oppHRSA-19-033-cfda93.914-cidHRSA-19-033-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

HIV/AIDS Bureau Division of Metropolitan HIV/AIDS Programs

Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program

Funding Opportunity Number: HRSA-19-033

Funding Opportunity Type(s): Competing Continuation Catalog of Federal Domestic Assistance (CFDA) Number: 93.914

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2019

Application Due Date: September 21, 2018

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

Deadline extensions are not granted for lack of registration.

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

Issuance Date: May 30, 2018

Steven R. Young, MSPH Director, Division of Metropolitan HIV/AIDS Programs Telephone: (301) 443-9091 Fax: (301) 443-5271 Email: SYoung@hrsa.gov

Authority: Public Health Service Act, Sections 2601-2610, and 2693 (42 USC 300ff-11 – 300ff-20, and 300ff-121), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) mailto:SYoung@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA), HIV/AIDS Bureau (HAB), Division of Metropolitan HIV/AIDS Programs (DMHAP) is accepting applications for fiscal year (FY) 2019 Ryan White HIV/AIDS Program (RWHAP) Part A HIV Emergency Relief Grant Program. The purpose of this program is to provide direct financial assistance to an Eligible Metropolitan Area (EMA) or a Transitional Grant Area (TGA) that has been severely affected by the HIV epidemic. This competition is open only to Part A jurisdictions to provide RWHAP services in the geographic service areas described in Appendix B.

Eligible jurisdictions may apply for an amount up to the defined funding ceiling listed in Appendix B, which represents a level five percent above the final FY 2018 award.

Funding Opportunity Title: Ryan White HIV/AIDS Program Part A

HIV Emergency Relief Grant Program Funding Opportunity Number: HRSA-19-033 Due Date for Applications: September 21, 2018 Anticipated Total Annual Available FY 2019 Funding:

$618,140,400, of which approximately $10,098,500 will be used for priority funding, and $50,992,100 will be available for MAI funding.*

Estimated Number and Type of Award(s): Up to 52 grants Estimated Award Amount: Varies, see Appendix B Cost Sharing/Match Required: No Project Period/Period of Performance: March 1, 2019 through February 29, 2020

(one (1) year) Eligible Applicants: RWHAP Part A recipients that are classified as an EMA or as a TGA and continue to meet the eligibility criteria as defined in the statute are eligible to apply for these funds.

See Section III-1 of this notice of funding opportunity (NOFO), formerly known as the funding opportunity announcement (FOA), for complete eligibility information.

*Estimated annual available funding level based on current projections.

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

HRSA-19-033 ii instructed in this NOFO to do otherwise. A short video explaining the Application Guide is available at http://www.hrsa.gov/grants/apply/applicationguide/.

Technical Assistance

All interested applicants are encouraged to participate in a technical assistance (TA) webinar for this funding opportunity. The purpose of this webinar is to assist potential applicants in preparing applications that address the requirements of this funding notice. Participation in the pre-application TA webinar is optional.

HRSA has scheduled the following technical assistance webinar:

Day and Date: Thursday, July 19, 2018 Time: 2 – 4 p.m. ET Call-In Number: 1-888-396-9925 Participant Code: 1527602# Weblink: https://hrsa.connectsolutions.com/ryanwhite_parta_fy19/ Playback: Webinar will be available on the TARGET Center website.

http://www.hrsa.gov/grants/apply/applicationguide/ https://hrsa.connectsolutions.com/ryanwhite_parta_fy19/ https://www.careacttarget.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 See Section 4.1.v. of HRSA’s SF-424 Application Guide. Note: The Budget Narrative/Justification required for this application should be uploaded under Budget Narrative in grants.gov

v. Attachments

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

SYSTEM FOR AWARD MANAGEMENT

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 AND OTHER PRE-AWARD ACTIVITIES

4. ANTICIPATED ANNOUNCEMENT AND AWARD DATES

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A

APPENDIX B

HRSA-19-033 1

I. Program Funding Opportunity Description

1. Purpose

This notice solicits applications for the Ryan White HIV/AIDS Program (RWHAP) Part A HIV Emergency Relief Grant Program. The purpose of this program is to provide direct financial assistance to an eligible metropolitan area (EMA) or a transitional grant area (TGA) that has been severely affected by the HIV epidemic. Grant funds assist eligible jurisdictions to develop or enhance access to a comprehensive continuum of high quality, community-based care for low-income people living with HIV (PLWH) through the provision of formula, supplemental, and Minority AIDS Initiative (MAI) funds.

