HAB HRSA-25-052 (H76) RW Part C EIS (sweep up)_final.pdf

U.S. Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2025

HIV/AIDS Bureau

Division of Community HIV/AIDS Programs

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

Limited Existing Geographic Service Areas

Funding Opportunity Numbers: HRSA-25-052

Funding Opportunity Type(s): Competing Continuation, New

Assistance Listings Number: 93.918

Application Due Date: December 10, 2024 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

We will not approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: October 8, 2024

Hanna Endale Chief, Atlantic Branch Division of Community HIV/AIDS Programs (DCHAP) Email: PARTCEIS@hrsa.gov

See Section VII for a complete list of agency contacts.

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

mailto:partceis.hrsa@hrsa.gov

HRSA-25-052 RWHAP Part C EIS i

508 COMPLIANCE DISCLAIMER

Persons using assistive technology may not be able to fully access information in this file. For assistance, email or call one of the HRSA staff listed in Section VII Agency Contacts.

SUMMARY

Funding Opportunity Title:

Ryan White HIV/AIDS Program (RWHAP) Part C Early Intervention Services Program: Limited Existing Geographic Service Areas

Funding Opportunity Number:

HRSA-25-052

Assistance Listing Number:

93.918

Due Date for Applications:

December 10, 2024

Purpose: The purpose of this program is to provide comprehensive primary health care and support services in an outpatient setting for low-income people with HIV in existing geographic service areas, as defined in Appendix C.

Program Objective(s):

Under this announcement, applicants must propose to provide all 5 RWHAP Part C Early Intervention Services (EIS) either directly or through referrals, contracts or memoranda of understanding (MOU). These services are:

(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.

Eligible Applicants: This competition is open to current RWHAP Part C EIS recipients and new organizations proposing to provide RWHAP Part C EIS funded services in the geographic service areas listed in Appendix C. Eligible applicants must be public or

HRSA-25-052, RWHAP Part C EIS ii nonprofit private entities that are: a) Federally qualified health centers under section 1905(1)(2)(B) of the Social Security Act (SSA); b) Grant recipients under section 1001 of the Public Health Service 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; 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.

Anticipated FY 2025 Total Available Funding:

$3,102,000

We are issuing this notice to ensure that, should funds become available for this purpose, we can process applications and award funds appropriately. You should note that we may cancel this program notice before award if funds are not appropriated.

Estimated Number and Type of Award(s):

6 awards

Estimated Annual Award Amount:

See Appendix C. Ceiling amounts are subject to the availability of appropriated funds

Cost Sharing or Matching Required:

No

Period of Performance:

Either April 1, 2025 through March 31, 2028 or May 1, 2025 through April 30, 2028, according to Appendix C Each period of performance will be for 3 years

Agency Contacts: Business, administrative, or fiscal issues:

Bria Haley Grants Management Specialist Division of Grants Management Operations, Office of Federal Assistance and Acquisition Management (OFAAM) Email: Bhaley@hrsa.gov mailto:Bhaley@hrsa.gov

HRSA-25-052, RWHAP Part C EIS iii

Program issues or technical assistance:

Hanna Endale Chief, Atlantic Branch Division of Community HIV/AIDS Programs (DCHAP) Email: PARTCEIS@hrsa.gov

Application Guide

You (the applicant organization / agency) are responsible for reading and complying with the instructions included in this NOFO and in the HRSA Application Guide (Application Guide). Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

We have scheduled the following webinar:

Day and Date: Thursday, October 17, 2024 Time: 2 – 4 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1600314058?pwd=3vyxmALogE5OS2YUOUzArViVkK4NGo.1

Attendees without computer access or computer audio can use the following dial-in information:

Call-In Number: 1-833-568-8864 Meeting ID: 160 031 4058 Passcode: hxYNzKu9

We will record the webinar. The link to the recording will be available on the TargetHIV site within five (5) business days.

mailto:partceis.hrsa@hrsa.gov http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://hrsa-gov.zoomgov.com/j/1600314058?pwd=3vyxmALogE5OS2YUOUzArViVkK4NGo.1 https://hrsa-gov.zoomgov.com/j/1600314058?pwd=3vyxmALogE5OS2YUOUzArViVkK4NGo.1 https://targethiv.org/ https://targethiv.org/

