Improving Hepatitis B and C Care Cascades; Focus on Increased Testing and Diagnosis - Supplement (CDC-RFA-PS17-17020301SUPP19 )

CDC has published a competitive Supplemental Notice of Funding Opportunity (NOFO) to the existing CDC-RFA-17-1702 to address the infectious disease consequences of the opioid crisis and award resources to jurisdictions with identified risks for viral hepatitis and HIV among people who inject drugs (PWID).  The NOFO awards $3.5M during FY2019-2020 to approximately seven existing recipients to collaborate with partner organizations that are within designated high-burden areas to conduct hepatitis B and hepatitis C testing and linkage to care in high-impact settings, (e.g., syringe services programs, substance abuse treatment facilities, emergency departments, correctional facilities).

 Background: The opioid crisis, involving the misuse of prescription opioid pain relievers as well as heroin and fentanyl usage, has resulted in accompanying increases in injection drug use in many jurisdictions across the nation.  This has caused an increase in overdose deaths and viral hepatitis infections annually and is threatening recent progress made in HIV prevention, especially among young adults.

PWID represent a group at high risk of viral hepatitis acquisition.  Recently there has been a national increase in hepatitis C incidence due primarily to an increase in PWID and sharing of injection equipment related to the opioid crisis.

In addition, a proportion of PWID are infected with hepatitis B virus and are susceptible to hepatitis A virus (HAV).  PWID is one of the groups at highest risk for acute HAV infection in recent widespread outbreaks of hepatitis A across the United States, suggesting a need to address this preventable disease among PWID.

Surveillance data indicate an urgent need to address infectious disease consequences of the opioid crisis, particularly viral hepatitis.  By offering testing and linkage to care in high-impact settings—where PWID are accessible— within designated high-burden or vulnerable areas, health departments will be able to efficiently address the infectious disease complications of the opioid crisis.

Primary Target Audience:  Existing recipients of CDC-RFA-PS17-1702 at State and local health departments only

FAQs

APPLICANT ACTIVITIES, ELIGIBILITY AND REPORTING

Can the patient navigator (or coordinator, etc.) drive a patient to their first appointment? Are there rules, regulations that prohibit that?

Yes.  This is an allowable travel expense for patient navigators as described in the program models noted on page 7 of the NOFO.  Patient navigator’s services for this supplemental NOFO include scheduling hepatitis B and hepatitis C medical appointments, preparing clients for medical appointments, and coordinating efforts with the client’s care team to ensure the first visit is scheduled and occurs.  The applicant is responsible for ensuring patient navigators are community-based and affiliated with the organization that has a high-impact setting (e.g., SSP, substance abuse treatment facility, MAT provider) and link patients to one or more clinics or hospitals in the community for evaluation, treatment and care.

For a small state of geographic size, can we identify all of its rural regions as one “area” and the rest of the state as the other “area” to satisfy the requirement of the grant?  In essence, this will be a statewide initiative.

Yes.

There is concern about meeting the expected rate of 772 diagnoses per 100,000 in the PWID population.  We don’t have rates that will currently match this, let alone in the targeted population.  I’m trying to understand how/where CDC obtained this number from.  Can you inform us what was used as the denominator?  Is this the required or a suggested target?

The 772/100,000 infection rate is based on calculations using national estimates according to the table on page 8 of the NOFO.  Applicants may use the table to determine their target number for hepatitis C diagnoses and linkage to care.  Applicants can adjust the estimates presented in the table for percent of PWID, percent of persons testing positive for hepatitis C (RNA positive), and/or percent of persons aware of infection if supporting evidence specific to the applicant’s jurisdiction is provided.  If the percent of PWID population in the applicant’s high-burden area is known and varies from 2.6% and higher, then the known percentage can be used and a justification should be included along with an updated calculation and target for hepatitis C diagnosis.

We are looking at partnering with the Department of Corrections which would include state inmates housed in both state and local jails and prisons throughout the state including rural areas.  Would this suffice to cover the two or more High-impact settings stipulation?