RWHAP Part A recipients must provide comprehensive primary health care and support services throughout the entire designated geographic service area. The goal is to provide optimal HIV care and treatment for low-income, uninsured, and underserved PLWH to improve their health outcomes. Your application must address the entire service area, as defined in Appendix B.

Comprehensive HIV care consists of core medical services and support services that enable PLWH and those affected by HIV to access and remain in HIV primary medical care to improve their medical outcomes. Based on an annual assessment of the services and gaps in the HIV care continuum within a jurisdiction, HIV Planning Councils/Planning Bodies (PC/PB) and recipients identify specific service categories to fund. Funded service categories should facilitate improvements at specific stages of the HIV care continuum.

RWHAP Part A EMAs and TGAs must use grant funds to support, further develop, and/or expand systems of care to meet the needs of low income PLWH within the EMA/TGA and strengthen strategies to reach disproportionately impacted subpopulations. The Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) requires EMAs/TGAs to collect data to identify need, set priorities, make allocations, and validate the use of RWHAP funding. A comprehensive application should reflect how you have used those data to develop and expand the system of care in EMA/TGA jurisdictions. HRSA encourages innovation and collaboration with other agencies and organizations to maximize impact on health outcomes and effectively meet the needs of PLWH within the EMA/TGA.

Important Notes:

• Budget: HAB has updated the budget section. You must submit a detailed budget narrative/justification as part of the application. You may apply for no more than the published ceiling amount in Appendix B. Please note that your application budget that is approved, or subsequently amended during the award process, will be your approved budget for the 2019 period of performance. HAB no longer requires you to provide a revised budget with the Program Submission reporting requirement.

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• Work Plan: HAB has updated the Work Plan requirements. You are required to submit an HIV Care Continuum Table, Service Category Plan Table, and narratives with this NOFO. You will not submit the Implementation Plan Table as part of your application or as a component of your Program Submission reporting requirement.

• Unmet Need: HAB has integrated the Unmet Need requirement in this NOFO into the Demonstrated Need section. New estimates for unmet need should not be submitted with this application. Please review carefully when preparing this section of your application.

The following information will assist you in understanding and completing your FY 2019 application:

• Policy Clarification Notices: Information on the RWHAP and HAB Policy Clarification Notices (PCN) are available online at http://hab.hrsa.gov/manageyourgrant/policiesletters.html.

• Allowable Services and Service Category Definitions: Core medical services are listed in Section 2604(c)(3) of the Public Health Service (PHS) Act. Support services allowed under RWHAP Part A are limited to services that are needed for PLWH to achieve their medical outcomes, as defined by RWHAP. The service definitions effective for awards issued on or after October 1, 2016 are listed in PCN 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds.

• Core Medical Services Waiver: RWHAP Part A funds are subject to Section 2604(c) of the PHS Act, which requires that not less than 75 percent of the funds remaining after reserving funds for administration and Clinical Quality Management (CQM) be used to provide core medical services. Applicants may seek a waiver of the core medical services requirement; a waiver request must be submitted prior to submission of the grant application, with this application, or up to four (4) months after the budget period start date. Submission should be in accordance with the PCN 13-07 Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts A, B, and C. You can find sample letters to fulfill the requirements of the Core Medical Services Waiver at https://hab.hrsa.gov/sites/default/files/hab/Global/samplereqwaiverletters.pdf.

In addition, your RWHAP Part A core medical services waiver request must include funds awarded under MAI. HAB will not consider a waiver request that does not include MAI funds. If submitting with the application, a core medical services waiver request should be included as Attachment 9. The waiver request does count toward the 100-page limit.

• Agreements and Compliance Assurances: The agreements and assurances, found in Appendix A of this NOFO, require the signature of the chief elected official (CEO), or the CEO’s designee. Include this document as Attachment 2.

http://hab.hrsa.gov/manageyourgrant/policiesletters.html 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://hab.hrsa.gov/sites/default/files/hab/Global/13-07waiver.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/13-07waiver.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/samplereqwaiverletters.pdf

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2. Background

This program is authorized by the PHS Act, Sections 2601-2610, and 2693 (42 USC 300ff-11– 300ff-20, and 300ff-121), as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87). Fifty-two (52) eligible metropolitan jurisdictions receive Part A formula, supplemental, and MAI funding through this program.

