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The State of ADAPs. Britten Pund National Alliance of State & Territorial AIDS Directors July 8, 2013. Presentation Agenda. Emerging trends in ADAP FY2012 Year in Review Looking Ahead to FY2013 ADAPs and Health Reform Expanded Access to Care Update on the ADAP Crisis ADAP waiting lists
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The State of ADAPs Britten Pund National Alliance of State & Territorial AIDS Directors July 8, 2013
Presentation Agenda • Emerging trends in ADAP • FY2012 Year in Review • Looking Ahead to FY2013 • ADAPs and Health Reform • Expanded Access to Care • Update on the ADAP Crisis • ADAP waiting lists • ADAP cost-containment • Questions and Answers
Overview of NASTAD • NASTAD is an international non-profit association of U.S. state health department HIV/AIDS program directors who administer HIV/AIDS and viral hepatitis programs funded by U.S. state and federal governments. • NASTAD was established in 1992 as the voice of the states. • NASTAD is governed by a 20 member, elected Executive Committee charged with making policy and program decisions on behalf of the full membership. • NASTAD has a Washington, DC headquarters with 38 staff and field offices/programs in Bahamas, Botswana, Ethiopia, Guyana, Haiti, Trinidad, South Africa and Zambia with 65 staff.
NASTAD Mission and Vision Mission NASTAD strengthens state and territory-based leadership, expertise and advocacy and brings them to bear on reducing the incidence of HIV and viral hepatitis infections and on providing care and support to all who live with HIV/AIDS and viral hepatitis. Vision NASTAD’s vision is a world free of HIV/AIDS and viral hepatitis.
ADAP Crisis • From FY2008 to FY2012, federal ADAP funding (including Part B ADAP Earmark, Part B ADAP Supplemental and ADAP Emergency Funding) increased 24%. • From FY2008 to FY2012, state contributions to ADAP decreased 12%. • From FY2008 to FY2012, estimated drug rebates increased 127%.
ADAP Emergency Funding • In August 2012, ADAPs received $75 million to address ADAP waiting lists and other unmet ADAP needs. • ADAP emergency funding awards were made to 25 states. • Funding amounts ranged from $74,324 in North Dakota to $10.1 million in California.
Funding Outlook – FY2013 • In FY2013, ADAPs were funded at $886 million, a cut of $47 million due to sequestration. • NASTAD estimates this sequester cut could affect over 8,200 clients currently enrolled on ADAP. • $35 million was transferred to ADAP for emergency relief funding from other HHS programs, including other parts of Ryan White. • This does not affect the sequester cut and it does not represent an increase in funding for FY2013. • With the implementation of health reform and continued fiscal challenges, ADAPs may continue to experience shifts in state funding allocations, including potential reductions.
Funding Outlook – FY2013(continued) • FY2013 also brings changes to the ADAP award formula calculations: • Normal shifts of proportion of the country’s living HIV/AIDS cases • Only name-based HIV cases reported to CDC will be used • The hold harmless provision will decrease to 92.5% of states’ FY2012 award • FY2013 is the final year of the transitional grant area (TGA) transfer • These funding shifts have not yet been realized by final FY2013 awards are just being received by states.
Funding Outlook – FY2014 • If sequestration is not fixed, it will continue each fiscal year until FY2021: • Discretionary spending caps for fiscal years 2012-2021 for $984 billion in savings over 10 years or $109 billion annually • $350 billion less over 10 years than in 2013 for non-defense discretionary programs • These cuts will be made through the appropriations process or through across-the-board cuts
Funding Outlook – FY2014(continued) • President Obama’s budget was released on April 10, 2013 and includes: • $20 million increase for Ryan White Program, including $10 million increase for ADAP • $35 million Emergency Relief Funding continued • Eliminates the sequester
Funding Outlook – FY2014(continued) • The House and Senate have very different FY2014 budgets: • The House allocation for Labor, Health and Human Services, Education, and Related Agencies is $121.8 billion, which represents an 18.6% cut from FY2013. • If applied universally, ADAP could be funded at $721 million, a $164 million cut. • The Senate’s budget funds at much higher levels than the House budget and eliminates the sequester • It is highly possible that FY2014 will result in a continuing resolution and probable sequestration causing prolonged fiscal uncertainty for ADAP.
