1. Medicaid: A Brief Overview and Case Studies on Access to Prescription Drugs Miriam Harmatz Florida Legal Services February 25, 2009

2. Medicaid Eligibility Need categorical connection - Aged or disabled - Child or parent Low income - Parent with child: income must be below $682 and assets less than $2,000 - Aged, blind or disabled: income must be below $657 assets less than $2,000

3. Medicaid Structure Federal/State funding State flexibility but federal law controls 42 U.S.C. § 1396 et seq. Entitlement* Complicated

4. Prescription Drug Benefit $$$: huge budget item, with costs rising more quickly than other benefits Prior authorization: tool for controlling costs required for certain brand name drugs and drugs not on PDL Result: patients did not get their meds

5. Due Process for Prescription Denials Hernandez et al. v. Medows, 209 F.R.D. 665 (S.D. Fla 2002.) Medicaid statute 42 U.S.C. § 1396a(a)(3) Goldberg v. Kelly Medicaid regulations 42 C.F.R. § 431.200 et seq. 14 th Amendment

6. Importance of data, experts and settlement Discovery regarding drug denials Relationship to class and permanent injunction Complexity of benefit: settlement best outcome

7. What drugs can be prescribed? On label Off label

8. Medically accepted indication 42 U.S.C. § 1396r-8(k)(6) The term “medically accepted indication” means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. § 301 et. Seq.], or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(b)(i) of this section. Compendia Applies to Medicaid & Medicare Part D

9. Edmonds et al. v. Levine Off label marketing abuses State response Adverse impact on recipients

10. Structure of prescription benefit Rebates Very limited grounds for denial Role of Compendia Can PA

11. Medicaid Reform Goal to block grant/privatize Defined benefit/predictable spending Plans determine amount, duration, and scope PD limits on # Lack of data regarding denials

12. Medicare Part D Privatized model Limited government role Lack of denial data or info on price negotiations Lack of uniform PDL structure

13. “Medically Needy” hurt by Part D Categorical connection: Aged or disabled – over income or over assets; share of cost (SOC) like deductible Before Part D those with high drug costs met SOC – Full Medicaid-including drug benefit/no co-payments – Full Medicare cost share benefit deductible, co-insurance, co payments After Part D – Lost Medicaid – Huge Part D co-payments – No Medicare cost sharing benefit

14. Medicare Part D “Victim” RB needs transplant Income $1200/month, plus Medicare Medically needy share of cost (SOC) $ 900 Transplant drugs Part B: $ 700 All other drugs covered by Part D Cannot meet Share of cost; or afford cost of Part B drugs Rejected for evaluation

15. Is health care right or responsibility? If right- for everyone or just the “categorically connected” poor? If right for everyone, cover every medically necessary service? Government v. private sector?