hrsa-25-046 Modification.pdf

Notice of Funding Opportunity

Application due November 4, 2024

HIV/AIDS Bureau Division of State HIV/AIDS Programs

AIDS Drug Assistance Program (ADAP) Emergency Relief Funds

(ERF)

Opportunity number: HRSA-25-046

Modified on 9/30/2024 - HRSA corrected formatting issues in certain sections of Notice of Funding Opportunity (NOFO) HRSA 25-046. As a result, HRSA is re-publishing HRSA 25-046 with corrected formatting in these sections.

Please note that the content within the NOFO has not changed.

The due date for HRSA 25-046 is not changing; applications are due November 4, 2024 at 11:59 p.m. ET.

Contents Before you begin 4

Step 1: Review the Opportunity 5

Basic information 6

Summary 6

Key facts 6

Key dates 6

Funding details 6

Eligibility 7

Program description 8

Award information 10

Step 2: Get Ready to Apply 16

Get registered 17

Find the application package 17

Application writing help 17

Step 3: Prepare Your Application 19

Application contents and format 20

Step 4: Learn About Review and Award 32

Application review 33

Selection process 37

Award notices 38

Step 5: Submit Your Application 39

Application submission and deadlines 40

Application checklist 41

Contents 2

Step 6: Learn What Happens After Award 42

Post-award requirements and administration 43

Contacts and Support 46

Appendix A: Model for Calculating Average Client Costs 49

Appendix B: Sample Format for ADAP Funding and Utilization Summary for

FY 2023 54

Appendix C: Sample Format for FY 2025 ADAP Emergency Relief Funds Work Plan 55

Appendix D: Agreements and Compliance Assurances 57

Contents 3

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on November 4, 2024.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 4 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 6

Summary 6

Key facts 6

Key dates 6

Funding details 6

Eligibility 7

Program description 8

Award information 10

Basic information HIV/AIDS Bureau

Division of State HIV/AIDS Programs

Have questions? Go to Contacts and Support

Key facts Opportunity name: AIDS Drug Assistance Program (ADAP) Emergency Relief Funds (ERF)

Opportunity number:

HRSA 25-046

Announcement version:

New

Federal assistance listing:

93.917

Statutory authority: 42 U.S.C. §§ 243(c) and 300ff-26 (§§ 311(c) and 2616 of the Public Health Service Act)

Key dates NOFO issue date:

September 3, 2024

Application deadline:

November 4, 2024

Expected award date: April 1, 2025

Expected start date: April 1, 2025

Summary The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2024 AIDS Drug Assistance Program (ADAP) Emergency Relief Funds (ERF). The purpose of this program is to provide funding to states/territories to prevent, reduce, or eliminate ADAP waiting lists or to address other ADAP shortfalls. Section 311 of Title III of the Public Health Service (PHS) Act authorizes the Secretary to utilize resources to control epidemics of any disease. These funds are to be used in conjunction with the Ryan White HIV/AIDS Program (RWHAP) Part B ADAP administered by the HRSA, HIV/AIDS Bureau (HAB), Division of State HIV/AIDS Programs (DSHAP).

Funding details Application type: Limited Competition, New, Competing Continuation

Expected total available funding FY 2025: $75,000,000

Expected number and type of awards: up to 25 grants

Funding range per award: $100,000 to $10,000,000

• If you have a current ADAP waiting list, you may apply for a ceiling amount of up to $10,000,000 total cost. If you do not have a current ADAP waiting list, you may apply for a ceiling amount of up to $7,000,000 total cost. The minimum award amount is $100,000.

We plan to fund awards in one 12-month budget period from April 1, 2025 to March 31, 2026.

The program and awards depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations.

To help you find what you need this NOFO uses internal links. In Adobe Reader you can return to where you were by pressing Alt + Backspace.

Step 1: Review the Opportunity 6

Eligibility Who can apply Eligible applicants are limited to states/territories that receive RWHAP Part B funding and need additional funding to:

• reduce or eliminate an existing ADAP waiting list,

• actively prevent the implementation of an ADAP waiting list,

• address a reduction in available resources to fund ADAP,

• address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S., and/or

• address other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

Individuals are not eligible applicants under this NOFO.

States/territories that do not currently meet one or more of the above criteria are not eligible to apply.

Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

Application limits You may not submit more than one application. If you submit more than one application, we will only accept the last on-time submission.

