HEDAP NOFO_FINALv2.pdf

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Rev.3/17/2023

U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services

Office of Minority Health

Health Equity Data Access Program

Notice of Funding Opportunity Type: New

Funding Opportunity Award Type: Grant

Notice of Funding Opportunity Number: CMS-2L2-23-001

Federal Assistance Listings Number (CFDA): 93.695

Notice of Funding Opportunity Posting Date: June 29, 2023

Applicable Dates:

Letter of Intent to Apply Due Date: July 16, 2023

Electronic Application Due Date: August 15, 2023, 3:00 pm Eastern Standard Time

Anticipated Issuance Notice(s) of Award: September 15, 2023

Anticipated Period of Performance: September 15, 2023 through September 14, 2023-06-29 Page 1 of 55

Table of Contents Executive Summary

A. Program Description

A1. Purpose

A2. Authority

A3. Background

A4. Program Requirements

B. Federal Award Information

B1. Total Funding

B2. Award Amount

B3. Anticipated Award Dates

B4. Period of Performance

B5. Number of Awards

B6. Type of Award

B7. Type of Competition

C. Eligibility Information

C1. Eligible Applicants

C2. Cost Sharing or Matching

C3. Letter of Intent

C4. Ineligibility Criteria

C5. Single Application Requirement

C6. Continued Eligibility

C7. EIN, UEI, Login.gov and SAM Regulations

C8. Faith-Based Organizations

Faith-Based Organizations are not eligible to apply

C9. Other Eligibility Requirements

D. Application and Submission Information

D1. Address to Request Application Package

D2. Content and Form of Application Submission

a. Application format

b. Standard forms

c. Application cover letter or cover page

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d. Program Requirements and Expectations

Project Narrative

e. Budget (SF-424A)

f. Business assessment of applicant organization (maximum 12 pages)

g. Required Appendices (20-page limit)

D3. Unique Entity Identifier and System for Award Management (SAM)

D4. Submission Dates and Times

D5. Intergovernmental Review

D6. Cost Restrictions

D7. Mandatory Disclosure

D8. HHS Form 690

E. Application Review Information

E1. Criteria

E2. Merit Review and Selection Process

E3. Federal Awardee Performance Integrity Information System (FAPIIS)

F. Federal Award Administration Information

F1. Federal Award Notices

F2. Administrative and National Policy Requirements

F3. Terms and Conditions

F4. Reporting

G. CMS Contacts

G1. Programmatic Questions

G2. Administrative/Budget Questions

H. Other Information

Appendix I. Guidance for Preparing a Budget Request and Narrative

Appendix II. Application and Submission Information

Appendix III. Business Assessment of Applicant Organization

Appendix IV. Accessibility Requirements

Appendix V. Merit Review and Selection Process

Appendix VI. Conflict of Interest

Appendix VII. Application Check-off List

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Executive Summary

The Health Equity Data Access program (HEDAP) provides funding for three (3) “seats” in the CMS Virtual Research Data Center (VRDC). The VRDC assists researchers in gaining access to CMS restricted data for minority health research. Seats, in this context are defined as an individual user with VRDC access. These researchers will conduct health services research focusing on, but not limited to, racial and ethnic minority groups; people with disabilities;

members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality. The HEDAP supports specific applied research projects that relate to creative and innovative methods utilizing CMS data to identify, document, assess, and evaluate health disparities among Medicare and Medicaid and CHIP enrollees.

The project should enhance the capacity of the researcher to understand and utilize CMS data in future research projects. Additionally, HEDAP encourages cutting-edge proposals that explore intersectionality. “Intersectionality” means that people belong to more than one group and, therefore, may have overlapping health and social inequities, as well as overlapping strengths and assets.

Results of the HEDAP will provide CMS and its partners, (e.g. Quality Improvement Organizations, Hospital Engagement Networks, and other stakeholders) with actionable information on the subgroups of enrollees. This will aid the efforts of CMS and its agents to identify and eradicate health disparities in underserved populations.

VRDC seat access will be funded for a period of 36 months each, based on the availability of funds.

Item Description

HHS Awarding Agency Centers for Medicare & Medicaid Services (CMS)

CMS Awarding Center CMS Office of Minority Health (OMH)

Notice of Funding Opportunity Title

Health Equity Data Access Program (HEDAP)

Authorization Section 1110 of the Social Security Act

Federal Assistance Listings Number

93.695

Funding Opportunity Type

New https://www.resdac.org/cms-virtual-research-data-center-vrdc https://www.cdc.gov/healthcommunication/HealthEquityGuidingPrinciples.pdf

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Funding Opportunity Number

CMS-2L2-23-001

Type of Award Grant

Type of Competition Competitive

Letter of Intent CMS highly recommends that interested applicants submit a Letter of Intent; however, it is not required. See Section C.3 for more information.

