HAB HRSA-24-064 (X09) ADAP ERF_Final.pdf

U.S. Department of Health and Human Services

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2024

HIV/AIDS Bureau

Division of State HIV/AIDS Programs

AIDS Drug Assistance Program (ADAP) Emergency Relief Funds (ERF)

Funding Opportunity Number: HRSA-24-064

Funding Opportunity Type(s): Limited Competition, New

Assistance Listings Number: 93.917

Application Due Date: October 24, 2023 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: July 20, 2023

Glenn Clark, MSW AIDS Drug Assistance Program Advisor, Division of State HIV/AIDS Programs Phone: (301) 443-6745 Email: GlClark@hrsa.gov

See Section VII for a complete list of agency contacts.

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

mailto:GlClark@hrsa.gov

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508 COMPLIANCE DISCLAIMER

Note: 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.

EXECUTIVE 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, including through cost-containment measures. 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 Opportunity Title: AIDS Drug Assistance Program (ADAP) Emergency Relief Funds (ERF)

Funding Opportunity Number: HRSA-24-064

Due Date for Applications: October 24, 2023

Anticipated FY 2024 Total Available Funding:

$75,000,000

Estimated Number and Type of Award(s): Up to 25 grants

Estimated Award Amount: Up to $10,000,000 per award for applicants with a current ADAP waiting list, up to $7,000,000 per award for applicants without a current ADAP waiting list, subject to the availability of appropriated funds

Cost Sharing/Match Required: No

Period of Performance: April 1, 2024 through March 31, 2025 (1 year)

Eligible Applicants: All 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S.

Virgin Islands, Guam, American Samoa, http://www.hrsa.gov/

HRSA-24-064 ii the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands.

Tribes and tribal organizations are not eligible.

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

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in this NOFO and in HRSA’s SF-424 Application Guide. Visit HRSA’s How to Prepare Your Application page for more information.

Technical Assistance

HRSA has scheduled the following webinar:

Wednesday, August 16, 2023 3 – 4:30 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1612363665?pwd=MHdtQkU3WHg2bWk5ZDA5WkF5dlphUT09

Attendees without computer access or computer audio can use the dial-in information below.

Meeting ID: 161 236 3665 Passcode: Z6SeNVrR One tap mobile +16692545252,,1612363665#,,,,*47617124# US (San Jose) +16469641167,,1612363665#,,,,*47617124# US (US Spanish Line)

Dial by your location +1 669 254 5252 US (San Jose) +1 646 964 1167 US (US Spanish Line) +1 646 828 7666 US (New York) +1 415 449 4000 US (US Spanish Line)

+1 551 285 1373 US

+1 669 216 1590 US (San Jose) 833 568 8864 US Toll-free Meeting ID: 161 236 3665 Passcode: 47617124 Find your local number: https://hrsa-gov.zoomgov.com/u/acRi6yErfZ 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/1612363665?pwd=MHdtQkU3WHg2bWk5ZDA5WkF5dlphUT09 https://hrsa-gov.zoomgov.com/j/1612363665?pwd=MHdtQkU3WHg2bWk5ZDA5WkF5dlphUT09 https://hrsa-gov.zoomgov.com/u/acRi6yErfZ

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HRSA will record the webinar and make it available on the TargetHIV website.

https://targethiv.org/

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

II. AWARD INFORMATION

1. TYPE OF APPLICATION AND AWARD

2. SUMMARY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICANTS

2. COST SHARING/MATCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICATION PACKAGE

2. CONTENT AND FORM OF APPLICATION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. 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: MODEL FOR CALCULATING AVERAGE CLIENT COSTS

APPENDIX B: SAMPLE FORMAT FOR ADAP FUNDING AND UTILIZATION SUMMARY FOR

FY 2022

APPENDIX C: SAMPLE FORMAT FOR FY 2024 ADAP EMERGENCY RELIEF FUNDS WORK

PLAN

APPENDIX D: AGREEMENTS AND COMPLIANCE ASSURANCES

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I. Program Funding Opportunity Description

1. 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, including through cost-containment measures (for example, the provision of health care coverage assistance). HRSA will base ADAP ERF awards upon your ability to successfully demonstrate need for additional funding. An external objective review committee (ORC) 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 an increase in potential clients in need of ADAP services due to loss of income and/or loss of health care coverage among people with HIV. 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 unanticipated increases in the number of clients in their ADAP.

