HRSA-22-015.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Division of Community HIV/AIDS Programs

Ryan White HIV/AIDS Program Part C Early Intervention Services Program:

Existing Geographic Service Areas

Funding Opportunity Numbers: HRSA-22-011, HRSA-22-014, HRSA-22-015

Funding Opportunity Type(s): New and Competing Continuation Assistance Listings (CFDA) Number: 93.918

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: June 21, 2021

Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems, including SAM.gov and Grants.gov, may take up to 1 month to complete.

Issuance Date: March 29, 2021

Hanna Endale Chief, Atlantic Branch Division of Community HIV/AIDS Programs (DCHAP) E-mail: HEndale@hrsa.gov Telephone: (301) 443-1326

Authority: 42 U.S.C. §§ 300ff-51-67 and 300ff-121 (sections 2651-2667 and 2693 of the Public Health Service (PHS) Act).

mailto:HEndale@hrsa.gov

HRSA-22-011, HRSA-22-014, HRSA-22-015 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for fiscal year (FY) 2022 – FY 2024 Ryan White HIV/AIDS Program (RWHAP) Part C HIV Early Intervention Services (EIS) Program: Existing Geographic Service Areas. The purpose of this program is to provide comprehensive primary health care and support services in an outpatient setting for low income, uninsured, and underserved people with HIV.

Under this announcement, applicants must propose to provide: (1) counseling for individuals with respect to HIV; (2) targeted HIV testing; (3) periodic medical evaluations of individuals with HIV and other clinical and diagnostic services regarding HIV; (4) therapeutic measures for preventing and treating the deterioration of the immune system, and for preventing and treating conditions arising from HIV; and (5) referrals for people with HIV to appropriate providers of health and support services. These services are to be provided directly or through referrals, contracts or memoranda of understanding (MOUs).

This competition is open to current recipients and new organizations proposing to provide RWHAP Part C EIS funded services in the geographic service areas, as described in Appendix B. Please note that there are three (3) funding announcement numbers included in this document with three (3) different periods of performance (see table below). Applicants must apply to the funding opportunity announcement number that corresponds to the period of performance start date for their project.

The application must address the entire service area, as defined in Appendix B.

Applicants applying for more than one service area listed in Appendix B must submit a separate application for each service area under the correct funding opportunity number.

Funding Opportunity Title: Ryan White HIV/AIDS Program Part C HIV Early

Intervention Services Program: Existing Geographic Service Areas

Funding Opportunity Number: HRSA-22-011 – January 1 start date HRSA-22-014 – April 1 start date HRSA-22-015 – May 1 start date

Due Date for Applications: June 21, 2021 Anticipated Total Annual Available Funding:

HRSA-22-011 – $62,400,000

HRSA-22-014 – $49,200,000

HRSA-22-015 – $69,000,000

Estimated Number and Type of Award(s):

HRSA-22-011: 90 grants HRSA-22-014: 112 grants HRSA-22-015: 145 grants

Estimated Award Amount: Varies; See Appendix B Cost Sharing/Match Required: No

NOFO # Period of Performance

HRSA-22-011, HRSA-22-014, HRSA-22-015 ii

Project Period/Period of Performance:

HRSA-22-011 January 1, 2022 through December 31, 2024

HRSA-22-014 April 1, 2022 through March 31, HRSA-22-015 May 1, 2022 through April 30, 2025 Each period of performance will be for three (3) years

Eligible Applicants: Public and nonprofit private entities that are: a) Federally qualified health centers under section 1905(1)(2)(B) of the Social Security Act; b) Grant recipients under section 1001 (regarding family planning) other than States; c) Comprehensive hemophilia diagnostic and treatment centers; d) Rural health clinics; e) Health facilities operated by or pursuant to a contract with the Indian Health Service; f) Community-based organizations, clinics, hospitals, and other health facilities that provide early intervention services to people who contracted HIV through intravenous drug use; or g) Nonprofit private entities that provide comprehensive primary care services to populations at risk of HIV, including faith-based and community-based organizations.

See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

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Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online at http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf, except where instructed in this NOFO to do otherwise.