Electronic Application Due Date and Time

August 15, 2023 by 3:00 pm EST (Baltimore, MD)

Anticipated Issuance Notice(s) of Award

September 15, 2023

Period of Performance Start Date

September 15, 2023

Period of Performance End Date

September 14, 2026

Anticipated Total Available Funding

$270,000 (pending the availability of funds)

Estimated Maximum Award Amount

$90,000

Estimated Maximum Number of Awardees

A. Program Description

A1. Purpose The Centers for Medicare & Medicaid Services (CMS) is announcing the availability of funds under the Health Equity Data Access Program (HEDAP). HEDAP provides funding for three (3) “seats” in the CMS Virtual Research Data Center (VRDC). to allow researchers from institutions of higher education access to CMS restricted data for minority health research. Seats, in this context are defined as an individual user with VRDC access. https://resdac.org/cms-virtual-research-data-center-vrdc-faqs

The HEDAP aims to:

https://www.resdac.org/cms-virtual-research-data-center-vrdc https://www.resdac.org/cms-virtual-research-data-center-vrdc https://resdac.org/cms-virtual-research-data-center-vrdc-faqs https://resdac.org/cms-virtual-research-data-center-vrdc-faqs

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• Help researchers gain access to CMS data to conduct health services research focusing on, but not limited to, racial and ethnic minority groups; people with disabilities;

members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community;

individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality.

• Produce specific applied research projects that relate to creative and innovative methods for using CMS data to identify, document, assess, and evaluate health disparities among Medicare, Medicaid and CHIP enrollees.

• Create data driven research that explores, but is not limited to, the relationship between health disparities and:

• Improving the quality of care

• Increasing access to care

• Estimating the economic burden/financial costs of disparities

• Evaluating the effects of health care delivery system and payment model reforms

• Exploring disparity sensitive conditions or diseases

• Strengthening population health

CMS will award HEDAP funds, through a competitive process, to up to three (3) institutions of higher education per cohort. The HEDAP timeline is three (3) years, pending the availability of funds. The award only covers the cost of for access to the VRDC for a three-year period. All research activities as described above must be funded by the recipients except for the access payment granted for the Chronic Conditions Data Warehouse (CCW) data in the VRDC to ResDAC. The parameters of the HEDAP are described throughout this Notice of Funding Opportunity (NOFO).

A2. Authority This HEDAP is under the authority of Section 1110 of the Social Security Act and is consistent with two executive orders:

• Executive Order 13985: Advancing Racial Equity and Support for Underserved

Communities Through the Federal Government

• Executive Order 14091: Further Advancing Racial Equity and Support for

Underserved Communities Through the Federal Government

More information about these Executive Orders may be found via each of the links above.

A3. Background The HEDAP is part of CMS’ efforts to identify and disseminate promising practices for reducing health disparities among racial and ethnic minority groups; people with disabilities; members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality.

https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal

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The HEDAP supports CMS’ mission of achieving health equity for all enrollees by granting researchers access to restricted CMS data to perform health services research focused on reducing disparities for the minority populations identified in Section A4.

Results will provide CMS and HEDAP’s recipients with actionable information on the subgroups of people with Medicare, Medicaid, and CHIP. This will aid the efforts of CMS and its agents to identify and eradicate health disparities in underserved populations.

The Chronic Conditions Data Warehouse (CCW) is a database of Medicare and Medicaid data to support research. The Virtual Research Data Center (VRDC) allows for virtual access to the CCW data. Researchers must pay a fee for a “seat” in the VRDC. This grant program funds VRDC seat access for a period of 36 months per seat for up to 3 recipients. The Research Data Assistance Center (ResDAC) is a CMS contractor that provides assistance to academic, non-profit, for-profit, and government researchers interested in CMS data.

https://resdac.org/#find-cms-data-file

A4. Program Requirements

The HEDAP requires applicants’ research project(s) align with CMS programs and policies as well as Executive Order 13985- Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. Satisfactory progress for selected recipients includes, but is not limited to: quarterly meeting check-ins with CMS OMH; publishing a manuscript based on data access received within the 36 month funding period; presentations based on data access received within the 36 month funding period; completion of a Disparities Impact Statement in the first 3 months of the funding period; standardized data collection (disability questions per 2011 HHS data standards, language preference, gender identity, assigned sex at birth, sexual orientation, and appropriate questions on social determinants of health [e.g. coverage type, transportation, social isolation, health literacy, housing insecurity, food insecurity, etc.]); analysis that includes demographic and social determinants of health (SDOH) data to conduct root cause analysis of disparities and results of solutions that were tested.

