v2 MODIFIED 6.24.22_FORHP HRSA-22-165 RCORP MAT Access_FINAL.pdf

U.S. Department of Health and Human Services

Federal Office of Rural Health Policy

Rural Strategic Initiatives Division

Rural Communities Opioid Response Program –

Medication Assisted Treatment Access Funding Opportunity Number: HRSA-22-165

Funding Opportunity Type: New

Assistance Listings Number: 93.912

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: July 29, 2022

MODIFIED on June 24, 2022:

Revision: Clarified the information required of applicants applying under the same UEI/EIN in Section III. Eligibility and Attachment 11.

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

HRSA will not approve deadline extensions for lack of registration.

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

Issuance Date: June 13, 2022

Anna Swanson Public Health Analyst, Federal Office of Rural Health Policy Telephone: 301.443.2398 Email: ruralopioidresponse@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. 912(b)(5) (§ 711(b)(5) of the Social Security Act) mailto:ruralopioidresponse@hrsa.gov

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508 COMPLIANCE DISCLAIMER

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

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Rural Communities Opioid Response Program (RCORP) – Medication Assisted Treatment (MAT) Access. RCORP is a multi-year HRSA initiative aimed at reducing the morbidity and mortality of substance use disorder (SUD), including opioid use disorder (OUD), in high risk rural communities. The purpose of this program is to improve health care in rural areas by establishing new MAT access points and increasing the capacity for sustainable MAT service provision in rural areas.

Funding Opportunity Title: Rural Communities Opioid Response Program (RCORP) –Medication Assisted Treatment (MAT) Access

Funding Opportunity Number: HRSA-22-165

Due Date for Applications: July 29, 2022

Anticipated FY 2022 Total Available Funding:

$10,000,000

Estimated Number and Type of Awards: Approximately 10 grants

Estimated Annual Award Amount: Up to $1,000,000 per award, per year

Cost Sharing/Match Required: No

Period of Performance: September 30, 2022 through September 29, 2025 (3 years)

Eligible Applicants: All domestic public and private, nonprofit and for-profit entities are eligible to apply.

Tribes and tribal organizations are eligible.

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

https://www.hrsa.gov/rural-health/rcorp

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Application Guide

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

Technical Assistance

HRSA has scheduled the following webinar:

Day and Date: Thursday, June 23, 2022 Time: 2 – 3 p.m. ET Weblink: https://hrsa-gov.zoomgov.com/j/1600963647

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

Call-In Number: 1-833-568-8864 Participant Code: 160 096 3647

HRSA will record the webinar. For a recording of the webinar, please email ruralopioidresponse@hrsa.gov http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://hrsa-gov.zoomgov.com/j/1600963647 https://hrsa-gov.zoomgov.com/j/1600963647 mailto:ruralopioidresponse@hrsa.gov

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. Purpose

2. Background

II. AWARD INFORMATION

1. Type of Application and Award

2. Summary of Funding

III. ELIGIBILITY INFORMATION

1. Eligible Applicants

2. Cost Sharing/Matching

3. Other

IV. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

2. Content and Form of Application Submission

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. Unique Entity Identifier (UEI) and System for Award Management (SAM) ……………………………………………………………………………………….27

4. Submission Dates and Times

5. Intergovernmental Review

6. Funding Restrictions

V. APPLICATION REVIEW INFORMATION

1. Review Criteria

2. Review and Selection Process

3. Assessment of Risk

VI. AWARD ADMINISTRATION INFORMATION

1. Award Notices

2. Administrative and National Policy Requirements

3. Reporting

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: PAGE LIMIT WORKSHEET

APPENDIX B: EXAMPLES OF ALLOWABLE ACTIVITIES

APPENDIX C: POTENTIAL PARTNER ORGANIZATIONS

APPENDIX D: RESOURCES FOR APPLICANTS

APPENDIX E: NATIONAL HEALTH SERVICE CORPS INFORMATION

APPENDIX F: THIRD-PARTY PAYER GUIDANCE

APPENDIX G: MAT ACCESS POINT EXAMPLES

APPENDIX H: APPLICATION COMPLETENESS CHECKLIST

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I. Program Funding Opportunity Description

1. Purpose

The Rural Communities Opioid Response Program (RCORP) is a multi-year HRSA initiative aimed at reducing the morbidity and mortality of substance use disorder (SUD), including opioid use disorder (OUD), in rural communities. This notice announces the opportunity to apply for funding under the RCORP-Medication Assisted Treatment (MAT) Access Program. RCORP-MAT Access will advance RCORP’s overall goal by improving access to and quality of MAT and supportive services in rural communities.