The Centers for Disease Control and Prevention (CDC) estimated in 2015 that more than 1.2 million people were living with HIV in the United States (U.S.) and one (1) in seven (7) (14 percent) are not aware of their HIV status. The ultimate goal in the U.S.

is to inform all people who test positive for HIV of their status and bring them into care to improve their health status, prolong their lives, and slow the spread of HIV to end the epidemic in the U.S.

Goals to End the HIV Epidemic The RWHAP promotes robust advances and innovations in HIV health care using national goals to end the epidemic as its framework. Therefore, activities funded by RWHAP focus on addressing these four goals:

1) Reduce new HIV infections;

2) Increase access to care and improve health outcomes for PLWH;

3) Reduce HIV-related health disparities and health inequities; and

4) Achieve a more coordinated national response.

To achieve these shared goals, recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, to ensure that PLWH are linked to and retained in care, and have timely access to HIV treatment and the supports needed (e.g., mental health and substance use disorder services) to achieve HIV viral suppression.

HIV Care Continuum Diagnosing PLWH, linking PLWH to HIV primary care, and PLWH achieving viral suppression are important public health steps toward ending the HIV epidemic in the U.S. The HIV care continuum has five main “steps” or stages that include: HIV diagnosis, linkage to care, retention in care, antiretroviral use, and viral suppression.

The HIV care continuum provides a framework that depicts the series of stages a person with HIV engages in from initial diagnosis through their successful treatment with HIV medication. It shows the proportion of individuals living with HIV or individuals diagnosed with HIV who are engaged at each stage. The HIV care continuum allows recipients and planning groups to measure progress and to direct HIV resources most effectively.

According to recent data from the 2016 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the U. S.

From 2010 to 2016, 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 69.5 percent to 84.9 percent, and https://hab.hrsa.gov/about-ryan-white-hivaids-program/ryan-white-hivaids-program-legislation https://hab.hrsa.gov/about-ryan-white-hivaids-program/ryan-white-hivaids-program-legislation https://hab.hrsa.gov/about-ryan-white-hivaids-program/ryan-white-hivaids-program-legislation https://hab.hrsa.gov/sites/default/files/hab/data/datareports/RWHAP-annual-client-level-data-report-2016.pdf

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racial/ethnic, age-based, and regional disparities have decreased.1 These improved outcomes mean more PLWH in the U.S. will live near normal lifespans and have a reduced risk of transmitting HIV to others.2 In a September 27, 2017, Dear Colleague letter, CDC notes that scientific advances have shown that antiretroviral therapy (ART) preserves the health of PLWH. There is also strong evidence of the prevention effectiveness of ART. When ART results in viral suppression, it prevents sexual HIV transmission. This means that people who take ART daily as prescribed and achieve and maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner. Such findings underscore the importance of supporting effective interventions for linking PLWH into care, retaining them in care, and helping them adhere to their ART.

RWHAP recipients are encouraged to assess the outcomes of their programs along this continuum of care. Recipients 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.

Minority AIDS Initiative The purpose of the RWHAP Part A MAI is to “improve HIV-related health outcomes to reduce existing racial and ethnic health disparities” (Section 2693 of the PHS Act). It is intended to address the disproportionate impact of HIV and to address the disparities in access, treatment, care, and outcomes for racial and ethnic minorities, including Black/African Americans, Alaska Natives, Hispanic/Latinos, American Indians, Asian Americans, Native Hawaiians, and Pacific Islanders.

As such, MAI funds provide direct financial assistance to RWHAP Part A recipients to develop or enhance access to high quality, community-based HIV core medical and support services for low-income minority PLWH and their families. You may target MAI funds to any new/emerging racial/ethnic minority populations identified in this application.

Clinical Quality Management Section 2618(b)(E) of the PHS Act requires recipients to establish a clinical quality management program to:

• Assess the extent to which HIV health services provided to clients under the grant are consistent with the most recent PHS guidelines (otherwise known as the HHS Guidelines), for the treatment of HIV disease and related opportunistic infections; and

1 Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2016. http://hab.hrsa.gov/data/data-reports. Published December 2017. Accessed December 1, 2017.