As stated above, recipients are required to develop a disparity impact statement within 3 months using local data and input to identify populations at highest risk for health, social, economic, or other disparities such as low health literacy. The disparity impact statement will identify social, policy, historical, and other context associated with root causes and drivers of disparities. It will also provide the framework and plan for ongoing action and accountability, such as program improvement, incorporation of the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care, monitoring and assessment of the impact of the project on the program’s equity goals. (See CMS.gov: Quality Improvement & Interventions:

Disparity Impact Statement).

Research topics of interest include, but are not limited to, the following two (2) examples:

• To research racial and ethnic minority groups; people with disabilities; members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely https://resdac.org/#find-cms-data-file https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/ https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Disparities-Impact-Statement-508-rev102018.pdf https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Disparities-Impact-Statement-508-rev102018.pdf https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0

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• The relationship between health disparities and improving the quality of care, increasing access to care, estimating the economic burden/financial costs of disparities, evaluating the effects of health care delivery system and payment model reforms, exploring disparity sensitive conditions or diseases and strengthening population health for all the above-mentioned populations.

Research topics that are not appropriate for this NOFO:

• Genome-Wide Association Studies (GWAS);

• Studies investigating biological mechanisms such as metabolic changes/chronic metabolic diseases on the microenvironment (including immune cells, surrounding blood vessels, soluble factors) in racial/ethnic minorities,

• Studies that do not propose health disparity research; and

• Studies not related to CMS programs as outlined in the Purpose (A1) and Background sections (A3) of this NOFO.

Past research topics include:

• Disparities in surgical care among racial and ethnic minorities in Medicare Accountable Care Organizations (ACOs).

• Disparities in rates of surgical intervention among racial and ethnic minorities in Medicare.

• Do Medicare Accountable Care Organizations reduce disparities after spinal fracture?

• Medicaid payment reform and disparities in cesarean birth and maternal morbidity.

• Cesarean delivery rates and cost of childbirth in a state Medicaid program after implementation of a blended payment policy.

• Accessing mental health care disparities by race and ethnicity, gender, and gender identity.

• Identifying gender minority patients’ health and health care needs in administrative claims data.

• Trends in mental health care use in Medicare from 2009 to 2014 by gender minority and disability status.

• Disparities in suicidality by gender identity among Medicare enrollees.

• Impact of the Medicare Shared Saving Program on Utilization of Mental Health and

Substance Use Services by Eligibility and Race/Ethnicity.

• Medicaid payment policy and disparities in mental health care among Medicaid and dual eligible enrollees.

• Health disparities in vascular access, peritoneal dialysis access, and kidney transplantation.

• Characterizing disparities in the HIV prevention and care continuum among transgender and cisgender Medicaid & Medicare enrollees.

• Documenting the Health of Aging and Disabled Transgender and Cisgender Medicare

Enrollees. 2009 – 2017.

• Value-base purchasing and persons with disabilities.

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A5. Technical Assistance and Information for Prospective Applicants

This NOFO encourages research projects that develop and test new methodologies, models, and research interventions and/or technologies focused on specific topics addressing social determinants of health. The availability of beneficiary data through the CMS Chronic Conditions Data Warehouse (CCW) makes it feasible to study factors that contribute to disparities in health outcomes among different racial and ethnic populations enrolled in CMS programs.

Applicants are strongly encouraged to include in their application how they propose to include data analysis by race and ethnicity (HHS 2011 data standards), disability (HHS 2011 data standards), geographic location (urban/rural), language preference, sexual orientation, gender identity, sex assigned at birth, and/or social determinants of health (e.g. coverage type, transportation, social isolation, health literacy, housing insecurity, food insecurity, socioeconomic status (SES), pollution/toxins, neighborhood safety, and effects of environmental change).

B. Federal Award Information

B1. Total Funding

The total anticipated amount of federal funds available is $270,000, pending the availability of funds.

B2. Award Amount

Individual fixed amount awards will not exceed $90,000. The period of performance is a 36-month budget period subject to availability of funds and satisfactory performance by the recipient. The sole purpose of each fixed amount award is to obtain a “seat” in the CMS Virtual Research Data Center (VRDC). This “seat” allows researchers from institutions of higher education access to CMS restricted data for minority health research as described in Section A1.