It is up to the applicant how to define their program model for high-impact settings.  Page 7 of the NOFO provides examples of program models.  The applicant is responsible for describing their approach and identifying a model for two or more high-impact settings.  A specific model could include jails and prisons that would account for two or more high-impact settings.

If the high-burden areas identified through the situational analysis does not include any rural or “mostly rural” areas can applicants justify using those non-rural areas as high-impact setting locations?

If the applicant did not identify any rural or “mostly rural” high-burden areas through their situational analysis, they must propose to work in a high-impact setting within a rural or “mostly rural” area as outlined in the NOFO.  The rural or “mostly rural” area selected must be justified based on using relevant data sources such as those listed on page 5 of the NOFO.  We also encourage applicants to look at the number of overdoses per capita to help determine if injection drug use is prevalent in rural communities within your respective jurisdiction.  Please refer to the below NOFO reference for defining rural or “mostly rural” areas:  “Ratcliffe M, et al. Defining Rural at the U.S. Census Bureau. ACSGEO-1, U.S. Census Bureau, Washington, DC, 2016”.

Can the patient navigators be housed at the health department (1702 awardee) if they are working with the high-impact setting to provide linkage to every client? For example, HCV-positive clients may be released from prison prior to linkage and staff at the prison would be inappropriate for further follow-up. Or does every aspect of linkage need to be performed on-site?

Yes, the patient navigators can be housed at the health department.  The applicant must clearly describe their approach and how the health department patient navigators will support and work with the high-impact settings to link patients to care.

We are preparing our grant application and have a question about the target population.  What does the application consider as the “high burden area population”?  Do we consider the high burden area population from the entire area or the population the clinic directly serves?  Our concern comes from our calculations and we were attempting to do them based on the full population of the area and then calculating 2.6% and so from that number.
Scenario #1: So for example a County is served by a high-impact setting, and have a population of 115,184, which by the calculation means the target number of HCV diagnosis would be 809 and linking 687 of those to care.  This seems like a large number to link and diagnosis in one year for one person at least.  Is this the correct thinking?
Scenario #2: Or should our base population be the number the clinics actually serves?  If the clinic serves on average 5,000 people a year and 2.6% of that population is PWID (130 people) and of those 86 of those are estimated to HCV positive, 43 have not been diagnosed (90% of that is 39).  So we should link 33 people to care at the end of the grant at this site?

The intent of this NOFO is to maximize the number of individuals tested and linked to care within the high-burden area(s) at the selected high-impact setting sites.  The applicant budget justification should provide a realistic cost estimate commensurable to the number of individuals tested and linked to care.

Are the activities of CDC-RFA-PS17-17020301SUPP19 to be completed in one year or by the end of the period of performance?

The activities of the supplemental NOFO should be completed within the anticipated period of performance dates of September 1, 2019 through August 31, 2020.  However, should the applicant require additional time to complete the required activities of the supplemental NOFO, a no-cost extension request and bona fide justification must be submitted to be considered for approval to complete the proposed activities; NOT to expend unobligated funds.

CDC-RFA-PS17-17020301SUPP19 states that updating the Data Management Plan (DMP) may be applicable; however later in the supplemental NOFO it describes how CDC will work with the applicant on the Performance Management Plan (PMP) and the DMP within the first 90 days of the project period.  Does the supplemental NOFO require updates to the existing DMP and if so, to what extent?

Yes.  CDC will collaborate with awardees on updating the respective PMP and DMP to reflect activities specific to the supplemental NOFO.  PMP and DMP updates are due within the first 90 days of the period pf performance.

The NOFO indicates applicants may propose to build capacity for Hepatitis C and Hepatitis B testing for their state laboratories which may include the purchase of necessary equipment and performance of validation testing and quality assurance.  What is meant by the purchase of equipment or to what extent does the applicant have the ability to purchase necessary testing equipment?