2 National Institute of Allergy and Infectious Disease (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2016 Mar 29]. Available from: https://clinicaltrials.gov/ NCT00074581 NLM Identifier:

NCT00074581.

https://docs.wixstatic.com/ugd/de0404_fab89a3aaeeb406bbd7898d0e90d5dac.pdf https://docs.wixstatic.com/ugd/de0404_fab89a3aaeeb406bbd7898d0e90d5dac.pdf http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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• Develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to and quality of HIV services.

Please see PCN 15-02 Clinical Quality Management and the accompanying FAQs for additional information.

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, needs assessments, unmet need estimates, reporting, quality improvement, the development of your HIV care continuum, and public health action. HRSA strongly encourages RWHAP Part A 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. HRSA strongly encourages establishing data sharing agreements between surveillance and HIV programs to ensure clarity about the process and purpose of the data sharing and utilization. Integrated HIV data sharing, analysis, and utilization approaches by state and territorial health departments can help further progress toward reaching the national goals to end the HIV epidemic and improve outcomes on the HIV care continuum.

To fully benefit from integrated data sharing, analysis, and utilization, HRSA strongly encourages complete CD4/viral load (VL) reporting to the state and territorial health departments’ surveillance systems. CD4 and VL data can be used to identify cases, classify stage of disease at diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into care and retention in care, measure viral suppression, and assess unmet health care needs. Analyses at the national level to monitor progress against HIV can only occur if all HIV-related CD4 and VL test results are reported by all jurisdictions. CDC recommends the reporting of all HIV-related CD4 results (counts and percentages) and all VL results (undetectable and specific values). Where laws, regulations, or policies are not aligned with these recommendations, states/territories might consider strategies to best implement these recommendations within current parameters or consider steps to resolve conflicts with these recommendations. In addition, consider reporting HIV-1 nucleotide sequences from genotypic resistance testing to monitor prevalence of antiretroviral drug resistance and HIV genetic diversity subtypes and transmission patterns.

Special Projects of National Significance (SPNS) Program Through its SPNS Program, HRSA’s HAB funds demonstration project initiatives focused on the development of effective interventions to quickly respond to emerging needs of PLWH receiving assistance under the RWHAP. Through these demonstration projects, SPNS evaluates the design, implementation, utilization, cost, and health related outcomes of innovative treatment models, while promoting dissemination, replication and uptake of successful interventions. SPNS findings have demonstrated promising new approaches to linking and retaining into care underserved and marginalized populations living with HIV. All RWHAP recipients are encouraged to review and integrate a variety of SPNS evidence-informed tools within their HIV system of care in accordance with the allowable service categories defined in PCN 16-02 Ryan http://hab.hrsa.gov/manageyourgrant/clinicalqualitymanagementpcn.pdf http://hab.hrsa.gov/manageyourgrant/clinicalqualitymanagementfaq.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds as resources permit. SPNS related tools can be found at the following locations:

• Integrating HIV Innovative Practices (IHIP) (https://careacttarget.org/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 technical assistance (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 (https://careacttarget.org/library/replication-resources-spns-systems-linkages-and-access-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 populations living with HIV.

• Dissemination of Evidence Informed Interventions (https://nextlevel.careacttarget.org/) The Dissemination of Evidence-Informed Interventions initiative runs from 2015- 2020 and disseminates four adapted linkage and retention interventions from prior SPNS and the Secretary’s Minority AIDS Initiative Fund (SMAIF) initiatives to improve health outcomes along the HIV care continuum. The end goal of the initiative is to produce four evidence-informed Care And Treatment Interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and easily adaptable to the changing healthcare environment.

Manuals are currently available at the link provided and will be updated on an ongoing basis.

II. Award Information

1. Type of Application and Award

Type of applications sought: Competing Continuation

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects approximately $618,140,400 to be available to fund 52 recipients.

Approximately $10,098,500 will be used for priority funding, and $50,992,100 will be available for MAI funding. You may apply for no more than the published ceiling amount in Appendix B. HRSA established ceiling amounts based on current funding with a five

(5) percent increase to accommodate fluctuations in formula and supplemental funding.

