CDC-RFA-PS17-1709.pdf

Image Description: Centers for Disease Control

Centers for Disease Control

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

Data to Care Rx: Using Real-time Prescription Claims Data to Support the HIV Care Continuum

CDC-RFA-PS17-1709

Application Due Date: 06/05/2017

Data to Care Rx: Using Real-time Prescription Claims Data to Support the HIV Care Continuum

CDC-RFA-PS17-1709

TABLE OF CONTENTS

Part I. Overview Information Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Application and Submission Information D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-PS17-1709. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Data to Care Rx: Using Real-time Prescription Claims Data to Support the HIV Care Continuum C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg /CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

New-Type 1

D. Agency Funding Opportunity Number:

CDC-RFA-PS17-1709

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.941 F. Dates:

1. Due Date for Letter of Intent (LOI): 05/05/2017

2. Due Date for Applications: 06/05/2017, 11:59 p.m. U.S.

Eastern Standard Time, at www.grants.gov.

LOIs will be accepted but not required for this FOA. The purpose of an LOI is to allow CDC program staff to estimate the number of and plan for the review of submitted applications.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

The purpose of this cooperative agreement is to develop and implement a “Data-to-Care Rx” model which uses pharmacy claims data to identify persons with HIV who fail to pick up prescribed ARV medications by 30, 60 and 90 days, and to target these individuals for adherence, retention and re-linkage interventions. The awardee must use pharmacy claims data to identify persons who fail to pick up prescribed ARVs after 30 days and conduct a low intensity 1 st line adherence intervention that may be conducted by a Pharmacy Benefits Manager, insurer, filling pharmacy or other source. Persons identified as 60 days late will receive 2nd line adherence and retention interventions at the prescribing project clinics and/or filling pharmacies. Persons identified as 90 days late will receive a 3rd line intervention where the health department uses Disease Intervention Specialists or similar staff to locate and re-link the individuals to the https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov prescribing clinic.

Specific activities of the cooperative agreement are broadly categorized into three areas: 1) develop the Data-to-Care Rx model 2) implement the model and 3) evaluate project outcomes and disseminate results.

After implementation and final adjustments to the model the model will be finalized. Key expected outcomes are: increased re-linkage to care; increased adherence to HIV medication therapy; increased retention in HIV care; and increased HIV viral load suppression.

a. Eligible Applicants: Open Competition

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $2,000,000 $250,000 first year, $875,000 year 2 and year 3

e. Average One Year Award Amount: $250,000 $250,000 first year, $875,000 year 2 and year 3

f. Total Project Period Length: 3

g. Estimated Award Date: 09/29/2017

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Re-engaging out-of-care persons with HIV back into care, confers important individual-level health benefits and population-level prevention benefits. Use of HIV surveillance data to identify out-of-care persons, is one strategy for identifying and re-engaging out-of-care persons in care and is called Data-to-Care or D2C.

Data-to-Care uses laboratory reports (i.e., CD4 and HIV viral load tests) received by a health department’s HIV surveillance program as markers of HIV care. The laboratory reports are used to identify individuals who either never linked to care, after diagnosis, or who did not continue to receive care and to offer these individuals outreach by health departments, providers, or both to assist them with getting into or back into HIV care.

In the current D2C model, there is a delay in identification of out-of-care persons due to the time interval between recommended monitoring tests and the subsequent reporting of these tests to surveillance. Thus, the current D2C model identifies persons already out of care rather than identifying persons at risk for dropping out of care; the current model cannot intervene in the short time interval between the start of a gap in care (typically 6 months from the last visit) and the point at which a person is declared out of care. More real-time data is needed to identify persons at risk of dropping out of care and to intervene prior to a gap in care or loss to care.

Pharmacy prescription (claims) data are a source to identify HIV-infected persons who have stopped filling antiretroviral (ARV) medications, and who are at risk for becoming out of care. Patients may fill prescriptions at one of potentially many pharmacies. Within one pharmacy network, prescriptions can be tracked across partnered pharmacies (e.g. chain drug stores). However, if a patient switches pharmacies (to another chain or independent pharmacy) the prior refill history remains with the first pharmacy. Pharmacy claims are adjudicated for an insurance company by a third-party claims processor or a pharmacy-benefit management (PBM) company. All pharmacy claims that are billed to an insurance company for an individual patient, can be tracked through the PBM regardless of where a patient filled the prescription. Because most ARVs are prescribed as a 30-day supply of medication, data from PBMs and other like sources can be used to identify persons who are not filling their medications on a monthly basis. Tracking ARV refill data can, therefore, be a more real-time indicator of poor adherence and can act as a harbinger of potential poor retention in care. Using real time pharmacy claims data to identify persons who fail to fill ARV prescriptions and to intervene could have a significant impact on adherence and potentially on retention in care.

