Georgia Ryan White Part B, AIDS Drug Assistance Program (ADAP), and Health Insurance Continuation Program (HICP) Policies & Procedures 2018 Georgia Department of Public Health Division of Health Protection Office of HIV/AIDS Policies and Procedures Contents Introduction………………………………………………………………………………………… 3 Section 1: Sub-Recipient Roles and Responsibilities…………………………………………...… 5 Section 2: Program Monitoring and Oversight…………………………………………………... 12 Section 3: Eligibility Policies and Procedures……………………………………………………. 16  Eligibility Determination…………………………………………………………………… 17  Part B/ADAP/HICP Application…………….……………………………………………... 30  Eligibility Recertification…………………………………………………………………… 32  ADAP Medications/ADAP Contract Pharmacy (ACP) Network…..………………………. 34  ADAP Waiting List…………………………………………………………………………. 37  Discontinuation of Services………………………………………………………………… 37  Security and Confidentiality………………………………………………………………... 38  Fair Hearings and Grievance Policy………………………………………………………... 39 References........................................................................................................................................... 41 Appendices………………………………………………………………………………………….. 42 A. Part B Primary Care Clinics………………………………………………………………… 43 B. ADAP/HICP Enrollment Sites.……………………………………………………………... 48 C. Justification for Order of Stop Gap Medications Worksheet……………………………….. 56 D. Medication Dispensing Log………………………………………………………………… 57 E. HIV Testing Algorithm……………………………………………………………………... 58 F. Case Report Form…………………………………………………….…………………….. 60 G. Georgia ADAP Formulary………………………………………………………………….. 63 H. Georgia ADAP Application for Prior Approval Medications……………………………… 66 I. ADAP Contract Pharmacy (ACP) Network……..………………………………………….. 70 J. 2018 Federal Poverty Level (FPL) Guidelines…..…………………………………………. 72 K. Ryan White Part B/ADAP Electronic Application and 12-Month Recertification…………. 73 L. Self-Attestation Form……………………..………………………………………………… 88 M. Support & Residency Verification Letter…………………………………………………... 92 N. Statement of Support……………………………………………………………………….. 93 O. Modified Adjusted Gross Income (MAGI) Factsheet…………………….………………… 94 P. MAGI/FPL Determination Worksheet………..…………………………….………………. 98 Q. Private Insurance Enrollment Screening Form……………………………………………... 100 R. Georgia’s ADAP & Medicare Part D FAQs………………………………………………... 101 S. Request to Remain on ADAP and to Decline other Coverage……………………………… 104 T. Notification of Client Responsibility for Participation in HICP……………………………. 106 U. Repayment Agreement Form……………………………………………………………….. 107 V. ADAP Emergency Program (AEP) Statement of Support..………………………………… 108 W. AEP Self-Attestation Form………...……………………………………………………….. 109 X. Medication Override Request Form………………………………………………………… 110 Y. ADAP/HICP Discontinuation Form.……………………………………………………….. 111 Last Revised 3/22/2018 Page 2 of 112 Policies and Procedures Introduction About this Document The Georgia Ryan White Part B/ADAP/HICP Policies and Procedures Manual provides guidance on the Ryan White Part B, the AIDS Drug Assistance Program (ADAP), and the Health Insurance Continuation Program (HICP), and defines the administrative functions and processes in Georgia. This manual provides an overview of the Ryan White CARE Act and its various revisions with a detailed description of the most recent law implemented. A discussion follows of Georgia’s Ryan White Part B Program with specific focus on its components. Included in this manual are also lists of Georgia Ryan White Part B Clinics and ADAP/HICP Enrollment sites. The manual is a living document to be updated as needed. All information, policies, procedures and documents found herein are effective as of April 1, 2018. Ryan White Overview The Ryan White Comprehensive AIDS Resources Emergency Act is a Federal legislation that addresses the unmet health needs of persons living with HIV/AIDS (PLWHA) by funding primary health care and support services that enhance access to and retention in care. First enacted by Congress in 1990, it was amended and reauthorized in 1996, 2000, 2006 and 2009; it was funded at $2.3 billion in 2018. The Ryan White HIV/AIDS Treatment Modernization Extension Act of 2009 Federal funds are awarded to agencies located around the country, which in turn deliver care to eligible individuals under funding categories called Parts. • Part A provides emergency assistance to Eligible Metropolitan Areas and Transitional Grant Areas that are most severely affected by the HIV/AIDS epidemic. • Part B provides grants to all 50 States, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, and five (5) U.S. Pacific Territories or Associated Jurisdictions. • Part C provides comprehensive