The actual amount available will not be determined until enactment of the final FY 2019 appropriation. This program announcement is subject to the appropriation of funds, and https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://careacttarget.org/ihip https://careacttarget.org/library/replication-resources-spns-systems-linkages-and-access-care https://careacttarget.org/library/replication-resources-spns-systems-linkages-and-access-care https://nextlevel.careacttarget.org/

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is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds in a timely manner. The period of performance is March 1, 2019, through February 29, 2020, (one (1) year).

HRSA will send notification of awards to the CEO or to the delegated administrative agency responsible for dispersing RWHAP Part A funds.

The RWHAP Part A provides non-discretionary formula grants that include MAI funds and discretionary supplemental awards. These funds assist eligible areas in developing or enhancing access to a comprehensive continuum of high quality, community-based care for low-income PLWH within the EMA/TGA and strengthening strategies to reach minority populations. HRSA awards two-thirds of the funds available for EMAs and TGAs according to a formula based on the number of living cases of HIV/AIDS in the EMAs and TGAs. HRSA awards the remaining funds as discretionary supplemental awards based on the demonstration of additional need by the eligible EMAs and TGAs, and as MAI funding. HRSA determines MAI awards based on the number of minorities living with HIV and AIDS in a jurisdiction. If determined eligible for priority funding, HRSA will calculate the additional amount awarded, and that amount will be included in the final award.

Eligible jurisdictions may apply for an amount up to the funding ceiling listed in Appendix B. If the RWHAP Part A award calculation results in an amount less than the budget submitted with your application, your budget will be proportionally reduced across all budget categories to reflect the actual award amount. If your award calculation results in an amount greater than the budget submitted with the application, you will be required to submit a revised budget prior to the Notice of Award (NOA) being issued.

Establishing realistic ceiling amounts ensures that there will be an approved project budget in place at the beginning of the project period.

Please note that the U.S. Secretary of Health and Human Services (Secretary) may reduce the amounts of grants under the RWHAP Part A to an EMA/TGA for a FY if, with respect to such grants for the second preceding FY, the subdivision fails to prepare audits in accordance with the procedures of Section 7502 of Title 31, United States Code. See Section 2682(a) of the PHS Act.

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

Please see Policy Clarification Notice 15-01 Treatment of Costs under the 10% Administrative Cap for Ryan White HIV/AIDS Program Parts A, B, C, and D along with the Frequently Asked Questions for information regarding the statutory 10 percent limitation on administrative costs.

III. Eligibility Information

1. Eligible Applicants

Eligibility for RWHAP Part A grants is based in part on the number of confirmed AIDS cases within a statutorily specified “metropolitan area.” The Secretary uses the Office of http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://hab.hrsa.gov/sites/default/files/hab/Global/pcn1501.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/pcn1501.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/faqpolicyclarificationnotice15-01.pdf

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Management and Budget’s (OMB) census-based definitions of a Metropolitan Statistical Area (MSA) in determining the geographic boundaries of a RWHAP metropolitan area.

HHS utilizes the OMB geographic boundaries that were in effect when a jurisdiction was initially funded under RWHAP Part A. For all newly eligible areas, the boundaries are based on current OMB MSA boundary definitions.

RWHAP Part A recipients that are classified as an EMA or as a TGA and continue to meet the status as an eligible area as defined in statute are eligible to apply for these funds. For an EMA, this is more than 2,000 cases of AIDS reported and confirmed during the most recent five (5) calendar years, and for a TGA, this is at least 1,000, but fewer than 2,000 cases of AIDS reported and confirmed during the most recent five (5) calendar years for which such data are available. In addition, for three (3 ) consecutive years, recipients must not have fallen below both the required incidence levels already specified, and required prevalence levels (cumulative total of living cases of AIDS reported to and confirmed by the Director of CDC, as of December 31 of the most recent calendar year for which such data are available). For an EMA, the required prevalence is 3,000 living cases of AIDS. For a TGA, the required prevalence is 1,500 or more living cases of AIDS. However, for a TGA with five (5) percent or less of the total amount from grants awarded to the area under Part A unobligated, as of the end of the most recent fiscal year, the required prevalence is at least 1,400 (and fewer than 1,500) living cases of AIDS.

This competition is open to eligible Part A jurisdictions to provide comprehensive primary health care and support services for low income, uninsured and underserved PLWH in their service areas as listed in Appendix B.

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.

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.