Recipients may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment.  However, due to the fact that most high-impact settings (e.g., SSPs, substance abuse treatment facilities, MAT providers, jails) will not have the capacity to conduct RNA reflex or confirmatory testing, applicants may propose to build capacity for hepatitis C and hepatitis B testing for their state laboratories.  Applicants should remember that the period of performance is only for one (1) year.  Therefore, a strong justification to purchase equipment for state laboratories must be included in the project narrative.

How is “linkage to care” defined for this supplemental project?

For this project, patients linked to care are those who have attended a first medical appointment for evaluation or treatment.  Referral visits for hepatitis C RNA testing only are not considered linked to care.

Is the expectation that we are subcontracting to these high-impact settings to do everything but the data analysis?

Awardees will be responsible for establishing and managing partnership subagreements or subcontracts with high-impact settings to conduct testing and linkage to care activities.  High-impact settings and linkage to care navigation personnel will be required to collect testing and linkage to care data.  Awardees will be responsible for monitoring and evaluating partnership activities, including their data collection processes.  CDC will provide data templates to awardees and collaborate with them on updating their respective PMP and DMP.

Who is eligible to apply for this Supplemental NOFO?

The Supplemental NOFO is open to all 50 currently funded grant recipients under CDC-RFA-PS17-1702 only.

Page 29 of the supplemental NOFO “Reporting” section states, “The interim progress report is due no less than 120 days before the end of the budget period [May 31, 2020].   The interim progress report will serve as the non-competing continuation application, and must contain the following elements…”  Is this a non-competing continuation for the supplement only?

No.  An interim progress report is not applicable to this supplemental funding opportunity.

OR, is the interim progress report the non-competing continuation for CDC-RFA-PS17-1702 and the supplement?
No.  There is no interim progress report required for this supplement since the period of performance is for one (1) year only — September 1, 2019 through August 31, 2020.

APPLICATION REQUIREMENTS

Can the CDC provide guidance to applicants who are not able to provide letters of support or MOUs from high-impact setting partners prior to being awarded?

Unfortunately, CDC cannot provide guidance to applicants who are not able to provide letters of support or MOUs from potential high-impact setting partners with their application.  The NOFO clearly outlines having such documentation is a “MUST” for this supplement.  Please refer to page 11, Program Implementation: Collaborations section of the NOFO for more information.

Are both the project narrative and work plan required for CDC-RFA-PS17-17020301SUPP19?

Yes.  A project narrative and work plan are required for the supplemental NOFO.

Can the supplement request be submitted with the upcoming APR for CDC-RFA-PS17-1702 YR04?

No.  Applicants must submit a separate proposal in response to NOFO CDC-RFA-PS17-17020301SUPP19.   </li

Page 18 of the NOFO states, “No more than 4 electronic attachments should be uploaded per application”.  Please clarify what this includes?

The following documents are NOT included in the four(4) electronic attachments limit:  Table of Contents; Form 424; Form 424A; Project Abstract; Project Narrative; and Budget Narrative.  However, MOU/MOA(s), organizational chart, and other additional supporting documents are required to be uploaded as part of the four(4) electronic attachments limit.  It is incumbent upon the applicant to organize and determine its four (4) electronic attachments.

Are applicants required to include a certain number of planned collaboration letter(s) of support, MOA, MOU letters of commitment or service agreements with the supplement proposal?

Yes.  Applicants must focus activities in “two or more” high-impact settings with relevant organizations working in partnership to provide testing and linkage to care.

Should the planned collaboration agreements be specific to the activities outlined in CDC-RFA-PS17-17020301SUPP19 and indicate the commitment to conduct testing and linkage to care services?

Yes.  The planned collaboration agreements should be specific to CDC-RFA-PS17-17020301SUPP19.  The activities of the supplemental NOFO are specific and separate from those outlined in CDC-RFA-PS17-1702.

The purpose of this message is to request guidance on the project abstract summary forms available in www.grants.govexternal icon.  The workspace includes two different versions of the mandatory project abstract forms (see below V1.2 and V1.1).  V1.2 is a mechanism for adding an attachment and V1.1 is a fillable form.

