The AIDS Drug Assistance Program Administrative Overview Training Ryan White Part A June 14, 2011 Kerry Hill, MSW Northeastern/Central Services Branch Jose Au Lay, MD, MMS, MSHA Director, AIDS Drug Assistance Program Department of Health and Human Services Health Resources and Services Administration HIV/AIDS Bureau Ryan White HIV/AIDS Program - Intent Signed into law 1990, last reauthorization 2009 Increase access to care for people living with HIV disease (PLWH) Only disease-specific discretionary grant program for care and treatment of PLWH Payer of last resort – safety net for uninsured and low- income individuals living with HIV/AIDS Funding for: Primary health care including medications and support services Provider training, Technical Assistance, Demonstration project Basic Tenets of Ryan White Local and State planning and prioritization of funding based on needs assessment Involvement of people living with HIV/AIDS and representatives of the continuum of service providers in the planning process Funding of both primary care and support services to improve access to care Support of a multidisciplinary team Building of a medical home Quality of care Core Medical Services Ambulatory/outpatient health Health insurance premium services and cost sharing assistance AIDS Drug assistance for low-income persons. Program treatments (Section Home health care 2616). Medical nutrition therapy AIDS pharmaceutical Hospice services assistance Home and community based Oral health care health services Mental health Early intervention services Medical case management Substance abuse outpatient and treatment adherence care services Ryan White HIV/AIDS Program Primary Care Services Funded Outpatient Medical Care (includes clinical evaluation, laboratory testing and specialty care) Oral Health Care Mental Health Substance Abuse Treatment Medications Medical Nutrition Therapy Medical Case management, including treatment adherence Ryan White HIV/AIDS Program Support Services Funded Outreach Medical Transportation Child care Respite care Psychosocial Services Rehabilitation Services Food Bank/Home Delivered Meals Housing Services (emergency/short-term) Legal services Ryan White HIV/AIDS Program - Clients Served Over 529,000 uninsured and underinsured persons affected by HIV/AIDS annually Approximately 205,446 people received medications through ADAP in 2009 1 in 4 receiving ARVs in USA use ADAP services ADAP served 228,708 clients in CY 2010. This represents a 10% increase over 2009. Reach those most in need, with an estimated 72 percent racial minorities, 33 percent women, and 79 percent uninsured/underinsured or receiving public health benefits (2007) CDC reported 64% minority, 23% women Ryan White HIV/AIDS Program Heavily Impacted Cities (Part A) States and Territories (Part B) AIDS Drug Assistance Program (ADAP) Community Based Organizations HIV Primary Care (Part C) Women, Infants, Children and Youth (Part D) Other programs Dental, Training (AETC), Planning, Capacity Development, Demonstrations (SPNS) FY 2010 Ryan White HIV/AIDS Program Appropriation: $2.29 Billion Note: Includes $25 million for SPNS funding from Evaluation Set-Aside Source: HAB/HRSA Budget Office Ryan White HIV/AIDS Program Appropriations History 1991-2010 $900 $800 $700 Part A $600 Part B Base ADAP $500 Part C Millions $400 Part D Dental Reimb. $300 AETCs $200 $100 $0 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Ryan White – Part B Provides grants to all 50 States, the District Columbia, Puerto Rico, Guam, U.S. Virgin Islands, Palau, American Samoa, Commonwealth of the Northern Mariana Islands, Marshall Islands and Federated States of Micronesia to pay for care for people living with HIV/AIDS The AIDS Drug Assistance Program (ADAP) component pays for: Medications to treat HIV disease Insurance continuation for eligible clients Services that enhance access, adherence, and monitoring of drug treatment FY 2009 Ryan White HIV/AIDS Program Spending N=2.15 billion Women, Infants, Health Insurance Children, and Youth Continuation (Part D) 3 1% Quality Management 3% 2% Administration / Program Support Capacity Building Dental Programs 4 7% <1% <1% Planning and Medical Care 1 Evaluation 2% 25% Training and Technical Assistance (AETC) 2% Medications - Case Management Discretionary 9% 2% Support Services 7% Medications (ADAP) 2 39% *Spending data reflected in this chart are based in part on planned spending reported by grantees. 1 Medical Care includes Part A and B outpatient/ambulatory health services; oral health care; home health care; home and community-based health services; hospice services; mental health services; medical nutrition therapy; outpatient substance abuse services; and Part A, B and C early intervention services 2 Approximately 10% of spending under Medications (ADAP) was for health insurance and adherence support. 