The purpose of the cooperative-agreement is to develop and implement a model using real-time pharmacy data to identify persons who fail to pick up prescribed medications by 30, 60 and 90 days, and target these individuals for adherence, retention and re-linkage interventions. The intent is to identify and control a health problem with the intended benefits directed primarily towards the participants. Specific activities of the cooperative agreement are broadly categorized into three areas: (1) develop a “Data-to-Care Rx” model (2) implement the model (3) evaluate project outcomes and disseminate results. The expected outcomes of the project are: increased re-linkage in care; increased ARV adherence; increased retention in care; and increased HIV viral suppression.

b. Statutory Authorities This program is authorized under Section 301(a) of the Public Health Service Act (42 U.S.C. section 241(a)

c. Healthy People 2020 This FOA supports the following Healthy People 2020 objectives:

HIV-2: Reduce number of new HIV infections among adolescents and adults HIV–3: Reduce the rate of HIV transmission among adolescents and adults HIV–4: Reduce new AIDS cases among adolescents and adults HIV-21: (Developmental) Increase the proportion of persons with an HIV diagnosis who had at least one HIV medical care visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits HIV-22: (Developmental) Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL at the last test during the 12-month measurement period

d. Other National Public Health Priorities and Strategies This FOA supports the following goals within the National HIV/AIDS Strategy (NHAS) available at: https ://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf

Goal 1, Step 1.B:Expand efforts to prevent HIV infection using a combination of effective, evidence-based approaches Goal 1, Step 1.B.4: Expand prevention with persons living with HIV Goal 2, Step 2.A.2: Ensure linkage to HIV medical care and improve retention in care for people living with HIV

This FOA also supports the following goals with the CDC National Center for HIV, Hepatitis, STD and TB Prevention available at: https://www.cdc.gov/nchhstp/strategicpriorities/

Goal 1: Decrease incidence of infection with HIV, viral hepatitis, STDs, and TB Goal 2: Decrease morbidity and mortality from HIV, viral hepatitis, STDs, and TB

e. Relevant Work https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf https://www.aids.gov/federal-resources/national-hiv-aids-strategy/nhas-update.pdf https://www.cdc.gov/nchhstp/strategicpriorities/

This FOA is informed by current Data-to-Care models where health departments have demonstrated success in using HIV surveillance data to identify persons living with HIV who are out-of-care and re-engaging these individuals in care. Successful Data-to-Care models have been implemented in both local and state health departments and in healthcare systems. More information about the current Data-to-Care model can be found at:

https://effectiveinterventions.cdc.gov/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

CDC-RFA-PS17-1709 Logic Model: Data to Care Rx: Using Real-time Prescription Claims Data to Support the HIV Care Continuum

Strategies and Activities

Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Develop model to use pharmacy claims data to identify persons who fail to pick up prescribed antiretroviral medications (ARVs) and to intervene

- Develop procedures for using pharmacy claims data to identify persons with HIV who failed to pick up prescribed ARVs by 30, 60 and 90 days

– Develop procedures and 1st, 2nd and 3rd line interventions for persons who failed to pick up prescribed ARVs

Among persons living with HIV in the project:

Increased re-linkage in care

Among persons living with HIV in the project:

Increased ARV adherence Increased retention in care Increased HIV viral suppression

Decreased HIV transmission Decreased HIV morbidity

Implement model

– Obtain access to pharmacy claims data

– Partner with project clinics and/or pharmacies to implement 2 nd line implement 2 nd line interventions

– Operationalize process at health department to implement the 3rd line intervention

– Arrange for and finalize agreements/contracts and necessary organization approvals with project partners

– Using the pharmacy claims data, identify persons who failed to pick up prescribed ARVs and conduct 1st, 2nd and 3rd line interventions

– Finalize model

Evaluate project outcomes and disseminate results

– Collect and clean project data

– Analyze project data

– Disseminate results

i. Purpose This FOA requires the awardee to develop and implement a model to use pharmacy claims data to identify persons with HIV who fail to pick up prescribed antiretroviral (ARV) medications and target these individuals for adherence and retention interventions and to re-link these individuals to care. The goal of the model is to improve re-linkage to care, ARV adherence, retention in care and HIV viral suppression.

ii. Outcomes

1) Increased re-linkage in care among persons living with HIV in the project

1) Increased re-linkage in care among persons living with HIV in the project

2) Increased ARV adherence among persons living with HIV in the project

3) Increased retention in care among persons living with HIV in the project

4) Increased viral suppression among persons living with HIV in the project

iii. Strategies and Activities Specific activities, of the cooperative agreement, are broadly categorized into three strategies: 1) develop the Data-to-Care Rx model 2) implement the model and 3) evaluate project outcomes and disseminate results.