The purpose of this program is to improve health care in rural areas by establishing new MAT access points and increasing the capacity for sustainable MAT service provision in rural areas. This program is intended to support MAT to treat OUD, however HRSA encourages award recipients to also target alcohol use disorder (AUD) with MAT if the need exists.

Over the course of the three-year period of performance, RCORP-MAT Access recipients will implement activities that are aligned with the following overarching program goals:

Goal 1 - Establish new MAT access points to provide both medications and supportive services to individuals with OUD and/or AUD in rural communities;

Goal 2 - Enhance the MAT workforce through recruitment, training, and the development of peer mentorship networks;

Goal 3 - Build community capacity and infrastructure to support more effective and efficient MAT service provision; and, Goal 4 - Ensure sustainability of the new MAT access points through improved billing and coding, as well as enrollment of eligible individuals into health insurance.

For the purposes of this NOFO, “MAT access” includes affordability, accessibility, acceptability, and availability of MAT treatment and supportive services for rural individuals who reside in the rural areas as defined by the Rural Health Grants Eligibility Analyzer. Additionally, HRSA defines MAT as the use of U.S. Food and Drug Administration (FDA)-approved medications, in combination with counseling and behavioral therapies, to provide a “whole-person” approach to the treatment of substance use disorders, including opioid use disorder and alcohol use disorder

(AUD).1,2

1 See https://www.samhsa.gov/medication-assisted-treatment.

2 See https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions FDA-approved MAT for:

OUD includes methadone, buprenorphine, and naltrexone; for opioid overdose includes naloxone; for AUD includes acamprosate, disulfiram, and naltrexone.

https://www.hrsa.gov/rural-health/rcorp https://data.hrsa.gov/tools/rural-health https://data.hrsa.gov/tools/rural-health https://www.samhsa.gov/medication-assisted-treatment https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions

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The target population for RCORP–MAT Access includes:

• Individuals living in rural communities who are at risk for OUD and/or AUD;

• Individuals living in rural communities who are diagnosed with OUD and/or AUD;

• Individuals living in rural communities who are in treatment and/or recovery for OUD and/or AUD;

• Their families and/or caregivers; and

• Impacted community members3 who reside in the rural target service area.

Applicants are encouraged to include populations that have historically suffered from poorer health outcomes, health disparities, and other inequities as compared to the rest of the population. Examples of these populations include, but are not limited to: racial and ethnic minorities, people who are pregnant, adolescents and youth, LGBTQ+ individuals, veterans, socioeconomically disadvantaged populations, the elderly, individuals with disabilities, etc.

For more details, see Program Requirements and Expectations.

2. Background

RCORP-MAT Access is authorized by Section 711(b)(5) of the Social Security Act (42 U.S.C. 912(b)(5)).

In January 2022, the Secretary of Health and Human Services renewed the public health emergency for opioids that was first issued in 2017. In recognition of the changing nature of the overdose crisis, in October 2021, the U.S. Department of Health and Human Services (HHS) published an Overdose Prevention Strategy, which includes four strategic priorities: primary prevention, harm reduction, evidence-based treatment, and recovery support. The RCORP initiative is explicitly included in this strategy, and RCORP-MAT Access supports the Strategy’s goal of “broadening access to evidence-based care that increases willingness to engage in treatment.” This program also supports the President’s National Mental Health Strategy.

Over 100,000 drug overdose deaths occurred in the United States in the 12 months ending in April 2021, the highest number of overdose deaths ever recorded in a 12-month period, according to recent provisional data from CDC.4 From 1999 through 2019, the rate of drug overdose deaths increased from 4.0 per 100,000 to 19.6 in rural counties.5

Rural providers and communities in particular face a number of challenges in providing and accessing OUD services. In July 2020, nearly two-thirds of all rural counties

3 Applicants are encouraged to include individuals in the community who are involved in improving health care delivery in rural areas in their RCORP projects.

4 See https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm 5 Hedegaard H, Spencer MR. Urban–rural differences in drug overdose death rates, 1999–2019. NCHS Data Brief, no 403.

