PKG00268333-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Division of State HIV/AIDS Programs

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

Funding Opportunity Number: HRSA-22-035

Funding Opportunity Type(s): New—Limited Competition Assistance Listings (CFDA) Number: 93.917

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: October 25, 2021

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

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: July 26, 2021

Susan Robilotto, D.O.

Director, Division of State HIV/AIDS Programs Telephone: (301) 443-6554 Email: SRobilotto@hrsa.gov

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

mailto:SRobilotto@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 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-22-035 Due Date for Applications: October 25, 2021 Anticipated Total Annual Available FY 2022 Funding:

$75,000,000

Estimated Number and Type of Award(s): Up to 25 grants Estimated Award Amount: Up to $7,000,000 per year subject to the availability of appropriated funds Cost Sharing/Match Required: No Period of Performance: April 1, 2022 through March 31, 2023

(1 year) 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 the Marshall Islands.

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

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Application Guide

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

Technical Assistance

HRSA has scheduled the following technical assistance:

Webinar

Day and Date: Wednesday, August 18, 2021 Time: 3 p.m. – 4:30 p.m.

https://hrsa-gov.zoomgov.com/j/1603212428?pwd=RExScWM4Y1RpWlVKdHZlblVXSE1HUT09

Meeting ID: 160 321 2428 Passcode: X09TA2021 One tap mobile +16692545252,,1603212428#,,,,*946833435# US (San Jose) +16468287666,,1603212428#,,,,*946833435# US (New York)

Dial by your location +1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York)

+1 551 285 1373 US

+1 669 216 1590 US (San Jose) 833 568 8864 US Toll-free Meeting ID: 160 321 2428 Passcode: 946833435 Find your local number: https://hrsa-gov.zoomgov.com/u/a2qIFlxIu

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

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa-gov.zoomgov.com/j/1603212428?pwd=RExScWM4Y1RpWlVKdHZlblVXSE1HUT09 https://hrsa-gov.zoomgov.com/j/1603212428?pwd=RExScWM4Y1RpWlVKdHZlblVXSE1HUT09 https://hrsa-gov.zoomgov.com/u/a2qIFlxIu https://targethiv.org/

HRSA-22-035 iii

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

TO THE 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: 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 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 resulting from the economic downturn within states/territories. 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, copays, and deductibles. The state/territory determines client eligibility, which includes verification of positive HIV status, financial eligibility, and residence eligibility criteria. Financial eligibility is usually determined as a percentage of the Federal Poverty Level (FPL). ADAPs are expected to recertify client eligibility at least every six months.

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

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been utilized. HRSA HIV/AIDS Bureau (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.

ADAPs with waiting lists are required to verify program eligibility for all individuals on a waiting list and prioritize individuals by a pre-determined criterion. The ADAP manages the waiting list to bring clients into the program as funding becomes available. 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;

• 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.

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

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

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

https://hab.hrsa.gov/sites/default/files/hab/Global/pcn_15-03_program_income.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/pcn_15-04_pharmaceutical_rebates.pdf

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

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

Strategic Frameworks and National Objectives

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

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

According to recent data from the 2019 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2015 to 2019, HIV viral suppression among RWHAP patients who have had one or more medical visits during the calendar year and at least one viral load with a result of <200 copies/mL reported, has increased from 83.4 percent to 88.1 percent.

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

In February 2019, the Ending the HIV Epidemic in the U.S. (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This 10-year

1 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2019.

http://hab.hrsa.gov/data/data-reports. Published December 2020. Accessed December 2, 2020.

2 Black/African American clients went from 79.4 percent viral suppression in 2015 to 85.2 percent in 2019, while 88.3 percent of white clients were virally suppressed in 2015 and 91.8 percent in 2019 3 National Institute of Allergy and Infectious Diseases (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In:

ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2016 Mar 29]. Available from:

https://clinicaltrials.gov/ NCT00074581 NLM Identifier: NCT00074581.

http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://health.gov/healthypeople https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hiv.gov/federal-response/hiv-national-strategic-plan/hiv-plan-2021-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2019.pdf https://www.hhs.gov/blog/2019/02/05/ending-the-hiv-epidemic-a-plan-for-america.html http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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

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

Using Data Effectively: Integrated Data Sharing and Use

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

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

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

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

HRSA strongly encourages complete CD4, viral load (VL) and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State health departments may use CD4, VL, and nucleotide sequence data to identify cases, stage of HIV disease at diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into and retention in HIV care, measure viral suppression, monitor prevalence of antiretroviral drug resistance, detect transmission clusters and understand transmission patterns, and assess unmet health care needs. Analyses at the national level to monitor progress toward ending the HIV epidemic in the 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.

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

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Program Resources and Innovative Models

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

An important technical assistance resource is the RWHAP Recipient Compilation of Best Practices Intervention Strategies (Best Practices Compilation). The Best Practices Compilation is currently under development, but will present strategies that have been implemented in real world settings and that improve outcomes along the HIV care continuum. The RWHAP Best Practices Compilation will be an easily searchable resource to support recipients’ work and the needs of the people served by the

RWHAP.

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

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

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

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

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

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

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

• Building Futures: Supporting Youth Living with HIV

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

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

II. Award Information

1. Type of Application and Award

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

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates approximately $75,000,000 to be available annually to fund up to 25 recipients. You may apply for a ceiling amount of up to $7,000,000 total cost (includes both direct and indirect, facilities, and administrative costs) per year. The actual amount available will not be determined until enactment of the final FY 2022 federal appropriation. 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, 2022 through March 31, 2023 (1 year).