Ryan White Program Reauthorization • The Ryan White Program authorization ends on September 30, 2013. • The authorization does not contain a sunset clause and can continue through appropriations. • The Ryan White Program may not likely to see legislative action this year. • Administration will not push for reauthorization • Need better understanding of changes to health system due to health reform before making major changes • Long term visioning and planning for reauthorization is underway with the HIV advocacy community • Potential for language to be introduced by the House or Senate in the appropriations process that could affect how the Ryan White Program continues.
ADAP in a Reformed Health System • What will ADAP “look like” after January 1, 2014? • Traditional ADAP • Full payment of medications for those not eligible for coverage under the Affordable Care Act • Insurance purchasing/continuation • Wrap-around of Medicaid and Medicare • Including Medicaid expansion and non-expansion states • Insurance purchasing – purchasing of a new policy • Including policies purchased through the Exchange • Insurance continuation – payment for an existing policy • Including policies purchased through the Exchange
ADAP in a Reformed Health System (continued) • What is the potential change in ADAP utilization between FY2013 and FY2014? • Client migration to Medicaid in a non-expanding state • Presumption that clients would not move • Client migration to Medicaid in an expanding state • Potential for clients to shift coverage to Medicaid • Client migration to Exchanges • Potential for clients to gain access to insurance for the first time, however ADAP may remain the payer for the policy (i.e., premiums, deductibles, and co-payments) • Clients remaining on ADAP • Individuals who are categorically ineligible for federal programs • Individuals needing wrap-around coverage for an existing or new insurance policy • Individuals who churn • Individuals who do not enroll
Current Initiative • Analyzed three current options for increased access to care for under and uninsured individuals living with HIV – ADAP, pharmaceutical patient assistance programs (PAPs) and Welvista. • In collaboration with HHS/HRSA and the Clinton Health Access Initiative, NASTAD has worked to develop a standardized PAP enrollment process and application. • This effort, in conjunction with industry and federal partners, will bring HIV/AIDS care and treatment for the under and uninsured to a new era.
Common PAP Process • Working toward reaching consensus on a common application and eligibility/fulfillment process. • Step One: simplifying and streamlining access to PAP medications (HHS Common Form) • Step Two: streamlining eligibility and prescription fulfillment distribution (HarborPath) • Reduce burden for providers, case managers and PLWH.
Common PAP Application • Working with industry and NASTAD, HHS/HRSA developed and announced the common form during the International AIDS Conference in July 2012 (www.NASTAD.org/CommonPAPForm). • Form “went live” on September 12, 2012
Instructions for Completing the Common PAP Application • Individual or case managers completes the online form • Form only needs to be completed once for all medications for which individual is applying. • Print out the completed form for the companies from which the individual needs medications. • Sign the form (most need an original signature). • Attached necessary documentation. • Submit to companies – each company has a separate fulfillment process (e.g., mail order, pharmacy, etc.).
Common PAP Application(continued) • In April 2013, all companies accepting the common form convened for a consultation to discuss the use and usefulness of the form. • Updates are being made to the form to ensure its efficacy and it will be relaunched in summer 2013.
HarborPath • NASTAD and the Clinton Health Access Initiative (CHAI) launched HarborPath (HP) to streamline PAP enrollment, eligibility processing and prescription fulfillment. • HP is a collaborative undertaking between pharmaceutical partners, NASTAD, donors, government agencies, and advocacy groups. • There are currently two prongs of HarborPath: • Online portal • ADAP waiting list program
HarborPath: Online Portal • HP has completed software development for the common portal and can process PAP forms as well and ADAP waiting list forms. • Gilead Sciences, Merck and Co, and ViiV Healthcare are supplying medications to the HarborPath online portal. • Discussions continue with AbbVie, Bristol-Myers Squibb, and Janssen Therapeutics. • The HarborPath online portal is currently in a pilot phase in seven states and Washington, DC (AL, FL, GA, NC, SC, TX, WA).