Purpose and A4. Program Requirements.

CMS will release funding in the amount of $30,000 annually. At the time of award, the recipient will only have access to funds in Year 1 conditional upon any restrictions noted on the Notice of Award for year 1 activities and costs. Funds for Years 2 and 3 will remain restricted. The recipient may not incur costs or drawdown funds for Year 2 and 3 until CMS issues a Notice of Award to release these funds and provides prior approval for the proposed activities/costs for the respective year. The process for release of funds will be further detailed in the Program Terms and Conditions of Award.

B3. Anticipated Award Dates https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0

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The anticipated award date is September 15, 2023.

B4. Period of Performance

The anticipated Period of Performance is 9/15/2023 – 9/14/2026.

• The anticipated Year 1 budget period is 9/15/2023 – 9/14/2024.

• The anticipated Year 2 budget period is 9/15/2024 – 9/14/2025.

• The anticipated Year 3 budget period is 9/15/2025 – 9/14/2026.

B5. Number of Awards

CMS will issue up to 3 awards maximum.

B6. Type of Award

The type of award issued under this NOFO is a grant.

B7. Type of Competition

Competitive:

Open to All Eligible Applicants that meet the Eligibility Requirements in Part C. A single institution may submit more than one application for consideration, provided that each application is scientifically distinct. An individual Principal Investigator (PI) must submit only one (1) application.

C. Eligibility Information

Applicants must meet the criteria selected in C1 as well as identify a Principal Investigator (PI) that meets the minimum requirements as described below:

1. Hold a Doctorate or Master’s Degree in health services research, social sciences, epidemiology, medicine, law, or other related scientific/medical field.

2. Have a primary appointment (51% time or more) at a not-for-profit college, university, policy institute, foundation, think tank, or state/territory/tribal agency.

3. Demonstrate evidence of having designed and conducted research on health disparities and health equity, and reported the results for projects of similar size and scope as the applicant proposes for this effort.

4. Must have research aligned and described in A4. and be able to fund their ongoing research efforts.

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a. Must provide evidence of the availability and adequacy of the facilities, equipment, staffing, and financial management systems to conduct the project (analyze the data and submit 1 manuscript for publication) for the entire three years.

b. Should an applicant be awarded funding, changes and staffing that affect this research must be reported. For example, reduction of staff or change in budget that would limit the ability to conduct research using HEDAP data.

C1. Eligible Applicants

Government Organizations

State governments County governments City of Township governments Special District governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than federally recognized tribal governments)

Education Organizations Independent School Districts Public and State Controlled Institutions of Higher Education Private institutions of higher education

Public Housing Organizations Public housing authorities Indian housing authorities

Nonprofit Organizations

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For-profit Businesses (organizations other than small businesses) Small Businesses Individuals Others Unrestricted

C2. Cost Sharing or Matching

No Cost Sharing or Matching required. All Applicants must be able to fund their research activities except for the access payment granted for CCW data to ResDAC.

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C3. Letter of Intent

Applicants are highly encouraged, though not required, to submit an electronic, non-binding Letter of Intent (LOI) by July 16, 2023. Information from the LOI will assist CMS with planning for the application review process.

Prospective applicants are asked to submit a LOI that includes the following information:

• Descriptive title of proposed research

• Name(s), address(es), and telephone number(s) of the PI(s)

• Names of other key personnel

• Participating institution(s)

• Number and title of this Notice of Funding Opportunity

Letter of Intent should be sent to:

Centers for Medicare & Medicaid Services Office of Minority Health E-mail: HEResearch@cms.hhs.gov

C4. Ineligibility Criteria

N/A

C5. Single Application Requirement

More than one application per Higher Education Institution may be submitted with different Principal Investigators.

C6. Continued Eligibility During the period of performance, award recipients must meet reporting and certification deadlines (as outlined in section F) to be eligible for continued funding throughout the 36-month budget and project period. In addition, award recipients must demonstrate satisfactory progress during the previous funding cycle(s) to ensure continued access to funding (as outlined in section A4.

Program Requirements). At any time in the award cycle, recipients could receive decreased funding or their award could be terminated in accordance with 2 CFR 200.340 “Termination” if they fail to perform the requirements of the award. Funds from terminated awards will be used to make awards to other applicants capable of meeting satisfactory progress.

Continued funding is also contingent on compliance with the terms and conditions of award, the availability of funds.