As noted, HRSA will cap FY 2022 ADAP ERF funds at a maximum of $7,000,000 and a minimum of $100,000, subject to the availability of funds. HAB will base the amount of each award on your ability to demonstrate the need for funding to prevent, reduce, or eliminate a 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 diagnoses, 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 waiting lists and therefore:

https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/chw

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• 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 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 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:

• have reported to HRSA an existing ADAP waiting list,

• have used the ADAP ERF to prevent, reduce, or eliminate an ADAP waiting list between January 2011 and July 2021,

• need additional funding for a projected increase in treatment needs aligned with ending the HIV epidemic in the U.S., or

• need additional funding for 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 did not: 1. report a new ADAP waiting list to HRSA, or 2. use the ADAP ERF to prevent, reduce, or eliminate an ADAP waiting list between January 2011 and July 2021, or 3. that do not have a 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, are not eligible to apply.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

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

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

NOTE: Multiple applications from an organization are not allowable.

HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, prior to the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

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

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for each NOFO you are reviewing or preparing in the workspace application package in order to receive notifications 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

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

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

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html

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Application Page Limit The total size of all uploaded files included in the page limit may not exceed the equivalent of 40 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Please note: Effective April 22, 2021, the abstract is no longer an attachment that counts in the page limit. The abstract is the standard form "Project_Abstract Summary.” Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-035, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline.

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

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

3) Where you are unable to attest to the statements in this certification, an explanation shall be included in Attachment 6-15: 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). Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness (ASPR) website via http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx.

http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx

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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 2.0 that is included in the workspace application package. Do not upload the abstract as an attachment. For information content required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide.

In addition, provide brief updated 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 waiting lists and to address cost-containment measures (including cost-cutting and/or cost-saving) 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.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and well organized 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 RWHAP ADAP ERF in support of preventing, reducing, or eliminating a 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 2022.

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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. Did you report to HRSA an ADAP waiting list between January 2011 and July 2021? (Yes/No)

ii. Do you have an existing ADAP waiting list as of the date of this application?

(Yes/No)

iii. Did you use ADAP ERF funds to prevent, reduce, or eliminate an ADAP waiting list between January 2011 and July 2021? (Yes/No)

iv. 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 four questions above are not eligible to apply for ADAP ERF funds.

b) ADAP Funding Summary for FY 2020 and FY 2021 In a table format, please list all sources of funding for ADAP and the amount received and the amount expended during the FY 2020 period of performance (April 1, 2020 through March 31, 2021) and year-to-date for the FY 2021 period of performance (April 1, 2021 through March 31, 2022):

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 (note if there were unexpended rebates)

ix. Carryover

x. Program Income (note if there was any unspent program income)

xi. Other Sources (describe)

xii. Total of ADAP Funding

Please include if there were unobligated balances in any of these above-mentioned funding sources reported on the FY 2020 X07 Federal Financial Report

(FFR).

c) Cost-Cutting Measures for FY 2020 and FY 2021 Please identify which, if any, of the following cost-cutting measures were in place or newly implemented in FY 2020 and FY 2021 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)

v. Reduction in formulary (if so, specify)

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

vii. Other (please specify)

d) Cost-Saving Measures for FY 2020 and FY 2021 Please identify which, if any, of the following cost-saving measures were in place or newly implemented in FY 2020 and FY 2021 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 recertification processes (if so, specify improvements)

v. Decrease in administrative expenditures

vi. Other (please specify)

e) Client Utilization Summary for FY 2020 and FY 2021

i. Total number of clients enrolled in ADAP for each fiscal year

ii. Average number of clients using ADAP each month for each fiscal year

B. Factors Affecting State 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. If you reported any unobligated balance (UOB), unexpended rebates and/or unexpended program income on your FY 2020 X07 Federal Financial Report (FFR), please explain why these emergency funds are needed given these other available resources. You should support this discussion by including data sources as appropriate when discussing trends and changes (including environmental changes) that have resulted in this need. 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, 2019 through December 31, 2020) 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.

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• 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 federal resources for ADAP and/or HIV services.

METHODOLOGY -- Corresponds to Section V’s Review Criterion 2 (Response)

A. 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 2022 ADAP ERF period of performance (April 1, 2022 through March 31, 2023). 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.

ii. Describe the projected impact of ADAP ERF, together with FY 2022 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 projected resources in addressing:

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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;

4) SMART Objectives: Provide the SMART objective associated with the planned service category, cost-containment measures/initiatives, and recipient administrative costs that will be funded with FY 2022 ADAP ERF funds. SMART objectives are Specific—identifying target population and activity, Measureable—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; and https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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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 2022 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 a new 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 improve ADAP operations and maximize ADAP resources; and

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

ADAP waiting list in FY 2022 (4/1/22-3/31/23) 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.

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) Provide a description of the anticipated outcomes resulting from ADAP ERF supported activities.

4) Describe how the anticipated outcomes will support ADAP service provision beyond the funding period. If you cannot support ADAP service provision beyond the funding period, identify any sustainability barriers and describe the plans on how to address them in the future.

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.

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RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion 2 (Response)

State/Territory Actions to address ADAP Challenges This section provides an opportunity for you to describe specific challenges and barriers and actions necessary to prevent, reduce, or eliminate an ADAP waiting list 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 in FY 2022 (April 1, 2022 – March 31, 2023).