Applicants must complete all Mandatory Forms in www.grants.govexternal icon in order for the system to count your application as a completed application package.

Is the 20-page limit inclusive of the work plan and the evaluation plan?  I apologize if I missed this response before.

Yes.  As outlined on page 17 of the published NOFO, the 20-page narrative MUST include the work plan and evaluation plan in this order, as follows:

  • Approach (including outcomes and targets, activities of testing and LTC through local community partnerships, and collaboration);
  • Applicant Evaluation and Performance Measurement Plan;
  • Organizational Capacity of Applicants to Implement the Approach; and
  • Work Plan, which specifies how the awardee plans to carry out achieving the NOFO outcomes and performance measurement.
Are state governments required to complete the CDC Risk Questionnaire as a component of the 1702 supplemental funding award?

Yes.  As outlined on page 19 of the published NOFO, CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920-1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdfpdf icon, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

Regarding the letters of support or MOUs, if we have an existing contract with a proposed partner, does that suffice as documentation of their commitment to participate in this project?

As outlined on page 11 of the published NOFO, applicants MUST document all planned collaborations with letters of support (Memoranda of Agreements (MOA), Memorandum of Understanding (MOU), Letters of Commitment, or Service Agreements) indicating commitment to conduct testing and linkage to care services and provide data. In forming the proposed local partnerships, applicants may consider consultation with state primary care offices and state mental health agencies.

Please provide advice on NOFO limitation of attachments for CDC-RFA-PS17-17020301SUPP19.

Additional information submitted via www.grants.gov MUST be uploaded in a PDF file format and should be named as follows:

  • ST_grant#4digit_Sup19_Title_Date
    • Example 1,  VA_5071_Sup19_Organizational Chart_AtchA_093119
    • Example 2, VA_5071_Sup19_MOU_AtchB_093119
    • Example 3, CT_5097_Sup19_Letter of Agreement_AtchC_093119
NOTE:  There should be no more than four (4) electronic attachments per application.
Please advise whether Risk Questionnaire and Indirect Cost Agreement are included in 4 attachments limit or it applies only to additional information that pertains to Project Narrative?

The attachment limit applies to the Project Narrative additional information. These specific documents are not inclusive of the four (4) attachment limit.

We are required to submit a Duplication of Efforts report for this application. One-hundred percent of my efforts are dedicated to the original NOFO, but my position is listed as the PI on the supplemental application and I will be using some funding for my travel to partner sites.  From my understanding, if awarded I will have to submit an amendment to the original agreement to balance the level of efforts between the two agreements.

Yes, an amendment would be required for the original agreement.

Does this need to be addressed in the Duplication of Efforts report?

Yes, this must be addressed in the Duplication of Efforts Report.

If so, how would I word this?

Any overlap in commitment should be addressed as part of the Duplication of Efforts Report by clearly outlining the effort by percentage and listing a brief description of how the applicant anticipate distributing the time/effort for the “existing” AND “proposed” commitments.

APPLICATION REVIEW AND EVALUATION

How will applications be scored, ranked, and selected under the supplement?  An

Objective Review Panel will be conducted to evaluate all eligible applications that are complete and responsive according to the criteria listed in Section V, Application Review Information, (pages 23 – 27) of the NOFO.

Will those applicants proposing to conduct hepatitis B activities receive less weight over applications proposing to conduct hepatitis C activities only?

No, applicants are encouraged to propose hepatitis B activities which will be evaluated equally as proposed hepatitis C activities.  Since PWIDs are highly susceptible for both hepatitis B and hepatitis C infections, applicants are encouraged to propose testing for both diseases.

Can any support activities besides evaluation and partnership building be provided by the health department to the high-impact settings? Or will applications with larger health department roles be at a disadvantage?

Yes, health departments can propose to support activities such as providing linkage to care patient navigators or health educators to work in coordination with high-impact setting partners.

AWARDING

Would awardees under the supplement be eligible for the 340B pricing?

