendar quarter for the life of the award. The report must be submitted within 30 days after the end of the quarter (January 31, April 30, July 31, and October 31).

http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5 http://www.ecfr.gov/cgi-bin/text-idx?SID=06a0b0411d1520fae5e2799030e64ebf&node=pt45.1.75&rgn=div5 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Federal Funding and Accountability and Transparency Act of 2006 The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier sub-awards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of ONC grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all sub-awards over $25,000.

Federal Recipient Performance and Integrity Information System (FAPIIS) As of January 1, 2016, recipients of Federal grants and cooperative agreements are subject to new mandatory disclosure requirements. Recipients that have Federal contracts, grants, and cooperative agreement awards with a cumulative total value greater than $10,000,000 must disclose in FAPIIS, semiannually, any information about criminal, civil, and administrative proceedings for the most recent five-year period in connection with the award or performance of a grant, cooperative, agreement, or procurement contract from the Federal Government. All information posted in FAPIIS on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.

Funding Restrictions Funds cannot be used for the following purposes:

• To supplant or replace current public or private funding

• To supplant ongoing 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

Conflict of Interest The term “organizational conflict of interest” means that the applicant, including its chief executives, directors, consultants, sub recipients, or any other personnel that are substantially involved in the performance of this assistance agreement, has interests which:

• May diminish its capacity to give impartial, technically sound, objective assistance and advise in performing this tasks;

• May otherwise result in a biased work product under this assistance agreement; or,

• May result in an unfair competitive advantage to itself or others.

In accordance with Section 75.112 of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHSAwards, all applicants and non-federal entities must disclose, in writing, any potential conflict of interest (COI) that they have with the awarding agency and/or any other pass-through entities. The applicant shall notify the ONC grants management officer (GMO) when they believe an actual or potential COI may exist.

If, after award, recipient discovers a COI, with respect to the assistance agreement, it shall make an immediate and full disclosure in writing to the ONC GMO. The disclosure shall include identification of the actual or potential conflict, the manner in which it arose, and a description of the action the recipient has taken, or proposed to take, to avoid, eliminate, or neutralize the conflict.

In the event the recipient was aware of an organizational COI, prior to award of the assistance agreement, and did not disclose the conflict to the GMO, or becomes aware of an organizational COI http://grants.nih.gov/grants/guide/url_redirect.htm?id=11170 after award of this assistance agreement and does not disclose the COI within ten (10) days of becoming aware of such conflict, the Government may terminate the assistance agreement and the recipient shall not be entitled to reimbursement of any costs incurred in performing the assistance agreement.

The rights and remedies of the Government, under this term and condition, shall not be exclusive and are in addition to any other rights and remedies provided to the Government under law, regulation, or any other available enforcement mechanism.

Non-Disclosure Requirements The federal award may require the recipient to have access to information relating to any and all aspects of grants management operations that may be of a technical, legal, sensitive and/or confidential nature and which may be the sole property of the U.S. Government. To mitigate risks associated with such access, the recipient shall ensure that all its personnel, including chief executives, directors, consultants, sub recipients, or any other personnel substantially involved in the performance of this award sign a non-disclosure agreement prior to the commencement of any work on the award.

In addition, recipients shall put in place appropriate procedures for the protection of such information and shall be liable to the Government for any misuse or unauthorized disclosure of such information by its personnel.

The rights and remedies of the Government, under this term and condition, shall not be exclusive and are in addition to any other rights and remedies provided to the Government under law, regulation, or any other available enforcement mechanism.

Mandatory Disclosures In accordance with Section 75.113, Mandatory Disclosures, of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards. The non-Federal entity or applicant for a Federal award must disclose, in a timely manner, in writing to the Federal awarding agency or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. Failure to make required disclosures can result in any of the remedies described in Section 75.371 of the Uniform Requirements including suspension or debarment.

Intangible Property and Copyrights Intangible property, as defined in OMB’s, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards means property having no physical existence, such as trademarks, copyrights, patents and patent applications and property, such as loans, notes and other debt instruments, lease agreements, stock, and other instruments of property, ownership (whether the property is tangible or intangible).

(a) Title to intangible property (see §75.2 Intangible property) acquired under a Federal award vests upon acquisition in the non-Federal entity. The non-Federal entity must use that property for the originally-authorized purpose, and must not encumber the property without approval of the HHS awarding agency. When no longer needed for the originally authorized purpose, disposition of the intangible property must occur in accordance with the provisions in §75.320(e).

(b) The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so. (Please note, for the purpose of this funding opportunity “work” can be considered as: writings, films, sound recordings, pictorial reproductions, drawings, designs, or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other technical research data.)

(c) The non-Federal entity is subject to applicable regulations governing patents and inventions, including government-wide regulations issued by the Department of Commerce at 37 CFR part 401.

(d) The Federal Government has the right to:

(1) Obtain, reproduce, publish, or otherwise use the data produced under a Federal award; and

(2) Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes

(e) Freedom of Information Act (FOIA). (1) In response to a Freedom of Information Act (FOIA) request for research data relating to published research findings produced under a Federal award that were used by the Federal Government in developing an agency action that has the force and effect of law, the HHS awarding agency must request, and the non-Federal entity must provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA. If the HHS awarding agency obtains the research data solely in response to a FOIA request, the HHS awarding agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by the Federal agency and the non-Federal entity. This fee is in addition to any fees the HHS awarding agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).

(2) Published research findings means when:

(i) Research findings are published in a peer-reviewed scientific or technical journal; or

(ii) A Federal agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law. “Used by the Federal Government in developing an agency action that has the force and effect of law” is defined as when an agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.

(3) Research data means the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the…