Hyattsvil le, MD: National Center for Health Statistics. 2021. DOI: https://dx.doi. org/10.15620/cdc:102891.

https://aspr.hhs.gov/legal/PHE/Pages/Opioid-3Jan22.aspx https://aspr.hhs.gov/legal/PHE/Pages/Opioid-3Jan22.aspx https://www.hhs.gov/overdose-prevention/ https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/31/fact-sheet-biden-harris-administration-highlights-strategy-to-address-the-national-mental-health-crisis/ https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/20211117.htm

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(63.1%) had at least one clinician with a Drug Enforcement Administration (DEA) waiver but more than half of small and remote rural counties lacked one.6 In addition to workforce shortages, rural providers face barriers of stigmatization, transportation, and costs associated with setting up MAT and other SUD services.7 At the same time, working with and learning from experienced rural providers can help to overcome some of these barriers and encourage new providers to pursue a DEA waiver.8

Addressing issues of equity should include an understanding of intersectionality and how multiple forms of discrimination impact individuals’ lived experiences. Individuals and communities often belong to more than one group that has been historically underserved, marginalized, or adversely affected by persistent poverty and inequality.

Individuals at the nexus of multiple identities often experience unique forms of discrimination or systemic disadvantages, including in their access to needed services.9

II. Award Information

1. Type of Application and Award

Type of applications sought: New

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates approximately $10,000,000 to be available annually to fund approximately 10 recipients. You may apply for a ceiling amount of up to $1,000,000 annually (reflecting direct and indirect, facilities and administrative costs) per year.

No competitive advantage, funding priority, or preference is associated with requesting an amount below the $1,000,000 per year ceiling amount. You may request different amounts each of the three years (up to the $1,000,000 ceiling) depending on the needs for each year of the period of performance. HRSA expects that MAT programs established using RCORP-MAT Access funding will be self-sustaining by the end of the period of performance. To that end, applicants’ proposed work plans and budgets/budget narratives should reflect a shift from capacity building activities to

6 Andril la CHA, Patterson DG. Tracking the geographic distribution and growth of clinicians with a DEA waiver to prescribe buprenorphine to treat opioid use disorder. J Rural Health. 2021; 1-6. https://doi.org/10.1111/jrh.12569 7 See, e.g., Implementing Medication-Assisted Treatment for Opioid Use Disorder in Rural Primary Care: Environmental Scan Volume 1, AHRQ, https://integrationacademy.ahrq.gov/sites/default/files/mat_for_oud_environmental_scan_volume_1_1.pdf 8 Andril la, C.H.A., Moore, T.E. and Patterson, D.G. (2019), Overcoming Barriers to Prescribing Buprenorphine for the Treatment of Opioid Use Disorder: Recommendations from Rural Physicians. The Journal of Rural Health, 35: 113-

121. https://doi.org/10.1111/jrh.12328 9 See Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, 86 FR 2023, at § 1 (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01761.pdf.

https://doi.org/10.1111/jrh.12328 https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01761.pdf

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service delivery and sustainability over the course of the three-year period of performance.

The period of performance is September 30, 2022 through September 29, 2025 (3 years). Funding beyond the first year is subject to the availability of appropriated funds for RCORP-MAT Access in subsequent fiscal years, satisfactory progress, and a decision that continued funding is in the best interest of the Federal Government.

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

Applicant Organization Specifications

Eligible applicants include all domestic public or private, non-profit and for-profit, entities. In addition to the 50 U.S. states, organizations in the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, the U.S. Virgin Islands, the Federated State of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau may apply. Tribes and tribal organizations are eligible.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

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

• Exceeds the funding ceiling amount

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

• Exceeds the page limit

• Fails to propose a service area that is entirely rural, as defined by the Rural Health Grants Eligibility Analyzer. All service delivery sites supported by RCORP- MAT Access, including all access points where MAT will be offered, must be exclusively located in HRSA-designated rural counties and rural census tracts.

Within partially rural counties, activities and services supported by this award http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://data.hrsa.gov/tools/rural-health

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may only occur in the HRSA-designated rural census tracts. Please reference the Program Requirements and Expectations section for additional guidance

NOTE: In general, multiple applications associated with the same Unique Entity Identifier (UEI), and/or EIN are not allowable. However, HRSA recognizes a growing trend towards greater consolidation within the rural health care industry and the possibility that multiple organizations with the same EIN and/or UEI could be located in different rural service areas that have a need for SUD/OUD services. Therefore, separate applications associated with a single UEI number and/or EIN are allowed, as long as the applicants provide HRSA with the following information in Attachment 11. Single organizations (e.g., a parent organization/headquarters) cannot apply more than once for this funding opportunity on behalf of its satellite offices or clinics. HRSA will only accept and review your last validated electronic submission before the Grants.gov application due date.