Cost sharing This program has no cost-sharing requirement.

Step 1: Review the Opportunity 7

Program description Purpose This notice announces the opportunity to apply for funding under the Ryan White HIV/ AIDS Program (RWHAP) Part B AIDS Drug Assistance Program (ADAP) Emergency Relief Funds (ERF). The Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB), Division of State HIV/AIDS Programs (DSHAP) administers this program.

ADAP ERF awards are intended for states/territories that demonstrate the need for additional resources to prevent, reduce, or eliminate ADAP waiting lists or to address other ADAP shortfalls. HRSA will base ADAP ERF awards upon your ability to successfully demonstrate need for additional funding. An external merit review panel (MRP) will evaluate this need based on criteria published in this notice of funding opportunity (NOFO), with priority given to addressing existing waiting lists.

HRSA first funded the ADAP ERF initiative in August 2010, when numerous states/ territories were experiencing ADAP waiting lists. At the time of this NOFO publication, there are no ADAP waiting lists. States/territories that establish a waiting list after the publication of this NOFO must report the waiting list to HRSA immediately and use funding awarded under this NOFO to remove clients from the waiting list. Previously, eligibility for this funding was limited to states/territories that had historically imposed waiting lists. HRSA continues to anticipate potential increases in clients in need of ADAP services due to reductions in program income or rebates, loss of health care coverage among people with HIV, and increased case finding. States/territories may use ERF funds to address current or projected increases in treatment needs aligned with ending the HIV epidemic in the U.S. or other increases in the number of clients in their ADAP.

Background This program is authorized by 42 U.S.C. §§ 243(c) and 300ff-26 (§§ 311(c) and 2616 of the Public Health Service Act. ADAPs ensure access to medication to treat HIV for eligible clients through the direct purchase of medication and through covering the costs of health care coverage premiums, deductibles, co-payments, and co-insurance.

The state/territory determines client eligibility, which includes documented diagnosis of HIV, financial eligibility, and residence eligibility criteria. Financial eligibility is usually determined as a percentage of the federal poverty level (FPL). ADAPs are expected to confirm client eligibility on a timely basis.

The HRSA Ryan White HIV/AIDS Program has five statutory funding parts that provide a comprehensive system of medical care, support, and medications for low-income people with HIV.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://ryanwhite.hrsa.gov/about/parts-and-initiatives

The HIV care continuum is key to the program. It shows the journey of someone with HIV from diagnosis to effective treatment, leading to viral suppression. People with HIV who reach viral suppression cannot sexually transmit HIV to their partner and can live longer and healthier lives.

This continuum also helps programs and planners measure progress and use resources effectively. We require you to assess your outcomes and work with your community and public health partners to improve outcomes across the HIV care continuum. To assess your program, learn more at HRSA’s Performance Measure Portfolio.

Strategic Frameworks and National Objectives

To address health challenges faced by low-income people with HIV, using national objectives and strategic frameworks is crucial. These frameworks include:

Healthy People 2030

National HIV/AIDS Strategy (NHAS) (2022–2025)

Sexually Transmitted Infections National Strategic Plan for the United States (2021–2025)

Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025)

These strategies offer guidance on the main principles, priorities, and steps for our national health response. They serve as a blueprint for collective action and impact.

Expanding the Effort

There have been significant accomplishments:

• From 2018 to 2022, HIV viral suppression among Ryan White program patients improved from 87.1% to 89.6%. For more, see the 2022 Ryan White Services Report

(RSR).

• Racial, ethnic, age-based, and regional disparities in viral suppression rates have significantly reduced. For more, see the Annual Client-Level Data Report 2022.

• The Ending the HIV Epidemic in the U.S (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. 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 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

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://ryanwhite.hrsa.gov/grants/performance-measure-portfolio https://health.gov/healthypeople 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/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/index.html 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://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/

HRSA and CDC promote integrated data sharing and use for program planning, quality improvement, and public health action.

We encourage you to:

• Follow the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs.

• Create data-sharing agreements between surveillance and HIV programs.

• Progress towards NHAS goals through integrated data sharing, analysis, and use of HIV data by health departments.

• Complete CD4, viral load, and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems. CDC mandates the reporting of all such data to the National HIV Surveillance System (NHSS).