primary health care in an outpatient setting for people living with HIV disease. • Part D provides family-centered care involving outpatient or ambulatory care for women, infants, children, and youth with HIV/AIDS. • Part F provides funds for a variety of programs: o The Special Projects of National Significance Program grants fund innovative models of care and supports the development of effective delivery systems for HIV care. o The AIDS Education and Training Centers Program supports a network of eight regional centers and several National centers that conduct targeted, multidisciplinary education and training programs for health care providers treating people living with HIV/AIDS. o Dental Programs provide additional funding for oral health care for people with HIV. o The Minority AIDS Initiative provides funding to evaluate and address the disproportionate impact of HIV/AIDS among African Americans and other minorities. Last Revised 3/22/2018 Page 3 of 112 Policies and Procedures Georgia Ryan White Part B Components Below is a description of the Georgia Ryan White Part B Program and its components. Ryan White Part B Program In Georgia, the Ryan White Part B Program is administered by the Georgia Department of Public Health (DPH), Division of Health Protection, Office of HIV/AIDS. The Office of HIV/AIDS funds agencies in 16 public health districts to deliver HIV/AIDS services throughout the state. The agencies are responsible for planning and prioritizing the delivery of HIV services in their respective geographic areas. All funded agencies provide primary care services. Support services are funded based on the availability of resources. Part B also funds the Georgia ADAP and HICP, which provide medications and health insurance coverage. Please see Appendix A for a list of the Part B Primary Care Clinics. Seventy-five percent of Part B funds must be used to fund “core medical services” which include outpatient and ambulatory health services; ADAP; AIDS pharmaceutical assistance; oral health care; early intervention services; health insurance premium and cost-sharing assistance; home health care; medical nutrition therapy; hospice care; community based health services; substance abuse outpatient care; and medical case management, including treatment adherence services. The remaining 25 percent of funds must go to support services that are needed for PLWHA to achieve their medical outcomes, such as respite care, outreach services, medical transportation, linguistic services, and referrals for health care and support services. Please refer to HRSA PCN #16-02 for definitions for each of the above HIV services. ADAP ADAPs are state administered programs that provide HIV/AIDS medications to low-income individuals living with HIV disease, who have little or no coverage from private or third party insurance. The ADAP started as a Health Resources and Services Administration (HRSA) demonstration project to provide zidovudine (AZT), the first drug approved by Food and Drug Administration (FDA) to treat HIV infection. Since that time, ADAPs have significantly expanded to cover other FDA approved drugs to treat HIV infection and HIV-related opportunistic infections. Georgia ADAP services are available to all eligible residents throughout all 18 health districts in the state. There are 27 enrollment sites (Appendix B) in Georgia, inclusive of seven (7) approved sites located in metro Atlanta. HICP The Georgia HICP is a state administered program which assists eligible persons who are unable to pay their health insurance premiums for private/individual or Consolidated Omnibus Budget Reconciliation Act (COBRA) plans. This special program pays a maximum monthly health insurance premium of $1,788.00, which may include a spouse and children on a family health insurance plan, as well as dental and vision. The HICP also covers medication co-pays, in addition to premiums, for eligible individuals. The program will only accept new clients who have insurance plans that include both outpatient primary care coverage and prescription coverage without a yearly cap. The HICP allows clients the opportunity and flexibility to continue to access their doctors, maintain a continuum of primary health care and sustain an improved quality of life. In addition, the program has also expanded prescription co-pay assistance to eligible Medicare Part D participants. The Medicare Part D co-pay assistance component of the program will assist individuals with out-of-pocket costs for ADAP approved formulary medications. Last Revised 3/22/2018 Page 4 of 112 Policies and Procedures The Office of HIV/AIDS has continued to evaluate the effectiveness of the HICP, which