1. Part C HIV Early Intervention Services New Geographic Service Areas HRSA-12-171 Pre-Review Orientation Conference Call June 8, 2012 Presented by: Department of Health and Human Services Health Resources and Services Administration HIV/AIDS Bureau Division of Community HIV/AIDS Programs Director: Dr. Margarita Figueroa-Gonzalez 1 1

2. Agenda Overview of Part C EIS Program Program Narrative: Review Criteria Need Epidemiology, unmet need, gaps in services, barriers Response Work Plan Evaluation & Technical Support Capacity Clinical quality management, data collection system Impact Resources/ Capabilities Staffing Plan, Organizational Information Support Requested Budget in relation to Proposed Project Funding Preference Q &A 2 2

3. Purpose President Obama’s 2011 World AIDS Day Announcement Provide HIV medical and psychosocial services to: 1. newly diagnosed/identified Persons Living With HIV/AIDS (PLWHA) who are not in care; 2. previously diagnosed PLWHA but never been in care; 3. PLWHA who have dropped out of care; and, 4. existing PLWHA clients 3 3

4. Part C EIS Overview The purpose is to provide HIV primary care in the outpatient setting. Applicants must propose a comprehensive continuum of outpatient HIV primary care services in the targeted area. Required Services include: HIV Counseling, testing, and referral; Medical evaluation and clinical care; Other primary care services; and Referrals to other health services. Applications should reflect a Medical Model of Care Budgets demonstrate allocations for providers who can Assess, Treat, and Refer PLWHA for HIV infection 4 4

5. Payer of Last Resort Part C programs are expected to use Ryan White funds as payer of last resort. Ryan White HIV/AIDS Program Part C funds cannot be used to supplant existing funding streams covering HIV primary care and other services. Part C funds cannot be used to pay for services when payment has been made or is expected from insurance or other health benefits program. 5 5

6. Eligible Applicants Organizations in the United States and its territories applying as new EIS applicants (not currently funded by Part C) --Note if applicant is a sub-contractor of a current Part C grantee and the justification for additional Ryan White funding in the proposed service area Public or private nonprofit entities, including but not limited to Federally Qualified Health Centers, Rural Health Centers, Health Centers under the Indian Health Service, University Medical Centers and affiliated clinics, Faith-based or community-based organizations 6 6

7. Part C Budget Categories 1.Early Intervention Services Costs (50%) 1.Core Medical Services Costs (75% after excluding CQM and Administrative) 2.Clinical Quality Management (CQM) Costs 3.Support Services Costs 4.Administrative Costs (10% of total annual request) 7 7

8. Part C Early Intervention Services Licensed medical providers who can assess, treat and refer Proportional medical support- nurses, med assistants Laboratory, immunizations and diagnostic tests Adherence monitoring/education Dental care Mental health Nutrition Substance abuse Specialty Care Services Travel to provide clinical care 8 8

9. EIS Funds cannot be used for: Services must be consistent with HAB Policy Notice 10-02 http://hab.hrsa.gov/manageyourgrant/pinspals/eligible1002.html  Inpatient services  Residential treatment  Clinical research  Nursing home care  Cash payments to clients  Purchase or improvement of real property  Syringe Services programs  Lobbying activities, advertising 9 9

10. Program Narrative Introduction Needs Assessment Methodology Work Plan Resolution of Challenges Evaluation and Technical Support Organizational Information 10

11. Needs Assessment: Four Major Sections 1.HIV Seroprevalence & Surrogate Markers – local HIV epidemiologic data from 2008 to 2010, unmet need calculation from Parts A/B 2.Social Context of HIV/AIDS— key community characteristics that support the need for Part C funding/services in the proposed area 3.Target Populations – are these consistent with those identified by the HIV epidemiologic data as new cases? 4.Local HIV Service Delivery System – are all HIV service providers, funding streams, and funded services described to assess current gaps and barriers? 11

12. OrganizationServices Provided Clients Served (Unduplicated) Funding Sources & Amts Access Barriers to Care Service Gaps Good Life ASO HIV Testing and Counseling, Substance Abuse Counseling 300Part A = $80,000 Part B= $60,000 County = $20,000 Known as AIDS Service org– fear of public exposure Need better protections for confidentiality Dr. DoolittlePrimary care for HIV+ 60Private, for profit Does not accept Medicaid No access for Medicaid, low income persons General Hospital Primary medication Dental, adherence counseling, mental health, substance abuse treatment, nutritional services 1,200Part A = $99,000 Limited access for persons outside of public trans limits Average 5 week waiting period Sample Service Delivery Chart 12

13. Review Criterion 1: Need The extent to which the applicant provides clear and reliable data showing an increased burden of HIV infection in the service area. The extent to which the applicant clearly describes the target population and the need for HIV- related health services in this population. This addresses the NHAS goal: to reduce HIV-related health disparities. The extent to which the applicant documents the public funding sources for HIV prevention and care in the proposed service area. The extent to which the applicant identifies unmet need, gaps in service and barriers to care. The extent to which the information shows a need for medical care paid by Part C for uninsured clients not covered by other Ryan White HIV/AIDS Parts. The extent to which the applicant demonstrates a need for Part C medical services based on epidemiological data, current HIV services, and funding available for the proposed service area. 13