HRSA-25-052, RWHAP Part C EIS iv

Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

THE RYAN WHITE HIV/AIDS PROGRAM

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING OR MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. UNIQUE ENTITY IDENTIFIER (UEI) AND SYSTEM FOR AWARD MANAGEMENT (SAM)

4. SUBMISSION DATES AND TIMES

5. INTERGOVERNMENTAL REVIEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REVIEW CRITERIA

2. REVIEW AND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: PAGE LIMIT WORKSHEET

APPENDIX B: RWHAP PART C EIS ADDITIONAL AGREEMENTS AND ASSURANCES

APPENDIX C: EXISTING GEOGRAPHIC SERVICE AREAS

HRSA-25-052, RWHAP Part C EIS 1

I. Program Funding Opportunity Description

Purpose

HRSA-25-052 announces the opportunity to apply for funding under Ryan White HIV/AIDS Program (RWHAP) Part C Early Intervention Services (EIS) Program: Limited 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 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).

This competition is open to current RWHAP Part C EIS recipients and new organizations proposing to provide RWHAP Part C EIS funded services in the geographic service areas listed in Appendix C. Please note that the period of performance varies by service area. If you are applying for more than one service area, you must submit a separate application for each proposed service area.

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 statute:

• At least 50 percent of the amount received under the award 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 award 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 as Attachment 15.

For more details, see Program Requirements and Expectations.

https://clinicalinfo.hiv.gov/en/guidelines https://clinicalinfo.hiv.gov/en/guidelines https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

HRSA-25-052, RWHAP Part C EIS 2

Background

The RWHAP Part C Early Intervention Services Program is authorized by 42 U.S.C. §§ 300ff-51 to -67 and 300ff-121 (sections 2651-2667 and 2693 of the Public Health Service (PHS) Act).

The Ryan White HIV/AIDS Program

The HRSA 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 priority 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 (TA); clinical training; and the development of innovative interventions and strategies for HIV care and treatment to respond to emerging needs of RWHAP clients.

An important framework in the RWHAP is the HIV care continuum, which is comprised of 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 required 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 Healthy People 2030, the National HIV/AIDS Strategy (NHAS) (2022–2025); 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 provide 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 the extent possible.

https://ryanwhite.hrsa.gov/ http://ryanwhite.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 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

HRSA-25-052, RWHAP Part C EIS 3

Expanding the Effort: Ending the HIV Epidemic in the United States

As demonstrated by recent data from the 2022 Ryan White HIV/AIDS Program Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2018 to 2022, 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 85.9 percent to 89.7 percent. Additionally, racial and ethnic, age-based, and regional disparities reflected in viral suppression rates have significantly decreased.[1]

The Ending the HIV Epidemic in the U.S (EHE) initiative expands the RWHAP’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 and in care but not yet virally suppressed, to the essential HIV care, treatment, and support services needed to help them reach viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and the Centers for Disease Control and Prevention’s (CDC) Division of HIV 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 NHAS 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 secure 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 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 in the United States can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence

[1] Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2022. https://ryanwhite.hrsa.gov/data/reports. Published December 2023. Accessed January 3, 2023.

https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2022.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2022.pdf 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 https://ryanwhite.hrsa.gov/data/reports

HRSA-25-052, RWHAP Part C EIS 4 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.

HRSA’s RWHAP Compass Dashboard is an interactive data tool to allow users to visualize the reach, impact, and outcomes of the RWHAP and supports data utilization to understand outcomes and inform planning and decision making. The dashboard provides a look at national-, state-, and metro area-level data and allows users to explore RWHAP client characteristics and outcomes, including age, housing status, transmission category, and viral suppression. The RWHAP Compass Dashboard also visualizes information about RWHAP services received and the characteristics of those clients accessing the AIDS Drug Assistance Program (ADAP).

In addition, RWHAP recipients and subrecipients are encouraged to develop data sharing strategies with other RWHAP recipients and relevant entities to reduce administrative burden across programs. As outlined in Policy Clarification Notice 21-02, Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program, recipients and subrecipients should use electronic data sources (for example, Medicaid enrollment, state tax filings, enrollment and eligibility information collected from health care marketplaces) to collect and verify client eligibility information, such as income and health care coverage (that includes income limitations), when possible. RWHAP recipients and subrecipients should first use available data sources to confirm client eligibility before requesting additional information from the client.