Satisfactory progress (outlined in section A4 and F4) for selected award recipients includes, but is not limited to: publications; presentations; completion of Disparities Impact Statement;

standardized data collection (disability questions per 2011 HHS data standards, language preference, gender identity, assigned sex at birth, sexual orientation, and appropriate questions mailto:HEResearch@cms.hhs.gov https://aspe.hhs.gov/reports/hhs-implementation-guidance-data-collection-standards-race-ethnicity-sex-primary-language-disability-0

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C7. EIN, UEI, Login.gov and SAM Regulations All applicants must have the following to apply to grants.gov.:

• a valid Employer Identification Number (EIN), otherwise known as a Taxpayer Identification Number (TIN)

• a Unique Entity Identifier (UEI)

• a Login.gov account, and

• registration in the System for Award Management (SAM) database

(https://www.sam.gov/) to be able to apply to grants.gov.

See Appendix II. Application and Submission Information for descriptions of EIN, UEI, and

SAM.

C8. Faith-Based Organizations

Faith-Based Organizations are not eligible to apply.

C9. Other Eligibility Requirements

Only Institutions of Higher Education are eligible to apply.

D. Application and Submission Information D1. Address to Request Application Package

Application materials are available at https://www.grants.gov. Please note that CMS requires electronic submission of applications for all Notice of Funding Opportunities through the Grants.gov website. Refer to Appendix II. Application and Submission Information for additional requirements and instructions.

D2. Content and Form of Application Submission

a. Application format

Applications determined to be ineligible, incomplete, and/or nonresponsive based on the initial screening may be eliminated from further review. However, in accordance with HHS Grants Policy, the CMS, Office of Acquisition and Grants Management (OAGM), Grants Management Officer in his/her sole discretion, may continue the review process for an ineligible application if it is in the best interests of the government to meet the objectives of the program.

https://sam.gov/content/home https://www.grants.gov/

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Each application must include all contents of the application package, in the order indicated, and conform to the following formatting specifications:

• The required page size is 8.5” x 11” letter-size pages (one side only) with 1” margins (top, bottom, and sides). CMS does not accept other paper sizes.

• All pages of the project and budget narratives as well as other required narrative documents must be paginated in a single sequence.

• Font size must be at least 12-point with an average of 14 characters per inch (CPI).

• The Project Narrative must be double-spaced. The page limit for this document is 25 pages.

• The Business Assessment of Applicant Organization may be single spaced. The page limit for this document is 12 pages.

• Tables included within any portion of the application must have a font size of at least 12-point with a 14 CPI and may be single spaced. Tables are counted towards the applicable page limits.

• The project abstract is restricted to a one-page summary that may be single-spaced.

• The following required application documents are excluded from the page limitations described previously:

o Standard Forms, Application Cover Letter/Cover Page (if applicable), copy of

Letter of Intent, Project Site Location Form.

• The total number of additional appendices per application may be no more than 20.

b. Standard forms The following forms must be completed with an electronic signature and enclosed as part of the application:

1. Project Abstract Summary

A one-page abstract serves as a succinct description of the proposed project and includes the goals of the project, the total budget, and a description of how the funds will be used. The abstract is often distributed to provide information to the public and Congress, so please write the abstract so that it is clear, accurate, concise, and without reference to other parts of the application. Exclude personal identifying information from the abstract. In the Grants Application Package at https://www.grants.gov, select the Project Abstract Summary and complete the form.

2. SF-424: Official Application for Federal Assistance

Note: On SF-424 “Application for Federal Assistance”

• On Item 15 “Descriptive Title of Applicant’s Project,” state the specific grant for which you are applying.

• Check “No” to item 19c, as Review by State Executive Order 12372 does not apply to this grant funding opportunity.

• The Authorized Organizational Representative (AOR) completes and signs this form.

Note: The signature of the individual that submits the application to Grants.gov populates throughout the application. The signature must match the name of the AOR. Other signatures will not be accepted.

https://www.grants.gov/

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The AOR is the designated representative of the applicant/Recipient organization with authority to act on the organization’s behalf in matters related to the award and administration of grants. In signing a grant application, the AOR agrees that the organization will assume the obligations imposed by applicable Federal statutes and regulations and other terms and conditions of the award, including any assurances, if a grant is awarded. These responsibilities include accountability both for the appropriate use of funds awarded and the performance of the grant-supported project or activities as specified in the approved application.