The project model requires: 1) a pharmacy claims data source; 2) project clinics and/or pharmacies and 3) a health department and Disease Intervention Specialists.

A pharmacy claims data source must be used to identify persons who have not picked up prescribed ARVs by 30, 60 and 90 days. For persons who failed to pick up prescribed ARVs by 30 days, a 1st line intervention will be conducted. The 1st line intervention should be a low intensity intervention and can be an intervention conducted by a PBM or insurer, filling pharmacy or other intervention. The 1 st line intervention should be designed to reach as many people as possible. For persons who failed to pick up prescribed ARVs by 60 days, a 2nd line intervention will be conducted. The 2nd line intervention will be conducted at project clinics and/or pharmacies. The 2nd line intervention must be conducted at a sufficient number of prescribing clinics and/or filling pharmacies to enroll a total of 400 patients. Lastly, the partnered health department will be informed of persons who failed to pick up prescribed ARVs by 90 days and will use Disease Intervention Specialists (or similar personnel) to locate these individuals and then re-link them to the prescribing clinic and provide follow-up. The 3 rd line intervention should be designed to reach as many people as possible.

The Data-to-Care Rx model will be developed in collaboration with CDC. The Project Team which will be composed of the awardee, CDC, and other partners including the health department. The applicant may suggest additional members for the Project Team. CDC and the Project Team will have substantial involvement in the development of the Data-to-Care Rx model. Data will be collected throughout the implementation phase of the project in order to determine project outcomes. First year of the project period will involve project planning and obtaining IRB approval (if required) and OMB approval. Second and third year will be implementation of the project model and analysis of project outcomes.

This 3-year project includes the following activities:

The applicant shall work with CDC and the Project Team to conduct the following activities:

Strategy #1: Develop model to use pharmacy claims data to identify persons who fail to pick up prescribed ARVs and to intervene

Activities:

-Develop procedures for using pharmacy claims data from Pharmacy Benefit Manager (PBM), insurer(s) or other source(s) to identify persons with HIV who failed to pick up prescribed ARVs by 30, 60 and 90 days.

-Develop procedures and 1st, 2nd and 3rd line interventions for persons who failed to pick up prescribed ARVs.

– 1st line intervention

- 1st line intervention should be a low intensity intervention (e.g., contacting the patient to remind them to pick up the prescribed ARV).

- The applicant must describe a process for the 1st line intervention that will be implemented for a very broad portion of the population who failed to pick up prescribed ARVs by 30 days (ideally, offered to all) that may be an 1) intervention from an insurer or PBM; 2) an intervention from the pharmacy where the prescription was last filled or 3) other intervention.

- The 1st line intervention must be designed such that it is easily integrated into the current business practice and workflow. For instance, if the intervention comes from the insurer or PBM, the model should use existing processes and staff that can be assigned to implement it.

- If the intervention comes from the pharmacy, it should be designed such that it can be integrated into the pharmacy’s usual daily workflow. The pharmacy intervention may include using a Medication Therapy Management intervention.

- The applicant must describe how relationships will be established with pharmacies to implement interventions. For example, if a partnered insurer(s) has contracted pharmacies in a network, they may establish a process whereby the pharmacy is paid to contact the patient(s) as the 1st line intervention. The funds for such an arrangement are expected to be in the course of typical business that the insurer would provide. The funds from this FOA are not intended to be used to provide this type of service fee.

– 2nd line intervention

- Develop process for sharing the pharmacy claims data from the PBM, insurer or other data source with the project clinics and/or pharmacies including data sharing agreements if required.

- Develop procedures for using the list of persons who failed to pick up prescribed ARVs by 60 days.

- Develop process to inform prescribing clinics of patients who fail to pick up prescribed ARVs by 60 days, for both project clinics and non-project clinics.

- Develop a new intervention, or implement an existing evidence-based intervention (such as interventions found at: https://www.cdc.gov/hiv/research/interventionresearch/compendium/lrc/index.html), to address adherence barriers and potential retention in care barriers.