Program Resources and Innovative Models

HRSA has several projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA HIV/AIDS Bureau (HAB) projects focused on specific TA, evaluation, demonstration, and intervention activities. A full list is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

II. Award Information

1. Type of Application and Award

Application type(s): Competing Continuation, New

We will fund you via a grant.

Summary of Funding

We estimate approximately $3,102,000 to be available annually (total amount of all service areas listed in Appendix C).You may apply up to the published ceiling amount in Appendix C. The actual amount available will not be determined until enactment of the final FY 2025 federal budget.

https://data.hrsa.gov/topics/hiv-aids/compass-dashboard https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf https://targethiv.org/help/ta-directory

HRSA-25-052, RWHAP Part C EIS 5

The funding announcement has two (2) period of performance start dates depending on the existing service areas listed in Appendix C.

Funding for each period of performance will be for three (3) years.

This program notice depends on the appropriation of funds. If funds are appropriated for this purpose, we will proceed with the application and award process.

Support beyond the first budget year will depend on:

• Appropriation

• Satisfactory progress in meeting the project’s objectives

• A decision that continued funding is in the government’s best interest

We encourage current RWHAP Part C recipients to assess your 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 considering the funding level for which to apply.

Appendix C describes the ceiling amount for each service area; you can request a funding level that is less than the listed amount in light of your history of expending Part C funds and availability of other resources. If there is an increase in appropriations during the period of performance, we propose to distribute these funds based on the number of new and/or re-engaged in care clients a recipient has served.

In addition, we reserve the right to reduce future funding, or to fund less than the amount requested, based on a recipient’s history of unobligated balances.

HRSA determines funding levels in the RWHAP Part C EIS program using a methodology to ensure funds are 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. This competitive discretionary funding opportunity continues using this same funding methodology to determine the funding ceiling amount per service area. HRSA may also apply additional funding considerations as noted in Section V.2 Review and Selection Process.

The RWHAP Part C funding methodology uses quantitative data primarily from the RSR to allocate funds to 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 and FY 2022, the RWHAP Part C funding methodology includes the following proportions and objective factors:

HRSA-25-052, RWHAP Part C EIS 6

1) 70 percent of funding is base funding (minimum award amount of $100,0001 per service area augmented by an amount corresponding to the number of eligible Part C clients served in that area as reported through the 2021 RSR); and

2) 30 percent of funding is based on

a) demographics as reported through the 2021 RSR (limited to the service area’s proportion of populations disproportionately impacted by the HIV epidemic with significant disparities in health outcomes, 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 number of clients new to care and/or re-engaged individuals in care, and performance in HIV viral suppression.

This approach ensures 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.

45 CFR part 75 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, or any superseding regulation applies to all HRSA awards.

If you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate of 15 percent of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely. If you choose this method, you must use it for all federal awards until you choose to negotiate a rate. You may apply to do so at any time. See Section 3.1.4 Budget Narrative in the Application Guide.

*Note: One exception is a governmental department or agency unit that receives more than $35 million in direct federal funding.

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

1 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.

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

HRSA-25-052, RWHAP Part C EIS 7 low income, uninsured, and underserved people with HIV in the service areas as described in Appendix C.

You can apply if your organization provides services in the service areas described in Appendix C, is in the United States, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, or the Republic of Palau, is a public or non-profit private entity, and, as identified in section 2652(a)(1) of the PHS Act, is one of the following types of eligible organizations:

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

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

• Comprehensive hemophilia diagnostic and treatment centers;

• Rural health clinics;

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

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

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

• Native American tribal governments and organizations are eligible.

2. Cost Sharing or Matching

Cost sharing or matching is not required for this program.

Other

We may not consider an application for funding if it contains any of the following non-responsive criteria:

• Exceeds the funding ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4

Maintenance of Effort

You must agree to maintain a level of non-federal funding 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). This must be at least at the same spending level for the fiscal year prior to the fiscal year for which you receive the award, as required by section 2664(d) of the PHS Act.

