Ann Lefert and Emily McCloskey NASTAD ADAP TA Meeting July 31, 2014

1. NASTAD Policy Update Ann Lefert and Emily McCloskey NASTAD ADAP TA Meeting July 31, 2014

2. Overview of Presentation • Congressional Outlook • Mid-term Elections Outlook • Appropriations • Affordable Care Act Implementation • 340B and ADAP • Ryan White Program Reauthorization

3. 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 the November elections

4. Congressional Outlook(cont.) • 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

5. Elections Outlook - Senate

6. 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

7. 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

8. FY2015 Funding(cont.) • President Obama’s budget included flat funding for ADAP and Part B Base • The Senate LHHS Subcommittee included a $5 million increase for ADAP and flat funding for Part B Base • The proposed bill also redistributes SPNS funding throughout the Ryan White Program parts instead of a separate funding line – we predict no change in allocation of funding to Parts

9. FY2015 Funding(cont.) • 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 • FY2015 awards will potentially be delayed

10. 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 increaseof $1.6 billion from FY2015 • Appropriators will have to allocate funding at the budget cap level to avoid across-the-board cuts • Low chance of a “grand bargain”

11. Affordable Care Act Implementation NH VT WA ME ND NY MT MN OR WI SD MI ID CT WY PA MA NJ OH IA NE IN DE NV RI IL CO WV UT VA MD KY KS MO CA NC DC TN OK AZ AR SC NM GA AL MS AK TX LA FL HI

12. Enrollments in the West WA MT OR ID WY NV CO UT CA AZ NM AK HI

13. Enrollments in the Midwest ND MN WI SD MI OH IA NE IN IL KS MO

14. Enrollments in the East NH VT ME NY MA RI CT PA NJ OH DE WV MD DC

15. Enrollments in the South WV VA KY NC TN OK AR SC GA AL MS TX LA FL

16. Addressing the “Medicaid Gap” in Non-Expansion States To help fill the gap… Most Ryan White Programs are: Purchasing insurance for those in the “Medicaid Gap” Providing safety net for those who cannot afford insurance or who are not otherwise eligible

17. ADAP/Part B Programs Currently Purchasing Qualified Health Plans (QHPs) for Clients (June 2014) NH VT WA ME ND NY MT MA MN OR WI RI 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 ADAP purchasing QHPs (premiums, Rx co-pays, or deductibles) ADAP piloting QHP purchase ADAP not currently purchasing QHPs (most are planning)

18. Challenges and Priorities

19. HRSA/HAB Policies and ADAP Insurance Purchasing • HRSA encourages state ADAP/Part B Programs to use their Ryan White funding to help clients access insurance, as long as: • Formulary includes at least one drug in each class of core ARVs from the HHS Clinical Guidelines • It is cost-effective in aggregate as compared to purchasing medications • Other Ryan White Program grantees may also use their funds to help clients with the cost of insurance • The Ryan White Program is the payer of last resort and grantees must “vigorously pursue” client eligibility for public and private insurance • Grantees may not dis-enroll clients from services for failure to enroll in public or private insurance coverage • Ryan White Program funds may be used to cover services not covered or inadequately covered by public and private insurance

20. 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 (full rebates on partial pay claims) in December In May, a judge ruled 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

21. 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)

22. Ryan White Next Steps • 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 vary by more than 5% (calls for Secretary report on how to do that) • Requires ADAPs to have pharmacy network that includes specialty pharmacies • Tightens up core medical services and waiver process • Bill is not getting traction in Congress

23. 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 as Ranking Member • Health, Education, Labor & Pensions (HELP): Sen. Harkin retiring; Sen. Murray (WA) likely to become Chair

24. The Future of Ryan White: Congressional & Community Conversations • Possible complicating changes (continued): • 2014 Congressional elections; Republicans will retain control of House. Senate control is up in 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 • Ryan White Parts C and D community push

25. The Future of Ryan White: Congressional & Community Conversations • Messages from Congressional staff at FAPP Ryan White 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”

26. Future of Ryan White: NASTAD Conversations Conversations within NASTAD membership to discuss state health department vision for future of Ryan White Intent is not to develop a set of publicly released policy recommendations but to have a vision to discuss with partner organizations and others Could develop a range of policy options on any specific provision Would discuss issues such as ones on following slides (obviously not an exhaustive list)

27. Future of Ryan White: NASTAD Conversations • Overarching question - does Ryan White support the HIV care continuum and goals of National HIV/AIDS Strategy? • Part Structure • If developing Ryan White today with what we have learned how would we set up the Program? • Are all Parts necessary? • Is Part A and Part B funding duplicative and does it lead to unfair distribution of resources? • Ideas such as block grant to states vs. additional Part A cities have been raised • Are Parts C and D working as they should – do they need to be retooled? • Planning and Community Engagement • How do we simplify the planning processes and still have meaningful engagement of interested parties (especially people living with HIV)?

28. Future of Ryan White: NASTAD Conversations • Funding formulas: • Is current formula which only uses HIV/AIDS cases sufficient at this point in the epidemic? • Issue of jurisdiction of diagnosis vs. jurisdiction where receiving care – client level data • Severity of Need process looked at other data points to include in formula: poverty, cost of care, death rate among people with HIV, etc. • Possible inclusion of performance-based incentives? • Looking at data along continuum as measure of needs of funding and performance • Formula vs. competitive pots of money that can be allocated in a more flexible manner

29. Future of Ryan White: NASTAD Conversations • Are health departments nimble enough to respond to changes in the health care system and provide clients with support to access and retain other primary coverage • Payments of insurance premiums and prescription deductibles and co-pays • Issue of co-payment of medical deductibles and co-pays • What do we do with states that are not able to implement insurance purchasing and continuation programs for political or other reasons • Payer of last resort • Clients unable to access same coverage options as individuals in other states

30. Future of Ryan White: NASTAD Conversations • Specific populations: • How do we ensure that Ryan White is reaching those populations most affected by HIV • Ryan White data shows that young black gay men are underrepresented in Ryan White Program • Is the Program meeting the needs of an aging population? • Other co-morbidities: • Is there more that can be done for co-infected individuals with HIV and viral hepatitis? • Should Ryan White Program be expanded to provide same range of services to individuals with conditions other than HIV (mono-infected individuals with HCV)?

31. Contact Information Ann Lefert Director, Health Care Access and Policy NASTAD Phone: (202) 434.8090 alefert@NASTAD.org Emily McCloskey Manager, Policy and Legislative Affairs Phone: (202) 434.8067 emccloskey@NASTAD.org