14. Methodology: Scope of Work 1) HIV Counseling, Testing, Referral, Partner Counseling, and Linking to Care – targeted at high risk populations 2) Medical Evaluation and Clinical Care – description of the HIV medical care services consistent with HHS guidelines 3) Referral System – to other medical/specialty services 4) Other Core Medical Services – behavioral health, oral health, nutritional services, medical case management 5) Support Services – linked to medical/health outcomes 6) MAI 7) Coordination and Linkages with Other HIV Programs (scored under Impact) – reduces non-duplication of services 14

15. Review Criterion 2: Response The strength of the medical evaluation and clinical care systems (such as periodic medical evaluations, CD4 monitoring, viral load testing, antiretroviral therapy, prophylaxis and treatment of opportunistic infections). Evidence of adequate support for laboratory and pharmacy services, plans for staff education, and the involvement of consumers in decisions regarding their care. The extent to which the applicant describes a sound policy for after-hours and weekend coverage for urgent or emergency medical and dental care needs. The effectiveness of formal systems in place for referrals of individuals to health and support services that are not directly provided by the applicant. Evidence of mechanisms to follow-up on referrals and receive feedback from the providers of health and support services to which patients are referred. This addresses the NHAS goal: to increase access to care and optimize health outcomes for people living with HIV. 15

16. Work Plan Summary Access to Care Comprehensive and Coordinated HIV Primary Medical Care Clinical Quality Management Program Consumer Involvement activities Include only the clients funded by Part C (as defined in the FOA). Attachment 8 16

17. Sample Work Plan Summary 17

18. Sample Work Plan Summary 18

19. Work Plan Summary: CQM 19

20. Work Plan Summary Consumer Involvement 20

21. Review Criterion 2: Response The extent to which the applicant demonstrates a lack of resources for other core medical services, including outpatient oral health, adherence, mental health/substance abuse, and nutritional services and how this funding will be used to address the gaps. The extent to which HIV prevention services are incorporated into medical care. The extent to which the applicant explains how clients applying for financial support and services from other publicly funded programs will be assisted? The strength of the work plan summary as evidenced by measurable objectives that reflect, access to care, the comprehensive continuum of HIV care, quality improvement, and consumer involvement funded under the grant. Overall, the extent to which the applicant documents the ability of the organization to provide, internally and/or by contract, the full comprehensive continuum of HIV care, funded under the grant without duplication. 21

22. Evaluation and Technical Support The application should fully address the evaluation activities including quality management (QM) and information systems. QM should include: Infrastructure Performance Measurement Quality Improvement 22

23. Information System Describe the applicant’s current information system and their ability to collect and report Part C required data to include the following:  The number of existing and new patients  Demographic profile of patients  Epidemiological data  Exposure and diagnostic categories services  The number of HIV infected individuals  Third party program income  Average costs of providing each service category Electronic Health Records Office of National Coordinator for Health Information Technology (ONC) www.hrsa.gov/healthit/ehrguidelines.html Department of Health and Human Services “Meaningful Use” www.cms.gov/ehrincentiveprograms 23

24. Review Criterion 3: Evaluation The strength of the proposed quality management infrastructure, including the key leaders and quality committee. The appropriateness of the role of consumers in the Quality Management program. The appropriateness of clinical indicators that will be used to measure performance. The extent to which the applicant describes how data will be used for quality improvement activities. The extent to which the applicant demonstrates how they will comply with reporting requirements of the program. The strength of the proposed data collection plan and process (e.g., frequency, key activities, and responsible staff). The strength of the process for reporting and disseminating future results and findings. 24

25. Review Criterion 4: Impact The extent to which the work plan summary provides objectives which are appropriate for the level of unmet need and gaps in services for the target population in the proposed service area, as described in the Needs Assessment. The extent to which the applicant describes how its proposed program will increase the number of (1) newly diagnosed PWLHA, (2) previously diagnosed PLWHA who have never been in care, and; (3) PLWHA who have dropped out of care that are linked to HIV medical care without duplication of services in the proposed service area. This addresses the President’s initiative stemming from World AIDS Day 2011 to increase access to primary HIV medical care and support services. 25

26. Organizational Information Describe the applicant organization’s capacity and expertise to provide primary care by describing the administrative, fiscal, and clinical operations. How does a Part C EIS project fit within the scope of the organization’s mission? The structure of the organization. Attachment 9: Project Organizational Chart – should demonstrate the placement of the proposed Part C program within the entire organization 26

27. Budget: Staffing Plan Should include all staff being funded under Part C and key staff not funded by the grant. Should demonstrate that project personnel are qualified by education/training, HIV experience and expertise to provide early intervention services under the grant. Should demonstrate language fluency and cultural competence Should provide the staff time/effort (FTE) and ALL funding sources for the HIV program Key personnel include: Lead for quality management activities Program coordinator Staff managing and overseeing grant activities Staff monitoring activities of contractors Medical Director 27