Federal funds should add to, not replace, existing non-federal spending for such activities.

Complete the Maintenance of Effort (MOE) information and submit as Attachment 9.

We will enforce statutory MOE requirements through all available mechanisms.

Multiple Applications

HRSA-25-052, RWHAP Part C EIS 8

You may submit multiple applications under the same Unique Entity Identifier (UEI), if each proposes a different service area. If you are applying for more than one service area listed in Appendix C, 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 C.

For each service area, we will only review your last validated application before the Grants.gov due date.

IV. Application and Submission Information

1. Address to Request Application Package

We require you to apply online through Grants.gov. Use the SF-424 workspace application package associated with this notice of funding opportunity (NOFO). Follow these directions:

How to Apply for Grants. If you choose to submit using an alternative online method, see Applicant System-to-System.

Note: Grants.gov calls the NOFO “Instructions.”

Select “Subscribe” and enter your email address for HRSA-25-052 to receive emails about changes, clarifications, or instances where we republish the NOFO. You will also be notified by email of documents we place in the RELATED DOCUMENTS tab that may affect the NOFO and your application. You are responsible for reviewing all information that relates to this NOFO.

2. Content and Form of Application Submission

Application Format Requirements Submit your information as stated in section 3 of the Application Guide and this program-specific NOFO state. Do so in English and budget figures expressed in U.S. dollars.

Application Page Limit The total number of pages that count toward the page limit shall be no more than 80 pages when printed. We will not review any pages that exceed the page limit. Using the pages within the page limit, HRSA will determine eligibility using Section III. Eligibility Information of the NOFO.

These items do not count toward the page limit:

• Standard Office of Management and Budget (OMB)-approved forms you find in the NOFO’s workspace application package

• Abstract (standard form (SF) “Project_Abstract Summary”)

• Indirect Cost Rate Agreement

• Proof of non-profit status (if it applies)

• Biographical Sketches

• Funding Preferences https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-information-kit/unique-entity-identifier-update https://www.grants.gov/ https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://www.grants.gov/system-to-system/applicant-system-to-system/

HRSA-25-052, RWHAP Part C EIS 9

If there are other items that do not count toward the page limit, we’ll make this clear in Section IV.2.vi Attachments.

If you use an OMB-approved form that is not in the workspace application package, it may count toward the page limit.

Applications must be complete and validated by Grants.gov before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

• When you submit your application, you certify that you and your principals2 (for example, program director, principal investigator) can participate in receiving award funds to carry out a proposed project. That is, no federal department or agency has debarred, suspended, proposed debarment, claimed you ineligible, or you have voluntarily excluded yourself from participating.

• If you fail to make mandatory disclosures, we may take an action such as those identified in 45 CFR § 75.371. This includes suspending or debarring you.3

• If you cannot make this certification, you must include an explanation in Attachment 15: Other Relevant Documents.

(See Section 3.1.10 “Certifications” of the Application Guide)

Program Requirements and Expectations

If you are awarded and receive funding under this announcement, you will be required to follow the requirements and expectations of this program. This section contains a list of requirements that your organization must follow, and they include requirements for how your organization provides clinical services, how your organization manages and administers the RWHAP Part C EIS Program, and how your organization manages the financial or fiscal responsibilities of this federal award.

Clinical Requirements:

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

You should establish linkages and formal referral agreements to ensure follow-up care and treatment for those persons you have identified as having HIV.

Please note that RWHAP Part C funds cannot (1) replace CTR services paid for by other sources, (2) support routine CTR services in the general patient population (those who are not high risk for HIV in your service area), or (3) pay for testing activities in the general population. If HIV CTR is provided, these services must

2 See definitions at eCFR :: 2 CFR 180.995 -- Principal. and eCFR :: 2 CFR 376.995 -- Principal (HHS supplement to government-wide definition at 2 CFR 180.995).