• Use HRSA’s interactive RWHAP Compass Dashboard to visualize reach, impact, and outcomes of the Ryan White program and to inform planning and decision making. The dashboard gives you a look at national, state, and metro area data and displays client demographics, services, outcomes, and viral suppression. It also includes data about clients using the AIDS Drug Assistance Program (ADAP).

• Develop data-sharing strategies with other RWHAP recipients and relevant entities to reduce administrative burden.

• Use electronic data sources to verify client eligibility when you can. See Policy Clarification Notice 21-02, Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program.

Program Resources and Innovative Models

HRSA offers multiple projects and resources to help you. A full list of resources is available on TargetHIV. We urge you to learn about them and use them in your project.

Award information Funding policies and limitations

Policies

• We will only make awards if this program receives funding. If Congress appropriates funds for this purpose, we will move forward with the review and award process.

◦ Award amounts are subject to demonstrated need and the availability of funds. Total cost includes both direct and indirect costs per year.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.cdc.gov/program-collaboration-service-integration/php/data-security/index.html https://www.cdc.gov/program-collaboration-service-integration/php/data-security/index.html https://ryanwhite.hrsa.gov/data/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/

◦ HAB will base the amount of each award on your ability to demonstrate the need for funding to:

▪ reduce or eliminate an existing ADAP waiting list,

▪ actively prevent the implementation of an ADAP waiting list,

▪ address a reduction in available resources to fund ADAP,

▪ address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S., and/or

▪ address other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

HRSA will base funding decisions on an external merit review panel (MRP) review and scoring of the criteria listed in the Merit Review section of this notice.

• HRSA places significant importance on the elimination of existing waiting lists and therefore:

◦ HRSA will use the MRP scores to establish the rank order for awarding funds.

◦ If sufficient funding is available, HRSA will make awards to all applicants that request funds to address an existing waiting list and that are recommended for an award by the MRP based on their MRP scores (see the funding preference).

◦ After funds addressing an existing waiting list are determined, HRSA will award funds to remaining applicants recommended for an award by the MRP based on their MRP scores.

• There are instances when the steady growth in the number of eligible clients combined with rising costs of complex HIV treatments has resulted in states/ territories experiencing greater demand for ADAP services than available resources can cover. As a last resort, a state/territory may implement an ADAP waiting list when adequate funding is not available to provide medications to all eligible persons requesting enrollment in their ADAP and after all other feasible cost-containment strategies have been used. HRSA HAB defines a waiting list as a register of individuals who have applied for and been deemed eligible for a state’s/ territory’s ADAP, but who the state cannot immediately serve due to insufficient resources. If an ADAP is proposing to implement a waiting list, the ADAP must be able to clearly demonstrate to HRSA HAB the need for a waiting list prior to establishing one.

An ADAP must have written policies and procedures for managing a waiting list that include:

• Criteria that are fair and equitable

Step 1: Review the Opportunity 11

• Compliance with state/territory laws and regulations that impact establishment of a waiting list

• A means for public input and communication to the public

• Methods for monitoring the waiting list ensuring that policies and procedures are consistently followed across the state/territory; and

• A revisions and appeals process.

An ADAP must assess each applicant for ADAP eligibility prior to placing the individual on an ADAP waiting list and must confirm eligibility according to a pre-established schedule outlined in a waiting list policy and procedure. An ADAP must prioritize individuals by a pre-determined criterion and bring clients into the program as soon as funding becomes available. Clients on waiting lists should be provided with information about:

• Why a waiting list is necessary

• Waiting list criteria

• The estimated length of time one might remain on the waiting list

• Options for securing medications in the interim that include:

◦ Recommendations or requirements for clients to work with a case manager

◦ Patient Assistance Programs (PAPs) applications and assistance in applying

◦ Other options available, e.g., RWHAP Part A Local Pharmacy Assistance Program (LPAP)

◦ Continuous assistance for applying and re-applying, as necessary, for other programs

HRSA HAB strongly discourages the use of a waiting list as a cost containment strategy, unless absolutely necessary. Establishment of a waiting list will result in increased monitoring of the RWHAP Part B grant by the DSHAP project officer and required reporting to HRSA HAB of data on the waiting list.

Cost-containment strategies employed by ADAPs can include cost-cutting measures and cost-saving measures. Eligible states/territories may request ADAP ERF funding to implement measures to help reverse cost-cutting measures and/or enhance cost-saving measures. HRSA HAB strongly recommends the use of cost-savings methods before engaging in cost-cutting that could reduce the availability or scope of services.