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Tuesday, April 20, 2021 Time: 2 – 4 p.m. ET Call-In Number: 1-833-568-9964 Participant Code: 04879305 Weblink:

https://hrsa-gov.zoomgov.com/j/1608895322?pwd=K3lZSm1vT3FaVEFkcHlSemNlREZaUT09

This TA webinar will be recorded and made available on the TargetHIV Center website at https://targethiv.org/library/nofos.

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa-gov.zoomgov.com/j/1608895322?pwd=K3lZSm1vT3FaVEFkcHlSemNlREZaUT09 https://hrsa-gov.zoomgov.com/j/1608895322?pwd=K3lZSm1vT3FaVEFkcHlSemNlREZaUT09 https://targethiv.org/calendar/2020-Ryan-White-Conference https://targethiv.org/library/nofos

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Program-Specific Forms

vi. Attachments

3. DUN AND BRADSTREET DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER TRANSITION

TO THE UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEM ENT (SAM) 33

4. SUBMISSION DATES AND TIM ES

5. INTERGOV ERNM ENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSM ENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIV E AND NATIONAL POLICY REQUIREM ENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: RWHAP PART C EIS ADDITIONAL AGREEMENTS AND ASSURANCES ... 46

APPENDIX B: GEOGRAPHIC SERVICE AREAS

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under Ryan White HIV/AIDS Program (RWHAP) Part C Early Intervention Services (EIS) Program: Existing Geographic Service Areas. The purpose of this program is to provide comprehensive primary health care and support services in an outpatient setting for low income, uninsured, and underserved people with HIV.

Under this announcement, successful applicants must provide: (1) counseling for individuals with respect to HIV; (2) targeted HIV testing; (3) periodic medical evaluations of individuals with HIV and clinical and diagnostic services for HIV care and treatment; (4) therapeutic measures for preventing and treating the deterioration of the immune system, and for preventing and treating conditions arising from HIV; and (5) referrals for people with HIV to appropriate providers of health care and support services. These services are to be provided directly or through referrals, contracts or memoranda of understanding (MOUs).

RWHAP Part C EIS recipients must provide comprehensive primary health care and support services throughout the entire designated geographic service areas (referred to as “service areas” throughout this Notice of Funding Opportunity (NOFO)) listed in Appendix B with the goals of providing optimal HIV care and treatment for low-income, uninsured, and underserved people with HIV and improving health outcomes. Your application must address the entire service area, as defined in Appendix B. If you are applying for more than one service area listed in Appendix B you must submit a separate application for each service area under the correct funding opportunity number.

All allowable services must relate to HIV diagnosis, care, and support, and must adhere to established HIV clinical practice standards consistent with U.S. Department of Health and Human Services (HHS) Guidelines. Please refer to the HIV/AIDS Bureau (HAB) Policy Clarification Notice (PCN) 16-02 Ryan White HIV/AIDS Program Services for a list of RWHAP allowable core medical and support services and their descriptions. According to the RWHAP Part C legislation:

• At least 50 percent of the amount received under the grant must be expended on EIS costs (except counseling and referrals/linkage to care);

• At least 75 percent of the award (after reserving amounts for administrative costs, planning/evaluation, and clinical quality management (CQM)) must be expended on core medical services costs (Please note: EIS is a subset of this 75 percent of the award) and;

• Not more than 10 percent of the total RWHAP Part C grant funds can be expended on administrative costs.

Applicants seeking a waiver to the core medical services requirement must submit a waiver request with this application. If submitting with the application, a core medical services waiver request should be included as Attachment 15.

https://aidsinfo.nih.gov/guidelines https://aidsinfo.nih.gov/guidelines https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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2. Background

The Ryan White HIV/AIDS Program (RWHAP) provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income people with HIV. The program funds grants to states, cities, counties, and local community-based organizations to provide care and treatment services to people with HIV to improve health outcomes and reduce HIV transmission among hard-to-reach populations.

The RWHAP has five statutorily defined Parts (Parts A, B, C, D and F) that provide funding for core medical, support services, and medications; technical assistance; clinical training;

and the development of innovative models of care to meet the needs of different communities and populations affected by HIV.

An important framework in the RWHAP is the HIV care continuum, which depicts the series of stages a person with HIV engages in from initial diagnosis through their successful treatment with HIV medication to achieve viral suppression. Supporting people with HIV to reach viral suppression not only increases their own quality of life and lifespan, it also prevents sexual transmission to an HIV-negative partner.

