Medicare Reimbursement and Diagnostic Imaging

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Medicare Reimbursement and Diagnostic Imaging

• Sean Tunis MD, MSc
• Chief Medical Officer
• Centers for Medicare Medicaid Services
• March 25, 2003

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Steps to Medicare Reimbursement

• Regulatory approval
• Benefit determination
• Screening in absence of signs or symptoms
• Coverage
• Reasonable and Necessary
• Coding
• Payment
• bundled payment and incremental advances

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Reasonable and Necessary

• Safe and effective (per FDA, if applicable)
• Adequate evidence to conclude that the item or
  service improves net health outcomes
• emphasis of outcomes experienced by patients
• function, QoL, morbidity, mortality
• generalizable to the Medicare population
• as good or better than current covered
  alternatives
• improvement is clinically meaningful (?)
• Evidence assessed using EBM framework

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EBM Definition

• ...Evidence-based medicine de-emphasizes
  intuition, unsystematic clinical experience, and
  patho-physiologic rationale as sufficient grounds
  for clinical decision making and stresses the
  examination of evidence from clinical research.
• Evidence-Based Medicine Working Group, JAMA (1992)

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MCAC diagnostic guidelines

• Question 1 Is the evidence adequate to determine
  whether the test provides more accurate
  diagnostic information?
• Question 2 If the test changes accuracy, is the
  evidence adequate to determine how the changed
  accuracy affects health outcomes?

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FDG-PET and breast cancer

• Initial diagnosis abnormal mammogram or
  palpable breast mass, undergoing bx
• Initial diagnosis low suspicion mammogram
  getting short interval repeat
• evaluation of axillary lymph nodes to decide on
  lymph node dissection
• adjunct to standard staging in locoregional
  recurrence or distant mets / recurrence
• monitoring response to therapy

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Natural History of Imaging Technology
Sensitivity/Specificity/Accuracy /- Clinical
Effects
First Technical Data
Proven Clinical Effectiveness
Initial Market Presence
Broad Market Presence
Discovery
Clinical Standard of Care
FDA Approval
Coverage Standard
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NCI-CMS workshop

• met to discuss framework for evaluation of dx
  imaging
• Goal to balance evidence with feasibility
• use of modeling encouraged
• sens/spec cannot be modeled
• consider lower evidence threshold for rare
  cancers
• explore collaboration to increase quantity and
  quality of high priority clinical research

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Clinical research catch-22

• Demonstrating effectiveness takes time and
  resources
• Catch-22 without coverage and revenue, less
  resources for adequate trials
• with coverage, little incentive to document
  effectiveness
• Clinical research agenda
• Well-designed studies of test performance
• Head to head studies and modeling
• Funding by industry, NIH, payers, ???