– 3rd line interventions

- Develop process for sharing the pharmacy claims data from the PBM, insurer or other data source with the health department including data sharing agreements, if required.

- Develop procedures for using the list of persons who failed to pick up prescribed ARVs by 90 days.

- Develop process for locating patients who failed to pick up prescribed ARVs by 90 days, including the use of Disease Intervention Specialists.

- Develop process to inform prescribing clinics of patients who fail to pick up prescribed ARVs by 90 days, for both project clinics and non-project clinics.

- Develop process for re-linking patients to prescribing clinic.

- Develop follow-up procedures.

Strategy #2: Implement model

Activities:

- Obtain access to pharmacy claims data from a PBM, insurer or other source.

- Partner with project clinics and/or pharmacies to implement 2nd line intervention

– Applicants are required to collaborate with a sufficient number of clinics and/or pharmacies to achieve 400 enrolled patients.

– Applicants are encouraged to collaborate with large HIV clinics in their jurisdiction and with a diversity of clinic types (e.g., Ryan White-funded, academic-affiliated, health maintenance organization, private, or veterans administration clinics).

– If applicant intends to use pharmacies as project sites, the applicant should describe how relationships will be established with pharmacies to implement interventions.

– Develop and conduct project site training including patient consent if required, data collection and project communications with each project clinic and/or pharmacy site.

– Monitor project recruitment and enrollment and address recruitment and enrollment problems as they occur.

– Manage project clinic and/or pharmacy sites, coordinate project site activities, and provide technical assistance to project sites (e.g., data collection and management).

- Operationalize process at health department to implement the 3rd line intervention

- Arrange for and finalize agreements/contracts with project partners including project clinics and/or pharmacies, health department and potentially the PBM or insurer(s),

– Establish necessary agreements with the clinic and/or pharmacy project sites and health department (e.g. Memorandum of Understandings, financial agreements [i.e. contracts] and clinic and/or pharmacy project sites work plans) and make necessary arrangements for clinic and/or pharmacy site and health department participation.

– Establish data sharing agreements between project partners if necessary.

- Using the pharmacy claims data, develop list of persons who failed to pick up prescribed ARVs by 30, 60 and 90 days and conduct 1st, 2nd and 3rd line interventions.

– Persons may receive 1, 2 or 3 interventions depending on whether the prior intervention was successful. The lines of interventions differ in approach, delivery and intensity.

– 1st and 3rd line interventions should aim to reach as many persons as possible who were identified as failing to pick up prescribed ARVs by 30 and 90 days, respectively.

– 2nd line interventions will be limited to the project clinic and/or pharmacy population unless otherwise decided by the Project Team. However, prescribing clinics (regardless of whether they are project clinics) should be informed of patients who fail to pick up prescribed ARVs by 60 days and 90 days.

– Because the 2nd line intervention is a clinic-based (or pharmacy-based) intervention that only includes the project clinics and/or pharmacies populations, while the 1st and 3rd line interventions aim to reach as many persons as possible, some individuals may receive 1st and 3rd line interventions without receiving the 2nd line intervention.

– Obtain ethical approval(s) including project IRB approval if required and assist project clinic and/or pharmacy sites and health department in obtaining local IRB approval, if required.

– Obtain participant consent, if required.

- Finalize the service model

– Document a comprehensive Data-to-Care Rx implementation model that includes a report to CDC with a detailed description of the implementation model and processes

Strategy #3: Evaluate project outcomes and disseminate results

Activities:

- Collect and clean project data

– Develop a data collection system which includes, but is not limited to:

- Development of appropriate clinical, pharmacy, medical, laboratory, sociodemographic, process, outcome and other variables to be collected.

- Development of data collection tools.

- Development of database(s).

- Standardized definitions.

- Quality control procedures.

- Procedures for secure reporting and storage of data.

- Development of a system for secure data sharing between project partners (PBM or insurer or other pharmacy claims data source, project clinic and pharmacy sites and health department).

– Manage data from the PBM, insurer or other source, project clinic and/or pharmacy sites and health department.

– Ensure that all required project data elements are collected including baseline data.

– Conduct process and outcome monitoring of the project sites and provide project progress reports of specified outcomes to CDC on a quarterly (at minimum) basis.

– Provide CDC with cleaned, analytic datasets of the required data elements, quarterly (at minimum).

- Analyze project data

– Work collaboratively with CDC and Project Team to develop analysis plans.

– Work collaboratively with CDC and Project Team to analyze project data and to determine project outcomes.