The HIV care continuum framework allows recipients and planning groups to measure progress and to direct HIV resources most effectively. RWHAP recipients are encouraged to assess the outcomes of their programs and should work with their community and public health partners to improve outcomes across the HIV care continuum. HRSA encourages recipients to use the performance measures developed for the RWHAP at their local level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

Strategic Frameworks and National Objectives

National objectives and strategic frameworks like the Healthy People 2030, the HIV National Strategic Plan: A Roadmap to End the HIV Epidemic (2021 – 2025); the Sexually Transmitted Infections National Strategic Plan for the United States (2021 – 2025); and the Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021 – 2025) are crucial to addressing key public health challenges facing low-income people with HIV. These strategies detail the principles, priorities, and actions to guide the national public health response and provides a blueprint for collective action across the federal government and other sectors. The RWHAP supports the implementation of these strategies and recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, with these strategies to extent possible.

Expanding the Effort: Ending the HIV Epidemic

According to recent data from the 2019 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2015 to 2019, HIV viral suppression among RWHAP patients who have had one or more medical visits during the calendar year and at least one viral load with a result of <200 copies/mL reported, has increased from 83.4 percent to 88.1 percent. Additionally, racial/ethnic, age-based, and regional disparities reflected in viral suppression rates have http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://health.gov/healthypeople https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2019.pdf

HRSA-22-011, HRSA-22-014, HRSA-22-015 3

significantly decreased.1 For example, the disparities in viral suppression rates between Black/African Americans and white clients have decreased since 2010.2 These improved outcomes mean more people with HIV in the United States will live near normal lifespans and have a reduced risk of transmitting HIV to others.3

In February 2019, the Ending the HIV Epidemic (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This 10-year initiative seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. The initiative promotes and implements four strategies to substantially reduce HIV transmissions – Diagnose, Treat, Prevent, and Respond. The initiative is a collaborative effort among key HHS agencies, primarily HRSA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

For the RWHAP, the EHE initiative expands the program’s ability to meet the needs of clients specifically focusing on linking people with HIV who are either newly diagnosed, diagnosed but currently not in care, or are diagnosed in care but not yet virally suppressed to the essential HIV care and treatment and support services needed to help them achieve viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and CDC’s Division of HIV/AIDS Prevention support integrated data sharing, analysis, and utilization for the purposes of program planning, conducting needs assessments, determining unmet need estimates, reporting, quality improvement, enhancing the HIV care continuum, and public health action. HRSA strongly encourages RWHAP recipients to:

• Follow the principles and standards in the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action.

• Establish data sharing agreements between surveillance and HIV programs to ensure clarity about the process and purpose of the data sharing and utilization.

Integrated data sharing, analysis, and utilization of HIV data by state and territorial health departments can help further progress toward reaching the HIV National Strategic Plan goals and improve outcomes on the HIV care continuum.

HRSA strongly encourages complete CD4, viral load (VL) and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State health departments may use CD4, VL, and nucleotide sequence data to identify cases, stage of HIV disease at

1 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2019. http://hab.hrsa.gov/data/data-reports. Published December 2020. Accessed December 2, 2020.

2 Black/African American clients went from 79.4 percent viral suppression in 2015 to 85.2 percent in 2019, while 88.3 percent of white clients were virally suppressed in 2015 and 91.8 percent in 2019 3 National Institute of Allergy and Infectious Diseases (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2016 Mar 29]. Available from: https://clinicaltrials.gov/ NCT00074581 NLM Identifier: NCT00074581.

https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

HRSA-22-011, HRSA-22-014, HRSA-22-015 4

diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into and retention in HIV care, measure viral suppression, monitor prevalence of antiretroviral drug resistance, detect transmission clusters and understand transmission patterns, and assess unmet health care needs. Analyses at the national level to monitor progress toward ending the HIV epidemic can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence test results are reported by all jurisdictions. CDC requires the reporting to the National HIV Surveillance System (NHSS) all HIV-related CD4 results (counts and percentages), all VL results (undetectable and specific values), and HIV nucleotide sequences.