2. 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 RWHAP provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income people with HIV. The

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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 quickly respond to emerging needs of RWHAP clients.

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.

Expanding the Effort: Ending the HIV Epidemic in the U.S.

According to recent data from the 2021 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2017 to 2021, 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]

In February 2019, the Ending the HIV Epidemic in the U.S (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This initiative seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. 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 achieve viral suppression.

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

[1] Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2021. https://ryanwhite.hrsa.gov/data/reports. Published December 2022. Accessed December 13, 2022.

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 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2021.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline https://ryanwhite.hrsa.gov/data/reports

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suppressed, to the essential HIV care, treatment, and support services needed to help them achieve viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and CDC’s Division of HIV 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’s RWHAP Compass Dashboard is a user-friendly, 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).

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 (e.g., 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.

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

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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 U.S. can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence test results are reported by all jurisdictions. CDC requires the reporting to the National HIV Surveillance System (NHSS) all HIV-related CD4 results (counts and percentages), all VL results (undetectable and specific values), and HIV nucleotide sequences.

Program Resources and Innovative Models

HRSA has 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.

Examples of these resources include:

• Access, Care, and Engagement Technical Assistance Center (ACE TA)

• Best Practices Compilation

• Center for Innovation and Engagement (CIE)

• Center for Quality Improvement and Innovation (CQII)

• Dissemination of Evidence-Informed Interventions (DEII)

• Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV (E2i)

• Ending Stigma through Collaboration and Lifting All to Empowerment (ESCALATE)

• Engage Leadership through Employment, Validation, and Advancing Transformation and Equity for persons with HIV (ELEVATE)

• Integrating HIV Innovative Practices (IHIP)

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: Limited Competition, New

HRSA will provide funding in the form of a grant.

https://targethiv.org/help/ta-directory https://targethiv.org/ace https://targethiv.org/blog/rwhap-best-practices-compilation-discover-and-share-innovations https://targethiv.org/CIE https://targethiv.org/cqii https://targethiv.org/deii https://targethiv.org/deii https://targethiv.org/e2i https://targethiv.org/e2i https://targethiv.org/escalate https://targethiv.org/elevate https://targethiv.org/elevate https://targethiv.org/ihip

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2. Summary of Funding

HRSA estimates approximately $75,000,000 to be available annually to fund 25 recipients. The actual amount available will not be determined until enactment of the final FY 2024 federal appropriation. 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, subject to the availability of funds. Total cost includes both direct and indirect costs per year. This program notice is subject to the appropriation of funds, and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately.

The period of performance is April 1, 2024 through March 31, 2025 (1 year).

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 or actively prevent the implementation of an ADAP waiting list, including through cost-cutting and/or cost-saving measures, or the need for additional funding for a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S., or other unanticipated 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 ORC review and scoring of the criteria published in Section V.1 of this notice.

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

• HRSA will use the ORC scores to establish the rank order for awarding funds.

• 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 ORC based on their ORC scores (see the funding priority in Section V.2).

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

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

III. Eligibility Information

1. Eligible Applicants

All 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S.

Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75

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the Marshall Islands are eligible to apply for funding if they meet the following requirements:

Eligible applicants are limited to RWHAP Part B states/territories that need additional funding:

• to reduce or eliminate an existing ADAP waiting list,

• to actively prevent the implementation of an ADAP waiting list,

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

• to address other unanticipated 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 that do not currently meet one or more of the above criteria are not eligible to apply. Tribes and tribal organizations are not eligible for this funding.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

• Exceeds the funding ceiling amount

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

Multiple Applications

Multiple applications from an organization are not allowed. HRSA will only accept and review your last validated electronic submission before the Grants.gov application due date.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this notice of funding opportunity (NOFO) following the directions provided at Grants.gov: HOW TO APPLY FOR GRANTS. If you use an alternative electronic submission, see Grants.gov:

APPLICANT SYSTEM-TO-SYSTEM.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-24-064 in order to receive notifications https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html

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including modifications, clarifications, and/or republications of the NOFO on Grants.gov.