IV. Application and Submission Information

1. Address to Request Application Package

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

APPLICANT SYSTEM-TO-SYSTEM.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-165 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

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

https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/s2s/applicant-system-to-system.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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

Application Page Limit The total of uploaded attachment pages that count against the page limit shall be no more than the equivalent of 80 pages when printed by HRSA. Standard OMB-approved forms included in the workspace application package do not count in the page limit. The abstract is the standard form (SF) "Project_Abstract Summary.” If there are other attachments that do not count against the page limit, this will be clearly denoted in Section IV.2.vi Attachments.

The abstract is no longer an attachment that counts in the page limit. Additionally, Indirect Cost Rate Agreement and proof of non-profit status (if applicable) do not count in the page limit. However, if you use an OMB-approved form that is not included in the workspace application package for HRSA-22-165, it will 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.

It is important to take appropriate measures to ensure your application does not exceed the specified page limit. Any application exceeding the page limit will not be read, evaluated, or considered for funding.

Applications must be complete, within the maximum specified page limit, and validated by Grants.gov under HRSA-22-165 before the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

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

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachments 11-15: Other Relevant Documents.

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

Program Requirements and Expectations

New MAT Access Point(s)

RCORP-MAT Access funds must be used to establish a new MAT access point(s), and not for expanding an existing MAT access point(s). MAT cannot currently be a clinical service offered at the proposed access point(s). To that end, applicants should https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371

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demonstrate in the Project Narrative section that the proposed MAT access point(s) do not currently offer MAT services.

HRSA will NOT fund proposals that do not demonstrate that they are a new MAT access point.

Please see Appendix F for illustrative examples of what does and does not constitute a new MAT access point for the purposes of this program.

Additionally, new MAT access points established under this program must be physically located in HRSA-designated rural areas, as defined by the Rural Health Grants Eligibility Analyzer (see “Target Rural Service Area” below for details).

NOTE: If the applicant organization is not the entity that will be physically serving as the new MAT access point(s), the applicant must provide a signed letter of commitment from the entity/entities that will be serving as the new MAT access point(s). This is in addition to the required letters of support from two partner organizations. See Attachment 7 for details.

Parameters for MAT Provision

For the purposes of this program, MAT is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-person” approach to the treatment of substance use disorders.

Every effort should be made to ensure that the services provided through the new MAT access point(s) are accessible and available to the target population, including (but not limited to) offering extended hours (such as nights and weekends) and not requiring abstinence/detoxification as a pre-requisite from treatment. Additionally, the new MAT access points(s) should provide the best treatment option(s) for the populations they are serving. This may include offering a single, or multiple, treatment options, depending on the needs of your community, though it is encouraged that multiple treatment options are offered10,11 (e.g. buprenorphine, naltrexone, methadone, etc.). While the primary focus of this program is using MAT to treat OUD, award recipients may also target alcohol use disorder (AUD) with MAT.

MAT Medications

The FDA has approved MAT as an evidence-based approach for both opioid use disorder and alcohol use disorder. Per the FDA, OUD can be treated with buprenorphine, methadone, and naltrexone. Naloxone is approved for opioid overdose reversal. AUD is most commonly treated with acamprosate, disulfiram, and naltrexone12. FDA-approved medications purchased with these grant funds may only be offered for the disorder (OUD or AUD) for which they are approved.

10 See https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf 11 "Where Multiple Modes Of Medication-Assisted Treatment Are Available", Health Affairs Blog, January 9, 2018.

12 See https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions https://data.hrsa.gov/tools/rural-health https://data.hrsa.gov/tools/rural-health https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions

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Buprenorphine for MAT is available for purchase in the 340B Drug Pricing Program by eligible covered entities. Covered entities may provide buprenorphine to patients of their entity using their in-house pharmacies, or via contract pharmacy arrangements. The 340B program enables covered entities to stretch resources to provide a broader array of services to patients – including but not limited to SUD and or behavioral health wrap around services – in order to facilitate achieving desired clinical outcomes.

Operationalizing MAT

As previously noted, the award recipients must use MAT to treat OUD, however HRSA encourages award recipients to also target alcohol use disorder (AUD) with MAT if the need exists.