Program Resources and Innovative Models

HRSA has a number of projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA HAB cooperative agreements, contracts, and grants focused on specific technical assistance (TA), evaluation, and intervention activities. A list of these resources is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

In addition, many RWHAP Special Projects of National Significance (SPNS) projects have demonstrated promising new approaches for linking and retaining priority populations into care. As resources permit, RWHAP recipients are encouraged to review and integrate these tools within their HIV system of care in accordance with the allowable service categories defined in PCN 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds. Examples of these resources include:

• E2i: Using Evidence-Informed Interventions to Improve Health Outcomes among

People Living with HIV E2i uses an implementation science approach to evaluate and understand existing and new intervention strategies that can be used in RWHAP provider settings. Once interventions or strategies are demonstrated and evaluated using implementation science, manuals, guides, interactive online tools, publications, and instructional materials are developed and disseminated for replication and integration into RWHAP provider settings.

• Integrating HIV Innovative Practices (IHIP) Resources on the IHIP website include easy-to-use training manuals, curricula, case studies, pocket guides, monographs, and handbooks, as well as informational handouts and infographics about SPNS generally. IHIP also hosts TA training webinars designed to provide a more interactive experience with experts, and a TA help desk exists for you to submit additional questions and share your own lessons learned.

• Replication Resources from the SPNS Systems Linkages and Access to Care There are intervention manuals for patient navigation, care coordination, state bridge counselors, data to care, and other interventions developed for use at the state and regional levels to address specific HIV care continuum outcomes among hard-to-reach people with HIV.

https://targethiv.org/help/ta-directory https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://targethiv.org/e2i https://targethiv.org/e2i https://targethiv.org/ihip https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care

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• Dissemination of Evidence Informed Interventions The Dissemination of Evidence-Informed Interventions initiative ran from 2015-2020 and disseminated four adapted linkage and retention interventions from prior SPNS and the Minority HIV/AIDS Funds (MHAF) from the HHS Secretary’s Office initiatives to improve health outcomes along the HIV care continuum. The initiative produced four evidence-informed care and treatment interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and easily adaptable to the changing healthcare environment. Manuals are currently available at the link provided and will be updated on an ongoing basis.

HRSA HAB also recognizes the importance of addressing emerging issues, as well as supporting the needs of special populations. To help recipients in responding to these critical issues, HRSA HAB funds projects to provide technical assistance and resources for recipients. Examples of projects include:

• Building Futures: Supporting Youth Living with HIV

• The Center for Engaging Black MSM Across the Care Continuum (CEBACC)

• Using Community Health Workers to Improve Linkage and Retention in Care

Social determinants of health (SDOH) are conditions in which people are born, grow, live, work, and age. They include factors like socioeconomic status, education, neighborhood and physical environment, community violence, employment, and social support networks, as well as access to health care. Intimate partner violence (IPV) is among these factors that can disproportionately affect underserved communities.

According to Centers for Disease Control and Prevention, National Intimate Partner and Sexual Violence Survey (NISVS), IPV describes physical violence, sexual violence, stalking, or psychological harm by a current or former partner or spouse, and can have both direct and indirect effects on individual, family, and community health. In 2017, HRSA launched its Strategy to Address IPV, an effort to address this critical social determinant of health through agency-wide collaborative action. The Strategy includes four priority areas including (1) Training the nation’s health workforce, (2) Building partnerships to raise awareness, (3) Increasing access to quality care, and (4) Addressing gaps in knowledge about IPV risks, impacts, and interventions. Applicants are encouraged to consider one or more of these priority areas, as relevant, in the development and measurement of their initiative.

Additional resources to assist you in determining how to effectively address intimate partner violence in your HRSA-funded programs may be found in the HRSA Strategy to Address IPV.