1. SF-424A: Budget Information Non-Construction

2. SF-424B: Assurances-Non-Construction Programs

3. SF-LLL: Disclosure of Lobbying Activities

All applicants must submit this SF-LLL form. If your entity does not engage in lobbying, please insert “Non-Applicable” on the form and include the required AOR name, contact information, and signature. Please note that the application kit available online on the Grants.gov website is utilized for many programs and therefore Grants.gov may designate this form as optional to allow for flexibility amongst programs. However, this form is required as part of the application package and must be submitted for the application to be considered eligible for review.

4. Project Site Location Form(s)

All applicants must submit this Project Site Location form. Please note that the application kit available online in Grants.gov is utilized for many programs and therefore Grants.gov may designate this form as optional to allow for flexibility amongst programs. However, this form is required as part of the application package and must be submitted for the application to be considered eligible for review.

c. Application cover letter or cover page

The applicant may choose to include a cover letter or cover page to detail its interest in participation in HEDAP.

d. Program Requirements and Expectations Project Narrative

Through the HEDAP, CMS provides funding to support three seats in the CMS VRDC in the CCW to allow researchers access to CMS restricted data for minority health research. Specifically, recipients will gain access to CMS data to conduct health services research focusing on, but not limited to, racial and ethnic minority groups; people with disabilities; members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality.

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Applicants are required to provide a project narrative for specific applied research projects related to creative and innovative methods for using CMS data to identify, document, assess, and evaluate health disparities among Medicare, Medicaid and CHIP enrollees.

The Project Narrative must articulate in detail the proposed goals, measurable objectives, and milestones to be completed in accordance with the instructions and content requirements provided below and the specific criteria described in F4. Reporting and E1. Criteria. Please include the title “Project Narrative” at the beginning of the Project Narrative.

The 25-page project narrative shall provide a concise and complete description of the proposed project. It shall contain the information necessary for the review panelists to fully understand the project and cover all aspects of the project.

The Project Narrative should be written using the following format:

1. Relevance, feasibility, and potential impact

2. Methodology

3. Ability to implement the research project

4. Institutional structure, capabilities and budget support

1) Relevance, Feasibility, and Potential Impact

The application must demonstrate that the applicant has a thorough understanding of the specific health problem(s) within the population identified. The applicant should clearly describe the proposed project explaining what the researcher plans to do and why. This section of the application must describe the:

• Background, significance, review of literature, and need for the project

• Project purpose, goals, and objectives

• Relevance of the project to CMS’ mission/programs

• Feasibility – Does the applicant demonstrate knowledge of CMS data sufficient to ensure that the research question is appropriate and may be addressed in a sound, scientific manner using CMS data?

• Potential impacts - What insights will the project provide that may improve the overall health outcomes and quality of care, and/or reduce health disparities, for the targeted populations in Section A4?

2) Methodology

The applicant should explain how the research team intends to implement the project. The applicant should make a complete and concise presentation of the methodology that will be used. The application should provide clear and convincing evidence and supporting materials that reflect how the project is likely to improve quality of care and reduce health disparities for populations referenced in Section A4. Any innovative features of the proposed project should be highlighted. The application must include:

• Study design

• Hypotheses/research questions

• Data analysis plan

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• Populations and setting

• Expected outcomes

3) Ability to Implement the Research Project

The applicant should provide detailed information to demonstrate their technical understanding and capability of performing the requirements of the project, including:

• A detailed implementation strategy and plan that includes a management plan describing tasks, responsible individuals, and timelines.

• The capabilities/responsibilities of all personnel and a description of how the personnel will be organized, to whom they will report, and their role in accomplishing the goals, objectives, and components of the project.

4) Institutional Structure, Capabilities, and Budget Support

The applicant should demonstrate clear and convincing evidence that the eligible entity has the organizational infrastructure and management capacity to conduct the research project effectively, including:

• Evidence of the availability and adequacy of the facilities, equipment, staffing, and financial management systems to conduct the project for the entire three years.

• Should an applicant be awarded funding, changes and staffing that affect this research should be reported. For example, reduction of staff or change in budget that would limit the ability to conduct research using HEDAP data.

e. Budget (SF-424A) Fixed amount awards based on the cost of the support of a “seat” has been established based on a reasonable estimate of actual cost to access and obtain data from ResDAC. Award amounts are based on meeting specific requirements of this funding opportunity.

Applicants must use the budget category “Other” in Section B on the SF-424A. The three-year VRDC seat access award amount shall not exceed $90,000 per award for a 36-month period.

Voluntary committed cost sharing or matching is not expected unless specifically stated otherwise in section C2.