Maintenance of Effort – The RWHAP Part A recipient must agree to maintain EMA/TGA political subdivision expenditures for HIV-related core medical services and support services at a level equal to the FY preceding the FY for which the grant recipient is applying to receive a RWHAP Part A grant. See Section 2605(a)(1)(B) of the PHS Act. Core medical services and support services are defined in Section 2604(c)(3) and 2604(d) of the legislation. Part A recipients must document they have met the maintenance of effort (MOE) requirement (included as Attachment 11).

NOTE: Multiple applications from an organization are not allowable.

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

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 NOFO following the directions provided at http://www.grants.gov/applicants/apply-for-grants.html.

HRSA recommends that you supply an email address to Grants.gov on the grant opportunity synopsis page when accessing this notice of funding opportunity (NOFO) (also known as “Instructions” on Grants.gov) or workspace application package. This allows Grants.gov to email organizations in the event HRSA changes and/or republishes the NOFO on Grants.gov before its closing date. Responding to an earlier version of a modified notice may result in a less competitive or ineligible application.

Please note you are ultimately responsible for reviewing the For Applicants page for all information relevant to desired opportunities.

2. Content and Form of Application Submission

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

See Section 8.5 of the SF-424 Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 100 pages when printed by HRSA. The page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Standard OMB-approved forms that are included in the application package do not count in the page limit. Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. We urge you to take appropriate measures to ensure your application does not exceed the specified page limit.

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

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

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) The prospective recipient certifies, by submission of this proposal, that neither it nor its principals is 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 the prospective recipient is unable to attest to the statements in this certification, an explanation shall be included in Attachment 12.

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

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), please include the following:

i. Project Abstract See Section 4.1.ix of HRSA’s SF-424 Application Guide. Your abstract should be limited to one page and include the following information in this order:

• A general overview of the HIV epidemic in the EMA/TGA, including epidemiologic, demographic and geographic information. You may present this information as a table.

• A description of the comprehensive system of care in the entire EMA/TGA, including the available core medical and support services funded by RWHAP Part A and by other sources, where services are located, and how clients access those services, including services for disproportionately impacted subpopulation(s) supported by MAI funds.

• The overall viral suppression rate for the EMA/TGA. Use readily available and validated data and indicate whether it represents data for Ryan White eligible clients only, or is population-based. Also, if available and appropriate, provide any meaningful subpopulation data that highlights disparities in this outcome measure.

ii. Project Narrative This section provides a comprehensive framework and description of all aspects of the proposed project. It should be succinct, self-explanatory 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:

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INTRODUCTION -- Corresponds to Section V’s Review Criterion #1

This section must briefly describe how the EMA/TGA will utilize RWHAP Part A grant funds in support of a comprehensive continuum of high-quality care and treatment for PLWH in the RWHAP Part A service area, as defined in Appendix B.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criterion #1

The purpose of this section is to demonstrate the severity of the HIV epidemic in the EMA/TGA, using quantifiable data on HIV epidemiology, the HIV care continuum, co-occurring conditions, complexity of providing care, service needs of emerging populations, past unmet need estimates, and unique service delivery challenges as required and cited in Section 2603(b)(2)(B) of the PHS Act.

A. Demonstrated Need The Demonstrated Need section includes the Epidemiological Overview, HIV Care Continuum, Co-occurring Conditions, and Complexities of Providing Care sub-sections.

Since 2003, unmet need has been defined as the number of individuals with HIV in a jurisdiction who are aware of their HIV status and are not in care.

HAB continues to consider the best approach to developing a new framework and methodology for accurately estimating unmet need based on current HIV treatment guidelines. No new unmet need estimates are required. For this NOFO, unmet need elements (as specified in Section 2603(b)(2)(B) of PHS Act) are captured in the Epidemiologic Overview and the Complexities of Providing Care sub-sections below. You may use your past unmet need estimate to help inform planning, resource allocation and work plan development for this application.

HAB will target supplemental funds to those eligible areas where epidemiologic data demonstrate that HIV infection prevalence rates are increasing, where there is documented demonstrated need and service gaps, and where there is a demonstrated disproportionate impact on vulnerable populations.