28. Review Criterion 5: Resources Evidence of the organization’s ability to implement the proposed project. The strength of the organization’s mission, structure and experience which support the provision of HIV Primary care services as evidenced by the clinic licensure information and organizational chart. Overall, the strength of the organization’s fiscal and MIS capacity to manage this grant, and meet program requirements including monitoring grant expenditures, a discounted fee schedule, annual cap on patient charges, and collecting, tracking and using program income to support the HIV program. If applicable, the applicant’s demonstration of the ability to manage and monitor subcontractor performance and compliance with Part C EIS requirements. 28

29. Review Criterion 6: Support Requested The appropriateness of the requested funding level for each year of the project period in comparison to the level of effort, performance, and total number of patients served. The reasonableness of the average cost of care for each service category. The number of patients to be served, the number of patients with AIDS versus HIV, and the number of patients with no form of third party reimbursement or funding from Part A or B. 29

30. Part C Budget Categories 1.Early Intervention Services Costs (50%) 2.Core Medical Services Costs (75%) 3.Clinical Quality Management (CQM) Costs 4.Support Services Costs 5.Administrative Costs (10%) 30

31. Early Intervention Services Licensed medical providers who can assess, treat and refer Proportional medical support- nurses, med assistants Laboratory, immunizations and diagnostic tests Adherence monitoring/education Dental care Mental health Nutrition Substance abuse Specialty Care Services Travel to provide clinical care 31

32. Part C Budget Requirements Shows only Federal Part C EIS funds At least 50% of Part C budget must be allocated for EIS/Primary care costs. At least 75% of the Part C budget, after CQM and Administrative costs are subtracted, must be allocated for Core Medical Services Administrative costs are capped at 10.0% of the total EIS award amount Calculations for all items in the budget justification should include unit cost, number of units, and number of persons to be served 32

33. Budget: Points Budget Period is ONE YEAR (July 1, 2012 to June 30, 2013) Organizations were instructed to submit three separate program specific line item budgets and one budget justification (which lists the changes in subsequent years reflected in the line-item budget). Section B of SF-424A: Years 1 to 3 line item budget summary 33

34. Budget: Sample Line-Item 34

35. Salary Limitations This is a new HRSA requirement resulting from the Appropriations Act for 2012, that salaries charged to grants are capped at $179,700 annually. This amount reflects an individual’s base salary, exclusive of fringe benefits and income earned outside of the applicant organization. The limitation also applies to subcontracts. 35

36. HRSA’s Scoring Rubric Available in the EHB-ARM system as a reference Good tool for gauging appropriate scoring of sections based upon analysis of the applicant’s response to the entire FOA and the Review Criteria 36

37. HRSA Scoring Rubric: Suggested Guidelines Total Point Value for a Review Criterion OutstandingVery GoodSatisfactoryMarginalPoor 554321-0 10 9-8765-0 1515-1413-121110-98-0 2020-1918-1615-1413-1211-0 2525-2423-2019-1817-1514-0 3030-2928-2423-2120-1817-0 3535-3332-2827-2524-2120-0 4040-3837-3231-2827-2423-0 4545-4342-3635-3231-2726-0 Approx.%95-100%80-94%70-79%60-69%59-0% 37

38. HRSA Scoring Rubric (cont.) OutstandingAll elements are clearly addressed, well conceived, thoroughly developed, and well supported. Documentation and required information are specific and comprehensive. Weaknesses identified will likely have no effect on the applicant’s proposed project. Very GoodElements are clearly addressed with necessary detail and adequate support. Most documentation and required information are specific and sufficient. Weaknesses identified will likely have minor effect on the applicant’s proposed project. SatisfactoryElements are addressed, although some do not contain necessary detail and/or support. Most documentation and required information are present and acceptable. Weaknesses identified will likely have moderate effect on the applicant’s proposed project. MarginalSome elements are not addressed, and those addressed do not contain necessary detail and/or support. Some documentation and required information are missing or deficient. Weaknesses identified will likely have significant effect on the applicant’s proposed project. Poor Few, if any, elements are addressed. Documentation and required information are deficient or omitted. Weaknesses identified will likely have substantial effect on the applicant’s proposed project. 38

39. Funding Preference Must meet all factors in Qualification #1 for 2009 and 2010 to qualify for Increased Burden, then if applicable, can apply for rural areas or underserved. Document in detail- Attachment 12 Qualification 1: Increased Burden ▫Increased number and increased rate of HIV/AIDS Cases ▫Lack of EIS services, from Parts A, B and C ▫Increased number and increased rate of  Other sexually transmitted diseases  TB  Drug Abuse  Co-infection of HIV and Hepatitis B or C ▫Lack of primary care providers, other than the applicant ▫Distance to service area with adequate HIV providers ▫Patient travel time to that area Qualification a: Rural Areas Qualification b: Underserved (from all EIS resources including Parts A/B/C) 37 39

40. Your questions are welcome Bob Settles rsettles@hrsa.gov 301-443-1049 HAB TARGET Website http://careacttarget.org/webcasts.asp 40