• Examples of cost-cutting measures include:

◦ reductions in ADAP financial eligibility below 300 percent of the FPL

◦ capped enrollment

Step 1: Review the Opportunity 12

◦ formulary reductions to antiretroviral and/or medications to treat opportunistic infections and complications of HIV disease; and/or

◦ restrictions to ADAP funded health care coverage assistance eligibility criteria.

• Examples of cost-saving measures include:

◦ RWHAP Part B structural or operational changes such as expanding health care coverage

◦ strategies to increase enrollment in health care coverage

◦ improved systems and procedures for the collection of rebates and/or program income; and

◦ data sharing agreements to facilitate coordination of benefits

ADAPs are required to secure the best price available for all products on their ADAP formularies to achieve maximum results with these funds. As covered entities, ADAPs are eligible to participate in the 340B Drug Pricing Program under Section 340B of the PHS Act. Funds received as a result of participating in the 340B Drug Pricing Program must be returned to the RWHAP Part B program, with priority given to ADAP (see Policy Clarification Notices 15-03 and 15-04 for more information).

General limitations

• For guidance on some types of costs we do not allow or restrict, see Project

Budget information in section 4.1.iv of the Application Guide. You can also see 45 CFR part 75, or any superseding regulation, General Provisions for Selected Items of Cost.

• You cannot earn profit from the federal award. See 45 CFR 75.400(g).

• Congress’s current appropriations act includes a salary limitation, which applies to this program. As of January 2024, the salary rate limitation is $221,900. This limitation may be updated.

Program specific limitations

• As outlined under applicable statute, regulation, or policy, you cannot use funds under this notice for the following purposes:

◦ Any costs unallowable under the ADAP service category (as defined in HAB

PCN 16-02).

◦ Payment for any item or service to the extent that payment has been made (or reasonably can be expected to be made), with respect to that item or service, under any state compensation program, insurance policy, federal or state benefits program, or any entity that provides health services on a

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-03-program-income.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-04-pharmaceutical-rebates.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=19 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E/subject-group-ECFRa03ab635e0c38d8/section-75.400 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf prepaid basis (except for a program administered by or providing the services of the Indian Health Service).

◦ Planning and evaluation activities as defined by the RWHAP Part B.

◦ Cash payment to intended recipients of RWHAP services.

◦ Clinical quality management.

◦ International travel.

◦ Construction (minor alterations and renovations to an existing facility to make it more suitable for the purposes of the award program are allowable with prior HRSA approval).

◦ Syringe Services Programs (SSPs). Some aspects of SSPs are allowable with HRSA’s prior approval and in compliance with HHS and HRSA policy.

◦ Development of materials designed to directly promote or encourage intravenous drug use or sexual activity, whether homosexual or heterosexual.

◦ Pre-Exposure Prophylaxis (PrEP) medications and related medical services or Post-Exposure Prophylaxis (PEP), as the person using PrEP or PEP is not diagnosed with HIV and therefore not eligible for RWHAP funded medication.

See Manage Your Grant for other information on costs and financial management.

Indirect costs Indirect costs are costs you charge across more than one project that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects). Learn more at 45 CFR 75.414, Indirect Costs.

Indirect costs are determined using one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency at the time of award.

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. This rate is 10% of modified total direct costs (MTDC). 45 CFR 75.2 defines MTDC. You can use this rate indefinitely. If you use the de minimis rate, you must use it for all federal awards unless you negotiate a rate.

Program income and rebates Program income is money earned as a result of your award-supported project activities. Find more about program income at 45 CFR 75.307. Rebates generated as a result of awarded funds must be used for the statutorily permitted purposes under the RWHAP Part B with a priority for ADAP.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-E/subject-group-ECFR1eff2936a9211f7/section-75.414 https://www.ecfr.gov/current/title-45/part-75#p-75.414(f)

Per 45 CFR § 75.305(b)(5), to the extent available, you must disburse funds available from program income and rebates before requesting grant funds. Please see HAB PCNs 15-03: Clarifications Regarding the Ryan White HIV/AIDS Program and Program Income and 15-04: Utilization and Reporting of Pharmaceutical Rebates for more information.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75#75.305 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-03-program-income.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-04-pharmaceutical-rebates.pdf

Step 2:

Get Ready to Apply

In this step

Get registered 17

Find the application package 17

Application writing help 17

Get registered SAM.gov You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and click Get Started. From the same page, you can also click on the Entity Registration Checklist for the information you will need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number HRSA-25-046.