3 Part D program reflects only a portion of spending for Women, Infants, Children, Youth and Families. 4 Dental Program reflects only a portion of spending for oral health. ADAPs: National Overview 56 ADAPs, including the District of Columbia, Puerto Rico, Virgin Islands, Guam, Marshall Islands, Northern Mariana Islands, and the American Samoa Islands. Wide variation in program characteristics due to individual State administration of each ADAP and HIV/AIDS prevalence in each State. Differences most pronounced in areas of funding, eligibility criteria, formulary size, and cost-saving strategies. ADAP Program Requirements Formulary must contain at least one medication from each class Many ADAPs have advisory boards ADAPs must set eligibility requirements and certify patients are eligible HIV infection or AIDS Low income: Federal Poverty Level (FPL) 200-500% In some cases meet the asset test ADAP Eligibility Criteria Determined by the State or Territory through an advisory committee Eligibility criteria include both financial and medical eligibility. Financial eligibility: is usually determined as a percentage of Federal Poverty Level (FPL), such as 200% FPL. Financial: proof of income < established __% of the Federal Poverty Level (FPL) based on household size and is updated annually. Financial eligibility is calculated on the gross income available to the household, excluding Medicare and Social Security withholding and the cost of health care coverage paid by the applicant. The eligibility criteria also include the determination of an assets test. Medical: Diagnosis of HIV-infection (symptomatic or asymptomatic) Some ADAPs may require applicants to bring in a CD4 and Viral Load laboratory results within the past six months and a prescription for an antiretroviral medicine in the ADAP formulary. Residency: proof of current State residency Lack of Insurance: proof of no other insurance coverage Recertification ADAPs are required to recertify the clients’ financial eligibility every six months. In some States, clients are required to go through a face-to-face ADAP eligibility determination every 6 months, based on FPL and household size which is updated annually. During the ADAP requirement determination, clients are screened for eligibility for Medicaid, Medicare, and other third party payer sources to ensure that the Ryan White program is the payer of last resort. Some ADAPs may require documentation of Medicaid denial or Department of Labor income screens, etc. Clients who are deemed underinsured for prescription medications may also be determined eligible for ADAP at this time. This can include inadequate insurance coverage under Medicare Part D, Medicaid Share-of Cost, No Brand Name Coverage, No Prescription Coverage, Open Enrollment (pending), Pharmaceutical Benefits Cap, Pre-existing Clause, Reimbursement and Discount Plans, and Unaffordable Co-payments. ADAP Services HIV/AIDS Medications Insurance Other services Adherence support Monitoring of drug treatment Enhanced access to services ADAP Funding FY 2010 federal funding $835,000,000 originally appropriated Added $25 million to assist states with waiting lists and cost containment measures Other sources State match, drug rebates, state general revenue funds, Part A/B contributions Overall, Federal ADAP line item is ~50% of the state’s total ADAP funding ADAP Funding Distribution 95% of funds distributed by formula, based on the number of living HIV/AIDS cases in the state in the most recent calendar year 5% set-aside for the ADAP Supplemental grant Distribution based on need, factors include: Reduction in eligibility standards, (FPL) Reduction in formulary Initiation of waiting list Unanticipated increase in eligible PLWH/A ADAP Supplemental In FY 2010, 27 Part B jurisdictions received ADAP Supplemental awards I In FY 2011, 42 Part B jurisdictions are eligible: 35 States District of Columbia, US Virgin Islands, Puerto Rico Pacific jurisdictions: American Samoa, Federated States of Micronesia, Guam and Northern Mariana Islands The ADAP Supplemental requires additional match of $1 for each $4 of federal funds Waived for states that meet match requirement for larger Part B grant ADAP Costs Approximately $11,500/year per client Vary significantly by state depending on formulary and program costs ADAPs have access to 340B pricing 340B discounts are required by the Veterans Health Care Act of 1992 (Section 602). States may either directly buy drugs (Direct Purchase) or collect rebates from drug companies (Rebate option) or distribute medications through a established pharmacy network. ADAP Waiting Lists