You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this

NOFO.

2. Content and Form of Application Submission

Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, and certifications. You must submit the information outlined in HRSA SF-424 Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in this NOFO and HRSA’s SF-424 Application Guide. You must submit the application in the English language and budget figures expressed in U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist to assist you in completing your application.

Application Page Limit The total number of pages that count toward the page limit shall be no more than 40 pages when we print them. HRSA 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 don’t count toward the page limit:

• Standard 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)

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

If you use an OMB-approved form that isn’t in the HRSA-24-064 workspace application package, it may count toward the page limit. We recommend you only use Grants.gov workspace forms related with this NOFO to avoid going over the page limit.

Applications must be complete and validated by Grants.gov under HRSA-24-064 before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachment 5-15: Other Relevant Documents.

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

Temporary Reassignment of State and Local Personnel during a Public Health Emergency Section 319(e) of the Public Health Service (PHS) Act provides the Secretary of the Department of Health and Human Services (HHS) with discretion upon request by a state or tribal organization to authorize the temporary reassignment of state, tribal, and local personnel during a declared federal public health emergency. The temporary reassignment provision is applicable to state, tribal, and local public health department or agency personnel whose positions are funded, in full or part, under PHS programs and allows such personnel to immediately respond to the public health emergency in the affected jurisdiction. Funds provided under the award may be used to support personnel who are temporarily reassigned in accordance with § 319(e), which sunsets / terminates on September 30, 2023. Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) website.

Program Requirements and Expectations 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 utilized. 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

• Compliance with state/territory laws and regulations that impact establishment of a waiting list 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 http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx

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• A means for public input and communications to the public

• Methods for monitoring the waiting list to ensure that the 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:

o Recommendations or requirements for clients to work with a case manager o Patient Assistance Programs (PAPs) applications and assistance in applying o Other options available, e.g., RWHAP Part A Local Pharmacy Assistance Program (LPAP) o 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 determined to be absolutely necessary. Establishment of a waiting list will result in increased monitoring of the RWHAP Part B grant by the DSHAP project officer and in required reporting to HRSA HAB of data on the waiting list.

At the time of the publication of this NOFO, there are no ADAP waiting lists.

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.

Examples of cost-cutting measures include:

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

• capped enrollment

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

• restrictions with respect 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

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• 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 in order 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). You must ensure that you use rebates and program income consistent with RWHAP requirements.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form that is included in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 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 and to address cost-containment measures (including cost-cutting and/or cost-saving measures) or to address a current or projected increase in treatment needs aligned with ending the HIV epidemic, or other unanticipated 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.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

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 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response

Work Plan (2) Response and (3) Impact

Resolution of Challenges (2) Response

Organizational Information (4) Resources/Capabilities and (5) Support Requested

Budget Narrative (5) Support Requested

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Successful applications will contain the information below. Please use the following section headers for the narrative:

INTRODUCTION -- Corresponds to Section V’s 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, including through cost-cutting or cost-saving measures, 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 unanticipated 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.

NEEDS ASSESSMENT -- Corresponds to Section V’s 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 2024.

A. State/Territory’s ADAP Profile Provide the following information regarding eligibility for this award and the structure, functions, and operational processes of the ADAP and the clients that it serves.

a) Eligibility for ADAP ERF Funding

i. Do you have an existing ADAP waiting list as of the date of this application? (Yes/No)

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ii. Do you need ADAP ERF funds to actively prevent the implementation of an ADAP waiting list? (Yes/No)

iii. Do you currently have or project an increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other unanticipated 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?