After you select the opportunity we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 17 https://sam.gov/content/entity-registration https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant

Join the webinar For more information about this opportunity, join the webinar on Wednesday, September 18, 2024, at 2 PM ET. You can join at https://hrsa-gov.zoomgov.com/j/ 1603071605?pwd=bEsyMEhnVkxjYUVkMXA4VVFrQlBhZz09

If you are not able to join through your computer, you can call in at 833-568-8864 with meeting ID: 160 307 1605 Passcode: 14725779.

We will record the webinar. If you are not able to join live, you can replay it at TargetHIV.

Need Help? See Contacts and Support.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 18 https://hrsa-gov.zoomgov.com/j/1603071605?pwd=bEsyMEhnVkxjYUVkMXA4VVFrQlBhZz09 https://hrsa-gov.zoomgov.com/j/1603071605?pwd=bEsyMEhnVkxjYUVkMXA4VVFrQlBhZz09 https://targethiv.org/

Step 3:

Prepare Your Application

In this step

Application contents and format 20

Application contents and format Applications include 5 main components. This section includes guidance on each.

Application page limit: 40-page limit for the overall application.

Submit your information in English and express budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission format

Project abstract Use the Project Abstract Summary form

Project narrative Use the Project Narrative Attachment form

Budget narrative Use the Budget Narrative Attachment form

Attachments Insert each in the Other Attachments form

Other required forms Upload using each required form

Required format

You must format your narratives and attachments using our required formats for fonts, size, color, format, and margins. See the formatting guidelines in section 4.2 of the [Application Guide]

Project abstract Complete the information in the Project Abstract Summary Form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve. For more information, see section 3.1.2.ix of the HRSA Application Guide.

In addition, provide brief up-to-date information, in this order:

• General demographics of the state/territory

• Demographics of the populations with HIV in the state/territory

• Brief description of the state ADAP and key environmental factors impacting the program

• Description of the need for additional resources to prevent, reduce, or eliminate an ADAP waiting list, address a reduction in available resources to fund ADAP, address a current or projected increase in treatment needs aligned with ending

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 20 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=24 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf the HIV epidemic in the U.S., or address other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

• Description of the planned use of ADAP ERF, if received.

Project narrative In this section, you will describe all aspects of your project. Project activities must comply with the nondiscrimination requirements.

Use section headers and order

Introduction See merit review criterion 1: Need This introduction section should briefly describe how you will utilize ADAP ERF in support of preventing, reducing, or eliminating an ADAP waiting list, to address a reduction in available resources to fund ADAP, or to address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. during the period of performance or other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

Need See merit review criterion 1: Need The purpose of this section is to demonstrate the need for additional resources to meet the projected ADAP client service needs for FY 2025. Provide the following information to justify eligibility for this award and the structure, functions, and operational processes of the ADAP and the clients that it serves.

• State/Territory’s ADAP Profile

◦ ADAP Funding Summary for FY 2023

In table format, please list all the following sources of funding for ADAP, the amount received, the amount expended, and the amount of unspent funds and unobligated balances during the FY 2023 period of performance (April 1, 2023 through March 31, 2024). If you did not receive funding from one or more of these categories, please list the source and enter zero. Also include the total number of unduplicated ADAP clients served under each funding stream in FY 2023. Please include the table as Attachment 4. A sample table format is provided in Appendix B.

▪ ADAP Base

▪ ADAP Supplemental

▪ RWHAP Part B Base Contribution to ADAP

Step 3: Prepare Your Application 21

▪ RWHAP Part B Supplemental Contribution to ADAP

▪ ADAP ERF Award

▪ RWHAP Part A Contribution to ADAP

▪ State Funds

▪ Pharmaceutical Rebates

▪ Carryover

▪ Program Income

▪ Other Sources (describe)

▪ Total of ADAP Funding

◦ Cost-Cutting Measures for FY 2023 and FY 2024

Please identify which, if any, of the following cost-cutting measures were in place or newly implemented in FY 2023 and FY 2024 for your ADAP:

▪ Enrollment cap (if so, specify the maximum number of enrollees)

▪ Capped number of prescriptions per month (if so, specify the cap)

▪ Capped expenditure (if so, specify the amount and timeframe)

▪ Drug-specific enrollment caps for antiretroviral medication (if so, specify the cap)

