Transcript Researchers and Medicaid Medical Directors

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)
Clinician Concerns
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How does . . . (fill in the blank) . . .
compare with current practices:
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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
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
Spheres of Concern
Policy maker concerns involve three
separate, but overlapping spheres:
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Clinical Concerns

Economic Concerns
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Non-economic Concerns
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):
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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
Economic Considerations
Must consider economic value
 Better results at a justifiable cost
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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
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
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Periodic Re-examination of Issues
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New data may lead to policy changes
Acceptance by other entities, even without
new data, may lead to policy changes
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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
Valuable Information

In depth economic analysis:
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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
Current Topics of Interest
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Analysis of treatments for autism or the
behaviors associated with that condition:
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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
Current Topics of Interest
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New drug and biologic therapies:
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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
Questions?
Marc Leib, M.D.
(602) 417-4240
[email protected]