3 See also 2 CFR parts 180 and 376, 31 U.S.C. § 3354, and 45 CFR § 75.113.

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=22 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180/subpart-I/section-180.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376/subpart-I/section-376.995 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-180 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-III/part-376 https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title31-chapter33&edition=prelim https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-B/section-75.113

HRSA-25-052, RWHAP Part C EIS 10 comply with sections 2661 to 2663 of the PHS Act. The revised HHS Guidelines for CTR are available at: https://clinicalinfo.hiv.gov/en/guidelines. When conducting CTR, you must assure the confidentiality of patient information and follow 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 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 – As a RWHAP Part C recipient, you must provide comprehensive patient-centered primary health care services in an outpatient setting for low-income people with HIV throughout your entire service area. In addition, you must ensure, directly or by referral agreement with other organizations, access for clients to core medical services as described in HAB PCN 16-02. If your program is unable to provide any of these services directly, you must have formal arrangements, such as contracts or MOUs, with other organizations who will provide these services.

You 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 infections that can also occur among the clients you plan to serve.

In addition, your clinical staff should track and coordinate all inpatient care. They should also develop plans for patients to be seen at your clinic after they are discharged from the hospital, or if there is any other disruption in the care that you provide. Finally, your RWHAP Part C program must have a system in place for after-hours and weekend clinical coverage for medical and dental services; and patients must be involved in 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. HRSA strongly encourages you 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 – You must have a process 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 tracking and monitoring those referrals, including the documentation of the outcome of these services in the medical record so your medical providers know the results from https://clinicalinfo.hiv.gov/en/guidelines 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

HRSA-25-052, RWHAP Part C EIS 11 seeing these other care providers.

• Linkage to Clinical Trials – You must have a plan 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 (CQM) – Section 2664(g)(5) of the PHS Act requires you to establish a CQM program to (1) assess the extent to which HIV health services provided to patients under the award 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) ensure that needed 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 – You will need to coordinate 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). We expect you to collaborate with entities that provide ongoing HIV prevention activities and establish formal linkages with those in your geographic service area for referral of people with HIV into care and treatment services at your site.

If you are located near existing RWHAP Part C funded program(s), we expect you to coordinate/collaborate with those programs and to avoid duplication of services provided in your designated service area. A searchable RWHAP recipient database is available at: http://findhivcare.hrsa.gov/index.html.

In addition, we require you to coordinate services with other RWHAP providers, including Parts A, B, D, and Part F Special Projects of National Significance (SPNS), AIDS Education and Training Centers (AETCs), the Dental Reimbursement Program, and the Community-Based Dental Partnership Programs. If your organization is located in an Eligible Metropolitan Area (EMA) or a Transitional Grant Area (TGA), we encourage you to participate in the activities of the RWHAP Part A Planning Council and demonstrate that you have coordinated with, and not duplicated, Part A services. We also encourage you to participate in the RWHAP Part B state/territory planning body and/or RWHAP Part B HIV Care Consortium. Further, as a RWHAP Part C recipient, we expect you to provide services consistent with your jurisdiction’s Integrated HIV Prevention and Care Plan, including the Statewide Coordinated Statement of Need. This https://www.niaid.nih.gov/research/hiv-research-enterprise https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-02-cqm.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/clinical-quality-management-faqs.pdf http://findhivcare.hrsa.gov/index.html

HRSA-25-052, RWHAP Part C EIS 12 information is available from the RWHAP Part B program for your state or territory. A list of current RWHAP Part B recipients is located here.

• 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 payor, including reimbursement under any insurance policy or under any federal or state health benefits program. If you are providing services directly pursuant to the award, you 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 within your service area, as required by your state and/or local jurisdiction (see Attachment 14).

Administrative/Fiscal Requirements:

• Involvement by People with Lived Experience – 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, your program should provide necessary training, mentoring, and supervision. Examples of involvement include but are not limited to the following:

o Representation on your 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 – You cannot deny services to someone who is unable to pay. The RWHAP does not allow you to charge people for services whose income is at or below 100 percent of the Federal Poverty Level (FPL). But it does require you to charge people with incomes greater than 100 percent of the FPL, according to a publicly available schedule of charges. See the Annual Cap on Charges table below.

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

https://ryanwhite.hrsa.gov/about/parts-and-initiatives/part-b-adap/fy-2023-grant-awards

HRSA-25-052, RWHAP Part C EIS 13 o *Waiver of imposition of charges requirements: If your organization operates as a free clinic, meaning that you do not impose a charge or accept payments available from any third-party payor, you may request a waiver of the imposition of charges requirements from HRSA.