▪ Reduction in formulary (if so, specify the reduction)

▪ Decrease in financial eligibility criteria (if so, specify the decrease)

▪ Other (please specify)

◦ Cost-Saving Measures for FY 2023 and FY 2024

Please identify which, if any, of the following cost-saving measures were in place or newly implemented in FY 2023 and FY 2024 for your ADAP:

▪ Expansion of health care coverage assistance (if so, specify the services currently offered)

▪ Enrolling eligible clients in health care coverage (if so, specify how many were enrolled and through what mechanism)

▪ Enrolling eligible clients into Medicaid

▪ Improved client eligibility confirmation processes (if so, specify improvements)

▪ Decrease in administrative expenditures (if so, specify decreases)

▪ Other (please specify)

Step 3: Prepare Your Application 22

• Factors Affecting State/Territory ADAP Capacity to Meet Need Provide a detailed narrative description of any key factors impacting the ADAP’s need for additional resources to prevent, reduce, or eliminate a waiting list, to address a reduction in available resources to fund ADAP, or to address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage. Include a description of why the ADAP is unable to meet the need with existing resources, any anticipated funding shortfalls for ADAP, and the cost-cutting measures that would need to be implemented if additional funding is not received. If you reported any unspent funds or unobligated balances in the ADAP Funding Summary for FY 2023, please explain why these emergency funds are needed given these other available resources.

Examples of factors include, but are not limited to:

◦ Trends or changes in the HIV disease prevalence over the past 2 calendar years (January 1, 2022, through December 31, 2023) that have affected the

ADAP.

◦ Increases in clients engaged in care due to ending the HIV epidemic in the U.S. or other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

◦ Changes to the state/territory’s service delivery system that may include client need and/or administrative burden as a result of the changing health care landscape.

◦ Changes in client population or demographics over the last two calendar years including, but not limited to, increased eligible clients, increased percentage of eligible clients below 100 percent of the FPL, high unemployment rates, increased co-morbidities (e.g., substance use disorder), and/or increased number of out-of-care clients seeking treatment.

◦ Increased program costs including, but not limited to, the cost of ADAP medications and/or cost to ADAP for health care coverage premiums, deductibles, and/or cost sharing.

◦ Decreased or level funding from state or RWHAP resources for ADAP and/or HIV services.

◦ Decreased program income and/or pharmaceutical rebates.

You should support this description by including data sources as appropriate when discussing trends and changes (including environmental changes) that have resulted in this need.

Step 3: Prepare Your Application 23

Approach See merit review criterion 2: Response

ADAP Average Annual Client Costs and Forecasting

Provide a calculation of the projected average cost per client for medication assistance and/or health care coverage for the FY 2025 ADAP ERF period of performance (April 1, 2025, through March 31, 2026). Important Note: You do not need to provide an average cost per client for a type of assistance for which you are not requesting funding.

Determine the average cost per client through your own calculations, or through the cost calculation template in Appendix A. Whichever calculation methodology is used, provide the step-by-step calculations utilized in developing the average cost per client.

Use the calculated average cost per client in developing the proposed budget for the use of the ADAP ERF funds and/or to project the impact of proposed cost-containment measures. Provide the calculation(s) that show how you multiplied the average cost per client by the projected number of clients to be served to determine the budget request for medication assistance and/or health care coverage assistance.

• ADAP Average Annual Client Costs

◦ Medication Costs If requesting funding for medication assistance, please provide:

▪ Current projected annual average medication cost per client, and

▪ All calculations used to determine such cost.

◦ Health Care Coverage Assistance Costs If requesting assistance for health care coverage assistance, please provide:

▪ Current projected annual average health care coverage assistance cost per client, and

▪ All calculations used to determine such cost.

• Forecasting

◦ States/Territories Requesting Funds to Purchase Medications or Health Care Coverage Assistance:

▪ For applicants with an existing ADAP waiting list, provide the current number of individuals on the waiting list.

▪ Describe the projected impact of ADAP ERF, together with FY 2025 RWHAP Part B funds, any RWHAP Part B carryover funds, funding provided by the state/territory, resources generated by rebates and program income, RWHAP Part A contributions, and any other projected resources in addressing:

▪ Your projected/potential ADAP waiting list, Step 3: Prepare Your Application 24

▪ Your current waiting list, and/or

▪ Your other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage.