Instructions for Using HarborPath: Online Portal • The HarborPath online portal is for clinics/case managers (requires an agreement between clinic and HarborPath). • Case managers enter all application data (stored). • HarborPath determines eligibility and then transmits shipping information to mail-order pharmacy. • Clients receive one shipment containing all medications available on HarborPath formulary. • Other medications not available require print out of company form based on data inputted into portal.
HarborPath: ADAP Waiting List Program • In May 2013, the ADAP waiting list program was transferred from Welvista to HarborPath. • AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen Therapeutics, Merck and Co, and ViiV Healthcare are supplying medications to the HarborPath ADAP waiting list program. • The HarborPath ADAP waiting list program is licensed in all states and currently available in all states that have a waiting list.
Instructions for Using HarborPath: ADAP Waiting List Program • ADAP coordinators or ADAP case managers, on behalf of new patients on ADAP waiting lists wishing to access the HarborPath ADAP waiting list program, should complete and certify a HarborPath ADAP Waiting List Program Enrollment Form, including prescriptions, and submit these to HarborPath in order to ensure the dispensing of available medications. • Patients who are prescribed medications not listed above (primarily from Boehringer Ingelheim Pharmaceuticals) will need to apply through the applicable patient assistance program (PAP). • Clients receive one shipment containing all medications available on the HarborPath: ADAP waiting list program formulary.
Factors Leading to Implementation of Cost-containment Measures • ADAPs reported the following factors contributing to consideration or implementation of cost containment measures: • Higher demand for ADAP services as a result of increased unemployment • Level federal funding awards • Increased demand for ADAP services due to comprehensive HIV testing efforts • Escalating drug costs • Budgets cuts in state Medicaid and other state programs • Demand for ADAP has not dwindled.
Access to Medications • Case management services are being provided to clients on ADAP waiting lists through: • ADAP • Ryan White Part B • Contracted agencies • Other agencies, including other Parts of Ryan White • ADAP waiting list states confirm that ADAP waiting list clients are receiving medications through other mechanisms.
NASTAD Process for Updates • Weekly updates • Monday-Thursday – connect with ADAPs anticipating cost-containment and waiting lists to check on current program status • Friday – e-mail requesting an updated number of individuals currently on each states ADAP waiting list, as of that date • Monday – compile information received and release ADAP waiting list update • Process aligns with ADAP waiting list reporting to HRSA.
NASTAD Reporting Process • ADAP waiting list update contains individuals who have: • Completed the application process for their state ADAP • Been deemed eligible for the ADAP in their state • Been placed on the states ADAP waiting list or unmet need list • Information captured each week at the same point in time (all states provide an updated number based on a date provided by NASTAD)
What the ADAP WatchDoes Not Capture • Individuals who have not presented to ADAP • Individuals who have presented but were not eligible • Individuals who may have been disenrolled • Individuals who have “fallen out” of ADAP (e.g., no longer taking drugs, moved, obtained other coverage) • Individuals who may be in one or more of the above categories and accessing a PAP for medications
ADAP Waiting Lists (227 individuals in 3 states), as of June 20, 2013
Waiting List Organization and Access to Medications • Waiting List Organization: Waiting list clients are prioritized by one of two models: • First-come, first-served model: placing individuals on the waiting list in order of receipt of a completed application and eligibility confirmation (3 ADAPs). • Medical criteria model: based on hierarchical medical criteria based on recommendations by the ADAP Advisory Committee (0 ADAPs). • Access to Medications: All three ADAPs with waiting lists confirm that case management services assist clients in obtaining medications through the HarborPath ADAP waiting list program or pharmaceutical company patient assistance programs (PAPs) while clients are on the waiting list.
Factors Leading to Implementation of Cost-containment • As of June 11, 2013, ADAPs reported the following factors contributing to consideration or implementation of cost containment measures: • Reduced or insufficient federal ADAP funding (9 ADAPs) • Increased clients/demand due to job loss/unemployment (9 ADAPs) • Escalating drug costs (7 ADAPs) • Increased utilization from already enrolled clients (6 ADAPs) • Increased insurance/Medicare Part D wrap around costs (6 ADAPs)