You must track the person’s income and charges imposed and have a system in place to ensure that you follow the limit (or cap) on what you charge people (also called out-of-pocket) according to the table above.

• Payor of Last Resort – With the exception of programs administered by or contracted with the Indian Health Service, the RWHAP is the payor of last resort.

RWHAP Part C funds may not be used for a service if payment has been made, or reasonably can be expected to be made by a state compensation program, an insurance policy, a federal or state health benefits program, or by an entity that provides health services on a pre-paid basis.

In accordance with the RWHAP client eligibility determination and payor of last resort requirements (see HAB PCN 21-02 Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program), we expect you and subrecipients (if any) to establish, implement, and monitor policies and procedures to determine client eligibility based on each of the three factors outlined in Section IV. of PCN 21-02, including documentation requirements. We do not require documentation to be provided in-person nor be notarized.

• As a RWHAP recipient (including subrecipients), you are expected to develop protocols to facilitate the rapid delivery of RWHAP services, including the provision of antiretrovirals for those newly diagnosed or re-engaged in care. If services are initiated prior to eligibility being established, you and your subrecipients (if applicable) must conduct a formal eligibility determination within a reasonable timeframe and reconcile (i.e., properly account for) any RWHAP funds to ensure that they are only used for allowable costs for eligible individuals.

• As a RWHAP recipient, you and any subrecipients must ensure that reasonable efforts are made to use non-RWHAP resources whenever possible, including establishing, implementing, and monitoring policies and procedures to identify any other possible payers to extend finite RWHAP funds. Your organization and any subrecipients must maintain policies and document efforts to ensure that you assist clients to vigorously pursue enrollment in health care coverage and that clients have accessed all other available public and private funding sources for which they may be eligible (e.g., Medicaid, Medicare, Children's Health Insurance Program (CHIP), state-

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 income

Over 300 percent of FPL No more than 10 percent of annual gross income https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-21-02-determining-eligibility-polr.pdf

HRSA-25-052, RWHAP Part C EIS 14 funded HIV/AIDS programs, employer-sponsored health insurance coverage, health plans offered through other private health insurance) to extend finite RWHAP Part C grant resources.

RWHAP Part C funds cannot be used to supplement the maximum cost allowance for services reimbursed by third party payors such as Medicaid, Medicare, or other insurance programs. Please note that you cannot use direct or indirect federal funds, such as RWHAP Parts A, B, D, and F Dental, to duplicate reimbursement for services funded under Part C. Additionally, recipients cannot bill services reimbursed by RWHAP Part C to RWHAP Parts A, B, D, or F.

• Information Systems – You must have an information system that has the capacity to manage and report at a minimum, the following administrative, fiscal, and clinical data:

o Client Demographic/Clinical Data and Service Provision Data as required by the

RSR – see the most recent Annual RSR Instruction Manual;

o Source and use of program income;

o Services according to funding source;

o Time and effort supported by grant funds; and o Number of people with HIV who received specific core medical and support services by funding source.

• Service Availability – HIV medical services should be available to clients no later than 90 days from the RWHAP Part C EIS award issuance date.

• Subawarded Services – In addition to the information included in 45 CFR § 75.352, subrecipient agreements must include: (1) the total number of people with HIV to be served; (2) eligibility for Medicaid certification of the medical providers and ambulatory care facilities; (3) details of the services to be provided; and (4) assurance that providers will comply with RWHAP Part C statutory and program requirements, including data sharing, submission of the RSR, and participation in the CQM program.

Per 45 CFR §§ 75.351 - .353, you must monitor the activities of your subrecipients as necessary to ensure that the subaward is used for authorized purposes, in compliance with federal statutes, RWHAP statutory and programmatic requirements, regulations, and the terms and conditions of the subaward; and that subaward performance goals are achieved. You must ensure that you track, appropriately use, and report program income generated by the subaward. You must also ensure that subrecipient expenditures adhere to legislative mandates regarding the distribution of funds.

• Medication Discounts – We expect RWHAP recipients that purchase, are reimbursed for, or provide reimbursement to other entities for outpatient prescription drugs to secure the best prices available for such products and to maximize results for their organization and its patients (see 42 CFR part 50, subpart E).