State managed Policies differ by state 8,072 PLWH in 13 states as of 6/6/11 Must make sure wait-listed patients have access to medications via manufacturers’ Patient Assistance Programs (PAPs) Increased Demand for ADAP 18% growth from 2008 to 2009 Factors: Economic downturn Increased HIV testing Push for earlier HIV treatment More effective medications Longer survival rates Increased HIV prevalence Cost Containment Measures Lower the FPL eligibility criteria Add an asset test Reduce formularies Initiate/increase co-pays Negotiate lower drug costs Aggressively pursue 3rd party payers (e.g. screening for Medicaid and Medicare Part D eligibility at least every 6 months) Local Pharmacy Assistance Program Overview of LPAP A local pharmacy assistance program is implemented by Ryan White grantees (Parts A or B) to provide HIV/AIDS medications to eligible clients who would otherwise not have access to them. A policy will be issued to address the requirement for accountability and coordination across all Ryan White HIV/AIDS Programs in developing, implementing, monitoring, and the administration of Ryan White funded LPAPs. LPAP Criterion Consistent with the most current HIV/AIDS Treatment Guidelines. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf Compliance with legislative and program requirements Ryan White is the payer of last resort. LPAP Criterion (continued) Coordinated with the State’s Part B AIDS Drug Assistance Program Achieve administrative and cost efficiencies Avoid duplication of services Ensure that clients are not receiving medications from LPAP that are available from other sources. Implemented in accordance with 340B Drug Pricing Program, Prime Vendor Program, and/or Alternative Methods Project. LPAP Criterion (continued) Coordinated with the State’s Part B AIDS Drug Assistance Program (continued) Structured to assure effective grantee administrative, fiscal, programmatic oversight. Consistent procedures/systems to account for tracking/ reporting of expenditures, income, drug pricing, utilization, client eligibility, clinical quality management, medication therapy management. Consistent administration throughout EMA/TGA. Uniform benefits should be available to all eligible individuals. LPAP Design The purpose of a LPAP in accordance with the Ryan White HIV/AIDS Program is to provide therapeutics to treat HIV/AIDS and prevent the deterioration of health arising from HIV infection. This includes measures for the prevention and treatment of opportunistic infections. The Purpose of LPAPs As a Bridge service to the Part B ADAP, Medicaid, Medicare Part D, and other local or State prescription drug programs for clients who are undergoing eligibility determination for one or more of these programs. As a Wrap-around service to those who are underinsured and/or the Part B ADAP in one or more of the following ways: Provide access to HIV medications not included on the covered formulary, Expand coverage to individuals whose incomes exceed the ADAP financial eligibility criteria, Provide time-limited emergency coverage of HIV prescriptions for low-income clients who cannot otherwise pay for their HIV medications. LPAPs “Musts” Establish a local advisory committee/board as defined in the LPAP Guidelines. Ensure that clients applying for LPAP undergo both ADAP and LPAP eligibility screening. Recertify the eligibility of clients every 6 months if the LPAP serves as an on-going wrap-around to the State run ADAP. Participate in the HRSA Office of Pharmacy Affairs 340B program. (http://www.hrsa.gov/opa/) Affordable Care Act Provisions that Impact ADAP Pre-Existing Conditions Insurance Plans (PCIPs) ADAP now counts toward Medicare Part D True Out of Pocket (TrOOP) Costs For ADAP-eligible patients who also are Medicare eligible, ADAP may cover their Part D co-pays and premium, and/or provide their HIV/AIDS medications when they are in the Part D “donut hole.” LPAPs “Musts” (continued) Require sub-grantees who do not dispense medications to set up pharmacy contracts with pharmacies. This will enable sub-grantees to purchase medications at 340B prices for LPAP clients thru contract pharmacy services. Ensure that a LPAP is not used to pay for non- prescription medications. Establish and implement processes and procedures for back billing Medicaid and other third-party payers for services What is Medicare Part D? Since January 1, 2006, Medicare prescription drug coverage has been available to everyone with Medicare. Known as Part D, this benefit provides outpatient prescription drug coverage. Private companies provide the drug coverage. Beneficiaries choose the drug plan and pay a monthly premium. Like other insurance, if a beneficiary decides not to enroll in a drug plan when they