RCORP-MAT Access award recipients are expected to begin delivering MAT services no later than the end of the first project year of the award and to increase the number of individuals receiving MAT each subsequent year of the grant. This should be accomplished through increasing the number individuals served at the new MAT access point(s), and/or through establishing additional new MAT access points in years 2 and 3 of the award. Services are expected to be fully sustainable by the end of the three-year period of performance. No individuals should be denied services due to an inability to pay.

Award recipients are expected to address the full spectrum of OUD treatment, including MAT and recovery support services, in an integrated and coordinated manner.

Recipients should ensure a “whole-person” approach to MAT which accounts for the specific needs and characteristics of impacted populations, including individuals with OUD as well as their families and caregivers.

Rural residents who use opioids are more likely than their urban counterparts to have socioeconomic vulnerabilities, including limited educational attainment, poor health status, lack of health insurance, and low income,13 which further limit their abilities to access treatment. RCORP supports and encourages projects that address the needs of a wide range of population groups, including, but not limited to, low-income populations, the elderly, pregnant women, youth, adolescents, ethnic and racial minorities, people/persons experiencing homelessness, and individuals with special health care needs.

Partner Requirements

Given the complex and multifaceted nature of OUD, as well as the need to generate adequate patient volume to sustain MAT services, HRSA requires that applicants partner with at least two other entities to implement project activities. These partnerships should augment, but not replace, the MAT services provided through the new MAT access point(s).

13 Lenardson, Jennifer et al (2016), “Rural Opioid Abuse: Prevalence and User Characteristics,” Maine Rural Health Research Center, http://muskie.usm.maine.edu/Publications/rural/Rural-Opioid-Abuse.pdf https://www.hrsa.gov/opa/index.html#:%7E:text=The%20340B%20Program%20enables%20covered,entities%20at%20significantly%20reduced%20prices.

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Applicants should make all reasonable effort to include a pharmacy as one of the two required partnerships to help address the barriers to care in the rural pharmacy setting14. Additionally, HRSA encourages a multisectoral approach to partnerships, and has a particular interest in projects that propose to include one or both of the following entity types:

• Correctional facilities (e.g., jails/prisons) to ensure that incarcerated individuals are able to initiate or continue their MAT upon release15,16; and

• Rural emergency departments, so that individuals presenting with overdose or other symptoms of OUD or AUD are able to initiate MAT immediately.

See Appendix B for a list of example partner organizations.

While the new MAT access point(s) must be located in physically located in HRSA-designated rural areas, as defined by the Rural Health Grants Eligibility Analyzer, HRSA recognizes that in certain cases key partners serving the target rural service area may not be physically located within that same area. Therefore, applicants may request an exception to enable partnerships outside of the target rural service area. Please see Attachment 8 for additional instructions on submitting required documentation for these exceptions.

Third-Party Reimbursement

Award recipients should ensure that all services covered by reimbursement are billed and every reasonable effort is made to obtain payment from third-party payers. Only after award recipients receive a final determination from the insurer regarding lack of full reimbursement can the RCORP-MAT Access grant be used to cover the cost of services for underinsured individuals. RCORP-MAT Access grant funds can be used to cover the cost of services for uninsured individuals. See Appendix E for more information.

Learning Collaborative

All recipients of this award are required to participate in the RCORP-MAT Access Learning Collaborative, facilitated by the RCORP Technical Assistance provider. The purpose of the learning collaborative is to network, share best practices, address challenges, and receive targeted technical assistance to advance the efforts of all participants. The learning collaborative will also provide mentorship opportunities for clinical providers that support MAT (such as, but not limited to, physicians, nurse practitioners, physician assistants, and pharmacists). The learning collaborative will equip RCORP-MAT Access award recipients with tools to develop and sustain their own training and mentorship initiatives within their target rural service area.

14 Kazerouni NJ, Irwin AN, Levander XA, Geddes J, Johnston K, Gostanian CJ, Mayfield BS, Montgomery BT, Graalum DC, Hartung DM. Pharmacy-related buprenorphine access barriers: An audit of pharmacies in counties with a high opioid overdose burden. Drug Alcohol Depend. 2021 Jul 1;224:108729. doi: 10.1016/j.drugalcdep.2021.108729. Epub 2021 Apr 24. PMID: 33932744.