◦ States/Territories Requesting Funds for other Cost-Cutting or Cost-Saving Measures:

For each proposed cost-cutting or cost-saving measure indicated in the work plan, describe the specific projected impact of ADAP ERF on enhancing cost-saving measures, reversing cost-cutting measures, improving ADAP operations, and/or maximizing available ADAP resources.

High-level work plan See merit review criteria 2: Response and 3: Impact

• Work Plan Provide a workplan, uploaded as Attachment 1, that lists each planned ADAP ERF service (e.g., purchase of ADAP medications, purchase of health care coverage premiums, payment of medication co-payments, deductibles, or co-insurance) and/or cost-containment measures (i.e., cost-cutting or cost-saving measures) designed to improve ADAP operations and maximize available ADAP resources.

Only costs allowed under ADAP service category (as defined in HRSA HAB 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds) can be funded through ADAP ERF. Any unallowable costs will be deducted from your proposed budget prior to calculation of award.

HRSA encourages you to use a table format with the following sections:

◦ Planned Expenditures Summary listing the amount budgeted by service category, cost-containment measures/initiatives, and recipient administrative costs;

◦ Planned Expenditures by Service Category with columns for Planned Service, Service Unit Description, # of Service Units, # of Clients, and amount budgeted for each service;

◦ Planned Expenditures by Cost-Containment Measures/Initiatives listing each planned cost-containment initiative with the date initiated and the amount budgeted for each initiative;

◦ Specific, Measurable, Attainable, Realistic and Time-Sensitive (SMART) Objectives: SMART objectives are Specific—identifying priority population and activity, Measurable—indicating how much or how many, Attainable—must be realistically accomplished using resources provided, Realistic—addressing and establishing reasonable programmatic steps, and Time-sensitive—indicating a timeline during which you will accomplish the

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 25 https://ryanwhite.hrsa.gov/about/parts-and-initiatives objective. Provide the SMART objective associated with the planned service category, cost-containment measures/initiatives, and recipient administrative costs that will be funded with FY 2025 ADAP ERF funds; and

◦ Service Unit Definition: Describe the definition of the unit of service for the planned service category, cost-containment measure/initiative, and recipient administrative cost that you will fund with FY 2025 ADAP ERF.

• Work Plan Narrative Provide a narrative that describes the following for each planned service, cost-containment measure/initiative, and recipient administrative cost identified in the work plan:

◦ How you will assure that you will spend funds allocated for each service/ activity within the 12-month period of performance;

◦ If you have an existing ADAP waiting list, how the services/activities will reduce the number of persons on the waiting list;

◦ If you do not have an existing waiting list:

▪ How the services/activities will prevent the implementation of an ADAP waiting list in FY 2025 (April 1, 2025- March 31, 2026), address a reduction in available resources to fund ADAP, or address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other increases in the number of clients in the program due to new diagnosis, re-engagement in care, loss of income, and/or loss of health care coverage; and

▪ How the services/activities will improve ADAP operations and maximize ADAP resources.

• Anticipated Impact of ADAP ERF Provide a brief description of the anticipated impact of the proposed ADAP ERF-funded planned service, cost-containment measure/initiative, and recipient administrative cost activities on currently implemented or anticipated cost-containment measures.

◦ Describe how you’ll monitor progress toward meeting the goals and objectives of the proposed period.

◦ Describe how these activities will support the continued function of the ADAP.

◦ Describe the anticipated outcomes resulting from ADAP ERF supported activities.

Step 3: Prepare Your Application 26

• Monitoring Provide a brief description of the methods in place to monitor and assess the effectiveness of the activities proposed on the ADAP ERF work plan. The narrative should include a description of how the ADAP will measure and monitor progress on outcomes and how the ADAP will address problems identified through monitoring.

Important Note: HRSA expects that the ADAP will utilize its current RWHAP Part B clinical quality management program when implementing services funded through the ADAP ERF award.

Resolving challenges See merit review criterion 2: Response

State/Territory Actions to Address ADAP Challenges

Please describe for each of the following sections how the program has addressed the specific challenges and barriers facing the ADAP through the employment of cost-cutting and/or cost-saving strategies in FY 2023 and FY 2024. Support each section with data showing how these strategies benefit the ADAP:

• Program Efficiencies:

Please describe any challenges regarding program efficiencies and how your program has addressed challenges, including through the use of ADAP ERF funding, by improving operations in order to reduce costs and improve efficiency.