pays health insurance premiums and medication co-pays for eligible clients with health coverage. The provision of health insurance assistance has proven to be a more cost effective way to meet the needs of clients in comparison to providing expensive HIV/AIDS medications at a much higher cost. Georgia HICP services are available to all eligible residents of Georgia at all ADAP-HICP enrollment sites (Appendix B). Hepatitis C The Georgia Hepatitis C is a state administered program that assists eligible ADAP/HICP participants living with HIV disease and Hepatitis C disease with medications covered on the Georgia ADAP formulary. The program will provide Hepatitis C medications for the entire course of treatment at one (1) ADAP Contract Pharmacy of the participant’s choice. The Georgia Ryan White Part B/ADAP program will approve only one (1) complete Hepatitis C regimen for each program participant. Georgia Hepatitis C services are available for active ADAP/HICP participants and should apply through their local ADAP- HICP enrollment site. Minority AIDS Initiative (MAI) The Georgia Ryan White Part B Program utilizes MAI funds for the implementation and continuation of the evidence-based Antiretroviral Treatment and Access to Services (ARTAS) Linkage Case Management intervention to conduct outreach, educate and link minority clients into care, ADAP, partner services, and other social services. Ryan White MAI funded health agencies use ARTAS as a method to identify and re-engage clients who have been “lost to care” and re-link them to care. Emerging Communities (EC) Georgia has one eligible emerging community, the Augusta-Richmond County, GA-SC metropolitan statistical area (MSA), part of the Augusta Health District. ECs are determined based on cumulative AIDS cases reported to and confirmed by the CDC during the most recent period of five calendar years. EC funds are used to provide increased access to unfunded or underfunded services. Section 1: Sub-Recipient Roles & Responsibilities The primary role of sub-recipients, also referred to as funded agencies, is to provide medical and support services to all eligible persons living with HIV/AIDS who reside in Georgia. Sub-recipients are responsible for maintaining appropriate relationships with entities in the area they serve that constitute key points of access to the health care system for individuals with HIV/AIDS (emergency rooms, substance abuse treatment programs, detoxification centers, adult and juvenile detention facilities, STD clinics, and others) for the purpose of facilitating early intervention for individuals newly diagnosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care. Services provided must meet all service standards set forth by the state, and must align with HRSA’s Ryan White Universal and Part B programmatic and fiscal National Monitoring Standards. HIV Care Continuum The continuum of interventions that begins with outreach and testing, and concludes with HIV viral load suppression is generally referred to as the HIV Care Continuum or the HIV Treatment Cascade. The HIV Care Continuum includes the diagnosis of HIV, linkage to HIV medical care, lifelong retention in HIV Last Revised 3/22/2018 Page 5 of 112 Policies and Procedures medical care, appropriate prescription of antiretroviral therapy (ART), and ultimately HIV viral load suppression. Sub-recipients are encouraged to assess the outcomes of their programs along the HIV Care Continuum. Funded agencies should work with their community and public health partners to improve outcomes across the Continuum, so that individuals diagnosed with HIV are linked and engaged in care, and started on ART as early as possible. Performance measures developed for the Ryan White Part B Program should be used to assess the efficacy of the programs and to analyze and improve the gaps along the Continuum. Care Consortium Sub-recipients must collaborate with their local Ryan White Part B HIV Care Consortia to conduct appropriate assessments of need, prioritizing and planning for the delivery of allowable Ryan White Part B medical and support services. Delivery of HIV medical and support services shall be provided either directly by the sub-recipient or indirectly through sub-contractual agreements with outpatient, home health care and support service providers. Each Ryan White Part B HIV Care Consortia should have written bylaws and procedures for membership in place. Consortia meetings should be conducted no less than quarterly. Minutes from each meeting shall be sent to the assigned District Liaison. Sub-recipients are responsible for submitting the Ryan White Part B HIV Care Application when required. Sub-recipients are