15 Joudrey, P.J., Khan, M.R., Wang, E.A. et al. A conceptual model for understanding post-release opioid-related overdose risk. Addict Sci Clin Pract 14, 17 (2019). https://doi.org/10.1186/s13722-019-0145-5 16 Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release: opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med. 2013;159(9):592–600.

https://doi.org/10.1186/s13722-019-0145-5

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The learning collaborative will meet virtually once a month starting no later than six months into the period of performance. You must designate one individual to serve as the point of contact for the learning collaborative. It is highly encouraged that that individual be a MAT provider due to the clinical nature of the information that will be presented in the learning collaborative. Additional methods for mentorship and peer learning will be communicated upon receipt of the award and throughout the period of performance.

Required Staffing

Applicants are expected to identify individuals who will fulfill the following roles in the proposed project:

• Project Director

• Healthcare Navigator

• Learning Collaborative Point of Contact

• Data Coordinator

Please see Section IV’s Organizational Information for more details on this requirement.

Sustainability

HRSA expects that MAT programs established using RCORP-MAT Access funding will be self-sustaining by the end of the period of performance. To that end, applicants’ proposed work plans and budgets/budget narratives should reflect a shift from capacity building activities to service delivery and sustainability over the course of the three-year period of performance.

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

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form that is included in the workspace application package. Do not upload the abstract as an attachment or it may count toward the page limit. For information required in the Project Abstract Summary Form, see Section 4.1.ix of HRSA’s SF-424 Application Guide. Note: Please see Attachment 10 for additional project information that should be included with your application.

NARRATIVE GUIDANCE

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

https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide.pdf

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Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need

Methodology (2) Response and (4) Impact

Work Plan (2) Response

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures and (4) Impact

Organizational Information (3) Evaluative Measures and (5) Resources/Capabilities

Budget Narrative (6) Support Requested

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

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

INTRODUCTION -- Corresponds to Section V’s Review Criterion(a) # 1 - “Need”

This section should clearly and succinctly summarize the proposed project and how it aligns with the goals and purpose of RCORP-MAT Access. In particular, you should provide a description of the target rural service area counties and/or rural census tracts; the characteristics and needs of the target population and service area; the proposed approach to meeting those needs; and capacity to implement and sustain the proposed project.

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

“Need”

Describe, in detail, the needs of the target rural population as they relate to the program goals. Provide supporting data and statistics from appropriate sources (e.g., local, state, tribal, and federal) that reflect the most recent timeframe available.

Where possible, compare the data for the target rural population to regional, statewide, and/or national data to demonstrate need. Please cite the data sources (including year) you use to provide this data.

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Specifically, the Needs Assessment section should include detailed, quantitative descriptions of the following:

• Overview of the need at the proposed new MAT access point(s) including, but not limited to, why MAT is not currently offered at the access point(s); why MAT is needed at the access point(s); what gaps in infrastructure and/or workforce at the access point(s) will this grant address.

• The target rural population, including demographic and social determinants of health indicators;

o Describe the extent to which the population you propose to serve includes subpopulations that have historically suffered from poorer health outcomes, health disparities, and other inequities compared to the rest of the target population. Examples of these populations include, but are not limited to, persons/people experiencing homelessness, racial and ethnic minorities, people who are pregnant, adolescents and youth, LGBTQ individuals, the elderly, individuals with disabilities, etc.

o Describe which segments of the target rural population are most at risk for, and/or are most likely to be diagnosed with OUD This may include certain age groups, racial/ethnic groups, persons/people experiencing homelessness, etc.

• The prevalence and impact of OUD in the target rural service area. Examples can include, but are not limited to, the number/ percentage of children in the foster care system as a result of their caregivers’ SUD/OUD; number of individuals with infectious complications as a result of OUD; the number of SUD/OUD hospitalizations and/or emergency room visits; etc.

• Overview of existing SUD/OUD-related prevention, treatment, and recovery support services in the target rural service area, including MAT. If no specific SUD/OUD services exist within in the target rural service area, describe how and where individuals with SUD are receiving care. Also include federal, state, or locally funded SUD/OUD initiatives such as other RCORP projects.

• Description of how the proposed project will complement, and not duplicate, any existing services or other efforts/initiatives within the target rural service area.

This includes all existing RCORP awards, held either by the applicant organization or other entities, which are operating within the target rural service area.

o Please reference the RCORP website for a list of active RCORP award recipients in each program—Implementation, Neonatal Abstinence Syndrome, Psychostimulant Support, and MAT Expansion—as well as this table of RCORP award recipient service areas for more information.