- Disseminate results

- Disseminate project results through publications, abstracts and presentations.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

N/A

b. With organizations not funded by CDC:

In addition to CDC, the awardee will work with the project partners including the project clinics and/or pharmacies, the health department and potentially the source of the pharmacy claims data.

Letters of Support

If the applicant is other than a health department the applicant must include in the application, a Letter of Support, from the proposed partnered health department. The Letter of Support should include the health department staff that will be responsible for health department program activities and the number of Disease Intervention Specialists that will be assigned to the project. The applicant should also include Letters of Support from the proposed project clinics and/or pharmacies.

If the applicant intends to partner with a PBM, insurer or other source of pharmacy claims data (i.e., make the PBM, insurer or other organization with the pharmacy claims data part of the Project Team) they must include a Letter of Support, from the organization, with the application. If the applicant intends to use consultants to assist with project activities the applicant must include, in the application, Letters of Support from the proposed consultant(s).

Memorandum of Understanding and Contracts

Post-award, the applicant will be expected to formalize collaborations with all project partners in the form of a Memorandum of Understanding (MOU) and/or contracts.

If the applicant is other than a health department, the applicant will formalize collaboration with the partnered health department in the form of a Memorandum of Understanding (MOU) and/or contract. The MOU and/or contract must clearly convey the objectives of the project, how the project objectives will be accomplished, interventions to be conducted, data that will be collected and who will collect the data, frequency of data collection, data collection method, reporting requirements and necessary permissions to collect the data (e.g. IRB approval and patient consent, if required). The applicant must include in the MOU the timeline of the collaboration, frequency of project communications, and methods of communication. The awardee must explain, in the MOU, what resources (e.g., project training, technical assistance and data collection assistance) the awardee plans to provide the health department in order to accomplish the program objectives. The MOU must state the health department’s agreement to participate in all required project activities and the roles and responsibilities of the health department and the awardee. Additional components for inclusion in the MOU may be decided upon by the Project Team.

If the awardee intends to use pharmacies as project sites, the awardee is expected to formalize collaborations in the form of a MOU or contract. The MOU with project pharmacies should have components similar to those for the health department as listed in the above paragraph. In the application, the awardee should explain how the pharmacies will be reimbursed for services, such as through the insurer.

The awardee must make arrangements (i.e. contracts) for funding the project clinic sites. Individual project clinic funding should depend on site capacity, intended number of patients to be enrolled within the site and other factors such as potential recruitment difficulties. Contracts should clearly state the project sites’ responsibilities including conducting interventions, data that will be collected and who will collect the data, frequency of data collection, data collection method, reporting requirements and necessary permissions to collect the data (e.g. IRB approval and patient consent if required). Each project clinic site should have a contract and all project clinic sites MOUs or contracts should have the same content unless decided otherwise by the Project Team. Additional components for inclusion in the contracts may be decided upon by the Project Team.

If the applicant intends to partner with pharmacies, the applicant should describe how relationships will be established with pharmacies to implement interventions. The funds for such an arrangement are expected to be in the course of typical business that the insurer would provide. The funds from this FOA are not intended to be used to provide service fees such as these.

Applicants must file the Letters of Support, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov

2. Target Populations Persons with HIV who are prescribed ARV therapy.

a. Health Disparities N/A

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement http://www.grants.gov/

i. CDC Evaluation and Performance Measurement Strategy In collaboration with the Project Team, the awardee will design a program performance monitoring plan that includes both outcomes and processes. Key evaluation questions, required performance measures, and potential data sources are listed below. The Project Team may suggest additional performance measures.

The CDC and the awardee will monitor program performance throughout the project period.

Program outcome and process data will be reviewed at least quarterly to monitor program performance. The data will be used to make adjustments to the Data-to-Care Rx model, as needed, throughout the project period. For example, if upon review of the data, it is determined that external factors are adversely affecting the conduct of the program, the awardee and Project Team will decide upon a corrective course of action.

The outcome and process monitoring will also be used to demonstrate the effectiveness of the Data-to-Care Rx model in increasing adherence to ARV therapy, HIV viral load suppression, retention in HIV care and re-linkage to care among the program cohort.

Dissemination channels for the program results will be decided upon by the Project Team. However, potential targeted audiences include professional public health associations (e.g. American Public Health Association), professional HIV organizations (e.g. American Academy of HIV Medicine), pharmacy associations (e.g. American Pharmacist Association) as well as public health, medical, and pharmacy practitioners. Results will be submitted for presentation at local, regional or national conferences and for publication in peer-reviewed journals or other publications.