responsible for completing a yearly needs assessment through their Ryan White Part B Care Consortia in order to gain community input that can assist in prioritizing and ranking service needs. Each sub-recipient must submit documentation of the current needs assessment to the assigned District Liaison. Information about the needs assessment is also required for the yearly Ryan White Part B HIV Care Application. Programmatic Expectations Each sub-recipient and sub-contractor is contractually required to be compliant with the audit requirements in 45 CFR 75 Subpart F. Each sub-recipient must also comply with the requirements listed in the Georgia DPH Annexes through which they receive funding for Ryan White, or applicable contract, as well as those expectations delineated in this manual. Sub-recipients are required to submit programmatic/quality reports, expenditure reports, and implementation plans, as well as utilize CAREWare to collect and report data and/or fiscal reports as necessary for all Part B Program funds. These reports are utilized for both programmatic and fiscal monitoring purposes. Programmatic/quality reports allow sub-recipients to report on the progress of goals and objectives as well as identify challenges, barriers, and technical assistance needs. Report templates can be found with the yearly annexes and by contacting your assigned District Liaison. As part of their quarterly responsibilities, sub-recipients are responsible for submitting a Quarterly Expenditure Report, Quarterly Implementation Plan, and the Quarterly Quality Management (QM) Report. The reports are due no later than the 20th day of the month following the end of the quarter (Figure 1) and must be submitted in the format provided by the state. Last Revised 3/22/2018 Page 6 of 112 Policies and Procedures Figure 1. Reporting Dates Quarter Due Date April-June July 20 July-September October 20 October-December January 20 January-March April 20 Before engaging in a sub-contractual process, sub-recipients must submit a justification as to why they have a need to sub-contract services, as well as a copy of the drafted contract for approval by the Office of HIV/AIDS Ryan White Part B Program. The justification is to verify that any sub-contracts paid for with Ryan White Part B funding are compliant with Ryan White regulations and guidelines. All contracts must be fully executed and signed prior to the provision of services. Reimbursements must be based on services provided and invoices must include an appropriate description of services. Flat rate reimbursement schedules are not permitted. Sub-recipients are responsible for verifying and documenting that any sub-contractors providing services to clients have appropriate credentials, licensure and liability coverage. Sub-recipients are required to conduct at least one on-site monitoring visit to all sub- contractors annually to assess the sub-contractors’ compliance with state and federal regulations, including HRSA Ryan White Universal and Part B programmatic and fiscal National Monitoring Standards. On-site monitoring reports and corrective action plans are submitted when indicated. A list of all sub-contractors and copies of all sub-contracts must be submitted to the state office on a yearly basis. These documents will also be reviewed by Georgia DPH auditors. Sub-recipients must submit a line-item budget using the form provided by the Office of HIV/AIDS Ryan White Part B Program. Unless otherwise directed, budgets are to be completed for the upcoming year using the same level of funding awarded the previous year. A narrative budget justification must accompany the budget form. When developing the budget, sub-recipients must be aware that the total amount of Administrative Costs and Indirect Costs paid with Ryan White Part B funds shall not exceed 10% of the total allocation. Personnel costs for direct service contractors, such as clinicians, case managers, etc., are not considered administrative and must be indicated under direct care costs. The budget total cannot be exceeded. However, a plus or minus deviation of 10% within budget line items is authorized. In the event that expenditures for a line item are expected to exceed these limits, a budget revision must be submitted and approved by the Office of HIV/AIDS in advance. A maximum of two (2) budget revisions are allowed in a single fiscal year. Requests for an exemption due to extenuating circumstances (e.g., unprecedented changes in staffing) must be submitted to the Office of HIV/AIDS for review and approval. If 75% of funds are not expensed by the end of December, the sub-recipient is required to submit a written report illustrating how the remaining