• Overview of the capacity at the proposed new MAT access point(s) including, but not limited to, current services offered; current infrastructure available;

current workforce available.

https://www.hrsa.gov/rural-health/rcorp https://www.rcorp-ta.org/sites/default/files/2021-11/Counties%20Served%20All%20Cohorts%2010.28.21%20for%20Portal_0.xlsx

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• Overview of gaps and opportunities for the integration and coordination of MAT services with key partners such as (but not limited to) criminal justice (e.g., jails/prison), emergency departments, and other entities that play a key role in MAT initiation and provision within the target rural service area. Overview of pharmacy access within the target rural service area as it relates to filling prescriptions for MAT; if no pharmacy exists within the target rural service area, describe where and how individuals with SUD are filling MAT prescriptions.

• Overview of the community services available within the service area to support MAT and recovery, including (but not limited to) educational opportunities, vocational training, housing, etc.

• Overview of barriers to access MAT for OUD and/or AUD in the target rural service area (e.g. lack of transportation, childcare, job flexibility, coordination of services upon release from incarceration, pharmacy access, initiation upon emergency room visit, etc.)

Applicants encountering difficulty obtaining data are encouraged to contact their state or local health departments and/or refer to data and information provided by the Rural Health Information Hub and the Opioid Misuse Community Assessment Tool developed by NORC at the University of Chicago. If you are still unable to locate appropriate and accurate data, please provide an explanation for why the data could not be found and how you will ensure that you will be able to meet HRSA reporting requirements if awarded.

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

Criterion(a) # 2 – “Response”

The Methodology Section should provide clear, actionable strategies and activities for how you will achieve each of the program goals. All strategies and activities should be evidence-based, data-driven, and needs-based. Please reference Appendix A for a list of examples of allowable activities under each program goal. NOTE: All proposed strategies and activities should directly adhere to the Program Requirements and Expectations section.

Goal-Specific Methodology

In addition, the Methodology section should also include the following for each program goal:

Goal 1 - Establish new MAT access point(s) to provide both medications and supportive services to individuals with OUD and/or AUD in rural community.

NOTE: If the applicant organization is not the entity that will be physically serving as the new MAT access point(s), the applicant must provide a signed letter of commitment from the entity that will be serving as the new MAT access point(s).

This is in addition to the required letters of support from two partner organizations.

See Attachment 7 for details.

https://www.ruralhealthinfo.org/contact https://www.ruralhealthinfo.org/contact https://opioidmisusetool.norc.org/ https://opioidmisusetool.norc.org/

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• Describe in detail the location of the new MAT access point(s), including a description of the facility/facilities in which services will be provided:

o Describe why the chosen modalities for care delivery (i.e. office visits, telehealth, mobile unit, etc.), are the most appropriate and effective approach for the target population;

o If applicable, describe any planned minor renovations, and why these renovations are necessary for the provision of MAT and supportive services;

• Describe how FDA-approved medication options for OUD, including buprenorphine and/or others, will be offered and administered in the new MAT access point(s) based on the needs of the individual and evidence-based practice;

• Describe how supportive services, including (but not limited to) counseling and behavioral therapies, will be integrated and coordinated with the provision of medication. Include a detailed description of the types of behavioral therapies and other supportive services that will be offered; and,

• Describe how you will ensure that the services provided through the new MAT access point(s) are accessible and available to the target population, including those that have historically suffered from poorer health outcomes, health disparities, and other inequities as compared to the rest of the population. This includes, but is not limited to, offering extended hours (such as nights and weekends, and not requiring abstinence/detoxification as a pre-requisite from treatment.

Goal 2 - Enhance the MAT workforce through recruitment, training, and the development of peer mentorship networks.

• Detail how grant funds will be used to recruit, hire, and retain interdisciplinary teams of OUD clinical, social service providers, and support staff who can provide MAT services at the new access point(s) (Applicants are strongly encouraged to explore opportunities to hire staff through the National Health Service Corps Loan Repayment Program; see Appendix D for details);

• Describe how you will support and retain clinical MAT providers through approaches including (but not limited to) professional development opportunities, trainings, certifications, mentorship, etc.;

• Describe how you will support and retain providers of supportive services (counseling, behavioral therapy, etc.), through approaches including (but not limited to) professional development, trainings, certifications, mentorship opportunities, etc.; and,

• Describe how you will utilize the learning collaborative and other HRSA-funded technical assistance resources to operationalize and sustain a network of peer mentors that will support and grow the clinical MAT workforce.

https://nhsc.hrsa.gov/ https://nhsc.hrsa.gov/

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Goal 3 - Build community capacity and infrastructure to support more effective and efficient MAT service provision.

