The State of ADAPs

1. The State of ADAPs Britten Pund National Alliance of State & Territorial AIDS Directors August 4, 2014

2. Presentation Agenda • Emerging trends in ADAP • FY2013 Year in Review • Looking Ahead to FY2014 and FY2015 • ADAPs role in public health • Update on the ADAP crisis • ADAP waiting lists • ADAP cost-containment • Questions and Answers

3. 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.

4. 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.

5. FY2013 Year in Review

6. The National ADAP Budget, by source, FY1996-FY2013

7. ADAP Client Enrollment and Utilization

8. ADAP Client Demographics

9. ADAP Client Demographics (continued)

10. ADAP Insurance Coordination,June 2013 and FY2013

11. Looking Ahead to FY2014 and FY2015

12. Congressional Outlook • The 113th Congress has grown increasingly partisan, resulting in very little accomplishment. • Have passed only 126 laws since January 2013; lowest level of productivity in many years • In the 107th Congress (2000-2001), the Senate and House were controlled by different parties and still managed to enact 200 new laws. • The House is scheduled for 12 working days between now and then

13. Congressional Outlook(continued) • Many “must address” issues: • Veterans’ Affairs health care access • Unaccompanied Immigrant Minors • Highway Trust Fund • Surface Transportation Bill • Tax Extenders • Terrorism Risk Insurance Act • Export‐Import Bank reauthorization • Foreign Affairs • 12 Appropriations Bills

14. Elections Outlook

15. FY2014 Funding • In FY2014, ADAPs were funded at $900.3 million, a $14 million increase. Part B Base was funded at $414.7 million, a $9.5 million increase • Increases were due to the alleviation of sequestration • FY2014 was the first year without the hold harmless provision, which shifted allocations of funding awards

16. FY2015 Funding • The Bipartisan Budget Act of 2013 established spending caps and reduced sequestration for FY2015 • The FY2015 302b allocations for the Labor, Health and Human Services bill are similar to FY2014, however there are increasing funding needs for other programs • The debt ceiling will expire in March 2015

17. FY2015 Funding(continued) • President Obama’s budget included flat funding for ADAP and Part B Base • The Senate LHHS Subcommittee mark included a $5 million increase for ADAP and flat funded Part B Base • The proposed bill also redistributes SPNS funding throughout the Ryan White Program parts instead of a separate funding line

18. FY2015 Funding(continued) • The House and Senate Appropriations Committees have no plans to mark up a LHHS bill until after the November election • There will be a continuing resolution (CR) through November, possibly January • House is readying a CR for vote before the August recess • Awards will potentially be delayed

19. FY2016 Funding • President Obama’s last full fiscal year in office • Potential changes in House and Senate • Sequestration will impact FY2016 funding • Budget cap for non-defense discretionary funding is $494 billion, an increase of $1.6 billion from FY2015 • Appropriators will have to allocate funding at this level to avoid across-the-board cuts • Low chance of another “grand bargain”

20. Ryan White Next Steps • Ryan White still critical despite ongoing implementation of the Affordable Care Act • Part B and ADAPs continue to see growth in programs and strive to address unmet need: • From 2003 to 2013, enrollment in ADAPs increased by 64%. • Forty-four ADAPs used funds for insurance purchasing and continuation in 2013 • Part B programs necessary to address gaps in covered populations and services and to ensure that clients receive all support necessary to access and maintain new coverage options (both in premium and co-pay assistance and support services)

21. Ryan White Next Steps(continued) • AIDS Healthcare Foundation (AHF) has introduced the “Ryan White Patient Equity and Choice Act” (HR 4260) • Introduced by Rep. Renee Elmers (R-NC), Bennie Thompson (D-MS) and Eddie Bernice Johnson (D-TX). • Bill proposes: • To ensure that funding to jurisdictions under Part B and Part A does not varyby more than 5% (calls for Secretary report on how to do that); • Requires ADAPs to have pharmacy network that includes specialty pharmacies; • Tightens up cover medical services and waiver process • Bill is not getting traction in Congress