funds will be spent or if the funds cannot be spent. If this occurs, the Office of HIV/AIDS Ryan White Part B Program reserves the right to unallocate funds anticipated to lapse and reallocate those funds to another sub-recipient. For those sub-recipients receiving Last Revised 3/22/2018 Page 7 of 112 Policies and Procedures the additional funds, the reallocations will be a one-time allotment and will not be reoccurring funds for the succeeding fiscal year. NOTE 1: Indirect costs taken out of Ryan White Part B funding are considered administrative and must fall within the 10% administrative cap. No indirect costs are to be charged to MAI or Emerging Community (EC) funds. NOTE 2: Please refer to HRSA Policy Clarification Notice (PCN) #15-01 for additional details regarding the 10% administrative cap. At a minimum of once a year, sub-recipients shall participate in a performance review (administrative site visit) of the Part B Program to be conducted by the Office of HIV/AIDS District Liaison and other staff as needed. Minimum requirements for site visits will be contingent on staffing and travel restrictions. Upon completion of the performance review, a summary of findings will be sent to the HIV Coordinator and Health Director. If the Office of HIV/AIDS Ryan White Part B Program recommends corrective action, the sub-recipient is expected to complete and submit an action plan that includes key actions and time frames to improve program performance for those areas identified. Upon receipt of the final administrative report, the sub-recipient will have 45 days to submit their corrective action plan to the Office of HIV/AIDS. If corrective action measures are not implemented within the specified timeframe, funding may be restricted. Sliding Fee Scale Sub-recipients shall implement a sliding fee scale policy. If the sub-recipient accepts reimbursement for primary care and support services from any third-party payer (such as private insurance or Medicaid), clients provided services under this agreement must be assessed for fees for services provided, according to a sliding fee schedule and in accordance with federal requirements outlined in the Ryan White CARE Act of 1990, as amended. Only clients whose incomes exceed 100% of the current FPL are to be assessed fees for Ryan White Part B services. Program Income Program income is gross income earned that is directly generated by a supported activity or earned as a result of the Federal award during the period of performance (the Part B period of performance is from April to March). Examples of program income include: • Charges imposed on clients for services; • Funds received by billing public or private health insurance for services provided to eligible clients; • Fees, payments, or reimbursement for the provision of a specific service, such as patient care reimbursements received under Medicare, Medicaid, or Children’s Health Insurance Program; • The difference between the third party reimbursement and the 340B drug purchase price. Program income must be used for activities related to Ryan White Part B care services; including core medical and support services, clinical quality management, and administrative expenses (including planning and evaluation). Sub-recipients should retain program income for use within their own Ryan White Part B programs, but must report program income earned through Part B and how they plan to use Last Revised 3/22/2018 Page 8 of 112 Policies and Procedures the funds to the state. While program income must be used for allowable services under Part B, income can be used to expand the services provided outside of what is approved in the sub-recipient Part B budget. NOTE 1: Program income is not subject to the 10% administrative cap in order to support a comprehensive system of care. NOTE 2: For additional information on program income refer to HRSA PCN #15-03. Recertification Ryan White Part B service providers should review client eligibility at every visit. All Ryan White Part B, ADAP and HICP clients are required to recertify every six months. Clients will be able to self- attest during one of their yearly recertification periods but must submit all appropriate documentation during their 12-month recertification period. Clients need to be screened for other payer sources and income to ensure program eligibility and compliance with “payer of last resort” regulations. In order to verify that Ryan White is the “payer of last resort” Ryan White clinics must collect and maintain client documentation regarding client eligibility for other health plans or lack thereof. Please see the Eligibility Recertification section for additional details. The local ADAP