• Describe how the new MAT Access point(s) will coordinate with other medical providers to ensure that MAT clients are able to access comprehensive care for non- OUD healthcare needs (e.g. primary care, reproductive care, chronic pain, etc.), in order to support sustained recovery;

• Describe how the new MAT access point(s) will coordinate and integrate service delivery with other MAT initiation sites, such as correctional facilities, hospital emergency departments, pharmacies, etc.;

• Describe how you will provide new, or expand access to existing, community resources to maximize the ability of MAT clients to achieve sustained, long-term recovery (examples of resources include, but are not limited to, transportation to care, educational opportunities, childcare, housing, vocational training, etc.);

and,

• Describe how you will build and strengthen partnerships to ensure integrated, coordinated access to community resources.

Goal 4 - Ensure sustainability of the new MAT access points through improved billing and coding, as well as enrollment of eligible individuals into health insurance.

• Describe how you will train clinical, social service, and administrative staff to optimize reimbursement for patient encounters through proper coding and billing across insurance types;

• Describe how you will collaborate and coordinate with state Medicaid agencies and other payers if applicable, to explore payment and reimbursement options to support the model of care delivery, ensure access, improve outcomes including potential ways to reduce costs, and sustain services after the end of the project period;

• Describe how you will ensure that services will be available to all individuals regardless of their ability to pay;

• Explain how you will ensure that eligible individuals are enrolled into health insurance, to maximize opportunities for reimbursement; and,

• Describe how you will ensure that community services and other non-billable supportive services will be sustained after the end of the period of performance.

WORK PLAN -- Corresponds to Section V’s Review Criterion(a) # 2 – “Response”

This section describes the processes that you will use to achieve the strategies in the “Methodology” section. Note that while the “Methodology” section of the Project Narrative centers on the overall strategy for achieving the project goals, the work plan

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is more detailed and focuses on the tasks, activities, and timelines by which you will execute your strategy.

The work plan activities should align with your methodology section, and should include the following:

• Specific activities that you will undertake to achieve all program goals

• Responsible individual(s) and/or partner(s) for each activity;

• Timeframes to accomplish all activities;

• How the proposed activity will ultimately increase the capacity for sustainable MAT service provision in the target rural service area.

The work plan must reflect a three-year period of performance. Each activity in the work plan should have beginning and completion dates. It is not acceptable to list “ongoing” as a timeframe.

Please provide your work plan in Attachment 1. (It is appropriate to refer reviewers to Attachment 1 in this section instead of including the work plan twice in the application.) It is strongly encouraged that you provide your work plan in a table format and that you clearly delineate which activities correspond to which program goals.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion(a) # 2 – “Response”

Describe challenges that you are likely to encounter in implementing the proposed work plan and the approaches you will use to resolve each challenge. You should highlight both internal challenges (e.g., maintaining cohesiveness among partners and/or referral agencies) and external challenges (e.g., stigma around SUD/OUD in the target rural service area, securing patient engagement in treatment, geographical limitations, policy barriers, etc.). You must also detail potential challenges to sustaining all grant-supported services after the period of performance ends and how you intend to overcome them.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criterion(a) # 3 and 4 – “Evaluative Measures” and “Impact”

Describe the process (including staffing and workflow) for how you will track, collect, aggregate, and report data and information from all partners to fulfill HRSA reporting requirements. (NOTE: Applicants must designate at least one individual in the staffing plan to serve as a “Data Coordinator.” The Data Coordinator is responsible for tracking, collecting, aggregating, and reporting quantitative and qualitative data and information to fulfill HRSA’s reporting requirements. See “Organizational information” for additional details.)

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You must clearly demonstrate how the applicant organization will support and enable partners to collect accurate data in response to HRSA reporting requirements.

Examples include, but are not limited to, allocating a portion of award funding to each partner to support data collection, and/or designating an individual at each member organization who will be responsible for collecting and reporting the HRSA-required data to the applicant organization.

It is the applicant organization’s responsibility to ensure compliance with HRSA reporting requirements. Applicants should make every reasonable effort to track, collect, aggregate, and report data and information from all partners throughout the period of performance. Finally, partners should commit to sharing performance data and information with the applicant organization to fulfill HRSA reporting requirements in the signed Letter of Support (Attachment 5).

Applicants should also demonstrate capacity and commitment to working with a HRSA-funded evaluator to take part in a larger, RCORP-wide evaluation.