II. Award Information

1. Type of Application and Award

Types of applications sought: New and Competing Continuation.

https://targethiv.org/deii https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/chw https://www.hrsa.gov/sites/default/files/hrsa/HRSA-strategy-intimate-partner-violence.pdf https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDAxMDguMTUyMTYxOTEiLCJ1cmwiOiJodHRwczovL3d3dy5ocnNhLmdvdi9zaXRlcy9kZWZhdWx0L2ZpbGVzL2hyc2EvSFJTQS1zdHJhdGVneS1pbnRpbWF0ZS1wYXJ0bmVyLXZpb2xlbmNlLnBkZiJ9.5XDYqcDgMZeOEOSLpa1La58JIGP-orrUu2yci7lJLkI/br/73794573613-l https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMDAxMDguMTUyMTYxOTEiLCJ1cmwiOiJodHRwczovL3d3dy5ocnNhLmdvdi9zaXRlcy9kZWZhdWx0L2ZpbGVzL2hyc2EvSFJTQS1zdHJhdGVneS1pbnRpbWF0ZS1wYXJ0bmVyLXZpb2xlbmNlLnBkZiJ9.5XDYqcDgMZeOEOSLpa1La58JIGP-orrUu2yci7lJLkI/br/73794573613-l

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HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates approximately $180,600,000 to be available annually to fund 347 recipients with three (3) different periods of performance start dates. You may apply up to the published ceiling amount in Appendix B per year. The actual amount available will not be determined until enactment of the final FY 2022 federal budget. This program announcement is subject to the appropriation of funds and is a contingency action taken to ensure that, should funds become available for this purpose, applications can be processed, and funds can be awarded in a timely manner. The funding announcement has three (3) period of performance start dates (see table below). Applications must be complete, within the specified page limit, and validated by Grants.gov prior to the deadline to be considered under this NOFO. Be sure to submit the application under the correct funding opportunity number.

Funding Opportunity Number Period of Performance HRSA-22-011 January 1, 2022 through December 31, 2024 HRSA-22-014 April 1, 2022 through March 31, 2025 HRSA-22-015 May 1, 2022 through April 30, 2025

Funding for each period of performance will be for three (3) years. Funding beyond the first year is subject to the availability of appropriated funds for RWHAP Part C HIV EIS Program:

Existing Geographic Service Areas in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

In FY 2018, HRSA implemented a systematic revision of the distribution of RWHAP Part C funding to ensure that it is awarded across service areas based on the following objective RWHAP data: the number and current demographics of clients served, HIV-related health disparities, and the number of uninsured clients. The RWHAP Part C funding methodology ensures baseline funding for the maintenance of program operations, minimizes disruptions by constraining the maximum allowable decrease in funding, and maintains the provision of quality HIV care in existing service areas. For this competition, HRSA has again used the funding methodology to determine the funding ceiling amount per service area under this NOFO, which continues to be a competitive, discretionary grant opportunity.

The RWHAP Part C funding methodology uses quantitative data primarily from the RSR to allocate funds to grant service areas in a more streamlined and consistent manner, achieving a reasonable and sustainable allocation of resources to improve health outcomes for people with HIV. Similar to FY 2018, the RWHAP Part C funding methodology includes the following proportions and objective factors: 1) 70 percent of funding is base funding (minimum award amount of $100,0004 per service area augmented by an amount corresponding to the number of eligible Part C clients served in that area as reported through the 2019 RSR); and 2) 30 percent of funding is based on a) demographics as reported through the 2019 RSR (limited to the service area’s proportion of populations

4 Due to efforts to constrain the degree of change in funding experienced by each service area, there is one service area whose base award amount is slightly lower than $100,000.

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disproportionately impacted by the HIV epidemic with significant disparities in health outcomes, including men of color who have sex with men, women of color, people who inject drugs, youth aged 13-24, transgender individuals, and uninsured populations), and b) RWHAP Part A resources (RWHAP Part C service areas outside of RHWAP Part A jurisdictions will receive additional funding). Future iterations of the RWHAP Part C funding methodology may include new proportions in funding and factors, such as performance in HIV viral suppression, to ensure that the funding allocation across service areas will be responsive to HIV health disparities and the changing demographics of the HIV epidemic, as well as the evolving health care landscape.

To maintain continued access to high quality HIV primary care and support services, funds will continue to be awarded across existing service areas. Existing service areas will be kept intact, as described in this NOFO. Under this three-year award, HRSA has constrained the degree of change in funding.

The funding ceiling amounts in Appendix B reflect the implementation of this methodology.