1) Epidemiologic Overview An epidemiologic overview provides a description of the demonstrated need for HIV care in the population of an area in terms of socio-demographic, geographic, behavioral, and clinical characteristics of persons newly diagnosed with HIV, PLWH, and persons at higher risk for infection. Understanding the populations affected by HIV provides the basis for setting priorities, identifying appropriate interventions and services, allocating funding to HIV care services, implementing appropriate service standards, and evaluating programs and policies.

The epidemiologic overview should focus on the most recent year for which data are available; when presenting trends, a minimum of three (3) years of data are recommended. Please cite data sources. Submit the https://hab.hrsa.gov/sites/default/files/hab/About/RyanWhite/legislationtitlexxvi.pdf https://hab.hrsa.gov/sites/default/files/hab/About/RyanWhite/legislationtitlexxvi.pdf

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HIV/AIDS Demographic Table as Attachment 3.

a) Provide a summary of the HIV epidemic in your EMA/TGA geographic area.

b) Describe the socio-demographic characteristics of: (1) persons newly diagnosed, (2) PLWH, and (3) persons at higher risk for HIV infection in the service area. Include the following, as available in the geographical region of the jurisdiction:

i. Demographic data (e.g., race, age, sex, transmission category, current gender identity); and

ii. Socioeconomic data (e.g., percentage of federal poverty level (FPL), income, education, health insurance status, language barriers).

c) Describe the relative rates of increase in HIV diagnosed cases within new and emerging populations.

i. Include information on how you identified emerging populations, any unique challenges, and estimated costs to the RWHAP Part A program, if applicable.

ii. Describe the increasing need for HIV-related services based on the relative increase of HIV cases.

2) HIV Care Continuum

Provide a graphic depiction of the HIV care continuum of the jurisdiction using the most current calendar year data. The definitions of the numerator and the denominator must be clearly stated for each step of the care continuum. Use readily available and validated data, and indicate whether it represents data for Ryan White eligible clients only or is population-based.

In addition, describe the viral suppression rates for three of the most disproportionately impacted minority populations that highlight disparities.

Pay special attention to populations where specific sub-populations may experience the greatest health disparities, for example, young black men who have sex with men (YBMSM) ages 13-24.

The steps of the diagnosed-based HIV care continuum using the HHS indicators are found at https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum.

3) Co-occurring Conditions Using the list below, provide quantitative evidence (i.e., incidence, prevalence, and estimates) describing the conditions co-occurring with HIV in the EMA/TGA in a table format (submit as Attachment 4) and document the data sources used. The table must include:

a) Hepatitis C virus

b) Sexually transmitted infection rates, including syphilis, gonorrhea, and chlamydia

c) Mental illness

d) Substance use disorder https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

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e) Homeless/Unstably Housed

f) Former incarceration

4) Complexities of Providing Care

a) If the EMA/TGA experienced a reduction in RWHAP Part A formula funding last year, provide a narrative that addresses both the impact and response to the funding reduction, as follows:

i. Impact: The specific services that were eliminated or reduced, and by how much, and

ii. Response: Any cost containment measures implemented (e.g., waiting lists, client cost sharing, or other measures), PC/PB response to the reduction in formula funding, and any transitional planning for clients receiving services that were either eliminated or reduced.

b) Provide, in a table format, current estimates on poverty and health care coverage status of PLWH in your jurisdiction. Include the following information, as available:

i. The number and percentage of PLWH who are enrolled in Medicaid, Medicare, and other health care coverage;

ii. The number and percentage of PLWH who are uninsured; and

iii. The number and percentage of PLWH living at or below 138 percent and 400 percent of the 2018 federal poverty level (FPL). Also, include the percentage of FPL used to determine RWHAP eligibility in the jurisdiction.

c) Discuss any relevant factors that limit access to health care, including geographic variation, adequacy of health insurance coverage, and language barriers. Also, describe any service gaps, especially for PLWH who are not in care, and how these service gaps will be addressed with FY 2019 RWHAP Part A funding.

B. Early Identification of Individuals with HIV/AIDS (EIIHA) The purpose of this section is to describe the data and information associated with ensuring that individuals who are unaware of their HIV status are identified, informed of their status, referred to supportive services, and linked to medical care if HIV positive. The goals of the EIIHA initiative are to present a strategy for: (1) identifying individuals with HIV who do not know their HIV status; (2) making such individuals aware of such status and enabling such individuals to use the health and support services; and (3) reducing barriers to routine testing and disparities in access and services among affected subpopulations and historically underserved communities. See Section 2603(b)(2)(A) of the PHS Act.