Process performance measures and key evaluation questions^

Key evaluation question Were procedures for using pharmacy claims data from Pharmacy Benefit Manager (PBM), insurer(s) or other source(s) to identify persons with HIV who failed to pick up prescribed ARVs by 30, 60 and 90 days developed?

Potential data sources Project records

Performance measures – Procedures for using pharmacy claims data from Pharmacy Benefit Manager (PBM), insurer(s) or other source(s) to identify persons with HIV who failed to pick up prescribed ARVs by 30, 60 and 90 days are developed

Key evaluation question Was the procedure and intervention for persons who failed to pick up prescribed ARVs by 30 days (1st line intervention) developed?

Potential data sources Project records

Performance measures – Procedure and intervention for persons who failed to pick up prescribed ARVs by 30 days (1st line intervention) is developed

Key evaluation question Was the procedure and intervention to address adherence to medications and potential barriers to retention in care for persons who failed to pick up prescribed ARVs by 60 days (2nd line intervention) developed?

Potential data sources Project records

Performance measures – Process for sharing the pharmacy claims data from the PBM, insurer or other data source with the project clinics and/or pharmacies is developed and data sharing agreements if required are developed

– Procedures for how the list of persons who failed to pick up prescribed ARVs by 60 days will be used to conduct the 2nd line intervention is developed

– Intervention to address adherence barriers and potential retention in care barriers (2nd line intervention) is developed

Key evaluation question Was procedure for health department to locate persons who failed to pick up prescribed ARVs by 90 days and to relink the patient to clinic (3rd line intervention) developed?

Potential data sources Project records

Performance measures – Process for sharing the pharmacy claims data from the PBM, insurer or other data source with the health department is developed and data sharing agreements if required are developed

– Procedures for how the list of persons who failed to pick up prescribed ARVs by 90 days will be used to conduct the 3rd line intervention is developed

– Process for locating patients including use of Disease Intervention Specialists is developed

– Process for re-linking patient to clinic is developed

– Follow-up procedures are developed

Key evaluation question Was pharmacy claims data from a partnered PBM, insurer or other source obtained?

Potential data sources N/A

Performance measures – Pharmacy claims data from a partnered PBM, insurer or other source is obtained

Key evaluation question Were final MOUs and contracts with project partners including the PBM or insurer(s), project clinics and/or pharmacies and health department completed?

Potential data sources Project records

Performance measures – Necessary agreements with the clinic and/or pharmacy project sites and health department (e.g. Memorandum of Understandings, financial agreements [i.e. contracts] and clinic and/or pharmacy project sites work plans) are created

– Data sharing agreements between project partners are developed

Key evaluation question Were ethical approval(s) obtained?

Performance measures – Project IRB package approved, if required

– Project clinic and/or pharmacy sites and health department IRB package(s) approved, if required

Key evaluation question Using the pharmacy claims data, were lists of persons who failed to pick up prescribed ARVs by 30, 60 and 90 days created and 1st, 2nd and 3rd line interventions conducted?

Potential data sources Pharmacy claims data, Project records

Performance measures – Lists of persons who failed to pick up prescribed ARVs by 30, 60 and 90 days are created

– 1st, 2nd and 3rd line interventions are conducted

Key evaluation question Was a process developed to inform prescribing clinics of patients who fail to pick up prescribed ARVs by 60 and 90 days, for both project clinics and non-project clinics?

Potential data sources Project records

Performance measures – Process for informing prescribing clinics of patients who fail to pick up prescribed ARVs by 60 and 90 days, for both project clinics and non-project clinics are developed

Key evaluation question Was participant consent obtained, if required?

Performance measures – Participant consent is obtained, if required

Key evaluation question Were project data collected, cleaned and transmitted to CDC?

Potential data sources N/A

Performance measures - List of appropriate clinical, pharmacologic, medical, laboratory, sociodemographic, process, outcome and other variables to collect is developed

– Data collection tools are developed

– Project database is developed

– Standardized definitions are developed

– Quality control procedures are developed

– Data management plan of data from the PBM, insurer or other source of the pharmacy claims data, project clinic/pharmacy sites and health department is developed

– Procedures for secure reporting and storage of data is developed

– A system for secure data sharing between project partners (PBM or insurer, project clinic and pharmacy sites and health department) is developed

– Project sites/partners collected the required data elements including baseline data

– Conduct process and outcome monitoring of the project sites and provide project progress reports of specified outcomes to CDC on a quarterly (at minimum) basis.

