National Forum on Biomedical Imaging in Oncology CMS UPDATE

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National Forum on Biomedical Imaging in Oncology
CMS UPDATE

• Steve Phurrough MD, MPA
• Director, Coverage and Analysis Group

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Recent Activities

• PET scanning
• NCI trials
• Coverage with evidence development

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PET for Alzheimers Disease

• Limited coverage as differential in FTD
• Clinical trials

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PET for Cancer Indications

• Added cervical cancer
• All current future noncoverage based on lack of
  evidence will be covered with data collection

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National Decisions

• National Coverage
• National Noncoverage
• National Coverage with restrictions
• Specific populations
• Specific providers/facilities
• Evidence development

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Percutaneous Coronary Interventions
CP1027346-1
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SCD-HeFT
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Contributors to Variation

• Inconsistent use of good evidence
• Lack of high quality evidence from studies
  selected and designed to inform clinical
  decisions
• Evidence gaps are systematic and widespread
• Existing clinical research enterprise will not
  correct the problem
• CMS aim is to help establish more robust research
  enterprise serving decision makers
• pts, clinicians, payers, policymakers
• One mechanism is through coverage authority

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Unanswered Questions

• Novel vs conventional imaging
• Comparative effectiveness of drugs
• Surgical procedures
• Off-label uses of approved drugs
• 510(k) devices
• Risks and benefits of treatments in subgroups of
  pts studied
• Patients with multiple co-morbidities

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Developing EvidenceCore concept

• Links coverage with prospective data collection
• Extends concept of medical necessity
• Adequate evidence of benefit
• Adequate evidence of potential value and provided
  in appropriately designed study
• i.e. promising, important, potentially high
  value, and under careful investigation
• Retains EBM as conceptual framework for coverage
  and payment

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Problems with EB coverage

• Viewed as interference with pt/doc decisions
• Payers appear to impede innovation in order to
  control spending / protect profits
• Insensitive to real barriers to doing adequate
  trials, and different challenges by technology
• When evidence limited, may still be strong demand
  for technology
• Does not promote promising but unproven high
  value technologies

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Benefits of approach

• Addresses economic barriers to good trials,
  especially for promising technologies
• Payers can promote innovation and access, while
  supporting better evidence
• One strategy to establish clinical research
  agenda oriented to decision makers
• Strong public/professional demand can be
  channeled to improve evidence
• Focus discussion around improving evidence with
  key stakeholders
• product developers, pt advocates, payers,
  clinicians

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Key conceptual issues

• How to evolve from ad hoc to systematic policy
  approach
• Priority setting criteria, participants,
  process
• Roles and governance what organizations oversee
  and implement various functions of the initiative
• Funding
• How much can be accomplished by PCE
• What are other sustainable sources and mechanisms
  of funding
• What is the business case for each potential
  funder?

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Implementation Issues

• Methods When to use registries, practical
  trials, registries, outcomes studies, etc
• Infrastructure what exists, what needs to be
  created, how can this be done most efficiently
• Legal and ethical private payer contractual
  issues, HIPAA, human subjects, conflicts of
  interest

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Next Steps

• Guidance on coverage plus data
• Open door forum 2/14
• Initial draft guidance soon
• ICD registry workgroup and CMS-NCI collaboration
  moving forward
• FDA discussions on Post Approval Studies
• IOM/AHRQ/CMS discussions
• Larger stakeholder mtg 3/1
• Initial focus on registries to break trail
• Priorities, governance, funding, implementation

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Contact Information

• Steve Phurrough
• SPhurrough_at_cms.hhs.gov
• 410-786-2281