Coordinator or case manager should initiate the recertification process during a face-to-face interview. Stop Gap Medications Stop Gap Medication funding provides sub-recipients with the resources to purchase medications on the ADAP formulary (antiretroviral and non-antiretroviral (OI) medications) for use while clients are waiting on ADAP approval/recertification. As Ryan White is considered the “payer of last resort,” stop gap medications are not to be used until all other resources have been exhausted. Before utilizing stop gap medications, sub-recipients should verify that ADAP applications/recertifications are submitted completely and in a timely manner to allow for processing and approval without resulting in a gap in services. In addition, sub-recipients should reach out to patient assistance programs (PAPs) whenever possible before utilizing stop gap medications. Steps taken before medications are prescribed must be documented to show that stop gap funding is being utilized appropriately. If available resources are limited, provision of stop gap medications should be prioritized for Ryan White Part B eligible clients with the following conditions: • Pregnancy • CD count below 200 cells/mm3 4 • History of an AIDS defining illness • Co-morbid conditions (e.g. HIV-associated dementia, HIV-associated nephropathy, Hepatitis B virus co-infection) • Acute HIV infection Stop Gap Medications cannot be utilized for individuals who do not qualify for Ryan White Part B services, as a long term solution to treating clients, or to purchase medications in bulk. Any credits from Last Revised 3/22/2018 Page 9 of 112 Policies and Procedures expired medications from past purchases with state funding must be reported to the Georgia Ryan White Part B Program through the assigned District Liaison. If a sub-recipient has a need to purchase stop gap medications, a staff member will need to complete the Justification for Order of Stop Gap Medications worksheet (Appendix C), and submit to the state office through the assigned District Liaison for approval before any medications are ordered from Cardinal or any invoices are submitted to the state. If approval is granted based on the justification, the sub-recipient may then place an order for the medications and the invoice can be submitted to the state office for payment. Sub-recipients approved for the purchase of medications must continue to submit a monthly copy of the Medication Dispending Log (Appendix D), utilizing the CAREWare URN as the client identifier and matching the information reported in the justification. This log must be submitted to the Office of HIV/AIDS on the 3rd of each month. MAI Funding Sub-recipients receiving MAI funding for the implementation and continuation of ARTAS Linkage Case Management must utilize funds to coordinate linkage efforts in order to maximize education and outreach strategies to link minorities to ADAP, and reduce duplication of services and efforts. The focus of the initiative is to target those minorities who know their HIV status and have not accessed care within 6-12 months, and effectively link these clients to medical care (specifically, medication services including ADAP) within 90 days. Funding can only be used for two service categories, outreach and health education. In addition to the quarterly expenditure reports and implementation plans, sub-recipients receiving MAI funding are required to utilized CAREWare for data collection and reporting, and submit monthly data reports which are due by the 15th of each month. As part of the collaborative efforts with the HIV Prevention Program, districts are also expected to participate in combined linkage efforts and ARTAS technical assistance calls. Table 1. Reports and other Programmatic Documents Required Report Supporting Documentation Due Date Fiscal Year (FY) Budget N/A Due April 25th of the new FY. Will need to be resubmitted as changes are made to the budget during the FY. FY Budget Narrative N/A Due April 25th of the new FY. Will need to be resubmitted as changes are made to the budget during the FY. Funding Document N/A Due April 25th of the new FY. FY Implementation Plan N/A Due April 25th of the new FY. Will need to be resubmitted as changes are made to the budget during the FY. Budget Revision Updated budget, budget narrative, No specified date, up to two per grant and FY implementation plan. year. Subcontractor List Copies of contracts and June 30 deliverables. Consortium Agreements and N/A June 30 Assurances Expenditure Report N/A Due quarterly (refer to Figure 1 for dates) Quarterly Implementation Plan N/A Due quarterly (refer to Figure 1 for dates) Last Revised 3/22/2018 Page 10 of 112