are first eligible, they may pay a penalty if they choose to join later. Coverage Gap: The Donut Hole All plans have a coverage gap, also known as the “donut hole.” Once a beneficiary reaches the gap, he/she must pay for 100% of the drug costs until reaching catastrophic coverage. After reaching catastrophic coverage, the beneficiary would be responsible for approximately 5% of the drug cost. What is the DONUT HOLE? Coverage gap Deductible Initial Coverage Catastrophic Coverage Period What is TrOOP? TrOOP (True Out-of-Pocket) Costs Drugs provided by AIDS Drug Assistance Programs (ADAP) or the Indian Health Service count as TrOOP Effective January 1, 2011 TrOOP (true out-of-pocket costs – “incurred costs”) is the amount a beneficiary must spend on covered Part D drugs to reach catastrophic coverage. Based on the 2008 standard benefit design: $275.00 (deductible) + $558.75 (beneficiary coinsurance during initial coverage) + $3,216.25 (beneficiary coinsurance during coverage gap) = $4,050 (total TrOOP spending before catastrophic coverage) Part D premium is not part of TrOOP Medicare Part D Closes the coverage gap over time Provides a $250 rebate to those who enter the gap (or “doughnut hole”) in 2010 CMS automatically sends a rebate check when a beneficiary’s Part D spending reaches the coverage gap Checks are issued each month through mid-2011 Checks are issued within 75 days of the quarter in which the beneficiary enters (or hits) the gap Two groups do NOT receive the $250 rebate LIS enrollees Enrollees in a qualified retiree drug plan What Counts Toward TrOOP? Payments count toward TrOOP if: They are made for covered Part D drugs through a coverage determination or appeal) at a network pharmacy They are made by: The beneficiary Another “person” (including charities) on behalf of a beneficiary CMS as part of the low-income subsidies A State Pharmaceutical Assistance Program (SPAP) What Doesn’t Count Toward TrOOP? Payments DO NOT count toward TrOOP if they are made by: A group health plan Insurance A government–funded health program Another third-party payment arrangement Data Sharing Agreements (DSA) A Data Sharing Agreement (DSA) permits CMS to share Medicare entitlement information with another entity – the DSA Partner. Partners are: Pharmaceutical Manufacturer Patient Assistance Programs – PAPS. State Pharmaceutical Assistance Programs (SPAPs or ADAPs), and Pharmaceutical Benefit Management companies (PBMs). Employers, or insurers acting for employers. Why Have A DSA? A DSA permits the exchange of health care coverage data between the Medicare program and another health benefit provider. The DSA partner can learn who among those it covers are also Medicare beneficiaries. Medicare can learn if a group of beneficiaries has other benefit coverage. Both Medicare and the DSA partner can then adjust their coverage activities, making sure all benefits provided are correct and appropriate. Claims Adjudication Process With TrOOP COB 1. Beneficiary presents prescription and health plan card(s) to pharmacist. 2. Pharmacist queries Medicare plan’s (primary payer) computer to communicate prescription and verify eligibility, coverage and cost- sharing terms. 3. Medicare Plan performs drug utilization review (e.g. safety checks) and verifies eligibility, coverage, and applicable co-pay. 4. Plan alerts pharmacy to presence of secondary payer. 5. Pharmacist queries secondary payer’s computer (e.g. employer or SPAP). 6. Secondary payer identifies share of remaining beneficiary cost it will pay. Record of contribution goes to Medicare plan for TrOOP calculation and to CMS for audit purposes. 7. Pharmacist dispenses drug and collects any co-pay that remains after all payers have paid. Ryan White HIV/AIDS Program Challenges Increased demand for services in an environment of few new/declining resources, Rising costs and Growing HIV/AIDS prevalence Increasing financial pressure on medical systems Focus on early initiation of treatment Chronicity of HIV disease/aging More co-morbidities, increased need for primary care Identifying HIV infection earlier Expanding HIV testing Improving linkage to and retention in care Supporting the HIV workforce Need for both primary care and specialty services Ryan White HIV/AIDS Program Accomplishments Provide care, treatment and support services to approximately half of the PLWH in the US. Of the estimated 1.0 – 1.2 million PLWH/A in USA, Ryan White programs served over 529,000 uninsured and underinsured. Built networks and systems of care with and between public and private providers for a comprehensive response to the epidemic. Extended our knowledge base and expertise to improve the quality of HIV/AIDS care and treatment across the health care system.