HRSA encourages current RWHAP Part C recipients to assess their history of expending Part C funds and to examine all resources available, including program income generated as a result of the RWHAP Part C award, when they consider the funding level for which to apply. Appendix B describes the ceiling amount for each service area; applicants can request a funding level that is less than the listed amount in light of their history of expending Part C funds and availability of other resources. HRSA HAB anticipates directing any balance in funds to support the funding of new RWHAP Part C service areas where there is the greatest burden of infection, illness, and disparities from HIV, as well as to support the RWHAP Part C Capacity Development grant program. In addition, HRSA reserves the right to fund less than the amount requested based on a history of current RWHAP Part C recipients’ unobligated balances.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

III. Eligibility Information

1. Eligible Applicants

This competition is open to current recipients and new eligible applicants proposing to provide comprehensive primary health care and support services in outpatient settings for low income, uninsured, and underserved people with HIV in the service areas as described in Appendix B.

As identified in section 2652(a)(1) of the PHS Act, the following public and non-profit private entities are eligible to apply:

a) Federally-qualified health centers under section 1905(1)(2)(B) of the Social Security Act;

b) Grant recipients under section 1001 of the PHS Act (regarding family planning) other than States;

c) Comprehensive hemophilia diagnostic and treatment centers;

d) Rural health clinics;

e) Health facilities operated by or pursuant to a contract with the Indian Health Service;

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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f) Community-based organizations, clinics, hospitals, and other health facilities that provide early intervention services to people who contracted HIV through intravenous drug use;

or

g) Nonprofit private entities that provide comprehensive primary care services to populations at risk of HIV, including faith-based and community-based organizations.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that exceeds the ceiling amount listed in Appendix B non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that exceeds the page limit referenced in Section IV non-responsive and will not consider it for funding under this notice.

NOTE: Multiple applications from an organization are allowable. If you are applying for more than one service area listed in Appendix B, you must submit a separate application for each service area under the correct funding opportunity number. Each application must address the entire service area, as defined in Appendix B.

Be sure to submit the application under the correct funding opportunity number.

As a reminder:

Funding Opportunity Number Period of Performance HRSA-22-011 January 1, 2022 through December 31, 2024 HRSA-22-014 April 1, 2022 through March 31, 2025 HRSA-22-015 May 1, 2022 through April 30, 2025

If for any reason (including submitting to the wrong funding opportunity number or making corrections/updates), an application is submitted more than once prior to the application due date, HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

Maintenance of Effort You must agree to maintain non-federal expenditures for EIS services (i.e., counseling of individuals with respect to HIV, targeted HIV testing, referrals/linkage to care, therapeutic measures, and periodic medical evaluations of people with HIV and other clinical and diagnostic services related to HIV diagnosis) at a level equal to or greater than your total non-federal expenditures for EIS during the most recently completed fiscal year prior to the competitive application deadline (as required by section 2664(d) of the PHS Act). You must report that you will meet the Maintenance of Effort requirement (see Attachment 7).

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IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

The NOFO is also known as “Instructions” on Grants.gov. You must provide your email address when reviewing or preparing the workspace application package in order to receive notifications including modifications and/or republications of the NOFO on Grants.gov before its closing date. You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application.

Responding to an earlier version of a modified notice may result in a less competitive or ineligible application. Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

2. Content and Form of Application Submission

Section 4 of HRSA’s SF-424 Application Guide provides instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract.

You must submit the information outlined in the Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files counted in the page limit may not exceed the equivalent of 80 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Indirect Cost Rate Agreement (if applicable) and proof of non-profit status do not count in the page limit. We strongly urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline to be considered under this notice. The three (3) funding opportunity numbers included in https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide.pdf

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this announcement are stated in the table below. Be sure to submit the application under the correct funding opportunity number.

Funding Opportunity Number Period of Performance HRSA 22-011 January 1, 2022 through December 31, 2024 HRSA 22-014 April 1, 2022 through March 31, 2025 HRSA 22-015 May 1, 2022 through April 30, 2025

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You, on behalf of the applicant organization certify, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. 3321).

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 15: Core Medical Services Waiver Request.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Program Requirements and Expectations

Recipients must adhere to the following clinical, administrative, and fiscal statutory requirements and program expectations.