Support your decision with data showing how the improved operational efficiencies will benefit ADAP.

• Ability to Enroll Clients in Other Payor Sources:

Please describe any challenges enrolling clients in other payor sources, and how your program has addressed challenges by improving systems to increase enrollment in Medicare Part D, Medicaid, and other health care coverage options.

Be sure to support your decision with data showing how improved enrollment in other payor sources will benefit the ADAP.

• Reallocation of ADAP Resources:

Please describe any challenges/limits with ADAP resources, and if/how you have reallocated funds to address ADAP challenges. Be sure to indicate if this reallocation represents a one-time augmentation to the program or an expected long-term, sustainable reallocation of funds.

• Generation and Collection of Rebates and Program Income:

Please describe any challenges with the generation or collection of rebates and program income. Include how your ADAP has modified its processes or monitoring

Step 3: Prepare Your Application 27 of processes to ensure that you purchase drugs at the best possible cost and/or that rebates and/or program income are fully collected and applied back to the RWHAP Part B program, with priority given to ADAP.

Organizational information See merit review criterion 4: Resources and Capabilities

• ADAP Oversight/Administration Provide a brief narrative that describes the organizational structure and resources that help the ADAP maintain compliance with legislative requirements and program expectations, including those of ADAP ERF funding. Include an organizational chart for the ADAP as Attachment 3.

• Compliance with Reporting Requirements Describe how you will meet reporting requirements by tracking and reporting ADAP ERF specific expenditures and client utilization.

Budget and budget narrative See merit review criterion 5: Support Requested

Your budget should follow the instructions in Section 3.1.4. Project Budget Information

- Non-Construction Programs (SF-424A) of the Application Guide and the instructions listed in this section. Your budget should show a well-organized plan.

The total project or program costs are all allowable (direct and indirect) costs used for the HRSA award activity or project. This includes costs charged to the award and non-federal funds used to satisfy a matching or cost-sharing requirement (which may include MOE, if applicable.

The budget narrative supports the information you provide in Standard Form 424-A.

See other required forms. It includes an itemized breakdown and a clear justification of the requested costs. The merit review committee reviews both.

As you develop your budget, consider:

• If the costs are reasonable and consistent with your project’s purpose and activities.

• The restrictions on spending funds. See Funding policies & limitations.

To create your budget narrative, see detailed instructions in Section3.1.5 of the Application Guide.

In addition, the ADAP ERF requires the following:

Please complete Sections A, B, E, and F of the SF-424A Budget Information—Non- Construction Programs form included with the application package, and then provide a

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 3: Prepare Your Application 28 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=19 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=30 line-item budget using Section B Object Class Categories of the SF-424A Budget Information—Non-Construction Programs form. In Section B, budget categories are limited to two columns. The required columns are:

• Medications/Health Care Coverage: The first column should include all requested FY 2025 ADAP ERF funds allocated to prevent, reduce, and/or eliminate your waiting list, to address a reduction in available resources to fund ADAP, or to address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other increases in the number of clients in the program who are newly diagnosed or re-engaged in care through the purchase of medication and/or health care coverage assistance. It may NOT include any funds for planning and evaluation or clinical quality management as defined by the RWHAP Part B program. These funds may not be used to supplant funds budgeted for any other federal award or state program.

• Other Cost-Containment: The second column should include all requested funds allocated to award activities to address any other cost-cutting and/or cost-saving measures to be charged to the FY 2025 ADAP ERF award. It may NOT include any funds for planning and evaluation or clinical quality management as defined by the RWHAP Part B. These funds may not be used to supplant funds budgeted for any other federal award or state program.

ADAP ERF applicants must also consider the following:

• Caps on Expenses: ADAP ERF funding recipient administrative costs may not exceed 10 percent of the total grant award. For further guidance on the treatment of costs under the 10 percent administrative limit, refer to HAB PCN 15-01 Treatment of Costs under the 10% Administrative Cap for Ryan White HIV/AIDS Program Part A, B, C, and D.

• Staffing: Due to the emergent nature of this award, HRSA expects that if any additional personnel are needed to administer this award, salaries for such staff will fit within the administrative cost cap. Usual and ordinary expenses for salaries associated with RWHAP awards must be allocated to the RWHAP Part B award, and therefore cannot be allocated to this award.

• Payor of Last Resort: Charges that are billable to third…