– Cleaned, analytic datasets of the required data elements are submitted to CDC quarterly (at minimum)

Key evaluation question Was project data analyzed?

Potential data sources Pharmacy claims data, clinic and/or pharmacy records, health department data

Performance measures – Analysis plans are developed

– Project data is analyzed

Key evaluation question Were project results disseminated?

Performance measures – Project results are disseminated

Key evaluation question Was final Data-to-Care Rx model produced?

Performance measures – Was a comprehensive Data-to-Care Rx implementation documented that includes a report to CDC with a detailed description of the implementation model and processes

Key evaluation question Were all program activities completed according to awardee proposed timelines?

Potential data sources Project records

Performance measure – Program activities are completed according to project timelines*

^ Additional performance measures may be proposed by the applicant or by the Project Team

* Specific performance measures related to project timelines will be determined post-award

Outcome program performance measures and key evaluation questions^

Key evaluation question Were persons who failed to pick up prescribed ARVs by 30, 60, 90 days identified through use of the pharmacy claims data?

Potential data sources Pharmacy claims data, project records

Performance measure – Number of persons identified as failing to pick up prescribed ARVs by 30 days

– Number of persons identified as failing to pick up prescribed ARVs by 60 days

– Number of persons identified as failing to pick up prescribed ARVs by 90 days

Reporting frequency† Quarterly, throughout implementation of project

Key evaluation question Were prescribing clinics informed of patients who failed to pick up prescribed ARVs by 60 and 90 days?

Potential data sources Project records

Performance measure – Number of persons who failed to pick up prescribed ARVs by 60 and 90 days whose prescribing clinics were contacted

Reporting frequency† Quarterly, throughout implementation of project

Key evaluation question Did persons who failed to pick up prescribed ARVs by 30, 60, 90 days receive 1st, 2nd and 3rd line interventions?

Potential data sources Project records

Performance measure – Number of persons who received 1st line intervention

– Number of persons who received 2nd line intervention

– Number of persons who received 3rd line intervention

Key evaluation question Does the implementation model lead to re-linkage to clinic?

Potential data sources Project clinic records, project health department records

Performance measure Number and proportion of persons who failed to pick up prescribed ARVs after ≥90 days who were re-linked to clinic?

Key evaluation question Does the service model lead to improved adherence to antiretroviral therapy?

Potential data sources pharmacy claims data

Performance measure – Number and proportion of persons adherent to their ARV therapy among persons who received 1st and/or 2nd and/or 3rd line interventions

– Percentage increase in adherence pre*- and post*- 1st and/or 2nd and/or 3rd line intervention

– Percentage difference in adherence among those that received only 1st line intervention but were ≥60 days late picking up ARVs, and those that received 2nd or 3rd line interventions

Reporting frequency† Once, at end of implementation of project

Key evaluation question Does the service model lead to improved viral load suppression?

Potential data sources viral load tests reported to partnered health department

Performance measures – Number and proportion of persons whose most recent viral load test in the calendar year showed that HIV viral load was suppressed (i.e., <200 copies/mL) among persons who received 2nd and/or 3rd line interventions

– Percentage increase in viral suppression pre*- and post*- 2nd and/or 3rd line intervention

– Percentage difference in viral suppression among those that received only 1st line intervention but were ≥60 days late picking up ARVs, and those that received 2nd and/or 3rd line interventions

Reporting frequency† Once, at end of implementation of project

Key evaluation question Does service model lead to improved retention in care?

Potential data sources Project clinic records, CD4/VL reported to partnered health department

Performance measures - Number and proportion of persons who had two care visits that were at least 90 days apart during the calendar year, as measured by documented test results for CD4 count or viral load among persons who received 2nd and/or 3rd line interventions

- Percentage increase in retention pre- and post- 2nd and/or 3rd line intervention

- Percentage difference in retention among those that received only 1st line intervention but were ≥60 days late picking up ARVs, and those that received 2nd and/or 3rd line interventions

Reporting frequency† Once, at end of implementation of project

^ Additional performance measures may be proposed by the applicant or by the Project Team

† Awardee reporting frequency to CDC. Mechanism for reporting will be determined post-award.

*pre- and post- measurement periods will be decided by the Project Team

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant) Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these FOA funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this FOA.