Clinical Requirements:

• HIV Counseling, Testing and Referral – RWHAP Part C funds can be used to provide HIV Counseling, Testing, and Referral (CTR) services to high risk targeted populations in the designated service area in order to identify people with HIV and link them into medical care. However, recipients must coordinate these services with other HIV prevention and testing programs to avoid duplication of effort.

Linkages and formal referral mechanisms should be established to ensure follow-up care and treatment for those persons identified as having HIV. Please note that RWHAP Part C funds cannot (1) supplant CTR efforts paid for by other sources, or

(2) support routine CTR services in the general patient population, or testing activities in the general population. If HIV CTR is provided, these services must comply with sections 2661 to 2663 of the PHS Act. The revised HHS Guidelines for CTR are available at: http://aidsinfo.nih.gov/guidelines. The CTR program also must assure the confidentiality of patient information in compliance with applicable federal, state, and local laws.

Pre-exposure prophylaxis (PrEP) or non-occupational post-exposure prophylaxis (nPEP) is intended for persons who do not have HIV; therefore, RWHAP Part C funds shall not be used to pay for PrEP or nPEP medication or associated medical services. However, RWHAP recipients, including Part C providers, may http://aidsinfo.nih.gov/guidelines

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provide services such as counseling and targeted testing, which should be part of a comprehensive PrEP program. For further guidance, please see the HAB Program Letter on PrEP.

• Medical Care Evaluation and Clinical Care – RWHAP Part C recipients must provide comprehensive patient–centered primary health care services in an outpatient setting for low income people with HIV throughout their entire designated service area (see Appendix B). In addition, recipients must ensure, directly or via referral, access for clients to core medical services as described in HAB PCN 16-02. If a program is unable to provide any of these services directly, it must enter into formal arrangements, such as contracts or MOUs, with appropriate providers.

Recipients must also be able to diagnose, provide prophylaxis, and treat or refer clients with tuberculosis, Hepatitis B or C, and sexually transmitted infections.

Program-wide clinical protocols should be in place to address these co-morbidities. In addition, program clinical staff should track and coordinate all inpatient care. They should develop plans for the resumption of patient care in the program if a patient has been discharged from the hospital or if there is any other disruption in outpatient care. Finally, recipients must also have a system in place for after-hours and weekend clinical coverage for medical and dental services;

and patients must be involved and fully educated about their medical needs and treatment options within the standards of medical care.

• Clinical Guidelines – All clinical care must be provided in accordance with HHS

Guidelines, which can be found on the HIV.GOV website at:

https://clinicalinfo.hiv.gov/en/guidelines. You are strongly encouraged to require, at least yearly, continuing education opportunities for RWHAP Part C program staff to ensure they remain knowledgeable of clinical advances in the treatment of HIV and are familiar with the most recent HHS Guidelines.

• Referral Systems - A process must be in place for referring patients to needed health care and support services such as oral health, specialty care, medical case management, etc. The referral system should include the tracking and monitoring of those referrals, including the documentation of the referral’s outcome in the medical record so that follow-up may occur.

• Linkage to Clinical Trials – A plan must be in place for referring appropriate patients to biomedical research facilities or community-based organizations that conduct HIV-related clinical trials. For information on these protocols, visit the NIH HIV Clinical Trials Network website at: https://www.niaid.nih.gov/research/hiv-research-enterprise

• Clinical Quality Management – Section 2664(g)(5) of the PHS Act requires

RWHAP Part C recipients to establish a CQM program to: (1) assess the extent to which HIV health services provided to patients under the grant are consistent with HHS Guidelines for the treatment of HIV and related opportunistic infections,

(2) develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to quality HIV health services, and (3) https://hab.hrsa.gov/sites/default/files/hab/Global/prepletter062216_0.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/prepletter062216_0.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://clinicalinfo.hiv.gov/en/guidelines https://www.niaid.nih.gov/research/hiv-research-enterprise https://www.niaid.nih.gov/research/hiv-research-enterprise

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ensure that improvements in the access and quality of HIV health services are addressed. Please see HAB PCN 15-02 Clinical Quality Management and related Frequently Asked Questions for PCN 15-02 for information on CQM program requirements.