22. The Future of Ryan White: Congressional & Community Conversations • NASTAD and majority of community still feel it is best to not seek a reauthorization at this time • Congressional staffers have said we need “at least one year of data on ACA implementation” before moving forward • Changes ahead could potentially complicate situation • Leadership changes to Committees of jurisdiction • Energy & Commerce: Rep. Waxman retiring; Rep. Pallone (NJ) likely to replace him (although Rep. Dingell (MI) is a possibility) as Ranking Member • Health, Education, Labor & Pensions (HELP): Sen. Harkin retiring; Sen. Murray (WA) likely to become Chair

23. The Future of Ryan White: Congressional & Community Conversations(continued) • Possible complicating changes (continued): • 2014 Congressional elections; Republicans will retain control of House and Democrats will likely retain control of Senate (Senate is more up in the air) • Community already worrying about implications of 2016 Presidential election and its impact on legislation • Unknown appropriation levels in near-future • Focus on drug pricing with new ADAP Crisis Task Force negotiations • Focus on 340B program overall – Congressional and regulatory efforts • Part C and D RW community push

24. The Future of Ryan White: Congressional & Community Conversations(continued) • Messages from Congressional staff at FAPP RW Work Group meeting: • Many priorities in 2014 • Medicare “doc fix” • Authorization bills with sunset provisions • Beginning to look at discretionary health bills with ONLY medical component • Need to have state “case studies” showing how allocation of funds changed after ACA implementation • Both Medicaid expansion & non-expansion states • Need to have data to describe the ongoing importance of both “core medical” & “support services”

25. 340B and ADAP • The Office of Pharmacy Affairs (OPA) intended to release a “mega-regulation” on 340B this summer and the rule on ADAP rebates in December • In May, a judge ruled that on OPA’s orphan drug rule and found that OPA does not have the authority to make rules • This has postponed the original timelines for rule release. OPA is currently working on rereleasing the orphan drug rule and then will address the “mega-regulation” and ADAP rebate rules • NASTAD released a Best Practice for Shared ADAP and 340B Drug Pricing Program Clients earlier this month

26. ADAP and the Affordable Care Act

27. 25,000 ADAP Clients Transitioned to Medicaid Expansion and Qualified Health Plans (QHPs) NH VT WA ME ND NY MT MN OR WI SD MI ID CT WY PA NJ OH IA NE IN DE NV IL CO WV UT KY VA MD KS MO CA NC DC TN OK AZ AR SC NM GA AL MS AK TX LA FL HI

28. Challenges and Priorities

29. ADAP and Affordable Care Act • QHPs have extremely high cost sharing and co‐insurance costs. • QHP formulary issues – commonly prescribed single-tablet regimens being left off. • Pharmacy and provider networks do not include Ryan White Program providers or ADAP pharmacies. • 24 states are not expanding Medicaid. • 68% of ADAP clients in non-Medicaid expansion states have an income below 138% FPL. • Some ADAP clients have remained ineligible for ACA.

30. ADAP and Affordable Care Act (continued) • Looking Forward: • Mitigating churn between Medicaid, QHPs and other forms of coverage • HRSA is examining if ADAPs can cover any costs when reconciling the Advance Premium Tax Credits • States may not disenroll clients who do not transition to new coverage options

31. ADAPs Role in Public Health

32. Using the ACA to Tackle the Treatment Cascade

33. ADAP’s Role in Public Health • ADAP remains the safety net provider for many people living with HIV. • ADAPs and the rest of the Ryan White Program provide more comprehensive services than QHPs and Medicaid. • Health insurance does not replace public health.

34. ADAP in a Reformed Health System • ADAP structure, pre- and post-health reform implementation • 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

35. 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

36. ADAP Waiting Lists

37. 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.

38. 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.

39. ADAP Waiting Lists (35 individuals in 1 state) as of July 24, 2014

40. 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. • Medical criteria model:  based on hierarchical medical criteria based on recommendations by the ADAP Advisory Committee (1 ADAP). • Access to Medications: Utah ADAP confirms 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.

41. ADAP Cost-containment Measures

42. Factors Leading to Implementation of Cost-containment

43. ADAPs and Cost-containment

44. Questions and Answers

45. Resources • For an electronic copy of the 2014 National ADAP Monitoring Project Annual Report, please visit www.NASTAD.org. • For more information about the National ADAP Monitoring Project or the state of ADAPs, please contact Britten Pund at bpund@NASTAD.org.

46. Contact Information Britten Pund Senior Manager, Health Care Access NASTAD Phone: (202) 434.8090 bpund@NASTAD.org www.NASTAD.org