1) Describe the planned EMA/TGA EIIHA activities for the 2019 project period.

Include the following information:

a) The primary activities that will be undertaken, including system level interventions (e.g., routine testing in clinical settings, expanding partner services);

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b) Major collaborations with other programs and agencies, including HIV prevention and surveillance programs; and

c) The anticipated outcomes of the jurisdiction’s overall EIIHA strategy.

2) Describe any planned efforts to remove legal barriers, including state laws and regulations, to routine HIV testing in medical settings, or program/policy efforts to expand implementation of routine HIV testing.

3) Select three (3) distinct target populations for the 2019 project period EIIHA Plan. For each selected target population describe:

a) Why you chose the target population and how the epidemiological data, social determinants of health, or other data supports that decision;

b) Specific challenges or opportunities for working with the target population;

and

c) The specific strategies that will be utilized with the target population.

C. AIDS Pharmaceutical Assistance (i.e., Local Pharmaceutical Assistance Program) – Not Scored Only complete this section if requesting funds for a Local Pharmaceutical Assistance Program (LPAP) that will be newly funded in the 2019 project period.

The purpose of this section is to describe the need for an LPAP, including a description of the systems and activities required to effectively operate an LPAP.

The RWHAP Part A needs assessment must determine that the State/Territory’s AIDS Drug Assistance Program (ADAP) does not adequately address the medication assistance needs of clients in the jurisdiction (e.g., existence of an ADAP waiting list, restrictive ADAP financial eligibility criteria, or a limited ADAP formulary). The needs assessment must also demonstrate that other resources are inadequate to meet the medication needs of clients residing in the jurisdiction.

The National Monitoring Standards and LPAP letter of clarification sent to RWHAP Parts A and B recipients on August 29, 2013, outline the systemic requirements necessary to comply with the LPAP service category definition. Implementation of an LPAP requires the development of a drug distribution system that includes, but is not limited to: client enrollment and eligibility determination process that includes screening for ADAP and LPAP eligibility, with rescreening at a minimum every six months; an LPAP advisory board; uniform benefits for all enrolled clients;

compliance with RWHAP requirement of payor of last resort; and a drug formulary approved by the local advisory committee/board. An LPAP may not be used to provide short-term or emergency medication assistance. Please refer to the RWHAP Part A National Monitoring Standards and PCN 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals and Allowable Uses of Funds for a complete list of LPAP requirements.

If you are planning to fund LPAP for the first time in the 2019 project period, describe the following:

1) The need for an LPAP in detail: include how the ADAP, other RWHAP funded service categories, and other resources (e.g., pharmaceutical assistance https://hab.hrsa.gov/sites/default/files/hab/Global/lpapletter.pdf https://hab.hrsa.gov/program-grants-management/ryan-white-hivaids-program-recipient-resources 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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programs, patient assistance programs, local/state funded medication assistance programs) are failing to meet the jurisdiction’s medication needs.

2) How the LPAP will be coordinated with the ADAP.

3) The client enrollment and eligibility process, including how the payor of last resort requirement is ensured.

4) The LPAP advisory board composition. Describe the process and timeframe for development of the LPAP advisory board.

5) How the recipient ensures that the LPAP follows the most recent HHS

HIV/AIDS Clinical Guidelines.

6) The mechanism to ensure “best price” for medications (e.g., 340B Drug

Pricing Program and/or Prime Vendor Program).

METHODOLOGY -- Corresponds to Section V’s Review Criteria #2 & #4

A. Impact of the Changing Health Care Landscape The availability of health care coverage options have an impact on RWHAP service needs and how services are provided in jurisdictions.

1) Provide an overall description of health care coverage options available to PLWH in the jurisdiction.

a) Explain how coverage options in the jurisdiction negatively or positively influence access to direct health care services and health outcomes.

2) Describe how changes in the health care landscape affect the following:

a) Service provision and the complexity of providing care to PLWH in the

EMA/TGA.

b) Changes in RWHAP Part A allocations, including activities related to health insurance premium and cost sharing assistance.

B. Planning Responsibilities Section 2602(b)(4)(C) of the PHS Act requires PC/PBs to determine the priority for RWHAP allowable services and service allocations of RWHAP Part A funds every year.