Transcript Document

Comparative Effectiveness Research:
Payer Perspectives
Sean Tunis MD, MSc
May 5, 2009
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Disclosure
 CMTP develops tools and strategies for
comparative effectiveness research
 We receive funding from government,
foundations, life sciences companies, health
plans, and medical professional societies
 Aim is to serve as a neutral convener
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Great Expectations
• “At the core of both the stimulus bill and
Obama’s budget is Orszag’s belief that a
government empowered with research on the
most effective medical treatments can, using
the proper incentives, persuade doctors to
become more efficient health care providers,
thus saving billions of dollars. Obama is in
effect betting his Presidency on Orszag’s
thesis.”
– The New Yorker. May 4, 2009.
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Medicare Coverage
• Sect. 1862 (a)(1)(A), Title 18, SSA
– “…no payment may be made…for items or
services . . [which] are not reasonable and
necessary for the diagnosis or treatment of
illness or injury.”
• Working definition of R&N
– “Adequate evidence to conclude that the item or
service improves net health outcomes”
Illustrating the Problem:
Tx of Clinically Localized Prostate Cancer
• Limited evidence on relative safety and effectiveness
of major treatment options
– prostatectomy, brachytherapy, radiation, active surveillance
• New technologies rapidly spreading without data
– robotic surgery, proton beam
• Rigorous trials needed to compare treatment options,
especially for side effects
115 Technologies Reviewed by Kaiser
Paul Wallace, Permanente Federation
Medically
appropriate
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Insufficient evidence
because the
evidence is:
Generally not
medically
appropriate
A. Of insufficient
quantity 66
and/or quality
B. Conflicting or
inconsistent3
C. There is no
evidence
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Critical Knowledge Gaps
• The paradox
– 18,000 RCTs published each year
– “Available evidence is limited or poor quality”
• Patients, settings, comparators, outcomes,
timing often not aligned with decision makers
– Patients, clinicians, payers, policy makers
• Decision makers have limited traction
– “didn’t invite CMS because it’s a scientific mtg”
– “don’t want patients messing up our protocols”
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CMS Efforts to Improve Evidence
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NETT trial (1995)
Category B IDE regulation (1996)
Cover routine costs of clinical trials (2000)
Coverage with evidence development (2003)
Promote pragmatic clinical trials (2003)
MCAC becomes MedCAC (2005)
Ad hoc collaborations with NIH
Creative application of existing authorities
– Functional equivalence, LCA, HCPCS coding
Implantable Defibrillator Registry
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Medicare coverage expanded 01/05
Registry intended for risk stratification
300k+ patients now in registry
Baseline data interesting
– Median age 74 (vs 60 in trials); LVEF higher
– 3.6% complication rate
• No firing info or other outcomes data
– Low priority for NHLBI, Industry, ACC/HRS
– AHRQ/NIH have recently identified funds
– Small fraction of $12.5B could have major ROI
• Funding of CED studies high priority
Impact of ARRA
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$1.1B is a good way to focus attention
Multiple Coordinating Councils
IOM priority setting committee
Many position papers developed / underway
New advocacy coalitions (e.g. PIPC)
Lots of sleep-derived, newly-minted
comparative effectiveness researchers
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IOM CER Working Definition
• “The generation and synthesis of evidence
that compares the effectiveness of alternative
methods to prevent, diagnose, treat, monitor,
and improve delivery of care for a clinical
condition.
• The purpose of CER is to assist patients,
clinicians, purchasers, and policy makers in
making informed health decisions.”
Implications of CER Purpose
• If primary purpose of CER is to inform
decisions by patients, clinicians, payers,
policymakers, then:
• CER requires high level of involvement of
these decision makers
– Implies collaborative approach
– Inherent tension with current PI-driven model
• Best practices for meaningful engagement of
patients/consumers, payers not yet clear
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CMTP Patient-Consumer
Advisory Committee
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Jessie Berlin (chair of PCAC)
Maureen Corry
Gene Kazmierczak
Jennifer Sweeney
Larry Sadwin (CMTP board chair)
Patience White
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Medicare Review of CCTA
• EPC report from Duke (April 2006)
– Limited evidence of clinical utility in any population
• MedCAC mtg (May 2006)
– “Uncertain confidence about existing evidence”
• Broad local coverage of CCTA
• Medicare draft policy in 12/07 proposed CED
for CCTA in “adequate” studies
Debate on CCTA Coverage
• Payers/researchers
– Propose RCT with death/AMI outcome
– 20k patients, 2-3 years of follow-up
• Vendors / clinicians
– existing evidence adequate for coverage
• Medicare final decision (March 2008)
– No adequately designed studies show improved outcomes
– “We believe large, well-designed prospective trials needed”
– Broad coverage by local contractors retained
• ICER review – unproven / promising
• NHLBI currently reviewing 3 RCTs
Cardiac Imaging Think Tank
• Goal was to move toward shared evidence
framework for non-invasive cardiac imaging
– Engage decision makers in study design
• Broad involvement of experts / stakeholders
– Co-sponsors: ICER, ACC, ACR, SCCT, ASNC
– private payers, CMS, imaging vendors, clinical
researchers, consumers, AHRQ, VA, etc.
• Result
– Modest reduction in hostility / some conversation
– Now developing “Effectiveness Guidance
Document” to guide future CER studies
Contact Info
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[email protected]
www.cmtpnet.org
443-759-3116 (D)
410-963-8876 (M)