(Yes/No)

Reminder: States/territories who answer “No” to all three questions above are not eligible to apply for ADAP ERF funds.

b) ADAP Funding Summary for FY 2022 In a table format, please list all the following sources of funding for ADAP (i.e., i.

through xii. below), the amount received, the amount expended, and the amount of unspent funds and unobligated balances during the FY 2022 period of performance (April 1, 2022 through March 31, 2023). If you did not receive funding from one or more of the categories listed below, please list the source and enter zero. Also include the total number of ADAP clients served under each funding stream in FY 2022. Please include the table as Attachment 4. A sample table format is provided in Appendix B.

i. ADAP Base

ii. ADAP Supplemental

iii. RWHAP Part B Base Contribution to ADAP

iv. RWHAP Part B Supplemental Contribution to ADAP

v. ADAP ERF Award

vi. RWHAP Part A Contribution to ADAP

vii. State Funds

viii. Pharmaceutical Rebates

ix. Carryover

x. Program Income

xi. Other Sources (describe)

xii. Total of ADAP Funding

c) Cost-Cutting Measures for FY 2022 and FY 2023 Please identify which, if any, of the following cost-cutting measures were in place or newly implemented in FY 2022 and FY 2023 for your ADAP:

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

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

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

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

v. Reduction in formulary (if so, specify the reduction)

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

vii. Other (please specify)

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d) Cost-Saving Measures for FY 2022 and FY 2023 Please identify which, if any, of the following cost-saving measures were in place or newly implemented in FY 2022 and FY 2023 for your ADAP:

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

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

iii. Enrolling eligible clients into Medicaid

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

v. Decrease in administrative expenditures (if so, specify decreases)

vi. Other (please specify)

B. 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 or to address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other unanticipated 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 2022, 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, 2021 through December 31, 2022) that have affected the

ADAP.

• Increases in clients engaged in care due to ending the HIV epidemic in the U.S. or other unanticipated 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 2 calendar years including, but not limited to, increased eligible applicants, increased percentage of eligible clients below 100 percent of the FPL, high unemployment rates, increased co-morbidities (e.g., opioid addiction), 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.

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• Decreased or level funding from state or federal 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.

METHODOLOGY -- Corresponds to Section V’s 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 2024 ADAP ERF period of performance (April 1, 2024 through March 31, 2025). 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.

1) ADAP Average Annual Client Costs

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

i. Current projected annual average medication cost per client, and

ii. All calculations used to determine such cost.

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

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

ii. All calculations used to determine such cost.

2) Forecasting

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

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

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ii. Describe the projected impact of ADAP ERF, together with FY 2024 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:

1) Your projected/potential ADAP waiting list,

2) Your current waiting list, and/or

3) Your other unanticipated 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.

b) 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.

WORK PLAN -- Corresponds to Section V’s Review Criteria 2 (Response) and 3 (Impact) Describe the steps that you will take to carry out each of the activities proposed during the entire work period. Please present this in the form of a work plan (HRSA suggests a table format), which is uploaded as Attachment 1, and a narrative.

A. Planned Services and Work Plan List 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:

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

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

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

https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/service-category-pcn-16-02-final.pdf

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4) 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 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 2024 ADAP ERF funds; and

5) 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 2024 ADAP ERF.

B. Planned Services and 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:

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

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

3) If you do not have an existing waiting list:

a) How the services/activities will prevent the implementation of an

ADAP waiting list in FY 2024 (April 1, 2024- March 31, 2025) or address a current or projected increase in treatment needs aligned with ending the HIV epidemic in the U.S. or other unanticipated 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

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

C. 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.

1) Describe how you will monitor progress toward meeting the goals and objectives of the proposed period.

2) Describe how these activities will support the continued function of the

ADAP.

3) Describe the anticipated outcomes resulting from ADAP ERF supported activities.

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D. 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.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s 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 2022 and FY 2023. Support each section by data showing how these strategies benefit the ADAP:

1) 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.

2) Ability to Enroll Clients in Other Payor Sources:

Please describe any challenges to enrolling clients in other payor sources, and how your program has addressed challenges by improving systems to increase enrollment in other forms of health care coverage including 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.

3) Reallocation of ADAP Resources:

Please describe any challenges/limits with ADAP resources, and if/how you have reallocated funds to address ADAP challenges.