We will provide an update to this question in the near future.  We also encourage applicants to review the HRSA 340B Drug Pricing Program website link for additional information.

https://www.hrsa.gov/opa/index.html

Since this is a separate grant from 1702, can staff funded through 1702 (not the supplement) provide in-kind services on this grant?  I am asking because my understanding is that, generally, staff who are federally grant funded cannot provide in kind support for other federal grants, but in this particular case it makes sense that staff funded through 1702 would provide some in-kind support to the new 1702 supplement.  Do you have any guidance on this issue?

In-kind services are not allowed between the agreements.  However, staff working on the original PS17-1702 agreement may also work on the PS17-1702 Supplement agreement if justified in the budget.  Recipients must be careful about the level of effort each staff is providing.  Staff may not provide more than 100% effort between the original and the Supplemental NOFO.  If proposed supplement staff is already at 100% under the original agreement, an amendment to the original agreement would be necessary if awarded supplement funds to balance the level of effort between the two agreements.

What is the anticipated approximate funding amount per award?

The approximate average award will be $500,000.  Page 14 of the published supplemental NOFO, CDC-RFA-PS17-17020301SUPP19, has been amended to reflect $500,000 as the Approximate Average Award.

The approximate number of awards is listed as 7.  Is this anticipated number of awards correct?

This is a competitive supplemental NOFO.  The approximate number of awards to be funded will be 7.

Does the period of performance for CDC-RFA-PS17-17020301SUPP19 coincide with CDC-RFA-PS17-1702 period of performance dates?

No.  The supplemental NOFO period of performance dates are separate from CDC-RFA-PS17-1702.  The anticipated period of performance dates are September 1, 2019 through August 31, 2020.

Do you think this supplemental funding will be continued in any way, either through the supplemental mechanism, or included in the next NOFO for care cascades?

No.  Supplemental funding for CDC-RFA-PS17-17020301SUPP19 has a 1 year period of performance which we anticipate will start September 1, 2019, and end August 31, 2020.  We do not anticipate funding continuing beyond the period of performance end date of August 31, 2020.  However, should the applicant require additional time to complete the required activities of the supplemental NOFO, a no-cost extension request and bona fide justification must be submitted to be considered for approval to complete the proposed activities only; NOT to expend unobligated funds.

Is there REALLY no award ceiling or floor?

This supplemental NOFO does not have an award ceiling or floor.  However, keep in mind that the approximate number of awards to be funded will be 7, and the approximate average award will be $500,000.

BUDGET

Can this project support providing incentives to patients such a gas cards?

Incentives are not an approved expense for this project.

Can supplemental funds be used to replace a high-impact setting partner’s funding source for a current project?

Recipients may not replace or supplant federal funds to meet project requirements.  Federal funds received may not be used to replace existing state, local, or other federal funds.  Existing State, local, or other federal funds for a project, may not be replaced by federal funds and reallocated for other organizational expenses.

Can a vehicle be purchased to conduct mobile hepatitis C testing and linkage to care?

No, the purchase of a vehicle is not an approved expense for this project.

Can staff salaries/EREs for wound care be paid for by the grant? (We are hoping to use these services at SSP sites to reach and draw in persons for testing who would not otherwise present for testing.)

Providing wound care services would be considered clinical care and is not an allowable expense under this NOFO.  Please refer to the funding restrictions section on page 21 of the NOFO.

Can we purchase wound care kits with grant funds?

Page 25 of the NOFO states that awardees should only establish partnerships to “link or refer” PWID to preventive services (e.g., vaccination, harm reduction services, HIV testing, family planning) as appropriate.

Can funds be utilized to develop hepatitis C elimination plans?

No, the development of viral hepatitis elimination plans are not within the scope of the NOFO.

Can these funds be used to pay for both rapid and conventional testing costs?

Yes.  Supplemental funds can be used to purchase both rapid and conventional testing supplies and materials for hepatitis C and hepatitis B testing.  However, all persons with a positive hepatitis C antibody rapid test result must receive a confirmatory RNA test.  Established mechanisms for obtaining blood samples for RNA testing from persons who are hepatitis C antibody positive via a rapid test must be described.