For additional information and instructions for completing the SF-424A please refer to Appendix I. Guidance for Preparing

f. Business assessment of applicant organization (maximum 12 pages)

As required by 45 CFR §75.205 for competitive grants and cooperative agreements, CMS evaluates the risk posed by an applicant before they receive an award. This analysis of risk includes items such as financial stability, quality of management systems, internal controls and the ability to meet the management standards prescribed in 45 CFR Part 75.

An applicant must review, answer, and submit the business assessment questions outlined in Appendix III. Business Assessment of Applicant Organization.

g. Required Appendices (20-page limit)

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• Key Staff Qualifications - Include resumes/curricula vitae of key personnel describing their qualifications. Resumes and/or curricula vitae should be a maximum of 5 pages each.

• Existing List of Research Projects and Roles.

• Letters of Agreement, Endorsement, or Support – An endorsement from the President or another equivalent official from your institution is required. Also required are endorsements from collaborating organizations outlining their contributions, roles, and responsibilities relative to the project and commitments that have been pledged for the proposed project. Include individual letters of support, as appropriate.

• Memoranda of Understanding/Agreements – Include documentation reflecting the collaborative relationships between relevant institutions.

• Institutional Review Board (IRB) Approval Plan – Describe plans to apply for IRB approval. Funding shall be contingent on obtaining IRB approval post-award.

Additional Supporting Documentation (10-page limit)

• Additional supporting documentation may be submitted; however, such materials shall be limited to information relevant to the specific scope and purpose of the proposed project.

D3. Unique Entity Identifier and System for Award Management (SAM) Unless the applicant is an individual or Federal awarding agency that is excepted from those requirements under 2 CFR 25.110(b) or (c), or has an exception approved by the Federal awarding agency under 2 CFR 25.110(d)), each applicant is required to:

i. register in SAM.gov before submitting its application;

ii. provide a valid unique entity identifier in its application; and

iii. continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency.

The Federal awarding agency may not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.

D4. Submission Dates and Times

All applications must be submitted electronically and be received through https//www.grants.gov by the date and time set forth below. Applications received after 3:00 pm, Eastern Time, of the date set forth below will not be reviewed or considered for award.

Due Date for Applications: August 15, 2023, 3:00 pm Eastern Time (Baltimore, MD).

http://www.grants.gov/

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D5. Intergovernmental Review

Program is not subject to 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 Executive Order 12372 does not apply to these grants.

D6. Cost Restrictions

Funding under this NOFO can only cover the cost of the payment for the access to the CMS CCW data under ResDAC for a three-year period. Funding cannot be used for any other purpose to include duplication or supplanting of other funding sources or to cover services provided after, or as a result of, the proposed approved research. Research must have its own budget for self-sustaining.

CMS prohibits funds under this award for any of the activities/costs outlined below unless an exception is specifically authorized by statute.

• To reimburse for pre-award costs.

• To match any other Federal funds.

• To provide services, equipment, or supports that are the legal responsibility of another party under Federal, State, or Tribal law (e.g., vocational rehabilitation or education services) or under any civil rights laws. Such legal responsibilities include, but are not limited to, modifications of a workplace or other reasonable accommodations that are a specific obligation of the employer or other party.

• To provide goods or services not allocable to the approved project.

• To supplant existing State, local, Tribal or private funding of infrastructure or services, such as staff salaries, etc.

• To be used by local entities to satisfy state matching requirements.

• To pay for construction.

• To pay for capital expenditures for improvements to land, buildings, or equipment which materially increase their value or useful life as a direct cost, except with the prior written approval of the Federal awarding agency.

• To pay for the cost of independent research and development, including their proportionate share of indirect costs (unallowable in accordance with 45 CFR 75.476).

• To expend funds related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive Order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body.

D7. Mandatory Disclosure Submission is required for all applicants, in writing, to the awarding agency and to the HHS Office of Inspector General (OIG), all information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Disclosures must be sent in writing to:

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Centers for Medicare and Medicaid Services Office of Acquisition and Grants Management Attn: Director, Division of Grants Management 7500 Security Blvd, Mail Stop B3-30-03 Baltimore, MD 21244-1850

AND

Office of Inspector General ATTN: Mandatory Grant Disclosures, Intake Coordinator 330 Independence Avenue, SW, Cohen Building Room 5527 Washington, DC 20201

URL: https://oig.hhs.gov/fraud/report-fraud/index.asp

(Include “Mandatory Grant Disclosures” in subject line)

Fax: (202) 205-0604 (Include “Mandatory Grant Disclosures” in subject line) or

Email: MandatoryGranteeDisclosures@oig.hhs.gov

Materials should be scanned and emailed to the Grants Management Specialist assigned to this

NOFO.

