Bridging the Gap Between Research and Medicaid Policy

1. Bridging the Gap Between Research and Medicaid Policy Academy Health Annual Research Meeting June 8, 2008 Marc Leib, M.D., J.D. Chief Medical Officer Arizona Health Care Cost Containment System (AHCCCS)

2. Clinician Concerns • How does . . . (fill in the blank) . . . compare with current practices: • Is it as safe, safer, or have different risks? • Is it as effective or significantly more effective than current practice • Are patients likely to demand this over what is currently offered • How much does it cost is a lesser concern

3. Policy Maker Concerns In addition to clinicians’ concerns: • Meta-analysis of multiple clinical studies • What is the “value” of the new treatment • Value = Quality / Cost • Quality or Cost (or a combination of the two) results in Value • Cost is not usually the only driver • Legislators may impose additional barriers

4. Spheres of Concern Policy maker concerns involve three separate, but overlapping spheres: • Clinical Concerns • Economic Concerns • Non-economic Concerns

5. Clinical Considerations • Clinical evidence should guide coverage, PA and “medical necessity” criteria • Should new therapy replace old therapy • Can new therapy be safely delayed for trial of older therapy (step therapy): • Are the two mutually exclusive • Will delay have significant detrimental affects • Other concerns that make step therapy of lesser value to patient, physician or program

6. Economic Considerations • Must consider economic value • Better results at a justifiable cost • Justifiable costs may be higher if improved outcomes outweigh new costs • If no improvement in results, new costs are more difficult, but not necessarily impossible, to justify

7. Non-economic Factors • Other options • Results of non-coverage • Political realities, legislative agendas, provider activities, advocacy groups, etc. • Likelihood of court actions/interventions and likely outcomes of those actions • Must be willing to re-examine issues

8. Periodic Re-examination of Issues • New data may lead to policy changes • Acceptance by other entities, even without new data, may lead to policy changes • Essure initially not covered by AHCCCS, then accepted by several private payors, followed by a few Medicaid programs, now by many Medicaid payors, including AHCCCS without significant new data

9. Valuable Information • In depth economic analysis: • New costs associated with new therapy • Possible achievable cost savings, both in terms of immediate and long-term savings • Results compared to older treatments--are the improvements worth the costs • Future savings may be reduced to present value for purposes of analysis comparisons

10. Current Topics of Interest • Analysis of treatments for autism or the behaviors associated with that condition: • Drug therapy--costs, effectiveness, safety and the political pressures not to medicate children • Applied Behavioral Analysis--how much is enough, is more really better, realistic expectations for parents, providers and payers • Efforts to minimize unnecessary C-sections while promoting optimal birth outcomes

11. Current Topics of Interest • New drug and biologic therapies: • Identify patients most likely to benefit • Criteria to begin therapy • Reasonable therapy trials • Criteria to discontinue therapy if no results • Optimum management of peptic ulcer disease, asthma, diabetes, cardiac disease and other chronic diseases

12. Questions? Marc Leib, M.D. (602) 417-4240 marc.leib@azahcccs.gov