In addition, the plan must describe:

Plans for how applicant will respond to the evaluation questions, and use evaluation findings for continuous program quality improvement A data collection plan which includes the following: proposed data variables to collect; the process of collecting data from the PBM (or other pharmacy claims data source), the project clinic and/or pharmacy sites and health department; quality control procedures; procedures for secure reporting and storage of data; and a plan for secure data sharing between project partners (e.g., PBM, project clinic and/or pharmacy sites and health department) Baseline data that will be collected and a description of how baseline data will be collected Applicant’s proposed performance measures (i.e., measures that applicant suggests that are in addition to the required performance measures), how these measures will be defined and calculated and data source(s) used to calculate the measures. Proposed performance measures should be aligned with the proposed data variables listed within the applicant’s data collection plan and should be consistent with the Department of Health and Human Services HIV Core Indictors, if applicable Available data sources, feasibility of collecting appropriate evaluation and performance data SMART objectives to be achieved by project activities Description of how the applicant will comply with project data reporting requirements Data Management Plan (DMP) and plans for updating the DMP, if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these FOA funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see: http ://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49 https://www.cdc.gov/grants/additionalrequirements/ar-25.html http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49 http://www.cdc.gov/grants/additionalrequirements/index.html#ui-id-49

c. Organizational Capacity of Awardees to Implement the Approach The applicant should describe how its organization has the capacity to execute the project strategies and meet the project outcomes outlined in this FOA. The following are expected of the applicant:

Access to or the ability to obtain pharmacy claims data from a Pharmacy Benefits Manager, insurer or other source that can be used to implement project activities.

– At a minimum, the data must include the ARV prescription date, prescription pick up date and prescribing physician or provider. The “reverse out date” (the date that indicates that a prescription was filled but not picked up by the patient) is also highly recommended.

– The pharmacy claims data source must be able to connect individual clients to project clinics and/or pharmacies.

– Applicant should state the estimated number of HIV infected persons, from the partnered health department’s jurisdiction, who will be covered by the pharmacy claims data?

– If the applicant does not currently have access to the required pharmacy claims data, the applicant must describe, in detail, how they will obtain the data, the timeline for procurement of the data and contingency plans for if they are unable to obtain pharmacy claims data from the intended source.

If the applicant plans to partner with a Pharmacy Benefits Manager or other pharmacy claims data organization (i.e., make the PBM, insurer or other organization with the pharmacy claims data part of the Project Team) the applicant must include a Letter of Support from the partnered source.

Applicants must describe how the project clinics were selected and should include Letters of Support from each collaborating clinic. The Letters of Support should include estimates of the total number of HIV-infected patients that receive care at their clinic and estimates of how many existing patients become disengaged from care per year. Letters of Support must also include language that data can be shared with the health department, for this project, or that approval to share data with the health department is anticipated.

If applicant intends to use pharmacies as project sites, the applicant should describe how the project pharmacies were selected and should include Letters of Support from each collaborating pharmacy.

If applicant is other than a health department, the applicant must have a Letter of Support from the proposed partnered health department. The Letter of Support should include the health department staff that will be responsible for health department program activities and the number of Disease Intervention Specialists that will be assigned to the project.

The proposed health department partner should have experience with implementation of the current CDC Data-to-Care (D2C) public health strategy that uses HIV surveillance data (i.e., CD4 and HIV viral load test results reported to the health department) to identify HIV-diagnosed individuals not in care and to re-engage these individuals in care.

If applicant is other than a health department, the applicant should have experience working with local or state health departments, preferably in HIV, STD or viral hepatitis prevention.

Experience conducting interventions to improve adherence to medication therapy.

Experience writing, awarding and managing contracts.

Knowledge of local IRB requirements and patient consent and obtaining local IRB approval and consent.

Experience working with medical clinics, medical providers and/or pharmacies and pharmacists.

Experience in program management of multi-site projects and multi-partner projects.

Program evaluation including collection of outcome and process monitoring data for continuous program improvement.

Experience developing data systems, data collection, data management and data analysis.

Letters of support from the following:

- Each collaborating clinic and/or pharmacy project site

- Each collaborating clinic and/or pharmacy project site

- The Letter of support from the project clinics must include estimates of the total number of HIV-infected patients that receive care at their clinic, estimates of how many existing patients become disengaged from care per year and language that data can be shared with the health department, for this project, or that approval to share data with the health department is anticipated

- Health department (if applicant is other than a health department)

- The Letter of support must include the health department staff that will be responsible for health department program activities and the number of Disease Intervention Specialists that will be assigned to the project

- Pharmacy Benefits Manager or other pharmacy claims data organization (if applicant intends for the organization to be part of the Project Team)

- Consultants, if applicable

The applicant must include a clear delineation of the roles and responsibilities of project staff and…