D8. HHS Form 690

Before CMS makes an award to a Recipient, the AOR must certify, by means of the signature on the application (SF-424), that the organization has on file with the HHS Office of Civil Rights (OCR) a one-time Assurance of Compliance with the statutes described in this subsection. The Assurance, Form HHS 690, is filed for the organization and is not required for each application.

(HHS 690 form (PDF | 324 KB)

The HHS 690 form may be filed electronically via the U.S. Department of Health and Human Services’ Assurance of Compliance online portal at:

https://ocrportal.hhs.gov/ocr/aoc/instruction.jsf or be mailed to:

U.S. Department of Health & Human Services Office for Civil Rights 200 Independence Ave., S.W. Room 509F Washington, D.C. 20201

Subrecipients that receive funding from Recipients (including contractors under grants) rather than directly from CMS, also are required to file an HHS 690. The applicant/recipient is https://oig.hhs.gov/fraud/report-fraud/index.asp mailto:MandatoryGranteeDisclosures@oig.hhs.gov https://www.hhs.gov/sites/default/files/form-hhs690.pdf https://ocrportal.hhs.gov/ocr/aoc/instruction.jsf

2023-06-29 Page 20 of 55 responsible for determining whether those organizations have the required Assurance on file and, if not, ensuring that it is filed with OCR.

E. Application Review Information

E1. Criteria

Applications must be submitted in the required format, no later than the deadline. If an applicant does not submit all the required documents and does not address each of the topics described in D2. Content and Form of Application Submission Information (with cross reference to E1. Criteria), the applicant risks not being eligible and/or awarded. Applications are reviewed in accordance with criteria outlined below.

The total score for the application review criteria is 100 points.

All applicants must submit the following:

• Standard Forms;

• A Cover Letter, optional;

• A Project Narrative;

• Project Abstract

• Project Location Form

• Business Assessment of Applicant Organization; and

• Federally Negotiated Indirect Cost Rate Agreement (if applicable)

Section Topics Total

Available Points

Scoring Criteria Breakdown

A. Overall Impact 25 Considering all other application components in total, reviewers will provide an overall impact score assessment of the potential of the project to contribute to advancements in health equity for all populations as referenced in A4. How does the project clearly describe research that is relevant to CMS programs? (6 points)

• How does the project propose to advance health care quality for racial and ethnic minorities; people with disabilities;

members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and/or individuals

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• How does the project align with Executive Order 13985 – Advancing Racial Equity and Support for Underserved Communities Through the Federal Government and Executive Order 14091 – Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government? (6 points)

• How well does the proposed project address upstream drivers, social, and non-medical determinants of health? (6 points)

B. Significance 25 The applicant should address the following questions:

• How does the project address an important health equity related problem(s)? (6 points)

• What is the scientific basis for your project? How does the project propose to address a health equity issue identified as a priority for CMS? (6 points)

• What are the project goals? Do the goals integrate diversity and inclusion efforts with population health, patient care, quality, and safety? (6 points)

• How will achieving the project’s aims improve knowledge, technical capability, workforce pipeline, or enhance quality, access, or outcomes for racial and ethnic minorities;

people with disabilities; members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality? (7 https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal

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C. Approach 15 The applicant should address the following questions:

• What are the key research questions and aims, and how do the proposed methodologies and analysis address them?

• How will the investigators ensure a robust and unbiased approach? (2.5 points)

• What is the target population and setting, including the size of the target population, the proportion that is expected to be reached by the study, and rationale for this figure?

(2.5 points)

• What is the data collection and analysis plan? (2.5 points)

CCW contains the following 100% Medicare files for years 1999 - 2020:

o Fee-for-service institutional and non-institutional claims o Enrollment/eligibility o Assessment data o 100% Medicaid files for years 1999

– 2016 o 100% Part D Prescription Drug

Event data for years 2006 - 2020 o Plan characteristics o Pharmacy characteristics o Prescriber characteristics o Formulary file - beginning with year o Other Research files – www.ccwdata.org

• What challenges does the applicant anticipate and what potential mitigation strategies might the applicant pursue? (2.5 points)

• How will the principal investigator of the award protect human subjects from research risks, particularly high risk and underserved populations, and what are the applicant’s plans to obtain IRB approval? (2.5 points)

D. Innovation 15 The applicant should address the following question:

https://www2.ccwdata.org/web/guest/home/

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• How does the proposed project, improve or develop new policy or program ideas that advance equity for all racial and ethnic minorities; people with disabilities;

members of the…