• Coordination/Linkages to Other Programs – Coordination must occur with all available and accessible community resources, such as federally-funded and non-federally-funded programs (e.g., substance use disorder treatment, mental health treatment, homelessness, housing, other support service programs). This may also include other publicly funded entities providing primary care services, such as Federally Qualified Health Centers (FQHCs) and behavioral health treatment service organizations, including those funded by the Substance Abuse and Mental Health Services Administration (SAMHSA). HRSA expects recipients to collaborate with entities that provide ongoing HIV prevention activities and establish formal linkages with them for referral of people with HIV into care and treatment services at your site.

HRSA expects applicants located near existing RWHAP Part C funded programs to coordinate/collaborate with those programs and to avoid duplication of services provided in the service area. A searchable RWHAP recipient database is available at: http://findhivcare.hrsa.gov/index.html. In addition, HRSA requires successful applicants to coordinate services with other RWHAP providers, including Parts A, B, D, Special Projects of National Significance (SPNS), AIDS Education and Training Centers (AETCs), the Dental Reimbursement Program, and the Community-Based Dental Partnership Program. HRSA encourages successful applicants located in an Eligible Metropolitan Area (EMA) or a Transitional Grant Area (TGA) to participate in the activities of the RWHAP Part A Planning Council and demonstrate that they have coordinated with and not duplicated Part A services. HRSA encourages RWHAP Part C recipients to participate in the RWHAP Part B state/territory planning body and/or RWHAP Part B HIV Care Consortium. Further, HRSA expects RWHAP Part C recipients to provide services consistent with their jurisdiction’s Integrated HIV Prevention and Care Plan, including the Statewide Coordinated Statement of Need.

• Medicaid Provider Status – All providers of services available under the state

Medicaid plan must have entered into a participation agreement under the state plan and be qualified to receive payments under such plan, or receive a waiver from this requirement. This requirement may be waived for entities with which RWHAP Part C recipients have an agreement to provide services under the award that do not impose a charge or accept reimbursement available from any third-party payer, including reimbursement under any insurance policy or under any Federal or State health benefits program. Recipients providing services directly pursuant to the award will not be eligible for a waiver.

• Clinic Licensure – Primary medical care providers and case management agencies must be fully licensed to provide clinical and case management services, as required by their state and/or local jurisdiction (see Attachment 13).

https://hab.hrsa.gov/sites/default/files/hab/Global/HAB-PCN-15-02-CQM.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/clinicalqualitymanagementfaq.pdf http://findhivcare.hrsa.gov/index.html

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Administrative/Fiscal Requirements:

• Consumer Involvement – People with HIV who receive services at a RWHAP-funded organization should be actively involved in the development, implementation, and evaluation of program and CQM activities. To receive effective input from people with HIV, programs should provide necessary training, mentoring, and supervision. Examples of involvement include but are not limited to the following:

o Representation on the organization’s Board of Directors.

o Representation on a newly established or existing consumer advisory board.

o Recruiting people with HIV to serve as volunteer peer trainers to work directly with patients to help them address issues related to making healthy decisions, treatment decisions and adherence, gaining access to clinical trials, and chronic disease self- management, etc.

o Participation on workgroups, committees, and task forces, such as a Quality Committee, a Linkage/Retention initiative, or a Patient Education Committee.

o Serving as peer educators, outreach workers, or staff in the clinic, with fair and equitable pay for the job they are hired to perform.

o Participation through patient satisfaction and needs assessment surveys, forums, and focus groups.

• Imposition of Charges for Services – Patients cannot be denied services if they are unable to pay. The RWHAP statute prohibits imposing a charge on individuals whose income is at or below 100 percent of the Federal Poverty Level (FPL) and requires that recipients impose a charge on individuals with incomes greater than 100 percent of the FPL, according to a publicly available schedule of charges.

o Annual Cap on Charges – The RWHAP statute requires recipients to limit the amount of charges for HIV-related services they can impose on patients per year:

Individual Income Maximum Charge* At or below 100 percent of FPL N/A – no charge

101 to 200 percent of FPL No more than 5 percent of annual gross income

201 to 300 percent of FPL No more than 7 percent of annual gross

Over 300 percent of FPL No more than 10 percent of annual gross o *Waiver of imposition of charges requirements: Entities operating as free clinics, meaning those that do not impose a charge or accept reimbursement available from any third party payer, may request a waiver of the imposition of charges requirements from HRSA.

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